United States: Paxil Verdict Overturned On Appeal – Preemption Evidence Couldn't Be Clearer

Last Updated: August 30 2018
Article by Michelle Yeary

This post is from the non-Reed Smith side of the blog.

We haven't talked about the district court decisions in Dolin v. GlaxoSmithKline LLC, because in our opinion there simply hasn't been anything good to talk about. Plaintiff sued the manufacturer of the brand drug Paxil arguing that the brand manufacturer should be liable for the death of her husband who took a generic version of the drug manufactured by a different company. Plaintiff alleged that the brand manufacturer should have amended the warning that accompanied its drug to include the risk of suicidality in adults even though the FDA had expressly rejected such a warning change several times. So, the fact that the defendant's innovator liability and federal preemption based summary judgment motions were denied left us frankly baffled at how two district courts got it wrong on both counts.

But, now we finally have something good to talk about. The Seventh Circuit just reversed the verdict for the plaintiff in this case overturning the district court's preemption decision. In Dolin v. GlaxoSmithKline LLC, ___ F.3d ___, 2018 WL 4001208, slip op. (7th Cir. Aug. 22, 2018), the appellate court found overwhelmingly clear evidence that the FDA rejected the very warning proposed by plaintiff, applied Mensing to a brand manufacturer, and also found no evidence of newly acquired information to support a unilateral label change. That's definitely worth talking about.

Before we get to all those great decisions, we note that the Seventh Circuit opted not to reach the innovator liability question finding that the "evidence of federal preemption is decisive." Id. at p.25. However, the court did note that the issue had not yet been decided by the Illinois courts, and therefore any ruling would have to be "a prediction of state law under Erie." Id. We point this out as one of problems with the district court decisions was that in the face of an undecided state law question, they over-reached in creating innovator liability where such a claim did not exist. It was an improper expansion of state law. Federal Erie predictions are supposed to be conservative, not radical as was the case here. As discussed in our " Innovator Liability at 100" post, every other court of appeals to consider innovator liability on its merits, has rejected it. That's seven courts of appeals (4th, 5th, 6th, 8th, 9th, 10th, & 11th), construing the law of 23 states — including Illinois. See In re Darvocet, Darvon, & Propoxyphene Products Liability Litigation, 756 F.3d 917, 944-45 (6th Cir. 2014).

Turning to the dispositive preemption question, defendant argued that that the FDA would not have allowed it to include the warning sought by plaintiff and therefore plaintiff's state law tort claim conflicted with federal law and was preempted. Under the standard announced in Wyeth v. Levine, 555 U.S. 555 (2009), a state law claim based on labeling is not preempted "if the manufacturer could have added the warning unilaterally under the [Changes Being Effected ("CBE")] regulation." Dolin, at p.15. Under the CBE regulation, a manufacturer can change its label without advance FDA permission if the manufacturer has "newly acquired information." Id. at p.4. But Levine also held that "there could be preemption if the manufacturer met the stringent standard of proving that there was clear evidence the FDA would have rejected the proposed change in the drug's label." Id. at p.16. So, the issue for the court was whether or not defendant could have changed the drug's label using the CBE regulation.

Before getting to the substance, we'll start with another question the court decided not to decide – whether preemption under Wyeth v. Levine, 555 U.S. 555 (2009) is a question of fact or law. The court acknowledged the recently created split in the circuits created by the Third Circuit's decision in In re Fosamax Products Liab. Litig., 852 F.3d 268 (3rd Cir. 2017) (our worst case of the year for 2017), on which, thankfully, the Supreme Court has granted certiorari to review. But even the Third Circuit decision left a window open. One in which Dolin certainly fit. "[W]hen no reasonable jury applying the clear-evidence standard could conclude that the FDA would have approved a label change, then the manufacturer will be entitled to judgement as a matter of law." Dolin, slip op. at p. 18 (quoting In re Fosamax).

More specifically, the Seventh Circuit held that "no reasonable jury could find that the FDA would have approved an adult-suicidality warning for Paxil under the CBE regulation between 2007 and [decedent's] suicide in 2010." Id. Why was it such an open and shut case? About one-third of the opinion is taken up with setting out the extensive regulatory history demonstrating that both GSK and the FDA thoroughly examined the issue and the FDA completely rejected the addition of an adult-suicidality warning.

