Client Alert
November 6, 2014
"Generic" Logic Helps Branded Drug Achieve Dismissal
By James W. Huston, Erin M. Bosman, and Julie Y. Park
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
1 Defendants had successfully moved for summary judgment on the failure-to-warn claim, among others. Defendants had also unsuccessfully
moved for judgment on the pleadings on the design and manufacturing defect claims, and re-raised those arguments here on a motion for
summary judgment.
2 Booker, 2014 WL 5113305, at *3 (quoting Bryant v. Hoffman-La Roche, Inc., 585 S.E.2d 723, 728 (Ga. Ct. App. 2003)).
1 © 2014 Morrison & Foerster LLP | mofo.com Attorney Advertising
