This update summarizes recent enforcement activity, provides an overview of notable legislative and policy developments at the federal and state levels, and analyzes significant court decisions from the first half of the year.

I. Introduction

When the False Claims Act (“FCA”) is not making headlines on the Supreme Court’s docket, the flow of enforcement developments nonetheless remains constant. The first half of 2024 is a reminder that that flow can surge at any moment, bringing with it massive settlements for the government—over $1 billion over six months, in the case of 2024. Meanwhile, as the first half of 2024 also makes clear, there is never a dull moment when it comes to caselaw developments in the lower federal courts, and even when the U.S. Department of Justice (“DOJ”) is not being particularly vocal about its FCA enforcement priorities in speeches and publications, it often is taking steps in other enforcement contexts that have implications for the FCA.

In the first half of 2024, DOJ has continued its focus on FCA matters related to cybersecurity; has initiated pilot programs in criminal enforcement that have implications for qui tam whistleblower incentives; and has concluded settlements across a range of industries and legal theories, with the primacy of settlements in the healthcare industry continuing. Courts have grappled with issues such as FCA causation and the scienter required in FCA cases premised on violations of the Anti-Kickback Statute (“AKS”), and the Supreme Court granted certiorari in a case involving the definition of “claim” under the FCA.

Below, we summarize recent enforcement activity, then provide an overview of notable legislative and policy developments at the federal and state levels, and finally analyze significant court decisions from the first half of the year. Gibson Dunn’s recent publications regarding the FCA may be found on our website, including in-depth discussions of the FCA’s framework and operation, industry-specific presentations, and practical guidance to help companies navigate the FCA. And, of course, we would be happy to discuss these developments—and their implications for your business—with you.

II. Noteworthy DOJ Enforcement Activity During the First Half of 2024

2024 has been a notable half-year for FCA settlements by DOJ: during the first six months of the year, the government announced resolutions totaling over $1 billion.[1] That dollar figure is the highest for the first half of a calendar year—by a significant margin—in recent memory. It also includes two nine-figure settlements, whereas the first half of 2023 included none and the first half of 2022 included only one. While both of those nine-figure settlements grant DOJ claims in the bankruptcy cases of the settling counterparties and the government thus stands to recover significantly less than the settlements’ face values, the fact of resolutions valued at those figures remains a significant development.

Below, we summarize the most notable settlements and judgments from the first half of this year, organized by industry and focused on key theories of liability at issue in the resolutions. As usual, FCA recoveries in the healthcare and life sciences industries dominated enforcement activity during the first half of the year in terms of the number and value of settlements. DOJ, however, also announced notable resolutions in the government contracting and procurement space, described below.

A. Healthcare and Life Science Industries

As usual, the vast majority of FCA recoveries in the first half of 2024 involved entities and individuals in the healthcare and life sciences industries.

• On January 4, a healthcare facility operator in Delaware agreed to pay $42.5 million to resolve allegations that the company provided ancillary service providers—including nurse practitioners and physician assistants—to assist with patients as an inducement to non-employee doctors to refer patients to the company’s hospitals. The complaint alleged that these arrangements violated the AKS and the Stark Law. The allegations underlying the settlement agreement stemmed from a qui tam suit brought by the company’s former chief compliance officer, who will receive an unspecified portion of the recovery.[2]
• On January 4, a Florida non-profit agreed to pay approximately $19.5 million to resolve allegations that it billed federal healthcare programs for items and services used in clinical trial research that it should have billed to non-government sponsors. The organization itself initiated an independent investigation into the alleged behavior and disclosed its findings to the government. The federal government will receive $18.2 million from the settlement, and Florida Medicaid will receive $1.3 million.[3]
• On January 4, a Memphis hospital system agreed to pay $7.25 million to resolve claims that it submitted false claims to Medicare that arose out of improper financial arrangements. Specifically, the government alleged the hospital system had a multi-agreement relationship with a medical clinic, and the hospital system used these various business contracts as a vehicle to pay kickbacks to the clinic to induce it to refer Medicare beneficiaries to the hospital system. The suit resolves a qui tam suit brought by a former president of a hospital within the system and a medical school dean, who will each receive an unspecified portion of the settlement.[4]
• On January 5, an Arizona home health agency agreed to pay nearly $10 million to resolve allegations that it submitted false claims to a healthcare program serving Department of Energy employees and contractors with occupational illness. The government alleged that the agency billed the program for nursing and care services when its employees were not physically present in the patients’ homes. It further alleged that the agency’s “friends and family” program violated the AKS by paying cash and in-kind payments for food, travel, and other expenses in exchange for patient referrals. The agency made a voluntary disclosure to the government regarding its friends and family program and in-kind remuneration, and the settlement agreement acknowledges the agency’s cooperation in this regard. The settlement resolves a qui tam suit brought by a former Corporate Administrator and Director of Human Resource Administration and Management at the agency and its predecessor, who will receive approximately $1.7 million from the settlement.[5]
• On January 10, a New Jersey clinical laboratory and its CEO agreed to pay $13.2 million to resolve allegations that it billed federal healthcare programs for laboratory tests procured through illegal kickbacks. The government alleged that the laboratory obtained referrals through five different kinds of kickbacks, including: (1) commissions paid based on volume and value of referrals to the laboratory through independent contractors; (2) payments disguised as management services organization fees that were actually incentives for laboratory referrals; (3) payments to healthcare providers disguised as consulting or medical director fees in exchange for ordering lab tests; (4) payments to substance abuse recover centers to induce referrals for lab testing; and (5) specimen collection fees to healthcare providers to induce referrals to the laboratory. In addition, the government alleged that the laboratory and CEO submitted claims for tests that were not medically necessary or not otherwise covered by Medicare and Medicaid.[6]
• On January 11, a long-term care hospital agreed to an ability-to-pay settlement requiring it to pay over $18.6 million plus 4.5% interest per year to resolve allegations that the hospital impermissibly claimed excessive cost outlier payments from Medicare. Specifically, the government alleged that the hospital manipulated the cost outlier payment system for supplemental reimbursement by increasing its charges in excess of its costs and beyond what the hospital would be able to repay once Medicare cost reports were reconciled to its charges. In addition to the FCA claim, the settlement involved a $12 million penalty resolving Federal Debt Collection Procedures Act allegations against certain hospital investors for their role in the hospital’s alleged fraudulent transfer of money without equivalence value exchange to its investment management company.[7]
• On January 17, a healthcare company and its owners consented to a $2 million judgment, admitting to FCA violations for using medical staff to submit claims for medically unnecessary care to federal healthcare programs. The government alleged that the company hired vulnerable or inexperienced medical staff and then pressured those staff members to provide unnecessary care, and to submit the claims for that care to federal payors. The government further alleged that the company falsified information to obtain Paycheck Protection Program (PPP) loan forgiveness. The consent agreement resolves allegations under the FCA, AKS, and Controlled Substances Act.[8]
• On January 23, a Philadelphia pharmacy and its current and former owners agreed jointly to pay approximately $3.9 million to resolve allegations that they billed Medicare and Medicaid for medications that were never dispensed from January 2018 through September 2020. The government also alleged that in some cases the pharmacy dispensed low-cost formulations to beneficiaries but billed Medicare for the high-cost versions of the formulations. The pharmacy and its principal pharmacist entered into an integrity agreement requiring them to undertake significant compliance obligations and conduct third-party audits of their Medicare claims and drug inventory through an Independent Review Organization.[9]
• On January 26, a group of durable medical equipment companies agreed to pay $2.1 million to resolve allegations that they submitted false claims to federal healthcare programs by selling used hospital beds as if they were new. The government also alleged the companies upcoded support products and mischaracterized non-reimbursable travel time as repair time in claims for payment made to federal programs and contractors. This settlement resolved a related qui tam suit brought by a former employee, who will receive an undisclosed portion of the settlement amount.[10]
• On January 30, a drug rehabilitation facility and a clinical laboratory agreed to resolve liability for submitting false claims for urine drug testing services to the federal Medicare and Kentucky state Medicaid programs by paying $2.2 million and $4.9 million respectively. The government alleged that the drug rehabilitation facility used the same complex panel of urine drug tests for all patients on a weekly basis, despite the results often not being used for diagnosis or treatment and without considering whether individual patients needed the panel. The clinical laboratory performed the urine tests and billed them to federal and state healthcare programs despite knowing that the tests were not typically used for diagnosis or treatment and also performed additional urine drug screens without proper medical orders requesting the screens. As a part of the settlement, the drug rehabilitation facility entered into a corporate integrity agreement with HHS-OIG, which requires the facility to appoint a compliance officer and retain an independent expert for its compliance program. The clinical laboratory’s share of the settlement will require it to cease operations and pay the United States 100% of the net proceeds of the sale of its assets, along with 70% of reimbursements from healthcare payors for one year and any employee retention tax credit funds received. The settlement resolves a related qui tam suit, with the relator receiving an undisclosed portion of the recovery.[11]
• On February 7, a Pennsylvania multi-hospital system agreed to pay $11.7 million to resolve allegations that it submitted claims to Medicare for services relating to annual wellness visits. The hospital system voluntarily disclosed that it submitted claims that were not supported by the medical record between December 2015 and November 2022. Following its self-disclosure, the government noted, the hospital system took corrective action, although in resolving the case the government did not specify what that action was.[12]
• On February 14, a medical equipment company that rented non-invasive ventilators agreed to pay $25.5 million to resolve allegations that it continued to bill federal health care programs after patients ceased using their devices. Additionally, DOJ alleged that the company failed to confirm that the devices it rented were medically necessary, impermissibly waived coinsurance payments to get more patients to rent their equipment, and paid kickbacks to induce Medicare beneficiaries to rent its equipment. The company admitted it received reimbursement for claims it submitted to federal healthcare programs that did not comply with Medicare billing guidelines. This resolved a related qui tam suit for which the relator will receive an unspecified portion of the proceeds.[13]
• On February 16, a Kentucky toxicology lab and its owner agreed to a nearly $5.6 million judgment for violating the FCA by charging court‑ordered urine tests to Medicare and Medicaid, even though the tests were not medically necessary. The lab’s compliance officer also agreed to a $4.87 million judgment against her for a related scheme in which she solicited urine drug tests from non-medical homeless shelters and charged those tests to Medicare and Medicaid. Both the owner and the compliance officer received prison sentences of 46 months and six months respectively for related criminal charges. Furthermore, the lab, the owner, and the compliance officer will be excluded from federal health care program participation for 20 years. The consent agreements resolve a qui tam suit for which the relator will receive an unspecified portion of the proceeds.[14]
• On February 28, a pharmaceutical manufacturer, DOJ and an ad hoc group of first lien creditors reached a comprehensive settlement of all federal government claims against the manufacturer. The settlement included resolution of FCA claims asserted by DOJ, which were resolved by granting DOJ a $475.6 million general unsecured claim in the manufacturer’s chapter 11 bankruptcy cases. DOJ alleged that the company marketed its opioid drug to providers the company knew prescribed the drug for non-medically accepted indications, and that the company incentivized such targeting through sales goals, employee incentive compensation plans, and employee performance reviews. In resolution of a parallel criminal investigation, the comprehensive settlement also required a debtor affiliate of the manufacturer to plead guilty to a misdemeanor violation of the Food, Drug and Cosmetic Act (“FDCA”) based on allegations that it introduced misbranded drugs into interstate commerce. Altogether the comprehensive settlement encompassed approximately $8 billion of alleged claims asserted by the IRS, the civil and criminal branches of DOJ, and several federal healthcare agencies. Under the terms of the comprehensive settlement, the company made a single $200 million payment in satisfaction of all the government’s claims upon the effective date of its chapter 11 plan of reorganization in April 2024, and the settlement allowed the company’s pharmaceutical business to emerge under such plan.[15] Gibson Dunn represented the first lien ad hoc group, which negotiated the foregoing economic settlement with DOJ, and was intimately involved in all aspects of this comprehensive resolution and its implementation.
• On February 28, a Georgia laboratory and its owner agreed to pay $14.3 million to partially resolve allegations that it submitted false claims to government healthcare programs. In particular, the government alleged that the owner paid independent contractors to recommend that senior living communities order expensive and unnecessary respiratory pathogen panels (RPPs), rather than the COVID-19 tests that the communities initially requested. The contractors also, with the owner’s alleged knowledge, performed COVID-19 tests in senior living communities, but then arranged for the laboratory to submit claims to federal health plans using sham Medicaid diagnosis codes that did not reflect the medical conditions of those receiving the tests. The contractors also allegedly forged physician signatures on RPP order forms. The owner, along with four other people, pleaded guilty to criminal charges connected to the scheme. The federal government will receive $13.9 million from the civil settlement, and Georgia will receive $400,000. The settlement also resolves a qui tam suit for which the relator will receive $2.86 million.[16]
• On March 6, a hospital system in New York agreed to pay $17.3 million to resolve allegations that it paid unlawful kickbacks to doctors at the hospital’s chemotherapy infusion center. The government alleged that the hospital entered into contracts with the physicians that linked the physicians’ compensation to the number of referrals made for services at the chemotherapy center. The settlement agreement also resolves claims that the physicians failed to adequately supervise these services as required by Medicare and Medicaid regulations, in addition to claims under New York’s state FCA statute. The hospital voluntarily disclosed the information to the United States.[17]
• On March 6, a generic pharmaceutical manufacturer agreed to pay $2 million to resolve allegations that it submitted false claims to TRICARE, the VA, the Federal Employees Health Benefits Program, and the Department of Labor Office of Works Compensation Programs. The government alleged that the company sold adulterated pharmaceuticals after failing to follow controls required by manufacturing regulations, which resulted in the submission of false claims. This settlement resolved the civil liability component of a criminal investigation related to the introduction of adulterated drugs into interstate commerce. The company also entered into a plea agreement to resolve the related criminal indictment, pursuant to which it agreed to a three-year deferred prosecution agreement and to pay an additional $1.5 million fine.[18]
• On March 20, two former Philadelphia-based pharmacy employees agreed to pay over $4.1 million to resolve liability under the FCA and Controlled Substances Act for illegally dispensing and distributing controlled substances and engaging in fraudulent billing. Specifically, the government alleged that the former employees dispensed opioids and other “cocktail” drugs in extreme doses and combinations under highly suspicious circumstances, including excessive cash payments and clearly forged prescriptions. The employees also engaged in a scheme using a “BBDF” (“Bill But Don’t Fill”) code to falsely claim to Medicare and other insurers that drugs had been dispensed to patients. The former employees also pled guilty to related criminal charges and were sentenced to several months imprisonment along with receiving permanent bans on dispensing controlled substances. The civil settlement and criminal convictions marked the end of a multi-year investigation into related fraudulent activity at the pharmacy, including activities by its owner and other employees.[19]
• On March 25, a clinical laboratory and its owners agreed to pay approximately $13.6 million and to be excluded from federal health care programs for 15 years to resolve allegations that they submitted Medicare claims for tests that were neither medically necessary nor ordered by healthcare providers. Specifically, the government alleged that the laboratory performed and submitted claims for medically unnecessary urinary tract infection panel of tests by PCR when physicians only ordered a less extensive urinalysis tests as part of an illegal kickback scheme. The laboratory allegedly did so because Medicare reimbursements for the PCR tests were significantly higher than reimbursements for the tests the physicians had ordered. This settlement resolved a related qui tam action brought by a physician who owned health care facilities and served patients for whom the laboratory ran tests. The physician relator will receive approximately $2.3 million of the settlement amount.[20]
• On March 25, a healthcare staffing company agreed to pay approximately $9.3 million to resolve FCA and criminal liability regarding its visa sponsorship program. Specifically, the government alleged the staffing company submitted false visa immigrant applications, provided false job placement letters, and made false statements to government officials while recruiting healthcare professionals into the United States. Along with undertaking extensive remedial efforts in its compliance, the company also pledged an additional $8 million to healthcare projects in an effort to address harms caused by its prior practices. The pledge will be distributed to various NGOs and non-profits involved with ethical recruitment, strengthening healthcare access and infrastructure in certain developing countries and in rural/underserved U.S. communities.[21]
• On March 27, a Georgia teleradiology company and its CEO agreed to pay $3.1 million to settle liability for violations of the FCA and comparable state laws for fraudulently billing federal health care programs. The government alleged that the company’s U.S.-based radiologists failed to adequately review interpretation reports prepared by overseas contractors who were not permitted to practice medicine in the U.S. or bill U.S. federal healthcare programs. The company also misrepresented which medical professionals actually rendered radiology services, and improperly sought reimbursement for services provided by medical professionals outside of the United States. Approximately $2.68 million of the settlement will be paid to the U.S., and the remaining $420,000 will be distributed to various states. The settlement additionally resolves a qui tam suit, but it was not disclosed whether the relators would receive a share of the settlement.[22]
• On April 2, a Texas oncology practice and diagnostic reference laboratory agreed to pay approximately $4 million to resolve allegations that they violated the AKS. The government alleged that the laboratory offered illegal kickbacks in exchange for bone marrow biopsy exams, which induced physicians to order the tests. Furthermore, the government contended that one of the practice’s physicians billed federal and state healthcare programs for medically unnecessary tests and services. This settlement resolved a qui tam suit brought by a former physician at the practice who will receive an unspecified amount. The oncology practice also entered into an integrity agreement for a period of three-years as part of the settlement.[23]
• On April 9, a California-based nursing home chain agreed to pay approximately $7 million to resolve allegations that it submitted claims to Medicare and Medicaid for reimbursement for skilled care that it did not actually provide. The government alleged that the company misused a COVID-19 emergency waiver that removed the three-day hospital stay requirement to receive reimbursement for skilled care for nursing home residents. The company allegedly submitted claims for skilled care reimbursement when residents at the home were merely exposed to COVID-19, rather than infected, and as a result did not actually receive skilled care in the nursing home. The company will pay the federal government approximately $6.8 million and the state of California approximately $242,000, plus interest. The company will also enter a Corporate Integrity Agreement (CIA) with the Department of Health and Human Services, Office of Inspector General (HHS-OIG). The settlement resolves a qui tam suit for which the relators will receive approximately $1.2 million, plus interest.[24]
• On April 24, an Atlanta-based company agreed to pay $2.7 million to resolve allegations that it violated the False Claims Act by failing to implement adequate cybersecurity measures to protect health information obtained through a contract with the Pennsylvania Department of Health to provide staffing for COVID-19 contact tracing. The government alleged that the company transmitted confidential and/or personally identifiable information in unencrypted emails, that it stored and transmitted information through Google files that were not password protected, and that staff used shared passwords to access the information. The government also alleged that the company received complaints for at least five months before the company started remediating the issue. The settlement resolves a qui tam lawsuit brought by a former staff member at the company, who will receive a $499,500 share of the lawsuit.[25]
• On April 25, a healthcare management company and its subsidiaries agreed to pay $4.2 million to resolve allegations that it knowingly submitted false Medicare claims. In particular, the government alleged that the company retained overpayments for hospice care claims when the patients were not terminally ill and therefore ineligible for hospice care. This settlement resolved a qui tam suit brought by a former employee, who received $672,000 of the settlement.[26]
• On May 6, the owner and operator of multiple medical diagnostic and laboratory-related LLCs agreed to pay $27 million to resolve allegations that he and his companies conspired to violate the FCA by submitting false claims to federal healthcare programs for medically unnecessary cancer genomic tests (CGx) procured through illegal kickbacks. In particular, the government alleged that he and his companies conspired with telemarketers to solicit Medicare beneficiaries for CGx tests and conspired with telemedicine providers to prescribe medically unnecessary CGx tests. The government further claimed that he and his companies conspired with reference laboratories that would perform the CGx tests, and with billing laboratories and a hospital to submit claims to Medicare and Medicaid. The Floridian owner and operator previously pled guilty to criminal healthcare fraud related to this same conduct in 2022. As part of this settlement agreement, his companies agreed to be excluded from all federal health care programs. This settlement resolves three related qui tam actions, including one action brought by a minority owner of one of the LLCs, who will receive approximately $4.7 million of the settlement amount.[27] The portion of the settlement that the other relators will receive is not specified.
• On May 8, a Michigan healthcare practice agreed to pay approximately $2 million to resolve allegations that it submitted claims for improperly supervised medical care to Medicare and Medicaid. In particular, the government alleged that the company submitted claims to Medicare and Medicaid for procedures performed by physician assistants in nursing home facilities without the required doctor supervision. The state of Michigan will receive approximately $66,000 from the settlement.[28]
• On May 16, a Massachusetts hospital agreed to pay $24.3 million to resolve allegations that it submitted claims to Medicare for medical treatments that did not comply with Medicare rules about evaluating patient suitability for the prescribed medical treatment. Specifically, the government alleged that the hospital knowingly submitted claims for transcatheter aortic valve replacement (TAVR) procedures without the required number of physicians either examining the patient or documenting their judgment regarding the patient’s suitability for the procedure. As part of the settlement, the hospital will enter into a five-year CIA with HHS-OIG under which an Independent Review Organization will annually review the hospital’s Medicare charges. Because the hospital voluntarily assisted the government during its investigation, the hospital received cooperation credit pursuant to DOJ guidelines. The settlement resolves a qui tam suit for which the relator will receive approximately $4.36 million.[29]
• On May 17, a medical clinic agreed to pay $7.6 million to resolve allegations that it violated the FCA in connection with three federal grant awards for its research. In particular, the government alleged the clinic failed to disclose that the Principal Investigator on each grant was an employee with pending or active grants from foreign institutions who supported that employee’s research and obligated the employee’s time, which violated the National Institute of Health (NIH)’s transparency requirements. The settlement also resolved allegations that the clinic impermissibly allowed its employees to share passwords for access to the NIH grant reporting platform, which resulted in other employees making false submissions in the name of the Principal Investigator without their knowledge. The HHS-OIG, FBI, and two assistant U.S. attorneys collaborated with the U.S. Attorney’s Office for the Northern District of Ohio to resolve these allegations. The clinic agreed to implement a Corrective Action Plan, and NIH imposed specific award conditions for future grants for at least a one-year period or until completion of the Corrective Action Plan.[30]
• On May 20, two New York not-for-profit corporations agreed to pay approximately $10 million to resolve allegations that they submitted false claims to Medicaid for certain long-term care services. The companies administered a Managed Long Term Care Plan (“MLTCP”) for Medicaid beneficiaries, under which they arranged for health and long-term care services and were reimbursed by Medicaid through per-member payments on a monthly basis. As part of the settlement, the companies admitted to collecting payments for the services under the MLTCP that they did not provide or did not adequately document the provision of. The settlement also resolves a qui tam suit brought by a relator. The portion of the settlement that relator will receive is not specified.[31]
• On May 22, a medical device manufacturer and two senior executives agreed to pay $12 million to resolve allegations that they violated the False Claims Act by paying kickbacks to spine surgeons to induce the surgeons to use the company’s spinal devices. According to the government’s allegations, the company provided improper renumeration to spinal surgeons in the form of consulting and other fees, registry payments, performance shares, and travel and lavish dinners. The settlement also resolves a qui tam action brought by a former regional sales director for the company, who will receive an approximately $2.2 million share of the recovery.[32]
• On May 28, three affiliated healthcare companies operating in Florida, Minnesota, and Wisconsin agreed to pay approximately $14.9 million to resolve allegations that they improperly billed Medicare, Medicaid, and TRICARE by knowingly submitting claims for two Evaluation and Management codes that did not support the level of service that the companies actually provided. Under the settlement, the federal government will receive approximately $13.8 million, and the state governments of Florida and Minnesota will receive approximately $1 million. The company must also enter into a five-year CIA with HHS-OIG, which will require the company to establish and maintain a compliance program and submit to an Independent Review Organization’s review of its Medicare claims to ensure that they are medically necessary. The settlement also resolves a qui tam suit for which the relator will receive approximately $2.8 million.[33]
• On June 6, defendants in a New-York ophthalmologist practice agreed to pay approximately $2.5 million to resolve claims that, over a three-year period, they billed federal healthcare programs for medically unnecessary tests and procedures, and services that could not have been performed because the doctor was not in the office at the time the services were purportedly rendered. The government further alleged that the scheme exploited residents in Brooklyn and Queens, many of whom were non-native English speakers or elderly. The settlement agreement resolves two qui tam actions but does not specify the relators’ shares of the recovery.[34]
• On June 11, a Chicago-based nurse practitioner group and its former owners agreed to pay approximately $2 million to resolve allegations that it submitted false claims to Medicare and Medicaid. The government alleged that the company and its owners developed patient charting software that generated false, upcoded claims for Medicare and Medicaid. According to the government’s allegations, the company and its owners required its nurse practitioners to use the software, despite knowing that it resulted in fraudulently upcoded claims being submitted to and paid by Medicare and Medicaid. The settlement also resolves a qui tam lawsuit brought by a former employee, which receive approximately $358,647 as part of the settlement.[35]
• On June 24, medical centers and a medical college in Texas agreed to pay $15 million to resolve claims they billed for concurrent heart surgeries in violation of Medicare teaching physician and informed consent regulations. According to the government’s allegations, three heart surgeons at the medical center ran a regular practice of running two operating rooms at once, delegating key aspects of the surgeries to unqualified medical assistants. The $15 million recovery is the largest settlement to date involving concurrent surgeries. Under the settlement, the qui tam relator will receive approximately $3.1 million.[36]

B. Government Contracting and Procurement

• On January 19, an oil and gas company agreed to pay $34.6 million to resolve allegations it knowingly underpaid royalties owed on oil and gas produced from federal lands. Specifically, the government alleged that the company submitted royalty payments to the federal government based on estimates and subsequently failed to make follow-up payments based on actual volumes and values as required by its agreements with the government. The company received credit under the settlement for cooperation by assisting with the determination of losses.[37]
• On January 30, a technology company agreed to pay $5 million to resolve allegations that it falsely overstated cost and pricing data in a subcontract proposal to the U.S. Army. Specifically, the government alleged that the company overstated its costs to a primary contractor who was negotiating with the Army, and that the primary contractor then relied on those estimated costs when negotiating its contract, leading to significant overcharges. The settlement resolves a related qui tam suit for which the relator will receive $900,000.[38]
• On January 30, a Virginia-based consulting agency and its parent company agreed to pay $3.9 million to resolve allegations that it made false statements about its status as a women-owned small business (WOSB) to obtain a Defense Health Agency contract regarding providing doctors to an Air Force treatment facility that had been set aside for WOSBs. In particular, the government alleged that the consulting company forfeited its WOSBs status when it failed to update its size certifications post-acquisition as required, and when asked by the government’s contracting official. The company was awarded the contract based on the allegedly false representation when it would not have been eligible had it provided correct information. This settlement resolved a qui tam action brought by an entity healthcare and support services provider, which purportedly discovered the misrepresentations through a report it developed to analyze Defense Health Agency contracts.[39] The settlement amount reflects cooperation from the companies during the government’s investigation.[40]
• On March 12, an information and advisory services company agreed to pay $37 million to settle allegations that it violated the FCA and the Financial Institutions Reform, Recovery and Enforcement Act it used data in violation of its government contracts. The government alleged that over a month-long period, the company improperly accessed, retained, and anonymized credit card data it received under various government contracts, which it subsequently used to create proxy data that was incorporated into products and services sold to commercial customers. The company failed to disclose this behavior both to the government and to the commercial clients to whom it sold the products.[41]
• On April 23, a company responsible for managing and operating a National Nuclear Security Administration site agreed to pay $18.4 million to settle liability for overpayments that resulted from production technicians submitting falsified timesheets over a six-year period. The company received credit under the settlement for self-disclosing the misconduct, cooperating with the government’s investigation, and for undertaking remediation efforts (including terminating the personnel who engaged in the misconduct).[42]
• On June 6, a Canadian manufacturer of protective head gear for U.S. military and law enforcement use agreed to pay approximately $2.5 million to resolve claims that it used foreign-sourced materials in its production of helmet inserts in violation of the Berry Amendment. The company sold its products to the U.S. military under the Defense Logistics Agency’s Special Operational Equipment Tailored Logistic Support Program, which requires that textiles be sourced from the United States in compliance with the Berry Amendment. The government initiated an investigation involving the US Department of Defense, the Defense Criminal Investigative Service, and the Department of the Army Criminal Investigation Division after receiving a complaint from the DLA hotline. The settlement amount reflected that the company accepted responsibility, cooperated with the government’s investigation, and implemented compliance measures.[43]
• On June 7, a conglomerate of three medical practice and management groups operating urgent care practices in New Jersey and New York agreed to pay over $12 million to resolve allegations that they submitted false claims for reimbursement of COVID-19 tests to a program that funds COVID-19 testing for uninsured individuals. The government alleged that operators did not adequately confirm whether test recipients had health insurance coverage before submitting their claims to the program, resulting in the erroneous submission of claims for insured persons. It also alleged that the operators caused laboratories to submit false claims for those COVID-19 tests by providing requisition forms that inaccurately indicated the test recipients were uninsured. The operators received credit in the settlement for their voluntary disclosure, cooperation, and remediation efforts. The settlement also resolves a qui tam suit brought by a patient, who will receive approximately $2 million of the settlement.[44]
• On June 17, two consulting companies agreed to settle allegations that they violated the False Claims by failing to meet cyber security requirements as part of the administration of the application system for the Emergency Rental Assistance Program. As part of the settlement, both companies admitted that they failed to satisfy their obligation to complete required cybersecurity testing for the systems. One company agreed to pay $7.6 million and the second agreed to pay $3.7 million as part of the settlement. The settlement also resolves a qui tam lawsuit brought by an entity owned by a former employee of one of the companies, which will receive a share of approximately $1.9 million of the settlement.[45]
• On June 21, two Wisconsin and Connecticut-based aerospace and parts companies agreed to pay $70 million to resolve False Claims Act allegations that they overcharged the Navy for spare parts and materials needed to repair and maintain Navy aircrafts. According to the government’s allegations, the two companies, which were both wholly-owned subsidiaries of the same parent company, knowingly entered into a contract under which one would purchase parts from the other at a markup. The purchasing company then submitted cost vouchers to the Navy for reimbursement. The settlement also resolves a qui tam suit but does not specify the relator’s share of the recovery.[46]

