In Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466 (2013), the Supreme Court held that federal law preempted a design defect claim against a generic drug manufacturer. Branded manufacturers have since argued that this holding applies equally to branded companies who lack authority under federal law to change the formulation of FDA-approved drugs. Several recent cases have found this argument persuasive and dismissed design defect claims against branded companies.
The leading case so far on this issue is Yates v. Ortho-McNeil-Janssen Pharm., Inc., 808 F.3d 281 (6th Cir. 2015). The plaintiff in Yates alleged that she suffered a stroke caused by the ORTHO EVRA® birth control patch. Plaintiff brought, among other claims, a New York state strict liability claim based on the patch's allegedly defective design. A district judge in the Northern District of Ohio granted summary judgment as to all of plaintiff's claims, including design defect.
A Sixth Circuit panel unanimously affirmed summary judgment. The panel found that Bartlett's framework applied here, even though a brand-name drug was at issue. First, plaintiff's argument that defendants had a post-approval duty to institute an alternative design was preempted because defendants could not have made such a change unilaterally. While plaintiff argued that a reduction in the drug's estrogen level "'would be minimal,'" the panel finely parsed FDA regulations and found this to be a more significant change requiring FDA pre-approval. Second, the panel rejected as "too attenuated" plaintiff's argument that defendants had a pre-approval duty to design the drug differently in the first instance because it required too many assumptions: (i) that "the FDA would have approved the alternate design"; (ii) that plaintiff "would have selected this method of birth control"; and (iii) that the alternate drug would not have caused plaintiff's alleged injury. Plaintiff was "essentially argu[ing] that defendants should never have sold the FDA-approved formulation of ORTHO EVRA® in the first place," and this "never-start-selling rationale" was akin to the "stop-selling rationale" rejected byBartlett.
Since the Yates decision, district courts in other circuits have reached similar conclusions. In March of this year, United States District Judge Michael P. Shea of the District of Connecticut granted summary judgment on a claim that Motrin was defectively designed on the basis of preemption. In Batoh v. McNeil-PPC, Inc., __ F. Supp. 3d __, 2016 WL 922779 (D. Conn. Mar. 10, 2016), the court quoted Bartlettfor the proposition that, "[o]nce a drug--whether generic or brand name--is approved, the manufacturer is prohibited from making any major changes to the 'qualitative or quantitative formulation of the drug product, including active ingredients, or in the specifications provided in the approved application.'" Thus, because the defendants could not have unilaterally substituted dexibuprofen for ibuprofen (presumably plaintiff's suggested change), plaintiff's defective design claim was preempted.
Only eleven days later, United States District Judge Madeline Hughes Haikala issued a memorandum opinion finding claims that Serophene, a brand-name fertility drug, was defectively designed were also preempted. In Barcal v. EMD Serono, Inc., No. 5:14-cv-01709, 2016 WL 1086028 (N.D. Ala. Mar. 21, 2016), the court converted defendant's motion to dismiss into a summary judgement motion and granted summary judgment as to the defective design claim. This grant was based on two independent grounds: (i) prescription drugs are "unavoidably unsafe" under Alabama law, and so it is their warnings that determine whether these products are defective; and (ii) the defendant could not have unilaterally changed the drug's composition without the FDA's permission, so the defective design claim was preempted.
As courts continue to apply the Bartlett framework to defective design claims, branded drug manufacturers may find preemption an increasingly powerful defense.