Gibson Dunn has a national and international health care litigation practice. Experienced litigators throughout the firm have represented industry clients in a broad array of matters. We have successfully tried to verdict numerous high profile cases, and derailed others in advance of trial, often with skilled and well-known trial counsel as our adversaries. We also have successfully argued many significant appeals on behalf of industry clients in state and federal court, including the United States Supreme Court. In the precedent-setting Davila case, the Supreme Court reversed the Fifth Circuit and held that ERISA completely preempts state law causes of action based upon a plan administrator’s denial of coverage for medical care.
Our health care litigation clients include, among others, hospitals, nursing home owners, HMOs and insurers. In representing these clients, we are able to draw upon the vast resources of a global law firm, including litigators with substantial specialized experience in antitrust, securities, False Claims Act/qui tam actions, business crimes and other governmental investigations, consumer class actions, intellectual property (patent and trademark), bankruptcy, and ERISA and other labor and employment matters.
Health Care Compliance and Enforcement
The health care and life sciences industries are coming under increasing scrutiny by Congress, the U.S. Department of Justice, the U.S. Department of Health and Human Services, state Attorneys General, and the plaintiffs’ bar. We bring a unique breadth of experience and talent to handling complex enforcement matters, as well as conducting sensitive and cost effective internal investigations. We bring that experience and perspective to a wide range of health care compliance counseling engagements, including reviews of company protocols and policies concerning interactions with health care providers, conceptualizing and instituting needs assessment reviews for the utilization of physician consultants, conducting analyses of how compliance policies are effectuated in the field, and analyzing and making improvements to health care compliance systems. Our practice is cross-disciplinary in nature, relying on experts in various areas to address issues such as health care privacy and data breaches, intellectual property licensing, and corporate governance.
Gibson Dunn litigators have substantial experience representing health care clients in civil and criminal proceedings and investigations brought by governmental entities, including False Claims Act cases brought by the government and/or qui tam plaintiffs. Drawing upon the collective experience of over 75 attorneys with deep government experience including numerous former federal prosecutors, as well as many other litigators with significant experience in defending health care entities, we have a strong bench ready to handle complex governmental investigations and related litigation.
Governmental Investigations and Related Litigation
Representative governmental investigations and related litigation (including False Claims Act cases brought by the government and qui tam plaintiffs) include:
- DePuy Orthopaedics, Inc. - Deferred Prosecution Agreement: Pursuant to a Deferred Prosecution Agreement (“DPA”) between the Department of Justice and DePuy Orthopaedics, Inc. (“DePuy”), a subsidiary of Johnson & Johnson, Gibson Dunn partner Debra Wong Yang was appointed an Independent Monitor to oversee DePuy’s compliance with the DPA and assist in restructuring the company’s health care compliance program. The case arose from a lengthy investigation into the nation’s five largest orthopaedic implant manufacturers and allegations of violations of the federal Anti-Kickback Statute in connection with physician consultation and royalty agreements.
- National Medical Enterprises/Psychiatric Institutes of America: Represented NME in parallel civil and criminal investigations across the United States arising out of allegations that its psychiatric subsidiary had paid illegal compensation to physicians. We successfully negotiated a guilty plea by the subsidiary and corresponding civil settlement that resolved all pending investigations and assured the parent entity’s survival.
- National Medical Enterprises - Private Plaintiff Proceedings: Following the settlement described above, prominent plaintiff lawyers cross the United States began to file lawsuits on behalf of former psychiatric patients. Referencing the guilty plea, the patients claimed to have been improperly hospitalized and treated due to a fraudulent scheme directed by NME. Ultimately, several thousand former patients asserted claims. We successfully tried to verdict the claims of nine former patients. One of the trials was recognized by the National Law Journal as the Defense Win of the Year. We also defended to successful verdict an antitrust claim brought by a competitor psychiatric hospital. Following these courtroom victories, the remaining pending cases across the country were settled for nominal amounts.
- Parkshore Nursing Home: Defended Parkshore in the largest Medicaid fraud case ever brought by the New York Attorney General’s Office. We negotiated a plea and civil settlement that permitted existing ownership to continue to operate the facility.
- Tenet Healthcare: Obtained summary judgment for the former General Counsel and Chief Compliance Officer of Tenet in an action brought by the Department of Justice alleging personal liability under the False Claims Act for alleged Stark Law violations by a Tenet hospital in Florida. The case generated substantial attention within the health care industry due to its unprecedented attempt to hold in-house counsel personally liable for alleged wrongdoing by a subsidiary entity.
