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| Heredia v Piccininni, A-5714-14T1 (App. Div. 2017)
http://njlaw.rutgers.edu/collections/courts/appellate/a5714-14.opn.html Before Judges O'Connor and Whipple. On appeal from Superior Court of New Jersey, Law Division, Atlantic County, Docket No. L-2182-13. Oliver T. Barry argued the cause for appellant (Barry, Corrado & Grassi, P.C., attorneys; Mr. Barry, on the briefs). Stephen A. Rudolph argued the cause for respondent (Rudolph & Kayal P.A., attorneys; Mr. Rudolph, on the brief). Michael J. Epstein argued the cause for amicus curiae New Jersey Association for Justice (The Epstein Law Firm, P.A., attorneys; Mr. Epstein, of counsel and on the brief; Michael A. Rabasca, on the brief). New Jersey State Bar Association, attorneys for amicus curiae New Jersey State Bar Association (Miles S. Winder, III, of counsel and on the brief; Lauren D. Fraser, John E. Gregory, Liana M. Nobile and Michael R. Paglione, on the brief). PER CURIAM In this automobile negligence action, plaintiff Jacqueline Heredia appeals from a September 2, 2015 judgment and an August 7, 2015 order denying her motion for new trial.1 Plaintiff contends the trial judge erred when he failed to ask prospective jurors open-ended questions, as mandated by Directive #4-07, (the Directive) depriving her of the opportunity to conduct meaningful jury voir dire. Additionally, plaintiff argues the trial judge erred when he declined to charge the jury with the aggravation of injury charge found in Model Civil Jury Charge 8.11F. It is an abuse of discretion for trial courts not to ask at least three open-ended questions of prospective jurors during jury selection, as mandated by the Directive; therefore, we vacate the judgment, and reverse and remand for a new trial. In her complaint, plaintiff alleged she and defendant were involved in a car accident, during which plaintiff sustained bodily injury.2 The limitation on lawsuit option (the so-called "verbal threshold") applies in this case. See N.J.S.A. 39:6A-8. Before trial, defendant stipulated liability. In preparation for jury selection, plaintiff submitted five open-ended questions to be asked of prospective jurors: 1. What are your feelings regarding the proposition that accidents resulting in serious damage to a vehicle may result in no bodily injuries and accidents resulting in little damage to a vehicle may result in serious bodily injuries? 2. Describe by way of an example an experience in your life that illustrates your ability to be fair and open-minded in this case. 3. Who are the two people that you least admire and why? 4. What would you do about the homeless situation? 5. What would you do about those without medical insurance? The trial judge declined to include any of plaintiff's proposed open-ended questions in the list of questions. The judge found the first question "redundant." As for the second question, the judge stated he would be asking many open-ended and non-leading questions when asking prospective jurors seated in the box about their biographical background; therefore, the judge found it inappropriate to ask the question. The judge rejected the third, fourth, and fifth questions because the questions did not "add to anything" or were irrelevant. As the array entered the courtroom for jury selection, each prospective juror received the Civil Model Jury Selection Questions, as promulgated by the Directive, without any open-ended questions. The judge asked each juror seated in the box multiple biographical questions required by the Directive.3 During jury selection, plaintiff used only two of her six peremptory challenges. See R. 1:8-3(c). Plaintiff's counsel advised the court on four separate occasions the jury was satisfactory. Trial commenced on June 18, 2015. Plaintiff called Dr. Young Lee, an anesthesiologist specializing in pain management. Dr. Lee testified plaintiff told him she had never been in a motor vehicle accident prior to June 3, 2011. Dr. Lee also testified plaintiff had disk herniation and while pain management could control the pain, the herniation was permanent. Plaintiff also called Dr. James Panaia, a chiropractor, who testified plaintiff had a permanent disk herniation. Lastly, plaintiff called radiologist Dr. Ralph Dauito, who stated MRIs taken after the accident revealed disk herniation that would never heal to function normally. Defendant called orthopedic surgeon, Dr. Robert Ponzio. Dr. Ponzio testified plaintiff suffered a cervical strain and sprain injury, and opined plaintiff's injuries were permanent. Dr. Ponzio testified plaintiff had disc bulging, but he considered her condition to be unrelated to the accident. Because plaintiff had no prior history of pain, Dr. Ponzio conceded on cross-examination it was possible to have degeneration in the spine without symptoms of pain or discomfort, and a single traumatic event could cause previously asymptomatic conditions to become symptomatic. Dr. Ponzio testified disc herniation is a permanent injury. At trial, plaintiff argued the judge erroneously denied her request to charge Model Civil Jury Charge 8.11F, aggravation/activation of preexisting asymptomatic conditions, based upon the testimony of Dr. Ponzio. The trial judge denied the request because neither Dr. Ponzio nor any other expert witness testified an underlying condition was aggravated as a result of the accident. The jury returned a verdict of no cause of action on the non-economic losses but awarded plaintiff economic damages of $18,534.41, representing the full value of plaintiff's outstanding medical bills. Plaintiff filed a motion for new trial on July 9, 2015, arguing the trial judge should have asked the open-ended voir dire questions she proposed, as well as charged the jury on aggravation of preexisting injury. After hearing arguments on August 7, 2015, the trial judge denied the motion. This appeal followed. I. On appeal, plaintiff argues the trial court improperly disregarded the Directive by failing to ask open-ended questions during voir dire. We agree a trial judge must ask open-ended questions pursuant to this Directive. We are therefore constrained to vacate the judgment, and reverse and remand for a new trial, to be conducted in accordance with the Directive. The Directive provides direction from our Supreme Court about how to conduct the voir dire process. See Administrative Directive #4-07, "Jury Selection – Model Voir Dire Questions Promulgated by Directive #21-06 – Revised Procedures and Questions" (May 16, 2007), http://www.judiciary.state.nj.us/directive/2007/dir_04_07.pdf. The purpose of the Directive is to "empanel a jury without bias, prejudice, or unfairness." Gonzalez v. Silver, 407 N.J. Super. 576, 596 (App. Div. 2009) (citing State v. Morales, 390 N.J. Super. 470, 472 (App. Div. 2007)). Among other things, pursuant to the Directive, the trial judge is required to ask each juror at least three questions that require answers in narrative form. Ibid. Specifically, the Directive directs, in pertinent part, the following: In addition to the printed questions, the judge shall also inform the jurors in the box and the array that jurors will also be individually asked several questions that they will be required to answer in narrative form. . . . .
The judge will then ask [the] juror each of the open-ended questions, to which a verbal response shall be given and for which appropriate follow up questions will be asked. . . . .
Some open-ended questions must be posed verbally to each juror to elicit a verbal response. The purpose of this requirement is to ensure that jurors verbalize their answers, so the court, attorneys and litigants can better assess the jurors' attitudes and ascertain any possible bias or prejudice, not evident from a yes or no response, that might interfere with the ability of that juror to be fair and impartial. Open-ended questions also will provide an opportunity to assess a juror's reasoning ability and capacity to remember information, demeanor, forthrightness or hesitancy, body language, facial expressions, etc. . . . .
