Today’s case has shocking facts but not a shocking result. It should come as no surprise that a complaint attacking the safety of an FDA-approved Class III medical device is squarely preempted by the express preemption provision of the Medical Device Amendments, 21 U.S.C. § 360k(a). But somehow, 17 years post-Riegel, that still does not seem to deter plaintiffs from filing plainly preempted claims.

In this case, Summers v. Medtronic, Inc., 2025 WL 863576 (D. Mass. Mar. 18, 2025), Plaintiff was implanted with a defibrillator and associated leads and devices, all Class III medical devices approved by FDA through the premarket approval process. Plaintiff alleged that her defibrillator activated and shocked her while she was walking from her car into a mall and continued to activate about every 45 seconds as she drove home and then continued to activate in the ambulance and at the hospital. Plaintiff alleged in her complaint that a doctor told her that it had shocked her 99 times before she went into cardiac arrest. She underwent surgery and had the defibrillator removed.

Plaintiff filed her lawsuit in Massachusetts state court alleging breach of the warranty of merchantability, breach of the warranty of fitness for a particular purpose, and negligence. Defendants removed and moved to dismiss on the basis of preemption under the Medical Device Amendments.

Plaintiff argued that her claims were not preempted because they were permissible parallel claims under Riegel v. Medtronic. The court didn’t buy it.

First, there was nothing parallel about the two breach of warranty claims. To the contrary, the breach of warranty claims asserted that the implants were not fit for use, which is just another way of saying that “the devices are not reasonably safe and effective despite the FDA’s findings to the contrary.” Id. at *3. Therefore, the claims were preempted.

As to the remaining negligence claim, Plaintiff alleged that Defendants “had prior knowledge of the malfunction of the implanted devices but failed to notify Plaintiff of the need to take corrective measures or actions.” Id. Of course, this claim has serious problems under the learned intermediary rule. But on the preemption front, the Court held that this claim was preempted “to the extent it asserts that the FDA-approved warnings that she received were inadequate.” Id. In her opposition brief, Plaintiff argued that the negligence claim was not based on premarket activity, but on an alleged defect discovered postmarket and a failure to act postmarket. The Court declined to consider these claims because they were not asserted in the complaint and “Summers may not add facts through her opposition brief that she did not plead in her complaint.” Id. at *4. The motion to dismiss was granted in full but with leave to amend, so we may be revisiting this case regarding the purported postmarket claims. But those claims too should meet the same fate, as it’s hard to imagine how any such claim would not be “different from or in addition to” the FDA-approved labeling.