This guest post is by Reed Smith‘s Devin Griffin. It deals with an important pending appeal in New Jersey’s version of Jarndyce v. Jarndyce – Accutane litigation. As always with our guest posts, the author is 100% responsible for what follows, deserving of all the credit, and any blame. Take it away Devin.
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.