Anybody who has litigated a prescription medical product liability case knows about the learned intermediary rule, which is now followed in all fifty states. Just as prescription medical product warnings are routed through prescribing physicians, so necessarily is the causation aspect of such warnings. The details vary from state to state, but in all learned intermediary cases, correcting an allegedly inadequate warning must cause the learned intermediary physician to do something differently, and that “something” must prevent the plaintiff’s claimed injury.
At the same time, the Supreme Court’s TwIqbal decisions require that plaintiffs plead facts to support the elements of their causes of action. From the defense perspective, that means that complaints against our clients should be required to plead (at minimum): (1) the identity of the relevant prescriber, (2) what that prescriber would have done differently with a “better” warning, and (3) how that difference would have prevented the claimed harm. We don’t ask for a lot, but at least one fact supporting these essential causal elements should certainly be mandatory.
Unfortunately, a lot of plaintiffs fail to meet even these minimal pleading requirements. These aren’t difficult facts, and nothing is peculiarly in the possession of the defense side. Quite the opposite, in some states defendants can’t even contact a plaintiffs’ treaters. Thus, we don’t see any good reason not to apply TwIqbal’s usual standard to the pleading of warning causation in learned intermediary cases.
Most courts appear to agree. TwIqbal-based dismissal was affirmed in Tutwiler v. Sandoz, Inc., 726 Fed. Appx. 753 (11th Cir. April 9, 2018) (applying Alabama law), since the plaintiff “failed to allege that if her physician had been aware of the risks of prescribing [the drug] he would not have prescribed the drug to her.” Id. at 756 (citation and quotation marks omitted). The Eleventh Circuit explained:
[Plaintiff] has still failed to plead that the failure to warn was the actual and proximate cause of [her] injury, as required by Alabama law. . . . Alabama’s separate requirement [is] that [plaintiff] also plead proximate causation − that [the prescriber] would not have prescribed her [the drug] had he known of its dangers. [Plaintiff] failed to do this. Instead, she claims that she would not have taken [the drug] had she known of its dangerous effects. Regardless of what [plaintiff] would or would not have done with the information, Alabama law requires a showing of what [the prescriber] would have done with it. Without more, [plaintiff] fails to allege what effect on the physician the allegedly-omitted information would have had. . . . This failure leaves [plaintiff] short of meeting her burden to plead proximate causation.
Id. at 756-57 (citations and quotation marks omitted). Accord McDaniel v. Mylan, Inc., 2020 WL 8175556, at *7 (N.D. Ala. June 19, 2020) (dismissal granted; “Nor does Plaintiff allege that either Decedent or his prescribing physician would have acted any differently had Defendant . . . provided a warning”); Allain v. Wyeth Pharmaceuticals, Inc., 2015 WL 178038, at *6 (N.D. Ala. Jan. 14, 2015) (“Plaintiff fails to allege that [the prescribing] physicians would not have prescribed the [drug] . . . if they had been adequately informed of all the risks associated with the drug. Accordingly, Plaintiff fails to plead facts sufficient to show causation”).
Applying California’s recent Himes learned intermediary rule decision, Higginbottom v. Dexcom, Inc., ___ F. Supp.3d ___, 2024 WL 3823023 (S.D. Cal. Aug. 13, 2024) (discussed here), held that warning causation still had to be supported by pleaded facts.
As to causation, Plaintiff fails to allege facts that the prescribing physician would still recommend [the device] if warnings had been given. Based upon the fact that Plaintiff fails to sufficiently allege a risk and causation for a failure to warn claim under either a theory of negligence or strict liability, the Court grants [defendant’s] Motion to Dismiss these claims.
Id. at *16 (citations and quotation marks omitted). Higgenbottom followed, inter alia, Tapia v. Davol, Inc., 116 F. Supp.3d 1149 (S.D. Cal. 2015), which reached a similar result.
In order to prove causation, Plaintiff must allege that the inadequate warning or lack of warning about the medical device risk would have altered the prescribing physician’s decision to use the product. . . . As to . . . causation, . . . [Plaintiff] does not allege that Defendants failed to warn his own prescribing physician and that his own physician would not have used the [device] if warnings had been given. Instead, Plaintiff makes allegations as to “physicians” in general, and the “healthcare community” and does not allege any facts as to his own prescribing physician. Based on the fact that Plaintiff has failed to allege that Defendants failed to warn his prescribing physician and failed to allege that if his prescribing physician had been warned, then he would not have prescribed the [device] to Plaintiff, the Court concludes that Plaintiff has not sufficiently alleged a cause of action for failure to warn under strict products liability.
