Supreme Court Hears Case Involving Drug Labels

The Supreme Court hears arguments Monday in a case involving drug labels and the Food and Drug Administration. The result could limit liability claims against drug makers, if one of their medicines causes harm. The case pits Wyeth Pharmaceuticals against a musician who lost part of an arm after she was improperly injected with an anti-nausea drug made by the company.

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The U.S. Supreme Court hears arguments today in a case that could mean a lot to drug companies and consumers. Drug firms have been seeking a legal shield from consumer lawsuits. The pharmaceutical industry has tried repeatedly and without success to get Congress to write such immunity into federal law. So in today's case, the industry is trying to win that sort of immunity from the U.S. Supreme Court. And for the first time, the drug companies are backed by the federal Food and Drug Administration. Here's NPR legal affairs correspondent Nina Totenberg.

(Soundbite of song "You Can't Sit Down")

Ms. DIANA LEVINE: (Singing) Hey, pretty baby. Don't you hear the drummer thumping...

NINA TOTENBERG: That's Diana Levine strumming her guitar and singing for a group of children before her arm was amputated. Levine was a successful musician in Vermont until April of 2000 when she got a migraine headache and went to a local clinic for help. The clinic's doctor ordered a drug called Phenergan to combat nausea. But instead of administering it by IV drip, the clinic injected the drug by the so-called IV push method, a method that has a small risk of error which sends the drug into the artery instead of the vein. That's what happened to Diana Levine, and within hours her hand and arm were turning purple and black.

Ms. DIANA LEVINE (Musician): And I could tell by the doctor's face right away how serious it was. I mean, I actually saw tears in his eyes.

TOTENBERG: It turns out that an IV push injection of Phenergan that goes into the artery causes irreversible gangrene. Levine's arm was amputated weeks later. She settled out of court with the clinic and then went after the drug maker, Wyeth Pharmaceuticals, claiming that the drug victimized both the patient and the doctor by not adequately warning of the risks of the IV push method.

Ms. LEVINE: This whole thing was avoidable. The only reason that it happened is because Wyeth had not changed their label to disallow this method of administration.

TOTENBERG: A unanimous jury awarded her $6 million in compensatory damages, and the Vermont Supreme Court upheld the award as justified. Wyeth appealed to the U.S. Supreme Court asserting that the federal law implicitly gives drug companies immunity from such lawsuits. Today in the Supreme Court, lawyer David Frederick representing Diana Levine will argue that the federal law gives no immunity to drug companies for failure to adequately warn about risks and that Wyeth had a duty to warn doctors not to use the IV push method.

Mr. DAVID FREDERICK (Lawyer): All of the evidence at trial indicated that it shouldn't be done through IV push, that the risks were simply too great.

TOTENBERG: No properly warned rational person, he argues, would choose the IV push method. And indeed some hospitals have now banned the procedure. Wyeth lawyer Bert Rein counters that the label does warn doctors about the risks. He contends that amputations resulting from using the IV push method have been extremely rare over the years, and that in any event, once the FDA approves a drug and a label, the pharmaceutical company is not free to change it.

Mr. BERT REIN (Lawyer): The label is part of the license. And the FDA says when you get a labeling approval, you must use this label in the precise form. We certainly believe that we didn't have grounds to change it.

TOTENBERG: So is the label a floor that a manufacturer can add to, or is it a fixed ceiling? That's essentially the question before the court today. Levine's lawyers backed by former FDA commissioners say it's a floor, that the manufacturer can on its own heighten the warning on the label. And Levine's lawyers cite trial testimony from Wyeth experts conceding that a stronger warning about the IV push method would have been appropriate. The labeling question is part of the larger issue in this case. The pharmaceutical industry asserts that once the FDA approves a label, that blocks any consumer lawsuits in state court for failure to adequately warn.

For decades, the FDA has taken the position that state lawsuits act in tandem with federal regulation to ensure drug safety. In a dramatic departure from that position, the Bush administration is now siding with the drug companies and arguing that once a drug is approved, its manufacturer cannot be sued in state court because the federal government has occupied the whole field. Wyeth lawyer Seth Waxman will make that argument today in the Supreme Court.

Mr. SETH WAXMAN (Lawyer): If we're going to have a single national economy that competes in any meaningful way, we certainly have to have a world in which a single expert agency will make these balancing decisions on the basis of all available information.

TOTENBERG: Diana Levine's lawyer, David Frederick, counters that Wyeth's argument would improperly close the courthouse door to people injured by the drug industry's failure to warn.

Mr. FREDERICK: It's closed to her because the drug company gets immunity from suit without having to prove whether it was negligent, or it should have warned, or it should have taken some greater step to protect the patient's safety.

TOTENBERG: Wyeth's Mr. Rein disagrees.

Mr. REIN: The issue is not whether the drug industry gets an immunity. It's whether the federal system gets to prevail in situations where a nonscientific lay jury is questioning federal judgment. And we think that the public health is better served by having FDA do it definitively.

TOTENBERG: That is not the view of former FDA commissioners who filed a brief in this case. Nor apparently is it the view of the career staff at FDA. According to documents obtained by a congressional committee, the highest level career officials at FDA strongly opposed the Bush administration's move to pre-empt state lawsuits. Dr. John Jenkins, the highest official in the FDA's drug review process, wrote that the argument for pre-empting state lawsuits is based on, quote, "the false assumption that the FDA-approved label is fully accurate and up to date in real time."

Experts note that there are two important phases of FDA drug monitoring, before the drug is approved and after. Dr. David Kessler, who served as head of the FDA in both the first President Bush's administration and the Clinton administration, notes that when a drug is approved, the FDA does indeed know all the relevant data. But as time wears on, he says, the FDA knows relatively little. It's the company that gets the reports about side effects or other problems and has the staff to monitor those reports.

Dr. DAVID KESSLER (Former Commissioner, FDA): No matter how many resources we give FDA, the company is always going to be in a better position to take action. My concern is if you take away state tort liability, you're taking away a very important incentive that's existed for decades to make sure that the company acts responsibly and expeditiously once it believes it might have a problem.

TOTENBERG: Kessler points to a number of cases in which it was only through lawsuits that the FDA learned that there were internal drug company concerns about a given drug. The outcome of today's case could well have an impact beyond the pharmaceutical industry. The FDA reversal on drug liability is part of a broader push by the Bush administration to block product liability lawsuits in a wide variety of areas.

The administration has set in motion some 50 new federal rules to block lawsuits by consumers or state governments, rules that govern products from motorcycle brakes to hazardous waste containers. Business and industry largely support that push. The U.S. Chamber of Commerce, for instance, argues on its Web site that it's exceedingly difficult to comply with 50 different state standards. Nina Totenberg, NPR News, Washington.

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