PharmExec Blog

Preemption Watch: The Solicitor General Weighs In

legalthumbnail1.jpgA 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 preemption—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 jury’s imposition of liability based on a drug’s FDA-approved labeling would interfere with FDA’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 “unreasonably dangerous.” … That finding would directly conflict with FDA’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.

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One Comment

  1. Carol
    Posted January 27, 2008 at 3:29 pm | Permalink

    http://jaynesdays.blogspot.com/

    This is a link to a blog that clearly explains the flawed reasoning that medical device and drug preemption advocates are dealing with. Far from being an all knowing, faultless administration, the FDA is actually fraught with corruption,lack of funds, overwork, and the inability to fully investigate and follow up on products they have approved for market. Should the public be expected to bow to the FDA’s decisions and be left with no recourse when, by the FDA’s own admission, they are a flawed administration?

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