Last week, the Supreme Court heard arguments in the long-awaited preemption case, Wyeth v. Levine.
For the first time, the highest court in the land is weighing in on whether federal approval of a drug preempts tort claims against a drugmaker, such as an injured consumer might bring in a state court. A decision for Wyeth upholding preemption could help end the proliferation of product liability and class-action lawsuits at the state levelâ€”as seen in the massive Vioxx litigation.
The details of the case verge on melodrama. A Vermont musician, Diana Levine, lost part of her right arm to gangrene after Wyethâ€™s anti-nausea drug Phenergan (mistakenly) came into contact with arterial blood.
Although the drugâ€™s label carries a warning about this bizarre potential side effect, which can result from an improper emergency â€œIV push,â€ the plaintiff has argued that the drugmaker should have either made the warning more prominent or not sought approval for this specific technique. A Vermont court agreed with the plaintiff, ordering Wyeth to pay Levine $6 million in damages. Wyeth appealed.
Following the arguments, Pharm Exec spoke to James Huston, a San Diegoâ€“based litigator at Morrison & Foerster, who has scored some big victories defending major manufacturers of drugs and medical devices. (He is also a bestselling crime-thriller novelist.)
We asked Huston for his take on how the arguments went, how the judges might decide, and other aspects of the case.
What can you tell us about the judgesâ€™ demeanor during questioning?
I talked to someone who was there, and I have read the briefs in the case as well as the questions that the judges asked. The lawyers on both sides seemed to be on their heels a lot of the time, and Wyeth was getting the more aggressive questioning from the judges, even some of the so-called â€œpro-businessâ€ judges.
They were asking fundamental questionsâ€”Judge Alito asked, â€œHow in the world could the FDA approve an IV push for this [anti-nausea] drug when there is a risk of developing gangrene?â€
Based on all the questioning, it seems clear that the court is very troubled by this case. And they should be. Itâ€™s not a good test case for preemption.
Because itâ€™s really a case of medical malpractice. The woman who got the IV push was a victim of medical error, not a regulatory or liability error. Whoever injected the IV push committed medical malpractice.
The plaintiff is arguing that FDA shouldnâ€™t have allowed this type of drug administration at all. And I tend to agree with her. And thatâ€™s the problem with this case: Weâ€™re all left wondering why neither Wyeth nor FDA can tell us about the potential medical event that is so critical as to make the severe risk associated with this IV push worth itâ€”rather than experiencing 15 minutes of nausea waiting for the regular [and safe] IV drip to take effect.
Wyeth didnâ€™t give a single example in their brief of why this was medically necessary.
Whatâ€™s the pro-preemption answer to Alitoâ€™s question?
The answer is, how FDA came to the conclusion is not up to us or a jury to second guess. The point is that it went to a medical committee, and FDA determined that the warning that this drug carried about this particular risk was adequate.
What does a jury know that medical experts do not know, and that enables them to and say, â€œNo, the warning is not adequateâ€? And then another jury in another state says, â€œYes, it is.â€ And then another jury says, â€œNo, it isnâ€™t.â€ And we skip across the country making some lawyers very rich. Itâ€™s a crazy patchwork of decisions and an awful waste of money.
Does that mean that under preemption, people who are injured by an FDA-approved drug will no longer be able to sue the drugmaker?
The short answer is yes. A decision supporting preemption would probably cover the vast majority of liability issues related to the design or warning label of a drug. You could probably still sue for manufacturing problems.
Could you sue FDA?
Thatâ€™s exactly what Judge Scalia said today during the arguments: â€œIf you have a problem with FDAâ€™s decision, sue â€™em.â€ But thatâ€™s a crazy idea. Youâ€™d have to bring a claim for negligence under the Federal Torts Claims Act, and it would almost certainly be struck down.
If itâ€™s a case of medical malpractice, why is the drugmaker held responsible?
Because of limitations and restrictions in the state medical malpractice rules. If Ms. Levine brought her case in California against her medical professional or the clinic, the amount of money she could recover is very limited. She would never get the $6 million a jury awarded her.
The drug company gets hit for $6 million for a risk that they knew about, identified, and warned against. Thatâ€™s a problemâ€”and addressing that problem would make a very interesting footnote. Weâ€™ll see if it makes it into the opinion. None of the briefs filed with the case mentioned it.
How do you think the Supreme Court will decide the case?
I think the decision, when it comes in three months, will be a very narrow affirmation of the lower courtâ€™s result and yet confirming that preemption does apply sometimes. The court will probably say that preemption only applies when we have actual knowledge that FDA considered the specific risk/benefit at issue.
The problem is that you donâ€™t get that proof because FDA never reveals how it comes to its decisions. So I think the decision will ultimately leave us with a big conundrum.
Basically, the judges will decide narrowly both for and against. They may give Ms. Levine her judgment and say, â€œIn this case preemption does not apply because Wyeth should have proposed a change in the warning on the label. But donâ€™t get us wrong, weâ€™re not saying preemption doesnâ€™t apply in general.â€
Would that set some kind of precedent for preemption?
It would be a very narrow extension of implied preemption. But even if the court recognized a broad preemption application, I think that Senator Waxman and others in Congress will, on the day after the decision, issue an amended Food and Drug Act saying that nothing in this act is intended to preempt any tort claim in any state anywhere. And given the Democratic majority, that law is likely to be enacted.
But weâ€™re seeing the courts pushing on preemption in a lot of different arenas right now.
For example, in the Ninth Circuit here in California, there was a recent case where the court said, â€œWeâ€™ve got the Federal Aviation Association regulating airports and aircraft and aircraft design already, so how can youâ€”a juryâ€”come in and tell us that the way an international airplane is designed is more likely to cause deep vein thrombosis injuries? The Ninth Circuit said you canâ€™tâ€”that the entire field of aviation is preempted by the FAA.
Is there a potential solution beyond the issue of preemption?
Congress could probably come up with a better solution. They passed a law for medical devices saying that state torts laws do not work, but they didnâ€™t extend it to drugs. Still, there has never been a federal tort standard on anything, and Congress isnâ€™t about to start generating one.