  • June 1991 – based on supplemental analysis of data related to suicide the FDA determined there was no signal for additional risk of suicide, id. at p.7;
  • September 1991 – an independent committee convened by the FDA "unanimously agreed that there is no credible evidence of a causal link," id.;
  • January 2004 – FDA concluded based on review of multiple data sets that there was no increased risk of suicide, id. at p.8;
  • 2004 – the FDA requires a black box warning regarding an association between SSRIs (the class of drugs to which Paxil belongs) and suicide in pediatric patients but not adults, id.;
  • April 2006 – GSK unilaterally changed its label under CBE regulations to include the risk of suicide in adults, id. at p.9;
  • November 2006 – the FDA completed a meta-analysis that led it to conclude "the net effect appears to be neutral on" adult suicidality, id. at p.10;
  • 2007 – the FDA orders class-wide labeling to state that "studies did not show an increase in the risk of suicidality with antidepressants . . . in adults beyond the age of 24," id. at p.11;
  • On at least 4 separate occasions in 2007, GSK asked the FDA whether it could retain the warning it added via CBE in 2006 and the FDA said no. Id. at p.11-13.

The court found this evidence "undisputed," id. at p. 18, and held "[i]t is hard to imagine clearer evidence that . . .the FDA would not have approved a change." Id. at p.19. It compared this regulatory history to the one the Supreme Court considered in Levine and found the Paxil evidence filled all the "evidentiary gaps" which led to the Levine non-preemption ruling. The risk of suicidality was given "more than passing attention" by the defendant and the FDA. Defendant provided the FDA with re-analyzed data in 2006. Defendant unilaterally changed the label to add a warning of the risk at issue. And, the FDA, more than once, rejected the warning. Id. at p.19-20.

Plaintiff made two arguments in response. First she argued that the FDA only rejected the defendant's proposed warning because defendant "proposed adding it to the wrong spot on the label." To which the court responded:

Plaintiff asks us to believe that the FDA – after deciding against an adult-suicidality warning based on its own analysis – rejected [defendant's] warning only because GSK proposed putting it in the wrong place. That is unreasonable.

Id. at p.21. The court called that "unreasonable." We'd probably have found a stronger adjective.

Plaintiff's second argument is more important because it emphasizes what Levine preemption is at its core. Plaintiff argued that the defendant could have asked for a formal meeting with the FDA and therefore defendant lacks clear evidence that the FDA would have rejected the warning after such a meeting. Id. This argument misses the mark because "[s]tate laws requiring a label change are preempted unless the manufacturer could unilaterally add the new warning under the CBE regulation." Id. In other words, if you need FDA approval there is conflict preemption.

This is where Pliva, Inc. v. Mensing, 564 U.S. 604 (2011), comes in and we of course laud its use in brand drug cases. Mensing held that claims against generic drug manufacturers were preempted because generic manufacturers are not permitted to unilaterally change a drug's label. Because generic manufacturers cannot independently comply with their state law duties — changing their label would require "special permission or assistance" from the FDA — claims against them are preempted. Equate that to plaintiff's argument in Dolin:

The preemption analysis asks only whether [defendant] could have added the adult-suicidality warning through the CBE regulation, not whether [defendant] might have been able to persuade the FDA to change its mind in a formal meeting – and certainly not whether [defendant] could have persuaded the FDA after already asking four times to include the warning and being told no four times.

Id. at p.22.

That takes care of the preemption issue up until 2007, when the FDA repeatedly rejected defendant's CBE warning language. But plaintiff's husband did not take the drug until 2010. So the remaining question is whether between 2007 and 2010, defendant acquired any "new" information that would have permitted a CBE label change during that period. Newly acquired information is defined as "data, analyses, or other information not previously submitted to the Agency." 21 C.F.R. § 314.3. Plaintiff argued that in the data defendant submitted to the FDA, it "improperly attributed suicides that occurred in the wash-out phase of the drug tests as occurring on the placebo." Dolin, slip op. at p.23. But the evidence showed that the FDA was aware that wash-out events were included and that defendant re-submitted the data to the FDA excluding the wash-out phase. Id. at p.24. Plaintiff also pointed to an article published in 2011 but the article was based on a 2006 analysis. So there was no evidence that the analysis was either new or not previously submitted to the FDA. Id. The court, therefore, concluded that plaintiff had offered no evidence that defendant acquired any new information after 2007 that would have supported a CBE label change.

All this was strong preemption evidence indeed. We note that Dolin was written by Judge Hamilton, who is no friend of preemption generally. See Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), also authored by Judge Hamilton.

We were always optimistic that the district court's decisions in Dolin and the verdict would not stand and the Seventh Circuit did not disappoint (well, maybe they could have tossed innovator liability too, but a nod to Erie doesn't hurt).

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
 
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