The judge must ask at least three such questions, in addition to the biographical question and the two omnibus qualifying questions. This is a minimum number and judges are encouraged to ask more where such action would be appropriate. The Directive is binding upon all trial courts. See Gonzalez, supra, 407 N.J. Super. at 598. Here, the trial judge asked what he considered open-ended questions; he defined open-ended questions as "questions that call for something other than an yes or no response." However, the questions the judge referred to were either the required biographical or omnibus questions. Such questions may offer some insight into the perspective of prospective jurors, but they do not satisfy the mandate to ask open-ended questions. The Directive unequivocally states the trial judge must ask at least three open-ended questions. While the trial judge was within his discretion to reject plaintiff's proposed open-ended questions, it was an abuse of discretion not to ask any other open-ended questions as directed by the Directive.4 We next turn to the question of whether the error warrants reversal of the trial judgment of no cause for action and the denial of a motion for new trial. We have previously said judges have an affirmative obligation to adhere to administrative directives governing the voir dire process, but counsel also has a duty to raise objection to the jury selection process. Gonzalez, supra, 407 N.J. Super. at 596. We have also said there must be a "miscarriage of justice" that resulted from the failure to follow the Directive in order to reverse a judgment. Ibid. Rule 2:10-2 provides "[a]ny error or omission shall be disregarded by the appellate court unless it is of such a nature as to have been clearly capable of producing an unjust result . . . ." Plaintiff here requested voir dire questions ultimately rejected by the court, with assurances open-ended questions would be asked. Accordingly, we apply the harmless error rule to determine whether the trial court's failure to ask additional open-ended questions was of "such a nature as to have been clearly capable of producing an unjust result." R. 2:10-2. Based upon our review of the record, we cannot conclude the voir dire was sufficiently comprehensive to ensure an impartial jury was ultimately empaneled; the omission of required open-ended questions was not harmless. II. Plaintiff also argues the trial judge erred by refusing to instruct the jury pursuant to Model Civil Jury Charge 8.11F. We disagree. Model Civil Jury Charge 8.11F states in relevant part, If you find that [plaintiff's] preexisting illness/injury(ies)/condition was not causing him/her any harm or symptoms at the time of the accident, but that the preexisting condition combined with injuries incurred in the accident to cause him/her damage, then [plaintiff] is entitled to recover for the full extent of the damage he/she sustained. [Model Jury Charge (Civil), 8.11F "Aggravation of the Preexisting Disability" (1997).] For an aggravation charge to be appropriate, plaintiff must provide evidence to support aggravation of a pre-existing injury. See Edwards v. Walsh, 397 N.J. Super. 567, 572 (App. Div. 2007). However, if defendant raises the issue on cross-examination, the charge would also be appropriate. Ibid. It is therefore the plaintiff's burden to "prepare for comparative medical evidence" or be "at risk of failing to raise a jury-worthy factual issue about whether the subject accident causes the injuries." Davidson v. Slater, 189 N.J. 166, 188 (2007). The failure to instruct the jury correctly constitutes reversible error, Velazquez v. Portadin, 163 N.J. 677, 688 (2000) (citing Patton v. Ambio, 314 N.J. Super. 1, 10 (App. Div. 1998)); however, the trial judge here correctly charged the jury. Plaintiff's witnesses testified plaintiff did not have a prior condition and the injuries she incurred were caused by the accident. Additionally, plaintiff's counsel stated prior to jury selection plaintiff was not making a claim of aggravation of a pre-existing condition. During trial, plaintiff's counsel asked hypothetical questions during cross-examination of Dr. Ponzio to which he responded it is possible to have degeneration of the spine without symptoms, and it is possible for a single incident to cause the conditions to become symptomatic. Dr. Ponzio did not testify plaintiff had a preexisting condition exacerbated by the accident. Counsel's questions merely elicited from Dr. Ponzio that it was "possible." Additionally, plaintiff presented no evidence of having a preexisting condition. The trial judge therefore properly denied plaintiff's request to charge the jury with Model Civil Jury Charge 8.11F. Because we reverse on other grounds, we need not address plaintiff's arguments about the cumulative effect of the trial court's errors. Judgment vacated. Reversed and remanded for a new trial consistent with this opinion. 1 Plaintiff originally filed a Notice of Appeal of the June 23, 2015 jury verdict of no cause of action; however, she subsequently filed an amended Notice of Appeal to reflect she was appealing from the September 2, 2015 final judgment denying her motion for a new trial. 2 Nicole Torres was a passenger in plaintiff's car at the time of the accident. Torres also filed a complaint against defendant but ultimately settled before the trial was over. 3 These questions included, among others, how they received their news, what their favorite television shows were, if they have any bumper stickers on their car, how they spend their time, and if there was anything else they thought the lawyers should know. 4 Appended to the Directive are examples of open-ended questions that may be used. The New Jersey Judiciary Jury Selection Manual contains additional questions. The examples are not the only questions that may be used. The court and parties may create their own questions. See Administrative Directive #4-07, "Jury Selection – Model Voir Dire Questions Promulgated by Directive #21-06 – Revised Procedures and Questions" (May 16, 2007), http://www.judiciary.state.nj.us/directive/2007/dir_04_07.pdf. Hunt v. Virtua Health, A-4196-14 (App. Div. 2017) http://njlaw.rutgers.edu/collections/courts/appellate/a4196-14.opn.html Before Judges Messano, Espinosa and Guadagno. On appeal from Superior Court of New Jersey, Law Division, Camden County, Docket No. L- 4509-11. Michael J. Confusione argued the cause for appellants (Hegge & Confusione, LLC, and Creedon & Feliciani, P.C., attorneys; Mr. Confusione and Heather A. Thomas, of counsel and on the briefs). Mary Kay Wysocki argued the cause for respondents Virtua Health, Inc., Virtua West Jersey Hospital Voorhees, Linda Faragasso, R.N., Barbara Jones, R.N., and Christine Pease, R.N. (Parker McCay, P.A., attorneys; Ms. Wysocki, Thomas M. Walsh and Andrew S. Winegar, on the brief). PER CURIAM Plaintiffs Lisa Hunt and Russell Hunt brought this medical malpractice action on behalf of themselves and their minor child Hailey Rosina Hunt (collectively, plaintiffs), alleging that defendants were negligent during Lisa's labor and the delivery of Hailey, causing extensive, permanent neurological injuries to Hailey. Plaintiffs appeal from the dismissal of their complaint against Virtua West Jersey Hospital Voorhees (Virtua Hospital) and Virtua Health, Inc. (collectively, Virtua); and Linda Faragasso, R.N., Barbara Jones, R.N., and Christine Pease, R.N (collectively, Nurses). 2 For the reasons set forth in this opinion, we affirm. 