Life Sciences

Wyeth releases its side of story for upcoming preemption case

Pharma Compliance Alert, October 22, 2008

The Supreme Court is set to begin hearing arguments in Wyeth v. Levine November 3, and Wyeth issued a release October 17 with its side of the case.

The case centers on whether consumers can sue pharmaceutical companies under state laws for injuries allegedly cause by a pharmaceutical product even if the product received FDA approval. The appeal before the Supreme Court focuses only on claims where the jury’s verdict conflicts with the FDA’s scientific judgment.

In April 2000, Diane Levine received Wyeth’s anti-nausea drug Phenergan intravenously (IV push) rather than through an intramuscular injection. Levine developed gangrene and had part of her arm amputated. Levine sued the health center, the supervising physician, and the physician assistant who gave the injection and reached a settlement. Levine then sued Wyeth, arguing the company should have changed the Phenergan labeling to prohibit physicians from administering the medicine through IV push.

Wyeth contends Levine’s injuries stem from improper administration by the physician’s assistant. Wyeth alleges the physician assistant administered twice the labeled maximum dose for IV use. In addition, the company said no evidence, argument, or even suggestion exists that Wyeth concealed or failed to provide the FDA with any relevant information about the risks associated with Phenergan.

Because the FDA approved Phenergan’s labeling, Wyeth said it could not change that labeling without violating federal law. Wyeth further argued having a single expert regulatory body, the FDA, make decisions about risks, benefits, and warnings is better than having a system that could produce conflicting results that would be impossible to reconcile.

In February, the Supreme Court ruled medical device makers are immune from liability for personal injuries if their devices passed the FDA’s most stringent pre-marketing review. In March, the Court deadlocked on a Pfizer preemption case, allowing 27 lawsuits in Michigan to go forward. If Wyeth is successful in its case, the court may bar any suit that questions the adequacy of an FDA-approved packaging insert to ensure drug safety.

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