This morning the Supreme handed down its ruling in Wyeth v. Levine. In its majority opinion, the Court rejected the argument of pharmaceutical giant Wyeth that the FDA’s approval of its label for Phenergan effectively “preempted” a tort suit brought against it by a patient claiming that the manufacturer failed to provide adequate warning about the dangers of the drug. The patient, Diana Levine, had the drug administered as part of treatment for a migraine, and ended up having her arm amputated after the drug reached an artery and killed tissue. Professor Mendelson issued the following statement:
Today’s ruling is a critical victory not just for Diana Levine but for consumers across the nation. The case marks a setback for manufacturer’s efforts to deny Americans the basic right to go to court when they suffer injuries from flawed products or inadequate warnings.
The Court rightly recognized the importance of state tort law as a necessary complement to federal regulation in responsibly protecting consumers. The Court noted that lawsuits like Ms. Levine’s reveal critical information about safety, give citizens an opportunity to be compensated for injury, and provide powerful incentives for manufacturers to continually improve the safety of their products and disclose safety risks.
When Congress wrote the law that guides the FDA pharmaceutical regulation, it steered clear of explicitly preempting state tort laws. The message from today’s ruling is that if Congress had wanted to preempt a state tort laws, it needed to say so. The Court rightly held that a federal agency like the FDA can’t simply preempt a state law on the strength of its own assertion.”
Mendelson is a professor of law at the University of Michigan. She is co-author with fellow CPR Member Scholars William Funk, Thomas McGarity, Nina Mendelson, Sidney Shapiro, David Vladeck, and CPR Policy Analyst Matthew Shudtz, of several white papers focused on preemption issues. The Truth About Torts series is available at http://www.progressivereform.org/torts.cfm.