1. We summarize the facts pertinent to this appeal in the light most favorable to plaintiffs. Brill v. Guardian Life Ins. Co., 142 N.J. 520, 540 (1995); R. 4:46-2[c]. Lisa was admitted to Virtua Hospital at approximately 8:30 a.m. on September 7, 2009. Dr. Kopelove and Faragasso were assigned as the attending physician and nurse, respectively, for the labor and delivery. The Nurses assessed Lisa and Hailey in approximately thirtyminute intervals throughout the entire day, checking – among other things – Lisa's blood pressure and Hailey's fetal heart rate (FHR), including any variability, accelerations or decelerations. Pease and Jones performed the assessments when Faragasso was unavailable. Dr. Kopelove personally assessed Lisa and Hailey approximately every two hours or as needed. Over the next six hours, Lisa was given morphine and an epidural, and her membranes were artificially ruptured. Variable decelerations in Hailey's FHR were consistently noted beginning at 11:30 p.m. At 2:40 p.m., Dr. Kopelove gave orders to begin inducing labor by administering Pitocin, with a beginning flow rate of one milliunit per minute (mu/min). Before Pitocin was administered, preeclampsia labs were drawn. The urinalysis revealed protein in Lisa's urine, "a sign of pregnancy induced hypertension and/or preeclampsia." As a result, Dr. Kopelove ordered that magnesium sulfate be administered. At 3:00 p.m., Pease began administering Pitocin at the rate ordered by Dr. Kopelove. The Pitocin was increased to two mu/min at 5:30 p.m., and then, per Dr. Kopelove's order, to four mu/min. at 6:00 p.m. At 6:10 p.m., the FHR decelerated to seventy-five, which constituted fetal bradycardia. Pitocin was turned off four minutes later at 6:14 p.m. due to the persistent late decelerations. At 6:30 p.m., "a severe bradycardia episode occurred"; Dr. Kopelove determined that an emergency cesarean section (C-section) was necessary and Lisa "was rushed to the operating room." Hailey was delivered at 6:43 p.m. She was described at birth as "lifeless," "limp, apneic, [and] pale with no heart rate." The diagnosis was severe asphyxia. Apgar scores were 0, 0 and 3 at one, five and ten minutes after birth, respectively. Hailey suffers from permanent neurological damage including neurodevelopmental delay and cerebral palsy. Plaintiffs filed their complaint in March 2012. The claims relevant to this appeal are: Virtua was negligent in credentialing and retaining Dr. Kopelove and the Nurses were negligent in treating Lisa and Hailey. We review each of these claims in turn. II. Plaintiffs did not produce any expert report to articulate the standard of care applicable to their direct claims against Virtua. Nonetheless, they argue the trial judge erred in granting summary judgment to Virtua because expert testimony was not required. Plaintiffs also argue the trial judge abused his discretion in issuing protective orders that limited their ability to pursue their claims against Virtua. We are unpersuaded by these arguments. Plaintiffs submit that expert testimony would only have been required if they had alleged "that Virtua 'should have known' about Dr. Kopelove's patient care problems yet failed to uncover her incompetence." They contend that because "Virtua actually knew about" Dr. Kopelove's "patient care issues and problems," expert testimony was not necessary to establish their claims. No legal authority is cited to support this proposition. "The admission or exclusion of expert testimony is committed to the sound discretion of the trial court." Townsend v. Pierre, 221 N.J. 36, 52 (2015). Expert testimony is generally indispensable to a plaintiff's burden of showing a breach of duty when "the matter to be dealt with is so esoteric that jurors of common judgment and experience cannot form a valid judgment as to whether the conduct of a party was reasonable." Butler v. Acme Markets, Inc., 89 N.J. 270, 283 (1982). In Davis v. Brickman Landscaping, Ltd., 219 N.J. 395 (2014), the Court noted that, in addition to the ordinary dental or medical malpractice action, the following types of cases have been acknowledged to concern matters sufficiently esoteric to require expert testimony: "the responsibilities and functions of realestate brokers with respect to open-house tours," precautions necessary to ensure "the safe conduct of a funeral procession," the appropriate "conduct of those teaching karate," the proper application of "pertinent skydiving guidelines," and the proper "repair and inspection" of an automobile. [Id. at 407-08 (citations omitted).] Plaintiffs describe the duty breached by Virtua as a duty "to select only competent physicians to appoint to its medical staff and to sufficiently oversee the physician's care within the walls of its facility." To determine the scope of such a duty without resorting to rank speculation, the jury would have to have an appreciation of what constituted a "competent" physician and what oversight was sufficient. Certainly, these are matters no less esoteric than any of the cases noted by the Supreme Court in Davis. We therefore discern no abuse of discretion in the trial judge's determination that expert testimony was necessary to support plaintiffs' claims. Because plaintiffs could not sustain their burden of establishing both a duty and the breach of that duty, Virtua was entitled to judgment as a matter of law. See Rowe v. Mazel Thirty, LLC, 209 N.J. 35, 41 (2012) (noting that "the moving party is entitled to summary judgment as a matter of law" unless "there is a genuine issue as to any material fact"). III. Plaintiffs also challenge the trial court's entry of protective orders entered in May and June 2014 that prohibited discovery on: (1) materials pertaining to Dr. Kopelove's guilty plea to a driving while intoxicated (DWI) offense in 20083; (2) Virtua's peer review of issues regarding Dr. Kopelove; and (3) Virtua's investigation of prior incidents involving Dr. Kopelove. Plaintiffs settled their claims against Dr. Kopelove in November 2014 and argue that these orders impeded their ability to pursue their claims against Virtua. They do not, however, argue that the entry of the protective orders precluded them from obtaining an expert to establish breach of duty by Virtua, a failure that justified summary judgment in Virtua's favor. Because summary judgment was properly granted on that basis, plaintiffs' challenges to the protective orders are moot and therefore warrant only limited discussion. We review this issue pursuant to an abuse of discretion standard. C.A. ex rel. Applegrad v. Bentolila, 219 N.J. 449, 459 (2014). We are satisfied that plaintiffs' argument regarding the discovery of Dr. Kopelove's DWI conviction lacks sufficient merit to warrant discussion, R. 2:11-3(e)(1)(E), and discern no abuse of discretion as to the other challenged rulings. The May 2014 order prohibited discovery of any factual information regarding the reviews and/or meetings conducted by the Virtua Medical Staff, Obstetrics Department and other members of the Executive and Administrative Staff of [Virtua] regarding complaints, incidents, and other issues raised about the behavior of [Dr. Kopelove] at Virtua Hospital. Defendants sought a second protective order to protect documents relating to Dr. Kopelove’s patient care issues, specifically Virtua’s investigation of an incident in May 2009. In June 2014, following an in camera review of the withheld documents, the trial court observed that they concerned Virtua's investigation of a patient care event in May 2009 and that, pursuant to N.J.S.A. 45:1-36, such materials remain confidential "if the result of the inquiry is a finding of no basis for disciplinary action." The June 2014 order prohibited plaintiffs "from demanding or eliciting in discovery any information regarding issues investigated and addressed at Virtua regarding the actions of Dr. Kopelove, including but not limited to the incident of May 2009."4 Plaintiffs argue the trial court made the following errors in these rulings: (1) failing to make specific determinations regarding each document that was withheld as required by Payton v. New Jersey Turnpike Authority, 148 N.J. 524 (1997); (2) misconstruing N.J.S.A. 45:1-36 by interpreting it to extend confidentiality after there has been a final disposition in an investigation; and (3) declaring the materials not relevant to plaintiffs' claims against Virtua. These arguments lack merit. In the first instance, plaintiffs' reliance on Payton is misplaced. In Payton, supra, 148 N.J. at 554, the Court determined that remand was necessary for the trial court to conduct an in camera review of the documents at issue. The trial court did so here prior to making its determination the documents should remain confidential pursuant to N.J.S.A. 45:1-36. Absent any authority that would require a trial court to provide "specific determinations" regarding precluded discovery in every case, plaintiffs' argument fails. Plaintiffs' second argument – that the trial court "misapplied" N.J.S.A. 45:1-36 because the withheld information should have been released after the final disposition of the investigation – also lacks merit. N.J.S.A. 45:1-36 explicitly states: If the result of the inquiry or investigation is a finding of no basis for disciplinary action, the information shall remain confidential, except that the board or division, as applicable, may release the information to a government agency to facilitate the discharge of its public responsibilities. [(Emphasis added).] In light of the fact that the materials continued to be protected as confidential, plaintiffs' last argument, that the materials were relevant, has no merit. Accordingly, we discern no abuse of discretion in the issuance of the protective orders. IV.
