Category: Failure to Warn

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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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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Lack of “Newly Acquired Information” Defeats Plaintiffs’ Claims in Zofran MDL

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Zofran (ondansetron) has often been used to combat nausea during pregnancy.  It has never been approved by the FDA for that indication, but clinical experience has not supported an association with pregnancy-related risks – for example, a recent systematic review and meta-analysis concluded that use of ondansetron during pregnancy was associated with a reduced incidence of miscarriage but “was not associated with abnormal pregnancy outcomes,” including a variety of birth defects.  Nevertheless, plaintiffs have alleged that Zofran causes birth defects and that the warnings accompanying the drug should have said so.  Those claims were dismissed in 2021 when the district court held them preempted, and the First Circuit recently affirmed that decision in In re Zofran (Ondansetron) Products Liability Litigation, — F.4th —, 2023 WL 128570 (1st Cir. Jan. 9, 2023).

Plaintiffs in the Zofran MDL alleged, among other things, that the defendants failed to warn of birth defects observed in certain animal studies.  Because such claims implicate the warnings accompanying an FDA-approved drug, they are preempted unless the manufacturer could have unilaterally amended the label through the Changes Being Effected (CBE) regulation.  The CBE regulation permits a manufacturer to amend a product’s labeling without prior FDA approval “to reflect newly acquired information” and thereby “add or strengthen” the warnings where there is “evidence of a causal association” between the drug and the subject on which the warnings are being amended.

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5 Major Drug and Device Developments of 2022

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As we ring in the new year, it is time once again to reflect on some of the most significant legal developments for drug and device companies this year. The list below is by no means exhaustive (who could forget the Rule 702 updates that took place this year, which will carry over into 2023?), but provides a brief recap and assessment of five of the most interesting and consequential developments affecting drug and device law in 2022.

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