United States: The Learned Intermediary Rule In Consumer Protection Claims

Last Updated: October 17 2016
Article by James Beck
Most Read Contributor in United States, October 2017

We recently posted about a new California decision that was notable, in part, because it applied the learned intermediary rule to often-asserted (and equally often abused) California consumer protection statutes. See Andren v. Alere, Inc., 2016 WL 4761806, at *9 (S.D. Cal. Sept. 13, 2016) (where "misrepresentations and omissions claims are based on a failure to warn" the learned intermediary rule applies" to claims under the two major California consumer protection statutes (CLRA & UCL)). Since we haven't addressed this issue recently (one guest post from 2007), we thought it would be a good idea to examine more generally decisions that also apply the learned intermediary rule to consumer fraud claims. Andren is definitely not an outlier, although in a lot of states precedent is not extensive.

We'll start with California. We know of several other cases reaching essentially the same result. One of them, Saavedra v. Eli Lilly & Co., 2013 WL 3148923, at *3-4 (C.D. Cal. June 13, 2013), is mentioned in Andren. Saavedra, a multi-plaintiff case also applying the laws of Massachusetts and Missouri (in addition to California), found the learned intermediary rule applicable to all three states' consumer protection statutes, based on uniform precedent:

Every case that this Court has found, and that the parties have identified, that has specifically addressed the questions has found that the learned intermediary doctrine applies to consumer protection claims predicated on a failure to warn.

Id. at *3. Thus, Saavedra "concur[ed] with the great weight of authority and conclude[d] that the learned intermediary doctrine applies to the consumer protection claims at issue."

Another relevant California case was not cited in Andren − the appellate decision in In re Vioxx Class Cases, 103 Cal. Rptr. 3d 83 (Cal. App. 2009). Vioxx held that the individual actions of learned intermediary prescribers physicians precluded class certification in cases under the same statutes:

[A]ll physicians are different and obtain their information about prescriptions from myriad sources. . . . [P]hysicians consider many patient-specific factors in determining which drug to prescribe, including the patient's history and drug allergies, the condition being treated, and the potential for adverse reactions with the patient's other medications − in addition to the risks and benefits associated with the drug. When all of these patient-specific factors are a part of the prescribing decision, the materiality of any statements made by [defendant] to any particular prescribing decision cannot be presumed.

Id. at 99 (footnote omitted). Thus, the Vioxx court presumed, albeit without holding, that the learned intermediary rule applied so that the physicians – rather than patients – are the recipients of information from manufacturers of prescription medical products. For other similar California law cases, see Weiss v. Astrazeneca Pharmaceuticals, 2010 WL 3387220, at *5 (Cal. App. Aug. 30, 2010) (similar result in unpublished affirmance of UCL/CLRA class certification denial); In re Yasmin & Yaz (Drospirenone) Marketing, Sales Practices & Products Liability Litigation, 2012 WL 865041, at *20 (S.D. Ill. March 13, 2012) (denying class certification under UCL "[b]ecause [the drug] is a prescription medication, [so] the question of uniformity must consider representations made to each putative class member and her prescribing physician") (applying California law); In re Celexa & Lexapro Marketing & Sales Practices Litigation, 751 F. Supp.2d 277, 288 (D. Mass. 2010) (applying learned intermediary prescriber-centric causation principles to UCL; denying summary judgment) (applying California law); In re Paxil Litigation, 218 F.R.D. 242, 246 (C.D. Cal. 2003) (rejecting argument that the learned intermediary rule "becomes irrelevant under [the UCL]").

As discussed in Saavedra, the learned intermediary rule has been applied to consumer protection actions in other states, such as Texas. The primary decision cited in Saavedra is In re Norplant Contraceptive Products Liability Litigation, 955 F. Supp. 700 (E.D. Tex. 1997), aff'd, 165 F.3d 374 (5th Cir. 1999), also holding that consumer protection claims are subject to the learned intermediary rule where brought against manufacturers of prescription medical products:

The gravamen of all of Plaintiffs' causes of action, including . . . violation of the DTPA [the Texas consumer fraud statute], is that [Defendant] failed to adequately warn of or disclose the severity of [the implant's] side effects. Therefore, the learned intermediary doctrine applies to all of Plaintiffs' causes of action. Additionally, whether the failure to warn is couched as an affirmative misrepresentation or a misrepresentation by concealment, the allegation collapses into a charge that the drug manufacturer failed to warn. If the doctrine could be avoided by casting what is essentially a failure to warn claim under a different cause of action such as violation of the DTPA or a claim for misrepresentation, then the doctrine would be rendered meaningless. Therefore, this summary judgment motion, based upon application of the learned intermediary doctrine, is dispositive of all of Plaintiffs' claims.

