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Ferebee Revisited

December 28th, 2017

The following post was originally published on November 8, 2012, but was hacked, no doubt by the lawsuit industry, and replaced with mindless fluff as is its wont. It is now restored.

Ferebee Revisited

I used to think of the infamous Ferebee decision as the Dred Scott decision of scientific evidence; in essence, declaring that science has no validity issues that the law is bound to respect. Ferebee v. Chevron Chem. Co., 552 F. Supp. 1297 (D.D.C. 1982), aff’d, 736 F.2d 1529 (D.C. Cir.), cert. denied, 469 U.S. 1062 (1984). The rhetoric on expert witnesses, from the district and circuit courts in this case is sometimes jarring, but the facts of the case make the holding, rather than the expansive dicta, not so unreasonable, under all the facts and circumstances of the case.

On rereading Ferebee, I was struck by several aspects of the case that rarely are discussed when Ferebee is cited. On sober second thought, Ferebee may not be such a bad decision, especially considering that it has no continuing validity as a rule of decision for expert witness admissibility in federal court.

1. Ferebee is a government negligence case.

The plaintiff worked for the federal government when he was exposed to the herbicide paraquat. Richard Ferebee began working for the Department of Agriculture’s Beltsville Agricultural Research Center (BARC), in Beltsville, Maryland. He started spraying paraquat in the summer of 1977, and used the herbicide regularly through the time he was diagnosed with pulmonary fibrosis, in November 1979. 736 F.2d at 1531-32. Ferebee brought a failure to warn claim against the supplier of paraquat, Chevron Chemical Company. The allegations of actual or constructive knowledge of a hazard, however, could just as readily be asserted against the federal government, which owned the BARC facility, employed Ferebee, controlled and supervised his use of paraquat, and failed to comply with Chevron’s instructions. The federal government further regulated the sale and use of paraquat extensively, first by the Department of Agriculture, and later by the Environmental Protection Agency. Id. at 1532.

2. The exposure.

Ferebee filed suit in 1981, he died in 1982. His case was tried twice. In the first trial, the jury deadlocked; in the second trial, the jury returned a verdict in favor of his estate, and for his family, for $60,000. In his deposition testimony, Ferebee described how sprayed paraquat, in the summer of 1977. The chemical was diluted for use, per Chevron’s instructions. There was no evidence that Ferebee ever had direct contact with undiluted paraquat, or that the paraquat he was exposed to was not diluted according to the proportions recommended on Chevron’s label. 552 F. Supp. at 1295 & n. 3. Ferebee frequently got the chemical on his hands. 552 F. Supp. at 1294-95. Ferebee further described an occasion when he was drenched with paraquat when he walked behind a tractor that was spraying the chemical, and another incident when he used a defective sprayer that leaked paraquat “all over his pants.” 736 F.2d at 1532. On both occasions, Ferebee did not wash, and apparently went home contaminated, where he fell asleep, tired and dizzy, without showering. Id. As we will see, the exposure that Ferebee described would not have occurred had his federal employer followed the instructions on the label that it mandated. In 1978, the federal Occupational Health & Safety Administration published Guidelines on the need for protective clothing, respirators, immediate washing of contaminated skin, etc. Ferebee’s federal employer recklessly disregarded its own guidelines.

3. The warnings.

Paraquat could be sold in the United States only when labeled in accordance with EPA regulations, promulgated pursuant to the Federal Insecticide, Fungicide, and Rodenticide Act, 7 U.S.C. § 136, et seq. (FIFRA) The statute bars EPA from allowing sale of regulated herbicides, such as paraquat, unless the chemicals, as labeled, will not cause “unreasonable adverse effects on the environment.” 7 U.S.C. § 136a(c)(5)(C). Such effects are in turn defined as any unreasonable risk to man or the environment, taking into account the economic, social, and environmental costs and benefits of the use of [the] pesticide. 7 U.S.C. § 136(bb). FIFRA further requires the EPA to require labeling that is “adequate to protect health and the environment” and that is “likely to be read and understood.” 7 U.S.C. § 136(q)(1)(E). 736 F.2d at 1539-40.

Unfortunately, the courts failed to provide the complete warning label and the material data safety sheets. There are “snippets” provided, which make clear that the federal government was largely to blame for failing to comply with the directions required under FIFRA. For instance, the district court, in a footnote, acknowledged:

“For example, the label advised the user spraying paraquat to wear waterproof clothing and goggles, to avoid working in spray mist, and to wash splashes on the skin or eyes immediately with water.”

552. F. Supp. at 1304 n.40. The Court of Appeals reported that “the label, in large bold letters states:

DANGER

CAN KILL IF SWALLOWED

HARMFUL TO THE EYES AND SKIN

736 F.2d at 1536. The label also informed users to wash any exposed areas immediately, and to remove contaminated clothing. Id.

4. The Stipulation.

A key fact, rarely described or explained in discussions of the Ferebee case, is the parties’ stipulation

“that Mr. Ferebee’s only significant exposure to paraquat was on his intact skin; i.e., there was no evidence that Mr. Ferebee swallowed or inhaled paraquat, or that he spilled or sprayed it on an area of his skin upon which he had any apparent cuts or scrapes. The jury was not, of course, precluded from concluding that a person engaged in Mr. Ferebee’s line of work could have had some, or even many, minor cuts or abrasions not readily discernible to the naked eye or likely to be remembered some time later.”

552. F. Supp. at 1295 & n. 3.

Why did the plaintiffs try to present their case solely as a dermal exposure cases? As we will see, this stratagem made their medical causation case more difficult, but it avoided serious misuse and lack of proximate cause issues. Ferebee had been instructed by his co-workers and supervisors that paraquat was extremely dangerous if swallowed, and probably also if inhaled. The warning label was unequivocal in detailing the dangers and the need to avoid ingestion. (Without the full label, it is difficult to evaluate how well the label warned against inhalation, but the 1978 OSHA guidelines address the use of a proper respirator for situations in which paraquat may be inhaled.) On the other hand, the label had a weakness, which could be exploited, as long as the preemption defense could be held at bay: the label urged protective clothing, goggles, and immediate washing of contaminated skin, but it failed to describe the consequence of dermal exposure other than irritation. Ferebee could thus avoid his culpable conduct, as well as a sophisticated intermediary defense, by claiming that his exposure was only dermal.

Why did Chevron agree to the stipulation? The defendant probably felt sanguine about its preemption defense, and thus also about the adequacy of its warnings overall. The stipulation limited the plaintiff’s medical causation case to a route of exposure that put it into an arguable “first instance” case report. Chevron stood to gain a claim of “lack of notice,” and thus lack of actual or constructive knowledge of the risk of lung disease from dilute dermal exposure. The clinical presentation itself differed from many of the cases of known paraquat poisoning, see infra, and Chevron probably believed that it could deal with the medical causation claim better if exposure was limited to transdermal absorption. Curiously, Chevron did not argue that Ferebee must have had some inhalational exposure, which he almost certainly did. I suspect that Chevron’s position on inhalation was hedged because its warning label did not specify respirator usage for ordinary work exposures of applicators (as opposed to workers who handled undiluted paraquat, worked in confined spaces, etc.).

5. Medical causation

Chevron took a strident position, standing on the fact that there had been no previous documented cases of pulmonary fibrosis in workers exposed to diluted paraquat through their skin. The following facts were uncontroverted:

Paraquat causes pulmonary fibrosis in humans.
The evidence that established paraquat as a cause of pulmonary fibrosis was largely case series of acute onset of pulmonary fibrosis after ingestion.
Paraquat induces pulmonary fibrosis relatively rapidly.
Paraquat can be absorbed through the skin.
The parties agreed that any type of exposure – ingestion, inhalation, or dermal absorption – could cause lung damage. 552. F. Supp. at 1300 & n.28.
Once paraquat is ingested, inhaled, or absorbed, it can travel to the lungs.
Lung fibrosis caused by dermal absorption of paraquat had been described previously only with skin lesions before or after the injury. 736 F.2d at 1538.
The lungs are the target organ for paraquat.
There are numerous causes of pulmonary fibrosis (such as asbestosis, scleroderma, rheumatoid arthritis, etc.).
The variants of pulmonary fibrosis do not all look alike, present alike, or progress alike.
Mr. Ferebee had no known other disease or exposure that could account for his pulmonary fibrosis.
There is are cases of pulmonary fibrosis with no identifiable cause, known as idiopathic pulmonary fibrosis (IPF).
IPF is relatively rare; it too has a rapid onset and progression, although not as fast as the cases described after exposure to undiluted paraquat.
Mr. Ferebee’s medical history was largely unhelpful in explaining his clinical course.
Ferebee had some shortness of breath before starting to use paraquat. 552. F. Supp. at 1295.
Ferebee used paraquat occasionally over three years before he was diagnosed with pulmonary fibrosis.

Some observations about these facts. General causation in a sense was not contested. Paraquat causes pulmonary fibrosis. The issue was whether dilute dermal exposure over three years causes pulmonary fibrosis. Chevron stridently asserted that the “scientific method” required controlled experimental or observational (epidemiologic) studies. The problem with Chevron’s position was that general causation had already been established, and not by analytical epidemiologic studies.

6. The expert witnesses.

Ferebee was initially treated by Dr. Muhammed Yusuf, a pulmonary specialist, who diagnosed pulmonary fibrosis. Dr. Yusef referred Ferebee to the National Institutes of Health (NIH), where he came under the care of Dr. Ronald G. Crystal of the Heart, Lung, and Blood Institute. (Dr. Crystal is now at Cornell-Weill, where he is Chairman of Genetic Medicine, and he practices pulmonary medicine.)

Chevron called Dr. Carrington, who diagnosed Ferebee with IPF. Dr. Carrington challenged the plaintiffs’ expert witnesses’ opinions for lacking reliance upon controlled observational or experimental studies. 552. F. Supp. at 1301. Dr. Carrington, however, acknowledged that dermal cases are too rare for observational epidemiologic analysis, but emphasized that no animal studies of sufficient size had been done to support plaintiffs’ hypothesis. Chevron also called a Dr. Fisher, who presented a toxicokinetic (TK) analysis of Ferebee’s dermal absorption. Based upon his TK analysis, Dr. Fisher concluded that the maximal amount of paraquat absorbed by Ferebee was too small, based upon known cases and animal studies, to have caused paraquat toxicity. Id.