Id. at 1158-59 (citations and footnote omitted). Higgenbottam is not alone in referencing Tapia. Other California decisions that did so and reached the same result are: Nazzal v. Wyeth, 2024 WL 2105601, at *2 (C.D. Cal. March 19, 2024) (quoting above language); Roshkovan v. Bristol-Myers Squibb Co., 2022 WL 3012519, at *7, 9 (C.D. Cal. June 22, 2022) (same; twice); Regina v. American Medical Systems Holdings, Inc., 2019 WL 13252519, at *6 (C.D. Cal. Oct. 2, 2019); Sidhu v. Bayer Healthcare Pharmaceuticals, Inc., 2022 WL 17170159, at *4 (N.D. Cal. Nov. 22, 2022) (same); Holcomb v. Pfizer, Inc., 2022 WL 17670003, at *3 (E.D. Cal. Dec. 14, 2022) (“a complaint will not demonstrate proof of causation if stronger warnings would not have altered the conduct of the prescribing physician”).
And that’s hardly all in the way of California/TwIqbal decisions. See Staten v. Astellas Pharma, Inc., 2024 WL 3745659, at *4 (C.D. Cal. July 29, 2024) (“Plaintiff must allege the inadequate warning would have altered the prescribing physician’s decision to use the product”) (citation and quotation marks omitted); Holcomb v. Pfizer, Inc., 2024 WL 169227 at *6 (Mag. E.D. Cal. Jan. 16, 2024) (complaint dismissed because “it provides no information about how knowledge of those failures would have changed Plaintiff’s physician decision to prescribe”) (citation and quotation marks omitted), adopted, 2024 WL 870603 (E.D. Cal. Feb. 29, 2024); Garcia v. Sanofi Pasteur Inc., 2023 WL 6387171, at *6 (E.D. Cal. Sept. 29, 2023) (plaintiff “failed to allege . . . that different warnings to her medical provider would have changed the prescribing decision”); Roshkovan v. Bristol-Myers Squibb Co., 2023 WL 6787444, at *7 (C.D. Cal. Sept. 19, 2023) (“the FAC does not sufficiently allege how an adequate warning would have altered the prescribing decision of Plaintiff’s physician. Absent further detail, the court finds these allegations too conclusory to plausibly plead causation.”) (citation omitted); Ta v. Merck & Co., 2022 WL 19793902, at *3 (C.D. Cal. Dec. 9, 2022) (“[plaintiff] presumably has access to her own doctors, and could have investigated their actual knowledge and included those allegations in her complaint”); Fussy v. RTI Surgical, 2022 WL 1122615 at *4 (E.D. Cal. April 14, 2022) (warning claim dismissed where plaintiff “failed to allege . . . that the inadequacy or absence of the warning caused” plaintiff’s injuries”) (citation and quotation marks omitted); Pettibone v. Medtronic, Inc., 2021 WL 4895051, at *1 (N.D. Cal. Oct. 20, 2021) (“the FAC fails to sufficiently allege causation”; “nowhere does it specifically allege that [the prescriber] would have acted differently if provided with adequate warnings”); Fischer v. Boston Scientific Corp., 2020 WL 2300138, at *3 (C.D. Cal. March 25, 2020) (plaintiff’s “allegations are devoid of details specific to her”; plaintiff “has not identified who her implanting physician was, what warning the physician received, or how the warnings that were disclosed to the physician were inadequate”); Broge v. ALN International, Inc., 2018 WL 6308194 at *2 (N.D. Cal. Dec. 3, 2018) (“to plead a strict liability claim based on inadequate warning, the plaintiff must allege both that the defendant failed to warn . . . and that the plaintiff’s physician would have altered the decision to use the medical device had an adequate working been given”); Torralbo v. Davol, Inc., 2017 WL 8292477, at *2 (C.D. Cal. April 12, 2017) (the “failure-to-warn claim is insufficiently pleaded” because it “does not allege that Defendants’ allegedly inadequate warnings affected his doctor’s decision to use the [device]”); Hammarlund v. C.R. Bard, Inc., 2015 WL 5826780, at *5 (C.D. Cal. Oct. 2, 2015) (“Plaintiff only alleges that ‘had his physician been adequately informed about the extensive dangers associated with the use of the [device], his physician would not have implanted the device. . . .’ This allegation is merely conclusory and does not satisfy the pleading requirements under” TwIqbal) (citation omitted); Dilley v. C.R. Bard, Inc., 2014 WL 1338877, at *4 (C.D. Cal. April 3, 2014) (applying California law) (dismissal where plaintiff “contends that [the prescriber] received the warnings yet still prescribed the” devices).