C. Other

• On January 31, an automobile accessory company agreed to pay $3 million to resolve allegations that it knowingly failed to pay antidumping and countervailing duties on materials it imported from China. In particular, the government alleged that the company failed to take any action after being informed that it was not paying the appropriate duties on extruded aluminum components from January 2012 through July 2021. This resolved a qui tam action brought by a former employee who will receive $510,000 plus $75,000 in legal fees as part of the settlement.[47]
• On February 29, two individuals in Colorado agreed to pay $3.5 million to resolve allegations that they defrauded the federal government by tampering with rain gauges. The government alleged that the two individuals were part of a conspiracy to tamper with the rain gauges by various means in order to make it appear as though there was below-average rainfall. Doing so would allow them to take advantage of a federal program that pays indemnities to farmers when there is below-average precipitation. In addition to civil penalties, the two individuals pled guilty to criminal charges for which they received prison sentences and were ordered to pay an additional $3.1 million in restitution. The settlement also resolves a qui tam suit for which the relator’s estate will receive approximately $500,000.[48]
• On March 13, a construction company agreed to pay $2.5 million plus interest to resolve allegations that it violated FCA by taking out EIDL and PPP loans that it was not entitled to. Specifically, the government alleged that the company’s owner falsely certified in loan applications that he had not been convicted of a felony involving fraud within the last five years even though he had pled guilty and was convicted of a fraud-related felony charge less than three years before the first loan application. This settlement also resolves a qui tam suit for which the relator will receive approximately $250,000.[49]
• On March 21, a New Jersey chemical importer and its owner agreed to pay $3.1 million to resolve claims that it fraudulently underpaid customs duties. In particular, the government alleged that the importer conspired with a Chinese vendor to mislabel imported chemicals, including hazardous chemicals, and submitted falsified documents to customs brokers. This settlement also resolves a qui tam suit for which the relator will receive $600,000. The company’s owner additionally pled guilty to wire fraud.[50]
• On May 2, a German airline and its Minneapolis-based subsidiary agreed to pay $26.8 million to resolve allegations that it failed to remit to the federal government mandatory travel fees that the airline collected from passengers. In particular, the government alleged that from 2012 to 2018, the company collected fees such as those owed to U.S. Customs and TSA but did not pay those fees to the appropriate government entities. The settlement resolved a qui tam lawsuit for which the relator will receive approximately $4.8 million.[51]
• On May 7, a now-bankrupt lender agreed to pay up to $120 million over two settlements to resolve allegations that it submitted false claims for loan forgiveness, loan guarantees, and processing fees to the government under PPP. Under the first settlement, the company agreed to pay up to $63.2 million to resolve allegations that the company inflated PPP loans, causing the Small Business Administration to guarantee and forgive greater loan amounts than borrowers were entitled to receive. And, under the second settlement, the company agreed to pay up to $56.7 million to resolve allegations that the company knowingly failed to implement adequate fraud controls to comply with its regulatory obligations to prevent fraudulent borrowers from seeking PPP benefits. Because the settlement gives the government an unsecured bankruptcy claim, the ultimate settlement amount will depend on the lender’s overall assets. The settlement resolves two qui tam actions for which the relators will receive a portion of the proceeds.[52]
• On June 12, multiple nonprofit organizations, including two private country clubs and two homeowners associations, paid approximately $5.8 million to settle allegations that they violated the False Claims Act by knowingly submitting false claims and obtaining PPP loans for which they were not eligible. The settlements also resolved a qui tam action for which the relator will receive approximately $700,000 of the total recovery.[53]
• On June 20, four restaurants, two fur apparel distributors, and five individuals agreed to pay approximately $4.6 million to settle allegations that they inflated payroll figures in their PPP loan and forgiveness applications. According to the government, the defendants misrepresented that family members and acquaintances were employed by the businesses, listed the same individuals as “full-time employees” of multiple businesses, inflated payroll figures, and improperly sought loan forgiveness for payroll costs that exceeded the maximum allowed. The settlement also resolved a qui tam lawsuit brought by a former manager at two of the restaurants, but does not specify what, if any, portion of the recovery he will receive.[54]

III. Cyber-Fraud Initiative Updates

The first half of 2024 witnessed notable developments in DOJ’s Civil Cyber-Fraud Initiative, an effort we reported on in our 2023 Year-End Update. The Initiative, launched on October 6, 2021, aims to use the FCA to pursue cybersecurity-related fraud by government contractors and grant recipients that are “knowingly providing deficient cybersecurity products or services, knowingly misrepresenting their cybersecurity practices or protocols, or knowingly violating obligations to monitor and report cybersecurity incidents and breaches.”[55] In February 2024, Principal Deputy Assistant Attorney General Brian Boynton emphasized that DOJ “will continue to dedicate resources to investigating companies that fail to comply with their cybersecurity obligations.”[56]

A. DOJ Intervenes in First-Of-Its-Kind Cybersecurity Suit Since Launch of Civil Cyber-Fraud Initiative

In the same month in which DOJ re-emphasized its commitment to cybersecurity enforcement, DOJ intervened in a first-of-its-kind qui tam lawsuit, alleging that the Georgia Institute of Technology and Georgia Tech Research Corporation failed to comply with mandatory cybersecurity controls in their Department of Defense (DOD) contracts. In United States ex rel. Craig v. Georgia Tech Research Corporation, et al., the Associate Director of Cybersecurity at Georgia Tech and Principal Information Security Engineer brought the suit in July 2022 against research organizations for allegedly failing to secure and interact with government information and data under standards by the National Institute of Standards and Technology (NIST).

DOD contractors must comply with DFARS 252.204-7012 (“Safeguarding Covered Defense Information and Cyber Incident Reporting”), which requires contractors provide “adequate security” to safeguard the defense information they handle during the course of their work for the DOD. In turn, “adequate security” is defined, at a minimum, as implementation of NIST Special Publication 800-171 (NIST SP 800-171), which has 110 security requirements relating to, among other things, identification and authentication measures; audit and accountability; and system and communications protection measures. The lawsuit alleges that defendants’ internal assessors assigned to determine compliance with NIST were not qualified, and they were pressured interpret the NIST controls to justify certain actions taken in labs as compliant.

The government’s deadline to serve defendants with a complaint-in-intervention is August 22, 2024.

B. Potential Civil Cyber-Fraud Initiative Case on Stay

Similarly, in our 2023 Year-End Update we also reported on an unsealed qui tam complaint against Penn State by a relator who alleged that the university submitted false cybersecurity certifications to DOD. Following a 90-day stay to allow the government additional time to determine whether it will intervene, the parties’ joint written status report updating the court on any developments is due by August 5, 2024.[57]

IV. Legislative and Policy Developments

A. Federal Policy and Legislative Developments

1. Proposed Revisions to Medicare Overpayment Rules

On July 10, 2024, the Centers for Medicare and Medicaid Services (“CMS”) issued a proposed rule regarding the Physician Fee Schedule (“PFS”), which governs Medicare payments for the services of physicians and other healthcare professionals.[58] While changes to the PFS were the headline purpose of the proposed rule, the rule also would bring about significant changes to existing provisions governing healthcare providers’ return of overpayments under Medicare Parts A and B. By way of context, the Affordable Care Act (“ACA”) requires providers to return overpayments to the government within 60 days of the date on which the overpayments are “identified,” and specifies that an overpayment not returned by the appropriate deadline counts as an “obligation” for purposes of the reverse FCA, which prohibits knowing and improper avoidance of an obligation to pay money to the government.[59]

The ACA does not specify what it means to “identify” an overpayment.[60] As originally promulgated, regulations governing the return of overpayments by the Medicare program stated that a provider “identifies” an overpayment when it “has determined, or should have determined through the exercise of reasonable diligence, that [it] has received an overpayment.”[61] In a proposed rule issued in late 2022, CMS proposed to replace this looser standard of knowledge with the relatively more stringent definition of “knowing” and “knowingly” contained in the FCA.[62] This change came in direct response to a district court decision that struck down the “reasonable diligence” standard as permitting the government to premise FCA liability on nothing more than negligence, when the FCA requires a minimum of reckless disregard.[63] That decision and CMS’s response to it, however, left unaddressed a core problem confronting large organizations that face overpayment risks—namely, that it can take much longer than 60 days to determine whether an overpayment has occurred, and the running of that clock without any action to return monies to the government is very often a sign that a good-faith investigation into potential overpayments remains underway, not that overpayments were quickly identified and are being concealed. CMS had previously acknowledged that internal investigations into potential overpayments could take around 180 days, but there was neither a requirement that such investigations be completed in that timeframe nor an explicit provision tolling the deadline for return of overpayments pending such investigations.[64]

The new proposed rule would permit the suspension of the 60-day clock to allow companies to conduct internal investigations, but the devil remains in the details. In particular, in order for the deadline to be suspended, a company would have to have already identified at least one overpayment and be in the midst of a “good-faith investigation to determine the existence of related overpayments,” and would have to actually conduct such a good-faith investigation.[65] And the deadline for returning overpayments would only be suspended until, at the latest, 180 days after the date on which the company identified the initial overpayment that triggered the broader investigation.[66] While these changes enhance incentives for companies to conduct investigations into potential overpayments by extending the reporting deadline pending the completion of such investigations, the reality is that even 180 days may prove an insufficient amount of time for such investigations to fully run their course in large companies. The 180‑day cutoff risks being weaponized by qui tam relators claiming that any investigation that takes longer than 180 days must not have been conducted in “good faith” under the new rule, and that thus any overpayments not returned after the expiration of the 180-day window should form the basis for reverse FCA liability.

CMS is accepting comments on the proposed rule until September 9, 2024.

2. DOJ Whistleblower Reward Program and Voluntary Self-Disclosures Pilot Program for Individuals

Qui tam cases account for the majority of FCA cases initiated in any given year, as well as for the bulk of the monies the government recovers from FCA matters through settlement or judgment. In 2023, qui tam cases represented about 59% of the new FCA cases filed, and about 87% of the recoveries obtained. The FCA qui tam framework has no counterpart in U.S. criminal statutes, but DOJ recently has taken steps to develop a more formal policy for whistleblower awards in the criminal context. In March 2024, DOJ announced the creation of a pilot program that would reward a whistleblower with a portion of the resulting forfeiture if he or she helps DOJ discover significant corporate or financial misconduct.[67] In announcing this program, DOJ noted the successes of similar programs created at the SEC, CFTC, IRS, and FinCEN but acknowledged that those programs were limited to misconduct within those agencies’ jurisdictions. DOJ also noted that qui tam whistleblower initiatives are limited to those actions where fraud against the government is alleged. Thus, DOJ’s new initiative would “fill[] these gaps” to “address the full range of corporate and financial misconduct that the Department prosecutes.”[68]

While details on this pilot program are still forthcoming, the announcement identified important “guardrails.”[69] Payments would be made (1) only after all victims have been properly compensated; (2) only to those who submit truthful information not already known to the government; (3) only to those not involved in the criminal activity itself; and (4) only in cases where there is not an existing financial disclosure incentive—including qui tam awards or an award under another federal whistleblower program.[70] Deputy Attorney General Monaco also told potential future whistleblowers that DOJ was especially interested in information regarding “[c]riminal abuses of the U.S. financial system; [f]oreign corruption cases outside the jurisdiction of the SEC, including FCPA violations by non-issuers and violations of the recently enacted Foreign Extortion Prevention Act; and [d]omestic corruption cases, especially involving illegal corporate payments to government officials.”[71]

Relatedly, in April 2024, DOJ’s Criminal Division announced a pilot program that would extend the benefits of voluntary self-disclosure to individuals who (1) voluntarily, (2) truthfully, and (3) completely self-disclose original information regarding misconduct that was unknown to the department in certain high-priority enforcement areas, (4) fully cooperate and are able to provide substantial assistance against those equally or more culpable, and (5) forfeit any ill-gotten gains and compensate victims.[72] To qualify, a disclosure must relate to at least one of six areas of DOJ focus:

• Schemes involving financial institutions (g., money laundering, criminal compliance-related schemes);
• Schemes relating to the integrity of financial markets involving financial institutions, investment advisors or funds, or public or large private companies;
• Foreign corruption schemes (e.g., violations of the Foreign Corrupt Practices Act, Foreign Extortion Prevention Act, and associated money laundering);
• Health care fraud and kickback schemes;
• Federal contract fraud schemes; or
• Domestic corruption schemes involving bribes or kickbacks paid by or through public or private companies.

Deputy Attorney General Lisa Monaco noted that at least two U.S. Attorney’s offices—in the Southern District of New York and the Northern District of California—established similar programs earlier in the year.[73]

Beyond their significance for DOJ’s criminal enforcement efforts, these developments have important implications for FCA practice as well. Because the FCA penalizes fraud, the conduct at issue in an FCA investigation can sometimes be of interest to criminal authorities too. Yet the risks for a would-be whistleblower in coming forward are magnified when the alleged conduct carries potential criminal, in addition to civil, liability. In such a scenario, the possibility that DOJ will decide the relator has unclean hands carries not just the potential for criminal liability, but also the prospect of outright denial of a qui tam award. The FCA explicitly provides that a relator who is “convicted of criminal conduct arising from his or her role in the [FCA] violation . . . shall be dismissed from the civil action and shall not receive any share of the proceeds of the action.”[74] The new criminal whistleblower pilot program creates an additional financial incentive for reporting misconduct that operates independently of the qui tam mechanism. Alongside that pilot program, the individual voluntary self-disclosure pilot program stands to remove the disincentive that otherwise exists in the form of qui tam award denial in the event of a criminal conviction. Relators may prove more forthcoming about alleged conduct and their own roles in it, if both non-prosecution and financial gain remain on the table. And the carve-out in the pilot whistleblower program for individuals already covered by another whistleblower regime will likely do little to stop relators from making simultaneous reports to both civil and criminal authorities in the hope of maximizing their chances of a recovery.

B. State Legislative Developments

There were no major developments with respect to state FCA legislation in the second half of 2022. HHS-OIG provides an incentive for states to enact false claims statutes in keeping with the federal FCA. If HHS OIG approves a state’s FCA, the state receives an increase of 10 percentage points in its share of any recoveries in cases involving Medicaid. The lists of “approved” state false claims statutes increased to 23 with the approval of Connecticut’s statute this year; while six states remain on the “not approved” list.[75] The other 21 states have either not enacted a state analogue or have not submitted the statue for approval.

V. Case Law Developments

A. U.S. Supreme Court Grants Certiorari in E-Rate Fraud Claims Case

In June, the Supreme Court granted a petition for a writ of certiorari filed by Wisconsin Bell on the question whether reimbursement requests submitted to the Federal Communications Commission’s E-rate program are “claims” under the FCA. See United States ex rel. Heath v. Wis. Bell, 92 F.4th 654, 657 (7th Cir. 2024), cert. granted, 2024 WL 3014477 (U.S. June 17, 2024). The $4.5 billion E-rate program, established under the Telecommunications Act of 1996, provides discounted services to eligible schools and libraries for which service providers competitively bid on pricing and subsidize cost of service. It is funded by private money and administered by a non-profit company. (Note: Gibson Dunn represents Wisconsin Bell in this matter.)

After relator Todd Heath alleged in 2008 that Wisconsin Bell violated the FCA by over-charging schools and libraries, causing the federal government to pay more than it should have, id. at 658, Wisconsin Bell argued that the relator could not satisfy the FCA because, among other things, the E-rate program does not involve government funds, and reimbursement requests are not “claims” within the meaning of the FCA. The district court granted summary judgment for Wisconsin Bell, holding that the relator had not established falsity, scienter, or harm to the government fisc. Id. The Seventh Circuit reversed the district court’s grant of summary judgment. Id. at 671. By reinstating the relator’s claims, the Seventh Circuit created a circuit split with the Fifth Circuit, which had previously held that the FCA does not apply to E-Rate reimbursement requests because the government lacks a financial stake in the allegedly lost funds. See generally United States ex rel. Shupe v. Cisco Sys., Inc., 759 F.3d 379, 388 (5th Cir. 2014).

The certiorari petition was granted on June 17, and oral argument is set for November 4, 2024.

B. The Seventh Circuit Remands on Causation and Upholds Damages Award Against Eighth Amendment Challenge

The Seventh Circuit heard argument in Stop Ill. Health Care Fraud, LLC v. Sayeed, 100 F.4th 899 (7th Cir. 2024) on the FCA causation issue but declined to take a position and remanded to the district court for further argument.

In Stop Ill. Health Care Fraud, Management Principles Inc. (“Management Principles”), a healthcare management company which provided home-based medical services to Medicare recipients, as well as its two subsidiaries and owner, faced AKS allegations for paying Healthcare Consortium of Illinois (“Healthcare Consortium”) $5,000 monthly in exchange for patient referrals. Id. at 902–03. The company allegedly relied on referrals from Healthcare Consortium, a healthcare diagnostic organization, that would refer seniors to local in-home healthcare providers. Id. Management Principles allegedly paid this organization $90,000 for referrals and access to client data, and allegedly billed the federal government over $700,000 for services provided to clients referred by Healthcare Consortium. Id. at 903. Following a bench trial, the district court found that this scheme violated the AKS by paying to induce referrals for medical services. Id. at 904. The district court also found the defendants liable under the FCA for submitting claims for payments stemming from an unlawful referral arrangement. Id. The district court imposed a judgment of nearly $6,000,000, comprised of the sum of per-claim penalties of $5,500 per claim and treble the value of the Medicare claims at issue. Id. The defendants appealed, challenging causation and the award of damages and penalties, “arguing that it [was] constitutionally excessive under the Eighth Amendment and improperly divorced form the actual loss incurred by the government.” Id. at 906.

The Seventh Circuit held the “resulting from” language in the AKS means “at a minimum, every claim that forms the basis of FCA liability must be false by virtue of the fact that the claims are for services that were referred in violation of the Anti-Kickback Statute.” Id. at 908. The court explained that it was “not able to determine with confidence whether any of the services represented in the plaintiff’s loss spreadsheet were provided to patients lawfully referred to the defendants by the [Healthcare] Consortium.” Id. at 909. The court remanded the case back to the district court for the limited task of determining which claims, if any, were the result of a referral process outside the kickback scheme. Id. at 909–10. Thus, in doing so, the Seventh Circuit declined to weigh in conclusively on the proper causation standard for AKS-predicated FCA claims, id. at 909, leaving the Seventh Circuit without a definitive position on either side of the deepening circuit split on this issue, which we covered in our 2023 Mid-Year and End-Year Updates. In declining to take a position, however, the Seventh Circuit signaled that, if it does take a side in the debate, it is unlikely to hold that the existence of a kickback “taints” all subsequent claims for payment, regardless of any causal connection between the kickback and the claims. The court made clear that “[t]hat broad suggestion . . . is inconsistent with [the FCA’s] directive that a false claim must ‘result[] from’ an unlawful kickback.” Id. (second alteration in original). We will continue to closely monitor developments around this issue, including as the related Regeneron case in the First Circuit proceeds to oral argument this summer.

Additionally, the Seventh Circuit also addressed whether the nearly $6 million judgment was unconstitutionally excessive under the Eight Amendment. The court held that the judgment did not violate the Eighth Amendment’s Excessive Fines Clause, but that the district court still erred by calculating those damages based on Medicare claims that might not have been related to the kickback scheme. Id. at 906–07. The court explained that while the Seventh Circuit has not explicitly held whether the Excessive Fines Clause applies to civil penalties under the FCA, the judgment in this particular case would not violate the clause even if it were to apply. Id. The Seventh Circuit held that because the defendants established an extensive scheme that defrauded the government, exploited the private health information of seniors, and undermined the public’s faith in government programs, the judgment was not “grossly disproportional to the gravity of the defendant’s offense,” thereby passing Eighth Amendment scrutiny. Id..

C. The Sixth Circuit Holds Courts Can Require Plaintiffs Take All Reasonable Steps to Dismiss an FCA Suit, Including Seek Government Consent

A relator cannot unilaterally settle FCA claims without the government’s consent. See 31 U.S.C. § 3730 (requiring the government’s consent to any voluntary dismissal of a qui tam case). In State Farm Mut. Auto. Ins. Co. v. Angelo, the Sixth Circuit clarified what steps a court can require a party take to dismiss a FCA suit. 95 F.4th 419 (6th Cir. 2024).

After State Farm sued Michael Angelo, alleging RICO violations, the parties entered into a settlement agreement. Id. at 424. In the agreement, Angelo agreed to take “all steps necessary” to release claims against State Farm. Id. Before the agreement was signed, Angelo filed an FCA suit against State Farm. Id. Because qui tam suits are required to be filed under seal, State Farm was unaware of the case until after the RICO settlement agreement was signed and the complaint was unsealed and served on State Farm. Id. In the ensuing litigation over State Farm’s motion to dismiss the FCA claims, Angelo argued that he could not dismiss the claims because the FCA prohibits relators from dismissing qui tam cases without the government’s consent. Id. at 425. The district court granted State Farm’s motion, ordering Angelo to take all steps necessary to dismiss his FCA claims, including seeking the necessary government consent. Id.

On appeal, the Sixth Circuit upheld the district court’s orders enforcing the RICO settlement agreement. The court explained that while “the FCA statute demands government consent before a qui tam relator can dismiss an FCA claim[,]” the law does not “prevent[] a relator from seeking the required consent or prohibit[] a district court from ordering a relator to seek such consent.” Id. at 429–30 (emphasis in original). The Sixth Circuit rejected Angelo’s argument that under this interpretation, the settlement agreement violates the public policy rationale behind the FCA. Id. at 430. The court held that the “primary goals of the FCA are to incentivize private individuals to bring suit and to alert the government to potential fraud,” goals which the RICO settlement did not undermine. Id. Because Angelo had filed the FCA suit two years before the settlement was signed, both Angelo and the government had ample time to investigate the claims. Id. at 431. The court further explained that even if there had not been ample time, the government still had the opportunity to deny consent to dismiss or to file its own FCA claims, as it was not a party to the RICO settlement and thus was not bound by agreement requiring Angelo to take steps to effectuate dismissal of the qui tam case. Id. at 432.

D. The Second Circuit Clarifies When a Worker Engages in “Protected Activity”

The FCA prohibits retaliation against employees who report potential FCA violations. See 31 U.S.C. § 3730(h)(1). In Pilat v. Amedisys, Inc., workers claimed they were fired in retaliation for raising concerns about certain practices of Amedisys, a home health and hospice company. No. 23-566, 2024 WL 177990 (2d Cir. Jan. 17, 2024). The workers alleged that they disclosed to superiors that Amedisys falsely certified unqualified patients for home care, provided unnecessary and improper treatment, falsified time records, and manipulated patient records. Id. at *1. These schemes allegedly resulted in fraudulent bills to the government for reimbursement under the Medicare and Medicaid programs. Id. The workers alleged that after they expressed concerns over the unethical nature of these practices and their effects on the health of patients and refused to comply with instructions to carry out these practices, Amedisys fired them. Id. at *1–2. The district court held that the Plaintiffs did not have a valid retaliation claim since they did not “engage in protected activity under the statute.” Id. at *1. The court explained that the complaints were “more appropriately characterized as concerns about patient care[,]” and “did ‘not have anything to do with potential false claims.’” Id. at *9 (citing United States v. Amedisys, No. 17-CV-136, 2023 WL 2481144, at *9 (W.D.N.Y. Mar. 13, 2023)).

The Second Circuit reversed and explained that “relators engage in protected activity if they engage in ‘efforts to stop 1 or more violations of’ the FCA.” Pilat, 2024 WL 177990 at *2 (quoting 31 U.S.C. § 3730(h)(1)). Such efforts can include raising concerns to supervisors or refusing to engage in violative practices. Id. Because in this case the workers refused to comply with instructions to engage in conduct that would have violated the FCA, they made “efforts to stop 1 or more violations,” even if their main concern was the safety of patients. Id. The court further rejected the district court reasoning that the Plaintiffs only raised concerns of patient care, not fraud. Even if the complaints were based on concerns of patient care, the Plaintiffs still raised concerns that the amounts billed to the government did not match the actual time spent treating patients, a concern which clearly implicated potential fraud. Id.

E. The Second Circuit Affirms Heightened Scienter Under the Anti-Kickback Statute

While the FCA is a civil statute, DOJ and relators often allege that violations of the AKS—a criminal statute—are what made certain claims for payment false. The two statutes contain different scienter requirements. The FCA imposes liability on any person who “knowingly presents . . . a false or fraudulent claim [to the government] for payment or approval.” 31 U.S.C. § 3729(a)(1)(A). The FCA defines “knowingly” to mean that a person (1) “has actual knowledge of the information,” (2) “acts in deliberate ignorance of the truth or falsity of the information,” or (3) “acts in reckless disregard of the truth or falsity of the information,” and “require[s] no proof of a specific intent to defraud.” 31 U.S.C. § 3729(b)(1)(A-B). The Supreme Court recently clarified that the FCA’s “knowingly” standard refers to the defendant’s knowledge and subjective beliefs, not what an objectively reasonable person might have known or believed. United States ex rel. Schutte v. SuperValu Inc., 143 S. Ct. 1391, 1404 (2023). The AKS, on the other hand, imposes liability on any person who “knowingly and willfully makes or causes to be made any false statement or representation of a material fact in any application for any benefit or payment under a Federal health care program.” 42 U.S.C. § § 1320a–7b. In United States ex rel. Hart v. McKesson Corp., the Second Circuit affirmed a key decision interpreting the willfulness requirement in cases where an FCA violation is premised on a violation of the AKS. 96 F.4th 145 (2d Cir. 2024).

Plaintiffs alleged that Defendants operated an illegal kickback scheme in violation of the AKS and the FCA. Id. at 150. According to the complaint, McKesson offered business management tools for free to customers who agreed to solely purchase drugs from McKesson. Id. at 151–52. Plaintiffs alleged that this scheme violated the AKS and thus the FCA. Id. The district court granted McKesson’s motion to dismiss, holding that to act “willfully” as required by the AKS, “a defendant must act knowing that its conduct is, in some way, unlawful,” a standard Hart failed to plead. Id. at 150. The district court held that because the FCA claim was premised on the AKS claims alone, the defendant failed to plausibly allege an FCA claim. Id.

The Second Circuit affirmed and interpreted the AKS’s “willful” requirement to mean that “a defendant must act with a ‘bad purpose’” and “‘with knowledge that his conduct was unlawful.’” Id. at 157 (quoting Bryan v. United States, 524 U.S. 184, 191 (1998)). The court held that “to violate the AKS, a defendant must act knowing that his conduct is unlawful, even if the defendant is not aware that his conduct is unlawful under the AKS specifically.” Id. at 154 (citing Pfizer v. U.S. Dep’t of Health & Hum. Servs., 42 F.4th 67, 77 (2d Cir. 2022)). The court held that “a defendant’s knowledge of his general legal obligations is not enough if he does not also know that his actions violate those obligations,” id. at 158, and affirmed the dismissal of Hart’s claim for failure to plead willfulness adequately, id. at 157–59. Notably, the Second Circuit looked to the specific knowledge of individuals other than the relator when determining whether the Plaintiff adequately pleaded willfulness. Id. at 160–62 (rejecting relator’s argument that he sufficiently alleged scienter because he pleaded that he told a supervisor that he thought certain conduct violated company policies).

VI. Conclusion

We will monitor these developments, along with other FCA legislative activity, settlements, and jurisprudence throughout the year and report back in our 2024 False Claims Act Year-End Update, which we will publish in early 2025.

[1] These figures, and the summaries that follow, cover the period from January 1, 2024 through June 30, 2024 and focus on settlements valued at $2 million or more.

[2] See Press Release, U.S. Atty’s Office for the Dist. of Del., ChristianaCare Pays $42.5 Million To Resolve Health Care Fraud Allegations (Jan. 4, 2024), https://www.justice.gov/usao-de/pr/christianacare-pays-425-million-resolve-health-care-fraud-allegations-0.

[3] See Press Release, U.S. Atty’s Office for the Middle Dist. of Fl., Florida Research Hospital Agrees To Pay More Than $19.5 Million To Resolve Liability Relating To Self-Disclosure Of Improper Billing For Clinical Trial Costs (Jan. 4, 2024), https://www.justice.gov/usao-mdfl/pr/florida-research-hospital-agrees-pay-more-195-million-resolve-liability-relating-self.

[4] See Press Release, U.S. Atty’s Office for the Middle Dist. of Tenn., Memphis-Based Methodist Le Bonheur Healthcare and Methodist Healthcare-Memphis Hospitals Pay $7.25 Million to Settle Allegations that They Violated the False Claims Act (Jan. 4, 2024), https://www.justice.gov/usao-mdtn/pr/memphis-based-methodist-le-bonheur-healthcare-and-methodist-healthcare-memphis.

[5] See Press Release, Dep’t of Justice, Home Healthcare Company Agrees to Pay Nearly $10 Million to Resolve False Claims Act Allegations Relating to Its Participation in the Energy Employees Occupational Illness Compensation Program (Jan. 5, 2024), https://www.justice.gov/opa/pr/home-healthcare-company-agrees-pay-nearly-10-million-resolve-false-claims-act-allegations.

[6] See Press Release, Dep’t of Justice, New Jersey Laboratory and Its Owner and CEO Agree to Pay Over $13 Million to Settle Allegations of Kickbacks and Unnecessary Testing (Jan. 10, 2024), https://www.justice.gov/opa/pr/new-jersey-laboratory-and-its-owner-and-ceo-agree-pay-over-13-million-settle-allegations.

