Laura G. Hoey
A deal the size the $13.35 billion merger of Biomet Inc. and Zimmer Holdings Inc. in a highly regulated industry like medical device manufacturing involves many moving parts. A team from Ropes & Gray that includes partners Laura G. Hoey and Joy J. Liu is providing regulatory counsel to Biomet. Hoey is part of the government enforcement practice at Ropes & Gray, and Liu is part of the life sciences practice.
In today’s regulatory environment, compliance is a major consideration in any medical device or pharmaceutical-related deal, according to Liu and Hoey.
“The diligence process in pharma and device deals continues to focus on FCPA, intellectual property and FDA regulatory issues,” Liu said. “On the FDA front, buyers want to know that the target is in compliance with complaint handling and adverse event reporting requirements and good manufacturing practices and good clinical practices, and they also want to know about the interactions between the target and the FDA, whether in relation to product development, recalls or safety issues.”
Liu, who is based in Washington, D.C., advises drug, biotech and device companies on a broad range of FDA regulatory matters. Liu, who did a secondment stint in-house at a pharmaceutical company, works on advertising and promotion compliance matters, Hatch-Waxman patent and exclusivity issues and regulatory risk management. She has also worked on a number of government investigations.
“The recent increase in FCPA enforcement activity in the medical device industry means that any transaction involving a medical device company will need an analysis of a company’s compliance measures,” agreed Hoey, a former federal prosecutor. Chicago-based Hoey represents a variety of clients in the health care, pharmaceutical and dental industries that are facing government investigations and Congressional inquiries. She directs internal investigations in all types of government and regulatory compliance matters including advising clients on potential violations involving health care fraud, the False Claims Act, the Anti-Kickback Statute, the Food Drug and Cosmetic Act, the U.S. Foreign Corrupt Practices Act and HIPAA privacy and security.