United States: Federal Pharmaceutical Regulations Pre-empt State-Tort Laws

Weeks v. Wyeth, Inc., et al., (M.D. Ala. Aug. 3, 2015)

Addressing whether federal labeling requirements imposed on generic drug manufacturers directly conflict with state-tort law claims, the U.S. District Court for the Middle District of Alabama recently determined that federal law pre-empted state-tort law claims against generic drug manufacturers in accordance with Supreme Court and circuit precedent. Weeks v. Wyeth, Inc., et al., 2015 WL 4635176 (M.D. Ala. Aug. 3, 2015) (J. Watkins, D.J.).

This case involves metoclopramide (MCP), the generic counterpart of the prescription drug Reglan®. Reglan is designed to increase the speed at which food travels through the digestive system in order to treat patients suffering from gastroesophageal reflux. The drug was approved by the U.S. Food and Drug Administration (FDA) in 1980 as a short-term therapy.

Plaintiffs Danny and Vicki Weeks sued several pharmaceutical companies, including Wyeth, the manufacturers of MCP. They alleged that Mr. Weeks developed a severe and incurable neurological disorder as a result of ingesting MCP over the course of two years as prescribed by his treating physician. The Weeks asserted that Defendants had actual knowledge of potential neurological side effects from long-term use of Reglan or MCP and that they failed to warn doctors and patients of these risks.

After the Weeks filed suit, the brand-name defendants moved to dismiss, since Mr. Weeks only ingested MCP and that liability against them, as manufacturers of Reglan, must fail. The court granted the motion with respect to the Weeks claims that the brand-name defendants owed Mr. Weeks a duty to disclose information about either Reglan or MCP, but denied the motion with respect to claims that the brand-name defendants owed Mr. Weeks' prescribing physician the same duty. While the issue of whether brand-name drug manufacturers can be held liable for harm caused by a generic product manufactured and distributed by an un-related generic manufacturer was being decided in the U.S. Court of Appeals for the 11th Circuit, the brand-name defendants moved the court to certify this question to the Supreme Court of Alabama. Ultimately, the Supreme Court of Alabama determined that liability could extend to brand-name manufacturers and developers for fraud or mis-representation made in connection with the manufacture and sale of a brand-name drug, by a plaintiff who was injured by the generic drug manufactured and distributed by a different company.

While the Supreme Court of Alabama was deciding the certification request, the generic defendants filed a motion to dismiss on the grounds that federal law pre-empted state-tort law claims against generic pharmaceutical manufacturers. The court stayed the action while the Supreme Court of Alabama addressed the certified question. Once its decision was issued, the stay was lifted and the generic defendants filed a motion for judgment on the pleadings. Despite the generic defendants having not filed answers to the Weeks' amended complaint, and consistent with other authorities, the court construed this motion under Rule 12(c) of the Federal Rules of Civil Procedure as a motion to dismiss for failure to state a claim pursuant to Rule 12(b)(6).

In addressing the generic defendants' motion to dismiss based on federal pre-emption, the court relied heavily on the Supreme Court of the United States' decision in PLIVA, Inc. v. Mensing, 131 S.Ct. 2567 (2011) case. The facts of Mensing are similar to the current case, in which the plaintiffs alleged that long-term use of MCP caused neurological disorders and that the generic drug manufacturers were liable under state-tort laws "for failing to provide adequate warning labels." Similar to the generic defendants' arguments, the Mensing defendants argued that "federal statutes and FDA regulations required them to use the same safety and efficacy labeling as their brand-name counterparts," which means that they could not "simultaneously comply with both federal law and any state tort-law duty that required them to use a different label." The Supreme Court found that defendants in these circumstances were without means to comply with both federal and state law, and that federal law prohibited generic drug manufacturers from unilaterally changing their labels or providing additional warnings directly to physicians. Thus, the Supreme Court (in Mensing) held that federal law pre-empted the failure-to-warn state-tort claims.

The U.S. District Court for the Middle District of Alabama recognized that the scope of Mensing covers any state-law claims based on a generic drug manufacture taking unilateral action. In these cases, the state-law claims are pre-empted by federal law, since federal pharmaceutical regulations requiring a "duty of sameness" from generic companies makes them dependent on brand-name manufacturers.

If the brand-name defendants were not required to communicate a warning to physicians or patients, then the generic defendants also would not be required to warn and any state-law claim based on that unilateral action would be pre-empted by federal law. Here, the Weeks expressly alleged in their amended complaint that the brand-name defendants failed to communicate any warnings to Mr. Weeks' prescribing physician. Accordingly, the district court concluded that the Weeks' state-law tort claims are pre-empted by federal law and granted the generic defendants' motion to dismiss.

Federal Pharmaceutical Regulations Pre-empt State-Tort Laws

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
 
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