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What is preemption, and what does it mean for drug lawsuits?

The Supreme Court considers whether patients hurt by drugs can sue drug companies that followed U.S. Food and Drug Administration guidelines



courtesy Sheila Scheuerman

In the spring of 2000 a professional guitarist named Diana Levine, then in her 50s, sought treatment for a migraine headache at a clinic in Vermont. She usually received the drug Demerol for pain relief, along with an injection of Wyeth’s antinausea drug Phenergan in the muscles of her butt to relieve the nausea that usually accompanies migraines. But this time the physician’s assistant used an alternative method for administering Phenergan approved by the U.S. Food and Drug Administration. In the method, called intravenous push, the drug is injected directly into a vein in the arm.

The physician’s assistant, however, missed Levine’s vein and accidentally injected Phenergan into her artery. Over the next few weeks, Levine experienced excruciating pain. Her hand and forearm turned black with infection, and both had to be amputated later.

Levine sued Wyeth for failing to warn her about the gangrene risk associated with IV push, and a Vermont jury ordered the drugmaker pay $6.7 million in damages. But Wyeth had, in fact, disclosed the risk of intra-arterial injection on their FDA-approved label, so they appealed. The Vermont Supreme Court upheld the lower court’s ruling in 2006. This week, the Supreme Court is hearing arguments on the case.

Suddenly, everyone within earshot of a trial lawyer is talking about "preemption," which is the legal issue at stake in the case. It's already generated a lot of coverage and buzz, and is being watched closely by lawyers and advocates who say it could dramatically change the drug lawsuit landscape. Similar cases are working their ways through other courts, including one in New Jersey involving Merck and Vioxx. You'll recall that people who took Vioxx—a painkiller now off the market—are suing Merck because studies later showed that it doubled the risk of heart attacks. Some are even speculating about what a new president and Congress will be able to do about the eventual ruling.

We asked Sheila Scheuerman, a professor at the Charleston School of Law and an expert in tort law and product liability, to explain preemption and what the case means for lawsuits. An edited transcript of the interview follows.

What does preemption mean?
Preemption refers to a defense when you are in a Federal Court where federal law supplants state law. There are two kinds of preemption.  Expressed preemption is where Congress expressly says no state law in contradiction to or related to an area is allowed. Implied preemption is where there is no expressed preemption provision but allowing state law would conflict with the purposes of a federal statute, such as the Food, Drug and Cosmetic Act that authorizes the FDA to approve the release of new drugs into the market.

How does implied preemption apply to Wyeth v. Levine?
Levine sued for negligence under Vermont state law. Her allegation was that Wyeth had failed to provide proper instruction regarding this IV push method.  It shouldn’t be administered that way, she alleges, and instead should use the IV drip method.

The argument that Wyeth is making here is it had to submit its labeling to the Food and Drug Administration for approval and that holding Wyeth liable under Vermont law conflicts with the approval process. Allowing Levine’s claim conflicts with the IV push method that the Food and Drug Administration has approved. It’s really a fascinating case in terms of the policy on both sides.



Why did this case make it to the Supreme Court?
Typically, a case like this wouldn’t get to the Supreme Court because there wasn’t a circuit split [a disagreement between one or more federal courts] that generally [implies] a Supreme Court review.  However, the court has granted review in a series of preemption cases, and it seems to me that the Court might be attempting to articulate a clear preemption doctrine. What we have, at least in the implied preemption context, is a lot of ambiguity. The Riegel v. Medtronic case last year was an express preemption case. [In the Riegel decision, the Supreme Court ruled that Congress’s premarket approval process for medical devices such as Medtronic’s pacemakers, expressly barred injured patients from filing lawsuits against device makers.]

Is this going to prevent injured consumers from suing manufacturers? Will we see a bunch of trial lawyers out of a job?

I don’t see tort lawyers going out of business anytime soon. Would you see a change to different series of litigation?  Absolutely.  We’ve already seen some of that shift where a lot of what used to be typical product liability suits are being brought under state consumer protection statutes, consumer fraud statutes, and false advertising statutes.  A lot of it may hinge on the election today, and there’s a lot of speculation that should the Democrats get control you will get congressional language eliminating preemption that could alter this playing field entirely.

What is the broader significance of the case?
For both manufacturers and injured plaintiffs this brings a lot of issues to the forefront. Think about the scope here: A manufacturer submitted products to federal agency as part of agency review process, product and warning label were approved by the agency.  If the court comes down in favor of a very broad implied preemption doctrine that is going to ricochet throughout other industries. A broad preemption doctrine would limit the number of tort suits. However, we do have a manufacturer here who went fully through the approved FDA process, did everything they were told to do, and they can’t change their label without FDA approval.

Now, it becomes a bit of a policy question. Do you view the tort system as complementing a federal agency’s role in regulating consumer goods or not?  That’s really where this case falls along policy lines. There have been congressional bills introduced that would do away with implied preemption. Congress can easily come out and amend the Food, Drug, and Cosmetic Act to say there is no preemption here. You could easily see a bit of a backlash on the Hill where they attempt to fix it on a legislative level.

So what do you think the Supreme Court will do?
I don’t have an opinion about how the court is going to come down on this. That’s the exciting thing about this case. Whatever the court does here very likely will apply in other contexts of agency regulation and that’s why everyone is following it so closely.

 

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