Enlarge By Alison Redlich, Burlington Free Press Diana Levine of Marshfield, Vt. lost her arm after a drug was administered incorrectly. The drug's label warned injecting into an artery could cause irreversible gangrene.  YOU CLICKED: WEEK'S MOST POPULAR HEALTH STORIES 1: Feds rate U.S. nursing homes 2: Doctors detail first U.S. face transplant 3: Surgeon finds foot in newborn's brain tumor 4: Nursing homes talk new ratings 5: Colonoscopy prep pills carry kidney risk 6: Duggars welcome 18th child No. 7-10: Diabetes drug risks, placebo effect   DAILY HEALTH BLOG Get wellness tips, medical study roundups and news for healthy living here, including info on ... • Fitness and nutrition • Parenting/kids' health • Watercooler-worthy bits

All she wanted was relief from a migraine.

So Levine went to a clinic near her home in Marshfield, Vt., in April 2000 and was given pain medicine and another drug, made by Wyeth, for nausea. The physician's assistant who gave her the anti-nausea drug, called Phenergan, mistakenly shot it into an artery, rather than a vein — despite warnings on the drug's label that injecting into an artery could cause irreversible gangrene.

Her arm had to be amputated. "My whole life was turned upside down," says Levine, 62, who used to play the guitar and piano. She still runs a small record company.

Levine sued the clinic and the physician's assistant for malpractice and reached a settlement out of court.

In 2004, a Vermont jury awarded her $6.7 million from Wyeth, finding that the drug's label offered insufficient warning about the danger of that injection method compared with two other, safer ways to administer the drug. The Vermont Supreme Court upheld the jury's verdict in 2006.

On Monday, Wyeth will argue before the U.S. Supreme Court that the state ruling should be overturned. At issue is whether patients can sue drug manufacturers under state laws if the U.S. Food and Drug Administration approved the drug and had been fully informed of its risks.

Far-reaching issue

The outcome of the case could affect thousands of potential lawsuits by consumers against drug companies each year. Most states allow such suits if companies fail to warn consumers about products' hazards that aren't obvious.

In February, the U.S. Supreme Court ruled 8-1 that FDA review and approval of medical devices, such as pacemakers, shields manufacturers from state lawsuits even if the devices go awry. Now it will consider whether FDA-approved warning labels on drugs offer similar protections to drug companies.

Levine's supporters — who include 47 states, public-health groups such as the Texas Medical Association and patient-advocacy organizations — say the FDA has reversed itself under the Bush administration by supporting the theory that FDA label approval provides protection from lawsuits in state courts.

"We were all taught that if you got hurt because someone made a bad product, you could sue and that the manufacturer was responsible for the safety of the product," says David Vladeck, a professor at Georgetown Law in Washington, D.C., who has filed briefs on behalf of two former FDA commissioners in support of Levine.

"What the drug industry wants and what the FDA is trying to give them is immunity from liability," Vladeck says.

Wyeth's lawyers counter that the FDA approved the drug knowing it could result in gangrene if injected incorrectly and that there was no new information about that risk to add to the label.

The Bush administration, the U.S. Chamber of Commerce and groups representing drugmakers are siding with Wyeth.

Wyeth's attorney, Burt Rein, argues that juries or states cannot second-guess the FDA. "I say that's turning the Constitution upside down" because federal law overrides state laws when they conflict, Rein says.

State vs. federal

The FDA-approved label on the Wyeth drug given to Levine allows it to be administered in three ways: "IV-push" — in which the drug is injected into a vein — intramuscular injection or a slow intravenous drip into a vein.

IV-push, the technique used on Levine, is faster than the other two. But the label warns of possible irreversible gangrene if done incorrectly.

Levine says she was never told the risks of the IV-push method and would have chosen an alternative rather than risk losing her arm. She says the drug's label should be changed to bar IV-push administration.

Wyeth argues that FDA rules say drugmakers must get its approval to change labels — and cannot do so on their own. The state, Wyeth says in its brief to the high court, cannot force drugmakers to violate federal law. The Vermont Supreme Court had ruled that Wyeth would not have violated federal or state law by strengthening its warning label.

Levine is optimistic that the U.S. Supreme Court will uphold the lower-court rulings: "This system (of lawsuits in state courts) has worked for years and years," she says.

Beyond the legal dispute between federal and state authority, she just wants to see the label changed. "If you asked anyone on the street, do you think this drug company, knowing people could lose limbs, should take this method of administration off the table? Of course they would say yes."