ReedGuest Commentary

by Matthew A. Reed, Sedgwick LLP

When plaintiffs bring state tort causes of action against the manufacturers of medical devices that have passed the Food and Drug Administration’s (“FDA”) rigorous pre-market approval (“PMA”) process, they enter a realm highly regulated by the federal government, and thus face a daunting task to avoid dismissal of their claims. They must demonstrate that their state-law claims require nothing more or different of the manufacturer than what the federal Food, Drug, and Cosmetic Act (“FDCA”) already requires, or else their claims are not “parallel” and thus expressly preempted by § 360k of the Medical Device Amendments (“MDA”) to the FDCA. But they also must show that their claims are based on state law distinct from the FDCA, because claims predicated on the FDCA are impliedly preempted as private attempts to enforce federal law.

As courts have increasingly rejected attempts to navigate this narrow gap, plaintiffs have sought to escape the pincers of express and implied preemption by alleging that the device manufacturer engaged in off-label promotion—that is, the manufacturer suggested or encouraged the use of the device in some way other than that approved by the FDA for inclusion on the label. This matters, plaintiffs claim, because the FDA’s approval and oversight of a device is predicated upon its on-label use, and thus neither federal regulation nor its preemptive effect should apply when off-label use is involved. Last year, in Caplinger v. Medtronic, Inc., 784 F.3d 1335 (10th Cir. 2015), the Tenth Circuit joined other courts in rejecting that theory, holding that it found no support in United States Supreme Court precedent.

Caplinger involved Medtronic’s Infuse, a 3-part medical device consisting of a bone morphogenetic protein, a collagen scaffold, and a cage. FDA PMA-approved Infuse for spine surgeries performed through the abdomen. The plaintiff brought suit in Oklahoma federal district court alleging that Medtronic promoted the device to her and her surgeon for an off-label use: spine surgery performed through the back. She further alleged that use in her case caused “exuberant bone growth,” which in turn caused leg and back problems, as well as further surgeries. In response to Caplinger’s complaint for various state-law tort claims, Medtronic filed a motion to dismiss arguing that each cause of action was either expressly or impliedly preempted by federal law.

Caplinger opposed the motion to dismiss, in part, by arguing that the express-preemption provision of the MDA (§ 360k) does not apply to any claim that arises out of the promotion of an off-label use of a medical device. The Oklahoma district court rejected that contention as inconsistent with the text of § 360k. That section, the court noted, grants preemptive effect to any federal requirement that applies to a device itself, not a particular use of a device: “Nothing in the statute suggests that the preemption analysis somehow depends on how the device is used.” The court went on to apply that analysis and find that each of Caplinger’s claims was either expressly or impliedly preempted, and thus dismissed the complaint.

On appeal, the Tenth Circuit affirmed the district court’s ruling. Caplinger, the court noted, failed to identify a single federal duty that was parallel to the state tort duties she was alleging. As a result, “the district court quite reasonably concluded that Medtronic had met its burden of showing that the law compelled dismissal of the complaint.” Caplinger also failed to point to any dispute as to what federal requirements applied to the device. The Tenth Circuit could therefore “hardly fault the district court for granting judgment as a matter of law when no one has suggested a material dispute of fact exists that might require otherwise.”

It was the “weakness of her position,” the Tenth Circuit noted, that compelled Caplinger to argue that the mere “fact that her suit concerns an off-label use is enough all by itself to insulate all her claims from preemption.” The court’s skepticism was immediate: “In not a single one of its many and involved encounters with the MDA has the Supreme Court so much as hinted at this alternative path around preemption. But Ms. Caplinger says its past obscurity shouldn’t stop us from recognizing it now. This we decline to do.”

In further justifying its refusal, the Tenth Circuit held, as the district court had, that § 360k imputes preemptive power to federal requirements that apply to a device, regardless of whether it is used on- or off-label. Moreover, the fact that the MDA elsewhere demonstrated awareness of, and solicitude for, off-label uses made it “harder to ignore” that Congress’ omission of any distinction between on- and off-label uses in crafting the preemptive effect of § 360k—“a sort of dog that didn’t bark.” In addition, the Supreme Court in Riegel v. Medtronic, Inc. had found all state tort claims preempted, despite the fact that the plaintiff had alleged off-label use of the medical device that had injured him. Finally, the legislative history of the MDA suggested that Congress had opted for the broadest preemption provision available, unmitigated by considerations of off-label use.

On January 11, 2016, the Supreme Court denied certiorari in Caplinger. The justices offered no reason for the denial, which of course carries no precedential value for lower courts. That said, federal courts have been nearly unanimous in rejecting the off-label promotion theory advanced in Caplinger. Medical-device companies have good reason to hope, then, that plaintiffs’ lawyers will see the Caplinger denial as a definitive signal that alleging off-label promotion is not a viable way to insulate state tort-law claims from federal preemption.