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Missing the Mark: Summary Judgment Granted Where Plaintiff’s Experts Opine on Defect but Fail to Support Causation


Product liability claims require proof of causation.  To be sure, they also require proof of some defect in the product and/or its accompanying warnings and product literature.  But defect and causation are separate elements of a prima facie claim, and both must be established – usually, through expert testimony.  As we have discussed on multiple occasions (for example, here and here), a plaintiff’s failure to offer admissible expert testimony on each element can lead to summary judgment.  A recent decision from the Eastern District of Pennsylvania offers yet another illustration.

In Slatowski v. Sig Sauer, Inc., 2024 WL 1078198 (E.D. Pa. Mar. 12, 2024), the plaintiff was an Immigration and Customs Enforcement (“ICE”) officer who was injured when his pistol fired unintentionally during a marksmanship training exercise.  He sued the gun manufacturer, alleging that a design defect in the gun’s integral safety feature – specifically, the lack of a tabbed trigger – caused the firearm to discharge unintentionally. The plaintiff proffered two experts in support of the claim:  a gunsmith and a certified firearms instructor and range safety officer with a Ph.D. in ergonomics.  The defendant moved to exclude both experts’ opinions and also moved for summary judgment, arguing that the plaintiff had no admissible expert testimony to establish causation.

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FDA Publishes New Artificial Intelligence & Medical Products White Paper


On March 15, the United States Food & Drug Administration published a white paper entitled “Artificial Intelligence & Medical Products: How CBER, CDER, CDRH, and OCP are Working Together.” FDA announced the paper by sharing a short letter from Commissioner Califf, where he reaffirmed the Agency’s commitment to “promoting the responsible and ethical development, deployment, use, and maintenance of safe and effective medical products that incorporate or are developed with AI.” The white paper does not contain any new pronouncements of FDA position, but refers to existing guidance and serves as a reinforcement for existing FDA policy regarding AI.

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EPA’s Final EtO Rule Has Landed: What Now?


The U.S. Environmental Protection Agency (EPA) recently released their long-awaited final rule regulating ethylene oxide (EtO) emissions from commercial sterilizers. The final rule comes after five years of development, over 1,000 comments, and with estimated compliance costs for industry of up to $900 million.

The final rule differs significantly from EPA’s initial proposed rule. See initial proposal back in April 2023. The changes result in a still restrictive and costly rule, but with more time and options for compliance. These changes come after significant interagency discussions, including discussions with the U.S. Food and Drug Administration (FDA) about the impact of these rules on the medical devices, about half of which are currently sterilized by EtO. According to EPA, there will be no need for companies to revalidate their medical devices due to this final rule. It seems likely, however, that a facility’s ability to comply with the new regulation ultimately may affect sterility validation, so revalidation concerns should not be completely discounted just yet.

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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.

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