TORTINI

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

The Judicial Labyrinth for Scientific Evidence

October 3rd, 2018

The real Daedalus (not the musician), as every school child knows, was the creator of the Cretan Labyrinth, where the Minotaur resided. The Labyrinth had been the undoing of many Greeks and barbarians, until an Athenian, Theseus, took up the challenge of slaying the Minotaur. With the help of Ariadne’s thread, Theseus solved the labyrinthic puzzle and slayed the Minotaur.

Theseus and the Minotaur on 6th-century black-figure pottery (Wikimedia Commons 2005)

Dædalus is also the Journal of the American Academy of Arts and Sciences. The Academy has been, for over 230 years, addressing issues issues in both the humanities and in the sciences. In the fall 2018 issue of Dædalus (volume 147, No. 4), the Academy has published a dozen essays by noted scholars in the field, who report on the murky interface of science and law in the courtrooms of the United States. Several of the essays focus on sorry state of forensic “science” in the criminal justice system, which has been the subject of several critical official investigations, only to be dismissed and downplayed by both the Obama and Trump administrations. Other essays address the equally sorry state of judicial gatekeeping in civil actions, with some limited suggestions on how the process of scientific fact finding might be improved. In any event, this issue, Science & the Legal System,” is worth reading even if you do not agree with the diagnoses or the proposed therapies. There is still room for a collaboration between a modern day Daedalus and Ariadne to help us find the way out of this labyrinth.

Introduction

Shari Seidman Diamond & Richard O. Lempert, “Introduction” (pp. 5–14)

Connecting Science and Law

Sheila Jasanoff, “Science, Common Sense & Judicial Power in U.S. Courts” (pp. 15-27)

Linda Greenhouse, “The Supreme Court & Science: A Case in Point,” (pp. 28–40)

Shari Seidman Diamond & Richard O. Lempert, “When Law Calls, Does Science Answer? A Survey of Distinguished Scientists & Engineers,” (pp. 41–60)

Accomodation or Collision: When Science and Law Meet

Jules Lobel & Huda Akil, “Law & Neuroscience: The Case of Solitary Confinement,” (pp. 61–75)

Rebecca S. Eisenberg & Robert Cook-Deegan, “Universities: The Fallen Angels of Bayh-Dole?” (pp. 76–89)

Jed S. Rakoff & Elizabeth F. Loftus, “The Intractability of Inaccurate Eyewitness Identification” (pp. 90–98)

Jennifer L. Mnookin, “The Uncertain Future of Forensic Science” (pp. 99–118)

Joseph B. Kadane and Jonathan J. Koehler, “Certainty & Uncertainty in Reporting Fingerprint Evidence” (pp. 119–134)

Communicating Science in Court

Nancy Gertner & Joseph Sanders, “Alternatives to Traditional Adversary Methods of Presenting Scientific Expertise in the Legal System” (pp. 135–151)

Daniel L. Rubinfeld & Joe S. Cecil, “Scientists as Experts Serving the Court” (pp. 152–163)

Valerie P. Hans and Michael J. Saks, “Improving Judge & Jury Evaluation of Scientific Evidence” (pp. 164–180)

Continuing the Dialogue

David Baltimore, David S. Tatel & Anne-Marie Mazza, “Bridging the Science-Law Divide” (pp. 181–194)

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).

Coffee with Cream, Sugar & a Dash of Acrylamide

June 9th, 2018

Causal statements are made all the time without much thought of their epistemic warrant. On a day that the stock market indices fall, would-be economic pundits point to some putative cause, such as concern about wage inflation. When the stock market rises on the following day, the explanation is that investors were buoyed by corporate tax cuts, even though those tax cuts were supposedly designed to help companies increase wages. As philosophy professor Harry Frankfurt has explained:

Bullshit is unavoidable whenever circumstances require someone to talk without knowing what he is talking about. Thus the production of bullshit is stimulated whenever a person’s obligations or opportunities to speak about some topic exceed his knowledge of the facts that are relevant to that topic.”1

Of course, Frankfurt’s dictum aptly describes the situation with much of expert witness testimony in health effects litigation.

Nothing seems to stimulate speculative causal claiming as much as the potential rewards of rent-seeking litigation under Proposition 65. By popular referendum, the State of California has taken upon itself to make pronouncements about the causal effects of various foods, drugs, and exposures. The referendum became a California statute with the Safe Drinking Water and Toxic Enforcement Act of 1986. Proposition 65 and the subsequent Enforcement Act require the State of California to publish a list of chemicals it “knows” cause cancers or birth defects. California knows a lot. The list, updated annually, now includes about 800 chemicals.

When California knows that a chemical or an exposure causes cancer, the state does not necessarily know that the chemical or exposure causes cancer in human beings; nor does it necessarily know that the chemical or exposure causes cancer at the exposure level experienced by the citizens of the state. Furthermore, many exposures occur in the context of complex mixtures in which a hypothetical effect of one chemical might be offset or antagonized by another chemical in the mixture. But nonetheless, what California “knows” can hurt you if you are on the wrong side of a Prop 65 enforcement action.

