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.

2 Comments

1. 1. bucketofsquid 11:52 AM 11/6/08

   Not being a lawyer I'm a little confused. The pharma company didn't miss the vein and hit the artery. That was the person that gave the treatment. If they had administered the treatment correctly there would have been no injury. How is this the pharma companys fault? The liability should fall on the facility and its staff.

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2. 2. Jaynesday 09:13 AM 11/9/08

   To learn more about Preemption go to the site
   - http://pharmaccountability.org See what
   organizations listed below have to say about
   the current state of drug and device safety in
   the United States along with the adverse effect
   that preemption will have on our safety and
   civil rights.
   1. The Journal of American Medical Association
   2. The New England Journal of Medicine
   3. The FDA itself
   4. The New York Times
   5. The Boston Globe
   6. The United States House of Representatives
   Committee on Oversight and Reform
   7. Past Commissioner of the FDA - David A.
   Kessler, M.D
   8. 47 State Attorneys Generals
   9. Senior Citizens League
   10. AARP
   11. National Conference of State Legislatures.
   12. California Medical Association
   13. Various others
   See what Preemption is all about and see what
   you can do about it by contacting your Congress
   person today.

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