Lawyers, especially those who represent plaintiffs in asbestos disease lawsuits, tend to think a good deal about warnings.  After all, the claim that the defendant companies failed to warn the plaintiff about the potential health hazards of exposure to asbestos dust from their products is at the core of every asbestos lawsuit.  Similarly, the failure to warn constitutes the basis of many other types of toxic exposure lawsuits, as well as lawsuits involving consumer goods and medications.  Therefore, it is worth commenting in this newsletter on the recent decision of the United States Supreme Court in Wyeth v. Levine, which involved the validity of a verdict in favor of a plaintiff against a drug company that manufactured and sold an antihistamine used to treat severe migraine headaches. Because the drug company lost its case before the Vermont courts and took an appeal to the United States Supreme Court, the case is now known as Wyeth v. Levine

In the Wyeth case, the plaintiff, Diana Levine, a musician by profession, sought treatment for a severe migraine headache and was given a drug manufactured by Wyeth.  The drug was administered by the use of a technique known as an “IV push”, as opposed to the use of a slower “IV drip.”  In the process of administering the injection, the drug was inadvertently introduced into one of the plaintiff’s arteries.  This caused Ms. Levine to suffer gangrene and the consequent amputation of her arm.

At issue in Wyeth v. Levine was the adequacy of the warning label, as well as the appropriateness of allowing a state court jury to weigh the adequacy of the drug company’s warning.  The label that warned against, but did not prohibit “IV push” administration, had previously been approved by the Food and Drug Administration (FDA). The label stated in relevant part “INADVERTENT INTRA-ARTERIAL INJECTION CAN RESULT IN GANGRENE OF THE AFFECTED EXTREMITY.”  The plaintiff’s lawyers argued to the jury that Wyeth was negligent because it merely cautioned against the injection technique, instead of outright barring it.  The jury agreed and awarded the plaintiff nearly seven million dollars. The judgment of the trial court was eventually upheld by the Vermont Supreme Court, and Wyeth appealed to the United States Supreme Court.  In March, the Court upheld the jury’s verdict.

In upholding the jury’s verdict,  the United States Supreme Court agreed with the plaintiff, as well as with the Vermont Supreme Court, that the FDA’s labeling regulations created only a minimum requirement, and did not in effect trump (or preempt) the right of the plaintiff to present her case against the drug company to a court or jury. Thus, the Court made it clear that injured plaintiffs may not be deprived of the right to have a jury of their peers determine the liability of a product manufacturer for failure to issue an adequate warning, even in the presence of some government regulation.   

The case of Wyeth v. Levine is illustrative of the classic tension between the policy arguments of product manufacturers, on one hand, and workers and consumers injured by mass-marketed products, on the other hand.  Manufacturers routinely ask juries and courts, as well as legislatures, to relieve them of liability for injuries caused by their products because such liability “might result in excessive risk control, stifle innovation, and impose unreasonable costs, including subjecting them to the costs of liability defense and insurance.”  1.This argument essentially attempts to place the risk of loss on the shoulders of workers and consumers and runs counter to our cherished notions of fair compensation for serious injury.  

Lipsitz & Ponterio represents families whose livelihoods have been lost and whose lives have been destroyed by defective products; we make the argument that product liability lawsuits serve the public interest (rather than frustrate it) by providing just compensation for innocent victims of hazardous products, by unearthing evidence of such hazards to better protect the public, and by providing powerful disincentives to risky behaviors on the part of product manufacturers.  Too often, manufacturers of products containing asbestos, beryllium, lead and other toxic substances are tempted to place profits before people.  Fortunately, in Wyeth v. Levine, at least, the argument in favor of the work we do everyday was vindicated by our Supreme Court, even if it was only by a vote of six to three.  

1. Brief of New England Journal of Medicine Editors & Authors as Amici Curiae in support of respondent.