United States: Guest Post – Accutane Amici Say: Relax Somewhere Else – Expert Testimony In New Jersey Should Be Held To A Higher Standard

Last Updated: November 6 2017
Article by Devin J. Griffin

The Accutane litigation in New Jersey has been covered closely by this Blog for its duration. The Blog's most recent Accutane post evaluated the Appellate Division's decision to reverse the trial court's order excluding certain plaintiff causation expert witnesses—a ruling that resulted in the revival of over 2000 cases. That post explained that the Appellate Division has proposed a "relaxed" standard for the admissibility of expert opinions, and that the application of this standard (i.e., the types of evidence that experts may rely upon in rendering their opinions) should evolve as more epidemiological studies (or the "gold standard" of scientific evidence) become available. The post explained that this has not occurred in the Accutane litigation. With the recent Appellate Division decision, it is clear that the New Jersey appellate court is attempting to impose its own unique standard that disregards the hierarchy of evidence, allowing animal studies and single-person case studies to be afforded the same weight as vast epidemiological studies. With the submission of four separate amicus curiae briefs to the Supreme Court of New Jersey by companies and groups spanning different industries and health-related interests, it has become clear that this Blog is not alone in feeling displeasure over the Appellate Division's recent decision. This is something that the New Jersey Supreme Court definitely needs to review, both as to the questionable legal basis for the decision and its negative impact on some of the state's largest employers.

Before delving into the substance of the amicus briefs, it is useful to revisit court decisions relevant to this case. In Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), the New Jersey Supreme Court established the applicable standard for reviewing expert testimony in toxic tort cases. Rubanick stated that an expert's opinion may be admissible "even though it is controversial and its acceptance is not widespread," but only if "it is based on a sound methodology that draws on scientific studies reasonably relied on in the scientific community and has actually been used and applied by responsible experts or practitioners in the particular field." Id. at 447. Rubanick created the so-called "relaxed" standard – with the "relevant field" seeming to be litigation testimony − declining to adopt the standard set forth in Rule 703 of the Federal Rules of Evidence. Then, in Kemp v. State, 174 N.J. 412 (2002), the court stated that "the appropriate inquiry is not whether the court thinks the expert's reliance on the underlying data was reasonable, but rather whether comparable experts in the field [would] actually rely on that information. Kemp, 174 N.J. at 412 (citations and quotations omitted). Since Rubanick and Kemp, New Jersey courts have continued to approach scientific expert testimony under a "Daubert lite" analysis that diverges significantly from the science-based federal approach to expert testimony. As a result, much confusion and inconsistency in New Jersey case law has ensued.

The Accutane litigation represents the culmination of the resulting confusion and inconsistency in the New Jersey expert witness standard. In addressing the admissibility of expert witness testimony, the Accutane trial court applied a standard ostensibly similar to the federal Daubert standard without expressly adopting the federal test. However, the Appellate Division reversed the trial court decision, citing Rubanick's "relaxed" standard. By applying that relaxed standard, the Appellate Division effectively disregarded the hierarchy of evidence and gave equal weight to the Plaintiff experts' evidence, which mostly consists of animal studies and case reports, as it did to the extensive body of exhaustive and robust epidemiological studies relied upon by Roche's experts. That result is a poor parody of the scientific method.

The practical effect of this Appellate Division decision will result in the admission of expert witness testimony that deserve to be excluded as unsound, and that has in fact been excluded in federal court on precisely that ground. Since the Blog's last Accutane litigation post, the defendant has sought further review in the New Jersey Supreme Court. Recent amicus brief filings indicate that we are not alone in our worry. Amici from various life science and medical industries recently joined forces to urge the court to reconsider the Appellate Division decision—specifically the decision of what standard should be applied to the admissibility of expert witness testimony. Notably, a remarkable array of groups including the HealthCare Institute of New Jersey, the New Jersey Chamber of Commerce, twenty-one of New Jersey's largest employers, the American Medical Association, and eight scholars and professors of law have joined forces to file amicus briefs that urge the New Jersey Supreme Court to abandon the anachronistic and peculiar "relaxed" standard for the federal standard. The perspectives of amici claiming a stake in the litigation are detailed below.

