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In re Accutane Litigation

Supreme Court of New Jersey

August 1, 2018

IN RE: ACCUTANE LITIGATION

          Argued April 23, 2018

          On certification to the Superior Court, Appellate Division, whose opinion is reported at 451 N.J.Super. 153');">451 N.J.Super. 153 (App. Div. 2017).

          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, Russell L. Hewit, 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 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, 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., 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, 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, 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 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).

          LaVECCHIA, J., writing for the Court.

         At issue in this appeal 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.

         Accutane is a prescription medication developed by defendants and approved by the FDA to treat recalcitrant nodular acne. Accutane's alleged role as a cause of gastrointestinal disease ultimately resulted in a series of lawsuits against defendants. The present matter involves over two thousand plaintiffs who allege that they developed Crohn's disease as a result of taking Accutane. In the years since many earlier Accutane cases were decided, epidemiological studies were published, all of which concluded that Accutane is not causally associated with the development of Crohn's disease. Defendants in this mass tort litigation filed a motion seeking a hearing on the association between Accutane and Crohn's disease.

         The hearing focused on the epidemiological studies. See pp. 12-20. The parties do not dispute that there is an acknowledged hierarchy of medical evidence and that, generally, epidemiological studies are preferred to unsystematic clinical observations. Researchers sometimes look to animal studies for determining a given agent's toxicity in humans. When there is a substantial body of epidemiologic evidence that addresses the causal issue, animal toxicology has much less probative value.

         Plaintiffs produced Dr. Arthur Asher Kornbluth, a gastroenterologist, and Dr. David Madigan, a statistician. Dr. Kornbluth's testimony had two themes: explaining why he found the epidemiological studies unreliable and uninformative regarding causation, and explaining his reliance on other forms of evidence such as case reports, animal studies, causality assessments, and his biological mechanism hypothesis. See pp. 20-27. He stated that most of the studies that looked specifically for Crohn's disease were fatally flawed because they did not account for its "prodrome," or the period between the onset of symptoms and diagnosis, and that some studies did not have enough patients and thus were "underpowered." Dr. Madigan focused on whether the epidemiological studies were appropriately designed to discover an association between Crohn's disease and Accutane, if such an association did exist. See pp. 27-32. He concluded that, after accounting for the prodrome, the epidemiological studies do not provide statistically reliable information.

         Defendants produced gastroenterologist Dr. Maria Oliva-Hemker, and biostatistician Dr. Steven Goodman. Dr. Oliva-Hemker's testimony focused on disputing Dr. Kornbluth's testimony and explaining why epidemiological studies are preferred to case reports and animal studies in the hierarchy of evidence. See pp. 32-36. She explained that Crohn's disease's cause is unknown, that any theory regarding a biological mechanism was therefore unreliable, and that scientists would not ignore the available epidemiological evidence in favor of a hypothesis about a biological mechanism that has not been submitted for peer review. She added that the study on which plaintiffs' experts relied for their determination of the prodrome was very small and not representative of the average prodromal period. She also explained why Dr. Kornbluth's reliance on animal studies was flawed, namely because dogs cannot get inflammatory bowel disease. Dr. Goodman's testimony focused on why the epidemiologic evidence is the best available evidence on the question of Accutane's causal relation to Crohn's disease and why a meta-analysis was a proper way of pooling those study results to reach a conclusion that Accutane does not cause Crohn's disease. See pp. 36-41. His testimony explained why he and others in the scientific community would not regard the epidemiological studies to be invalid due to a prodrome issue.

         After the hearing, the trial court excluded plaintiffs' experts' testimony. The court regarded the standard established in Rubanick v. Witco Chemical Corp., 125 N.J. 421 (1991), as requiring an expert opinion to be based on a "sound, adequately-founded scientific methodology involving data of the type reasonably relied on by experts in the scientific field." The court found plaintiffs' experts' testimony lacking, determining their examination of the evidence was a "conclusion-driven" attempt to cherry-pick evidence supportive of their opinion while dismissing better forms of evidence that did not support their opinion.