We next turn to the arguments presented by plaintiffs relating to their claims against the Nurses. These arguments arise from the trial court's grant of summary judgment to the Nurses based upon its determination that the plaintiffs failed to establish proximate causation. Plaintiffs initially presented an expert report by a nurse practitioner to support their argument that the Nurses breached a duty that proximately caused Hailey's injuries. They argue the trial court erred in finding the nurse practitioner was not qualified to render an opinion on proximate cause.5 Plaintiffs also argue the trial court erred in barring a supplemental expert report provided by a physician on the issue of proximate causation. To provide context for these issues, we note that the complaint was filed in March 2012. In May 2014, a trial notice set the fourth listing for trial, November 10, 2014. Plaintiffs' expert reports were due June 30, 2014. A court order was entered on August 15, 2014, requiring defendants to submit expert reports by September 12, 2014, and plaintiffs to submit rebuttal expert reports by October 20, 2014. In addition, the order explicitly provided that the October 10, 2014 discovery end date would not be extended. A. Plaintiffs timely served expert reports from Dr. Bruce L. Halbridge, an obstetrics expert, and Jennifer Johnson, R.N., a registered nurse and board-certified nurse practitioner in women's health. The contents of these reports plainly reveal that Dr. Halbridge's opinion was intended to support plaintiffs' claim against Dr. Kopelove and Johnson's opinion was intended to provide the necessary expert opinion to support plaintiffs' claims against the Nurses. Dr. Halbridge's report identified the following "[d]epartures": 1. The failure of Dr. Kopelove to recognize the presence of: a) Recurrent late and variable decelerations b) Significant and persistent loss of fetal heart variability 2. The failure of Dr. Kopelove to deliver the fetus by [1:30 p.m.] due to the presence of recurrent late and variable fetal heart rate decelerations and significantly decreased fetal heart rate variability indicating fetal hypoxia. 3. The failure of Dr. Kopelove to recognize that it is contraindicated to administer Pitocin to increase contraction frequency, intensity, and duration in the presence of recurrent late and variable fetal heart rate decelerations and associated significantly decreased fetal heart rate variability.
Plaintiffs attempted to revive their claims against the Nurses by submitting new expert reports by Dr. Halbridge and Johnson and filing a motion for reconsideration. As we have noted, in his first report, Dr. Halbridge offered no opinions regarding the nurses and laid the blame for Hailey's injuries squarely and unequivocally upon Dr. Kopelove, stating her failure to deliver the fetus approximately five hours earlier "was the direct and proximate cause of" Hailey's injuries. Dr. Halbridge prefaced his second report with: "In this report I will list additional departures from the standard of care. . . ." The "additional departures," however, did not address Dr. Kopelove's departures from the standard of care. Instead, for the first time, he added "[t]he Labor [and] Delivery nurses" as persons who deviated from the standard of care and caused Hailey's injuries. Their alleged deviations were that, like Dr. Kopelove, they failed to recognize the presence of repetitive variable and late decelerations in the presence of significantly reduced variability that clearly indicated that the fetus was experiencing significant hypoxia and needed to be delivered promptly. Dr. Halbridge did not opine that the Nurses had any duty to take action to override, rather than follow, the orders given by Dr. Kopelove throughout Lisa's labor. In her supplemental report,6 Johnson opined for the first time that the Nurses breached a duty in failing to challenge Dr. Kopelove's orders: If the nurse is concerned about the progression or issues of variability and compromise of the infant or the Mother the nurse is required to follow the chain of command per policy in order to assure a positive outcome in both the Mother and infant. In failing to do so, the labor and delivery nurses in this situation breached the standard of care and [sic] resulting in the injury to [Hailey]. These reports were submitted as rebuttal reports and as grounds for the trial court to reconsider its order granting summary judgment. Reconsideration is not appropriate merely because a litigant is dissatisfied with a decision of the court or wishes to reargue a motion. Palombi v. Palombi, 414 N.J. Super. 274, 288 (App. Div. 2010). To be entitled to reconsideration, "a litigant must initially demonstrate that the Court acted in an arbitrary, capricious, or unreasonable manner, before the Court should engage in the actual reconsideration process." D'Atria v. D'Atria, 242 N.J. Super. 392, 401 (Ch. Div. 1990). Reconsideration is properly utilized only in cases "in which either 1) the Court has expressed its decision based upon a palpably incorrect or irrational basis, or 2) it is obvious that the Court either did not consider, or failed to appreciate the significance of probative, competent evidence." Palombi, supra, 414 N.J. Super. at 288 (quoting D'Atria, supra, 242 N.J. Super. at 401). Plainly, the submission of new expert reports that differed from the reports available when the summary judgment motion was decided did not bring the trial court's decision within either of these two narrow categories of cases in which reconsideration is appropriate. Notwithstanding the dubious grounds for granting reconsideration, the trial court found that Dr. Halbridge's new report established causation as to Faragasso. By order dated October 27, 2014, the trial court granted reconsideration in part, reinstating plaintiffs' claims against Faragasso, but affirmed the dismissal of claims against Jones and Pease. Thereafter, defendants moved to bar Dr. Halbridge's and Johnson's supplemental expert reports, arguing they did not constitute proper rebuttal. The trial court barred Dr. Halbridge's report, later clarifying that only the new opinions expressed on the standard of care and causation regarding the Nurses were barred. The trial court denied defendant’s motion to bar Johnson's report, finding that her opinion as to the chain-of-command was a logical extension of her initial report. Faragasso filed a motion for summary judgment, arguing that since Dr. Halbridge's opinion regarding the Nurses was barred, there was no admissible opinion that any alleged deviation attributed to her caused Hailey's injuries. Plaintiffs argued Johnson's opinion that the Nurse's actions increased the risk of harm to Hailey "satisfie[d] the causation requirements." The trial court agreed with Faragasso that this was a medical diagnosis Johnson was not qualified to make; and thus, without Dr. Halbridge's rebuttal report, plaintiffs could not establish causation as to Faragasso. The trial court granted summary judgment to Faragasso, and dismissed the complaint and any crossclaims with prejudice. B. We turn first to the argument that the trial court erred in concluding Johnson was not qualified to render the requisite opinion regarding causation. "Ordinarily, the competency of a witness to testify as an expert is remitted to the sound discretion of the trial court. Absent a clear abuse of discretion, an appellate court will not interfere with the exercise of that discretion." Carey v. Lovett, 132 N.J. 44, 64 (1993); see also Townsend, supra, 221 N.J. at 52- 53.
