Category: Failure to Warn

NY Federal Court Ruling Strengthens FDA Preemption for Class III Device Manufacturers

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A recent preemption decision out of the Southern District of New York offers encouraging news for medical device manufacturers. In Wieder v. Advanced Bionics LLC, 2025 WL 3237257 (S.D.N.Y. Nov. 20, 2025), the magistrate judge has recommended that most of the state law claims asserted against a cochlear implant manufacturer be dismissed as preempted by federal law under the Medical Device Amendments (MDA) to the Food, Drug, and Cosmetics Act (FDCA). While this is not a final decision yet, should the report and recommendation be adopted, it will be a welcome decision for device manufacturers because it reaffirms that state law claims challenging the safety or effectiveness of a pre-market approved (PMA) medical device are broadly preempted.

Weider involved allegations against the manufacturer of a Class III PMA cochlear implant. The plaintiffs alleged the device, which was implanted in their young child, was defectively manufactured and designed, citing issues with a silicone seal and alleging the manufacturer knew of a design flaw that was revealed by a company-backed clinical study. The manufacturer moved to dismiss the case in its entirety, arguing that federal preemption barred the claims or, alternatively, that the claims were inadequately pleaded.

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Nothing Shocking Here – Eleventh Circuit Affirms Defense Win in Electroconvulsive Therapy Case

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When a case involves electroconvulsive therapy (ECT), one might think it originated out of the Twilight Zone. Despite the misrepresentation of such therapies in popular media, modern ECT serves as a valuable option for patients with certain severe mental health conditions who have tried other therapies without success. Although ECT is far safer today than it was when the stigma attached to it was formed, it still carries risks such as confusion, memory loss, and some physical side effects. One need not enter another dimension to envision why a plaintiff might claim damages arising from those risks. Much like Rod Serling’s anthology, the Eleventh Circuit recently closed the door on one such episode.

In Thelen v. Somatics, LLC, — F.4th —, 2025 WL 2749888 (11th Cir.), the plaintiff suffered from depression and mental health issues so severe that he attempted to take his life numerous times in numerous ways. During a two-year span, he received 95 ECT treatments to address his conditions. He was later diagnosed with a neurocognitive disorder that caused severe memory loss.

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No Defect, No Negligence: Lessons from Rudzinskas v. Retractable Technologies, Inc.

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A recent summary judgment decision out of the Southern District of Georgia illustrates the critical role of defect evidence (or lack thereof) in negligence claims involving medical devices. As the plaintiff in Rudzinskas v. Retractable Technologies, Inc., No. 4:24-cv-009, 2025 WL 22772490 (S.D. Ga. Sep. 29, 2025) recently learned, allegations that a medical device malfunctioned are not sufficient evidence to survive summary judgment on negligent manufacturing and failure to warn claims.

In Rudzinskas, the plaintiff alleged that on two different occasions, when her husband injected her with vitamin B12 at home, the needles shot off their syringes and became dislodged inside her body (first in her buttock, and a few months later, in her arm). Plaintiff asserted that the syringes were marketed as containing needles that automatically retract from a patient into the barrel of the syringe when the plunger handle is fully depressed. Plaintiff sought medical attention following the alleged incidents. Plaintiff’s physicians confirmed the presence of the first needle and attempted to surgically extract it, but the surgery was unsuccessful. After the second incident two months later, the same surgeon attempted to confirm the presence of the second needle, but did not see it and did not perform surgery. Arising from these allegations, the plaintiff asserted two claims against the defendant for (1) negligent manufacture and (2) negligent failure to warn.

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Defective Logic: Why Recall Evidence Falls Short in Court

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In product liability litigation, plaintiffs often treat a product recall as though it is conclusive proof that the product is defective or that its warnings are inadequate. Some plaintiffs even cite clearly inapplicable recalls — for example, lot-specific recalls spurred by a manufacturing or labeling issue that did not impact the unit that the plaintiff received — in an effort to bolster their case before a court or in settlement discussions. Federal Rule of Evidence 407’s prohibition on the use of recall evidence to prove those points seems to do little to quell the enthusiasm. Of course, Rule 407 is grounded in part on “a social policy of encouraging people to take, or at least not discouraging them from taking, steps in furtherance of added safety.” Fed. R. Evid. 407 advisory committee’s note. But Rule 407 is not the only grounds on which recall evidence can (and should) be excluded.

For example, in Pecan Trust v. Nexus RVs, LLC, 2025 WL 1503940 (N.D. Ind. May 27, 2025), the plaintiffs sued the manufacturers of an RV and certain component parts alleging, among other things, that a defect in the brake pressure switch represented a fire risk. In support of that claim, they pointed solely to a safety recall for the part due to a possible fire risk and an expert witness who, based on the recall alone, concluded that the issue might pose a fire risk. The parts manufacturer moved for summary judgment, and the court granted the motion as to the breach of warranty claim after concluding that the plaintiffs had not proffered sufficient evidence of a defect. As the court noted: “That a recall has occurred may be evidence of certain things—namely as a subsequent remedial measure—but it cannot show a product defect. In reality, products subject to a recall might have a defect or might not, as a recall implements a safety campaign to ensure that none do or will manifest one.” (internal citations omitted). And, as the court noted in the specific context of the warranty claim, the fact that the plaintiffs had never presented the RV for work under the recall posed a second, equally problematic obstacle to their claim.

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Yes, Michigan Applies the Learned Intermediary Doctrine

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For decades, both state and federal courts in Michigan have routinely applied the learned intermediary doctrine in products liability cases involving prescription medical products. Under the doctrine, a manufacturer’s duty to warn runs not to a plaintiff but to the plaintiff’s prescribing physician. Although “[e]very state in the country, along with the District of Columbia and Puerto Rico, has adopted the learned intermediary doctrine in some iteration,” Dearinger v. Eli Lilly & Co., 510 P.3d 326, 329 (Wash. 2022) — including courts applying Michigan law — a Michigan federal court recently expressed doubt about the doctrine’s applicability and certified a question to the Michigan Supreme Court. The answer, if the court accepts the question, should be clear — yes, Michigan applies the learned intermediary doctrine.

In Osos v. NuVasive, Inc., No. 23-CV-12331, 2024 WL 3585092 (E.D. Mich. July 30, 2024), the plaintiff alleged injury from an implantable medical device manufactured by the defendant. The defendant filed a motion to dismiss, which among other things argued that the plaintiff’s failure to warn claim was barred by the learned intermediary doctrine because she had not alleged any failure to warn the implanting surgeon. 2023 WL 9322029 (motion to dismiss). The plaintiff did not take issue with the learned intermediary doctrine in general but argued that, because she alleged that the implanting surgeon was an inventor of the product and an agent of the defendant, there was no true “intermediary” between the defendant and the plaintiff. 2023 WL 11081568 (opposition). Thus, according to the plaintiff, the case represented an exception to the learned intermediary doctrine.

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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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