TORTINI

For your delectation and delight, desultory dicta on the law of delicts.

Ninth Circuit’s Difficulty with Process of Elimination

September 16th, 2018

Differential etiology is a high-fallutin’ term given to a simple disjunctive syllogism in which all disjuncts in the premise but one are eliminated. The syllogism would be a persuasive argument for the one remaining disjunct but only if all the other premises are effectively eliminated. Otherwise, we are left with competing disjunctive premises that remain, without any way of embracing the “one,” for which someone is contending.

Over 100 years ago, the United States Supreme Court recognized the need for eliminating all but the claimed cause in a simple FELA negligence action. In a unanimous decision, the Court declared:

And where the testimony leaves the matter uncertain and shows that any one of half a dozen things may have brought about the injury, for some of which the employer is responsible and for some of which he is not, it is not for the jury to guess between these half a dozen causes and find that the negligence of the employer was the real cause, when there is no satisfactory foundation in the testimony for that conclusion. If the employe is unable to adduce sufficient evidence to show negligence on the part of the employer, it is only one of the many cases in which the plaintiff fails in his testimony, and no mere sympathy for the unfortunate victim of an accident justifies any departure from settled rules of proof resting upon all plaintiffs.”

Patton v. Texas & Pacific RR, 179 U.S. 658, 663-64 (1901).

Recently the United States Court of Appeals, for the Ninth Circuit, recognized the need to rule out alternative factual explanations before a court could enter judgment on a claim of copyright infringement.1 Cobbler Nevada, LLC v Thomas Gonzales, No. 17-35041 (9th Cir., Aug. 27, 2018). The facts of Cobbler Nevada are illustrative.

Someone with access to an IP address registered to Thomas Gonzales used BitTorrent to download a copy of “The Cobbler,” an Adam Sandler movie. Cobbler Nevada LLC sued Mr. Gonzales, not for bad taste, but for infringing on its copyright to the movie. Mr. Gonzales, however, was the owner of an adult foster home, in which several other people had access to Gonzales’ IP address. Cobbler Nevada had no evidence that eliminated the possibility of downloading by other people in the home.

An amended complaint accused Mr. Gonzales of directly infringing the copyright, and alternatively, of contributing to the infringement by not policing this own internet connection.

The panel affirmed the rejection of the infringement claim because the claimant had failed to rule out downloading by someone who other Gonzales:

The direct infringement claim fails because Gonzales’ status as the registered subscriber of an infringing IP address, standing alone, does not create a reasonable inference that he is also the infringer… .”

Id. The panel reasoned that others in the household could have accessed Gonzales’ internet connection, and that the law did not impose a duty to secure the connection from a “frugal” neighbor.

In personal injury cases, the Ninth Circuit takes a very different, and thoroughly illogical approach from its astute reasoning in Cobbler Nevada. In one Ninth Circuit case, the plaintiff claimed without much of any supporting evidence that he had sustained a drug-induced disease, when over 70 percent of cases of that disease were idiopathic. The trial court accurately diagnosed the situation as an impossible proof problem for the plaintiff because the differential etiology method could not eliminate idiopathic causes in the case before the court. Rule 702 led to the exclusion of plantiffs’ proffered opinions, and the trial court entered summary judgment for the defendants. The Ninth Circuit reversed in an ipse dixit judgment that threw logic to the wind. Wendell v. Johnson & Johnson, No. 09-cv-04124, 2014 WL 2943572, at *5 (N.D. Cal. June 30, 2014), rev’d sub nom. Wendell v. GlaxoSmithKline LLC, 858 F.3d 1227 (9th Cir. 2017).2

The two cases, Wendell and Cobbler Nevada, cannot be reconciled. The aberrant and costive reasoning of Wendell will give rise to unflattering speculation about the Circuit’s motivation. Perhaps the next edition of the Reference Manual on Scientific Evidence should have a chapter on elementary logic, to help avoid such embarrassing situations.


1 Jason Tashea, “9th Circuit rules that sharing IP address is insufficient for copyright infringement,” Am. Bar. Ass’n J. (Sept. 4, 2018).

2 For a lively vivisection of the Ninth Circuit’s decision in Wendell, see David L. Faigman & Jennifer Mnookin, “The Curious Case of Wendell v. GlaxoSmithKline LLC,” 48 Seton Hall L. Rev. 607 (2018).

