With more than 21 years of experience in private practice and government, I help pharmaceutical and medical device companies comply with, and defend against, FDA regulation. I regularly counsel clients on managing FDA inspections, and responding to seizure and injunction actions, warning letters, and recalls. I have specific expertise in matters involving health care fraud, off-label promotion, and manufacturing practices, and have investigated and negotiated dozens of matters that have implicated False Claims Act liability and exclusion by the HHS Office of Inspector General.
I frequently apply this compliance and enforcement expertise to aid clients needing FDA perspective in M&A transactions. I lead teams of attorneys to conduct a comprehensive FDA-related diligence, and advise clients on making determinations concerning the deal and its valuation.
My litigation experience is comprehensive and diverse, from defending product liability claims in state court, bringing suit under the Lanham Act, prosecuting individuals and corporations in federal court, and suing FDA for violating the Administrative Procedure Act.
Prior to joining Hyman, Phelps & McNamara, I served as Associate Chief Counsel with FDA’s Office of Chief Counsel, and received several awards for my work from FDA, DOJ, HHS Office of Inspector General, FDA’s Office of Criminal Investigations, and U.S. Attorney’s Offices throughout the country.