To visit the Butler Snow Coronavirus Hub, click here.

Paradigm Shift or Same-Old-Same-Old?

THE NEW JERSEY SUPREME COURT’S AUGUST 1, 2018, IN RE: ACCUTANE DECISION MAY HELP STEM THE TIDE OF UNRELIABLE EXPERT TESTIMONY[1]

With deepest apologies to Charles Dickens, the Accutane litigation could be dubbed “A Tale of Two Cities”[1] in one critical respect: the trial courts’ varying treatment of expert testimony.[2] Over the span of 13-plus years, the courts in two different jurisdictions diverged in their exclusion/admission of Plaintiffs’ general causation experts, who claimed that Accutane — a prescription drug that treats recalcitrant nodular acne — was capable of causing Irritable Bowel Disease (IBD) or Crohn’s Disease, a specific type of IBD.

One city (Tampa, Florida) was home to a federal court that applied the federal “Daubert[3] standard to Plaintiffs’ general causation testimony. The district court excluded Plaintiffs’ experts’ testimony under Daubert, then entered the logical corollary of summary judgment because Plaintiffs could not prove their claims. After the Eleventh Circuit Court of Appeals affirmed the district court’s decisions a couple of different times in 2008 and then in 2010, the litigation eventually whimpered to a close.[4]

But in the other city (Atlantic City, New Jersey), the trial court applied New Jersey’s then-current “Kemp” expert testimony standard, generally considered to be a more relaxed standard in favor of admission than the federal standard.[5] For many years, applying Kemp and its progeny, the New Jersey state court permitted Plaintiffs’ general causation expert testimony on the alleged connection between Accutane and Crohn’s Disease. That landscape changed, however, on August 1, 2018, with the New Jersey Supreme Court’s issuance of In Re: Accutane Litigation, 2018 WL 3636867, – A.3d – (N.J. Aug. 1, 2018).[6] In Re: Accutane defeated Plaintiffs’ general causation theory in New Jersey by affirming the trial court’s exclusion of Plaintiffs’ general causation experts. The primary basis for exclusion was that Plaintiffs’ experts disregarded epidemiological studies and, instead, relied upon evidence “at the bottom of the evidence hierarchy.”[7] Finding their opinions lacked sound methodology, their testimony was excluded, which resulted in the dismissal of more than 2,000 cases in the New Jersey Accutane Multicounty Litigation (MCL).

The New Jersey Supreme Court’s decision in In Re: Accutane is a significant victory for the Defendants in that litigation, Hoffmann-La Roche Inc. and Roche Laboratories Inc. Overall, from the defense standpoint, the era of new “Accutane motions” is a paradigm shift that aligns New Jersey law with federal law expert testimony standards. Plaintiffs will, in contrast, argue there’s “nothing to see here” and that New Jersey law is basically unchanged in this aspect. This article discusses the key points from In Re: Accutane’s key components and shares a few suggestions of how to attack Plaintiffs’ general causation theories in the new “Accutane motion” era.

THE ERA OF NEW “ACCUTANE MOTIONS” IS A PARADIGM SHIFT THAT ALIGNS NEW JERSEY LAW WITH FEDERAL LAW EXPERT TESTIMONY STANDARDS.

I. IN RE: ACCUTANE: TRIAL COURT PROCEEDINGS

A. GENERAL CAUSATION WAS “THE” ISSUE.

The first New Jersey Accutane case was filed in July 2003 — and the Accutane litigation in Atlantic City, New Jersey, was designated as an MCL or “mass tort” in May 2005.[8] Thousands of cases were filed in the New Jersey MCL, with Plaintiffs alleging that they had developed Crohn’s Disease from taking Accutane.[9] To prove these product liability claims, Plaintiffs had to establish that Accutane was capable of causing the alleged injury (general causation) and that it did, in fact, cause the claimed injury for a particular Plaintiff (specific causation). The key issue of In Re: Accutane — and the reason it is such an important decision — is general causation. Without expert testimony to establish general causation, Plaintiffs’ claims fail, and there is no need to evaluate specific causation.

