Stephen Payne is a former federal prosecutor and partner in the Washington, D.C. office of Gibson, Dunn & Crutcher LLP. He is Chair of the Firm’s FDA and Health Care Practice Group. His practice focuses on compliance and enforcement for drug and device manufacturers and institutional health care providers, and also spans crisis management strategy, regulatory counseling, corporate transaction support, and litigation across the spectrum of regulated products and health care entities.
Mr. Payne advises clients’ General Counsel, C-Suites, and Boards of Directors on some of their highest-profile crisis and litigation matters. His experience has centered on criminal and civil False Claims Act investigations based on underlying FDA and health care regulatory issues that present enterprise- and product line-level risk. Those regulatory matters have often included, among other things, FDA good manufacturing practice regulations, product recalls, product promotion, product diversion and counterfeiting, medical necessity, quality of care, and fraud and abuse.
Mr. Payne has handled the defense of several dozen criminal and civil investigations conducted by the Department of Justice, state Attorneys General, and many federal and state investigative and regulatory agencies, including the Department of Health and Human Services Office of Inspector General, the FDA Office of Criminal Investigations, and the Federal Bureau of Investigation. Mr. Payne has led the defense of more than 50 False Claims Act investigations and litigation matters. He has represented clients in matters across the country, including before, among others, the U.S. Attorney’s Offices in the Eastern District of Pennsylvania, the District of Massachusetts, the Southern District of New York, the Northern District of Illinois, the Central District of California, the District of Maryland, and the District of the District of Columbia. He often defends clients in multi-state investigations by Attorneys General, including those conducted under the auspices of the National Association of Medicaid Fraud Control Units and those led by such states as New York, Massachusetts, California, Texas, Illinois, Oregon, North Carolina, and Florida.
Mr. Payne has defended many clients across the FDA-regulated product spectrum in traditional FDA regulatory and enforcement actions, such as manufacturing quality inspections, warning letters, recalls, and seizures. He also regularly supports corporate transactions by conducting regulatory due diligence on FDA and health care matters. He has advised many clients on whistleblower matters, including employment retaliation claims. He also has assisted clients with Capitol Hill and press strategies, Securities and Exchange Commission inquiries, and Foreign Corrupt Practices Act compliance and investigations.
Mr. Payne has received the highest rating of “Leading” by the Practical Law Company in the Cross-Border Life Sciences Handbook in the category “Life Sciences: Government Enforcement and Investigations,” and was named a “Life Sciences Star” in LMG Life Sciences (2012-2016) in the category “Non-IP Litigation and Enforcement.”
Crisis Management Strategy
- Represented global drug and device manufacturer in off-label promotion, kickback, and product defect investigation by the Department of Justice, with components including Congressional interest, an SEC inquiry, a criminal grand jury investigation in a separate federal district, a civil deceptive trade practices suit, and extensive press coverage; resulted in small civil settlement with Department of Justice, no Congressional investigation, declination of SEC inquiry, being designated as cooperating witness in grand jury investigation, and dismissal of deceptive trade practices suit, which was affirmed on appeal
- Represent large, publicly-traded health care provider in national investigation by Department of Justice and states in criminal and civil False Claims Act investigation with respect to quality of care, medical necessity, and billing of government programs; regularly brief C-Suite and Board and advise on press strategy in context of extensive investigative reporting
- Represent pharmaceutical company in criminal and civil investigation by Department of Justice and regularly brief and strategize with C-Suite and Board of Directors on investigation strategy, status, progress, and press
- Regularly briefed and strategized with C-Suite of drug company on cGMP compliance and remediation matter that temporarily shut down largest manufacturing facility
- Briefed and strategized with C-Suite and Board of global drug manufacturer on cGMP review of European facilities
- Presented to C-Suite of global consumer products company on cGMP investigation of OTC drugs
- Advised pet food distributor in FDA mass seizure case and related consent decree
Investigations and Litigation
- Represented drug manufacturer in criminal and civil off-label promotion investigation led by DoJ’s Consumer Protection Branch; resulted in no government action
- Represented major pharmaceutical manufacturer in novel False Claims Act suit brought by generic drug competitor; resulted in complete dismissal after trial on public-disclosure bar issues
- Conducted internal investigation for major pharmaceutical manufacturer regarding representations of data made to FDA for product approval and handled related whistleblower claims; resulted in no government action
- Represented hospital in False Claims Act suit alleging health care regulatory violations; resulted in dismissal with prejudice, affirmance by Seventh Circuit, and denial of petition for certiorari. U.S. ex rel. Bellevue v. UHS of Hartgrove, N.D. Ill.
