United States: Probably The Best Wisconsin Law Decision We've Ever Seen

Last Updated: November 1 2016
Article by James Beck

Bexis, who took some lumps in probably the worst Wisconsin product liability decision ever (he filed PLAC's amicus brief in Thomas v. Mallett, 701 N.W.2d 523 (Wis. 2005)), just read what we believe is the best Wisconsin law decision ever – at least in the drug/medical device sandbox that we inhabit. The decision is In re Zimmer Nexgen Knee Implant Products Liability Litigation, 2016 WL 6135685 (N.D. Ill. Oct. 21, 2016) (since the caption is a mouthful, we'll call it "ZNKI").

Here's why ZNKI is favorable on Wisconsin legal issues.

First, as our longstanding 50-state survey on the learned intermediary rule points out, Wisconsin is one of nine states in which only federal courts predicting state law have had occasion to adopt the learned intermediary rule. Looking more closely at these nine, Wisconsin is one of only two states (South Dakota being the other) where only federal district courts have reached this holding. What isn't there, but is discussed in ZNKI, is that some courts have (without much reasoning) refused to predict Wisconsin's adherence to the rule. Refusing to dodge the issue, ZNKI forthrightly examines both Wisconsin precedent and the general state of the law and concludes that Wisconsin would join the nationwide learned intermediary consensus:

[F]ederal courts applying Wisconsin law have reached different conclusions about the doctrine's applicability. The vast majority of states, however, do employ some version of the doctrine. In addition, this court's research suggests that those courts that have declined to apply the doctrine under Wisconsin law have done so in cases involving prescription drugs, not medical devices, and those courts offer no reason to believe that the Wisconsin Supreme Court would not adopt this majority rule if presented with the issue.

In the context of . . . surgery, a patient must rely on the experience and judgment of his or her surgeon, who selects the appropriate implant and educates the patient about the particular risks − based on the patient's particular circumstances and physiology. . . . Given that context, and given the widespread acceptance of the doctrine throughout the country, the court believes it is likely that the Wisconsin Supreme Court would apply the learned intermediary doctrine in this case.

ZNKI, 2016 WL 6135685, at *19-20 (numerous citations omitted). As we've pointed out recently, the learned intermediary rule is, if anything, enjoying a renaissance, with thirteen straight state high court adoptions since the infamous Karl case (since overruled by statute) was the only supreme court to go the other way.

But as ZNKI discussed, other Wisconsin law decisions have followed learned intermediary principles, so what else is there?

Second, ZNKI is the first Wisconsin law case to hold proximate causation is defeated, in an inadequate warning case, by the actor's (here, the implanting surgeon's) not reading the warnings in question. The implanter "admit[ed] that he has never read the package insert that accompanied [the] implant and that he still had not read the insert as of the day he was deposed." Id. at *20. The court quite reasonably concluded that the inadequacy of an unread warning could not be causal. "Because [the implanter] did not read or rely upon the warnings [defendant] actually provided, Plaintiffs cannot prove that an improved warning − whether about the risks . . . or about proper surgical technique − would have led to a different outcome." Id. ZNKI distinguished prior Wisconsin precedent, not involving prescription medical products, because there is no alternative to the prescriber in learned intermediary cases.

In [that ordinary case], the plaintiff's failure to read the product's warning label was not fatal to his failure-to-warn claim because the fact-finder could assume that other users would have read the warning, which could have prevented his injury. . . . There is no such argument in this case − that is, no contention that an improved warning would have prevented [the] injury because someone other than [the implanting surgeon] would have read it.

Id. (citation omitted). Thus, ZNKI necessitated us updating our failure to read 50-state survey as well.

Third, Wisconsin relatively recently passed thorough-going tort reform. Among other things, the new statute mandated that plaintiffs establish an alternative design for all design defect claims. Wis. Stat. §895.047(1)(a). ZNKI refused to water down the will of the Wisconsin legislature by letting in the rejected "consumer expectation" standard through the back door. A comment to a "pattern jury instruction" did not suggest retention of consumer expectations. 2016 WL 6135685, at *16. Nor did plaintiffs' claim that the statute in effect adopted the Third Restatement of Torts, Product Liability, and thus a comment favorable to consumer expectations:

This court is uncertain that this comment in the Restatement (Third) is an accurate statement of the law in Wisconsin. Even if it is, the comment provides only that consumer expectations are a factor to be considered. . . . Whether or not consumer expectations are an appropriate factor to consider in judging the defectiveness of a product's design, the statutory language makes clear that a plaintiff bringing a design defect claim in Wisconsin must propose a reasonable alternative design.

