November 10, 2008
FDA Preemption of State Pharmaceutical Suits
Very interesting article in the ABA Journal -- The Pre-emption Prescription, by Terry Carter. The FDA has been increasingly moving to pre-empt state suits based on its approval of pharmaceutical labeling. I'm troubled at the prospect of a large, unwieldy regulatory agency trying to assess reasonable care in warning when information on safety changes all the time, one can't even assume that the FDA has all the pertinent information when it decides, and the FDA's assessment of that information may not be correct. On the flip side, defendants shouldn't be held liable for adhering to any label they are forbidden to change by the FDA. While the prospect of regulation through juries is sometimes pilloried, one wonders whether individual litigation with well-credentialed expert witnesses and negligence standards incorporating arguments from custom wouldn't be more nimble in adapting legal standards to changing safety information and more effective at incentivizing adequate safety in warning. One could argue that juries may result in inconsistent decisions, but in a mass tort involving numerous cases and trials, wouldn't one prefer the verdict pattern that emerges (and the deterrence benefits of anticipating such jury accountability) to the rigidity, slowness, and possible regulatory capture affecting the FDA? I'll take traditional contract and tort law over FDA attempts at micro-management in both approval and liability.
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Byron, good summary of the issue. Thanks.
You hit on what to me is the main concern with preemption. That is incentivizing adequate safety. For an industry that produces a product that is beyond the understanding of 99% of the consumers, it is too easy for some (as we have seen) to take advantage of the situation; especially when some of those products can maim or kill. An industry such as this must learn to live with more regulation, including the only input that the consumer is afforded, that being state tort. It’s obvious that the industry can do a better job of designing, testing and manufacturing their product; they just need the incentive to do so up front in the design stage.
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Posted by: Rachael | Dec 5, 2008 12:03:47 PM
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Posted by: Clinical Trials | Jan 27, 2009 2:17:23 AM