What has California gotten for all its “knowledge”? Clearly, the Proposition 65 statute has created huge incentives for private citizens to sue for violations by creating private rights of action against businesses that supposedly violate the law by failing to warn about what California knows. The proof standards for “known to cause cancer” are so removed from scientific discourse that forcing monetary settlements out of California businesses has become at once a big business itself, and a twisted process that distorts the truth of health hazards and benefits. There have been occasional outcries about the abusive system created from what once was perhaps a well-intentioned reform,2 but for the most part, Prop 65 has become the abnormal normal in California.

Mostly California has gotten lawsuits and a glut of warnings with no difference in cancer or birth defect rates than those observed in states less knowledgeable on such matters.3 Some of California’s cancer rates may be a bit lower than the national rates but this outcome is largely the result of lower state rates for smoking and obesity. Some birth defect rates (neural tube defects) are actually higher in California than in the country as a whole.4

Last year, 681 Prop 65 settlements worth $25.6 million were reported to the California attorney general’s office. Attorneys’ and expert witness fees and other litigation costs made up more than 75% of the total.5 The rate of return has been steady over the years. In 2011, 74 percent of Proposition 65 awards went to attorneys’ fees and costs.6

Council for Education and Research on Toxics (CERT)

For all the hoopla over CERT’s lawsuit against Starbucks,7 there has been little coverage of the actual testimony from the trial. One journalist did report that Peter Infante, a frequent testifier for the lawsuit industry, testified on epidemiology for CERT’s lawyer, Raphael Metzger.8 Apparently, Infante described some studies as showing statistically significant correlations between coffee drinking and some kinds of cancer. Infante demurred on whether coffee caused these kinds of cancer, and admitted that one “would need a clinical trial to resolve the issue.” David Kessler, the former FDA commissioner who helped create the breast implant litigation fiasco and who now testifies frequently for the Lawsuit Industry, testified for Starbucks. Despite his substantial fear-mongering credentials, Dr Kessler emphasized that coffee is a “staple of the American diet,” and that drinking coffee has known health benefits. As everyone now knows, Starbucks failed to persuade the California trial judge that coffee, acrylamide and all, should come under the statute’s safe harbor provisions.

Almost five years ago, I first blogged about the CERT, in connection with the Milward case.9 When I first wrote back in 2013, and until the present, CERT, has not had a website, which is odd for an organization that professes to have an educational mission. In 2013, my research on CERT showed it to be a California corporation, EIN: 42-1571530, founded in 2003, with a business address at 401 E. Ocean Blvd., Ste. 800, Long Beach, California 90802-4967, and a telephone number:  1-877-TOX-TORT. CERT’s reported mission statement was furthering scientific understanding of toxins. Plaintiffs’ lawyer Ralph Metzger, a denizen of the Prop 65 world, was noted as the contact person for CERT, and indeed, the telephone number for CERT was the same as that for Metzger’s lawfirm, the Metzger Law Group.

As I started to watch the activities of CERT, I detected some curious patterns. I saw CERT file amicus briefs in legal cases, which is not the typical activity of a scientific research organization.10 Even more curious, and somewhat dubious, in two cases in which Ralphael Metzger of the Metzger Law Group represented the plaintiffs, another firm, Richard Alexander of the Alexander Law Group, represented CERT as an amicus in the same cases.11

Given the publicity created by CERT’s victory in its Proposition 65 citizen’s action against Starbucks, I recently revisited this research. See Alexander Nazaryan, “Will coffee in California come with a cancer warning?Los Angeles Times (Feb. 18, 2018). One group, “Deniers for Hire,” which describes itself as committed to “debunk anti-science propaganda and expose the activists who produce it,” identified CERT as:

a sham environmentalist nonprofit that sues food companies and collects settlements to fund additional lawsuits against other food companies. Founded in 2002 by toxicologist Martyn T. Smith, with backing from the shameless trial lawyers at Metzger Law Group, CERT uses junk science to target California businesses that can be sued under the state’s ill-conceived Proposition 65.”

The connection with Martyn T. Smith, was news to me, and interesting given how frequently Smith testifies for plaintiffs in cases involving even minimal benzene exposure. If correct, this website’s connecting Martyn Smith with CERT raises additional conflict-of-interest issues.