7. Chevron’s challenge to plaintiffs’ expert witnesses’ causation opinion.

None of the defendant’s expert witnesses examined Ferebee. The courts thought this was relevant, but they never articulated what would have been observed on physical examination that was important to resolving the differential diagnosis of paraquat toxicity versus IPF. There was no dispute that Ferebee had rapidly progressing pulmonary fibrosis. The expert witnesses on both sides evaluated Ferebee’s clinical data, presentation, clinical course, and arrived at different diagnoses. The plaintiffs’ expert witnesses’ diagnosis, however, involved a causal attribution to paraquat exposure.

The Ferebee case was litigated under Maryland law because federal statutory law requires state law to control in a wrongful death action arising out of the neglect or wrongful act of another on a federal enclave. 16 U.S.C. § 457. 736 F.2d at 1533. (Maryland law is actually favorable to a sophisticated intermediary defense, although the key decisions post-date Ferebee.) Chevron appears to have relied upon Maryland’s articulation of the Frye general acceptance doctrine, and the courts analyzed Chevron’s arguments as a Frye challenge. 552 F. Supp. at 1301; 736 F.2d at 1535. Although the use of Maryland law to determine an evidentiary issue seems suspect, Chevron pressed apparently pressed its challenge in terms of Maryland’s version of Frye, and not based upon Federal Rule of Evidence 702. The infamous language used by both the district and the circuit courts was, therefore, not an interpretation of federal law. Rule 702 was never cited or discussed in either the trial or the appellate court’s opinion.

My re-reading of Ferebee has softened my criticisms of state courts that had relied upon the case, even after the Supreme Court’s decision in Daubert. Softened but not eliminated my criticism — Ferebee is still a case largely confined to its facts, and the language quoted as a standard of admissibility is really a statement of the appellate standard of review for the jury’s determination of medical causation.

8. The judicial resolution of Chevron’s Frye challenge

The district court insightfully recognized that Chevron was demanding a level of evidence, which had never been required to establish paraquat’s generally accepted ability to cause pulmonary fibrosis. This recognition led to the district court’s colorful language:

“It is true that medical expert testimony must be grounded in proper scientific methodology, but the extremely stringent standard that defendant suggests is beyond reason. Product liability law, especially as it relates to relatively new products or those with a relatively rare yet significant danger, would be rendered next to meaningless if a plaintiff could prove he was injured by a product only after a ‘statistically significant’ number of other people were also injured. A civilized legal system does not require that much human sacrifice before it can intervene. The fact that this is the first case of this exact type-or at least the first of its exact type in which the involvement of paraquat was discovered by alert doctors — cannot be enough by itself to shield defendant from liability. Defendant’s experts were not able to fault Dr. Crystal for his basic diagnostic methodology; in fact, they used the same kinds of test results, consultations, and other tools that he did. What they disagreed with chiefly were his conclusions.”

552 F. Supp. at 1301. The important observation is that general causation had been established case series and reports of human exposure. There never was statistical evidence that had been evaluated for “significance,” to establish general causation for undiluted paraquat, and the trial court refused, under Maryland law, to require such evidence for general causation for diluted paraquat. In this context, we can see that the trial court’s suggestion that statistical significance was not required has little bearing upon, cases in which general causation could only be established using epidemiologic evidence, with its attendant statistical inferences.

Of course, the matter only became worse when Chevron persisted in its argument and presented it to a liberal panel of the D.C. Circuit. (Judge Mikva wrote the opinion for a panel that included Judge Wald, and Senior Judge Bazelon.) The panel’s decision ratcheted up the rhetoric:

“Thus, a cause-effect relationship need not be clearly established by animal or epidemiological studies before a doctor can testify that, in his opinion, such a relationship exists. As long as the basic methodology employed to reach such a conclusion is sound, such as use of tissue samples, standard tests, and patient examination, product liability does not preclude recovery until a ‘statistically significant’ number of people have been injured or until science has had the time and resources to complete sophisticated laboratory studies of the chemical. In a courtroom, the test for allowing a plaintiff to recover is not scientific certainty, but legal sufficiency; if reasonable jurors could conclude from the expert testimony that paraquat more likely than not caused Ferebee’s injury, the fact that another jury might reach the opposite conclusion or that science would require more evidence before conclusively considering the causation question resolved is irrelevant. That Ferebee’s case may have been the first of its exact type, or that his doctors may have been the first alert enough to recognize such a case, does not mean that the testimony of those doctors, who are concededly well qualified in their fields, should not have been admitted.”

736 F.2d at 1535-36 (emphasis in original).

Again, the dismissive attitude towards statistically significant evidence is limited to the context of a causal analysis that had been made, to everyone’s satisfaction, for undiluted paraquat, without the need for epidemiologic, statistical evidence. Statistical significance was never at issue. In this way, Ferebee resembles the untoward language on statistical significance from Matrixx Initiatives Inc. v. Siracusano. In both cases, statistical significance was never really at issue. In Ferebee, there was no statistical evidence needed or used to reach causal conclusions about paraquat’s ability to induce pulmonary fibrosis. In Matrixx Initiatives, allegations of statistical significance and causation were not necessary because the plaintiffs needed only to allege materiality of the facts suppressed by the company in order to plead a securities fraud case. Materiality could be established without causation, and thus neither causation nor statistical significance needed to be alleged.

As for Chevron’s Frye challenge, the district court rejected the implied call for a vote on the general acceptance of Dr. Crystal’s reasoning. Frye may require “vote counting” of some sort, but the process becomes irrelevant when virtually no one has registered to vote. Otherwise, the defense and the plaintiffs’ expert witnesses appeared to be using the same technique of arguing by analogy to accepted cases of paraquat poisoning or IPF. Dr. Crystal opined that Ferebee’s case was “similar” to three other cases he had identified. Dr. Carrington argued that Ferebee’s case was more like IPF cases, although IPF cases themselves have some clinical heterogeneity as well. Paraquat cases described onset to death as a very rapid process. Ferebee did not present with significant symptoms for three years after his first exposure, and then he survived for another two plus years. Ferebee did not report skin lesions, which had been reported in previous cases of dermal exposure leading up to pulmonary fibrosis. The case presented, on the diagnostic level, a difficult call, but it is easy to see the courts’ impatience with the defendant’s insistence upon more stringent criteria and evidence than was used to establish the causal connection with undiluted paraquat.

9. Expert witness qualifications.

Chevron never challenged Dr. Yusuf’s or Dr. Crystal’s qualifications. The oft-quoted comments about expert witness qualifications were made in the context of describing the appellate court’s standard of review, and the court’s role in not assessing credibility or weighing the evidence:

“These admonitions apply with special force in the context of the present action, in which an admittedly dangerous chemical is alleged through long-term exposure to have caused disease. Judges, both trial and appellate, have no special competence to resolve the complex and refractory causal issues raised by the attempt to link low-level exposure to toxic chemicals with human disease. On questions such as these, which stand at the frontier of current medical and epidemiological inquiry, if experts are willing to testify that such a link exists, it is for the jury to decide whether to credit such testimony.”

736 F.2d at 1534.

This procedural posture is obviously very different from the initial determination of admissibility. As far as credentials are concerned, Drs. Yusuf and Crystal were hardly “hired guns”; both physicians were well qualified. Dr. Crystal had outstanding qualifications, and Chevron wisely never challenged them. Remarkably, this language has been mistakenly invoked as a standard for trial courts to use in determining the admissibility of expert witness opinion testimony. It is no such thing.

10. Preemption and Warnings Causation.

Ultimately, Chevron’s preemption defense was rejected by both the district and the circuit court. FIFRA preemption has had its ups and downs; no surprise there. More interesting is the emphasis that both courts gave to the important role of the employer in the case. The evidence overwhelming showed that Ferebee had never read the warning label, and thus the element of proximate causation between allegedly inadequate warning and harm was in jeopardy of going unproved. The courts, however, emphasized the role that the employer, through its supervisors and responsible co-workers, play in the complex organizational situation of a modern workplace:

“Mr. Ferebee’s situation was quite different, however. He did not purchase paraquat for his personal use; rather, it was provided to him by his employer for use on the job. The evidence showed that his principal source of information about paraquat was the oral instructions of his supervisors and co-workers, not the written label. He learned from them how to mix the product and how to spray it. It was also from this source that he learned of the danger of getting the product in his mouth: one of his co-workers warned him that if he accidently swallowed paraquat, it would ‘get in his blood’ and poison him. This is a common pattern of instruction and use of occupational materials in the workplace. Learning by doing and learning by oral instruction are tried and true methods of educating manual workers in their jobs. Therefore, although it is crucial to plaintiff’s case that someone would have read the label, it was not necessary for Mr. Ferebee to have done so. And it is obvious that one or more employees at BARC did read the label, since information did reach Mr. Ferebee about the proportions for diluting the product and about the dangers about which the label did warn. It was appropriate for the jury to infer that a warning about the danger of fatal lung disease from dermal exposure would also have been communicated to Mr. Ferebee. See Restatement (Second) of Torts § 388 comment n (seller normally entitled to assume that adequate warning will be passed on by purchaser to ultimate user); cf. Chambers v. G.D. Searle & Co., 441 F.Supp. at 381 (in product liability case involving prescription drug, relevant warning is the one given to doctor, not patient).”

552 F. Supp. at 1303-04 (internal citations omitted). So here we have Ferebee, the subject of so much derision and aspersion from defense counsel, embracing the Section 388, comment n, as well as applying learned intermediary principles to a case not involving prescription drugs. The appellate court was waxed enthusiastic about the principles of Section 388, and went so far as to cite Victor Schwartz in support:

“We live in an organizational society in which traditional common-law limitations on an actor’s duty must give way to the realities of society. *** In this case, Mr. Ferebee did not purchase the paraquat for his personal use, and there was substantial evidence that workplace communication about the dangers associated with various chemicals usually took the form of oral instructions from supervisors to workers, the latter of whom then retransmitted the information to co-workers. This, rather than individual reading of product warnings, is a typical method by which information is disseminated in the modern workplace. See Schwartz & Driver, “Warnings in the Workplace: The Need for a Synthesis of Law and Communication Theory,” 52 U. Cinn. L. Rev. 38, 66-83 (1983). The requirement that an improper warning proximately ‘cause’ the injury should be elaborated against this background. We believe Maryland would construe its tort law in this case to require only that someone in the workplace have read the label, not that Mr. Ferebee personally have read it. Because there is no dispute that one or more employees at BARC did read the label, we hold that the jury could properly have inferred that, had a warning about the danger of disease from dermal exposure been included on the label, that warning would have been communicated to Mr. Ferebee and that he would as a result have acted differently. Alternatively, the jury could have inferred that an adequate warning would have led Ferebee’s employers to undertake steps that would have protected him from paraquat poisoning-for example, provision of showers for use after spraying.”

