AdvaMed Asks U.S. Court of Appeals to Recognize FDA, CMS, and Health Care Provider Decision-Making Concerning Patient Safety

Washington, DC.—AdvaMed, the medtech association, asked the Court of Appeals for the Third Circuit to vacate the judgment of the District Court, which if allowed to stand, would have significant and deleterious effects on patient care.

There are a number of issues raised on appeal in this False Claims Act (FCA) case.  In addition to evidentiary, legal, and instructional errors at the District Court level, the Court of Appeals will be asked to explore if the qui tam provision of the FCA is unconstitutional.

AdvaMed believes allowing a jury to hold a defendant liable under the FCA simply because that defendant promoted or prescribed for unapproved uses a federally reimbursed drug or device is not only legally incorrect, it would also seriously impair the provision of health care in the United States.

“The District court’s decision effectively gives private parties the power to regulate health care by turning every manufacturer’s alleged off-label promotion and every provider’s off-label prescription into grounds for FCA liability,” said Pat Fogarty, Deputy General Counsel & Senior VP of Legal at AdvaMed. “Congress has already decided those decisions are best left to the FDA, CMS, and individual health care providers.”

Read a copy of the AdvaMed amicus brief.  Douglas H. Hallward-Driemeier of Ropes & Gray LLP served as Counsel of Record on behalf of AdvaMed and PhRMA.