Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
Podcast - Developments in FDA & DOJ Regulation and Enforcement of Manufacturer Communications
The Sixth Circuit's recent decision in U.S. ex rel. Ibanez v. Bristol-Myers Squibb Co. reinforced Federal Rule of Civil Procedure 9(b)'s requirement that plaintiffs plead fraud "with particularity" in False Claims Act cases....more
Last year continued the trend of robust False Claims Act (FCA) enforcement by the U.S. Department of Justice (DOJ) and proliferating qui tam lawsuits brought by whistleblowers on behalf of the United States. In 2012, DOJ...more
This week, the DOJ announced that J&J has agreed to pay over $2.2 billion in civil and criminal fines in one of the nation’s largest ever health care fraud settlements. As part of the resolution, J&J subsidiary Jannsen will...more
On December 3, 2012, the United States Court of Appeals for the Second Circuit held that the First Amendment protects pharmaceutical companies who truthfully promote the lawful, off-label use of prescription drugs from...more