New York’s consumer protection statute (N.Y. Gen. Business Law §§349-50) has a “consumer orientation” element that has largely prevented that enactment from being abused by P-side purveyors of prescription medical product class actions. We’re looking at how that works today.
The New York Court of Appeals held that, “as a threshold matter, plaintiffs claiming the benefit of section 349 . . . must charge conduct of the defendant that is consumer-oriented.” Oswego Laborers’ Local 214 Pension Fund, 647 N.E.2d 741, 744 (N.Y. 1995). The “standard of recovery” for §350, limited to “false advertising,” “is otherwise identical” to §349. Goshen v. Mutual Life Insurance Co., 774 N.E.2d 1190, 1195 n.1 (N.Y. 2002). Thus, “[t]o successfully assert a claim under . . . §349(h) or §350, a plaintiff must allege that a defendant has engaged in . . . consumer-oriented conduct.” Koch v. Acker, Merrall & Condit Co., 967 N.E.2d 675, 675 (N.Y. 2012) (citation and quotation marks omitted) (per curiam). To be considered “consumer-oriented” for purposes of the statute, conduct must “have a broad impact on consumers at large.” New York University v. Continental Insurance Co., 662 N.E.2d 763, 770 (N.Y. 1995). Thus, purely “[p]rivate . . . disputes, unique to the parties, for example, [do] not fall within the ambit of the statute.” Id. (quoting Oswego Laborers’, supra).
This “consumer oriented” requirement has significant consequences in prescription medical product liability litigation. An appellate New York decision, Wholey v. Amgen, Inc., 86 N.Y.S.3d 16 (N.Y. App. Div. 2018), construed that element in prescription medical product-related litigation, declaring that “the generally alleged deceptive practice of failing to provide adequate warnings by concealing information is, as a matter of law, not a practice directed at consumers.” Id. at 17-18.
Wholey referenced the discussion in Amos v. Biogen Idec, Inc., 28 F. Supp.3d 164, 173-74 (W.D.N.Y. 2014), a “useful” decision that we originally blogged about here. After quoting the Oswego Laborers’ holding, Amos recognized that consumer protection claims against a prescription drug fail as a matter of law, since under New York’s learned intermediary rule, purportedly inadequate drug information was directed solely to physicians. That’s important because patients are the statute’s “consumers,” whereas the learned intermediary rule directs warnings to physicians – who are not “consumers”:
[P]laintiff alleges that the defendants deceived consumers by concealing information about the dangers of taking [the drug], and that [the decedent] died as a result of the defendants deceptive practices. I find, however, that because a drug manufacturer’s duty to warn of a drug’s side effects runs to the doctor prescribing the drug, and not to the user of the drug, the issuance of drug warnings, for purposes of Section 349, is not an act directed at consumers, and therefore any alleged deceptive act related to the issuance of those warnings is not a “consumer oriented” act actionable under Section 349.
Amos, 28 F. Supp.3d at 173 (emphasis added). New York’s consumer fraud statute requires “conduct of the defendant that is “consumer-oriented.” Id. (quoting Oswego Laborers’). But under the learned intermediary rule, “a manufacturer’s duty to warn extends to a patient’s doctor” and “not to the patient himself.” Id. (citation omitted).
Accordingly, because the defendants’ alleged deceptive practice of failing to provide adequate warnings by concealing information is not, as a matter of law, a practice directed at consumers, plaintiff has failed to allege a consumer-oriented practice cognizable under Section 349.
Id. at 173-74. Thus, the New York consumer plaintiff in Amos could pursue product liability, but not consumer protection, claims. Id. at 174.
This requirement of New York’s consumer protection statute has precluded numerous claims by product liability plaintiffs. The learned intermediary rule precluded any “consumer-oriented” conduct from existing in Zottola v. Eisai, Inc., 564 F. Supp.3d 302 (S.D.N.Y. 2021). Plaintiffs alleged no more than “deceptive, unfair, and misleading acts and practices” through misrepresentations to physicians about the safety of a drug. Id. at 311.
But under the “informed intermediary” doctrine, it was the duty of doctors − not Defendants − to disclose the Medications’ cancer risks to patients, i.e., consumers. Accordingly, and as a matter of law, Defendants’ alleged deception by failing to disclose the Medications’ . . . risks was not “consumer-oriented” conduct.
Id. (citations omitted). Plaintiff’s attempt to avoid the learned intermediary rule failed in Zottola:
Plaintiff counters that it is “wrong” to apply the “informed intermediary” doctrine here, because [defendant’s drug] was not a “life-saving medication,” and instead, was “more akin to a consumer product.” But Plaintiff’s purported exception to the “informed intermediary” doctrine for non-lifesaving medications fails for two reasons. . . . Second, the nature of the drug is irrelevant to the Court’s analysis, because what matters is whether Defendants’ conduct was consumer-oriented − not whether the Medications themselves were. As the “informed intermediary” doctrine makes clear, Defendants’ alleged conduct here, i.e., “[t]he generally alleged deceptive practice of failing to provide adequate warnings [for a prescription drug] by concealing information is, as a matter of law, not a practice directed at consumers.” Accordingly, Plaintiff fails to plausibly allege that Defendants’ conduct was “consumer-oriented.”
