Today’s post is our second installment about a case in the District of Massachusetts alleging injury from a Class III medical device. We blogged about it this spring when the court dismissed plaintiff’s claim that an implanted defibrillator and associated leads caused her numerous, unnecessary shocks. The court dismissed that complaint based on straightforward, premarket approval preemption. But the court granted plaintiff leave to amend, and she moved to file an amended complaint. Today’s decision, Summers v. Medtronic, Inc., 2025 WL 2201110 (D. Mass. Aug. 1, 2025), denied plaintiff’s motion for leave based on the learned intermediary rule in Massachusetts. It’s a helpful decision because it applies the learned intermediary rule at the 12(b)(6) stage in the context of a device recall.
Having struck out based on preemption, plaintiff sought to add claims that the manufacturer failed to notify her of a device recall. Her amended complaint sought to add the following allegations:
On March 28, 2007, [Plaintiff] was implanted with a . . . defibrillator lead and about a month later received an unnecessary jolt. She reported the incident to her doctor who, in turn, reported the matter to Medtronic. Medtronic dispatched one of its technicians to examine the implant, but Medtronic gave no information or instruction to [Plaintiff]. A similar electric jolt subsequently occurred, which [Plaintiff] reported to her doctor, who again reported the matter to Medtronic. . . .
On October 15, 2007, Medtronic issued a Class 1 Recall of the implanted lead because of the potential for lead fractures which could cause the defibrillator to deliver an unnecessary electric jot. Medtronic failed to communicate the recall to [Plaintiff] even though it was aware that she was among the recipients of the implanted lead who were being adversely affected by the product.
Id. at *1 (internal citations omitted).
The manufacturer argued that the amended complaint failed to state a claim because its duty to warn ran to the prescribing physician rather than the patient. The court agreed. Under the learned intermediary rule, “a medical-device manufacturer’s obligation to warn of dangers associated with its product runs to the physician, not the patient.” Id. at *2, quoting Bell v. Covidien LP, 2023 WL 3006175, at *6 (D. Mass. Apr. 19, 2023). Under the rule, the plaintiff has the burden of showing that the defendant failed to warn of a “non-obvious risk about which the manufacturer knew or should have known,” and then a rebuttable presumption arises that the physician would have heeded an adequate warning. Id., quoting Garside v. Osco Drug, Inc., 976 F.2d 77, 80 (1st Cir. 1992).
Plaintiff did not meet her burden. Her additional allegations failed to state a claim because the manufacturer had no duty to warn her directly about anything – including the alleged recall. Plaintiff did not allege that the implanting physician was not informed of the recall, so there was nothing in the proposed amendment sufficient to allege that the manufacturer breached any duty to warn. The court found the proposed amendment futile, denied the motion to amend, and dismissed the case. No shock there.