U.S. SUPREME COURT ISSUES MAJOR DECISION IN PRESCRIPTION DRUG CASE
On March 4, 2009, the U.S. Supreme Court issued an opinion which the pharmaceutical industry, and many consumer attorneys have been waiting for. Thankfully, the Court sided with consumers in Wyeth vs. Levine, No. 06-49, with six justices voting in favor of consumer rights and three voting against. Hopefully, this case signals the end of a trend in previous Supreme Court decisions which prohibited consumer law suits for injuries caused by inadequate or improper warnings by prescription drug manufacturers.
Diana Levine, a musician, received the medication Phenergan by the IV-push method, which resulted in complications requiring amputation of her right forearm. Ms. Levine brought suit in state court in Vermont, alleging that, despite many known previous complications resulting from administration of Phenergan by the IV-push method, drug manufacturer Wyeth did not adequately warn of the severe risks the use of that method, or prohibit the IV-push method. A Vermont trial jury ruled in favor of Ms. Levine, and awarded damages to her for the loss of her arm. The case was affirmed by the Vermont appellate courts. The drug manufacturer, Wyeth, then asked the U.S. Supreme Court to hear the case. Wyeth claimed that federal regulations from the Food and Drug Administration would be frustrated if state court law suits could be brought against the company. Wyeth also claimed that it would be impossible to comply with both the FDA requirements and state law requirements. Over the years, drug manufacturers have argued that, once the FDA approves their warning information, injured consumers should have no right to challenge that warning in state court. The manufacturers asserted that the state laws conflicted with Federal law, and thus the supreme Feral law “preempted” the state laws.
In Wyeth v. Levine, The Supreme Court rejected both of the above manufacturer arguments, and found that Wyeth could comply with both federal and state law. The Court found that nothing would have prevented Wyeth from providing a stronger warning regarding IV-push administration, even though that stronger warning had not previously been approved by the FDA. The Court also found that allowing a state court jury to declare that the warning was insufficient would not interfere with Congress’ purpose of having the FDA apply its expertise to drug labeling and warning decisions. The Supreme Court noted that Wyeth apparently held a fundamental misunderstanding that the Federal government, rather than the manufacturer, has the primary responsibility for labeling drugs. Significantly, the Court curtailed the circumstances in which Federal law will preempt state law. It declared that it is insufficient for an agency, such as the FDA, to simply assert that state law is an obstacle to achieving agency’s objectives. Although the FDA had done that, it did not allow interested parties any notice of opportunity to comment before effecting its preemption decision, that policy conflicted with the available evidence of Congress’ purposes, and the preemption policy reversed the FDA’s own long-held position that state law may complement Federal law to regulate drugs.
This decision is extremely important to consumers injured by drugs which are not properly labeled, since there is no federal right to claim damages when a consumer is injured in that manner. Thus, if the Federal law is allowed to preempt state law, injured consumers are simply left with no remedy and no access to justice.
The decision in Wyeth v. Levine, 40 pages in length, is also interesting because it demonstrates a split amongst the various Supreme Court justices as to when and to what extent Federal law should preempt state law. Although, based upon constitutional principles, Federal law is only allowed to preempt state law when Congress has made it clear that it intends that result, recent cases have seriously eroded that concept. Justice Clarence Thomas, in a concurring opinion, agreed with the result in Wyeth, but criticized the majority’s apparent position that preemption may still be applied in cases where Congress has “implied” it wishes to preempt state law. Justice Thomas’s position is consistent with that of true conservative jurists. They recognize that states’ rights are paramount, and that the Federal government should have a minimal intrusion on those rights. Many conservative commentators pay only lip service to this principle, while arguing for preemption and a restriction in consumer’s rights. Justice Thomas’s position, if eventually accepted by the majority, will end this hypocrisy.
The dissenting Justices, Roberts, Alito, and Scalia, would have found that Vermont’s law was preempted by the FDA regulations, and would have denied Diana Levine her day in Court in Vermont, to seek compensation for her injuries. Luckily, those Justices are in the minority.
It is expected that many lower court cases throughout the United States will be affected by the decision in Wyeth v. Levine, since the preemption defense is argued in nearly every prescription drug case filed in this country. Clearly this Supreme Court decision represents a great victory for consumers injured by prescription medications which do not provide complete or adequate warnings.
To read the full text of the Supreme Court decision in Wyeth, go to: http://www.supremecourtus.gov/opinions/08pdf/06-1249.pdf
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