United States: In A Twiqbal State Of Mind

Last Updated: August 10 2018
Article by James Beck

Every now and then, the Reed Smith powers that be make seats in the firm's skybox at the Phillies' (first place – who woulda thunk?) stadium available to folks like us. As a result we attended back-to-back concerts by the Eagles and Billy Joel last weekend. Yes, we know that dates us – that was obvious from crowd demographics – but we don't mind. Joel (who according to Wikipedia, caught his first big break in Philly back in 1972) played until nearly midnight after the show's opening was delayed by a cloudburst. He made sure to perform "Allentown" with its Pennsylvania themes, but Joel being Joel, he also played "New York State of Mind."

Our immediate Philadelphian chip-on-our-shoulder reaction was, "Don't bring that New York %@#&*! down here. If you have to sing about New York CIty, at least play "Miami 2017" (he didn't)." But then we got back to work, and we ended up thinking, actually there is at least one good recent reason for us to look to New York.

TwIqbal.

Over the last few weeks, New York courts have produced two of the best TwIqbal decisions that we've ever seen: Quintana v. B. Braun Medical, Inc., 2018 WL 3559091 (S.D.N.Y. July 24, 2018), and Oden v. Boston Scientific Corp., ___ F. Supp.3d ___, 2018 WL 3102534 (E.D.N.Y. June 4, 2018). If more courts applied TwIqbal as faithfully as this duo, you know what? Lawyers on the other side might actually have to comply with Rule 11 and actually investigate their cases before filing them.

Both cases involve Class II medical devices (IVC filters), so their TwIqbal application is not related to federal preemption and so-called "parallel" violation claims. They're just straight-out TwIqbal fundamentalism. So, for those of you who file TwIqbal motions in order to force plaintiffs to plead what the heck their cases are about (most of us D-siders these days), and who use our TwIqbal Cheat Sheet to find good cases in your jurisdiction to cite, here's a rundown of the relevant rulings.

Warning Defect

Given the nature of a warning-based product defect claim, "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, 2018 WL 3102534, at *6. "[C]onclusory" warning allegations that failed TwIqbal are:

  • "Defendant failed to provide sufficient warnings and instructions"
  • "Defendant knew or should have known, and adequately warned that its product created a risk of serious and dangerous side effects, including but not limited to. . . ."
  • "The warnings given did not accurately reflect the risk, incidence, symptoms, scope or severity of such injuries to the consumer"
  • Defendant "only provides limited information [concerning] possible complications"
  • "Defendant's warnings page on their website . . . fails to address the full extent of complications [and] magnitude of risks involved"

Id. None of this boilerplate, individually or collectively, survived TwIqbal. "[T]he Complaint fails to provide facts identifying how or why the included warnings were inadequate." Id. at *7. Given the warnings referenced in the complaint (labeling, broduct brochure, instructions for use, website), the complaint came nowhere near meeting TwIqbal requirements:

[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 . . . were inadequate. Moreover, Plaintiff has failed to provide the necessary factual nexus showing how the warnings that were provided were insufficient since merely asserting that warnings were not "adequate" or "sufficient" are nothing more than legal conclusions. Without facts setting forth what the warnings stated and how and/or why the warnings were inadequate, Plaintiff's failure to warn claim is insufficiently pleaded.

Id. at *7 (citations and quotation marks omitted).

Another pleading deficiency was the complaint's failure to distinguish between "actual injuries Plaintiff experienced versus those complications which potentially could result from implantation of the [device]." Id. (emphasis original). "Nor does the Complaint contain any nonconclusory allegations that Plaintiff's treating physician was not adequately informed or apprised of the potential risks." Id. In a learned intermediary case, "to the extent Plaintiff's failure to warn claim is premised upon Defendant's alleged failure to warn 'consumers' . . . such a claim is not viable in the first instance." Id. Thus a plaintiff must plead "facts to suggest that [the] physician did not possess independent knowledge about the risks associated with" the device. Id.