Funding of Research

Does CERT actually support research? Perhaps, after a fashion, but the money trail is as sketchy as is the ownership issue. Searching in Google Scholar turns up several publications that openly acknowledge funding from CERT. Perhaps only the young and naïve will be surprised that CERT money went to Martyn Smith, alleged founder of CERT and testifier for plaintiffs’ counsel, and to Smith’s students.12 In one instance, CERT support has been acknowledged by Martyn Smith and co-authors for the production of a meta-analysis, which can then be relied upon by Smith and other plaintiffs’ expert witnesses in benzene litigation. Although this meta-analysis credits funding from CERT, most readers of a professional journal will have little idea of the funding’s litigation provenance.13 The corresponding author of the CERT-funded meta-analysis was an official in the California state Office of Environmental Health Hazard Assessment, an office which is in a position to make decisions that help CERT in its California litigation goals.14

The funding of Martyn Smith and his students would certainly be questionable if Smith was a founder of or a participant in CERT. When Smith’s litigation opinions were challenged in one high-profile case, CERT rallied to his rescue with an amicus brief, which did not disclose any relationship between CERT and Martyn Smith, or CERT’s funding of Smith’s research. Milward v. Acuity Specialty Prods. Group, Inc., 639 F.3d 11 (1st Cir. 2011).

A current online listing at Guidestar gives Nancy Quam-Wickham as the “principal officer,” with the same EIN for CERT, as I saw five years ago. Quam-Wickham is a professor of history at California State University, in Long Beach. She seems an unlikely person to head up an organization given to research and education on “toxics.” The phone number for CERT is now 6101824891, but the mailing address is still Ralphael Metzger’s law office.

The Charity Navigator website does not rate CERT because its annual revenue is below $1 million. The website describes CERT as a 501(c)(3), with the same current address as Metzger’s lawfirm. According to Charity Navigator, CERT’s IRS 990 return listed assets of $21,880, and income of $137,354, for 2017.

So what are CERT’s educational activities? The sketchiness of CERT’s appearance as an “amicus” in Ralphael Metzger’s own lawsuits seems matched by the sketchiness of the organization’s professed educational mission. A deeper dive discovered that CERT has garnered some acknowledgements on the websites of other organizations. For instance, the Green Science Policy Institute, founded in 2008, for instance, acknowledges CERT for its “generous support” of the Institute’s work.

Some of CERT’s “educational” efforts have not fared particularly well. In the Chemtura Corporation bankruptcy, CERT attempted to intervene to assert a $9 billion claim to compensate “the public” for alleged injuries from the bankrupt’s allegedly toxic chemicals. In re Chemtura Corp., No. 09-11233, U.S. Bankruptcy Court (S.D.N.Y. 2010). Bankruptcy Judge Robert Gerber was not impressed with CERT’s educational efforts, and dismissed the entity as lacking the necessary standing to make a claim.15


1 Harry Frankfurt, On Bullshit 63 (2005).

2 See, e.g., Lisa L. Halko, “California’s Attorney General Acknowledges Prop 65 Abuse,” 22 no. 29 Wash. Leg. Fdtn. Legal Backgrounder (July 27, 2007); Pamela A. MacLean, “California Judge Blasts Firm in Toxic-Warnings Case,” Nat’l L.J. (April 13, 2006); Consumer Defense Group v. Rental Housing Industry Members40 Cal. Rptr. 3d 832 (Cal. Ct. App. 4th 2006) (“As the Attorney General pointed out in oral argument, it does not serve the public interest to have the almost the entirety of the state of California ‘swamped in a sea [of] generic warning signs’.”).

7 Council for Education and Research on Toxics v. Starbucks Corp., BC435759, California Superior Court, Los Angeles County.

8 Edvard Pettersson, “Toxic Java? California Law Carries Big Fines, Little Evidence,” Bloomberg (Oct. 25, 2017).

10 See, e.g., Parker v. Mobil Oil Corp., 7 N.Y.3d 434, 857 N.E.2d 1114, 824 N.Y.S.2d 584 (2006).

11 In Uriarte v. Scott Sales Co., 226 Cal. App. 4th 1396, 172 Cal. Rptr. 3d 886 (2014); Ramos v. Brenntag Specialties, Inc., 63 Cal.4th 500, 203 Cal. Rptr. 3d 273, 372 P.3d 200 (2016). In both of these cases, CERT was joined by a band of scientists proclaiming neutrality and failing to disclose their significant litigation activities and income: Dr. Jerrold Abraham, Dr. Richard W. Clapp, Dr. Ronald Crystal, Dr. David A. Eastmond, Dr. Arthur L. Frank, Dr. Robert J. Harrison, Dr. Ronald Melnick, Dr. Lee Newman, Dr. Stephen M. Rappaport, Dr. David Joseph Ross and Dr. Janet Weiss. SeeSand in My Shoe – CERTainly” (June 17, 2014). Of course, California appellate courts require that amici disclose financial interests. A motion for leave to file an amicus brief must include, among other things, the names of all persons or entities that contributed financially to the brief, and acknowledgments about whether any party of party’s lawyer helped fund the preparation or filing of the brief. Cal. Rules of Court, Rule 8.200(c)(3)(A)(ii), (B), 8.882(d)(3)(A)(ii) and (B).