The Expert Witness Who Put God on His Reference List

August 28th, 2018

And you never ask questions
When God’s on your side”

                                Bob Dylan, “With God on Our Side” 1963.

Cases involving claims of personal injury have inspired some of the most dubious scientific studies in the so-called medical literature, but the flights of fancy in published papers are nothing compared with what is recorded in the annals of expert witness testimony. The weaker the medical claims, the more outlandish is the expert testimony proffered. Claims for personal injury supposedly resulting from mold exposure are no exception to the general rule. The expert witness opinion testimony in mold litigation has resulted in several commentaries1 and professional position papers,2 offered to curb the apparent excesses.

Ritchie Shoemaker, M.D., has been a regular expert witness for the mold lawsuit industry. Professional criticism has not deterred Shoemaker, although discerning courts have put the kibosh on some of Shoemaker’s testimonial adventures.3

Shoemaker cannot be everywhere, and so in conjunction with the mold lawsuit industry, Shoemaker has taken to certifying new expert witnesses. But how will Shoemaker and his protégées overcome the critical judicial reception?

Enter Divine Intervention

Make thee an ark of gopher wood; rooms shalt thou make in the ark, and shalt pitch it within and without with pitch.4

Some say the age of prophets, burning bushes, and the like is over, but perhaps not so. Maybe God speaks to expert witnesses to fill in the voids left by missing evidence. Consider the testimony of Dr. Scott W. McMahon, who recently testified that he was Shoemaker trained, and divinely inspired:

Q. Jumping around a little bit, Doctor, how did your interest in indoor environmental quality in general, and mold in particular, how did that come about?

A. I had — in 2009, I had been asked to give a talk at a medical society at the end of October and the people who were involved in it were harassing me almost on a weekly basis asking me what the title of my talk was going to be. I had spoken to the same society the previous four years. I had no idea what I was going to speak about. I am a man of faith, I’ve been a pastor and a missionary and other things, so I prayed about it and what I heard in my head verbatim was pediatric mold exposure colon the next great epidemic question mark. That’s what I heard in my head. And so because I try to live by faith, I typed that up as an email and said this is the name of my topic. And then I said, okay, God, you have ten weeks to teach me about this, and he did. Within three, four weeks maybe five, he had connected me to Dr. Shoemaker who was the leading person in the world at that time and the discoverer of this chronic inflammatory response.

*****

I am a man of faith, I’ve been a pastor and everything. And I realized that this was a real entity.

*****

Q. And do you attribute your decision or the decision for you to start Whole World Health Care also to be a divine intervention?

A. Well, that certainly started the process but I used my brain, too. Like I said, I went and I investigated Dr. Shoemaker, I wanted to make sure that his methods were real, that he wasn’t doing, you know, some sort of voodoo medicine and I saw that he wasn’t, that his scientific practice was standard. I mean, he changes one variable at a time in tests. He tested every step of the way. And I found that his conclusions were realistic. And then, you know, over the last few years, I’ve 1 gathered my own data and I see that they confirm almost every one of his conclusions.

Q. Doctor, was there anything in your past or anything dealing with your family in terms of exposure to mold or other indoor health issues?

A. No, it was totally off my radar.

Q. *** I’m not going to go into great detail with respect to Dr. Shoemaker, but are you Shoemaker certified?

A. I am.

Deposition transcript of Dr. Scott W. McMahon, at pp.46-49, in Courcelle v. C.W. Nola Properties LLC, Orleans Parish, Louisiana No. 15-3870, Sec. 7, Div. F. (May 18, 2018).

You may be surprised that the examining lawyer did not ask about the voice in which God spoke. The examining lawyer seems to have accepted without further question that the voice was that of an adult male voice. Still did the God entity speak in English, or in tongues? Was it a deep, resonant voice like Morgan Freeman’s in Bruce Almighty (2003)? Or was it a Yiddische voice like George Burns, in Oh God (1977)? Were there bushes burning when God spoke to McMahon? Or did the toast burn darker than expected?

Some might think that McMahon was impudent if not outright blasphemous for telling God that “He” had 10 weeks in which to instruct McMahon in the nuances of how mold causes human illness. Apparently, God was not bothered by this presumptuousness and complied with McMahon, which makes McMahon a special sort of prophet.

