Supreme Court takes up drug warning labels

The US Supreme Court is examining whether medical patients can sue a pharmaceutical manufacturer over the adequacy of a drug's warning label.

The issue arises in the case of a Vermont musician whose right arm had to be amputated after she experienced a negative reaction to an injected antinausea drug.

Diana Levine, a professional guitarist, sued drugmaker Wyeth, claiming that the company had given insufficient warning of the possible severe effects of its product. A Vermont jury awarded her $6.7 million in compensatory and punitive damages.

On Monday, the high court hears oral argument over whether Ms. Levine's suit was preempted by federal law and, thus, should have been thrown out of the Vermont courts before the trial even began.

The dispute is one of the closest-watched cases of the court's term. Forty-seven states and an array of consumer advocacy, medical, and other groups have filed friend of the court briefs supporting Levine. Wyeth has received supporting briefs from drug industry lobbyists, business groups, and the Bush administration.

The case pits two competing visions of how best to regulate the pharmaceutical industry. The industry favors centralized regulatory power wielded nationwide by the Food and Drug Administration (FDA). Consumer groups and trial lawyers prefer an overlapping system of national FDA regulations combined with the ability of injured patients to sue drug companies in state court for damages.

"Patients are best protected by a single, strong, uniform regulatory authority that is the sole arbiter of the benefits and risks of medicines," says Ken Johnson, senior vice president with the industry trade group Pharmaceutical Research and Manufacturers of America.

Critics say FDA protects drug companies

Levine disagrees. She says the FDA is protecting the drug companies from lawsuits, rather than protecting consumers from dangerous drugs. "I had no idea what the risks were," she says of her ordeal with the Wyeth-produced antinausea drug.

Lawyers for Wyeth say Levine's lawsuit is preempted by federal law and federal regulations. They say the antinausea drug, Phenergan, is approved by the FDA and that the agency authorized the content of the company's warning about the possible negative effects of the drug. The warning label said that if the drug was improperly injected it could lead to the onset of gangrene and the necessary amputation of a limb.

"FDA concluded that Phenergan was safe and effective for use under the conditions described in the approved labeling," writes Washington lawyer Seth Waxman in Wyeth's brief to the court. "That labeling included specific cautionary language" related to the intravenous injection of the drug.

Levine's lawyers say the FDA approved a general warning for Phenergan, but did not conduct a detailed assessment of the dangers and benefits of the intravenous injection of Phenergan.

The Vermont jury found that Wyeth had violated state law by failing to adequately warn of the dangers of intravenous injection.

Such state lawsuits are not preempted because they help protect public health and safety and thus advance FDA goals, writes Washington lawyer David Frederick in Levine's brief to the court. "Until 2002, the Food and Drug Administration viewed such state-law failure-to-warn claims as complementing federal regulatory efforts by bringing to light drug risks unknown or underappreciated by FDA," Mr. Frederick writes.

Mr. Waxman counters in his brief that patient safety is not the sole objective of federal drug laws and regulations. "All drugs are unsafe in at least some circumstances, particularly when they might be administered incorrectly," he says. Federal drug laws require the FDA to "strike a balance between safety and efficacy by identifying and managing acceptable levels of risk ... while also promoting availability of beneficial drugs."

Waxman says Levine's lawyers impermissibly asked the Vermont jurors to second-guess the FDA's judgment concerning the potential intravenous application of Phenergan.

Should federal law preempt that of states?

The case, Wyeth v. Levine (06-1249), is part of a recent trend at the high court examining the scope of federal preemption of state laws. Last month, the court heard argument in a case involving a lawsuit by smokers in Maine accusing a tobacco company of fraud by suggesting their "light" or "low tar" cigarettes are a healthier alternative to regular cigarettes.

In addition, in February, the Supreme Court ruled in a major preemption case that individuals injured by a defective medical device could not sue the manufacturer if the device received pre-market approval by the FDA.

The 8-to-1 ruling effectively insulates many corporations from potentially expensive product liability litigation. It has been cited as evidence of an emerging pro-business tilt at the high court under Chief Justice John Roberts.

In the Levine case, the question is whether preemption applies to consumer lawsuits filed against FDA-regulated drug companies.

After losing her arm, Levine sued the technician who incorrectly injected the drug into her arm and the clinic where the injection took place. That case was settled out of court for about $700,000.

Levine's lawyers also filed the lawsuit against Wyeth, claiming the company's warnings were not vigorous enough to satisfy Vermont failure-to-warn laws protecting consumers.

Levine's plight has been championed by the legal advocacy group Alliance for Justice. In a speech this fall in Washington, she told the group: "I am the real-life face for this legal issue." She said when she went to her local clinic in April 2000 seeking medical treatment for a migraine headache she was told nothing of the administered drugs. "I had no idea of the dangers," she said. "Wyeth, however, knew all about it."

She said she endured weeks of pain before her hand and much of her forearm turned black and were amputated. "For a musician of 30 years, it was catastrophic," she said. Levine says if Wyeth had given a more explicit warning she might still have her hand and arm.

Some analysts suggest that given current trends at the high court Levine faces an uphill fight. But she says she'll continue to speak out against drug companies and on behalf of injured patients. "They took away my instruments," she said, "but they didn't take away my voice."