12 See, e.g., Jimmy Phuong, Simon Kim, Reuben Thomas & Luoping Zhang, “Predicted Toxicity of the Biofuel Candidate 2,5-Dimethylfuran in Envt’l & Biological Systems,” 53 Envt’l & Molecular Mutagenesis 478 (2012); Michele Fromowitz, Joe Shuga, AntonioYip Wlassowsky, Zhiying Ji, Matthew North, Chris D. Vulpe, Martyn T. Smith, and Luoping Zhang, “Bone Marrow Genotoxicity of 2,5-Dimethylfuran, a Green Biofuel Candidate,” 53 Envt’l & Molecular Mutagenesis 488 (2012); Reuben Thomas, Jimmy Phuong, Cliona M. McHale and Luoping Zhang, “Using Bioinformatic Approaches to Identify Pathways Targeted by Human Leukemogens,” 9 Internat’l J. Envt’l. Research & Public Health 2479 (2012).

13 Frolayne M. Carlos-Wallace, Luoping Zhang, Martyn T. Smith, Gabriella Rader & Craig Steinmaus, “Parental, In Utero, and Early-Life Exposure to Benzene and the Risk of Childhood Leukemia: A Meta-Analysis,” 183 Am. J. Epidem. 1 (2016).

14 Dr. Craig Steinmaus, Office of Environmental Health Hazard Assessment, 1515 Clay Street, 16th Floor, Oakland, CA 94612.

15 Caroline Humer, “Judge rules against big Chemtura bankruptcy claim,” Reuters (April 8, 2010); John Parry, “Chemtura hits back at $9 billion claim over toxins,” Reuters (Mar. 24, 2010).

The Amicus Curious Brief

January 4th, 2018

Friends – Are They Boxers or Briefers*

Amicus briefs help appellate courts by bringing important views to bear on the facts and the law in disputes. Amicus briefs ameliorate the problem of the common law system, in which litigation takes place between specific parties, with many interested parties looking on, without the ability to participate in the discussion or shape the outcome.

There are dangers, however, of hidden advocacy in the amicus brief. Even the most unsophisticated court is not likely to be misled by the interests and potential conflicts of interest of groups such as the American Association for Justice or the Defense Research Institute. If the description of the group is not as fully forthcoming as one might like, a quick trip to its website will quickly clarify the group’s mission on Earth. No one is fooled, and the amicus briefs can be judged on their merits.

What happens when the amici are identified only by their individual names and institutional affiliations? A court might be misled into thinking that the signatories are merely disinterested academics, who believe that important information or argument is missing from the appellate discussion.

The Pennsylvania Supreme Court has offered itself up as an example of a court snookered by “58 physicians and scientists.”1 Rost v. Ford Motor Co., 151 A.3d 1032, 1052 (Pa. 2016). Without paying any attention to the provenance of the amicus brief or the authors’ deep ties with the lawsuit industry, the court cited the brief’s description of:

“the fundamental notion that each exposure to asbestos contributes to the total dose and increases the person’s probability of developing mesothelioma or other cancers as an ‘irrefutable scientific fact’. According to these physicians and scientists, cumulative exposure is merely an extension of the ancient concept of dose-response, which is the ‘oldest maxim in the field’.”

Id. (citing amicus brief at 2).

Well, irrefutable in the minds of the 58 amici curious perhaps, who failed to tell the court that not every exposure contributes materially to cumulative exposure such that it must be considered a “substantial contributing factor.” These would-be friends also failed to tell the court that the human body has defense mechanisms to carcinogenic exposures, which gives rise to a limit on, and qualification of, the concept of dose-response in the form of biological thresholds, below which exposures do not translate into causative doses. Even if these putative “friends” believed there was no evidence for a threshold, they certainly presented no evidence against one. Nonetheless, a confused and misguided Pennsylvania Supreme Court affirmed the judgment below in favor of the plaintiffs.

The 58 amici also misled the Pennsylvania Supreme Court on several other issues. By their failure to disclose important information about themselves, and holding themselves out (falsely but successfully) as “disinterested” physicians and scientists, these so-called friends misled the court by failing to disclose the following facts:

1. Some of them were personal friends, colleagues, and fellow-party expert witnesses of the expert witness (Arthur Frank), whose opinion was challenged in the lower courts;

2. Some of the amici had no reasonable claim to expertise on the issues addressed in the brief;

3. Some of the amici have earned substantial fees in other asbestos cases, involving the same issues raised in the Rost case;

4. Some of the amici have been excluded from testifying in similar cases, to the detriment of their financial balance sheets;

5. Some of the amici are zealous advocates, who not only have testified for plaintiffs, but have participated in highly politicized advocacy groups such as the Collegium Ramazzini.

Two of the amici are historians (Rosner and Markowitz), who have never conducted scientific research on asbestos-related disease. Their work as labor historians added no support to the scientific concepts that were put over the Pennsylvania Supreme Court. Both of these historians have testified in multiple asbestos cases, and one of them (Markowitz) has been excluded in a state court case, under a Daubert-like standard. They have never been qualified to give expert witness testimony on medical causation issues. Margaret Keith, an adjunct assistant professor of sociology, appears never to have written about medical causation between asbestos and cancer, but she at least is married to another amicus, James Brophy, who has.

