Using TwIqbal To Require Plaintiffs To Identify Claimed Warning Inadequacy

Our prior TwIqbal post concerning learned intermediary causation was well received by our readers, so we're back with a second, related (and, as it turned out, even longer)...
United States California Food, Drugs, Healthcare, Life Sciences

Our prior TwIqbal post concerning learned intermediary causation was well received by our readers, so we're back with a second, related (and, as it turned out, even longer) discussion of pleading in prescription medical product warning litigation.

In addition to pleading causation, a product liability plaintiff alleging an inadequate warning must plead how the warning was inadequate. Sounds rather obvious, but never underestimate the capacity of plaintiffs in our sandbox for failing to plead their cases. The amount of precedent bouncing lazy plaintiffs for not bothering to allege what (they claim) is wrong with prescription medical product warnings is surprisingly (or maybe not) extensive.

But hardly unanimous, which is why we've dug pretty deeply in this post.

We've noticed, from reading TwIqbal decisions until our eyes glaze over, that particularly in mass tort, pattern litigation, defendants filing these motions rely primarily on their own prior wins. That's all well and good, but we've seen more adverse opinions than we would like that minimize a defendant's reliance on "a few" or "a couple" of "out-of-state" decisions.

We think it would it would lead to better results for defendants to rely where possible on in-state precedent, even though TwIqbal involves federal pleading standards. If there isn't any (or much) in-state TwIqbal authority – for example in Missouri, Georgia, or Kentucky – defendants need to cite a lot of (not just a little) authority from other jurisdictions.

Unfortunately, many favorable TwIqbal cases focus on the pleadings before the particular court, and don't cite much law, so legal research can be difficult. Well, we've now looked at over 500 TwIqbal cases involving learned intermediary rule situations, and in what follows readers will find just about everything there probably is to support defense TwIqbal motions in prescription medical product liability litigation.

Use it with our compliments.

Two non-precedential court of appeals decisions lead the parade. Most recently, the Fifth Circuit affirmed a TwIqbal dismissal of a warning claim in Harrison v. Medtronic, Inc., because the "complaint mostly parrots the legal elements of a marketing defect claim, without identifying which of [defendant's] warnings were allegedly defective." 2022 WL 17443711, at *3 (5th Cir. Dec. 6, 2022) (applying Texas law).

General allegations − such as that the "warnings failed to inform the user of the nature of the danger" − do not meet the pleading standard. [Plaintiff's] only specific allegations are really design-defect claims in disguise. For instance, he claims [defendant] should have warned doctors that the device's [component] could result in malfunction. But this allegation does not claim the warning, or lack thereof, renders this otherwise adequate [device] unreasonably dangerous.

Id. (citations and quotation marks omitted).

Shortly after the TwIqbal decisions themselves, the Eleventh Circuit decided Bailey v. Janssen Pharmaceutica, Inc., 288 F. Appx. 597 (11th Cir. 2008) (applying Florida law). Bailey affirmed dismissal of a strict liability warning claim in prescription drug litigation where "[i]n only one conclusory sentence, the complaint pleads the inadequacy of the warnings to doctors." Id. at 608. That sentence said nothing, only that the product was "not accompanied by adequate instructions and/or warnings to fully apprise the prescribing physicians of the full nature or extent of the risks and side effects associated with its use." Id. (citation to complaint, and quotation marks omitted). Pathetic.

Nowhere does the complaint recite the contents of the warning label or the information available to [plaintiff's] physician or otherwise describe the manner in which the warning was inadequate. [The complaint] only asserts that the warning was insufficient because it failed to warn of various dangers of the use of this [drug], without explaining either the information available to [plaintiff's] physician at the time of the administration of the drug or how the contents of the label were inadequate.

Id. at 609. Witt v. Stryker Corp., 648 F. Appx. 867 (11th Cir. 2016) (applying Florida law), applied Bailey to hold that "[s]imply stating that the warnings were insufficient only recites the elements of this cause of action" and failed the TwIqbal standard. Id. at 871. The Witt plaintiff "failed to allege a plausible set of facts to state a claim for failure to warn. We are left only with the bald [warning] allegation, asserted at the highest order of generality and unsupported by any factual claims." Id. For more discussion, see Witt v. Howmedica Osteonics Corp., 2013 WL 6858395 (S.D. Fla. Dec. 30, 2013), the opinion that the Eleventh Circuit affirmed:

The Amended Complaint does not allege any facts as to the content of any warnings given. It only states that Defendant failed to give proper warnings and that the warnings were "inadequate." Simply stating that the warnings were insufficient only recites the elements of this cause of action. The Amended Complaint contains insufficient details as to the facts surrounding these warning. Without more facts, a count for failure to warn cannot stand.

Id. at *3.

Bailey, in particular, is cited frequently by favorable warning pleading cases. See Ganz v. Grifols Therapeutics LLC, 688 F. Supp.3d 1209, 1226 (S.D. Fla. 2023) (Plaintiff "fails to plead sufficient facts to satisfy the first element of inadequate warnings. The Complaint makes various references to [defendant's] failure to warn of risks, but nowhere in the Complaint does Plaintiff actually assert how the label offered was defective or inadequate.") (footnote omitted); Dye v. Covidien LP, 470 F. Supp.3d 1329, 1341 (S.D. Fla. 2020) ("[p]laintiff must allege facts relating to the learned intermediary doctrine, such as whether plaintiff's physician had 'adequate' warning of the resulting injury"; "[p]laintiff cannot maintain a cause of action . . . for failing to warn of injuries he did not experience") (emphasis original); Stephens v. Teva Pharmaceuticals, U.S.A., Inc., 70 F. Supp.3d 1246, 1254 (N.D. Ala. 2014) ("plaintiffs' failure to allege [that the] prescribing physician was not adequately informed about the risks of [the drug] . . . is fatal to plaintiffs' claims").

Here are more unpublished opinions from Eleventh Circuit courts likewise dismissing inadequately pleaded warning claims in prescription medical product liability litigation. Most recently Jones v. Angiodynamics, Inc., 2024 WL 4430671 (M.D. Fla. Sept. 9, 2024), held:

[Plaintiff's] allegations merely conclude that Defendants' warnings were inadequate without identifying the warning or warnings at issue, or the contents thereof. This is insufficient for pleading purposes. Moreover, because Plaintiff received the . . . device from his physician, the learned intermediary doctrine applies. Plaintiff must therefore allege what information was available to his physician and explain why it was inadequate. The Amended Complaint fails entirely to allege what warnings or information were available to his physician. And, as already noted, Plaintiff makes only a conclusory allegation that Defendants' warnings were inadequate. Plaintiff therefore fails to state a claim.

