Life Sciences

Supreme Court hears arguments in preemption case

Pharma Compliance Alert, November 5, 2008

The Supreme Court will determine whether consumers can sue pharmaceutical companies for injuries allegedly cause by an FDA-approved drug after hearing arguments in Wyeth v. Levine November 3.

In April 2000, Diane Levine received Wyeth’s anti-nausea drug Phenergan intravenously (IV push) rather than through an intramuscular injection. A physician’s assistant improperly administered the drug and Levine had part of her arm amputated after developing gangrene.

She sued Wyeth under Vermont laws related to manufacturer negligence and failure to warn about dangerous side effects. Levine won a $6.7 million jury award, upheld by the Vermont Supreme Court. The appeal before the Supreme Court focuses only on claims where the jury’s verdict conflicts with the FDA’s scientific judgment.

The justices questioned at what point FDA-approved labeling shields drug companies from state lawsuits, according to a article.

Wyeth’s attorney claimed the FDA knew improperly administering Phenegren though an IV push could lead to problems and the label contained information about the risks.

Levine’s attorney argued the FDA never compared methods of administering Phenegren and the label’s warning was weak. He also said the drug manufacturer was responsible for updating product labels to reflect all risks and benefits.

The case is the third centering on preemption to go before the Court this year. 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.


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