United States ex rel. Hopper v. Solvay Pharmaceuticals, Inc.
- Case Date: 3/24/2009
- Project Name: Health Care Project
On December 4, 2009, the U.S. Court of Appeals for the Eleventh Circuit issued a decision that advances efforts to rein in use of the federal False Claims Act (FCA) as a tool for suppressing truthful speech about off-label uses of medical products approved by the Food and Drug Administration (FDA). The decision was a victory for WLF, which had filed a brief urging dismissal of the FCA claim. The court agreed with WLF that in the absence of specific factual allegations that a drug manufacturer took steps to encourage others to seek federal reimbursement for drug costs the manufacturer knew were not reimbursable, a complaint is subject to dismissal. The court noted that the plaintiff had failed to identify with specificity a single instance in which a doctor or pharmacist sought federal Medicaid or Medicare reimbursement for the drugs they provided to patients. It also held that any FCA suit must allege that the false claim was actually paid, not merely that it was submitted.
More Information and Downloads:
3/30/2009: Download the Brief
Litigation Update: Court Dismisses False Claims Act Suit that Threatened to Chill Speech