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.

Id. at *58-59.

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 motivates consumers to purchase the product − simply does not apply.

Even assuming that some version of the consumer expectations test should apply to complex medical products which are provided to a consumer through a learned intermediary, . . . the relevant expectations are those of the health care professional.

Id. at 155-56 (citations omitted).  Accord Cates v. Zeltiq Aesthetics, Inc., 535 F. Supp.3d 1222, 1230 n.15 (M.D. Fla. 2021) (following Cavanaugh), aff’d, 73 F.4th 1342 (11th Cir. 2023).  See Tillman v. C.R. Bard, Inc., 96 F. Supp.3d 1307, 1339 (M.D. Fla. 2015) (pre-Cavanaugh; “[b]ecause this case pertains to a complex medical device, accessible to the consumer only through a physician, the Court finds that the consumer-expectation test is not applicable”); Rydzewski v. Depuy Orthopaedics, Inc., 2012 U.S. Dist. Lexis 187963, at *9 (S.D. Fla. Aug. 13, 2012); In re Fosamax Products Liability Litigation, 2010 U.S. Dist. Lexis 33260, at *18 n.4 (S.D.N.Y. March 26, 2010) (same) (applying Florida law).  Cf. In re Davol, Inc./C.R Bard, Inc., Polypropylene Mesh Products Liability Litigation, 2022 U.S. Dist. Lexis 121467, at *199-200 (S.D. Ohio July 8, 2022) (instructing jury that, under the “consumer expectations test” that “the relevant consumer” is the patient’s “implanting surgeon”; “the instruction made clear that the relevant expectations were those of [the implanter], not of Plaintiffs”) (applying Florida law).

Under Pennsylvania’s learned intermediary rule, as well, “[t]he intended ‘user’ in a case involving a prescription drug or device is, of course, the prescribing physician.”  Rosci v. Acromed, Inc., 669 A.2d 959, 969 (Pa. Super. 1995).  “The purpose of the requirement that all warnings as to potential dangers associated with prescription drugs be provided to prescribing physicians is that the prescribing physicians are, in the case of prescription drugs, the actual consumers.”  Makripodis v. Merrell-Dow Pharmaceuticals, Inc., 523 A.2d 374, 378 (Pa. Super. 1987) (citation and quotation marks omitted).  Accord Lineberger v. Wyeth, 894 A.2d 141, 150 (Pa. Super. 2006); Cohen v. Johnson & Johnson, 634 F. Supp.3d 216, 238 (W.D. Pa. 2022); Moultrie v. Coloplast Corp., 2020 U.S. Dist. Lexis 45304, at *31 (W.D. Pa. March 16, 2020); Kline v. Zimmer Holdings, Inc., 2015 U.S. Dist. Lexis 88061, at *52 (W.D. Pa. Feb. 27, 2015); Brown v. Johnson & Johnson, 64 F. Supp.3d 717, 721 (E.D. Pa. 2014); Rowland v. Novartis Pharmaceuticals Corp., 34 F. Supp.3d 556, 571 (W.D. Pa. 2014); Dopson-Troutt v. Novartis Pharmaceuticals Corp., 975 F. Supp.2d 1209, 1212 (M.D. Fla. 2013) (applying Pennsylvania law); Gross v. Stryker Corp., 858 F. Supp.2d 466, 501 n.44 (W.D. Pa. 2012); Robinson v. Wolters Kluwer Health, Inc., 2011 U.S. Dist. Lexis 138597, at *8 n.2 (E.D. Pa. Dec. 2, 2011); In re Zyprexa Products Liability Litigation, 489 F. Supp.2d 230, 267 (E.D.N.Y. 2007) (applying Pennsylvania law); Soufflas v. Zimmer, Inc., 474 F. Supp.2d 737, 751 (E.D. Pa. 2007) (prescriber is “intended user”) (applying Pennsylvania law); Colacicco v. Apotex, Inc., 432 F. Supp.2d 514, 545 (E.D. Pa. 2006), aff’d on other grounds, 521 F.3d 253 (3d Cir. 2008), vacated on other grounds, 556 U.S. 1101 (2009); Burton v. Danek Medical, Inc., 1999 U.S. Dist. Lexis 2619, at *24 (E.D. Pa. March 1, 1999); Caltagirone v. Cephalon, Inc., 2017 Phila. Ct. Com. Pl. Lexis 107, at *12 (Pa. C.P. March 23, 2017, aff’d on other grounds, 190 A.3d 596 (Pa. Super. 2018); Pasqual v. I-Flow Corp., 2013 Pa. Dist. & Cnty. Dec. Lexis 15739, *18 (Pa. C.P. Oct. 15, 2013); Simon v. Wyeth Pharmaceuticals, Inc., 2010 Phila. Ct. Com. Pl. Lexis 105, at *11 (Pa. C.P. May 5, 2010) (all for the proposition that physicians are the “intended users” or “actual consumers” of prescription medical products under Pennsylvania law).

