Supreme Court Declines to Hear Pliva-Related Petition Over Generic Liability

The U.S. Supreme Court has declined to hear one of three petitions submitted over a Pennsylvania appellate decision refusing to recognize generic drugs as largely immune from product liability lawsuits.

As is its custom, the court offered no explanation when it denied a petition for appeal in Morton Grove Pharmaceuticals v. Adams, Sparkell, et al.

Morton had asked the Supreme Court to consider whether state courts must defer to a regulatory agency’s interpretation of statute, just as was found of federal courts in its 2011 PLIVA v. Mensing decision.

The statute in question is the prohibition on generics makers changing their product warning labels without prior FDA approval, which many courts have held essentially immunizes generic drugs from failure-to-warn lawsuits.

However, the Superior Court of Pennsylvania ruled in 2013 in In Re: Reglan/Metoclopramide Litigation that the state’s liability law allows the pursuit of damages over injury sustained from generic drugs even in the face of federal precedent saying otherwise. The ruling stemmed from a case involving injuries sustained from the heartburn drug Reglan (metoclopramide HCL). That liability lawsuit is ongoing.

The petition denial does not rule out the Supreme Court from taking on related cases, however, as two other petitions are pending that ask for reconsideration of the Pennsylvania court’s decision. — Bryan Koenig