Industries
FDA and Health Care
Leveraging deep industry and government expertise, Gibson Dunn excels at counseling clients on complex legal issues related to regulated products and health care services.
80+ practice lawyers across 12 offices worldwide
Tier 1-ranked, LMG Life Sciences Guide
Deep bench of former prosecutors and government officials, including former Director of DOJ’s Consumer Protection Branch and Deputy GC at HHS
Tier 1-ranked, False Claims Act – Nationwide, Chambers USA
Overview
Gibson Dunn’s FDA and Health Care Industry Group advises clients on complex legal issues related to regulated products and health care services.
Leveraging unique government and industry experience, we defend companies and executives in government investigations and litigation involving pharmaceuticals, medical devices, food, cosmetics, tobacco products, and consumer products, as well as in matters concerning hospitals, pharmacies, health technology, and retail sales. Our lawyers also help companies navigate compliance with laws and regulations administered by key agencies that oversee regulated products and services, including the U.S. Food and Drug Administration (FDA), the Federal Trade Commission (FTC), the Drug Enforcement Administration (DEA), the Consumer Product Safety Commission (CPSC), the Centers for Medicare and Medicaid Services (CMS), and analogous state agencies.
Investigations and Litigation
Gibson Dunn has a robust and experienced U.S. and international health care litigation practice, with a proven track record of high-profile trial victories and successful appeals in state and federal courts, including the U.S. Supreme Court. Our clients run the gamut of the health care industry, including pharmaceutical and medical device manufacturers; hospitals, nursing homes, and other health care providers; diagnostic testing companies; and companies in the digital health space.
We excel in responding to investigations and actions initiated by the U.S. Department of Justice (DOJ) including the DEA; the FDA, HHS, Office of Inspector General, and other offices of the Department of Health and Human Services (HHS); consumer protection agencies such as the FTC and the CPSC; and state attorneys general.
Our experience includes defending companies and executives against alleged violations of the Federal Food, Drug, and Cosmetic Act, Anti-Kickback Statute, False Claims Act (FCA), Controlled Substances Act, Consumer Product Safety Act, Federal Trade Commission Act, and other fraud and consumer protection laws. We are skilled at handling multiagency investigations, crisis situations, and complex litigation, including class actions, antitrust matters, mass-tort litigation, securities lawsuits, and commercial disputes.
We also advise on significant and complex regulatory questions arising in civil litigation, including licensing disputes and lawsuits from competitors, and in administrative enforcement actions and government health program audits.
Regulatory and Enforcement Guidance
Our Group provides strategic regulatory and compliance advice, particularly for FDA-regulated companies. Our attorneys draw on decades of regulatory knowledge and an intimate understanding of important regulatory agencies. We work with our clients on a wide array of key regulatory questions, including product development, clinical research, manufacturing, quality, approval and clearance, labeling and advertising, marketing, sampling, and health care programs. We also help navigate FDA inspections and enforcement actions, product recalls, and other post-market challenges. Additionally, we counsel on fraud and abuse issues, telehealth/telemedicine, and privacy matters. Clients also turn to our Group to identify and evaluate risks associated with mergers and acquisitions, licensing arrangements, joint ventures, as well as to advise on regulatory aspects of capital markets transactions.
Compliance Programs
Clients rely on us to develop and implement effective corporate compliance programs. We offer sophisticated, practical guidance on risk-based compliance measures and conduct reliable internal investigations and program assessments. Our attorneys provide expert advice on governance practices and industry developments.
Cross-Disciplinary Coverage
The attorneys in our Group leverage Gibson Dunn’s firmwide capabilities and resources, including in areas particularly relevant to life sciences, consumer product, and health care companies. This includes expertise in antitrust, capital markets, class actions, corporate governance, data privacy, environmental, social, and governance (ESG), intellectual property, international anti-corruption, licensing and joint ventures, technology transactions, private equity, finance, mergers and acquisitions, international trade, securities, and tax.
“This team is strategically aggressive. They know when to push and when to compromise. It is a team with excellent knowledge, experience and judgment.”
Chambers USA, client quote
Experience
Litigation
Recent representations include:
- Immunomedics: Defended Immunomedics, a biotech company, in a shareholder suit arising from a Company stock price drop resulting from difficulties in obtaining FDA approval for one of our client’s breast cancer drugs.
- Presbyterian Health Plan (PHP): Obtained dismissal of a False Claims Act whistleblower suit filed against Presbyterian, the largest healthcare provider in New Mexico, alleging that PHP improperly retained certain Medicaid payments in violation of contractual accounting and reconciliation requirements.
- Pharmaceutical Company: Persuaded DOJ not to intervene in (and relators to dismiss) qui tam suit against pharmaceutical company based on AKS and drug pricing theories. After the U.S. Attorney’s Office (USAO) and Civil Frauds declined to intervene, relators (two former sales reps) dismissed their FCA claims voluntarily.
- Pharmaceutical Company: Defended pharmaceutical company in novel case alleging that fraud on the U.S. Patent and Trademark Office (USPTO) caused the submission of inflated claims to federal payors. The district court dismissed the claims on public disclosure bar grounds in the wake of a favorable Ninth Circuit decision.
- Pharmaceutical Retailer: Obtained a dismissal of an FCA suit alleging pharmaceutical retailer falsely certified beneficiaries’ compliance with the Medicaid program’s preauthorization requirements for certain, saying federal law barred cost-based controls for medically necessary drugs.
