Right now’s case has stunning info however not a stunning outcome. It ought to come as no shock {that a} grievance attacking the security of an FDA-approved Class III medical gadget is squarely preempted by the categorical preemption provision of the Medical System Amendments, 21 U.S.C. § 360k(a). However someway, 17 years post-Riegel, that also doesn’t appear to discourage plaintiffs from submitting plainly preempted claims.
On this case, Summers v. Medtronic, Inc., 2025 WL 863576 (D. Mass. Mar. 18, 2025), Plaintiff was implanted with a defibrillator and related leads and gadgets, all Class III medical gadgets authorised by FDA by means of the premarket approval course of. Plaintiff alleged that her defibrillator activated and shocked her whereas she was strolling from her automotive right into a mall and continued to activate about each 45 seconds as she drove dwelling after which continued to activate within the ambulance and on the hospital. Plaintiff alleged in her grievance that a health care provider advised her that it had shocked her 99 instances earlier than she went into cardiac arrest. She underwent surgical procedure and had the defibrillator eliminated.
Plaintiff filed her lawsuit in Massachusetts state court docket alleging breach of the guarantee of merchantability, breach of the guarantee of health for a specific objective, and negligence. Defendants eliminated and moved to dismiss on the premise of preemption beneath the Medical System Amendments.
Plaintiff argued that her claims weren’t preempted as a result of they have been permissible parallel claims beneath Riegel v. Medtronic. The court docket didn’t purchase it.
First, there was nothing parallel concerning the two breach of guarantee claims. On the contrary, the breach of guarantee claims asserted that the implants weren’t match to be used, which is simply one other manner of claiming that “the gadgets will not be moderately secure and efficient regardless of the FDA’s findings on the contrary.” Id. at *3. Due to this fact, the claims have been preempted.
As to the remaining negligence declare, Plaintiff alleged that Defendants “had prior information of the malfunction of the implanted gadgets however did not notify Plaintiff of the necessity to take corrective measures or actions.” Id. After all, this declare has severe issues beneath the realized middleman rule. However on the preemption entrance, the Court docket held that this declare was preempted “to the extent it asserts that the FDA-approved warnings that she acquired have been insufficient.” Id. In her opposition temporary, Plaintiff argued that the negligence declare was not primarily based on premarket exercise, however on an alleged defect found postmarket and a failure to behave postmarket. The Court docket declined to contemplate these claims as a result of they weren’t asserted within the grievance and “Summers could not add info by means of her opposition temporary that she didn’t plead in her grievance.” Id. at *4. The movement to dismiss was granted in full however with depart to amend, so we could also be revisiting this case concerning the purported postmarket claims. However these claims too ought to meet the identical destiny, because it’s exhausting to think about how any such declare wouldn’t be “completely different from or along with” the FDA-approved labeling.