Id. at *2 (citations omitted). Accord Jimenez v. Holiday CVS, LLC, 2023 WL 4251176, at *2 (S.D. Fla. June 29, 2023) ("Plaintiff fails to allege what the instructions or warning that did accompany [defendant's] Product, nor does Plaintiff otherwise explain how the information provided was inadequate") (following Bailey and "multiple" other cases); Garcia v. Covidien LP, 2022 WL 3597055, at *4 (M.D. Fla. Jan. 6, 2022) ("Nowhere in the Complaint does Plaintiff provide any allegations as to the substance of the warning given to the operating physician. . . . Without any further explanation of the information provided to [plaintiff's]doctors, there is no way to show that the warning was inadequate.") (footnote omitted); Cates v. Zeltiq Aesthetics, Inc., 2020 WL 13786612, at *3 (M.D. Fla. March 11, 2020) ("The Complaint makes no allegations regarding the contents of the warnings. . . . In the absence of such allegations, the Court concludes that Plaintiff fails to allege a failure to warn.") (footnote omitted); Wright v. Howmedica Osteonics Corp., 2017 WL 9939182, at *3 (M.D. Fla. Nov. 21, 2017) ("even if she properly pleaded the duty element, Plaintiff fails to recite the contents of the warning label or describe why it was inadequate, just like in Bailey"), aff'd, 741 F. Appx. 624 (11th Cir. 2018); Tsavaris v. Pfizer, Inc., 2016 WL 375008, at *3 (S.D. Fla. Feb. 1, 2016):

[Plaintiff's] Complaint, however, does not identify the content of the warnings in question or adequately present the alleged defects in the warnings. . . . [Plaintiff] fails to identify what risks . . . Defendants actually warned of, including whether those warnings accompanied the [drug] she received, and exactly how those warnings should have been rewritten to avoid any alleged inaccuracy. As such, [plaintiff] has not pleaded enough facts to state a claim under a failure to warn theory.

Id. at *3 (citation omitted); Elliott v. Sandoz, Inc., 2016 WL 4398407, at *7 (N.D. Ala. Aug. 18, 2016) ("Plaintiff has not pleaded any plausible facts that show Defendant failed to adequately warn [the prescriber] of the dangers of [the drug]. Instead, she has made a conclusory statement that 'Defendant failed to provide adequate and required warnings to physicians,' which the court disregards.") (citation omitted); Miller v. Pfizer Inc., 2014 WL 2155020, at *3 (N.D. Ala. May 22, 2014) ("the complaint briefly mentions that the warnings were inadequate, it does not explain why they were inadequate") (emphasis original); Jones v. Novartis Pharmaceuticals Co., 2014 WL 12597334, at *4 (N.D. Ala. Feb. 5, 2014) ("failure to provide factual allegations to support the theory that there was an inadequate or dishonest warning is fatal to the plaintiff's claim"); Batchelor v. Pfizer, Inc., 2013 WL 3873242 (M.D. Ala. July 25, 2013):

Plaintiff has pleaded no facts supporting liability under the learned intermediary doctrine. She has not pleaded that Defendant failed to warn her physician(s). She has not pleaded that the warning issued to her physicians, if any, was inadequate or misrepresented the risk. Instead, Plaintiff continues to insist Defendant is liable because it failed to warn her. Defendant had no duty to warn Plaintiff, only to warn her physicians adequately and honestly, and Plaintiff offers no factual allegations to support the theory that there was an inadequate or dishonest warning. . . . The court cannot assess the adequacy of the warning to Plaintiff's physician without knowing what − if any − warning appeared.

Id. at *2-3 (following Bailey other citations omitted). Why no Georgia cases? We don't believe that plaintiffs' lawyers in Georgia are that much more punctilious pleaders than their Alabama or Florida colleagues. We hope that this compilation of Eleventh Circuit TwIqbal precedent can lead to better Georgia results.

Bailey also influenced a Second Circuit case. Reed v. Pfizer, Inc., 839 F. Supp.2d 571 (E.D.N.Y. 2012), found Bailey persuasive in dismissing a similarly underpleaded warning claim.

[A] failure to warn cause of action is appropriately dismissed if a plaintiff does not plead facts indicating how the provided warnings were inadequate. . . . In contrast with their thorough recitation of [their] claimed injuries, plaintiffs plead nothing about the content of [the drug's] warnings. . . . [Plaintiffs] fall short of stating a failure to warn claim because the amended complaint does not allege facts identifying how the provided warnings were inadequate. Instead it first alleges (1) "the drug was not accompanied by adequate warnings;" and (2) the drug was promoted "without sufficient disclosure of its dangerous propensities." But assertions that warnings were not "adequate" or "sufficient" are nothing more than legal conclusions unsupported by factual content.

Id. at 575-76 (citing Bailey) (other citations omitted). Numerous New York cases follow suit. "At the motion to dismiss phase, a plaintiff must plead facts that show how the warning was inadequate or insufficient." Krulewich v. Covidien, LP, 498 F. Supp.3d 566, 577 (S.D.N.Y. 2020) (citation omitted).

The plaintiffs' failure to warn claim . . . failed because the plaintiffs did not provide factual support for the conclusory statements that the defendant's warnings "were not sufficient, accurate or clear". . . . The plaintiffs' allegations in this regard were entirely conclusory, and did not amount to anything more than repeated statements that the defendant's warnings and instructions for use were inadequate.

Id. at 577 (citations omitted). See also Dunham v. Covidien LP, 498 F. Supp.3d 549, 559-60 (S.D.N.Y. 2020) (similar result on similar allegations); Webb v. Mentor Worldwide LLC, 453 F. Supp.3d 550, 560 n.3 (N.D.N.Y. 2020) ("Plaintiff's complaint contains only conclusory allegations that the . . . Implants 'contained warnings which were insufficient to alert consumers,' which is inadequate to avoid dismissal."). Thus, "a plaintiff is required to plead facts illustrating that the product did not contain adequate warnings," and "a claim premised upon a failure to warn theory should be dismissed in the event a plaintiff fails to plead facts establishing how or why the warning provided was inadequate." Oden v. Boston Scientific Corp., 330 F. Supp.3d 877, 892 (E.D.N.Y. 2018) (citations omitted).

[T]he Complaint fails to provide facts identifying how or why the included warnings were inadequate. Although Plaintiff claims that Defendant failed to warn or otherwise provided inadequate warnings of all of the aforementioned risks, the Complaint is silent as to how the warnings that were indisputably provided, both in Defendant's Instructions for Use as well as the product brochure, were inadequate.

Id. See Trisvan v. Heyman, 305 F. Supp.3d 381, 399 (E.D.N.Y. 2018) ("Plaintiff fails to provide any non-conclusory allegations to suggest that his treating physicians were not informed of the potential side-effects of [the drugs] of which he complains.").

