Debunking Another Stunningly Wrong MDL Expansion of Liability

In Clemens v. DaimlerChrysler Corp., 534 F.3d 1017 (9th Cir. 2008), the court, applying California law, correctly “decline[d plaintiff’s] invitation to create a new exception” to that state’s privity requirement “that would permit [plaintiff’s] action to proceed.”  Id. at 1023-24.  “[A] federal court sitting in diversity is not free to create new exceptions” to state law limiting liability.  Id. at 1024 (citing Day & Zimmermann, Inc. v. Challoner, 423 U.S. 3, 4 (1975)).  D&Z held, as we’ve discussed many times:

A federal court in a diversity case is not free to engraft onto those state rules exceptions or modifications which may commend themselves to the federal court, but which have not commended themselves to the State in which the federal court sits.

423 U.S. at 4.  And the Supreme Court has kept on saying this.  Erie principles prohibit “federal judges” from “displac[ing] the state law that would ordinarily govern with their own rules.”  Boyle v. United Technologies Corp., 487 U.S. 500, 517 (1988).  “[A] federal court is not free to apply a different rule however desirable it may believe it to be, and even though it may think that the state Supreme Court may establish a different rule in some future litigation.”  Hicks v. Feiock, 485 U.S. 624, 630 n.3 (1988).

But when updating the learned intermediary section of his treatise, Bexis came across a peculiar MDL holding, that because a defendant supposedly “cite[d] no cases” for the proposition “that the learned intermediary doctrine should apply to Plaintiffs’ . . . consumer protection claims” under the laws of California, Maryland, Illinois, and Florida, then “the learned intermediary doctrine should not apply” to claims brought by plaintiffs in any of these states.  In re Natera Prenatal Testing Litigation, 664 F. Supp.3d 995, 1007-08 (N.D. Cal. 2023).  The decision did not cite any precedent from any of these states (not even a trial court decision) affirmatively creating any exception to the learned intermediary rule for consumer fraud claims.  Id.

Thus, this MDL decision did exactly what the Ninth Circuit rejected in Clemens – “create[d] a new exception” to California’s well-established learned intermediary rule.  How well established?  See our post here, discussing Himes v. Somatics, LLC, 549 P.3d 916 (Cal. 2024), which reaffirmed:

The learned intermediary doctrine provides that manufacturers have a duty to warn physicians, but not the physicians’ patients, about certain risks accompanying use of their prescription drugs and many medical devices.  The manufacturer need not warn of risks that are merely speculative or conjectural, or so remote and insignificant as to be negligible.  Nor must the manufacturer warn of risks that are already known to the medical community.  But the manufacturer is required to warn physicians of any non-negligible risks that are generally unknown to the medical community, as this will allow the health-care provider, and thereby the patient, to make an informed choice whether to utilize the drug or medical device.  Once the manufacturer has fulfilled its duty to warn the physician of non-negligible risks, the duty then devolves on the health-care provider to supply to the patient such information as is deemed appropriate under the circumstances so that the patient can make an informed choice as to therapy.

Id. at 922 (numerous citations and quotation marks omitted).

Moreover, the overwhelming majority of courts nationwide has held that the learned intermediary rule applies to claims brought under state consumer protection statutes.  Here are the cases from Bexis’ book that do so.  We start with the Texas Supreme Court in Centocor, Inc. v. Hamilton, 372 S.W.3d 140, (Tex. 2012), refusing to let plaintiffs avoid the learned intermediary rule by using the Texas consumer statute (“DTPA”) as a basis for challenging physician-directed labeling, finding “persuasive” the following reasoning:

The gravamen of all of Plaintiffs’ causes of action, including misrepresentation and violation of the DTPA, is that the prescription drug manufacturer failed to adequately warn of or disclose the severity of [its product’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.

Id. at 168 (quoting and following In re Norplant Contraceptive Products Liability Litigation, 955 F. Supp. 700, 709 (E.D. Tex. 1997), aff’d, 165 F.3d 374 (5th Cir. 1999)); see Wyeth-Ayerst Laboratories Co. v. Medrano, 28 S.W.3d 87, 94 (Tex. App. 2000) (reaching same result before Hamilton).  A second state high court held

[W]e are simply not convinced that a causal connection exists within the context of prescription drug purchases. Prescription drug cases are not the type of private causes of action contemplated under the terms and purposes of the [West Virginia consumer protection statute] because the consumer can not and does not decide what product to purchase.