- Multinational Pharmaceutical Company: Successfully defended a multinational pharmaceutical company in an FCA suit alleging a kickback scheme to provide surgeons with free advertising in exchange purchases of devices used to treat obesity.
- Major Medical Device Manufacturer: Served as FDA regulatory advisor to a major medical device manufacturer during False Claims Act litigation involving allegations of off-label promotion. The case was dismissed.
Regulatory
Recent representations include:
- Health Care Provider: Counseled health care provider and pharmaceutical clients on compliance and enforcement risks associated with telehealth programs and technologies, including risks under the Anti-Kickback Statute, FCA, and relevant Medicare and Medicaid regulations.
- Health Provider: Advised women’s health provider regarding coding and billing compliance risks, and response to payor audits, pertaining to asynchronous patient encounters and prescriptions resulting from same.
- Pharmaceutical Manufacturer: Advised pharmaceutical manufacturers regarding potential Anti-Kickback Statute and similar enforcement risks of manufacturer-provider telehealth arrangements.
- Health management services company: Representing large health management services company in FCA investigation by Department of Justice regarding cybersecurity compliance related to health data security and privacy.
- Fortune 50 Company: Conducted an enterprise-wide risk assessment of a Fortune 50 company’s health care communications, marketing and social media practices.
- Fortune 50 Company: Advised a Fortune 50 company on the premarket pathway and clinical testing strategy for its first mobile health medical device. The FDA cleared the device for marketing.
- Various Companies: Counseled confidential companies on FDA and FTC regulatory strategies for digital health technologies, including mobile apps and telehealth devices.
- Three Health Plans: Representation of three health plans administering MediCal in California in False Claims Act investigations by the U.S. Attorney’s Office for the Central District of California, the U.S. Department of Justice, and the California Attorney General, focused on the health plans’ distribution of funds for the treatment of the Medicaid Adult Expansion (AE) population under the Affordable Care Act. These investigations are believed to be the first governmental investigations of the disbursement of Affordable Care Act funds. We negotiated a favorable non-admission settlement for two of the plans and the third matter is still under investigation.
- Pharmaceutical Company: Successfully defended a pharmaceutical company in a DOJ FCA investigation focused on impact of significant sampling on reported prices. Gibson Dunn convinced the USAO for the Southern District of New York to decline to intervene, and the Southern District of New York dismissed the matter after a favorable Second Circuit decision.
- Coalition of Manufacturers: Represented a coalition of manufacturers in a medical device reclassification matter and public hearing before the FDA. The coalition prevailed.
- Confidential Companies: Counseled confidential companies through appeals of FDA decisions and the dispute resolution process, including issues relating to premarket pathways and product classifications.
- Confidential Clients: Counseled confidential clients on FDA and FTC regulatory strategies for digital health technologies, including mobile apps and telehealth devices.
- Biotechnology Company: Successfully represented biotechnology company in an investigation by the California Attorney General’s Office (CAAG) regarding pharmaceutical company marketing of its diagnostic tests to California consumers.
Transactional
Recent representations include:
- Concentra Biosciences: Advised Concentra Biosciences on the $96.5 million acquisition of Jounce Therapeutics, a clinical-stage developer of cancer immunotherapies.
- CTI BioPharma: Advised CTI BioPharma, a biopharmaceutical developer of targeted therapies for blood-related cancers, on its $1.7 billion acquisition by Sobi, a global hematology, immunology and specialty care biotech company
- Merck: Advised Merck on its $3 billion acquisition of EyeBio, an ophthalmology biotech company.
- Cullgen: Advised Cullgen, a developer of new chemical entities for disease treatment, on a $1.9 billion strategic collaboration and option agreement to advance innovative targeted protein degraders with Astellas Pharma, a Tokyo-based developer of drugs for unmet medical needs.
- Amryt Pharma: Advised Amryt Pharma, a commercial-stage biopharmaceutical company, on its $1.25 billion acquisition by Chiesi Farmaceutici, an Italian biopharmaceuticals and healthcare group.
- Epygenix Therapeutics: Advised Epygenix Therapeutics, a clinical-stage developer of genetic epilepsy treatments, on its acquisition by Harmony Biosciences, developer of commercial-stage drugs for rare neurological diseases.
- CPE: Advised CPE, a private equity firm in China, on the $523 million sale of its majority stake in Acotec, a Chinese interventional medical device company, to Boston Scientific, a U.S. medical device company.
- Apogee Therapeutics: Advised Apogee Therapeutics, a developer of therapies for immunological and inflammatory disorders, on its upsized initial public offering.
- Dianthus Therapeutics: Advised Dianthus Therapeutics, a clinical-stage developer of monoclonal antibodies for autoimmune disease, on its private placement of shares of common stock and pre-funded warrants to new and existing investors.
- Bora Pharmaceuticals: Advised Bora Pharmaceuticals, a Taiwan pharmaceutical manufacturer, on its acquisition of Upsher-Smith Laboratories, a generics manufacturer, from shareholders Sawai Group, a Japanese over-the-counter drug company, and Sumitomo, a trading and investment company.
- Spyre Therapeutics: Advised Spyre Therapeutics, a biotechnology company advancing a robust pipeline of antibody therapeutics with the potential to transform the treatment of inflammatory bowel disease, on its sale to Aeglea BioTherapeutics.