Id. Plaintiffs, of course, did not produce evidence of the requisite alternative design, "the omission of which renders the product not reasonably safe." Id.

The alternative design upon which Plaintiffs appear to rely primarily − and the design they pointed to at oral argument − is the one proposed by [their expert]. . . . Significantly, however, [he did] not offer any opinion − or any analysis in support of an opinion − that [this] proposed design would be safer than that of the [product]. Indeed, he does not discuss what the proposed design modification was, what made it "biomechanically reasonable," or how it would have reduced any of the risks he identified with the [product] design.

Id. at *21. This enforcement of the Wisconsin statutory alternative design requirement is also one of the first, we believe, in design defect litigation involving prescription medical products. Cf. Yakich v. C.R. Bard, 2016 WL 743476, at *11 (New Jersey Super. Law Div. Feb. 19, 2016) (much more cursory holding) (applying Wisconsin law).

Plaintiffs' negligent design claim also failed, first for lack of alternative design, because "in the negligence context, the reasonableness of a product's design turns essentially on whether the seller could have come up with a less dangerous design. ZNKI, 2016 WL 6135685, at *18 (citation and quotation marks omitted). Nor could plaintiffs pursue negligent testing as an aspect of negligent design – and the burden of proof remained where it belonged:

Plaintiffs fail to produce any evidence to establish what such testing would have shown had [defendant] actually conducted it. Plaintiffs suggest that because it was [defendant's] duty to conduct the required testing and it failed to do so, it is [defendant] who carries the burden of demonstrating what such testing would or would not have shown. Plaintiffs offer no support for this burden-shifting approach, and the court sees no reason to adopt it. Plaintiffs are the ones asserting that [a] failure to test constituted negligence and that the lack of testing had some causal relationship with [the] injury; it is their burden to produce evidence to support such a claim.

Id. (footnote omitted).

There's even more. ZNKI includes some good Daubert rulings that exclude a shoddy "differential etiology" and other aspects of plaintiffs' experts' opinions. 2016 WL 6135685, at *3-4, 9-14 (the expert "does not even explain to the court what his reasoning is, how the sources he reviewed inform his conclusion, or why he applies the methods that he does. These problems render the etiology unreliable"). The critique of the inadequate methodology is quite detailed, so readers interested in Daubert issues would be well-advised to review it. But to us, the expert rulings are far less important than the decision's tour de force concerning Wisconsin law.

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
James Beck
 
In association with
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
Check to state you have read and
agree to our Terms and Conditions

Terms & Conditions and Privacy Statement

Mondaq.com (the Website) is owned and managed by Mondaq Ltd and as a user you are granted a non-exclusive, revocable license to access the Website under its terms and conditions of use. Your use of the Website constitutes your agreement to the following terms and conditions of use. Mondaq Ltd may terminate your use of the Website if you are in breach of these terms and conditions or if Mondaq Ltd decides to terminate your license of use for whatever reason.

Use of www.mondaq.com

You may use the Website but are required to register as a user if you wish to read the full text of the content and articles available (the Content). 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 & conditions or with the prior written consent of Mondaq Ltd. You may not use electronic or other means to extract details or information about Mondaq.com’s content, users or contributors in order to offer them any services or products which compete directly or indirectly with Mondaq Ltd’s services and products.

Disclaimer

Mondaq Ltd and/or its respective suppliers make no representations about the suitability of the information contained in the documents and related graphics published on this server for any purpose. All such documents and related graphics are provided "as is" without warranty of any kind. Mondaq Ltd and/or its respective suppliers hereby disclaim all warranties and conditions with regard to this information, including all implied warranties and conditions of merchantability, fitness for a particular purpose, title and non-infringement. In no event shall Mondaq Ltd 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 or performance of information available from this server.

The documents and related graphics published on this server could include technical inaccuracies or typographical errors. Changes are periodically added to the information herein. Mondaq Ltd and/or its respective suppliers may make improvements and/or changes in the product(s) and/or the program(s) described herein at any time.

Registration

Mondaq Ltd requires you to register and provide information that personally identifies you, including what sort of information you are interested in, for three primary purposes:

  • To allow you to personalize the Mondaq websites you are visiting.
  • To enable features such as password reminder, newsletter alerts, email a colleague, and linking from Mondaq (and its affiliate sites) to your website.
  • To produce demographic feedback for our information providers who provide information free for your use.

Mondaq (and its affiliate sites) do not sell or provide your details to third parties other than information providers. The reason we provide our information providers with this information is so that they can measure the response their articles are receiving and provide you with information about their products and services.

If you do not want us to provide your name and email address you may opt out by clicking here .

If you do not wish to receive any future announcements of products and services offered by Mondaq by clicking here .