Barry Castleman,2 David F. Goldsmith, John M. Dement, Richard A. Lemen, and David Ozonoff have all testified in asbestos or other alleged dust-induced disease cases, with Castleman having the distinction of having made virtually his entire livelihood in connection with plaintiffs-side asbestos litigation testifying and consulting. Castleman, Goldsmith, and Ozonoff have all been excluded from, or severely limited in, testifying for plaintiffs in chemical exposure cases.

(Rabbi) Daniel Thau Teitelbaum has the distinction of having been excluded in case that went to the United States Supreme Court (Joiner), but Shira Kramer,3 Richard Clapp, and Peter F. Infante probably make up for the lack of distinction with the number of testimonial adventures and misadventures. L. Christine Oliver and Colin L. Soskolne have also testified for the lawsuit industry, in the United States, and for Soskolne, in Canada, as well.

Lennart Hardell has testified in cellular telephone brain cancer cases,4 for plaintiffs of course, which qualified as an expert for the IARC on electromagnetic frequency and carcinogenesis.5

Celeste Monforton has earned credentials serving with fellow skapper David Michaels in the notorious Project on Scientific Knowledge and Public Policy (SKAPP) organization.6 Laura S. Welch, like Monforton, another George Washington lecturer, has served the lawsuit industry in asbestos personal injury and other cases.

Exhibit A to the Amicus brief lists the institutional affiliations of each amicus. Although some of the amici described themselves as “consultants,” only one amicus (Massimiliano Bugiani) listed his consultancy as specifically litigation related, with an identification of the party that engaged him: “Consultant of the Plaintiff in the Turin and Milan Courts.” Despite Bugiani’s honorable example, none of the other amici followed suit.

* * * * * * * *

Although many judges and lawyers agree that amicus briefs often bring important factual expertise to appellate courts, there are clearly some abuses. I, for one, am proud to have been associated with a few amicus briefs in various courts. One law professor, Allison Orr Larsen, in a trenchant law review article, has identified some problems and has suggested some reforms.7 Regardless of what readers think of Larsen’s proposed reforms, briefs should not be submitted by testifying and consulting expert witnesses for one side in a particular category of litigation, without disclosing fully and accurately their involvement in the underlying cases, and their financial enrichment from perpetuating the litigation in question.

* Thanks to Ramses Delafontaine for having alerted me to other aspects of the lack of transparency in connection with amicus briefs filed by professional historian organizations.


1 Brief of Muge Akpinar-Elci, Xaver Bauer, Carlos Bedrossian, Eula Bingham, Yv Bonnier-Viger, James Brophy, Massimiliano Buggiani, Barry Castleman, Richard Clapp, Dario Consonni, Emilie Counil, Mohamed Aquiel Dalvie, John M. Dement, Tony Fletcher, Bice Fubini, Thomas H. Gassert, David F. Goldsmith, Michael Gochfeld, Lennart Hadell [sic, Hardell], James Huff, Peter F. Infante, Moham F. Jeebhay, T. K. Joshi, Margaret Keith, John R. Keyserlingk, Kapil Khatter, Shira Kramer, Philip J. Landrigan, Bruce Lanphear, Richard A. Lemen, Charles Levenstein, Abby Lippman, Gerald Markowitz, Dario Mirabelli, Sigurd Mikkelsen, Celeste Monforton, Rama C. Nair, L. Christine Oliver, David Ozonoff, Domyung Paek, Smita Pakhale, Rolf Petersen, Beth Rosenberg, Kenneth Rosenman, David Rosner, Craig Slatin, Michael Silverstein, Colin L. Soskolne, Leslie Thomas Stayner, Ken Takahashi, Daniel Thau Teitelbaum, Benedetto Terracini, Annie Thebaud-Mony, Fernand Turcotte, Andrew Watterson, David H. Wegman, Laura S. Welch, Hans-Joachim Woitowitz as Amici Curiae in Support of Appellee, 2015 WL 3385332, filed in Rost v. Ford Motor Co., 151 A.3d 1032 (Pa. 2016).

2 SeeThe Selikoff – Castleman Conspiracy” (Mar. 13, 2011).

4 Newman v. Motorola, Inc., 218 F. Supp. 2d 769 (D. Md. 2002) (excluding Hardell’s proposed testimony), aff’d, 78 Fed. Appx. 292 (4th Cir. 2003) (affirming exclusion of Hardell).

6 See, e.g., SKAPP A LOT” (April 30, 2010); Manufacturing Certainty” (Oct. 25, 2011); “David Michaels’ Public Relations Problem” (Dec. 2, 2011); “Conflicted Public Interest Groups” (Nov. 3, 2013).

