United States: Supreme Court Sides With Merck In Unanimous Fosamax® Product-Liability Decision

The Situation: Name-brand pharmaceutical manufacturers are often sued with claims that they should have strengthened the warnings on their labels, even where (as here) the Food and Drug Administration ("FDA") would not allow them to do so. The U.S. Court of Appeals for the Third Circuit held that, to defeat such claims as preempted by federal law, manufacturers must prove to a jury, by clear and convincing evidence, that the FDA would have rebuffed the plaintiff's desired warning. The U.S. Supreme Court granted Merck's request to review that decision.

The Result: The Supreme Court unanimously held that a judge, not a jury, should assess a manufacturer's preemption defense in these circumstances. It also held that the judge should treat that defense as an ordinary legal question, not a factual one with a uniquely difficult evidentiary burden.

Looking Ahead: Several jurisdictions had followed the Third Circuit's lead in sending these questions to a jury. Manufacturers in those jurisdictions and others can now rest assured that this key aspect of their case will be evaluated by experienced judges, not lay jurors.


Pharmaceutical company Merck recently obtained a unanimous win before the Supreme Court in a product-liability matter involving Merck's prescription medicine Fosamax®. Merck's victory will significantly help name-brand drug manufacturers fend off allegations that they should have more strongly warned against a medicine's possible side effects.

Merck's medicine Fosamax is prescribed, among other things, to prevent and treat osteoporosis in post-menopausal women. In the late 2000s, evidence began to emerge suggesting that long-term use of Fosamax and other drugs in its class might be related to an extremely unusual type of femur fracture. After telling the FDA what it knew about this possible link, Merck sought to revise Fosamax's label and suggested revisions. But the FDA said no. As its regulatory actions and its communications with Merck and the general public demonstrated, the FDA did not believe the scientific evidence supported such a warning until over a year and a half later, after an expert task force assessed the issue.

Merck got sued anyway, by thousands of plaintiffs claiming that it should have changed its warning before that task force report. Merck argued successfully in the District Court that it couldn't have changed the warning—the FDA didn't let it—and so these claims against it were preempted.

But the Third Circuit disagreed. It held that such claims are preempted only if the manufacturer can prove to a jury, by clear and convincing evidence, that the FDA would have rejected a properly phrased warning. Because the Third Circuit believed some evidence suggested that the FDA had semantic rather than substantive problems with Merck's request, it held Merck lacked the "smoking gun" to establish this defense. Merck had been successful in the trials that had gone to verdict to date, but it lost this important pre-trial defense.

The Supreme Court unanimously held that "a judge, not a jury, must decide the pre-emption question" in cases like this one, using ordinary legal burdens. Slip op. 9; see also slip op. 1 (Alito, J., concurring in the judgment). That question "often involves the use of legal skills to determine whether agency disapproval fits facts that are not in dispute," and "judges ... are better equipped to evaluate" it in the first instance. Slip op. 16; see id. (noting that allowing judges to decide preemption "should produce greater uniformity among courts"). Thus, questions about the preemptive effect of the FDA's actions—even "factual questions" that are "subsumed" within the analysis—go to judges, not juries. Id. at 17.

In keeping with this holding, the Court also explained that its prior references to "clear evidence" were not meant to serve as an "evidentiary standard," because "courts should treat the critical question ... as a matter of law for the judge to decide," "simply ask[ing] himself whether the relevant federal and state laws irreconcilably conflict." Slip op. 14; see also slip op. 3 (Alito, J., concurring) (noting the Court's "hold[ing]" that prior usage of the phrase "clear evidence" "was merely a rhetorical flourish").

The Court vacated and remanded in light of the Third Circuit's erroneous holding to the contrary. It explained that, on remand, Merck is entitled to its preemption defense if it demonstrates that "it fully informed the FDA of the justifications for the warning required by state law and that the FDA, in turn, informed the drug manufacturer that the FDA would not approve changing the drug's label to include that warning." Slip op. 13. In conducting that analysis, courts should "obvious[ly]" focus on whether the FDA disapproved a change through action "within the scope of its [congressionally delegated] authority." Slip op. 15.

Merck's victory restores hope to the many other pharmaceutical manufacturers facing failure-to-warn claims under state law. It is now clear that manufacturers' preemption defense goes to the judge, not a jury. It is also clear (ironically enough) that "clear evidence" is not code for "impossibly difficult burden"—the judge must simply ask whether federal law prohibited what state law supposedly required.

With those two barriers out of the way, manufacturers should have an easier time convincing judges that, despite their best efforts, the FDA would not allow them to change their labels as the plaintiffs demand.

Jones Day represented Merck Sharp & Dohme Corp. in Merck Sharp & Dohme Corp. v. Albrecht, No. 17-290 (U.S.).


Three Key Takeaways

  1. Judges, not juries, must assess whether it was impossible for a manufacturer to revise its label while complying with federal law.
  2. In answering any factual questions that arise in that inquiry, courts should use the ordinary preponderance standard, not a clear-and-convincing-evidence standard.
  3. Manufacturers should work with counsel to identify the best way to frame their argument that the FDA's actions demonstrate the impossibility of complying with both state and federal law. 

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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
 
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.

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