A federal district court has held that design defect claims against a brand pharmaceutical manufacturer are preempted by federal law. Booker v. Johnson & Johnson, No. 3:12 oe 40000, 2014 WL 5113305 (N.D. Ohio Oct. 10, 2014).

SETTING THE STAGE – MUTUAL V. BARTLETT -

In 2013, the United States Supreme Court held that federal law preempts failure-to-warn design defect claims against generic drug manufacturers. Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013). The Supreme Court based its Bartlett decision in part on PLIVA, Inc. v. Mensing, 131 S. Ct. 2567 (2011), which held that federal law prohibited generic manufacturers from implementing unilateral label changes, and therefore preempted state-law requirements (through statutes or juries) that a drug company strengthen its warnings. Of particular relevance, the Supreme Court also stated in Bartlett that the drug at issue—a single-molecule drug—was "chemically incapable of being redesigned." 133 S. Ct. at 2475. However, the Supreme Court fell short of holding that design defect claims against brand manufacturers were preempted, setting the stage for the Booker case, decided last month.