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Brooks Schuelke
Brooks Schuelke
Contributor •

The Other Side of Preemption

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Those of us at Injuryboard have been doing a series on the dangers of complete immunity preemption, and we’ve been talking about the dangers of preemption. In order to be fair, I wanted to highlight a press release from Wyeth, who has a highly publicized preemption case coming before the Supreme Court, in which they attempt to describe the benefits of preemption. (Hat tip to Pharmalot for the link.)

In the release, Wyeth argues:

The public health is better served by having a single expert regulatory body making decisions about risks, benefits, and warnings – rather than an ad hoc system that could produce hundreds of conflicting results that would be impossible for manufacturers, physicians, and patients to reconcile or interpret. Such a system would undermine the careful balance struck by the FDA when making approval decisions.

This reminds me of my first appellate argument where one of the three judges on the Austin Court of Appeals told me, "Frankly, Mr. Schuelke, I’ve read your brief, and I don’t buy it." I have the same reaction to Wyeth’s pro-preemption arguments. First, there hasn’t been the "careful balance" historically. Until the Bush administration came along, the FDA and other regulatory agencies went forward with their regulations knowing that the federal regulations and the state tort system "regulation" worked in concert with one another. Federal safety regulations were not meant to be the end all, be all word on safety. Attempting to use those regulations in such a manner now does not properly protect the public.

Second, federal regulatory agencies clearly aren’t nimble enough to protect the public. With today’s science and technology, we are always discovering new risks of drugs, finding safer ways to make products, or discovering new dangers from materials (plastic baby bottles anyone?). Changing federal regulations can take years; on the other hand, allowing regulation through tort law means that these standards can be incorporated on an on-going basis, and more citizens are protected.

Finally, the federal government just doesn’t have the resources to be the "great guarantor of safety." In the last year, we’ve seen story after story where the FDA doesn’t have resources to properly test new drugs or inspect drugs or food arriving from China or other countries or stories where the Consumer Product Safety Commission doesn’t have the resources to inspect imported toys. We just can’t rely on the federal government to make sure that our country is safe. That responsibility has to fall on the states and the tort systems as well.