The Sixth Circuit has become the first circuit to weigh in on the scope of the Supreme Court’s recent decision on federal preemption in Wyeth v. Levine, 129 S. Ct. 1187 (2009).  Here’s the background:  Mary Buchanan began taking Wyeth’s prescription diet drug Redux in 1996.  She was diagnosed with primary pulmonary hypertension (“PPH”) in 2001 and passed way in 2003, after bringing suit in 2003 alleging that her PPH was a side effect of Redux, which was removed from the market in 1997.  The suit claimed (1) strict liability for defective design; (2) negligence; and (3) wrongful death.

At the times Buchanan took Redux, it was marketed with several warnings about the possible health effects of the drug.  Additionally, in 1996 Wyeth sent letters to physicians warning of the risk “of a serious, potentially life-threatening cardiovascular condition [PPH] . . . associated with the use of all types of prescription weight loss drugs.”  This warning was also printed in bold-faced letters on the Redux label.

On February 28, 2008, the district court granted summary judgment in favor of Wyeth on all claims.  The district court concluded that FDA’s approval of Redux preempted plaintiff’s claims based on pre-approval actions and that plaintiff’s remaining post-approval claims failed on their merits under Ohio law.  Plaintiff moved to alter or amend the judgment.

While plaintiff’s motion to alter or amend the judgment was pending and being actively litigated, the Supreme Court decided Wyeth v. Levine.  In one of the first rulings to address that decision by the Supreme Court, the district court held that Wyeth v. Levine was limited to failure to warn claims, which were not at issue in Buchanan’s suit over Redux.  The district court reasoned that the Supreme Court’s decision recognized that drug manufacturers have a duty to update warning labels after the FDA approves a product and it enters the market.  In contrast, the district court acknowledged that a manufacturers’ duties before approval by FDA are different and were not addressed by the Supreme Court in Wyeth v. Levine.  Therefore, the district court drew the line at FDA approval of a drug and held that, while Wyeth v. Levine may not preempt post-approval failure-to-warn claims, the Supreme Court’s decision did not hold that pre-FDA approval claims are not preempted.

In Wimbush v. Wyeth (pdf) the Sixth Circuit reversed this part of the district court’s ruling and held that FDA approval did not preempt the plaintiff’s state-law negligence claims.  In doing so, the Sixth Circuit has become the first circuit to extend Wyeth v. Levine beyond the context of failure to warn claims.  The significance of the Sixth Circuit’s ruling is highlighted by a passage from the Court’s opinion, authored by Judge Martin (joined by Judge Boggs; Judge White concurred with the majority’s pre-emption finding, but found the panel should have allowed plaintiff’s other claims to proceed as well):

We are aware of no federal appeals court decision since Levine concluding that FDA regulation preempts any aspect of state tort law, though we admit that, until today, there is also no post-Levine court of appeals authority for the proposition that the Levine rationale extends beyond the realm of failure-to-warn claims to apply to all pre-approval state law claims.

The Court specifically rejected the distinction between preemption of failure-to-warn and other types of state-law tort claims the district court found in Wyeth v. Levine.

Wimbush v. Wyeth squarely places the burden on drug companies to show that it is “impossible to comply with both state law duties and FDA regulations in the process leading up to FDA approval.”  Citing Levine, the Court noted that the FDA traditionally regards state law as a “complementary form of drug regulation” and that state negligence law did not demand that Wyeth do something forbidden by the FDA (or vice versa).  The Court noted that the FDA requirements and state negligence duties were complimentary since “whether the FDA approves a drug for market depends, in very large part, upon the results of the manufacturer’s investigation an testing prior to approval. . . . If the manufacturer is negligent in this investigation, then the entire FDA approval process is tainted from the outset.”

One significant aspect of the Court’s decision that will likely be overlooked in the attention paid to the issue of federal preemption also bears mention.  Even as it affirmed summary judgment under Ohio law on plaintiff’s claims other than negligence, the Sixth Circuit passed on the opportunity to provide some guidance and clarity on the question of which party bears the burden of proving the adequacy of warnings in a design defect claim under Ohio law.  Although it acknowledged a dispute over that issue, the Court declined to address it.

On another issue of Ohio law, however, the Court reversed its prior holdings on the question of whether negligence claims arising before 2005 amendments to the Ohio Products Liability Act (“OPLA”) are abrogated.  Previously, the Sixth Circuit had held in Tomkin v. American Brands, 219 F.3d 616, 619 (6th Cir. 2009), that enactment of OPLA abrogated common-law negligence claims.  Based on Doty v. Fellhauer Elec., Inc., 888 N.E.2d 1138, 1142 (Ohio Ct. App. 2008), the Court reversed its ruling in Tomkin and held that the Ohio Supreme Court would likely conclude that common-law negligence claims arising prior to the 2005 amendments to OPLA are not abrogated.