736 F.2d at 1539 (emphasis in original; internal citation omitted). Judge Mikva’s prediction, of course, was absolutely accurate; Maryland tort law did, soon thereafter, embrace the sophisticated intermediary defense to exculpate the defendant in such remote supplier situations. See, e.g., Kennedy v. Mobay Corp., 84 Md. App. 397 (1990) (applying sophisticated user defense to bar claims against manufacturers of toluene diisocyanate), aff’d, 325 Md. 385 (1992); Higgins v. E.I. DuPont de Nemours, Inc., 671 F. Supp. 1055 (D. Md. 1987) (Maryland law; holding that manufacturer of paint was in better position than bulk supplier to communicate warnings to customers’ employees), aff’d, 863 F.2d 1162 (4th Cir. 1988). The principle invoked to excuse plaintiff from reading the warning label also works to exculpate the defendant when that warning label is otherwise adequate, or when the intermediary knows of the hazard in any event.

Posted in Causation, Rule 702, Scientific Evidence, statistical evidence | Comments Off on Ferebee Revisited

Some High-Value Targets for Sander Greenland in 2018

December 27th, 2017

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

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

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

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

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

“If a 95% confidence interval is specified, the range encompasses the results we would expect 95% of the time if samples for new studies were repeatedly drawn from the same population.”

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

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

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

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

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

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

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

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

* * * * *

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

Id. at 886.

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

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

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

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

Posted in Cognitive Biases, Conflicts of Interest, Expert Witnesses, Rule 702, statistical evidence | Comments Off on Some High-Value Targets for Sander Greenland in 2018

Gatekeeping of Expert Witnesses Needs a Bair Hug

December 20th, 2017

For every Rule 702 (“Daubert”) success story, there are multiple gatekeeping failures. See David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89 Notre Dame L. Rev. 27 (2013).¹ Exemplars of inadequate expert witness gatekeeping in state or federal court abound, and overwhelm the bar. The only solace one might find is that the abuse-of-discretion appellate standard of review keeps the bad decisions from precedentially outlawing the good ones.

Judge Joan Ericksen recently provided another Berenstain Bears’ example of how not to keep the expert witness gate, in litigation claims that the Bair Hugger forced air warming devices (“Bair Huggers”) cause infections. In re Bair Hugger Forced Air Warming, MDL No. 15-2666, 2017 WL 6397721 (D. Minn. Dec. 13, 2017). Although Her Honor properly cited and quoted Rule 702 (2000), a new standard is announced in a bold heading:

“Under Federal Rule of Evidence 702, the Court need only exclude expert testimony that is so fundamentally unsupported that it can offer no assistance to the jury.”

Id. at *1. This new standard thus permits largely unsupported opinion that can offer bad assistance to the jury. As Judge Ericksen demonstrates, this new standard, which has no warrant in the statutory text of Rule 702 or its advisory committee notes, allows expert witnesses to rely upon studies that have serious internal and external validity flaws.

Jonathan Samet, a specialist in pulmonary medicine, not infectious disease or statistics, is one of the plaintiffs’ principal expert witnesses. Samet relies in large measure upon an observational study², which purports to find an increased odds ratio for use of the Bair Hugger among infection cases in one particular hospital. The defense epidemiologist, Jonathan B. Borak, criticized the McGovern observational study on several grounds, including that the study was highly confounded by the presence of other known infection risks. Id. at *6. Judge Ericksen characterized Borak’s opinion as an assertion that the McGovern study was an “insufficient basis” for the plaintiffs’ claims. A fair reading of even Judge Ericksen’s précis of Borak’s proffered testimony requires the conclusion that Borak’s opinion was that the McGovern study was invalid because of data collection errors and confounding. Id.

Judge Ericksen’s judicial assessment, taken from the disagreement between Samet and Borak, is that there are issues with the McGovern study, which go to “weight of the evidence.” This finding obscures, however, that there were strong challenges to the internal and external validity of the study. Drawing causal inferences from an invalid observational study is a methodological issue, not a weight-of-the-evidence problem for the jury to resolve. This MDL opinion never addresses the Rule 703 issue, whether an epidemiologic expert would reasonably rely upon such a confounded study.

The defense proffered the opinion of Theodore R. Holford, who criticized Dr. Samet for drawing causal inferences from the McGovern observational study. Holford, a professor of biostatistics at Yale University’s School of Public Health, analyzed the raw data behind the McGovern study. Id. at *8. The plaintiffs challenged Holford’s opinions on the ground that he relied on data in “non-final” form, from a temporally expanded dataset. Even more intriguingly, given that the plaintiffs did not present a statistician expert witness, plaintiffs argued that Holford’s opinions should be excluded because

(1) he insufficiently justified his use of a statistical test, and

(2) he “emphasizes statistical significance more than he would in his professional work.”

Id.

The MDL court dismissed the plaintiffs’ challenge on the mistaken conclusion that the alleged “contradictions between Holford’s practice and his testimony impugn his credibility at most.” If there were truly such a deviation from the statistical standard of care, the issue is methodological, not a credibility issue of whether Holford was telling the truth. And as for the alleged over-emphasis on statistical significance, the MDL court again falls back to the glib conclusions that the allegation goes to the weight, not the admissibility of expert witness opinion testimony, and that plaintiffs can elicit testimony from Dr Samet as to how and why Professor Holford over-emphasized statistical significance. Id. Inquiring minds, at the bar, and in the academy, are left with no information about what the real issues are in the case.

Generally, both sides’ challenges to expert witnesses were denied.³ The real losers, however, were the scientific and medical communities, bench, bar, and general public. The MDL court glibly and incorrectly treated methodological issues as “credibility” issues, confused sufficiency with validity, and banished methodological failures to consideration by the trier of fact for “weight.” Confounding was mistreated as simply a debating point between the parties’ expert witnesses. The reader of Judge Ericksen’s opinion never learns what statistical test was used by Professor Holford, what justification was needed but allegedly absent for the test, why the justification was contested, and what other test was alleged by plaintiffs to have been a “better” statistical test. As for the emphasis given statistical significance, the reader is left in the dark about exactly what that emphasis was, and how it led to Holford’s conclusions and opinions, and what the proper emphasis should have been.

Eventually appellate review of the Bair Hugger MDL decision must turn on whether the district court abused its discretion. Although appellate courts give trial judges discretion to resolve Rule 702 issues, the appellate courts cannot reach reasoned decisions when the inferior courts fail to give even a cursory description of what the issues were, and how and why they were resolved as they were.

1 “The Misbegotten Judicial Resistance to the Daubert Revolution” (Dec. 8, 2013).

2 P. D. McGovern, M. Albrecht, K. G. Belani, C. Nachtsheim, P. F. Partington, I. Carluke, and M. R. Reed, “Forced-Air Warming and Ultra-Clean Ventilation Do Not Mix: An Investigation of Theatre Ventilation, Patient Warming and Joint Replacement Infection in Orthopaedics,” 93 J. Bone Joint 1537 (2011). The article as published contains no disclosures of potential or actual conflicts of interest. A persistent rumor has it that the investigators were funded by a commercial rival to the manufacturer of the Bair Hugger at issue in Judge Ericksen’s MDL. See generally, Melissa D. Kellam, Loraine S. Dieckmann, and Paul N. Austin, “Forced-Air Warming Devices and the Risk of Surgical Site Infections,” 98 Ass’n periOperative Registered Nurses (AORN) J. 354 (2013).

3 A challenge to plaintiffs’ expert witness Yadin David was sustained to the extent he sought to offer opinions about the defendant’s state of mind. Id. at *5.

Posted in Causation, Conflicts of Interest, Data Sharing, Rule 702, Rule 703, Scientific Evidence, Underlying Data | Comments Off on Gatekeeping of Expert Witnesses Needs a Bair Hug

Stuck in Silicone

December 12th, 2017

There was a time when silicone chemistry, biocompatibility, toxicity, and litigation weighed upon my mind. What started with a flurry of scientific interest, led to a media free for all, then FDA Commissioner David Kessler’s moratorium on silicone breast implants, and then to a feeding frenzy for the lawsuit industry. Ultimately, the federal court system found its way to engage four non-party expert witnesses, who cut through the thousands of irrelevant documents that plaintiffs’ counsel used to obfuscate the lack of causation evidence. The court-appointed experts in MDL 926 were unanimous in their rejection of the plaintiffs’ claims.¹ Not long after, the Institute of Medicine (now the National Academy of Medicine) issued its voluminous review of the scientific evidence, again with the conclusion that the evidence, when viewed scientifically and critically, showed a lack of association between silicone and autoimmune disease.²

Along the way to this definitive end of the lawsuit industry’s assault on the medical device industry, the parties assembled in the courtroom of the Hon. Jack B. Weinstein, for Rule 702 hearings on the opinions proffered by the plaintiffs’ expert witnesses. Judge Weinstein, along with the late Judge Harold Baer, of the Southern District of New York, and Justice Lobis, of the New York Supreme Court, held hearings that lasted two weeks, and entertained virtually unlimited argument. In characteristic style, Judge Weinstein did not grant the defendants’ Rule 702 motions; rather he cut right to the heart of the matter, and granted summary judgment in favor of the defense on plaintiffs’ claims of systemic diseases.³

Over a dozen years later, in reflecting upon a long judicial career that involved many so-called mass torts, Judge Weinstein described the plaintiffs’ expert witnesses more plainly as “charlatans” and the silicone litigation as largely based upon fraud.⁴

****************************

Last week, I received an email from Arthur E. Brawer, who represented himself to be an Associate Clinical Professor of Medicine.⁵ Dr. Brawer kindly forwarded some of his publications on the subject of silicone toxicity.⁶ Along with the holiday gift, Dr Brawer also gave me a piece of his mind:

“I recommend you rethink your prior opinions on the intersection of science and the law as it relates to this issue, as you clearly have no idea what you are talking about regarding the matter of silicone gel-filled breast implants. Perhaps refresher courses in biochemistry and biophysics at a major university might wake you up.”

