CINCINNATI - (Mealey's) Citing the Supreme Court's rejection of implied preemption of pharmaceutical product liability in Wyeth v. Diana Levine (No. 06-1249, U.S. Sup.; 2009 U.S. LEXIS 1774), the Sixth Circuit U.S. Court of Appeals on Aug. 18 reversed a trial court's dismissal of claims based in negligence alleging that Wyeth's diet drug Redux caused fatal primary pulmonary hypertension (PPH), as well as a related claim for punitive damages (Oliver Wimbush v. Wyeth, et al., No. 09-3380, 6th Cir.).
The Sixth Circuit panel said that even before the Supreme Court's "clarification" in Levine, it had found in Tobin v. Astra Pharm. Prods., Inc. (993 F.2d 528, 537-38 [6th Cir. 1993]) that the Food, Drug and Cosmetic Act (FDCA) does not implicitly preempt pre-approval design defect claims for drugs. The action allows Oliver Wimbush, executor of the estate of Mary Buchanan, to assert that Wyeth was negligent in bringing its diet drug Redux to the market.
"Both the district court . . . and Wyeth seek to distinguish Levine from the present case on the basis that Levine involved a state law inadequate warning claim whereas the instant case involves a state law negligent-bringing-to-market claim," the panel said in a footnote. "It is indeed true that the question presented in Levine dealt solely with state tort inadequate warning claims versus FDA-approved labels, Levine, 129 S. Ct. at 1193, whereas this case pits state tort negligent-bringing-to-market claims against FDA approval to market.
"However, we find this to be a distinction without a difference, as the rationale in Levine applies with equal force to this claim as it did to the inadequate warning claim. Just as state tort law on adequacy of warnings can be seen as 'complementary,' id. at 1201, to the FDA's labeling regulation, so too can state law duties regarding the decision to bring a product to market be seen as complementary to the FDA's function of approving a drug for market."
The panel affirmed the dismissal of the balance of Wimbush's claims. The majority's decision was delivered by Judge Boyce F. Martin Jr., joined by Judge Danny Julian Boggs. Judge Helene N. White delivered a separate opinion concurring in part and dissenting in part. Judge White said she would have gone farther than the majority and reversed dismissal of claims based on Wyeth's alleged negligence in failing to adequately investigate adverse reports regarding Redux after FDA approval and in failing to remove Redux from the market.
"Although I agree with the majority that Buchanan failed to present evidence in support of these claims," Judge White said, "my review of the record convinces me that this is because Wyeth's motions for summary judgment did not attack the factual support for these claims. . . . In effect, the district court granted summary judgment on these claims sua sponte. Although this is permitted, it is disfavored."
Buchanan took Redux for several months in 1996 and 1997, according to the panel. She was diagnosed with PPH in November 2001 and brought suit in her own right before her death two years later, the panel said. The case was subsequently prosecuted by a previous executor, Ramona Longs, as Ramona Longs v. Wyeth, et al. (No. 1:03 CV 2042, N.D. Ohio, Eastern Div.) U.S. Judge Solomon Oliver Jr. of the Northern District of Ohio had found in Longs v. Wyeth (536 F. Supp. 2d 843 [N.D. Ohio 2008]) that Buchanan's strict liability and negligence claims stemming from Wyeth's conduct before the FDA's approval of Redux for placement on the market were preempted by the FDA's subsequent approval of the drug and that any non-preempted post-FDA approval claims failed on the merits.
[Editor's Note: Full coverage will be in the September issue of Mealey's Litigation Report: Diet Drugs. In the meantime, the opinion is available at www.mealeysonline.com or by calling the Customer Support Department at 1-800-833-9844. Document #87-100908-001Z. For all of your legal news needs, please visit www.lexisnexis.com/mealeys.]
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