Last week, the Sixth Circuit affirmed dismissal of Plaintiff’s design defect claim, among others, against brand name drug manufacturers on the basis of impossibility preemption. In Yates v. Ortho-McNeil-Janssen Pharm., et al., No. 15-3104 (6th Cir. Dec. 11, 2015), Plaintiff sued Ortho-McNeil-Janssen Pharmaceuticals, Inc., Alza Corporation, and Johnson & Johnson Pharmaceutical Research & Development, L.L.C., and Johnson & Johnson (“Defendants”), alleging failure to warn, design and manufacturing defect, negligence, and breach of implied and express warranty. The Northern District of Ohio granted summary judgment, dismissing Plaintiff’s claims.
Plaintiff’s design defect claim was comprised of a pre-FDA approval claim and a post-FDA approval claim. The issue presented was whether Defendants could have complied with their alleged duty under New York law to have designed a safer drug before submitting Ortho Evra for approval to the FDA or to change its formulation post-approval while simultaneously complying with federal law. Opinion at 12-13. The court found both claims preempted.
In its analysis, the Sixth Circuit recounts the Supreme Court’s decisions in Wyeth v. Levine, 555 U.S. 555 (2009), PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), and Mutual Pharmaceutical Co. v. Bartlett, 133 S. Ct. 2466 (2013). The court explained that important to the preemption findings in the Supreme Court’s decisions in Bartlett and Mensing is that generic drug manufacturers are prohibited from making any unilateral changes to a drug’s label or composition, which is known as the “sameness” requirement. Id. at 16. The Court in Mensing therefore determined that plaintiffs’ state law failure to warn claims regarding the generic drugs were barred by impossibility preemption because the duty of sameness prohibited the generic manufacturers from unilaterally strengthening the drug’s label to comply with their state law duties. Id. Similarly, the Court in Bartlett found that the plaintiff’s state law design defect claim regarding the generic drug was barred by impossibility preemption because the sameness requirement prohibited the manufacturer from unilaterally changing the composition or labeling of the drug as required by state law. Id. The Court in Mensing clarified that “it is beyond dispute that the federal statutes and regulations that apply to brand name drug manufacturers are meaningfully different than those that apply to generic drug manufacturers and such different federal statutes and regulations may…lead to different pre-emption results.” Id. As a result, despite Plaintiff’s claim that the impossibility preemption in Mensing and Bartlett is limited to generic drugs, the court viewed Levine, Mensing, and Bartlett as “together stating the same test for impossibility preemption.” Id.
Applying the federal impossibility preemption analysis, the court first established Defendants’ duty under state law. Under New York law, a product is defectively designed if the product, as designed, was not reasonably safe because there was a substantial likelihood of harm and it was feasible to design the product in a safer manner. New York follows a risk-utility approach in determining whether a product is not reasonably safe, which takes into account several factors. A brand name drug manufacturer can avoid liability by choosing a safer design for a drug. Id. at 17.
Next, the court determined whether federal law expressly prohibits Defendants from complying with state law and concluded that Plaintiff’s post-approval design defect claim was clearly preempted. FDA regulations provide that once a drug is approved, the manufacturer is prohibited from making any “major” changes to the qualitative or quantitative formulation. Although Plaintiff claimed that reducing the amount of estrogen would be minimal, the court disagreed. The court emphasized that changing the dosage level of an active ingredient constitutes a “major change” such that prior FDA approval is necessary. The court thus found that Defendants could not have altered the dose of estrogen without submissions to the FDA and approval prior to distribution. Id. at 18-19.
Although Plaintiff also argued that no federal law would have prohibited Defendants from designing a different drug prior to approval, the court found that Defendants’ pre-approval duty was too attenuated. In order for the court to adopt this claim, it would have to “speculate” that had Defendants designed Ortho Evra differently, the FDA would have approved the alternative design, and that this alternative design would not have caused Plaintiff’s stroke. Id. at 19. The court emphasized that “[t]his is several steps too far.” Id. at 20.
The court explained that Plaintiff’s pre-approval claim further failed because in arguing that Defendants’ pre-approval duty would have resulted in a birth control patch with a different formulation, she essentially argues that Defendants should never have sold the FDA approved formulation of the drug in the first place. The court rejected this argument for the same reason the Supreme Court in Barlett rejected the stop-selling rationale of the First Circuit. Id. at 21.
We will continue to report on notable preemption cases, like this one, as they arise.