To say that we’re not big fans of the “consumer expectation” test in prescription medical product liability litigation is a gross understatement. That supposed “test” for design defect – the Third Restatement expressly ditched it as a separate test, Restatement (Third) of Torts, Products Liability §2, comment g (1998) – exists primarily to let plaintiffs claim they never expected that any product would ever injure them, no matter how badly they misused it. So again and again, we’ve decried the consumer expectation “test” on the Blog.
But at least in some states, the learned intermediary rule ameliorates the consumer expectation test in our sandbox – by considering the relevant “consumer” to be the physician to whom a drug or device warning is directed. Generally speaking, consumers of prescription medical products lack any expectations about the performance and safety of those products other than what their physicians tell them. Thus, quite a few courts have held that, in the context of prescription medical products, the physician is actually the “consumer” or the “intended user” of such products.
We start with the California Supreme Court, which has held repeatedly that a consumer’s “expectations regarding the effects of a prescription drug or medical device are those related to the patient by his or her physician.” Himes v. Somatics, LLC, 549 P.3d 916, 923 (Cal. 2024) (citation and quotation marks omitted).
We emphasize, . . . that the “consumer expectation” aspect of a breach of warranty action is subject, in the prescription drug context, to the general rule . . . that warnings concerning the drug’s properties are properly directed to the physician rather than the patient. Thus, for purposes of liability for breach of warranty, ordinarily it is the prescribing doctor who in reality stands in the shoes of ‘the ordinary consumer.
Carlin v. Superior Court, 920 P.2d 1347, 1355 (Cal. 1996) (citations and quotation marks omitted). Thus:
We agree that the ‘consumer expectation’ . . . test is inappropriate to prescription drugs. While the ‘ordinary consumer’ may have a reasonable expectation that a product such as a machine he purchases will operate safely when used as intended, a patient’s expectations regarding the effects of such a drug are those related to him by his physician, to whom the manufacturer directs the warnings regarding the drug’s properties.
Brown v. Superior Court, 751 P.2d 470, 477 (1988) (footnote omitted). See also Amiodarone Cases, 300 Cal. Rptr.3d 881, 895 (Cal. App. 2022); Trejo v. Johnson & Johnson, 220 Cal. Rptr.3d 127, 156 (Cal. App. 2017); Valentine v. Baxter Healthcare Corp., 81 Cal. Rptr.2d 252, 263 (Cal. App. 1999); Plenger v. Alza Corp., 13 Cal. Rptr.2d 811, 816 (Cal. App. 1992); Bean v. Upsher-Smith Pharmaceuticals, 765 F. Appx. 934, 936 (4th Cir. 2019) (applying South Carolina law); Crawford v. Zimmer Biomet Holdings, Inc., 2023 U.S. Dist. Lexis 30663, at *24 (E.D. Cal. Feb. 23, 2023); Kamlade v. Leo Pharma Inc., 2022 U.S. Dist. Lexis 21963, at *10 (E.D. Cal. Feb. 6, 2022); Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152, 1164 (E.D. Cal. 2019); James v. Medtronic, 2020 WL 13310413, at *6 (Cal. Super. July 23, 2020) (all quoting relevant Brown or Carlin language). Cf. Carmichael v. Reitz, 95 Cal. Rptr. 381, 401 (Cal. App. 1971) (holding that “the prescribing doctor . . . in reality stands in the shoes of the ‘ordinary consumer’”) (pre-Brown).
Likewise, in Connecticut, “[t]he anticipated awareness of an expected user with respect to the dangers of the product is not an issue in prescription drug cases because the ‘expected user’ is the physician.” Vitanza v. Upjohn Co., 778 A.2d 829, 846 (Conn. 2001). Thus, “the relevant expectations are those of the physician, not the ultimate consumer,” and “the analysis involves . . . the expectations and expertise of her prescribing physician.” Moss v. Wyeth, Inc., 872 F. Supp.2d 162, 170-71 (D. Conn. 2012). See Desmarais v. Dow Corning Corp., 712 F. Supp. 13, 18 (D. Conn. 1989) (learned intermediary rule “substitutes the physician for the consumer as the person to receive those warnings”).
In Tennessee, “for purposes of the learned intermediary doctrine, the physician stands in the place that the consumer would otherwise occupy.” Nye v. Bayer Cropscience, Inc., 347 S.W.3d 686, 705 (Tenn. 2011); see Pittman v. Upjohn Co., 890 S.W.2d 425, 430 (Tenn. 1994) (physicians considered the “users” of prescription medical products). Similarly, under Tennessee’s learned intermediary rule, “physicians are the ‘consumers’ who must be warned.” Harden v. Danek Medical, Inc., 985 S.W.2d 449, 451 (Tenn. App. 1998); accord Johnson v. Settle, 2001 Tenn. App. Lexis 412, at *25-26 (Tenn. App. June 1, 2001); Orr v. Ethicon, Inc., 2020 U.S. Dist. Lexis 252768, at *16 (E.D. Tenn. Sep. 11, 2020) (both quoting Harden).
In a broken device case under Tennessee law, Hill v. Medical Device Business Services, Inc., 2024 U.S. Dist. Lexis 140272 (M.D. Tenn. Aug. 7, 2024), recently held that the consumer expectation test could not apply to a prescription medical product.
Plaintiffs have not explained how a consumer can have reasonable expectations of a product when his or her physician is legally responsible for setting his or her expectations. Rather than a common household . . ., the Implant is a medical device as to which expectations are learned through the informed-consent process and subject to the learned-intermediary doctrine.
Id. at *58 (footnote omitted). Further, the kind of “I didn’t expect to get hurt” that testimony that plaintiffs so often get away with in ordinary product cases didn’t fly. The plaintiff’s professed “expectation” that a weightbearing implant would never break simply wasn’t reasonable.
While a breakage from fatigue fracture . . . is of course not the desired outcome, its breakage cannot be said to run contrary to reasonable consumer expectations when it is specifically within the scope of the ordinary warnings and informed consent process.
The Alaska Supreme Court “question[ed] the significance of the expectations of the ordinary consumer in determining whether strict liability should be imposed on the manufacturer of the typical prescription drug” in Shanks v. Upjohn Co., 835 P.2d 1189, 1194 (Alaska 1992). Shanks reasoned that “[c]onsumers vary widely in their knowledge, sophistication, and ability to understand and evaluate the risks associated with the use of prescription drugs, making it extremely difficult to ascertain the expectations of the ‘ordinary’ consumer” and because:
[I]it is doubtful that the average consumer has the information necessary to form a reasonable expectation regarding the performance safety of most prescription products, since neither the common law nor the Federal Food Drug and Cosmetic Act require prescription drug manufacturers to provide full warning information directly to the patient/consumer.
Id. at 1194-95. Shanks thus “conclude[d]” that “strict liability should be imposed on [a drug’s] manufacturer if the prescription drug failed to perform as safely as an ordinary doctor would expect.” Id. at 1195.
In Florida, for similar reasons, the consumer expectation test also doesn’t apply to prescription medical products. Cavanaugh v. Stryker Corp., 308 So.3d 149 (Fla. App. 2020)
[W]e hold that the consumer expectations test cannot be logically applied here, where the product in question is a complex medical device available to an ordinary consumer only as an incident to a medical procedure. After all, medical device manufacturers generally do not market their products to “ordinary consumers”. . . . The rationale for the consumer expectations test − that a manufacturer plays a central role in establishing the consumers’ expectations for a particular product, which in turn...
