Big Pharma Swallows Bitter Pill
Recently, the U.S. Supreme Court ruled that even if drug manufacturers comply with FDA labeling requirements, they may be subject to litigation arising from state tort laws.

August 26, 2009 /24-7PressRelease/ -- Big Pharma Swallows Bitter Pill

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Wyeth v. Levine: Supreme Court Rules For State Court Claims Arguing Failure to Warn on FDA-Approved Labels

If pharmaceutical companies use FDA-approved warning labels, are they shielded from state tort claims? The United States Supreme Court recently took up this issue in Wyeth v. Levine, and ruled that the FDA is not the only layer of drug safety protection for consumers; even if manufacturers have complied with FDA labeling requirements, they may still be subject to litigation arising from state tort laws. In reaching this conclusion, the court acknowledged that personal injury lawsuits in state courts can promote drug safety by providing an incentive for drug manufacturers to improve their products and drug information they provide to medical professionals and consumers.

A Known Risk Becomes Reality for Vermont Musician

Diana Levine was a professional bass player and children's music producer. In 2000, she sought medical treatment at a Vermont clinic for a severe headache. To combat nausea from her headache, medical staff administered a shot of Phenergan into one of Ms. Levine's arms using a method known as an "IV push." The drug inadvertently entered one of Ms. Levine's arteries, later causing gangrene. Her arm was eventually amputated, ending her musical career as she knew it and changing her life dramatically.

While the FDA had approved a warning label that warned against the "IV push" method for Phenergan, it had also not prohibited this method -- even though the FDA and the drug's manufacturer, Wyeth, knew of the risk that the drug could inadvertently enter an artery. Drug manufacturers have historically relied on FDA approval of warning labels as a shield against failure-to-warn claims.

The Lawsuit Against Wyeth in Vermont State Court

Levine sued Wyeth in Vermont state court arguing that Wyeth failed to label Phenergan to adequately warn about the risk of arterial damage when the IV push injection method was used. In turn, Wyeth argued that federal law preempted Vermont state law because the FDA had already approved Wyeth's label for Phenergan. Wyeth argued that it could not have satisfied the FDA's labeling requirements while also satisfying Vermont state law. Wyeth also argued that the objectives of the Food, Drug and Cosmetic Act (FDCA) would be thwarted by personal injury lawsuits under Vermont law.

The jury found Levine's claims credible and awarded her $6 million in damages. Wyeth appealed, but a majority of the Vermont Supreme Court agreed with the lower court's jury instruction that Wyeth could still comply with federal FDA regulations by strengthen its warning labels, although Wyeth could not weaken the label warnings without violating FDA regulations. In effect, the FDA regulations create a baseline that drug manufacturers must meet, but drug manufacturers can draft more restrictive warnings to avoid state tort claims in the interests of public safety.

Wyeth Takes the Case to the United States Supreme Court

Wyeth appealed the Vermont high court's ruling to the United States Supreme Court. Wyeth argued that the Vermont Supreme Court was mistaken on its interpretation of the FDCA on the letter and the spirit of the law. First, Wyeth argued that the FDCA only permits drug manufacturers to alter drug labels prior to FDA approval to add known risks. Second, the FDA approval process for drug labels requires a careful balancing of public safety with the benefits of the drug's treatment so the FDA-approved drug label should not be characterized as a baseline, but as a reasoned mandate to drug manufacturers.

Levine responded that, from the early days of drug regulation, FDA regulations and personal injury lawsuits have pursued different, but parallel paths, to promote drug and medical safety for American consumers. Congress has recognized the role of state personal injury lawsuits in promoting public safety, thus the FDCA should not be read to preempt state tort claims.

Supreme Court Prescribes State Tort Claims to Promote Public Safety

In a 6-3 vote, the Supreme Court ruled against Wyeth. Writing for the majority, Justice John Paul Stevens held that Congress did not intend to bar failure-to-warn claims in state courts. These state claims, if meritorious, tend to promote public safety because drug manufacturers will increase their warnings or reconsider the drug product entirely to avoid future litigation. Stevens also noted that Congress had not expressly delegated authority to the FDA to preempt state lawsuits by issuing regulations against state tort claims.

Consumers may hail the ruling because it promotes safety and provides for more informed decision-making by consumers and medical providers. On the other hand, manufacturers face an increase in litigation and the administrative burden of determining the adequacy of any given drug label against all tort laws of all 50 states. Drug manufacturers will most assuredly pass these costs on to the consumer.

As for the FDA, its labels no longer provide a shield for manufacturers. The weight and authority of FDA processes for determining appropriate drug uses and methods of use may be questioned at trial, or even by doctors, nurses and other medical professionals who administer FDA-approved drugs and products to millions on a daily basis. Congress may weigh in on this decision with future legislation, but that remains to be seen.

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