United States: The Circuit Court Split On 'Fraud On The FDA' Continues

Originally published on Products Liability Law360

On Feb. 22, 2012, the U.S. Court of Appeals for the Fifth Circuit unanimously affirmed the U.S. District Court for the Northern District of Texas' granting of a defendant drug manufacturer's motion for summary judgment on all claims, including the plaintiffs' failure-to-warn claims, in Lofton v. McNeil Consumer & Specialty Pharmaceuticals Co., No. 10-10956, slip op. (5th Cir. Feb. 22, 2012).

At issue was whether, under Texas law, "a drug manufacturer enjoys a rebuttable presumption that it is not liable for failure to warn if the FDA [U.S. Food and Drug Administration] has approved 'the warnings or information' accompanying the product alleged to have harmed the plaintiff."

The defendant drug manufacturer asserted as an affirmative defense the rebuttable presumption that it had complied with all FDA requirements governing its product's labeling. Under Texas law, a defendant drug manufacturer is afforded a rebuttable presumption defense against failure-to-warn claims if "the FDA has approved 'the warnings or information' accompanying the product alleged to have harmed the plaintiff."

Pursuant to Texas law, the affirmative defense may be rebutted if the plaintiff can establish the defendant drug manufacturer "withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant's injury." Tex. Civ. Prac. & Rem. Code § 82.007(a)(1).

The Lofton decision was rendered in the context of the U.S. Court of Appeals for the Sixth Circuit holding in Garcia v. Wyeth-Ayerst Labs., 385 F.3d 961 (6th Cir. 2004), in which the Sixth Circuit held that a Michigan statute akin to Texas' adequacy presumption statute was preempted in some applications.

The Fifth Circuit also issued its opinion in Lofton in the wake of the U.S. Court of Appeals for the Second Circuit decision in Desiano v. Warner-Lambert & Co., 467 F.3d 85 (2d Cir. 2006), aff'd by an equally divided court sub nom. Warner-Lambert Co. LLC v. Kent, 552 U.S. 440, 128 S. Ct. 1168 (2008). In Desiano, the Second Circuit addressed whether Michigan's adequacy presumption statute, the same statute at issue in Garcia, was federally preempted, and the court held that the statute was not preempted.

The Fifth Circuit found that the plaintiffs' claims were tantamount to a fraud-on-the-FDA claim analogous to the plaintiffs' allegation in Buckman Co. v. Plaintiffs' Legal Comm., 531 U.S. 341, 121 S. Ct. 1012 (2001). In Buckman, the U.S. Supreme Court held that state law fraud-on-the-FDA claims are preempted insofar as they "conflict with the FDA's responsibility to police fraud consistently with the administration's judgment and objectives." Id. at 1018.

In Lofton, the Fifth Circuit reasoned that section 82.007(b)(1) of the Texas statute in question required the plaintiff to prove fraud-on-the-FDA in order to establish a failure-to-warn claim. Such a requirement in the Fifth Circuit's judgment invokes federal preemption analysis pursuant to the U.S. Supreme Court's Buckman decision.

Specifically, the Lofton court emphasized that the Texas statute "requires a plaintiff to establish that a drug maker 'withheld from or misrepresented to the United States Food and Drug Administration required information that was material and relevant to the performance of the product and was causally related to the claimant's injury.'"

The Fifth Circuit stressed that the term "required information" "refers to federal requirements under the FDCA [Food, Drug and Cosmetic Act]; what is 'material' and 'relevant' must be determined by FDA itself, not by state court juries."

Because the Fifth Circuit determined that the Texas presumption of adequacy statute required the plaintiff to "establish" a violation of FDA disclosure requirements, "the plaintiff necessarily re-treads the FDA's administrative ground both to conduct discovery and to persuade a jury."

Furthermore, the Lofton court held that in cases where "the FDA has not found fraud, the threat of imposing state liability on a drug manufacturer for defrauding the FDA intrudes on the competency of the FDA and its relationship with regulated entities."

Accordingly, the Fifth Circuit concluded that the Texas presumption of adequacy statute was federally preempted, unless the factual record revealed that the FDA had found fraud.

Analysis

The Fifth Circuit's decision in Lofton deepens the split among the U.S. circuit courts on whether or not the U.S. Supreme Court's "fraud-on-the-FDA" preemption decision in Buckman applies broadly and forcefully to all claims that, either explicitly or implicitly, include an allegation that a drug or medical device manufacturer did not appropriately satisfy its disclosure obligations vis-à-vis the FDA.

Similar to the presumption of adequacy statute in question in the Lofton case, several other states have analogous statutes that will likely be the focus of decisions by other circuit courts. Thus, it is probable that the U.S. Supreme Court will have to provide further clarification with reference to the scope of the application of Buckman.

In the interim, both drug and medical device manufacturers can rely on the Fifth Circuit's Lofton opinion in trying to defeat state-law-based failure-to-warn claims that implicate the manufacturers' dealings with the FDA.

Sharon Caffrey is a partner in Duane Morris' Philadelphia office. Paul da Costa is an associate in the firm's Newark, N.J., office.

This article is for general information and does not include full legal analysis of the matters presented. It should not be construed or relied upon as legal advice or legal opinion on any specific facts or circumstances. The description of the results of any specific case or transaction contained herein does not mean or suggest that similar results can or could be obtained in any other matter. Each legal matter should be considered to be unique and subject to varying results. The invitation to contact the authors or attorneys in our firm is not a solicitation to provide professional services and should not be construed as a statement as to any availability to perform legal services in any jurisdiction in which such attorney is not permitted to practice.

Duane Morris LLP, a full-service law firm with more than 700 attorneys in 24 offices in the United States and internationally, offers innovative solutions to the legal and business challenges presented by today's evolving global markets. Duane Morris LLP, a full-service law firm with more than 700 attorneys in 24 offices in the United States and internationally, offers innovative solutions to the legal and business challenges presented by today's evolving global markets. The Duane Morris Institute provides training workshops for HR professionals, in-house counsel, benefits administrators and senior managers.

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