JAMES C. STANSEL is co-head of the firm’s Global Life Sciences Team, which provides a wide range of legal services to manufacturers in the pharmaceutical, biotechnology, medical device and food industries throughout the world. Mr. Stansel has represented health care manufacturers and providers, including pharmaceutical, biotechnology and medical device manufacturers, hospitals, nursing homes, therapy centers, mental health facilities, clinical laboratories and consultants. These representations have included regulatory and administrative counseling on a wide range of health care issues, as well as complex civil, criminal, appellate and administrative enforcement actions, internal corporate investigations and audits. He also regularly advises on policy matters and on healthcare issues arising in the context of mergers, acquisitions and licensing arrangements. Representative engagements have involved Medicare and Medicaid reimbursement and pricing, off-label promotion of pharmaceuticals, anti-kickback violations, and false claims actions.
Mr. Stansel previously served as Acting General Counsel of the United States Department of Health & Human Services, where he was the chief legal officer of HHS, including its sub-agencies the Food and Drug Administration, the Centers for Medicare and Medicaid Services, the Centers for Disease Control and Prevention and the National Institutes of Health. At HHS, he also served as Deputy General Counsel and as Counselor to the Secretary, where he coordinated with the White House and advised the Secretary on the development of health policy.
Mr. Stansel is ranked among the top life sciences regulatory lawyers by The Practical Law Company in The Cross-Border Life Sciences Handbooks 2012, and he is featured as a “Life Sciences Star” for his outstanding healthcare pricing and reimbursement work in the inaugural edition of LMG Life Sciences 2012. He is listed in the Legal 500 United States: 2012 Edition, where he was praised as an “outstanding advisor,” and he has been recognized since 2011 in The Best Lawyers in America in both Biotechnology Law and Healthcare Law. In addition, he was named to the Nightingale’s Healthcare News 2009 list of “Outstanding Young Healthcare Lawyers” as one of 12 lawyers recognized nationwide. He currently serves on Law360’s Life Sciences Editorial Advisory Board.
After graduation from Yale Law School, where he was Senior Editor on the Yale Law Journal, Mr. Stansel served a clerkship with the Honorable Stephen H. Anderson of the United States Court of Appeals for the Tenth Circuit. Mr. Stansel received a Bachelor of Science in Economics summa cum laude from Brigham Young University.