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Finding Big Blue

July 26th, 2021

The Washington Supreme Court recently upheld an $81.5 million verdict, against GPC and NAPA, in an asbestos peritoneal mesothelioma case. The award included $30 million for loss of consortium. Coogan v. Borg-Warner Morse Tec Inc., 12 Wash. App. 2d 1021, 2020 WL 824192 (2020), rev’d in part, No. 98296-1, 2021 Wash. LEXIS 383 *, 2021 WL 2835358 (Wash. July 8, 2021).[1] The main points of contention on appeal were plaintiffs’ counsel’s misconduct and the excessiveness of the verdict, which was for only compensatory damages. Twelve defendants settled before trial for a total of $4.4 million. Of the settling defendants, Defendant Manville paid $1.5 million.

Plaintiffs’ proofs against GPC and NAPA were for chrysotile exposure from their brake and clutch parts used by Coogan. Not surprisingly, given that Coogan died of peritoneal mesothelioma, there was a strong suspicion of crocidolite exposure from Manville’s transite product over the course of two years.  Apparently, GPC and NAPA failed to show that Coogan was exposed to crocidolite, even though the workplace was small and other workers had succumbed to asbestos disease.

While the court’s opinion on misconduct and the excessiveness of the verdict are of interest, the most interesting part of the story is what was not told. It is hard to imagine that defense counsel did not try hard to establish the workplace exposures to Manville’s transite. What is not clear is why they failed. Obviously, Manville took the threat seriously enough to pay a significant sum to settle the case before trial. Why could GPC and NAPA not prove at trial what Manville knew?  Were GPC and NAPA the victims of budgetary pressures or limited resources, or were they misled or stonewalled by plaintiffs’ counsel or co-workers?

Given the propensity for crocidolite, such as was used in Manville’s transite, to cause mesothelioma, and especially peritoneal mesothelioma, the trial defendants certainly had an adequate motivation to investigate and to document the crocidolite exposure. 

A recent, large, long-term cohort study in Denmark showed that vehicle mechanics, who use brake linings and clutch parts, as did Coogan, have no increased risk of mesothelioma. Compared with other workers, automobile mechanics actually had a lower than expect risk of mesothelioma or pleural cancer, with an age-adjusted hazard ratio of HR=0.74 (95% CI 0.55 to 0.99)), based upon 47 cases.[2]

The Danish study is in accord with previous studies and meta-analyses,[3] and stands in stark contrast with the epidemiology of mesothelioma among men and women exposed to crocidolite. By way of example, in a cohort of British workers who assembled gas masks during World War II, close to 9% of all deaths were due to mesothelioma.[4] In a published cohort study of workers at Hollingsworth & Vose, a company that made the filters for the Kent cigarette, close to 18 percent of all deaths were due to mesothelioma.[5]

Dr. Irving Selikoff and his colleagues worked assiduously to obscure the vast potency difference between chrysotile and crocidolite, by arguing falsely that crocidolite was not used in the United States,[6] and by suppressing their own research into disease at the Johns-Manville plant that manufactured transite and other products. What is interesting about the Coogan case is what has not been reported. Crocidolite is clearly the most potent cause of mesothelioma.[7] Even if chrysotile were to have posed a risk to someone such as Mr. Coogan, crocidolite exposure, even for just two years, likely represented multiple orders of magnitude greater risk for peritoneal mesothelioma. Without evidence that Coogan was exposed to crocidolite from Mansville’s transite, the manufacturers of brake and clutch parts were unable to seek an apportionment between exposures from their chrysotile and Mansville’s crocidolite. Trying the so-called chrysotile defense is more difficult without being able to show substantial amphibole asbestos exposure.  The bar, both plaintiffs’ and defendants’, could learn a great deal from what efforts were made to establish the crocidolite exposure, why they were unsuccessful, and how the efforts might go better in the future.

[1] Kirk Hartley kindly called my attention to this interesting case.

[2] Reimar Wernich Thomsen, Anders Hammerich Riis, Esben Meulengracht Flachs, David H Garabrant, Jens Peter Ellekilde Bonde, and Henrik Toft Sørensen, “Risk of asbestosis, mesothelioma, other lung disease or death among motor vehicle mechanics: a 45-year Danish cohort study,” Thorax (July 8, 2021), online ahead of print at <doi: 10.1136/thoraxjnl-2020-215041>.

[3] David H. Garabrant, Dominik D. Alexander, Paula E. Miller, Jon P. Fryzek, Paolo Boffetta, M. Jane Teta, Patrick A. Hessel, Valerie A. Craven, Michael A. Kelsh, and Michael Goodman, “Mesothelioma among Motor Vehicle Mechanics: An Updated Review and Meta-analysis,” 60 Ann. Occup. Hyg. 8 (2016); Michael Goodman, M. Jane Teta, Patrick A. Hessel, David H. Garabrant, Valerie A. Craven, Carolyn G. Scrafford, and Michael A. Kelsh, “Mesothelioma and lung cancer among motor vehicle mechanics: a meta-analysis,” 48 Ann. Occup. Hyg. 309 (2004).

[4] See J. Corbett McDonald, J. M. Harris, and Geoffry Berry, “Sixty years on: the price of assembling military gas masks in 1940,” 63 Occup. & Envt’l Med. 852 (2006). 

[5] James A. Talcott, Wendy A. Thurber, Arlene F. Kantor, Edward A. Gaensler, Jane F. Danahy, Karen H. Antman, and Frederick P. Li, “Asbestos-Associated Diseases in a Cohort of Cigarette-Filter Workers,” 321 New Engl. J. Med. 1220 (1989).

[6] “Selikoff and the Mystery of the Disappearing Amphiboles” (Dec. 10, 2010); “Playing Hide the Substantial Factors in Asbestos Litigation” (Sept. 27, 2011).

[7] See, e.g., John T. Hodgson & Andrew A. Darnton, “The quantitative risks of mesothelioma and lung cancer in relation to asbestos exposure,” 14 Ann. Occup. Hygiene 565 (2000); Misty J Hein, Leslie T Stayner, Everett Lehman & John M Dement, “Follow-up study of chrysotile textile workers: cohort mortality and exposure-response,” 64 Occup. & Envt’l Med. 616 (2007); David H. Garabrant & Susan T. Pastula, “A comparison of asbestos fiber potency and elongate mineral particle (EMP) potency for mesothelioma in humans,” 361 Toxicology & Applied Pharmacol. 127 (2018) (“relative potency of chrysotile:amosite:crocidolite was 1:83:376”). See also D. Wayne Berman & Kenny S. Crump, “Update of Potency Factors for Asbestos-Related Lung Cancer and Mesothelioma,” 38(S1) Critical Reviews in Toxicology 1 (2008).

Posted in Asbestos, Causation, Scientific Misconduct | No Comments »

Epistemic Virtue – Dropping the Dime on Tenpenny

July 18th, 2021

When Marjorie Taylor Greene came under fire for propagating lies about Jewish space lasers and other fantastical conspiracy theories, she did not apologize. Rather she turned the opproprium into a grievance about being “allowed” to believe the lies. Blaming the media, Greene complained: “I was allowed to believe things that weren’t true… .”[1]

In a stunning show of bad faith, Greene attempted to redirect fault to the media. Beneath the failed attempt was a stratagem that appears to have prevalent appeal in this day of electronic and social media. There are some people who believe that telling a lie may be a moral failing, but believing a lie simply means you have been victimized. And being a victim is the ticket for admission into our grievance society.

Greene’s transparent attempt to foist blame on those who would allow her to believe hateful and crazy sidesteps her personal responsibility for her beliefs, and ignores that she chose to propagate the pernicious claims. Greene’s metaphor of passivity is essentially false in failing to come to grips with how we form beliefs, curate them, test, and verify them, even before we take to the social media “airways” to publish or re-publish them.

For the last few years, there has been scholarly and popular criticism of social media for its ability to propagate falsehoods, lies, conspiracy theories, and dis-, mis-, and mal-information.[2] Clearly, social media can do these things, but is it really surprising that social media can be an information cesspool? Descriptively, we can acknowledge that people are influenced by false claims made on social media platforms. Prescriptively, we can, and should, hold people to higher standards.

Earlier this week, the United States Surgeon General, Dr. Vivek Murthy proclaimed health misinformation on social media to be “urgent threat.”[3] Dr. Murthy stated that tech and social media companies needed to fight information rot more aggressively, and the Surgeon General’s office issued an advisory about “building a healthy information environment.”[4] Later last week, President Biden criticized social media companies for their failure to control misinformation, and announced a plan for government to participate in fact checking claims made on social media.[5] Biden’s initiative may be creating the state action needed for the yutzballs on the right and the left to make out state action in their claims of unconstitutional censorship.

I hate to play the “what about” game that was made so popular during the Trump Administration, but I have moments of weakness. What about governmental platforms for speech? After centuries of allowing any willing, able, and marginally qualified person, with a reasonable pretense to expertise, to give opinions in court, the federal judicial system cracked down on unsound, poorly supported expert witness opinion testimony. Most state courts dragged their judicial feet, but at least uttered in dicta that they were concerned.

Legislative platforms for speech have no gatekeeper. Any quack can show up, and she does. Take Sherri Jane Tenpenny.  Please.

Sherri Tenpenny is an osteopathic physician who is a well-known, virulent disease vector of disinformation. In its March 2021 report, The Disinformation Dozen, the Center for Countering Digital Hate identified Tenpenny as a top anti-vaccination shyster. As a social media vector, she is ranked in the top dozen “influencers.”[6]

Tenpenny is an anti-vaccination osteopathic physician, who shakes down fearful parents at vaccination bootcamps, and hangs out with internet hoodlums such as Alex Jones, and the plumped-up pillow purveyor, Mike Lindell. She is the author of the 2008 book, Saying No to Vaccines: A Resource Guide for all Ages, where you can find hyperbolic claims, such as “[t]he skyrocketing autism epidemic, controversy surrounding mercury and thimerosal, and the rampant childhood epidemics — asthma, allergies, eczema, attention deficit disorders (ADD), attention deficit hyperactivity disorders (ADHD) and cancer — have been linked to vaccines.”

In federal court, Tenpenny has been blocked from disseminating her malarkey at the gate. In one case, Tenpenny served as an expert witness in support of a claim that a man’s receipt of a hepatitis B vaccination caused him to develop Guillain-Barré syndrome. The Special Master incorrectly wrote that the law required him to presume the admissibility of Tenpenny’s proffered testimony. The law actually requires the proponent to show the admissibility of his expert witness’s opinion testimony. But even with the non-existent presumption, Tenpenny’s opinion was ultimately found to be worth less than a plugged nickel, when the Special Master found her methodology “so divergent from the scientific method as to be nonsensical and confusing.”[7]

In other branches of government, a Tenpenny can go a lot further. Last month, the Ohio legislature invited Tennpenny to testify in support of House Bill 248, Enact Vaccine Choice and Anti-Discrimination Act (June 8, 2021). Introduced into the Ohio House of Representatives by Republican member Jennifer Gross, Bill 248 would “prohibit mandatory vaccinations and vaccination status disclosures.” Indeed, the proposed legislation would prohibit requiring, or creating incentives for, any vaccines, not just vaccinations against SARS-CoV-2. Tenpenny’s testimony did not fail to disappoint.

