Risk-mitigation strategies in light of Endo Pharmaceuticals

In 2014, the U.S. Justice Department finalized its $192.7 million settlement with Endo Pharmaceuticals of claims related to alleged off-label promotion by announcing that the whistleblower in the False Claims Act civil lawsuit that led to the settlement was awarded $33.6 million.

The matter’s resolution exemplifies the unhappy predicament of a life sciences industry increasingly faced by “parallel” proceedings, which typically involve both criminal and civil components of the U.S. Department of Justice, and attorneys from regulatory agencies such as the Food and Drug Administration and the Department of Health and Human Services. This article briefly proposes some risk-mitigation strategies available to life-sciences companies facing this double-barreled threat. Read more.