- Tenet Healthcare: Successfully defended Tenet (formerly NME) in a number of False Claims Act cases brought by the government and/or qui tam plaintiffs involving issues such as coding and whether physician contracts were in violation of Stark. We have also represented Tenet in antitrust representations on matters before the FTC and DOJ, and numerous other state and federal investigations.
- Confidential U.S. Pharmaceutical Company: Represented a large U.S. pharmaceutical client with respect to an investigation involving alleged kickbacks to government officials in India.
- Confidential Accounting Firm: Represented an accounting firm in connection with a joint investigation by the SEC, DOJ, and FBI of an audit of a medical products company that allegedly made illegal payments to government officials in China.
- Confidential Health Care Company: Represented a health care company in State AG and DOJ civil investigation into services provided and reimbursed under Medicare and Medicaid.
- Confidential Health Care Company: Represented one of the largest diagnostic laboratories in a DOJ investigation focused on reimbursements, expenses for laboratory services and diagnostic testing, including Part B reimbursements.
- Other Governmental Experience: We have represented many other health care entities and physician groups such as EmCare, Inc., Allergan, MedAmerica, Inc., and California Emergency Physicians in litigation with state and federal agencies over billing, reimbursement and compliance issues.
Health Care Patent Litigation
Gibson Dunn’s IP litigators represent the leading technology companies in the world in their most significant and challenging patent and other intellectual property litigation matters, including successes before the United States Supreme Court on behalf of Microsoft and Metabolite Laboratories. With a dedicated team of experienced IP trial and appellate lawyers, Gibson Dunn handles these matters effectively, efficiently and successfully.
Pharmaceutical Litigation
- Amgen v. Columbia University. Successfully defended Columbia in declaratory judgment action challenging validity of patent pertaining to fundamental recombinant DNA technologies; prosecuted counterclaim for $75 million in past due patent royalties.
- American Bioscience v. Florida State University. Successfully represented Florida State University in the trial of its claim that it is the rightful owner of a patent for cancer drugs including the synthetic drug Taxol. FSU has earned in excess of $150 million in royalties from its various cancer drug patents.
- Allergan v. Elan Pharmaceuticals. Represented Allergan in infringement suit relating to Elan’s sales of product to treat cervical dystonia. Our client alleged that a pharmaceutical product being sold by defendant infringed our client’s patent, which claimed the use of certain botulinum toxin compounds for the treatment of cervical dystonia. The action was settled following the pleading and discovery stages.
- Forest Laboratories, Inc. v. Ivax Pharmaceuticals, Inc. Successfully represented patentee H. Lundbeck A/S, its exclusive licensee Forest Laboratories Ireland, Ltd., and its U.S. distributor and NDA-holder Forest Laboratories, Inc., in Hatch-Waxman litigation against various ANDA applicants seeking to market a generic version of Forest’s LEXAPRO-brand escitalopram prior to the expiration of Lundbeck’s Orange Book-listed patent on the compound. Following a bench trial, the district court entered judgment upholding the validity of Lundbeck’s patent and enjoining the ANDA applicants from entering the market. The District Court’s judgment was affirmed by the Court of Appeals for the Federal Circuit.*
- Israel Bio-Engineering Project v. Amgen. Represented Merck Serono, the world’s third largest biotechnology company, in litigation pertaining to tumor necrosis factor binding proteins.
- Metabolite Laboratories. Successfully represented Metabolite Laboratories before the United States Supreme Court in a case against Laboratory Corporation of America. At issue was whether our client’s patent was invalid for claiming a “law of nature.” Gibson Dunn had already won at the trial court and before the Court of Appeals. The Supreme Court dismissed the case after our oral argument, thereby affirming the previous successes in the courts below.
- Schering Corp. v. Glenmark Pharmaceuticals, Inc. Represented generic drug manufacturer in ANDA litigations involving desloratadine (Clartin-D®) and ezetimibe (Zetia®).*
Medical Device Patent Litigation:
- Cardiac Pacemakers, Inc. v. St. Jude Medical, Inc. Gibson Dunn litigators represented St. Jude Medical, Inc. in a major patent case where the Federal Circuit, in an 11-1 en banc decision, held that the statute prohibiting exporting the components of patented inventions, does not apply to method claims. The court’s ruling, which reversed the district court, has important ramifications for all companies that do business both in the United States and abroad.