Other New York cases for the same general propositions are: Greenwood v. Arthrex, Inc., 2023 WL 3570436, at *8-9 (W.D.N.Y. May 19, 2023) (plaintiff neither "alleged an alternative warning that [defendant] should have furnished" nor "allege[d] when [defendant] learned [of] the potential . . . risk"); Warren v. ResMed Corp., 2022 WL 2334055, at *3 (S.D.N.Y. June 28, 2022) (rejecting information and belief pleading; "Plaintiff's allegation that [her physician] received the relevant warnings from the Defendants is 'wholly conclusory'") (citation and quotation marks omitted); Gioia v. Janssen Pharmaceuticals, 2021 WL 5447330, at *2 (E.D.N.Y. Nov. 22, 2021) (dismissal for failure to "identify what warnings were provided to plaintiff's physician or how the provided warnings were inadequate"); Koublani v. Cochlear Ltd., 2021 WL 2577068, at *17 (E.D.N.Y. June 23, 2021) ("Plaintiff's failure-to-warn allegations, at their most specific, state that Defendants withheld the 'risks and dangers associated with use of the [product]'"; other "courts have dismissed near-identical failure-to-warn claims as inadequately pleaded"; this "Court agrees"); Greenwood v. Arthrex, Inc., 2022 WL 2117763, at *13 (W.D.N.Y. June 13, 2022) (plaintiff "fails to allege what warnings [defendant] should have given"; these "conclusory allegation also fails to state a duty to warn claim"); Cosh v. Atrium Medical Corp., 2021 WL 1177770, at *4 (S.D.N.Y. March 29, 2021) (allegations "that [defendant] represented that its product was safe and effective . . . point[ed] to no specific statements"; nor could plaintiffs "transmute" "insufficient" design and manufacturing allegations into warning claims); Gioia v. Janssen Pharmaceuticals, 2021 WL 602683, at *3 (E.D.N.Y. Feb. 16, 2021) ("Wholly lacking from plaintiff's complaints are any allegations as to the contents of [defendant's] warnings, and, specifically, whether or not plaintiff's physician was warned of the side effects plaintiff allegedly suffered."); O'Neil v. Argon Medical Devices, Inc., 2020 WL 1149904, at *7 (Mag. N.D.N.Y. Feb. 13, 2020) ("Plaintiff does not provide any factual allegations regarding the content of the warnings which were in fact provided to him or his healthcare providers, nor does he explain how those warnings were inadequate" "Without stating what warnings were in fact given to Plaintiff or his healthcare providers, the allegations that the warnings were inadequate or failed to properly warn of the risks are no more than legal conclusions.") (citations omitted), adopted, 2020 WL 1140511 (N.D.N.Y. March 9, 2020); Boris v. Atrium Medical Corp., 2020 WL 589440, at *7 (S.D.N.Y. Feb. 6, 2020) ("Notably absent . . . is the exact language of the warnings contained on the device. The Court therefore finds, Plaintiff's allegations do not include any factual content regarding how the provided warnings and information failed to accurately reflect reality"); Cosh v. Atrium Medical Corp., 2020 WL 583826, at *3-4 (S.D.N.Y. Feb. 6, 2020) (same as Boris); Bustamante v. Atrium Medical Corp., 2020 WL 583745, at *7 (S.D.N.Y. Feb. 6, 2020) (same as Boris); Green v. Covidien LP, 2019 WL 4142480, at *5 (S.D.N.Y. Aug. 30, 2019) ("Plaintiff has not alleged facts making out a failure to warn claim," as the "allegations do not include any factual content"); Fleming v. Endo International PLC, 2019 WL 4378964, at *3 (S.D.N.Y. Aug. 27, 2019) ("Plaintiff's complaint provides only conclusory allegations that are insufficient"; "[w]hen, as here, [plaintiff] fails to address the warning's inadequacies . . ., a court must deny a failure to warn claim as a matter of law") (citations and quotation marks omitted); Dunham v. Covidien LP, 2019 WL 2461806, at *3 (S.D.N.Y. May 22, 2019) ("conclusory" warning claim "does not particularize specific omissions or inadequacies supporting its allegations"); Kennedy v. Covidien, LP, 2019 WL 1429979, at *5 (S.D.N.Y. March 29, 2019) ("Plaintiff has failed to provide factual support for his conclusory assertion that Defendant's warnings did not adequately caution physicians and patients concerning the risks associated with [the device]"); Quintana v. B. Braun Medical, Inc., 2018 WL 3559091, at *6 (S.D.N.Y. July 24, 2018) ("Although Plaintiff vaguely discusses aspects of Defendants' [labeling] that she claims were deficient, she fails to identify how those warnings were inadequate.") (citations omitted) (emphasis original); Black v. Covidien, PLC, 2018 WL 573569, at *3 (W.D.N.Y. Jan. 26, 2018) ("Plaintiffs do not identify what warnings Defendant gave to [their] physicians, how they were inadequate, or what warnings should have been given"; "alleged 'facts' supporting Plaintiffs' failure to warn claim are merely legal conclusions"); Hingos v. W.L. Gore & Assoc., 2017 WL 3309095, at *6 (N.D.N.Y. Jan. 27, 2017) ("speculative" allegations "d[id] not identify what warnings were given, how they were inadequate, [or] what warnings should have been given"); Morrison v. Hoffmann-La Roche, Inc., 2016 WL 5678546, at *8 (E.D.N.Y. Sept. 29, 2016) ("mere assertions that warnings on product labels are inadequate constitute conclusory statements lacking in empirical support"); Parillo v. Stryker Corp., 2015 WL 12748006, at *7 (N.D.N.Y. Sept. 29, 2015) ("Plaintiff fails to state a plausible failure to warn claim because he does not allege any facts whatsoever as to what the warning was, or how it was inadequate."); Bertini v. Smith & Nephew, Inc., 2013 WL 6332684, at *3 (E.D.N.Y. July 15, 2013) ("plaintiffs plead no facts related to any specific warnings or how these warnings were inadequate"); Goldin v. Smith & Nephew, Inc., 2013 WL 1759575, at *5 (S.D.N.Y. April 24, 2013) ("Plaintiff does not identify the allegedly defective warnings, nor does she allege facts in support of her claim that these warnings were, in fact, defective."); Henson v. Wright Medical Technology, Inc., 2013 WL 1296388, at *2 (N.D.N.Y. March 28, 2013) ("Plaintiff has insufficiently pled a failure to warn claim because his allegations lack facts as to how or why the acknowledged warning was inadequate, . . ., about what risk of harm, or in what way") (citation and quotation marks omitted); Lewis v. Abbott Laboratories, 2009 WL 2231701, at *5 (S.D.N.Y. July 24, 2009) ("plaintiff has not alleged that [defendant] failed to provide warnings to her doctors" and thus "has not alleged sufficient evidence to support a failure to warn claim") (citation omitted). We've found enough New York precedent so that, if properly presented in a TwIqbal motion, the result should always be dismissal of an inadequate complaint.

In California, "[a] plausible claim for a failure to warn should include allegations that inter alia identify which danger was not warned against, explain that the danger was substantial, and that the danger was known or reasonably knowable, or explain how any warning that was given was inadequate." Marroquin v. Pfizer, Inc., 367 F. Supp.3d 1152, 1160-61 (E.D. Cal. 2019) (citations omitted). "Merely stating that the Defendants failed to 'adequately warn' of [the relevant risk] is a bare legal conclusion." Id. 1161.

"[A] complaint must do more than regurgitate the legal standard." Garcia v. Sanofi Pasteur Inc., 617 F. Supp.3d 1169, 1175 (E.D. Cal. 2022). Thus, California courts have also "routinely dismissed similar claims where a plaintiff fails to describe how the warnings at issue were inadequate." Staten v. Astellas Pharma US, Inc., 2024 WL 3745659, at *3 (C.D. Cal. July 29, 2024). A complaint "without clarification as to why [the] warnings were insufficient [] cannot support a failure to warn claim." Id.Staten cited the following cases:

  • Nazzal v. Wyeth, 2024 WL 2105601, at *2 (C.D. Cal. March 19, 2024) (dismissing claims for strict liability and negligent failure to warn because plaintiff "fail[ed] to explain how or why the warning on the . . . drugs were inadequate, or what an adequate warning might look like.");
  • Fischer v. Boston Scientific Corp., 2020 WL 2300138, at *3 (C.D. Cal. March 25, 2020) (dismissing failure to warn claim, in relevant part, because plaintiff did not identify "what warning the physician received, or how the warnings that were disclosed to the physician were inadequate");
  • Alvarez v. Bayer US, Inc., 2021 WL 8742153, at *3 (C.D. Cal. Dec. 15, 2021) (finding plaintiff failed to plead facts supporting a failure to warn claim because "although Plaintiff quotes a portion of a warning about the [medical device] purportedly supplied by Defendant, Plaintiff fails to allege how the warning is inadequate, the source of that warning, or whether the healthcare provider who prescribed the [device] to Plaintiff received that particular warning").

