The federal preemption defense for manufacturers in pharmaceutical product liability cases suffered a huge and potentially fatal blow in the U.S. Supreme Court's recent 6-3 decision in Wyeth v. Levine, released on March 4, 2009. In the long awaited and much publicized case, the Court rejected Wyeth's argument that federal law preempts state law tort claims regarding allegedly inadequate product warning labels. The Court found that, despite packaging approved by the federal Food and Drug Administration (FDA), Wyeth is liable under the applicable state law of Vermont.
This decision, and the decline of federal preemption generally, renders the pharmaceutical industry a more perilous and complex place to do business. Manufacturers can no longer rely on the FDA "stamp of approval" on designs, manufacturing processes, warnings and packaging to protect them from liability under tort law. Instead, manufacturers must be prepared to cope with the rigors and potential liabilities of state law imposed tort duties—duties that vary from state to state and are in large part defined by the unpredictable determinations of lay juries.
Wyeth manufactures Phenergan, an anti-nausea drug. It was administered to a patient, Diana Levine, via the "IV-push" method, directly into her vein. She developed gangrene, leading to the eventual amputation of her forearm. A Vermont jury found that the injury would not have occurred had the Phenergan label included an additional warning on this method of injection, and awarded Ms. Levine money damages of nearly $7 million. In post trial motions, the trial court rejected Wyeth's argument that federal law, by virtue of the FDA's approval of the Phenergan label which evolved since its introduction in 1955, preempted plaintiff's state law tort claims. The Vermont Supreme Court affirmed.
Wyeth sought relief from the U.S. Supreme Court on the basis of two arguments: 1) that it was impossible to simultaneously comply with the federal labeling scheme and the competing state law tort duties; and 2) that complying with the state-law duty would be contrary to the congressional intent of entrusting these labeling determinations to the FDA and not the wisdom of the various states laws. The Court rejected both arguments.
In unfavorably disposing of the argument regarding the difficulty of simultaneous compliance, the Court noted that the FDA's "changes being affected" (CBE) regulation would have allowed Wyeth to add a stronger warning to the label, and pointed out rather tersely that the manufacturer, not the FDA, bears ultimate responsibility at all times for its label's content, indeed raising the industry bar on product safety. The Court then found the argument on Congressional intent unsupported since it was predicated not on any statements by Congress, but solely upon a preamble to a 2006 FDA regulation regarding the potential that failure-to-warn claims may stand to compromise the FDA's authority. The Court found that this statement did not outweigh contrary evidence of Congress' intent and the FDA's own longstanding regulations which provide for the evolution of labeling as the post-approval clinical use of a product raises safety concerns which can be ameliorated by changes to the labeling and ultimately promote the "safer use of the product by clinicians who are also charged with the duty of using products in accord with labeling advice."
Justice Breyer's concurring opinion offers the best hope that some life may still remain in the preemption defense. Breyer stated, "[t]he FDA may seek to determine whether and when state tort law acts as a help or a hindrance to achieving the safe drug-related medical care that congress sought .... describing, for example, when labeling requirements serve as a ceiling as well as a floor. And it is possible that such determinations would have pre-emptive effect." It is impossible to say whether a majority of the justices might share Breyer's apparent openness to entertaining a preemption argument under different circumstances in the future.
If Congress acts this year, as many expect, on proposed legislation to abolish the federal preemption defense for medical device manufacturers, the remains of the once-promising preemption defense may be undone by the pen stroke of Congress and agreement of the Executive Branch. The landscape is changing, and understanding the difference between the weeds and the grass is more critical than ever in the successful management of pharmaceutical and medical device product risks and the defense of prescription drug and medical device cases.
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