[This post is from the non-Reed Smith side of the blog.]

Today we report on Dickson v. Dexcom, Inc, 2024 WL 4291511 (W.D. La. 2024), an important medical-device preemption case that started with a doctrinal bang but ended on a factual whimper.

Committed to nationally uniform standards based on good science, we believe that the FDA rather than lay juries should determine how medical devices are designed and labeled. Fortunately, our policy preference is enshrined in law: 21 U.S.C. § 360k(a) prohibits states (and juries applying state tort law) from imposing safety or efficacy requirements on medical devices that are “different from, or in addition to,” those imposed by the FDA. Unfortunately, many courts—led astray by Medtronic, Inc. v. Lohr, 518 U.S. 470 (1996)—have unduly limited § 360k(a)’s preemptive scope, holding that it applies only to Class III medical devices that have received premarket approval (or an investigational-device exemption) from the FDA.

Dissatisfied with the judicially imposed limitation on § 360k(a)’s scope, we were pleased when Dickson v. Dexcom, Inc, 2024 WL 2846055 (W.D. La. 2024), correctly held that § 360k(a) preempts claims challenging the safety and effectiveness of a Class II device whose sale was authorized by the FDA through the de novo classification process. As we reported at the time, the decision was very good insofar as it squarely recognized that § 360k(a)’s preemptive shield covers such devices.

Still, we were troubled by the court having granted the plaintiff leave to replead her failure-to-warn claim. Without explicitly saying so, the court held that the claim could survive preemption if the plaintiff alleged facts that, if true, would have allowed the defendant manufacturer to unilaterally the revise device’s labeling under the FDA’s changes-being-effected (CBE) regulation codified at 21 C.F.R. § 814.39(d). Specifically, the court concluded that the claim might not be preempted if the plaintiff adequately alleged the existence of “newly acquired information,” which is a necessary precondition for changes under that provision. 2024 WL 3417392, at *8.

As we explained at the time, the hypothesized loophole to express preemption—which the court derived from inapposite pharmaceutical cases addressing implied preemption—is foreclosed as a matter of law. The only labels that may be revised under the CBE regulation are those for Class III medical devices that have received premarket approval; the regulation does not allow a manufacturer to revise the labeling of a device that received de novo classification. But even “assum[ing] for the sake of argument that there might have been some way for” the defendant to have invoked the CBE regulation (Dickson, 2024 WL 3417392, at *8), it would not save the plaintiff’s failure-to-warn claim from express preemption because the regulation does not require a manufacturer to unilaterally revise device labeling based on newly acquired information and any state-law requirement that it do so would be “different from, or in addition to,” the federal requirements and therefore barred by 21 U.S.C. § 360k(a).

When recounting Dickson, we expressed the hope that the court would correct its error if the plaintiff chose to amend her complaint to include purportedly sufficient allegations of “newly acquired information.”

Alas, that did not happen.

Ruling on the defendant’s motion to dismiss the plaintiff’s amended complaint, the court dismissed her failure-to-warn claim as preempted but on factual rather than legal grounds, concluding that “[e]ven if plaintiff could show a mechanism like the CBE regulation requiring [the manufacturer] to independently reevaluate and amend its label, she has twice failed to show sufficient ‘newly acquired information’ to trigger any relevant change to the existing warnings.” Dickson, 2024 WL 4291511, at *4. In reaching that conclusion, the court correctly recognized that adverse-event reports by themselves do not constitute such information. We welcome that. But we sure wish that the court had also recognized that § 360k(a) categorically bars claims based on a manufacturer’s purported ability to revise a device’s labeling under the CBE regulation.

So, at the end of the day, the Dickson duology represents a significant step forward and a minor step back. Let us hope that future courts apply § 360k(a) to claims implicating devices that received de novo classification but do so with the understanding that the CBE regulation cannot save otherwise preempted failure-to-warn claims.

In the meantime, thanks to friend-of-the-blog P.J. Cosgrove of UB Greensfelder LLP for bringing Dickson to our attention.