New York courts have repeatedly enforced the same TwIqbal pleading requirements in learned intermediary cases. Among the pleading deficiencies that warranted dismissal of the cookie-cutter warning claim in Oden v. Boston Scientific Corp., 330 F. Supp.3d 877 (E.D.N.Y. 2018), was that “Plaintiff has pleaded no facts to suggest that his physician did not possess independent knowledge about the risks associated with use of the [device] separate and apart from of any such warnings.” Id. at 893 (citation omitted). In Dunham v. Covidien LP, 498 F. Supp.3d 549 (S.D.N.Y. 2020), the plaintiff’s pleading failed twice. Even the amended allegations:
do not cure the deficiencies in the plaintiff’s failure to warn claim because the allegations do not identify how the warnings given were insufficient to warn physicians and the plaintiff of the potential dangers of using the [device]. . . . And beyond conclusory statements, the plaintiff does not allege adequately that [plaintiff] or her physicians would have chosen not to use the [device] but for the allegedly inadequate warnings.
Id. at 560 (citations omitted).
“[C]onclusory allegations that [plaintiff] has suffered injuries as a ‘direct and proximate result of Defendants’ wrongful conduct,” are merely “legal conclusions,” not facts. Dains v. Bayer HealthCare LLC, 2022 WL 16572021, at *7 (N.D.N.Y. Nov. 1, 2022). Further, “conclusory statements . . . do not allege adequately that [plaintiff]or his physicians would have chosen not to use the [device] but for the allegedly inadequate warnings.” Krulewich v. Covidien, LP, 498 F. Supp.3d 566, 577 (S.D.N.Y. 2020); Gioia v. Janssen Pharmaceuticals, 2021 WL 602683 at *3 (E.D.N.Y. Feb. 16, 2021) (TwIqbal dismissal where “Plaintiff fails to allege any facts to suggest that her treating physician was not informed of the risks”); Dunham v. Covidien LP, 2019 WL 2461806, at *3 (S.D.N.Y. May 22, 2019) (dismissed complaint did “not particularize” anything “supporting its allegations that [plaintiff’s] physicians “would not have elected to use those products if they had been accompanied by adequate warnings”).
In Texas, a “[p]laintiff must identify what his [physician] was warned or what the [physician] reviewed in order to allege that the [physician] would have decided against using [the prescription product] had the warning been different.” Cofresi v. Medtronic, Inc., 450 F. Supp.3d 759, 769 (W.D. Tex. 2020). Where a plaintiff does not “identify the warnings or materials which her doctor received or reviewed, much less demonstrate that the doctor would not have prescribed [a drug] if the warning had been different, and does not allege facts necessary to show causation, she fails to satisfy Twombly and Iqbal as a matter of law.” Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp. 2d 808, 818 (S.D. Tex. 2013). Thus, Harrison v. Medtronic, Inc., 561 F. Supp.3d 698, 706 (N.D. Tex. 2021), aff’d in pertinent part, rev’d on other grounds, 2022 WL 17443711 (5th Cir. Dec. 6, 2022), likewise resulted in dismissal of the plaintiff’s warning claim on TwIqbal grounds:
Plaintiffs also inadequately allege that [the prescriber] would have changed his treatment decision had he received an adequate warning. Other than the unsupported assertion that a different product would have been used if Defendant had provided adequate warnings for the [the device], Plaintiffs do not explain how [their doctor] would have changed his treatment decision.
Id. at 706 (citations omitted). The same thing occurred in Fearrington v. Boston Scientific Corp., 410 F. Supp.3d 794 (S.D. Tex. 2019), in which “conclusory assertions” could not prevent dismissal:
[Plaintiff] then alleges that she “would not have consented to use Defendant’s P[device] had Defendant given adequate warnings to Plaintiff and Plaintiff’s implanting physicians.” These conclusory assertions amount to a recitation of the requirements of the learned intermediary doctrine. . . . The pleadings therefore do not comport with the pleading requirements established by Twombly and Iqbal and do not support a plausible claim that Defendant failed to warn Plaintiff’s physicians and that this failure was the producing cause of her injury.