Wow, that woke me up! Who was this Dr Brawer? His name seemed vaguely familiar. I thought he might have been a lawsuit industry expert witness I encountered in the silicone litigation, but none of his articles had a disclosure of having been a retained expert witness. Perhaps that was a mere oversight on his part. Still, I went to my archives, where I found the same Dr Brawer engaged in testifying for plaintiffs all around the country. In one early testimonial adventure, Brawer described how he came up with his list of signs and symptoms to use to define “silicone toxicity”:

Q. Doctor, if a patient presented to you with green hair and claimed that her green hair was attributable to her silicone breast implants, unless you could find another explanation for that green hair, you’d put that on your list of signs and symptoms; right?

A. The answer is yes.

Notes of Testimony of Arthur E. Brawer, at 465:7-12, in Merlin v. 3M Co., No. CV-N-95-696-HDM (D. Nev.Dec. 11, 1995) (Transcript of Rule 702 hearing)

A year later, Brawer’s opinions were unceremoniously excluded in a case set for trial in Dallas, Texas.⁷ Surely this outcome, along with Judge Weinstein’s rulings, the findings of the court-appointed witnesses in MDL 926, and the conclusions of the Institute of Medicine would have discouraged this Brawer fellow from testifying ever again?

Apparently not. Brawer, like the Black Knight in Monty Python and the Holy Grail, still lives and breathes, but only to be cut again and again. A quick Westlaw search turned up another, recent Brawer testimonial misadventure in Laux v. Mentor Worldwide, LLC, case no. 2:16-cv-01026, 2017 WL 5235619 (C.D. Calif., Nov. 8, 2017).⁸ Plaintiff Anita Laux claimed that she developed debilitating “biotoxin” disease from her saline-filled silicone breast implants. In support, she proffered the opinions of three would-be expert witnesses, a plastic surgeon (Dr Susan Kolb), a chemist (Pierre Blais), and a rheumatologist (Arthur Brawer).

Plaintiffs’ theory of biotoxin disease causation started with Blais’ claim to have found mold debris in the plaintiff’s explanted implants. The court found Blais unqualified, however, to offer an opinion on microbiology or product defects, and his opinions in the case, unreliable. Id. at *4-6. Dr Kolb, the author of The Naked Truth about Breast Implants, attempted to build upon Blais’ opinions, a rather weak foundation, to construct a “differential diagnosis.” In reasoning that Ms. Laux’s medical complaints arose from a mold infection, Kolb asserted that she had ruled out all other sources of exposure to mold. Unfortunately, Kolb either forgot or chose to hide correspondence with Ms. Laux, in which the plaintiff directly provided Kolb with information about prior environmental mold exposure on multiple occasions. Id. at *3. The trial court severely deprecated Kolb’s rather selective and false use of facts used to make the attribution of Ms. Laux’s claimed medical problems.

Dr Brawer, the author of Holistic Harmony: A Guide To Choosing A Competent Alternative Medicine Provider (1999), and my recent email correspondent, also succumbed to Judge Wright’s gatekeeping in Laux. The court found that Brawer had given a toxicology opinion with no supporting data. His report was thus both procedurally deficient under Federal Rule of Civil Procedure 26, and substantively deficient under Federal Rule of Evidence 702. Finding Brawer’s report “so lacking of scientific principles and methods,” and thus unhelpful and unreliable, the trial court excluded his report and precluded his testimony at trial. Id. at *7.

Thankfully, the ghost of litigations past, communicating now by email, can be safely disregarded. And I do not have to dig my silicone polymer chemistry and biochemistry textbooks out of storage.

1 See Barbara Hulka, Betty Diamond, Nancy Kerkvliet & Peter Tugwell, “Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction: A Report by a National Science Panel to the Hon. Sam Pointer Jr., MDL 926 (Nov. 30, 1998).” The experts appointed by the late Judge Pointer all committed extensive time and expertise to evaluating the plaintiffs’ claims and the entire evidence. After delivering their reports, the court-appointed experts all published their litigation work in leading journals. See Barbara Hulka, Nancy Kerkvliet & Peter Tugwell, “Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants,” 342 New Engl. J. Med. 812 (2000); Esther C. Janowsky, Lawrence L. Kupper., and Barbara S. Hulka, “Meta-Analyses of the Relation between Silicone Breast Implants and the Risk of Connective-Tissue Diseases,” 342 New Engl. J. Med. 781 (2000); Peter Tugwell, George Wells, Joan Peterson, Vivian Welch, Jacqueline Page, Carolyn Davison, Jessie McGowan, David Ramroth, and Beverley Shea, “Do Silicone Breast Implants Cause Rheumatologic Disorders? A Systematic Review for a Court-Appointed National Science Panel,” 44 Arthritis & Rheumatism 2477 (2001).

2 Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (Institute of Medicine) (Wash. D.C. 1999).

3 See In re Breast Implant Cases, 942 F. Supp. 958 (E. & S.D.N.Y. 1996) (granting summary judgment because of insufficiency of plaintiffs’ evidence, but specifically declining to rule on defendants’ Rule 702 and Rule 703 motions).

4 See Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009)

5 At the Drexel University School of Medicine, in Philadelphia, as well as the Director of Rheumatology at Monmouth Medical Center, in Long Branch, New Jersey.

6 Included among the holiday gift package was Arthur E. Brawer, “Is Silicone Breast Implant Toxicity an Extreme Form of a More Generalized Toxicity Adversely Affecting the Population as a Whole?,”1 Internat’l Ann. Med. (2017); Arthur E. Brawer, “Mechanisms of Breast Implant Toxicity: Will the Real Ringmaster Please Stand Up,”1 Internat’l Ann. Med. (2017); Arthur E. Brawer, “Destiny rides again: the reappearance of silicone gel-filled breast implant toxicity,” 26 Lupus 1060 (2017); Arthur E. Brawer, “Silicon and matrix macromolecules: new research opportunities for old diseases from analysis of potential mechanisms of breast implant toxicity,” 51 Medical Hypotheses 27 (1998).

7 Bailey v. Dow Corning Corp., c.a. 94-1199-A (Dallas Cty. Texas Dist. Ct., Sept. 15, 1996).

8 I later found that another blog had reviewed the Laux decision. Stephen McConnell, “C.D. Cal. Excludes Three Plaintiff Experts in Breast Implant Case,” Drug & Device Law (Nov. 16, 2017).

Posted in Causation, Conflicts of Interest, Expert Witness Hall of Shame, Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Stuck in Silicone

Mississippi High Court Takes the Bite Out of Forensic Evidence

November 3rd, 2017

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

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

Criminal versus Civil

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

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

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

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

A Grudging Look at the Scientific Invalidity of Bite Mark Evidence

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

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

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

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

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

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

5 See Jeff Amy, “Mississippi Court Overturns Convictions in 1993 Slayings,” Forensic Mag. (Oct. 27, 2017); Therese Apel, “Death row inmate’s triple killing conviction overturned,” The Clarion-Ledger (Oct. 26, 2017).

Posted in Expert Witnesses, Frye, Rule 702 | Comments Off on Mississippi High Court Takes the Bite Out of Forensic Evidence

Multiplicity in the Third Circuit

September 21st, 2017

In Karlo v. Pittsburgh Glass Works, LLC, C.A. No. 2:10-cv-01283 (W. D. Pa.), plaintiffs claimed that their employer’s reduction in force unlawfully targeted workers over 50 years of age. Plaintiffs lacked any evidence of employer animus against old folks, and thus attempted to make out a statistical disparate impact claim. The plaintiffs placed their chief reliance upon an expert witness, Michael A. Campion, to analyze a dataset of workers agreed to have been the subject of the R.I.F. For the last 30 years, Campion has been on the faculty in Purdue University. His academic training and graduate degrees are in industrial and organizational psychology. Campion has served an editor of Personnel Psychology, and as a past president of the Society for Industrial and Organizational Psychology. Campion’s academic website page notes that he manages a small consulting firm, Campion Consulting Services ¹.

The defense sought to characterize Campion as not qualified to offer his statistical analysis². Campion did, however, have some statistical training as part of his master’s level training in psychology, and his professional publications did occasionally involve statistical analyses. To be sure, Campion’s statistical acumen paled in comparison to the defense expert witness, James Rosenberger, a fellow and a former vice president of the American Statistical Association, as well as a full professor of statistics in Pennsylvania State University. The threshold for qualification, however, is low, and the defense’s attack on Campion’s qualifications failed to attract the court’s serious attention.

On the merits, the defense subjected Campion to a strong challenge on whether he had misused data. The defense’s expert witness, Prof. Rosenberger, filed a report that questioned Campion’s data handling and statistical analyses. The defense claimed that Campion had engaged in questionable data manipulation by including, in his RIF analysis, workers who had been terminated when their plant was transferred to another company, as well as workers who retired voluntarily.

Using simple z-score tests, Campion compared the ages of terminated and non-terminated employees in four subgroups, ages 40+, 45+, 50+, and 55+. He did not conduct an analysis of the 60+ subgroup on the claim that this group had too few members for the test to have sufficient power³. Campion found a small z-score for the 40+ versus <40 age groups comparison (z =1.51), which is not close to statistical significance at the 5% level. On the defense’s legal theory, this was the crucial comparison to be made under the Age Discrimination in Employment Act (ADEA). The plaintiffs, however, maintained that they could make out a case of disparate impact by showing age discrimination at age subgroups that started above the minimum specified by the ADEA. Although age is a continuous variable, Campion decided to conduct z-scores on subgroups that were based upon five-year increments. For the 45+, 50+, and 55+ age subgroups, he found z-scores that ranged from 2.15 to 2.46, and he concluded that there was evidence of disparate impact in the higher age subgroups⁴. Karlo v. Pittsburgh Glass Works, LLC, C.A. No. 2:10-cv-01283, 2015 WL 4232600, at *11 (W.D. Pa. July 13, 2015) (McVerry, S.J.)

The defense, and apparently the defense expert witnesses, branded Campion’s analysis as “data snooping,” which required correction for multiple comparisons. In the defense’s view, the multiple age subgroups required a Bonferroni correction that would have diminished the critical p-value for “significance” by a factor of four. The trial court agreed with the defense contention about data snooping and multiple comparisons, and excluded Campion’s opinion of disparate impact, which had been based upon finding statistically significant disparities in the 45+, 50+, and 55+ age subgroups. 2015 WL 4232600, at *13. The trial court noted that Campion, in finding significant disparities in terminations in the subgroups, but not in the 40+ versus <40 analysis:

“[did] not apply any of the generally accepted statistical procedures (i.e., the Bonferroni procedure) to correct his results for the likelihood of a false indication of significance. This sort of subgrouping ‘analysis’ is data-snooping, plain and simple.”