B. EPIDEMIOLOGICAL STUDIES REVEALED A LACK OF CAUSAL CONNECTION BETWEEN ACCUTANE AND CROHN’S DISEASE.

Regarding general causation, there had been a “series of epidemiological studies” in the years since many of the earlier Accutane cases had been decided; studies conducted and papers published from 2009 to 2014 examined whether there was a causal relationship between Accutane and Crohn’s Disease, including the following:

  • 2009: One of the first studies in 2009, with approximately 21,500 subjects, concluded there “may be anecdotes” of Accutane causing inflammation of the colon, but the data suggested that “[Accutane] is not likely to cause chronic IBD.”[10]
  • 2010-2013: Another epidemiological study in 2010 examined approximately 29,000 subjects and found no apparent association between Accutane and Crohn’s Disease.[11] A 2013 study of 45,000 women, similarly, found no increase in the risk for IBD, including Crohn’s Disease.[12]
  • 2013-2014: An even larger-subject study in 2013 with almost 177,000 subjects,[13] as well a study of nearly 1,100 subjects in 2014,[14] both concluded that Accutane was not causally related to IBD. A 2013 study of nearly 47,000 subjects found “no significant association” between Accutane use and IBD.[15] Another 2014 study of approximately 44,000 subjects concluded that use of Accutane was associated with a decreased risk of Crohn’s Disease.[16]

As the Court noted, “all of [these studies] concluded that Accutane is not causally associated with the development of Crohn’s disease.”[17]

C. THE TRIAL COURT REQUESTED SCIENTIFIC LITERATURE, CONDUCTED A KEMP HEARING, AND RECEIVED TESTIMONY FROM EXPERTS.

To establish general causation, Plaintiffs produced two experts: a gastroenterologist (Dr. Arthur Kornbluth) and a statistician (Dr. David Madigan). Defendants moved to exclude those experts under New Jersey Rule of Evidence 702 in accordance with Kemp ex rel. Wright v. State, 174 N.J. 412, 809 A.2d 77 (2002).

In addition to the briefing, the trial court asked the parties to provide “all such reports, abstracts, peer-reviewed studies, etc.” relied upon by the witnesses in formulating their opinions — which totaled more than 400 items, and which the trial court described as being “invaluable in preparing for the Kemp hearing.”[18]

At the Kemp hearing, the trial court heard testimony from the experts.[19] The court explained that “the inquiry at a Kemp Hearing must be ‘flexible,’” the “focus must be on principles and methodology and not necessarily on the conclusions/opinions that such scientific methodology may generate,” and the “expert must be able to identify the factual basis for his/her conclusion, explain his/her methodology, and demonstrate that both the factual basis and underlying methodology are scientifically reliable . . . .”[20]

D. THE TRIAL COURT EXCLUDED PLAINTIFFS’ GENERAL CAUSATION EXPERTS, PRIMARILY BASED ON THEIR DISREGARD FOR SCIENTIFIC STUDIES THAT WERE CONTRARY TO THEIR OPINIONS.

After addressing the grounds upon which Plaintiffs’ experts relied in forming their general causation opinions, the trial court ultimately granted the motion to exclude. The court introduced its ruling by stating:

It is one thing to stand alone in the world of science, advancing a hypothesis that others do not accept. It is quite another thing to advance a hypothesis that can only be supported by disregarding valid scientific research. The court embraces its obligation to be flexible in applying scientific evidence to novel personal injury claims falling within the penumbra of “toxic torts” nonetheless, such claimants have a reciprocal obligation to be mindful of the standards of the scientific community. The foundations of the hypothesis for general causation of an injury cannot be contrived; they must be based upon sound methodology sufficiently reliable to be presented to a jury.[21]

