Today, in In re Accutane Litigation, No. A-25-17, slip op. (N.J. Aug. 1, 2018), the New Jersey Supreme Court unanimously upgraded the state’s standards for admission of expert testimony.  This decision, we hope, will finally break the back of the long-running – and scientifically bogus – Accutane litigation that has plagued New Jersey courts.

The gist of the opinion can be appreciated in the court’s summary:

HELD: There is little distinction between Daubert’s principles regarding expert testimony and New Jersey’s, and Daubert’s factors for assessing the reliability of expert testimony will aid New Jersey trial courts in their role as the gatekeeper of scientific expert testimony in civil cases.  Accordingly, the Court now reconciles the 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.  Analysis of the record in this case leads to a clear result:  the trial court properly excluded plaintiffs’ experts’ testimony.  Moreover, the Court reaffirms 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.

Accutane, slip op. at 2-3.

Specifically, after Accutane, the trial courts’ “gatekeeping role” for expert testimony must “assess both the methodology used by the expert . . . and the underlying data.”  Id. at 5.  New Jersey now is close to being a Daubert state.  Id. (“not much light between New Jersey’s standard and . . . the federal sphere under Daubert”; but “stops short of declaring New Jersey a ‘Daubert jurisdiction’”).  Non-exclusive “general factors” applicable to expert admissibility are:

(1) Whether the scientific theory can be, or at any time has been, tested; (2) Whether the scientific theory has been subjected to peer review and publication, noting that publication is one form of peer review but is not a “sine qua non”; (3) Whether there is any known or potential rate of error and whether there exist any standards for maintaining or controlling the technique’s operation; and (4) Whether there does exist a general acceptance in the scientific community about the scientific theory.

Id. “[P]roper gatekeeping . . . requires the proponent to demonstrate that the expert applies his or her scientifically recognized methodology in the way that others in the field practice the methodology.”  Id. Finally, the Appellate Division’s “less deferen[tial]” standard of appellate review is rejected, and the trial court’s dismissal of over 2000 cases for lack of scientific validity is affirmed under an abuse of discretion standard.  Id. at 4; id. at 6 (“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”).

Under proper Daubert-like standards, the result wasn’t even close.  The “clear result” was exclusion of the “expert” testimony purporting to link the drug to Crohn’s disease.  Id. at 6.

The opinion is 85 pages long. In the interest of brevity (and getting our other work done) we’re simply bullet pointing anything we find of particular interest.  We heartily recommend that all defense counsel with matters in New Jersey read the whole thing.

  • The court relies heavily on the federal Reference Manual on Scientific Evidence (here’s a link to the manual). Id. at 12-18, 24, 73-74, 77-78. That means that defense counsel should feel comfortable citing the Manual in New Jersey state courts.
  • “A majority of states have adopted some form of the Daubert standard, either explicitly or implicitly.” Id. at 65 (citing cases).
  • That N.J.R.E. 702 – unlike the federal rule − has not been amended to include the “Daubert factors” is not dispositive. Id. at 66-67.
  • Expert admissibility is “not credibility,” but rather a “legal determination” as to which “rigor [is] expected of the trial court.” Id. at 67.
  • “The gatekeeping role necessitates examination of a methodology espousing a new theory in medical cause-and-effect cases,” and “properly exercised,” it “prevents the jury’s exposure to unsound science through the compelling voice of an expert.” Id. at 68-69.
  • “[T]he gatekeeping role must be rigorous.” Id. at 69.
  • Anything less than “abuse of discretion” appellate review “is not appropriate in the context of a civil mass tort case.” Id. at 71.
  • “[T]his Court has continued to apply a pure abuse of discretion standard in civil matters concerning expert testimony.” Id. at 72.
  • “[C]ase reports are at the bottom of the evidence hierarchy, and other courts have been skeptical of their value in proving causation.” Id. at 73 (citations and quotation marks omitted).
  • “[A]nimal studies” are “far less probative in the face of a substantial body of epidemiologic evidence.” Id. at 74 (citations and quotation marks omitted).
  • “[E]xperts cannot selectively choose lower forms of evidence in the face of a large body of uniform epidemiological evidence.” Id. at 77 (citations omitted).
  • Bradford-Hill criteria “are invoked only after an association between an agent and a particular disease has been determined to be present,” and “their pointed purpose . . . is not to create an association that has not already been detected through appropriate studies.” Id. at 78.
  • “It is not for a trial court to bless new ‘inspired’ science theory; the goal is to permit the jury to hear reliable science to support the expert opinion.” Id. at 80 (citation omitted).
  • “[B]oth our law and the Daubert trilogy are aligned in their general approach to a methodology-based test for reliability.” Id.
  • “[B]oth standards look to whether that reasoning or methodology properly can be applied to facts in issue. Id. at 81 (citations omitted).
  • “[A] technique with minimal support [is] to be viewed with skepticism.” Id. at 82 (citation omitted).
  • “[T]he factors identified originally in Daubert should be incorporated for use by our courts.” Id.
  • Daubert is not “adopted” because “[w]e hesitate to sweep in adherence to the various approaches taken among the circuits and state jurisdictions when applying the Daubert factors.” Id. at 83.
  • “[A] methodology-based approach to reliability for expert scientific testimony requires the proponent to demonstrate that the expert applies his or her scientifically recognized methodology in the way that others in the field practice the methodology.” Id. at 84.
  • “When a proponent does not demonstrate the soundness of a methodology, both in terms of its approach to reasoning and to its use of data, from the perspective of others within the relevant scientific community, the gatekeeper should exclude the proposed expert testimony on the basis that it is unreliable.” Id. (citations omitted).
  • Plaintiffs’ theories “fl[y] in the face of consistent findings of no causal association as determined by higher levels of scientific proof” and were properly excluded. Id. at 85.

Given the size of New Jersey’s medical products industry, and the tightening of personal jurisdiction, the New Jersey courts are likely to be one of those jurisdictions seeing a greater number of mass torts involving injury claims against prescription medical products.  The importance of today’s Accutane decision cannot be overstated.

And to top it all off, for Roche, this huge victory occurred on Switzerland’s national day.