         The Appellate Division reversed. 451 N.J.Super. 153');">451 N.J.Super. 153, 163-64 (App.Div. 2017). While noting the trial court's opportunity to view the witnesses firsthand, the panel expressed the view that the trial court's negative reaction to plaintiffs' experts was not supported by the record. Id. at 211. The panel further noted that, although a trial court's decision to admit or exclude evidence is subject to an abuse of discretion standard, a reviewing court owes "somewhat less deference" to determinations regarding expert testimony. Id. at 196-97.

         The Court granted certification in this matter, 231 N.J. 531 (2017), to address whether the trial court properly excluded plaintiffs' experts' testimony, whether the Appellate Division employed the correct standard in reviewing that decision, and whether New Jersey's standard for assessing the reliability of expert witnesses is in need of clarification. With regard to the last issue, the Court considers whether the factors set forth in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993), would further elucidate New Jersey's standard for the admissibility of expert testimony.

         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.

         1. New Jersey Rules of Evidence 702 and 703 control the admission of expert testimony. In State v. Kelly, 97 N.J. 178');">97 N.J. 178, 223 (1984), the Court 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." The Kelly criteria elucidated application of the then-applicable "general acceptance" standard for admitting scientific evidence. For many years, the majority of state and federal jurisdictions, including New Jersey, adhered to the "general acceptance" standard first put forth in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923). Then, in 1991, the New Jersey Supreme Court moved away from rigid adherence to the general acceptance standard. (pp. 6-9)

         2. Rubanick marked the broadening of that standard. The Rubanick Court instructed courts to "consider whether others in the field use similar methodologies," 125 N.J. at 449-50, and explained that the proper inquiry is whether comparable "experts in the field would actually rely on that information," id. at 452. In Landrigan v. Celotex Corp., the Court elaborated: when relying on epidemiological studies, the trial court should review them and "then determine whether the expert's opinion is derived from a sound and well-founded methodology that is supported by some expert consensus in the appropriate field." 127 N.J. 404, 417 (1992). Moreover, Landrigan suggested tools for trial courts to use in rendering gatekeeping determinations about the reliability of an expert's methodology when the ultimate scientific opinion is not itself generally accepted, including "reference to professional journals, texts, conferences, symposia, or judicial opinions accepting the methodology." Ibid. Thus, methodology may be assessed for soundness using some of the same tools as general acceptance identifies for outcome. (pp. 55-58)

         3. Not long after those dual holdings, the Supreme Court issued its seminal Daubert opinion, pronouncing that Frye had been superseded by the adoption of the Federal Rules of Evidence, 509 U.S. at 585-87, and fashioning a new standard that "entails a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and . . . can be applied to the facts in issue," id. at 592-93. The Court noted that "many factors will bear on the inquiry," which became known as the Daubert factors. Id. at 593-94. The Court described the trial court's task as a "flexible" inquiry into the scientific principles at issue, ibid., one whose "overarching subject is the scientific validity -- and thus the evidentiary relevance and reliability -- of the principles that underlie a proposed submission," id. at 594-95. As in Rubanick and Landrigan, the Daubert Court underscored that the trial court must focus on the expert's principles and methodology -- not on the conclusions they generate. Id. at 595. The Supreme Court elaborated on its Daubert standard with two cases which, combined, round out the Daubert trilogy: General Electric Co. v. Joiner, 522 U.S. 136 (1997), and Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999). Federal Rule of Evidence 702 was amended in 2000 to reflect the Supreme Court's trilogy of cases outlining the Daubert standard. A majority of states have adopted some form of the Daubert standard, either explicitly or implicitly. (pp. 58-65)

         4. After the Daubert trilogy, the Court revisited the topic of the trial court's gatekeeping role under N.J.R.E. 702. In Kemp ex rel. Wright v. State, 174 N.J. 412 (2002), the Court held that the Rubanick standard should apply whenever "a medical cause-effect relationship has not been confirmed by the scientific community but compelling evidence nevertheless suggests that such a relationship exists." Id. at 430. The Court explained that, by requiring a pretrial Rule 104 evidentiary hearing, the trial court would be able to properly "assess whether the expert's opinion is based on scientifically sound reasoning or unsubstantiated personal beliefs couched in scientific terminology." Id. at 427. The Kemp Court observed that New Jersey had not amended N.J.R.E. 702 to include "the three-factor test for the admissibility of expert testimony that is part of the Federal rule as amended in response to Daubert." Id. at 424 n.3. Nor has any such action has been taken since. (pp. 65-67)