Id. at 802 (citation and footnote omitted). For Texas unpublished decisions to the same effect, see McGuire v. Abbott Laboratories, Inc., 2023 WL 3262033, at *4 (E.D. Tex. May 3, 2023) (failure to report claim; allegations that “do[] not specify what warning was defective, what adverse incident(s) was(were) not reported, or how such warning or report would have prevented the alleged harm” warrant dismissal); Adams v. Indivior, Inc., 2022 WL 4662565, at *6 (Mag. S.D. Tex. Sept. 13, 2022) (“Plaintiff has failed to plead how a different warning would have changed his physician’s actions and he has also failed to otherwise include facts necessary to allege the failure to warn caused him injury”), adopted, 2022 WL 4734407 (S.D. Tex. Sept. 30, 2022); Burch v. KLS Martin, LP, 2021 WL 5868329, at *8 (Mag. N.D. Tex. Nov. 18, 2021) (the “[c]omplaint does not specify what particular warnings could or should have been given that would have materially altered [plaintiff’s] choice to consent to surgery with the” device); Adams v. Medtronic, Inc., 2020 WL 5868113, at *5 (E.D. Tex. Oct. 1, 2020) (“In cases where the learned-intermediary doctrine applies, plaintiffs must allege that the manufacturer’s failure to warn the intermediary caused the intermediary to act differently than she otherwise would have.”); Castillo v. Boston Scientific Corp., 2020 WL 5608510, at *7 (S.D. Tex. Sept. 18, 2020) (“Plaintiff cannot overcome the learned intermediary doctrine to hold Defendant liable because she does not identify any warning given to her physician, does not allege how the warning was inadequate, and does not demonstrate that a different, better warning would have affected her physician’s decision to use the Product to treat Plaintiff.”) (footnote omitted); Miles v. Boston Scientific Corp., 2020 WL 3871329, at *7 (S.D. Tex. July 9, 2020) (“To prevail under the learned intermediary doctrine, a plaintiff must plead facts that would show her doctors were inadequately warned and but for those inadequacies her doctors would have recommended different treatment or given her counsel that would have led her to withhold consent.”) (citation and quotation marks omitted); Woodhouse v. Sanofi-Aventis U.S. LLC, 2011 WL 3666595, at *3 (W.D. Tex. June 23, 2011) (“fail[ure] to allege that [plaintiff’s] doctor detrimentally relied on an inadequate warning” “fails to state sufficient factual matter, accepted as true, to state a claim”) (citation and quotation marks omitted).
In Flagg v. Stryker Corp., 647 Fed. Appx. 314 (5th Cir. 2016) (applying Louisiana law), beyond the manufacturing claims that were the focus of the opinion, the court noted that, the plaintiff also “failed to include any allegations about whether the . . . Defendants failed to warn [plaintiff’s] doctor of the risk involved and whether [the] doctor would have used the implants if given such a warning, as required.” Id. at 316 n.3. The plaintiffs failed to plead causation in failure to report case for similar reasons in McKenzie v. Abbott Laboratories, 563 F. Supp.3d 512, 523-524 (M.D. La. 2021). To do so, “requires alleging a causal connection between the failure to warn and [plaintiff’s] injury, which in turn requires a plausible inference that had Defendant timely reported adverse events, [their surgeon] would have either implanted the [device] differently or not implanted it at all.” Id. at 523-24. Unless “it is plausible that the reports of those events would have reached [the surgeon] in time for him to act differently when implanting the [device] . . .. Plaintiffs have not alleged an adequate causal link.” Id. at 524. Here is additional unpublished Louisiana precedent. Holloway v. Abbvie, Inc., 2024 WL 477523, at *5 (Mag. M.D. La. Feb. 7, 2024) (“Plaintiff has failed to allege whether her treating physician would have prescribed the [device] had the physician been adequately warned. Consequently, Plaintiff’s failure to warn claim must be dismissed.”); Oliver v. Covidien LP, 2020 WL 564957, at *3 (E.D. La. Feb. 5, 2020) (“[Plaintiff] has not alleged causation. Read together and in her favor, [plaintiff’s] allegations do not create a reasonable inference that, but for [defendant’s] inadequate warning, her treating physician would either (a) not have used the [device] or (b) used it differently.”); Dubroc v. Bristol-Myers Squibb, 2019 WL 3756469, at *5 (M.D. La. Aug. 8, 2019) (plaintiff “failed to state a cognizable failure to warn claim [by] fail[ing] to allege anything regarding [defendant’s] warning to her physician, or that he would have treated her differently had he received a warning”); Brooks v. Amgen, Inc., 2019 WL 507491, at *4 (M.D. La. Feb. 8, 2019) (“No allegation is made as to whether the treating physician would have prescribed [the drug] or not,” which