There is still a lot of 2026 left, and the Blog has already published two posts discussing (among other things) informed consent claims brought against manufacturers of prescription medical products.  The first post reviewed Graw v. Eli Lilly & Co., 821 F. Supp.3d 981 (E.D. Mo. 2026), where the plaintiff unsuccessfully brought such a claim against the manufacturer sponsor of a clinical trial involving an investigational drug.

[Plaintiff] has not shown that [the manufacturer/clinical trial sponsor] is a “medical practitioner” as defined by [state] law.  To adequately plead lack of informed consent, a plaintiff must plausibly allege whether a reasonable person in plaintiff’s position would have consented to the procedure had the treating medical practitioner made the proper disclosures of the risks and alternatives. . . .  Moreover, [plaintiff] fails to plausibly allege why [the manufacturer], as opposed to [actual healthcare providers], would have been responsible for disclosing the information.  As [the manufacturer] points out, in the clinical trial context, the investigator is typically responsible for obtaining the participants’ informed consent. . . .  [Plaintiff] has not sufficiently alleged why she should be able to sustain a lack of informed consent claim against [the manufacturer].

Id. at 994-95 (citation and quotation marks omitted) (emphasis original).  The second post did the same with Petty v. Schwartz, 2026 WL 2806936 (N.Y. Sup. Sept. 1, 2026), which rejected informed consent as a viable theory against the manufacturer of an implantable medical device.

Plaintiff concedes that . . . manufacturers were not medical practitioners and that the decedent was not their patient for [New York law]. . . .  [T]he complaint does not state causes of action based upon [the manufacturer’s] alleged failure to warn [the implanting surgeon] and the wider medical community of the risks associated with the implant of which it knew, or, in the exercise of reasonable care, should have known to exist.  [Defendant], as the manufacturer of the implant, cannot be held liable for lack of informed consent.

Id. at *3 (citations omitted).

We reviewed our nearly two decades of blogposts and determined that we have never comprehensively researched precedent on this question – informed consent claims against manufacturers of prescription medical products.  Rather, our research posts on informed consent have focused on judicial rejection of informed consent claims against healthcare providers in off-label use cases concerning FDA regulatory status.  So rather than beat that very dead horse, we decided to research informed consent precedent involving manufacturers.  In that regard, Graw and Petty are very much in the judicial mainstream.

We start with Moore v. Regents of University of California, 793 P.2d 479 (Cal. 1990).  Most lawyers, if they’re familiar with Moore, know it as a case that expanded physician informed consent obligations, but in Moore, the plaintiff also sued several non-physician defendants, including a drug company involved in developing a “cell line” derived from the plaintiff’s tissue.  Id. at 482.  Plaintiff sought to assert the informed consent claims against all of the defendants, but Moore said no.  Against anyone other than treating doctors, the California Supreme Court held that informed consent was not a viable cause of action.  “The [other defendants], and [the drug company] are not physicians. . . .  [N]one of these defendants stood in a fiduciary relationship with [plaintiff] or had the duty to obtain [plaintiff’s] informed consent to medical procedures.”  Id. at 486.

That’s one.  Several federal courts of appeals agree.  “[I]t is not the manufacturer’s job to ensure the patient gave ‘informed consent’ to a medical procedure when a learned intermediary is involved.”  Cates v. Zeltiq Aesthetics, Inc., 73 F.4th 1342, 1350 (11th Cir. 2023) (applying Florida law).  Informed consent claims “have little merit against” an investigational drug manufacturer because “under the FDA’s regulatory scheme it is not the pharmaceutical companies that are charged with ensuring trial participants’ well being.”  Abney v. Amgen, Inc., 443 F.3d 540, 551 (6th Cir. 2006) (applying Kentucky law).  “[T]he predicate of a claim for informed consent addresses the duty of the physician, not the manufacturer, to the patient.”  Gile v. Optical Radiation Corp., 22 F.3d 540, 551 (3d Cir. 1994) (citation omitted) (applying New Jersey law).  See also Anderson v. George H. Lanier Memorial Hospital, 982 F.2d 1513, 1516, 1520 (11th Cir. 1993) (holding that the district court’s determination “federal law did not impose a duty upon [a manufacturer/sponsor] to ensure that its ‘investigators’ obtained informed consent from each subject of the study” was “without an error of law”) (applying Alabama law).  As these appellate cases demonstrate, informed consent claims against prescription medical product manufacturers arise as often in the investigational context as they do with products that the FDA has decided can be generally prescribed.

