Pharmalot: Why do you call this case an unfortunate example of preemption to have the court decide? Zipursky: The nature of Supreme Court adjudication is such that they end up deciding broad principles that have a large impact but the structure of our system is that they make those decisions by looking at a particular example before them. A risk in any form of Supreme Court adjudication is that the power of the facts will lead the court one way, even though, as a broad principle, that might really not be the best way to go. There are some cases that are hard cases that make bad law, and this may well be one of them.
Pharmalot: Why is that? Zipursky: It's because the very facts of the case that would have made it so appealing for a jury to come out in favor of the plaintiff and against Wyeth are facts that would typically make an appellate court think it may have to play some large-system protection role. Here's a woman who did aboslutely nothing wrong - she had a headache and went to a clinic and because of the defendant's drug, she had an arm amputated. And it's a tragic case; (Diana Levine) is a guitarist. It's just the kind of case you can imagine a jury jumping up for a plaintiff, and they did. On the other hand, apppellate courts see their role as taking a broader view and insulating large, rich defendants against verdicts they believe are precipitated by sympathy. I think, to the US Supreme Court, this is going to look exactly like that sort of case.
Pharmalot: What is about the facts here that make you say that? Zipurksy: Wyeth was aware of the risk that its Phenergan IV drug could cause gangrene if administered improperly, and warned about this on its package insert, and explicitly cautioned against injecting the drug. But the language of Wyeth's package insert did not prohibit the IV push method of delivery and the plaintiff argued the warning should have been even stronger.
The alleged basis for liabilty here is really just too thin to sustain a proper tort. The predicate for a liability is a failure to warn and Wyeth did warn. Failure to warn law has become quite subtle, so it is possible for a plaintiff to argue the warning was not adequate. But if you look at Wyeth's warning, it was quite extensive - it warned of risk of gangrene and indicated that if you have the syringe go into artery by mistake, there was no reversing damage done. It was a very serious warning. And what you sometimes find is, after the fact, looking at this sort of tragedy, a jury will be persuaded that maybe an even more severe warning would have saved aplaintiff from a serious injury they incurred. That's extraordinarily speculative. The reality is it is was the clinic's fault, but the clinic is a much smaller financial entity and Vermont law is designed to give the plainitiff multiple options. The drug company really didn't do anything wrong, it appears. And the previous ruling delivers the message that state judges and juries across America are hostile to big corporations. This is what the tort reform movement is saying.
Pharmalot: Why couldn't Wyeth have stated plainly that the drug should not have been injected into the artery at all? Zipursky: First, I think Wyeth would argue that it could not have done that without running afoul of what the FDA told it to do. But more important, I think the plaintiff's lawyers appear to have been anxious about the risk they would face a more serious preemption argument if they phrased their argument to say it simply should have been prohibited. It was a failure to warn argument.
Pharmalot: So you've written that for the Supreme Court to reverse the case would make bad law. Why is that? Zipurksy: The reasons Wyeth should win all have to do with the way Vermont law should be interpreted. But these don't have anything to do with preemption defense. The Supreme Court has no business deciding Vermont law. The only hook for the court is federal preemption. It's only tool for delivering Wyeth a victory here is to craft a defendent-protective rule and federal premption law and give Wyeth a vctory. And if that were done in a broad way, it could be a disaster. The world of big drug companies are hoping the court will be so tempted to find a way to make Wyeth win this case, using federal law, that it will craft federal preemption doctrine.
Pharmalot: In other words, you're describing an overreaction. But do you think this is likely? Zipursky: There is the possibility the court will craft a very narrow preemption idea. It could say the essence of whatever the plaintiff is arguing is this: that Wyeth needed to say you can never use this product for an IV push. And since the FDA had decided that should not be on the label, the court might decide clinics and hospitals may have that particular method available to them. And, therefore, Wyeth is put in a bind by this particular case of facts and, therefore, the claim is preempted. The court could do that and have a much narrower effect.