Wyeth v. Levine: The Most Highly Anticipated Pharmaceutical Products Liability Ruling Since 1993

Next term the United States Supreme Court will decide Wyeth v. Levine—perhaps the most highly anticipated pharmaceutical products liability ruling since the court's 1993 decision in Daubert v. Merrell Dow Pharmaceuticals. Many prognosticators expect the Supreme Court to rule that the Food and Drug Administration's approval of a prescription drug preempts certain state-law tort claims. But there is less consensus about the likely scope of the court's ruling: Will it put an end to pharmaceutical mass-tort litigation as we know it? Or will it stay close to the facts of Levine, and leave room for argument that claims involving different drugs and different circumstances may not be preempted? The recent decision by the U.S. Court of Appeals for the Third Circuit in Colacicco v. Apotex Inc. may be a harbinger of a less-than-sweeping preemption ruling in Levine.

Colacicco: A Cautious Step Towards Preemption of State Product Liability Claims

In Colacicco, the Third Circuit addressed whether and when the FDA's approval of a medication's label preempts state-law failure-to-warn claims. At issue in the case was whether two drugs from the widely prescribed class of antidepressants known as selective serotonin reuptake inhibitors (SSRIs) should carry a warning about the risk of suicide. The sharply divided court did not adopt the ruling urged by the defendant pharmaceutical companies and the FDA, that failure-to-warn theories are preempted by the mere fact of FDA approval. Instead, the appellate court limited its holding to "circumstances in which the FDA has publicly rejected the need for a warning that plaintiffs argue state law requires." The court determined that the FDA's "active monitoring" of the issue for 20 years and its determination that the warning sought by plaintiffs would be "false and misleading" warranted preemption of their claim. Dissenting Judge Thomas L. Ambro applauded the majority for their "well-crafted and responsibly narrow" opinion, but noted that he "would not move even [this] short distance" toward preemption, since in his view state-law claims do not conflict with the federal regulatory system.

At first glance Colacicco could be read as an outright endorsement of prescription drug preemption. But by crafting its holding around the regulatory history peculiar to the specific drugs at issue, the Third Circuit took a restrained, middle-of-the-road approach that could prove popular with other courts, including the Supreme Court.

For example, less than a month after the Colacicco decision was announced in April 2008, a federal district court in Illinois, citing Colacicco, dismissed a claim that the SSRI Paxil should have carried a suicide warning. In Mason v. SmithKline Beecham Corp., the court explained that the approval of Paxil's package insert by the FDA, which "had repeatedly rejected the scientific basis for the warnings claimed to have been lacking on the labeling," precluded a finding that the manufacturer should have warned about the alleged risk. Drawing from Colacicco, the district court noted that Colacicco presented "the precise question" before it and intuited that "the Seventh Circuit would reach the same conclusion when presented with the same issue." The court did not, however, suggest that FDA approval preempts failure-to-warn claims in circumstances other than the specific factual context surrounding the FDA's approval of Paxil's warnings and instructions.

The Supreme Court May Follow Colacicco's Measured Approach

The Supreme Court's decisions in two cases last term suggest that the court, while generally favorable toward preemption of product liability claims involving FDA-approved products, remains divided on whether and how far to extend the doctrine to pharmaceutical cases. The first case was Riegel v. Medtronic, in which the court interpreted the express preemption clause of the Medical Device Amendments to the Food, Drug, and Cosmetic Act. In that case, the court ruled 8-1 that product liability claims against FDA-approved medical devices are preempted.

The second case, Warner-Lambert v. Kent, gave a different signal. Kent involved a Michigan statute that bars suits against pharmaceutical manufacturers over FDA-approved drugs. The law contains an exception for cases where the pharmaceutical manufacturer bribed an agency official or committed fraud by withholding or misrepresenting information that was material to the approval process. The question in Kent was whether a claim excepted by the Michigan statute was nevertheless preempted under the logic of a previous Supreme Court opinion, Buckman v. Plaintiffs' Steering Committee, which held that private claims of "fraud-on-the-FDA" interfere with key FDA functions.

With Chief Justice John Roberts recused, the Supreme Court deadlocked 4-4 on whether to preempt product liability claims falling within the exception to the Michigan immunity statute. The statutory interpretation that carried the day in Riegel was notably unavailable in Kent, as it will be in Levine—there is no express preemption clause for prescription drugs analogous to that of the Medical Device Amendments. Because the court split 4-4 in Kent, the Second Circuit's ruling that the plaintiff's claim is not barred by the Michigan statute stands. But the split decision means that the case is not a binding Supreme Court precedent, and that other circuits are free to decide the issue differently.

Many commentators had expected Kent to provide an indication of the Supreme Court's leanings with respect to the larger question presented by Levine—whether FDA approval preempts all product liability claims for prescription drugs. Kent was distinctly unsatisfying in this regard, producing only a non-precedential one-sentence decision. Moreover, the idiosyncrasies of Kent blur its predictive value for Levine; that Kent turned on the interpretation of an exception to a Michigan immunity statute makes it difficult to draw any generalizations. Still, the fact that Kent ended in a 4-4 tie is telling, and suggests that the addition of Chief Justice Roberts in Levine may be enough to tilt the court in favor of preemption. In previous opinions, such as his dissenting opinion in Massachusetts v. Environmental Protection Agency and his joinder of the majority opinion in Riegel, the chief justice has indicated a willingness to take a broad view of the preemptive powers of federal law.

Another factor that may lead to a narrow ruling in Levine is the importance the Supreme Court will place on reaching at least a five-justice majority. If forming a majority around preemption for all FDA-approved pharmaceuticals proves unattainable in Levine, the more restrained and particularized analysis of Colacicco might emerge as an attractive compromise.

Levine is amenable to the narrow disposition reached in Colacicco. In Levine, as in Colacicco, there is a significant regulatory history surrounding the labeling of the drug at issue, Phenergan, which is used to treat nausea. The plaintiff claims that the drug's package insert should expressly contraindicate administration by "IV push," in which the drug is injected directly into a patient's vein, due to the risk of gangrene when Phenergan contacts arterial blood. At the time of the plaintiff's treatment with the drug, the FDA-approved package insert warned of the risk of gangrene in several places but did not prohibit administration by IV push.

The Vermont Supreme Court rejected the defendant's argument that repeated FDA approval of Phenergan package inserts containing information about IV push—which had been on the label for more than 40 years—precluded the plaintiff's defective labeling claim. In the court's view, only if the FDA had considered and rejected the plaintiffs' specific request (that IV push be contraindicated entirely) would there be a basis for preemption. The court found no clear evidence that the FDA had been presented with the plaintiff's exact question, and on that ground held that the plaintiff's claim was not preempted.

In sum, Phenergan, like the SSRI antidepressants at issue in Colacicco, has a long and well-developed regulatory history with regard to the health risk at issue in the case. Unfortunately, the same may not be true of newer medicines, or older ones with newly discovered risks. For that reason, consistent with the Third Circuit's approach in Colacicco, the U.S. Supreme Court may frame its preemption decision in Levine around the FDA's consideration of the risks of administering Phenergan by IV push, and not attempt a broader ruling that FDA approval as a general matter precludes common-law product liability claims.

Colacicco demonstrates a reasonable and measured approach to federal preemption of state pharmaceutical product liability claims. While a sweeping drug preemption ruling is certainly still possible, there are several indications that the Supreme Court's decision in Levine will not end the debate over the scope of prescription drug preemption.

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