- Riegel v. Medtronic. We won an 8-1 Supreme Court victory on behalf of Medtronic, Inc. in which the Court held that federal law preempts products liability claims challenging the design and labeling of medical devices that the federal Food and Drug Administration has found to be safe and effective.
- Medtronic v. Abbott Vascular. In a long-running patent case against Abbott Vascular, we took over the remedy phase after a jury verdict of patent infringement against Medtronic involving the Endeavor® “drug-eluting” stent, persuading the district court to deny a permanent injunction.
- Guidant v. St. Jude Medical. Secured important victories for St. Jude Medical, Inc. in a high-stakes patent-infringement case brought by Guidant Corporation. In a case that has resulted in a series of lengthy opinions by the District Court and the Federal Circuit, two of the four patents asserted by Guidant were invalidated by the trial court and claims on a third were dismissed with prejudice.
- Inamed v. Johnson & Johnson. Represented Johnson & Johnson in patent litigation against Inamed pertaining to bariatric surgical devices and methods, and against Spa Sciences, Inc.
- GE Medical Systems v. Resonance Technology, Inc. and Mokhtar Ziarati. Represented the plaintiff in a patent ownership dispute with a former employee over the use of technology developed at GE pertaining to MRI systems. After a series of successful summary judgment rulings in favor of our client, this case was resolved by a settlement on favorable terms.
- Allergan Medical Optics v. Staar Surgical Co. Patent infringement action in which the client was the patentee plaintiff. Successfully tried to a jury, which rendered a verdict in the client’s favor.
- Allergan, Inc. v. Bausch & Lomb. Patent infringement action in which the client was the plaintiff patentee. Action was settled favorably for the client.
- Pharmacia v. Allergan, Inc. Patent infringement action in which the client was the defendant and alleged infringer. Action settled one day before trial, pursuant to which the client received a license to the patent-in-suit.
Health Care Consumer Class Actions
Gibson Dunn has a preeminent consumer class action defense practice. The firm frequently defends health care clients targeted by the plaintiff class action bar.
- Aetna Health of California, Inc., AT&T Wireless Services, Cingular Wireless LLC -- Korea Supply v. Lockheed Martin. Represented Aetna Health of California, Inc., Cingular Wireless LLC, and AT&T Wireless Services as amici curiae on behalf of Lockheed Martin before the California Supreme Court. Adopting arguments of amici, the California Supreme Court concluded that the disgorgement of profits is not an authorized remedy in an individual action under California’s Unfair Competition Law where the alleged profits constitute neither money taken from the plaintiff nor funds in which the plaintiff has an ownership interest.
- DaVita Corp. -- Consumer Cause v. Represented DaVita Corp. in defense of nationwide private attorney general action under California’s Unfair Competition Law challenging alleged billing irregularities involving patients with End Stage Renal Disease. Obtained dismissal of complaint on demurrer for failure to allege violations with sufficient particularity.
- Express Scripts, Inc., et al. -- Bradley et al. v. Represented Express Scripts, Inc. in state court action proceedings challenging pharmacy benefit managers’ obligations under a reporting statute and California’s Unfair Competition Law. State court dismissed entire action based on application of Proposition 64 and on the ground that the state statute upon which plaintiffs based their claims were unconstitutional. California Court of Appeal affirmed the decision (Bradley v. First Health Servs. Corp., 2007 Cal. App. Unpub. LEXIS 1625 (Cal. Ct. App. Feb. 28, 2007)), and the Supreme Court of California denied review. Defending client in identical federal proceedings currently on review in Ninth Circuit.
- Express Scripts, Inc. -- In re Pharmacy Benefits Manager Cases. Represented Express Scripts, Inc., a Fortune 500 company and one of the nation’s largest Pharmacy Benefits Managers, in coordinated class action proceedings challenging prescription pricing practices of twelve national PBMs. After extensive litigation, we obtained dismissal of consumer class action asserting fraud, false advertising and unlawful and unfair practice claims. Earlier, we had prepared and argued a successful motion supporting application of California’s Proposition 64 in coordinated case, limiting Unfair Competition Law actions to cases already pending on the date of enactment. The dual wins resulted in an end to many years of litigation.
- Golden Living -- Gordon v. Beverly Enterprises, dba Hy-Lond Convalescent Center, et al. Represented national nursing home owner and operator in action in Santa Clara County Superior Court alleging violations of California’s Unfair Competition Law based upon allegations that skilled nursing facility employees engaged in a pattern of elder abuse (Cal. Welf. & Inst. Code § 15657), regulatory violations, and assault and battery against elderly Alzheimer patients, including plaintiff. Complaint also sought treble damages (Cal. Civ. Code § 3345) based upon these allegations. Our demurrer to Unfair Competition Law claim was sustained and the prayer for treble damages stricken.