         5. When the Court modified the general acceptance standard to adopt a more relaxed approach for causation expert testimony in toxic tort litigation, and later for all medical cause-effect expert testimony, it envisioned the trial court's function as that of a gatekeeper -- deciding what is reliable enough to be admitted and what is to be excluded. Those are not credibility determinations that are the province of the jury, but rather legal determinations about the reliability of the expert's methodology. The Court reinforces the rigor expected of the trial court in that role under existing New Jersey case law. (pp. 67-70)

         6. Here, the Appellate Division panel stated that, although a trial court's decision to admit or exclude evidence is subject to an abuse of discretion standard, a reviewing court owes "somewhat less deference to a trial court's determination" regarding expert testimony. 451 N.J.Super. at 197. As support for that proposition, the panel relied on a criminal case that applied the Frye standard. The Court now reaffirms that the abuse of discretion standard applies in the appellate review of a trial court's determination to admit or deny scientific expert testimony on the basis of unreliability in civil matters. (pp. 70-72)

         7. The Court details the assessments made by the trial court in reaching its decision to exclude the testimony of plaintiffs' experts in this case. Both Doctors Madigan and Kornbluth employed a methodology whereby they disregarded eight of nine epidemiological studies and relied on case reports and animal studies. Despite their expressed concerns regarding study power -- which is based in part on the size of the study at issue -- in rejecting the epidemiological studies, plaintiffs' experts were willing to ignore any such concern when relying on other studies to form their opinion as to the median prodromal period. The many contradictions in the experts' methodology were not lost on the trial court, which concluded that experts in the scientific community would not accept as consistent with scientific norms a methodology such as that used by plaintiffs' experts. Moreover, Dr. Kornbluth never submitted his ideas concerning biological mechanism or Accutane's relation to Crohn's disease for peer review or publication. In sum, the trial court explained its reasons for concluding that plaintiffs' experts deviated from core scientific principles and strayed from their own claimed methodology in order to reach their conclusions. Under the abuse of discretion standard and the principles of Rubanick, Landrigan, and Kemp, the trial court's determination is unassailable. The Appellate Division judgment is reversed. (pp. 72-79)

         8. In respect of the gatekeeping role, the Court emphasizes that it expects the trial court to assess both the methodology used by the expert to arrive at an opinion and the underlying data used in the formation of the opinion. There is not much light between New Jersey's standard and that which has developed in the federal sphere under Daubert's initial instruction. Importantly, Daubert identified a non-exhaustive list of factors for courts to consider using, if helpful. See 509 U.S. at 593-95. Distilled, the general factors identified as perhaps pertinent for consideration, but not dispositive or exhaustive, 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. That last consideration -- general acceptance in the scientific community -- continues to have a bearing. The Court adopts the use of the Daubert factors but stops short of declaring New Jersey a "Daubert jurisdiction." First, to date New Jersey retains the general acceptance test for reliability in criminal matters. Second, while the factors are helpful, and while individual cases may be persuasive in appropriate settings, there are discordant views about the gatekeeping role among Daubert jurisdictions. The Court's view of proper gatekeeping in 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. That approach was employed by the trial court here. (pp. 79-85)

         REVERSED.

          CHIEF JUSTICE RABNER and JUSTICES ALBIN, FERNANDEZ-VINA, SOLOMON, and TIMPONE join in JUSTICE LaVECCHIA's opinion. JUSTICE PATTERSON did not participate.

          OPINION

          LaVECCHIA JUSTICE.

         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" standard[1] for testing the reliability of scientific expert testimony to a methodology-based approach. See Landrigan v. Celotex Corp., 127 N.J. 404, 414 (1992); Rubanick v. Witco Chem. Corp., 125 N.J. 421, 447 (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 (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');">97 N.J. 178, 223 (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 originated in Frye v. United States, 293 F. 1013 (D.C. Cir. 1923). In Frye, the then Court of Appeals for the District of Columbia excluded an expert's testimony concerning results from an early form of lie-detector test. Id. at 1013-14 ("[W]hile courts will go a long way in admitting expert testimony deduced from a well-recognized scientific principle or discovery, the thing from which the deduction is made must be sufficiently established to have gained general acceptance in the particular field in which it belongs."). For many years, the majority of state and federal jurisdictions, including New Jersey, adhered to the "general acceptance" standard first put forth in Frye. See Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 585-87 (1993) (observing that Frye had been "the dominant standard for determining the admissibility of novel scientific evidence" for over seventy years). Then, in 1991, prior to the United States Supreme Court's seminal Daubert decision, in which the Court interpreted the Federal Rules of Evidence on expert testimony, our Court moved away from rigid adherence to the general acceptance standard.