[7] See Press Release, U.S. Atty’s Office for the Dist. of N.J., New Jersey Hospital and Investors to Pay United States $30.6 Million for Alleged False Claims (Jan. 16, 2024), https://www.justice.gov/usao-nj/pr/new-jersey-hospital-and-investors-pay-united-states-306-million-alleged-false-claims#:~:text=Alleged%20False%20Claims-,New%20Jersey%20Hospital%20and%20Investors%20to%20Pay%20United,Million%20for%20Alleged%20False%20Claims&text=NEWARK%2C%20N.J.%20%E2%80%93%20A%20New%20Jersey,violations%2C%20U.S.%20Attorney%20Philip%20R.

[8] See Press Release, U.S. Atty’s Office for the Dist. of Idaho, AmeriHealth Clinics Consent to a $2 Million Judgment to Resolve Healthcare Fraud Allegations (Jan. 17, 2024), https://www.justice.gov/usao-id/pr/amerihealth-clinics-consent-2-million-judgment-resolve-healthcare-fraud-allegations.

[9] See Press Release, U.S. Atty’s Office for the Dist. of Pa., Current and Former Owners of Center City Philadelphia Pharmacy Agree to Pay Over $4.6 Million to Resolve Civil Investigations of Improper Medicare and Medicaid Billing (Jan. 23, 2024), https://www.justice.gov/usao-edpa/pr/current-and-former-owners-center-city-philadelphia-pharmacy-agree-pay-over-46-million.

[10] See Press Release, U.S. Atty’s Office for the Dist. of S.C., Durable Medical Equipment Companies to Pay Millions in False Claims Settlement (Jan. 26, 2024), https://www.justice.gov/usao-sc/pr/durable-medical-equipment-companies-pay-millions-false-claims-settlement.

[11] See Press Release, U.S. Atty’s Office for the Eastern Dist. of Ky., Kentucky Lab Agrees to $4.9 Million Civil Judgment and Drug Treatment Center Enters Settlement to Pay $2.2 Million to Resolve False Claims Act Allegations (Jan. 30, 2024), https://www.justice.gov/usao-edky/pr/kentucky-lab-agrees-49-million-civil-judgment-and-drug-treatment-center-enters.

[12] See Press Release, U.S. Atty’s Office for the Mid. Dist. of Pa., Penn State Health Agrees To Pay More Than Eleven Million Dollars Following Its Voluntary Disclosure Of Improper Billings Related To Medicare Annual Wellness Visit Services (Feb. 7, 2024), https://www.justice.gov/usao-mdpa/pr/penn-state-health-agrees-pay-more-eleven-million-dollars-following-its-voluntary.

[13] See Press Release, U.S. Atty’s Office for the Southern Dist. of N.Y., U.S. Attorney Announces $25.5 Million Settlement With Durable Medical Equipment Supplier Lincare Inc. For Fraudulent Billing Practices (Feb. 15, 2024), https://www.justice.gov/usao-sdny/pr/us-attorney-announces-255-million-settlement-durable-medical-equipment-supplier.

[14] See Press Release, U.S. Atty’s Office for the Eastern Dist. of Ky., Lexington Lab Agrees to $10.4 Million in Civil Judgments to Resolve False Claims Act Allegations; Owner and Lab Officer Sentenced to Prison (Feb. 16, 2024), https://www.justice.gov/usao-edky/pr/lexington-lab-agrees-104-million-civil-judgments-resolve-false-claims-act-allegations.

[15] See Press Release, U.S. Dep’t of Justice, Opioid Manufacturer Endo Health Solutions Inc. Agrees to Global Resolution of Criminal and Civil Investigations into Sales and Marketing of Branded Opioid Drug (Feb. 29, 2024), https://www.justice.gov/opa/pr/opioid-manufacturer-endo-health-solutions-inc-agrees-global-resolution-criminal-and-civil; Settlement Agreement, Endo Health Solutions Inc., https://content.govdelivery.com/attachments/USDOJOPA/2024/02/29/file_attachments/2799079/Endo%20Civil%20FCA%20Settlement%20Agmt%20%28Fully%20Executed%29.pdf.

[16] See Press Release, U.S. Atty’s Office for the Northern Dist. of Ga., Georgia Laboratory Owner Pleads Guilty to Felony Charge and Agrees to Pay $14.3 Million to Resolve False Claims Act Allegations (Feb. 28, 2024), https://www.justice.gov/usao-ndga/pr/georgia-laboratory-owner-pleads-guilty-felony-charge-and-agrees-pay-143-million; Settlement Agreement, U.S. Dep’t of Justice and Capstone Laboratories (Feb. 28, 2024), https://www.justice.gov/opa/media/1340321/dl?inline.

[17] See Press Release, U.S. Atty’s Office for the Eastern Dist. of N.Y., New York-Presbyterian/Brooklyn Methodist Hospital Settles Health Care Fraud Claims for $17.3 Million (Mar. 12, 2024), https://www.justice.gov/usao-edny/pr/new-york-presbyterianbrooklyn-methodist-hospital-settles-health-care-fraud-claims-173.

[18] See Press Release, U.S. Atty’s Office for the Eastern Dist. of Pa., Generic Pharmaceuticals Manufacturer Pleads Guilty, Agrees to $1.5 Million Criminal Penalty for Distributing Adulterated Drugs and $2 Million to Resolve Civil Liability under the False Claims Act (Mar. 6, 2024), https://www.justice.gov/usao-edpa/pr/generic-pharmaceuticals-manufacturer-pleads-guilty-agrees-15-million-criminal-penalty.

[19] See Press Release, U.S. Atty’s Office for the Eastern Dist. of Pa., Philadelphia Pharmacy Criminal Pleas and Civil Resolutions Result in Multiple Criminal Convictions and Over $4 Million Recovered (Mar. 20, 2024), https://www.justice.gov/usao-edpa/pr/philadelphia-pharmacy-criminal-pleas-and-civil-resolutions-result-multiple-criminal.

[20] See Press Release, U.S. Dep’t of Justice, Gamma Healthcare and Three of Its Owners Agree to Pay $13.6 Million for Allegedly Billing Medicare for Lab Tests That Were Not Ordered or Medically Necessary (Mar. 27, 2024), https://www.justice.gov/opa/pr/gamma-healthcare-and-three-its-owners-agree-pay-136-million-allegedly-billing-medicare-lab.

[21] See Press Release, U.S. Atty’s Office for the Southern Dist. of Ohio, Cincinnati healthcare staffing company agrees to pay $9.25 million to resolve visa fraud investigations (Mar. 25, 2024), https://www.justice.gov/usao-sdoh/pr/cincinnati-healthcare-staffing-company-agrees-pay-925-million-resolve-visa-fraud.

[22] See Press Release, U.S. Atty’s Office for the Southern Dist. of N.Y., U.S. Attorney Announces $3.1 Million False Claims Act Settlement With Radiology Company And Its CEO For Fraudulent Billing Practices (Mar. 28, 2024), https://www.justice.gov/usao-sdny/pr/us-attorney-announces-31-million-false-claims-act-settlement-radiology-company-and-its; Stipulation and Order of Settlement and Dismissal (Mar. 26, 2024), https://www.justice.gov/usao-sdny/media/1345696/dl.

[23] See Press Release, U.S. Atty’s Office for the Western Dist. of Tex., Oncology Practice, Physicians, and Reference Laboratory To Pay Over $4 Million to Settle False Claims Act Allegations (Apr. 2, 2024), https://www.justice.gov/usao-wdtx/pr/oncology-practice-physicians-and-reference-laboratory-pay-over-4-million-settle-false.

[24] See Press Release, U.S. Atty’s Office for the Central Dist. of Cal., San Gabriel Valley-Based Nursing Home Chain and Executives to Pay Over $7 Million to Settle COVID-Related False Claims Allegations (Apr. 26, 2024), https://www.justice.gov/usao-cdca/pr/san-gabriel-valley-based-nursing-home-chain-and-executives-pay-over-7-million-settle; Settlement Agreement, U.S. Dep’t of Justice and ReNew (Apr. 26, 2024), https://www.justice.gov/opa/media/1349866/dl?inline.

[25] See Press Release, U.S. Dep’t of Justice, Office of Public Affairs, Staffing Company to Pay $2.7M for Alleged Failure to Provide Adequate Cybersecurity for COVID-19 Contact Tracing Data (May 1, 2024), https://www.justice.gov/opa/pr/staffing-company-pay-27m-alleged-failure-provide-adequate-cybersecurity-covid-19-contact; Settlement Agreement, U.S. Dep’t of Justice and Insight Global (May 15, 2024), https://www.justice.gov/opa/media/1350311/dl?inline.

[26] See Press Release, U.S. Dep’t of Justice, Elara Caring Agrees to Pay $4.2 Million to Settle False Claims Act Allegations That It Billed Medicare for Ineligible Hospice Patients (May 1, 2024), https://www.justice.gov/opa/pr/elara-caring-agrees-pay-42-million-settle-false-claims-act-allegations-it-billed-medicare.

[27] See Press Release, U.S. Atty’s Office for the Dist. of N.J., Florida Businessman Daniel Hurt to Pay Over $27 Million for Medicare Fraud in Connection With Cancer Genomic Tests (May 24, 2024), https://www.justice.gov/usao-nj/pr/florida-businessman-daniel-hurt-pay-over-27-million-medicare-fraud-connection-cancer.

[28] See Press Release, U.S. Atty’s Office for the Eastern Dist. of Mich., Local Physician and Practice Agree to Pay Over $2 Million to Settle False Claims Act Allegations (May 8, 2024), https://www.justice.gov/usao-edmi/pr/local-physician-and-practice-agree-pay-over-2-million-settle-false-claims-act/.

[29] See Press Release, U.S. Atty’s Office for the Dist. of Mass., Cape Cod Hospital to Pay $24.3 Million to Resolve Allegations That It Failed to Comply With Medicare Cardiac Procedure Rules (May 16, 2024), https://www.justice.gov/usao-ma/pr/cape-cod-hospital-pay-243-million-resolve-allegations-it-failed-comply-medicare-cardiac; Settlement Agreement, U.S. Dep’t of Justice and Cape Cod Hospital (May 16, 2024), https://www.justice.gov/usao-ma/media/1352226/dl.

[30] See Press Release, U.S. Atty’s Office for the Northern Dist. of Ohio, Cleveland Clinic to Pay Over $7 Million to Settle Allegations of Undisclosed Foreign Sources of Funding on NIH Grant Applications and Reports (May 17, 2024), https://www.justice.gov/usao-ndoh/pr/cleveland-clinic-pay-over-7-million-settle-allegations-undisclosed-foreign-sources.

[31] See Press Release, U.S. Atty’s Office for the Southern Dist. of N.Y., U.S. Attorney Announces $10.1 Million Settlement With Managed Long-Term Care Plan For Improper Receipt Of Medicaid Payments (May 23, 2024), https://www.justice.gov/usao-sdny/pr/us-attorney-announces-101-million-settlement-managed-long-term-care-plan-improper.

[32] See Press Release, Dept. of Justice, Office of Public Affairs, Medical Device Manufacturer Innovasis Inc. and Two Top Executives Agree to Pay $12M to Settle Allegations of Improper Payments to Physicians (May 29, 2024), https://www.justice.gov/opa/pr/medical-device-manufacturer-innovasis-inc-and-two-top-executives-agree-pay-12m-settle.

[33] See Press Release, U.S. Atty’s Office for the Middle Dist. of Fl., Chronic Disease Management Provider to Pay $14.9M to Resolve Alleged False Claims (June 5, 2024), https://www.justice.gov/usao-mdfl/pr/chronic-disease-management-provider-pay-149m-resolve-alleged-false-claims; Settlement Agreement, U.S. Dep’t of Justice and Bluestone National, LLC (June 5, 2024), https://www.justice.gov/opa/media/1354511/dl?inline=&utm_medium=email&utm_source=govdelivery.

[34] See Press Release, U.S. Atty’s Office for the Eastern Dist. of N.Y., Queens and Brooklyn-Based Eye Doctor Settles Health Care Fraud Claims for More Than $2.4 Million (June 6, 2024), https://www.justice.gov/usao-edny/pr/queens-and-brooklyn-based-eye-doctor-settles-health-care-fraud-claims-more-24-million.

[35] See Press Release, U.S. Atty’s Office for the Northern Dist. of Ill., Chicago Health Care Company and Its Former Owners To Pay Nearly $2 Million To Settle False Claims Act Lawsuit (June 18, 2024), https://www.justice.gov/usao-ndil/pr/chicago-health-care-company-and-its-former-owners-pay-nearly-2-million-settle-false; Settlement Agreement, U.S. Dep’t of Justice and KFM Holdings et al. (June 17, 2024), https://www.justice.gov/usao-ndil/media/1356316/dl?inline.

[36] See Press Release, U.S. Atty’s Office for the Southern Dist. Of Tex., Texas Medical Center Institutions Agree to Pay $15M Record Settlement Involving Concurrent Billing Claims for Critical Surgeries, https://www.justice.gov/usao-sdtx/pr/texas-medical-center-institutions-agree-pay-15m-record-settlement-involving-concurrent.

[37] See Press Release, U.S. Atty’s Office for the Southern Dist. of Tex., Hilcorp San Juan resolves False Claims Act claims for oil and natural gas royalty underpayments to the United States (Jan. 19, 2024), https://www.justice.gov/usao-sdtx/pr/hilcorp-san-juan-resolves-false-claims-act-claims-oil-and-natural-gas-royalty.

[38] See Press Release, U.S. Atty’s Office for the Eastern Dist. of Mich., Federal Subcontractor Agrees to Pay $5 Million to Settle False Claims Act Allegations (Jan. 30, 2024), https://www.justice.gov/usao-edmi/pr/federal-subcontractor-agrees-pay-5-million-settle-false-claims-act-allegations.

[39] See Complaint, United States ex rel. The Arora Group, Inc. v. Planned Systems International, Inc., No. 1:21-cv-657 (May 28, 2021 E.D. Va.).

[40] See Press Release, U.S. Atty’s Office for the Eastern Dist. of Va., Government Contractors Agree to Pay $3.9 Million to Resolve Claims of Misrepresenting Women-Owned Small Business Status (Jan. 30, 2024), https://www.justice.gov/usao-edva/pr/government-contractors-agree-pay-39-million-resolve-claims-misrepresenting-women-owned.

[41] See Press Release, U.S. Atty’s Office for the Eastern Dist. of Va., Argus Information & Advisory Services agrees to pay $37M to settle allegations that it misused data obtained under government contracts (Mar. 12, 2024), https://www.justice.gov/usao-edva/pr/argus-information-advisory-services-agrees-pay-37m-settle-allegations-it-misused-data.

[42] See Press Release, U.S. Dep’t of Justice, Consolidated Nuclear Security Agrees to Pay $18.4 Million to Settle False Claims Act Allegations of Timecard Fraud (Apr. 23, 2024), https://www.justice.gov/opa/pr/consolidated-nuclear-security-agrees-pay-184-million-settle-false-claims-act-allegations; Settlement Agreement, Consolidated Nuclear Security, LLC (Apr. 22, 2024), https://www.justice.gov/opa/media/1349116/dl?inline.

[43] See Press Release, U.S. Atty’s Office for the Dist. of Vt. Galvion To Pay $2,495,000 To Resolve False Claims Act Allegations (June 6, 2024), https://www.justice.gov/usao-vt/pr/galvion-pay-2495000-resolve-false-claims-act-allegations.

[44] See Press Release, Dep’t of Justice, CityMD Agrees to Pay Over $12M for Alleged False Claims to the COVID-19 Uninsured Program (June 7, 2024), https://www.justice.gov/opa/pr/citymd-agrees-pay-over-12-million-alleged-false-claims-covid-19-uninsured-program.

[45] See Press Release, U.S. Atty’s Office for the Northern Dist. of N.Y., Consulting Companies to Pay $11.3 Million for Failing to Comply with Cybersecurity Requirements in Federally Funded Contract (June 17, 2024), https://www.justice.gov/usao-ndny/pr/consulting-companies-pay-113-million-failing-comply-cybersecurity-requirements.

[46] See Press Release, U.S. Atty’s Office for the Eastern Dist. of Wis., Sikorsky Support Services, Inc. and Derco Aerospace, Inc. Agree to Pay $70 Million to Settle False Claims Act Allegations of Improper Markups on Spare Parts for Navy Trainer Aircraft (June 21, 2024), https://www.justice.gov/usao-edwi/pr/sikorsky-support-services-inc-and-derco-aerospace-inc-agree-pay-70-million-settle.

[47] See Press Release, U.S. Atty’s Office for the Western Dist. of Wash., Automobile accessory company Yakima Products Inc. settles allegations failed to pay duties on extruded aluminum from China (Jan. 31, 2024), https://www.justice.gov/usao-wdwa/pr/automobile-accessory-company-yakima-products-inc-settles-allegations-failed-pay-duties.

[48] See Press Release, U.S. Atty’s Office for the Dist. of Colo., Two Southeastern Colorado Farmers Sentenced to Federal Prison and Will Pay Over $6.5 Million for Defrauding Federal Crop Insurance Programs (Feb. 29, 2024), https://www.justice.gov/usao-co/pr/two-southeastern-colorado-farmers-sentenced-federal-prison-and-will-pay-over-65-million.

[49] See Press Release, U.S. Atty’s Office for the Dist. Of N.J., South Carolina Construction Company and Its Owner Settle Matter Alleging Receipt of Improper CARES Act Loans (Apr. 26, 2024), https://www.justice.gov/usao-nj/pr/south-carolina-construction-company-and-its-owner-settle-matter-alleging-receipt.

[50] See Press Release, U.S. Atty’s Office for the Dist. Of N.J., Owner of New Jersey Company Admits to Evading U.S. Customs Duties and His Company Agrees to $3.1 Million Settlement Agreement (Mar. 21, 2024), https://www.justice.gov/usao-nj/pr/owner-new-jersey-company-admits-evading-us-customs-duties-and-his-company-agrees-31; Information, U.S. v. George Volpe, available at https://www.justice.gov/usao-nj/media/1344671/dl?inline.

[51] See Press Release, U.S. Atty’s Office for the Dist. of D.C., Hahn Air Lines Agrees to Pay $26.8 Million to Resolve False Claims Act Liability for Its Alleged Failure to Pay Travel Fees Collected from Passengers (May 2, 2024), https://www.justice.gov/usao-dc/pr/hahn-air-lines-agrees-pay-268-million-resolve-false-claims-act-liability-its-alleged.

[52] See Press Release, U.S. Atty’s Office for the Dist. of Mass., Kabbage Agrees to Pay up to $120 Million to Resolve Allegations that it Defrauded the Paycheck Protection Program (May 13, 2024), https://www.justice.gov/usao-ma/pr/kabbage-agrees-pay-120-million-resolve-allegations-it-defrauded-paycheck-protection; Settlement Agreement, U.S. Dep’t of Justice and Kabbage, Inc. (May 13, 2024), https://www.justice.gov/usao-ma/media/1351711/dl; Settlement Agreement, U.S. Dep’t of Justice and Kabbage, Inc. (May 13, 2024), https://www.justice.gov/usao-ma/media/1351716/dl.

[53] See Press Release, U.S. Atty’s Office for the Southern Dist. of Cal., Nonprofit Organizations Pay Over $5.8 Million to Resolve Allegations of Fraudulently Obtaining Pandemic-Related Loans (June 12, 2024), https://www.justice.gov/usao-sdca/pr/nonprofit-organizations-pay-over-58-million-resolve-allegations-fraudulently-obtaining.

[54] See Press Release, U.S. Atty’s Office for the Southern Dist. of N.Y., U.S. Attorney Announces $4.6 Million False Claims Act Settlement With Restaurants, Fur Apparel Companies, And Their Owners And Managers For Submitting False Information To Obtain Paycheck Protection Program Loans (June 20, 2024), https://www.justice.gov/usao-sdny/pr/us-attorney-announces-46-million-false-claims-act-settlement-restaurants-fur-apparel.

[55] See Press Release, U.S. Dep’t of Justice, Deputy Attorney General Lisa O. Monaco Announces New Civil Cyber-Fraud Initiative (Oct. 6, 2021), https://www.justice.gov/opa/pr/deputy-attorney-general-lisa-o-monaco-announces-new-civil-cyber-fraud-initiative.

[56] See Speech, U.S. Dep’t of Justice, Principal Deputy Assistant Attorney General Brian M. Boynton Delivers Remarks at the 2024 Federal Bar Association’s Qui Tam Conference (Feb. 22, 2024), https://www.justice.gov/opa/speech/principal-deputy-assistant-attorney-general-brian-m-boynton-delivers-remarks-2024.

[57] See United States ex rel. Matthew Decker v. Pennsylvania State University, 22-cv-03895-PD (E.D. Pa. Oct. 5, 2022).

[58] See Centers for Medicare & Medicaid Servs., Calendar Year (CY) 2025 Medicare Physician Fee Schedule Proposed Rule (July 10, 2024), https://www.cms.gov/newsroom/fact-sheets/calendar-year-cy-2025-medicare-physician-fee-schedule-proposed-rule.

[59] See 42 U.S.C. § 1320a-7k(d); 31 U.S.C. § 3729(a)(1)(G).

[60] See 42 U.S.C. § 1320a-7k(d).

[61] See, e.g., 42 C.F.R. § 422.326(c) (Medicare Advantage rule); see also 42 C.F.R. § 401.305(a)(2) (Part A and B rule), 42 C.F.R. § 423.360(c) (Part D rule) (both similar).

[62] See Dep’t of Health & Hum. Servs., Centers for Medicare & Medicaid Servs., Proposed Rule RIN 0938-AV33, at 1169 (hereinafter “Proposed PFS Rule”).

[63] See id. at 1171–72; see also UnitedHealthcare Ins. Co. v. Azar, 330 F. Supp. 3d 173, 191 (D.D.C. 2018), rev’d in part on other grounds sub nom. UnitedHealthcare Ins. Co. v. Becerra, 16 F.4th 867 (D.C. Cir. 2021).

[64] See Medicare Program; Contract Year 2015 Policy and Technical Changes to the Medicare

Advantage and the Medicare Prescription Drug Benefit Programs, 79 Fed. Reg. 29,844, 29,923

(May 23, 2014).

[65] Proposed PFS Rule at 1173.

[66] Id.

[67] See Speech, U.S. Dep’t of Justice, Deputy Attorney General Lisa Monaco Delivers Keynote Remarks at the American Bar Association’s 39th National Institute on White Collar Crime (Mar. 7, 2024), https://www.justice.gov/opa/speech/deputy-attorney-general-lisa-monaco-delivers-keynote-remarks-american-bar-associations.

[68] Id.

[69] Id.

[70] See id.

[71] Id.

[72] See Blog Post, U.S. Dep’t of Justice, Criminal Division’s Voluntary Self-Disclosures Pilot Program for Individuals (Apr. 22, 2024), https://www.justice.gov/opa/blog/criminal-divisions-voluntary-self-disclosures-pilot-program-individuals; U.S. Dep’t of Justice, Criminal Division Pilot Program On Voluntary Self-Disclosures For Individuals, https://www.justice.gov/criminal/criminal-division-pilot-program-voluntary-self-disclosures-individuals; U.S. Dep’t of Justice, Voluntary Self Disclosures for Individuals Policy (April 15, 2024), https://www.justice.gov/criminal/media/1347991/dl?inline.

[73] See Speech, U.S. Dep’t of Justice, Deputy Attorney General Lisa Monaco Delivers Keynote Remarks at the American Bar Association’s 39th National Institute on White Collar Crime (Mar. 7, 2024), https://www.justice.gov/opa/speech/deputy-attorney-general-lisa-monaco-delivers-keynote-remarks-american-bar-associations

[74] 31 U.S.C. § 3730(d)(3).

[75] State False Claims Act Reviews, HHS-OIG, https://oig.hhs.gov/fraud/state-false-claims-act-reviews/ (last visited July 1, 2024) (FCA Reviews); 42 U.S.C. § 1396h(a).

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The following Gibson Dunn lawyers prepared this update: Jonathan Phillips, Winston Chan, John Partridge, James Zelenay, Michael Dziuban, Chumma Tum, Alyse Ullery, José Madrid, Mary Aline Fertin, Hayley Lawrence, Azad Niroomand, Nicole Waddick, Erin Wall, and Sara Zamani.

Gibson Dunn lawyers regularly counsel clients on the False Claims Act issues and are available to assist in addressing any questions you may have regarding these issues. Please contact the Gibson Dunn lawyer with whom you usually work, the authors, or any leader or member of the firm’s False Claims Act/Qui Tam Defense practice group:

Washington, D.C.
Jonathan M. Phillips – Co-Chair (+1 202.887.3546, [email protected])
Stuart F. Delery (+1 202.955.8515,[email protected])
F. Joseph Warin (+1 202.887.3609, [email protected])
Gustav W. Eyler (+1 202.955.8610, [email protected])
Lindsay M. Paulin (+1 202.887.3701, [email protected])
Geoffrey M. Sigler (+1 202.887.3752, [email protected])
Joseph D. West (+1 202.955.8658, [email protected])

San Francisco
Winston Y. Chan – Co-Chair (+1 415.393.8362, [email protected])
Charles J. Stevens (+1 415.393.8391, [email protected])

New York
Reed Brodsky (+1 212.351.5334, [email protected])
Mylan Denerstein (+1 212.351.3850, [email protected])
Alexander H. Southwell (+1 212.351.3981, [email protected])

Denver
John D.W. Partridge (+1 303.298.5931, [email protected])
Ryan T. Bergsieker (+1 303.298.5774, [email protected])
Robert C. Blume (+1 303.298.5758, [email protected])
Monica K. Loseman (+1 303.298.5784, [email protected])

Dallas
Andrew LeGrand (+1 214.698.3405, [email protected])

Los Angeles
James L. Zelenay Jr. (+1 213.229.7449, [email protected])
Nicola T. Hanna (+1 213.229.7269, [email protected])
Jeremy S. Smith (+1 213.229.7973, [email protected])
Deborah L. Stein (+1 213.229.7164, [email protected])
Dhananjay S. Manthripragada (+1 213.229.7366, [email protected])

Palo Alto
Benjamin Wagner (+1 650.849.5395, [email protected])

*Sara Zamani is an associate in the firm’s Denver office currently admitted to practice only in California.

We are pleased to provide you with Gibson Dunn’s Accounting Firm Quarterly Update for Q2 2024. The Update is available in .pdf format at the below link, and addresses news on the following topics that we hope are of interest to you:

• PCAOB Undertakes Significant Standard-Setting and Rulemaking Projects
• Supreme Court Issues Key Securities and Administrative Law Rulings
• President Biden Vetoes Resolution Overturning SEC Crypto Accounting Guidance
• Major Ruling in SEC Cybersecurity Case as SEC Clarifies Cyber Disclosure Obligations
• SEC Permanently Suspends BF Borgers CPA PC and Grants Extension to Affected Registrants
• Unanimous Fifth Circuit Panel Strikes Down SEC Private Funds Rule
• European Parliament Adopts Corporate Sustainability Due Diligence Directive
• PCAOB Staff Issues Spotlight Reports on Root Cause Analysis and Company Information
• SEC Leaders Issue Regulation and Enforcement Statements
• Other Recent SEC and PCAOB Enforcement and Regulatory Developments

Please let us know if there are topics that you would be interested in seeing covered in future editions of the Update.

Download Full Newsletter

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Warmest regards,
Jim Farrell
Monica Loseman
Michael Scanlon

Chairs, Accounting Firm Advisory and Defense Practice Group, Gibson, Dunn & Crutcher LLP

In addition to the practice group chairs, this update was prepared by David Ware, Timothy Zimmerman, Benjamin Belair, Adrienne Tarver, and Monica Limeng Woolley.

Accounting Firm Advisory and Defense Group Chairs:

James J. Farrell – Co-Chair, New York (+1 212-351-5326, [email protected])

Monica K. Loseman – Co-Chair, Denver (+1 303-298-5784, [email protected])

Michael Scanlon – Co-Chair, Washington, D.C.(+1 202-887-3668, [email protected])

© 2023 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

From the Derivatives Practice Group: ISDA released their Document Negotiation Survey, which found that the average time taken to negotiate key derivatives documents hasn’t fallen since 2006.

New Developments

• CFTC Staff Issues No-Action Letter Regarding Reporting and Recordkeeping Requirements for Fully Collateralized Binary Options. On July 12, the CFTC announced the Division of Market Oversight and the Division of Clearing and Risk have taken a no-action position regarding swap data reporting and recordkeeping regulations in response to a request from ForecastEx LLC, a designated contract market and derivatives clearing organization. The divisions will not recommend the Commission initiate an enforcement action against ForecastEx or its participants for certain swap-related recordkeeping requirements and for failure to report data associated with binary option transactions executed on or subject to the rules of ForecastEx to swap data repositories. [NEW]
• President Biden Announced Intent to Nominate Julie Brinn Siegel as a Commissioner of the CFTC. On July 11, President Biden announced his intent to nominate Julie Brinn Siegel to be a Commissioner of the CFTC. Siegel currently serves as the federal government’s deputy chief operating officer as Senior Coordinator for Management at the Office of Management and Budget (OMB). Prior to that, Siegel served as Secretary of the Treasury Janet Yellen’s Deputy Chief of Staff and served as Senior Counsel and Policy Advisor to U.S. Senator Elizabeth Warren (D-MA). Last month, President Biden nominated CFTC Commissioner Johnson to be Assistant Secretary for Financial Institutions at the Department of Treasury and nominated CFTC Commissioner Christy Goldsmith Romero to be Chair and Member of the Federal Deposit Insurance Corporation (FDIC) which, if confirmed by the Senate, would leave open two Democratic Commissioner seats at the CFTC. Siegel, if nominated and confirmed by the Senate, would take the seat of Commissioner Goldsmith Romero.
• First Interagency Fraud Disruption Conference Focuses on Combatting Crypto Schemes Commonly Known as “Pig Butchering.” On July 11, the CFTC and the DOJ’s Computer Crime and Intellectual Property Section’s National Cryptocurrency Enforcement Team (“NCET”) convened the first Fraud Disruption Conference to work on efforts to combat a type of fraud commonly known as “pig butchering.” It is estimated that Americans are scammed out of billions per year, making this a top law enforcement priority. The working group addressed strategies to prevent victimization; using technology to disrupt the fraud; and collaboration on enforcement efforts. Several agencies also collaborated on an anti-victimization messaging campaign to warn Americans to remain vigilant against emerging fraud threats.

