Pharmaceutical and Device Manufacturers: Buyer Seller Beware

Pharmaceutical and medical device manufacturers continue to face intense scrutiny from regulatory and enforcement agencies, as well as whistleblowers seeking large payouts for disclosing potential wrongdoing. There are a number of risk areas (some new, some not-so-new) that provide the basis for the government and relators to pursue alleged violations of the False Claims Act liability. Some of those areas are discussed below.

Pharmaceutical and medical device manufacturers continue to be on the radar of government enforcers and whistleblowers. In particular, the government’s False Claims Act (“FCA”) enforcement efforts have continued to focus on key areas concerning the pharmaceutical and medical device industries. In fact, drug and device manufacturers accounted for nearly half of the enforcement recoveries from the healthcare industry last year. Manufacturers also saw enforcement agencies focus on product promotion and speaker program practices, as well as alleged violations of Current Good Manufacturing Practices (“cGMP”).