In 2000, a professional guitarist received an injection of the anti-nausea drug phenergan to treat a migraine. The injection of the drug, however, was not properly administered, causing her to lose her arm to gangrene. The woman won $6.8 million in a product liability lawsuit against Wyeth, the maker of the drug, on the basis that the company failed to sufficiently warn the public and doctors about the drug’s risks if not properly injected.

Wyeth has since appealed the lawsuit, arguing that because the United States Food and Drug Administration (FDA) approved the drug based on the information Wyeth presented, the company is not liable – a legal doctrine known as pre-emption. The case is now headed to the Supreme Court, which will test the doctrine for prescription drugs.

If the Court rules in favor of Wyeth, drugmakers will be shielded from product liability lawsuits involving FDA-approved prescription drugs, even if the drugmakers fail to disclose all risks associated with treatment. This would make the FDA the only regulator guaranteeing drug safety – a guarantee that may not be questioned by state-level lawsuits.

On August 14, 2008, the editors of the New England Journal of Medicine wrote an editorial claiming the FDA lacks the ability to adequately protect consumers against drugmakers’ treatments, citing 23 FDA-approved drugs that have been withdrawn from the market since 1997 due to safety risks. In addition, two former FDA commissioners and 47 state attorneys general oppose pre-emption, claiming the agency is unable to assume the role.

Pending the outcome of the Wyeth case, which is scheduled for November 3, several product liability lawsuits have been put on hold, including three involving GlaxoSmithKline PLC’s antidepressant Paxil. If the Court sides with Wyeth, these lawsuits, and dozens of others, could be dismissed.

Sources: Alicia Mundy, “Plaintiffs’ lawyers fight restrictions on product-liability suits,” Wall Street Journal, August 13, 2008; “Lawsuits help ensure drug safety, NEJM editors say,” Medical News Today, August 19, 2008.