In Patton v. Forest Laboratories, LLC, 2018 WL 5270476 (C.D. Cal. May 10, 2018), aff'd, 793 F. Appx. 608 (9th Cir. 2020), the complaint's warning claim:

Contains nothing more than an unadorned allegation that the suicide warning on the [drug's] labeling was somehow not "proper." Because it fails to explain how or why the warning was not "proper," or what a "proper" warning might look like, the [complaint] does not include sufficient factual enhancement to cross the line between possibility and plausibility.

Id. at *15 (citation and quotation marks omitted). Similarly, in Garcia, the complaint was dismissed because it "fail[ed] to allege facts that even circumstantially reveal which danger was not warned against, how that danger was substantial, that the danger was known or reasonably knowable, or how any warning that was given was inadequate." 617 F. Supp.3d at 1175.

Other California TwIqbal decisions turning on plaintiffs' failure to plead basic warning-related facts include: Holcomb v. Pfizer, Inc., 2024 WL 169227, at *6 (Mag. E.D. Cal. Jan. 16, 2024) ("the first amended complaint provides no additional facts that speak to these alleged . . . failures, what they were, [or] when they occurred"), adopted 2024 WL 870603 (E.D. Cal. Feb. 29, 2024); Boyer v. Abbott Vascular Inc., 2023 WL 4269764, at *2 (N.D. Cal. June 29, 2023) ("A plaintiff's pleadings are insufficient when they do not identify the warning that her doctor received or allege how it was inadequate") (citation and quotation marks omitted); Holcomb v. Pfizer, Inc., 2022 WL 17670003, at *4 (E.D. Cal. Dec. 14, 2022) (original complaint "fails to allege how Defendant might have altered [the drug's] label" or the "what" and "when" of alleged adverse events); Rathkey v. Zimmer, Inc., 2022 WL 3130878, at *4 (C.D. Cal. June 22, 2022) (plaintiff "has failed to state a claim because there are no allegations regarding the inadequacy of any warnings given by [defendant] to [the implanting surgeon]"); Fussy v. RTI Surgical, 2022 WL 1122615 (E.D. Cal. April 14, 2022):

[T]o successfully allege a failure to warn claim here, plaintiff must allege facts sufficient to show that: (1) defendant did not warn plaintiff's doctors of the risks associated with the [device] or the warning was inadequate, and (2) that the inadequacy or absence of the warning caused plaintiff's injuries. Having failed to allege any such facts, plaintiff has not adequately alleged a failure to warn claim.

Id. at *4 (citation and quotation marks omitted); Alvarez v. Bayer US, Inc., 2021 WL 8742153, at *3 (C.D. Cal. Dec. 15, 2021) ("Plaintiff fails to allege how the warning is inadequate, the source of that warning, or whether the healthcare provider who prescribed the [device] to Plaintiff received that particular warning"); Nichols v. Covidien LP, 2021 WL 764134, at *5 (N.D. Cal. Feb. 26, 2021) (plaintiff "has not provided any details about the warnings which [his surgeon] received before the surgery, and why those warnings were inadequate"; nor "alleged with specificity what warning was feasible"); Hogg-Johnson v. Merz North America, 2020 WL 13157998, at *2 (S.D. Cal. Aug. 25, 2020) (quoting and following Marroquin); Fischer v. Boston Scientific Corp., 2020 WL 2300138, at *3 (C.D. Cal. March 25, 2020) (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"); 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 indicate how Defendants' warnings were inadequate"); Dilley v. C.R. Bard, Inc., 2014 WL 1338877, at *4 (C.D. Cal. April 3, 2014) (plaintiff "has not identified any warnings that were given with the [device] let alone how they are allegedly deficient"); Nimtz v. Cepin, 2011 WL 831182, at *2 (S.D. Cal. March 3, 2011):

Plaintiff's defective warning claim . . . does not identify what warning was given, or how the warning given was inadequate. In other words, plaintiff does not identify which specific danger [defendant] should have been warning against. To state a plausible claim for failure to warn, a complaint should at least identify which danger was not warned against, that the danger was substantial, that the danger was not readily recognizable to an ordinary consumer, that the manufacturer knew or should have reasonably known of the danger, and causation.

Id. at *2 (citations omitted); Wendell v. Johnson & Johnson, 2010 WL 271423, at *4 (N.D. Cal. Jan. 20 2010) (dismissing warning claim because the plaintiffs "fail[ed] to allege how [the] warnings about [the drug] were inadequate").

In Texas, Harrison, supra, has yet to influence TwIqbal warning decisions. That doesn't mean that vague allegations are being tolerated, however. Cofresi v. Medtronic, Inc., 450 F. Supp.3d 759 (W.D. Tex. 2020), did away with a pelvic mesh warning claim. "The aim of a marketing defect claim [the Texas name for warning claims] is to impose liability where the failure to warn itself caused a product to be unreasonably dangerous. Here, the Court finds that Plaintiff's claim cannot survive Defendant[]'s dismissal motion because Plaintiff fails to identify how the warning was inadequate or insufficient." Id. at 767-68 (citation omitted). Fearrington v. Boston Scientific Corp., 410 F. Supp.3d 794 (S.D. Tex. 2019), cited in Harrison, similarly dismissed a complaint because it only "allege[d] generally" that defendant failed to provide adequate warnings. Id. at 802. That "Complaint d[id] not identify [plaintiff's] treating physicians or facts as to the allegedly deficient warnings Defendant provided to them." Id. Earlier, Gonzalez v. Bayer Healthcare Pharmaceuticals, Inc., 930 F. Supp.2d 808 (S.D. Tex. 2013), TwIqballed a drug warning claim because "Plaintiff does not allege that the warning to her healthcare provider was inadequate nor identify the warnings or materials which her doctor received or reviewed." Id. at 818. A month before that, Rojas v. Teva Pharmaceuticals, USA, Inc., 920 F. Supp.2d 772 (S.D. Tex. 2013), did the same because "Plaintiff's failure-to-update-the-labeling and any other remaining failure to warn claims are inadequate. . . . Plaintiff fails to mention her doctor. . . . In short, she makes nothing more than conclusory allegations that [defendant] breached a duty to her doctor." Id. at 781.

