With more than 21 years of experience in private practice and government, Ms. Walsh helps pharmaceutical and medical device companies comply with, and defend against, FDA regulation. She regularly counsels clients on managing FDA inspections, and responding to seizure and injunction actions, warning letters, and recalls. She has specific expertise in matters involving health care fraud, off-label promotion, and manufacturing practices, and has investigated and negotiated dozens of matters that have implicated False Claims Act liability and exclusion by the HHS Office of Inspector General.
Ms. Walsh frequently applies this compliance and enforcement expertise to aid clients needing FDA perspective in M&A transactions. She leads teams of attorneys to conduct a comprehensive FDA-related diligence, and advise clients on making determinations concerning the deal and its valuation.
Her 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, Ms. Walsh served as Associate Chief Counsel with FDA’s Office of Chief Counsel, and received several awards for her work from FDA, DOJ, HHS Office of Inspector General, FDA’s Office of Criminal Investigations, and U.S. Attorney’s Offices throughout the country.