Usually, a witness presented as an expert "must be a licensed member of the profession whose standards he professes to know." Sanzari v. Rosenfeld, 34 N.J. 128, 136 (1961). However, licensed or even unlicensed individuals involved in another profession can testify as an expert "depend[ing] on the claim involved, the specific allegations made, and the opinions that the expert proposes to offer at trial." Garden Howe Urban Renewal Assocs. v. HACBM Architects Eng'rs Planners, L.L.C., 439 N.J. Super. 446, 456 (App. Div. 2015). It is undisputed that the causation issue in this case requires sufficient knowledge, training and experience to determine the cause of a complex neurological injury in the context of labor and delivery. Plaintiffs rely on the Advanced Practice Nurse Certification Act (APNCA), N.J.S.A. 45:11-45 to -52, to support their argument that Johnson was qualified to opine on the causation issue in this case. N.J.S.A. 45:11-49(a), articulates the [p]ermitted duties of [an] advanced practice nurse"7 and states: In addition to all other tasks which a registered professional nurse may, by law, perform, an advanced practice nurse may manage preventive care services and diagnose and manage deviations from wellness and long-term illnesses, consistent with the needs of the 200 N.J. Super. 620, 634 (App. Div.), certif. denied, 102 N.J. 303 (1985). patient and within the scope of practice of the advanced practice nurse, by: (1) initiating laboratory and other diagnostic tests; (2) prescribing or ordering medications and devices, as authorized by subsections b. and c. of this section; and (3) prescribing or ordering treatments, including referrals to other licensed health care professionals, and performing specific procedures in accordance with the provisions of this subsection. [(Emphasis added).] Plaintiffs argue legislative amendments clarify that the scope of an advanced practice nurse's permitted practices exceeds that of a registered nurse and encompasses the diagnosis and management of a patient's condition. Notably, however, the statute does not provide any clear authority that an advanced practice nurse may diagnose the neurological injury at issue here or, more important, how it was caused. We note further that the autonomy of an advanced practice nurse is limited. N.J.A.C. 13:37-8.1 requires that a nurse practitioner be supervised by an appropriate physician under joint protocols or collaborative agreements. Given the complexity of the medical causation in this case and the limits upon Johnson's scope of expertise, we cannot conclude the trial court abused its discretion in concluding she was not qualified to render the requisite opinion on causation. Relying upon Kemp v. State, 174 N.J. 412 (2002), plaintiffs also contend the trial court erred in ruling Johnson was not qualified to render an opinion without first conducting, sua sponte, an N.J.R.E. 104 hearing. Because plaintiffs did not ask the trial court to conduct an N.J.R.E. 104 hearing, we review this argument for plain error. R. 2:10-2. In Kemp, supra, 174 N.J. at 432, the Court held it was plain error for the trial court to exclude the testimony of an expert without conducting an evidentiary hearing to determine the reliability of the expert's testimony. The issue in Kemp was whether the expert's analysis was "scientifically reliable," meaning "the scientific medical community accepts the process by which [the expert] arrived at his conclusion as one that is consistent with sound scientific principles." Id. at 430-31. Although the Court noted that an in limine hearing provides an efficient means for determining the reliability of expert testimony when a Daubert8 objection is raised, it did not require an in limine hearing in every case in which such an objection is made: Whether to hold one rests in the sound discretion of the [trial] court. But when the ruling on admissibility turns on factual issues, as it does here, at least in the summary judgment context, failure to hold such a hearing may be an abuse of discretion. [Id. at 428 (quoting Padillas v. Stork-Gamco, Inc., 186 F. 3d 412, 418 (3d Cir. 1999)).] There was no Daubert objection here. The issue regarding the admissibility of Johnson's expert opinion was not its scientific reliability but, rather, whether the witness was qualified in her profession to render an expert opinion. Plainly, the trial judge had the authority to conduct an in limine hearing regarding Johnson's qualifications to render an opinion on causation. N.J.R.E. 104(a) provides that a "judge may hear and determine" matters relating to "the qualification of a person to be a witness" at an in limine hearing. See also Rubanick v. Witco Chem. Corp., 125 N.J. 421, 454 (1991); Biunno, Weissbard and Zegas, Current N.J. Rules of Evidence, comment 1 on N.J.R.E. 104 (2017) ("If there is a dispute about the qualifications of a proffered expert witness to testify in a particular field, a preliminary hearing may be utilized to resolve the question." But the decision to conduct a N.J.R.E. 104 hearing rests within the sound discretion of the trial court. Kemp, supra, 174 N.J. at 432. Under the circumstances here, we discern no abuse of discretion and, therefore, no plain error. C. Plaintiffs next contend the trial court abused its discretion by barring Dr. Halbridge's second expert report based on its finding that the report expressed "entirely new opinion[s]" rather than an appropriate rebuttal report. They argue the report was sufficiently related to Dr. Halbridge's first report because his initial opinions "applied to both Dr. Kopelove and [the Nurses]" and the alleged breaches by the Nurses arose from the same set of facts as for Dr. Kopelove. Plaintiffs also argue the additional opinions expressed by Dr. Halbridge constituted "proper rebuttal evidence . . . with respect to the causation element" because he "respond[ed] to the opinions set forth in the defense reports."9 The limited purpose of rebuttal evidence is to rebut evidence presented for the first time in the opposing party's case, and should not be cumulative or repetitive. D.G. ex rel. J.G. v. N. Plainfield Bd. of Educ., 400 N.J. Super. 1, 22-23 (App. Div.), certif. denied, 196 N.J. 346, cert. denied, 555 U.S. 1085, 129 S. Ct. 776, 172 L. Ed. 2d 756 (2008). Determining "[w]hat is proper rebuttal evidence and whether it should be admitted" is a decision that rests "within the sound discretion of the trial judge, and the exercise of that discretion will not be disturbed in the absence of gross abuse." State v. Sanducci, 150 N.J. Super. 400, 402 (App. Div.), certif. denied, 75 N.J. 524 (1977). We discern no abuse of discretion in the trial court's decision to bar the opinion in Dr. Halbridge's supplemental report that the Nurses deviated from a standard of care that proximately caused the injury here. These opinions cannot remotely be considered an amplification of the opinion he expressed in his initial report, before summary judgment was granted to the Nurses, when he unequivocally opined that Dr. Kopelove's deviation was the proximate cause for the injury suffered. Rather than a genuine rebuttal report, this report represented a transparent effort to take a second bite at the apple after expert reports had been exchanged and summary judgment had been granted to the Nurses based on the very deficiency in expert opinion that Dr. Halbridge's second report was designed to cure. Plaintiffs urge that they should be spared the ultimate sanction of dismissal with prejudice because lesser sanctions, such as an extension of discovery or the assessment of counsel fees and costs, could suffice to serve the interests of justice. We disagree. The expert report plaintiffs seek to rely upon was not produced until October 20, 2014, approximately three weeks before the fourth listed trial date, after the October 10, 2014 discovery end date and after summary judgment had been granted to the Nurse defendants. No argument has been made that the opinion in question could not have been obtained and presented during the normal course of discovery. There are, then, no