7 See Allison Orr Larsen, “The Trouble with Amicus Facts,” 100 Virginia L. Rev. 1757 (2014). See also Caitlin E. Borgmann, “Appellate Review of Social Facts in Constitutional Rights Cases,” 101 Calif. L. Rev. 1185, 1216 (2013) (“Amicus briefs, in particular, are often submitted by advocates and may be replete with dubious factual assertions that would never be admitted at trial.”).

Some High-Value Targets for Sander Greenland in 2018

December 27th, 2017

A couple of years ago, Sander Greenland and I had an interesting exchange on Deborah Mayo’s website. I tweaked Sander for his practice of calling out defense expert witnesses for statistical errors, while ignoring whoopers made by plaintiffs’ expert witnesses. SeeSignificance Levels Made a Whipping Boy on Climate-Change Evidence: Is p < 0.05 Too Strict?” Error Statistics (Jan. 6, 2015).1 Sander acknowledged that he received a biased sample of expert reports through his service as a plaintiffs’ expert witness, but protested that defense counsel avoided him like the plague. In an effort to be helpful, I directed Sander to an example of bad statistical analysis that had been proffered by Dr Bennett Omalu, in a Dursban case, Pritchard v. Dow Agro Sciences, 705 F. Supp. 2d 471 (W.D. Pa. 2010), aff’d, 430 F. App’x 102, 104 (3d Cir. 2011).2

Sander was unimpressed with my example of Dr. Omalu; he found the example “a bit disappointing though because [Omalu] was merely a county medical examiner, and his junk analysis was duly struck. The expert I quoted in my citations was a full professor of biostatistics at a major public university, a Fellow of the American Statistical Association, a holder of large NIH grants, and his analysis (more subtle in its transgressions) was admitted” (emphasis added). Sander expressed an interest in finding “examples involving similarly well-credentialed, professionally accomplished plaintiff experts whose testimony was likewise admitted… .”

Although it was heartening to read Sander’s concurrence in the assessment of Omalu’s analysis as “junk,” Sander’s rejection of Dr. Omalu as merely a low-value target was disappointing, given that Omalu also has a master’s degree in public health, from the University of Pittsburgh, where he claims he studied with Professor Lew Kuller. Omalu has also gained some fame and notoriety for his claim to have identified the problem of chronic traumatic encephalopathy (CTE) among professional football players. After all, even Sander Greenland has not been the subject of a feature-length movie (Concussion), as has Omalu.

I lost track of our exchange in 2015, until recently I was reminded of it when reading an expert report by Professor Martin Wells. Unlike Omalu, Wells meets all the Greenland criteria for high-value targets. He is not only a full, chaired professor but also the statistics department chairman at an ivy-league school, Cornell University. Wells is a fellow of both the American Statistical Association and the Royal Statistical Society, but most important, Wells is a frequent plaintiffs’ expert witness, who is well known to Sander Greenland. Both Wells and Greenland served, side by side, as plaintiffs’ expert witnesses in the pain pump litigation.

So here is the passage in the Wells’ report that is worthy of Greenland’s attention:

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.”

In re Testosterone Replacement Therapy Prods. Liab. Litig., Declaration of Martin T. Wells, Ph.D., at 2-3 (N.D. Ill., Oct. 30, 2016). Unlike the Dursban litigation involving Bennett Omalu, where the “junk analysis” was excluded, in the litigation against AbbVie for its manufacture and selling of prescription testosterone supplementation, Wells’ opinions were not excluded or limited. In re Testosterone Replacement Therapy Prods. Liab. Litig., No. 14 C 1748, MDL No. 2545, 2017 WL 1833173 (N.D. Ill. May 8, 2017) (denying Rule 702 motions).

Now this statement by Wells surely offends the guidance provided by Greenland and colleagues.3 And it was exactly the sort of misrepresentation that led to a confabulation of the American Statistical Association, and that Association’s consensus statement on statistical significance.4

And here is another example, which occurs not in a distorting litigation forum, but on the pages of an occupational health journal, where the editor in chief, Anthony L. Kiorpes, ranted about the need for better statistical editing and writing in his own journal. See Anthony L Kiorpes, “Lies, damned lies, and statistics,” 33 Toxicol. & Indus. Health 885 (2017). Kiorpes decried he misuse of statistics:

I am not implying that it is the intent of the scientists who publish in these pages to mislead readers by their use of statistics, but I submit that the misuse of statistics, whether intentional or otherwise, creates confusion and error.”

Id. at 885. Kiorpes then proceeded to hold himself up as Exhibit A to his screed:

Remember that p values are estimates of the probability that the null hypothesis (no difference) is true.”

Id. Uggh; we seem to be back sliding after the American Statistical Association’s consensus statement.

Almost all scientists have stated (or have been tempted to state) something like ‘the mean of Group A was greater than that of Group B, but the difference was not statistically significant’. With very few exceptions (which I will mention below), this statement is nonsense.”

* * * * *

What the statistics are indicating when the p-value is greater than 0.05 is that there is ‘no difference’ between group A and group B.”

Id. at 886.