Information Collection and Use

We require site users to register with Mondaq (and its affiliate sites) to view the free information on the site. We also collect information from our users at several different points on the websites: this is so that we can customise the sites according to individual usage, provide 'session-aware' functionality, and ensure that content is acquired and developed appropriately. This gives us an overall picture of our user profiles, which in turn shows to our Editorial Contributors the type of person they are reaching by posting articles on Mondaq (and its affiliate sites) – meaning more free content for registered users.

We are only able to provide the material on the Mondaq (and its affiliate sites) site free to site visitors because we can pass on information about the pages that users are viewing and the personal information users provide to us (e.g. email addresses) to reputable contributing firms such as law firms who author those pages. We do not sell or rent information to anyone else other than the authors of those pages, who may change from time to time. Should you wish us not to disclose your details to any of these parties, please tick the box above or tick the box marked "Opt out of Registration Information Disclosure" on the Your Profile page. We and our author organisations may only contact you via email or other means if you allow us to do so. Users can opt out of contact when they register on the site, or send an email to unsubscribe@mondaq.com with “no disclosure” in the subject heading

Mondaq News Alerts

In order to receive Mondaq News Alerts, users have to complete a separate registration form. This is a personalised service where users choose regions and topics of interest and we send it only to those users who have requested it. Users can stop receiving these Alerts by going to the Mondaq News Alerts page and deselecting all interest areas. In the same way users can amend their personal preferences to add or remove subject areas.

Cookies

A cookie is a small text file written to a user’s hard drive that contains an identifying user number. The cookies do not contain any personal information about users. We use the cookie so users do not have to log in every time they use the service and the cookie will automatically expire if you do not visit the Mondaq website (or its affiliate sites) for 12 months. We also use the cookie to personalise a user's experience of the site (for example to show information specific to a user's region). As the Mondaq sites are fully personalised and cookies are essential to its core technology the site will function unpredictably with browsers that do not support cookies - or where cookies are disabled (in these circumstances we advise you to attempt to locate the information you require elsewhere on the web). However if you are concerned about the presence of a Mondaq cookie on your machine you can also choose to expire the cookie immediately (remove it) by selecting the 'Log Off' menu option as the last thing you do when you use the site.

Some of our business partners may use cookies on our site (for example, advertisers). However, we have no access to or control over these cookies and we are not aware of any at present that do so.

Log Files

We use IP addresses to analyse trends, administer the site, track movement, and gather broad demographic information for aggregate use. IP addresses are not linked to personally identifiable information.

Links

This web site contains links to other sites. Please be aware that Mondaq (or its affiliate sites) are not responsible for the privacy practices of such other sites. We encourage our users to be aware when they leave our site and to read the privacy statements of these third party sites. This privacy statement applies solely to information collected by this Web site.

Surveys & Contests

From time-to-time our site requests information from users via surveys or contests. Participation in these surveys or contests is completely voluntary and the user therefore has a choice whether or not to disclose any information requested. Information requested may include contact information (such as name and delivery address), and demographic information (such as postcode, age level). Contact information will be used to notify the winners and award prizes. Survey information will be used for purposes of monitoring or improving the functionality of the site.

Mail-A-Friend

If a user elects to use our referral service for informing a friend about our site, we ask them for the friend’s name and email address. Mondaq stores this information and may contact the friend to invite them to register with Mondaq, but they will not be contacted more than once. The friend may contact Mondaq to request the removal of this information from our database.

Security

This website takes every reasonable precaution to protect our users’ information. When users submit sensitive information via the website, your information is protected using firewalls and other security technology. If you have any questions about the security at our website, you can send an email to webmaster@mondaq.com.

Correcting/Updating Personal Information

If a user’s personally identifiable information changes (such as postcode), or if a user no longer desires our service, we will endeavour to provide a way to correct, update or remove that user’s personal data provided to us. This can usually be done at the “Your Profile” page or by sending an email to EditorialAdvisor@mondaq.com.

Notification of Changes

If we decide to change our Terms & Conditions or Privacy Policy, we will post those changes on our site so our users are always aware of what information we collect, how we use it, and under what circumstances, if any, we disclose it. If at any point we decide to use personally identifiable information in a manner different from that stated at the time it was collected, we will notify users by way of an email. Users will have a choice as to whether or not we use their information in this different manner. We will use information in accordance with the privacy policy under which the information was collected.

How to contact Mondaq

You can contact us with comments or queries at enquiries@mondaq.com.

If for some reason you believe Mondaq Ltd. has not adhered to these principles, please notify us by e-mail at problems@mondaq.com and we will use commercially reasonable efforts to determine and correct the problem promptly.