Id. at 709. On appeal, the Fifth Circuit affirmed specifically on this point, making an "Erie guess" that Texas would apply the learned intermediary rule to its consumer protection statute. In re Norplant Contraceptive Products Liability Litigation, 165 F.3d 374, 378 (5th Cir. 1999).

Guessing, however, is no longer necessary in Texas. In Centocor, Inc. v. Hamilton, 372 S.W.3d 140 (Tex. 2012), the Texas Supreme Court adopted the Norplant decision's reasoning in toto – including the block quotation from above. "If the [learned intermediary rule] could be avoided by casting what is essentially a failure to warn claim under a different cause of action such a violation of the DTPA . . ., then the doctrine would be rendered meaningless." Id. at 168. Thus, the Centocor court concluded, "We find the Norplant I court's application of Texas law persuasive." Id. at 169. Whenever "the crux" of the claim "rests on [the defendant's] alleged failure to provide an adequate warning of the potential risks and side effects" of a prescription medical product, "the learned intermediary doctrine applies." Id. See also Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 94 (Tex. App. 2000) (agreeing with Norplant); Bean v. Baxter Healthcare Corp., 965 S.W.2d 656, 664 (Tex. App. 1998) (applying learned intermediary rule to consumer protection case without discussion); Jordan v. Geigy Pharmaceuticals, 848 S.W.2d 176, 182 (Tex. App. 1992) (learned intermediary prescriber-centric evaluation of DTPA claim); Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 814 (S.D. Tex. 2013) (following Centocor); Johnson v. Medtronic, Inc., 2005 WL 1515402, at *3 (S.D. Tex. June 23, 2005) ("[t]he learned intermediary doctrine applies to all causes of action, including DTPA violations, based on a failure to warn"); Rivera v. Wyeth-Ayerst Laboratories, 121 F. Supp.2d 614, 620 (S.D. Tex. 2000) ("the learned intermediary doctrine applies to claims under the DTPA"), reversed on other grounds, 283 F.3d 315 (5th Cir. 2002); Dyer v. Danek Medical, Inc., 115 F. Supp.2d 732, 740-41 (N.D. Tex. 2000) ("learned intermediary doctrine applies to all causes of action, including . . . DTPA violations, based on a failure to warn"); A.B. vs. Ortho-McNeil-Janssen Pharmaceuticals, 2013 WL 2917651, at *26-27 (Pa. C.P. April 5, 2013) ("the LID properly applies to Plaintiffs' DTPA claim" under Texas law); Banks vs. Ortho-McNeil-Janssen Pharmaceuticals, 2013 WL 2321107, at *20-21 (Pa. C.P. April 5, 2013) (same).

Pennsylvania is another state with numerous decisions applying the learned intermediary rule in consumer protection cases. A recent decision sums up the relationship between the two in Pennsylvania:

Under Pennsylvania law, a medical device manufacturer has a duty to warn implanting physicians about the dangers of a medical device, but has no duty to warn patients directly. . . . Because a medical device manufacturer does not have a duty to disclose information directly to the consumer under Pennsylvania law, a consumer does not have a cause of action under the UTPCPL [the Pennsylvania consumer fraud statute] against the manufacturer of a medical device. This is because the UTPCPL requires proof of justifiable reliance and causation, and such requirements cannot be present when the defendant is a medical device manufacturer that did not sell its product directly to the patient or have a duty to warn the patient directly. As one court has further explained, the "learned intermediary [i.e., the doctor] breaks the chain in terms of reliance, since the patient cannot obtain [a] prescription [device] without the physician no matter what [the patient] believe[s] about [the device]." Thus, it is only the prescribing physician who can provide the grounds for justifiable reliance" under the UTPCPL.