White v. Wyeth, 705 S.E.2d 828, 837-38 (W. Va. 2010)

The requirement that physicians make informed choices on behalf of each of their patients doomed class certification of California consumer protection claims in In re Vioxx Class Cases, 180 Cal. App.4th 116, 134, 103 Cal. Rptr.3d 83 (Cal. App. 2009):

[T]he cardiovascular risks of [the drug] were not material for all patients.  Some patients would still take [it] today if it were on the market; some physicians would still prescribe it regardless of risks. . . . [A]ll physicians are different and obtain their information about prescriptions from myriad sources.  For those physicians with a distrust of statements made by the pharmaceutical industry, [defendant’s] statements could not have been material. . . .  [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 98-99 (footnote omitted).  None of these differences would have been relevant had the learned intermediary rule not applied.  See also Weiss v. Astrazeneca Pharmaceuticals, 2010 WL 3387220 at *8-10 (Cal. App. Aug. 30, 2010) (same result in unpublished Cal App. decision).

In Illinois, the “concept . . . known as the learned intermediary doctrine” holds that “physicians act[] as the agents for their patients in making the decision to use defendants’ products.”  Gredell v. Wyeth Laboratories, Inc., 2005 WL 4774219 at *44 (Ill. Cir. June 10, 2005).  Thus, a consumer protection plaintiff “was not able to demonstrate that he, the patient, was deceived by any act or omission of defendants,” which precluded causation under the Illinois statute.  “[W]ithout a deceptive act, practice, or omission and without the injury or damage proximately caused by that act, practice, or omission, plaintiff has not met his burden of proving consumer fraud.”  Id. at *44-45.  The intermediate Illinois appellate court affirmed:

Since the [drugs] were marketed to doctors and pharmacists directly, not to individual consumers, the alleged misrepresentations and/or omissions on [their] 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.  The evidence supports the court’s finding that plaintiff failed to prove his Consumer Fraud action because he failed to prove he suffered damage from defendants’ alleged deceptive conduct or that this conduct proximately caused his damage.

Gredell v. Wyeth Laboratories, Inc., 854 N.E.2d 752, 757 (Ill. App. 2006).

The learned intermediary rule’s interruption of loss causation similarly doomed a New Jersey consumer fraud claim:

[A]s a practical matter, the products remain available only through a physician’s prescription. . . .  [T]he 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 protects consumers in ways respecting efficacy that are lacking in advertising campaigns for other products.  In this context, that is, within a highly regulated industry in which the ultimate consumer is not in fact free to act on claims made in advertising in any event, the relationship between words used in the advertising and purchase of the product is at best an attenuated one.

New Jersey Citizen Action v. Schering-Plough Corp., 842 A.2d 174, 177-78 (New Jersey Super. App. Div. 2003) (citation omitted).  See also Flynn v. American Home Products Corp., 627 N.W.2d 342, 351-352 (Minn. App. 2001) (consumer protection claim fails for lack of evidence, of physician or plaintiff reliance); Golden v. Brown, 2017 WL 4239015 at *3 (Colo. Dist. Sept. 24, 2017) (learned intermediary principles precluded consumer protection claims); Baron v. Pfizer, Inc., 2006 WL 1623052, at *3 (in table at 820 N.Y.S.2d 841) (N.Y. Sup. May 2, 2006) (“no allegations relating defendant’s alleged deceptive practice of encouraging physicians to prescribe [the drug] for off-label use to plaintiff’s physician prescribing [that drug] for plaintiff”), aff’d, 840 N.Y.S.2d 445 (N.Y. App. Div. 2007); S.B. v. Ortho-McNeil-Janssen Pharmaceuticals, 2013 WL 3286808 at *24 (Pa. C.P. June 12, 2013) (“the existence of the LID makes it difficult for a plaintiff to succeed on a UTPCPL claim in product liability litigation of prescription drugs”); Albertson v. Wyeth, Inc., 63 D. & C.4th 514, 539 (Pa. C.P. 2003) (refusing to recognize direct-to-consumer exception to learned intermediary rule that would allow consumer protection claim); Luke v. American Home Products Corp., 1998 WL 1781624 at *8 (Pa. C.P. Nov. 18, 1998) (same).

