Preemption survives another test. A federal appeals in Ohio court last week partially reinstated a lawsuit over the Redux diet pill after deciding that FDA approval did not preempt state claims that Wyeth was negligent in marketing the drug, which was withdrawn in 1997 over links to serious heart and lung ailments. The US Court of Appeals for the Sixth Circuit reversed dismissal of negligence over Wyeth’s actions prior to the 1996 approval of Redux, as well the dismissal of punitive damages (read the ruling here).

The lawsuit was filed by Mary Buchanan, who was diagnosed with primary pulmonary hypertension in 2001 and died in 2003. Her estate is pressing her claim, which accused Wyeth - now owned by Pfizer, of course - of negligence and design defects. Two years ago, a federal district court judge dismissed the case after deciding that FDA approval of Redux preempted the state lawsuit claiming the pill should never have been sold, given the health risks. The appeals court ruled that Congress had not intended to preempt state tort law claims when it passed the Federal Food, Drug and Cosmetic Act.

You may recall that, last year, the US Supreme Court denied an argument by drugmakers and the FDA that agency approval of a drug supercedes state law claims challenging safety, efficacy, or labeling. Both pharma and the FDA maintained preemption was valid, because the agency’s actions were the final word on safety and effectiveness. The issue was decided in lawsuit a involving a Vermont musician named Diana Levine, who lost her right arm below the elbow in a clinic after being administered a Wyeth drug. She sued for inadequate labeling and won (background here).

In the Buchanan case, Pfizer’s Wyeth had once again argued the claims were blocked by preemption, but sought to distinguish this lawsuit from the Levine case by maintaing the Levine lawsuit involved a state law inadequate warning claim, while Buchanan involved a state law negligent-bringing-to-market claim. The appeals court agreed there were different assertions, but then wrote that “we find this to be a distinction without a difference, as the rationale in Levine applies with equal force to this claim as it did to the inadequate warning claim.”

In the end, the panel ruled that her estate was entitled to a presumption that Congress had not intended to preempt her claims. “We can discern no physical impossibility between complying with a state law duty to exercise reasonable care in the process leading up to placing a drug on the market and complying with the federal government’s process for approving drugs,” Judge Boyce Martin Jr. wrote.

Benjamin Anderson, an attorney who represents the Buchanan estate, issued this statement: “This is an important decision in the case and for the harms and losses she sustained, as well as the many millions of Americans taking prescription medications who have long been concerned about drug companies being shielded from appropriate state negligence laws,” it says, in part. “Drug companies are now on notice that they cannot lie to and conceal from the FDA crucial information in the pre-approval process and then expect to be held harmless once their drugs are responsible for causing pain, suffering and, as in Mrs. Buchanan’s case, death.”

pic thx to alancleaver_2000 on flickr