The phrase emphasized above pointing out Plaintiffs’ experts’ effort “to advance a hypothesis that can only be supported by disregarding valid scientific research” [22] — i.e., an attempt to “cherrypick evidence supportive of their opinion while dismissing other, better forms of evidence that did not support their opinion” — was the lynchpin for both the trial court’s ruling and the Supreme Court’s affirmance, which reversed the Appellate Court.[23]

II. THE NEW JERSEY SUPREME COURT UPHOLDS EXCLUSION OF PLAINTIFFS’ GENERAL CAUSATION EXPERTS

Three aspects of the New Jersey Supreme Court’s rulings are important to pharmaceutical defense practice and are discussed briefly below. First, the Court sought to clarify New Jersey’s expert testimony standard vis-à-vis Daubert. Second, the Court rejected the “less deference” standard and reaffirmed that appellate review of expert decisions in civil cases is the “pure” abuse of discretion standard. Third, the Court affirmed the trial court’s approach to excluding Plaintiffs’ general expert testimony, thereby reaffirming the trial court’s important role in performing “rigorous gatekeeping that is necessary when faced with a novel theory of causation, particularly one . . . that flies in the face of consistent findings of no causal association as determined by higher levels of scientific proof.”[24]

A. THE “NEW” NEW JERSEY EXPERT TESTIMONY STANDARD: #DAUBERTNOTDAUBERT?

As noted, the New Jersey Supreme Court accepted review of the case to address the proper standard to evaluate expert testimony under Rule 702:

We intend by this case to clarify and reinforce the proper role for the trial court as the gatekeeper of expert witness testimony. Defendants and several amici have good reason to ask for clarification of the judicial gatekeeping role to be performed in New Jersey courtrooms.[25]

A detailed analysis of the history behind New Jersey’s expert testimony standard is beyond the scope of this article; review of In Re: Accutane is recommended for those who desire a deeper dive on that issue. Suffice to say that the Court, in In Re: Accutane, took pains to both align itself with, but at the same time distance itself from, the federal Daubert standard.[26] At the end of the day, the Court concluded that although it was “adopting use of the Daubert factors, ‘we stop short of declaring ourselves a Daubert jurisdiction.’”[27]

Despite the Court’s careful crafting of boundaries on its clarified standard, revealed by its “hesitat[ion] to sweep in” adherence to Daubert given the “various approaches taken among the circuits and state jurisdictions when applying the Daubert factors,”[28] several aspects of the opinion are familiar and favorable. All of the following issues should resonate with students of Daubert, as these items focus on the key inquiry — i.e., whether “sound methodology” has been demonstrated:

  • Plaintiff bears the burden to establish that his/her general causation expert has employed a sound methodology: this requires the plaintiff to demonstrate “that the expert applies his or her scientifically recognized methodology in the way that others in the field practice the methodology.”
  • Sound methodology has two aspects: both (1) its approach to reasoning and (2) its use of data.
  • Sound methodology is viewed “from the perspective of others within the relevant scientific community.”[29] In Re: Accutane also highlighted the trial court’s role as “gatekeeper” of testimony. The Court explained that:
  • The trial court is not just permitted, but is obligated when faced with a novel theory of causation, to perform “rigorous gatekeeping.”[30]
  • “The trial court is the spigot that allows novel expert testimony in areas of evolving medical causation science, provided the proponent of the expert can demonstrate that the expert adheres to scientific norms in distinct ways that we have identified.”[31]
  • Trial courts “should exclude the proposed expert testimony on the basis that it is unreliable” if the proponent fails to establish sound methodology.
  • “Difficult as it may be, the gatekeeping role must be rigorous.”[32]

Even if Daubert has not been “formally” adopted in New Jersey, these clarifications/affirmations are familiar stalwarts in keeping unreliable expert opinions out of the courtroom. Indeed, In Re: Accutane itself cited to recent federal cases, including expert-excluding-rulings in the Lipitor litigation that demonstrate the rigorous gatekeeping employed by the trial court.