Those are the published Texas TwIqbal involving prescription medical product warning adequacy. Here are some more favorable unpublished decisions: Adams v. Indivior, Inc., 2022 WL 4662565, at *6 (Mag. S.D. Tex. Sept. 13, 2022) ("Plaintiff does not address what warnings he was given by his prescribing physician, what warnings were included when he received his prescription or what warnings his prescribing physician received from [defendant] nor does he plead any allegations as to how these warnings were inadequate or whether they were approved by the FDA."), adopted, 2022 WL 4734407 (S.D. Tex. Sept. 30, 2022); Dubay v. Boston Scientific Corp., 2021 WL 3771769, at *2 (N.D. Tex. Jan. 21, 2021) (plaintiff "did not identify her prescribing physicians nor did she identify the warning her physicians received"); Marrufo v. Ethicon, Inc., 2020 WL 7680562, at *3 (W.D. Tex. Nov. 20, 2020) ("A plaintiff's pleadings are insufficient when they do not identify the warning that her doctor received, [or] allege how it was inadequate"); 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, [and] does not allege how the warning was inadequate"); Miles v. Boston Scientific Corp., 2020 WL 3871329 at *7 (S.D. Tex. July 9, 2020) ("these statements are vague and conclusory as they do not identify the warning her doctor received or allege how it was inadequate"); Carlton v. Olympus Corp., 2019 WL 6037322, at *11 (Mag. W.D. Tex. July 26, 2019) ("Plaintiffs' allegations are still inadequate to support their failure to warn and related claims: they do not allege any particular inadequacy in the warnings provided by the . . . Defendants"), adopted, 2019 WL 6037277 (W.D. Tex. Aug. 23, 2019); Carpenter v. Boston Scientific Corp., 2019 WL 3322091, at *9 (N.D. Tex. July 24, 2019) ("Plaintiff's pleadings . . . lack sufficiently specific allegations regarding the warnings provided to the prescribing physicians . . . and the basis for the warnings being inadequate. . . . [Plaintiff], accordingly, has not met the pleading standard with respect to her failure-to-warn claim").

Finally (for Texas), McGuire v. Abbott Laboratories, Inc., 2023 WL 3262033 (E.D. Tex. May 3, 2023), TwIqballed a failure-to-report claim:

[The] Complaint fails to do more than assert conclusory allegations regarding [plaintiff's] failure to warn and marketing defect claims. While [plaintiff] states that [defendant] "failed to report adverse incidents," he does 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. Accordingly, [plaintiff's] claims for failure to warn and negligent marketing are dismissed for failure to state a claim

Id. at *4 (citations omitted).

In Pennsylvania, warning claims survive only "where plaintiffs' complaints contained factual allegations as to the content of the warnings defendants should have provided," since "to assert a viable . . . failure to warn claim, a plaintiff must allege facts sufficient to plausibly show that the defendant failed to exercise reasonable care to inform those for whose use the product is supplied of the facts which make it likely to be dangerous." Foge, McKeever LLC v. Zoetis, Inc., 565 F. Supp.3d 647, 653 (W.D. Pa. 2021) (citations and quotation marks omitted). Where plaintiffs fail to "specify what information was missing from Defendant's warnings or how and why the warnings were inadequate," they have not met the TwIqbal plausibility standard. Id. at 653-54.

In Salvio v. Amgen, Inc., 810 F. Supp.2d 745, 752 (W.D. Pa. 2011), the plaintiff's "conclusory averments that Defendants failed to adequately warn, ignored and/or understated the risks and side effects associated with the use of [the drug]" failed utterly – particularly in light of the drug's boxed warning. Id. at 753. "Other than a vague reference that the FDA demanded a 'strengthened' black box warning . . ., Plaintiff does not describe the alleged failure-to-warn." Id. at 752.

At a minimum, Plaintiff has failed to plead facts regarding how this warning was not reasonable. Plaintiff has also failed to plead facts showing that Defendants did not properly discharge their duty by warning Decedent's physician through the Package Insert or otherwise. He has also failed to provide any facts about how the change in the "black box" warning affected her choice to either continue taking [the drug], or stop taking it. Without these facts, the Plaintiff cannot sufficiently state a cause of action.

Id. at 753. Similarly conclusory pleading resulted in dismissal of the warning claim in McGrain v. C.R. Bard, Inc., 551 F. Supp.3d 529 (E.D. Pa. 2021):

[Plaintiff's] allegations, however, do not specify what information was missing from Defendants' warnings. Nor do any of the allegations address the precise injury posed by the use of the device. Without this information, Plaintiff has not plausibly stated a connection between her alleged injuries and Defendants' failure to warn. Plaintiff's negligent failure to warn claim is, therefore, dismissed.

Id. at 543. In Bergstresser v. Bristol-Myers Squibb Co., 2013 WL 1760525, at *5 (M.D. Pa. April 24, 2013), the plaintiff's warning claim was TwIqballed for essentially the same reasons:

The plaintiff does not address the warnings provided on the [drug] label, nor does he point to any deficiencies in the labeling. Further, the plaintiff fails to indicate what warning should have been given or that any alternative warning would have prevented his physician from prescribing him [the drug]. Thus, the allegations of the plaintiff's complaint are insufficient to state a claim for negligent failure to warn.

Id. at *5 (citations and footnote omitted). Accord DiCair v. Gilead Sciences, Inc., 2022 WL 2703611, at *3 (E.D. Pa. July 12, 2022) ("Plaintiff's failure to warn claim fails" where "the Complaint does not contain any allegations regarding Decedent's prescribing doctor, let alone any warning (or lack thereof) directed to them"); Bell v. Boehringer Ingelheim Pharmaceuticals, Inc., 2018 WL 2447788, at *4 (W.D. Pa. May 31, 2018) ("conclusory repackaging of the elements of the claim without supporting facts" dismissed; plaintiff "did not plead how the original warnings about [the drug] fell below the required standard of care, what new information defendants obtained or when they obtained it, [or] what the strengthened warning should have said").

In Massachusetts, Taupier v. Davol, Inc., 490 F. Supp.3d 430, 447 (Mag. D. Mass. 2020), TwIqballed the warning claims in a mesh case because the plaintiff "fail[ed] to offer any description of the warnings and instructions that Defendant provided or should have provided to his physician." Id. at 447

[The] assertions that [plaintiff] was not informed of and had no knowledge of the known complications and risks . . . and that the warnings and instructions were incorrect, inadequate, and incomplete are conclusory and insufficient to state a claim for negligent failure to warn even under the relatively lenient standard afforded to the pleadings.

Id. These "conclusory allegations . . . are insufficient to allege a claim for . . . failure to warn and are dismissed." Id. at 448.

Similarly, the warning claim in Acevedo v. Johnson & Johnson, 2018 WL 4693958, at *4 (D. Mass. Sept. 30, 2018), was dismissed for inadequate pleading:

Count II fails to assert a valid claim for relief because it fails to assert facts to show that the defendants failed to inform the plaintiff's physician regarding [the drug's] side effects. The amended complaint fails to identify the plaintiff's physician or to assert when s/he treated the plaintiff or what information, if any, the physician possessed regarding [the drug]. Without more, the claim is too vague and imprecise to provide meaningful guidance to the defendants.