extraordinary circumstances to justify the late alteration in expert theory that was adopted to rescue plaintiffs' claims against the Nurses. See R. 4:24-1[c]. Moreover, even if Dr. Halbridge's report were accepted in full, it fails to establish a critical point necessary for the imposition of liability upon the Nurses. It is undisputed that Dr. Kopelove was the attending physician and that the Nurses followed her orders throughout labor. Dr. Halbridge opined that it was Dr. Kopelove's five-hour delay in ordering a C-section that was the proximate cause of Hailey's injuries. Nowhere in his supplemental report does Dr. Halbridge state the Nurses had grounds to attempt to override Dr. Kopelove's orders, a duty to do so and deviated from that duty. Absent that, his supplemental report fails to provide the requisite opinion regarding causation to support plaintiffs' claims against the Nurses. Affirmed. Footnotes 1. Virtua Health, Inc. was improperly pleaded as "Virtua"; Virtua West Jersey Hospital Voorhees was improperly pleaded as "Virtue Hospital" and "Virtua Health Systems Voorhees"; Linda Faragasso, R.N., was improperly pleaded as "L. Faragasso, R.N.C.,"; and Jean Torrance, R.N. was improperly pleaded as "Jean Torrance, R.N.C." 2. Plaintiffs' claims against Pamela Kopelove, M.D. and Women's Group for OB/GYN were settled. Plaintiffs have not appealed from the order granting summary judgment to defendant nurses Jean Torrance, R.N., and Noreen Palmay, R.N. It is unclear from the record what the disposition of plaintiffs' claims against Dr. Lynch was but those claims are not part of this appeal. Plaintiffs also made additional claims against all defendants that are not relevant to this appeal. 3. 3. The trial judge found the DWI conviction was not relevant in the absence of any evidence that she was under the influence at the time she treated plaintiffs or that the charge had any impact on her ability to adhere to the appropriate standard of care, and also found the only purpose for such discovery was to intimidate, harass, offend and embarrass Dr. Kopelov 4. `Plaintiffs argue that they were entitled to discovery of the documents protected in the June 2014 order pursuant to the common law privilege recognized in Christy v. Salem, 366 N.J. Super. 535, 543 (App. Div. 2004). Although the trial court apparently failed to consider the competing interests of the plaintiff's right to discover the information for litigation purposes and the public interest involved to determine if the peer review privilege applied, id. at 541; see Applegrad, supra, 219 N.J. at 465; any error is of no consequence because this issue is moot. 5. Plaintiffs argued in the alternative that a jury could have found proximate cause proven by application of the "substantial factor" analysis in the absence of expert opinion. This argument lacks sufficient merit to warrant discussion, R. 2:11-3(e)(1)(E), beyond the following brief comment. "New Jersey courts apply the substantial factor test in medical malpractice cases involving preexisting conditions." Reynolds v. Gonzalez, 172 N.J. 266, 280 (2002). Because plaintiffs did not allege there was a preexisting condition, their claim would not be properly subject to analysis under the substantial factor test. 6. Johnson's supplemental report was provided after the due date for plaintiffs' rebuttal reports. 7. Under the APNCA, the titles "advanced practice nurse," "nurse practitioner" and "clinical nurse specialist" are used interchangeably. N.J.S.A. 45:11-46(c). 8. Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579, 113 S. Ct. 2786, 125 L. Ed. 2d 469 (1993). 9. Three of defendants' experts opined that the Nurses' actions during the labor and delivery met the appropriate standard of care. Three other defense experts opined that Hailey's injuries were due to preexisting conditions that defendants had no control over, with one expert stating: "Nothing the health care providers caring for Hailey's mother did or did not do could have prevented the child's injury." In re Accutane Litigation, N.J. Super. (App. Div. 2017) http://njlaw.rutgers.edu/collections/courts/appellate/a4698-14.opn.html Before Judges Reisner, Koblitz and Sumners. On appeal from the Superior Court of New Jersey, Law Division, Atlantic County, Case No. 271 (MCL). Bruce D. Greenberg and David R. Buchanan argued the cause for appellants (Seeger Weiss, LLP, Lite, DePalma, Greenberg, LLC, and Weitz & Luxenberg, PC, attorneys; Mr. Buchanan and Peter Samberg, of counsel; Mr. Buchanan, on the briefs). Paul W. Schmidt (Covington & Burling, LLP) of the District of Columbia bar, admitted pro hac vice, argued the cause for respondents Hoffman LaRoche, Inc. and Roche Laboratories, Inc. (Gibbons PC, Dughi Hewit & Domalewski, PC and Mr. Schmidt, attorneys; Michelle M. Bufano, Natalie H. Mantell, Russell L. Hewit, Mr. Schmidt and Michael X. Imbroscio (Covington & Burling, LLP) of the District of Columbia bar, admitted pro hac vice, of counsel; Ms. Bufano, on the brief). Hollingsworth LLP, attorneys for amicus curiae Pharmaceutical Research and Manufacturers of America (Gregory S. Chernack, of counsel and on the brief). The parties have not filed briefs in A-0910-16. The opinion of the court was delivered by REISNER, P.J.A.D. Plaintiffs, in these 2076 multicounty litigation (MCL) products liability cases, alleged that they developed Crohn's disease1 as a result of taking Accutane (isotretinoin), a prescription acne drug manufactured by defendants Hoffman-La Roche Inc. and Roche Laboratories Inc. (collectively Roche or defendants). After a Kemp2 hearing, the trial court issued a February 20, 2015 order granting defendants' omnibus motion to bar plaintiffs' experts - Dr. David Madigan, a statistician, and Dr. Arthur Kornbluth, a gastroenterologist - from testifying, among other things, that the epidemiology studies on which the defense relied were flawed and unreliable, and that Accutane can cause Crohn's disease. The trial court also directed the parties to prepare an order listing the lawsuits affected by the ruling, and subsequently issued a May 8, 2015 order dismissing 2076 MCL claims with prejudice. Plaintiffs appeal from those orders.3 On this appeal, plaintiffs primarily contend that the trial court misapplied its discretion in finding that the methodologies Madigan and Kornbluth used were scientifically unreliable and inadmissible. After reviewing the record, we reverse the orders on appeal and remand this case to the trial court. We agree with plaintiffs that the trial court went beyond its gatekeeping function, as set forth in Rubanick v. Witco Chemical Corp., 125 N.J. 421, 449 (1991), Landrigan v. Celotex Corp., 127 N.J. 404 (1992), and Kemp, supra, 174 N.J. at 412.4 The trial court took too narrow a view in determining whether the experts were using accepted scientific methodologies to analyze the evidence, and improperly determined the weight and credibility of the experts' testimony. Among other things, the judge inappropriately condemned the experts for relying on relevant scientific evidence other than epidemiological studies, despite their plausible explanations for doing do.5 Consequently, we conclude that the trial court mistakenly exercised discretion in barring the experts' testimony. In reaching our conclusion, we emphasize that we are not placing this court's imprimatur on plaintiffs' experts or on their opinions. The experts on both sides are highly reputable scientists, who view the evidence differently. We find no basis to describe plaintiffs' experts pejoratively as "hired guns," any more than the defense experts are "hired guns." Their testimony should not have been barred because their analyses emphasized different evidence and produced different conclusions than those reached by the defense experts. The fact that plaintiffs' experts found certain evidence to be critically important did not constitute improper "cherry picking," because they provided plausible scientific explanations for their choices. See State v. Dreher, 302 N.J. Super. 