B. THE “PURE ABUSE OF DISCRETION” STANDARD APPLIES; THE LESS-DEFERENTIAL STANDARD APPLIED BY THE APPELLATE DIVISION IS NOT PROPER IN CIVIL CASES.

The New Jersey Supreme Court also addressed the proper standard of appellate review. The Court explained that “[a] reviewing court must apply an abuse of discretion standard to a trial court’s determination, after a full Rule 104 hearing, to exclude expert testimony on unreliability grounds. . . . [But] Here, the Appellate Division was persuaded to veer off that standard of review.”[33]

More specifically, the Appellate Division stated that it would apply the abuse of discretion standard, but determined that it “owe[d] ‘somewhat less deference to a trial court’s determination’ regarding expert testimony.” The Supreme Court rejected that approach, finding that the appellate panel had wrongly relied on the standard from the criminal setting; “it is not appropriate in the context of a civil mass tort case, where the trial court has been entrusted with methodology-based review as the gatekeeper of expert testimony.” Instead, In Re: Accutane confirmed that the “pure abuse of discretion standard” applies in civil matters concerning expert testimony.[34]

C. THE TRIAL COURT PROPERLY EMPLOYED RIGOROUS GATEKEEPING TO EXCLUDE PLAINTIFFS’ GENERAL CAUSATION EXPERTS, WHO TRIED TO DISREGARD VALID EPIDEMIOLOGICAL STUDIES WHILE RELYING ON THE WEAKEST FORMS OF SCIENTIFIC PROOF.

Applying that standard of review, the Supreme Court concluded that the appellate court should be reversed, as the trial court “did the type of rigorous gatekeeping that was necessary when faced with a novel theory of causation.” The Court emphasized that rigorous examination was indeed needed where, as was the case with Drs. Kornbluth and Madigan in the Accutane MCL, their opinions “fl[y] in the face of consistent findings of no causal association as determined by higher levels of scientific proof.”[35]

In affirming the exclusion of the testimony, the Supreme Court focused primarily on Plaintiffs’ experts’ reasoning, which sought to discredit the epidemiological evidence and instead rely on weaker forms of evidence. Both of Plaintiffs’ experts “disregarded eight of nine epidemiological studies and relied on case reports and animal studies to support their opinion.”[36]

To this point, with heavy reliance on the The Reference Manual on Scientific Evidence (3d ed.) issued by the Federal Judicial Center and the National Research Council of the National Academies, the Court explained the role of various forms and levels of scientific evidence in establishing a valid reasoning.[37] The Reference Manual’s section on Medical Testimony contains a likely-familiar “hierarchy of medical evidence,” including the following examples:

Evidence at the top of the hierarchy:

  • Systematic review of randomized trials (meta-analysis)
  • Single randomized trials
  • Systematic reviews of observational studies
  • Single observational studies
  • Physiological studies
  • Unsystematic clinical observations

Evidence at the bottom of the hierarchy:

  • First signals of adverse events or associations (case reports)
  • Animal studies

Reviewing the trial court’s “gatekeeping” in light of these principles, the New Jersey Supreme Court recognized that Plaintiffs’ general causation experts had correctly been excluded. Both experts eschewed the uniform body of epidemiological studies demonstrating no causal association between Accutane and Crohn’s Disease. They instead relied on the lowest forms of scientific evidence in forming their opinions. Importantly, it was not merely the fact that the experts relied on animal studies and case reports. Their key downfall was that they rejected published studies that had examined thousands of subjects, while instead pointing to a single, unpublished study with a small number of subjects and otherwise relying on the “lowest” forms of proof.[38]

III. IS THE BEST YET TO COME IN NEW JERSEY?

In Re: Accutane brought a long-awaited end to this aspect of Accutane litigation in the New Jersey MCL; without expert testimony, Plaintiffs’ pharmaceutical product liability claims could not proceed.