Of course, McMahon says he used his “brain,” in addition to following God’s instructions. But really why bother? Were there evidentiary or inferential gaps filled in by the Lord? The deposition does not address this issue.

In federal court, and in many state courts, an expert witness may base opinions on facts or data that are not admissible if, and only if, expert witnesses “in the particular field would reasonably rely on those kinds of facts or data in forming an opinion on the subject.5

Have other expert witnesses claimed divine inspiration for opinion testimony? A quick Pubmed search does not reveal any papers by God, or papers with God as someone’s Co-Author. It is only a matter of time, however, before a judge, some where, takes judicial notice of divinely inspired expert witness testimony.


1 See, e.g., Howard M. Weiner, Ronald E. Gots, and Robert P. Hein, “Medical Causation and Expert Testimony: Allergists at this Intersection of Medicine and Law,” 12 Curr. Allergy Asthma Rep. 590 (2012).

2 See, e.g., Bryan D. Hardin, Bruce J. Kelman, and Andrew Saxon, “ACOEM Evidence-Based Statement: Adverse Human Health Effects Associated with Molds in the Indoor Environment,” 45 J. Occup. & Envt’l Med. 470 (2003).

3 See, e.g., Chesson v. Montgomery Mutual Insur. Co., 434 Md. 346, 75 A.3d 932, 2013 WL 5311126 (2013) (“Dr. Shoemaker’s technique, which reflects a dearth of scientific methodology, as well as his causal theory, therefore, are not shown to be generally accepted in the relevant scientific community.”); Young v. Burton, 567 F. Supp. 2d 121, 130-31 (D.D.C. 2008) (excluding Dr. Shoemaker’s theories as lacking general acceptance and reliability; listing Virginia, Florida, and Alabama as states in which courts have rejected Shoemaker’s theory).

4 Genesis 6:14 (King James translation).

5 Federal Rule of Evidence. Bases of an Expert.

The Appeal of the Learned Treatise

August 16th, 2018

In many states, the so-called “learned treatise” doctrine creates a pseudo-exception to the rule against hearsay. The contents of such a treatise can be read to the jury, not for its truth, but for the jury to consider against the credibility of an expert witness who denies the truth of the treatise. Supposedly, some lawyers can understand the distinction between the treatise’s content’s being admitted for its truth as opposed to the credibility of an expert witness who denies its truth. Under the Federal Rules of Evidence, and in some states, the language of the treatise may be considered for its truth as well, but the physical treatise may not be entered into evidence. There are several serious problems with both the state and the federal versions of the doctrine.1

Legal on-line media recently reported about an appeal in the Pennsylvania Superior Court, which heard arguments in a case that apparently turned on allegations of trial court error in refusing to allow learned treatise cross-examination of a plaintiff’s expert witness in Pledger v. Janssen Pharms., Inc., Phila. Cty. Ct. C.P., April Term 2012, No. 1997. See Matt Fair, “J&J Urges Pa. Appeals Court To Undo $2.5M Risperdal Verdict,” Law360 (Aug. 8, 2018) (reporting on defendants’ appeal in Pledger, Pa. Super. Ct. nos. 2088 EDA 2016 and 2187 EDA 2016).

In Pledger, plaintiff claimed that he developed gynecomastia after taking the defendants’ antipsychotic medication Risperdal. Defendants warned about gynecomastia, but the plaintiff claimed that the defendants had not accurately quantified the rate of gynecomastia in its package insert.

From Mr. Fair’s reporting, readers can discern only one ground for appeal, namely whether the “trial judge improperly barred it from using a scientific article to challenge an expert’s opinion that the antipsychotic drug Risperdal caused an adolescent boy to grow breasts.” Without having heard the full oral argument, or having read the briefs, the reader cannot tell whether there were other grounds. According to Mr. Fair, defense counsel contended that the trial court’s refusal to allow the learned treatise “had allowed the [plaintiff’s] expert’s opinion to go uncountered during cross-examination.” The argument, according to Mr. Fair, continued:

Instead of being able to confront the medical causation expert with an article that absolutely contradicted and undermined his opinion, the court instead admonished counsel in front of the jury and said, ‘In Pennsylvania, we don’t try cases by books, we try them by live witnesses’.”

