United States: Excellent Infuse Preemption Decision Out Of Eastern District Of Michigan

Last Updated: August 7 2019
Article by Rachel B. Weil

On our office bulletin board, we keep a post-it listing the states we have not yet visited. We are down to ten, and we expected to cross Oregon off after a deposition last week. But our deponent moved from Bend, Oregon to St. George, Utah. We've been to Utah lots of times, and were annoyed at this development. And St. George is not easy to reach. The local airport is temporarily closed, and the closest major airport is in Las Vegas, 130 miles away. So we flew to Las Vegas and gritted our teeth for the drive. We needn't have. The drive is entirely on I-15, passing through Nevada and a tiny corner of Arizona before hitting Utah. It traverses the spectacular Virgin River Gorge – you should Google it – and was altogether a lovely surprise. The takeaway (spoiler alert – this is the clumsy transition to today's case): "not new" doesn't necessarily mean "not good."

We warned you. Today's case, actually from a few months ago, treads familiar ground: medical device preemption under Riegel, and Buckman preemption. But it is very good. In White v. Medtronic, Inc., 2019 WL 1339613 (E.D. Mich. Feb. 20, 2019), the plaintiff alleged that his now-deceased wife was injured by the defendant's bone graft device, a Class III medical device.. The plaintiff alleged that the device was implanted in an "off-label" manner and asserted the usual litany of product liability claims. The defendant moved to dismiss, arguing that the plaintiff's claims were preempted by the MDA.

The court explained that, under Riegel, the MDA expressly preempts any state law claims related to a Class III medical device (a device subject to premarket approval, or "PMA") that impose a requirement that is "different from or in addition to" those imposed by the MDA. White, 2019 WL 1339613 at *2 (citation to Riegel omitted). Under Riegel's two-pronged test, a state claim is preempted by the MDA when: 1) the federal government has established requirements applicable to the device in question; and 2) the state law claims, rather than asserting claims that parallel the federal requirements, seek to impose requirements that relate to safety and effectiveness and are different from, or in addition to, the federal requirements. White, 2019 WL 1339613 at *2 (citation to Riegel omitted). In addition, under Buckman, only the federal government can enforce the MDA and the FDCA, so claims are impliedly preempted to the extent that they are based on violations of either statute.

The first prong of the Riegel test was easily satisfied, as there was no dispute that the FDA had established requirements that applied to the defendant's device. As such, the "critical question" was whether the state-law claims "invoke[d] requirements beyond those established by the federal government." Id. at *3. "The short answer," according to the court, was "they do." Id.

Claims Grounded in Negligence and Failure to Warn

The plaintiff based a number of his claims on allegations that the defendant had failed to warn of risks associated with the bone graft device, including risks of implanting the device in the allegedly off-label manner in which it was implanted in the plaintiff's wife. But the plaintiff did not allege that the defendant failed to provide any of the warnings required by the FDA through the PMA process; rather, the claims were "premised on the theory that Defendants had a duty to provide warnings different from or in addition to" those FDA required. Id. at *4 (emphasis in original). As such, the MDA expressly preempted the warnings claims. Moreover, with respect to the negligence claims, the court held, "No negligence claims can be maintained as to [Class III] devices that complied with the FDA requirements because success on those claims requires a showing that the FDA requirements themselves were deficient. These claims cannot be presented to a jury because, if successful, they would be inconsistent with the federal requirements." Id. (citation omitted). This is true even if the claims come "in the guise of a general tort suit addressing only safety issues related to off-label uses," id. at *5, because "off-label usage of medical devices is an accepted and necessary corollary of the FDA's mission to regulate in this area without directly interfering in the practice of medicine." Id. (internal punctuation and citation omitted). Moreover, the claims related to off-label promotion didn't "pass muster as parallel state torts" claims, because there is "no Michigan law duty to refrain from off-label promotion of a medical device." Rather, "off-label promotion exists only as a creation of the FDCA scheme." Id. In addition, the court held, the plaintiff's claims related to off-label use and failure to report adverse events were impliedly preempted under Buckman as impermissible attempts to enforce violations of the FDCA.

Other Preempted Claims

The plaintiff asserted breaches of express and implied warranties and violations of Michigan's consumer protection statute. Like the warnings claims, the court held that these claims were preempted because the duties the claims sought to enforce "relate[d] to, and [were] potentially inconsistent with, the federal regulatory scheme." Id. at *7. In addition, Michigan's consumer protection statute contains a safe harbor for conduct regulated under state or federal statutory authority, which "of course [included] the FDCA and the MDA." Id. Finally, the court held that the plaintiff's design and manufacturing defect claims were preempted because "PMA constitutes approval of the product's design, testing, intended use, and manufacturing methods," so permitting the claims to go forward would "in essence, impose [requirements] different from or in addition to that already approved by the FDA." Id. (citations omitted).

Other Bases for Dismissal

The court went on to dismiss the plaintiff's fraud claims for failure to satisfy Rule 9(b) and also as "fraud on the FDA claims" preempted under Buckman. In an interesting twist, the court added that the fraud claims – in essence, that the defendant made false statements about the safety of off-label use of the device or concealed information about the device to induce doctors to use the device – were not tied specifically to the plaintiff's late wife or to her doctors. Instead, they "attempted to advance a 'fraud on the market' theory, with the 'market' being the medical community at large" that had "no place in a products liability case. . . ." Finally, the court held that, in any event, the plaintiff's claims were time-barred.

We like this no-doubt-about-it defense victory. We'll keep you posted on similar decisions, and on our continuing adventures as we cross states off of our post-it.

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
 
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