Id. at 4. Accord Gonzalez v. Johnson & Johnson Co., 2022 WL 2658975, at *4 (D. Mass. July 8, 2022) (plaintiff "fails to offer any description of the warning and instructions that [defendants] provided or should have provided [the implanting surgeon]"); Cunningham v. Abbott Vascular, Inc., 2022 WL 2387903, at *6 (Mag. D. Mass. March 1, 2022) (plaintiff "has made no allegations that [defendant] failed to provide adequate warnings to his doctors"), adopted, 2022 WL 970593 (D. Mass. Sept. 29, 2023); Sundaramurthy v. Abbott Vascular, Inc., 2021 WL 7542704, at *3 (D. Mass. Dec. 6, 2021) ("The complaint does not allege . . ., in what way the defendant failed to warn") (citations omitted); Engren v. Johnson & Johnson, Inc., 2021 WL 4255296 at *4 (D. Mass. Sept. 17, 2021) (plaintiff's complaint "does not offer any description of the warnings and instructions that [defendants] provided or should have provided to her healthcare providers") (citation and quotation marks omitted).

Because "[p]laintiff has made only conclusory statements as to the failure of Defendants to warn about the dangers of [the drug]," those claims suffered dismissal in Fleming v. Janssen Pharmaceuticals, Inc., 186 F. Supp.3d 826, 836 (W.D. Tenn. 2016). "[I]t is not enough that plaintiff suffered injuries from using . . . a product." Moore v. C.R. Bard, Inc., 217 F. Supp.3d 990, 996 (E.D. Tenn. 2016).

[T]he information relevant to plaintiff's condition and the causes therefore are solely available to him. The defendants presumably have detailed information as to the characteristics of their products, but they have no information as to plaintiff's medical condition, the causes of his condition, or his prognosis. The Twombly/Iqbal standard requires the plaintiff to have greater knowledge of those factual details in order to draft a plausible claim.

Id. (citations omitted). Because the plaintiff in Moore "ha[d] not . . . alleged the specific defect or dangerous condition of each product," that "lack of specificity [wa]s also fatal to his complaint." Id.Accord McDonald v. West-Ward Pharmaceuticals Corp., 2018 WL 6499353, at *7 (Mag. W.D. Tenn. Oct. 3, 2018) ("the complaint is devoid of facts regarding the [drug's] warnings"), adopted, 2019 WL 1040978 (W.D. Tenn. March 5, 2019).

In New Mexico, Nowell v. Medtronic, Inc., 372 F. Supp.3d 1166 (D.N.M. 2019), likewise held that plaintiff's "lean assertions" were "too generalized to assist the Court in evaluating the sufficiency of the Defendants' warnings, nor do they plausibly assert that the Defendants were aware of the specific defect." Id. at 1251.

[Plaintiff] has not alleged that the Defendants sold their [device] absent any warning, and the Court will not presume this fact on [plaintiff's] behalf. Because her allegations do not specify a plausible, causal danger about which the Defendants did not warn, . . ., [plaintiff's] failure-to-warn claim cannot survive a motion to dismiss.

Id. at 1255 (footnote omitted). The TwIqbal cases "are screening devices, and plaintiffs' counsel are going to have to up their game to avoid these new hurdles to bringing federal cases." Id. at 1255 n.20.

A warning claim in Aston v. Johnson & Johnson, 248 F. Supp.3d 43 (D.D.C. 2017), was "also reject[ed] as inadequately pled" due to plaintiffs' failure to allege any facts in support.

The amended complaint here 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. "Nowhere," for example, "does the complaint recite the contents of the warning label . . . at the time of the administration of the drug" or explain "how the contents of the label were inadequate." [citing Bailey] Nor does it plead facts about the timing of each plaintiff's use of [the drug]. . . . But without factual allegations supporting this claim, it is nothing more than a legal conclusion couched as a factual allegation. As such, it is insufficient to state a claim for product defect based upon failure to warn.

Id. at 53-54 (other citations and quotation marks omitted). Accord Rollins v. Wackenhut Services, 802 F. Supp.2d 111, 123 (D.D.C. 2011) ("the Complaint does not attempt to identify what about [the drug] made it 'defective,' other than its 'known risk['] . . . that the plaintiff admits was specifically described in the drug's FDA-mandated warning materials"), aff'd, 703 F.3d 122 (D.C. Cir. 2012).

In Illinois, Aquino v. C.R. Bard, Inc., 413 F. Supp.3d 770, 790 (N.D. Ill. 2019), TwIqballed a warning claim where:

[Plaintiff] does not allege either what her surgeon knew generally as a member of the medical community, or what [defendant] warned her surgeon of specifically. And neither the SAC nor [plaintiff's] brief provide any information about the warnings [defendant] gave.

Id. at 790 (footnote omitted). Accord Grzanecki v. Smith & Nephew, Inc., 2019 WL 2297452, at *2 (N.D. Ill. May 30, 2019) ("[plaintiff] does not allege any specifics regarding defendants' warnings, beyond the conclusory allegation that the warnings issued were insufficient. The allegations of undisclosed warnings are too vague to establish that [defendants] failed to disclose anything to [plaintiff's] doctors"); Tyler v. Boston Scientific Corp., 2018 WL 2220531, at *4 (N.D. Ill. May 15, 2018) ("plaintiff's] claim fails as alleged, where he has not identified how the warnings [defendant] provided are inadequate").

Louisiana courts have issued several favorable TwIqbal decisions, only none of them appear to be reported. Doe v. AstraZeneca Pharmaceuticals, LP, 2015 WL 4661814 (E.D. La. Aug. 5, 2015), discussed at some length the interplay between TwIqbal and Louisiana law:

Plaintiff's complaint contains unnecessarily repetitive legally conclusive assertions that [defendant] failed to provide adequate warnings to either Plaintiff or Plaintiff's physician regarding the nature and extent of the adverse effects of [the drugs]. However, despite the lengthiness of Plaintiff's allegations, nowhere in her complaint does she make mention of any specific adverse effect of which [defendant] failed to warn, or assert a proper warning which she contends would have been appropriate. Due to the vagueness of Plaintiff's complaint, an issue remains regarding whether [defendant] failed to provide adequate warnings regarding specific adverse effects of the drugs. Plaintiff must amend her complaint to specifically allege the reasons why the warnings provided by [defendant] regarding the adverse effects of [the drug] were inadequate.