The cross-examination at issue, on the other hand, related to whether gynecomastia could occur naturally in pre-pubertal boys. Plaintiffs’ expert witness, Dr. Mark Solomon, a plastic surgeon, opined that gynecomastia did not occur naturally, and the defense counsel attempted to confront him with a “learned treatise,” an article from the Journal of Endocrinology, which apparently stated to the contrary. Solomon, following the usual expert witness playbook, testified that he had not read the article (and why would a surgeon have read this endocrinology journal?) Defense counsel pressed, and according to Mr. Fair, the trial judge disallowed further inquiry on cross-examination. On appeal, the defendants argued that the trial judge violated the learned treatise rule that allows “scholarly articles to be used as evidence.” The plaintiffs contended, in defense of their judgment below, that the “learned treatise rule” does not allow “scholarly articles to simply be read verbatim into the record,” and that the defense had the chance to raise the article in the direct examination of its own expert witnesses.

The Law360 reporting is curious on several fronts. The assigned error would have only been in support of a challenge to the denial of a new trial, and in a Risperdal case, the defense would likely have made a motion for judgment notwithstanding the verdict, as well as for new trial. Although the appellate briefs are not posted online, the defense’s post-trial motions in Pledger v. Janssen Pharms., Inc., Phila. Cty. Ct. C.P., April Term 2012, No. 1997, are available. See Defendants’ Motions for Post-Trial Relief Pursuant to Pa.R.C.P. 227.1 (Mar. 6, 2015).

At least at the post-trial motion stage, the defendants clearly made both motions for judgment and for a new trial, as expected.

As for the preservation of the “learned treatise” issue, the entire assignment of error is described in a single paragraph (out of 116 paragraphs) in the post-trial motion, as follows:

27. Moreover, appearing to rely on Aldridge v. Edmunds, 750 A.2d 292 (Pa. 2000), the Court prevented Janssen from cross-examining Dr. Solomon with scientific authority that would undermine his position. See, e.g., Tr. 60:9-63:2 (p.m.). Aldridge, however, addresses the use of learned treatises in the direct examination, and it cites with approval the case of Cummings v. Borough of Nazareth, 242 A.2d 460, 466 (Pa. 1968) (plurality op.), which stated that “[i]t is entirely proper in examination and cross-examination for counsel to call the witness’s attention to published works on the matter which is the subject of the witness’s testimony.” Janssen should not have been so limited in its cross examination of Dr. Solomon.

In Cummings, the issue revolved around using manuals that contained industry standards for swimming pool construction, not the appropriateness of a learned scientific treatise. Cummings v. Nazareth Borough, 430 Pa. 255, 266-67 (Pa. 1968). The defense motion did not contend that the defense counsel had laid the appropriate foundation for the learned treatise to be used. In any event, the trial judge wrote an opinion on the post-trial motions, in which he did not appear to address the learned treatise issue at all. Pledger v Janssen Pharms, Inc., Phila. Ct. C.P., Op. sur post-trial motions (Aug. 10., 2017) (Djerassi, J.).

The Pennsylvania Supreme Court has addressed the learned treatise exception to the rule against hearsay on several occasions. Perhaps the leading case described the law as:

well-settled that an expert witness may be cross-examined on the contents of a publication upon which he or she has relied in forming an opinion, and also with respect to any other publication which the expert acknowledges to be a standard work in the field. * * * In such cases, the publication or literature is not admitted for the truth of the matter asserted, but only to challenge the credibility of the witness’ opinion and the weight to be accorded thereto. * * * Learned writings which are offered to prove the truth of the matters therein are hearsay and may not properly be admitted into evidence for consideration by the jury.”

Majdic v. Cincinnati Mach. Co., 537 A. 2d 334, 621-22 (Pa. 1988) (internal citations omitted).

The Law360 report is difficult to assess. Perhaps the reporting by Mr. Fair was non-eponymously unfair? There is no discussion of how the defense had laid its foundation. Perhaps the defense had promised “to connect up” by establishing the foundation of the treatise through a defense expert witness. If there had been a foundation established, or promised to be established, the post-trial motion would have, in the normal course of events, cited the transcript for the proffer of a foundation. And why did Mr. Fair report on the oral argument as though the learned treatise issue was the only issue before the court? Inquiring minds want to know.