Id. After excluding Campion’s opinions under Rule 702, as well as other evidence in support of plaintiffs’ disparate impact claim, the trial court granted summary judgment on the discrimination claims. Karlo v. Pittsburgh Glass Works, LLC, No. 2:10–cv–1283, 2015 WL 5156913 (W. D. Pa. Sept. 2, 2015).

On plaintiffs’ appeal, the Third Circuit took the wind out of the attack on Campion by holding that the ADEA prohibits disparate impacts based upon age, which need not necessarily be on workers’ being over 40 years old, as opposed to being at least 40 years old. Karlo v. Pittsburgh Glass Works, LLC, 849 F.3d 61, 66-68 (3d Cir. 2017). This holding took the legal significance out of the statistical insignificance of Campion’s comparison 40+ versus <40 age-group termination rates. Campion’s subgroup analyses were back in play, but the Third Circuit still faced the question whether Campion’s conclusions, based upon unadjusted z-scores and p-values, offended Rule 702.

The Third Circuit noted that the district court had identified three grounds for excluding Campion’s statistical analyses:

(1) Dr. Campion used facts or data that were not reliable;

(2) he failed to use a statistical adjustment called the Bonferroni procedure; and

(3) his testimony lacks ‘‘fit’’ to the case because subgroup claims are not cognizable.

849 F.3d at 81. The first issue was raised by the defense’s claims of Campion’s sloppy data handling, and inclusion of voluntarily retired workers and workers who were terminated when their plant was turned over to another company. The Circuit did not address these data handling issues, which it left for the trial court on remand. Id. at 82. The third ground went out of the case with the appellate court’s resolution of the scope of the ADEA. The Circuit did, however, engage on the issue whether adjustment for multiple comparisons was required by Rule 702.

On the “data-snooping” issue, the Circuit concluded that the trial court had applied “an incorrectly rigorous standard for reliability.” Id. The Circuit acknowledged that

“[i]n theory, a researcher who searches for statistical significance in multiple attempts raises the probability of discovering it purely by chance, committing Type I error (i.e., finding a false positive).”

849 F.3d at 82. The defense expert witness contended that applying the Bonferroni adjustment, which would have reduced the critical significance probability level from 5% to 1%, would have rendered Campion’s analyses not statistically significant, and thus not probative of disparate impact. Given that plaintiffs’ cases were entirely statistical, the adjustment would have been fatal to their cases. Id. at 82.

At the trial level and on appeal, plaintiffs and Campion had objected to the data-snooping charge on ground that

(1) he had engaged in only four subgroups;

(2) virtually all subgroups were statistically significant;

(3) his methodology was “hypothesis driven” and involved logical increments in age to explore whether the strength of the evidence of age disparity in terminations continued in each, increasingly older subgroup;

(4) his method was analogous to replications with different samples; and

(5) his result was confirmed by a single, supplemental analysis.

Id. at 83. According to the plaintiffs, Campion’s approach was based upon the reality that age is a continuous, not a dichotomous variable, and he was exploring a single hypothesis. A.240-241; Brief of Appellants at 26. Campion’s explanations do mitigate somewhat the charge of “data snooping,” but they do not explain why Campion did not use a statistical analysis that treated age as a continuous variable, at the outset of his analysis. The single, supplemental analysis was never described or reported by the trial or appellate courts.

The Third Circuit concluded that the district court had applied a ‘‘merits standard of correctness,’’ which is higher than what Rule 702 requires. Specifically, the district court, having identified a potential methodological flaw, did not further evaluate whether Campion’s opinion relied upon good grounds. 849 F.3d at 83. The Circuit vacated the judgment below, and remanded the case to the district court for the opportunity to apply the correct standard.

The trial court’s acceptance that an adjustment was appropriate or required hardly seems a “merits standard.” The use of a proper adjustment for multiple comparisons is very much a methodological concern. If Campion could reach his conclusion only by way of an inappropriate methodology, then his conclusion surely would fail the requirements of Rule 702. The trial court did, however, appear to accept, without explicit evidence, that the failure to apply the Bonferroni correction made it impossible for Campion to present sound scientific argument for his conclusion that there had been disparate impact. The trial court’s opinion also suggests that the Bonferroni correction itself, as opposed to some more appropriate correction, was required.

Unfortunately, the reported opinions do not provide the reader with a clear account of what the analyses would have shown on the correct data set, without improper inclusions and exclusions, and with appropriate statistical adjustments. Presumably, the parties are left to make their cases on remand.

Based upon citations to sources that described the Bonferroni adjustment as “good statistical practice,” but one that is ‘‘not widely or consistently adopted’’ in the behavioral and social sciences, the Third Circuit observed that in some cases, failure to adjust for multiple comparisons may “simply diminish the weight of an expert’s finding.”⁵ The observation is problematic given that Kumho Tire suggests that an expert witness must use “in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.” Kumho Tire Co. v. Carmichael, 526 U.S. 137, 150, (1999). One implication is that courts are prisoners to prevalent scientific malpractice and abuse of statistical methodology. Another implication is that courts need to look more closely at the assumptions and predicates for various statistical tests and adjustments, such as the Bonferroni correction.

These worrisome implications are exacerbated by the appellate court’s insistence that the question whether a study’s result was properly calculated or interpreted “goes to the weight of the evidence, not to its admissibility.”⁶ Combined with citations to pre-Daubert statistics cases⁷, judicial comments such as these can appear to be a general disregard for the statutory requirements of Rules 702 and 703. Claims of statistical significance, in studies with multiple exposure and multiple outcomes, are frequently not adjusted for multiple comparisons, without notation, explanation, or justification. The consequence is that study results are often over-interpreted and over-sold. Methodological errors related to multiple testing or over-claiming statistical significance are commonplace in tort litigation over “health-effects” studies of birth defects, cancer, and other chronic diseases that require epidemiologic evidence⁸.

In Karlo, the claimed methodological error is beset by its own methodological problems. As the court noted, adjustments for multiple comparisons are not free from methodological controversy⁹. One noteworthy textbook¹⁰ labels the Bonferroni correction as an “awful response” to the problem of multiple comparisons. Aside from this strident criticism, there are alternative approaches to statistical adjustment for multiple comparisons. In the context of the Karlo case, the Bonferroni might well be awful because Campion’s four subgroups are hardly independent tests. Because each subgroup is nested within the next higher age subgroup, the subgroup test results will be strongly correlated in a way that defeats the mathematical assumptions of the Bonferroni correction. On remand, the trial court in Karlo must still make his Rule 702 gatekeeping decision on the methodological appropriateness of whether Campion’s properly considered the role of multiple subgroups, and multiple anaslyses run on different models.

1 Although Campion describes his consulting business as small, he seems to turn up in quite a few employment discrimination cases. See, e.g., Chen-Oster v. Goldman, Sachs & Co., 10 Civ. 6950 (AT) (JCF) (S.D.N.Y. 2015); Brand v. Comcast Corp., Case No. 11 C 8471 (N.D. Ill. July 5, 2014); Powell v. Dallas Morning News L.P., 776 F. Supp. 2d 240, 247 (N.D. Tex. 2011) (excluding Campion’s opinions), aff’d, 486 F. App’x 469 (5th Cir. 2012).

2 See Defendant’s Motion to Bar Dr. Michael Campion’s Statistical Analysis, 2013 WL 11260556.

3 There was no mention of an effect size for the lower aged subgroups, and a power calculation for the 60+ subgroup’s probability of showing a z-score greater than two. Similarly, there was no discussion or argument about why this subgroup could not have been evaluated with Fisher’s exact test. In deciding the appeal, the Third Circuit observed that “Dr. Rosenberger test[ed] a subgroup of sixty-and-older employees, which Dr. Campion did not include in his analysis because ‘[t]here are only 14 terminations, which means the statistical power to detect a significant effect is very low’. A.244–45.” Karlo v. Pittsburgh Glass Works, LLC, 849 F.3d 61, 82 n.15 (3d Cir. 2017).

4 In the trial court’s words, the z-score converts the difference in termination rates into standard deviations. Karlo v. Pittsburgh Glass Works, LLC, C.A. No. 2:10-cv-01283, 2015 WL 4232600, at *11 n.13 (W.D. Pa. July 13, 2015). According to the trial court, Campion gave a rather dubious explanation of the meaning of the z-score: “[w]hen the number of standard deviations is less than –2 (actually–1.96), there is a 95% probability that the difference in termination rates of the subgroups is not due to chance alone” Id. (internal citation omitted).

5 See 849 F.3d 61, 83 (3d Cir. 2017) (citing and quoting from Paetzold & Willborn § 6:7, at 308 n.2) (describing the Bonferroni adjustment as ‘‘good statistical practice,’’ but ‘‘not widely or consistently adopted’’ in the behavioral and social sciences); see also E.E.O.C. v. Autozone, Inc., No. 00-2923, 2006 WL 2524093, at *4 (W.D. Tenn. Aug. 29, 2006) (‘‘[T]he Court does not have a sufficient basis to find that … the non-utilization [of the Bonferroni adjustment] makes [the expert’s] results unreliable.’’). And of course, the Third Circuit invoked the Daubert chestnut: ‘‘Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but

admissible evidence.’’ Daubert, 509 U.S. 579, 596 (1993).

6 See 849 F.3d at 83 (citing Leonard v. Stemtech Internat’l Inc., 834 F.3d 376, 391 (3d Cir. 2016).

7 See 849 F.3d 61, 83 (3d Cir. 2017), citing Bazemore v. Friday, 478 U.S. 385, 400 (1986) (‘‘Normally, failure to include variables will affect the analysis’ probativeness, not its admissibility.’’).

8 See Hans Zeisel & David Kaye, Prove It with Figures: Empirical Methods in Law and Litigation 93 & n.3 (1997) (criticizing the “notorious” case of Wells v. Ortho Pharmaceutical Corp., 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S. 950 (1986), for its erroneous endorsement of conclusions based upon “statistically significant” studies that explored dozens of congenital malformation outcomes, without statistical adjustment). The authors do, however, give an encouraging example of a English trial judge who took multiplicity seriously. Reay v. British Nuclear Fuels (Q.B. Oct. 8,1993) (published in The Independent, Nov. 22,1993). In Reay, the trial court took seriously the multiplicity of hypotheses tested in the study relied upon by plaintiffs. Id. (“the fact that a number of hypotheses were considered in the study requires an increase in the P-value of the findings with consequent reduction in the confidence that can be placed in the study result … .”), quoted in Zeisel & Kaye at 93. Zeisel and Kaye emphasize that courts should not be overly impressed with claims of statistically significant findings, and should pay close attention to how expert witnesses developed their statistical models. Id. at 94.