There are many more federal court decisions invoking the learned intermediary rule to preclude consumer protection claims under the laws of various states.  In Schrott v. Bristol-Myers Squibb Co., 403 F.3d 940 (7th Cir. 2005), summary judgment against an Illinois consumer protection claim was affirmed where the evidence established:

that the package inserts for the [devices] 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.

Id. at 944.  Since “to sustain a cause of action under the Consumer Fraud Act, the plaintiffs must further allege that damages were proximately caused by the fraud,” this unrebutted evidence precluded showings of either materiality or causation.  Id. at 944-45.

As the Texas Supreme Court observed in Hamilton, the Fifth Circuit had previously, and properly, recognized the applicability of the learned intermediary rule to the Texas consumer fraud statute:

We . . . make an Erie guess that the Texas Supreme Court would hold that the learned intermediary doctrine is not a common law defense but instead a common law doctrine . . ., that establishes the degree to which a prescription drug manufacturer is liable for an end user’s reliance on the effects of a prescription drug.  Because we hold that the learned intermediary doctrine is not a common law defense . . ., [plaintiff’s] argument that the district court incorrectly applied it to the DTPA fails.

In re Norplant Contraceptive Products Litigation, 165 F.3d 374, 377-78 (5th Cir. 1999).  Accord Rivera v. Wyeth-Ayerst Laboratories, 283 F.3d 315, 321 n.7 (5th Cir. 2002) (applying Texas law) (noting applicability of learned intermediary rule to Texas consumer protection claims).

A physician was unable to assert a Pennsylvania consumer protection claim against a medical device manufacturer in Balderston v. Medtronic Sofamor Danek, Inc., 285 F.3d 238 (3d Cir. 2002), because learned intermediary principles made clear that the doctor “was neither the purchaser nor the consumer of the [medical device].”  Id. at 242.

[The physician] suggests his purchase qualifies, because he “purchased” the [devices] for his patients’ “personal use.”  But we have uncovered no Pennsylvania decision finding actionable a non-representative plaintiff’s claim based on others’ “personal uses.”  [The physician] employed the [devices] only in his medical practice.  His alleged losses were not “personal,” but affected only his medical practice.

Id.

A Connecticut consumer fraud claim was properly dismissed in Travelers Indemnity Co. v. Cephalon, Inc., 620 F. Appx. 82 (3d Cir. 2015)

[T]he allegations in the Amended Complaint fail to establish proximate cause. Indeed, Plaintiffs did not allege that any doctor relied on Defendants’ alleged misrepresentations in prescribing [the drugs], or that these prescriptions would not have been written if these physicians had not received the allegedly fraudulent information from [defendant].  Thus, Plaintiffs have not sufficiently pleaded causation , as required by CUTPA, and we will affirm the District Court’s dismissal of the CUTPA claims.

Id. at 87.  See also Southeast Laborers Health & Welfare Fund v. Bayer Corp., 444 F. Appx. 401, 408 (11th Cir. 2011) (“rel[iance] on the intermediaries of prescribing physicians” breaks the “causal nexus” of New Jersey consumer fraud claim).

A horde of federal district court cases has applied learned intermediary principles to state-law consumer fraud claims.  We start with those under the four states addressed by the MDL decision.  We know of six cases interpreting California law.  In Andren v. Alere, Inc., 2017 WL 6509550, at *22 (S.D. Cal. Dec. 20, 2017), the plaintiffs were “patient self-testers who were prescribed their devices by their healthcare providers” and also obtained “monitoring services” from the defendant.  Id. at *3. Individualized issues created by the learned intermediary rule defeated class actions certification.

Defendants have raised the defense of learned intermediary arguing that the doctrine is not amenable to class wide treatment due to the predominance of individual questions. . . .  Because the . . . products were prescribed medical devices, in order to determine whether the learned intermediary doctrine applies, individualized inquiries will be required to determine whether Defendants informed the prescribing physicians and whether each treating physician knew about the risks.

Id. at *23.  See also Andren v. Alere, Inc., 207 F. Supp.3d 1133, 1144 (S.D. Cal. 2016) (“If [the product] was prescribed by a physician, then the doctrine applies to [plaintiffs’] case and if so, Plaintiffs must properly allege a failure to warn Plaintiffs’ prescribing physician in an amended complaint.”) (footnote omitted).