For similar reasons, Lewis v. Intermedics Intraocular, Inc., 56 F.3d 703 (5th Cir. 1995) (applying pre-LPLA Louisiana law), rejected an informed consent claim against a device manufacturer – but on statutory grounds, since Louisiana doesn’t recognize common law in this area:

Louisiana, being a Civil Law state, would not recognize a common law duty on the part of a manufacturer to obtain informed consent. . . .  The Louisiana Uniform Consent Law clearly does not apply to manufacturers. . . .  [O]nly a physician or health care provider who will actually perform the procedure is required to obtain informed consent. . . .  Moreover, we also note that Gile provides support for our determination that an informed consent claim does not automatically flow from an assertion of negligence. . . .  Although Gile did not arise in Louisiana, it is illustrative of the concept that a general tort duty not to be negligent is not enough to bring a manufacturer within the purview of an informed consent claim.  Based upon the above, we conclude that Louisiana law does not recognize plaintiffs’ state claims against [the manufacturer] for failure to obtain informed consent.

Id. at 707-08 (citations omitted).  Lewis has been followed as an accurate statement of Louisiana law.  Touchet v. Ace Medical Co., 1998 WL 531887, at *8 (E.D. La. Aug. 24, 1998) (plaintiff’s informed consent claim “does not implicate [the manufacturer/sponsor’s] wrongdoing, but questions her doctors’ judgment”); Borskey v. Medtronics, 1998 WL 122602, at *4 (E.D. La. March 18, 1998) (“The LPLA clearly preclude[s] plaintiffs’ cause of action against the manufacturer for failure to obtain informed consent, because the LPLA contains no provision for such a cause of action.”); McMurtrie v. Iolab Corp., 914 F. Supp. 1372, 1374 (E.D. La. 1995) (applying Louisiana law) (“Louisiana law does not recognize a cause of action against a manufacturer for failure to obtain informed consent”).

The only other state appellate decision on point is Salva v. Blum, 716 N.Y.S.2d 527, 528 (N.Y. App. Div. 2000), finding “lack of viability of the cause of action for lack of informed consent against [manufacturer] defendants.”  Id. at  528 (citations omitted).

Lack of informed consent is not a theory of liability upon which an injured person may sue the manufacturer of a defective product.  Defendants are not medical practitioners, nor was decedent their patient.

Id.  See also Wholey v. Amgen, Inc., 86 N.Y.S.3d 16, 17 (N.Y. App. Div. 2018) (holding generally that, “[a]s the sponsors of a clinical trial, [sponsor] defendants owed no duty to . . . an enrollee in the trial”; not specifically mentioning informed consent).  Thus, the result in Petty under New York law was hardly a surprise.

Several other New York decisions agree, including Chandler v. Janssen Pharmaceuticals, Inc., 322 F. Supp.3d 314 (E.D.N.Y. 2018).

[T]hat Plaintiff’s guardian, according to her affirmation, would not have consented to the [drug] prescription had [her physician] advised her of the risk . . . is irrelevant to Plaintiff’s claims against Defendants.  [citing Salva]  A failure to obtain informed consent might be a viable theory of liability against the physician or the hospital where the operation was performed.  However, neither . . . is a party to this lawsuit.

Id. at 329.  Accord Gioia v. Janssen Pharmaceuticals, 2021 WL 602683, at *2 (E.D.N.Y. Feb. 16, 2021) (“a failure to obtain informed consent might be a viable theory of liability against the physician who prescribed the medication, however, it is not a sufficient basis to hold a manufacturer liable”) (citations omitted); Fleming v. Endo International PLC, 2019 WL 4378964, at *4 (S.D.N.Y. Aug. 27, 2019) (informed consent allegations insufficient under learned intermediary rule to state warning claim against drug manufacturer); Tomaselli v. Zimmer, Inc., 2017 WL 2820065, at *5 (Mag. S.D.N.Y. Jan. 20, 2017) (plaintiff’s “affirmation that she would not have consented to the surgery had [her surgeon’ advised her of the [relevant] risk is irrelevant to her claims against the defendant manufacturer”), adopted, 2017 WL 1011492 (S.D.N.Y. March 15, 2017), aff’d, 728 F. Appx. 41 (2d Cir. 2018); Greenwood v. Tehrani, 2017 WL 4083099, at *3 (N.Y. Sup. Sept. 15, 2017) (“Lack of informed consent is not a theory of liability upon which an injured person may sue the manufacturer of a defective product.”) (quoting Salva).

