Health Law Daily Shocking turn, no preemption in defective defibrillator lawsuit
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Friday, February 9, 2018

Shocking turn, no preemption in defective defibrillator lawsuit

By Dietrich Knauth

The Eleventh Circuit revived a lawsuit over a LifeVest® medical device that allegedly failed to protect against heart attacks as promised, finding that a lower court had improperly dismissed claims as preempted by an FDA determination that the medical device was safe. In reversing, the appellate court found that the claims made it through the "narrow" path between express and implied preemption under the Medical Devices Amendments of 1976 (MDA) (Godelia v. Zoll Services, Inc., February 8, 2018, Martin, B.).

Background. The patient suffered a fatal cardiac arrest while wearing a LifeVest, and her estate sued the device manufacturer, alleging strict products liability, negligence, fraudulent misrepresentation, fraudulent marketing and promotion, breach of express warranty, negligent misrepresentation, and negligent infliction of emotional distress. The LifeVest is an external defibrillator designed to be worn by patients at risk of sudden cardiac arrest, and is intended to prevent heart attacks by administering a treatment shock when it detects dangerous heartbeat patterns. The FDA approved LifeVest for sale in 2001, and classified it as a Class III medical device, which is the highest risk category.

The district court previously granted Zoll’s motion to dismiss the suit, finding that the claims were expressly preempted by federal law governing medical devices, notably the MDA (see FDC Act preempts patient’s products liability claims, January 20, 2017). The district court found that the claims were premised on the LifeVest being defective, which was at odds with the FDA’s determination that LifeVest was safe.

Reversal. The Eleventh Circuit, on appeal, reversed that ruling, instead finding that the plaintiffs’ claims made it through the "narrow" path between express and implied pre-emption under the MDA. The patient did not challenge the FDA’s finding that the device was safe, avoiding express preemption, and did not base claims only on Zoll’s alleged deviance from the FDA-approved manufacture of its devices, avoiding implied preemption. Instead, the appellate court noted, the patient alleged that the LifeVest’s defect was result a result of deviation from approved practices, as shown by an FDA warning letter sent to Zoll after the patient’s death, and that the deviation resulted in actual harm to the plaintiffs. The appeals court noted that the district court’s reasoning relied on a previous district court ruling that was later overturned by the Eleventh Circuit.

The Eleventh Circuit also rejected Zoll’s argument that the patient did not plead sufficient detail in the complaint, finding the patient pleaded a sufficiently plausible claim, and did not need to pinpoint the precise defect that caused the LifeVest malfunction before proceeding with discovery.

The case is No. 17-10736.

Attorneys: Jermaine Lee (Wallen Hernandez Lee Martinez, LLP) for Dennis Godelia. Jordan Scott Cohen (Wicker Smith O'Hara McCoy & Ford, PA) for Zoll Services, LLC.

Companies: Zoll Services, LLC

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