Saavedra v. Eli Lilly & Co., 2013 WL 6345442, at *6 (C.D. Cal. Feb. 26, 2013), first determined that, while consumer fraud claims not absolutely barred by learned intermediary rule, the rule’s applicability might require summary judgment on plaintiff-specific facts) (applying California, Massachusetts, Missouri, and New York law).  Later, the same court concluded, “[e]very 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.”  Saavedra v. Eli Lilly & Co., 2013 WL 3148923, at *3 (C.D. Cal. June 13, 2013).  See Utts v. Bristol-Myers Squibb Co., 251 F. Supp.3d 644, 683 n.32 (S.D.N.Y. 2017), aff’d, 919 F.3d 699 (2d Cir. 2019) (following Saavedra to conclude that the learned intermediary rule applied to California consumer protection litigation); In re Yasmin & Yaz Marketing, Sales Practices & Products Liability Litigation, 2012 WL 865041 at *20-21 (S.D. Ill. March 13, 2012) (“Obtaining a prescription drug necessarily involves a considerable interaction between the individual patient and his or her prescribing physician.”  Thus, “the varied information conveyed by each prescribing physician to putative class members prevents a finding of uniformity” in a California consumer protection class action).

Beale v. Biomet, Inc., 492 F. Supp.2d 1360, 1372-1373 (S.D. Fla. 2007), followed “federal courts in jurisdictions across the country, including Florida, . . . that the learned intermediary doctrine encompasses all claims based upon a pharmaceutical manufacturer’s failure to warn, including claims for fraud, misrepresentation, and violation of state consumer protection laws.”  Id. at 1372.

The same result [as in Norplant] is warranted here.  While Plaintiffs have provided various names for their claims . . ., the claims are all ultimately based upon [defendant’s] alleged failure to warn of the risks of the device.  Because Florida has adopted the learned intermediary doctrine, I conclude that it would follow the reasoning above and hold that the doctrine bars the Plaintiffs’ claims in this case.

Id. at 1373.

An Illinois consumer class action failed for learned intermediary reasons in Dhamer v. Bristol-Myers Squibb Co., 183 F.R.D. 520, 531-532 (N.D. Ill. 1998), because of the learned intermediary rule requires individualized prescription decisions, including what information each patient receives abut a prescription medical product. 

[T]he physician acts as a “learned intermediary” between the manufacturer and consumer.  As a prescription medicine, [the drug] is not directly marketed to the consuming patient. Rather, physicians are advised about the product [and] . . . determine whether or not to prescribe the medicine to a particular patient and what to tell the patient. . . .  Pharmacists may also make representations about the product. Additionally, the information available to the medical community changes over time. . . .  Thus, it is likely that no two patients receive exactly the same information.

Id. at 531-32 (citations and footnote omitted).  See In re Avandia Marketing, Sales Practices & Products Liability Litigation, 2011 WL 4007858 at *2 (E.D. Pa. Sept. 7, 2011) (causation failed in Illinois consumer protection claim; “Plaintiff has not alleged that any misrepresentations were communicated to him or to his prescribing physician or that either of them relied upon the alleged misrepresentations”).

Thus, Maryland is the only one of the four states at issue in Natera lacking precedent holding specifically that the learned intermediary rule applies to consumer protection claims.  There’s a reason for that.  Prescription medical products are not considered “consumer” goods in Maryland.  See Hogan v. Maryland State Dental Assoc., 843 A.2d 902, 906 (Md. Spec. App. 2004) (dental fillings not consumer goods because they “are not purchased by consumers as a good but are selected and used by a practitioner as part of a professional service”); Donalds v. Ethicon, Inc., 2021 WL 6126297, at *12 n.14 (D. Md. Dec. 28, 2021) (following Hogan).

Finally, there are so many federal district court decisions applying learned intermediary principles in the context of other states’ consumer protection laws that we’ll simply list them here.

Colorado: Curtin v. Ethicon, Inc., 2021 WL 825986, at *8 (D. Colo. March 4, 2021); Carver v. American Medical Systems, Inc., 2020 WL 8258217, at *3 (D. Colo. May 18, 2020).

Maine: Herzog v. Arthrocare Corp., 2003 WL 1785795 at *10 (D. Me. March 21, 2003).

Missouri: Foster v. Ethicon, Inc., 2021 WL 1700060, at *4 (W.D. Mo. March 31, 2021).

New Jersey: In re Avandia Marketing, Sales Practices & Products Liability Litigation, 2011 WL 4007878, at *1 (E.D. Pa. Sept. 7, 2011) (applying New Jersey law); Zafarana v Pfizer, Inc., 724 F. Supp.2d 545, 556 (E.D. Pa. 2010) (applying New Jersey law).