Likewise, in Washington, “the relevant ‘ordinary consumer’ under the consumer expectation test is the prescribing physician.”  Adams v. Synthes Spine Co., 298 F.3d 1114, 1119 (9th Cir. 2002) (following Terhune v. A.H. Robins Co., 577 P.2d 975, 978 (Wash. 1978)).  Thus, “[u]nder the reasonable expectation of the consumer test, the issue is whether the reasonable expectations of . . . the prescribing physician, were met.”  Id.  Accord Thomas v. C.R. Bard, Inc., 2021 U.S. Dist. Lexis 220226, at *7 (W.D. Wash. Nov. 15, 2021); Shafer v. C.R. Bard, Inc., 2021 U.S. Dist. Lexis 191190, at *8 (W.D. Wash. Oct. 4, 2021) (both following Adams).

Phelps v. Sherwood Medical Industries, 836 F.2d 296 (7th Cir. 1987), held, under Indiana law, that the prescribing physician was the “consumer” where the learned intermediary rule applied:

Here [the physician] stood in a similar position.  He received the label warning from [the defendant] and thus should certainly be considered as a “user” of the [device].  [The physician  also fits into the Restatement’s definition of “consumer” since he prepared and employed the [device] for ultimate “consumption” by [plaintiff].  Even more significantly, he utilized the [device] for the purpose of surgery.

Id. at 302-03.  Similarly, Kaiser v. Johnson & Johnson, 947 F.3d 996, 1014 (7th Cir. 2020) (applying Indiana law), “agree[d] that the relevant consumers here are [plaintiff’s] surgeons,” for purposes of the consumer expectation test in a pelvic mesh case.  Id. at 1014.  Accord Martinez v. Coloplast Corp., 2022 U.S. Dist. Lexis 27507, at *12 (N.D. Ind. Feb. 4, 2022) (under “Indiana’s learned-intermediary doctrine,” “the consumer is a physician”).

New York courts have held that, because under the learned intermediary rule, “the manufacturer’s duty is to warn the doctor, not the patient,” and “as a matter of law,” a manufacturer’s “fail[ure] to disclose [a drug’s] risks was not consumer-oriented conduct.”  Zottola v. Eisai, Inc., 564 F. Supp.3d 302, 312 (S.D.N.Y. 2021).  “[B]ecause 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 . . . is not an act directed at consumers.”  Amos v. Biogen Idec, Inc., 28 F. Supp.3d 164, 173 (W.D.N.Y. 2014).  See Buoniello v. Ethicon Women’s Health & Urology, 2022 WL 17784995, at *14 (E.D.N.Y. Aug. 18, 2022) (instructional “materials [that] are intended to be used by the physician . . . are in no way directed at the consumer”).

Decisions under other states’ laws have also concluded the prescribing physicians, not lay patients, are the true “consumers” of prescription medical products.  See Craft v. Peebles, 893 P.2d 138, 155 (Haw. 1995) (learned intermediary rule “substitutes the physician for the consumer as the person to receive those warnings”); Peterson v. Parke Davis & Co., 705 P.2d 1001, 1003 (Colo. App. 1985) (product “user” of a prescription drug was the “attending physician” for purposes of misuse); James v. Coloplast Corp., 2022 U.S. Dist. Lexis 173766, at *15 (D. Minn. Sept. 26, 2022) (under Oklahoma law, “the ordinary consumers of the [prescription medical device] are the implanting surgeons” because such expectations are “evaluated from the perspective of the typical user”); In re Ethicon Pelvic Repair Systems Products Liability Litigation, 2014 U.S. Dist. Lexis 15288, at *2562 (S.D. W. Va. Feb. 3, 2014) (“adopt[ing]” defendant’s argument that “consumer” and “user” in the context of the learned intermediary rule “refer to the physician, not the patient, in a medical device case”) (applying Texas law); St. Clair v. Nellcor Puritan Bennett LLC, 2011 U.S. Dist. Lexis 128842, at *20 (D. Ariz. Nov. 7, 2011) (“the consumer in this case [are] the medical professionals who used the” prescription device).

Finally, even under Nebraska law, which ostensibly does apply the consumer expectation test in prescription drugs, the plaintiff in Thelen v. Somatics, LLC, 672 F. Supp. 3d 1216 (M.D. Fla. 2023), could not avoid summary judgment by relying solely on his own purported expectations.  Id. at 1227 (plaintiff “presented no evidence” when he merely “point[ed] to his own expectations, which may or may not reflect the ‘ordinary knowledge common to the community’”).

Keep in mind that, in assessing this research, the issue may well not even be pertinent in a lot of states – those that for other reasons (including statutory prohibitions) do not apply the consumer expectation test in the context of prescription medical products.