New Jersey's business sector weighed in two separate briefs. In one brief, twenty-one of New Jersey's largest companies (many of whom are each other's competitors) submitted an amicus brief supporting Defendant Roche. The twenty-one signatory companies include the likes of Allergan, Bayer, Bristol-Myers Squibb, C.R. Bard, Merck, Honeywell, GlaxoSmithKline, Quest Diagnostics, Pfizer, and Verizon. These businesses provided their perspectives on the Appellate Division's decision. The companies argue that the decision would have the effect of allowing inconsistent rulings. The companies stated that they as companies choose to conduct extensive business in New Jersey and should not suffer the uncertainty and inconsistency in causation rulings that the "relaxed" standard's dumbing down of the scientific method encourages. The companies explain that the Appellate Division's standard would allow plaintiffs experts to "cherry-pick" data, or rely on studies that support their result-oriented opinions while ignoring the sweeping and conclusive studies that conflict with their propounded opinions. Ultimately, the companies highlight the importance of expert admission standards to New Jersey business, stating that over the past two years alone, companies have been forced to spend nearly $4 billion defending against New Jersey products liability suits. These amici warn that, should the Appellate Division's decision be upheld, the impact would be felt far beyond the courtroom. Loose admission standards for expert testimony will adversely affect the "very real public benefit derived from the products" that these companies manufacture.

In the other business sector brief, the HealthCare Institute of New Jersey, New Jersey Business and Industry Association, the Commerce and Industry Association of New Jersey, and the New Jersey Chamber of Commerce weigh in on the errors of the Appellate Division. Notably, these amici address the confusion in New Jersey case law regarding what standard to apply in assessing expert witness testimony. These amici state that the New Jersey Supreme Court and its Committee on the Rules of Evidence have studied the question presented by the recent Appellate Division decision as early as 2000, but the court failed to provide a conclusive answer, because it was waiting for a hard-fought adversarial case to address this question. To these amici, it is abundantly clear that this is exactly the zealously litigated adversarial setting that the court has been waiting for. In their critique of the Appellate Division decision, the organizational amici state that by allowing the Appellate Division decision to stand, the court is allowing "junk science" to be presented to lay juries. Most significantly, the amici discuss how the Appellate Division's proposed standards for the admissibility of expert testimony would subject defendants to extensive civil liability by allowing juries to challenge exhaustive, FDA-approved, scientific evidence with opinions based on novel and unsupported theories that the FDA would never permit. Ultimately, these amici urge the court to adopt Daubert to reinstate the court's role in gatekeeping to prevent further litigation-driven expert opinion testimony from clouting this science-based field.

Next, eight legal scholars and professors of law (" the scholars") urge the New Jersey Supreme Court to clear up the confusion that has ensued as a result of the "relaxed" standard. The scholars detail the benefits of New Jersey adopting rule 702 of the Federal Rules of Evidence. The scholars contend that adoption of the federal Daubert test is especially important in toxic tort cases because a jury will likely be unable to wade through the sophisticated terminology and standards that these cases present. By depriving the jury of the tools it needs in complex litigations of this type, the "relaxed" standard allows precedent that equates the scientific value of anecdotal evidence with gold standard epidemiology. The scholars point out that, while the Appellate Division freely cites to federal decisions such as Daubert in its decisions, it simultaneously unmoors those decisions from their foundation by disregarding the very federal gatekeeping requirements that make those decisions persuasive – thereby adding to the confusion within New Jersey case law in this area. The scholars warn that if this decision is upheld, the role of court in excluding unreliable testimony will effectively be eliminated.

Finally, organizations representing physicians, both in New Jersey and nationwide, weigh in with their own amicus brief. Six different federal and state-based medical societies join to urge the New Jersey Supreme Court to reconsider this decision. These amici argue that the Appellate Division's decision is not only contrary to legal precedent, but more importantly does violence to well-established scientific principles. The medical amici explain that the hierarchy of evidence is vitally important to evidence-based medicine and science. According to these amici, whether evidence being considered in expert opinions has been subject to peer review is key to assessing its reliability. Notably, the medical amici establish that scientific consensus is a strong indicator of good science and that the Appellate Division erred in ignoring the consensus relied upon by Roche's expert witnesses. These medical amici warn strongly of the profound impact that this decision could have on medical practice in New Jersey. These amici discuss that this decision will further complicate the patient-doctor relationship because now doctors will be forced to address and debunk unproven theories during informed consent discussions with their patients. Doctors will likely feel the need to address these unsupported theories for fear of being sued. Lastly, doctors may simply choose to forgo certain reliable treatments altogether. The medical amici state that this decision endangers patients who need treatments, especially where there is a lack of other treatment options as is the case with Accutane and severe cystic acne.

This Blog has been quite critical of the latest twist in the seemingly unending saga of Accutane litigation in New Jersey. Thus, it is gratifying to find amici representing such a large cross-section of New Jersey's business, life science, and healthcare industries coming together to voice their disapproval as well. The Appellate Division's decision nullifies any meaningful gatekeeping role for the New Jersey judiciary and, if allowed to stand, will have the harmful effect of letting any hired expert share scientifically unsupported opinions with all future juries. With this kind of support, the odds increase that the New Jersey Supreme Court will appreciate the importance of removing junk science from state courts and will accept review in Accutane to reinstate the fundamental principles of science and the hierarchy of evidence in New Jersey courts.

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
 
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