         This Court held in Rubanick that a court may admit expert scientific evidence on a causation theory in toxic tort litigation so long as "it is based on a sound, adequately-founded scientific methodology involving data and information of the type reasonably relied on by experts in the scientific field." 125 N.J. at 449. One year later, in Landrigan, we reinforced that in toxic tort matters involving novel theories of causation the trial court is obliged to review data and studies relied on by experts proffering an opinion in order to "determine whether the expert's opinion is derived from a sound and well-founded methodology that is supported by some expert consensus in the appropriate field." 127 N.J. at 417. In Kemp, we expanded Rubanick to all novel medical causation circumstances and solidified the requirement of a pretrial Rule 104 hearing for assessing an expert's testimony. 174 N.J. at 430. Presently, a Kemp hearing is a common pretrial occurrence for resolving the reliability of expert scientific testimony.

         A Kemp hearing provides the record for the present matter. After the conclusion of that hearing, the trial court determined that the contested evidence did not pass muster under our Rubanick evidentiary standard for assessing the reliability of proffered expert scientific testimony. The court made its findings in response to argument by the parties, rejecting the soundness of plaintiffs' experts' methodology.

         II.

         A.

         Accutane is a prescription medication developed by defendants Hoffman-La Roche Inc. and Roche Laboratories Inc. (defendants) and approved by the FDA in 1982 to treat recalcitrant nodular acne. Known chemically as isotretinoin, Accutane is part of a family of Vitamin A derivatives called retinoids. During the pre-approval clinical studies of Accutane, roughly a fifth of patients suffered some form of gastrointestinal side effects. Defendants also learned, after Accutane was on the market, that users were suffering symptoms of gastrointestinal upset such as inflammatory bowel disease (IBD) and peptic ulceration. Defendants eventually amended Accutane's warning label in 1984 to add that Accutane was "temporally associated with inflammatory bowel disease."

         Accutane's alleged role as a cause of gastrointestinal disease ultimately resulted in a series of lawsuits against defendants. On May 2, 2005, this Court designated all pending and future New Jersey actions involving Accutane as a mass tort Multicounty Litigation (MCL) pursuant to Rule 4:38A. All cases involving Accutane were subsequently transferred to Atlantic County to be heard on a coordinated basis.

         The present matter, the latest in a series of cases, [3]involves over two thousand plaintiffs who allege that they developed Crohn's disease as a result of taking Accutane. The following basic information is not a matter of dispute between the parties. Crohn's disease is a form of IBD characterized by inflammation and ulcers in the digestive tract that can result in abdominal pain and other complications. Crohn's disease is distinguished from ulcerative colitis, the other form of IBD, by its ability to appear in any portion of the digestive tract, such as the esophagus and small intestine, whereas ulcerative colitis appears only in the large intestine. The scientific community appears to agree that Crohn's disease and ulcerative colitis are subject to slightly different risk factors. The exact cause of Crohn's disease is unknown.

         In the years since many of the earlier cases regarding Accutane and IBD were decided, a series of epidemiological studies were published regarding the potential connection between Accutane and IBD, all of which concluded that Accutane is not causally associated with the development of Crohn's disease. On September 23, 2014, defendants filed a motion seeking a Kemp hearing on the association between Accutane and Crohn's disease. Defendants argued that epidemiological studies published in the scientific literature over the last several years effectively disproved any general causal association between Accutane and Crohn's disease. They contended that those studies are "the most important and reliable data that exists on Accutane and Crohn's disease" and are superior to other forms of evidence previously used in the MCL litigation such as case reports, animal studies, and theories on biological mechanisms.

         The trial court scheduled a Kemp hearing to begin on February 2, 2015.

