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Federal Law Requiring Preclearance to Market Medical Devices Does Not Preempt State Tort Law

Terreski Mullins, et al. v. Ethicon, Inc., et al.
United States District Court for the Southern District of West Virginia (December 4, 2015)

by Matthew J. McCloskey, Associate
Semmes, Bowen & Semmes (

Available at:

In a recent decision, the United States District Court for the Southern District of West Virginia held that federal law requiring that medical device manufacturers obtain preclearance to market their products did not preempt state tort law related to design defects.

Plaintiffs sued Defendants related to Defendants’ design, manufacturing, and distribution of Tension-free Vaginal Tape (“TVT”), “a mesh product [intended] to treat stress urinary incontinence.” After experiencing complications from the product, Plaintiffs (along with approximately 23,000 other similarly situated individuals) sued Defendants, asserting, inter alia, claims for strict liability design defect and negligent design.

Defendants moved for summary judgment on the grounds of federal preemption. Defendants noted that, in PLIVA, Inc. v. Mensing, 131 S. Ct. 2567, 2580-81 (2011), the Supreme Court held that “when a party cannot satisfy its state duties without the Federal Government’s special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes,” and thus the state duties were preempted by federal law. Applying that holding, in Mutual Pharm. Co. v. Bartlett, 133 S. Ct. 2466, 2476 (2013), the Supreme Court held that federal law preempted a state duty affecting generic prescription labels because generic drug manufacturers could not change their labels without permission from the FDA. Analogizing to these cases, Defendants noted that section 510(k) of the Food, Drug, and Cosmetic Act, codified at 21 U.S.C. § 360(k), required them to obtain clearance from the Food and Drug Administration (FDA) prior to distributing TVTs in interstate commerce. Thus, if Plaintiffs were successful in establishing that TVTs were defectively designed, West Virginia would essentially be imposing a duty on Defendants to adjust the design of TVTs, which they could not do without obtaining preclearance from the FDA if they wished to continue to market TVTs. Because they could not unilaterally adjust the design of TVTs, Defendants argued it was impossible for them to comply with both federal law and the state duty.

Judge Joseph R. Goodwin disagreed, stating that he did not believe that Defendants’ argument sufficed to show that the state law posed some impediment to Defendants’ ability to comply with federal law. First, the Court noted that there is a strong presumption against preemption, especially where the preemption of a state’s police powers, such as a state’s imposition of a tort duty, is at issue. Absent the clear intent of Congress to preempt such powers, Defendants’ argument would fail. The Court, therefore, looked to Medtronic v. Lohr, 518 U.S. 470 (1996), a case in which the Supreme Court held that Congress did not intend the 510(k) preclearance procedures to preempt state tort law relating to design defects. According to the Supreme Court, such procedures were intended simply to ascertain whether a substantially similar product was already in existence on the health market in order to prevent products from gaining an unfair foothold on the market while other products cleared separate regulatory hurdles. The Supreme Court therefore held that, in light of this limited purpose, the 510(k) procedures preserved the status quo with respect to the possibility that a medical device manufacturer would have to defend itself in a design defect lawsuit. In view of this precedent, the Court was compelled to conclude that the 510(k) procedures did not preempt state tort law.

The Court rejected Defendants’ attempts to shift the Court’s attention from Lohr. Defendants contended that, because the FDA could reject their altered design, just like the defendants in Mensing and Bartlett, it could not comply with a state tort duty and the FDA’s approval procedures. The Court, however, noted that it was a firm impossibility for the state duties at issue in Mensing and Bartlett to be reconciled with federal regulation. In those cases, the Supreme Court found that it was entirely impossible for generic drug manufacturers to comply with a state duty to adjust the warning labels on their products when federal law required them to maintain warning labels identical to those on the brand name drugs. By contrast, here, Defendants could both make a reasonably safe product and obtain clearance from the FDA to place it on the market. As a result, the Court concluded that federal law did not preempt the state tort duty.