Id. at *4. See Batiste v. Stryker Corp., 2020 WL 3451690, at *8 (M.D. La. June 24, 2020) ("Plaintiff's allegation of inadequate warning falls short of the required pleading standard"; "Plaintiff has failed to allege that Defendants failed to warn Plaintiff's treating physicians"); Allo v. Allergan USA, Inc., 2020 WL 32439, at *3 (E.D. La. Jan. 2, 2020) ("[plaintiff] alleges no facts showing how, exactly, [defendant's] warning was inadequate. Instead, she simply concludes that the implant product 'was unreasonably dangerous because an adequate warning about the product was not provided[.]' Rule 8(a) requires more."); Dubroc v. Bristol-Myers Squibb, 2019 WL 3756469, at *5 (M.D. La. Aug. 8, 2019) ("[plaintiff] has failed to state a cognizable failure to warn claim. Specifically, [plaintiff] failed to allege anything regarding [defendant's] warning to her physician"); 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 of the risks of the implant. . . . Rather, plaintiff's complaint is a bare invocation of the failure to warn theory of recovery."), adopted, 2019 WL 2166539 (W.D. La. May 17, 2019); Dendinger v. Covidien LP, 2018 WL 4462579, at *3 (E.D. La. Sept. 18, 2018) (plaintiff's "inadequate warning claim is also deficient. He fails to mention any specific risks that were not disclosed to his physician"); Pierre v. Medtronic, Inc., 2018 WL 1911829, at *4 (E.D. La. April 23, 2018) (allegation that "that the warnings that were given by Defendants failed to properly warn [plaintiff's] treating/implanting physicians of the increased risks of permanent physical injuries" was "too broad to state a claim because it does not identify . . . which aspects of the product warranted a warning"); Lussan v. Merck Sharp & Dohme Corp., 2017 WL 2377504, at *3 (E.D. La. June 1, 2017) (plaintiff "merely asserts that any warnings were 'insufficient.' She makes no mention of any specific risks that were not disclosed to her doctor"); Guidry v. Janssen Pharmaceuticals, Inc., 2016 WL 633673, at *4 (E.D. La. Feb. 17, 2016) ("In no way does the plaintiff assert how the defendants failed to use reasonable care to provide an adequate warning. . . . Nor does she provide any factual basis for her claim that the defendants failed to adequately warn of [certain risks]"); Lewis v. Baxter International, Inc., 2017 WL 661324, at *5 (E.D. La. Feb. 17, 2017) ("Plaintiff is required to allege that Defendants did not adequately warn Plaintiff's treating physician of risks associated with the product that are not otherwise known to the patient or physician"); Kennedy v. Pfizer, Inc., 2014 WL 4092918, at *5 (W.D. La. Aug. 15, 2014) ("the complaint merely states that the warning was defective because it failed to warn of the potential for the development of [plaintiff's claimed risk]"); Lirette v. DePuy Mitek, L.L.C., 2014 WL 3341358, at *5 (W.D. La. July 7, 2014) ("For the plaintiffs to allege that the defendants' obligation to the plaintiffs was not discharged by appropriately informing the physician of all necessary side effects and risks would require more than the bare recitation of the elements provided by the plaintiffs."); Watson v. Bayer Healthcare Pharmaceuticals, Inc., 2013 WL 1558328, at *5 (E.D. La. April 11, 2013) ("plaintiff fails to allege that she actually experienced any of these particular complications. She simply alleges that she was injured" by the device).

New Jersey courts have also produced several favorable unpublished TwIqbal decisions in warning cases. See Bond v. Johnson & Johnson, 2021 WL 6050178, at *11 (D.N.J. Dec. 21, 2021) ("[Plaintiff] has not alleged the specific language in the warnings associated with the [device]," thus "the Court is unable to assess the warnings against the omissions [plaintiff] alleges.") (citations omitted), aff'd, 2022 WL 4594185 (3d Cir. Sept. 30, 2022) (applying Michigan law); Stich v. Smith & Nephew, Inc., 2021 WL 1997411, at *3 (D.N.J. May 19, 2021) ("Plaintiff's conclusory allegations fall short of alleging a failure to warn claim. Critically, Plaintiff does not identify what warnings were on the [device], if any, or, specifically, what dangers should have been disclosed.") (citation omitted); Vicente v. Johnson & Johnson, 2020 WL 7586907, at *12 (D.N.J. Dec. 21, 2020), amended, 2021 WL 2328159 (D.N.J. June 7, 2021):

[T]he Amended Complaint contains no allegations about the warnings associated with the product at issue or how such warnings are inadequate. With respect to Plaintiff's inadequate warning claim, the Amended Complaint states only this: "The aforesaid product surgically implanted in plaintiff's body was due to inadequate warning because the defendants knew or should have known there existed a serious risk that the device could fail after surgery, thereby giving rise [plaintiff's alleged injuries." Such a blanket assertion of entitlement to relief does not pass the plausibility test.

Id. at *12 (citation omitted); Becker v. Smith & Nephew, Inc., 2015 WL 268857 (D.N.J. Jan. 20, 2015):

The complaint does not state specific facts regarding the alleged inadequate warning. There is no identification of the latent danger, assertion that the danger is not obvious, or allegation that Defendant knew or should have known about it at a particular time. The complaint is silent as to whether Defendant gave a warning that did not reveal a particular danger, gave a warning that was untimely, or gave no warning at all. . . . The complaint does not identify [plaintiff] as an intended user of the product, or state how the warning was inadequate in light of the ordinary knowledge common to intended users.

Id. at *4.

Numerous other cases from other states have likewise TwIqballed warning claims in prescription medical product liability litigation for insufficient identification of the warning involved and/or the warning's purported deficiencies. See Hawkins v. Kaiser Foundation Health Plan, 2024 WL 2894771, at *4 (D. Or. June 10, 2024) (plaintiff "does not allege what warnings were provided for the device or how the warnings were misleading, ambiguous, contained important omissions or similar"); Williams v. Boston Scientific Corp., 2023 WL 9596983, at *2 (N.D. Ohio Dec. 11, 2023) ("Plaintiff does not allege facts explaining Defendant's duty or how they breached such a duty"; the "Complaint asserts no facts regarding what warnings were provided regarding Defendant's product"); Warmoth v. Medtronic, Inc., 2023 WL 3938464, at *10 (W.D. Okla. June 9, 2023):

Plaintiff's failure to warn claim . . . does not contain any factual allegations regarding warnings, how Defendants' warnings were deficient, or a specific danger Defendants failed to warn about. The only failure to warn allegations are conclusory statements. . . . These generic allegations without supporting facts are insufficient to state a claim. . . . Without any factual allegations related to warnings or reporting associated with the [device], Plaintiff's failure to warn claim is subject to dismissal.

Id. at *10 (citations omitted); Neto v. Bristol-Myers Squibb, 2023 WL 3689533, at *3 (D. Conn. May 26, 2023) ("there are no facts provided within the Complaint that show [defendant] providing any warnings to the decedent's physician, which, in turn, could show that the provided warning was purportedly inaccurate"); Armstrong v. Atrium Medical Corp., 2022 WL 17258345, at *4 (E.D. Wash. Nov. 10, 2022) ("Plaintiff fails to allege that his surgeon was inadequately warned or instructed. . . . This alone renders his claim deficient pled."); Flores v. Merck & Co., 2022 WL 798374, at *5 (D. Nev. March 16, 2022) ("[Plaintiff's] allegations are conclusory and do not yield a facially plausible claim."; "[Plaintiff] fails to clarify what these characteristics were, and which risks were and were not conveyed to [plaintiff's] doctor, specifically."); Schulz v. Medtronic, Inc., 2022 WL 503960, at *4 (D. Conn. Feb. 18, 2022) ("[plaintiff] fails to state a claim for failure to warn . . . because he does not allege that [defendant] failed to give any warnings or that [defendant's] warnings . . . were inadequate. In fact, he does not identify any warnings in the Complaint."); Green v. W. L. Gore & Assocs., Inc., 2020 WL 1666790, at *9 (D. Idaho April 3, 2020):

[Plaintiff's] second [warning] cause of action . . . fails to allege how the [device] was defective or dangerous. [Plaintiff] also fails to identify exactly how [defendant] failed to warn consumers. . . . Instead, [plaintiff] simply states that there were "inadequate warning and/or [in]adequate clinical trials . . ., and inadequate reporting regarding the results" without identifying any information concerning the warnings, trials, testing, studies, and reports, either concerning what was done or what should have been done. . . . [T]hese conclusory allegations, without any factual support suggesting defect or causation, are likewise insufficient.

