Experts Call on Congress to Hold Drug Companies Liable in Failure-to-Warn Cases
The authors of a new JAMA viewpoint argued generic and brand companies are currently protected in most jurisdictions in cases over failures to warn of adverse drug effects.“It is a troublesome feature of current law that a patient harmed by a generic drug may have no legal recourse to pursue a failure-to-warn claim,” write JAMA deputy editor Gregory Curfman and Marcia M. Boumil, a professor at Tufts University School of Medicine. “Congress should fully consider this issue and fill the gap in the current legal framework through legislation.”
The conclusion was based on a review of several cases dating back to 2008, including a 2017 ruling in California’s Supreme Court against Novartis which held that brand-name manufacturers’ duty to warn consumers extends to its generic counterparts.
In the most recent court decision from March, the Massachusetts Supreme Judicial Court held in Rafferty v. Merck & Co. that brand-name manufacturers can be held liable for harm linked to the use of generics over intentionally failing to update labels, though not over failure to warn.
The recent court rulings follow a precedent the US Supreme Court set in Pliva v. Mensing (2011) that shielded generic drugmakers from lawsuits regarding the labeling on their drugs.
The authors also speak to a 2013 proposed FDA rule that would provide generic drugmakers with control over updates to labels that can reflect changes made by their brand-name counterparts. But this rule was withdrawn in December 2017.
“At this point, only Congress could change this situation by writing new law,” the authors argued.
Legal Liability of Generic vs Brand Drug Manufacturers for Inadequate Product Labels