McLaughlin v. Bayer Corp., ___ F. Supp.3d ___, 2016 WL 1161578 (E.D. Pa. March 22, 2016). McLaughlin cited numerous other UTPCPL/learned intermediary rule cases for these propositions: In re Avandia Marketing, Sales, Practices & Products Liability Litigation, 2013 WL 3486907, at *2 (E.D. Pa. July 10, 2013); Kee v. Zimmer, Inc., 871 F. Supp.2d 405, 411 (E.D. Pa. 2012); In re Avandia Marketing, Sales Practices & Products Liability Litigation, 2011 WL 4006639 (E.D. Pa. Sept. 7, 2011); Zafarana v. Pfizer, Inc., 724 F. Supp.2d 545, 558 (E.D. Pa. 2010); Kester v. Zimmer Holdings, Inc., 2010 WL 2696467, at *14 (W.D. Pa. June 16, 2010); Heindel v. Pfizer, Inc., 381 F. Supp.2d 364, 384 (D.N.J. 2004) (applying Pennsylvania law). Accord In re Avandia Marketing, Sales Practices & Products Liability Litigation, 2011 WL 4007858, at *2-3 (E.D. Pa. Sept. 7, 2011) (reaching same result as other Avandia cases); Smith v. Bristol-Myers Squibb Co., 2009 WL 5216982, at *6 (D.N.J. Dec. 30, 2009) ("It is clear that the learned intermediary doctrine indeed operates to bar Plaintiff's UTPCPL claim") (applying Pennsylvania law).

Numerous Pennsylvania state trial courts (all in Philadelphia County) have reached the same result. In Albertson v. Wyeth, Inc., 63 Pa. D. & C. 4th 514 (Pa. C.P. Phila. Co. 2003), the court held:

Under the learned intermediary doctrine, a manufacturer of prescription drugs must direct information and warnings to prescribing physicians, not the patient. There can be no cause of action based on defendants' alleged omissions because defendants had no duty to disclose any information directly to plaintiff.

Further, to permit a cause of action under the UTPCPL in this case would effectively make a drug manufacturer the absolute guarantor of the anticipated results and effects of a prescription drug. Pennsylvania law, however, recognizes that some prescription drugs by their very nature can never be made safe. An inconsistency would result if we were to hold that drug manufacturers must guarantee that prescription drugs are completely safe. The premise behind the UTPCPL was not meant to engender such a result.

Id. at 538-39 (quoting and following Luke v. American Home Products Corp., 1998 WL 1781624, at *8 (Pa. C.P. Phila. Co. Nov. 18, 1998)) (other citations omitted). Accord S.B. vs. Ortho-McNeil-Janssen Pharmaceuticals, No. 10053629, 2013 WL 3286808, at *26 n.173 (Pa. C.P. June 12, 2013) (following Albertson and Luke); Pennsylvania Employees Benefit Trust Fund v. Eli Lilly & Co., 2008 WL 7259683 (Pa. C.P. Phila. Co. May 5, 2008) ("Count II (UTPCPL) is barred by the learned intermediary doctrine and is dismissed"); Greenwood v. Pennsylvania Hospital, 1999 WL 1133313, at *2 (Pa. C.P. Phila. Co. June 9, 1999) (under "the Unfair Trade Practices Law, success must be based on proof of conduct by the defendant which was directed to the physician"); Hall v. Balderston, 1998 WL 1167030, at *3-4 (Pa. C.P. Phila. Co. Dec. 16, 1998) (same), aff'd mem., 748 A.2d 1258 (Pa. Super. 1999).

Illinois is another state with developed law on consumer fraud and the learned intermediary rule. The Illinois Supreme Court held in De Bouse v. Bayer, 922 N.E.2d 309 (Ill. 2009), that under the Illinois Consumer Fraud Act the defendant was entitled to summary judgment where the plaintiff "fails to allege that her particular doctor was actually deceived by any of [the drug manufacturer's] advertisements or statements." Id. at 319 ("the circuit court erred in denying [defendant's] motion for summary judgment"). Similarly, in Gredell v. Wyeth Laboratories, Inc., 854 N.E.2d 752 (Ill. App. 2006), under the same statute, the court held:

[A] valid consumer fraud claim must show that the alleged fraud proximately caused the plaintiff's injury a valid consumer fraud claim must show that the alleged fraud proximately caused the plaintiff's injury. . . . Plaintiff cannot and did not establish that here. Since the [drugs] were marketed to doctors and pharmacists directly, not to individual consumers, the alleged misrepresentations and/or omissions on the [drugs'] labels, packaging inserts and advertising materials were not seen by the public at large. . . . If plaintiff never saw the alleged misrepresentations, he cannot have been deceived by them and any misrepresentation cannot have proximately caused him injury.

Id. at 757 (citations omitted). Similarly, the Seventh Circuit, under the same statute, determined:

[A]s with any other tort, to sustain a cause of action under the Consumer Fraud Act, the plaintiffs must further allege that damages were proximately caused by the fraud. The defendants pointed to evidence that the package inserts for the implants disclosed the medically relevant risks, that the medical community knew about these risks, and that . . . the physician who performed the procedures . . . knew about the risks. . . . [Plaintiff] did not show what causal link existed between the disclosures (or omissions) and her damages.

