Pennsylvania's high court put drug design-defect claims on the menu for patients looking to sue for damages. In a closely watched case against Pfizer's ($PFE) Wyeth unit, the state Supreme Court reinstated claims that the company negligently designed and marketed a diet pill, Redux, that's now withdrawn from the market.
Pfizer, which bought Wyeth in 2009, had argued that the only bases for liability lawsuits are manufacturing defects and inadequate drug-safety warnings. The court voted 4-2 against that argument, The Legal Intelligencer reports.
The ruling sends Pfizer back to trial court to fight a lawsuit filed by Patsy Lance, the mother of a woman, Catherine Lance, who took Redux in early 1997. Catherine died of complications of primary pulmonary hypertension. Redux, one component of the notorious weight-loss combo fen-phen, was pulled off the market in September of that year.
Pfizer says it's "prepared to defend against the plaintiff's claims" when the case goes back to court. Meanwhile, it's weighing other options. "Novel design-defect claims have never been previously recognized in Pennsylvania law, and we are considering all our legal options," the company told the Intelligencer in a statement.
One of Lance's lawyers sees the high court's ruling as the catalyst for design-defect liability elsewhere. "Not only does this confirm the existence of these claims in Pennsylvania law, but it may lay the groundwork in other states to consider the availability of claims like these," he said. "Not very many state appellate courts have yet had the occasion to consider the availability of negligent design and negligent marketing claims against an available drug."
Wyeth has faced design-defect claims before, in a case involving its DTP vaccine. Parents of a child who experienced seizures after a shot sued in a special vaccine court and lost, and then sued in Georgia state court. The Georgia Supreme Court had previously ruled that design defect claims were allowed. The cast ended up at the U.S. Supreme Court, which decided that design-defect claims weren't allowed, at least not under the National Childhood Vaccine Injury Act.
In another design defect case, the U.S. high court ruled that patients can't sue over design defects in generic drugs in state court because generics must be patterned on an FDA-approved drug--and that approval preempts state court claims.
- read the Intelligencer coverage