Id. at *9 (citation omitted); Marshall v. Smith & Nephew, Inc., 2020 WL 362803, at *7 (D. Minn. Jan. 22, 2020) ("[plaintiff] has failed to offer facts showing that the [device] was dangerous, [defendant's] knowledge of any risk, [and] what warnings were or should have been issued (by and to whom)"); Meredith v. Medtronic, Inc., 2019 WL 6330677, at *6 (S.D. Iowa Oct. 25, 2019) (plaintiff "does not indicate what warnings were given or how they were insufficient," thus the "failure to warn allegations are legal conclusions without factual support"); Lynch v. Olympus America, Inc., 2018 WL 5619327, at *12 (D. Colo. Oct. 30, 2018) ("Plaintiff claims fails because it does not allege any particular inadequacy in the warnings"); Proffitt v. Bristol-Myers Squibb Co., 2018 WL 3318893, at *4-5 (S.D.W. Va. July 5, 2018) ("plaintiffs' failure to warn claims are inadequately pled because they have failed to address how the [drug] label is inadequate"); Harrison v. Davol, Inc., 2017 WL 10109447, at *3 (D.S.C. Nov. 8, 2017) ("regardless of the applicability of the learned intermediary doctrine as an affirmative defense, Plaintiffs make only generalized allegations in regard to this cause of action. . . . Plaintiffs fail to allege facts about the alleged misrepresentation and when Defendants made them."); Jeffries v. Boston Scientific Corp., 2017 WL 2645723, at *5 (D. Md. June 20, 2017) (plaintiff "has provided only conclusory allegations that [defendant's] warnings to her doctors were insufficient without describing any of the warnings or their alleged deficiencies. Therefore, [plaintiff's] failure to warn claims must be dismissed"); Perry v. Boston Scientific Family, 2016 WL 10637082, at *6 (Mag. D. Minn. Dec. 1, 2016) ("while Plaintiff apparently asserts a failure to warn cause of action, . . . he does not allege whether any warning was given, what it said, how it was inadequate, to whom it was given, or whether it reached Plaintiff. The bare bones assertion of a cause of action, without more, is insufficient to sustain a claim") (footnote omitted), adopted, 2017 WL 44845 (D. Minn. Jan. 4, 2017); Christison v. Biogen Idec, Inc., 2013 WL 6834371, at *3 (D. Utah Dec. 26, 2013) (warning claim must "assert[] specific facts about the existence of information that made the labeling of [the drug] inadequate at times material to Plaintiff's decedent's ingestion"); Kwasniewski v. Sanofi-Aventis U.S., LLC, 2013 WL 2558283, at *2 (D. Nev. June 8, 2013)

Plaintiffs allege only that [defendant] "under-warned" physicians. . . . The Complaint does not contain any factual allegations about what information was provided . . . or how that information was deficient. Plaintiffs' own unsupported conclusion that warnings were insufficient does not satisfy the pleading standard.

Id. at *2 (citation omitted), aff'd, 637 F. Appx. 405 (9th Cir. 2016); Tolliver v. Bristol-Myers Squibb Co., 2012 WL 3074538, at *4 (N.D. Ohio July 30, 2012):

Here, Plaintiffs' allege only that Defendants breached their duty to warn . . . "of the true risks and dangers of taking [the drug]". . . . [S]uch a generic legal conclusion need not be accepted as true under Twombly and Iqbal. . . . Plaintiffs have failed to allege a specific risk or danger about which Defendants would need to provide warning. Moreover, although the Complaint does allege that Defendants exaggerated the potential benefits . . ., it provides no factual allegations as to how Defendants allegedly failed to warn of any dangers of [the drug]. In fact, the Complaint fails to reference the [drug's] warning label altogether . . . [and] contains no reference at all to the Plaintiff's prescribing physician − the relevant recipient of the warning.

Id. at *4 (citations and quotation marks omitted); Mills v. Bristol-Myers Squibb Co., 2011 WL 3566131, at *3 (D. Ariz. Aug. 12, 2011) ("plaintiff must show that the product was defective because it contained an inadequate warning. Plaintiff does not plead any facts about what the [drug's] label said or how it was deficient.". Moreover, the warning did describe a risk of excessive bleeding."); Adams v. Stryker Pain Pump Corp., 2010 WL 4909564, at *2 (D. Minn. Dec. 1, 2010) ("Plaintiff does not allege that [defendant] gave any instruction to [plaintiff's] surgeon regarding placement of the [device]. . . . Nor does Plaintiff allege any facts to support the conclusion that [defendant] knew or should have known that its [device] would be dangerous when used"); Tyler v. Bristol-Meyer Squibb, 2010 WL 1664967, at *2 (D. Neb. April 23, 2010) (alleging a "recall" insufficient; "Plaintiff does not allege that he, or his health-care provider, were not provided with reasonable warnings about the side effects of [the drug]").

Another recurring aspect of TwIqbal warning cases is the use of judicial notice or related doctrines to bring before courts on Rule 12 motions the actual warnings that plaintiffs are alleging were inadequate. In case after case, it turns out that the purportedly inadequate warning mentioned the exact adverse event that allegedly injured the plaintiff – which, to us, raises Rule 11 concerns. See Krulewich, 498 F. Supp.3d at 577 ("The warnings given noted the risks of the complications that [plaintiff] actually experienced"); Dye, 470 F. Supp.3d at 1341 ("the IFU contradicts all of Plaintiff's allegations with the exception of one" and "this does not save Plaintiff's claim," since "Defendant need only warn of complications stemming from the use of the Product − not the subsequent measures . . . to treat those complications"); Marroquin, 367 F. Supp.3d at 1162 ("More than once, [the relevant risk] is clearly and expressly identified as the most dangerous toxicity/potential side effect."); Tears v. Boston Scientific Corp., 344 F. Supp.3d 500, 512 (S.D.N.Y. 2018) (various FDA-approved labeling "all contain warnings regarding the possibility of [the relevant risk]"); Trisvan, 305 F. Supp.3d at 400 (judicial notice); Neto, 2023 WL 3689533, at *5 ("the [drug's] labels contradict the allegations made by Plaintiff that [defendant] failed to warn of these risks"); Holcomb, 2022 WL 17670003, at *4 & n.1 (granting unopposed request for judicial notice); Moreland v. Microgenics Corp., 2022 WL 2657287, at *3 n.9 (E.D.N.Y. June 1, 2022) (taking judicial notice of drug warnings "reference[d]" in the complaint); Johnson v. Ethicon, Inc., 2022 WL 1744697, at *7 (D.N.J. May 31, 2022) ("Plaintiffs fail to plausibly allege that several of the ostensibly missing warnings were in fact 'absent' from the IFU"); Green v. Covidien LP, 2021 WL 1198833, at *8 (S.D.N.Y. March 30, 2021) (considering product labeling as "incorporated by reference in the complaint") (citation and quotation marks omitted); Gioia, 2021 WL 602683, at *4 ("Despite having the opportunity to do so, plaintiff has not contested the authenticity of these FDA warnings"); Proffitt, 2018 WL 3318893, at *3 (the drug's "label does and always has warned about the very condition of which plaintiffs complain"); Mills, 2011 WL 3566131, *3 ("Moreover, the warning did describe [the] risk").

We like TwIqbal – and not just because we helped popularize the portmanteau. Thus, we invite defense counsel to use this full arsenal of favorable precedent to create still more favorable caselaw.

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

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