In the last few months, we have discussed two decisions rejecting claims made by plaintiffs in prescription medical product liability litigation that medical device manufacturers somehow had a duty to warn about claimed risks that occurred when their products were used (by physicians, of course) in conjunction with some other product. In Silverstein v. Coolsculpting – Zeltiq Aesthetics, Inc., 2025 N.Y. App. Div. Lexis 1118 (N.Y. App. Div. Feb. 27, 2025), discussed here, a plaintiff claimed unsuccessfully that a device manufacturer had a duty to warn about the risks of a different product (ice packs) that physicians may, or may not, choose to use during the patient’s recovery period.
[U]nder New York law, the manufacturer of a product has a duty to warn of the danger arising from the known and reasonably foreseeable use of its product in combination with a third-party product which, as a matter of design, mechanics or economic necessity, is necessary to enable the manufacturer’s product to function as intended. . . . [T]he ice packs were not necessary in any way for the . . . device to function as intended. Indeed, the device functioned without incorporating ice packs, and the ice packs were not included as supplies with the . . . device.
Id. at *2-3 (citations and quotation marks omitted).
A little earlier, in Lin v. Solta Medical, Inc., ___ F. Supp.3d ___, 2021 U.S. Dist. Lexis 228901 (N.D. Cal. Dec. 18, 2024), discussed here, a plaintiff lost an argument that a medical device manufacturer had to warn about “enhanced” risks that only arose when the defendant’s device was used in conjunction with a second device made by someone else. However, a defendant “cannot be liable for a product it did not manufacture, control, or create.” Id. at *7.
[T]here is no warning specifically about greater risk when a different medical device [is also used]. Plaintiff argues that failing to specifically warn that another medical device . . . enhances the risk of injury constituted a failure to adequately warn. . . . But plaintiff asks too much by proposing that defendant must warn with specificity about every conceivable element that might enhance the [risk of injury].
Id. at *24 (emphasis original).
These two cases demonstrate that plaintiffs regularly attempt (fortunately, without much success) to impose on prescription medical product manufacturers expansive duties to warn about the products of other manufacturers that, presumably, are judgment proof or otherwise difficult to sue. Similar attempts, with similar motivations, are reflected in the economically absurd, and largely rejected, “innovator liability” theory that would require branded drug manufacturers to warn about risks of competing generic products (immunized by preemption). See, e.g., our Innovator Liability Scorecard. An earlier example, that thankfully seems to have largely run its course, is “market share liability,” which would create industry-wide warning liability in situations where plaintiffs couldn’t prove which manufacturers’ drug they took. A 50-state survey of ours from 2010 hasn’t changed much, except for Wisconsin having since abolished the theory through legislation. See Wis. Code §895.046(3-4) (added in 2011).
To counter the continuing threat of non-manufacturer warning liability, we offer the following discussion of the law.
We start in our sandbox, with prescription medical product liability litigation. As our scorecard demonstrates, courts overwhelmingly reject attempts to create the “innovator liability” form non-manufacturer prescription drug warning liability. In Huck v. Wyeth, Inc., the Iowa Supreme Court cautioned:
It may well be foreseeable that competitors will mimic a product design or label. But, we decline [plaintiff’s] invitation to step onto the slippery slope of imposing … liability on manufacturers for harm caused by a competitor’s product. Where would such liability stop?
850 N.W.2d 353, 380 (Iowa 2014) (citation omitted). Similarly, McNair v. Johnson & Johnson, 818 S.E.2d 852 (W. Va. 2018), held:
[W]hile our law states that manufacturers are subject to the duty to warn about the risks of their products, the generic drug in this case is not a product of the brand manufacturer. Consequently, brand manufacturers cannot be held strictly liable for failure to warn of another manufacturer’s product.
