United States: Most Claims Dismissed With Prejudice In N.D. Cal. Amiodarone Case

Last Updated: July 12 2019
Article by Rachel B. Weil

Indulge us for a moment as we recount another airline adventure. Recently, we traveled thousands of miles to an important argument. Our first flight boarded right on time, left the gate right on time, and taxied down the runway . . . partway. Then stopped. Enter the inevitable announcement: "Ladies and gentlemen, we're very sorry, but . . . ." This time, there was "cargo" that had been loaded onto the plane by mistake. Lest the perpetrator of the mistake suffer the consequences, the airline jeopardized the connections of a planeload of business travelers. Finally, we left the gate again. And taxied again. And stopped again. "Ladies and gentlemen . . . ." This time, the captain pointed out the crew cleaning up a deceased bird on our runway. We finally took off, more than an hour late. The crew radioed ahead to the connecting city. And we held our breath. We ran up the jetway in the connecting airport with only a few minutes until our connecting flight was scheduled to depart. The plane was a few gates over and was still there. But . . . "We're very sorry, ma'am, but boarding is closed." And we watched the plane fly away without us. Needless to say, we were not terribly polite about this. We ended up renting a car and driving, luckily only a few hours, to our destination. It was our only chance, and we took it. (We also scored 7.500 bonus miles with a very annoyed call to the airline's customer service department.)

In today's very short decision, Collette v. Wyeth Pharms., Inc, 2019 WL 2603280 (N.D. Cal. June 25, 2019), the plaintiff was similarly afforded a chance to save his claims but mostly failed to seize the opportunity. The plaintiff alleged that the defendant's generic heart medication had caused him to develop pulmonary fibrosis. He sued the manufacturer of the branded version of the drug along with the subsidiary that manufactured the generic version, asserting the usual product liability claims. The court had granted the defendants' original motion to dismiss the complaint but had granted the plaintiff leave to amend several of the claims.

Not so the warnings-related claims, which were dismissed with prejudice on the original motion because, as the court correctly held, they were preempted under Mensing and Bartlett. In his amended complaint, the plaintiff stated that he did not "allege that the warning label or package insert [was] inadequate or should be changed" and that he "[made] no allegations regarding the adequacy of the label." Collette, 2019 WL 2603280 at *1. The court disagreed, citing language in the complaint that contained "echoes of the warning and labeling claim" that had been dismissed with prejudice. The court held that these claims had "already been dismissed and [were] not properly before the Court." Id.

Failure to Provide Medication Guides

In his original complaint, the plaintiff claimed that the defendants failed to distribute a "medication guide" with the drug. On the original motion to dismiss, the court held that the plaintiff had not included enough detail to state a plausible cause of action; for example, he had not even identified the pharmacy where he filled his prescriptions. The court also noted that the claim was likely preempted by Buckman to the extent that it was based only on duties arising from federal regulations.

In his amended complaint, the plaintiff failed to supply any additional factual support for the claim – not even the name of the pharmacy where he filled his prescription. The court held that the claim "continue[d] to fail" Twiqbal's "plausibility requirements." In addition, the court held that the claim did "indeed" appear to be based only on federal regulatory duties – that the plaintiff had failed to identify a parallel state duty that would have required the defendants to distribute a medication guide. As such, preemption provided an "alternative and independent basis for dismissal." Id. at *2. This time, the court dismissed the claim with prejudice.

Off-Label Marketing

On the original motion, the court had held that the plaintiff's off-label marketing claim sounded in fraud and failed to meet the heightened particularity standard of Rule 9(b). The court instructed the plaintiff to "say much more about what, specifically, each defendant said and did, and how these statements and actions (or lack thereof)" related to the plaintiff and to his doctor. Id. The amended complaint again failed to provide this detail, mentioning FDA enforcement actions against one of the defendants but not tying "any of this in any concrete way" to the plaintiff or to his doctors. The court held that the claim read "much more like a general investigative report than an actionable complaint" for a specific injury attributable to the defendants. Id. Inexplicably, however, the court again dismissed this claim without prejudice and gave the plaintiff one final opportunity to amend this claim.

So the plaintiff has one last chance to save his sole remaining claim. We'll be watching to see if he does. And we'll keep you posted.

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.

In association with
Related Topics
Related Articles
Related Video
Up-coming Events Search
Font Size:
Mondaq on Twitter
Mondaq Free Registration
Gain access to Mondaq global archive of over 375,000 articles covering 200 countries with a personalised News Alert and automatic login on this device.
Mondaq News Alert (some suggested topics and region)
Select Topics
Registration (please 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.


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.


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