Supreme Court Could Shape Product Safety Warnings

Next month the Supreme Court will hear Wyeth v. Levine, a case that could shape product safety laws affecting everything from automobile makers to pharmaceutical companies.

The case will be a test of the Bush administration's rewrite over the last several years of language affecting a wide array of federal rules that could block product safety lawsuits by states and consumers -- the underlying principle of which is preemption of federal rules over state laws.

The administration's efforts have a high degree of stickiness and can't easily be undone by the next president, so plaintiffs' attorneys, consumer groups, and industry groups have a lot at stake. Business groups are, of course, bullish on the administration's efforts to protect companies that comply with federal rules from trial lawyers who argue different state standards, some of which conflict with federal standards.

Pharmaceutical companies have been hit with multimillion-dollar product liability lawsuits over states' "failure to warn rules," which can be far more stringent in some states than others -- and conflict with federal standards as well. Labeling drugs differently from state-to-state opens a Pandora's box of confusion and danger, according to drug company lobbyists. Patients and their attorneys have a different perspective. "The application of federal preemption doctrine to drug injury lawsuits would effectively eliminate a significant incentive for the drug company to ensure that its drug labels reflect accurate and up-to-date safety information, i.e., the possibility of failure-to-warn product liability litigation," writes Tom Lamb at the Web site Drug Injury Watch.

Wyeth v. Levine, a Vermont case involving a woman whose arm became gangrenous and was amputated after receiving a Wyeth anti-migraine drug in an emergency room is a case in point. Diana Levine and her attorneys claim that the drug label didn't adequately warn about side effects under state law. Wyeth claims to have followed federal warning label standards.

The Court's decision in the case could be a memorable part of the Bush legacy.