is “insufficient”); Calloway v. Coloplast Corp., 2019 WL 2169222, at *7 (Mag. W.D. La. Feb. 5, 2019), (“[plaintiff] did not set forth requisite facts to show that [defendant] failed or inadequately warned his surgeon . . ., or that this failure was the cause of plaintiff’s injury.”) adopted, 2019 WL 2166539 (W.D. La. May 17, 2019) (applying Louisiana law); Pellegrin v. C.R. Bard, 2018 WL 3046570, at *4 (E.D. La. June 20, 2018) (“conclusory allegations” that plaintiff’s “healthcare providers, acting as reasonably prudent healthcare providers, would have elected not to use the product” are “naked assertions devoid” of “factual enhancement necessary to survive a motion to dismiss”) (citation and quotation marks omitted); Lussan v. Merck Sharp & Dohme Corp., 2017 WL 2377504, at *3 (E.D. La. June 1, 2017) (“Nor does [plaintiff] allege that but for this insufficient warning, her doctor would not have used or prescribed the product. These deficiencies are fatal”); Huffman v. Bristol-Myers Squibb, 2016 WL 6024532, at *2 (E.D. La. Oct. 14, 2016) (dismissal because the plaintiff failed to allege that the “doctor would not have prescribed [a drug] had [he] received an adequate warning”); Hargrove v. Boston Scientific Corp., 2014 WL 4794763, at *11 (E.D. La. Sept. 24, 2014) (“conclusory allegations do not address whether a proper warning would have changed the decision of the treating physician . . . fail to state a claim”) (citation and quotation marks omitted).
Applying Pennsylvania law, Short v. Pfizer, Inc., 2023 WL 3919536 (E.D. Pa. June 8, 2023), dismissed warning claims for failure to allege “proximate cause”:
As to proximate causation, Plaintiff does not assert any facts showing how his alleged injuries would have been foreseen by an ordinary person. . . . Plaintiff alleges in conclusory fashion that Defendant “failed to adequately warn the medical profession and the prescribing physicians and doctors and the plaintiff of the risk . . . without providing further detail. Plaintiff makes no allegations that a different warning from Defendant would have affected a physician’s decision to prescribe the medication . . . and that any alleged injury would have been avoided and therefore fails to raise a right to relief above the speculative level.
Id. at *3 (citations omitted). Bergstresser v. Bristol-Myers Squibb Co., 2013 WL 6230489 (M.D. Pa. Dec. 2, 2013), did much the same thing, reaffirming a prior ruling that the plaintiff’s “fail[ure] to indicate . . . that any alternative warning would have prevented his physician from prescribing [the drug] such that his injury would have been avoided.” Id. at *8.
[Plaintiff is required to] make the factual allegations which would support the essential elements of his claims as is required under the law. plaintiff cannot in a conclusory manner simply allege that his injury would not have resulted if his physician was provided with some unspecified information. He must provide sufficient factual allegations as to why the information provided to the intermediary was inadequate, what information should have been provided, and how that information would have caused the intermediary to act differently which would have prevented the plaintiff’s injury.
Id. (reaffirming Bergstresser v. Bristol-Myers Squibb Co., 2013 WL 1760525, at *5 (M.D. Pa. April 24, 2013)). Cf. Esposito v. I-Flow Corp., 2011 WL 5041374, at *6 (E.D. Pa. Oct. 24, 2011) (“a complaint is not adequately plead if it names several defendants whose products might have been used, but does not actually identify which defendants’ products allegedly caused the injury”).
Another decision applying TwIqbal to learned intermediary causation is Asby v. Medtronic, Inc., 673 F. Supp.3d 787 (E.D.N.C. 2023).
[Plaintiffs’] allegations do not move their failure to warn claim from possible to plausible. . . . [They] do not allege that [their] health care providers read or heard any of the defendants’ warnings regarding the [device], let alone relied on them. Without such allegations, [plaintiffs] fail to plausibly allege the required proximate cause required to state a failure to warn claim. [Plaintiffs] respond that the complaint states that “[h]ad Plaintiff’s surgeon been adequately warned,” then the surgeon would not have recommended using the [device]. This counterfactual, however, does not allege that the surgeon actually read or relied on the warnings that defendants gave.
Id. at 794-95. Accord Burgess v. Pfizer, Inc., 2020 WL 1812010, at *5 (E.D.N.C. April 9, 2020) (dismissing because “plaintiff has not alleged that the warning label played any role in the decision of plaintiff’s physician to prescribe Lyrica or plaintiff’s decision to take it, or that a different label plausibly would have changed that decision”).
