Federal Appellate Court Rules State-Based Claims Alleging Defective Cardiac Defibrillator Were Preempted

In its unpublished opinion dated October 18, 2021, the United States Court of Appeals for the Fifth Circuit stated, “21 U.S.C. § 360k … expressly preempts state laws which impose “different” or “addition[al]” safety requirements on medical devices subject to the FDA’s PMA [premarket approval] process. 21 U.S.C. § 360k(a). The devices that Naquin claims harmed him were concededly subject to the PMA process. So, to the extent that the LPLA [Louisiana Products Liability Act] imposed different or additional requirements on those devices, it was preempted. And Naquin failed to specifically plead any non-preempted “parallel” claim—that is, a claim where LPLA requirements align with FDA requirements and thus avoid preemption.”

Underlying Facts

To mitigate various heart conditions, an unidentified cardiologist recommended that Plaintiff Matthew Naquin (“Naquin”) use a Medtronic Evera XT VR Implantable Cardiac Defibrillator (the “ICD”). On March 30, 2016, an unidentified surgeon implanted the ICD into Naquin’s chest, along with a Medtronic Sprint Quattro Lead (the “lead”). The FDA has designated both the ICD and the lead as Class III medical devices, which means, among other things, that both underwent a lengthy FDA premarket approval (“PMA”) process before their commercial use.

According to Naquin, the ICD shocked him unnecessarily, caused severe pain, and created a burning sensation in his chest. Naquin also claims that the lead was defective and caused the whole device to fail roughly three years after implantation, necessitating surgery to replace the device. The replacement surgery was performed on June 23, 2019, and resulted in a three-month hospitalization.

Naquin sued Medtronic in Louisiana state court, bringing products liability and breach of contract claims. The products liability claim sought damages under the Louisiana Products Liability Act (“LPLA”) for defective construction, defective design, failure to warn, and breach of express warranty. Naquin also asserted a breach of contract claim, arguing that Medtronic had agreed to provide “reliable 24 hour and 7 day a week service to Matthew Naquin.” Naquin alleged that the contract was breached because “Medtronic Inc. and its employees and representative provided bad service to Matthew Naquin.” Medtronic also allegedly failed to provide “appropriate qualified staff and professionals for service” to Naquin, and “failed to provide reliable software.”

Medtronic filed a motion to dismiss. The district court granted the motion with respect to the products liability claim, finding it preempted by 21 U.S.C. § 360k. That statute expressly preempts state laws which impose “different” or “addition[al]” safety requirements on medical devices subject to the FDA’s PMA process. 21 U.S.C. § 360k(a).

The Federal Appellate Court affirmed the District Court’s dismissal.

Source Naquin v. Medtronic, Incorporated, No. 20-30793.

If you or a loved one suffered harm due to a defective medical device or implant in the United States, you should promptly consult with a medical device claim lawyer in your U.S. state who may investigate your defective medical device claim for you and represent you or your loved one in a medical device claim, if appropriate.

Visit our website or call us toll-free in the United State at 800-295-3959 to find medical device lawyers in your state who may assist you.

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This entry was posted on Thursday, November 18th, 2021 at 5:30 am. Both comments and pings are currently closed.

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