New Developments Outside the U.S.

• ESAs Publish Joint Final Report on the Draft Technical Standards on Subcontracting under DORA. On July 26, the European Supervisory Authorities published their joint Final Report on the draft Regulatory Technical Standards (“RTS”) specifying how to determine and assess the conditions for subcontracting information and communication technology (“ICT”) services that support critical or important functions under the Digital Operational Resilience Act (“DORA”). These RTS aim to enhance the digital operational resilience of the EU financial sector by strengthening the financial entities’ ICT risk management over the use of subcontracting. [NEW]
• ESMA Sets Out Its Long Term Vision on the Functioning of the Sustainable Finance Framework. On July 24, ESMA published an Opinion on the Sustainable Finance Regulatory Framework, setting out possible long-term improvements. ESMA considers that, in the longer-term, the Framework could further evolve to facilitate investors’ access to sustainable investments and support the effective functioning of the Sustainable Investment Value Chain. The opinion recommends several action items, including that all financial products should disclose some minimum basic sustainability information, covering environmental and social characteristics, and a product categorization system, based on a set of clear eligibility criteria and binding transparency obligations. [NEW]
• ESAs Establish Framework to Strengthen Coordination in Case of Systemic Cyber Incidents. On July 17, the ESAs announced they will establish the EU systemic cyber incident coordination framework (“EU-SCICF”), in the context of the Digital Operational Resilience Act (“DORA”), that will aim to facilitate an effective financial sector response to a cyber incident that poses a risk to financial stability, by strengthening the coordination among financial authorities and other relevant bodies in the European Union, as well as with key actors at international level.
• ESAs Publish Second Batch of Policy Products under DORA. On July 17, the ESAs published the second batch of policy products under DORA. This batch consists of four final draft regulatory technical standards, one set of Implementing Technical Standards and 2 guidelines, all of which aim at enhancing the digital operational resilience of the EU’s financial sector.
• Hong Kong HKMA and FSTB Publishes Results from Stablecoin Consultation. On July 17, 2024, the Hong Kong Monetary Authority (“HKMA”) and Financial Services and the Treasury Bureau (“FSTB”) published the Consultation Conclusions on the Legislative Proposal to Implement the Regulatory Regime for Stablecoin Issuers in Hong Kong (“Consultation Conclusions”). The Consultation Conclusions outlined the legislative proposal to implement a regulatory regime for fiat-referenced stablecoin (“FRS”) issuers in Hong Kong. The regime will primarily focus on representations of value which rest on ledgers that are operated in a decentralized manner in which no person has the unilateral authority to control or materially alter its functionality or operation. Under this regime, FRS issuers will require a license. Foreign entities intending to apply for a license will be required to establish a Hong Kong subsidiary and have key management personnel in the territory. [NEW]
• ESMA Consults on Firms’ Order Execution Policies Under MiFID II. On July 16, ESMA launched a consultation on draft technical standards specifying the criteria for how investment firms establish and assess the effectiveness of their order execution policies. The objective of the proposed technical standards is to foster investor protection by enhancing investment firms’ order execution. [NEW]
• ESMA Publishes 2023 Data on Cross-Border Investment Activity of Firms. On July 15, ESMA announced they completed an analysis of the cross-border provision of investment services during 2023. The main findings include that a total of around 386 firms provided services to retail clients on a cross-border basis in 2023; compared to 2022, the cross-border market for investment services grew by 1.6% in terms of firm numbers, and by 5% in terms of retail clients, while the number of complaints increased by 31%; and Germany, France, Spain, and Italy are the most significant destinations (in terms of number of retail clients) for investment firms providing cross-border services in other Member States. [NEW]
• ESAs Consult on Guidelines under the Markets in Crypto-Assets Regulation. On July 12, the ESAs published a consultation paper on Guidelines under Markets in Crypto-assets Regulation (“MiCA”), establishing templates for explanations and legal opinions regarding the classification of crypto-assets along with a standardized test to foster a common approach to classification.
• ESAs Report on the Use of Behavioral Insights in Supervisory and Policy Work. On July 11, the ESAs published a joint report following their workshop on the use of behavioral insights by supervisory authorities in their day-to-day oversight and policy work. The report provides a high-level overview of the main topics discussed during the workshop held in February 2024 for national supervisors and other competent authorities, where participants explored the added value of behavioral insights in their work by exchanging their experiences and discussing the challenges they face.
• ESMA Publishes the 2024 ESEF Reporting Manual. On July 11, ESMA published the update of its Reporting Manual on the European Single Electronic Format (“ESEF”) supporting a harmonized approach for the preparation of annual financial reports. ESMA has also updated the Annex II of the Regulatory Technical Standards (“RTS”) on ESEF.

New Industry-Led Developments

• ISDA Survey Shows Need for Greater Efficiency and Automation in Document Negotiation. ISDA has published its survey on document negotiation, which shows the average time taken to negotiate key derivatives documents hasn’t fallen since 2006, with some negotiations taking longer due to resource constraints, regulatory pressures and operational challenges. The ISDA Document Negotiation Survey collects and reports data on the composition, negotiation and digital automation of ISDA documentation. The results are based on responses from 42 institutions, most of which are banks or broker-dealers. [NEW]
• ISDA Submits Letter to IASB on Contracts for Renewable Electricity. On July 17, ISDA submitted a comment letter to the International Accounting Standards Board (“IASB”) in response to its exposure draft, which seeks to address the accounting matters related to renewable electricity contracts and the impact on hedge accounting. ISDA provided additional information and proposed other instances, in addition to contracts for renewable electricity, where ISDA believes that hedge accounting with a variable notional should be permitted, such as balance guaranteed swaps. [NEW]
• ISDA Publishes Response to Bank of England and Financial Conduct Authority on UK EMIR Refit. On July 23, ISDA responded to a consultation from the Bank of England (“BoE”) and Financial Conduct Authority (“FCA”) on the additional draft Q&A for position-level reporting of spread bets under the UK European Market Infrastructure Regulation (“UK EMIR”) Refit. In the response, ISDA agreed with the proposal to require reporting of spread bets at position level only, while highlighting that ISDA thinks that the requirement for all derivatives to be reported at the trade level, and the mutual agreement needed between parties for position-level reporting to occur.
• ISDA Publishes Whitepaper: Hedge Accounting Under US GAAP. On July 16, ISDA published a whitepaper that explores the issues faced by financial and non-financial institutions in applying hedge accounting for interest rate risk, foreign exchange risk and other risks. It highlights both the prescriptive nature of Accounting Standards Codification 815 and the inconsistent interpretations among auditors, which together create operational burdens and can limit hedging strategies. The paper proposes potential solutions to these challenges, including the expansion of hedge eligibility and the revision of hedge accounting criteria, to allow better use of existing risk management tools.
• ISDA and SIFMA Submit Addendum on GIRR Curvature to US Basel III NPR. On July 15, ISDA and the Securities Industry and Financial Markets Association (“SIFMA”) submitted an addendum to the joint US Basel III “endgame” notice of proposed rulemaking. The addendum contains a proposal for general interest rate risk (“GIRR”) curvature to fix an issue that was recently identified.
• ISDA Chief Executive Officer Scott O’Malia Offers Informal Comments on Terminating Derivatives Contracts. On July 15, ISDA CEO Scott O’Malia opined on the process to terminate a derivatives contract. ISDA is developing wo initiatives – the ISDA Close-out Framework and the ISDA Notices Hub – that will help ensure a key part of the termination process is more efficient. The ISDA Close-out Framework is designed to illustrate the various steps and decisions firms need to take and is intended as a preparatory tool for future stress events. The ISDA Notices Hub allows the instantaneous delivery and receipt of notices via a secure online platform, eliminating risk exposures and potential losses that can result from delays in terminating derivatives contracts.

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The following Gibson Dunn attorneys assisted in preparing this update: Jeffrey Steiner, Adam Lapidus, Marc Aaron Takagaki, Hayden McGovern, and Karin Thrasher.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding these developments. Please contact the Gibson Dunn lawyer with whom you usually work, any member of the firm’s Derivatives practice group, or the following practice leaders and authors:

Jeffrey L. Steiner, Washington, D.C. (202.887.3632, [email protected])

Michael D. Bopp, Washington, D.C. (202.955.8256, [email protected])

Michelle M. Kirschner, London (+44 (0)20 7071.4212, [email protected])

Darius Mehraban, New York (212.351.2428, [email protected])

Jason J. Cabral, New York (212.351.6267, [email protected])

Adam Lapidus  – New York (212.351.3869,  [email protected] )

Stephanie L. Brooker, Washington, D.C. (202.887.3502, [email protected])

William R. Hallatt , Hong Kong (+852 2214 3836, [email protected] )

David P. Burns, Washington, D.C. (202.887.3786, [email protected])

Marc Aaron Takagaki , New York (212.351.4028, [email protected] )

Hayden K. McGovern, Dallas (214.698.3142, [email protected])

Karin Thrasher, Washington, D.C. (202.887.3712, [email protected])

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

Quach v. California Commerce Club, Inc., S275121 – Decided July 25, 2024

The California Supreme Court held yesterday that, consistent with federal law, California courts should not consider prejudice to the party resisting arbitration when deciding whether a party has waived its right to compel arbitration.

“Because the state law arbitration-specific prejudice requirement finds no support in statutory language or legislative history, we now abrogate it.”

Justice Groban, writing for the Court

Background:

Parties can waive their right to compel arbitration by waiting too long to assert it or engaging in other conduct inconsistent with an intent to arbitrate. Under the test for waiver the California Supreme Court adopted in St. Agnes Medical Center v. PacifiCare of California (2003) 31 Cal.4th 1187, the most “critical” (and often “determinative”) factor is prejudice to the party resisting arbitration. The St. Agnes rule is an arbitration-specific exception to general state-law principles governing waiver of contract rights, which focus entirely on the conduct of the party that assertedly waived the right. In Morgan v. Sundance (2022) 142 S.Ct. 1708, however, the U.S. Supreme Court rejected a similar rule under the Federal Arbitration Act. The Court held that the FAA does not authorize courts to apply an arbitration-only rule asking whether a party’s waiver resulted in prejudice for the other side.

Peter Quach sued his former employer, the California Commerce Club, after he was fired. Although the Club asserted in its answer that Mr. Quach had agreed to arbitrate any disputes, it initially demanded a jury trial and proposed a discovery plan. The Club didn’t move to compel arbitration until more than a year after the complaint had been filed, and after the parties had engaged in significant discovery. The trial court denied the Club’s motion to compel, ruling that it had waived its arbitration right. A divided panel of the California Court of Appeal reversed, holding that Mr. Quach had not sufficiently shown that he had been prejudiced by the delay under St. Agnes.

Issue Presented:

In deciding whether a party has waived its right to compel arbitration, should courts consider prejudice to the party resisting arbitration (as St. Agnes held), or instead focus only on the conduct of the waiving party (as Morgan held)?

Court’s Holdings:

Courts should not consider prejudice to the party resisting arbitration. The St. Agnes rule has been abrogated.

What It Means:

• Parties seeking to enforce arbitration agreements should move to compel arbitration promptly and should avoid engaging in any conduct—including litigation of the merits and factual development through discovery—that suggests an inconsistent intent to proceed in court.
• The Court’s decision brings California law in line with federal law, ensuring that courts will apply the same waiver principles regardless of whether a case is governed by the Federal Arbitration Act or the California Arbitration Act. Under those principles, courts should focus “exclusively … on the waiving party’s words or conduct.”
• By eliminating the “stringent” prejudice requirement, the decision will make it easier for parties resisting arbitration to show that the party invoking an arbitration agreement had waived its rights under the agreement. Future courts will be especially on the lookout for signs of “undue delay and gamesmanship” in the invocation of an arbitration agreement.
• The Court also cautioned that lower courts “should separately evaluate each generally applicable state contract law defense raised by [a] party opposing arbitration,” including waiver, forfeiture, estoppel, laches, and untimeliness, rather than “lump[ing] distinct legal defenses into a catch-all category called ‘waiver.’”

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The Court’s opinion is available here.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding developments at the California Supreme Court. Please feel free to contact the following practice group leaders:

Appellate and Constitutional Law Practice

Thomas H. Dupree Jr. +1 202.955.8547 [email protected]	Allyson N. Ho +1 214.698.3233 [email protected]	Julian W. Poon +1 213.229.7758 [email protected]
Lucas C. Townsend +1 202.887.3731 [email protected]	Bradley J. Hamburger +1 213.229.7658 [email protected]	Michael J. Holecek +1 213.229.7018 [email protected]

Related Practice: Labor and Employment

Jason C. Schwartz +1 202.955.8242 [email protected]

Katherine V.A. Smith +1 213.229.7107 [email protected]

Jesse A. Cripps +1 213.229.7792 [email protected]

Related Practice: Litigation

Theodore J. Boutrous, Jr. +1 213.229.7804 [email protected]

Theane Evangelis +1 213.229.7726 [email protected]

This alert was prepared by associates Daniel R. Adler, Ryan Azad, and Matt Aidan Getz.

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

Ilissa Samplin and Grace Hart are the authors of “Questions Linger About DTSA’s Scope After Motorola Ruling” [PDF] published by Law360 on July 25, 2024.

The SEC’s action against SolarWinds related to a highly publicized compromise of the company in 2020 that was attributed to Russia’s Foreign Intelligence Service who had inserted malware into a routine SolarWinds software update.

On July 18, 2024, the U.S. District Court for the Southern District of New York largely granted SolarWinds’ motion to dismiss and dismissed most of the SEC’s claims against the company and its former Chief Information Security Officer (CISO).[1]  The SEC’s action against SolarWinds related to a highly publicized compromise of the company in 2020 that was attributed to Russia’s Foreign Intelligence Service (SVR) who had inserted malware into a routine SolarWinds software update.  Although thousands of SolarWinds customers received the software update, the SVR used the compromise to access the environments of certain SolarWinds customers in the government and private sector (the “SUNBURST” incident).

The court dismissed most of the claims advanced by the SEC relating to its disclosures, including SolarWinds’ Form 8-K filings, but did sustain claims against SolarWinds and its CISO alleging that a “Security Statement” posted on its website in 2017 may have been false or misleading.

The decision is noteworthy for several reasons:

• The court dismissed the SEC’s claim that cybersecurity-related deficiencies were actionable under its rules relating to internal accounting and disclosure controls. The court concluded that the claim was “ill-pled” because “cybersecurity controls are not—and could not have been expected to be—part of the apparatus necessary to the production of accurate” financial reports, noting that “[a]s a matter of statutory construction, [the SEC’s] reading is not tenable.”[2]  This is noteworthy because the SEC just last month entered into a settlement in cybersecurity-related case under the theory that internal accounting controls-related regulations could encompass traditional IT assets that were unrelated to financial systems or financial/accounting data.[3]  The Solar Winds decision will likely impact how the SEC thinks about its broad use of accounting controls as a basis to charge a violation related to a cyber incident.
• The court’s decision makes clear that more than isolated disclosure failures are required to put the adequacy of a company’s disclosure controls and procedures in issue. The decision also leaves open the question of whether, in a close case where the SEC may be inclined to allege fraud, the SEC will continue to be willing to enter into a settlement on the basis of a disclosure controls and procedures violation if the company was willing to do so in order to avoid a fraud charge, as has been their practice to date.
• While the decision is an encouraging sign that the SEC’s aggressive attempts to hold CISOs individually liable for company conduct will be evaluated on the factual record and the law, the decision did not dismiss all claims against the CISO (allowing the claims based on allegations of contemporaneous knowledge of falsity of public statements to go forward), and companies and CISOs should remain vigilant in responding to cybersecurity incidents and ensuring the accuracy of all public statements that are made about cybersecurity.

Background

On October 30, 2023, the SEC filed a complaint against SolarWinds and its former CISO alleging that they made materially false and misleading statements and omissions on the company website, blog posts, press releases, Form S-1, and quarterly and annual SEC reports prior to the incident and did the same in two reports on Form 8-K in which the company disclosed the incident.[4]  The SEC also conducted an investigation regarding the SUNBURST incident and issued a letter to certain companies because the SEC staff believed those entities were impacted by the SolarWinds compromise and requested that they provide information to the staff on a voluntary basis.[5]  In February 2024, the SEC filed an amended complaint including factual details to support its allegations that SolarWinds and its CISO were aware of the company’s weak security practices yet made contrary statements about its strength in SolarWinds’ Security Statement.[6]  The Defendants filed a motion to dismiss in March 22, 2024,[7] and the court issued its order on July 18, 2024.

July 18, 2024 Order

The court largely granted Defendants’ motion to dismiss, sustaining only the SEC’s claims alleging securities fraud based on allegations that the company made false or misleading representations in a “Security Statement” posted to SolarWinds’ website.  Specifically:

1. Fraud and False and Misleading Statements

The court dismissed most of the SEC’s securities fraud claims regarding SolarWinds’ statements about its strong security that it made in press releases, blog posts, podcasts and securities filings.  However, the court allowed the SEC’s claims based on the Securities Statement on SolarWinds’ website to proceed.[8]

The “Security Statement”

The court found that the SEC adequately pled that the Security Statement posted on SolarWinds’ website contained materially misleading and false representations as to at least two of SolarWinds’ cybersecurity practices: access controls and password protection policies.  The court’s holding was based on the allegations in the complaint that SolarWinds had made statements touting that it had strong access controls and password policies when its internal practices and discourse instead “portrayed a diametrically opposite representation for public consumption.”[9]  Specifically, the court found that the complaint alleged that the company’s access controls had “deficiencies” that “were not only glaring—they were long-standing, well-recognized within the company, and unrectified over time,” and its password policies were generally not enforced.[10]  The court also found that the amended complaint “amply” alleged scienter, including that the former CISO knew of the substantial body of data that impeached the security statement’s content as false and misleading.[11]

The court importantly explained that false statements on public websites can sustain securities fraud liability, as the security statement at issue appeared on SolarWinds’ public website, accessible to all, including investors, and therefore was, according to the court, unavoidably part of the “total mix of information” that SolarWinds furnished to the investing public.[12]  The court emphasized that for purposes of evaluating materiality, each representation should be considered collectively, rather than in isolation, as investors evaluate the whole picture.

Press Releases, Blog Posts, and Podcasts

The court dismissed the SEC’s claims that SolarWinds made false and misleading statements related to the 2020 incident in press releases, blog posts, and podcasts explaining that each qualifies as non-actionable corporate puffery, “too general to cause a reasonable investor to rely upon them.”[13]  As the court noted, while public statements, such as the website security statement, can serve as the basis for a material misstatement when they contain a degree of specificity, general statements by an issuer about the strength of their cybersecurity program were not sufficient to support a fraud violation.

Pre-Incident Public Filings

The court dismissed each of the SEC’s claims that SolarWinds’ cybersecurity risk disclosures in its SEC filings did not accurately reflect the risks that the company faced.  The court found that, viewed in totality, the risk disclosures sufficiently alerted the investing public of the types and nature of the cybersecurity risks SolarWinds faced and the consequences these could present for the company’s financial health and future.[14]  The court also held that, on the facts pled, SolarWinds was not required to amend its cybersecurity risk disclosures for certain cyber incidents as the company’s cybersecurity risk disclosures already warned investors of the risks “in sobering terms.”[15]

In the court’s view, issuers are not required to disclose cybersecurity risks with “maximum specificity,” as, according to the court, spelling out a cybersecurity risk may backfire in various ways, such as by arming malevolent actors with information to exploit or by misleading investors as other disclosures might be disclosed with relatively less specificity.[16]

Post-incident Form 8-K

The court found that the SEC did not adequately plead that the post-incident Form 8-K was materially false or misleading, as the disclosure fairly captured the known facts and disclosed what was required for reasonable investors. The court also acknowledged that the impact on stock prices indicated that the market “got the message” (noting SolarWinds’ share prices dropped more than 16% the day of the announcement, and another 8% the next day),[17] and emphasized that SolarWinds published the disclosure just two days after discovering the compromise, when it was still in the early phases of its investigation and had a limited understanding of the attack.

2. Internal Accounting Controls

The court found that the SEC’s attempt to bring a claim under Section 13(b)(2)(B) of the Exchange Act (relating to internal accounting controls) was unsupported by legislative intent, as the surrounding terms that Congress used when drafting Section 13(b)(2)(B), which refer to “transactions,” “preparation of financial statements,” “generally accepted accounting principles,” and “books and records,” are uniformly consistent with financial accounting. [18]  The court’s deep skepticism of the claim that Congress intended to confer the SEC with such authority is reflected in the analogy that doing so would be tantamount to “hid[ing] elephants in mouseholes.”[19]The court also found that the few courts that interpreted the term “internal accounting controls” as used in this section “have consistently construed it to address financial accounting.”[20]  In this respect, the court’s conclusion is consistent with the views expressed in several dissents by Commissioners in other settled enforcement actions in which the SEC has used the internal accounting controls provision to impose liability for non-financial related conduct.[21]

3. Disclosure Controls and Procedures

The court sided with SolarWinds in rejecting the SEC’s claims that the company failed to maintain and adhere to appropriate disclosure controls for cybersecurity incidents.  The court was unwilling to accept the SEC’s argument that one-off issues—even if the company misapplied its existing disclosure controls in considering cybersecurity incidents—gave rise to a claim that the company failed to maintain such controls.  Importantly, this case relates to conduct prior to the adoption of the SEC’s 2023 cybersecurity rules, which have made it even more important for companies to maintain appropriate controls.

The court acknowledged that SolarWinds had misclassified the severity level of two incidents under its Incident Response Plan (IRP) and failed to elevate a vulnerability to the CEO and CTO for disclosure.[22]  However, the court found that these instances—without more—did not support a claim that SolarWinds maintained ineffective disclosure controls.

The SEC did not plead deficiency in the “construction” of SolarWinds’ IRP, nor did it allege routine misclassification of incidents or frequent errors as a result of applying that framework.[23]  The court implied that disclosure controls do not have to be perfect—they should provide reasonable assurance that information is being collected for disclosure consideration.  The court thus found that the one-off issues identified by the SEC in applying the IRP and associated cybersecurity disclosure controls were not, without more, sufficient to “plausibly impugn [a] company’s disclosure controls systems.”[24]

Key Takeaways

Internal Accounting Controls. 

• Notably, on June 18, 2024 the SEC claimed in a settlement that another company that had experienced cyber incidents violated rules relevant to internal accounting controls.  The SEC alleged that the company failed to “provide reasonable assurances…that access to company assets is permitted only in accordance with management’s…authorization.”[25]  The SEC’s claims and approach in that settlement were seen as particularly aggressive as the predicate cybersecurity incident (for which the controls would be relevant) did not impact financial systems or corporate financial and accounting data.   That settlement also evoked a notable dissent from two Commissioners arguing that the internal accounting controls provision did not apply to a company’s overall cybersecurity program.
• The court in this case comprehensively repudiated the SEC’s effort to bring an internal accounting controls violation based on Section 13(b)(2)(B) in the context of cybersecurity-related actions.  The court found the SEC’s position that their authority to regulate an issuer’s “system of internal accounting controls” includes authority to regulate cybersecurity controls “not tenable,” and unsupported by the statute, legislative intent, or precedent. [26]  The court held that the statute cannot be construed to broadly cover all systems public companies use to safeguard their valuable assets and that the statute’s reach is limited as it governs systems of “internal accounting controls.”[27]
• As such, the SolarWinds decision calls into question—and may signal an end to—the SEC’s recent attempts to adopt an expansive reading of its rules relating to internal accounting controls to govern cybersecurity controls—whether or not such cybersecurity controls are relevant to the production of financial reports.

Disclosure Controls and Procedures.

• The decision also calls into question the SEC’s ability to rely on claims of inadequate disclosure controls and procedures in similar circumstances, given that the court found that more than a single disclosure failure is required to put the adequacy of a company’s disclosure controls and procedures in issue.
• While this fact-based finding provides reassurance that good-faith, day-to-day mistakes at a company may not be actionable, it remains important to design and maintain disclosure controls that provide for appropriate escalation and consideration.

Assessing Fraud Claims Based on Public Disclosures.

• When evaluating the accuracy of public disclosures in the context of a securities fraud claim, representations are to be evaluated based on a holistic assessment, rather than each statement in isolation. The court rearticulated the long-standing view the investing public “evaluates the information available to it ‘as a whole.’”  Nevertheless, a securities fraud claim may be pursued where there is evidence that the company—or a CISO or other company officer—is aware of inaccuracies at the time such statements are made.

[1] Opinion and Order, SEC v. SolarWinds Corp. and T. Brown, 1:23-cv-09518-PAE (S.D.N.Y. July 18, 2024) (hereinafter “Order”).

[2] Order at 3, 94–102.

[3] See Gibson Dunn Client Alert, “SEC as Cybersecurity Regulator” (June 20, 2024), available at https://www.gibsondunn.com/wp-content/uploads/2024/06/sec-as-cybersecurity-regulator.pdf?v2; R.R. Donnelley & Sons, No. 3-21969 (S.E.C. June 18, 2024) (order instituting cease and desist proceedings), available at https://www.sec.gov/files/litigation/admin/2024/34-100365.pdf.

[4] Complaint, SEC v. SolarWinds Corp. and T. Brown, No. 23-cv-9518 (Oct. 30, 2023), https://www.sec.gov/files/litigation/complaints/2023/comp-pr2023-227.pdf.

[5] In the Matter of Certain Cybersecurity-Related Events (HO-14225) FAQs, U.S. Securities and Exchange Commission, available at https://www.sec.gov/enforce/certain-cybersecurity-related-events-faqs.

[6] Am. Compl., SEC v. SolarWinds Corp. and T. Brown, No. 23-cv-9518-PAE (S.D.N.Y. Feb. 20, 2024).

[7] Mem. of Law in Support of Mot. to Dismiss, SEC v. SolarWinds Corp. and T. Brown, No. 23-cv-9518-PAE (S.D.N.Y. Mar. 22, 2024).

[8] See Order at 3.

[9] Order at 54.

[10] Order at 54.

[11] Order at 61.

[12] Order at 51 (citation omitted).

[13] Order at 68 (citation omitted).

[14] Order at 71–79.

[15] Order at 75.

[16] Order at 73.

[17] Order at 90.

[18] Order at 96.

[19] Order at 100.

[20] Order at 97–98.

[21] 2023 Year-End Securities Enforcement Update – Gibson Dunn (end notes 20–22); SEC Statement, The SEC’s Swiss Army Statute:  Statement on Charter Communications, Inc. (Nov. 14, 2023), available at https://www.sec.gov/news/statement/peirce-uyeda-statement-charter-communications-111423#_ftn6.

[22] Order at 102–106.

[23] Order at 104.

[24] Order at 106.

[25] R.R. Donnelley & Sons, No. 3-21969 (S.E.C. June 18, 2024) (order instituting cease and desist proceedings), available at https://www.sec.gov/files/litigation/admin/2024/34-100365.pdf.

[26] Order at 96.

[27] Order at 96–97.

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The following Gibson Dunn lawyers prepared this update: Mark Schonfeld, David Woodcock, Ronald Mueller, Brian Lane, Vivek Mohan, Stephenie Gosnell Handler, Sophie Rohnke, Michael Roberts, Sarah Pongrace, and Ashley Marcus.

Gibson Dunn lawyers are available to assist in addressing any questions you may have regarding these developments. Please contact the Gibson Dunn lawyer with whom you usually work, the authors, or any leader or member of the firm’s Securities Enforcement, Privacy, Cybersecurity & Data Innovation, or Securities Regulation & Corporate Governance practice groups:

Securities Enforcement:
Tina Samanta – New York (+1 212.351.2469, [email protected])
Mark K. Schonfeld – New York (+1 212.351.2433, [email protected])
David Woodcock – Dallas/Washington, D.C. (+1 214.698.3211, [email protected])

Privacy, Cybersecurity and Data Innovation:
Ahmed Baladi – Paris (+33 (0) 1 56 43 13 00, [email protected])
S. Ashlie Beringer – Palo Alto (+1 650.849.5327, [email protected])
Stephenie Gosnell Handler – Washington, D.C. (+1 202.955.8510, [email protected])
Joel Harrison – London (+44 20 7071 4289, [email protected])
Jane C. Horvath – Washington, D.C. (+1 202.955.8505, [email protected])
Vivek Mohan – Palo Alto (+1 650.849.5345, [email protected])
Rosemarie T. Ring – San Francisco (+1 415.393.8247, [email protected])
Sophie C. Rohnke – Dallas (+1 214.698.3344, [email protected])

Securities Regulation and Corporate Governance:Elizabeth Ising – Washington, D.C. (+1 202.955.8287, [email protected])
Thomas J. Kim – Washington, D.C. (+1 202.887.3550, [email protected])
Brian J. Lane – Washington, D.C. (+1 202.887.3646, [email protected])
Julia Lapitskaya – New York (+1 212.351.2354, [email protected])
James J. Moloney – Orange County (+1 1149.451.4343, [email protected])
Ronald O. Mueller – Washington, D.C. (+1 202.955.8671, [email protected])
Michael Scanlon – Washington, D.C.(+1 202.887.3668, [email protected])
Lori Zyskowski – New York (+1 212.351.2309, [email protected])

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

Katharina Humphrey and Sophie Rohnke are the authors of “SEC weitet Zuständigkeit deutlich auf Cybersicherheit aus” [PDF] (SEC significantly expands jurisdiction to include cybersecurity), published by Börsen-Zeitung on July 19, 2024. The article outlines the issue of cyber security with a view to internal accounting control regulations in the U.S. and its impact on German companies with a U.S. listing.

