On Nov. 3, a day before the election, the U.S. Supreme Court hears Wyeth v. Levine, a case with profound implications for the health of all Americans.
In 2000, plaintiff Diane Levine was given Wyeth’s anti-nausea drug Phenergan, then on the market for 45 years. In rare instances, as the label warns, Phenergan can cause gangrene if it comes in contact with arterial vessels.
There is no doubt that Phenergan was wrongly administered to Levine. Not only was she given double the recommended dose, but the physician’s assistant who injected the drug ignored Levine’s complaints of intense pain. The label identifies such pain as a sign of arterial exposure.
Levine, who lost part of her right arm, successfully sued the health center and several staff members for her injury. But that was not the end of the matter. Next she sued Wyeth.
Levine’s product-liability lawsuit, brought in the state of Vermont, argues that the Food and Drug Administration-approved label failed to provide sufficient warning about the drug’s potentially devastating effects if administered improperly. The plaintiff’s lawyers argue that the warning should have been stronger. They claim the FDA-approved label did not meet Vermont’s requirements–putting the state directly at odds with the FDA. A jury agreed and awarded Levine $7.4 million in damages which, on appeal, was upheld by the Vermont Supreme Court.
The core issue now before the U.S. Supreme Court in the Wyeth case is the principle of federal pre-emption, derived from “the supremacy clause” of the U.S. Constitution. Federal pre-emption holds that federal law pre-empts state law when the two conflict.
Wyeth has argued that it cannot comply with both state and federal labeling requirements. The company says FDA scientists approved the warnings on Phenergan’s label only after extensive research. The label provided strict instructions for proper administration and highlighted the risk of gangrene. The label met federal requirements and had been reviewed over the years by the FDA and an expert advisory committee.
Since the FDA is the ultimate public health agency in the country, pre-emption ensures that drug label information is subject to the approval of expert federal scientists, not the whims of local judges, juries or personal injury lawyers. Pre-emption guarantees that labeling is consistent across the country and ensures a level of legal uniformity that keeps us from “regulatory balkanization.” The last thing drug developers need to worry about is complying with 50 different state labeling requirements.
Put simply, a ruling in favor of Levine would dramatically undermine the FDA’s effectiveness and authority. Frivolous liability lawsuits pose other negative consequences for public health.
Increased lawsuits divert financial resources from research and development on life-saving treatments and raise the cost of drugs. In 1995, the Government Accountability Office concluded that liability costs incurred by drug companies were eventually passed on to hospitals, physicians and consumers.
Liability concerns also affect the availability of medicines. Consider the assault on morning-sickness drugs and anti-depressants a decade ago. The personal injury lawyers targeted the popular morning-sickness drug Bendectin, which a National Enquirer article had linked to birth defects.
Subsequent scientific studies demonstrated no reproductive risks. Still, lawsuit costs forced the manufacturer to stop selling the drug. Hospital admissions for morning sickness soon doubled, increasing the risk of pregnancy complications.
Personal injury lawyers later went after a popular anti-depressant, claiming its manufacturer had failed to warn about the risk of suicide in extreme cases. The successful lawsuit resulted in “over-warnings,” which led to a 17% decline in prescriptions for depressed youths and a 14% increase in youth suicides. Psychiatrists concluded that, on balance, more people committed suicide thanks to the new labeling requirement. This tragic outcome could have been avoided had they been prescribed the drug.
Liability lawsuits benefit the lawsuit-industry middlemen more than truly injured people. Most multimillion-dollar payoffs end up in the pockets of lawyers, while less than 15 cents of every tort-cost dollar goes to compensating victims.
In Wyeth v. Levine, the U.S. Supreme Court has a chance to rein in unscrupulous tort lawyers and to re-affirm the supremacy of federal law over state law when the two conflict. As they consider the arguments, the justices should remember that the health of all Americans is at stake.
Lawrence J. McQuillan, [EMAIL TO: [email protected] ] Ph.D., is director of business and economic studies at the Pacific Research Institute and co-author of the 2008 U.S. Tort Liability Index.