New York: Zottola v. Eisai, Inc., 564 F. Supp.3d 302, 312-13 (S.D.N.Y. 2021) (applying New York law); Quintana v. B. Braun Medical Inc., 2018 WL 3559091, at *10 (S.D.N.Y. July 24, 2018); Becker v. Cephalon, Inc., 2015 WL 5472311, at *8 (S.D.N.Y. Sept. 15, 2015); Amos v. Biogen Idec, Inc., 28 F. Supp.3d 164, 173-74 (W.D.N.Y. 2014); Colacicco v. Apotex, Inc., 432 F. Supp.2d 514, 549-50 (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) (applying New York law).

Pennsylvania: Cohen v. Johnson & Johnson, 634 F. Supp.3d 216, 232-33 (W.D. Pa. 2022); Brown v. C.R. Bard, Inc., 2022 WL 420914, at *7 (E.D. Pa. Feb. 11, 2022); Crockett v. Luitpold Pharmaceuticals, Inc., 2020 WL 433367, at *9 (E.D. Pa. Jan. 28, 2020); Wallace v. Boston Scientific Corp., 2018 WL 6981220, at *9 n.6 (Mag. M.D. Pa. Nov. 29, 2018), adopted, 2019 WL 137605 (M.D. Pa. Jan. 8, 2019); McLaughlin v. Bayer Corp., 172 F. Supp.3d 804, 831-32 (E.D. Pa. 2016); White v. Medtronic, Inc., 2016 WL 4539494, at *3 (E.D. Pa. Aug. 31, 2016); Stout v. Advanced Bionics, LLC, 2013 WL 12133966, at *9 (W.D. Pa. Sept. 19, 2013); 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, at *2 (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); Smith v. Bristol-Myers Squibb Co., 2009 WL 5216982, at *5-6 (D.N.J. Dec. 30, 2009) (applying Pennsylvania law); Heindel v. Pfizer, Inc., 381 F. Supp.2d 364, 384 (D.N.J. 2004) (applying Pennsylvania law).

South Carolina: Carnes v. Eli Lilly & Co., 2013 WL 6622915, at *3 & n.2 (D.S.C. Dec. 16, 2013).

Texas: Gomez v. ALN International, Inc., 2022 WL 6468725, at *6-7 (S.D. Tex. Oct. 10, 2022); Gutierrez v. Ethicon, Inc., 535 F. Supp.3d 608, 633-34 (W. D. Tex. 2021); Perez v. American Medical Systems, Inc., 461 F. Supp.3d 488, 507-08 (W.D. Tex. 2020); Marrufo v. Ethicon, Inc., 2020 WL 7680562, at *3-4 (W.D. Tex. Nov. 20, 2020); Casey v. Bristol-Myers Squibb Co., 2018 WL 8545854, at *2 (W.D. Tex. April 20, 2018), aff’d, 741 F. Appx. 243 (5th Cir. 2018); Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808, 814 (S.D. Tex. 2013) (applying Texas law); Johnson v. Medtronic, Inc., 2005 WL 1515402, at *3 (S.D. Tex. June 23, 2005) (applying Texas law); Dyer v. Danek Medical, Inc., 115 F. Supp.2d 732, 740-41 (N.D. Tex. 2000) (applying Texas law); In re Norplant Contraceptive Products Litigation, 955 F. Supp. 700, 709 (E.D. Tex. 1997), aff’d, 165 F.3d 374, 377-378 (5th Cir. 1999).

Utah:  In re Avandia Marketing, Sales Practices & Products Liability Litigation, 286 F. Supp.3d 667, 674 (E.D. Pa. 2017), aff’d, 746 F. Appx. 122 (3d Cir. 2018) (applying Utah law).

Wisconsin: Valente v. Sofamor, S.N.C., 48 F. Supp.2d 862, 873 (E.D. Wis. 1999).

In sum, we’ve had it with federal district courts, particularly in multi-district litigation, ignoring the Supreme Court’s – and relevant circuit court – prohibitions against expansive predictions of state law in diversity jurisdiction cases.  Defendants do not have the burden of disproving every possible theory of liability that plaintiffs can invent.  Rather, plaintiffs have the obligation to demonstrate affirmatively that the relevant state’s high court would likely adopt any given theory.  If there is no law, then federal courts are without power to create new state-law theories of tort liability.