Federal pre-emption as tort reform

A case before the U.S. Supreme Court this fall will consider whether federal law -- in this case, approval by the Food & Drug Administration -- pre-empts (or trumps) state tort law. State law in the case at hand permitted plaintiff Diana Levine to recover for injuries caused by products such as the Wyeth drug that Levine was given to treat a migraine headache. The drug was administered incorrectly, caused gangrene to set in to Levine's wrist, ultimately requiring its amputation. A Vermont jury awarded Levine $6 million in compensation for the injury, but that could be overturned by the Supreme Court.

Both NPR and the New York Times have recently reported on the case. In his September 2008 story in the NYT Adam Liptak suggests that the case is one of the most important business cases in the current term. As compelling as the underlying facts are, the looming legal issue in the case is fairly dry: whether federal pre-emption can bar suits based on state law if the products were in compliance with federal standards.

Liptak nicely summarizes the issue this way: "Do the F.D.A. and other federal regulators set minimum safety standards that states are free to augment? Or do they make judgments about the optimal balance between risks and benefits that states must follow?" Professor Catherine Sharkey of NYU is quoted as calling pre-emption "the fiercest battle in products liability law today. The court clearly recognizes this, as it has agreed to hear so many cases and seems eager to give clarity to what has been, to date, an undisputably muddled area of law.”

From a state tort law standpoint, Levine's products liability claim was based on a marketing defect theory, also known as "failure to warn." Here's what happened. Suffering a migraine in early 2000, Ms. Levine received a treatment she had been given before: Demerol for pain and a drug called Phenergan for nausea. The latter is a Wyeth product. Both drugs are safe when properly administered, but the physician's assistant on this occasion gave Levine the Phenergan with and "IV push," rather than by intramuscular injection or IV drip, as had been done before. The physician's assistant accidentally injected the drug into an artery rather than into the vein she was aiming for. The drug's label, which had FDA approval, had warned that "inadvertent intr-arterial injection" may cause "gangrene requiring amputation," but it did not instruct against using the IV push method.

Levine's suit complained that no one at the clinic discussed with her the risks and benefits of how the drug would be administered. The only benefit associated with intravenous administration is speedier relief, and Levine says she would never have opted for that if she had known she risked losing her arm.

Levine settled her suit against the clinic where the drug was administered, but her case against Wyeth went to trial. Her theory was that Wyeth should have used a stronger warning, i.e., "don't give it this way," even if the label used had FDA approval. Wyeth argued that different wording was not an option. Wyeth's brief said it "could not change Phenergan’s labeling to comply with Vermont law without violating federal law.”

Here is a link to a Nov. 7, 2008, New York Times editorial about this case.