9 See David B. Cohen, Michael G. Aamodt, and Eric M. Dunleavy, Technical Advisory Committee Report on Best Practices in Adverse Impact Analyses (Center for Corporate Equality 2010).

10 Kenneth J. Rothman, Sander Greenland, and Timoth L. Lash, Modern Epidemiology 273 (3d ed. 2008); see also Kenneth J. Rothman, “No Adjustments Are Needed for Multiple Comparisons,” 1 Epidemiology 43, 43 (1990)

Posted in Expert Witnesses, Rule 702, Rule 703, statistical evidence | Comments Off on Multiplicity in the Third Circuit

Seventh Circuit Franks ‘Every Exposure’ Theory for Extinction

September 11th, 2017

In Krik v. Exxon Mobil Corp., no. 15-3112, 2017 WL 3768933, Slip op. (7th Cir. Aug. 31, 2017) [slip op. cited as Krik], a jury found that smoking cigarettes causes lung cancer, which is not particularly noteworthy. The plaintiff, Charles Krik, however, wanted the jury to find that asbestos exposure, either alone or with his 45 pack-year smoking history caused his lung cancer. The jury found that smoking was the sole cause. Hannah Meisel, “7th Circuit Affirms Exxon’s Trial Win In Asbestos Cancer Suit,” Law360 (Sept. 1, 2017).

Krik’s asbestos exposure was not particularly impressive, and he apparently did not have asbestosis. He claimed asbestos exposure from his four years of work aboard naval vessels, occasionally removing insulation materials, and his two weeks as an independent contractor at an Exxon Mobil refinery, where he replaced heaters supposedly insulated with asbestos. Exxon Mobil disputed whether the heaters even had asbestos in them. The naval vessels would have had asbestos insulation from many manufacturers, but Krik focused on Owens-Illinois because it is the only solvent company remaining in the plaintiffs’ asbestos-powered perpetual litigation machine.

Lung cancer in a man with minor asbestos exposure with very substantial tobacco consumption – who are you going to call? See Arthur Frank Report, 2011 WL 12192776 (2011).

Arthur Frank is a physician who counts himself among the intellectual progeny of the late Irving Selikoff. Like Selikoff, Frank is intensely interested in outcomes that help workers show that their work has caused them illness. In furthering his interests, Frank sometimes makes things up, such as the “each and every exposure” theory. Frank is also a proponent of the “big-tent” theory of causation, which attempts to keep every possible defendant in a lawsuit, bu asserting that every asbestos exposure, regardless of its intensity, duration, quantity, variety of asbestos, or fiber length, constitutes a cause of plaintiff’s lung cancer.

Defendants moved to bar Frank’s opinions under Federal Rule of Evidence 702. See Exxon Mobil’s motion, at 2013 WL 10847058. Judge Lee of the Northern District of Illinois found that Arthur Frank’s opinions, in the form of the “each and every exposure theory,” “any exposure theory,” “single fiber theory,” or “no safe level of exposure theory” was scientifically insubstantial and inadmissible under Rule 702. Krik at 2-3. Judge Lee thus ruled that Krik could not offer expert witness opinions that espoused “every exposure” is substantial.

After Judge Lees’ ruling, Krik’s case was transferred to Judge Manish Shah, for trial. Despite the earlier ruling by Judge Lee, Krik’s counsel called Dr. Frank to testify at trial, with a repackaged opinion about Krik’s “cumulative exposure” caused his lung cancer, and every constituent exposure to that cumulative exposure was causally responsible.

After a voir dire examination of Frank, Judge Shah concluded that Frank’s opinion was still untethered to any “specific quantum of exposure attributable to the defendants, but was instead based on his medical and scientific opinion that every exposure is a substantial contributing factor to the cumulative exposure that causes cancer.” Krik v. Owens‐Illinois, Inc., No. 10‐CV‐07435, 2015 WL 5050143, at *1 (N.D. Ill. Aug. 25, 2015). Frank and plaintiffs’ counsel had attempted to circumvent the earlier ruling by Judge Lee, but their ruse failed to fool Judge Shah. On appeal to the Seventh Circuit¹, a panel affirmed Judge Shah’s reasoning and exclusion of Arthur Frank’s opinions. Krik at 4-5.

Arthur Frank is used to making things up, including the law. The law of causation in most jurisdictions distinguishes between substantial and insubstantial contribution, but Frank decreed: “Either it’s zero or it’s substantial; there is no such thing as not substantial.” R. 66‐3 at 23, pageID 923. Really? In Frank’s mind, even a minute, perhaps a second, of fleeting exposure, would be a substantial contributing factor to a plaintiff’s lung cancer because he has legislated insubstantial out of existence. R. 376 at 273–74, pageID 10146‐47.

Frank’s testimony presented several problems:

First, his cumulative exposure theory was no different from the previously excluded “each and every exposure” theory. Even Frank, in his deposition testimony conflated “each and every exposure” with a cumulative exposure theory.

Second, Frank’s opinion did not conform to the legal standard. In the initial ruling on Frank, Judge Lee held that plaintiff must show that asbestos was a “substantial contributing factor” to his injury².

Third, Frank’s opinion lacked an adequate scientific foundation. Krik was tasked with showing that asbestos was a “substantial contributing factor” to his lung cancer. Krik at 7; Krik, 76 F. Supp. 3d at 747 (Lee, J.). Frank’s opinion on “every exposure” did not help him make out his case.

The trial court judges recognized, putting aside the issue of thresholds, that asbestos‐induced lung cancers are dose dependent. At the very least, any attempt to attribute a person’s lung cancer to an exposure requires a consideration of the timing and quantum of exposure. Frank, in defiance of basic common sense and basic toxicologic principles, would – if allowed by courts – treat every exposure, regardless how de minimis, as a substantial contribution to the total exposure and the total risk. Krik at 8; Krik, 76 F. Supp. 3d at 753 (Lee, J.).

The panel of the Seventh Circuit found the trial judges’ exclusion of the Frank nonsense to be well supported and well within their discretion as gatekeepers³. Krik at 14

Krik’s counsel also complained that the trial court refused to admit the so-called Helsinki document⁴, a 1997 statement of public policy statement of scientists who opined that “[c]umulative exposure on a probability basis should thus be considered the main criteria for the attribution of a substantial contribution by asbestos to lung cancer risk.” R. 412‐4 at 4, pageID 13657.

The problem for counsel, and for Frank, was that Frank never referred to or embraced the Helsinki statement as an “authoritative text.” If he had, he would have been roundly impeached by the statement’s pronouncement that the “likelihood that asbestos exposure has made a substantial contribution increases when the exposure increases.” Id. The Seventh Circuit held that the exclusion of this document as a stand-alone piece of evidence did not support plaintiff’s theory, and that its exclusion was not an abuse of discretion⁵. Krik at 15-17.

1 The appellate court noted that it reviewed de novo the question whether the trial court properly applied Rule 702. The district court’s decision to exclude or admit expert witness opinion testimony is reviewed only for “abuse of discretion.” Krik at 4 (citing C.W. ex rel. Wood v. Textron, Inc., 807 F.3d 827, 835 (7th Cir. 2015). The party proponent has the burden of showing that the challenged expert witness testimony satisfies the Rule 702 statutory requirements, by a preponderance of evidence. Id. (citing Lewis v. CITGO Petroleum Corp., 561 F.3d 698, 705 (7th Cir. 2009).

2 Krik v. Crane Co., 76 F. Supp. 3d 747, 753 (N.D. Ill. 2014) (citing Lindstrom v. A‐C Prod. Liab., 424 F.3d 488, 493 (6th Cir. 2005) (applying maritime law); Thacker v. UNR Indus., Inc., 603 N.E.2d 449, 457 (Ill. 1992) (Illinois law).

3 The panel noted that the Sixth and Ninth Circuits had ruled similarly. McIndoe v. Huntington Ingalls Inc., 817 F.3d 1170, 1177 (9th Cir. 2016); Lindstrom v. A‐C Prod. Liab., 424 F.3d 488, 493 (6th Cir. 2005) (“The requirement, however, is that the plaintiff make a showing with respect to each defendant that the defendant’s product was a substantial factor in plaintiff’s injury … . A holding to the contrary would permit imposition of liability on the manufacturer of any product with which a worker had the briefest of encounters on a single occasion.”).

4 See also Panu Oksa, et al., eds., “Asbestos, Asbestosis, and Cancer, Helsinki Criteria for Diagnosis and Attribution,” (2014).

5 Accord Rockman v. Union Carbide Corp., No. CV RDB‐16‐1169, 2017 WL 3022969, at *5 (D. Md. July 17, 2017); Bell v. Foster Wheeler Energy Corp., No. CV 15‐6394, 2016 WL 5847124, at *3, n.3 (E.D. La. Oct. 6, 2016), recon. denied, No. CV 15‐6394, 2017 WL 876983 (E.D. La. Mar. 6, 2017); Watkins v. Affinia Group, 2016‐Ohio‐2830, ¶ 37, 54 N.E.3d 174, 182; In reJames Wilson Assoc., 965 F.2d 160, 173 (7th Cir.1992); United States v. Dixon, 413 F.3d 520, 524–25 (5th Cir. 2005); Yates v. Ford Motor Co., 113 F. Supp. 3d 841, 862 (E.D.N.C. 2015); Betz v. Pneumo Abex, LLC, 44 A.3d 27, 47, 55 n.35 (Pa. 2012); Bostic v. Georgia‐Pacific Corp., 439 S.W.3d 332, 356–57 (Tex. 2014).

