Stephen Payne is a 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 and a member of the Life Sciences Practice Group. His practice focuses on FDA and health care compliance, enforcement, and litigation for pharmaceutical and medical device clients.
Mr. Payne has significant FDA and health care regulatory and compliance counseling experience in the areas of good manufacturing practice regulations, product recalls, product promotion, product diversion and counterfeiting, and fraud and abuse. He has handled criminal and civil investigations conducted by the FDA Office of Criminal Investigations and the Department of Health and Human Services Office of Inspector General, civil False Claims Act qui tam suits, investigations and litigation conducted by state Attorneys General, and other inquiries and litigation relating to health care fraud and abuse and the enforcement of FDA regulations. He has also led internal investigations and compliance audits concerning good manufacturing practice regulations, drug sampling and pricing, and promotional practices, including potential off-label promotion and anti-kickback issues.
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 the inaugural edition of LMG Life Sciences 2012 in the category “Non-IP Litigation and Enforcement.”
- Represented global pharmaceutical company in numerous product diversion and counterfeit product investigation matters involving the United States, the United Kingdom, Finland, Turkey, and Canada, including advising the client on strategy associated with interactions with the U.S. Food and Drug Administration, the U.S. Department of Justice, and several states, related federal healthcare program matters, handling supply chain integrity/distribution control issues, assisting the government with the investigation and prosecution of individuals, and public relations and brand protection.*
- Defending pharmaceutical company in False Claims Act qui tam suit and related state Attorney General investigations based on novel kickback theory.
- Defended pharmaceutical company in criminal investigation by the Department of Justice and related False Claims Act qui tam suit based on allegations of off-label promotion.
- Defending medical device manufacturer in False Claims Act investigation by the Office of Inspector General of the Department of Health and Human Services and the Department of Justice based on allegations of product design defects, improper promotion, and kickbacks.
- Defending medical device manufacturer in criminal grand jury investigation by the Department of Justice based on allegations relating to conditions of FDA approval, labeling, and advertising.
- Defended pharmaceutical company in False Claims Act qui tam suit filed in the Northern District of New York (Syracuse) based on off-label promotion.
- Defending pharmaceutical company in False Claims Act qui tam suit filed in the Central District of California (Los Angeles) based on antitrust and patent inequitable conduct theory.
- Defending medical device manufacturer in Securities and Exchange Commission inquiry related to alleged product defects and related safety issues, promotion, and advertising.
- Represented medical device manufacturer in internal FDA and health care compliance review across all device product lines, involving, among other things, clinical trials, investigational device exemptions (IDEs), manufacturing quality (QSR), and product promotion issues.
- Defending pharmaceutical company in False Claims Act investigation by the Department of Justice based on allegations related to sampling and price reporting (Average Manufacturer Price and Best Price).
- Defended a major pharmaceutical company in a multi-year criminal and civil investigation by the Boston U.S. Attorney’s Office of alleged kickbacks and product promotion violations. The government declined the case in its entirety.*
- Defended a major pharmaceutical company in a multi-year criminal and civil investigation by the Chicago U.S. Attorney’s Office, the Department of Health and Human Services Office of Inspector General, and the FDA’s Office of Criminal Investigations of alleged off-label promotion and kickbacks related to a blockbuster drug. Notwithstanding criminal charges against, and convictions of, two individuals, including a former manager of the company, the government declined the criminal case and the related False Claims Act qui tam. Later obtained an industry precedent-setting dismissal of the related qui tam suit, arguing successfully that off-label use of the drug was immaterial to government reimbursements made in certain circumstances under prospective payment systems such as Medicare Part A.*
- Defended a pharmaceutical company in a False Claims Act investigation by the Philadelphia U.S. Attorney’s Office based on kickback allegations. The government declined the case.*
- Defended a major pharmaceutical company in a federal and multi-state Attorney General False Claims Act investigation of drug price reporting and the Medicaid Rebate Program involving the use of the nominal price exemption. The governments declined the case.*
- Defended with co-counsel a biotech company in a False Claims Act qui tam suit in the District of Maine based on off-label promotion. Prevailed against the qui tam claims at the motion to dismiss stage.*
- Represented pharmaceutical manufacturer in global FDA enforcement scenario involving compliance with good manufacturing quality regulations, including manufacturing facilities in Sweden, the United Kingdom, Italy, and the United States. Resulted in no government enforcement.*
- Counsel for biologics manufacturer in Europe for significant good manufacturing practice and pharmacovigilance system remediation and preparation efforts in connection with FDA and global regulatory inspections and findings.*
* Representations occurred prior to attorney’s affiliation with Gibson Dunn.
Before joining Gibson Dunn, Mr. Payne was a partner at Sidley Austin LLP. 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.