Oct. 29 (Bloomberg) -- Children's musician Diana Levine watched her right hand gradually turn black in the six weeks after she was injected with a Wyeth anti-nausea drug. The pain, so powerful even morphine couldn't mask it, subsided only when doctors amputated the arm just below the elbow.

``It was totally shocking to wake up to this,'' said Levine, motioning toward her sleeve-covered stump as she sat in the kitchen of her Marshfield, Vermont, farmhouse. ``I just didn't think it would be that short. It took me quite a while to be able to look at it, to unwrap the bandage.''

Levine's story -- and the $7 million judgment she won from a Vermont state jury -- comes before the U.S. Supreme Court next week. Wyeth and other drugmakers are asking the court to put new limits on patient lawsuits over medications approved by the Food and Drug Administration.

A victory for pharmaceutical companies would put them closer to long-sought goals: uniform national safety rules, a ban on imposition of tougher standards by juries and a shield from billions of dollars in patient claims. At the same time, it would leave at least some injured patients without compensation even if they can show a drugmaker gave short shrift to patient safety.

``Even if the court rules narrowly, it could still be a blockbuster,'' said Mark Herrmann, a Chicago product-liability lawyer at Jones Day who represents companies and co-writes a blog on drug and medical-device law.

At the center of the debate is the role of the FDA, the agency that determines whether a new drug's benefits outweigh its risks and whether the manufacturer's safety warnings to doctors and patients adequately convey the risks.

Striking a Balance

The pharmaceutical industry says the FDA's doctors, epidemiologists and other staff experts are best positioned to strike the right balance. When jurors look at the case of a single injured person, they aren't considering the benefits the drug provides other patients, said Bert Rein, a lawyer for Wyeth.

``A lay jury, really no matter how many experts you throw at it, is not going to be able to make that same kind of sophisticated assessment,'' said Rein, a partner at Wiley Rein in Washington.

The Bush administration is backing the industry, arguing that jury awards can interfere with the FDA's work by forcing drugmakers to exaggerate some dangers.

``Overwarning can both deter beneficial uses of a drug and limit physician appreciation of potentially far more significant risks,'' the government argued.

High Court Success

The administration has joined business groups in making federal pre-emption of lawsuits brought under state law a priority, generally meeting with success at the Supreme Court. The court in February curbed suits against makers of medical devices.

The FDA came out in favor of pre-emption in the drug context in 2006, saying the Federal Food, Drug and Cosmetic Act establishes ``both a floor and a ceiling'' for warnings. The agency took that position over the objections of some of its top staff members, according to a report released today by congressional Democrats.

Levine's supporters point to what they say has been a dismal FDA track record. Six current and former editors of the New England Journal of Medicine told the court that tens of thousands of people may have died from Merck & Co.'s Vioxx painkiller, Wyeth's Pondimin and Redux diet drugs and Bayer AG's Trasylol bleeding treatment. All four drugs have since been withdrawn.

11,000 Regulated Drugs

With 11,000 regulated drugs on the market and almost 100 more approved every year, the understaffed agency doesn't have the resources to adequately ensure both efficacy and reasonable safety, the editors said in a court filing.

``The FDA alone simply lacks the ability to serve as the sole guarantor of drug safety,'' the editors said. The filing was the first Supreme Court brief to be signed by every editor-in- chief of the medical journal.

The FDA is particularly hard-pressed to evaluate the volumes of safety information that become available only after a drug hits the market, said Theodore Ruger, a University of Pennsylvania law professor who specializes in food and drug law and joined a brief backing Levine.

``The FDA has done a better job at the upfront approval decision than in monitoring the safety of already marketed drugs,'' said Ruger, a former law clerk to Justice Stephen Breyer. Two former FDA commissioners, Donald Kennedy and David Kessler, are making similar arguments in support of Levine.

FDA's Views

Ruger also questioned whether the FDA's views on pre- emption, developed without the notice-and-comment process that usually accompanies agency rulemaking, should carry any weight in interpreting a federal statute.

Levine received two injections of Phenergan in April 2000 to treat nausea associated with a migraine headache. The first dose, like ones she had received previously, was injected into a muscle. For the second, the physician's assistant chose the faster-acting ``IV push'' method, using a syringe to inject the medication directly into a vein in her arm.

A portion of the second dose accidentally penetrated Levine's artery, destroying it and eventually killing tissue in her arm and hand. Levine underwent two amputations, first losing her right hand and then her arm up to her elbow.

Although Phenergan's two-page packaging insert warned that injection into an artery could cause gangrene, Levine says the IV push method is so risky the company should have told doctors not to use it.

Favorite Instrument

Now 63, Levine can no longer play her favorite instrument, the bass guitar. Even writing songs has become a chore, complicated by the carpal tunnel syndrome that afflicts her left hand and limits her piano playing and typing.

``The biggest loss was the music, for sure,'' she said. ``It was just heartbreaking to me.''

Wyeth blames Levine's injuries on the physician's assistant who administered the drug. Levine previously received $700,000 to settle her case against the physician's assistant and the clinic where she was treated.

Rein, the company's lawyer, says that the IV push method should be an option for doctors seeking immediate relief of a patient's symptoms. Wyeth no longer makes Phenergan, now sold only in generic form.

The company is seeking to distinguish the Phenergan case from the higher-profile Vioxx litigation, which involves allegations that Merck didn't tell the FDA about post-approval studies indicating increased health risks. Merck has agreed to pay $4.85 billion to settle claims that Vioxx caused heart attacks, strokes and sudden death.

Rein said Wyeth's Supreme Court argument would leave room for suits if drugmakers withhold safety data from the FDA or promote products for uses not approved by the FDA.

``We're not arguing for a principle that is so broad that no one could sue a drug manufacturer,'' Rein said.

To contact the reporter on this story: Greg Stohr in Washington at gstohr@bloomberg.net.

Last Updated: October 29, 2008 11:27 EDT