Aquino v. C.R. Bard, Inc., 413 F. Supp.3d 770, 790 (N.D. Ill. 2019), reached the same result applying Illinois substantive law, holding:
But even assuming some of the risks about which [plaintiff] complains were neither warned of by [defendant] nor known by the medical community generally, [plaintiff] still must allege that if there had been a proper warning, her surgeon would have declined to use the product. She does not. Accordingly, [plaintiff’s] failure to warn claims fail.
Id. at 790 (citations omitted). See Perkins v. Johnson & Johnson, 2021 WL 6118241, at *4 (C.D. Ill. Dec. 23, 2021) (dismissal where the plaintiff’s “allegations do not address whether the physician who implanted the [device] would have still recommended or used [it] had the physician been adequately warned of the alleged dangerousness of the product”); Grzanecki v. Smith & Nephew, Inc., 2019 WL 2297452, at *2 (N.D. Ill. May 30, 2019) (plaintiff’s “allegations of undisclosed warnings are too vague to establish that [defendants] failed to disclose anything to [her] doctors that they did not already know”).
Similarly, in Neto v. Bristol-Myers Squibb, 2023 WL 3689533 (D. Conn. May 26, 2023), the plaintiff’s failure to plead any facts alleging warning causation resulted in dismissal (without prejudice) of warning-based claims:
[T]he Complaint fails to allege facts sufficient to determine whether there is causation. [Discussion of learned intermediary rule omitted] Consistent with this doctrine, a plaintiff therefore must plead that an adequate warning would have changed a doctor’s decision to prescribe [the drug] to the decedent. But Plaintiff fails to allege any reason for the decedent’s doctor to prescribe [the drug] to him or provide the reason why any warning would change the prescriber’s decision. Accordingly, Plaintiff’s Complaint fails to state a plausible [state-law] Products Liability . . . claim.
Id. at *3.
Preemption probably doomed the plaintiff’s claims in Grinage v. Mylan Pharmaceuticals, Inc., 840 F. Supp.2d 862 (D. Md. 2011), but causation was another obstacle – despite a state law heeding presumption. Id. at 868.
This presumption does not, however, relieve a plaintiff of the requirement that she adequately allege causation in the first place. Here, there is no allegation that [plaintiff] and his doctor did not see the labeling as it was approved and take into consideration the information. . . . Nor has [plaintiff] alleged any other facts sufficient to support a reasonable inference that further communications consistent with the approved label would have affected the choices made by [plaintiff] or his doctor.
Id. at 868-69 (citations omitted).
In New Mexico, Nowell v. Medtronic, Inc., 372 F. Supp.3d 1166, 1254-55 (D.N.M. 2019), aff’d, 2021 WL 4979300 (10th Cir. Oct. 27, 2021), held that the plaintiff failed to “direct the Court to specific statements” pleading causation. Id. at 1251. In particular, plaintiff “d[id] not allege that any of the above warnings would have prevented [her surgeon] from using the Defendants’ [device]” and “that her injuries would not have occurred if adequate warning and instruction had been provided” Id. (citation and quotation marks omitted).
Because her allegations do not specify a plausible, causal danger about which the Defendants did not warn, one which would have compelled her physician to make a different treatment decision, [plaintiff’s] failure-to-warn claim cannot survive a motion to dismiss.
Id. at 1255 (footnote omitted). See Garcia v. Bayer Essure, Inc., 2023 WL 4235670, at *4 (D.N.M. June 28, 2023) (“To the extent that Plaintiff argues Defendants ’ failed to fully inform Plaintiff’ s healthcare providers regarding the proper implantation technique and necessity of . . . determin[ing] correct positioning’ of the device, Plaintiff fails to allege that her device was actually improperly implanted or positioned.”
In next-door Arizona, the Baca v. Johnson & Johnson, 2020 WL 6450294 (D. Ariz. Nov. 2, 2020), decision gave as good an explanation of what TwIqbal requires for causation alledations in learned intermediary cases as we’ve seen anywhere:
The Complaint needs to show how the alleged failure to warn caused the injury. . . . The Complaint does say that Plaintiff would not have relied on the Product if she had known the “true facts” about the risks. But because of the learned intermediary doctrine, a defendant’s duty to warn ends once it provides an adequate warning to the healthcare provider. Therefore, the focus of this failure to warn claim is on what Defendants told the health-care provider and whether inadequacies in those warnings caused Plaintiff’s injuries. On this point, the Complaint is silent. It does not name the treating physicians who received the allegedly inadequate warning, nor does it state that these physicians would have acted differently had they received a different warning. Therefore, the Court finds that Complaint fails to allege facts raising a plausible failure to warn claim.
