United States: Passive "Gatekeeping" In Biomet Hip Implant Daubert Decision

Last Updated: August 12 2019
Article by Rachel B. Weil

A couple of years ago, we were overjoyed to learn that our very favorite old-fashioned Broadway musical was being revived. The lead role – a famously brassy female character – was being played by a famously brassy singer and sometime-actress we believed was perfectly cast.   We bought tickets the day they went on sale, and we saw the show nearly as soon as it opened.   We could feel our excitement building at the swell of the first chords of the overture and at our first view of the Candy Land colors of the old-school set and costumes.   There was no place in the world we'd rather have been at that moment . . . and we were sorely disappointed. We thought the lead actress – notoriously bawdy and broad – played the role in much too "small" a fashion. The male lead was completely miscast. Inexplicable cuts had trimmed the best finale ever written to a mere footnote. And, once again, we were reminded that too-high expectation expectations beg to be dashed.

As they were in today's case.  We really liked the first half of In re Biomet M2a Magnum Hip Implant Prods. Liab. Litig., 2017 WL 10845178 (N.D. Ind. Dec. 21. 2017), an older decision that inexplicably just appeared in our weekly search.  The judge in the metal-on-metal hip implant litigation was asked to decide Daubert motions filed by both sides.  He started with the plaintiffs' motions to exclude five of the defendants' experts.   First, the plaintiffs moved to exclude the opinions of the defendants' mechanical engineering expert, a mechanical engineer and professor of tribology (the science of friction, wear, and lubrication – who knew??) related to the "reasonableness" of the defendant's "design and safety decision-making," Biomet, 2017 WL 10845178 at *2.   The court denied the motion, explaining that the expert's opinions were based on his review of "a large design file," which met "Rule 702's threshold requirement that an opinion be based on sufficient facts or data." Id. at *3. The defendant argued that the expert's "reasonableness" opinions were based on his review of "relevant literature, depositions, and [the defendant's] design files for the devices at issue in this case." Id. at *3. The court held that the files the expert reviewed met "Rule 702's threshold requirement that an opinion be based on sufficient facts or data," id. at *4, and that questions about other documents he could have considered were appropriately left for cross-examination.

Second, the judge considered the plaintiffs' motion to exclude two categories of opinions of the defendant's biomaterials expert. The judge held that the expert was not qualified to offer "sweeping" opinions about regulatory compliance but that he could offer opinions about the defendants' compliance with regulatory requirements to the extent that such compliance played a role in the development of the devices at issue. The judge denied the motion to exclude the expert's general opinions about factors surgeons consider in selecting a hip implant device.

Third, the plaintiffs moved to exclude the testimony of the defendant's regulatory expert on issues related to the 510(k) clearance process. The plaintiffs argued that: 1) they did not contend that the defendant violated the 510(k) process and regulatory compliance was a question of law an expert could not resolve; 2) the expert's opinion that the 510(k) process considers safety and effectiveness in addition to "substantial compliance: was contrary to FDA statutory and regulatory authority; and 3) evidence of 510(k) clearance was more prejudicial than probative.   Id. at *5. The court explained the split of authority on the admission of testimony about 510(k) clearance, then held that it would be premature for the court to rule on the admissibility of the expert's testimony on a litigation-wide basis at the MDL level.   Instead, the court held, resolution of the motion fell into the category of state-law determinations that should be made on remand to transferor courts.

Fourth, the Plaintiffs moved to exclude the testimony of the defendant's orthopedic surgeon/joint replacement specialist. The defendant offered the expert to testify about, "among other things, the rationale for second generation metal-on-metal devices." Id. at *8. The plaintiffs moved to exclude the expert's opinions on tribology, offering that he was unqualified to offer them. The court explained that the expert's opinions on "allegedly improved tribological characteristics of the second-generation metal-on-metal implants" were admissible to the extent that "they [were] the type on which an orthopedic surgeon would commonly rely." Id.   But, the court emphasized, the expert couldn't "take the place of a tribology expert and offer opinions beyond those on which an orthopedic surgeon would commonly rely." Id. As such, the court granted the motion to the extent that the expert was attempting to testify as a tribology expert and denied it to the extent that an orthopedic surgeon would reasonably rely on the opinions.

