Pre-emption For Real?
Posted by Derek
There's talk again about an idea that's been kicking around for some years: are drug companies shielded from liability after the FDA has approved their drugs for sale?
Obviously, the current answer is "Not at all": consider the lawsuits over Vioxx. But the decision by the Supreme Court in February in Riegel v. Medtronic has the idea being taken seriously again. That ruling seems to shield medical device companies from lawsuits over safety or efficacy after the FDA has signed off on those issues - as long as the device is the same, and used in the approved manner. And no, for the politically motivated among the readership, this wasn't some barely-realized 5:4 scheme from Justice Scalia; the decision went 8 to 1.
There's a roughly similar case before the court now, Wyeth v. Levine. At issue is the labeling and usage of Wyeth's histamine antagonist Phenergan (promethazine), with the suit being brought by a patient who was injured after the drug was used in a method warned against on the label. This one hinges on a federal/state dispute, though, as the petition for certiorari (PDF) makes clear:
"Whether the prescription drug labeling judgments imposed on manufacturers by the Food and Drug Administration pursuant to the FDA's comprehensive safety and efficacy authority. . .preempt state law product liability claims premised on the theory that different labeling judgments were necessary to make drugs reasonably safe to use".
This seems, if it goes Wyeth's way, as if it would keep various state jurisdictions from coming in with different liability claims, but the situation seems less stark to me if a state's standards were the same as the federal government's. Would this really pre-empt liability suits entirely? I'll let actual lawyers set me straight on that if I'm looking at it incorrectly.
There's another case that was granted cert. last fall, Warner-Lambert v. Kent, which could also have a bearing on the whole issue. This hinges on the approval (and later withdrawal) of the PPAR drug Rezulin (troglitazone), and whether Michigan state law on pre-emption of lawsuits is in conflict with the federal law. Again, I would have thought this one would probably be decided as a state-versus-federal issue, without extending to any sweeping thoughts on pre-emption in general. But that Medtronic decision makes a person wonder if the Court is in the mood for just that.
So, there's the background. Arguing will now commence on whether pre-emption is a good idea or not. I've thought for some time that all approved medications should be labeled as "investigational new drugs", and that everyone taking them agrees that they are participating in a post-approval clinical study of their safety and efficacy. (I suppose that's my own form of pre-emption). But there's room to argue if the FDA is ready to take on the full responsibility of drug approval, without the option of later redress in the courts if something goes wrong. (Counterargument: that's what they're supposed to be doing now. . .) And all of these schemes have to make room for new information turning up, or for outright fraud (which is most definitely in the eye of the beholder). Personally, I'm glad not to be a judge.
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