WASHINGTON — Diana Levine went to the doctor with a migraine headache. She ended up losing her arm.
Now the Vermont resident and former professional guitarist is the human center of one of the most important business cases to reach the Supreme Court this term. Her right arm is gone forever, but one way or another, her legal reach could extend longer than most.
"I never expected to sue anyone in my life," Levine declared at the start of her legal odyssey, but "sometimes it takes something like this to make it known when a drug is not being used right."
On Tuesday, the Supreme Court will consider Levine's case seemingly stripped of its core human drama. Instead of gangrene and amputated arms, the justices will weigh a dry-sounding but crucial concept called pre-emption. It refers to federal rules trumping state authority. It can mean the world to big business, consumers and state officials alike.
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"The pharmaceutical industry stands the most to gain from a favorable ruling in this case," Washington-based corporate attorney David Gossett noted in an e-mail, but "the court's ruling could also have implications for other heavily regulated industries."
Levine's allies call the Food and Drug Administration's requirements for warnings on drug labels a floor, the bare minimum, which a state can strengthen on its own. Allies of the drug manufacturing company Wyeth, the target of the suit, call the FDA's actions a ceiling, beyond which states cannot go.
In some ways, pre-emption represents the cutting edge of the Supreme Court under Chief Justice John G. Roberts. In February, siding with Gossett's client, the court ruled that federal law pre-empted many lawsuits concerning medical devices. Several weeks ago, the court considered whether federal law pre-empts state action on allegedly deceptive cigarette labels.
The case started with a human drama.
Levine, who's now 62, went to a Vermont medical clinic in April 2000 complaining of nausea and migraine headaches. A physician's assistant injected her with Demerol and the drug Phenergan. Phenergan combats nausea but is dangerous if injected into arteries.
The FDA-required label warns about the arterial danger, though it permits a fast-acting "IV-push" method in which the drug is injected into a vein. This was the method used on Levine.
"I felt that in order to give her some relief, that I would give it intravenously and try to get it in a more effective and swifter manner," physician assistant Jessica Fisch testified during trial.
Fisch apparently missed the mark, and the drug entered Levine's artery. Levine subsequently developed gangrene. In two separate amputations, doctors first removed her hand and then her forearm.
In a five-day jury trial in state court, Levine successfully argued that the drug manufacturer hadn't provided adequate warnings about the dangers of getting an IV injection of Phenergan. She was awarded $6.7 million.
Wyeth argues that the FDA's approval of Phenergan pre-empts the state's authority over warning labels.
"Wyeth could not change Phenergan's labeling to comply with Vermont law without violating federal law," argues Seth Waxman, who'll represent Wyth before the Supreme Court.
Levine argues that the "IV-push" method that federal regulators permitted is inherently dangerous and properly subject to stricter state requirements.
With so much at stake, Wyeth v. Levine has brought out the big guns.
Waxman, the Clinton administration's former solicitor general, has argued more than 50 cases before the high court. Levine is represented by David C. Frederick, who once worked for Waxman and who's argued nearly two dozen times before the court.
Some 30 amicus briefs have been filed, an unusually high number. The California Medical Association, 18 members of Congress including Sen. Dianne Feinstein, D-Calif., and Rep. Debbie Wasserman Schultz, D-Fla., and dozens of states including California, Florida and North Carolina have lined up with Levine.
The U.S. Chamber of Commerce, drug manufacturers and the Bush administration have aligned with Wyeth, arguing for national uniformity.
The FDA's "approval strikes a balance between competing considerations, (so) state laws that strike a different balance conflict with FDA's determination," then-Solicitor General Paul Clement reasoned in a legal brief.
Clement stressed that states shouldn't "second-guess" the "careful balance of risks and benefits" made by federal regulators, and that state laws were implicitly pre-empted by the federal action. Wyeth's other allies add that without federal pre-emption, business will suffer.