- Syncor International Corporation -- Cardinal Health. Secured summary judgment for Syncor International Corporation (now operating as a subsidiary of our client Cardinal Health, Inc.) in an ERISA action in federal court in Los Angeles. Plaintiffs – a certified class of Syncor’s ERISA plan participants – sought over $65 million in damages, alleging that Syncor breached its ERISA fiduciary duties of prudence and monitoring by offering Syncor stock under the company’s ERISA plan. Quoting liberally from Syncor’s motion for summary judgment, the court granted summary judgment on all claims. The order addresses favorably to defendants a number of important issues concerning the burgeoning field of ERISA company stock cases.
- Tenet Healthcare Corporation -- Hospital Lien Cases. Represented Tenet Healthcare Corporation in defense of California Unfair Competition Law, Consumers Legal Remedies Act, and breach of contract claims seeking restitution on behalf of all individuals against whom liens have been filed by Tenet hospitals for care relating to provider service contracts. Cases removed to federal court and motion to dismiss filed based on ERISA preemption grounds. We successfully demurred to state complaint based upon litigation privilege and successfully demurred to breach of contract claims.
- Tenet Healthcare Corporation -- Hospital Photocopier Litigation (National Medical Enterprises). Represented Tenet Healthcare Corp. in successful litigation and settlement of three quasi-class actions consolidated in San Francisco Superior Court charging hospitals and photocopy companies with violations of California’s Unfair Competition Law arising from allegedly unlawful and unfair copy costs to patients. We coordinated litigation strategy with scores of other defendants state-wide and obtained a successful settlement.
- Tenet Healthcare Corporation -- Pricing Cases. Served as national coordinating counsel for Tenet Healthcare in a series of consumer class actions filed across the country alleging that the pricing practices at Tenet’s subsidiary hospitals violated various consumer protection laws. A favorable global settlement was achieved.
- Tenet Healthcare Corporation -- Whiteside v. Represented Tenet Healthcare Corp. and all its California hospitals in consumer class action in Los Angeles Superior Court alleging violations of California’s Unfair Practices Law arising from hospitals’ alleged practice of collecting payments from more than one insurance company when a patient claims coverage under more than one policy. We obtained summary judgment, the California Court of Appeal affirmed the Superior Court’s ruling, and the Supreme Court of California denied review.
Health Care ERISA Litigation
We have handled cutting-edge ERISA cases throughout the country, including representing several clients in high-profile lawsuits alleging fiduciary breaches in connection with the administration of 401(k) plans, particularly the investment of plan assets in company stock.
- Aetna Health Inc. v. Davila. In this important, precedent-setting case, the U.S. Supreme Court unanimously held that ERISA completely preempts state law causes of action based on a plan administrator’s denial of coverage for medical care.
- Egelhoff v. Egelhoff. Successfully represented the petitioner before the U.S. Supreme Court in a 7-2 decision overturning the State Supreme Court of Washington in Egelhoff v. Egelhoff, which affirmed the scope of ERISA’s statutory preemption provision as it relates to state regulation of pension and life insurance benefits.
- IBEW-NECA Southwestern Health and Benefit Fund. We obtained summary judgment for our client, IBEW-NECA Southwestern Health and Benefit Fund, awarding million dollar judgment against former investment manager for breach of fiduciary duties. The judgment was affirmed on appeal by the Ninth Circuit.
Health Care Antitrust and Securities Litigation
Gibson Dunn is well known for the quality of its litigators, particularly in specialized practice areas such as securities and antitrust. We routinely draw upon the resources of those practice areas to represent health care clients.
- Tenet Healthcare v Community Health Systems (N.D. TX. 2011) Represent Tenet in securities litigation arising out of competitor’s allegedly false and misleading proxy solicitation materials issued in connection with contest for control of Tenet’s board of directors. Four weeks after the suit was filed, Defendant withdrew its proposed slate of directors and dropped its attempt to acquire Tenet.
- Timberlawn Psychiatric Hospital v Tenet Healthcare (Dallas County District Court 1998). Defended Tenet in antitrust/RICO case brought by preeminent psychiatric hospital which alleged it had been driven into bankruptcy due to a scheme by Tenet and its subsidiaries to bribe the plaintiffs’ traditional referral sources and thus divert patients to Tenet-owned hospitals. Obtained take-nothing jury verdict.
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