Subject: Affirmative Defenses

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

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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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Michigan Repeals Pharma Immunity Provision

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Michigan recently signed into law a repeal of the immunity provision under its Product Liability Act, presenting a new litigation risk in Michigan for pharmaceutical companies. The provision had granted near-complete immunity to pharma for the past 30 years, as the only of its kind nationwide.  Michigan’s new law—Senate Bill 410 (SB 410)—removes this immunity, leaving intact a rebuttable presumption of non-liability and caps on non-economic damages.

SB 410 goes into effect on February 13, 2024, and is likely non-retroactive, meaning alleged injuries would have to occur after that date for the new law to apply.  Commentators predict increased Michigan litigation relating to opioid use, insulin price gouging, and Medicaid fraud.

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Indiana Court of Appeals Holds Product Misuse Unforeseeable in Light of Product Warnings, Reverses Denial of Summary Judgment

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Key Takeaway:  In Superior Oil Company, Inc. v. Labno-Fritchley, 207 N.E.3d 456 (Ind. Ct. App. 2023), the Indiana Court of Appeals reversed a trial court’s denial of summary judgment in a product liability case.  The court held that summary judgment should have been granted because the defendant’s designated evidence related to the product’s warning label established the affirmative defenses of misuse and incurred risk as a matter of law.  Notably, the opinion illustrates how failure to heed the warnings that accompany a product can amount to unforeseeable product misuse.

Background:  Plaintiff’s decedent attempted to remove the top of an empty 55-gallon metal drum with a cutting torch when it exploded, resulting in his death.  The top of the drum – at which the decedent had to have been looking as he cut – bore an 8” x 12” warning label that, among other things, warned of the dangers of an empty metal drum and advised “[d]o not flame cut, braze, or weld empty container.”  Although not emphasized by the Labno-Fritchley court, a picture of the label in the court’s opinion suggests that this language comprised only a very small portion of the label and was not in boldfaced or underlined font.

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