In re Accutane Litig.

• Decision Date: 01 August 2018
• Docket Number: 079958,A-25 September Term 2017
• Citation: 191 A.3d 560,234 N.J. 340
• Parties: IN RE: ACCUTANE LITIGATION
• Court: New Jersey Supreme Court

234 N.J. 340

191 A.3d 560

IN RE: ACCUTANE LITIGATION

A-25 September Term 2017

079958

Supreme Court of New Jersey.

Argued April 23, 2018

Decided August 1, 2018

Paul W. Schmidt (Covington & Burling) of the District of Columbia bar, admitted pro hac vice, argued the cause for appellants Hoffmann-La Roche Inc. and Roche Laboratories Inc. (Gibbons, Dughi Hewit & Domalewski, Covington & Burling, and Peabody & Arnold, attorneys; Natalie H. Mantell, Newark, Russell L. Hewit, Cranford, Paul W. Schmidt, Michael X. Imbroscio (Covington & Burling) of the District of Columbia bar, admitted pro hac vice, and Colleen M. Hennessey (Peabody & Arnold) of the Massachusetts bar, admitted pro hac vice, of counsel and on the briefs).

Bruce D. Greenberg, Newark and David R. Buchanan argued the cause for respondents Craig Abernethy, et al. (Lite DePalma Greenberg, Seeger Weiss, Weitz & Luxenberg, and Beggs & Lane, attorneys; Bruce D. Greenberg, Newark, David R. Buchanan, Peter Samberg, and Mary Jane Bass (Beggs & Lane) of the Florida bar, admitted pro hac vice, on the briefs).

Edward J. Fanning, Jr., Newark, argued the cause for amici curiae HealthCare Institute of New Jersey, New Jersey Business & Industry Association, Commerce and Industry Association of New Jersey, and New Jersey Chamber of Commerce (McCarter & English, attorneys; Edward J. Fanning, Jr., and David R. Kott, Newark of counsel and on the brief, and Gary R. Tulp, on the brief).

Christopher M. Placitella argued the cause for amicus curiae New Jersey Association for Justice (Cohen, Placitella & Roth, attorneys; Christopher M. Placitella and Jared M. Placitella, of counsel and on the brief).

Allan Kanner submitted a brief on behalf of amicus curiae Allan Kanner, Esquire (Kanner & Whiteley, attorneys).

Diana C. Manning submitted a brief on behalf of amicus curiae DRI – The Voice of the Defense Bar (Bressler, Amery & Ross, Plunkett Cooney, and DRI – The Voice of the Defense Bar, attorneys; Diana C. Manning, Florham Park, Mary Massaron (Plunkett Cooney) of the Michigan and New York bars, admitted pro hac vice, Hilary A. Ballentine (Plunkett Cooney) of the Michigan bar, admitted pro hac vice, and John F. Kuppens (DRI – The Voice of the Defense Bar) of the South Carolina bar, admitted pro hac vice, on the brief).

Susan J. Kraham submitted a brief on behalf of amicus curiae Ironbound Community Corporation (Morningside Heights Legal Services, attorneys; Susan J. Kraham and Edward Lloyd, on the brief).

Shalom D. Stone, Roseland submitted a brief on behalf of amicus curiae New Jersey Civil Justice Institute (Stone Conroy, attorneys).

Melinda Martinson submitted a brief on behalf of amici curiae American Medical Association, Medical Society of New Jersey, American Academy of Dermatology, Society for Investigative Dermatology, American Acne and Rosacea Society, and Dermatological Society of New Jersey (Medical Society of New Jersey and Powers Pyles Sutter & Verville, attorneys; Melinda Martinson, and Ronald S. Connelly (Powers Pyles Sutter & Verville) of the District of Columbia and Maryland bars, admitted pro hac vice, on the brief).

Gavin J. Rooney submitted a brief on behalf of amici curiae Kenneth S. Broun, Daniel J. Capra, Joanne A. Epps, David L. Faigman, Laird Kirkpatrick, Michael M. Martin, Liesa Richter, and Stephen A. Saltzburg (Lowenstein Sandler, attorneys).

Gregory S. Chernack submitted a letter brief on behalf of amicus curiae Pharmaceutical Research and Manufacturers of America (Hollingsworth, attorneys).

JUSTICE LaVECCHIA delivered the opinion of the Court.

At issue in this appeal involving a civil mass tort action is the admissibility of scientific evidence under the New Jersey Rules of Evidence.