Likewise, in Quintana, "Plaintiff's allegations of inadequate warnings" were "for the most part, conclusory." 2018 WL 3559091, at *6. Plaintiff "fails to identify how those warnings were inadequate." Id. Further, plaintiff failed to plead warning causation under the learned intermediary rule:

To this point, Plaintiff alleges, "as a direct and proximate cause of the wrongful acts and omissions of Defendants, Plaintiff suffered economic damages, severe injuries, and emotional distress." This conclusion, however, is not sufficient to plausibly show that the failure to warn Plaintiff's physician caused Plaintiff's injuries because we know nothing about what caused her [injury] – i.e., what about the device failed or what was Plaintiff's diagnosis – nor anything about whether Plaintiff would have heeded an appropriate warning.

Id.

Design Defect

Oden held that a design defect claim is properly TwIqballed where it "fails to identify a particular problem in the design of [the device] and . . . merely plead[s] that the [device] is 'defective.'" 2018 WL 3102534, at *4. A mere "list of allegedly unreasonable risks" "does not identify a specific component or particularized issue with the design itself." Id. Similarly, describing a product as "unreasonably dangerous" when it "left the hands of the Defendant" does not adequately allege a defect. Such descriptions "lack[] any facts indicating the particular component that was defective or otherwise identifying a specific problem." Id. "Without such facts, Plaintiff's design defect claim fails." Id. Moreover, a design defect claim must allege an alternative design:

Plaintiff's design defect claim also fails on the independent ground that the Complaint does not plead the existence of a feasible alternative design. . . . [A] plaintiff must plead facts alleging the existence of a feasible alternative design. The only paragraph in the Complaint specifically referring to this element merely states that "safer, reasonable alternative designs existed and could have been utilized," but fails to identify what feasible alternative designs are available.

Id. at (citations and quotation marks omitted). Pleading the availability of a "different" product ("retrievable," as opposed to "permanent[]") doesn't hack it, "since the design and purpose of these two products is different." Id.

In pleading design defect, Quintana required plaintiffs to allege "a specific defect" as well as "facts about the "circumstances of the purported failure of the [device] that would give rise to the inference of proximate cause." 2018 WL 3559091, at *4. "A boilerplate reference to a design defect" that the product was "unable to withstand . . . normal" conditions failed TwIqbal. Id. As to product "risks," a complaint must "state [] facts to indicate how those risks resulted from a specific design defect" and "how that defect was a substantial factor in causing [plaintiff's] injuries." Id. "[T]he assumption that [a] device must have failed because of reports of failures or complications by other consumers is plainly inadequate" to plead a design defect. Id. As in Oden, alleging a product to be "unreasonably dangerous" doesn't adequately allege a defect. Id. A plaintiff must plead "how [a] problem rendered the product defective, whether it affected his [device], [and] how it caused [the] alleged injuries." Id. (citation and quotation marks omitted). Further, "res ipsa loquitur is an evidentiary principle and does not apply to pleading requirements." Id. at *5. Even if res ipsa were appropriate, it is insufficient when "Plaintiff fails to provide sufficient factual exposition to account for the possibility that other factors caused [the] injury." Id. Finally, "[i]t also appears that Plaintiff's design defect claim fails for failure to allege a feasible design alternative." Id. at 5 n.5.

Manufacturing Defect

The plaintiff's "conclusory" allegations in Oden failed to plead a manufacturing defect "since they fail to allege a specific manufacturing defect affecting the [device] implanted in Plaintiff as compared to other [devices] that were produced by Defendant." 2018 WL 3102534, at *5 (emphasis original). "[A] claim devoid of allegations that a particular unit differed when compared to others in the same product line will be dismissed." Id. "[A]lleg[ing] that some 'condition or conditions' existed that ultimately caused Plaintiff's injuries" is a "vague assertion" that "fails to place Defendant on notice as to what the particular error in the manufacturing process was." Id.

Quintana did not involve a manufacturing defect claim.

