Federal Judge Dismisses Generic Liability Lawsuit Against Wyeth, Alaven

A federal judge tossed out a liability lawsuit filed against brandmakers Wyeth and Alaven Pharmaceuticals, saying they were not responsible for the death of a patient who took generic Reglan not made by the companies.

The judge, from the Northern District of Mississippi, granted Wyeth and Alaven’s bid for dismissal last week. The ruling mirrors the vast majority of liability cases, in which judges have overwhelmingly found that patients can only sue the company that actually made the generic drug they took and not the innovator firm that developed it.

At issue was the 2008 suicide of a 19-year-old who was prescribed Reglan (metoclopramide) for a gastric ulcer. His family claimed the drug induced hallucinations and suicidal desires that drove him to take his life. They sued the brandmakers, as well as generics firms Generics Bidco, Qualitest Pharmaceuticals and Vintage Pharmaceuticals that manufactured versions of Reglan.

The judge dismissed the claims against the generics makers in 2012. That ruling tracked with the PLIVA v. Mensing decision, in which the Supreme Court held that generics makers are largely immune from failure-to-warn and similar lawsuits because they are required to carry labels imposed by the brandmaker. Mensing has left many patients with little legal recourse for generics-related injuries.

The FDA has tried to address that reality through a hotly contested rule change that would allow generics firms to change their labels prior to agency consent, an authority only brandmakers currently have. — Bryan Koenig