Schrott v. Bristol-Myers Squibb Co., 403 F.3d 940, 944-45 (7th Cir. 2005) (applying Illinois law) (citation and quotation marks omitted). Accord In re Avandia Marketing, Sales Practices & Products Liability Litigation, MDL No. 1871, 2011 WL 4007858, at *2 (E.D. Pa. Sept. 7, 2011) (no causation under Illinois statute where "[p]laintiff has not alleged that any misrepresentations were communicated to him or to his prescribing physician or that either of them relied"); Dhamer v. Bristol-Myers Squibb Co., 183 F.R.D. 520, 531 (N.D. Ill. 1998) (class certification under Illinois statute denied because "plaintiff must show that the physician would not have prescribed [the drug], if [defendant] had provided adequate warnings").

Other states have considered the learned intermediary rule in connection with actions brought under consumer protection/fraud statutes have reached the same result. Indeed, in In re Warfarin Sodium Antitrust Litigation, 212 F.R.D. 231 (D. Del. 2002), aff'd, 391 F.3d 516 (3d Cir. 2004), a case ostensibly applying the consumer fraud statutes of all fifty states, the court observed that "the learned intermediary doctrine presents a barrier to proving that any deceptive representations made by defendant were the proximate cause of plaintiffs' injuries." Id. at 256. We note that many states have not been called upon to address the learned intermediary rule because claims under their statutes fail on other grounds, such as preemption by exclusive product liability statutes (e.g., Connecticut, New Jersey), non-recovery for personal injuries (e.g., Maine, Washington), or lack of a private right of action (e.g., Iowa).

Another peculiarity on this issue we noticed was how frequently it was decided in aggregated litigation/litigation tourism cases, where courts were deciding the issue based on the law of some other state.

Alabama: Cooper v. Bristol-Myers Squibb Co., 2009 WL 5206130, at *10 (D.N.J. Dec. 30, 2009) (Alabama consumer fraud claim failed where plaintiffs "did not plead a single instance in which they, themselves, or any of their prescribing doctors received a misrepresentation of fact in which they relied upon in either taking or prescribing any of the subject drugs").

Arizona: Bellew v. Ethicon, Inc., 2014 WL 6886129, at *6 (S.D.W. Va. Nov. 24, 2014) (after holding fraud claims barred by learned intermediary rule, "because the plaintiff's claim under the Arizona Consumer Fraud Act presents the same concerns as her common law fraud claims, this claim is also DISMISSED").

Arkansas: Kreves v. Ortho-McNeil-Janssen Pharmaceuticals, 2013 WL 3480286, at *30 (Pa. C.P. June 19, 2013) (applying learned intermediary prescriber-centric causation principles to Arkansas consumer protection statute; granting summary judgment because plaintiffs "lack evidence demonstrating Defendants knowingly misrepresented or concealed any information from Plaintiff's prescribing physician").

Delaware: Barba v. Boston Scientific Corp., 2015 WL 6336151, at *5 (Del. Super. Oct. 9, 2015) (in learned intermediary situation, consumer fraud claim stated where the defendant "is aware that the learned intermediary may act in reliance on the representations in treating a consumer patient").

Florida: Scelta v. Boehringer Ingelheim Pharmaceuticals, Inc., 404 F. Appx. 92, 94 (8th Cir. 2010) (plaintiff's "statutory claims for deceptive advertising and deceptive trade practices" fails because "the learned intermediary doctrine prevents [plaintiff] from proving that the [defendants'] alleged deception proximately caused his injuries") (applying Florida law); Beale v. Biomet, Inc., 492 F. Supp.2d 1360, 1372-73 (S.D. Fla. 2007) ("the learned intermediary doctrine encompasses all claims based upon a pharmaceutical manufacturer's failure to warn, including claims for . . . violation of state consumer protection laws") (following Norplant).

Indiana: Kantner v. Merck & Co., 2007 WL 3092779, ¶¶22-24 (Ind. Super. April 18, 2007) (claim under Indiana Deceptive Consumer Sales Act "fails because [plaintiff] does not allege reliance by her physician on anything [defendant] said or did, and under the 'learned intermediary' doctrine such an allegation is essential to her claim").