Tenpenny claimed that vaccines “magnetize” people, such that keys and spoons will stick to their bodies:

“I’m sure you’ve seen the pictures all over the Internet of people who have had these shots and now they’re magnetized. They can put a key on their forehead. It sticks. They can put spoons and forks all over them and they can stick, because now we think that there’s a metal piece to that.”

Tenpenny did not, however, discuss the obvious issue of polarity, and whether people would line up “north” to “south,” when together in a crowd. She vaguely suggested that “[t]here’s been people who have long suspected that there’s been some sort of an interface, yet-to-be-defined interface, between what’s being injected in these shots and all of the 5G towers.”[8]

The fallout from the Tenpenny testimony has been amusing. After the hearing, another Republican, Representative Scott Lipps, blamed Gross for having invited Tenpenny. During the hearing, however, none of the legislators strongly pushed back. Republican legislators thanked her for testifying, and praised her work as “enlightening.” The bill sponsor, Jennifer Gross, who trained as a nurse, told Tennpenny that it was “an honor to have you here.” According to some media reports (sorry), Gross previously compared businesses’ requiring vaccination to the Holocaust. Importantly, none of the legislators asked her for the studies upon which she relied.

Why would anyone think that Facebook, Twitter, or YouTube would act with more epistemic virtue than the Ohio Legislature? The Tenpenny phenomenon raises other interesting and important questions. Tenpenny has been licensed in Ohio as a “D.O.” (Doctor of Osteopathy), no. 34.003789, since 1984. Her online record shows no “board actions” taken or pending. Apparently, the state of Ohio, the American Osteopathic Association, and other professional and regulatory bodies do not see a problem with Tenpenny’s performance in the Ohio House of Representatives.

The American Medical Association (AMA) recognizes that medical evidence in legal and administrative proceedings is critical, and that physicians have a duty to assist.[9] Testifying for a legislative committee would certainly qualify for a legal proceeding. Testifying is the practice of medicine, and physicians who testify must do so “honestly,” with “continuous self-examination to ensure that their testimony represents the facts of the case,” and “only in areas in which they have appropriate training and recent, substantive experience and knowledge.”[10] The AMA Ethical Guidelines further provide that a testifying physician has a responsibility to ensure that his or her testimony “reflects current scientific thought and standards of care that have gained acceptance among peers in the relevant field.”[11]

Perhaps most important, the AMA Ethical Guidelines specify that medical societies and medical licensing boards are responsible for maintaining high standards for medical testimony, and must assess “claims of false or misleading testimony.” When the testimony is false or misleading, these bodies should discipline the offender “as appropriate.”[12]

Where are the adults in the room?

[1] Josh K. Elliott, “GOP’s Marjorie Taylor Greene regrets being ‘allowed’ to believe hoaxes,” Global News Canada (Feb. 4, 2021).

[2] See, e.g., Catherine D. Tan, “Defending ‘snake oil’: The preservation of contentious knowledge and practices,” 51 Social Studies of Science 538 (2021).

[3] Sheryl Gay Stolberg & Davey Alba, “Surgeon General Assails Tech Companies Over Misinformation on Covid-19,” N.Y. Times (July 15, 2021).

[4] Vivek H. Murthy, Health Misinformation: The U.S. Surgeon General’s Advisory on

Building a Healthy Information Environment (2021).

[5] The Associated Press, “Biden Slams Social Media Companies for Pandemic Misinformation,” N.Y. Times (July 16, 2021).

[6] Jonathan Jarry, “A Dozen Misguided Influencers Spread Most of the Anti-Vaccination Content on Social Media: The Disinformation Dozen generates two thirds of anti-vaccination content on Facebook and Twitter,” McGill Univ. Office for Science & Soc’y (Mar. 31, 2021).

[7] Shaw v. Sec’y Health & Human Servs., No. 01-707V, 2009 U.S. Claims LEXIS 534, *84 n.40 (Fed. Cl. Spec. Mstr. Aug. 31, 2009).

[8] Andrea Salcedo, “A doctor falsely told lawmakers vaccines magnetize people: ‘They can put a key on their forehead. It sticks.’,” Wash. Post (June 9, 2021); Andy Downing, “What an exceedingly dumb time to be alive,” Columbus Alive (June 10, 2021); Jake Zuckerman, “She says vaccines make you magnetized. This West Chester lawmaker invited her testimony, chair says,” Ohio Capital Journal (July 14, 2021).

[9] A.M.A. Code of Medical Ethics Opinion 9.7.1.

[10] Id.

[11] Id.

[12] Id.

Posted in Expert Witness Hall of Shame, Expert Witnesses, Public Nuisances, Scientific Misconduct | 1 Comment »

Judge Jack B. Weinstein – A Remembrance

June 17th, 2021

There is one less force of nature in the universe. Judge Jack Bertrand Weinstein died earlier this week, about two months shy of a century.[1] His passing has been noticed by the media, lawyers, and legal scholars[2]. In its obituary, the New York Times noted that Weinstein was known for his “bold jurisprudence and his outsize personality,” and that he was “revered, feared, and disparaged.” The obituary quoted Professor Peter H. Schuck, who observed that Weinstein was “something of a benevolent despot.”

As an advocate, I found Judge Weinstein to be anything but fearsome. His jurisprudence was often driven by intellectual humility rather than boldness or despotism. One area in which Judge Weinstein was diffident and restrained was in his exercise of gatekeeping of expert witness opinion. He, and his friend, the late Professor Margaret Berger, were opponents of giving trial judges discretion to exclude expert witness opinions on ground of validity and reliability. Their antagonism to gatekeeping was, no doubt, partly due to their sympathies for injured plaintiffs and their realization that plaintiffs’ expert witnesses often come up with dodgy scientific opinions to advance plaintiffs’ claims. In part, however, Judge Weinstein’s antagonism was due to his skepticism about judicial competence and his own intellectual humility.

Although epistemically humble, Judge Weinstein was not incurious. His interest in scientific issues occasionally got him into trouble, as when he was beguiled by Dr. Irving Selikoff and colleagues, who misled him on aspects of the occupational medicine of asbestos exposure. In 1990, Judge Weinstein issued a curious mea culpa. Because of a trial in progress, Judge Weinstein, along with state judge (Justice Helen Freedman), attended an ex parte private luncheon meeting with Dr. Selikoff. Here is how Judge Weinstein described the event:

“But what I did may have been even worse [than Judge Kelly’s conduct that led to his disqualification]. A state judge and I were attempting to settle large numbers of asbestos cases. We had a private meeting with Dr. Irwin [sic] J. Selikoff at his hospital office to discuss the nature of his research. He had never testified and would never testify. Nevertheless, I now think that it was a mistake not to have informed all counsel in advance and, perhaps, to have had a court reporter present and to have put that meeting on the record.”[3]

Judge Weinstein’s point about Selikoff’s having never testified was demonstrably false, but I impute no scienter for false statements to the judge. The misrepresentation almost certainly originated with Selikoff. Dr. Selikoff had testified frequently up to the point at which he and plaintiffs’ counsel realized that his shaky credentials and his pronouncements on “state of the art,” were hurtful to the plaintiffs’ cause. Even if Selikoff had not been an accomplished testifier, any disinterested observer should, by 1990, have known that Selikoff was himself not a disinterested actor in medical asbestos controversies.[4] The meeting with Selikoff apparently weighed on Judge Weinstein’s conscience. He repeated his mea culpa almost verbatim, along with the false statement about Selikoff’s never having testified, in a law review article in 1994, and then incorporated the misrepresentation into a full-length book.[5]

In his famous handling of the Agent Orange class action, Judge Weinstein manipulated the defendants into settling, and only then applied his considerable analytical ability in dissecting the inadequacies of the plaintiffs’ causation case. Rather than place the weight of his decision on Rule 702, Judge Weinstein dismembered the causation claim by finding that the bulk of what the plaintiffs’ expert witnesses relied upon under Rule 703 was unreasonable. He then found that what remained, if anything, could not reasonably support a verdict for plaintiffs, and he entered summary judgment for the defense in the opt-out cases.[6]

In 1993, the U.S. Supreme Court breathed fresh life into the trial court’s power and obligation to review expert witness opinions and to exclude unsound opinions.[7] Several months before the Supreme Court charted this new direction on expert witness testimony, the silicone breast implant litigation, fueled by iffy science and iffier scientists, erupted.[8] In October 1994, the Judicial Panel on Multi-District Litigation created MDL 926, which consolidated the federal breast implant cases before Judge Sam Pointer, in the Northern District of Alabama. Unlike most contemporary MDL judges, however, Judge Pointer did not believe that Rule 702 and 703 objections should be addressed by the MDL judge. Pointer believed strongly that the trial judges, in the individual, remanded cases, should rule on objections to the validity of proffered expert witness opinion testimony. As a result, so-called Daubert hearings began taking place in district courts around the country, in parallel with other centralized proceedings in MDL 926.

By the summer of 1996, Judge Robert E. Jones had a full-blown Rule 702 attack on the plaintiffs’ expert witnesses before him, in a case remanded from MDL 926. In the face of the plaintiffs’ MDL leadership committee’s determined opposition, Judge Jones appointed four independent scientists to serve as scientific advisors. With their help, in December 1996, Judge Jones issued one of the seminal rulings in the breast implant litigation, and excluded the plaintiffs’ expert witnesses.[9]

While Judge Jones was studying the record, and writing his opinion in the Hall case, Judge Weinstein, with a judge from the Southern District of New York, conducted a two-week Rule 702 hearing, in his Brooklyn courtroom. Judge Weinstein announced at the outset that he had studied the record from the Hall case, and that he would incorporate it into his record for the cases remanded to the Southern and Eastern Districts of New York.