Judge Djerassi’s opinion on post-trial motions was perhaps more notable for embracing some testimony on statistical significance from Dr. David Kessler, former Commissioner of the FDA, and now a frequent testifier for the lawsuit industry on regulatory matters. Judge Djerassi, in his opinion, stated:

This statistically significant measure is shown in Table 21 and was within a chi-square rate of .02, meaning within a 98% chance of certainty. In Dr. Kessler’s opinion this is a statistically significant finding. (N.T. 1/29/15, afternoon, pp. p. 27, ln. 2 10-11, p. 28, lns. 7-12).”

Post-trial opinion at p.11.2 Surely, the defense’s expert witnesses explained that the chi-square test did not yield a measure of certainty that the measured statistic was the correct value.

The trial court’s whopper was enough of a teaser to force me to track down Kessler’s testimony, which was posted to the internet by the plaintiffs’ law firm. Judge Djerassi’s erroneous interpretation of the p-value can indeed be traced to Kessler’s improvident testimony:

Q. And since 2003, what have you been doing at University of California San Francisco, sir?

A. Among other things, I am currently a professor of pediatrics, professor of epidemiology, professor of biostatistics.

Pledger Transcript, Thurs., Jan. 28, 2015, Vol. 3, Morning Session at 111:3-7.

A. What statistical significance means is it’s mathematical and scientific calculations, but when we say something is statistically significant, it’s unlikely to happen by chance. So that association is very likely to be real. If you redid this, general statistically significant says if I redid this and redid the analysis a hundred times, I would get the same result 95 of those times.

Pledger Transcript, Fri., Jan. 29, 2015, Vol. 4, Morning Session at 80:18 – 81:2.

Q. So, sir, if we see on a study — and by the way, do the investigators of a study decided in their own criteria what is statistically significant? Do they assign what’s called a P value?

A. Exactly. So you can set it at 95, you can set it at 98, you can set it at 90. Generally, 95 significance level, for those of you who are mathematicians or scientifically inclined, it’s a P less than .05.

Q. As a general rule?

A. Yes.

Q. So if I see a number that is .0158, next to a dataset, that would mean that it occurs by chance less than two in 100. Correct?

A. Yes, that’s what the P value is saying.

Pledger Transcript, Fri., Jan. 29, 2015, Vol. 4, Morning Session at 81:5-20

Q. … If someone — if something has a p-value of less than .02, the converse of it is that your 98 — .98, that would be 98 percent certain that the result is not by chance?

A. Yes. That’s a fair way of saying it.

Q. And if you have a p-value of .10, that means the converse of it is 90 percent, or 90 percent that it’s not by chance, correct?

A. Yes.

Pledger Transcript, Fri., Jan. 29, 2015, Vol. 4, Afternoon Session at 7:14-22.

Q. Okay. And the last thing I’d like to ask about — sorry to keep going back and forth — is so if the jury saw a .0158, that’s of course less than .02, which means that it is 90 — almost 99 percent not by chance.

A. Yes. It’s statistically significant, as I would call it.

Pledger Transcript, Fri., Jan. 29, 2015, Vol. 4, Afternoon Session at 8:7-13.


2 See also Djerassi opinion at p.13 n. 13 (“P<0.02 is the chi—square rate reflecting a data outcome within a 98% chance of certainty.”).

N.J. Supreme Court Uproots Weeds in Garden State’s Law of Expert Witnesses

August 8th, 2018

The United States Supreme Court’s decision in Daubert is now over 25 years old. The idea of judicial gatekeeping of expert witness opinion testimony is even older in New Jersey state courts. The New Jersey Supreme Court articulated a reliability standard before the Daubert case was even argued in Washington, D.C. See Landrigan v. Celotex Corp., 127 N.J. 404, 414 (1992); Rubanick v. Witco Chem. Corp., 125 N.J. 421, 447 (1991). Articulating a standard, however, is something very different from following a standard, and in many New Jersey trial courts, until very recently, the standard was pretty much anything goes.

