Last week, Goodwin Procter attorneys helped secure a victory for long-time client Teva Pharmaceuticals and for manufacturers of generic drugs generally, when the U.S. Supreme Court ruled in PLIVA v. Mensing. Goodwin’s team was instrumental in drafting the certiorari and merits briefs before the Court.
PLIVA v. Mensing involved two cases in which users of a generic acid reflux drug sued the manufacturer, alleging that the drug’s side effect warning label was insufficient. The circuit court in each case had held that the manufacturer was not protected against failure-to-warn claims by the federal Hatch-Waxman Amendments to the Food, Drug, and Cosmetic Act. Despite the lack of a circuit split, the Supreme Court agreed to hear the case, ultimately overruling the circuit courts.
Goodwin has been lead counsel to Teva since the case was filed in federal district court in Minnesota. In 2008, the firm helped obtain summary judgment on federal preemption grounds, similar to those used by the Supreme Court majority in its ruling.
“The court’s decision is very broad and represents a significant victory for our client and the generic drug industry in general,” said Goodwin Products Liability & Mass Torts partner Richard Oetheimer.