I had one of the first witnesses, Dr. Donnard Dwyer, before Judge Weinstein during that chilly autumn of 1996. Dwyer was a very earnest immunologist, who appeared on direct examination to endorse the methodological findings of the plaintiffs’ expert witnesses, including a very dodgy study by Dr. Douglas Shanklin. On cross-examination, I elicited Dwyer’s view that the Shanklin study involved fraudulent methodology and that he, Dwyer, would never use such a method or allow a graduate student to use it. This examination, of course, was great fun, and as I dug deeper with relish, Judge Weinstein stopped me, and asked rhetorically to the plaintiffs’ counsel, whether any of them intended to rely upon the discredited Shanklin study. My main adversary Mike Williams did not miss a beat; he jumped to his feet to say no, and that he did not know why I was belaboring this study. But then Denise Dunleavy, of Weitz & Luxenberg, knowing that Shanklin was her listed expert witness in many cases, rose to say that her expert witnesses would rely upon the Shanklin study. Incredulous, Weinstein looked at me, rolled his eyes, paused dramatically, and then waved his hand at me to continue.

Later in my cross-examination, I was inquiring about another study that reported a statistic from a small sample. The authors reported a confidence interval that included negative values for a test that could not have had any result less than zero. The sample was obviously skewed, and the authors had probably used an inappropriate parametric test, but Dwyer was about to commit to the invalidity of the study when Judge Weinstein stopped me. He was well aware that the normal approximation had created the aberrant result, and that perhaps the authors only sin was in failing to use a non-parametric test. I have not had many trial judges interfere so knowledgably.

In short order, on October 23, 1996, Judge Weinstein issued a short, published opinion, in which he ducked the pending Rule 702 motions, and he granted partial summary judgment on the claims of systemic disease.[10] Only the lawyers involved in the matters would have known that there was no pending motion for summary judgment!

Following up with grant of summary judgment, Judge Weinstein appointed a group of scientists and a legal scholar, to help him assemble a panel of Rule 706 expert witnesses for future remanded case. Law Professor Margaret Berger, along with Drs. Joel Cohen and Alan Wolff, began meeting with the lawyers to identify areas of expertise needed by the court, and what the process of court-appointment of neutral expert witnesses would look like.

The plaintiffs’ counsel were apoplectic. They argued to Judge Weinstein that Judge Pointer, in the MDL, should be supervising the process of assembling court-appointed experts. Of course, the plaintiffs’ lawyers knew that Judge Pointer, unlike Judges Jones and Weinstein, believed that both sides’ expert witnesses were extreme, and mistakenly believed that the truth lay between. Judge Pointer was an even bigger foe of gatekeeping, and he was generally blind to the invalid evidence put forward by plaintiffs. In response to the plaintiffs’ counsel’s, Judge Weinstein sardonically observed that if there were a real MDL judge, he should take it over.

Within a month or so, Judge Pointer did, in fact, take over the court-appointed expert witness process, and incorporated Judge Weinstein’s selection panel. The process did not going very smoothly in front of the MDL judge, who allowed the plaintiffs lawyers to slow down the process by throwing in irrelevant documents and deploying rhetorical tricks. The court-appointed expert witnesses did not take kindly to the shenanigans, or to the bogus evidence. The expert panel’s unanimous rejection of the plaintiffs’ claims of connective tissue disease causation was an expensive, but long overdue judgment from which there was no appeal. Not many commentators, however, know that the panel would never have happened but for Judge Weinstein’s clever judicial politics.

In April 1997, while Judge Pointer was getting started with the neutral expert selection panel,[11] the parties met with Judge Weinstein one last time to argue the defense motions to exclude the plaintiffs’ expert witnesses. Invoking the pendency of the Rule 706 court-appointed expert witness processs in the MDL, Judge Weinstein quickly made his view clear that he would not rule on the motions. His Honor also made clear that if we pressed for a ruling, he would deny our motions, even though he had also ruled that plaintiffs’ could not make out a submissible case on causation.

I recall still the frustration that we, the defense counsel, felt that April day, when Judge Weinstein tried to explain why he would grant partial summary judgment but not rule on our motions contra plaintiffs’ expert witnesses. It would be many years later, before he let his judicial assessment see the light of day. Two decades and then some later, in a law review article, Judge Weinstein made clear that “[t]he breast implant litigation was largely based on a litigation fraud. …  Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”[12] Indeed.

Judge Weinstein was incredibly smart and diligent, but he was human with human biases and human fallibilities. If he was a despot, he was at least kind and benevolent. In my experience, he was always polite to counsel and accommodating. Appearing before Judge Weinstein was a pleasure and an education.

[1] Laura Mansnerus, “Jack B. Weinstein, U.S. Judge With an Activist Streak, Is Dead at 99,” N.Y. Times (June 15, 2021).

[2] Christopher J. Robinette, “Judge Jack Weinstein 1921-2021,” TortsProf Blog (June 15, 2021).

[3] Jack B. Weinstein, “Learning, Speaking, and Acting: What Are the Limits for Judges?” 77 Judicature 322, 326 (May-June 1994).

[4] “Selikoff Timeline & Asbestos Litigation History” (Dec. 20, 2018).

[5] See Jack B. Weinstein, “Limits on Judges’ Learning, Speaking and Acting – Part I- Tentative First Thoughts: How May Judges Learn?” 36 Ariz. L. Rev. 539, 560 (1994) (“He [Selikoff] had never testified and would never testify.”); Jack B. Weinstein, Individual Justice in Mass Tort Litigation: The Effect of Class Actions, Consolidations, and other Multi-Party Devices 117 (1995) (“A court should not coerce independent eminent scientists, such as the late Dr. Irving Selikoff, to testify if, like he, they prefer to publish their results only in scientific journals.”)

[6] In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 785 (E.D.N.Y. 1984), aff’d 818 F.2d 145, 150-51 (2d Cir. 1987)(approving district court’s analysis), cert. denied sub nom. Pinkney v. Dow Chemical Co., 487 U.S. 1234 (1988);  In re “Agent Orange” Prod. Liab. Litig., 611 F. Supp. 1223 (E.D.N.Y. 1985), aff’d, 818 F.2d 187 (2d Cir. 1987), cert. denied, 487 U.S. 1234 (1988).

[7] Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579 (1993).

[8] Reuters, “Record $25 Million Awarded In Silicone-Gel Implants Case,” N.Y. Times (Dec. 24, 1992).

[9] See Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Ore. 1996).

[10] In re Breast Implant Cases, 942 F. Supp. 958 (E.& S.D.N.Y. 1996).

[11] MDL 926 Order 31 (May 31, 1996) (order to show cause why a national Science Panel should not be appointed under Federal Rule of Evidence 706); MDL 926 Order No. 31C (Aug. 23, 1996) (appointing Drs. Barbara S. Hulka, Peter Tugwell, and Betty A. Diamond); Order No. 31D (Sept. 17, 1996) (appointing Dr. Nancy I. Kerkvliet).

[12] Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (emphasis added).

Posted in Asbestos, Causation, Expert Witnesses, Rule 702, Rule 703, Scientific Evidence, Scientific Misconduct | No Comments »

Scientists Suing Scientists, and Behaving Badly

June 2nd, 2021

In his 1994 Nobel Prize acceptance speech, the Hungarian born chemist George Andrew Olah acknowledged an aspect of science that rarely is noted in popular discussions:

“[One] way of dealing with errors is to have friends who are willing to spend the time necessary to carry out a critical examination of the experimental design beforehand and the results after the experiments have been completed. An even better way is to have an enemy. An enemy is willing to devote a vast amount of time and brain power to ferreting out errors both large and small, and this without any compensation. The trouble is that really capable enemies are scarce; most of them are only ordinary. Another trouble with enemies is that they sometimes develop into friends and lose a good deal of their zeal. It was in this way the writer lost his three best enemies. Everyone, not just scientists, need a few good enemies!”[1]

If you take science seriously, you must take error as something for which we should always be vigilant, and something we are committed to eliminate. As Olah and Von Békésy have acknowledged, sometimes an enemy is required. It would thus seem to be quite unscientific to complain that an enemy was harassing you, when she was criticizing your data, study design, methods, or motives.

Elisabeth Margaretha Harbers-Bik would be a good enemy to have. Trained in the Netherlands in microbiology, Dr. Bik came to the United States, where for some years she conducted research at Stanford University. In 2018, Bik began in earnest a new career in analyzing published scientific studies for image duplication and manipulation, and other dubious practices.[2]

Her blog, Scientific Integrity Digest, should be on the reading list of every lawyer who labors in the muck of science repurposed for litigation. You never know when your adversary’s expert witness will be featured in the pages of the Digest!

Dr. Bik is not a lone ranger; there are other scientists who have committed to cleaning up the scientific literature. After an illustrious career as an editor of prestigious journals, and a director of the Rockefeller University Press, Dr. Mike Rossner founded Image Data Integrity, Inc., to stamp out image fraud and error in scientific publications.

On March 16, 2020, a gaggle of French authors, including Dr. Didier Raoult, uploaded a pre-print of a paper to medRxiv, reporting on hydroxychloroquine (HCQ) and azithromycin in Covid-19 patients. The authors submitted their manuscript that same day to the International Journal of Antimicrobial Agents, which accepted it in 24 hours or less, on March 17, 2020. The journal published the paper online, three days after acceptance, on March 20th. Peer-review, to the extent it took place, was abridged.[3]

The misleading title of the paper, “Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial,” may have led some untutored observers into thinking the paper reported a study high in the hierachy of evidence. Instead the paper was a rather flawed observational study, or perhaps just a concatenation of anecdotes. In any event, the authors reported that patients who had received both medications cleared the SARS-CoV2 the fastest.

Four days after publication online at a supposedly peer-reviewed journal, Elisabeth Bik posted an insightful analysis of the Raoult paper.[4] If peer review it were, her blog post pointed out the review’s failure by identifying an apparent conflict of interest and various methodological flaws, including missing data on six (out of 26) patients, including one patient who died, and three whose conditions worsened on therapy.

Raoult’s paper, and his overly zealous advocacy for HCQ did not go unnoticed in the world of kooks, speculators, and fraudfeasors. Elon Musk tweeted about Raoult’s paper; and Fox News amplified Musk’s tweet, which made it into the swamp of misinformation, Trump’s mind and his twitterverse.[5]

In the wake of the hoopla over Raoult’s paper, the journal owner admitted that the paper did not live up to the society’s standards. The publisher, Elsevier, called for an independent investigation. The French Infectious Diseases Society accused Raoult of spreading false information about hydroxychloroquine’s efficacy in Covid-19 patients. To date, there has been no further official discussions of disciplinary actions or proceedings at the Society.

