By George Basharis, J.D.
Implant recipient’s claim for negligent manufacturing of Essure® device was upheld, but her claims for breach of express warranty were dismissed in part and granted in part.
A claim for negligent manufacturing of a birth control implant device was not preempted by federal law, a federal district court in Georgia held, allowing the claim to move forward. However, the implant recipient’s additional claim for breach of express warranty by the manufacturers based on representations in marketing materials that track language approved by the Food and Drug Administration (FDA) was preempted and, therefore, was dismissed. Additionally, the patient’s breach of express warranty claim that her device did not conform to the device manufacturers’ representations because of a manufacturing defect caused by the manufacturers’ failures to comply with FDA manufacturing requirements was not preempted and, therefore, not dismissed (Frey v. Bayer Corp., October 9, 2020, Land, C.).
The patient was implanted with Bayer Corporation’s Essure® device, described as "a form of permanent female birth control." After implantation, she complained of a number of injuries she attributed to the device. After undergoing a hysterectomy and salpingectomy to remove the device, the patient filed suit, claiming negligent manufacturing and breach of express warranty. Bayer argued that the patient’s claims were preempted by the Medical Device Amendments (MDA) to the federal Food, Drug, and Cosmetic Act (FDC Act).
Under the MDA, the device was classified as a Class III medical device. Class III devices undergo the highest federal oversight, including premarket approval that is granted only if the FDA determines there is a "reasonable assurance" of the device’s "safety and effectiveness." Under the MDA’s express preemption clause, state requirements are expressly preempted if they are different from or in addition to federal requirements. The court noted that for a plaintiff to bring suit claiming preemption, the duty allegedly breached cannot be one owed only to the FDA but to the person using the product. Essure’s manufacturers contended that the patient’s claims were preempted by federal law. The patient argued that her claims were grounded in traditional state tort duties that predated the MDA and were parallel to and not different from or in addition to federal requirements.
Negligent manufacturing. The patient argued that there were manufacturing defects in the device and that the device deviated "materially" from the FDA-approved design and specifications, causing increased and unreasonable risks of serious bodily harm. According to the patient, the manufacturers were in non-compliance with the MDA. The patient also alleged that FDA inspections discovered specific violations of the current good manufacturing practices at manufacturers’ facilities that contributed to manufacturing defects.
The court noted that Georgia law recognizes a common law negligence claim based on a manufacturing defect theory of liability and was satisfied that the patient adequately alleged that a negligent manufacturing defect caused her injuries. Taking the patient’s manufacturing defect allegations in her amended complaint as true, they "plausibly [gave] rise to an entitlement to relief." In response, the manufacturers contended that even if the patient adequately alleged negligent manufacturing, the claim was preempted by federal law. The patient argued that the manufacturers violated the Georgia common-law duty to use reasonable care and that the manufacturers’ violation of a federal requirement caused a violation of state-law duty. The court found that the patient’s negligent manufacturing claim was not preempted by federal law to the extent that it was premised on a manufacturing defect theory in violation of federal requirements. The claim also was not impliedly preempted, the court said.
Breach of express warranty. The patient also alleged that the manufacturers made a number of misrepresentations—in a patient brochure, a physician manual, a product fact sheet, advertising, and news releases—including express warranties to patients and that she and her physicians relied on them when choosing the device. The manufacturers contended that the alleged misrepresentations used language that was approved by the FDA during the premarket approval process and that the patient’s warranty claim, therefore, was preempted. The court noted that the patient did not respond to the manufacturers’ argument and could not dispute that any claim for breach of express warranty based on these alleged misrepresentations would require a finding that the FDA’s approved labeling was false.
In addition to the alleged misrepresentations, the patient argued that the manufacturers warranted Essure as a low-risk, safe procedure. She alleged that because of a manufacturing defect, her Essure device did not conform to the manufacturers’ representations that it was safe and effective. The court found that permitting the patient’s breach of warranty claim would not have the effect of imposing state requirements with respect to the device that are different from or in addition to federal ones and relate to safety and effectiveness. Therefore, the patient’s claim was not preempted and not dismissed.
The case is No. 3:20-cv-00041-CDL.
Attorneys: Matthew Orren (Fischer Redavid PLLC) for Kimberly Frey. Christopher Grey Campbell (DLA Piper) for Bayer Corp., Bayer HealthCare LLC, Bayer Essure Inc. and Bayer HealthCare Pharmaceuticals Inc.
Companies: Bayer Corp.; Bayer HealthCare LLC; Bayer Essure Inc.; Bayer HealthCare Pharmaceuticals Inc.
MainStory: TopStory CourtDecisions PreemptionNews MedicalDevicesNews DesignManufacturingNews GeorgiaNews
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