Enforcement in Life Sciences Series:
Key Cases in 2020 Reflect Emerging DOJ Focus for Pharmaceutical and Medical Device Makers
About the Enforcement in Life Sciences Series
Recent settlements between the U.S. Department of Justice (DOJ) and a range of FDA-regulated drug and medical device manufacturers provide a snapshot of the DOJ’s enforcement focus. These settlements involve new DOJ theories of liability or new ways of evaluating long-standing industry practices, and may be harbingers of future DOJ enforcement activity. In this six-part series of client alerts, we take an in-depth look at the facts and legal theories in each case or set of cases, discuss what makes each novel, and consider the compliance implications for each.
Our first edition tracks the more expansive lens and stringent controls developing around speaker programs.
The second installment of this series looks at the DOJ’s evolving enforcement approach to off-label promotion.
The third installment of the series explores the compliance risks that health care manufacturing companies can face in vendor arrangements featuring new technology options.