Id. at *3 (citations omitted). Earlier, in Mills v. Bristol-Myers Squibb Co., 2011 WL 4708850 (D. Ariz. Oct. 7, 2011), another Arizona court rejected “information and belief” allegations about the conduct of plaintiff’s own physicians because those physicians were hardly “solely in the control of defendants. Id. “[P]laintiff could have contacted her physician to determine facts that were not solely in the control of defendants. Plaintiff has not done so.” Id. Therefore, “plaintiff ha[d] not pled a plausible strict liability [warning] claim.” Id. at *4.
The warning claim in Aston v. Johnson & Johnson, 248 F. Supp.3d 43, 54 (D.D.C. 2017), was “inadequately pled” because the complaint did “does not allege any facts that, when taken as true, support a plausible inference that [the drug’s] warning labels were a substantial factor in causing plaintiffs’ injuries.” Id. at 54. The allegation that “Plaintiffs’ physicians, on information and belief, would not have prescribed” the drug had they received “an alternative warning which fully disclosed the hidden deadly risks” was “nothing more than “a legal conclusion couched as a factual allegation.” Id. (citations and quotation marks omitted).
Numerous unreported cases from other states also hold plaintiffs to TwIqbal’s requirements that they plead case-specific facts to establish warning causation in learned intermediary rule litigation. See Hawkins v. Kaiser Foundation Health Plan, 2024 WL 2894771, at *4 (D. Or. June 10, 2024) (dismissal; “Plaintiff does not allege [that the] surgeon would have performed the procedure differently if . . . Defendants had provided an adequate warning of the danger associated with the device.”); Pacheco v. Johnson & Johnson, 2024 WL 1641777, at *6 & n.7 (M.D. Ga. April 16, 2024) (“Plaintiff alleges only that she received the implant . . . and suffered injuries,” and pleaded no “information about her meeting with her doctor”); Williams v. Boston Scientific Corp., 2023 WL 9596983, at *2 (N.D. Ohio Dec. 11, 2023) (dismissal where “Plaintiff’s Amended Complaint asserts no facts regarding what warnings were provided regarding Defendant’s product or how an adequate warning may have influenced her doctors.”); Dearinger v. Eli Lilly & Co., 2022 WL 2357008, at *2 (W.D. Wash. June 30, 2022) (dismissal because plaintiffs “have failed to allege that the prescribing physician would have acted differently had Defendant provided an adequate warning”); LaTouche v. Merck & Co., 2023 WL 3604655, at *3 (D.N.J. May 22, 2023) (“for proximate cause, the Amended Complaint fails to allege facts that would make it plausible that different word usage for the same symptoms would have altered the doctor’s prescription to prescribe the medicine to him”); Armstrong v. Atrium Medical Corp., 2022 WL 17258345, at *4 (E.D. Wash. Nov. 10, 2022) (“Plaintiff’s Complaint is also devoid of factual allegations demonstrating that Defendants’ failure to warn Plaintiff’s surgeon was the proximate cause of his injuries as required”); Knapp v. Zoetis, Inc., 2022 WL 989015, at *6 (E.D. Va. March 31, 2022) (“A plaintiff must also allege that adequate warnings would have altered the physician’s decision to prescribe the drug.”) (citation omitted); Spencer v. Bristol-Myers Squibb Co., 2021 WL 864148, at *2 (W.D. Okla. March 8, 2021) (“Plaintiff does not allege any facts from which it can be inferred that, if Defendant had properly informed the prescribing physician of the risks of [the drug], . . . the physician would not have prescribed it. . . . Absent such allegations, the Petition is insufficient.”) (citation omitted); Durham v. Johnson & Johnson, 2021 WL 3745730, at *5 (E.D. Tenn. Aug. 24, 2021) (dismissal where plaintiff failed to allege “that a warning would have altered the doctor’s actions and that the change in the doctor’s actions would have averted [plaintiff’s] injury); Dolan v. Boston Scientific Corp., 2021 WL 698777, at *3 (D. Minn. Feb. 23, 2021):
[Plaintiff] has not, however, alleged how [defendant’s] failure to warn [her] physician caused her injuries. There are no allegations that a hypothetical warning would have changed the course of events. In other words, she has not alleged that her prescribing physician would not have used the [device] if he or she had been properly apprised of the risks. Therefore, [plaintiff’s] failure to warn claim must be dismissed.