Express Warranty

Oden reiterated that, to pursue a claim for breach of express warranty, "plaintiff must allege that there was an affirmation of fact or promise by the seller, the natural tendency of which was to induce the buyer to purchase and that the warranty was relied upon to [Plaintiff's] detriment." 2018 WL 3102534, at *8 (citation and quotation marks omitted). An allegation that, somewhere in the defendant's "literature, advertisements, promotions and . . . representations by their marketing team and sales agents," a promise was made that the device was "safe, effective and fit for implantation" in various ways didn't cut the mustard. Id. Even assuming these were "material statements amounting to a warranty," no reliance was pleaded:

[T]he Complaint merely alleges Plaintiff's purported "reliance" without providing any underlying factual details concerning when, where and how such reliance arose. Even assuming that Plaintiff was provided with a brochure . . ., the Complaint is devoid of any facts that would permit the inference that Plaintiff actually read these statements and directly relied upon them when making the decision to utilize Defendant's product. In addition, there are no facts illustrating that Plaintiff's physicians ever reviewed the statements contained on Defendant's website or those set forth in the product brochure prior to making the decision to recommend use of the [device]. Without such allegations, any purported claim that such reliance existed is implausible.

Id. at *9 (citations and quotation marks omitted).

In Quintana express warranty claims failed equally miserably. "Plaintiff has failed to adequately plead reliance because her amended complaint lacks details regarding whether and how Plaintiff or her physicians reviewed and relied upon these warranties." 2018 WL 3559091, at *7 (citations omitted).

Implied Warranty

Quintana did not involve implied warranty claims, but Oden did – two claims, for both merchantability and fitness for a particular purpose. 2018 WL 3102534, at *9-10. Merchantability claims were TwIqballed, for lack of a proper defect claim, as already detailed. Id. at *9. Fitness claims failed because they were "altogether conclusory." Id. at *10. "Where a plaintiff fails to plead that a defendant knew of the particular purpose for which that plaintiff was buying a product, a complaint will be dismissed." Id. at *9 (citation and quotation marks omitted). This complaint didn't so plead. Id. at *10. "[A] product's intended or ordinary purpose is not necessarily equivalent with a particular purpose for which Plaintiff seeks to purchase a product." Id. "Moreover, the Complaint does not contain any factual allegations leading to the inference that Defendant was aware that Plaintiff and/or his physicians were directly relying upon Defendant's skill and judgment when the determination was made to purchase the" device. Id.

Other

Both the Oden and Quintana complaints also contained the usual litany of fraud, fraudulent concealment, negligent misrepresentation, and consumer fraud claims. These were all dismissed as well. Oden, 2018 WL 3102534, at *10-15; Quintana, 2018 WL 3559091, at *7-10. The fate of these claims was mostly decided under the particularity standards of Fed. R. Civ. P. 9(b) rather than TwIqbal. Oden was of the view that the consumer fraud claims were subject only to TwIqbal standards, 2018 WL 3102534, at *14, and dismissed them on that basis:

[T]his cause of action fails because Plaintiff has not sufficiently pleaded causation. Although Plaintiff sets forth certain statements contained on Defendant's website and in its product brochure, these allegations neither explicitly state nor permit the plausible inference that Plaintiff actually saw these statements prior to making the determination (in conjunction with his physicians) to purchase the [device]. . . . [T]he relevant factual background to support the above [allegations] is simply lacking. As a result, Plaintiff has failed to sufficiently plead the third element of this claim.

Id. (citations omitted).

Quintana dismissed consumer fraud claims on the same basis, 2018 WL 3559091, at *10, although it is unclear whether the dismissal was under Rule 8 or Rule 9(b). Unlike Oden, Quintana also applied TwIqbal to the plaintiff's negligent misrepresentation claim, out of an abundance of caution, Id. at *9 and held the claim inadequately pleaded under the learned intermediary rule.

[E]ven under the more lenient standards of Rule 8(a), Plaintiff's negligent misrepresentation fails because she has not plausibly alleged reliance. . . . [Plaintiff's] allegation indicates only that Plaintiff relied on her physician's advice and leaves open the question whether the physician relied on Defendants' representations when giving Plaintiff that advice. Because Plaintiff fails to plausibly allege what misrepresentation her physician relied on, her negligent misrepresentation claim is dismissed.