Id. at 861. Liability for other manufacturers’ products “stretches foreseeability too far.” McNair, 818 S.E.2d at 862. For convenience, here is a current list of all other appellate authority rejecting innovator liability (see the Scorecard for trial level decisions). Forest Laboratories, LLC v. Feheley, 296 So.3d 302, 315 (Ala. 2019) (a “manufacturer cannot be held liable for injury caused by a product it did not manufacture”); Rafferty v. Merck & Co., 92 N.E.3d 1205, 1213 (Mass. 2018) (“a manufacturer may be found liable for a failure to warn only where the product that caused the injury was made by that manufacturer”); Johnson v. Teva Pharmaceuticals USA, Inc., 758 F.3d 605, 614-15 (5th Cir. 2014) (applying Louisiana law); In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 938, 941-54 (6th Cir. 2014) (applying the laws of 22 states); Eckhardt v. Qualitest Pharmaceuticals, Inc., 751 F.3d 674, 681 (5th Cir. 2014) (applying Texas law); Lashley v. Pfizer, Inc., 750 F.3d 470, 476-78 (5th Cir. 2014) (applying Mississippi & Texas law); Schrock v. Wyeth, Inc., 727 F.3d 1273, 1284 (10th Cir. 2013) (applying Oklahoma law); Fullington v. PLIVA, Inc., 720 F.3d 739, 744 (8th Cir. 2013) (applying Arkansas law); Guarino v. Wyeth, 719 F.3d 1245, 1251-53 (11th Cir. 2013) (applying Florida law); Smith v. Wyeth, Inc., 657 F.3d 420, 423-24 (6th Cir. 2011) (applying Kentucky law); Foster v. American Home Products Corp., 29 F.3d 165, 168-71 (4th Cir. 1994) (applying Maryland law); Moretti v. Wyeth, Inc., 579 F. Appx. 563, 564-65 (9th Cir. 2014) (applying Nevada law); PLIVA, Inc. v. Dement, 780 S.E.2d 735, 743 (Ga. App. 2015); Franzman v. Wyeth, Inc., 451 S.W.3d 676, 689-92 (Mo. App. 2014) (applying Kentucky law); Stanley v. Wyeth, Inc., 991 So.2d 31, 34-35 (La. App. 2008); Flynn v. American Home Products Corp., 627 N.W.2d 342, 350 (Minn. App. 2001). Only California has allowed innovator liability on anything less than intentional conduct. See T.H. v. Novartis Pharmaceuticals. Corp., 407 P.3d 18, 27- 40 (Cal. 2017).
Other prescription medical product cases have rejected non-manufacturer warning liability in the context of comparative warning claims. Yates v. Ortho-McNeil-Janssen Pharmaceuticals, Inc., 808 F.3d 281 (6th Cir. 2015) (applying New York law), held that drug manufacturers’ warning duties did not extend to allegedly lower risks of competing drugs. Warning duties existed only about a product’s own risks, “not to different drugs treating the same ailment.” Id. at 291-92. Earlier, Pluto v. Searle Laboratories, 690 N.E.2d 619 (Ill. App. 1997), rejected the same argument, finding no duty to warn about the comparative risks of “competing products”:
[Defendant] is under no duty to provide information on other products in the marketplace. Such a duty would require drug manufacturers to rely upon the representations made by competitor drug companies. This arrangement would only lead to greater liability on behalf of drug manufacturers that were required to vouch for the efficacy of a competitor’s product.
Id. at 621. Accord Nelson v. C.R. Bard, Inc., 553 F. Supp.3d 343, 355 (S.D. Miss. 2021) (refusing to take the “slippery slope” of requiring warnings “of danger compared with other products”), aff’d, 44 F.4th 277 (5th Cir. 2022). See Ackley v. Wyeth Laboratories, 919 F.2d 397, 405 (6th Cir. 1990) (manufacturer “not obligated to provide a comparison of its drug with others”) (applying Ohio law); Batoh v. McNeil-PPC, Inc., 167 F. Supp.3d 296, 314 (D. Conn. 2016) (defendant owed no duty to warn “about a product that it did not make or sell”); Adamson v. Ortho-McNeil Pharms., Inc., 463 F. Supp.2d 496, 504 (D.N.J. 2006) (“courts have routinely held that competitors have no duty to advertise or sell a competitor’s products”); Smith v. Wyeth Laboratories, Inc., 1986 U.S. Dist. Lexis 21331, at *28 (S.D.W. Va. Aug. 21, 1986) (“no authority for [plaintiffs’] argument that a drug manufacturer may be required to represent that other drugs with similar effects are safer”).
Additional medical product decisions rejecting non-manufacturer warning claims in other situations are: Johnson v. American Cyanamid Co., 718 P.2d 1318, 1326 (Kan. 1986) (rejecting claim that defendant “did not provide information on alternate vaccines”); Martinez v. Medical Depot, Inc., 434 F. Supp. 3d 537, 547 (S.D. Tex. 2020) (“no duty to warn or instruct about another manufacturer’s products, though those products might be used in connection with the manufacturer’s own products”) (citation and quotation marks omitted); Kapps v. Biosense Webster, Inc., 813 F. Supp.2d 1128, 1158 (D. Minn. 2011) (defendant “does not reprocess its own” devices; therefore no duty to warn of risks of third-party reprocessing); Doe v. Ortho-Clinical Diagnostics, Inc., 335 F. Supp.2d 614, 626-27 (M.D.N.C. 2004) (knowledge “that other manufacturers were copying [defendant’s] expired patent” did not create duty to warn).
Going outside our sandbox, we continue with the seemingly perpetual plague of asbestos litigation, which has turned to non-manufacturer warning liability as the funds of actual asbestos manufacturers were depleted by endless litigation and liability. In Air & Liquid Systems Corp. v. DeVries, 586 U.S. 446 (2019), the not-so-business-friendly Supreme Court allowed limited non-manufacturer warning liability in a maritime law case, while invoking “[m]aritime law’s longstanding solicitude for sailors.” Id. at 456. The limited duty in DeVries exists only “when: (i) a manufacturer directs that the part be incorporated; (ii)...
