Wyeth Pharmaceuticals wants the Supreme Court to overturn the multimillion-dollar damage award that a Vermont jury awarded to Diana Levine because of allegedly inadequate warnings about the risks of its anti-nausea drug, Phenergan. The company's case depends on a theory of federal preemption that most courts have rejected and that the Bush administration adopted over the objections of career officials in the Food and Drug Administration (FDA).
Levine, a professional musician, had her right forearm amputated after suffering a gangrenous infection from a medical mistake: an "IV-push" injection of Phenergan into an artery instead of a vein. The FDA-approved labeling that Wyeth provides with the drug included a warning — with an upper-case heading — about the risk of "gangrene requiring amputation" from "inadvertent intra-arterial injection."
Wyeth, the nation's 10th-largest drug company, with $22 billion in sales in 2007, argued at trial and in subsequent appeals that it could not change or add to the warnings as approved by the FDA. On those grounds, Wyeth said, federal law preempted, or barred, a suit like Levine's claiming a violation of a duty to warn based on state law.
The Vermont jury awarded Levine $7.5 million, which was later reduced by the amount of her $700,000 settlement with the clinic where she was treated. In upholding the award, the Vermont Supreme Court rejected the drug company's preemption argument.
Wyeth "could have warned against IV-push administration without prior FDA approval," the court said in a 4-1 decision. "Federal labeling requirements," the majority said, "create a floor, not a ceiling for state regulation." In a lone dissent, Chief Justice Paul Reiber wrote, "It would be impossible for defendant Wyeth to comply with the requirements of both state and federal law."
The Vermont court's ruling was in line with the vast majority of state and federal courts that have considered whether federal drug law preempts personal injury suits based on state law — either state statutes or judge-made common law. In asking the U.S. Supreme Court to review the ruling, Wyeth's lawyers cited only three decisions from federal trial courts upholding preemption arguments. Wyeth also pointed to what it called Reiber's "strong" dissent in Levine's case.
For years, the FDA had also taken the position that federal law did not preempt state court suits over drug safety. Instead, the agency viewed state court suits as a complement to its own regulatory efforts. The Bush administration changed the agency's position. In 2004, for example, it filed a brief in a pending federal case arguing that the 1976 law regulating medical devices preempted state court suits over devices specifically approved by the FDA.
The FDA rewrote drug labeling regulations in 2006 and 2008 and included in the new rules specific language aimed at preempting state court suits. Career FDA officials opposed the change, according to a report by the Democratic staff of the House Committee on Oversight and Government Reform.
The report, released in October not long before the Supreme Court's argument in Levine's case, quoted memos by FDA officials lamenting the agency's inability to effectively regulate drug warning labels. In one of the memos, John Jenkins, described as the highest official in FDA's drug-review process, wrote, "It is unwise to suggest that FDA-approved labeling is always up-to-date and always contains a full and complete listing of all pertinent risk information."
Vermont musician Diana Levine plays the guitar with a prosthetic arm after a medical mistake involving the nausea drug Phenergan led to gangrene and the amputation of her arm. (AP Photo/Toby Talbot)
After Levine's lawyers filed the report with the Supreme Court, Wyeth's lawyers submitted a reply. They claimed that Jenkins' comments had been taken out of context and he in fact favored FDA preemption. But Jenkins was also quoted as saying that drugmakers can add new drug-safety information to labels without FDA approval.
At the Supreme Court, Levine's lawyer, Washington attorney David Frederick, argued that Wyeth had known for at least 40 years of the risk of amputation from inadvertent arterial injection of Phenergan. He also emphasized that in addition to the usual intramuscular injection, the drug could also be safely administered intravenously by a conventional IV drip instead of an IV injection.
Representing Wyeth, Washington lawyer Seth Waxman countered that the label "plainly" warned about the risks of IV-push injection. A stronger warning, he said, would have gone too far in discouraging use of the technique. "Taking options away from a physician isn't always better," he told the justices.
The justices are expected to decide the case this spring, sometime before taking a recess at the end of June.