United States: Guest Post – The Wild West Of MDL: Off-Label Promotion, Negligent Testing, & Gross Negligence Claims Survive In Farxiga

Last Updated: May 21 2018
Article by James Beck

This guest post is by Reed Smith associate Lora Spencer, who (as you might suspect) calls Texas her home.  In her first rodeo on the blog, she discusses a recent MDL decision that she thinks is a few pickles short of a barrel, and hopes it's not a harbinger of things to come.  Not exactly a conniption fit, but close.  As always our guest posters deserve 100% of the credit (and any blame) for what they write.

**********

"Everything is bigger in Texas"—or is it? The plaintiffs in Aron v. Bristol-Myers Squibb, 2018 U.S. Dist. LEXIS 39146 (S.D.N.Y. Mar. 9, 2018), would have y'all believe that pharmaceutical manufacturer tort liability, at least, is bigger in Texas. But, first, before getting to this "Texas Expansion," here are some interesting "reported" facts about Texas. Pay attention, there may be a pop quiz, if not now, perhaps at your next networking event. Knowing such factoids will surely make your "lone star" shine brightly.

Texas is a really BIG state. Texas is ranked 2nd in the country in population and size. Texas's total area is twice the size of Germany (albeit half the size of Alaska). Of 45 United States presidents – three of them hail from Texas—all of them since 1963, hence the slogan "read my lips, no new Texans." King Ranch, located in south Texas, is considered "the birthplace of Texas ranching" and is larger than Rhode Island. Texas also has the most rattlesnakes of any state. And the weight of the catfish consumed by Texans each year exceeds that of the Paris Eiffel Tower (at least the one in Texas). "Texas is just too big," said no Texan ever. Apparently Aron takes the same view.

Aron purported to apply Texas law in what appears to be the first reported opinion from the Farxiga MDL. Maybe future opinions will be better. Aron denied the defendants' motion to dismiss plaintiffs' amended complaints under Rule 12(b)(6). Id. at *9. Farxiga has only one labeled indication—lowering blood glucose in adults with type 2 diabetes. Id. Because everything is bigger in Texas, so is the complaint, which included three Texas plaintiffs with no business being joined in the same complaint. Getting a free pass on misjoinder, these three plaintiffs brought "causes of action claims, under Texas law, based on the defendants' failure to warn of [drug] risks ..., negligent testing, and gross negligence." Id. *16.

Failure to Warn

The most important thing about Texas product liability law is that most of it is now statutory. Under Texas law, in a products liability suit, a statutory presumption precludes a defendant drug manufacturer from being liable for failure to warn claims if its warnings were approved by the Food and Drug Administration (FDA). Texas Civ. Prac. & Rem. Code Ann. § 82.007. However, a plaintiff may rebut this presumption by establishing one or more of five statutory exceptions. Id. at (b)(1-5).

In Aron, the relevant exceptions were § 82.007 (b)(1) and (3). 2018 U.S. Dist. LEXIS 39146, at *17. Section (b)(1) allows a plaintiff to rebut the presumption by proving fraud on the FDA—that "the defendant, before or after pre-market approval ... withheld from or misrepresented to the [FDA] required information that was material and relevant to the performance of the product and causally related to the claimant's injury." Civ. Prac. & Rem. § 82.007(b)(1). Section (b)(3) avoids the presumption if the plaintiff can show off-label promotion – that "the defendant recommended, promoted, or advertised the pharmaceutical product for an indication not approved by the [FDA], the product was used as recommended, promoted or advertised; and the claimant's injury was causally related to the recommended, promoted, or advertised use of the product." Id. at (b)(3).

As regular blog readers know, a claim predicated on fraud on the FDA should be preempted. Buckman Co. v. Plaintiffs Legal Committee, 531 U.S. 341 (2001). Unsurprisingly, the defendants argued the FDA fraud exception is preempted by federal law. Aron, 2018 U.S. Dist. LEXIS 39146, at *20. The court noted conflicting Fifth and Second Circuit decisions concerning § 82.007(b)(1) and a similar Michigan statute. Compare Lofton v. McNeil Consumer & Specialty Pharms., 672 F.3d 372 (5th Cir. 2012) (applying Texas law) (discussed here), with Desiano v. Warner Lambert & Co., 467 F.3d 85, 95 (2d Cir. 2006) (applying Michigan law), aff'd by equally divided court, 552 U.S. 440 (2008). However, because the plaintiffs did not plead the fraud exception with "sufficient particularity," Aron did not decide the preemption issue. Id. at *21. Given the other rulings in Aron, its punting on preemption is probably just as well. In true Texas fashion, Hi-Yo Silver away! The plaintiffs failed to rebut the presumption using §82.007 (b)(1). Id.