Posted in Asbestos, Causation, Rule 702 | Comments Off on Seventh Circuit Franks ‘Every Exposure’ Theory for Extinction

WOE — Zoloft Escapes a MDL While Third Circuit Creates a Conceptual Muddle

July 31st, 2017

Multidistrict Litigations (MDLs) can be “muddles” that are easy to get in, but hard to get out of. Pfizer and subsidiary Greenstone fabulously escaped a muddle through persistent lawyering and the astute gatekeeping of a district judge, in the Eastern District of Pennsylvania. That judge, the Hon. Cynthia Rufe, sustained objections to the admissibility of plaintiffs’ epidemiologic expert witness Anick Bérard. When the MDL’s plaintiffs’ steering committee (PSC) demanded, requested, and begged for a do over, Judge Rufe granted them one more chance. The PSC put their litigation industry eggs in a single basket, carried by statistician Nicholas Jewell. Unfortunately for the PSC, Judge Rufe found Jewell’s basket to be as methodologically defective as Bérard’s, and Her Honor excluded Jewell’s proffered testimony. Motions, paper, and appeals followed, but on June 2, 2017, the Third Circuit declared that the PSC and its clients had had enough opportunities to get through the gate. Their baskets of methodological deplorables were not up to snuff. In re Zoloft Prod. Liab. Litig., No. 16-2247 , __ F.3d __, 2017 WL 2385279, 2017 U.S. App. LEXIS 9832 (3d Cir. June 2, 2017) (affirming exclusion of Jewell’s dodgy opinions, which involved multiple methodological flaws and failures to follow any methodology faithfully) [Slip op. cited below as Zoloft].

Plaintiffs Attempt to Substitute WOE for Depressingly Bad Expert Witness Opinion

The ruse of conflating “weight of the evidence,” as used to describe the appellate standard of review for sustaining or reversing a trial court’s factual finding with a purported scientific methodology for inferring causation, was on full display by the PSC in their attack on Judge Rufe’s gatekeeping. In their appellate brief in the Court of Appeals for the Third Circuit, the PSC asserted that Jewell had used a “weight of the evidence method,” even though that phrase, “weight of the evidence” (WOE) was never used in Jewell’s litigation reports. The full context of the PSC’s argument and citations to Milward make clear a deliberate attempt to conflate WOE as an appellate judicial standard for reviewing jury fact finding and a purported scientific methodology. See Appellants’ Opening Brief at 54 (Aug. 10, 2016) [cited as PSC] (asserting that “[a]t all times, the ultimate evaluation of the weight of the evidence is a jury question”; citing Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11, 20 (1st Cir. 2011), cert. denied, 133 S. Ct. 63 (2012).

Having staked the ground that WOE is akin to a jury’s factual finding, and thus immune to any but the most extraordinary trial court action or appellate intervention, the PSC then pivoted to claim that Jewell’s WOE-ful method was nothing much more than an assessment of “the totality of the available scientific evidence, guided by the well-accepted Bradford-Hill criteria.” PSC at 3, 4, 7. This maneuver allowed the PSC to argue, apparently with a straight face, that WOE methodology as used by Jewell, had been generally accepted in the scientific community, as well as by the Third Circuit, in previous cases in which the court accepted the use of Bradford Hill’s considerations as a reliable method for establishing general causation. See PSC at 4 (citing Gannon v. United States, 292 F. App’x 170, 173 n.1 (3d Cir. 2008)). Jewell then simply plugged in his expertise and “40 years of experience,” and the desired conclusion of causation popped out. Id. Quod erat demonstrandum.

In pressing its point, the PSC took full advantage of loose, inaccurate language from the American Law Institute’s Restatement’s notorious comment C:

“No algorithm exists for applying the Hill guidelines to determine whether an association truly reflects a causal relationship or is spurious.”

PSC at 33-34, citing Restatement (Third) of Torts: Physical and Emotional Harm § 28 cmt. c(3) (2010). Well true, but the absence of a mathematical algorithm hardly means that causal judgments are devoid of principles and standards. The PSC was undeterred, by text or by shame, from equating an unarticulated use of WOE methodology with some vague invocation of Bradford Hill’s considerations for evaluating associations for causality. See PSC at 43 (citing cases that never mentioned WOE but only Bradford Hill’s 50-plus year old heuristic as somehow supporting the claimed identity of the two approaches)¹.

Pfizer Rebuffs WOE

Pfizer filed a comprehensive brief that unraveled the PSC’s duplicity. For unknown reasons, tactical or otherwise, however, Pfizer did not challenge the specifics of PSC’s equation of WOE with an abridged, distorted application of Bradford Hill’s considerations. See generally Opposition Brief of Defendants-Appellees Pfizer Inc., Pfizer International LLC, and Greenstone LLC [cited as Pfizer]. Perhaps given page limits and limited judicial attention spans, and just how woefully bad Jewell’s opinions were, Pfizer may well have decided that a more directed approach of assuming arguendo WOE’s methodological appropriateness was a more economical, pragmatic approach. A close reading of Pfizer’s brief, however, makes clear that it never conceded the validity of WOE as a scientific methodology.

Pfizer did point to the recasting of Jewell’s aborted attempt to apply Bradford Hill considerations as an employment of WOE methodology. Pfizer at 46-47. The argument reminded me of Abraham Lincoln’s famous argument:

“How many legs does a dog have if you call his tail a leg?

Four.

Saying that a tail is a leg doesn’t make it a leg.”

Allen Thorndike Rice, Reminiscences of Abraham Lincoln by Distinguished Men of His Time at 242 (1909). Calling Jewell’s supposed method WOE or Bradford Hill or WOE/Bradford Hill did not cure the “fatal methodological flaws in his opinions.” Pfizer at 47.

Pfizer understandably and properly objected to the PSC’s attempt to cast Jewell’s “methodology” at such a high level of generality that any consideration of the many instances of methodological infidelity would be relegated to mere jury questions. Acquiescence in the PSC’s rhetorical move would constitute a complete abandonment of the inquiry whether Jewell had used a proper method. Pfizer at 15-16.

Interestingly, none of the amici curiae addressed the slippery WOE arguments advanced by the PSC. See generally Brief of Amici Curiae American Tort Reform Ass’n & Pharmaceutical Research and Manufacturers of America (Oct. 18, 2016); Brief of Washington Legal Fdtn. as Amicus Curiae (Oct. 18, 2016). There was no meaningful discussion of WOE as a supposedly scientific methodology at oral argument. See Transcript of Oral Argument in In re Zoloft Prod. Liab. Litig., No. 16-2247 (Jan. 25, 2017).

The Third Circuit Acknowledges that Some Methodological Infelicities, Flaws, and Fallacies Are Properly the Subject of Judicial Gatekeeping

Fortunately, Jewell’s methodological infidelities were easily recognized by the Circuit judges. Jewell treated multiple studies, which were nested within one another, and thus involved overlapping and included populations, as though they were independent verifications of the same hypothesis. When the population at issue (from the Danish cohort) was included in a more inclusive pan-Scandivanian study, the relied-upon association dissipated, and Jewell utterly failed to explain or account for these data. Zoloft at 5-6.

Jewell relied upon a study by Anick Bérard, even though he later had to concede that the study had serious flaws that invalidated its conclusions, and which flaws caused him to have a lack of confidence in the paper’s findings.² In another instance, Jewell relied innocently upon a study that purported to report a statistically significant association, but the authors of this paper were later required by the journal, The New England Journal of Medicine, to correct the very calculated confidence interval upon which Jewell had relied. Despite his substantial mathematical prowess, Jewell missed the miscalculation and relied (uncritically) upon a finding as statistically significant when in fact it was not.

Jewell rejected a meta-analysis of Zoloft studies for questionable methodological quibbles, even though he had relied upon the very same meta-analysis, with the same methodology, in his litigation efforts involving Prozac and birth defects. Not to be corralled by methodological punctilio, Jewell conducted his own meta-analysis with two studies Huybrechts (2014) and Jimenez-Solem (2012), but failed to explain why he excluded other studies, the inclusion of which would have undone his claimed result. Zoloft at 9. Jewell purported to reanalyze and recalculate point estimates in two studies, Jimenez-Solem (2012) and Huybrechts (2014), without any clear protocol or consistency in his approach to other studies. Zoloft at 9. The list goes on, but in sum, Jewell’s handling of these technical issues did not inspire confidence, either in the district or in the appellate court.

WOE to the Third Circuit

The Circuit gave the PSC every conceivable break. Because Pfizer had not engaged specifically on whether WOE was a proper, or any kind of, scientific method, the Circuit treated the issue as virtually conceded:

“Pfizer does not seem to contest the reliability of the Bradford Hill criteria or weight of the evidence analysis generally; the dispute centers on whether the specific methodology implemented by Dr. Jewell is reliable. Flexible methodologies, such as the “weight of the evidence,” can be implemented in multiple ways; despite the fact that the methodology is generally reliable, each application is distinct and should be analyzed for reliability.”

Zoloft at 18. The Court acknowledged that WOE arose only in the PSC’s appellate brief, which would have made the entire dubious argument waived under general appellate jurisdictional principles, but the Court, in a footnote, indulged the assumption, “for the sake of argument,” that WOE was Jewell’s purported method from the inception. Zoloft at 18 n. 39. Without any real evidentiary support or analysis or concession from Pfizer, the Circuit accepted that WOE analyses were “generally reliable.” Zoloft at 21.

The Circuit accepted, rather uncritically, that Jewell used a combination of WOE analysis and Bradford Hill considerations. Zoloft at 17. Although Jewell had never described WOE in his litigation report, and WOE was not a feature of his hearing testimony, the Circuit impermissibly engrafted Carl Cranor’s description of WOE as involving inference to the best explanation. Zoloft at 17 & n.37, citing Milward v. Acuity Specialty Prods. Grp., Inc., 639 F.3d 11, 17 (1st Cir. 2011) (internal quotation marks and citation omitted).

There was, however, a limit to the Circuit’s credulousness and empathy. As the Court noted, there must be some assurance that the purported Bradford Hill/WOE method is something more than a “mere conclusion-oriented selection process.” Zoloft at 20. Ultimately, the Court put its markers down for Jewell’s putative WOE methodology:

“there must be a scientific method of weighting that is used and explained.”

Zoloft at 20. Calling the method WOE did not, in the final analysis, exclude Jewell from Rule 702 gatekeeping. Try as the PSC might, there was just no mistaking Jewell’s approach as anything other than a crazy patchwork quilt of numerical wizardry in aid of subjective, result-oriented conclusion mongering.

In the Court’s words:

“we find that Dr. Jewell did not 1) reliably apply the ‘techniques’ to the body of evidence or 2) adequately explain how this analysis supports specified Bradford Hill criteria. Because ‘any step that renders the analysis unreliable under the Daubert factors renders the expert’s testimony inadmissible’, this is sufficient to show that the District Court did not abuse its discretion in excluding Dr. Jewell’s testimony.”

