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From Products Liability Law Daily, May 17, 2013

Claim That Pacemaker Manufacturer Violated Duty to Warn FDA of Defect Dangers Preempted

By John W. Scanlan, J.D.

A claim that a pacemaker manufacturer was negligent in breaching a duty to notify the U.S. Food and Drug Administration (FDA) of the dangers of defects in the pacemaker that could cause serious injury or death was preempted both expressly and impliedly, a U.S. District Court for the Middle District of Florida held (McClelland v. Medtronic, Inc., May 16, 2013, Honeywell, C.).

Background. In 2004, a Medtronic EnPulse pacemaker Model E1DR21 was implanted into Breanne McClelland. In July 2009, she visited her cardiologist regarding heart palpitations, and he reprogrammed the pacemaker. Less than three weeks later, the cardiologist again reprogrammed the pacemaker due to heart palpitations, but within hours of the procedure, her symptoms worsened and she died. A Medtronic representative examined the pacemaker and found that it had failed because of certain deficiencies, and about a year and a half later, Medtronic recalled many of its devices, including the E1DR21, and issued a software update to program the recalled devices.

Peggy McClelland, Breanne McClelland’s daughter and the representative of her estate, brought strict liability and negligence claims against Medtronic. Medtronic removed the case to federal court, and Peggy McClelland subsequently amended her complaint to assert claims for negligence per se and failure to warn. After the court dismissed her claims, she filed another amended complaint asserting a claim for state law negligence, alleging that Medtronic had a duty to inform the FDA of defects in the E1DR21 that could cause serious injury or death, that Medtronic breached this duty and violated federal laws and regulations, and that if Medtronic had complied with this duty, the E1DR21 would have been recalled before Breanne McClelland’s death. Medtronic again moved to dismiss, arguing that McClelland’s claim was preempted by the Medical Device Amendments (MDA) to the Federal Food, Drug, and Cosmetic Act (FDCA).

Express preemption. McClelland’s negligence claim was expressly preempted, according to the district court. The federal government established requirements applicable to the E1DR21 when the FDA granted the device its premarket approval (PMA), and McClelland’s claim that Medtronic had breached a duty owed to Breanne McClelland to provide an adequate warning of the dangers of its product would impose requirements in addition to or different from the federal requirements. The MDA and its regulations created a comprehensive regulatory scheme that included reports by manufacturers to the FDA of incidents in which a product contributed to a serious injury or death, but McClelland did not show any requirement that manufacturers inform patients of these incidents.

Implied preemption. The court determined that McClelland’s negligence claim also was impliedly preempted. To the extent her claim alleged a breach of duty to the FDA, it essentially was an attempt to recharacterize a claim for violation of the FDCA as a state law claim. There was no private right of action for an FDCA violation because all actions to enforce FDA requirements must be brought by and in the name of the United States.

The case number is 6:11-cv-1444-Orl-36TBS.

Attorneys: Diana L. Martin (Leopold Law, PA) for Peggy McClelland; Justin Benjamin Aronson (Greenberg Traurig, LLP) for Medtronic, Inc.

Companies: Medtronic, Inc.

MainStory: TopStory PreemptionNews MedicalDevicesNews FloridaNews

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