By Jeffrey H. Brochin, J.D.
For patient’s state-law claim to survive, it must have been premised on conduct that both violated the FDCA and would give rise to a recovery under state law even in the absence of the FD&C Act.
A federal district court in Michigan has dismissed the products liability lawsuit filed against Bayer Corp. (Bayer), manufacturer of the Essure implantable birth control device, after finding that the patient’s claims were preempted by federal regulation. Enforcing the FD&C Act is exclusively within the province of the federal government, and there is no private right of action under the Act. Furthermore, her claims as to negligent training of her physician failed because she did not allege facts supporting a plausible inference that her doctor was negligently trained in violation of federal standards, that her doctor erred in placing her device, or that her alleged injuries were causally linked to physician error arising from inadequate training (Hill v. Bayer Corp., September 8, 2020, Steeh, G.).
FDA CPMA. Essure is a permanent female birth control device that blocks the fallopian tubes by the insertion of micro-inserts into the fallopian tubes which then anchor and elicit tissue growth. The device received Conditional Premarket Approval (CPMA) by the FDA and was classified as a Class III medical device, meaning that it underwent the most federal oversight. The patient had the device implanted in December, 2011, and subsequently complained that it migrated from her fallopian tubes and perforated other organs causing her to suffer from various maladies including depression, heavy bleeding, severe back pain, and other complications. Bayer discontinued sales of Essure after December 31, 2018.
The patient filed suit alleging negligent training, negligent risk management, breach of express warranty, negligent misrepresentation, and negligent failure to warn. Bayer moved to dismiss which, for the reasons stated below, the court granted.
FDA labeling approval. The FDA reviews a device’s proposed labeling, which includes the Instructions for Use (IFU) for physicians, and a Patient Information Booklet (PIB), for patients, as part of the premarket approval process. The agency evaluates safety and effectiveness under the conditions of use set forth on the label, and the agency may also specify requirements that apply to the training of practitioners who use the device. Such requirements must appear in the FDA-approved labeling.
Escaping FD&C Act preemption. The federal Food, Drug and Cosmetic Act (FD&C Act) includes an express preemption clause that provides, in relevant part that no state may establish or continue in effect with respect to a device intended for human use any requirement which is different from, or in addition to, any requirement applicable under the FD&C Act (21 U.S.C. § 360k(a)) to the device. The Supreme Court addressed the meaning of § 360k(a) explaining that to the extent that a state common-law duty imposes requirements ‘different from, or in addition to’ the requirements imposed by the FD&C Act, those state common-law duties are expressly preempted by § 360k(a).
To escape preemption by § 360k(a), a state-law claim must be premised on the breach of a state-law duty that is the same as a duty imposed under the FD&C Act. The conduct that is alleged to give a plaintiff a right to recover under state law must be conduct that is forbidden by the FD&C Act. To determine whether the patient’s claims were preempted, it was first necessary to identify the conduct by Bayer that was alleged to have given rise to a claim under Michigan law.
No private right of action. The court noted that even if a claim is not expressly preempted by § 360k(a), it may be impliedly preempted per a Supreme Court ruling which held that, because enforcing the FD&C Act is exclusively the province of the federal government, there is no private right of action under the Act. For the patient’s state-law claim to survive, the claim needed to be be premised on conduct that both violated the FD&C Act and would give rise to a recovery under state law even in the absence of the FDCA.
Negligent training claim. Bayer argued that the patient’s negligent training claim should be dismissed because it was preempted by federal law, and because she did not allege facts supporting the inference that her doctor was negligently trained in violation of federal standards. To survive a preemption challenge, the negligent training claim required allegations that Bayer breached FDA-approved training obligations. The court noted that under federal law, when the FDA specifies training requirements for Class III medical devices, those requirements must appear in the device’s approved labeling, and that Essure’s labeling in fact included such requirements. Because her negligent training claim was based on breach of FDA training requirements, the claim was not preempted by federal law.
However, to the extent the claim was premised on training that was outside Essure’s FDA training guidelines, her claim as to those alleged deficiencies were preempted. The court found that the complaint generally alleged that a failure to train caused the implanting physician’s technique to result in her injuries, but she did not even identify her own doctor let alone plead facts suggesting a viable failure to train claim. Accordingly, her negligent training claim was dismissed.
Failure to report to FDA. The patient’s failure to warn claim alleged that Bayer was liable due to a failure to notify the FDA of adverse reports about Essure. However, the court found that she did not cite any Michigan requirement that a manufacturer report adverse events to the FDA, rather, she relied solely on Bayer’s alleged failure to warn the FDA of adverse events in support of her failure to warn claim. Accordingly, the court ruled that her negligent misrepresentation and negligent failure-to-warn-FDA claims were impliedly preempted under and must be dismissed.
Based on the foregoing, all of Bayer’s motions to dismiss were granted.
The case is No.: 2:19-cv-12198-GCS-MKM.
Attorneys: Jerard M. Scanland (Mussin and Scanland, PLLC) for April Hill. Alison L. Carruthers (Dykema Gossett PLLC) for Bayer Corp., Bayer HealthCare, LLC and Bayer HealthCare Pharmaceuticals, Inc.
Companies: Bayer Corp.; Bayer HealthCare, LLC; Bayer HealthCare Pharmaceuticals, Inc.
MainStory: TopStory CaseDecisions MDeviceNews PLDeviceNews SafetyNews MichiganNews
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