Health Law Daily Wrap Up, PRODUCTS LIABILITY (DEVICES)—C.D. Cal.: Cardiac defibrillator manufacture not liable in patient’s death from alleged defects, (Apr 14, 2025)

By Jody Coultas, J.D.

There was insufficient evidence that a member of a board overseeing device performance had direct influence over Medtronic so as to be liable for failure of the company’s devices.

The federal district court in Los Angeles, California dismissed claims for negligence and strict liability filed against medical device manufacturer Medtronic Inc. for an alleged failure that caused a patient to die. The estate of a deceased patient alleged that Medtronic’s implantable cardioverter defibrillator malfunctioned and caused the patient to die after going into ventricular fibrillation. The estate filed suit against Medtronic and a member of Medtronic’s Independent Physician Quality Panel based on a manufacturing defect and failure to warn. The court dismissed the claims, with leave to amend, for failure to allege how Medtronic violated specific federal requirements when manufacturing the Implant and failure to identify any specific adverse events that Medtronic was required to report to the FDA (Laucella v. Medtronic, Inc., No. 2:25-cv-00466-SB-PVC (C.D. Cal. Apr. 4, 2025)).

Medtronic Evera XT DR DDBB1D4 implantable cardioverter defibrillator (ICD) was designed to deliver full-energy shocks of approximately 36 joules to terminate life-threatening arrhythmias and had a typical battery life of 10 years. The Implant was also designed to alert doctors when its battery begins to reach the end of its normal service life by triggering a “recommended replacement time” (RRT) status once the battery measures below a certain voltage on three consecutive daily checks, after which it should remain operational for three months.

The patient went into ventricular fibrillation, but the ICD only delivered about 5.2 joules of energy on the first shock and none on the second and the patient died. The ICD had delamination and cracks in crucial internal components. The family of the patient alleged that the ICD did not adhere to the design, battery, and performance specifications in the FDA’s premarket approval.

The patient’s estate filed suit against Medtroic and Dr. Mead, a California-licensed cardiologist who served on Medtronic’s Independent Physician Quality Panel for cardiac rhythm products. The complaint alleged claims for negligence and strict products liability, both for its manufacturing-defect and failure-to-warn theories, and derivative claims for wrongful death and loss of consortium. The patient’s family moved to remand and Medtronic moved to dismiss.

Remand. Because the estate had no possibility of recovering from Dr. Mead, the motion to remand was denied and Dr. Mead was dismissed as fraudulently joined by the court. While the estate denied suing Dr. Mead to defeat diversity, they have not asserted claims against any non-California Panel member. The Panel had eight members in 2016 and nine members in 2021. Only two of the members are California residents. As to whether the estate could recover from Dr. Mead, the court noted that Dr. Mead is not an employee of Medtronic and was not involved in the design or manufacturing of the ICD. The estate’s allegations that Dr. Mead was “a key contributor” to evaluating performance data, that he had a direct impact on the decisions that left the ICD in place, and that Dr. Mead “directly influenced how—and whether—Medtronic warned physicians and patients” were unsupported by evidence. Nothing contradicted Dr. Mead’s sworn testimony that he “was not involved in any research, design, manufacture, labeling, warnings, marketing, distribution, or any other pre or post-market activity related to the Device at Issue” and “never provided Medtronic consultation specific to the Device at Issue.” Nor did the estate cite any cases in which any member of a similar advisory panel has been found liable on a negligence or products liability claim based on a product’s failure.

Motion to dismiss. The estate failed to adequately allege how Medtronic violated specific FDA requirements when manufacturing the Implant, according to the court. The estate alleged that after the Implant malfunctioned, it was found to have material failures that signified nonconformance with FDA-mandated specifications. However, there were no facts supporting the assumption that the cracking and other failures observed in 2023 had been present when the Implant was installed in 2014, much less identify which of the numerous cited requirements Medtronics violated or identify how the ICD deviated from the blueprint. To survive preemption, a plaintiff cannot simply demonstrate a defect or a malfunction and rely on res ipsa loquitur to suggest only that the thing speaks for itself. Rather, a plaintiff must show that the defendant deviated from a particular pre-market approval or other FDA requirement applicable to the Class III medical device. The estate simply identified numerous requirements to which Medtronic was subject and defects at the time of failure, and assumed that Medtronic must have failed to comply with some of the requirements nine years earlier

The court found that the estate failed to identify any specific adverse events that Medtronic was required to report to the FDA and did not report—and that, if reported, would have caused the FDA to act differently and prevented the patient’s death. The complaint alleged that “between 2016 and 2023, Defendants received or became aware of several internal complaints or adverse events—substantially similar to Decedent’s device failures—where the Evera™ XT DR DDBB1D4 ICD provided only a fraction of the intended shock energy or no shock at all” and that Medtronic failed to report those adverse events to the FDA as required. The allegations of unspecified events during the seven years from 2016 to 2023, while not wholly conclusory, do not state a plausible claim.

Absent such allegations, the estate failed to plausibly allege any claims for violations of state laws that parallel the federal requirements and survive preemption. The claims were therefore dismissed.

Leave to amend. Although the estate has already amended the complaint once, this was the first request to amend in response to a pleading challenge. Medtronic did not suggest that it would be unfairly prejudiced if Plaintiffs are allowed to amend. Most importantly, it was not evident on this record that amendment would necessarily be futile. Accordingly, the court granted the request for leave to amend their claims against Medtronic.

The case is No. 2:25-cv-00466-SB-PVC.

Judge: Blumenfeld, S.

Attorneys: Matthew Whibley (Vartazarian Law Firm) for Patricia Laucella, Natalia Jovovich and Nicole Rose Lomis. Vicki Chou (Hueston Hennigan LLP) and Alycia Degen (Shook, Hardy and Bacon L.L.P.) for Medtronic, Inc.

Companies: Medtronic, Inc.

Cases: CaseDecisions FDCActNews MDeviceNews PreemptionNews PLDeviceNews CaliforniaNews