In Ashley Glennen v. Allergan, Inc., 2016 Cal. App. LEXIS 347, published April 29, 2016, the California Court of Appeal, First District, affirmed the trial court’s sustaining of a demurrer in a Lap-Band injury case on the ground that Plaintiff’s claims that defendant Allergan Inc. improperly trained the surgeon are preempted by federal law.
Plaintiff underwent a surgical procedure to implant a Lap-Band. The Lap-Band eventually eroded into both her stomach and her liver causing a portion of her stomach to die and the tubing attached to the Lap-Band to become entangled with her small intestine, resulting in the death of a portion of her small intestine. Plaintiff sued Allergan, the manufacturer of the Lab-Band, for negligence asserting that Allergan did not properly train physicians in the use of its product. Allergan filed a Demurrer on the basis that Plaintiff’s claims were preempted by federal law. The trial court sustained the Demurrer without leave to amend and Plaintiff timely appealed.
Prior to Plaintiff’s surgery, Allergan applied for Food and Drug Administration (“FDA”) premarket approval to manufacture and market the Lap-Band. The Lap-Band received premarket approval on June 5, 2001. In the premarket approval letter, the FDA indicated that the Lap-Band’s labeling must “specify the requirements that apply to the training of practitioners who may use the device as approved in this order … .” Thus, a brochure was prepared providing a list of training requirements that surgeons planning laparoscopic placement must complete. The Lap-Band was classified by the FDA as a Class III medical device and was thus subject to strict federal regulation.
Cases asserting injuries allegedly stemming from an FDA-approved medical device arise within a complex and highly regulated area of federal law pursuant to which the contours of permissible private enforcement suits are carefully circumscribed. Consistent with the command of the supremacy clause, state laws that conflict with federal law are preempted. Preemption can occur either expressly or impliedly. Express preemption occurs when Congress defines explicitly the extent to which its enactments preempt state law. Implied preemption occurs: (1) when state law regulates conduct in a field that Congress intended the federal government to occupy exclusively, or (2) when state law actually conflicts with federal law, which exists where it is impossible for a private party to comply with both state and federal requirements, or where state law stands as an obstacle to the accomplishment and execution of the full purposes and objectives of Congress.
The federal Medical Device Amendments of 1976 (“MDA”), 21 U.S.C. § 360c et seq., expressly preempt state requirements “different from, or in addition to,” any requirement applicable to the device under federal law. The court has set forth a two-part test to determine whether a state-law claim is preempted under the MDA: (1) the federal government has established requirements applicable to the medical device in question, and (2) the state-law claims concerning the device are based on requirements that are different from, or in addition to, the federal requirements, and relate to the safety and effectiveness of the device. The first prong is automatically satisfied if the FDA authorizes commercial distribution of a Class III medical device following the premarket approval process.
The MDA does not prevent a state from providing a damages remedy for claims premised on a violation of FDA regulations where the state duties parallel, rather than add to, federal requirements. In order for a state requirement to be parallel to a federal requirement, and thus not expressly preempted under the MDA, the plaintiff must show that the requirements are genuinely equivalent. State and federal requirements are not genuinely equivalent if a manufacturer could be held liable under the state law without having violated the federal law. If state law liability could be found notwithstanding compliance with the federal requirements, those state law duties are not parallel to the federal requirements and will be preempted.
Even if a medical device claim is not expressly preempted, it will be deemed impliedly preempted if it conflicts with the enforcement scheme of the Federal Food, Drug, and Cosmetic Act (“FDCA”). Implied preemption under the MDA bars claims seeking to enforce an exclusively federal requirement that is not grounded in traditional state tort law. Claims not tied to state law tort duties are essentially private actions to enforce the FDCA and are barred by 21 U.S.C. § 337(a), a provision authorizing the federal government to enforce the MDA.
Together, express preemption and implied preemption identify a narrow gap through which a state-law medical device claim must fit to escape preemption. The plaintiff must be suing for conduct that violates the FDCA (or else the claim is expressly preempted by the MDA), but the plaintiff must not be suing solely because the conduct violates the FDCA (such a claim would be impliedly preempted). Thus, to avoid preemption, a plaintiff must assert a state-law claim that is premised on a violation of federal law, but that is not based solely on such a violation. Stated another way, in order to survive preemption, such claims must be premised on conduct that both (1) violates the FDCA and (2) would give rise to a recovery under state law even in the absence of the FDCA.
In Glennen, the Court of Appeal held that Plaintiff’s claim that Allergan failed to provide adequate training to physicians with respect to the implantation of its devices was expressly preempted because the claim did not parallel federal requirements as the operative Complaint did not identify where the training provided by Allergan deviated from what the FDA required. The Court of Appeal further concluded that even if Plaintiff’s allegations reflected actual violations of federal law, her claim is subject to implied preemption. Allergan did not voluntarily undertake to train physicians in the use of the Lap-Band. Instead, the FDA mandated this physician training as a condition of its approval for the Lap-Band. Thus, the training program at issue arose solely out of requirements imposed by the FDA. Under this set of facts, plaintiff could not allege a state law claim for negligent undertaking. To the contrary, plaintiff’s claim for failure to adequately train physicians existed solely by virtue of the FDCA requirements as set forth in the Lap-Band’s premarket approval. Thus, the claim did not exist independently of the FDCA, and was impliedly preempted.
This case further highlights the preemptive power of the Medical Device Amendments and the limited circumstance of a parallel claim that exists to defeat preemption. Where the challenged conduct is part of the premarket approval process and subject to FDA requirements, preemption should always lie except where the state law claim parallels the federal requirements.
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