Finally, the defendant offered a biomedical engineer to testify about its testing of the hip implant device. The plaintiffs sought to exclude the expert's conclusion that: 1) the defendant's postmarket surveillance and use of the information it obtained were appropriate; and 2) the defendant "reviewed information in peer-reviewed journals concerning clinical experience with [its] devices and appropriately applied any new knowledge that was acquired" in assessing the products' long-term safety and efficacy.   Id. at *9. The plaintiffs argued that the expert lacked the specialized training or experience that would qualify him to offer these opinions, including training or experience with FDA regulatory procedures, that the expert did not employ a sound methodology, and that the defendant did not need an expert to testify to the fact of post-market surveillance. The court disagreed, noting that the expert's field was hip device wear testing and holding that his qualifications in analyzing data form those tests qualified him to analyze data from post-market testing and reports. The court rejected the "unreliable methodology" argument, holding that the expert's opinions were admissible because they were "reasoned, use[d] the methods of [his] discipline, and [were] founded on data."   Id.   The court excluded a single opinion offered by the expert – the opinion that metal-on-metal revision rates might be artificially high because of heightened scrutiny of the devices, finding that the theory was not supported by any of Daubert's indicia of scientific reliability – the theory was not tested, peer-reviewed, evaluated for error rates, or accepted within the scientific community.

The Defendant's Motions to Exclude the Plaintiff's Experts

By this point in the decision, we hoped that the judge's denial of the vast majority of the plaintiffs' motions signaled a pro-defense approach that would translate into exclusion of the plaintiffs' experts. By and large, this was not to be.

The court first considered the defendant's motion to exclude the plaintiffs' biomedical engineering expert, who offered the opinions that: 1) the defendant's products were defective; 2) metal-on-polyethylene implants were a safer, feasible alternative design; 3) the defendant's testing of its devices was inadequate; 4) the defendant's warnings were inadequate; 5) the defendant downplayed the risks of the devices; and 6) excessive metal ions produced by metal-on-metal devices cause clinical effects in patients.   The defendant moved to exclude all of the opinions.

First, the defendant argued that the expert was not qualified to offer the opinion that all metal-on-metal devices are defectively designed. The court denied the motion, holding that the expert's experience as an engineer qualified her to opine on the design issues even though her degrees were in mechanical engineering and not tribology. Next, the court held that the expert could testify to her proposed "alternative design," and that omissions in the information she considered were appropriately reserved for cross-examination. The court found that the expert was qualified to opine about the adequacy of the defendant's testing, notwithstanding her lack of training in tribology, and that she employed a reliable methodology in formulating those opinions when she "examined the testing [the defendant] conducted and pointed to other testing employed in peer-reviewed studies."

With respect to the expert's "inadequate warnings" opinions, the court held that the expert's experience "developing and reviewing warnings for orthopedic products" qualified her to offer the opinions, notwithstanding the fact that she was not an orthopedic surgeon and had no medical training. The court also held that the expert employed a reliable methodology when she "compared [the defendant's] warnings with relevant research on the alleged risks associated with metal-on-metal devices and opined on what additional warnings were necessary based on the deficiencies she found," even though she did not "explain whether and how additional warnings would have affected a surgeon's decisions" and did not "test her theories through studies or other mechanisms." Id. at *13.

Finally, the court held that the expert could not testify "as an expert on the clinical effects of metal ions" but could "permissibly rely on other experts' opinions that metal ions cause clinical effects to support her opinion that metal-on-metal devices [were] unreasonably dangerous." Id. at *15.

The plaintiffs' second expert was an orthopedic surgeon specializing in joint replacement. Like the first expert, he offered opinions that the defendant's devices, and metal-on-metal devices generally, were defectively designed and that the defendant's testing and instructions for use were inadequate.

The defendant argued that the expert was not qualified to offer his design opinions because he had no training in tribology. The court rejected this argument, explaining, "While [the expert] discusses issues that arguably fall within the field of tribology, . . . Rule 703 allows an orthopedic surgeon to reasonably rely on the opinions of other experts." Id. at *16. The court held that the expert permissibly relied on the expertise of others when his opinions required knowledge outside of his own field of expertise, and that that he employed reliable methodology in arriving at his general opinions about metal-on-metal devices. The court did exclude the expert's specific opinions about the design of the defendant's devices, holding that he had not considered sufficient device-specific data in developing these opinions. The court also excluded the expert's opinion that the defendant's testing of its devices was inadequate because he had not conducted a sufficient review of the relevant testing data.   But the expert was permitted to testify about the adequacy of the defendant's instructions for use because he "compared the facts in evidence with the content shown" in the instructions for use.   Id. at *18.

So while the judge excluded an opinion here and there, he admitted most of the plaintiffs' experts' opinions.  Call us biased, but we thought that the judge's analysis of the defendant's experts' opinions was mostly quite strong but that he stretched too far in allowing the plaintiffs' experts to testify far outside of their fields of expertise and to offer opinions that were the products of questionable methodologies.  No great surprise there.  But hope springs eternal, and we will continue to watch for the "good" while we report on the "bad" and the "ugly."

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
 
In association with
Related Topics
 
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