CPR Member Scholar Thomas McGarity had op-eds over the weekend in three Texas newspapers -- the Dallas Morning News, Houston Chronicle and Austin American-Statesman. His topic is Wyeth vs. Levine, last week's blockbuster case from the Supreme Court, in which the Court rejected the Bush Administration's multi-year effort to use the federal regulatory process as a backdoor method of shielding manufacturers from lawsuits brought by customers their products injure.
The case was brought by professional musician Diana Levine, who went to a clinic with a migraine headache, and received nausea medication that eventually resulted in her arm being amputated. Such outcomes were a possibility known to Wyeth, the manufacturer, but the label on the drug, according to the jury that decided the case in Levine's home state of Vermont, failed to adequately warn about how to prevent it from happening. Wyeth argued in court that Levine's case was "preempted" because the FDA had approved its label, thus insulating the company from such failure-to-warn suits brought under state tort law. That's an argument that the Bush Administration made with some regularity over the past several years, in the context of medicine (FDA), cars (the National Highway Traffic Safety Administration), and consumer products (the Consumer Product Safety Commission). In this case, the Supreme Court, on a 6-3 vote, found otherwise. (Read about the Bush push for preemption, here.)
McGarity writes:
In this case, the relevant federal statute did not mention preemption, so Wyeth argued that preemption was implied because it was impossible for the company to comply with both its duty to use the federally approved label and the asserted common law duty to use a more stringent warning. The Supreme Court brushed this argument aside, noting that, under FDA regulations, the company was free to add a more stringent warning unilaterally.
The court also rejected Wyeth's argument that allowing juries to entertain such claims would hamper the broader objectives of the federal statute. Indeed, it noted that the FDA had always welcomed state common law actions until it suddenly changed its position in 2006.
The court stressed that the "manufacturer bears responsibility for the content of its label at all times." In our civil justice system, innocent people generally have recourse to state courts to hold companies accountable when they shirk their legal responsibilities. The court wisely prevented Wyeth from palming its responsibility off onto an overworked and underfunded federal agency that was more concerned with approving drugs than with protecting patients.
Federal agencies and state courts have complementary roles to play in protecting consumers from dangerous products and activities. The decision in this case is a welcome sign that the Supreme Court will allow both of them to remain on the stage.
Preemption is also the subject Professor McGarity's latest book: The Preemption War: When Federal Bureaucracies Trump Local Juries. CPR's Nina Mendelson issued a statement last week in response to the ruling, and Professors McGarity and Mendelson distributed an editorial memo on the subject as well.
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Matthew Freeman | March 9, 2009
CPR Member Scholar Thomas McGarity had op-eds over the weekend in three Texas newspapers — the Dallas Morning News, Houston Chronicle and Austin American-Statesman. His topic is Wyeth vs. Levine, last week’s blockbuster case from the Supreme Court, in which the Court rejected the Bush Administration’s multi-year effort to use the federal regulatory process as […]
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Nina Mendelson | March 4, 2009
This morning the Supreme handed down its ruling in Wyeth v. Levine. In its majority opinion, the Court rejected the argument of pharmaceutical giant Wyeth that the FDA’s approval of its label for Phenergan effectively “preempted” a tort suit brought against it by a patient claiming that the manufacturer failed to provide adequate warning about […]
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Shana Campbell Jones | March 2, 2009
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Rena Steinzor | February 27, 2009
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