Raoult apparently stewed over Bik’s criticisms and debunking of his over-interpretation of his flawed HCQ study.  Last month, Raoult filed a complaint with a French prosecutor, which marked the commencement of legal proceedings against Bik for harassment and “extortion.” The extortion charge is based upon nothing more than Bik’s having a Patreon account to support her search for fraud and error in the published medical literature.[6]

The initial expression of outrage over Marseille Raoult’s bad behavior came from Citizen4Science, a French not-for-profit organization that works to promote scientific integrity. According to Dr. Fabienne Blum, president of Citizen4Science, the organization issued its press release on May 5, 2021, to call on authorities to investigate and to intervene in Raoult’s harassment of scientists. Their press release about “the French scandal” was signed by scientists and non-scientists from around the world; it currently remains open for signatures, which number well over 4,000. “Harassment of scientific spokespersons and defenders of scientific integrity: Citizen4Science calls on the authorities to intervene urgently” (May 5, 2021). Dr. Blum and Citizen4Science are now harassed on Twitter, where they have been labeled “Bik’s gang.” Inevitably, they will be sued as well.

On June 1st, Dr. Raoult posted his self-serving take on the controversy on that scholarly forum known as YouTube. An English translation of Raoult’s diatribe can be found at Citizen4Science’s website. Perhaps others have noted that Raoult refers to Bik as “Madame” (or Mrs.) Bik, rather than as Dr. Bik, which leads to some speculation that Raoult has trouble taking criticism from intelligent women.

Having projected his worst characteristics onto adversaries, Raoult lodged accusations against Bik, which actually reflected his own behaviors closely. Haven’t we seen someone in public life who operates just like this? Raoult has criticized Bik in the lay media, and he released personal information about her, including her residential address. Raoult’s intemperate and inappropriate personal attacks on Bik have led several hundred scientists to sign an open letter in support of Bik.[7]

This scientist doth protest too much, methinks.

[1] George Andrew Olah Nobel Prize Speech (1994) (quoting from George Von Békésy, Experiments in Hearing 8 (1960).

[2] Elisabeth M. Bik, Arturo Casadevall, and Ferric C. Fang, “The Prevalence of Inappropriate Image Duplication in Biomedical Research Publications,” 7 mBio e00809 (2016); Daniele Fanelli, Rodrigo Costas, Ferric C. Fang, Arturo Casadevall, Elisabeth M. Bik, “Testing Hypotheses on Risk Factors for Scientific Misconduct via Matched-Control Analysis of Papers Containing Problematic Image Duplications,” 25 Science & Engineering Ethics 771 (2019); see also Jayashree Rajagopalan, “I have found about 2,000 problematic papers, says Dr. Elisabeth Bik,” Editage Insights (Aug 08, 2019).

[3] Philippe Gautret, Jean-Christophe Lagier, Philippe Parola, Van Thuan Hoang, Line Meddeb, Morgane Mailhe, Barbara Doudier, Johan Courjon, Valérie Giordanengo, Vera Esteves Vieira, Hervé Tissot Dupont, Stéphane Honoré, Philippe Colson, Eric Chabrière, Bernard La Scola, Jean-Marc Rolain, Philippe Brouqui, and Didier Raoult, “Hydroxychloroquine and azithromycin as a treatment of COVID-19: results of an open-label non-randomized clinical trial,” 56 Clinical Trial Internat’l J. Antimicrob. Agents e105949 (2020).

[4] Bik, “Thoughts on the Gautret et al. paper about Hydroxychloroquine and Azithromycin treatment of COVID-19 infections,” Scientific Integrity Digest (March 24, 2020).

[5] Charles Piller, “‘This is insane!’ Many scientists lament Trump’s embrace of risky malaria drugs for coronavirus,” Science Mag. (Mar. 26, 2020).

[6] Melissa Davey, “World expert in scientific misconduct faces legal action for challenging integrity of hydroxychloroquine study,” The Guardian (May 22, 2021); Kristina Fiore, “HCQ Doc Sues Critic,” MedPage Today (May 26, 2021).

[7] Lonni Besançon, Alexander Samuel, Thibault Sana, Mathieu Rebeaud, Anthony Guihur, Marc Robinson-Rechavi, Nicolas Le Berre, Matthieu Mulot, Gideon Meyerowitz-Katz, Maisonneuve, Brian A. Nosek, “Open Letter: Scientists stand up to protect academic whistleblowers and post-publication peer review,” (May 18, 2021).

Posted in Cognitive Biases, Conflicts of Interest, Peer Review, Scientific Evidence, Scientific Misconduct | No Comments »

Carl Cranor’s Inference to the Best Explanation

February 12th, 2021

Carl Cranor pays me the dubious honor of quoting my assessment of weight of the evidence (WOE) pseudo-methodology as used by lawsuit industry expert witnesses, in one of his recent publications:

“Take all the evidence, throw it into the hopper, close your eyes, open your heart, and guess the weight. You could be a lucky winner! The weight of the evidence suggests that the weight-of-the-evidence (WOE) method is little more than subjective opinion, but why care if it helps you to get to a verdict!”[1]

Cranor’s intent was to deride my comments, but they hold up fairly well. I have always maintained that if were wrong, I would eat my words, but that they will be quite digestible. Nothing to eat here, though.

In his essay in the Public Affairs Quarterly, Cranor attempts to explain and support his advocacy of WOE in the notorious case, Milward, in which Cranor, along with his friend and business partner, Martyn Smith, served as partisan, paid expert witnesss.[2] Not disclosed in this article is that after the trial court excluded the opinions of Cranor and Smith under Federal Rule of Evidence 702, and plaintiff appealed, the lawsuit industry, acting through The Council for Education and Research on Toxics (CERT) filed an amicus brief to persuade the Court of Appeals to reverse the exclusion. The plaintiffs’ counsel, Cranor and Smith, and CERT failed to disclose that CERT was founded by the two witnesses, Cranor and Smith, whose exclusion was at issue.[3] Many of the lawsuit industry’s regular testifiers were signatories, and none raised any ethical qualms about the obvious conflict of interest, or the conspiracy to pervert the course of justice.[4]

Cranor equates WOE to “inference to the best explanation,” which reductively strips science of its predictive and reproducible nature. Readers may get the sense he is operating in the realm of narrative, not science, and they would be correct. Cranor goes on to conflate WOE methodology with “diagnostic induction,” and “differential diagnosis.”[5] The latter term is well understood in both medicine and in law to involve the assessment of an individual patient’s condition, based upon what is already known upon good and sufficient bases. The term has no accepted or justifiable meaning for assessing general causation. Cranor’s approach would pretermit the determination of general causation by making the disputed cause a differential.

Cranor offers several considerations in support of his WOE-ful methodology. First, he notes that the arguments for causal claims are not deductive. True, but indifferent as to his advocacy for WOE and inference to the best explanation.

Second, Cranor describes a search for relevant evidence once the scientific issue (hypothesis?) is formulated. Again, there is nothing unique about this described step, but Cranor intentionally leaves out considerations of validity, as in extrapolations between high and low dose, or between species. Similarly, he leaves out considerations of validity of study designs (such as whether any weight would be given to case studies, cross-sectional, or ecological studies) or of validity of individual studies.

Cranor’s third step is the formulation of a “sufficiently complete range of reasonable and plausible explanations to account for the evidence.” Again, nothing unique here about WOE, except that Cranor’s WOE abridges the process by ignoring the very real possibility that we do not have the correct plausible explanation available.

Fourth, according to Cranor, scientists rank, explicitly or implicitly, the putative “explanations” by plausibility and persuasiveness, based upon the evidence at hand, in view of general toxicological and background knowledge.[6] Note the absence of consideration of the predictive abilities of the competing explanations, or any felt need to assess the quality of evidence or the validity of study design.

For Cranor, the fifth consideration is to use the initial plausibility assessments, made on incomplete understanding of the phenomena, and on incomplete evidence, to direct “additionally relevant /available evidence to separate founded explanations from less well-founded ones.” Obviously missing from Cranor’s scheme is the idea of trying to challenge or test hypotheses severely to see whether withstand such challenges.

Sixth, Cranor suggests that “all scientifically relevant information” should be considered in moving to the “best supported” explanation. Because “best” is determined based upon what is available, regardless of the quality of the data, or the validity of the inference, Cranor rigs his WOE-ful methodology in favor of eliminating “indeterminate” as a possible conclusion.

In a seventh step, Cranor points to the need to “integrate, synthesize, and assess or evaluate,” all lines of “available relevant evidence.” There is nothing truly remarkable about this step, which clearly requires judgment. Cranor notes that there can be convergence of disparate lines of evidence, or divergence, and that some selection of “lines” of evidence may be endorsed as supporting the “more persuasive conclusion” of causality.[7] In other words, a grand gemish.

Cranor’s WOE-ful approach leaves out any consideration of random error, or systematic bias, or data quality, or study design. The words “bias” and “confounding” do not appear in Cranor’s essay, and he erroneously discusses “error” and “error rates,” only to disparage them as the machinations of defense lawyers in litigation. Similarly, Cranor omits any serious mention of reproducibility, or of the need to formulate predictions that have the ability to falsify tentative conclusions.

Quite stridently, Cranor insists that there is no room for any actual weighting of study types or designs. In apparent earnest, Cranor writes that:

“this conclusion is in accordance with a National Cancer Institute (NCI) recommendation that ‘there should be no hierarchy [among different types of scientific methods to determine cancer causation]. Epidemiology, animal, tissue culture and molecular pathology should be seen as integrating evidences in the determination of human carcinogenicity.”[8]

There is much whining and special pleading about the difficulty, expense, and lack of statistical power of epidemiologic studies, even though the last point is a curious backdoor endorsement of statistical significance. The first two points ignore the availability of large administrative databases from which large cohorts can be identified and studied, with tremendous statistical power. Case-control studies can in some instances be assembled quickly as studies nested in existing cohorts.

As I have noted elsewhere,[9] Cranor’s attempt to level all types of evidence starkly misrepresents the cited “NCI” source, which is not at all an NCI recommendation, but rather a “meeting report” of a workshop of non-epidemiologists.[10] The cited source is not an official pronouncement of the NCI, the authors were not NCI scientists, and the NCI did not sponsored the meeting. The meeting report appeared in the journal Cancer Research as a paid advertisement, not in the NCI’s Journal of the National Cancer Institute as a scholarly article:

“The costs of publication of this article were defrayed in part by the payment of page charges. This article must therefore be hereby marked advertisement in accordance with 18 U.S.C. Section 1734 solely to indicate this fact.”[11]

Tellingly, Cranor’s deception was relied upon and cited by the First Circuit, in its Milward, decision.[12] The scholarly fraud hit its mark. As a result of Cranor’s own dubious actions, the Milward decision has both both ethical and scholarship black clouds hovering over it.  The First Circuit should withdraw the decision as improvidently decided.

