Thursday, November 20, 2008

Preemption, Drugs, Juries, and Tort Law

Didn't get around to it this weekend, but I had a few things to say in regards to this Reason post on this Richard Epstein column. The issue is the upcoming Supreme Court case Wyerth v. Levine, in which the court will rule on the issue of implied preemption via FDA approval. Interestingly enough, there are few substantive comments at Reason, but I'll return to that in a minute. Fist, a brief explanation of the case for those who care about such things.

At issue is the anti-nausea drug Phenergan, which was administered to Vermont musician Diana Levine. The drug was administered improperly, the end result of which was that Levine had to have her arm amputated. She's already recovered damages against the doctor and the hospital, so the issue here is solely the warnings on the drug. There are two methods of injection, the IM method, which is less risky, but less effective, and the IV method, which was used, which is more risky, but also potentially more effective. The drug had stated warnings against IV injections made directly into the artery, warning against precisely what wound up happening in the case of Ms. Levine. A Vermont court ruled that the drug's warning label should not have just warned about the risk of injection into the artery, it should have proscribed the practice of IV injection all together.

It's important to keep in mind that under federal law, all drug label warnings must be approved by the FDA. Federal drug laws (unlike laws governing medical devices) do not have an explicit preemption clause, by which federal law and FDA rules would override any state laws on the subject. So the question the Supreme Court will be answering is whether preemption is implicit in the nature of the FDA and federal drug laws or whether state tort law can require different warnings than those mandated by federal law.

It's a complicated issue, one that holds no easy answers for legal or political theorists of any stripe. Libertarians may oppose the FDA on philosophical grounds, but assuming there is going to be an FDA around for the foreseeable future, how much weight should the FDA's decisions hold? No one would disagree that there are numerous problems with the FDA, but if state court decisions are permitted to bypass the FDA's authority, then the agency's mission as a whole would be compromised. Why should we spend billions of tax dollars on an agency who's decisions can be overruled by a single jury verdict?

This is not a question of the jury correcting a mistake, but a jury substituting the judgment of the FDA about drug safety with their own. It's important to keep in mind that all drugs have risks and side effects and the job of the FDA is to weigh those risks with the benefits, not in regard to one individual, but in regards to society as a whole. And there's no one right answer.

Personally, despite the libertarian in me that hates to grant more authority to the FDA, I'm in favor of preemption. As unreliable as the FDA may be, they are more reliable and undeniably more consistent than jury verdicts. At least there are scientists and experts at the FDA. Juries made up of laypeople not trained in the sciences seem a poor choice to set drug policy. And just as importantly, the drug industry would have difficulty functioning if each state were able to determine their own liability rules in regards to drug safety.

I've been reading bits and pieces of late on libertarian theories of tort law, which surprisingly, there seems to be little of. Certainly there are property rights bases analysis and criticisms of specific instances in which the tort system has overextended itself. But I've had difficulty finding any libertarian who will come out and say precisely what our tort system should be and more importantly, where it should come from. Libertarians certainly do believe in the notion of restitution, but the problem that we see in these drug cases is precisely where the authority to decide the circumstances of restitution should actually come from. I've made the point in previous posts that certain forms of government regulation aren't such horrible things, namely those regulations that give regulatory effect to what already is or could easily be tort law, the sorts of regulations that say things like you can't sell contaminated milk.

Now, this isn't to say our various levels of government have adopted the best means of crafting regulations, only that at some level, having rules written down before the fact is a better means of determining law than after the fact tort law making by the courts. Certainly, when it comes to drugs and other complicated scientific matters, the benefit of experts versus laypeople on juries should be obvious. There's a lot more here, both in terms of this particular issue and in terms of how libertarians and the rest of the world should view tort law in an increasingly complex world, but for now, I'll leave you with this thought:

Those who argue againast preemption are by implication arguing that the Vermont verdict was correct- that Diana Levine should recover a large verdict and that the Phenergan label should be changed to warn againast all IV injections. So would those opposed to preemption be willing to take a new drug- one that hadn't been approved by the FDA- solely on the say so of that same Vermont jury?


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