Plaintiffs claim that a causal connection exists between Accutane

, a prescription drug used in the treatment of nodular acne, and Crohn's disease, a chronic gastrointestinal illness. Litigation in New Jersey over Accutane's side effects has spanned more than a decade. This action is a continuation in that series of litigated matters. Since those actions first commenced in New Jersey in 2005, a number of epidemiological studies have been published, all concluding that there is no causal relationship between Accutane and Crohn's disease. Plaintiffs' experts dispute the conclusions of those studies, calling them flawed and lacking in value. Having rejected the evidence and conclusions of those epidemiological studies, one of plaintiffs' experts, relying on other facts and forms of data, asserts the contrary view that Accutane can in fact cause Crohn's disease. Defendants challenged the methodology used by both of plaintiffs' experts as unreliable and sought the exclusion of that expert testimony.

After a Rule 104 pretrial evidentiary hearing, the trial court excluded the testimony, holding that plaintiffs' experts' methodology was unsound because they did not interpret the relevant data and apply it to the facts of this case as would other experts in the field. The Appellate Division reversed, concluding that plaintiffs' experts employed a sound methodology and simply interpreted the data differently than defendants' experts.

Our Court was among the foremost to shift from exclusive reliance on a "general acceptance" standard¹ for testing the reliability of scientific expert testimony to a methodology-based approach. See Landrigan v. Celotex Corp., 127 N.J. 404, 414, 605 A.2d 1079 (1992) ; Rubanick v. Witco Chem. Corp., 125 N.J. 421, 447, 593 A.2d 733 (1991). We initially took that step to allow the parties in toxic tort civil matters to present novel scientific evidence of causation if, after the trial court engages in rigorous gatekeeping when reviewing for reliability, the proponent persuades the court of the soundness of the expert's reasoning and methodology. Two years later, with its Daubert ² decision, the United States Supreme Court also abandoned the general acceptance test in favor of a methodology-based approach that entrusted trial courts with the role of gatekeeper. Both our civil standard and the federal standard moved in the same direction and towards the same common goal. Although the two standards are similar both in practice and in overall philosophy, we have never adopted Daubert or incorporated the factors identified in Daubert for use by our courts when performing the gatekeeper role.

We granted certification in this matter to address whether the trial court properly excluded plaintiffs' experts' testimony, whether the Appellate Division employed the correct standard in reviewing and overturning that decision, and whether our standard for assessing the reliability of expert witnesses is in need of clarification. It is with regard to the last issue that we are asked whether the Daubert standard's factors would further elucidate our own standard for the admissibility of expert testimony. We believe that they would.

We perceive little distinction between Daubert's principles regarding expert testimony and our own, and believe that its factors for assessing the reliability of expert testimony will aid our trial courts in their role as the gatekeeper of scientific expert testimony in civil cases. Accordingly, we now reconcile our standard under N.J.R.E. 702, and relatedly N.J.R.E. 703, with the federal Daubert standard to incorporate its factors for civil cases.

This case -- with its adversarial setting and full record -- provides the appropriate setting for illustrating how courts should evaluate the methodology of a credentialed expert when determining whether an opinion is based on scientifically sound reasoning. See Kemp ex rel. Wright v. State, 174 N.J. 412, 427, 809 A.2d 77 (2002). Our analysis of this record leads to a clear result: the trial court properly excluded plaintiffs' experts' testimony. Moreover, we reaffirm that the abuse of discretion standard must be applied by an appellate court assessing whether a trial court has properly admitted or excluded expert scientific testimony in a civil case. In this matter, the trial court did not abuse its discretion in its evidential ruling and, therefore, the Appellate Division erred in reversing the trial court's exclusion of the testimony of plaintiffs' experts.

I.

Before diving into the record and its contested scientific evidence, we set forth some basic background to the evidential standards in issue.

New Jersey Rules of Evidence 702 and 703 control the admission of expert testimony. N.J.R.E. 702 provides that "[i]f scientific, technical, or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training, or education may testify thereto in the form of an opinion or otherwise." N.J.R.E. 703 states that

[t]he facts or data in the particular case upon which an expert bases an opinion or inference may be those perceived by or made known to the expert at or before the hearing. If of a type reasonably relied upon by experts in the particular field in forming opinions or inferences upon the subject, the facts or data need not be admissible in evidence.

In State v. Kelly, this Court applied Rule 702's similarly worded predecessor, Evidence Rule 56, and identified three prerequisites to a determination that expert testimony is permissible:

(1) the intended testimony must concern a subject matter that is beyond the ken of the average juror; (2) the field testified to must be at a state of the art such that an expert's testimony could be sufficiently reliable; and (3) the witness must have sufficient expertise to offer the intended testimony.

[ 97 N.J. 178, 223, 478 A.2d 364 (1984).]

That standard provides the baseline for the admissibility of expert testimony. See Official Comments to N.J.R.E. 702 (noting that N.J.R.E. 702 incorporates standard articulated by Kelly ).

The Kelly criteria elucidated application of the then-applicable "general acceptance" standard for admitting scientific evidence, which...