The article ends with Cranor’s triumphant view of Milward,[13] which he published previously, along with the plaintiffs’ lawyer who hired him.[14] What Cranor leaves out is that the First Circuit’s holding is now suspect because of the court’s uncritical acceptance of Cranor’s own misrepresentations and CERT’s omissions of conflict-of-interest disclosures, as well as the subsequent procedural history of the case. After the Circuit reversed the Rule 702 exclusions, and the Supreme Court denied the petition for a writ of certiorari, the case returned to the federal district court, where the defense lodged a Rule 702 challenge to expert witness opinion that attributed plaintiff’s acute promyelocytic leukemia to benzene exposure. This specific causation issue was not previously addressed in the earlier proceedings. The trial court sustained the challenge, which left the plaintiff unable to show specific causation. The result was summary judgment for the defense, which the First Circuit affirmed on appeal.[15] The upshot of the subsequent proceedings, with their dispositive ruling in favor of the defense on specific causation, is that the earlier ruling on general causation is no longer necessary to the final judgment, and not the holding of the case when all the proceedings are considered.

In the end, Cranor’s WOE leaves us with a misdirected search for an “explanation of causation,” rather than a testable, tested, reproducible, and valid “inference of causation.” Cranor’s attempt to invoke the liberalization of the Federal Rules of Evidence ignores the true meaning of “liberal” in being free from dogma and authority. Evidence does not equal eminence, and expert witnesses in court must show their data and defend their inferences, whatever their explanations may be.

——————————————————————————————————–

[1]  Carl F. Cranor, “How Courts’ Reviews of Science in Toxic Tort Cases Have Changed and Why That’s a Good Thing,” 31 Public Affairs Q. 280 (2017), quoting from Schachtman, “WOE-fully Inadequate Methodology – An Ipse Dixit by Another Name” (May 1, 2012).

[2]  Milward v. Acuity Specialty Products Group, Inc., 639 F. 3d 11 (1st Cir. 2011), cert. denied, 132 S.Ct. 1002 (2012).

[3]  See “The Council for Education and Research on Toxics” (July 9, 2013).

[4] Among the signatures were Nachman Brautbar, David C. Christiani, Richard W. Clapp, James Dahlgren, Arthur L. Frank, Peter F. Infante, Philip J. Landrigan, Barry S. Levy, David Ozonoff, David Rosner, Allan H. Smith, and Daniel Thau Teitelbaum.

[5]  Cranor at 286-87.

[6]  Cranor at 287.

[7]  Cranor at 287-88.

[8]  Cranor at 290.

[9]  “Cranor’s Defense of Milward at the CPR’s Celebration” (May 12, 2013).

[10]  Michelle Carbone, Jack Gruber, and May Wong, “Modern criteria to establish human cancer etiology,” 14 Semin. Cancer Biol. 397 (2004).

[11]  Michele Carbone, George Klein, Jack Gruber and May Wong, “Modern Criteria to Establish Human Cancer Etiology,” 64 Cancer Research 5518 (2004).

[12]  Milward v. Acuity Specialty Products Group, Inc., 639 F. 3d 11, 17 (1st Cir. 2011) (“when a group from the National Cancer Institute was asked to rank the different types of evidence, it concluded that ‘[t]here should be no such hierarchy’.”), cert. denied, 132 S.Ct. 1002 (2012).

[13]  Cranor at 292.

[14]  See “Wake Forest Publishes the Litigation Industry’s Views on Milward” (April 20, 2013).

[15]  Milward v. Acuity Specialty Products Group, Inc., 969 F. Supp. 2d 101 (D. Mass. 2013), aff’d sub nom. Milward v. Rust-Oleum Corp., 820 F.3d 469 (1st Cir. 2016).

Posted in Causation, Conflicts of Interest, Public Nuisances, Scientific Evidence, Scientific Misconduct, Systemic Bias | 1 Comment »

The Knowledge Remedy Proposal

November 14th, 2020

Alexandra D. Lahav is the Ellen Ash Peters Professor of Law at the University of Connecticut School of Law. This year’s symposium issue of the Texas Law Review has published Professor Lahav’s article, “The Knowledge Remedy,” which calls for the imposition of a duty to conduct studies by defendants, to provide evidence relevant to plaintiffs’ product liability claims. Alexandra D. Lahav, “The Knowledge Remedy,” 98 Texas L. Rev. 1361 (2020) [cited as Lahav].

Professor Lahav’s advocated reform is based upon the premises that (1) the requisite studies needed for causal assessment “are too costly for plaintiffs to fund,” (2) are not done by manufacturers, or (3) are not done in good faith, and (4) are not conducted or adequately funded by government. Lahav believes that plaintiffs are injured by exposure to chemicals but they cannot establish causation in court because the defendant “hid its head in the sand,” or worse, “engaged in misconduct to prevent or hide research into its products.”[1] Lahav thus argues that when defendants have been found to have engaged in misconduct, courts should order them to fund studies into risks posed by their products.

Lahav’s claims are either empty or non-factual. The suggestion that plaintiffs are injured by products but cannot “prove” causation begs the question how she knows that these people were injured by the products at issue. In law professors’ language, Lahav has committed the fallacy of petitio principia.

Lahav’s poor-mouthing on behalf of claimants is factually unsupported in this article. Lahav tells us that:

“studies are too expensive for individuals or even groups to fund.”

This is assertion is never backed up with any data or evidence about the expense involved. Case-control studies for rare outcomes suffer from potential threats to their validity, but they can be assembled relatively quickly and inexpensively. Perhaps a more dramatic refutation of Lahav’s assertions come from the cohort studies done in administrative databases, such as the national healthcare databases of Denmark or Sweden, or the Veterans’ Administration database in the United States. These studies involve querying existing databases for the exposures and outcomes of interest, with appropriate controls; such studies are frequently of as high quality and validity as can be had in observational analytical epidemiology.

There are, of course, examples of corporate defendants’ misconduct in sponsoring or conducting studies. There is also evidence of misconduct in plaintiffs’ sponsorship of studies,[2] and outright fraud.[3] And certainly there is evidence of misconduct or misdirection in governmentally funded and sponsored research, sometimes done in cahoots with plaintiffs’ counsel.[4]

Perhaps more important for the intended audience of the Texas Law Review, Lahav’s assertion is demonstrably false. Plaintiffs, plaintiffs’ counsel, and plaintiffs’ advocacy groups have funded studies, often surreptitiously, in many litigations, including those involving claims of harm from Bair Hugger, asbestos, silicone gel breast implants, welding fume, Zofran, isotretinoin, and others. Lahav’s repetition of the claim does not make it true.[5] Plaintiffs and their proxies, including scientific advocates, can and do conduct studies, very much with a view toward supporting litigation claims. Mass tort litigation is a big business, often run by lawyer oligarchs of the plaintiffs’ bar. Ignorantia facti is not an excuse for someone who argues for a radical re-ordering of an already fragile litigation system.

Lahav also complains that studies take so long that the statute of limitations will run on the injury claims before the scientific studies can be completed. There is a germ of truth in this complaint, but the issue could be resolved with minor procedural modifications. Plaintiffs could be allowed a procedure to propound a simple interrogatory to manufacturing firms to ask whether they believe that causality exists between their product and a specific kind of harm, or whether a claimant should reasonably know that such causality exists to warrant pursuing a legal claim. If the manufacturers answer in the negative, then the firms would not be able to assert a limitations defense for any injury that arose on or before the date of its answer. Perhaps the court could allow the matter to stay on its docket and require that the defendant answer the question annually. Plaintiffs and their proxies would be able to sponsor studies necessary to support their claims, and putative defendants would be on notice that such studies are underway.

Without any serious consideration of the extant regulations, Lahav even extends her claims of inadequate testing and lax regulation to pharmaceutical products, which are subject to extensive requirements of showing safety and efficacy, both before and after approval for marketing. Lahav’s advocacy ignores that an individual epidemiologic study rarely “demonstrates” causation, and many such studies are required before the scientific community can accept the causal hypothesis as “disproven.” Lahav’s knowledge remedy is mostly an ignorance ruse.

[1]  Lahav at 1361.

[2]  For a recent, egregious example, see In re Zofran Prods. Liab. Litig., MDL No. 1:15-md-2657-FDS, Order on Defendant’s Motion to De-Designate Certain Documents as Confidential Under the Protective Order (D.Mass. Apr. 1, 2020) (uncovering dark data and dark money behind April Zambelli‐Weiner, Christina Via, Matt Yuen, Daniel Weiner, and Russell S. Kirby, “First Trimester Pregnancy Exposure to Ondansetron and Risk of Structural Birth Defects,” 83 Reproductive Toxicology 14 (2019)). See also In re Zofran (Ondansetron) Prod. Liab. Litig., 392 F. Supp. 3d 179, 182-84 (D. Mass. 2019) (MDL 2657);  “April Fool – Zambelli-Weiner Must Disclose” (April 2, 2020); “Litigation Science – In re Zambelli-Weiner” (April 8, 2019); “Mass Torts Made Less Bad – The Zambelli-Weiner Affair in the Zofran MDL” (July 30, 2019). See also Nate Raymond, “GSK accuses Zofran plaintiffs’ law firms of funding academic study,” Reuters (Mar. 5, 2019).

[3]  See Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (“[t]he breast implant litigation was largely based on a litigation fraud. …  Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”) (emphasis added).

[4]  See, e.g., Robert M. Park, Paul A. Schulte, Joseph D. Bowman, James T. Walker, Stephen C. Bondy, Michael G. Yost, Jennifer A. Touchstone, and Mustafa Dosemeci, “Potential Occupational Risks for Neurodegenerative Diseases,” 48 Am. J. Ind. Med. 63, 65 (2005).

[5]  Lahav at 1369-70.

Posted in Cognitive Biases, Rule 702, Scientific Misconduct, Underlying Data | Comments Off on The Knowledge Remedy Proposal

Sharpiegate – Trump’s Assault on Scientific Expertise

July 10th, 2020

Trump lies so often, so irresponsibly, so ruthlessly, that the American people have become numb to the assault on truth. Remarkably, Trump’s lies are frequently casual, random, non-ideological, and wanton. When the lies are about scientifically verifiable processes and outcomes, the lies are particularly reprehensible because they further dumb the American people’s shaky aptitude for scientific discourse.

Take Trump’s lie last September that Hurricane Dorian would hit Alabama much harder than had been anticipated. Thousands of lies later, perhaps only a few may remember the doctored weather map, on which a falsified projection had been drawn with a sharpie pen, to suggest that the hurricane was moving towards southeastern Alabama. A few days later, the National Oceanic and Atmospheric Administration (NOAA) issued a statement that purported to support Trump’s bogus forecast.[1]

Now, almost a year later, the Inspector General for the Commerce Department, Peggy Gustafson, has issued a report that lambasts the White House (Trump and cronies) for pressuring the NOAA into issuing its unscientific, unsupportable statement.[2] The Inspector General found that the NOAA had politicized a straightforward scientific assessment, backed the Trumpian forecast, criticized the agency’s own scientists, and eroded public trust in the agency, by succumbing to pressure from the White House.