One counter-example to the general rule of dog-eat-dog in New Jersey was Judge Nelson Johnson’s careful review and analysis of the proffered causation opinions in cases in which plaintiffs claimed that their use of the anti-acne medication isotretinoin (Accutane) caused Crohn’s disease. Judge Johnson, who sits in the Law Division of the New Jersey Superior Court for Atlantic County held a lengthy hearing, and reviewed the expert witnesses’ reliance materials.1 Judge Johnson found that the plaintiffs’ expert witnesses had employed undue selectivity in choosing what to rely upon. Perhaps even more concerning, Judge Johnson found that these witnesses had refused to rely upon reasonably well-conducted epidemiologic studies, while embracing unpublished, incomplete, and poorly conducted studies and anecdotal evidence. In re Accutane, No. 271(MCL), 2015 WL 753674, 2015 BL 59277 (N.J.Super. Law Div., Atlantic Cty. Feb. 20, 2015). In response, Judge Johnson politely but firmly closed the gate to conclusion-driven duplicitous expert witness causation opinions in over 2,000 personal injury cases. “Johnson of Accutane – Keeping the Gate in the Garden State” (Mar. 28, 2015).

Aside from resolving over 2,000 pending cases, Judge Johnson’s judgment was of intense interest to all who are involved in pharmaceutical and other products liability litigation. Judge Johnson had conducted a pretrial hearing, sometimes called a Kemp hearing in New Jersey, after the New Jersey Supreme Court’s opinion in Kemp v. The State of New Jersey, 174 N.J. 412 (2002). At the hearing and in his opinion that excluded plaintiffs’ expert witnesses’ causation opinions, Judge Johnson demonstrated a remarkable aptitude for analyzing data and inferences in the gatekeeping process.

When the courtroom din quieted, the trial court ruled that the proffered testimony of Dr., Arthur Kornbluth and Dr. David Madigan did not meet the liberal New Jersey test for admissibility. In re Accutane, No. 271(MCL), 2015 WL 753674, 2015 BL 59277 (N.J.Super. Law Div. Atlantic Cty. Feb. 20, 2015). And in closing the gate, Judge Johnson protected the judicial process from several bogus and misleading “lines of evidence,” which have become standard ploys to mislead juries in courthouses where the gatekeepers are asleep. Recognizing that not all evidence is on the same analytical plane, Judge Johnson gave case reports short shrift.

[u]nsystematic clinical observations or case reports and adverse event reports are at the bottom of the evidence hierarchy.”

Id. at *16. Adverse event reports, largely driven by the very litigation in his courtroom, received little credit and were labeled as “not evidentiary in a court of law.” Id. at 14 (quoting FDA’s description of FAERS).

Judge Johnson recognized that there was a wide range of identified “risk factors” for irritable bowel syndrome, such as prior appendectomy, breast-feeding as an infant, stress, Vitamin D deficiency, tobacco or alcohol use, refined sugars, dietary animal fat, fast food. In re Accutane, 2015 WL 753674, at *9. The court also noted that there were four medications generally acknowledged to be potential risk factors for inflammatory bowel disease: aspirin, nonsteroidal anti-inflammatory medications (NSAIDs), oral contraceptives, and antibiotics. Understandably, Judge Johnson was concerned that the plaintiffs’ expert witnesses preferred studies unadjusted for potential confounding co-variables and studies that had involved “cherry picking the subjects.” Id. at *18.

Judge Johnson had found that both sides in the isotretinoin cases conceded the relative unimportance of animal studies, but the plaintiffs’ expert witnesses nonetheless invoked the animal studies in the face of the artificial absence of epidemiologic studies that had been created by their cherry-picking strategies. Id.

Plaintiffs’ expert witnesses had reprised a common claimants’ strategy; namely, they claimed that all the epidemiology studies lacked statistical power. Their arguments often ignored that statistical power calculations depend upon statistical significance, a concept to which many plaintiffs’ counsel have virulent antibodies, as well as an arbitrarily selected alternative hypothesis of association size. Furthermore, the plaintiffs’ arguments ignored the actual point estimates, most of which were favorable to the defense, and the observed confidence intervals, most of which were reasonably narrow.

The defense responded to the bogus statistical arguments by presenting an extremely capable clinical and statistical expert witness, Dr. Stephen Goodman, to present a meta-analysis of the available epidemiologic evidence.

