United States: Sixth Circuit Affirms Branded Drug Preemption and Trial Win

Last Updated: March 4 2017
Article by Eric Alexander

In the aftermath of Levine, with its generous interpretation of the CBE regulation and its novel "clear evidence" standard, we wondered how long it would be until we saw a court holding that a failure to warn claim with a branded prescription drug was preempted.  Courts were chilled for a while, but eventually the right sort of cases found their way to judges who understood preemption.  Now, we have a pretty big list of decisions finding preemption of such claims, along with decisions exhibiting supportive reasoning.  We are not yet at the point where preemption of failure to warn claims with branded prescription drugs—for a long time, the core claim in the biggest litigations in our bailiwick—is no longer news.  Preemption is still the exception—limited to cases with a strong regulatory history of FDA rejecting the warning plaintiff wanted—rather than the rule, particularly when it comes to favorable appellate decisions.

Rheinfrank v. Abbott Labs., Inc., __ Fed. Appx. __, 2017 WL 680349 (6th Cir. Feb. 21, 2017), is another favorable appellate decision on preemption.  You may recognize the name—especially if you are a blog aficionado—from our prior posts on the case.  We posted on partial summary judgment being granted as to part of the failure to warn claims being offered—on preemption—and the punitive damages claim—on lack of proof of relevant FDA fraud to meet the exception under the Ohio Product Liability Act provision generally precluding punitives for FDA-approved drugs.  We posted on the expansion of the preemption ruling on motion to reconsider to include design defect.  (These garnered an honorable mention in our list of the best decisions of 2015.)  We even posted on motions in limine rulings.  Even with all of those posts, a brief recap of the facts might help.  The minor plaintiff's mother took the prescription anti-seizure medication at issue for fifteen years, including through four pregnancies, before she became pregnant with plaintiff.  She kept taking the medication at issue, along with another anti-seizure medication she had been taking, through the birth of plaintiff, who was diagnosed with "physical deformities and cognitive disabilities, including Fetal Valproate Syndrome."  2017 WL 680349, *1.  The label for the medication at issue had long featured a black box warning and other warnings about birth defects, focusing on neural tube defects like spina bifida and discouraging use during pregnancy unless use of the medications "are clearly shown to be essential in the management of their seizures." Id. at *2.  Over the course of seven years after plaintiff's birth, FDA refused the manufacturer's repeated efforts to revise the label to address developmental delays in offspring based on data from a study that was ultimately published in the New England Journal of Medicine. Id. at **2-4.  A revision of the labeling was ultimately submitted by CBE and accepted by FDA in 2011. Id. at *4.  The prescriber back in 2003 and 2004 testified that she was aware of the black box warning on birth defects, would have relayed it to plaintiff, and would not have relied on other materials outside the label. Id. at *2.

Somehow, on this record, the plaintiff got to trial.  Under the logic of "all's well that ends well," we will limit our rant on this point.  After all, we have discussed other birth defect cases that got to trial despite obvious issues, resulted in big verdicts, and got affirmed on appeal. Rheinfrank proceeded to trial under the portion of the strict liability failure to warn claim that was not preempted, a strict liability claim for failure to confirm to representations, the portion of a common law negligent failure to warn claim that was not preempted, and a common law negligent design claim.  Among the reasons why the two failure to warn claims should not have seen a court are that 1) Ohio law requires the allegedly inadequate warning to relate to the injury plaintiff claims, 2) claims relating to developmental delays (including as part of Fetal Valproate Syndrome) were preempted, and 3) the prescriber was aware of black box warnings about really serious birth defects and the recommendation against prescription during pregnancy in most situations.  It is hard to see how plaintiff mustered evidence of proximate cause—that is, that a proposed (non-preempted) alternative warning as to a risk of an injury the plaintiff had (based on evidence that existed when the prescription was written) would have changed the prescriber's decision to prescribe—to survive summary judgment.  Based on the jury instructions that plaintiff proposed at trial, it seems like a broader discussion of risks and the impact of different warnings about risks was permitted than maybe should have been, which is often a reason why failure to warn claims get past summary judgment.  Given that the prescriber denied reliance on any representations outside the label, it is hard to see how that claim got to the jury.  As for the negligent design claim, it is hard to see how the same reasoning for preempting the strict liability design claim would not have applied or how a design of the drug—without being a different drug—that lacked the same birth defect risk could have been offered.  Anyway, the trial judge may have known what was coming, because the jury listened to the just about the best plaintiff could offer and returned a defense verdict on all counts after two weeks.