A number of other federal and state trial courts have also considered informed consent claims asserted against prescription medical product manufacturers and likewise concluded that they are legally impermissible.  Kernke v. The Menninger Clinic, Inc., 173 F. Supp.2d 1117 (D. Kan. 2001), considered an informed consent claim arising in the investigational drug context, and held informed consent “duties do not rest with” the manufacturer/sponsor of the clinical trial.  Id. at 1124.

All of the duties alleged by plaintiffs in this case fall within the purview of the [health care provider] defendants as the investigator conducting the . . . study; the duties do not rest with [the manufacturer/sponsor]. . . .  [I]nformed consent is the duty of the physician and not the manufacturer. . . .  For that reason, the court grants summary judgment to [the manufacturer] on plaintiffs’ negligence claim.

Id. (following Gile and Anderson, other citations omitted).

Otis-Wisher v. Fletcher Allen Health Care, Inc., 951 F. Supp.2d 592, 602 (D. Vt. 2013), aff’d, 616 F. Appx. 433 (2d Cir. 2015), rejected an informed consent claim purportedly about a physician’s financial ties with the manufacturer.

[The manufacturer], however, is a different question.  Vermont law defines lack of informed consent as the failure to disclose to the patient such alternatives thereto and the reasonably foreseeable risks and benefits involved in the professional treatment.  Plaintiff’s claim regarding the relationship between her doctor and [the manufacturer] fails to state a viable claim for lack of informed consent because it does not concern alternatives, risks or benefits of the treatment.

Id. at 602 (citations omitted).

Guinan v. A.I. duPont Hospital for Children, 597 F. Supp.2d 485 (E.D. Pa. 2009), rev’d on other grounds, 393 F. Appx. 884 (3d Cir. 2010), decided under Delaware law, reached the same result.  The Delaware informed consent statute “place[d] the burden of obtaining informed consent on health care providers, not manufacturers.”  Since the defendant manufacturer was “not a health care provider[, t]herefore [it] had no duty to obtain informed consent from Plaintiff.”  Id. at 501 (statutory citations omitted).  See Gobin v. Eli Lilly & Co., 2026 WL 1728155, at *1 (S.D. Ind. May 27, 2026) (“inadequate-informed-consent component” of plaintiff’s complaint dismissed because there is “no Indiana authority that imposes a duty of care on a clinical study sponsor, which is what [defendant] is”); Cantwell v. De La Garza, 2019 WL 2166541, at *3 (W.D. Okla. May 17, 2019) (informed consent claim dismissed against device manufacturer; manufacturer “had no duty to obtain her informed consent to the procedure”); Mink v. Smith & Nephew, Inc., 145 F. Supp.3d 1208, 1217 (S.D. Fla. 2015) (“federal post-approval study requirements . . . obligate the physician ‘investigator,’ not the manufacturer, to obtain the patient’s informed consent”), aff’d in part & rev’d in part on other grounds, 860 F.3d 1319 (11th Cir. 2017); Sykes v. United States, 2011 WL 3739017, at *17 (Mag. S.D. Ohio July 22, 2011) (informed consent “claims fail as a matter of law because the pharmaceutical defendants owed no legal duty to the decedent under” Ohio law because the “tort of lack of informed consent applies only to physicians and hospitals”) (citation and quotation marks omitted), adopted, 2011 WL 3739306 (S.D. Ohio Aug. 24, 2011), aff’d, 507 F. Appx. 455, 462 (6th Cir. 2012) (quoting and following Abney); Dyer v. Danek Medical, Inc., 115 F. Supp.2d 732, 742 (N.D. Tex. 2000) (“The informed consent standard, however, applies to negligence actions against physicians, rather than failure to warn actions against product manufacturers and suppliers.) (citation omitted); cf. Knoth v. Apollo Endosurgery US, Inc., 425 F. Supp.3d 678, 688 (S.D. Miss. 2019) (when brought against a product manufacturer, an informed consent claim is subsumed by Mississippi’s product liability statute).  See also Dare v. Isner, 2005 WL 6000374, at ??? (Mass. Super. Nov. 15, 2005) (clinical trial “sponsor[] did not directly owe specific duties to” study participant, such as “obtaining the informed consent of each human subject”).

We found only two contrary cases, which we are not citing because we don’t believe in doing the other side’s research for them.

If any reader is currently litigating an informed consent claim against a prescription medical product manufacturer, here’s what can beat it.  Otherwise, just keep this research handy – because you never know when you might encounter such a case.