408, 464 (App. Div. 1997) ("Expert testimony should not be excluded merely because it fails to account for some condition or fact that the opposing party considers relevant."). We are not predicting whether a jury will find plaintiffs' experts - or defendants' experts - credible or persuasive. That is not our role, as it was not the trial court's role in the Kemp hearing. See Hisenaj v. Kuehner, 194 N.J. 6, 24 (2008) (N.J.R.E. 104 hearings "are intended to determine admissibility, not credibility."). We only hold that, on the record created in the Kemp hearing in this case, the plaintiffs' experts provided well-explained scientific reasons for analyzing the available evidence differently from the defense experts, and for relying more heavily on different evidence than the defense experts relied on. Accordingly, plaintiffs are entitled to present the experts' testimony at trial. I This case cannot be viewed in a vacuum. It is one in a long series of mass tort litigations concerning Accutane.6 We need not review the history in detail, as it is set forth in a series of previous unpublished opinions issued by different panels of this court. We summarize only what is important to this case. For more than a decade, the same trial judge had handled the Accutane cases. To some extent, that judge's familiarity with the prior litigation, and with the multiplicity of scientific issues involved, may have shaped the way the parties and their experts prepared for the current litigation.7 The first judge's rulings no doubt also shaped the parties' litigation strategies. In particular, during the course of the litigation, the first judge determined that the opinions of plaintiffs' experts, based on the same types of evidence relied on by plaintiff's experts in this case, would be admissible as scientifically reliable. We affirmed that determination in McCarrell I, supra, A-3280-07,8 finding that animal studies, case reports, analogous medications, and other evidence relied on by plaintiffs' experts, were types of evidence accepted in the scientific community.9 In the present case, defendants contend that the existence of epidemiological studies now precludes reliance on the other types of evidence on which plaintiff's experts had previously relied. However, the studies on which defendants rely are not the controlled clinical trials that the Federal Judicial Center's Research Manual on Scientific Evidence calls "the gold standard" of scientific evidence. Rather they are observational studies that depend on the collection of information from databases or from patient questionnaires. Plaintiffs' experts testified that the studies are biased and otherwise flawed. We conclude that plaintiffs should be entitled to present that testimony at trial, along with their affirmative evidence in support of their case. II We begin with some background as to Accutane, the epidemiological studies of the drug, and relevant scientific principles of epidemiology. A. Accutane 3 In 1982, the Food and Drug Administration (FDA) approved defendants' application to market Accutane, the brand name for isotretinoin, "to treat recalcitrant nodular acne that has not responded to other regimens." Kendall I, supra, 209 N.J. at 180. The drug is a retinoid, derived from vitamin A, and is very effective in treating severe acne. Ibid. It is well established that Accutane "has a number of known side effects, including dry lips, skin and eyes; conjunctivitis; decreased night vision; muscle and joint aches; elevated triglycerides; and a high risk of birth defects if a woman ingests the drug while pregnant." Ibid. There is also some evidence that Accutane, which was originally studied for use in treating cancer, has an effect on the gastrointestinal tract. The MCL cases concern the alleged propensity of Accutane to cause IBD, a chronic disease which primarily manifests as one of two diseases: Crohn's disease or ulcerative colitis. Id. at 180-81. Although both ulcerative colitis and Crohn's disease share the same core symptoms, including abdominal pain, frequent and often bloody bowel movements, and rectal bleeding, there are differences in the clinical presentation of the disease and the triggers statistically associated for developing it, which include family history, infections, frequent use of some antibiotics, smoking, and possibly the use of oral contraceptives and nonsteroidal anti-inflammatory drugs. Id. at 181. The peak onset of the disease occurs during adolescence—the same period that individuals are likely to have been prescribed Accutane. Ibid. For both diseases there may be a significant latency effect (the time from the exposure to the trigger for IBD to the first symptom of the disease) and a prodromal period (the time from the first symptom of the disease to diagnosis). B. Epidemiological studies For the first six years of this MCL litigation, from 2003 to 2009, there were no epidemiological studies regarding Accutane and IBD. In previous trials, the plaintiffs were permitted to present expert testimony that relied on animal studies, human clinical studies, case reports, class effects, published scientific literature, causality assessments, and biological plausibility. McCarrell I, supra, slip op. at 86; Kendall I, supra, slip op. at 85-86; Sager, supra, slip op. at 20. The first two epidemiological studies (Crockett and Bernstein),10 were published in 2009 and in 2010, finding no statistically significant increased risk of developing Crohn's disease from the use of Accutane, although the Crockett study found ulcerative colitis is associated with exposure to the drug. The Crockett and Bernstein studies were addressed in expert testimony in Gaghan, McCarrell II, and Rossitto. In Kendall II, the expert witnesses addressed four new epidemiological studies (Etminan, Alhusayen, Fenerty, and Racine).11 After the trial in Kendall II, two additional studies were published (Rashtak and Sivaraman).12 The epidemiological studies vary in whether they show that Accutane increases or decreases the risk of developing Crohn's disease. However, with one exception, none of them demonstrates a statistically significant increased risk of developing Crohn's disease from exposure to Accutane. One small study (Sivaraman) did find a statistically significant increased risk. However, when the study authors adjusted the study results for antibiotic use, the results were no longer statistically significant. Plaintiffs' experts questioned the appropriateness of that adjustment. C. Epidemiology In understanding the epidemiological studies, it is first helpful to define the methodology used in conducting such studies and the relevant terms, as testified by the experts at the hearing and as set forth in the Federal Judicial Center, Reference Manual on Scientific Evidence 549, 555 (3d. ed. 2011) (Reference Manual or Manual).13 "Epidemiology is the field of public health and medicine that studies the incidence, distribution, and etiology of disease in human populations." Id. at 551. "Epidemiology assumes that disease is not distributed randomly in a group of individuals and the identifiable subgroups, including those exposed to certain agents [such as prescription drugs], are at increased risk of contracting particular diseases." Ibid. Epidemiological studies identify agents that are associated with an increased risk of a disease in groups of individuals, but "is not equivalent to causation." Id. at 552. There are two types of epidemiological studies: experimental and observational. Id. at 555. Experimental studies, or double-blind randomized control trials, in which one group is exposed to an agent and the other is not, are "considered the gold standard for determining the relationship of an agent to a health outcome or adverse side effect." Ibid. There are, however, no Accutane experimental studies because although such studies have the potential to provide higher quality evidence, they cannot ethically be conducted if researchers suspect that a drug's side-effects are harmful. Id. at 555-56. Instead, all of the Accutane epidemiological studies to date are less rigorous observational studies, which are considered to be the next best