However, fraud on the FDA is only one of § 82.007's five exceptions. Properly raising any one of them will get a plaintiff past a presumption-based motion to dismiss. Id. at *17. Plaintiffs got away with pleading the "off-label" marketing exception, under § 82.007 (b)(3). Id. at *20. Plaintiffs alleged: (i) defendants promoted Farxiga to prescribing physicians for off-label uses, specifically obesity and hypertension, (ii) such off-label promotion caused the physician to prescribe Farxiga for off-label use, (iii) plaintiffs used Farxiga for off-label purposes, and (iv) off-label use caused the plaintiffs injuries. Id. at *20-22. Plaintiffs cited press releases, advertisements, and clinical trial protocols to support their claim that off-label marketing occurred. Id. However, Aron failed to discuss the pleading of causation Not one of the various off-label statements was linked to any particular prescriber, let alone to a prescription that caused these plaintiffs' injuries. Never mind that physicians may, and often do, prescribe drugs for unapproved uses as part of their practice of medicine. Aron let the plaintiffs slide on causation. All hat and no cattle.

Negligent Testing

Aron also allowed the plaintiffs' negligent failure to test claim to stand. 2018 U.S. Dist. LEXIS 39146, at *22. The plaintiffs alleged the defendants negligently failed to test Farxiga thoroughly before releasing the drug into the market, failed to analyze pre-market test results, and failed to conduct sufficient post market testing and surveillance." Id. at *23. Defendants argued the plaintiffs' negligent testing claim is "inextricably intertwined" with the plaintiffs' failure to warn claim and is inadequately pleaded. Id. The Fifth Circuit, applying Texas law, has so held—twice. "[A] negligent testing claim is, as a matter of Texas law, a variation of an action for failure to warn." Dow Agrosciences LLC v. Bates, 332 F.3d 323, 333 (5th Cir. 2003) (applying Texas law), reversed on other grounds, 544 U.S. 431 (2005) (preemption). Plaintiff's "negligence claims, such as the alleged failure to adequately test [the product], are subsumed within" a failure to warn claim. Skotak v. Tenneco Resins, Inc., 953 F.2d 909, 912 n.5 (5th Cir. 1992) (applying Texas law).

Even though Fifth Circuit law should have controlled on this point of state law, Aron chose to follow cases that it asserted recognized "an independent cause of action based on negligent failure to test." Id. at *22-23. The most significant of the three, Am. Tobacco Co. v. Grinnell, 951 S.W. 2d 420 (Tex. 1997), certainly did not. Rather, the Texas Supreme Court's holding was quite the opposite:

[Plaintiff's] negligent testing claim is predicated on [defendants'] duty to test and ascertain the dangers inherent in its products about which it must warn consumers. Because the negligent testing claim is inextricably intertwined with the [plaintiffs'] negligent failure to warn claim, we hold that summary judgment was also proper on this claim.

Id. at 437. "Inextricably intertwined" is about as far from "an independent cause of action" as you can get. Of the other two cases, Murthy v. Abbott Laboratories, 847 F. Supp.2d 958 (S.D. Texas 2012), is notorious for improperly construing Texas law. The other, Romero v. Wyeth Pharmaceuticals, Inc., 2012 WL 12547449, at *4 (E.D. Tex. Aug. 31, 2012), essentially followed Murthy. Aron is another instance of improper federal court judicial activism attempting to push state (Texas) law where no state court has ever gone.

Gross Negligence

Apparently, in Texas, it is not enough just to plead negligent testing. The plaintiffs also pled gross negligence. 2018 U.S. Dist. LEXIS 39146, at *24. The defendants argued that "[i]t is merely a restatement of plaintiff's deficient negligence count." Id. However, Aron looked to the elements of gross negligence, and held the plaintiffs sufficiently pled facts to support an inference of gross negligence. Id. at *25. Those facts oddly included a September 2013 "post market" study. Id. at *26. Supposedly, the defendants "terminated" that study in "2013 without posting any results." Id. at *9. However, the FDA did not approve Farxiga until January 8, 2014. Id. at *9. That does not sound like gross negligence, but rather a preempted fraud on the FDA claim. Whether or not anything was "posted," the alleged study termination occurred before the FDA's approval of this product, so the only reporting duty was imposed by federal law—not Texas law—and it ran to the FDA. Any public "posting" of product-related information before FDA approval would illegally promote an unapproved product, which almost certainly explains lack of any such post.

With Aron, the Farxiga MDL is not exactly off to a good start. Will this be another instance of MDL abuse in the making? Saddle up, and get ready for a wild ride, the prominent phrase "Everything is BIGGER in Texas" is unfortunately reflected in Aron's approach to product liability.

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
 
In association with
Related Topics
 
Related Articles
 
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