Whether In Re: Accutane represents a sea change to litigation in this pharmaceutical-industry home state remains to be seen. Even though In Re: Accutane is an affirmation of rigorous scrutiny of unreliable general causation theories, each litigation — and its own corresponding history, experts, and jurists — is unique.

There are, however, takeaways from In Re: Accutane that bode well for defendants where a challenge to general causation appears viable. In no particular order, here are a few tips for defense practitioners with product liability cases in New Jersey:

  • Stockpile the evidence from epidemiological studies and other “higher forms” of scientific evidence. And keep updating it. The history of Accutane showed that over the years, the studies became more and more robust. No client wants litigation to drag on; but to the extent new studies are out there, and of course if they are favorable, put them at the top of your list.
  • Think long and hard about how to organize the scientific proof, and be able to provide a succinct “elevator speech” to summarize it. If helpful, review the Supreme Court’s repeated references in In Re: Accutane to the “uniform epidemiological studies” that showed no causal link to the claimed injury. That’s the type of recitable snippet that a court can embrace.
  • Present that evidence to the presiding judge (see note from the trial court proceedings in Accutane) in a user-friendly format. Ideally, you will have a jurist who will dig in to the material in advance of any testimony or hearing. On this point, it’s a strategy call whether you want to ask for a “Science Day” on the front end of the litigation — or if it would be more effective to let a single case (e.g., bellwether trial pick) go through a full workup, then present testimony in a Rule 104 hearing as part of your Accutane Motion(s) to exclude Plaintiffs’ experts.
  • Reiterate, at every turn in briefs and oral arguments, that Plaintiffs bear the burden of proof to demonstrate their experts’ opinions are reliable. The defense has no obligation to disprove its case. It’s tempting not to try to prove the defense is right and plaintiffs are wrong, but that’s not the standard. Put Plaintiffs to their burden at every turn, whether in an Accutane motion or dispositive motion.
  • Keep In Re: Accutane front and center. The defense has a daunting task in pointing out (not proving!) that Plaintiffs’ general causation experts have not employed sound methodology. That’s a huge task, and as Accutane’s lengthy history shows, it is not for the faint of heart. Even so, In Re: Accutane should be relied on and cited in every defense motion to exclude expert testimony.

In closing, on a personal note, this author is now using the term “Accutane motions” to emphasize that there’s a new standard in town (in New Jersey). Plaintiffs have already begun to downplay any change in the standard; and frankly, there’s a fair argument in the equivocal #DaubertNotDaubert (my term) sections of In Re: Accutane to make a judge think twice. But if the defense bar can uniformly remind judges that Accutane motions are “the” standard, it may bode well for the pharmaceutical industry.


[1] Full disclosure: Butler Snow represents the manufacturer of Accutane, Hoffmann-La Roche Inc. and Roche Laboratories Inc., in a number of cases. This article was prepared strictly from public filings as cited herein.


[1] Dickens, Charles. A Tale of Two Cities. New York, NY: New American Library.

[2] This article does not suggest that the treatment of expert testimony is the only difference in the way the federal versus state litigations progressed. There are undoubtedly several factors, including but not limited to the jurists, counsel, plaintiffs/plaintiffs’ injuries, legal theories, proposed experts, legal arguments (e.g., adequacy of the warnings), respective courts of appeals, and many other issues that all played a role in different life spans of the MDL versus New Jersey MCL proceedings. To be sure, the treatment of expert testimony is just one facet.

[3] Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 585-87, 113 S. Ct. 2786 (1993).

[4] See In Re: Accutane Prods. Liab., 511 F. Supp. 2d 1288 (M.D. Fla. 2007), aff’d, Rand v. Hoffmann-LaRoche Inc., 291 F. App’x 249 (11th Cir. 2008); In Re: Accutane Prod. Liab., 2009 WL 2496444 (M.D. Fla. Aug. 11, 2009), and In Re: Accutane Prod. Liab., 2009 WL 3462395 (M.D. Fla. Oct. 28, 2009), aff’d, 378 F. App’x 929 (11th Cir. 2010).

