United States: Indiana Judge Relies On Bausch To Bounce Preemption Motion

Last Updated: May 24 2017
Article by Jeffery Kruse

The old adage "location, location, location" applies as much for medical device preemption as it does for real estate. Despite acknowledging that the plaintiff's Amended Complaint "would likely not survive a motion to dismiss if this case was pending in a court in the Eighth Circuit (or perhaps the Eastern District of New York)," an Indiana federal judge recently denied Medtronic's motion to dismiss the Amended Complaint in Cavender v. Medtronic, Inc. (Cavender II), 2017 U.S. Dist. LEXIS 57376 (N.D. Ind. Apr. 14, 2017).

As frequently happens in cases involving pre-market approved medical devices, the court dismissed the initial complaint. He dismissed the initial Complaint because it was "nothing more than the sort of "unadorned, the-defendant-unlawfully-harmed-me accusation" and was "still in the 'assembly required' stage." Cavender v. Medtronic, Inc. (Cavender I), 2016 U.S. Dist. LEXIS 154540 *20-21 (N.D. Ind. Nov. 8, 2016). But, just as many other courts do, the judge in this case, Judge William C. Lee, granted the motion to dismiss without prejudice and gave the plaintiff another chance to try to plead a valid claim.

In Cavender I, the plaintiff alleged that her implantable cardioverter defibrillator malfunctioned and injured her. She filed her initial complaint "apparently asserting product liability, breach of warranty and negligence claims against Medtronic." Cavender I, at *2. Judge Lee's first task in Cavender I was to determine whether the Indiana Product Liability Act (IPLA) preempted and subsumed plaintiff's attempted product liability claims. Judge Lee concluded that the IPLA subsumed the negligence and product defect claims.

However, plaintiff's complaint lacked specifics and was "nothing more than the sort of 'unadorned, the-defendant-unlawfully-harmed-me accusation'" which was "chock-full of keywords that imply" that the plaintiff was "attempting to assert various product liability claims." Id. at *20. Because the plaintiff's complaint "need[ed] work" and was "still in the 'assembly required' stage," Judge Lee gave plaintiff another chance to plead valid claims. Id. at *21-22 and 37.

In his order in Cavender I, Judge Lee offered guidance for what plaintiff needed to do to plead valid claims. For example, in response to Medtronic's argument that federal law preempts plaintiff's claims, Judge Lee noted that the Complaint "is completely devoid of any facts whatsoever that would even imply that she is alleging a violation of federal law." Id. at *28. Judge Lee advised the plaintiff that the "amended complaint will clarify this issue also." Id. at 29.

Rather than directly clarifying the issue as instructed by Judge Lee, in the Amended Complaint, the plaintiff switched which device she was claiming caused her injury. In the initial Complaint, she vaguely alleged that a defibrillator malfunctioned and injured her. Id. at *2. In the Amended Complaint, she copied allegations from the Master Consolidated Complaint in the Sprint Fidelis Leads Prods. Liab. Litig. MDL and alleged a separate device, a Sprint Fidelis lead, caused her injuries.

Plaintiff copied the allegations from the Sprint Fidelis Leads Prods. Liab. Litig. MDL even though the MDL judge dismissed those claims with prejudice at the pleading stage. See In re Medtronic, Inc. Sprint Fidelis Leads Prods. Liab. Litig., 592 F.Supp.2 1147 (D. Minn. 2009) (dismissing the Master Complaint because federal law preempted the negligence and strict liability claims) aff'd Bryant v. Medtronic, Inc. (In re: Medtronic, Inc., Sprint Fidelis Leads Prods. Liab. Litig, 623 F.3d 1200 (8th Cir. 2010).

By copying the preexisting and previously dismissed complaint, the plaintiff added more detail than in her initial complaint. Judge Lee noted that:

[W]hile the claims contained in her original Complaint were barely discernible, they now jump vividly off the page in full regalia, all because they are clothed in language taken—largely verbatim—from another complaintfiled against Medtronic that was summarily dismissed by another district court eight years ago. Id. at *8-9.

Despite the product switcheroo and the blatant copying of a previously dismissed complaint, in Cavender II, Judge Lee concluded that the Seventh Circuit's decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), "precludes dismissal of Cavender's IPLA claim at this point and the motion to dismiss must be denied as to the issue of federal preemption of that claim." Cavender at *33.

Judge Lee noted that the Seventh Circuit in Bausch agreed with the dissent in the Eighth's Circuit's decision affirming the dismissal of the Master Complaint in the Sprint Fidelis Leads Prods. Liab. Litig. MDL. In short, "the Seventh Circuit took a decidedly different approach to the issue of MDA preemption as it applies to state law claims." Cavender II at *26-27. Thus, according to Judge Lee, "the Bausch decision mandates that [plaintiff] be permitted, at this juncture, to proceed with that claim notwithstanding the preemption clause in the MDA." Id. at *38.

One other aspect of Judge Lee's order is noteworthy. The plaintiff argued that because preemption is an affirmative defense, that she should not have to "defend" against an affirmative defense at this stage, thus the Court should not consider the defense as a basis for dismissal." Id. at n.5 *21. Medtronic did not take issue with "that statement of the law" and Judge Lee declared that plaintiff was "correct, of course." Id. Rather than take issue with the statement of law, Medtronic argued that because the plaintiff copied and pasted the very detailed, dismissed MDL complaint relating to this Lead[,]" she has, "[u]nder Seventh Circuit law . . . pled enough facts for the Court to consider the affirmative defense of preemption." Id. Because Judge Lee concluded that the Bausch decision precluded preemption at the pleading stage in this case, he determined that the issue was "rendered irrelevant." Id.

Judge Lee's order is yet another example of how the Bausch decision continues to cause problems for medical device makers at the motion to dismiss phase in cases in the Seventh Circuit. The plaintiff in Cavender II simply copied allegations the Eighth Circuit had already dismissed as preempted. But because of the overly permissive language of Bausch, those same claims survive the motion to dismiss in the Seventh Circuit. Medtronic's preemption argument may very well prevail at the summary judgment stage, but only after spending on unnecessary litigation expenses.

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
 
In association with
Related Topics
 
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