United States: Chantix: A Lesson In Why Litigation Should Not Be Allowed To Get Ahead Of Science

Last Updated: September 9 2016
Article by Michelle Yeary

We here at the DDL Blog try to stay on top of the goings on at the FDA. We've learned that on September 14, 2016, the FDA will hold an advisory committee meeting to review the results of a recently completed, randomized, placebo-controlled clinical trial (Evaluating Adverse Events in a Global Smoking Cessation Study or "EAGLES"), as well as findings from other studies that have assessed the neuropsychiatric effects of Chantix (varenicline). See September 14, 2016: Joint Meeting of the Psychopharmacologic Drugs Advisory Committee and the Drug Safety and Risk Management Advisory Committee. The committee will consider whether data from these studies supports changing the Chantix product labeling, including potentially removing the boxed warning regarding serious neuropsychiatric events. The meeting comes approximately three years after Pfizer agreed to pay nearly $300 million to settle thousands of lawsuits filed by plaintiffs alleging that they experienced adverse neuropsychiatric effects while taking Chantix. See Pfizer 2012 Financial Report, at 107.

This chain of events seems to be a clear cut example of litigation marching ahead of the science, and at that cost, we thought we'd probe the situation a little deeper. Chantix was approved by FDA in May 2006. It was the first new smoking cessation medication to come to market in more than a decade, and was recognized at the time to be one of the most effective treatments available to help smokers break their addiction to nicotine. The following, year, however, a highly publicized incident involving a Texas musician named Carter Albrecht raised concerns about potential adverse neuropsychiatric effects of the medication. The musician, who was taking Chantix and was heavily intoxicated at the time, was shot and killed by a neighbor who thought that Mr. Albrecht was burglarizing his home. Mr. Albrecht's girlfriend publicly blamed Mr. Albrecht's behavior on his use of Chantix. See Girlfriend Believes Chantix Contributed to Texas Musician's Death. The incident sparked national media attention, which led to an increasing number of anecdotal reports of patients experiencing neuropsychiatric events while taking Chantix.

Based largely on these anecdotal reports, the FDA instructed Pfizer to include warnings about potential neuropsychiatric effects in the Chantix product labeling, and, in July 2009, mandated the addition of a boxed warning. The boxed warning advised that patients being treated with Chantix should be monitored for neuropsychiatric symptoms "including changes in behavior, hostility, agitation, depressed mood, and suicide-related events, including ideation, behavior, and attempted suicide" and recommended stopping Chantix if any of these symptoms are observed. To further evaluate this issue, FDA also asked Pfizer to conduct a clinical trial—the recently completed EAGLES study—to assess the neuropsychiatric safety of Chantix.

Shortly after the boxed warning was added, thousands of lawsuits were filed by plaintiffs across the country alleging various neuropsychiatric injuries related to their Chantix use. The cases were coordinated in an MDL proceeding in the Northern District of Alabama. While the litigation was ongoing, several controlled studies, including EAGLES, were underway to answer questions raised by the anecdotal reports. See McClain v. Metabolife Int'l, Inc., 401 F.3d 1233, 1254 (11th Cir. 2005) (noting that anecdotal reports simply "raise questions" about potential adverse effects of a medication, but that those questions can be answered only with controlled studies). Defendant argued that the court should not allow the litigation to get ahead of this evolving science, but the court disagreed ruling that there was no need to suddenly halt the judicial process because of worries by the defendant that science was lagging behind the Chantix lawsuit litigation, noting that some studies may not be completed until 2017. See Order, Case No. 2:10-cv-01463, Doc. 232, Oct. 16, 2012, at 2-3. Not long after the ruling, Pfizer settled the majority of lawsuits, and the MDL was terminated in late 2014.

Two years after the litigation ended, Pfizer announced the results of the EAGLES study. According to the press release, EAGLES was the largest clinical trial of approved smoking cessation medicines—including 8,144 adult smokers—and was designed to compare the neuropsychiatric safety of Chantix and bupropion with placebo and nicotine patch. The authors concluded that the trial did not show a significant increase in the incidence of serious neuropsychiatric adverse events with Chantix compared to placebo and nicotine patch and, just as importantly, showed that patients taking Chantix had significantly higher continuous abstinence rates than patients treated with bupropion, nicotine patch, or placebo. These results were consistent with other controlled studies—including meta-analyses of clinical trials and large-scale observational studies involving tens of thousands of patients—which did not find evidence of an association between Chantix use and serious neuropsychiatric events.

While all of these studies have their limitations, the totality of this controlled data stands in stark contrast to the anecdotal reports that led to the addition of the boxed warning and served as the basis for thousands of lawsuits. Indeed, in light of this new data, leading researchers and clinicians have called for removal of the boxed warning from the Chantix label. See e.g., Davies and Thomas, The FDA and Varenicline: Should Risk Communication Be Improved?, Addiction 2016, doi: 10.1111/add.13592; Niaura, Ray. Varenicline and Suicide: Reconsidered and Reconciled, Nicotine & Tobacco Research 2016, doi:10.1093/ntr/ntv247. The FDA advisory committee will review the study results next week, and FDA is expected to make a final decision by the end of the year.

While we await the outcome of the advisory committee meeting and FDA's ultimate decision on the labeling, it is worth taking a moment to reflect on the Chantix litigation moving forward while controlled studies were underway to fully evaluate the scientific question at hand. The court was certainly correct in recognizing that waiting for studies to be completed would have delayed resolution of cases that, in some instances, had been pending for years. But, as the Supreme Court explained in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 597 (1993), the goal of "reaching a quick, final, and binding legal judgment" on matters that are "often of great consequence" is not advanced by accepting hypotheses and conjectures in the place of reliable scientific evidence. That is why both the Sixth and Seventh Circuit have emphasized that the law must lag science, not lead it. See Rosen v. Ciba-Geigy Corp., 78 F.3d 316, 319 (7th Cir. 1996); Tamraz v. Lincoln Elec. Co., 620 F.3d 665, 677 (6th Cir. 2010).

The Chantix litigation ignored this admonition, and instead went forward based largely on anecdotal reports. The parties expended precious legal and financial resources, and the litigation result was at odds with subsequent evidence from the most reliable scientific studies. Worse still, the public perception of Chantix was adversely affected, and it is likely that use of a highly effective smoking cessation medication declined as a result. Considering that cigarette smoking is a factor in more than 480,000 deaths each year in the United States alone, that is certainly not a desirable outcome from a public health perspective. In a sense, this is all water under the bridge. We hope, however, that courts will look to the Chantix example, be reminded of the potential consequences of letting a litigation get ahead of the science, and avoid similar results in the future.

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 Video
Up-coming Events Search
Font Size:
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
Confirm Password
Mondaq Topics -- Select your Interests
 Law Performance
 Law Practice
 Media & IT
 Real Estate
 Wealth Mgt
Asia Pacific
European Union
Latin America
Middle East
United States
Worldwide Updates
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.


Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.


Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.


A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.


This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.


If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.


This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.