Meta-analysis has become an important facet of pharmaceutical and other products liability litigation[1]. Fortunately for Judge Johnson, he had before him an extremely capable expert witness, Dr. Stephen Goodman, to explain meta-analysis generally, and two meta-analyses he had performed on isotretinoin and irritable bowel outcomes.

Dr. Goodman explained that the plaintiffs’ witnesses’ failure to perform a meta-analysis was telling when meta-analysis can obviate the plaintiffs’ hyperbolic statistical complaints:

the strength of the meta-analysis is that no one feature, no one study, is determinant. You don’t throw out evidence except when you absolutely have to.”

In re Accutane, 2015 WL 753674, at *8.

Judge Johnson’s judicial handiwork received non-deferential appellate review from a three-judge panel of the Appellate Division, which reversed the exclusion of Kornbluth and Madigan. In re Accutane Litig., 451 N.J. Super. 153, 165 A.3d 832 (App. Div. 2017). The New Jersey Supreme Court granted the isotretinoin defendants’ petition for appellate review, and the issues were joined over the appropriate standard of appellate review for expert witness opinion exclusions, and the appropriateness of Judge Johnson’s exclusions of Kornbluth and Madigan. A bevy of amici curiae joined in the fray.2

Last week, the New Jersey Supreme Court issued a unanimous opinion, which reversed the Appellate Division’s holding that Judge Johnson had “mistakenly exercised” discretion. Applying its own precedents from Rubanick, Landrigan, and Kemp, and the established abuse-of-discretion standard, the Court concluded that the trial court’s ruling to exclude Kornbluth and Madigan was “unassailable.” In re Accutane Litig., ___ N.J. ___, 2018 WL 3636867 (2018), Slip op. at 79.3

The high court graciously acknowledged that defendants and amici had “good reason” to seek clarification of New Jersey law. Slip op. at 67. In abandoning abuse-of-discretion as its standard of review, the Appellate Division had relied upon a criminal case that involved the application of the Frye standard, which is applied as a matter of law. Id. at 70-71. The high court also appeared to welcome the opportunity to grant review and reverse the intermediate court reinforce “the rigor expected of the trial court” in its gatekeeping role. Id. at 67. The Supreme Court, however, did not articulate a new standard; rather it demonstrated at length that Judge Johnson had appropriately applied the legal standards that had been previously announced in New Jersey Supreme Court cases.4

In attempting to defend the Appellate Division’s decision, plaintiffs sought to characterize New Jersey law as somehow different from, and more “liberal” than, the United States Supreme Court’s decision in Daubert. The New Jersey Supreme Court acknowledged that it had never formally adopted the dicta from Daubert about factors that could be considered in gatekeeping, slip op. at 10, but the Court went on to note what disinterested observers had long understood, that the so-called Daubert factors simply flowed from a requirement of sound methodology, and that there was “little distinction” and “not much light” between the Landrigan and Rubanick principles and the Daubert case or its progeny. Id at 10, 80.

Curiously, the New Jersey Supreme Court announced that the Daubert factors should be incorporated into the New Jersey Rules 702 and 703 and their case law, but it stopped short of declaring New Jersey a “Daubert” jurisdiction. Slip op. at 82. In part, the Court’s hesitance followed from New Jersey’s bifurcation of expert witness standards for civil and criminal cases, with the Frye standard still controlling in the criminal docket. At another level, it makes no sense to describe any jurisdiction as a “Daubert” state because the relevant aspects of the Daubert decision were dicta, and the Daubert decision and its progeny were superseded by the revision of the controlling statute in 2000.5

There were other remarkable aspects of the Supreme Court’s Accutane decision. For instance, the Court put its weight behind the common-sense and accurate interpretation of Sir Austin Bradford Hill’s famous articulation of factors for causal judgment, which requires that sampling error, bias, and confounding be eliminated before assessing whether the observed association is strong, consistent, plausible, and the like. Slip op. at 20 (citing the Reference Manual at 597-99), 78.

The Supreme Court relied extensively on the National Academies’ Reference Manual on Scientific Evidence.6 That reliance is certainly preferable to judicial speculations and fabulations of scientific method. The reliance is also positive, considering that the Court did not look only at the problematic epidemiology chapter, but adverted also to the chapters on statistical evidence and on clinical medicine.

