Posted by Brad @ 7:02 pm on August 16th 2008

Wyeth v. Levine and the War on Litigation

There’s an interesting case likely to come before the Supreme Court soon, Wyeth v. Levine. In it, a woman was injected with a drug to counteract nausea, and developed gangrene, which eventually forced the amputation of her right arm below the elbow. She sued the drug-maker, on the grounds that they didn’t sufficiently warn consumers of said side effect. She was awarded 7 million dollars. The drug company appealed, claiming that since the FDA regulatory judgment consummate with their drug being approved cleared them on that particular side-effect, that their say was the final word, and in essence state court rulings that contradict the FDA findings don’t have standing.

It seems like a pretty basic question as it relates to the FDA, but as yet, it is an issue that is not at all clear as it relates to American law, and the Supreme Court case will likely have to decide one way or the other. The case will be go before the USSC on November 3rd, and as the question as I just framed it is at the heart of the matter, it would seem unlikely that they’d render a decision that doesn’t clearly come down on that one way or the other.

This also goes right to the heart of the libertarian critique of the FDA (and federal regulatory agencies in general), and the heart of the liberal response to said critique. Libertarians have long maintained that putting government agencies between the markets and the companies shields them from market forces, both productive and destructive. A ruling for Wyeth would more or less set that regulatory agency shield in stone. Liberals have long maintained that the markets cannot be trusted on these matters, so presumably, if you extend that argument, one would have to be in favor of FDA preemption of lawsuits, i.e. what the FDA says goes (also worth noting: if one can sue the companies and that can override the regulatory ruling, i.e. decide that the regulatory agency was wrong, the FDA is also going to have some major liability issues). So the case has some fascinating implications for the statist vs. market-based debate on federal regulation.

Which is why it fascinates me that the New England Journal of Medicine and its editors (and top contributors) have filed a brief, as have 47 state attorney generals, arguing that lawsuits are a necessary mechanism to guarantee drug safety. Interestingly, a number of economists have also filed briefs, on behalf of the FDA. And obviously, Chambers of Commerces’ and business interests are throwing down in favor of the FDA on this one. The Bush administration has also quietly been aligning behind the corporate slash regulatory side of things.

And of course, if it hasn’t occurred to you already, how the USSC comes down on this doesn’t just affect drugs. It theoretically affects everything that the federal government regulates, from cars, to toys, to flammable mattresses, whatever. And if it also occurs to you that this matter may well be the critical keystone for effective tort reform in America, give yourself a gold star for seeing the picture clearly.

In any case, if you want a good primer on this issue, The Wall Street Journal does a pretty fair job. Me? I’m a big fan of litigation.


  1. 47 state attorney generals? Wow.

    On a side note, your use of ‘the USSC’ to describe what I’ve always seen abbreviated as ‘SCOTUS’ was interesting.

    Comment by Cameron — 8/16/2008 @ 7:13 pm

  2. Hrm. Mine is the archaic. I come from a family of lawyers, and that’s just how I always picked it up.

    Comment by Brad — 8/16/2008 @ 7:24 pm

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