available evidence. Id. at 556. There are two types of observational 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. In these studies, researchers "observe" individuals who have already been exposed to the drug and compare them to a group of individuals who have not. Id. at 555-56. Unlike experimental studies in which risk factors can be controlled, observational studies generally focus on individuals living in a community, "for whom characteristics other than the one of interest, such as diet, exercise, exposure to other environmental agents, and genetic background, may distort a study's results." Id. at 556. "[T]he Achilles' heel of observational studies is the possibility of differences in the two populations being studied with regard to risk factors other than exposure to the agent." Ibid. Epidemiological studies commonly express the strength of association between exposure to a drug and a disease in numerical terms as: 1) "relative risk" (RR), the ratio of the incidence rate of a disease in exposed individuals to the risk among the unexposed; or 2) "odds ratio" (OR), the ratio of the odds that an individual with the disease was exposed to the drug to the odds that an individual without the disease was exposed. Id. at 566-69.14 An RR of 1.0 means that the relative risk is equal to the "null hypothesis," that is, that the risk in individuals exposed to Accutane is the same as the risk in unexposed individuals, or that Accutane use is not associated with an increased risk of developing Crohn's disease. Id. at 567. If the RR is greater than 1.0, the risk in exposed individuals is greater than the risk in unexposed individuals. Ibid. For example, an RR of 1.5 means that an exposed individual has a 50% greater chance of contracting Crohn's disease. If the RR is less than 1.0, the exposed group has a decreased risk of contracting the disease. Ibid. Thus, an RR of .32 represents a 68% reduction in risk, which might mean that the drug had a protective effect on developing the disease. The OR or RR is, however, only an estimate of the true value. Determining whether an association identified in an epidemiological study is causal "requires an understanding of 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 553. An assessment must be made of the power of the study to detect associations, the role of chance, and what sources of error might have produced a false result, including sampling variability, bias, and confounding variables (extraneous variables that may affect result). Id. at 566-97. Therefore, a showing of an increased relative risk for Crohn's disease does not automatically prove that Accutane use creates a higher risk of developing the disease because the discrepancy between the exposed and unexposed groups could be the product of chance as a result of random sampling error. Id. at 553. In determining whether a relative risk greater than 1.0 is a true association or the result of random error, researchers consider whether the association is statistically significant. Id. at 628. In making that assessment, researchers calculate a p-value, which "represents the probability that an observed positive association could result from random error even if no association were in fact present." Id. at 576. The p-value quantifies the statistical significance of a relationship; the smaller the p-value the greater the likelihood that associations determined in a study do not result from chance. Id. at 626. The most commonly used p-value is .05, that is for example, that there is a 5% chance that the relative risk could have occurred by random error. Id. at 576-77. A more sophisticated approach, which was used in the studies at issue in this case, involves calculating a confidence interval (CI): A confidence interval is a range of possible values calculated from the results of a study. If a 95% confidence interval is specified, the range encompasses the results we would expect 95% of the time if samples for new studies were repeatedly drawn from the same population. . . . The advantage of a confidence interval is that it displays more information than significance testing. "Statistically significant" does not convey the magnitude of the association found in the study or indicate how statistically stable that association is. A confidence interval shows the boundaries of the relative risk based on selected levels of . . . statistical significance. . . . [T]he confidence interval reveals the likely range of risk estimates consistent with random error. [Id. at 580.] If, for example, a study reveals a RR of 1.5, which represents an elevated risk of developing Crohn's disease, that result might or might not be considered statistically significant, depending on the boundaries of the confidence interval. If the CI includes 1.0 (the null hypothesis, meaning that taking Accutane neither increases nor decreases the risk of developing Crohn's disease), then the 1.5 result is said not to be statistically significant. However, if the CI is entirely above 1.0, for example if it ranges from 1.2 to 3.2, then the 1.5 RR would be considered statistically significant. Id. at 580-81. In assessing whether the failure of a study to find a statistically significant association was exonerative of the drug or simply inconclusive, scientists consider the "power" of a study, or "the probability of finding a statistically significant association of a given magnitude (if it exists) in light of the sample sizes used in the study." Id. at 582. "The power of a study depends on several factors: the sample size; the level of statistical significance specified; the background incidence of disease; and the specified relative risk that the researcher would like to detect." Ibid. The higher the power of the study the less likely it will show a false negative. Ibid. For example, a study with a likelihood of .25 of failing to detect a true RR of 2.0, has a power of .75, meaning the study has a 75% chance of detecting a true RR of 2.0. Ibid. On the other hand, a study with low power has a greater likelihood of failing to detect a significant relative risk, even though such a risk exists. "With large numbers [of individuals included in the study group], the outcome of the test is less likely to be influenced by random error, and the researcher would have greater confidence in the inferences drawn from the data." Id. at 576. Under the proper circumstances, researchers can increase the power of a series of studies by conducting a meta-analysis, which involves pooling the results of different studies, some of which are small and lack statistical power, to arrive at a single figure to represent the totality of the studies. Id. at 608. The Manual indicates, however, that a meta-analysis may produce an unreliable result. The appeal of a meta-analysis is that it generates a single estimate of risk (along with an associated confidence interval), but this strength can also be a weakness, and may lead to a false sense of security regarding the certainty of the estimate. A key issue is the matter of heterogeneity of results among the studies being summarized. If there is more variance among study results than one would expect by chance, this creates further uncertainty about the summary measure from the meta-analysis. Such differences can arise from variations in study quality, or in study populations or in study designs. Such differences in results make it harder to trust a single estimate of effect; the reasons for such differences need at least to be acknowledged and, if possible, explained. People often tend to have an inordinate belief in the validity of the findings when a single number is attached to them, and many of the difficulties that may arise in conducting a meta-analysis, especially of observational studies such as epidemiologic ones, may consequently be overlooked. [Ibid.] III We next address the parties' conflicting testimony on the subjects of gastroenterology and epidemiology. As background, the following chart15 summarizes the epidemiological studies at issue in this case:
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