United States: Never Too Late To Celebrate Preemption

Last Updated: October 9 2017
Article by Michelle Yeary

Can you recall what you were doing back in March of this year? To be more precise the day before St. Patty's Day and the day after the Ides. No? Well, apparently the defendants in the Risperdal and Invega Products Liability Cases pending in California state court were celebrating but they forgot to invite us to the party. We just learned about the very nice preemption decision entered by the trial court in that litigation. Since it's never too late to celebrate a preemption victory, here are the highlights.

Before we get into the case specifics, the court's general preemption analysis merits a minute of our time. '[I]f the tort plaintiff's failure to warn theory was already tested by FDA action or inaction or would have required the use of a label on a prescription drug which the FDA would have prohibited," the claim is preempted. Risperal and Invega Product Liability Cases, 2017 WL 4100102 at *5 (Cal. Super. Mar. 16, 2017). What remains for private plaintiffs to challenge in a tort setting, therefore, is the adequacy of the label or the reasonableness of the manufacturer in updating the label based on new or additional information not already considered by the FDA. Id.

  In discussing whether information was presented to the FDA for consideration, of course, fraud-on-the-FDA and Buckman enter the discussion. The court nicely summarized the public policy reasons supporting Buckman preemption:

The understandable concern is that allowing a private right of action for "fraud on the FDA" would embroil the agency's staff, particularly its scientific staff, in court litigation to the derogation of their performance of their primary duties. This would result both from the consumption of time in litigation activity and from a concern that their routine duties, decision-making processes and public communications would all have to be vetted with litigation avoidance in mind.

Id. at *6.

Next the court establishes that the Wyeth v. Levine "clear evidence" standard does not require indisputable evidence, but rather defendants must establish impossibility preemption by "clear and convincing evidence." Id. And finally, the court found that preemption is a question of law, not fact and therefore an issue for the court, not the jury. To the extent deciding preemption requires the court to rule on a factual dispute regarding what the FDA would do, "the dispute is one regarding a legislative fact, not an adjudicative fact. Thus it presents a legal question for judicial resolution." Id. at *7.

With that as background, we turn to the specific facts of the case. Risperdal is an anti-psychotic medication. Id. at *1. The Risperdal label that plaintiffs claim is inadequate was modified in 2006 to include language about prolactin elevation and the reported rate of gynecomastia (enlargement of male breasts) among Risperdal users. Id. at *3. Plaintiffs allege that defendants failed to adequately warn of this risk because the labeling did not include the "true" rate of gynecomastia and should have included an instruction to physicians to monitor blood prolactin levels. Id. at *1. Defendants moved for summary judgment on preemption grounds in 5 cases involving plaintiffs from 4 different states. Id.

With respect to the rate of gynecomastia set forth in the label, the FDA specifically approved the pooling of data from 18 studies to arrive at the rate that was used in the labeling. Id. The FDA re-examined the label in 2007-2008 and concluded that it required no labeling changes regarding gynecomastia or prolactin elevations. Id. Plaintiffs argue that the pooled average was lower and that defendants should have disclosed the higher incident rates observed in 2 of the 18 studies. Id. at *8. Because those 2 studies were among those considered by the FDA during the approval process, "the FDA's position is clear [as to] how information regarding the 18 studies should be described in the label." Id. This portion of plaintiffs' claim is therefore preempted.

As to plaintiffs' allegation that defendants failed to adequately warn about monitoring prolactin levels, plaintiffs rely on "Table 21." This is a table containing an analysis of 5 studies purportedly showing a statistically significant association between elevated prolactin levels and gynecomastia. Id. The table was in a draft of a journal article but not in the final publication and therefore not submitted to the FDA during the approval process. The studies reviewed in the table, however, were among those considered by the FDA. Id.

  Plaintiffs argued that based on the information in the table, defendants should have independently changed their label under the Changes Being Effected ("CBE") regulations. However, to implement a CBE label change without prior FDA approval, the change must be based on "newly acquired information" which is defined as

data, analyses, or other information not previously submitted to the agency, which may include (but are not limited to) data derived from new clinical studies, reports of adverse events, or new analyses of previously submitted data (e.g., meta-analyses) if the studies, events or analyses reveal risks of a different type or greater severity or frequency than previously included in submissions to FDA.

Id. at *9. Table 21 doesn't fit that definition. It may be a different analysis of the data, but it did not show a different type or greater severity or frequency of the risk of gynecomastia which is the focus of the CBE regulation. To the extent plaintiffs also tried to rely on their litigation experts' analysis of the data, the court point out that that was a tactic tried and rejected in several other litigations as a means of avoiding preemption. Id. So, plaintiffs' claims are also preempted because the data they rely on to suggest defendants could have changed the label is not newly acquired and could not serve as the basis for an independent label change.

Not only could defendants not have changed the label on their own, the court found clear evidence that the FDA also wouldn't have approved it.  In 2012, one plaintiffs' counsel submitted a Citizen's Petition to the FDA alleging that the Risperdal label did not adequately address elevated prolactin levels, the need to monitor for elevated prolactin levels, or the rates of gynecomastia. Id. at *4. Essentially the same allegations raised in the litigation. In its response denying the petition, the FDA stated that it was commonly known that Risperdal increases prolactin and that gynecomastia is one of the manifestations of increased prolactin. Id. at *5. Based on that the court concluded:

This Court is persuaded that these reasons articulated by the FDA in response to the very claims alleged here provide the kind of "clear evidence" of "legislative fact" which the U.S. Supreme Court requires before a court can hold that impossibility preemption applies. By any standard, there is "clear evidence" that Plaintiffs' entire theory of label inadequacy focused on prolactin levels was not only considered and rejected by the FDA but also rests on information (and allegations) known to the FDA and the medical community. The FDA's review of the 18 clinical studies—which form the underlying data of any theory that Plaintiffs posit—both pre-approval and in subsequent reviews, and its subsequent inaction, seem to be the definite upshot of a conscious FDA choice on information before the agency. It is not this Court's job to revisit a decision made by the FDA.

Id. at *11.

It may not be the court's job to revisit FDA decisions, but it is certainly this blog's job to visit strong preemption decisions like this one. So, just a reminder that if you get a good decision – forward it along. Don't make us wait 6 months to join the party.

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
Similar Articles
Relevancy Powered by MondaqAI
 
In association with
Related Topics
 
Similar Articles
Relevancy Powered by MondaqAI
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