[5] Kemp ex rel. Wright v. State, 174 N.J. 412, 427, 809 A.2d 77 (2002).

[6] In Re: Accutane Litig., 2018 WL 3636867, – A.3d – (N.J. Aug. 1, 2018).

[7] Id. at *29.

[8] https://www.njcourts.gov/attorneys/mcl/atlantic/accutane.html (last visited Aug. 22, 2018). See also In Re: Accutane Litig., No. 271(MCL), 2015 WL 753674, at *1 (N.J. Super. L. Feb. 20, 2015).

[9] In Re: Accutane Litig., 2018 WL 3636867, at *7.

[10] Id. at *10 & n. 7 (citing Charles N. Bernstein et al., Isotretinoin is Not Associated with Inflammatory Bowel Disease: A Population-Based Case-Control Study, 104 Am. J. Gastroenterol. 2774 (2009)).

[11] Id. at *10 & n. 8 (citing Seth D. Crockett et al., Isotretinoin Use and the Risk of Inflammatory Bowel Disease: A Case-Control Study, 105 Am. J. Gastroenterol. 1986 (2010)). That study did find a statistically significant increased risk between Accutane and ulcerative colitis. Id.

[12] Id. at *10 & n. 9 (citing Mahyar Etminan et al., Isotretinoin and Risk for Inflammatory Bowel Disease, 149 JAMA Dermatol. 216 (2013)).

[13] Id. at *10 & n.12 (citing Sarah Fenerty et al., Impact of Acne Treatment on Inflammatory Bowel Disease, 68 J. Am. Acad. Dermatol. AB5 (2013)).

[14] Id. at *10 & n.13 (citing Shadi Rashtak et al., Isotretinoin Exposure and Risk of Inflammatory Bowel Disease, 150 JAMA Dermatol. 1322 (2014)).

[15] Id. at *10 & n.11 (citing Raed O. Alhusayen et al., Isotretinoin Use and the Risk of Inflammatory Bowel Disease: A Population-Based Cohort Study, 133 J. Investigative Dermatol. 907 (2013)).

[16] Id. at *10 & n. 14 (citing Antoine Racine et al., Isotretinoin and Risk of Inflammatory Bowel Disease: A French Nationwide Study, 109 Am. J. Gastroenterol. 563 (2014)).

[17] Id. at *7.

[18] In Re: Accutane Litig., No. 271(MCL), 2015 WL 753674, at *2 (N.J. Super. L. Feb. 20, 2015).

[19] Id. at *1.

[20] Id. at *6.

[21] Id. at *21 (emphasis added).

[22] In Re: Accutane Litig., 2018 WL 3636867, at *18.

[23] In Re: Accutane Litig., 451 N.J. Super. 153, 165 A.3d 832 (App. Div. 2017), rev’d, 2018 WL 3636867 (N.J. Aug. 1, 2018).

[24] In Re: Accutane Litig., 2018 WL 3636867, at *33.

[25] Id. at *23.

[26] Id. at *5-6, 22-28, 31-33.

[27] Id. at *27-28, 32.

[28] Id. at *32.

[29] Id. at *33.

[30] Id. at *33.

[31] Id. at *27.

[32] Id. at *27.

[33] Id. at *28.

[34] Id. at *28.

[35] Id. at *33.

[36] Id. at *28-29.

[37] The trial court explained that the “[t]The Reference Manual is a valuable tool, providing excellent guidance in sifting through the information generated at the Kemp Hearing because it is indicative of what the scientific community deems to be reasonable. At this hearing, the court is asked to assess whether the experts in the field would reasonably rely on methods and data as Plaintiffs’ experts have done. Through the Reference Manual, the scientific community speaks to trial courts and confirms what may be considered to be reasonable.” In Re: Accutane Litig., 2015 WL 753674, at *2.

[38] In Re:: Accutane Litig., 2018 WL 3636867, at *28-31.

Finis