Id. at *3 (citation, quotation marks, and footnote omitted); Hernandez v. Johnson & Johnson, 2021 WL 320612, at *4 (E.D. Wash. Jan. 8, 2021) (under the learned intermediary rule, “[plaintiff] does not sufficiently allege that any failure to warn proximately caused her injuries and the eventual need for the additional surgery”); Evans v. Gilead Sciences, Inc., 2020 WL 5189995, at *13 (D. Haw. Aug. 31, 2020) (“[plaintiff] must allege that had the [drug’s] label contained a stronger warning . . ., this would have altered his prescribing physician’s course of action in some meaningful way. Because [plaintiff] has not done so, his failure-to-warn claim is dismissed”); Marshall v. Smith & Nephew, Inc., 2020 WL 362803, at *7 (D. Minn. Jan. 22, 2020) (“[plaintiff] has failed to offer facts showing . . . how such a hypothetical warning would have changed the course of events”);McLeod v. Sandoz, Inc., 2018 WL 1456739, at *3 (D.S.C. March 23, 2018) (“The Amended Complaint does not allege that Plaintiff’s prescribing physicians would have changed their decision to prescribe [the drug] had they been aware of the risk. . . . Accordingly, Plaintiffs have failed to state a claim to relief that is plausible on its face as Plaintiffs have not pled facts sufficient to establish causation in light of the learned intermediary doctrine.”) (footnote omitted); MacMurray v. Boehringer Ingelheim Pharmaceuticals, Inc., 2017 WL 11496825, at *9 (D. Utah Dec. 6, 2017) (“Plaintiff has not alleged that an adequate warning would have prevented the harm she suffered. Consequently, Plaintiff has not alleged sufficient facts); Bean v. Upsher-Smith Pharmaceuticals, Inc., 2017 WL 4348330, at *8 (D.S.C. Sept. 29, 2017) (same as McLeod), aff’d, 765 F. Appx. 934 (4th Cir. 2019); Harrison v. Davol, Inc., 2017 WL 10109447, at *3 (D.S.C. Nov. 8, 2017) (“Plaintiffs, however, have not alleged that the prescribing physician would have changed his decision to implant the [device] had he been aware of the risk.”); Sich v. Pfizer Pharmaceutical, 2017 WL 4407930, at *3 (D.N.J. Oct. 4, 2017) (“[a]s a direct and proximate result of” allegation, without more, insufficient to plead causation); Little v. Smith & Nephew, Inc., 2015 WL 3651769, at *9 (N.D. Miss. June 11, 2015) (dismissal where plaintiff “fails to allege that the physician would not have used the [device] if he had received an adequate warning. In fact, Plaintiff fails to mention his physician at all.”); Dimieri v. Medicis Pharmaceuticals Corp., 2014 WL 3417364, at *4 (M.D. Fla. July 14, 2014) (“Since Plaintiff does not allege the warnings to his physician were inadequate or that any were given, the Court cannot determine whether the inadequacy of Defendant’s warnings to Plaintiff’s physician proximately caused Plaintiff’s injury.”); Christison v. Biogen Idec, Inc., 2013 WL 6834371, at *3 (D. Utah Dec. 26, 2013) (dismissal with leave to amend “specific facts alleging that a change in warnings would have had an impact on the prescribing physician’s decision to prescribe [the drug] to Plaintiff’s decedent”); Deese v. Immunex Corp., 2012 WL 463722, at *5 (S.D. Miss. Feb. 13, 2012) (dismissal ordered where the plaintiff “falls short of alleging that an adequate warning would have kept his physician from prescribing [the drug”); Tumblin v. Pfizer Pharmaceutical, 2010 WL 11565310, at *1 (W.D. Okla. July 22, 2010) (“Nowhere in the complaint does plaintiff allege that defendant . . . failed to provide adequate warning to the prescribing or administering doctor of dangers associated with the use of [the drug] and that had it done so, the doctor would not have prescribed or given the drug to plaintiff and plaintiff would not have suffered the side effects of which he complains, as is necessary to state a claim.”).
Many, but not all, of these decisions are found in our TwIqbal cheat sheet. That is because we are very particular in what goes into the cheat sheet – only decisions that dismiss all challenged counts qualify. Our research here is broader, and laser focused on warning causation claims.
Still, there are also decisions that fail to apply TwIqbal, and thus let plaintiffs get away with conclusory causation allegations that could be identical in any case. One thing we’ve noticed in our research is that adverse decisions often fail to address relevant precedent from the same state, and that even favorable decisions do not reference other in-state favorable precedent. We hope that this post makes it easier for defense counsel to access the most persuasive precedent, and thus to win more causation-related TwIqbal motions.