Bass, Berry & Sims attorneys John Kelly and Rob Platt authored an article in Life Science Compliance Update outlining risk areas faced by pharmaceutical and medical device manufacturers related to False Claims Act (FCA) violations. According to Department of Justice data, these manufacturers accounted for nearly half of FCA recoveries within the healthcare industry in 2016. As John and Rob discuss, last year’s enforcement targeted several key risk areas, including speaker programs and off-label promotions, discount pricing programs, and violations of current good manufacturing practices (cGMP). Continue Reading John Kelly and Rob Platt Author Article on FCA Liability for Pharmaceutical and Device Manufacturers
DOJ recently reached settlements in connection with three long running enforcement efforts, amassing more than $1 billion in settlement funds. These settlements reflect the continued expansion of aggressive government enforcement in the healthcare industry. Since January 2009, DOJ claims recovery of more than $16.2 billion in healthcare-related FCA cases alone.
Swiss pharmaceutical company Novartis AG agreed to pay $390 million to settle allegations that it provided unlawful rebates to specialty pharmacies to boost prescription refills for Novartis products. While Novartis did not admit that these rebates constituted illegal kickbacks, it did acknowledge providing rebates to three specialty pharmacies to incentivize an increase of prescription refills. This settlement comes at the conclusion of Novartis’ five-year CIA resulting from a settlement with DOJ in 2010. As part of its latest settlement, Novartis has agreed to extend its CIA for an additional five year period. Additionally, Novartis has agreed to amend its CIA to include obligations covering the company’s interactions with specialty pharmacies and to provide an annual report to DOJ detailing Novartis’ compliance with the CIA.
In U.S. ex rel. Petratos v. Genentech, Inc., the U.S. District Court for the District of New Jersey dismissed a qui tam action claiming that Genentech underreported side effects of the widely-used cancer drug Avastin. In its opinion, the district court reiterated that the FCA is not intended to reach wrongful behavior that does not lead to a false claim or regulatory violations not tied to payment.
Relator’s complaint alleged that defendants made false submissions to the FDA by relying on patient databases that contained inadequate information about drug risks and side effects and otherwise refused to provide data regarding such risks to a Key Opinion Leader based upon defendants’ false assertion that this information was unavailable. The relator claimed that this conduct cost taxpayers “hundreds of millions of dollars,” because fewer doctors would have prescribed Avastin if defendants had provided complete and accurate information, and government payers would have reimbursed for fewer Avastin indications, for lower dosages, or not at all.
We recently authored an article on False Claims Act (FCA) enforcement actions brought against pharmaceutical and medical device manufacturers during the past year. In the article, we analyzed the recent settlements for Ansun Biopharma, Inc. (formerly known as NexBio, Inc.); Smith & Nephew, Inc.; McKesson Corporation; and Stryker Corporation and Alliant Enterprises.
The article, “Lessons Learned From FCA Settlements With Pharmaceutical and Medical Device Manufacturers,” was published in BNA Medical Devices Law & Industry Report on February 18.