Let’s hope that this gets Sander Greenland away from his biased sampling of expert witnesses, off the backs of defense expert witnesses, and on to some of the real culprits out there, in the new year.


See also Sander Greenland on ‘The Need for Critical Appraisal of Expert Witnesses in Epidemiology and Statistics’” (Feb. 8, 2015).

See alsoPritchard v. Dow Agro – Gatekeeping Exemplified” (Aug. 25, 2014); Omalu and Science — A Bad Weld” (Oct. 22, 2016); Brian v. Association of Independent Oil Distributors, No. 2011-3413, Westmoreland Cty. Ct. Common Pleas, Order of July 18, 2016 (excluding Dr. Omalu’s testimony on welding and solvents and Parkinson’s disease).

3 See, e.g., Sander Greenland, Stephen J. Senn, Kenneth J. Rothman, John B. Carlin, Charles Poole, Steven N. Goodman, and Douglas G. Altman, “Statistical tests, P values, confidence intervals, and power: a guide to misinterpretations,” 31 Eur. J. Epidem. 337 (2016).

4 Ronald L. Wasserstein & Nicole A. Lazar, “American Statistical Association Statement on statistical significance and p values,” 70 Am. Statistician 129 (2016)

Mississippi High Court Takes the Bite Out of Forensic Evidence

November 3rd, 2017

The Supreme Court’s 1993 decision in Daubert changed the thrust of Federal Rule of Evidence 702, which governs the admissibility of expert witness opinion testimony in both civil and criminal cases. Before Daubert, lawyers who hoped to exclude opinions lacking in evidentiary and analytical support turned to the Frye decision on “general acceptance.” Frye, however, was an outdated rule that was rarely applied outside the context of devices. Furthermore, the meaning and application of Frye were unclear. Confusion reigned on whether expert witnesses could survive Frye challenges simply by adverting to their claimed use of a generally accepted science, such as epidemiology, even though their implementation of epidemiologic science was sloppy, incoherent, and invalid.

Daubert noted that Rule 702 should be interpreted in the light of the “liberal” goals of the Federal Rules of Evidence. Some observers rejoiced at the invocation of “liberal” values, but history of the last 25 years has shown that they really yearned for libertine interpretations of the rules. Liberal, of course, never meant “anything goes.” It is unclear why “liberal” cannot mean restricting evidence not likely to advance the truth-finding function of trials.

Criminal versus Civil

Back on April 27, 2009, then President Barack Obama announced the formation of the President’s Council of Advisors on Science and Technology (PCAST). The mission of PCAST was to advise the President and his administration on science and technology, and their policy implications. Although the PCAST was a new council, presidents have had scientific advisors and advisory committees back to Franklin Roosevelt, in 1933.

On September 20, 2016, PCAST issued an important report to President Obama, Report to the President on Forensic Science in Criminal Courts: Ensuring Scientific Validity of Feature-Comparison Methods. Few areas of forensic “science,” beyond DNA matching, escaped the Council’s withering criticism. Bite-mark evidence in particular received a thorough mastication.

The criticism was hardly new. Seven years earlier, the National Academies of Science issued an indictment that forensic scientists had largely failed to establish the validity of their techniques and conclusions, and that the judiciary had “been utterly ineffective in addressing this problem.”1

The response from Obama’s Department of Justice, led by Loretta Lynch, was underwhelming.2 The Trump response was equally disappointing.3 The Left and the Right appear to agree that science is dispensable when it becomes politically inconvenient. It is a common place in the community of evidence scholars that Rule 702 is not applied with the same enthusiasm in criminal cases, to the benefit of criminal defendants, as the rule is sometimes, sporadically and inconsistently applied in civil cases. The Daubert revolution has failed the criminal justice system perhaps because courts are unwilling to lift the veil on forensic evidence, for fear they may not like what the find.4

A Grudging Look at the Scientific Invalidity of Bite Mark Evidence

Sherwood Brown was convicted of a triple murder in large measure as a result of testimony from Dr. Michael West, a forensic odontologist. West, as well as another odontologist, opined that a cut on Brown’s wrist matched the shape of a victim’s mouth. DNA testing authorized after the conviction, however, rendered West’s opinions edentulous. Samples from inside the female victim’s mouth yielded male DNA, but not that of Mr. Brown.5

Did the PCAST report leave an impression upon the highest court of Mississippi? The Supreme Court of Mississippi vacated Brown’s conviction and remanded for a new trial, in an opinion that a bitemark expert might describe as reading like a bite into a lemon. Brown v. State, No. 2017 DR 00206 SCT, Slip op. (Miss. Sup. Ct. Oct. 26, 2017). The majority could not bring themselves to comment upon the Dr. West’s toothless opinions. Three justices would have kicked the can down to the trial judge by voting to grant a new hearing without vacating Brown’s convictions. The decision seems mostly predicated on the strength of the DNA evidence, rather than the invalidity of the bite mark evidence. Mr. Brown will probably be vindicated, but bite mark evidence will continue to mislead juries, with judicial imprimatur.


