The People v. Industry
For the second consecutive year, the Supremes will decide whether, because of federal regulation of an industry, that industry is immune from state court lawsuits involving personal injury.
In Wyeth, the Vermont Supreme Court upheld a $6.8 million verdict for a professional musician who lost her arm because a Wyeth drug was misadministered. In doing so, the Vermont court rejected Wyeth's argument that, because Wyeth's drug labeling and warnings were FDA-approved, her claim under state law was pre-empted by federal law. In last year's term, the Supremes, in Riegel v. Medtronic, favored such a pre-emption argument in ruling that state laws--allowing a personal injury claim because of a defectively designed medical device--were pre-empted by the federal regulatory scheme that had approved that device.
For some context, under the U.S. Constitution's Supremacy Clause, federal laws are "supreme" over state laws when they conflict. In addition, if Congress intends that the federal government pervasively regulate and oversee a particular industry, this deprives the state of any authority to enforce any laws in that area, whether these laws conflict with federal law or not. In other words, the federal government has pre-empted or appropriated the area to itself--to the exclusion of any state law.
Back to the case, Diana Levine suffered from migraine headaches, which occasionally drove her to an emergency room. There, she received medicine for her headache and nausea. The Wyeth anti-nausea medicine was administered by injection intramuscularly to the buttocks. On her last visit, Levine received the Wyeth drug via IV injection, leading to certain problems and, ultimately, amputation of her right arm up to her elbow. Levine sued Wyeth alleging the drug was mislabeled because it failed to warn that IV injection might lead to such terrible consequences. Wyeth countered that the FDA had approved its labeling and that her state law personal injury claim was pre-empted by federal regulation.
The federal "pre-emption" doctrine has its basis in the theory that some industries, such as aviation, are unique and require a uniform set of rules and regulations, as opposed to possibly differing requirements from state-to-state. This theory, while not provocative in the abstract, has encountered stiff opposition when applied to personal injury lawsuits. In 1992, the Supreme Court ruled that Congress had pre-empted the area of adequate warnings on cigarette packs, and that state court lawsuits alleging inadequate warnings could not be allowed. However, this was in contrast to an earlier Supreme Court ruling that Karen Silkwood's estate could sue a nuclear power plant owner for punitive damages, despite the intense federal regulation of the nuclear power industry.
In Wyeth one could predict that the Supremes will favor big business and the drug industry given their support of Medtronic last year. Regardless, the Supreme Court's possible "immunization" of the drug industry from personal injury lawsuits involving adequate warnings is an issue of staggering social importance. Wyeth is poised to impact many other industries also heavily regulated by the federal government that often face personal injury lawsuits--cosmetics, food, automobiles, aviation, to name just a few. With a decision expected next spring, all eyes will be on a case that could dramatically alter the future of personal injury litigation in these areas.
PHILIP G. KIRCHER is co-chairman of the commercial litigation department at the law firm of Cozen O'Connor.
December 1, 2008
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