Of course, 40 percent of the United States’ electorate will not care, as long as they have their theocracy. Ms. Gustafson’s days are numbered, even as the End Times draw nigh for Trump. You may not need a weatherman to know which way the blows, but you do if you want to know which way the wind will blow.

Remember, that 40 percent could be on your jury. And there may be another 40% that blows the other way. Sharpiegate is a poignant reminder that abuse of science occurs in all three branches of government.

[1]  Andrew Freedman & Jason Samenow, “Investigation rebukes Commerce Department for siding with Trump over forecasters during Hurricane Dorian: Report confirms Commerce officials responded to orders from the White House,” Wash. Post (July 9, 2020).

[2]  Gustafson, Evaluation of NOAA’s September 6, 2019, Statement about Hurricane Dorian Forecasts (June 26, 2019).

Posted in Scientific Evidence, Scientific Misconduct | Comments Off on Sharpiegate – Trump’s Assault on Scientific Expertise

Legal Remedies for Suspect Medical Science in Products Cases – Part One

June 2nd, 2020

Expert witness opinions about the nature and cause of plaintiffs’ medical conditions, are the linchpin of mass tort cases involving claims of bodily injury from allegedly harmful products.  The quality of these expert witness opinions has long been the subject of debate, but the explosion of products liability cases has brought increasing scrutiny, especially in cases involving asbestos, silica, and pharmaceutical claims.[1]

Courts, Congress, and commentators have raised concerns about the scientific and medical validity of the opinions offered in support of certain product liability claims, whether certain of the individuals who offer such opinions have a proper degree of independence from the lawyers representing the plaintiffs, and whether there is any way to address these questions apart from a rejection of the individual claims in which the bogus opinions are offered.  Famously, Judge Janis Jack of the United States District Court for the Southern District of Texas addressed these issues in a lengthy decision in which she excoriated physicians, medical screeners, and plaintiffs’ lawyers who she concluded had transgressed basic ground rules of medical and legal propriety in connection with silicosis claims.[2]

The stakes generated by the availability of these medical/technical opinions are especially high in mass torts that involve medical assessments of thousands of claimants.  The pendency of asbestos claims has driven well over 100 companies into bankruptcy, and with that example, any industry facing a substantial wave of repetitive liability claims must be concerned about how to respond to what it believes are false or unfounded claims. Clients ask whether there are remedies for the promotion of false, fraudulent, or just inadequate medical science under the banner of seeking compensation in products liability cases. The answers remain less than clear.

Some Past Attempts to Remedy the Harm from Dubious Science in Products Cases

GAF’s Litigation against the Asbestos Lawsuit Industry

On January 10, 2001, G-I Holdings Inc., the successor to GAF Corporation (“GAF”), filed suit against a group of asbestos personal injury lawyers who it alleged had “orchestrated a scheme to inundate the judicial system with hundreds of thousands of asbestos cases without regard to their merit.”[3] Among the allegations were claims that the plaintiffs’ firms had “suborned perjury and fabricated evidence” and “induced expert witnesses to provide false and misleading testimony, all for the purpose of extracting unwarranted and inflated settlements, judgments and, correspondingly, attorneys’ fees, from GAF and other asbestos defendants.”  The complaint alleged that, in 1978, a group of

“approximately 125 plaintiffs’ asbestos contingency fee attorneys banded together to form and fund the Asbestos Litigation Group (“ALG”) in order to further their scheme of promoting asbestos litigation.”  GAF asserted that “acting jointly through the ALG, and through less formal asbestos-related organizations, defendants, upon information and belief, solicited tens of thousands of asbestos claimants and sued manufacturers without regard for, or in conscious disregard of, the merits of their claims against particular individual defendants such as GAF. . . . .pursuant to agreements with each network [of local counsel] member, a share of the fees . . . .is typically channeled back to the referring ALG member, and ultimately to the ALG, to be invested  in future claimant solicitations, including mailed advertisements in newsletters.  This has resulted in the filing of further claims, thereby continuing the scheme, and increasing the network, which spirals ever larger.”

GAF’s complaint specifically included claims relating to the alleged “fabricat[ion]” of “medical evidence.”  In this regard, GAF alleged, upon information and belief, that the plaintiffs’ lawyers had:[4]

  1. . . . .induced medical “experts” to testify falsely. As set forth in the “Toxic Justice” report, [the plaintiffs’ law firm] paid off what one of the firm’s paralegals described as “whore docs” i.e., doctors who for money eagerly attributed virtually any lung abnormality to asbestos exposure, regardless of what medical evidence actually showed.

And GAF complained that:

  1. . . . . these practices induced false and misleading testimony to be given by expert witnesses in support of claims brought against GAF and others, which resulted in GAF’s payment of inflated verdicts and settlements in a number of cases.

While much of GAF’s complaint did not focus specifically on the quality of the medical evidence, it is nonetheless instructive as an overall perspective on the factual framework within which these medical issues arise. GAF’s complaint understandably focused heavily on defendant’s Baron & Budd’s memorandum, entitled “Preparing for Your Deposition.”  GAF alleged that this

“memorandum, apparently created for use in preparing asbestos plaintiffs for deposition, improperly exhorts witnesses to testify in a pre-scripted manner, regardless of the truth.”

For particularity’s sake, GAF alleged, with extensive quotations from the Baron & Budd memorandum, that the memorandum told

“witnesses to identify only those products listed on the Work History Sheets prepared by Baron & Budd (lest the witness identify the product of a bankrupt entity from whom no damages or attorneys’ fees could be collected). . . .and to memorize the product names provided by Baron & Budd on the “Work History Sheets” and to testify that they actually saw those names on containers where they worked. . . .”[5]

The complaint alleges that the memorandum gave further improper instructions to plaintiffs about their testimony, including directions to omit any mention of exposures resulting “from the replacement or removal of old product that could not be identified by brand”; making false claims of “equal exposure to all products”; denying “that they ever saw any warnings or had knowledge concerning the harmful effects of asbestos.”

GAF alleged a variety of other concerted actions to file false asbestos claims.  These activities allegedly included withholding “from production in discovery death certificates for asbestos claimants that did not support the conclusion that the individual had died as a result of an asbestos-related disease”; conducting “periodic in-house training sessions to teach other attorneys and/or paralegals how to prepare all asbestos claimants to give scripted testimony in their depositions. . . . .without regard for whether or not the testimony was true”; participating in a scheme to falsify Court records to indicate that complaints were filed before the running of the statute of limitations; and submitting affidavits containing false information concerning the identity of products.

The complaint also contained a number of allegations to the effect that the defendant law firms had “used their considerable resources and power in an attempt to intimidate and deter GAF (and others) from exercising their constitutionally protected rights to petition Congress in support of legislation that would establish a fair and efficient administrative facility for resolving legitimate asbestos claims without the years of delay and wasteful fees and transaction costs that are characteristic of the current system.  Defendants have waged a full-scale, multi-front war against those seeking passage of a Congressional bill entitled the “Fairness in Asbestos Compensation Act.”

The suit pled claims under the Racketeer Influenced and Corrupt Organizations Act (“RICO”),[6] and under numerous other headings of state, and federal, law.[7]  The lawsuit industry defendants brought a series of motions to dismiss on the pleadings, with successive amended complaints filed, until there was nothing left of GAF’s complaint.[8]  For example, part of the case – relating to the Baron & Budd memorandum discussed above — pleaded fraud based on information and belief.  Judge Sweet dismissed that aspect of the fraud claims on the grounds that Federal Rule of Civil Procedure 9(b) requires that allegations of fraud be pleaded with specificity and that the plaintiff must provide a statement of facts upon which the belief of the existence of fraud is founded.  Judge Sweet concluded that GAF had repeatedly failed to meet this requirement.

Federal and State Prosecutions against Physicians and Screening Companies

After Judge Jack’s exposé of fraudulent and false diagnoses in the silicosis MDL, various news media reported that the United States Attorney’s office in the Southern District of New York was investigating possible criminal charges against the physicians and lawyers who orchestrated the screenings. Historically, there has been little interest among prosecutors in the questionable activities of screening physicians, with some notable exceptions.  In 1990, the United States Attorney’s office, for the Eastern District of Philadelphia, filed a civil RICO against several Philadelphia-area physicians for their role in submitting false and fraudulent Medicare claims.[9]  As pleaded by the government, the fraudulent scheme consisted of soliciting industrial workers for “free” lung screening, at the behest of lawyer clients, for asbestos-related diseases.  The physicians conducted radiologic and pulmonary function examinations, and submitted requests to Medicare for reimbursement of inflated costs for these services and falsely stated that the services were reasonably medically necessary because of diagnoses of chronic obstructive pulmonary disease.[10]  This matter appears to have been resolved before trial, although the docket fails to reveal the exact nature of the resolution.

The false claim problem continues, although the silicosis screenings have abated, and most asbestos plaintiffs’ lawyers have shifted their efforts to the high-yield mesothelioma and lung cancer cases, for which diagnostic accuracy is not typically the dominant issue. Some within the lawsuit industry appear to continue the practice of referring clients to friendly physicians for an examination that will form the basis of a lawsuit, with the consulting physician in turn filing a request for reimbursement with the claimant’s private or public health insurer.  For most insurers, such a claim for reimbursement impliedly represents that the services were reasonably medically necessary, and sometimes the services may well be necessary.  At other times, the services are redundant and provided only for purposes of preparing the examining physician to serve as an expert witness.  In a case I tried early in my career, the testifying expert witness first saw the plaintiff two weeks before trial for no purpose other than to serve as a witness.  The plaintiff had a regular treating physician, and had been examined by another testifying witness, but the plaintiff’s lawyer wanted to have a second testifying witness for trial.  The “Saturday-night” expert witness conducted his examination, and then requested reimbursement for the examination from the plaintiff’s health insurer, and indicated the name of the plaintiff’s counsel as the “referring physician” on the insurance forms.  The trial judge remarkably would not permit cross-examination of the testifying expert witness on the fraud, and suggested that such cross-examination was prohibited by the collateral source rule!  The health insurance industry will occasionally act vigilantly to enforce a lien against a tort recovery, but there has been little evidence of civil or criminal litigation arising from the practice of billing insurers for examinations by physicians who are essentially expert witnesses and not treating physicians.

The Pennsylvania Silicosis Litigation Cock Up

In February 2002, Texas invaded Pennsylvania. No conventional weapons were fired. The Texans took up positions in mobile vans in motel parking lots across eastern Pennsylvania. Without prescriptions, physicians’ orders, or regulatory approval, the Texans directed unlawful X-ray radiation at Pennsylvania workers in the hopes of creating evidence to be used in lawsuits for silicosis. To help establish their litigation beachhead, the Texans hired local mercenaries – a New Jersey company in the business of providing mobile X-ray screenings. Dozens of silicosis lawsuits were created and filed in Philadelphia as a result of the invasion.