The challengers to the Rule have explained that if the court rules for them on the merits, then the remedy is for the court to vacate the Rule nationwide, in an order that is not limited to the parties in the case. A decision is expected by August 30.

This past Friday, July 19, global tax-consulting firm Ryan, LLC moved for summary judgment in its challenge to the Federal Trade Commission’s Non-Compete Rule in the U.S. District Court for the Northern District of Texas.[1]  Gibson Dunn represents Ryan.  A group of trade associations led by the United States Chamber of Commerce has likewise moved for summary judgment.  Ryan and the trade associations previously won a preliminary injunction and stay of the Rule’s effective date (see Gibson Dunn’s July 5 client alert), which was limited to the parties to the case.[2]

Ryan’s primary argument—which the Court already found was likely to succeed—is that the FTC lacks statutory authority to promulgate the Non-Compete Rule.  Ryan also argues that a grant of rulemaking authority to define “unfair methods of competition” would constitute an unconstitutional delegation of legislative power; that the rule is unlawfully retroactive; and that the FTC Commissioners are unconstitutionally insulated from the President’s control.  Ryan further contends that the Non-Compete Rule is arbitrary and capricious in violation of the Administrative Procedure Act, because the FTC failed to justify the nearly universal breadth of its ban, overstated the Rule’s purported benefits, and understated its costs.

Ryan has asked the Court to vacate the Non-Compete Rule, with nationwide effect.  As Ryan explained in its motion, under applicable Fifth Circuit precedent, if the Court rules for Ryan on the merits, then under the Administrative Procedure Act it is required to vacate the Rule in an order that is not limited to the parties to the case.

The Court has stated that it will rule on the summary judgment motions by August 30, shortly before the Rule is set to take effect on September 4.  Briefing on Ryan’s and the trade associations’ motions, as well as the FTC’s expected cross-motion for summary judgment, is scheduled to be completed on August 16.

[1] Ryan’s brief in support of its motion is available here.

[2] Further analysis of the FTC’s Non-Compete Rule is available here.

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Eugene Scalia, Allyson N. Ho, Amir C. Tayrani, Andrew Kilberg, Elizabeth A. Kiernan, Aaron Hauptman, and Josh Zuckerman represent Ryan, LLC and prepared this update.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding the issues discussed in this update. Please contact the Gibson Dunn lawyer with whom you usually work, the authors, or any leader or member of the firm’s Administrative Law & Regulatory, Labor & Employment, or Antitrust & Competition practice groups:

Administrative Law and Regulatory:
Allyson N. Ho – Dallas (+1 214.698.3233, [email protected])
Eugene Scalia – Washington, D.C. (+1 202.955.8673, [email protected])
Amir C. Tayrani – Washington, D.C. (+1 202.887.3692, [email protected])
Helgi C. Walker – Washington, D.C. (+1 202.887.3599, [email protected])

Labor and Employment:
Andrew G.I. Kilberg – Washington, D.C. (+1 202.887.3759, [email protected])
Karl G. Nelson – Dallas (+1 214.698.3203, [email protected])
Jason C. Schwartz – Washington, D.C. (+1 202.955.8242, [email protected])
Katherine V.A. Smith – Los Angeles (+1 213.229.7107, [email protected])

Antitrust and Competition:
Rachel S. Brass – San Francisco (+1 415.393.8293, [email protected])
Svetlana S. Gans – Washington, D.C. (+1 202.955.8657, [email protected])
Cynthia Richman – Washington, D.C. (+1 202.955.8234, [email protected])
Stephen Weissman – Washington, D.C. (+1 202.955.8678, [email protected])

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

From the Derivatives Practice Group: This week, the Hong Kong Monetary Authority and Financial Services and the Treasury Bureau published the Consultation Conclusions on the Legislative Proposal to Implement the Regulatory Regime for Stablecoin Issuers in Hong Kong.

New Developments

• President Biden Announced Intent to Nominate Julie Brinn Siegel as a Commissioner of the CFTC. On July 11, President Biden announced his intent to nominate Julie Brinn Siegel to be a Commissioner of the CFTC. Siegel currently serves as the federal government’s deputy chief operating officer as Senior Coordinator for Management at the Office of Management and Budget (OMB). Prior to that, Siegel served as Secretary of the Treasury Janet Yellen’s Deputy Chief of Staff and served as Senior Counsel and Policy Advisor to U.S. Senator Elizabeth Warren (D-MA). Last month, President Biden nominated CFTC Commissioner Johnson to be Assistant Secretary for Financial Institutions at the Department of Treasury and nominated CFTC Commissioner Christy Goldsmith Romero to be Chair and Member of the Federal Deposit Insurance Corporation (FDIC) which, if confirmed by the Senate, would leave open two Democratic Commissioner seats at the CFTC. Siegel, if nominated and confirmed by the Senate, would take the seat of Commissioner Goldsmith Romero.
• First Interagency Fraud Disruption Conference Focuses on Combatting Crypto Schemes Commonly Known as “Pig Butchering.” On July 11, the CFTC and the DOJ’s Computer Crime and Intellectual Property Section’s National Cryptocurrency Enforcement Team (“NCET”) convened the first Fraud Disruption Conference to work on efforts to combat a type of fraud commonly known as “pig butchering”. It is estimated that Americans are scammed out of billions per year, making this a top law enforcement priority. The working group addressed strategies to prevent victimization; using technology to disrupt the fraud; and collaboration on enforcement efforts. Several agencies also collaborated on an anti-victimization messaging campaign to warn Americans to remain vigilant against emerging fraud threats.
• Supreme Court Overrules Chevron, Sharply Limiting Judicial Deference To Agencies’ Statutory Interpretation. On June 28, the Supreme Court overruled Chevron v. Natural Resources Defense Council, a landmark decision that had required courts to defer to agencies’, including the CFTC’s, reasonable interpretations of ambiguous statutory terms. For a more detailed analysis of the ruling please refer to Gibson Dunn’s client alert, available here.
• CFTC Announces Supervisory Stress Test Results. On July 1, the CFTC issued Supervisory Stress Test of Derivatives Clearing Organizations: Reverse Stress Test Analysis and Results, a report detailing the results of its fourth Supervisory Stress Test (“SST”) of derivatives clearing organization (“DCO”) resources. Among other findings, the 2024 report concluded the DCOs studied hold sufficient financial resources to withstand many extreme and often implausible price shocks. The purpose of the analysis was twofold: (1) to identify hypothetical combinations of extreme market shocks, concurrent with varying numbers of clearing member (“CM”) defaults, that would exhaust prefunded resources (DCO committed capital, and default fund), and unfunded resources available to the DCOs (this represents the reverse stress test component), and (2) to analyze the impacts of DCO use of mutualized resources on non-defaulted CMs.

New Developments Outside the U.S.

• ESAs Establish Framework to Strengthen Coordination in Case of Systemic Cyber Incidents. On July 17, the European Supervisory Authorities (“ESAs”) announced they will establish the EU systemic cyber incident coordination framework (“EU-SCICF”), in the context of the Digital Operational Resilience Act (“DORA”), that will aim to facilitate an effective financial sector response to a cyber incident that poses a risk to financial stability, by strengthening the coordination among financial authorities and other relevant bodies in the European Union, as well as with key actors at international level. [NEW]
• ESAs Publish Second Batch of Policy Products under DORA. On July 17, the ESAs published the second batch of policy products under DORA. This batch consists of four final draft regulatory technical standards, one set of Implementing Technical Standards and 2 guidelines, all of which aim at enhancing the digital operational resilience of the EU’s financial sector. [NEW]
• Hong Kong HKMA and FSTB Publishes Results from Stablecoin Consultation. On July 17, 2024, the Hong Kong Monetary Authority (“HKMA”) and Financial Services and the Treasury Bureau (“FSTB”) published the Consultation Conclusions on the Legislative Proposal to Implement the Regulatory Regime for Stablecoin Issuers in Hong Kong (“Consultation Conclusions”). The Consultation Conclusions outlined the legislative proposal to implement a regulatory regime for fiat-referenced stablecoin (“FRS”) issuers in Hong Kong. The regime will primarily focus on representations of value which rest on ledgers that are operated in a decentralized manner in which no person has the unilateral authority to control or materially alter its functionality or operation. Under this regime, FRS issuers will require a license. Foreign entities intending to apply for a license will be required to establish a Hong Kong subsidiary and have key management personnel in the territory. [NEW]
• ESMA Consults on Firms’ Order Execution Policies Under MiFID II. On July 16, ESMA launched a consultation on draft technical standards specifying the criteria for how investment firms establish and assess the effectiveness of their order execution policies. The objective of the proposed technical standards is to foster investor protection by enhancing investment firms’ order execution. [NEW]
• ESMA Publishes 2023 Data on Cross-Border Investment Activity of Firms. On July 15, ESMA announced they completed an analysis of the cross-border provision of investment services during 2023. The main findings include that a total of around 386 firms provided services to retail clients on a cross-border basis in 2023; compared to 2022, the cross-border market for investment services grew by 1.6% in terms of firm numbers, and by 5% in terms of retail clients, while the number of complaints increased by 31%; and Germany, France, Spain, and Italy are the most significant destinations (in terms of number of retail clients) for investment firms providing cross-border services in other Member States. [NEW]
• ESAs Consult on Guidelines under the Markets in Crypto-Assets Regulation. On July 12, the ESAs published a consultation paper on Guidelines under Markets in Crypto-assets Regulation (“MiCA”), establishing templates for explanations and legal opinions regarding the classification of crypto-assets along with a standardized test to foster a common approach to classification.
• ESAs Report on the Use of Behavioral Insights in Supervisory and Policy Work. On July 11, the ESAs published a joint report following their workshop on the use of behavioral insights by supervisory authorities in their day-to-day oversight and policy work. The report provides a high-level overview of the main topics discussed during the workshop held in February 2024 for national supervisors and other competent authorities, where participants explored the added value of behavioral insights in their work by exchanging their experiences and discussing the challenges they face.
• ESMA Publishes the 2024 ESEF Reporting Manual. On July 11, ESMA published the update of its Reporting Manual on the European Single Electronic Format (“ESEF”) supporting a harmonized approach for the preparation of annual financial reports. ESMA has also updated the Annex II of the Regulatory Technical Standards (“RTS”) on ESEF.
• ESMA Publishes Statement on Use of Collateral by NFCs Acting as Clearing Members. On July 10, ESMA issued a public statement on deprioritizing supervisory actions linked to the eligibility of uncollateralized public guarantees, public bank guarantees, and commercial bank guarantees for Non-Financial Counterparties (“NFCs”) acting as clearing members, pending the entry into force of EMIR 3.
• ESMA Launches New Consultations. On July 10, ESMA published a new package of public consultations with the objective of increasing transparency and system resilience in financial markets, reducing reporting burden and promoting convergence in the supervisory approach.
• ESMA Consults on Rules to Recalibrate and Further Clarify the Framework. On July 9, ESMA launched new consultations on different aspects of the Central Securities Depositories Regulation (“CSDR”) Refit. The proposed rules relate to the information to be provided by European CSDs to their national competent authorities (“NCA”s) for the review and evaluation, the information to be notified to ESMA by third-country CSDs, and the scope of settlement discipline.
• ESMA Consults on Liquidity Management Tools for Funds. On July 8, ESMA announced it is seeking input on draft guidelines and technical standards under the revised Alternative Investment Fund Managers Directive (“AIFMD”) and the Undertakings for Collective Investment in Transferable Securities (“UCITS”) Directive. Both Directives aim to mitigate potential financial stability risks and promote harmonization of liquidity risk management in the investment funds sector.
• ESMA Consults on Reporting Requirements and Governance Expectations for Some Supervised Entities. On July 8, ESMA launched two consultations on proposed guidance for some of its supervised entities. The consultations are aimed at the following entities supervised by ESMA: Benchmark Administrators, Credit Rating Agencies, and Market Transparency Infrastructures. The Consultation Paper sets out the information ESMA expects to receive and a timeline for supervised entities to provide the required information. The objective of the Draft Guidelines is to ensure consistency in cross-sectoral reporting.
• ESMA Puts Forward Measures to Support Corporate Sustainability Reporting. On July 5, ESMA published a Final Report on the Guidelines on Enforcement of Sustainability Information (“GLESI”) and a Public Statement on the first application of the European Sustainability Reporting Standards (“ESRS”). ESMA reports that these documents will support the consistent application and supervision of sustainability reporting requirements.
• ESMA Releases New MiCA Rules To Increase Transparency for Retail Investors. On July 4, ESMA published the second Final Report under the Markets in Crypto-Assets Regulation (MiCA) covering eight draft technical standards that aim to provide more transparency for retail investors, clarity for providers on the technical aspects of disclosure and record-keeping requirements, and data standards to facilitate supervision by National Competent Authorities (“NCAs”). The report covers public disclosures, as well as descriptions on how issuers should disclose price-sensitive information to the public to prevent market abuses, such as insider dealing.
• ESMA Reappoints Three Members to its Management Board. On July 4, ESMA announced that it has reappointed three current members to its Management Board. The appointments took place at the Board of Supervisors meeting on July 3. The Management Board, chaired by Verena Ross, Chair of ESMA, is responsible for ensuring that the Authority carries out its mission and performs the tasks assigned to it under its founding Regulation.

New Industry-Led Developments

• ISDA Publishes Whitepaper: Hedge Accounting Under US GAAP. On July 16, ISDA published a whitepaper that explores the issues faced by financial and non-financial institutions in applying hedge accounting for interest rate risk, foreign exchange risk and other risks. It highlights both the prescriptive nature of Accounting Standards Codification 815 and the inconsistent interpretations among auditors, which together create operational burdens and can limit hedging strategies. The paper proposes potential solutions to these challenges, including the expansion of hedge eligibility and the revision of hedge accounting criteria, to allow better use of existing risk management tools. [NEW]
• ISDA and SIFMA Submit Addendum on GIRR Curvature to US Basel III NPR. On July 15, ISDA and the Securities Industry and Financial Markets Association (“SIFMA”) submitted an addendum to the joint US Basel III “endgame” notice of proposed rulemaking. The addendum contains a proposal for general interest rate risk (“GIRR”) curvature to fix an issue that was recently identified. [NEW]
• ISDA Chief Executive Officer Scott O’Malia Offers Informal Comments on Terminating Derivatives Contracts. On July 15, ISDA CEO Scott O’Malia opined on the process to terminate a derivatives contract. ISDA is developing wo initiatives – the ISDA Close-out Framework and the ISDA Notices Hub – that will help ensure a key part of the termination process is more efficient. The ISDA Close-out Framework is designed to illustrate the various steps and decisions firms need to take and is intended as a preparatory tool for future stress events. The ISDA Notices Hub allows the instantaneous delivery and receipt of notices via a secure online platform, eliminating risk exposures and potential losses that can result from delays in terminating derivatives contracts. [NEW]
• Trade Associations Submit Letter on EMIR IM Model Validation. On July 8, ISDA, the Alternative Investment Management Association (“AIMA”), the European Fund and Asset Management Association (“EFAMA”) and the Securities Industry and Financial Markets Association’s asset management group (“SIFMA AMG”) submitted a letter to the ESAs and the European Commission on initial margin (“IM”) model approval requirements set out in the European Market Infrastructure Regulation (“EMIR 3.0”). The letter highlights challenges posed by the three-month period granted to the European Banking Authority and NCAs to validate changes to an IM model and describes how the ISDA Standard Initial Margin Model (“ISDA SIMM”) schedule can be amended to address these issues.
• ISDA Proceeds with Development of an Industry Notices Hub. On July 1, ISDA announced it will proceed with the development of an industry-wide notices hub, following strong support from buy- and sell-side institutions globally. The new online platform will allow instantaneous delivery and receipt of critical termination-related notices and help to ensure address details for physical delivery are up to date, reducing the risk of uncertainty and potential losses for senders and recipients of these notices.

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The following Gibson Dunn attorneys assisted in preparing this update: Jeffrey Steiner, Adam Lapidus, Marc Aaron Takagaki, Hayden McGovern, and Karin Thrasher.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding these developments. Please contact the Gibson Dunn lawyer with whom you usually work, any member of the firm’s Derivatives practice group, or the following practice leaders and authors:

Jeffrey L. Steiner, Washington, D.C. (202.887.3632, [email protected])

Michael D. Bopp, Washington, D.C. (202.955.8256, [email protected])

Michelle M. Kirschner, London (+44 (0)20 7071.4212, [email protected])

Darius Mehraban, New York (212.351.2428, [email protected])

Jason J. Cabral, New York (212.351.6267, [email protected])

Adam Lapidus  – New York (212.351.3869,  [email protected] )

Stephanie L. Brooker, Washington, D.C. (202.887.3502, [email protected])

William R. Hallatt , Hong Kong (+852 2214 3836, [email protected] )

David P. Burns, Washington, D.C. (202.887.3786, [email protected])

Marc Aaron Takagaki , New York (212.351.4028, [email protected] )

Hayden K. McGovern, Dallas (214.698.3142, [email protected])

Karin Thrasher, Washington, D.C. (202.887.3712, [email protected])

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

Ashley Johnson and Jennafer Tryck are the authors of “Dueling Calif. Rulings Offer Insight On 401(k) Forfeiture Suits” [PDF] published by Law360 on July 17, 2024.

Gibson Dunn’s Workplace DEI Task Force aims to help our clients develop creative, practical, and lawful approaches to accomplish their DEI objectives following the Supreme Court’s decision in SFFA v. Harvard. Prior issues of our DEI Task Force Update can be found in our DEI Resource Center. Should you have questions about developments in this space or about your own DEI programs, please do not hesitate to reach out to any member of our DEI Task Force or the authors of this Update (listed below).

Key Developments

Following his recent attacks on Tractor Supply, social media personality Robby Starbuck launched another campaign on July 9, this time against John Deere. In a series of posts on X, Starbuck criticized John Deere for its DEI policies, workplace affinity groups, sponsorship of Pride events, and affiliation with shareholder Bill Gates. In dozens of tweets and social media posts, Starbuck characterized John Deere’s policies as “woke,” “creepy,” “communist”-like, and “crazy,” and called upon his followers to complain to John Deere’s customer service office and directly to its CEO. On July 16, apparently in response to Starbuck’s campaign, John Deere announced that it will no longer participate in or support “social or cultural awareness parades, festivals, or events,” that it will audit training materials “to ensure the absence of socially-motivated messages,” that it will “reaffirm” that the “existence of diversity quotas and pronoun identification have never been and are not company policy,” and that its Business Resource Groups will focus exclusively on things like professional development, networking, and mentoring. However, John Deere said that it would “continue to track and advance the diversity of our organization.” Starbuck immediately claimed victory, but called John Deere’s commitments “half measures,” saying that customers “want to hear that DEI policies are entirely gone.” Starbuck has said that he is planning to “expose” another company soon and that he will be targeting companies that rely on politically conservative consumers.

On June 24, 2024 and July 10, 2024, the Equal Protection Project (EPP) filed complaints with the U.S. Department of Education’s Office for Civil Rights (OCR) against Ithaca College and Rochester Institute of Technology. The EPP alleges that two of Ithaca College’s scholarship programs discriminate based on race and skin color in violation of Title VI because they are offered only to students of color. The EPP also alleges that Rochester Institute of Technology’s “Women in STEM” scholarship, which is offered exclusively to female, female-identifying, or non-binary students, discriminates based on sex and gender identity in violation of Title IX. OCR is evaluating both of EPP’s complaints.

On July 10, a three-judge panel for the Seventh Circuit affirmed summary judgment for Honeywell in Charles Vavra v. Honeywell International, Inc., No. 23-2823 (7th Cir.). Vavra argued that Honeywell violated Title VII and Illinois law by retaliating against him for refusing to watch a training video he claimed discriminated against white people. The district court granted summary judgment on Vavra’s claims last August after finding that he failed to show either that he was terminated due to bias or that the training itself was racist. Vavra appealed, and argued before the Seventh Circuit that the video crossed a line when it stated that workers carry unconscious biases. In an opinion written by Judge Kirsch, the court reasoned that Vavra could not have reasonably believed that the training video was discriminatory because he never watched it, and Vavra had failed to prove retaliatory motive..

On July 10, EEOC Vice Chair Jocelyn Samuels told attendees of an agency webinar that the Supreme Court’s recent decision in Muldrow v. City of St. Louis should have “no impact” on “lawful and appropriate” DEI work. While some have speculated that Muldrow will result in more challenges to company DEI programs, Vice Chair Samuels maintained that most company DEI efforts will remain unaffected by the decision. “The vast majority of the kinds of DEIA initiatives that employers are undertaking are what I call race-neutral,” she said, noting such programs “are carried out in ways that benefit everyone in the workplace.” EEOC Commissioner Kalpana Kotagal, who also spoke during the webinar, supported Samuels’ position, stating that “[a]s the case law is starting to really demonstrate, there are so many ways to lawfully implement DEIA initiatives that shouldn’t be difficult to defend and support.” Kotagal discussed examples of policies that she said remain lawful, such as targeted outreach to increase the diversity of applicant pools, voluntary employee affinity groups, and mentorship and training opportunities open to all applicants. “In general,” she said, “these kinds of programs are not going to be problematic because there’s no need to tie them to a protected class.”

Media Coverage and Commentary:

Below is a selection of recent media coverage and commentary on these issues:

• Wall Street Journal, “How Tractor Supply Decided to End DEI, and Fast” (June 30): The Journal’s Sarah Nassauer reports on Tractor Supply’s June 27 decision to end its DEI programming and climate change goals, in response to a public pressure campaign launched on June 6 by “former Hollywood director turned conservative activist” Robby Starbuck. Using publicly available statements and videos, including a video of Tractor Supply Chief Executive Hal Lawton talking about the importance of company diversity and inclusion, Starbuck called upon customers to boycott the company. The “effectiveness of Starbuck’s campaign,” writes Nassauer, seems like a sign of “how the tide has turned” against corporate DEI programming. Nassauer suggests that companies like Tractor Supply, whose customers skew more male, rural and conservative, are increasingly seeing DEI initiatives as presenting “too much of a risk.” But companies’ reactions to the current DEI backlash have varied. As David Glasgow, executive director of the Meltzer Center for Diversity, Inclusion and Belonging, told Nassauer, companies favored by “liberal consumers” are largely maintaining their DEI commitments. Tractor Supply’s decision, says Glasgow, represents “an illustration of the two Americas.”
• Reuters, “Fearless Fund: Diversity funds and Black founders feel chill” (July 2): Reuters’ Krystal Hu reports that the Eleventh Circuit’s June 3 decision enjoining Fearless Fund’s Strivers Grant Contest, which provides financial support to Black female entrepreneurs, is having “a chilling effect across the small industry of diversity-focused venture capital funds.” The court’s decision could affect some $200 billion committed to similar funding initiatives nationwide, writes Hu. Recent data from Crunchbase indicates that venture funding of Black entrepreneurs, which “surged in 2021,” has since “plunged.” Hu notes that several of Fearless Fund’s financing partners have withdrawn, citing the court’s decision. But Hu says that the minority venture capital community is not backing down. “People have the right to fund marginalized communities if and when racial disparities exist, and that is something needs to be protected,” Arian Simone, CEO of Fearless Fund, told Hu. Shila Nieves Burney, a general partner at Zane Venture Fund, another Atlanta-based fund, told Hu that she will continue to “back diverse teams” despite the Eleventh Circuit decision. But Burney expressed concern that the already limited funding provided to Black entrepreneurs is under threat: “If Fearless Fund is not able to raise their next fund, that creates a huge gap in the ecosystem. When there’s an attack on Black VCs, who’s going to fill that gap?”
• Law360, “Armstrong Teasdale Resisted Diversity, Ex-DEI VP Says” (July 5): Law360’s Lauren Berg reports on a lawsuit filed June 30 in Missouri state court by Armstrong Teasdale LLP’s former vice president of diversity, equity and inclusion. Sonji R. Young, a Black woman hired in February 2021 to be the firm’s first DEI officer, claims that she experienced sex, age, race, color, and disability discrimination, as well as retaliation and defamation. Young alleges that firm officers, partners, and staff—most of whom are white—repeatedly obstructed her efforts to improve diversity and inclusion at the firm by refusing to train her on firm systems, denying her requests for additional staff and for funding of employee resource groups, undermining her efforts to recruit diverse talent, and otherwise withholding their support for DEI initiatives. Young also alleges that she was terminated in February 2023 after recommending certain DEI-related changes to the firm’s managing partner.
• Washington Post, “Many universities are abandoning race-conscious scholarships worth millions” (July 9): The Post’s Danielle Douglas-Gabriel reports on the elimination of race-conscious scholarship criteria at dozens of colleges and universities. The Post has identified nearly 50 institutions that have “paused, ended or reconfigured hundreds of race-conscious scholarships worth . . . at least $45 million.” Most of these changes are occurring at public universities in states like Wisconsin, Ohio, and Missouri, where Republican legislators have passed laws banning race-conscious financial aid. Because far more colleges and universities rely on financial aid to improve student body diversity, as opposed to race-conscious admissions policies, Douglas-Gabriel reports that higher education experts are worried that this shift will have “a more profound impact on diversity in higher education” than the SFFA affirmative action decision itself. Faced with legislative mandates, institutions in these states are now shifting scholarship eligibility criteria away from race and toward alternatives like household income, zip code, or first generation-student status. But even these alternatives, if too close a proxy for race, “could run afoul of the law,” New York University School of Law professor Kenji Yoshino told the Post. Douglas-Gabriel notes that many donors are unhappy with these changes, including Mary Willis and Cynthia Willis-Esqueda, sisters who helped create a scholarship for Black, Hispanic, and Native students in honor of their father, a former professor at the University of Missouri at Kansas City. Willis and Willis-Esqueda are considering legal action of their own, expressing anger “that anybody would dare to say that we can’t decide where our little bit of inheritance goes.”

Case Updates:

Below is a list of updates in new and pending cases:

1. Contracting claims under Section 1981, the U.S. Constitution, and other statutes:

• Do No Harm v. Pfizer, Inc., 646 F. Supp. 3d 490 (S.D.N.Y. 2022); No. 23-15 (2d Cir. 2024): On September 15, 2022, conservative medical advocacy organization Do No Harm filed suit against Pfizer, alleging that Pfizer discriminated against white and Asian students by excluding them from its Breakthrough Fellowship Program which provides college seniors with summer internships, two years of employment post-graduation, mentoring, and a two-year scholarship for a full-time master’s program. To be eligible, applicants must “[m]eet the program’s goals of increasing the pipeline for Black/African American, Latino/Hispanic and Native Americans.” Do No Harm requested a temporary restraining order and preliminary and permanent injunctions against the program’s eligibility criteria. In December 2022, the district court denied Do No Harm’s motion for a preliminary injunction and dismissed the case for lack of subject matter jurisdiction, finding that Do No Harm lacked Article III standing because it did not identify at least one member by name. Do No Harm appealed to the Second Circuit, which on March 6, 2024 affirmed the district court’s dismissal, holding that an organization must name at least one affected member to establish Article III standing under the “clear language” of Supreme Court precedent. (We previously covered this decision here.) Do No Harm petitioned for rehearing en banc.
  • Latest update: On July 1, Pfizer filed its opposition to Do No Harm’s petition for rehearing en banc, arguing that the case does not conflict with Supreme Court or Second Circuit authority, create a conflict among the circuits, or present “a question of exceptional importance.”
• Do No Harm v. Gianforte., No. 6:24-cv-00024-BMM-KLD (D. Mont. 2024): On March 12, 2024, Do No Harm filed a complaint on behalf of “Member A,” a white female dermatologist in Montana, alleging that a Montana law violates the Equal Protection Clause by requiring the governor to “take positive action to attain gender balance and proportional representation of minorities resident in Montana to the greatest extent possible” when making appointments to the state’s twelve-member Medical Board. Do No Harm alleges that since the ten already-filled seats are currently held by six women and four men, Montana law requires that the remaining two seats be filled by men, which would preclude Member A from holding the seat. On June 7, Governor Gianforte moved to dismiss for lack of jurisdiction.
  • Latest update: On June 28, 2024, Do No Harm filed its opposition, arguing that its individual members have standing because the Supreme Court treats any statute that denies equal treatment as causing an injury in fact, regardless of whether a candidate has actually applied for a position. Further, Do No Harm argued that Governor Gianforte’s promise to interpret the Montana statute without discriminating does not fix the constitutional problem, because the plain text of the law “authorizes or encourages unconstitutional consideration of race and gender.”
• Do No Harm v. National Association of Emergency Medical Technicians, No. 3:24-cv-11-CWR-LGI (S.D. Miss. 2024): On January 10, 2024, Do No Harm challenged the diversity scholarship program operated by the National Association of Emergency Medical Technicians (NAEMT), an advocacy group representing paramedics, EMTs, and other emergency professionals. NAEMT awards up to four $1,250 scholarships annually to students of color hoping to become EMTs or paramedics. Do No Harm requested a temporary restraining order, preliminary injunction, and permanent injunction against the program. On January 23, 2024, the court denied Do No Harm’s motion for a TRO, and NAEMT moved to dismiss Do No Harm’s amended complaint on March 18.
  • Latest update: On June 6, 2024, Do No Harm filed a notice of supplemental authority, drawing the court’s attention to the Eleventh Circuit’s decision in Fearless Fund, which it argued supports the claim that Do No Harm has associational standing because its members are able and ready to apply for a scholarship. On June 25, the defendant submitted a response, arguing that Fearless Fund does not help establish injury in fact because there “was never any racial requirement” for applicants to the NAEMT scholarship, whereas Fearless Fund involved a diversity program that explicitly barred everyone but black females from applying.
• Suhr v. Dietrich, No. 2:23-cv-01697-SCD (E.D. Wis. 2023): On December 19, 2023, a dues-paying member of the Wisconsin State Bar filed a complaint against the Bar over its “Diversity Clerkship Program,” a summer hiring program for first-year law students. The program’s application requirements had previously stated that eligibility was based on membership in a minority group. After the Supreme Court’s decision in SFFA, the eligibility requirements were changed to include students with “backgrounds that have been historically excluded from the legal field.” The plaintiff claims that the Bar’s program is unconstitutional even with the new race-neutral language, because, in practice, the selection process is still based on the applicant’s race or gender. The plaintiff also alleges that the Bar’s diversity program constitutes compelled speech and association in violation of the First Amendment. After reaching a partial settlement agreement with the Bar to remove the eligibility requirements concerning historically excluded backgrounds, the plaintiff filed an amended complaint, challenging three mentorship and leadership programs that allegedly discriminate based on race, which are funded by mandatory dues paid to the Bar. On May 31, the Bar moved to dismiss the amended complaint for failure to state a claim.
  • Latest update: On June 28, 2024, the plaintiff opposed the Bar’s motion to dismiss, arguing that the Bar’s dues-funded programs are not “germane to the constitutional purpose” of a bar association, thereby violating the First Amendment. The plaintiff also argued that his claims are not time-barred because they accrue every day that the diversity program continues.