- Represented global drug manufacturer in off-label promotion and kickback criminal investigation and civil False Claims Act suit; resulted in declination by government of criminal investigation and False Claims Act suit and dismissal of most of relator’s civil FCA claims. U.S. ex rel. Kennedy v. Aventis, N.D. Ill.
- Represented drug company in global GMP enforcement scenario, including extensive on-the-floor manufacturing quality system reviews and remediation efforts, involving facilities in the U.S., United Kingdom, and Sweden
- Advise clients on internal compliance programs and regulatory requirements, including organizational structure, policies and procedures, and best practices
- Regularly negotiate with HHS OIG on Corporate Integrity Agreement (CIA) issues
- Collaborating with Cornell University faculty to develop academic and empirical underpinnings for corporate compliance practices; recently gave guest lecture at Cornell, “Corporate Compliance Programs and Conflict Management”
- Conducted numerous compliance effectiveness reviews and compliance investigations for pharmaceutical, medical device, and health care companies
- Conducted annual reviews of compliance at biologics manufacturer to support certification of compliance with Corporate Integrity Agreement
- Conducted Foreign Corrupt Practices Act compliance reviews for drug manufacturer involving more than 40 countries
- Represented vaccine manufacturer to conduct internal review of quality systems and investigate potential contamination and tampering; advised on FDA communications strategy
- Advised cosmetics manufacturer on labeling and marketing issues
- One of the principal contributors to the industry-proposed cGMP regulations for the tobacco product industry
- Represented animal drug manufacturer to respond to FDA inspection and warning letter
- Represented food company in product contamination and recall scenario, including negotiations with FDA and remediation efforts
- Advised Japanese drug and device manufacturer on U.S. go-to-market strategies and FDA registration, approval, and import issues
- Participated in preparation for committee sessions on drug pricing
- Advised on potential health care legislation (particularly the risks associated with the potential Affordable Care Act repeal and replace efforts)
- Advised on issues related to the opioid crisis and Congressional oversight investigations
- Regularly assist corporate transactions with regulatory due diligence on drug, device, and diagnostics manufacturers and health care provider entities, such as hospitals
- Recently conducted regulatory diligence to support acquisition of hospital
- Conducted diligence of target diagnostics company that resulted in discovering significant compliance issue and disclosure to and settlement with HHS OIG so that transaction could be successfully consummated
Mr. Payne is an Adjunct Professor at the Antonin Scalia Law School at George Mason University, where he teaches FDA Regulation and Health Law & Policy.
Before joining Gibson Dunn, Mr. Payne was a partner in the FDA and health care practices of another global law firm. Prior to private practice, he served as Senior Trial Counsel for the U.S. Army Judge Advocate General’s Corps at Fort Benning, Georgia and as a Special Assistant U.S. Attorney in the Middle District of Georgia. While serving in that capacity, he was lead counsel in dozens of investigations and prosecutions, including successful civilian and military jury trials.
Mr. Payne received the American Bar Association award for finishing first in his class at the United States Army Judge Advocate General’s (JAG) School, and the City of New York Bar Association award for being named best advocate at the JAG School’s 10th Criminal Law Advocacy Course.
Mr. Payne is a 1996 graduate of Yale Law School, where he was a prize finalist in the Thomas Swann Barristers’ Union Mock Trial Competition and a John M. Olin Fellow in Law and Economics. He received his undergraduate degree in 1993 from the School of Industrial and Labor Relations at Cornell University, where he finished first in his class.
Mr. Payne is a member of the Bars of the District of Columbia and the State of New York.