On January 25, 2007, the Commonwealth of Pennsylvania, through its Department of Environmental Protection (DEP), responded by fining the New Jersey company, MOST Health Services, Inc. The DEP found that MOST violated Pennsylvania law by conducting X-ray screenings without physician or regulatory approval. For having unlawfully exposed 161 persons to ionizing radiation, DEP assessed a civil penalty of $80,500.00, against MOST. The DEP did not charge the plaintiffs’ lawyers with any violation of Commonwealth regulations.

MOST’s participation in unlawful litigation screenings was not a momentary lapse in judgment. Back in 2000, defense counsel in asbestos cases compelled the testimony of MOST principal Kenneth Warner, who acknowledged then that MOST had not been in the practice of complying with screening regulations. Mr. Warner, however, claimed that the company was in the process of filing appropriate applications to comply.

Workers were invited to the February 2002 MOST screenings by their unions, but the invitation letters were written by Texas lawyers. To participate in the screenings, the workers had to sign a retainer agreement to engage the Texas-based law firm. The workers were told that “legal ethics” required that they hire the sponsoring law firm to represent them before “the attorneys can provide [them] with medical tests.”

Of course, the law in no state permits attorneys to provide medical tests, and especially not X-rays. DEP, like most other states’ regulatory agencies, has promulgated comprehensive regulations that govern virtually every aspect of the use of medical radiation. In Pennsylvania, anyone proposing a “healing arts screening” with X-rays must submit, in advance, a comprehensive, written proposal with details of the proposed screening, the description of the population to be examined, the qualifications of the radiation technician and operator, the quality control to be used, the qualifications of the supervising physician, and the identity and qualifications of the physician who will interpret the radiographs.

The MOST screenings, commissioned by the Texas lawyers, were never authorized by the DEP. No physician was present on site. None of the workers presented prescriptions or physicians’ orders before being unlawfully exposed to radiation. The identity of the physician slated to receive the chest radiographs was never disclosed to DEP.

Ultimately, the films created by MOST were sent to a West Virginia physician, well known and well compensated in dust-disease litigation. This off-site physician diagnosed virtually all of the workers with either asbestosis or silicosis, and a majority of litigants with both asbestosis and silicosis, although he never examined the workers, never interviewed them, and never reviewed their medical records.

In December 2005, the defendants in the silicosis cases that arose from the MOST screenings moved to dismiss on grounds that the claims were the direct result of unlawful activities that violated Pennsylvania public policy. The trial court denied the motion without opinion. Despite the obvious conspiracy between the plaintiffs’ lawyers and MOST to violate Pennsylvania health regulations, no disciplinary actions were brought against the plaintiffs’ lawyers in the cases.

The Pennsylvania fine against MOST seems to have been an exceptional finding. Although the predatory screening practices decried in federal Judge Janis Graham Jack’s now judicial opinion, In re Silica Products Liability Litigation, no other states to my knowledge have taken action against the conspiracies among lawyers, physicians, and mobile screening companies, to violate state health regulations. These conspiracies thrived for some time, in part because of the entrepreneurial enthusiasm of the conspirators, and the failure of courts, bar associations, adversary counsel, state and federal regulators, and medical societies to condemn the screening practices. In the context of silicosis litigation, the “red flags of fraud,” go beyond the manufacturing of diagnoses for money; they mark as dubious the entire enterprise of suing sand suppliers for failure to warn about hazards that were well known to government, industry, labor, and academia from the 1930s, forward.

[1]  The following commentary flows from a joint project that the late R. Nicholas (Nick) Gimbel and I worked on some years ago. Nick’s illness and tragic death prevented us from publishing this work, but I believe it still bears some sort of public airing. Nick Gimbel and I presented some of this commentary in a paper, “Legal Remedies to Address Suspect Medical Science in Product Liability Cases,” for Mealey’s Advanced Insurance Coverage Conference, in Philadelphia, Pennsylvania (Jan. 23, 2006).

[2]  In re Silica Products Liability Litigation, 398 F.Supp. 2d 563 (S.D.Tex. 2005) (“In re Silica”). Although Judge Jack’s deconstruction of the silicosis “epidemic” is famous among defense counsel, Her Honor’s work has been met with willful ignorance by the lawsuit industry. See, e.g., David Michaels, “Deadly Dust,” chap. 8, in The Triumph of Doubt: Dark Money and the Science of Deception (2020) (exhibiting amnesia about one of the largest litigation frauds in the 21st century, so far.)

[3]  For a more complete, scholarly exposition of this case, see Lester Brickman, “Civil RICO: An Effective Deterrent to Fraudulent Asbestos Litigation?” 40 Cardozo L. Rev. 2301, 2344-2402 (2019).

[4]  Fourth Amended Complaint dated August 19, 2002.

[5]  Fourth Amended Complaint, ¶ 61.

[6]   18 U.S.C. § 1961, et seq.

[7]  Other claims in the GAF complaint asserted tortious interference with contract and economic advantage, breach of contract, common law fraud and falsification of documents.  Claims that were dismissed include malicious interference with GAF’s right to petition Congress, violation of 15 U.S.C. § 1 (antitrust laws) and fraudulent inducement.

[8]  See G-I Holdings, Inc. v. Baron & Budd, No. 01-Civ. 0216, 2005 WL 1653623 (S.D.N.Y.); G-I Holdings, Inc. v. Baron & Budd, No. 01-Civ. 0216, 2004 WL 638141 (S.D.N.Y. Mar. 30, 2004);  G-I Holdings, Inc. v. Baron & Budd, 2004 WL 540456 (S.D.N.Y. Mar. 17, 2004); G-I Holdings, Inc. v. Baron & Budd, 2004 WL 374450 (S.D.N.Y. Feb. 27, 2004); G-I Holdings, Inc. v. Baron & Budd, 218 F.R.D. 409 (S.D.N.Y. 2003); G-I Holdings, Inc. v. Baron & Budd, 213 F.R.D. 146 (S.D.N.Y. 2003); G-I Holdings, Inc. v. Baron & Budd, 01 Civ. 0216, 2002 WL 31251702 (S.D.N.Y. Oct. 8, 2002); G-I Holdings, Inc. v. Baron & Budd, 238 F.Supp.2d 521 (S.D.N.Y. 2002); and G-I Holdings, Inc. v. Baron & Budd, 179 F.Supp.2d 233 (S.D.N.Y. 2001).

[9]  U.S. v. MRS Diagnostics, Inc., Civil Action No. 90-3517 (E.D.Pa. May 23, 1990), Complaint.

[10]  Id. at Complaint para. 1(a)-(i).

Posted in Asbestos, Scientific Misconduct, Silica | Comments Off on Legal Remedies for Suspect Medical Science in Products Cases – Part One

Data Games – A Techno Thriller

April 22nd, 2020

Data Games – A Techno Thriller

Sherlock Holmes, Hercule Poirot, Miss Marple, Father Brown, Harry Bosch, Nancy Drew, Joe and Frank Hardy, Sam Spade, Columbo, Lennie Briscoe, Inspector Clouseau, and Dominic Da Vinci:

Move over; there is a new super sleuth in town.

Meet Professor Ken Wheeler.

Ken is a statistician, and so by profession, he is a data detective. In his day job, he teaches at a northeastern university, where his biggest challenges are managing the expectations of students and administrators, while trying to impart statistical learning. At home, Ken rarely manages to meet the expectations of his wife and son. But as some statisticians are wont to do, Ken sometimes takes on consulting gigs that require him to use his statistical skills to help litigants sort out the role of chance in cases that run from discrimination claims to rare health effects. In this contentious, sharp-elbowed environment, Ken excels. And truth be told, Ken actually finds great satisfaction in identifying the egregious errors and distortions of adversary statisticians

Wheeler’s sleuthing usually involves ascertaining random error or uncovering a lurking variable, but in Herberg I. Weisberg’s just-published novel, Data Games: A Techno Thriller, Wheeler is drawn into a high-stakes conspiracy of intrigue, violence, and fraud that goes way beyond the run-of-the-mine p-hacking and data dredging.

An urgent call from a scientific consulting firm puts Ken Wheeler in the midst of imminent disaster for a pharmaceutical manufacturer, whose immunotherapy anti-cancer wonder drug, Verbana, is under attack. A group of apparently legitimate scientists have obtained the dataset from Verbana’s pivotal clinical trial, and they appear on the verge of blowing Verbana out of the formulary with a devastating analysis that will show that the drug causes early dementia. Wheeler’s mission is to debunk the debunking analysis when it comes.

For those readers who are engaged in the litigation defense of products liability claims against medications, the scenario is familiar enough. The scientific group studying Verbana’s alleged side effect seems on the up-and-up, but they appear to engaged in a cherry-picking exercise, guided by a dubious theory of biological plausibility, known as the “Kreutzfeld hypothesis.”

It is not often that mystery novels turn on surrogate outcomes, biomarkers, genomic medicine, and predictive analytics, but Data Games is no ordinary mystery. And Wheeler is no ordinary detective. To be sure, the middle-aged Wheeler drives a middle-aged BMW, not a Bond car, and certainly not a Bonferroni. And Wheeler’s toolkit may not include a Glock, but he can handle the lasso, the jacknife, and the logit, and serve them up with SAS. Wheeler sees patterns where others see only chaos.

Unlike the typical Hollywood rubbish about stereotyped evil pharmaceutical companies, the hero of Data Games finds that there are sinister forces behind what looks like an honest attempt to uncover safety problems with Verbana. These sinister forces will use anything to achieve their illicit ends, including superficially honest academics with white hats. The attack on Verbana gets the FDA’s attention and an urgent hearing in White Oak, where Wheeler shines.

The author of Data Games, Herbert I. Weisberg, is himself a statistician, and a veteran of some of the dramatic data games he writes about in this novel. Weisberg is perhaps better known for his “homework” books, such asWillful Ignorance: The Mismeasure of Uncertainty (2014), and Bias and Causation: Models and Judgment for Valid Comparisons (2010). If, however, you ever find yourself in a pandemic lockdown, Weisberg’s Data Games: A Techno Thriller is a perfect way to escape. For under $3, you will be entertained, and you might even learn something about probability and statistics.

Posted in Data Sharing, Scientific Misconduct, Scientific Publishing, Underlying Data | Comments Off on Data Games – A Techno Thriller

Dark Money, Scott Augustine, and Hot Air

April 11th, 2020

Fraud by the litigation industry takes many different forms. In the massive silicosis litigation unleashed in Mississippi and Texas in the early 2000s, plaintiffs’ lawyers colluded with physicians to concoct dubious diagnoses of silicosis. Fraudulent diagnoses of silicosis led to dismissals of thousands of cases, as well as the professional defrocking of some physician witnesses.[1] For those trying to keep up with lawsuit industry’s publishing arm, discussion of the Great Silicosis Fraud is completely absent from David Michaels’ recent book, The Triumph of Doubt.[2] So too is any mention of “dark money” that propelled the recently concluded Bair Hugger litigation.