Id.

Finally, remember that we're very picky on our TwIqbal Cheat Sheet. We only include cases where a motion to dismiss was granted in its entirety. In none of our 200+ drug/device TwIqbal cases did a single claim survive dismissal (sometimes on grounds other than TwIqbal). New York has always been a productive source for TwIqbal Cheat Sheet cases:

Black v. Covidien, PLC, 2018 WL 573569 (W.D.N.Y. Jan. 26, 2018); Rincon v. Covidien, 2017 WL 2242969 (S.D.N.Y. May 22, 2017); Teixeria v. St. Jude Medical S.C., Inc., 193 F. Supp.3d 218 (W.D.N.Y. 2016); Morrison v. Hoffmann-La Roche, Inc., 2016 WL 5678546 (E.D.N.Y. Sept. 29, 2016); Adams v. Stryker Orthopaedics, 2016 WL 2993213 (S.D.N.Y. May 23, 2016); Ortiz v. Allergan, Inc., 2015 WL 5178402 (S.D.N.Y. Sept. 4, 2015); Rodman v. Stryker Sales Corp., 2014 WL 5002095 (S.D.N.Y. Oct. 7, 2014), aff'd, 604 F. Appx. 81 (2d Cir. 2015); Cordova v. Smith & Nephew, Inc., 2014 WL 3749421 (E.D.N.Y. July 30, 2014); Burkett v. Smith & Nephew GMBH, 2014 WL 1315315 (E.D.N.Y. March 31, 2014); Simon v. Smith & Nephew, Inc., 990 F. Supp.2d 395 (S.D.N.Y. 2013); Bertini v. Smith & Nephew, Inc., 2013 WL 6332684 (E.D.N.Y. July 15, 2013); Goldin v. Smith & Nephew, Inc., 2013 WL 1759575 (S.D.N.Y. April 24, 2013); In re Pamidronate Products Liability Litigation, 842 F. Supp.2d 479 (E.D.N.Y. 2012); Reed v. Pfizer Inc., 839 F. Supp.2d 571 (E.D.N.Y. 2012); Bowdrie v. Sun Pharmaceutical Industries Ltd., 2012 WL 5465994, (E.D.N.Y. Nov. 9, 2012); Desabio v. Howmedica Osteonics Corp., 817 F. Supp.2d 197 (W.D.N.Y. 2011); Gelber v. Stryker Corp., 752 F. Supp.2d 328 (S.D.N.Y. Sept. 14, 2010); In re Fosamax Products Liability Litigation, 2010 WL 1654156 (S.D.N.Y. April 9, 2010); Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582 (E.D.N.Y. 2009); Horowitz v. Stryker Corp., 613 F. Supp.2d 271 (E.D.N.Y. 2009); Lewis v. Abbott Laboratories, 2009 WL 2231701 (S.D.N.Y. July 24, 2009).

But you will find a couple of citations in Quintana and Oden to TwIqbal cases that we don't include because they only dismissed complaints in part. See Parillo v. Stryker Corp., 2015 WL 12748006 (N.D.N.Y. Sept. 29, 2015); DiBartolo v. Abbott Laboratories, 914 F. Supp.2d 601 (S.D.N.Y. 2012). That's OK – it's a matter of legal judgment what to cite for any particular proposition. Our philosophy is that we want to be picky, so we don't give anyone a bum steer with a case citation that may be harmful on some other TwIqbal point. As Billy Joel would say, "It's no big sin to stick your two cents in if you know when to leave it alone."

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

To print this article, all you need is to be registered on Mondaq.com.

Click to Login as an existing user or Register so you can print this article.

Authors
James Beck
Similar Articles
Relevancy Powered by MondaqAI
Reed Smith
Reed Smith
Reed Smith
Reed Smith
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
Reed Smith
Reed Smith
Reed Smith
Reed Smith
Related Articles
 
Related Video
Up-coming Events Search
Tools
Print
Font Size:
Translation
Channels
Mondaq on Twitter
 
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).
 