On appeal, the plaintiff had a number of gripes.  Among them was that her regulatory expert—one Dr. Parisian, whose regulatory experience with drugs has been the subject of considerable commentary—was precluded (kind of) from opining that the drug had greater birth defect risks than other drugs and that her medical experts were precluded from giving a range of regulatory opinions—even though they were allowed to opine on whether the drug's label accurately reflected the state of the science at the time.  We will not discuss these other topics except to say that plaintiff clearly got quite a bit of latitude to present his case and the preemption rulings appear not to have excluded all the evidence that they might have.  That lets us focus on the Sixth Circuit's de novo consideration and affirmance—although without a recommendation for publication—of the ruling on preemption of failure to warn claims related to the risk of developmental delay.  It looks like plaintiff did not appeal as to the preemption of the strict liability design defect claim or the application of the OPLA's punitive damages provisions, which should tell you something (and Yates v. Ortho, 808 F.3d 281 (6th Cir. 2015), undoubtedly had something to do with the former).

"Because the FDA twice refused Abbott's attempts to strengthen [the drug's] label, based on its own review of the evidence that the drug adversely affected the development of children exposed to it in utero, Rheinfrank's failure-to-warn claim is preempted by federal drug labeling law." Id. at *13.  Looking at the entire history of the labeling, it was arguably three rejections of a labeling change like the plaintiff wanted, but who is counting?  This was clear evidence that FDA would not have allowed the label to change before the prescription to plaintiff, based on far less evidence of a risk.  "Together Wyeth and Mensing therefore indicate that 'a court cannot order a drug company to place on a label a warning if there is 'clear evidence' that the FDA would not approve it.'" Id. (citing Robinson v. McNeil Consumer Healthcare, 615 F.3d 861, 873 (7th Cir. 2010) (an OTC drug warnings preemption case)).  Part of the manufacturer's evidence was the denial of a Prior Approval Supplement, which negates the typical argument that there is no conflict with federal law when a Changes Being Effected supplement could have been submitted by the manufacturer.  "As the Court has since clarified [after Levine], given the FDA's authority to rescind any unilateral CBE, all that [the manufacturer] need have done—and did do here—is show that 'the FDA would have rescinded any change in the label,' a showing that does not appear to exclude the kind of informal communications from FDA higher-ups that [the manufacturer]." Id. at *14 (citing Mensing, 564 U.S. at 624 n.8).

An important preemption holding in Rheinfrank has to do with the timing of the FDA's rejections of the relevant proposed label change as against the plaintiff's injuries.  The court held, "[g]iven, then, that as of 2008 the FDA did not believe the state of the data supported a developmental delay warning, it stands to reason that as of 2003, with even less data to go on, the FDA would similarly have rejected a developmental delay warning." Id. Thus, Rheinfrank joins those courts that have drawn a preemptive line barring all plaintiffs who used a drug prior to an FDA insufficient evidence decision concerning the risk at issue.  We discussed those cases here.

The court also revealed an appreciation that the facts of Levine, where FDA's attention to the risk at issue was considered merely "passing," may not have broad application.  "Here, by contrast, there is considerable evidence in the record showing that [the manufacturer] followed up on new data surrounding developmental delay and [the drug], that [the manufacturer] contacted the FDA multiple times to propose modifications to reflect that data, and that each time officials from the FDA unit responsible for reviewing those modifications unequivocally stated that they were inappropriate at the time." Id. This level of attention provides evidence "clear enough to satisfy Wyeth's standard" and "make clear that the FDA would have rejected the proposed change to [the drug's] label." Id. The court even rejected plaintiff's attempt to inject a failure to test theory into the preemption analysis—that there should not be preemption because maybe the FDA would have done something different if the defendant had done extra studies and they had reported a risk of developmental delay.  Relying on Mensing, this was "too conjectural to defeat preemption." Id. at *15.  And, with that, plaintiff's last argument to reverse the well-thought out preemption decision of the district court ended.

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
 
In association with
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
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.

Disclaimer

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.

Registration

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.

Cookies

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.

Links

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.

Mail-A-Friend

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.

Security

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.