Category: Failure to Warn

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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“Alternative Avenues” Argument in Failure-to-Warn Cases Adding an Additional Wrinkle to Medical Device Litigation

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A developing line of cases across the nation may have large implications for medical device manufacturers defending against failure-to-warn claims.  While a treating physician’s failure to read or rely on the manufacturer’s warnings has historically been fatal to a failure-to-warn claim in many jurisdictions (at least those without a “read and heed” presumption), plaintiffs have tried novel “alternative avenues” arguments to make summary disposition of the claim more difficult.

There are two theories under which a failure-to-warn claim may be brought in the products liability context:  a manufacturer with a duty to warn may breach its duty by either (1) failing to provide an adequate warning of the product’s potential risks (the “content theory”) or (2) failing to adequately communicate the warning to the ultimate consumer (the “communication theory”).  Plaintiffs have traditionally pursued failure-to-warn claims in prescription medical device cases under the content theory, with most courts holding that a treating physician’s failure to read or rely on the manufacturer’s warnings in the product’s instruction for use (“IFU”) is fatal to the claim.  See, e.g., Foster v. Ethicon, Inc., 2021 WL 1169473, at *7 (D.S.D. Mar. 26, 2021).

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Blurry Vision in Two Courts Leads to Denial of Preemption in Intraocular Lens Implant Case

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A recent Second Circuit preemption decision illustrates the importance of a clear-eyed approach to medical device preemption issues.

In Glover v. Bausch & Lomb, Inc., 6 F.4th 229 (2d Cir. 2021), the district court dismissed as preempted a complaint concerning vision loss from defective intraocular lenses implanted during cataract surgery. Plaintiff developed “Z syndrome,” permanently impairing her vision, and sued the manufacturer under the Connecticut Product Liability Act (CPLA) for failing to warn.  She alleged the defendant had failed to report prior Z Syndrome cases to the FDA, as required by the Federal Food, Drug, and Cosmetic Act (FDCA).

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