Email Address
Company Name
Password
Confirm Password
Position
Mondaq Topics -- Select your Interests
 Accounting
 Anti-trust
 Commercial
 Compliance
 Consumer
 Criminal
 Employment
 Energy
 Environment
 Family
 Finance
 Government
 Healthcare
 Immigration
 Insolvency
 Insurance
 International
 IP
 Law Performance
 Law Practice
 Litigation
 Media & IT
 Privacy
 Real Estate
 Strategy
 Tax
 Technology
 Transport
 Wealth Mgt
Regions
Africa
Asia
Asia Pacific
Australasia
Canada
Caribbean
Europe
European Union
Latin America
Middle East
U.K.
United States
Worldwide Updates
Registration (you must scroll down to set your data preferences)

Mondaq Ltd requires you to register and provide information that personally identifies you, including your content preferences, for three primary purposes (full details of Mondaq’s use of your personal data can be found in our Privacy and Cookies Notice):

  • To allow you to personalize the Mondaq websites you are visiting to show content ("Content") relevant to your interests.
  • To enable features such as password reminder, news alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our content providers ("Contributors") who contribute Content for free for your use.

Mondaq hopes that our registered users will support us in maintaining our free to view business model by consenting to our use of your personal data as described below.

Mondaq has a "free to view" business model. Our services are paid for by Contributors in exchange for Mondaq providing them with access to information about who accesses their content. Once personal data is transferred to our Contributors they become a data controller of this personal data. They use it to measure the response that their articles are receiving, as a form of market research. They may also use it to provide Mondaq users with information about their products and services.

Details of each Contributor to which your personal data will be transferred is clearly stated within the Content that you access. For full details of how this Contributor will use your personal data, you should review the Contributor’s own Privacy Notice.

Please indicate your preference below:

Yes, I am happy to support Mondaq in maintaining its free to view business model by agreeing to allow Mondaq to share my personal data with Contributors whose Content I access
No, I do not want Mondaq to share my personal data with Contributors

Also please let us know whether you are happy to receive communications promoting products and services offered by Mondaq:

Yes, I am happy to received promotional communications from Mondaq
No, please do not send me promotional communications from Mondaq
Terms & Conditions

Mondaq.com (the Website) is owned and managed by Mondaq Ltd (Mondaq). Mondaq grants you a non-exclusive, revocable licence to access the Website and associated services, such as the Mondaq News Alerts (Services), subject to and in consideration of your compliance with the following terms and conditions of use (Terms). Your use of the Website and/or Services constitutes your agreement to the Terms. Mondaq may terminate your use of the Website and Services if you are in breach of these Terms or if Mondaq decides to terminate the licence granted hereunder for any reason whatsoever.

Use of www.mondaq.com

To Use Mondaq.com you must be: eighteen (18) years old or over; legally capable of entering into binding contracts; and not in any way prohibited by the applicable law to enter into these Terms in the jurisdiction which you are currently located.

You may use the Website as an unregistered user, however, you are required to register as a user if you wish to read the full text of the Content or to receive the Services.

You may not modify, publish, transmit, transfer or sell, reproduce, create derivative works from, distribute, perform, link, display, or in any way exploit any of the Content, in whole or in part, except as expressly permitted in these Terms or with the prior written consent of Mondaq. You may not use electronic or other means to extract details or information from the Content. Nor shall you extract information about users or Contributors in order to offer them any services or products.

In your use of the Website and/or Services you shall: comply with all applicable laws, regulations, directives and legislations which apply to your Use of the Website and/or Services in whatever country you are physically located including without limitation any and all consumer law, export control laws and regulations; provide to us true, correct and accurate information and promptly inform us in the event that any information that you have provided to us changes or becomes inaccurate; notify Mondaq immediately of any circumstances where you have reason to believe that any Intellectual Property Rights or any other rights of any third party may have been infringed; co-operate with reasonable security or other checks or requests for information made by Mondaq from time to time; and at all times be fully liable for the breach of any of these Terms by a third party using your login details to access the Website and/or Services

however, you shall not: do anything likely to impair, interfere with or damage or cause harm or distress to any persons, or the network; do anything that will infringe any Intellectual Property Rights or other rights of Mondaq or any third party; or use the Website, Services and/or Content otherwise than in accordance with these Terms; use any trade marks or service marks of Mondaq or the Contributors, or do anything which may be seen to take unfair advantage of the reputation and goodwill of Mondaq or the Contributors, or the Website, Services and/or Content.

