California Appellate Court Upholds Federal Preemption of Negligent Undertaking Claim Under the Medical Device Amendments of 1976


Federal preemption can be a very powerful defense.  For example, claims concerning Class III medical devices requiring pre-market approval are generally preempted by the Medical Device Amendments of 1976, 21 U.S.C. § 360c, et seq. (“MDA”).  In Regwan v. Abbott Laboratories, Case No. B319606, 2023 WL 8818748 (Cal. App. 2d Dec. 21, 2023), the California Court of Appeal relied on that principle in holding preempted a negligent failure to warn claim premised on a sales representative’s intraoperative communications and presented as a “negligent undertaking” claim.  This holding continues a California trend that federal law may preempt negligence-based claims regarding Class III PMA medical devices even if they are not presented as traditional design defect or failure to warn claims.

In Regwan, the plaintiff alleged she suffered serious injuries following implantation of a MitraClip that the defendant manufactured.  During the procedure, the saline bag ran dry, causing the plaintiff to allegedly suffer an air embolism and brain injuries.  The plaintiff asserted negligence and products liability causes of action against the defendant after discovering a defendant representative attended the surgery and was allegedly “responsible for the flow of saline.”  The defendant demurred, arguing federal law preempted the plaintiff’s products liability claims.

The appellate court determined federal law preempted the plaintiff’s negligence cause of action.  The product at issue is a Class III medical device, which must undergo a “rigorous premarket approval process to provide reasonable assurance of its safety and effectiveness.”  See 21 U.S.C. § 360c(a)(1)(C)(i)(II).  The MDA contains an express preemption provision where Congress decreed, “no State…may establish or continue in effect with respect to a device intended for human use any requirement (1) which is different from, or in addition to, any requirement applicable under this chapter to the device, and (2) which relates to the safety or effectiveness of the device or to any other matter included in the requirement applicable to the device under this chapter.”  See 21 U.S.C. § 360k(a).

Applying the preemption doctrine, the Court reasoned medical device manufacturers only face a federal standard of care.  In Regwan, the state law claim involved a Class III device that received premarket approval for commercial distribution.  Furthermore, the plaintiff’s negligence claim was based on common law duties that were different from, or in addition to the federal requirements and that “relate to safety and effectiveness,” given her claim was the defendant breached its duty of care by failing to confirm the correct amount of saline, while the product at issue came with numerous written federally mandated warnings requiring continuous saline flow for a successful implantation procedure.  Liability under the plaintiff’s negligent undertaking theory hinged on whether the defendant representative gave additional oral warnings during surgery, whereas under the FDA requirement, the written warning label accompanying the device is sufficient.  As a result, the defendant could have been found negligent under the plaintiff’s state law claim despite having complied with the FDA labeling requirement.

This decision, which is unfortunately unpublished, is laudable in that the appellate panel saw through the plaintiff’s negligent undertaking argument.  The plaintiff clothed the claim in the representative’s duty to act reasonably, having supposedly assumed responsibility for the saline bag and failed to adequately monitor it and alert physicians when it ran low.  However, the court recognized the claim as running directly through an alleged failure to “tell[] the medical staff to supply more saline when required.”  Thus, the plaintiff was asking the court to find the defendant negligent under state law for failure to warn “despite having complied with the FDA labeling requirement.”  No matter how plaintiff sought to package that claim, it was preempted.

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About the Author: Mary Katherine Planchet

Mary-Kate Planchet counsels clients in product liability and mass tort litigation. She performs legal research and prepares pleadings, motions to compel, demurrers, motions to dismiss, and motions for summary judgment. Mary-Kate takes and defends depositions and examinations under oath and has previously performed substantive work in insurance coverage, tort and catastrophic loss, and labor and employment matters.

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Adrienne Franco Busby puts science and strategy to work for companies facing product liability litigation. She is an experienced litigator in product liability, commercial, employment, class action and mass tort matters.

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Eric Friedman guides clients through all stages of product liability litigation, particularly working with expert witnesses to present the science behind clients' products. By leaning on his pre-law history as a biochemist, he is able to identify key arguments for and against clients and craft winning strategies for both motion practice and trial.

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