Podcast: Non-binding Guidance: Former FDA Commissioner Scott Gottlieb’s Unfinished Business
The False Claims Act (“FCA”) permits a person, known as a “qui tam relator” (or more commonly, a “whistleblower”), to bring a lawsuit on behalf of the federal government when that person has information that a healthcare...more
Bass, Berry & Sims is pleased to announce the release of its fifth annual Healthcare Fraud and Abuse Review 2016. The Review, compiled by the firm’s Healthcare Fraud Task Force, is an industry-leading guide to healthcare...more
From 2015 to 2016, FDA appeared to open the door to loosening the standards around intended use and off-label use, but recent rule-making and public comments suggest that FDA is becoming more sclerotic instead of flexible....more
We are pleased to present Bradley’s annual review of significant False Claims Act (FCA) cases, developments, and trends. From a relatively short article several years ago, the Review has grown to a significant publication...more
The United States Court of Appeals for the Second Circuit recently affirmed an Order of the Eastern District of New York dismissing a qui tam False Claims Act (FCA) suit based on “off-label” marketing of prescription drugs....more
Latest Healthcare False Claims Act Roundup and Top 3 Best Practices to Reduce Exposure - As the legal landscape in healthcare becomes increasingly complex, healthcare companies that receive federal program funds face...more
This week, a federal district court denied Cephalon Inc.’s (Cephalon) motion to dismiss a third amended complaint filed under the False Claims Act (FCA) by three qui tam relators in United States ex rel. Boise v. Cephalon,...more
As of March 3, Solvay Pharmaceuticals is ready to second P.T. Barnum’s famous dictum that there’s no such thing as bad publicity. That’s the day a federal court in Texas dismissed a qui tam action against Solvay....more
A healthy market for M&A activity, particularly cross-border deals, and a strict regulatory environment are the big factors influencing the health and activities of life sciences companies. Skadden partners John T....more
In Brief - When an alleged scheme to market drugs for unapproved “off-label” uses had already been identified by an earlier complaint, a later complaint providing additional details, but alleging the same “essential...more
Mintz Levin’s most recent Qui Tam Update authored by our Health Care Enforcement Defense Practice provides focused analysis of four health care-related qui tam cases in which the government declined to intervene, including...more
Trends and Analysis: ..We have identified 21 health care–related qui tam cases unsealed since last month’s Qui Tam Update. Of those, two were filed in 2013, 15 were filed in 2011 or 2012, and four were filed in 2010 or...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