2. Employment discrimination and related claims:

• Beneker v. CBS Studios, No. 2:24-cv-01659-JFW-SSC (C.D. Cal. 2024): On February 29, 2024, a straight, white, male writer sued CBS, alleging that the network’s de facto hiring policy discriminated against him on the bases of sex, race, and sexual orientation in violation of Section 1981 and Title VII. CBS declined to hire the plaintiff as a staff writer multiple times, but did hire several black writers, female writers, and a lesbian writer. The plaintiff requested a permanent injunction against the de facto policy, a staff writer position, and damages. On May 23, 2024, CBS Studios and parent company Paramount Global moved to dismiss.
  • Latest update: On June 24, 2024, the defendants filed a second motion to dismiss in light of the plaintiff’s voluntary dismissal of his Title VII claims and Section 1981 claims with respect to only the white female/lesbian writers. The defendants reaffirmed their theory that the First Amendment is a “complete bar” to the plaintiff’s remaining claims because CBS is an “expressive enterprise” and has the right to “select which writers are best suited” to convey its message. In the alternative, the defendants argued that two of the Section 1981 claims are time barred, in part because courts should not view discrete hiring decisions as creating “continuing violations” of Section 1981.
• Sobol v. DeJoy, No. 1:22-cv-00170-MWJS-RT (D. Haw. 2022): On April 15, 2022, a white man sued the United States Postal Service (USPS) for selecting a Black woman for a managerial role instead of him, alleging retaliation, hostile work environment, constructive discharge, and discrimination in violation of Title VII and the ADEA. On March 18, 2024, USPS moved for summary judgment.
  • Latest update: On July 9, 2024, the court granted USPS’s motion for summary judgment, finding that the plaintiff lacked sufficient evidence that the adverse employment action was discriminatory. The court also held that, even if the plaintiff could establish a prima facie case of discrimination, the USPS had asserted a legitimate, nondiscriminatory reason for its hiring decision.

3. Challenges to agency rules, laws and regulatory decisions:

• Do No Harm v. Lee, No. 3:23-cv-01175-WLC (M.D. Tenn. 2023): On November 8, 2023, Do No Harm sued Tennessee Governor Bill Lee under the Equal Protection Clause of the Fourteenth Amendment, seeking to enjoin a 1988 Tennessee law requiring the governor to “strive to ensure” that at least one board member of the six-member Tennessee Board of Podiatric Medical Examiners is a racial minority. On February 2, 2024, Governor Lee moved to dismiss the complaint for lack of standing. On February 16, Do No Harm opposed, contending that it satisfied standing requirements despite relying only on anonymous members. On March 1, 2024, the Governor replied in support of his motion.
  • Latest update: On June 28, 2024, Do No Harm filed a notice of supplemental authority, drawing the court’s attention to the Eleventh Circuit’s decision in the Fearless Fund case and the proceedings in American Alliance for Equal Rights v. Ivey, No. 2:24-cv-00104-RAH-JTA (M.D. Ala. 2024)—in both cases, the courts found that plaintiffs had satisfied the standing requirements even when they were suing on behalf of individual anonymous members. Do No Harm argued that these cases support its claim that its members individually have standing, even if they remain anonymous.
• American Alliance for Equal Rights v. Ivey, No. 2:24-cv-00104-RAH-JTA (M.D. Ala. 2024): On February 13, 2024, AAER filed a complaint against Alabama Governor Kay Ivey, challenging a state law that requires the governor to ensure there are no fewer than two individuals “of a minority race” on the Alabama Real Estate Appraisers Board. The Board has nine seats, including one for a member of the public with no real estate background, which has been unfilled for years. Because there was only one minority member among the Board at the time of filing, AAER asserts that state law requires that the open seat go to a minority. AAER states that one of its members applied for this final seat, but was denied purely on the basis of race, in violation of the Equal Protection Clause of the Fourteenth Amendment. On March 29, 2024, Governor Ivey answered the complaint, admitting that the Board quota is unconstitutional and will not be enforced. On May 7, 2024, the court granted a motion to intervene by the Alabama Association of Real Estate Brokers (AAREB), a trade association and civil rights organization for Black real estate professionals. On May 14, 2024, AAREB answered the complaint, seeking a declaration that the challenged law is valid and enforceable. On May 20, 2024, AAER moved for judgment on the pleadings. On June 10, Governor Ivey responded in support of AAER’s motion for judgment on the pleadings, but Intervenor AAREB opposed the motion.
  • Latest update: On June 26, 2024, AAER filed a reply brief in support of its motion for judgment on the pleadings, arguing that any “contested material factual allegations” related to standing were decided before AAREB intervened in the litigation, and that no other disputes remain outstanding.
• Lynn v. Goff, No. 1:24-cv-00211-CL (D. Or. 2024): On February 1, 2024, a white public school teacher filed a complaint against the Interim Executive Director of the Oregon Teacher Standards and Practices Commission, alleging that a state program reimbursing “diverse” teachers for the cost of obtaining or renewing their teaching licenses violated the Equal Protection Clause of the Fourteenth Amendment. In its answer, Oregon denied that it engaged in discriminatory treatment on the basis of skin color alone.
  • Latest update: On June 28, 2024, the parties filed a notice of joint advanced dispute resolution after Oregon issued a temporary rule to end the reimbursement program. The plaintiff agreed to voluntarily dismiss the case once the state issues a permanent rule.

4. Board of Director or Stockholder Actions:

• Ardalan v. Wells Fargo, No. 3:22-cv-03811 (N.D. Cal. 2022): On June 28, 2022, a putative class of Wells Fargo stockholders brought a class action against the bank related to an internal policy requiring that half of the candidates interviewed for positions that paid more than $100,000 per year be from an underrepresented group. The plaintiffs alleged that the bank conducted sham job interviews to create the appearance of compliance with this policy and that this was part of a fraudulent scheme to suggest to shareholders and the market that Wells Fargo was dedicated to DEI principles.
  • Latest update: On June 4, 2024, the plaintiffs moved to certify a class of all people and entities who had purchased Wells Fargo stock during the period when the bank allegedly engaged in sham job interviews. The plaintiffs also sought to remove the stay on discovery in order to prove that there are issues of law and fact common to the putative class. On June 25, 2024, the defendants opposed class certification, arguing that plaintiffs had not proved that they affirmatively met the requirements due to the stay. On July 7, the court granted the parties’ motion to continue certain deadlines and set a telephonic case management conference for August 1, 2024.

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The following Gibson Dunn attorneys assisted in preparing this client update: Jason Schwartz, Mylan Denerstein, Blaine Evanson, Molly Senger, Zakiyyah Salim-Williams, Matt Gregory, Zoë Klein, Mollie Reiss, Jenna Voronov, Alana Bevan, Marquan Robertson, Janice Jiang, Elizabeth Penava, Skylar Drefcinski, Mary Lindsay Krebs, David Offit, Lauren Meyer, Kameron Mitchell, Maura Carey, and Jayee Malwankar.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding these developments. Please contact the Gibson Dunn lawyer with whom you usually work, any member of the firm’s Labor and Employment practice group, or the following practice leaders and authors:

Jason C. Schwartz – Partner & Co-Chair, Labor & Employment Group
Washington, D.C. (+1 202-955-8242, [email protected])

Katherine V.A. Smith – Partner & Co-Chair, Labor & Employment Group
Los Angeles (+1 213-229-7107, [email protected])

Mylan L. Denerstein – Partner & Co-Chair, Public Policy Group
New York (+1 212-351-3850, [email protected])

Zakiyyah T. Salim-Williams – Partner & Chief Diversity Officer
Washington, D.C. (+1 202-955-8503, [email protected])

Molly T. Senger – Partner, Labor & Employment Group
Washington, D.C. (+1 202-955-8571, [email protected])

Blaine H. Evanson – Partner, Appellate & Constitutional Law Group
Orange County (+1 949-451-3805, [email protected])

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

This update provides key takeaways on the new draft guidance and Diversity Action Plan requirements, including when the new requirements will go into effect, the types of clinical studies that require submission of a Diversity Action Plan, whether FDA intends to issue waivers for the requirements, and the consequences of failure to submit a Diversity Action Plan.

On June 26, 2024, FDA released its long-awaited draft guidance on Diversity Action Plans to increase enrollment of underrepresented populations in clinical trials of drugs and devices.[1] The highly anticipated guidance comes months after FDA’s statutory deadline for issuance of the guidance in December 2023.[2] The draft guidance reflects new congressional mandates and replaces FDA’s 2022 draft guidance on diversity plans.[3] The statutory requirement for drug and device sponsors to submit Diversity Action Plans will go into effect 180 days after FDA publishes a final guidance.[4] Failure to comply with Diversity Action Plan submission requirements is a prohibited act under the Federal Food, Drug, and Cosmetic Act (FD&C Act) and could result in civil or criminal penalties.[5]

In April 2022, FDA released draft guidance recommending that sponsors of drugs and devices develop and submit Diversity Plans for clinical trials. In December 2022, Congress passed the Food and Drug Omnibus Reform Act (FDORA), which amended the FD&C Act to require the submission of Diversity Action Plans for certain drugs and devices.[6] This provision goes into effect 180 days after the publication of final guidance.[7]

FDA has described Diversity Action Plans as strategies for the enrollment and retention of clinically relevant study populations.[8] The new draft guidance describes the format and content of Diversity Action Plans, including the timing and process for submitting and receiving feedback on such plans. The guidance also outlines the criteria and process for FDA evaluation of requests for waivers of Diversity Action Plan requirements. Finally, the guidance provides recommendations for sponsors that publicly post information about their Diversity Action Plans.

Interested parties may submit comments on the draft guidance by September 26, 2024.[9] FDA is required to issue final guidance not later than June 2025 (9 months after the comment period closes on the draft guidance).[10] Sponsors of clinical trials for drugs and devices should monitor developments in this area, and work to ensure their clinical trial submissions meet these new standards.

When do the new Diversity Action Plan requirements go into effect?

The new Diversity Action Plan requirements will take effect 180 days after publication of final guidance and will apply to clinical trials for which enrollment begins after that date. However, because sponsors plan clinical trials in advance of enrollment, FDA provides in the new draft guidance three circumstances in which the agency does not expect submission of a Diversity Action Plan:

• Clinical studies of drugs with protocols submitted within 180 days after publication of the final guidance, when enrollment is scheduled to begin 180 days after publication;
• Clinical studies of devices received by FDA in investigational device exemption (IDE) applications within 180 days after publication of the final guidance; or
• Clinical studies of devices that do not require submission of an IDE that are approved by an institutional review board or independent ethics committee within 180 days after publication of the final guidance.[11]

In these circumstances, there will continue to be a legal requirement to submit a Diversity Action Plan but, as indicated in the new draft guidance, FDA does not intend to take action to enforce that requirement.

What categories of study subjects must be included in a Diversity Action Plan?

Diversity Action Plans are not required to include any particular demographics. Under Sections 505(z) and 520(g)(9) of the FD&C Act, sponsors must submit Diversity Action Plans that include goals for clinical study enrollment. FDA encourages sponsors to list enrollment goals for race, ethnicity, sex, and age group in Diversity Action Plans. If goals for race, ethnicity, sex, and age group are listed in a Plan, Section 3602 of FDORA requires that each of those goals be disaggregated.

FDORA also requires that FDA issue guidance on the inclusion in Diversity Action Plans of certain categories of study subjects (i.e., age group, sex, race, and ethnicity) and provides that FDA “may include” guidance on other characteristics of study subjects (e.g., geographic location, socioeconomic status).[12] In the new draft guidance, FDA encourages sponsors to consider additional factors when developing enrollment goals, including geographic location, gender identity, sexual orientation, socioeconomic status, physical and mental disabilities, pregnancy, lactation, and comorbidity.

What types of clinical studies require submission of a Diversity Action Plan?

For drugs (including biologics regulated as drugs), sponsors conducting a Phase III study, or another pivotal study, must submit a Diversity Action Plan to FDA by the time they submit their study protocol.

For devices, sponsors must submit a Diversity Action Plan for any clinical study of a device:

• in an application for an investigational device exemption (IDE); or
• if an IDE is not required, in any premarket notification under Section 510(k) of the FD&C Act, request for de novo classification under Section 513(f)(2), or application for premarket approval under Section 515.[13]

Notwithstanding this statutory requirement, FDA explains in the new draft guidance that, because Diversity Action Plans may not be meaningful for certain device studies, the agency does not intend to receive or review Diversity Action Plans for device studies that are not designed to collect definitive evidence of the safety and effectiveness of a device for a specified use.[14]

In addition, although not a requirement, FDA strongly recommends that sponsors develop and implement a comprehensive diversity strategy across their entire clinical development program, including early studies, when possible.[15]

What information must be included in Diversity Action Plans?

Under Section 505(z) and 520(g)(9) of the FD&C Act, sponsors must include the following criteria in Diversity Action Plans:

• Goals for enrollment, disaggregated by age group, sex, race, and ethnicity;
• A rationale for enrollment goals; and
• An explanation of how the sponsor intends to meet such goals

In the new draft guidance, FDA states that, to meet the statutory requirement for inclusion of a rationale for enrollment goals, a sponsor’s rationale must include sufficient information and analysis to explain how the sponsor determined its enrollment goals and provides detailed recommendations on information the rationale should include.[16] On measures to meet enrollment goals, FDA recommends that Diversity Action Plans include enrollment, retention, and monitoring strategies.[17] A Diversity Action Plan may be modified either at the sponsor’s request or based on FDA feedback.[18]

As required under FDORA, Diversity Action Plans must include a sponsor’s goals for enrollment, its rationale for such goals, and an explanation of how the sponsor intends to meet such goals.[19] FDORA directs FDA to issue updated guidance for sponsors on the form, manner, and content of Diversity Action Plans. Of note, sponsors are required to submit Diversity Action Plans in the “form and manner” specified by FDA in guidance. As such, though FDA guidance is typically nonbinding, once final, provisions in FDA guidance pertaining to the form and manner (i.e., process) of submission for Diversity Action Plans will have binding effect on drug and device sponsors.[20] Any FDA recommendations as to the content of Diversity Action Plans will not be binding.

Will FDA issue waivers for the Diversity Action Plan requirements?

The new draft guidance includes information on waivers for the Diversity Action Plan requirement, including eligibility criteria and FDA’s process of review. FDORA authorizes FDA to waive the submission and content requirements for Diversity Action Plans, if FDA determines:

• A waiver is necessary based on what is known or can be determined about the prevalence or incidence of the disease or condition for which the product is under investigation (including in terms of the patient population that may use the product);
• Conducting a clinical investigation in accordance with a Diversity Action Plan would otherwise be impracticable; or
• A waiver is necessary to protect public health during a public health emergency.[21]

However, FDA notes that, given the importance of increasing enrollment of historically underrepresented populations in clinical research, full or partial waivers will be granted only in “rare instances.”[22] For example, FDA states that it generally does not intend to waive the Diversity Action Plan requirement even if the disease or condition being studied is “relatively homogenous with respect to race, ethnicity, sex, or age group.”[23] Because FDA is required to respond to a waiver request within 60 days of receipt, sponsors should submit waiver requests as early as feasible, and no later than 60 days before the Diversity Action Plan is required for submission.[24]

What are the consequences for failure to submit a Diversity Action Plan?

As discussed above, under sections 505(z) and 520(g)(9) of the Federal Food, Drug, and Cosmetic Act, submission of a Diversity Action Plan is required for certain clinical studies for drugs and devices. A Diversity Action Plan must include the sponsor’s goals for enrollment, rationale for such goals, and an explanation of how the sponsor intends to meet such goals. The Plan must be submitted in the form and manner specified by FDA in guidance, not later than, for drugs, the date on which the sponsor submits the protocol to FDA for a Phase III or other pivotal study, and for devices, in an investigational device exemption or, if an investigational device exemption is not required, in any premarket notification under section 510(k), request for classification under section 513(f)(2), or application for premarket approval under section 515. Any modifications to the Plan must be in the form or manner specified by FDA in guidance.

Failure to comply with these Diversity Action Plan statutory requirements constitute a prohibited act under the FFDCA. For drugs, it is a prohibited act under Section 301(d) of the FFDCA to introduce or deliver for introduction, or cause the introduction or delivery for introduction, into interstate commerce any drug in violation of Section 505, including Section 505(z). For devices, it is a prohibited act under 301(q)(1) to fail or refuse to comply with any requirement prescribed under Section 520(g), or to fail or refuse to furnish any notification or other material or information required by or under 520(g).

FDA’s new draft guidance does not discuss consequences for failure to comply with the new Diversity Action Plan statutory requirements. The absence of information in the draft guidance on enforcement mechanisms for failure to comply with the Diversity Action Plan requirements signals that, at this time, FDA is looking to encourage compliance on the part of drug and device sponsors, as opposed to appearing enforcement focused. This approach may change in the final guidance, given strong stakeholder interest in this issue.

Notably, there is no requirement that a sponsor meet the goals outlined in a Diversity Action Plan. FDA notes in the new draft guidance that if such goals are not being met or not expected to be met at the conclusion of a trial, sponsors should include as part of applicable periodic reporting requirements (e.g., investigational new drug application (IND) or IDE annual reports) an explanation for that outcome and mitigation strategies.[25]

[1] FDA, Diversity Action Plans to Improve Enrollment of Participants from Underrepresented Populations in Clinical Studies: Draft Guidance for Industry (June 2024) (hereinafter referred to as “Guidance”).

[2] See Section 3602(b) of the Food and Drug Omnibus Reform Act of 2022 (FDORA), passed as part of the Consolidated Appropriations Act, 2023, Pub. L. No. 117-328, 136 Stat. 4459 (2023).

[3] FDA, Diversity Plans to Improve Enrollment of Participants From Underrepresented Racial and Ethnic Populations in Clinical Trials; Draft Guidance for Industry; Availability (April 2022).

[4] See Section 3602(c) of FDORA. This submission requirement applies only with respect to clinical studies for which enrollment begins after 180 days after the publication of final guidance.

[5] See Sections 505(z)(3), 520(g)(9) of the Federal Food, Drug, and Cosmetic Act; see also Sections 301(d), (q)(1), 303 of the FD&C Act.

[6] See Section 3601 of FDORA.

[7] See Section 3602(c) of FDORA. This submission requirement applies only with respect to clinical studies for which enrollment begins after 180 days after the publication of final guidance.

[8] FDA Notice of Availability: Draft Guidance on Diversity Action Plans, 89 Fed. Reg. 54010 (June 28, 2024).

[9] 89 Fed. Reg. 54010, 54011 (June 28, 2024).

[10] See Section 3602(b)(2) of FDORA.

[11] Guidance at 2.

[12] See Section 3602(a) of FDORA.

[13] Sponsors of devices being studied as described in section 21 CFR 812.2(c) are not required to submit Diversity Action Plans. See 520(g)(9)(A)(ii).

[14] Guidance at 6-7.

[15] Guidance at 7.

[16] Guidance at 22-23.

[17] Guidance at 23.

[18] Guidance at 18.

[19] See Sections 505(z)(2), 520(g)(9)(B).

[20] 89 Fed. Reg. 54010 (June 28, 2024).

[21] See Sections 505(z)(4), 520(g)(9)(C).

[22] Guidance at 20.

[23] Guidance at 20.

[24] Guidance at 20.

[25] Guidance at 19.

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The following Gibson Dunn lawyers assisted in preparing this update: Katlin McKelvie and Carlo Felizardo.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding the issues discussed in this update. Please contact the Gibson Dunn lawyer with whom you usually work, the authors, or any leader or member of the firm’s FDA and Health Care practice group:

Gustav W. Eyler – Washington, D.C. (+1 202.955.8610, [email protected])
Katlin McKelvie – Washington, D.C. (+1 202.955.8526, [email protected])
John D. W. Partridge – Denver (+1 303.298.5931, [email protected])
Jonathan M. Phillips – Washington, D.C. (+1 202.887.3546, [email protected])
Carlo Felizardo – Washington, D.C. (+1 202.955.8278, [email protected])

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

Ramirez v. Charter Communications, Inc., S273802 – Decided July 15, 2024

The California Supreme Court held today that an arbitration agreement may be unconscionable if it requires a party resisting arbitration to pay the other party’s attorney’s fees, requires arbitration of claims commonly brought by employees but not those commonly brought by employers, or unreasonably shortens a statute of limitations. Yet even if an agreement contains unconscionable provisions, a court must analyze whether they may be severed and the rest of the agreement enforced.

“[T]he decision whether to sever unconscionable provisions and enforce the balance is a qualitative one, based on the totality of the circumstances. The court cannot refuse to enforce an agreement simply by finding that two or more collateral provisions are unconscionable as written and eschewing any further inquiry.”

Justice Corrigan, writing for the Court

Background:

Angelica Ramirez, a former employee of Charter Communications, filed a lawsuit alleging discrimination, harassment, retaliation, and wrongful discharge under California’s Fair Employment and Housing Act. Charter sought to compel arbitration under the arbitration agreement Ramirez signed as a condition of her employment. The trial court found the arbitration agreement procedurally and substantively unconscionable, determined that severance of those provisions was improper, and denied the motion to compel arbitration. The Court of Appeal affirmed.

The California Supreme Court granted review to determine whether various provisions of the arbitration agreement were in fact unconscionable and, if so, whether they could be severed from the agreement.

Issues:

1. Is an arbitration agreement unconscionable when it lacks mutuality in terms of the claims subject to and excluded from arbitration, shortens the period for filing claims, truncates discovery, or requires a party resisting arbitration to pay the other side’s attorney’s fees?
2. Is severance improper when an arbitration agreement contains more than one unconscionable provision?

Court’s Holdings:

1. While the lack of mutuality, shortening of the period for filing claims, and requirement that a party resisting arbitration pay the other side’s attorney’s fees may be unconscionable, a provision limiting discovery is not unconscionable when an arbitrator can order additional discovery.
2. No. Even if an arbitration agreement contains more than one unconscionable provision, courts must conduct a qualitative analysis to determine, under the totality of the circumstances, whether the unconscionable provisions may be severed from the agreement.

What It Means:

• The Court clarified that, when analyzing whether a provision limiting discovery renders an arbitration agreement unconscionable, courts must focus on circumstances known at the time the agreement was made and should not consider post-contract formation circumstances.
• When drafting arbitration agreements, employers should ensure mutuality in terms to prevent a finding of unconscionability. An agreement may not, for example, compel arbitration of claims more likely to be brought by an employee but exclude arbitration of claims likely to be brought by an employer.
• There is no bright line rule prohibiting severance when an arbitration agreement contains more than one unconscionable provision. Regardless of how many unconscionable provisions an agreement contains, courts must conduct a qualitative analysis to determine whether the agreement’s unconscionability can be cured by severing the unconscionable provisions.
• The Court concluded that enforcing the rules of unconscionability does not violate the Federal Arbitration Act.

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The Court’s opinion is available here.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding developments at the California Supreme Court. Please feel free to contact the following practice group leaders:

Appellate and Constitutional Law Practice

Thomas H. Dupree Jr. +1 202.955.8547 [email protected]	Allyson N. Ho +1 214.698.3233 [email protected]	Julian W. Poon +1 213.229.7758 [email protected]
Lucas C. Townsend +1 202.887.3731 [email protected]	Bradley J. Hamburger +1 213.229.7658 [email protected]	Michael J. Holecek +1 213.229.7018 [email protected]

Related Practice: Labor and Employment

Jason C. Schwartz +1 202.955.8242 [email protected]

Katherine V.A. Smith +1 213.229.7107 [email protected]

Jesse A. Cripps +1 213.229.7792 [email protected]

Related Practice: Litigation

Theodore J. Boutrous, Jr. +1 213.229.7804 [email protected]

Theane Evangelis +1 213.229.7726 [email protected]

This alert was prepared by Michael Holecek, Ryan Azad, and Thomas Cochrane.

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

With several landmark decisions this Term, the U.S. Supreme Court accelerated a substantial transformation of the law governing actions by regulatory agencies. The Court overruled Chevron, sharply limiting judicial deference to agencies’ statutory interpretation. It gave regulated entities more time to challenge agency rules in court. It stayed enforcement of a major EPA rule concerning ozone pollution. And it determined that the Constitution requires agencies to bring at least many civil penalty actions in federal court, not in agency administrative tribunals. The webcast takes stock of what these major cases mean for regulatory agencies going forward, particularly against the backdrop of other significant Supreme Court administrative law decisions in recent years.

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PANELISTS:

Stuart F. Delery is a partner in Gibson, Dunn & Crutcher’s Washington, D.C. office, where he is a member of the firm’s Litigation Department and Co-Chair of the Administrative Law and Regulatory Practice Group and the Crisis Management Practice Group. Stuart is an experienced appellate and district court litigator who brings 30 years of experience at the highest levels of government and the private sector to help clients navigate major matters that present complex legal and reputational risks, particularly matters involving difficult statutory, regulatory and constitutional issues. His practice focuses on representing corporations and individuals in high-stake litigation and investigations that involve the federal government across the spectrum of regulatory litigation and enforcement.

Prior to re-joining the firm, Stuart served as White House Counsel for President Biden from 2022-2023. As Counsel to the President, he advised the President on the full range of constitutional, statutory, and regulatory legal issues, including on questions of presidential authority, domestic policy, and national security and foreign affairs. He managed responses to high-profile congressional and other investigations, and he assisted the President in nominating and confirming federal judges. Stuart also served as Deputy Counsel to the President from 2021-2022. Previously, Stuart served as the Acting Associate Attorney General of the United States, the third-ranking position at the Department of Justice, and the Senate-confirmed Assistant Attorney General for the Civil Division. Stuart is admitted to practice law in the District of Columbia.

Matt Gregory is a partner in the Washington D.C. office of Gibson, Dunn & Crutcher. He practices in the firm’s Litigation Department and Appellate and Constitutional Law and Administrative Law Practice Groups. Matt has been recognized in the 2023 and 2024 editions of Best Lawyers: Ones to Watch® in America for both Administrative / Regulatory Law and Appellate Practice, and is a member of the Edward Coke Appellate Inn of Court. Matt represents corporate clients in a wide range of appellate, administrative law, and litigation matters. Prior to joining Gibson Dunn, Matt clerked for Justice Anthony M. Kennedy of the U.S. Supreme Court and Judge Raymond M. Kethledge of the U.S. Court of Appeals for the Sixth Circuit. Matt is admitted to practice law in Virginia and the District of Columbia.

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MCLE CREDIT INFORMATION:

This program has been approved for credit in accordance with the requirements of the New York State Continuing Legal Education Board for a maximum of 1.0 credit hour, of which 1.0 credit hour may be applied toward the areas of professional practice requirement. This course is approved for transitional/non-transitional credit.

Attorneys seeking New York credit must obtain an Affirmation Form prior to watching the archived version of this webcast. Please contact [email protected] to request the MCLE form.

Gibson, Dunn & Crutcher LLP certifies that this activity has been approved for MCLE credit by the State Bar of California in the amount of 1.0 hour in the General Category.

California attorneys may claim “self-study” credit for viewing the archived version of this webcast. No certificate of attendance is required for California “self-study” credit.

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

From the Derivatives Practice Group: This week, President Biden announced his intent to nominate Julie Brinn Siegel to be a Commissioner of the CFTC. Siegel is the Senior Coordinator for Management at the Office of Management and Budget.