1 National Research Council, Committee on Identifying the Needs of the Forensic Sciences Community, Strengthening Forensic Science in the United States: A Path Forward 53 (2009).

2 See Jordan Smith, “FBI and DoJ Vow to Continue Using Junk Science Rejected by White House Report,” The Intercept (Sept. 23, 2016); Radley Balko, “When Obama wouldn’t fight for science,” Wash. Post (Jan. 4, 2017).

3 See Radley Balko, “Jeff Sessions wants to keep forensics in the Dark Ages,” Wash. Post (April 11, 2017); Jessica Gabel Cino, “Session’s Assault on Forensic Science Will Lead to More Unsafe Convictions,” Newsweek (April 20, 2017).

4 See, e.g., Paul C. Giannelli, “Forensic Science: Daubert’s Failure,” Case Western Reserve L. Rev. (2017) (“in press”).

Disappearing Conflicts of Interest

October 29th, 2017

As the story of who funded the opposition research into Trumski and the Russian micturaters unfolds, both sides of the political spectrum seem obsessed with who funded the research. Funny thing that both sides had coins in the fountain. Funding is, in any event, an invalid proxy for good and sufficient reason. The public should be focused on the truth or falsity of the factual claims. The same goes in science, although more and more, science is evaluated by “conflicts of interest” (COIs) rather than by the strength of evidence and validity of inferences.

No one screams louder today about COIs than the lawsuit industry and its scientist fellow travelers. Although I believe we should rid ourselves of this obsession with COIs, to the extent we must put up with it, the obsession should at least be symmetrical, complete, and non-hypocritical.

In an in-press publication, Morris Greenberg has published an historical account of the role that the U.K. Medical Research Council had in studying asbestos health effects.1 Greenberg often weighs in on occupational disease issues in synch with the litigation industry, and so no one will be entirely surprised that Greenberg suspects undue industry influence (not the lawsuit industry, but an industry that actually makes things). Greenberg may be right in his historical narrative and analysis, but my point today is different. What was interesting about Greenberg’s paper was the disclosure at its conclusion, by the “American Journal of Industrial Medicine editor of record”:

Steven B. Markowitz declares that he has no conflict of interest in the review and publication decision regarding this article.”

Markowitz’s declaration is remarkable in the era when the litigation industry and its scientific allies perpetually have their knickers knotted over perceived COIs. Well known to the asbestos bar, Markowitz has testified with some regularity for plaintiffs’ lawyers and their clients. Markowitz is also an editor in chief of the “red” journal,” the American Journal of Industrial Medicine. Many of the associate editors are regular testifiers for the lawsuit industry, such as Arthur L. Frank and Richard A. Lemen.

Even more curious is that Steven Markowitz, along with fellow plaintiffs’ expert witness, Jacqueline M. Moline, recently published a case report about mesothelioma occuring in an unusual exposure situation, in the red journal. This paper appeared online in February 2017, and carried a disclosure that “[t]he authors have served as expert witnesses in cases involving asbestos tort litigation.2” A bit misleading given how both appear virtually exclusively for claimants, but still a disclosure, whereas Markowitz, qua editor of Greenberg’s article, claimed to have none.

Markowitz, as an alumnus of the Mount Sinai School of Medicine, is, of course, a member of the secret handshake society of the litigation industry, the Collegium Ramazzini. At the Collegium, Markowitz proudly presents his labor union consultancies, but these union ties are not disclosed in Markowitz’s asbestos publications.

Previously, I blogged about Markowitz’s failure to make an appropriate COI disclosure in connection with an earlier asbestos paper.3 See Conflicts of Interest in Asbestos Studies – the Plaintiffs’ Double Standard” (Sept. 18, 2013). At the time, there appeared to be no disclosure of litigation work, but I was encouraged to see, upon checking today, that Markowitz’s disclosure for his 2013 paper now reveals that he has received fees for expert testimony, from “various law firms.” A bit thin to leave out plaintiffs’ law firms, considering that the paper at issue is used regularly by Markowitz and other plaintiffs’ expert witnesses to advance their positions in asbestos cases. A more complete disclosure might read something like: “Markowitz has been paid to consult and testify in asbestos personal injury by plaintiffs’ legal counsel, and to consult for labor unions. In his testimony and consultations, he relies upon this paper and other evidence to support his opinions. This study has grown out of research that was originally funded by the asbestos workers’ union.”

Or we could just evaluate the study on its merits, or lack thereof.


1 Morris Greenberg, “Experimental asbestos studies in the UK: 1912-1950,” 60 Am. J. Indus. Med. XXX (2017) (doi: 10.1002/ajim.22762).

2 Steven B. Markowitz & Jacqueline M. Moline, “Malignant Mesothelioma Due to Asbestos Exposure in Dental Tape,” 60 Am. J. Indus. Med. 437 (2017).