A key legal issue for pharma these days is whether FDA approval preempts liability lawsuits at the state level. Three cases are wending their way toward the Supreme Court, of which the most important is arguably Wyeth v. Levine, a suit concerning Wyeth’s antinausea med, Phenergan (promethazine). Over the holidays, the Solicitor General released an amicus curiae brief in the case, and it comes out strongly in favor of preemptionâ€”good news for the industry. The brief focuses on the idea that FDA approval is based on a balanced assessment of risks and benefits, and that pharma companies (and state courts) aren’t supposed to overturn those judgments:
Where, as here, FDA was presented with information concerning the relevant risk, a juryâ€™s imposition of liability based on a drugâ€™s FDA-approved labeling would interfere with FDAâ€™s expert judgment.
That conflict is especially clear in this case because, as the dissent explained, any recovery under state law would be predicated on a finding that Phenergan, as labeled, was â€œunreasonably dangerous.â€ … That finding would directly conflict with FDAâ€™s determination that the drug, as labeled, was safe and effective.
Not everyone agrees with the idea of preemption, of course. An editorial in the current New England Journal of Medicine argues against preemption in Riegel v. Medtronic, a medical-device preemption case:
Ultimately, we believe that the pivotal question for the justices in Riegel v. Medtronic resides in what is in the best interest of American society. Is it in the people’s interest to shield medical-device companies from product-liability claims? Would such a decision benefit patients by making more lifesaving medical devices available, or would there be adverse effects on the overall safety of devices? Is the FDA premarketing approval process sufficiently rigorous and comprehensive to justify immunization of the industry against tort claims? And if medical-device manufacturers are shielded from liability, what about drug manufacturers?
The scary idea in the editorial is that FDA isn’t reliable and lawsuits are the only way to protect patients. I see where the doctors who wrote the editorial are coming from. But as anyone who pays malpractice ought to know, there’s got to be a better way to manage risk.