The Supreme Court recognized that the Appellate Division had essentially sanctioned an anything goes abandonment of gatekeeping, an approach that has been all-too-common in some of New Jersey’s lower courts. Contrary to the previously prevailing New Jersey zeitgeist, the Court instructed that gatekeeping must be “rigorous” to “prevent[] the jury’s exposure to unsound science through the compelling voice of an expert.” Slip op. at 68-9.

Not all evidence is equal. “[C]ase reports are at the bottom of the evidence hierarchy.” Slip op. at 73. Extrapolation from non-human animal studies is fraught with external validity problems, and such studies “far less probative in the face of a substantial body of epidemiologic evidence.” Id. at 74 (internal quotations omitted).

Perhaps most chilling for the lawsuit industry will be the Supreme Court’s strident denunciation of expert witnesses’ selectivity in choosing lesser evidence in the face of a large body of epidemiologic evidence, id. at 77, and their unprincipled cherry picking among the extant epidemiologic publications. Like the trial court, the Supreme Court found that the plaintiffs’ expert witnesses’ inconsistent use of methodological criteria and their selective reliance upon studies (disregarding eight of the nine epidemiologic studies) that favored their task masters was the antithesis of sound methodology. Id. at 73, citing with approval, In re Lipitor, ___ F.3d ___ (4th Cir. 2018) (slip op. at 16) (“Result-driven analysis, or cherry-picking, undermines principles of the scientific method and is a quintessential example of applying methodologies (valid or otherwise) in an unreliable fashion.”).

An essential feature of the Supreme Court’s decision is that it was not willing to engage in the common reductionism that has “all epidemiologic studies are flawed,” and which thus privileges cherry picking. Not all disagreements between expert witnesses can be framed as differences in interpretation. In re Accutane will likely stand as a bulwark against flawed expert witness opinion testimony in the Garden State for a long time.


1 Judge Nelson Johnson is also the author of Boardwalk Empire: The Birth, High Times, and Corruption of Atlantic City (2010), a spell-binding historical novel about political and personal corruption.

2 In support of the defendants’ positions, amicus briefs were filed by the New Jersey Business & Industry Association, Commerce and Industry Association of New Jersey, and New Jersey Chamber of Commerce; by law professors Kenneth S. Broun, Daniel J. Capra, Joanne A. Epps, David L. Faigman, Laird Kirkpatrick, Michael M. Martin, Liesa Richter, and Stephen A. Saltzburg; by medical associations the 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, by the Defense Research Institute; by the Pharmaceutical Research and Manufacturers of America; and by New Jersey Civil Justice Institute. In support of the plaintiffs’ position and the intermediate appellate court’s determination, amicus briefs were filed by political action committee the New Jersey Association for Justice; by the Ironbound Community Corporation; and by plaintiffs’ lawyer Allan Kanner.

3 Nothing in the intervening scientific record called question upon Judge Johnson’s trial court judgment. See, e.g., I.A. Vallerand, R.T. Lewinson, M.S. Farris, C.D. Sibley, M.L. Ramien, A.G.M. Bulloch, and S.B. Patten, “Efficacy and adverse events of oral isotretinoin for acne: a systematic review,” 178 Brit. J. Dermatol. 76 (2018).

4 Slip op. at 9, 14-15, citing 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.”).

5 The Court did acknowledge that Federal Rule of Evidence 702 had been amended in 2000, to reflect the Supreme Court’s decision in Daubert, Joiner, and Kumho Tire, but the Court did not deal with the inconsistencies between the present rule and the 1993 Daubert case. Slip op. at 64, citing Calhoun v. Yamaha Motor Corp., U.S.A., 350 F.3d 316, 320-21, 320 n.8 (3d Cir. 2003).

6 See Accutane slip op. at 12-18, 24, 73-74, 77-78. With respect to meta-analysis, the Reference Manual’s epidemiology chapter is still stuck in the 1980s and the prevalent resistance to poorly conducted, often meaningless meta-analyses. SeeThe Treatment of Meta-Analysis in the Third Edition of the Reference Manual on Scientific Evidence” (Nov. 14, 2011) (The Reference Manual fails to come to grips with the prevalence and importance of meta-analysis in litigation, and fails to provide meaningful guidance to trial judges).