In 2013, the United States Supreme Court announced that state law claims for design defects against generic drug manufacturers are preempted by federal law. See Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013). Since that time, commentators have speculated regarding the possible ramifications for branded prescription drug manufacturers. Applying Bartlett to claims under Georgia law, the United States District Court for Western District of Ohio recently held that design defect claims against a branded pharmaceutical manufacturer are preempted just as claims against generic manufacturers.
In Booker v. Johnson & Johnson, --- F. Supp. 3d ---, No. 12-cv-40000, 2014 WL 5113305 (W.D. Ohio Oct. 10, 2014), Plaintiff brought suit against branded pharmaceutical manufacturers alleging that her daughter suffered from a pulmonary embolism and died as a result of taking Defendants' product, Ortho Evra birth control patch. Under Georgia law, design defect claims focus on the feasibility of alternative designs, as well as on the availability of effective substitutes for the product at issue that meet the need but that are safer. Id. at *3. Plaintiff's design defect claim was premised on the idea that defendants manufactured and marketed Ortho Evra despite the existence of safer and effective substitutes -- namely, oral birth control pills. Id. at *4.
Defendants moved for summary judgment, arguing that Plaintiff's design defect claims are preempted under Bartlett because a state tort law duty to adopt a different design conflicts with federal law mandating use of the FDA-approved design. Despite finding that Plaintiff had "otherwise stated a valid design defect cause of action under Georgia law," id. at *5, the court nonetheless granted Defendants' motion for summary judgment. Relying on Bartlett, the court held that it "was impossible for the Defendants to comply with both its state-law duty to alter the composition of the drug, and its federal-law duty not to alter an FDA approved design." Id. Moreover, the court found that the "remedial 'alternative design' requirement" at issue was "precisely the type contemplated by the United States Supreme Court" in Bartlett. Id.
The Booker decision does not limit its holding to its facts and is a significant decision for branded pharmaceutical manufacturers. This issue is one to watch as branded companies continue to argue preemption of design defect claims under Bartlett.