Maine: Doe v. Solvay Pharmaceuticals, Inc., 350 F. Supp.2d 257, 274 n.13 (D. Me. 2004) (with summary judgment granted on learned intermediary rule grounds, no need to "engage in a separate analysis as to whether summary judgment would have been otherwise appropriate" against deceptive trade practices claim), aff'd, 153 Fed. Appx. 1 (1st Cir. 2005) (applying Maine law).

Massachusetts: Linnen v. A.H. Robins Co., 2000 WL 89379, at *6 (Mass. Super. Dec. 14, 1999) (applying learned intermediary prescriber-centric causation principles to Massachusetts consumer protection statute; denying summary judgment on all claims). See also Saavedra v. Eli Lilly & Co., 2013 WL 3148923, at *3-4 (C.D. Cal. June 13, 2013) (discussed above, and also applying Massachusetts law).

Minnesota: Flynn v. American Home Products Corp., 627 N.W.2d 342, 351-52 (Minn. App. 2001) (summary judgment affirmed against consumer fraud claims; "plaintiff "presented no evidence that either she or her physician relied on the physician's desk reference, any representations, or the absence of representations made by [defendants] concerning" the drug).

Missouri: Carr-Davis v. Bristol-Myers Squibb Co., 2013 WL 322616, at *10 (D.N.J. Jan. 28, 2013) (plaintiff's failure to prove prescriber reliance under the learned intermediary rule also barred Missouri Merchandising Practices Act). See also Saavedra v. Eli Lilly & Co., 2013 WL 3148923, at *3-4 (C.D. Cal. June 13, 2013) (discussed above, and also applying Missouri law).

New Jersey: New Jersey Citizen Action v. Schering-Plough Corp., 842 A.2d 174, 177-78 (N.J. Super. A.D. 2003) (affirming dismissal of consumer fraud claim; advertisements not actionable due to "the intervention by a physician in the decision-making process necessitated by his or her exercise of judgment whether or not to prescribe a particular medication"); Southeast Laborers Health & Welfare Fund v. Bayer Corp., 444 F. Appx. 401, 408 (11th Cir. 2011) (plaintiff "alleges no facts indicating how it would have independently evaluated [the drug's] medical appropriateness, aside from relying on the intermediaries of prescribing physicians") (applying New Jersey law); In re Avandia Marketing, Sales Practices & Products Liability Litigation, 2011 WL 4007878, at *2 (E.D. Pa. Sept. 7, 2011) (quoting and following Zafarana) (applying New Jersey law); Zafarana v. Pfizer, Inc., 724 F. Supp.2d 545, 556 (E.D. Pa. 2010) ("Due to the discretion of the prescribing physician, the injury alleged is entirely hypothetical, and cannot provide the basis for a claim under the NJCFA") (applying New Jersey law).

New York: Becker v. Cephalon, Inc., 2015 WL 5472311, at *8 (S.D.N.Y. Sept. 15, 2015) ("courts, in applying New York law . . ., have found that the ID ["informed intermediary" doctrine] bars claims arising under consumer protection laws that are based on a failure-to-warn theory); Colacicco v. Apotex, Inc., 432 F. Supp.2d 514, 552 (E.D. Pa. 2006) (learned intermediary rule precludes consumer protection claim "because the consumer protection statute forbids deceptive acts or practices likely to mislead a reasonable consumer, specifically requiring proof that the defendant's acts are directed at consumers . . . while the [rule] dictates that all pharmaceutical information is directed at physicians, not consumer-patients") (emphasis original), aff'd on other grounds, 521 F.3d 253 (3d Cir. 2008), vacated on other grounds, 556 U.S. 1101 (2009) (applying New York law).

South Carolina: Carnes v. Eli Lilly & Co., 2013 WL 6622915, at *3 & n.2 (D.S.C. Dec. 16, 2013) (applying learned intermediary prescriber-centric causation principles to South Carolina consumer protection statute; granting summary judgment).

Vermont: Otis-Wisher v. Medtronic, Inc., 616 F. Appx. 433, 435 (2d Cir. 2015) ("Plaintiff did not constitute a "consumer" under the [Vermont] statute because she did not, for her personal use, purchase [the device], which in any event is not available for consumer purchase, but rather was prescribed the medical device by her doctor").

Wisconsin: Valente v. Sofamor, S.N.C., 48 F. Supp.2d 862, 873 (E.D. Wis. 1999) (applying learned intermediary prescriber-centric causation principles to Wisconsin consumer protection statute; granting summary judgment).

This article is presented for informational purposes only and is not intended to constitute legal advice.

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