Toby Talbot/AP
Diana Levine

Supreme Court Rejects Appeal in Pharmaceutical Warning Label Case

March 05, 2009 04:30 PM
by Liz Colville
The Supreme Court refused to limit consumer lawsuits against drug companies, rejecting the claim that FDA review of warning labels can shield a company from lawsuits.

Drug Company Not Protected by Federal Law

Pharmaceutical company Wyeth, the makers of Phenergan, argued in an appeal to the Supreme Court that the FDA approval of the drug and its warning label, under the doctrine of preemption, served to shield the company from consumers’ legal action, the Associated Press reported on March 4.

The Supreme Court rejected the appeal, upholding an award of $6.7 million to plaintiff Diana Levine of Vermont, a 63-year-old musician who had part of her arm amputated after an improper IV injection of Wyeth’s Phenergan led to gangrene.

The Court wrote that Wyeth’s appeal was based on “the fundamental misunderstanding that the FDA, rather than the manufacturer, bears primary responsibility for drug labeling.” The Court also noted that Wyeth has a right under federal law to unilaterally strengthen a warning label prior to obtaining FDA approval of the change.
Wyeth’s lawyer Bert Rein argued that Wyeth’s labeling of Phenergan “provided clear instructions and warnings about its use, including clear warnings about the very risk at issue in this case.” He added that the ruling would impact doctors’ decisions about “whether to use the most effective or least risky method of administering a drug,” AP reported.

The case is important, FindLaw’s Anthony J. Sebok notes, because the Supreme Court, for the second time this term, ruled against the doctrine of preemption, which generally provides that federal law trumps state law. Businesses including tobacco companies have frequently used the preemption doctrine as a defense against consumer lawsuits. Last year, the Supreme Court ruled in favor of preemption in a case involving medical devices, Riegel v. Medtronic, Inc.

Levine told the New York Times last year that “no one had discussed the risks of IV push with her, or the only benefit generally associated with intravenous administration—‘more potent and expeditious antinausea relief,’ in the words of Wyeth’s brief.”

“The benefit-risk is just outrageously ridiculous,” Levine said to the Times. “Any child could figure this out.”

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Background: Previous Supreme Court rulings on the doctrine of preemption

At the heart of Wyeth v. Levine is the doctrine of preemption, referenced by Wyeth in this case and used by businesses to defend themselves against consumer lawsuits. The doctrine “can bar injured consumers like Ms. Levine from suing in state court when the products that hurt them had met federal standards,” the New York Times explained in a 2008 article.

By ruling in Levine’s favor, the Supreme Court under Chief Justice Roberts continued to redefine its stance on the doctrine of preemption. In a preceding case this term, Altria Group v. Good, smoker plaintiffs argued that tobacco companies had mislabeled “light” cigarettes. The Supreme Court case only dealt with one specific element of this case: whether the plaintiffs’ case could be heard, or whether their claims were preempted by federal law, namely the Federal Cigarette Labeling and Advertising Act (Labeling Act) of 1965.
The Labeling Act was created to enforce FDA warnings on cigarette labels and in cigarette advertisements. According to an article on the educational site eNotes, it stated that “no requirement or prohibition based on smoking and health shall be imposed under state law with respect to the advertising or promotion of any cigarettes the packages of which are labeled in accordance with the provisions of this Act.” In other words, the federal act preempted state laws.
Professor Anthony J. Sebok of FindLaw explained the “[s]urprising” decision in Altria Group v. Good: The Supreme Court ruled that there was no federal preemption against the smokers’ claims. He noted another “lightning rod” of a tobacco case concerning preemption, Cipollone v. Liggett Group of 1992, and explained its relevance in this term’s preemption cases.

In a separate article, Sebok pointed out that the Supreme Court recently ruled in the other direction—in favor of preemption—in a medical device case: 2008’s Riegel v. Medtronic, Inc.

Reference: Phenergan

The FDA page on Promethazine HCl (marketed as Phenergan) is prefaced with a message reflecting the medication’s strengthened warning labels, which were added in 2006 after cases of respiratory depression, “including fatalities,” were reported in the use of the drug in infants under two years of age. The “Prescribing Information” sheet has information for health care professionals and patients.

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