Mondaq reserves the right, in its sole discretion, to take any action that it deems necessary and appropriate in the event it considers that there is a breach or threatened breach of the Terms.

Mondaq’s Rights and Obligations

Unless otherwise expressly set out to the contrary, nothing in these Terms shall serve to transfer from Mondaq to you, any Intellectual Property Rights owned by and/or licensed to Mondaq and all rights, title and interest in and to such Intellectual Property Rights will remain exclusively with Mondaq and/or its licensors.

Mondaq shall use its reasonable endeavours to make the Website and Services available to you at all times, but we cannot guarantee an uninterrupted and fault free service.

Mondaq reserves the right to make changes to the services and/or the Website or part thereof, from time to time, and we may add, remove, modify and/or vary any elements of features and functionalities of the Website or the services.

Mondaq also reserves the right from time to time to monitor your Use of the Website and/or services.

Disclaimer

The Content is general information only. It is not intended to constitute legal advice or seek to be the complete and comprehensive statement of the law, nor is it intended to address your specific requirements or provide advice on which reliance should be placed. Mondaq and/or its Contributors and other suppliers make no representations about the suitability of the information contained in the Content for any purpose. All Content provided "as is" without warranty of any kind. Mondaq and/or its Contributors and other suppliers hereby exclude and disclaim all representations, warranties or guarantees with regard to the Content, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. To the maximum extent permitted by law, Mondaq expressly excludes all representations, warranties, obligations, and liabilities arising out of or in connection with all Content. In no event shall Mondaq and/or its respective suppliers be liable for any special, indirect or consequential damages or any damages whatsoever resulting from loss of use, data or profits, whether in an action of contract, negligence or other tortious action, arising out of or in connection with the use of the Content or performance of Mondaq’s Services.

General

Mondaq may alter or amend these Terms by amending them on the Website. By continuing to Use the Services and/or the Website after such amendment, you will be deemed to have accepted any amendment to these Terms.

These Terms shall be governed by and construed in accordance with the laws of England and Wales and you irrevocably submit to the exclusive jurisdiction of the courts of England and Wales to settle any dispute which may arise out of or in connection with these Terms. If you live outside the United Kingdom, English law shall apply only to the extent that English law shall not deprive you of any legal protection accorded in accordance with the law of the place where you are habitually resident ("Local Law"). In the event English law deprives you of any legal protection which is accorded to you under Local Law, then these terms shall be governed by Local Law and any dispute or claim arising out of or in connection with these Terms shall be subject to the non-exclusive jurisdiction of the courts where you are habitually resident.

You may print and keep a copy of these Terms, which form the entire agreement between you and Mondaq and supersede any other communications or advertising in respect of the Service and/or the Website.

No delay in exercising or non-exercise by you and/or Mondaq of any of its rights under or in connection with these Terms shall operate as a waiver or release of each of your or Mondaq’s right. Rather, any such waiver or release must be specifically granted in writing signed by the party granting it.

If any part of these Terms is held unenforceable, that part shall be enforced to the maximum extent permissible so as to give effect to the intent of the parties, and the Terms shall continue in full force and effect.

Mondaq shall not incur any liability to you on account of any loss or damage resulting from any delay or failure to perform all or any part of these Terms if such delay or failure is caused, in whole or in part, by events, occurrences, or causes beyond the control of Mondaq. Such events, occurrences or causes will include, without limitation, acts of God, strikes, lockouts, server and network failure, riots, acts of war, earthquakes, fire and explosions.

By clicking Register you state you have read and agree to our Terms and Conditions