Significant decision alert - no. 36

C A S E A L E R T , N O . 3 6
N O V E M B E R 6 , 2 0 0 8
Supreme Court Hears Preemption Arguments in
Wyeth v. Levine
On November 3, 2008, the Supreme Court of for its alleged failure to remove from Phen- Wyeth v. Levine, a case that many legal com- mentators have described as having the po- tential to reshape the landscape of pharma- Levine, the benefit of IV-push – faster alle- ceutical litigation in the United States. The viation of nausea – is far outweighed by the issue before the Court was whether Food and Drug Administration (“FDA”) approval of a drug’s label preempts state tort “failure to warn” claims alleging that the labeling was inadequate. Questions asked by the various proved, clearly warned of the risks associ- Justices, combined with the general tenor of ated with IV-push administration, including the argument, suggest that a split Court may the risk of arterial injection leading to gan- find in favor of a narrowly-defined form of gued that FDA approval of a drug and itslabeling preempts state tort lawsuits alleg- The facts of Levine, although tragic, are ing failure to warn. A jury award of nearly $7 million in favor of Levine was affirmed gangrene in her right arm, which was even- tually amputated at the forearm, after receiv- ing an intravenous injection of Phenergan, an anti-nausea medication manufactured by vine’s right arm via the IV-push method, Court, Seth P. Waxman, counsel for Wyeth, whereby medication is injected directly into the patient’s vein. Unfortunately, the needle tical drug’s label preempts state tort law- penetrated one of Levine’s arteries, causing suits that allege the label was inadequate.
gangrene to develop and leading to the am- Mr. Waxman argued that to conclude other- wise would place a pharmaceutical com-pany in an impossible situation: either it About Coughlin Duffy LLP
Coughlin Duffy LLP is one of the fastest growing law firms in the northeastern United States, servicing a sophisticated national and international clientele. We provide a full range of legal services including all types of litigation, arbitration and transactional work on behalf of corporate, institutional, governmental and individual clients. We have one of the largest groups of attorneys dedicated to repre- senting insurers and reinsurers throughout the United States and internationally, and specialize in the representation of multi-national organizations faced with international disputes.
The materials presented herein are for information purposes only and are not offered as legal advice. No reader should act on the basis of these materials without seeking appropriate professional advice as to the particular facts and applicable law involved. Opinions presented herein are the opinions of the individual authors, and do not necessarily reflect the opinion of the firm of Coughlin Duffy LLP, or any of follows federal law and uses the FDA-approved Justice John Roberts and possibly Justice label or it conforms to state tort law and adds additional warnings that were not approved by seemed to be leaning against preemption, he vinced by Wyeth’s argument. Specifically, the reasoned decision in favor of preemption.
questions and tones of Justices John Paul Ste- Justice Stephen Breyer may be similarly per- vens, David Souter and Ruth Bader Ginsburg suaded. Finally, Justice Clarence Thomas did suggest they will likely find that FDA approval not ask any questions, as is his custom. How- does not preempt state tort lawsuits questioning ever, Justice Thomas often votes with Chief the adequacy of FDA-approved labels. Justice Justice Roberts and Justice Scalia and may Ginsburg’s position is not surprising in light of her dissenting opinion in Riegel v. Medtronic, Inc., a Supreme Court decision issued earlier this There is therefore a distinct possibility that the year in which the Court found in favor of pre- Supreme Court will find in favor of preemp- emption of state product liability claims involv- tion of state tort actions alleging failure to warn in narrowly-defined cases in which the David C. Frederick argued on behalf of Levine sented by the pharmaceutical company regard- against preemption of state tort claims. Justice ing the specific potential injury suffered by the Antonin Scalia asked Mr. Frederick a series of patient. However, it is likely that this decision questions regarding whether the fact that the will result in a split in the Court and be ac- FDA-approved label allowed for IV-push as a companied by a powerful dissent against pre- method of administration demonstrates that the FDA considered the risks and benefits associatedwith IV-push and concluded that it was an al- Regardless of the Court’s ruling, Levine is not lowable method of administration. Mr. Freder- likely to end all state tort actions against drug ick disputed whether the FDA actually con- manufacturers. Both sides in Levine agree that ducted a risk-benefit analysis specifically for IV- lawsuits against pharmaceutical companies push, which he argued is necessary before a fail- alleging withholding of information from the ure to warn claim may be preempted. Mr. Fre- FDA are not preempted. Moreover, lawsuits derick agreed with Justice Samuel Alito that if against manufacturers who promoted “off la- the FDA, after consideration, determined that bel” use of their products or failure to warn IV-push should not be contraindicated, and then approved the current label, Levine’s claim The results of this year’s presidential and Con- Our impressions at oral argument, the questions gressional elections will likely also have a asked by the various Justices, and the Justices’ significant impact on the preemption land- prior positions on similar issues, lead us to be- scape. With the Democrats maintaining their lieve that the Court will likely be split on the Congressional majority, it is likely we will see issue of preemption and may narrowly find in attempts to enact legislation overturning or favor of preemption based on the specific facts limiting any preemption decision. In fact, the United States House of Representatives Com-mittee on Oversight and Government Reform The tenor of the questions suggests that Justices held hearings earlier this year in connection Ginsburg, Stevens and Souter oppose preemp- decision in Levine will be issued before the opinion in Riegel, will likely rule in favor of preemption. He will likely be joined by Chief Should you have any questions or commentsregarding this matter, please feel free to con-tact us.



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