New Developments

• President Biden Announced Intent to Nominate Julie Brinn Siegel as a Commissioner of the CFTC. On July 11, President Biden announced his intent to nominate Julie Brinn Siegel to be a Commissioner of the CFTC. Siegel currently serves as the federal government’s deputy chief operating officer as Senior Coordinator for Management at the Office of Management and Budget (OMB). Prior to that, Siegel served as Secretary of the Treasury Janet Yellen’s Deputy Chief of Staff and served as Senior Counsel and Policy Advisor to U.S. Senator Elizabeth Warren (D-MA). Last month, President Biden nominated CFTC Commissioner Johnson to be Assistant Secretary for Financial Institutions at the Department of Treasury and nominated CFTC Commissioner Christy Goldsmith Romero to be Chair and Member of the Federal Deposit Insurance Corporation (FDIC) which, if confirmed by the Senate, would leave open two Democratic Commissioner seats at the CFTC. Siegel, if nominated and confirmed by the Senate, would take the seat of Commissioner Goldsmith Romero. [NEW]
• First Interagency Fraud Disruption Conference Focuses on Combatting Crypto Schemes Commonly Known as “Pig Butchering.” On July 11, the CFTC and the DOJ’s Computer Crime and Intellectual Property Section’s National Cryptocurrency Enforcement Team (“NCET”) convened the first Fraud Disruption Conference to work on efforts to combat a type of fraud commonly known as “pig butchering”. It is estimated that Americans are scammed out of billions per year, making this a top law enforcement priority. The working group addressed strategies to prevent victimization; using technology to disrupt the fraud; and collaboration on enforcement efforts. Several agencies also collaborated on an anti-victimization messaging campaign to warn Americans to remain vigilant against emerging fraud threats. [NEW]
• Supreme Court Overrules Chevron, Sharply Limiting Judicial Deference To Agencies’ Statutory Interpretation. On June 28, the Supreme Court overruled Chevron v. Natural Resources Defense Council, a landmark decision that had required courts to defer to agencies’, including the CFTC’s, reasonable interpretations of ambiguous statutory terms. For a more detailed analysis of the ruling please refer to Gibson Dunn’s client alert, available here.
• CFTC Announces Supervisory Stress Test Results. On July 1, the CFTC issued Supervisory Stress Test of Derivatives Clearing Organizations: Reverse Stress Test Analysis and Results, a report detailing the results of its fourth Supervisory Stress Test (“SST”) of derivatives clearing organization (“DCO”) resources. Among other findings, the 2024 report concluded the DCOs studied hold sufficient financial resources to withstand many extreme and often implausible price shocks. The purpose of the analysis was twofold: (1) to identify hypothetical combinations of extreme market shocks, concurrent with varying numbers of clearing member (“CM”) defaults, that would exhaust prefunded resources (DCO committed capital, and default fund), and unfunded resources available to the DCOs (this represents the reverse stress test component), and (2) to analyze the impacts of DCO use of mutualized resources on non-defaulted CMs.
• CFTC Staff Issues a No-Action Letter Regarding Certain Reporting Requirements for Swaps Transitioning from CDOR to CORRA. On June 27, the CFTC Division of Market Oversight (“DMO”) and Division of Data (“DOD”) issued a staff no-action letter regarding certain Part 43 and Part 45 swap reporting obligations for swaps transitioning under the ISDA LIBOR fallback provisions from referencing the Canadian Dollar Offered Rate (“CDOR”), to referencing the risk-free Canadian Overnight Repo Rate Average (“CORRA”) following the cessation of CDOR after June 28, 2024. The letter states DMO and DOD will not recommend the CFTC take enforcement action against an entity for failure to timely report under Part 45 the change in a swap’s floating rate. This letter covers those floating rate changes that are made under the ISDA LIBOR fallback provisions from CDOR to CORRA, but only in the event the entity uses its best efforts to report the change by the applicable deadline in Part 45 and in no case reports the required information later than five business days from, but excluding, July 2, 2024. The letter also states DMO and DOD will not recommend the CFTC take enforcement action against an entity for failure to report under Part 43 the change in the floating rate for a swap modified after execution to incorporate the ISDA LIBOR fallback provisions to transition from referencing CDOR to referencing CORRA.
• CFTC Extends Public Comment Period for Proposed Amendments to Event Contracts Rules. On June 27, the CFTC announced it is extending the deadline for public comment on a proposal to amend its event contract rules. The extended comment period will close on August 8, 2024. The CFTC is providing an extension to allow interested persons additional time to analyze the proposal and prepare their comments. The proposal would amend CFTC Regulation 40.11 to further specify types of event contracts that fall within the scope of Commodity Exchange Act (“CEA”) Section 5c(c)(5)(C) and are contrary to the public interest, such that they may not be listed for trading or accepted for clearing on or through a CFTC-registered entity.

New Developments Outside the U.S.

• ESAs Consult on Guidelines under the Markets in Crypto-Assets Regulation. On July 12, the European Supervisory Authorities (“ESAs”) published a consultation paper on Guidelines under Markets in Crypto-assets Regulation (“MiCA”), establishing templates for explanations and legal opinions regarding the classification of crypto-assets along with a standardized test to foster a common approach to classification. [NEW]
• ESAs Report on the Use of Behavioral Insights in Supervisory and Policy Work. On July 11, the ESAs published a joint report following their workshop on the use of behavioral insights by supervisory authorities in their day-to-day oversight and policy work. The report provides a high-level overview of the main topics discussed during the workshop held in February 2024 for national supervisors and other competent authorities, where participants explored the added value of behavioral insights in their work by exchanging their experiences and discussing the challenges they face. [NEW]
• ESMA Publishes the 2024 ESEF Reporting Manual. On July 11, ESMA published the update of its Reporting Manual on the European Single Electronic Format (“ESEF”) supporting a harmonized approach for the preparation of annual financial reports. ESMA has also updated the Annex II of the Regulatory Technical Standards (“RTS”) on ESEF. [NEW]
• ESMA Publishes Statement on Use of Collateral by NFCs Acting as Clearing Members. On July 10, ESMA issued a public statement on deprioritizing supervisory actions linked to the eligibility of uncollateralized public guarantees, public bank guarantees, and commercial bank guarantees for Non-Financial Counterparties (“NFCs”) acting as clearing members, pending the entry into force of EMIR 3.
• ESMA Launches New Consultations. On July 10, ESMA published a new package of public consultations with the objective of increasing transparency and system resilience in financial markets, reducing reporting burden and promoting convergence in the supervisory approach. [NEW]
• ESMA Consults on Rules to Recalibrate and Further Clarify the Framework. On July 9, ESMA launched new consultations on different aspects of the Central Securities Depositories Regulation (“CSDR”) Refit. The proposed rules relate to the information to be provided by European CSDs to their national competent authorities (“NCA”s) for the review and evaluation, the information to be notified to ESMA by third-country CSDs, and the scope of settlement discipline. [NEW]
• ESMA Consults on Liquidity Management Tools for Funds. On July 8, ESMA announced it is seeking input on draft guidelines and technical standards under the revised Alternative Investment Fund Managers Directive (“AIFMD”) and the Undertakings for Collective Investment in Transferable Securities (“UCITS”) Directive. Both Directives aim to mitigate potential financial stability risks and promote harmonization of liquidity risk management in the investment funds sector. [NEW]
• ESMA Consults on Reporting Requirements and Governance Expectations for Some Supervised Entities. On July 8, ESMA launched two consultations on proposed guidance for some of its supervised entities. The consultations are aimed at the following entities supervised by ESMA: Benchmark Administrators, Credit Rating Agencies, and Market Transparency Infrastructures. The Consultation Paper sets out the information ESMA expects to receive and a timeline for supervised entities to provide the required information. The objective of the Draft Guidelines is to ensure consistency in cross-sectoral reporting. [NEW]
• ESMA Puts Forward Measures to Support Corporate Sustainability Reporting. On July 5, ESMA published a Final Report on the Guidelines on Enforcement of Sustainability Information (“GLESI”) and a Public Statement on the first application of the European Sustainability Reporting Standards (“ESRS”). ESMA reports that these documents will support the consistent application and supervision of sustainability reporting requirements.
• ESMA Releases New MiCA Rules To Increase Transparency for Retail Investors. On July 4, ESMA published the second Final Report under the Markets in Crypto-Assets Regulation (MiCA) covering eight draft technical standards that aim to provide more transparency for retail investors, clarity for providers on the technical aspects of disclosure and record-keeping requirements, and data standards to facilitate supervision by National Competent Authorities (“NCAs”). The report covers public disclosures, as well as descriptions on how issuers should disclose price-sensitive information to the public to prevent market abuses, such as insider dealing.
• ESMA Reappoints Three Members to its Management Board. On July 4, ESMA announced that it has reappointed three current members to its Management Board. The appointments took place at the Board of Supervisors meeting on July 3. The Management Board, chaired by Verena Ross, Chair of ESMA, is responsible for ensuring that the Authority carries out its mission and performs the tasks assigned to it under its founding Regulation.
• EBA and ESMA Publish Guidelines on Suitability of Management Body Members and Shareholders for Entities Under MiCA. On June 27, EBA and ESMA published joint guidelines on the suitability of members of the management body, and on the assessment of shareholders and members with qualifying holdings for issuers of asset reference tokens (“ARTs”) and crypto-asset service providers (“CASPs”), under the MiCA. The first set of guidelines covers the presence of suitable management bodies within issuers of ARTs and CASPs. The second set of guidelines concerns the assessment of the suitability of shareholders or members with direct or indirect qualifying holdings in a supervised entity.

New Industry-Led Developments

• Trade Associations Submit Letter on EMIR IM Model Validation. On July 8, ISDA, the Alternative Investment Management Association (“AIMA”), the European Fund and Asset Management Association (“EFAMA”) and the Securities Industry and Financial Markets Association’s asset management group (“SIFMA AMG”) submitted a letter to the ESAs and the European Commission on initial margin (“IM”) model approval requirements set out in the European Market Infrastructure Regulation (“EMIR 3.0”). The letter highlights challenges posed by the three-month period granted to the European Banking Authority and NCAs to validate changes to an IM model and describes how the ISDA Standard Initial Margin Model (“ISDA SIMM”) schedule can be amended to address these issues. [NEW]
• ISDA Proceeds with Development of an Industry Notices Hub. On July 1, ISDA announced it will proceed with the development of an industry-wide notices hub, following strong support from buy- and sell-side institutions globally. The new online platform will allow instantaneous delivery and receipt of critical termination-related notices and help to ensure address details for physical delivery are up to date, reducing the risk of uncertainty and potential losses for senders and recipients of these notices.
• ISDA Publishes Framework to Prepare for Close Out of Derivatives Contracts. On June 27, ISDA published the ISDA Close-out Framework that market participants can use to help prepare for potential terminations of collateralized derivatives contracts. ISDA stated that the launch of the ISDA Close-out Framework is in response to the March 2023 failure of Signature Bank and SVB in the US, which, according to ISDA, highlighted the complexities of potentially terminating over-the-counter derivatives trading relationships following various post-crisis regulatory reforms. Specifically, the reforms require that in-scope entities post margin for non-cleared derivatives transactions, while various jurisdictions have introduced mandatory stays on termination rights and remedies as part of bank resolution regimes. ISDA stated that the ISDA Close-out Framework is intended to be used as a preparatory resource to help firms coordinate internal business functions and stakeholders and internal and external legal, operational, risk management, infrastructure and other relevant service providers to ensure they are adequately prepared for any potential future stress events.

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The following Gibson Dunn attorneys assisted in preparing this update: Jeffrey Steiner, Adam Lapidus, Marc Aaron Takagaki, Hayden McGovern, and Karin Thrasher.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding these developments. Please contact the Gibson Dunn lawyer with whom you usually work, any member of the firm’s Derivatives practice group, or the following practice leaders and authors:

Jeffrey L. Steiner, Washington, D.C. (202.887.3632, [email protected])

Michael D. Bopp, Washington, D.C. (202.955.8256, [email protected])

Michelle M. Kirschner, London (+44 (0)20 7071.4212, [email protected])

Darius Mehraban, New York (212.351.2428, [email protected])

Jason J. Cabral, New York (212.351.6267, [email protected])

Adam Lapidus  – New York (212.351.3869,  [email protected] )

Stephanie L. Brooker, Washington, D.C. (202.887.3502, [email protected])

William R. Hallatt , Hong Kong (+852 2214 3836, [email protected] )

David P. Burns, Washington, D.C. (202.887.3786, [email protected])

Marc Aaron Takagaki , New York (212.351.4028, [email protected] )

Hayden K. McGovern, Dallas (214.698.3142, [email protected])

Karin Thrasher, Washington, D.C. (202.887.3712, [email protected])

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

This edition of Gibson Dunn’s Federal Circuit Update for June 2024 summarizes the current status of a couple petitions pending before the Supreme Court and recent Federal Circuit decisions concerning damages, trade secret misappropriation, patent eligibility under 35 U.S.C. § 101, and induced infringement.

Federal Circuit News

Noteworthy Petitions for a Writ of Certiorari:

There was a new potentially impactful petition filed before the Supreme Court in June 2024:

• United Therapeutics Corp. v. Liquidia Technologies, Inc. (US No. 23-1298): “1. Whether the IPR statute and SAS require the Federal Circuit to review de novo, or only for an abuse of discretion, the PTO’s reliance on new grounds and new printed publications—not raised in the initial petition—when deciding to cancel patent claims. 2. Whether, if § 312 is deemed ambiguous, the Court should overrule Chevron.”  The respondent waived its right to respond, the Court requested a response, which is due August 12, 2024.

We also provide an update below of the petitions pending before the Supreme Court that were summarized in our May 2024 update:

• In Chestek PLLC v. Vidal (US No. 23-1217), the response brief is due August 14, 2024. Five amicus curiae briefs have been filed.  In Cellect LLC v. Vidal (US No. 23-1231), the response brief is due August 21, 2024, and seven amicus curiae briefs have been filed.

Upcoming Oral Argument Calendar

The list of upcoming arguments at the Federal Circuit is available on the court’s website.

Key Case Summaries (June 2024)

EcoFactor, Inc. v. Google LLC, No. 23-1101 (Fed. Cir. June 3, 2024):  EcoFactor sued Google alleging infringement of patents directed to smart thermostats in computer-networked heating and cooling systems, which adjusts the user’s thermostat settings to reduce strain on the electricity grid during periods of high demand.  Following a jury trial, the jury found infringement and awarded damages to EcoFactor.  Google moved for a new trial on damages, which the district court denied.

The majority (Reyna, J., joined by Lourie, J.) affirmed.  The majority reasoned that EcoFactor’s damages expert based his royalty rate on comparable license agreements and the testimony of EcoFactor’s CEO, and thus, the royalty rate was sufficiently reliable.  The majority therefore concluded that the district court did not abuse its discretion in denying the motion for a new trial.

Judge Prost dissented-in-part.  Judge Prost reasoned that the royalty rate from EcoFactor’s damages expert “rests on EcoFactor’s self-serving, unilateral recitals of its beliefs in the license agreements,” which were “directly refuted” by two of the license agreements and “have no other support . . . to back them up.”  Judge Prost concluded that the “law does not allow damages to be so easily manufactured.”  Judge Prost then noted that the royalty rate suffered from another problem in that it included the value of non-asserted patents, which EcoFactor’s damages expert did not properly apportion.  Judge Prost therefore determined that the analysis performed by EcoFactor’s damages expert was unreliable, and the district court abused its discretion by not granting a new trial on damages.

Insulet Corp. v. EOFlow, Co. Ltd., No. 24-1137 (Fed. Cir. June 17, 2024):  Insulet and EOFlow manufacture insulin pump patches.  Starting in the early 2000s, Insulet developed the wearable insulin pump OmniPod® followed by next generation products in 2007 and 2012.  EOFlow began developing its own product in 2011, the EOPatch®, followed by its next generation product in 2017.  Around that time, four former Insulet employees were hired by EOFlow, and allegedly passed confidential information to EOFlow.  Insulet sued EOFlow for misappropriation of trade secrets.  Insulet moved for a preliminary injunction, arguing it was likely to be irreparably harmed by the misappropriation, particularly in light of news that Medtronic would imminently acquire EOFlow, which would provide a source of capital for EOFlow and increase competition with Insulet.  The district court granted the preliminary injunction.

The Federal Circuit (Lourie, J., joined by Prost and Stark, JJ.) reversed.  Under the Defend Trade Secrets Act (“DTSA”), the statute of limitations to bring a trade secret misappropriation claim is three years.  18 U.S.C. § 1836(d).  EOFlow had raised a statute of limitations challenge; however, the district court expressed no opinion on the matter.  The Federal Circuit held that it was an abuse of discretion to ignore this argument, which was a material factor in evaluating a likelihood of success on the merits.  The Court further held that, even if the statute of limitations argument had been addressed, Insulet had not established a likelihood of success on the merits because it had not alleged a trade secret with particularity, as required by the DTSA. Specifically, Insulet “advanced a hazy grouping of information that the court did not probe with particularity to determine what, if anything, was deserving of trade secret protection.” Instead, the district court should have determined what “specific information” was alleged to be the trade secret, such as “particular design drawings and specifications for each physical component and subassembly.”  The Court also determined that the district court failed to assess whether the information was generally known or reasonably ascertainable through proper means, such as reverse engineering, particularly in light of tear-down videos and Insulet’s own publications that were available on the internet.  And finally, the Court determined that the district court failed to consider the disclosures in Insulet’s own patents related to the OmniPod.  If certain components of the OmniPod were known to the public through patent disclosures, then those components would unlikely merit trade secret protection.

Beteiro, LLC v. DraftKings Inc., No. 22-2275 (Fed. Cir. June 21, 2024):  Beteiro owns four patents directed to methods that enable users to participate in online gambling using a user communication device by first determining whether the user is physically located in a state that allows gambling by using the GPS on the mobile device.  DraftKings filed a motion to dismiss under Rule 12(b)(6) on the grounds that the patents were directed to patent-ineligible subject matter under 35 U.S.C. § 101, and the district court granted the motion.

The Federal Circuit (Stark, J., joined by Dyk and Prost, JJ.) affirmed.  At step one, the Court stated that the claims are directed to the abstract idea of “exchanging information concerning a bet and allowing or disallowing the bet based on where the user is located.”  In doing so, the Court specifically found that Beteiro’s patent claims “exhibit several features that are well-settled indicators of abstractness,” such as detecting information, generating and sending notifications, receiving messages (bets), determining legality (GPS location), and processing information (allowing/disallowing bets).  The Court also determined that the claims were drafted in a result-oriented, functional manner, using language that described the desired outcomes without explaining how to achieve them.  The Court further determined that the claims did not recite any improvement in the way computers operate, and thus, the claims were directed to an abstract idea.  As to step two, the Court determined that the use of GPS on a mobile phone was conventional, contrary to Beteiro’s contentions.

Amarin Pharma, Inc. v. Hikma Pharmaceuticals USA Inc., No. 23-1169 (Fed. Cir. June 25, 2024):  Amarin sells icosapent ethyl (an omega-3 fatty acid commonly found in fish oils) under the brand name Vascepa® for the treatment of patients with high triglyceride levels.  In 2012, Amarin received FDA approval for treatment of severe hypertriglyceridemia, a condition where a patient’s blood triglyceride is at least 500 mg/dL (“the SH indication”), and later in 2019, for treatment to reduce cardiovascular risk in patients having blood triglyceride levels of at least 150 mg/dL (“the CV indication”).  Hikma submitted an Abbreviated New Drug Application (“ANDA”) for approval of its generic icosapent ethyl in 2016 when Vascepa® was only approved for the SH indication, and in 2019, opted to carve out the additional CV indication by seeking FDA approval only for uses not covered by Amarin’s newly listed CV indication patents.  However, around the same time, Hikma also removed the CV limitation of use from its product label, which had originally been included when it initially filed its ANDA.  Hikma then issued several press releases advertising its product as a generic version of Vascepa®, referencing Vascepa®’s $1.1 billion in sales, which included sales for all uses of Vascepa® including the CV indication that made up 75% of the sales.

Amarin sued Hikma for inducing infringement of two of its patents directed to uses of icosapent ethyl based on (1) Hikma’s public statements in press releases and on its website, and (2) the product label for its generic icosapent ethyl product.  Hikma moved to dismiss under Rule 12(b)(6), and the district court granted the motion.  The district court found that the removal of the CV limitation of use from the product label would not be understood by physicians as suggesting that Hikma’s product had been approved for the CV indication.  The district court also found that while Hikma’s press releases and website were relevant to an intent to induce, it did not rise to the level of encouraging, recommending, or promoting Hikma’s generic for the CV indication.

The Federal Circuit (Lourie, J., joined by Moore, C.J., and Albright, J. (sitting by designation)) reversed, holding that the district court had to examine the label and public statements in its totality to determine what they “would communicate to physicians and the marketplace.”  In so holding, the Court noted that while the underlying case was a traditional Hatch-Waxman case, the issue on appeal was nothing more than “a run-of-the-mill induced infringement case.”  The Court concluded that while the label alone would not recommend, encourage, or promote infringement, a physician would read Hikma’s press releases as an instruction or encouragement to prescribe Hikma’s product for any FDA-approved use, which included the CV indication that Hikma carved out from its ANDA.  The Court concluded that these allegations, taken together, plausibly stated a claim for induced infringement.

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The following Gibson Dunn lawyers assisted in preparing this update: Blaine Evanson, Audrey Yang, Al Suarez, Evan Kratzer, and Julia Tabat.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding developments at the Federal Circuit. Please contact the Gibson Dunn lawyer with whom you usually work, any leader or member of the firm’s Appellate and Constitutional Law or Intellectual Property practice groups, or the following authors:

Blaine H. Evanson – Orange County (+1 949.451.3805, [email protected])
Audrey Yang – Dallas (+1 214.698.3215, [email protected])

Appellate and Constitutional Law:
Thomas H. Dupree Jr. – Washington, D.C. (+1 202.955.8547, [email protected])
Allyson N. Ho – Dallas (+1 214.698.3233, [email protected])
Julian W. Poon – Los Angeles (+ 213.229.7758, [email protected])

Intellectual Property:
Kate Dominguez – New York (+1 212.351.2338, [email protected])
Y. Ernest Hsin – San Francisco (+1 415.393.8224, [email protected])
Josh Krevitt – New York (+1 212.351.4000, [email protected])
Jane M. Love, Ph.D. – New York (+1 212.351.3922, [email protected])

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

A proposed rule from the Committee on Foreign Investment in the United States would substantially expand the scope of covered real estate transactions subject to national security review during a time of growing concern around foreign acquisitions of U.S. land.

Over the past year, national security risks associated with foreign acquisitions of certain real estate, including agricultural land, have been an issue of growing concern.  This increasing national security concern has manifested in several key developments: (i) a rise in efforts by state and local governments to implement their own real-estate focused national security reviews, which we described in a previous client alert, (ii) a notable and recent presidential block of a major real estate transaction,[1] and (iii) bipartisan federal legislative support for stronger restrictions on acquisitions of U.S. land by foreign adversaries.[2]

Most recently, on July 8, 2024, the Committee on Foreign Investment in the United States (“CFIUS”) issued a Notice of Proposed Rulemaking (“NPRM” or the “proposed rule”) to expand its jurisdiction to review and potentially block certain real estate transactions involving foreign persons.  The scope of the update is noteworthy.  The proposed rule would add nearly 60 locations to CFIUS’s existing list of military installations whose proximity to a potential real estate purchase could create CFIUS jurisdiction, bringing the total list to over 250 installations—and representing a roughly 30% increase in a single update.[3]

This alert provides: (i) a brief refresher on CFIUS’s jurisdiction over real estate transactions, (ii) a summary of the proposed rule, (iii) a discussion of historical trends and projections regarding CFIUS’s review of real estate transactions, and (iv) key takeaways for dealmakers.

I. Refresher on CFIUS’s Jurisdiction Over Real Estate Transactions.

The Foreign Investment Risk Review Modernization Act of 2018 (“FIRRMA”) provided CFIUS with expanded jurisdiction over (among other things) certain real estate transactions.  Using that new jurisdiction, CFIUS drafted rules for “certain transactions by foreign persons involving real estate in the United States” (the “real estate rules”), which became effective in February 2020.  The real estate rules provided the process for CFIUS to review acquisitions involving a foreign person purchasing, leasing, or gaining certain other land rights in property close to military installations and other sensitive areas.  Specifically, the real estate rules set out four categories of locations that could subject a real estate transaction to CFIUS’s jurisdiction and listed each of these sets of locations in an Appendix to the rules (“Appendix A”).

• Part 1 of Appendix A provides locations for which a property may be subject to review based on being in “close proximity” to (i.e., within one mile of) a listed military installation.
• Part 2 of Appendix A provides locations for which a property may be subject to review based on being within the “extended range” (i.e., between one and one hundred miles from) a listed military installation.
• Part 3 of Appendix A lists missile launch ranges (i.e., geographic areas) for which a property being in the extended area of that range may subject it to CFIUS review.
• Part 4 of Appendix A lists offshore training areas where a property being in the extended range of that area may subject it to CFIUS review.

Congress’s policy rationale for providing CFIUS with authority over real estate transactions was—and remains—driven by intelligence collection risks.  As CFIUS’s press release for the NPRM noted, FIRRMA allows CFIUS to review transactions that could “reasonably provide the foreign person the ability to collect intelligence on activities being conducted at such an installation, facility, or property; or could otherwise expose national security activities at such an installation, facility, or property to the risk of foreign surveillance.”

There are limited exceptions to CFIUS jurisdiction over “covered real estate”; most notably, if such real estate falls within an “urbanized area” or “urban cluster.”  Yet, there is a meaningful limitation to this exception, as it does not apply where such real estate is (1) located within, or will function as part of, a covered port or (2) is within “close proximity” to certain military installations or other sensitive government sites.

II. Updates to CFIUS’s List of Sensitive U.S. Military Installations.

The proposed rule seeks to expand the list of covered military installations, the second such expansion of covered real estate installations since the real estate rules were promulgated under FIRRMA.  The real estate rules themselves note that the Department of Defense (“DoD”) will continue “on an ongoing basis” to assess and update Appendix A.[4]

A noteworthy transaction served as the precursor to the first update to Appendix A.  In January 2023, CFIUS determined that it did not have jurisdiction to review an acquisition of land by Chinese food manufacturer Fufeng Group Ltd.  That land was near Grand Forks Air Force Base, which was not among the military installations listed in Appendix A.  Ostensibly in response to public outcry around CFIUS’s determination that it lacked jurisdiction over this acquisition, in August 2023, DoD issued a final rule adding eight military installations to Appendix A, including Grand Forks Air Force Base.

This NPRM, coming nearly a year after the prior Appendix A expansion, would add a substantially increased number of military installations, with 59 proposed additions.  The proposed rule is not immediately effective.  CFIUS provided for a 30-day public comment period, following which CFIUS is expected to promptly publish a final rule.  Once implemented, and assuming no changes are made to the proposed list of new military installations, the NPRM will bring the total number of military installations listed in Part 1 of Appendix A to 162 and Part 2 to 65, while making the following updates:

• Expand CFIUS’s jurisdiction over real estate transactions to include 40 new military installations in Part 1 of the list (“close proximity,” i.e., within a one-mile radius);
• Expand CFIUS’s jurisdiction over real estate transactions to include 19 new military installations in Part 2 of the list (“extended range,” i.e., within a 100-mile radius);
• Move eight military installations from part 1 to part 2;
• Remove one installation from part 1 and two installations from part 2;
• Revise the definition of the term “military installation,” including to expand the definition of an installation to encompass “Army depots, arsenals, and military terminals,” “Marine Corps installations, logistic battalions and support facilities,” and Space Force bases, and expand other parts of the definition to encompass each of the Armed Forces; and
• Update the names of 14 installations and the location of seven others.

III. Trends and Projections for CFIUS Review of Real Estate Transactions.

Since the CFIUS real estate rules became effective in 2020, there have been very few reviews of “covered real estate transactions.”  CFIUS’s annual report to Congress for 2021 provided data showing that zero of the 272 notices and only one of the 164 short-form declarations filed with the Committee were for a covered real estate transaction.  In 2022, only one of the 286 notices and five of the 154 short-form declarations were for covered real estate transactions.

There are likely several reasons why there have been so few covered real estate CFIUS filings in the past years.  One possible reason is that many transactions that involved covered real estate also implicate a U.S. target’s broader assets and operations, governance rights, or access to technical information or personal data, resulting in CFIUS jurisdiction based on its authority to review “control” transactions and “non-controlling” covered investments.

Another reason is that, following FIRRMA, some transactions require mandatory filings with CFIUS, but covered real estate transactions are subject only to voluntary filings.  In fact, a covered real estate transaction for which the parties did not file a voluntary CFIUS notice was the subject of a recent presidential order.  In May 2024, following a CFIUS-initiated review that identified a risk to national security arising from the potential for foreign surveillance and intelligence collection activities, President Biden issued a presidential decision requiring Chinese cryptocurrency mining company MineOne to divest an acquisition of Wyoming real estate located in “close proximity” to a U.S. Air Force base with strategic missile silos.[5]

We do not expect the overall number of real estate reviews to rise substantially because of the additions in the NPRM, but we do expect CFIUS to closely scrutinize the more limited universe of transactions that implicate covered real estate—whether or not those transactions result in voluntary filings with the Committee—and to take bold action with respect to those transactions when warranted.

CFIUS is likely to consider possibilities to further expand or enhance its jurisdiction over real estate transactions owing, in part, to bipartisan support from U.S. legislators.  As is often the case for national security initiatives, there exists bipartisan federal legislative support for tougher scrutiny on foreign acquisitions of U.S. land.  In response to the NPRM, Chairman of the House Select Committee on the Strategic Competition Between the United States and the Chinese Communist Party John Moolenaar (R-MI) made a statement in support of the proposed rule calling for even tougher measures to restrict “foreign adversaries” from purchasing land that would “leave our military facilities susceptible to surveillance.”  U.S. Senator Sherrod Brown (D-OH) also issued a statement in support, noting the importance of protecting agricultural land near military bases.  As the presidential election draws near, lawmakers on both sides of the aisle are likely to maintain focus on national security issues.  This continued support paves the way for CFIUS to continue updating its rulemaking around real estate, echoed in Assistant Secretary of the Treasury for Investment Security Paul Rosen’s comments in the NPRM press release that CFIUS “will remain responsive to the evolving nature of the risks we face to ensure we are protecting our military installations and related defense assets.”

IV. Key Takeaways and Next Steps for Dealmakers.

The proposed rule is likely to be finalized and implemented by fall of this year.  Considering this timeline, transaction parties should act now to update their approach to potentially implicated transactions.  We recommend taking note of the following:

• CFIUS will continue its efforts to identify and review non-notified real estate transactions. Especially given the intense scrutiny of foreign investments in U.S. real estate by U.S. federal, state, and local government authorities, as well as certain segments of the private sector and U.S. media, CFIUS will continue its efforts to identify and review covered real estate transactions.  Some reviews could result in CFIUS identifying a threat to national security posed by a prior investment and the need for mitigation measures up to and including divestment.