Id. at 311-12 (quoting Wholey, supra). See Buoniello v. Ethicon Women’s Health & Urology, 2022 WL 17784995, at *14 (E.D.N.Y. Aug. 18, 2022) (“materials [that] are intended to be used by the physician . . . are in no way directed at the consumer”); Dupere v. Ethicon, Inc., 2022 WL 523604, at *8 (S.D.N.Y. Feb. 22, 2022) (failing to allege any “misleading consumer-facing statement regarding [the device]” precluded consumer protection claim); Frei v. Taro Pharmaceuticals U.S.A., Inc., 443 F. Supp.3d 456, 470 (S.D.N.Y. 2020) (quoting and following Amos), aff’d, 844 F. Appx. 444 (2d Cir. 2021); Green v. Covidien LP, 2019 WL 4142480, at *9 (S.D.N.Y. Aug. 30, 2019) (dismissing allegations that did “not quote or attach any consumer-oriented marketing material” concerning prescription-only device); Richards v. Johnson & Johnson, Inc., 2018 WL 2976002, at *9 (N.D.N.Y. June 12, 2018) (action dismissed where plaintiff “has not identified a specific advertisement” that was “directed and available to the public at large”); Aston v. Johnson & Johnson, 248 F. Supp.3d 43, 57 (D.D.C. 2017) (following Amos) (applying New York law); In re Rezulin Products Liability Litigation, 392 F. Supp.2d 597, 613 (S.D.N.Y. 2005) (third-party payors could not recover for alleged safety misrepresentations because “the nature of this marketing effort − communication from one sophisticated business to another − was quite different from that of any promotion aimed directly at . . . patients”).
Poulin v. Boston Scientific Corp., 2022 WL 18215865 (Mag. W.D.N.Y. Dec. 9, 2022), adopted, 2023 WL 146069 (W.D.N.Y. Jan. 9, 2023), applied a slightly different reasoning to reach the same result. The Poulin plaintiff’s run-of-the-mill product liability claims could not support a New York consumer protection claims because, to be “consumer-oriented,” the allegations must assert “injury . . . to the public generally as distinguished from the plaintiff alone.” Id. at *10 (citation and quotation marks omitted).
In the instant case, the allegations in the Amended Complaint fall short of alleging Defendant’s marketing of the [device] engaged in consumer-oriented conduct because there are no allegations, even broadly construed, showing Defendant engaged in any conduct having a broader impact on consumers at large.
Id. (citation omitted). Similarly, the personal injury plaintiff in Scism v. Ethicon, Inc., 2020 WL 1245349 (N.D.N.Y. March 16, 2020), was “not a consumer in the sense that New York contemplates” because “[t]he physician ultimately makes the call as to which products he or she uses,” and plaintiff “did not make those choices. Id. at *8. Thus, “a medical warning is not an act directed at consumers, but is instead directed at the prescribing physician” (quoting Amos, supra). See Pfizer, Inc. v. Stryker Corp., 2003 WL 21660339, at *4 (S.D.N.Y. Jul.15, 2003) (“Although consumers eventually stood to be affected by any defects in the product at issue, the questions whether [seller] told [buyer] the truth when it represented that the business was in compliance with law . . . are essentially private matters.”).
Also outside the scope of “consumer-oriented” conduct are allegations “that Defendants concealed information or deceived the FDA.” Dains v. Bayer HealthCare LLC, 2022 WL 16572021, at *9 (N.D.N.Y. Nov. 1, 2022); accord Gale v. Smith & Nephew, Inc., 989 F. Supp.2d 243, 250 (S.D.N.Y. 2013) (“Plaintiff alleges [defendant] deceived the FDA, but he does not explain how this allegedly improper conduct was ‘consumer-oriented.’”) (citation omitted).
Finally, in Vitolo v. Mentor H/S, Inc., 426 F. Supp. 2d 28, 34 (E.D.N.Y. 2006), aff’d, 213 F. Appx. 16 (2d Cir. 2007), a physician’s action against a medical device manufacturer for alleged reputational and other damages caused by his use of that purportedly defective product was held not “consumer-oriented” as a matter of law. Id. at 33-34.
What kind of information is within the scope of the statute’s “consumer orientation” element? We don’t do the other side’s research for them, but the kind of product-related information that could be “consumer-oriented” (but held to be non-causal) would be like the “brochure” and “website” “assumed” to meet that standard in Tears v. Boston Scientific Corp., 344 F. Supp.3d 500, 516 (S.D.N.Y. 2018).
Thus, the New York statute’s well-recognized consumer-orientation element renders it generally inapplicable to prescription-only medical products. Most information about such products is designed for physicians, not end-user consumer/patients, as per the learned intermediary rule. Unless plaintiffs are asserting something along the lines of DTC advertising, and can plead plaintiff-specific causation from such advertising, the New York statute should not be an available cause of action.