         B.

         The testimony focused intently on the aforementioned epidemiological studies. Accordingly, some background on the use of such studies in the formation of causal analyses provides context for the discussion of the evidence by the parties and the trial court. Much of the following discussion is taken from the Federal Judicial Center's Reference Manual on Scientific Evidence (3d ed. 2011), a source frequently relied on in the trial court proceedings.[4]

         Epidemiology "studies the incidence, distribution, and etiology of disease in human populations." Id. at 551. More particularly, epidemiology focuses on the question of "general causation," that is, whether the agent under study is "capable of causing disease," and does not focus on specific causation in a particular individual. Id. at 552. Epidemiology is premised on the idea "that disease is not distributed randomly" and that certain groups are at increased risk of contracting a particular disease. Id. at 551.

         Epidemiological studies are used to test whether exposure to a particular agent causes a harmful effect or disease. Id. at 551-52. Although such studies may reveal an association between a particular agent and a particular disease, "[a]n association identified in an epidemiological study may or may not be causal," and causation must be assessed in consideration with the "strengths and weaknesses of the study's design and implementation, as well as a judgment about how the study findings fit with other scientific knowledge." Id. at 552-53. When evaluating a study's evidential value, a basic consideration is whether the particular study used a sound methodology, as well as the extent to which the study's results may be due to "bias, confounding, or sampling error." Id. at 554.

         Among the different kinds of epidemiological studies, randomized trials are "considered the gold standard for determining the relationship of an agent to a health outcome or adverse side effect." Id. at 555.[5] Where randomized trials cannot be performed, researchers rely on "observational" studies. Id. at 555-57. There are two types of such studies: (1) a case-control study, which measures and compares the frequency of exposure in the group with the disease (cases) and a similar group without the disease (controls); and (2) a cohort study, which compares a group of exposed and unexposed individuals over a period of time. Id. At 557-59. Observational studies identify a group of individuals exposed to the agent in question and then compare their rate of disease to that of an unexposed group. Id. at 556. A weakness in such studies is "the possibility of differences in the two populations being studied with regard to risk factors other than exposure to the agent." Ibid. Investigators generally cannot control for a variety of "confounders" that may distort such a study's results. Ibid. A confounder's influence on a study's results therefore must be considered in the study's design and in the interpretation of its results. Ibid.

         Thus, when it comes to using epidemiological studies in legal matters, three basic questions arise in the assessment of a study's methodological soundness:

1. Do the results of an epidemiologic study or studies reveal an association between an agent and disease?
2. Could this association have resulted from limitations of the study (bias, confounding, or sampling error), and, if so, from which?
3. Based on the analysis of limitations in Item 2, above, and on other evidence, how plausible is a causal interpretation of the association?

[Id. at 554.]

         Once an association has been found between exposure to a particular agent and development of a specific disease, researchers then consider whether that association "reflects a true cause-effect relationship." Id. at 597. To do so, researchers look to alternative explanations, such as bias or confounding factors, and then consider how well-recognized "guidelines for inferring causation from an association apply to the available evidence." Id. at 598. However, and importantly, those accepted "guidelines are employed only after a study finds an association to determine whether that association reflects a true causal relationship." Id. at 598-99. Commonly referred to as the "Hill criteria" or "Hill factors, "[6] they consist of the following:

1. Temporal relationship,
2. Strength of the association,
3. Dose-response relationship,
4. Replication of the findings,
5. Biological plausibility (coherence with existing knowledge),
6. Consideration of alternative explanations,
7. Cessation of exposure,
8. Specificity of the association, and
9. Consistency with other knowledge.

[Id. at 600.]

         The Reference Manual contains a section entitled Reference Guide on Medical Testimony, which provides a "Hierarchy of medical evidence." Id. at 723. The parties in this matter do not dispute that the Reference Manual and the scientific community as a whole acknowledge such a hierarchy. The Reference Manual summarizes it as follows: "[w]hen ordered from strongest to weakest, systematic review of randomized trials (meta-analysis) is at the top, followed by single randomized trials, systematic reviews of observational studies, single observational studies, physiological studies, and unsystematic clinical observations." Id. at 723-24. Evidence at the bottom of the hierarchy may ...


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