The health care industry has faced explosive growth—and uncertainty—in recent years. Health care and life sciences companies must contend with constantly evolving business, litigation, and regulatory compliance risks, which may rise and fall with political tides.
Hueston Hennigan plays a central role in helping health care and life sciences companies keep up with rapid and unpredictable change, providing counsel and representation to high-profile pharmaceutical, biotechnology, and medical device companies; institutional health care providers; insurers; doctors; and corporate executives. We have extensive experience addressing the increasingly complex civil, regulatory, and criminal issues that challenge our health care clients. We also safeguard clients’ business interests and guide them through intricate business and regulatory environments to avoid litigation whenever possible.
When litigation is unavoidable, however, we have the know-how to represent our clients from pre-litigation counsel through trial and appeals, in state and federal court, and before arbitral tribunals. We have a record of success in prosecuting and defending allegations of health care fraud; have secured prosecution declinations in high-profile criminal investigations; and successfully defended our health care clients in national litigation alleging trade secret violations, off-label promotion, and false advertising. Our team leverages extensive experience in litigation across a wide range of legal issues, including anti-kickback, licensing, privacy, corporate practice of medicine, unfair business and trade practices laws, RICO, the Food, Drug, and Cosmetic Act, the Health Insurance Portability and Accountability Act, federal and state false claims acts, Medicare, Medicaid, workers’ compensation fraud, and a variety of other state and federal statutes.
In addition, we have conducted more than 25 high-stakes investigations on behalf of governing boards of health care companies, hospitals, and research institutions.
- Represented Amgen in a multibillion-dollar securities action and obtained dismissal with prejudice of multiple shareholder derivative suits and a favorable resolution of related actions alleging off-label marketing and misrepresentations concerning drug safety. (See “Amgen Beats Decade-Old Investor Suit over Off-Label Scheme,” Law360)
- Defending Bausch Health Companies in a dispute concerning alleged misappropriation of interocular lens technology as well as several additional contract and tort claims.
- GlaxoSmithKline v. Abbott Laboratories. Represented Glaxo in a high-profile antitrust, unfair competition, and breach of contract action against Abbott Laboratories, alleging Abbott abused its market dominance and engaged in predatory pricing of HIV drugs. Settled on favorable grounds for the client.
- Defending Valeant Pharmaceuticals in a false claims act action alleging Valeant fraudulently obtained patents on certain medications and misrepresented claims for payment submitted to various state and federal agencies.
- Won dismissal of putative class action against Allergan subsidiary Zeltiq Aesthetics alleging that customers of the company’s high-profile CoolSculpting fat-freezing system were deceived by marketing materials that described the medical device as having been “cleared” but not “approved” by the U.S. Food and Drug Administration. (See “Allergan’s Fat-Freezing Unit Freed From False Ad Claims,” Law360)
- Defended Amgen and several former executives in several securities class actions, including shareholder, derivative, and ERISA matters. After moving for summary judgment, obtained favorable settlements in the shareholder and ERISA matters and dismissals of the derivative matters.
- Representing a pharmacy and pharmacy owner in criminal and civil fraud investigation related to the unauthorized distribution of controlled substances.
- Defended Valeant Pharmaceuticals in multibillion-dollar securities class actions alleging violation of insider trading and control person liability statutes. After argument on summary judgment motions, obtained favorable settlements on all matters.
- Conducted an internal investigation of the nation’s largest publicly operated health plan, concluding with actionable items designed to enhance the integrity of the system.
- Secured decertification of a consumer class action against Nutraceutical International Corporation, a publicly traded and leading manufacturer of health and dietary supplements, in litigation alleging that one of its top-selling products violated California false advertising and unfair competition laws. (See “Class Decertified…,” Law360)
- Obtained dismissal of a trade secrets case brought by Teva against Amgen. (See “Teva Loses Amgen Spying Suit Over Blood Drug Secrets,” Law360)
- Terminated criminal and parallel civil investigations targeting the CEO of a Fortune 500 medical device manufacturer for alleged complicity in an off-label promotion scheme and false and misleading public statements and filings regarding device development.
- Terminated criminal investigation of Fortune 500 medical device manufacturer alleging FDA violations and a cover-up without payment of a fine or civil settlement.
- Obtained prosecution declinations for the University of California, Irvine (UCI) and former individual “targets” in high-profile health care fraud investigation of the UCI liver transplant program.
- Obtained a prosecution declination for Kaiser Permanente in investigations of alleged HIPAA violations.
- Resolved tristate attorneys general investigation into alleged false advertising by Fortune 500 health care company without fines or penalties.
- Obtained dismissal with prejudice of False Claims Act against a public entity alleged to be worth tens of millions of dollars.
- Represented an individual charged in a conspiracy related to the illegal import of Canadian pharmaceutical drugs for sale in the United States. The case was resolved with dismissal of criminal charges against our client.
- Represented a Fortune 500 medical device manufacturer in a criminal investigation concerning alleged violations of the Food, Drug, and Cosmetic Act, including allegations of knowingly manufacturing adulterated and misbranded medical devices, and violations of the FDA’s Good Manufacturing Practices. No charges were filed against our client.