'Generic' Logic Helps Branded Drug Achieve Dismissal

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.

BACKGROUND

Booker arose out of the Ortho Evra MDL pending in the Northern District of Ohio. The plaintiff sued on behalf of her deceased daughter, who allegedly died from a pulmonary embolism after using Ortho Evra, a branded birth control patch.

Defendants moved for summary judgment on plaintiff's design and manufacturing defect claims, subsequent to the court's ruling that the package insert adequately warned of increased risk of blood clots and pulmonary embolism.1

DESIGN DEFECT UNDER GEORGIA LAW

The court evaluated the alleged design defect under Georgia law. Like many states, Georgia follows the Restatement (Second) of Torts, section 402A, comment k. Under comment k, pharmaceutical products, "properly prepared, and accompanied by proper directions and warnings, [are] not defective, nor [are they] unreasonably dangerous."2 To assert comment k as an affirmative defense under Georgia law, the defendant must show that "(1) the product is properly manufactured and contains adequate warnings; (2) its benefits justify its risks; and (3) the product was at the time of the manufacture and distribution incapable of being made more safe."3

Because the court had already determined the warnings were adequate as a matter of law, the only remaining issues were whether the benefits of the product outweighed its risks...