Wyeth v. Levine

2009-03-04

Headline: Court rules FDA approval of a drug label does not block state failure-to-warn lawsuits, keeping patients’ ability to sue manufacturers over inadequate warnings and jury verdicts intact.

Holding: The Court held that FDA approval of Phenergan’s label does not automatically preempt a state-law failure-to-warn claim, because manufacturers can strengthen warnings under FDA rules and Congress did not clearly displace state tort remedies.

Real World Impact:

Allows patients to sue drug makers over inadequate warnings.
Requires manufacturers to monitor safety and update labels when risks emerge.
Leaves open whether specific FDA regulations can preempt state tort claims.

Topics: drug labeling, state torts, FDA preemption, patient safety

Summary

Background

Diana Levine, a patient, received Phenergan by an IV-push injection and suffered arterial exposure, gangrene, and amputation of her forearm. She sued Wyeth, the drug company, saying the label failed to warn clinicians to use the safer IV-drip method. A Vermont jury found for Levine and awarded damages. The FDA had approved Phenergan’s label decades earlier and had reviewed labeling changes over time; Wyeth argued that federal law and FDA approval barred Levine’s state-law claim.

Reasoning

The central question was whether FDA approval of a drug label prevents a patient from bringing a state failure-to-warn lawsuit. The Court said no. It explained that federal rules (the CBE regulation) allow manufacturers to add or strengthen warnings before the FDA completes review, and that manufacturers remain responsible for keeping labels current. There was no clear evidence the FDA would have forbidden a stronger IV-push warning for Phenergan. The Court also found the FDA’s 2006 preamble claiming a broad pre-emptive “ceiling” unpersuasive given procedural flaws and the long coexistence of state tort law and FDA oversight. Because Congress had not plainly displaced state remedies for drugs, Levine’s claim survived.

Real world impact

This decision keeps state jury verdicts available to injured patients and preserves state tort law as a backstop to federal regulation. Drug makers must monitor postmarket reports and can change labels under FDA rules. The ruling does not eliminate all pre-emption questions; specific formal FDA regulations might preempt state law in other cases.

Dissents or concurrances

Justice Breyer emphasized the Court did not decide whether a formal agency regulation could preempt state law. Justice Thomas joined the judgment but warned against broad implied pre-emption doctrines. Justice Alito dissented, arguing the jury verdict improperly second-guessed the FDA’s labeling judgment.