Back in 2017, I wrote about the denial of a Rule 702 motion in the Bair Hugger litigation.[3] At the time, I viewed the trial court’s denial, on the facts of the case, to be a typical failure of gatekeeping.[4] Events in the Bair Hugger cases were only warming up in 2017.

After the court’s ruling, 3M took the first bellwether case to trial and won the case with jury, on May 30, 2018. Perhaps this jury verdict encouraged the MDL trial judge to take 3M’s motion for reconsideration of the Rule 702 motion seriously. In July 2019, the MDL court granted 3M’s motion to exclude the opinion testimony of plaintiffs’ general causation and mechanism expert witnesses, Drs. Jarvis, Samet, Stonnington, and Elghobashi.[5] Without these witnesses, over 5,000 plaintiffs, who had been misled about the merits of their cases, were stranded and set up for dismissal. On August 2, 2019, the MDL cases were dismissed for want of evidentiary support on causation. On August 29, 2019, plaintiffs filed a joint notice of appeal to the Eight Circuit.

The two Bair Hugger Rule 702 federal court decisions focused (or failed to focus) on scientific considerations. Most of the story of “dark money” and the manufacturing of science to support the litigation were suppressed in the Rule 702 motion practice, and in the federal jury trial. In her second Rule 702 reconsideration opinion, the MDL judge did mention undisclosed conflicts of interest by authors of the key studies relied upon by plaintiffs’ witnesses.[6]

To understand how the Bair Hugger litigation got started, and to obtain a full understanding of the nature of the scientific evidence was, a disinterested observer will have to read the state court decisions. Defendant 3M moved to exclude plaintiffs’ causation expert witnesses, in its Minnesota state court cases, under the so-called Frye standard. In response, the state judge excluded plaintiffs’ witnesses for advancing a novel scientific theory that lacked acceptance in the relevant scientific community. The Minnesota Court of Appeals affirmed, with a decision that talked rather more freely about the plaintiffs’ counsel’s dark money. In re 3M Bair Hugger Litig., 924 N.W.2d 16 (Minn. App. 2019) [cited as Bair Hugger].

As the Minnesota Court of Appeals explained, a forced-air warming device (FAWD) is a very important, useful device to keep patients’ body temperatures normal during surgery. The “Bair Hugger” is a FAWD, which was invented in 1987, by Dr. Scott Augustine, an anesthesiologist, who at the time was the chief executive officer of Augustine Medical, Inc. Bair Hugger at 19.

In the following 15 years, the Bair Hugger became the leading FAWD in the world. In 2002, the federal government notified Augustine that it was investigating him for Medicare fraud. Augustine resigned from the company that bore his name, and the company purged the taint by reorganizing as Arizant Healthcare Inc. (Arizant), which continued to make the Bair Hugger. In the following year, 2003, Augustine pleaded guilty to fraud and paid a $2 million fine. His sentence included a five-year ban from involvement in federal health-care programs.

During the years of his banishment, fraudfeasor Augustine developed a rival product and then embarked upon a global attack on the safety of his own earlier invention, the Bair Hugger. In the United Kingdom, his claim that the Bair Hugger increased risks of surgical site infections attacks was rejected by the UK National Institute for Health and Clinical Excellence. A German court enjoined Augustine from falsely claiming that the Bair Hugger led to increased bacterial contamination.[7] The United States FDA considered and rejected Augustine’s claims, and recommended the use of FAWDs.

In 2009, Augustine began to work as a non-testifying expert witness with the Houston, Texas, plaintiffs’ law firm of Kennedy Hodges LLP. A series of publications resulted in which the authors attempted to raise questions about the safety of the Bair Hugger. By 2013, with the medical literature “seeded” with several studies attacking the Bair Hugger, the Kennedy Hodges law firm began to manufacture law suits against Arizant and 3M (which had bought the Bair Hugger product line from Arizant in 2010). Bair Hugger at 20.

The seeding studies were marketing and litigation propaganda used by Augustine to encourage the all-too-complicit lawsuit industry to ramp up production of complaints against 3M over the Bair Hugger. Several of the plaintiffs’ studies included as an author a young statistician, Mark Albrecht, an employee of, or a contractor for, Augustine’s new companies, Augustine Temperature Management and Augustine Medical. Even when disclosures were made, they were at best “anemic”:

“The author or one or more of the authors have received or will receive benefits for personal or professional use from a commercial party related directly or indirectly to the subject of this article.”[8]

Some of these studies generally included a disclosure that Albrecht was funded or employed by Augustine, but they did not disclose the protracted, bitter feud or Augustine’s confessed fraudulent conduct. Another author of some of the plaintiffs’ studies included David Leaper, who was a highly paid “consultant’’ to Augustine at the time of the work on the study. None of the studies disclosed Leaper’s consultancy for Augustin:

  1. Mark Albrecht, Robert Gauthier, and David Leaper, “Forced air warming, a source of airborne contamination in the operating room?” 1 Orthopedic Rev. (Pavia) e28 (2009)
  2. Mark Albrecht, Robert L. Gauthier, Kumar Belani, Mark Litchy, and David Leaper, “Forced-air warming blowers: An evaluation of filtration adequacy and airborne contamination emissions in the operating room,” 39 Am. J. Infection Control 321 (2011)
  3. P.D. McGovern, Mark Albrecht, Kumar Belani, C. Nachtsheim, “Forced-air warming and ultra-clean ventilation do not mix,” 93 J. Bone & Joint Surg. – British 1537 (2011)
  4. K.B. Dasari, Mark Albrecht, and M. Harper, “Effect of forced-air warming on the performance of operating-theatre laminar-flow ventilation,” 67 Anaesthesia 244 (2012)
  5. Mike Reed, Oliver Kimberger, Paul D. McGovern, and Mark C. Albrecht, “Forced-Air Warming Design: Evaluation of Intake Filtration, Internal Microbial Buildup, and Airborne-Contamination Emissions,” 81 Am. Ass’n Nurse Anesthetists 275 (2013)
  6. Kumar Belani, Mark Albrecht, Paul McGovern, Mike Reed, and Christopher Nachtsheim, “Patient warming excess heat: the effects on orthopedic operating room ventilation performance,” 117 Anesthesia & Analgesia 406 (2013)

In one study, Augustine’s employee Mark Albrecht conducted the experiment with one of the authors, but was not listed as an author although he wrote an early draft of the study. Augustine provided all the equipment used in the experiment. The published paper failed to disclose any of these questionable activities:

  1. A.J. Legg & A.J. Hammer, “Forced-air patient warming blankets disrupt unidirectional flow,” 95 Bone & Joint J. 407 (2013)

Another study had more peripheral but still questionable involvement of Augustine, whose company lent the authors equipment used to conduct the study, without proper acknowledgment and disclosure:

  1. A.J. Legg, T. Cannon, and A. J. Hamer, “Do forced-air warming devices disrupt unidirectional downward airflow?” 94 J. Bone & Joint Surg. – British 254 (2012)

In addition to the defects in the authors’ disclosures, 3M discovered that two of the studies had investigated whether the Bair Hugger spread bacteria in the surgical area. Although the experiments found no spread with the Bair Hugger, the researchers never publicly disclosed their exculpatory evidence.[9]

Augustine’s marketing campaign, through these studies, ultimately fell flat at the FDA, which denied his citizen’s petition and recommended that surgeons continue to use FAWDs such as the Bair Hugger.[10] Augustine’s proxy litigation war against 3M also fizzled, unless the 8th Circuit revives his vendetta. Nonetheless, the Augustine saga raises serious questions about how litigation funding of “scientific studies” will vex the search for the truth in pharmaceutical products litigation. The Augustine attempt to pollute the medical literature was relatively apparent, but dark money from undisclosed financiers may require greater attention from litigants and from journal editors.

[1]  In re Silica Products Liab. Litig., MDL No. 1553, 398 F. Supp. 2d 563 (S.D.Tex. 2005).

[2]  David Michaels, The Triumph of Doubt: Dark Money and the Science of Deception (2020).

[3]  In re Bair Hugger Forced Air Warming, MDL No. 15-2666, 2017 WL 6397721 (D. Minn. Dec. 13, 2017).

[4]  “Gatekeeping of Expert Witnesses Needs a Bair Hug” (Dec. 20, 2017).

[5]  In re Bair Hugger Forced Air Warming Devices Prods. Liab. Litig., MDL No. 15-2666, 2019 WL 4394812 (D. Minn. July 31, 2019). See Joe G. Hollingsworth & Caroline Barker, “Exclusion of Junk Science in ‘Bair Hugger’ MDL Shows Daubert Is Still Breathing,” Wash. Leg. Foundation (Jan 23, 2020); Christine Kain, Patrick Reilly, Hannah Anderson and Isabelle Chammas, “Top 5 Drug And Medical Device Developments Of 2019,” Law360 (Jan. 9, 2020).

[6]  In re Bair Hugger Forced Air Warming Devices Prods. Liab. Litig., 2019 WL 4394812, at *10 n.13 (D. Minn. July 31, 2019) (observing that “[i]n the published study, the authors originally declared no conflicts of interest”).

[7]  Dr. Augustine has never been a stranger to the judicial system. See, e.g., Augustine Medical, Inc. v. Gaymar Industries, Inc., 181 F.3d 1291 (Fed. Cir. 1999); Augustine Medical, Inc. v. Progressive Dynamics, Inc., 194 F.3d 1367 (Fed. Cir. 1999); Cincinnati Sub-Zero Products, Inc. v. Augustine Medical, Inc., 800 F. Supp. 1549 (S.D. Ohio 1992).

[8]  P.D. McGovern, Mark Albrecht, Kumar Belani, and C. Nachtsheim, “Forced-air warming and ultra-clean ventilation do not mix,” 93 J. Bone & Joint Surg. – British 1537, 1544 (2011).

[9]  See https://www.truthaboutbairhugger.com/truth-science-behind-claims-3m-bair-hugger-system-look-augustine-connections-research-studies/.

[10]  William Maisel, “Information about the Use of Forced Air Thermal Regulating Systems – Letter to Health Care Providers”; Center for Devices and Radiological Health, U.S. Food and Drug Administration (Aug. 30, 2017).

Posted in Conflicts of Interest, Expert Witnesses, Rule 702, Scientific Misconduct, Scientific Publishing | Comments Off on Dark Money, Scott Augustine, and Hot Air

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