• The expanded list of installations should inform current deal diligence. Because transactions under consideration or negotiation today may not sign until after a final rule is published later this year, transaction parties should immediately begin considering the NPRM when conducting due diligence of real estate investments and acquisitions.  Moreover, for transactions subject to CFIUS’s “control” or “covered investment” jurisdiction, the NPRM provides important insight into the locations that CFIUS considers most sensitive and likely to raise national security considerations.

• Foreign parties can still acquire rights in covered real estate. Although the proposed rule does not distinguish between investors of different jurisdictions,[6] CFIUS will continue to evaluate transactions using a case-by-case, transaction-specific approach that accounts for the risk profile of the investors.  CFIUS filings for covered real estate transactions remain voluntary, and foreign investors will continue to be able to receive CFIUS approvals for these transactions.  Of note, the blocked acquisition we discussed in this alert involved a Chinese-backed acquirer and indications that the real estate could be used for surveillance.  Not every covered real estate transaction poses a risk to U.S. national security and, even when CFIUS does identify a threat, in many cases the threat can be mitigated through manageable conditions on the foreign investor’s physical access to, and use of, the land.  Moreover, the “urbanized area” and “urban cluster” exceptions discussed above continue to apply.

• In addition to conducting CFIUS-focused risk analysis, transaction parties must consider state and local foreign investment reviews—at least for now. Currently, approximately twenty states have implemented some form of restriction on foreign investment in real estate, and over a dozen states are currently considering bills that would establish similar restrictions.[7]  As described in a previous client alert, these state-level restrictions may not ultimately survive legal challenges on the grounds of the U.S. Constitution’s “supremacy clause” —the legal argument being that Congress has already reserved the power to regulate foreign investment in real estate with FIRRMA.  However, until successfully challenged, these state and local rules also merit consideration for parties undergoing real estate transactions near U.S. military installations.

[1] See Order of May 13, 2024, Regarding the Acquisition of Certain Real Property of Cheyenne Leads by MineOne Cloud Computing Investment I L.P., 89 Fed. Reg. 43,301 (May 16, 2024).

[2] See, e.g., Protecting America’s Agricultural Land from Foreign Harm Act of 2023, S. 926, 118th Cong. (2023); Countering Communist China Act, H.R. 7476, 118th Cong. (2024).

[3] Note that the proposed rule would not amend the lists of three missile launch areas and twenty-three offshore training “geographic areas” also enumerated in the CFIUS rules, and discussed herein in Section I.

[4] “The Department of Defense will continue on an ongoing basis to assess its military installations and the geographic scope set under the rule to ensure appropriate application in light of national security considerations.”  Provisions Pertaining to Certain Transactions by Foreign Persons Involving Real Estate in the United States, 85 Fed. Reg. 3,158, 3,160 (Jan. 17, 2020)

[5] Order of May 13, 2024, Regarding the Acquisition of Certain Real Property of Cheyenne Leads by MineOne Cloud Computing Investment I L.P., 89 Fed. Reg at 43,301

[6] Note that CFIUS’s real estate rules do provide for certain “excepted investors” from the United Kingdom, Canada, Australia, and New Zealand.

[7] See Micah Brown & Nick Spellman, “Statutes Regulating Ownership of Agricultural Land,” The Nat’l Agric. L. Center, https://nationalaglawcenter.org/state-compilations/aglandownership (last updated Nov. 30, 2023); April J. Anderson et al., Cong. Rsch. Serv., LSB11013, State Regulation of Foreign Ownership of U.S. Land: January to June 2023 (2023).

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The following Gibson Dunn lawyers prepared this update: Michelle Weinbaum, Chris Mullen, Mason Gauch, Stephenie Gosnell Handler, and David Wolber.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding these issues. For additional information about how we may assist you, please contact the Gibson Dunn lawyer with whom you usually work, the authors, or the following leaders and members of the firm’s International Trade practice group:

United States:
Ronald Kirk – Co-Chair, Dallas (+1 214.698.3295, [email protected])
Adam M. Smith – Co-Chair, Washington, D.C. (+1 202.887.3547, [email protected])
Stephenie Gosnell Handler – Washington, D.C. (+1 202.955.8510, [email protected])
Christopher T. Timura – Washington, D.C. (+1 202.887.3690, [email protected])
David P. Burns – Washington, D.C. (+1 202.887.3786, [email protected])
Nicola T. Hanna – Los Angeles (+1 213.229.7269, [email protected])
Courtney M. Brown – Washington, D.C. (+1 202.955.8685, [email protected])
Samantha Sewall – Washington, D.C. (+1 202.887.3509, [email protected])
Michelle A. Weinbaum – Washington, D.C. (+1 202.955.8274, [email protected])
Mason Gauch – Houston (+1 346.718.6723, [email protected])
Chris R. Mullen – Washington, D.C. (+1 202.955.8250, [email protected])
Sarah L. Pongrace – New York (+1 212.351.3972, [email protected])
Anna Searcey – Washington, D.C. (+1 202.887.3655, [email protected])
Audi K. Syarief – Washington, D.C. (+1 202.955.8266, [email protected])
Scott R. Toussaint – Washington, D.C. (+1 202.887.3588, [email protected])
Claire Yi – New York (+1 212.351.2603, [email protected])
Shuo (Josh) Zhang – Washington, D.C. (+1 202.955.8270, [email protected])

Asia:
Kelly Austin – Hong Kong/Denver (+1 303.298.5980, [email protected])
David A. Wolber – Hong Kong (+852 2214 3764, [email protected])
Fang Xue – Beijing (+86 10 6502 8687, [email protected])
Qi Yue – Beijing (+86 10 6502 8534, [email protected])
Dharak Bhavsar – Hong Kong (+852 2214 3755, [email protected])
Felicia Chen – Hong Kong (+852 2214 3728, [email protected])
Arnold Pun – Hong Kong (+852 2214 3838, [email protected])

Europe:
Attila Borsos – Brussels (+32 2 554 72 10, [email protected])
Patrick Doris – London (+44 207 071 4276, [email protected])
Michelle M. Kirschner – London (+44 20 7071 4212, [email protected])
Penny Madden KC – London (+44 20 7071 4226, [email protected])
Irene Polieri – London (+44 20 7071 4199, [email protected])
Benno Schwarz – Munich (+49 89 189 33 110, [email protected])
Nikita Malevanny – Munich (+49 89 189 33 224, [email protected])
Melina Kronester – Munich (+49 89 189 33 225, [email protected])
Vanessa Ludwig – Frankfurt (+49 69 247 411 531, [email protected])

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

Gibson, Dunn & Crutcher LLP announces release of Edition 14 of Lexology In-Depth: International Investigations.

Gibson, Dunn & Crutcher LLP is pleased to announce with Lexology the release of International Investigations. Gibson Dunn partner Stephanie L. Brooker was the Contributing Editor of the publication, which explores the scope of corporate and individual liability and the regulatory and criminal investigations process in the United States and abroad. The Treatise is FREE for a limited time to access HERE.

Ms. Brooker, partners M. Kendall Day and David C. Ware, of counsel Bryan H. Parr, and associate Jack Strachan jointly authored the United States chapter.

You can view this informative and comprehensive treatise via the links below:

CLICK HERE to view Lexology In-Depth: International Investigations

CLICK HERE to view the United States chapter

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The following Gibson Dunn lawyers contributed to this publication: Stephanie L. Brooker, M. Kendall Day, David C. Ware, Bryan H. Parr, Jack Strachan.

Gibson Dunn has deep experience with investigations, corporate compliance, and white collar defense.

About the Authors:

Stephanie Brooker, a partner in the Washington, D.C. office of Gibson Dunn, is Co-Chair of the firm’s Global White Collar Defense and Investigations, Anti-Money Laundering, and Financial Institutions Practice Groups. Stephanie served as a prosecutor at DOJ, including serving as Chief of the Asset Forfeiture and Money Laundering Section, investigating a broad range of white-collar and other federal criminal matters, and trying 32 criminal trials. She also served as the Director of the Enforcement Division and Chief of Staff at FinCEN, the lead U.S. anti-money laundering regulator and enforcement agency. Stephanie has been consistently recognized by Chambers USA for enforcement defense and BSA/AML compliance as an “excellent attorney,” who clients rely on for “important and complex” matters, and for providing “excellent service and terrific lawyering.” She has also been named a National Law Journal White Collar Trailblazer and a Global Investigations Review Top 100 Women in Investigations.

Kendall Day is a nationally recognized white-collar partner in the Washington, D.C. office of Gibson Dunn, where he is Co-Chair of Gibson Dunn’s Global Fintech and Digital Assets Practice Group, Co-Chair of the firm’s Financial Institutions Practice Group, co-leads the firm’s Anti-Money Laundering practice, and is a member of the White Collar Defense and Investigations and Crisis Management Practice Groups. Kendall is recognized as a leading White Collar Attorney in the District of Columbia by Chambers USA – America’s Leading Business Lawyers. Most recently, Kendall was recognized in Best Lawyers 2024 for white-collar criminal defense. Prior to joining Gibson Dunn, Kendall had a distinguished 15-year career as a white-collar prosecutor with DOJ, rising to the highest career position in DOJ’s Criminal Division as an Acting Deputy Assistant Attorney General (“DAAG”). As a DAAG, Kendall had responsibility for approximately 200 prosecutors and other professionals. Kendall also previously served as Chief and Principal Deputy Chief of the Money Laundering and Asset Recovery Section. In these various leadership positions, from 2013 until 2018, Kendall supervised investigations and prosecutions of many of the country’s most significant and high-profile cases involving allegations of corporate and financial misconduct. He also exercised nationwide supervisory authority over DOJ’s money laundering program, particularly any BSA and money-laundering charges, DPAs and non-prosecution agreements involving financial institutions.

David C. Ware is a partner in the Washington, D.C. office of Gibson, Dunn & Crutcher. He is a member of the firm’s Securities Enforcement, Securities Litigation, Accounting Firm Advisory and Defense, and White Collar Defense and Investigations Practice Groups. David’s practice focuses on government investigations and enforcement actions, internal investigations, and litigation in the areas of auditing and accounting, securities fraud, and related aspects of federal regulatory and criminal law. He also counsels clients concerning compliance with SEC and PCAOB rules and standards. Prior to joining Gibson Dunn, Mr. Ware spent nearly six years at the PCAOB’s Division of Enforcement and Investigations, rising to the position of Associate Director. While at the PCAOB, David was responsible for numerous complex and high-profile investigations, including acting as the lead attorney in some of the PCAOB’s most significant enforcement actions.

Bryan H. Parr is of counsel in the Washington, D.C. office of Gibson, Dunn & Crutcher and a member of the White Collar Defense and Investigations, Anti-Corruption & FCPA, and Litigation Practice Groups. His practice focuses on white-collar defense and regulatory compliance matters around the world. Bryan has extensive expertise in government and corporate investigations, including those involving the Foreign Corrupt Practices Act (FCPA) and anticorruption. He has defended a range of companies and individuals in U.S. Department of Justice (DOJ), SEC, and CFTC enforcement actions, as well as in litigation in federal courts and in commercial arbitrations. In his FCPA practice, Bryan regularly guides companies on creating and implementing effective compliance programs, successfully navigating compliance monitorships, and conducting appropriate M&A-related FCPA diligence and integration. He is recognized as a leading corporate crime and investigations lawyer by Chambers & Partners Latin America for his significant activity and experience in the region. He is proficient in Portuguese, French, and Spanish, and works professionally in all three languages.

Jack Strachan is an associate in the Washington, D.C. office of Gibson, Dunn & Crutcher. He is a member of the firm’s Corporate Department. Jack earned his law degree from the University of Michigan Law School, as well as a B.A. in Economics and Philosophy from the University of Michigan.

Contact Information:

For assistance navigating these issues, please contact the Gibson Dunn lawyer with whom you usually work, the leaders or members of the firm’s White Collar Defense and Investigations practice group, or the authors:

Stephanie L. Brooker – Washington, D.C. (+1 202.887.3502, [email protected])
M. Kendall Day – Washington, D.C. (+1 202.955.8220, [email protected])
David C. Ware – Washington, D.C. (+1 202.887.3652, [email protected])
Bryan H. Parr – Washington, D.C. (+1 202.777.9560, [email protected])
Jack Strachan – Washington, D.C. (+1 202.777.9445, [email protected])

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

From the Derivatives Practice Group: This week, the CFTC released a report detailing the results of its fourth Supervisory Stress Test of derivatives clearing organization resources. The report concluded the derivatives clearing organization hold sufficient resources to withstand extreme price shocks.

New Developments

• Supreme Court Overrules Chevron, Sharply Limiting Judicial Deference To Agencies’ Statutory Interpretation. Last week, the Supreme Court overruled Chevron v. Natural Resources Defense Council, a landmark decision that had required courts to defer to agencies’, including the CFTC’s, reasonable interpretations of ambiguous statutory terms. For a more detailed analysis of the ruling please refer to Gibson Dunn’s client alert, available here. [NEW]
• CFTC Announces Supervisory Stress Test Results. On July 1, the CFTC issued Supervisory Stress Test of Derivatives Clearing Organizations: Reverse Stress Test Analysis and Results, a report detailing the results of its fourth Supervisory Stress Test (“SST”) of derivatives clearing organization (“DCO”) resources. Among other findings, the 2024 report concluded the DCOs studied hold sufficient financial resources to withstand many extreme and often implausible price shocks. The purpose of the analysis was twofold: (1) to identify hypothetical combinations of extreme market shocks, concurrent with varying numbers of clearing member (“CM”) defaults, that would exhaust prefunded resources (DCO committed capital, and default fund), and unfunded resources available to the DCOs (this represents the reverse stress test component), and (2) to analyze the impacts of DCO use of mutualized resources on non-defaulted CMs. [NEW]
• CFTC Staff Issues a No-Action Letter Regarding Certain Reporting Requirements for Swaps Transitioning from CDOR to CORRA. On June 27, the CFTC Division of Market Oversight (“DMO”) and Division of Data (“DOD”) issued a staff no-action letter regarding certain Part 43 and Part 45 swap reporting obligations for swaps transitioning under the ISDA LIBOR fallback provisions from referencing the Canadian Dollar Offered Rate (“CDOR”), to referencing the risk-free Canadian Overnight Repo Rate Average (“CORRA”) following the cessation of CDOR after June 28, 2024. The letter states DMO and DOD will not recommend the CFTC take enforcement action against an entity for failure to timely report under Part 45 the change in a swap’s floating rate. This letter covers those floating rate changes that are made under the ISDA LIBOR fallback provisions from CDOR to CORRA, but only in the event the entity uses its best efforts to report the change by the applicable deadline in Part 45 and in no case reports the required information later than five business days from, but excluding, July 2, 2024. The letter also states DMO and DOD will not recommend the CFTC take enforcement action against an entity for failure to report under Part 43 the change in the floating rate for a swap modified after execution to incorporate the ISDA LIBOR fallback provisions to transition from referencing CDOR to referencing CORRA.
• CFTC Extends Public Comment Period for Proposed Amendments to Event Contracts Rules. On June 27, the CFTC announced it is extending the deadline for public comment on a proposal to amend its event contract rules. The extended comment period will close on August 8, 2024. The CFTC is providing an extension to allow interested persons additional time to analyze the proposal and prepare their comments. The proposal would amend CFTC Regulation 40.11 to further specify types of event contracts that fall within the scope of Commodity Exchange Act (“CEA”) Section 5c(c)(5)(C) and are contrary to the public interest, such that they may not be listed for trading or accepted for clearing on or through a CFTC-registered entity.
• CFTC Grants ForecastEx, LLC DCO Registration and DCM Designation. On June 25, the CFTC announced that it has issued ForecastEx, LLC an Order of Registration as a DCO and an Order of Designation as a designated contract market (“DCM”) under the CEA. DCO registration was granted under Section 5b of the CEA. DCM designation was granted under Section 5a of the CEA. ForecastEx is a limited liability company registered in Delaware and headquartered in Chicago, Illinois.
• CFTC Approves Final Capital Comparability Determinations for Certain Non-U.S. Nonbank Swap Dealers. On June 25, the CFTC announced it has approved four comparability determinations and related comparability orders granting conditional substituted compliance in connection with the CFTC’s capital and financial reporting requirements to certain CFTC-registered nonbank swap dealers organized and domiciled in Japan, Mexico, the European Union (France and Germany), or the United Kingdom. Pursuant to the orders, non-U.S. nonbank swap dealers subject to prudential regulation by the Financial Services Agency of Japan, the National Banking and Securities Commission of Mexico and the Mexican Central Bank, the European Central Bank, or the United Kingdom Prudential Regulation Authority may satisfy certain CEA capital and financial reporting requirements by being subject to, and complying with, comparable capital and financial reporting requirements under the respective foreign jurisdiction’s laws and regulations, subject to specified conditions.

New Developments Outside the U.S.

• ESMA Puts Forward Measures to Support Corporate Sustainability Reporting. On July 5, ESMA published a Final Report on the Guidelines on Enforcement of Sustainability Information (“GLESI”) and a Public Statement on the first application of the European Sustainability Reporting Standards (“ESRS”). ESMA reports that these documents will support the consistent application and supervision of sustainability reporting requirements. [NEW]
• New MiCA Rules Increase Transparency for Retail Investors. On July 4, ESMA published the second Final Report under the Markets in Crypto-Assets Regulation (MiCA) covering eight draft technical standards that aim to provide more transparency for retail investors, clarity for providers on the technical aspects of disclosure and record-keeping requirements, and data standards to facilitate supervision by National Competent Authorities (“NCAs”). The report covers public disclosures, as well as descriptions on how issuers should disclose price-sensitive information to the public to prevent market abuses, such as insider dealing. [NEW]
• ESMA Reappoints Three Members to its Management Board. On July 4, ESMA announced that it has reappointed three current members to its Management Board. The appointments took place at the Board of Supervisors meeting on July 3. The Management Board, chaired by Verena Ross, Chair of ESMA, is responsible for ensuring that the Authority carries out its mission and performs the tasks assigned to it under its founding Regulation. [NEW]
• EBA and ESMA Publish Guidelines on Suitability of Management Body Members and Shareholders for Entities Under MiCA. On June 27, EBA and ESMA published joint guidelines on the suitability of members of the management body, and on the assessment of shareholders and members with qualifying holdings for issuers of asset reference tokens (“ARTs”) and crypto-asset service providers (“CASPs”), under the MiCA. The first set of guidelines covers the presence of suitable management bodies within issuers of ARTs and CASPs. The second set of guidelines concerns the assessment of the suitability of shareholders or members with direct or indirect qualifying holdings in a supervised entity.
• ESAs Propose Improvements to the Sustainable Finance Disclosure Regulation. On June 18, the EBA, the European Insurance and Occupational Pensions Authority (“EIOPA”), and ESMA (the three European Supervisory Authorities , i.e., “ESAs”)
  published a Joint Opinion on the assessment of the Sustainable Finance Disclosure Regulation (“SFDR”). In the joint opinion, the ESAs call for a coherent sustainable finance framework that caters for both the green transition and enhanced consumer protection, considering the lessons learned from the functioning of the SFDR.

New Industry-Led Developments

• ISDA Proceeds with Development of an Industry Notices Hub. On July 1, ISDA announced it will proceed with the development of an industry-wide notices hub, following strong support from buy- and sell-side institutions globally. The new online platform will allow instantaneous delivery and receipt of critical termination-related notices and help to ensure address details for physical delivery are up to date, reducing the risk of uncertainty and potential losses for senders and recipients of these notices. [NEW]
• ISDA Publishes Framework to Prepare for Close Out of Derivatives Contracts. On June 27, ISDA published the ISDA Close-out Framework that market participants can use to help prepare for potential terminations of collateralized derivatives contracts. ISDA stated that the launch of the ISDA Close-out Framework is in response to the March 2023 failure of Signature Bank and SVB in the US, which, according to ISDA, highlighted the complexities of potentially terminating over-the-counter derivatives trading relationships following various post-crisis regulatory reforms. Specifically, the reforms require that in-scope entities post margin for non-cleared derivatives transactions, while various jurisdictions have introduced mandatory stays on termination rights and remedies as part of bank resolution regimes. ISDA stated that the ISDA Close-out Framework is intended to be used as a preparatory resource to help firms coordinate internal business functions and stakeholders and internal and external legal, operational, risk management, infrastructure and other relevant service providers to ensure they are adequately prepared for any potential future stress events.
• ISDA Responds to CCIL on Proposal for USD/INR FX Options. On June 21, ISDA submitted a response to a consultation paper from the Clearing Corporation of India Limited (“CCIL”) on a proposal to introduce an electronic trading platform and clearing and settlement services for USD/INR FX options of up to one year maturity initially. The response sets out the features of the trading platform, the risk management framework and a questionnaire on the parameters of the product. ISDA’s response focuses mainly on the risk management framework aspect, including the margin models and default management framework. It asks for more clarity and transparency on the choice of margin models and encourages the implementation of scheduled variation margin calls and stress-based anti-procyclicality measures.
• ISDA Responds to FSB Consultation on Liquidity Preparedness for Margin and Collateral Calls. On June 18, ISDA submitted a response to the Financial Stability Board’s (FSB) consultation on liquidity preparedness for margin and collateral calls. The response notes that the recommendations are generally sensible and seek to incorporate a proportionate and risk-based approach. It also highlights a number of considerations relevant to the non-bank financial intermediation (“NBFI”) sector’s liquidity preparedness for margin and collateral calls.

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The following Gibson Dunn attorneys assisted in preparing this update: Jeffrey Steiner, Adam Lapidus, Marc Aaron Takagaki, Hayden McGovern, and Karin Thrasher.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding these developments. Please contact the Gibson Dunn lawyer with whom you usually work, any member of the firm’s Derivatives practice group, or the following practice leaders and authors:

Jeffrey L. Steiner, Washington, D.C. (202.887.3632, [email protected])

Michael D. Bopp, Washington, D.C. (202.955.8256, [email protected])

Michelle M. Kirschner, London (+44 (0)20 7071.4212, [email protected])

Darius Mehraban, New York (212.351.2428, [email protected])

Jason J. Cabral, New York (212.351.6267, [email protected])

Adam Lapidus  – New York (212.351.3869,  [email protected] )

Stephanie L. Brooker, Washington, D.C. (202.887.3502, [email protected])

William R. Hallatt , Hong Kong (+852 2214 3836, [email protected] )

David P. Burns, Washington, D.C. (202.887.3786, [email protected])

Marc Aaron Takagaki , New York (212.351.4028, [email protected] )

Hayden K. McGovern, Dallas (214.698.3142, [email protected])

Karin Thrasher, Washington, D.C. (202.887.3712, [email protected])

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.

In Ryan, LLC v. Federal Trade Commission, the Northern District of Texas concluded “The role of an administrative agency is to do as told by Congress, not to do what the agency think[s] it should do.”

On July 3, 2024, the United States District Court for the Northern District of Texas concluded that the Federal Trade Commission’s Non-Compete Rule, which would retroactively invalidate over 30 million employment contracts and preempt the laws of 46 states, exceeds the FTC’s statutory authority and is arbitrary and capricious in violation of the Administrative Procedure Act.  The court preliminarily enjoined enforcement of the Rule and stayed its effective date, but limited the scope of relief to the parties to the case.  The court did not issue a nationwide preliminary injunction.

Background

Section 5 of the FTC Act authorizes the FTC “to prevent” the use of “unfair methods of competition” through case-by-case adjudication.  Section 6(g) of the Act grants the FTC ancillary powers to support administrative adjudication, including the powers to make recommendations, publish reports, classify corporations, and “make rules and regulations for the purposes of carrying out the provisions of this subchapter.”

On April 23, the FTC promulgated the Non-Compete Rule by a 3-2 vote.  The Rule invokes the FTC’s purported authority under Sections 5 and 6 and declares that nearly all non-compete agreements between employers and employees are “unfair methods of competition.”  The Rule accordingly prohibits businesses from entering into new non-competes except for those associated with the sale of certain business interests and bans the enforcement of nearly all non-competes (with narrow exceptions for the sale of certain business interests and for agreements with certain senior executives).  The Rule also expressly preempted the laws of the 46 states that allow non-compete agreements.

Ryan, LLC, is a global tax-consulting firm headquartered in Dallas.  Its principals and other workers are sought-after tax experts, many of whom agree to temporally limited non-compete agreements.

Represented by Gibson Dunn, Ryan filed suit against the FTC in the Northern District of Texas, alleging that the Non-Compete Rule exceeds the FTC’s statutory authority, violates the Administrative Procedure Act, and defies the major questions doctrine, which instructs that federal agencies cannot regulate questions of deep economic and political significance absent clear authority from Congress.  A group of trade associations led by the United States Chamber of Commerce intervened in the case to challenge the Rule as well.

The Court’s Opinion

• The court determined that the Non-Compete Rule exceeds the scope of the FTC’s statutory authority. “By a plain reading, Section 6(g) of the Act does not expressly grant the Commission authority to promulgate substantive rules regarding unfair methods of competition.”  The court emphasized that, unlike Section 5, Section 6(g) “contains no penalty provision—which indicates a lack of substantive force.”  Further, the court noted that “the location of the alleged substantive rulemaking authority is suspect . . . .  Section 6(g) is the seventh in a list of twelve almost entirely investigative powers.”
• The court further concluded that the Non-Compete Rule is arbitrary and capricious in violation of the Administrative Procedure Act. First, the Rule “is unreasonably overbroad without a reasonable explanation.”  The FTC “lack[ed] . . . evidence as to why they chose to impose such a sweeping prohibition—that prohibits entering or enforcing virtually all non-competes—instead of targeting specific, harmful non-competes.”  Second, “the FTC insufficiently addressed alternatives to issuing the Rule.”  It “dismissed any possible alternatives, merely concluding that either the pro-competitive justifications outweighed the harms, or that employers had other avenues to protect their interests.”
• The court did not address the major questions doctrine.
• The court determined that Ryan and the intervenors would suffer irreparable harm if the Rule takes effect because they would face “financial injury” and expend “nonrecoverable costs [when] complying with the Rule.”
• The court declined to enter a nationwide preliminary injunction. The preliminary injunction and stay are limited to Ryan and the intervenors, and do not extend to intervenors’ member companies or other nonparties.

What It Means:

• The Non-Compete Rule was scheduled to take effect on September 4. As long as the preliminary injunction and stay are in place, the FTC cannot enforce the Rule against Ryan or the intervenors.  Their existing non-compete agreements remain enforceable under federal law, and they are free to enter into new non-compete agreements.
• In the absence of nationwide relief, the Rule will go into effect on September 4 as to all other employers, meaning that state non-compete laws will be preempted, existing non-compete agreements will be retroactively invalidated, and businesses will be unable to enter into new non-compete agreements unrelated to certain sales of businesses.
• The decision is not binding precedent on other courts.
• Proceedings before the district court will continue. The court indicated that it would enter a final ruling on the merits by August 30.

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Gibson Dunn attorneys Eugene Scalia, Allyson N. Ho, Amir C. Tayrani, Andrew Kilberg, Elizabeth A. Kiernan, Aaron Hauptman, and Josh Zuckerman represent Ryan, LLC.

The following Gibson Dunn lawyers prepared this update: Eugene Scalia, Allyson N. Ho, Amir C. Tayrani, Andrew Kilberg, Elizabeth A. Kiernan, Aaron Hauptman, and Josh Zuckerman.

Gibson Dunn’s lawyers are available to assist in addressing any questions you may have regarding the issues discussed in this update. Please contact the Gibson Dunn lawyer with whom you usually work, the authors, or any leader or member of the firm’s Appellate & Constitutional Law, Labor & Employment, Administrative Law & Regulatory, or Antitrust & Competition practice groups:

Appellate and Constitutional Law:
Thomas H. Dupree Jr. – Washington, D.C. (+1 202.955.8547, [email protected])
Allyson N. Ho – Dallas (+1 214.698.3233, [email protected])
Julian W. Poon – Los Angeles (+ 213.229.7758, [email protected])

Labor and Employment:
Andrew G.I. Kilberg – Washington, D.C. (+1 202.887.3759, [email protected])
Karl G. Nelson – Dallas (+1 214.698.3203, [email protected])
Jason C. Schwartz – Washington, D.C. (+1 202.955.8242, [email protected])
Katherine V.A. Smith – Los Angeles (+1 213.229.7107, [email protected])

Administrative Law and Regulatory:
Eugene Scalia – Washington, D.C. (+1 202.955.8673, [email protected])
Helgi C. Walker – Washington, D.C. (+1 202.887.3599, [email protected])

Antitrust and Competition:
Rachel S. Brass – San Francisco (+1 415.393.8293, [email protected])
Svetlana S. Gans – Washington, D.C. (+1 202.955.8657, [email protected])
Cynthia Richman – Washington, D.C. (+1 202.955.8234, [email protected])
Stephen Weissman – Washington, D.C. (+1 202.955.8678, [email protected])

© 2024 Gibson, Dunn & Crutcher LLP.  All rights reserved.  For contact and other information, please visit us at www.gibsondunn.com.

Attorney Advertising: These materials were prepared for general informational purposes only based on information available at the time of publication and are not intended as, do not constitute, and should not be relied upon as, legal advice or a legal opinion on any specific facts or circumstances. Gibson Dunn (and its affiliates, attorneys, and employees) shall not have any liability in connection with any use of these materials.  The sharing of these materials does not establish an attorney-client relationship with the recipient and should not be relied upon as an alternative for advice from qualified counsel.  Please note that facts and circumstances may vary, and prior results do not guarantee a similar outcome.