Zoloft at 28. As heartening as the Circuit’s conclusion is, the Court’s couching its observation as a finding (“we find”) is disheartening with respect to the Third Circuit’s apparent inability to distinguish abuse-of-discretion review from de novo appellate findings. Equally distressing is the Court’s invocation of Daubert factors, which were dicta in a Supreme Court case that was superseded by an amended statute over 17 years ago, in Federal Rule of Evidence 702.

On the crucial question whether Jewell had engaged in an unreliable application of methods or techniques that superficially, at a very high level of generality, claim to be generally accepted, the Court stayed on course. The Court “found” that Jewell had applied techniques, analyses, and critiques so obviously inconsistently that no amount of judicial indulgence, assumptions arguendo, or careless glosses could save Jewell and his fatuous opinions from judicial banishment. Zoloft 28-29. Returning to the correct standard of review (abuse of discretion), but the wrong governing law (Daubert instead of Rule 702), the Court announced that:

“[b]ecause ‘any step that renders the analysis unreliable under the Daubert factors renders the expert’s testimony inadmissible’, this is sufficient to show that the District Court did not abuse its discretion in excluding Dr. Jewell’s testimony.”

Zoloft at 21 n.50 (citation omitted). The Court found itself unable to say simply and directly that “the MDL trial court decided the case well within its discretion.”

The Zoloft case was not the Third Circuit’s first WOE rodeo. WOE had raised its unruly head in Magistrini v. One Hour Martinizing Dry Cleaning, 180 F. Supp. 2d 584, 602 (D.N.J. 2002), aff’d, 68 F. App’x 356 (3d Cir. 2003), where an expert witness, David Ozonoff, offered what purported to be a WOE opinion. The Magistrini trial court did not fuss with the assertion that WOE was generally reliable, but took issue with how Ozonoff tried to pass off his analysis as a comprehensive treatment of the totality of the evidence. In Magistrini, Judge Hochberg noted that regardless of the rubric of the methodology, the witness must show that in conducting a WOE analysis:

“all of the relevant evidence must be gathered, and the assessment or weighing of that evidence must not be arbitrary, but must itself be based on methods of science.”

Magistrini, 180 F. Supp. 2d at 602. The witness must show that the methodology is more than a “mere conclusion-oriented selection process,” and that it has a “a scientific method of weighting that is used and explained.” Id. at 607. Asserting the use of WOE was not an excuse or escape from judicial gatekeeping as specified by Rule 702.

Although the Third Circuit gave the Zoloft MDL trial court’s findings a searching review (certainly much tougher than the prescribed abuse-of-discretion review), the MDL court’s finding that Jewell “failed to consistently apply the scientific methods he articulates, has deviated from or downplayed certain well-established principles of his field, and has inconsistently applied methods and standards to the data so as to support his a priori opinion” were ultimately vindicated by the Court of Appeals. Zoloft at 10.

All’s well that ends well. Perhaps. It remains unfortunate, however, that a hypothetical method, WOE — which was never actually advocated by the challenged expert witnesses, which lacks serious support in the scientific community, and which was merely assumed arguendo to be valid — will be taken by careless readers to have been endorsed the Third Circuit.

1 Among the cases cited without any support for the PSC’s dubious contention were Gannon v. United States, 292 F. App’x 170, 173 n.1 (3d Cir. 2008); Bitler v. A.O. Smith Corp., 391 F.3d 1114, 1124-25 (10th Cir. 2004); In re Joint E. & S. Dist. Asbestos Litig., 52 F.3d 1124, 1128 (2d Cir. 1995); In re Avandia Mktg., Sales Practices & Prods. Liab. Litig., No. 2007-MD-1871, 2011 WL 13576, at *3 (E.D. Pa. Jan. 4, 2011) (“Bradford-Hill criteria are used to assess whether an established association between two variables actually reflects a causal relationship.”).

2 Anick Bérard, Sertraline Use During Pregnancy and the Risk of Major Malformations, 212 Am. J. Obstet. Gynecol. 795 (2015).

Posted in Expert Witnesses, Rule 702, Scientific Evidence, statistical evidence | Comments Off on WOE — Zoloft Escapes a MDL While Third Circuit Creates a Conceptual Muddle

Weight of the Evidence in Science and in Law

July 29th, 2017

“woe to that man by whom the offense cometh”

Matthew 18:7

Weight of the evidence (WOE) has cropped up again in recent trial and appellate court proceedings involving the admissibility of scientific expert witness opinion testimony. With some consistency, the WOE approach advocated is vacuous. The proponents of WOE do not specify what type of evidence is considered, whether all evidence was considered, or how competing and conflicting evidence was weighed.

Interpreted sympathetically, WOE might be taken to mean that “scientific judgment” was exercised with respect to causal inference, without describing exactly what was done. Although sympathetic, this interpretation renders the purported methodology meaningless. WOE-ful scientists might just as well say that they used scientific method. Not surprisingly, WOE is absent from virtually all major epidemiology textbooks

Despite the vacuity of WOE, or because of it, some lawyers, who constitute the lawsuit industry, are particularly fond of WOE.¹ Expert witnesses who support the lawsuit industry have defended their “right” to inflict WOE on the litigation system, tooth and nail.²

Carl Cranor, a philosophy professor and a hired expert witness in litigation for plaintiffs’ counsel, has written about WOE and attempted to defend WOE as a scientific methodology. Cranor has caricaturized criticisms of WOE, including mine, by suggesting that the International Agency for Research on Cancer’s use of WOE rebuts my suggestion that WOE is no method at all.³ Cranor’s defense fails, however, because IARC’s method, for all its deficiencies, never invokes a method mired in WOE.

Perhaps the Lawsuit Industry likes WOE as much as it likes the equally vague term, “link.” WOE frees them from the requirement of any meaningful methodology, which means that any conclusion is possible. Under WOE, any conclusion can survive gatekeeping as an opinion. WOE frees the putative expert witness from the need to consider the quality of research. WOE-ful authors such as Carl Cranor invoke WOE or seek to inflict WOE without mentioning the crucial “nuts and bolts” of scientific inference, such as concepts of

Internal and external validity
Assessment of random error
Assessment of known and residual confounding
Known and potential threats to validity in
Appropriate methods of systematic review
Appropriate synthesis across studies, such as systematic review and meta-analysis

These important concepts are lost in the miasma of WOE.

In the published scientific literature, it is a commonplace that WOE is either poorly or not defined and specified. The phrase is vague and ambiguous; its use, inconsistent.⁴ Even authors sympathetic to the WOE mission have reluctantly concluded that the term is most often used in a way that “does not lend itself to transparency or repeatability except in simple cases.”⁵

Another reason that WOE resonates so strongly with the Lawsuit Industry is that having expert witnesses proclaim WOE as their methodology permits trial counsel to claim that the proffered opinions are immune to gatekeeping because, after all, weight-of-the-evidence questions are for the jury. Lawyers learn early on about WOE factual issues in appellate review of a wide variety of evidentiary and sufficiency issues in criminal and civil cases.⁶ Unless against the great WOE, WOE questions are for the jury.

Even venerable judges fall for this semantic confusion. In 1995, the Second Circuit, before the major revision of Rule 702, in 2000, noted that in discharging their gatekeeping role, trial judges do not assume:

“‘the role of St. Peter at the gates of heaven, performing a searching inquiry into the depth of an expert witness’s soul’ that would ‘inexorably lead to evaluating witness credibility and weight of the evidence, the ageless role of the jury’.”

McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1045 (2d Cir.1995) (internal citations omitted).

Of course, the expert witness’s soul is not at issue, but his methodology is. More important, however, note how the appellate court adverted to “weight of the evidence” as something that the jury must evaluate, along with witness credibility. The expert witness WOE litigation strategy deliberately trades upon the confusion between WOE in the allocation between judge and jury, and valid scientific methodology in causal inference. McCullock is proof that judges can be, and are, bamboozled by the litigation strategy.

Twenty years after McCullock, federal appellate judges are still falling for the deliberate confusion between legal and scientific WOE. The Ninth Circuit recently held that the reliability test of Federal Rule of Evidence 702 is:

“‘is not the correctness of the expert’s conclusions but the soundness of his methodology’, and when an expert meets the threshold established by Rule 702, the expert may testify and the fact finder decides how much weight to give that testimony. Challenges that go to the weight of the evidence are within the province of a fact finder, not a trial court judge. A district court should not make credibility determinations that are reserved for the jury.”

City of Pomona v. SQM North America Corp., 750 F.3d 1036, 1044 (9th Cir. 2014) (internal citation omitted), cert. denied, 135 S. Ct. 870 (2014). Characterizing a methodological dispute as one that “merely” concerns the “weight of the evidence” is a strategy to remove the dispute from judicial gatekeeping altogether.

Recently, the Third Circuit displayed this confusion of WOE with methodological impropriety by mischaracterizing failure to correct for multiple testing as merely an improper calculation that ordinarily goes to the weight of the evidence, not its admissibility. Karlo v. Pittsburgh Glass Works, LLC, 849 F.3d 61, 83 (3d Cir. 2017).

The Third Circuit, in Karlo, cited to a Supreme Court case that predated Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993), and which did involve any Rule 702 challenge to the use of a flawed statistical analysis. In Bazemore v. Friday, 478 U.S. 385, 400 (1986), plaintiffs sued as a class for employment discrimination, and sought to show the discrimination through the use of a regression analysis. The defense challenged the plaintiffs’ regression on grounds that key variables were omitted. The Court rejected a sufficiency challenge to a finding of discrimination in plaintiffs’ class action, and noted:

“Normally, failure to include variables will affect the analysis’ probativeness, not its admissibility.”

The lesson of the last two decades of judicial gatekeeping is that methodological infirmity will affect both probitiveness and admissibility⁷. Courts cannot escape their important gatekeeping duties by shifting their responsibility to juries under the guise of WOE.

1 See, e.g., “WOE-fully Inadequate Methodology – An Ipse Dixit By Another Name” (May 1, 2012); “As They WOE, So No Recovery Have the Reeps,” (May 22, 2013).

2 See Schachtman, “Desultory Thoughts on Milward v. Acuity Specialty Products,” (Oct. 2015).

3 Carl F. Cranor, Toxic Torts: Science, Law, and the Possibility of Justice 146 (2d ed. 2016) (citing and selectively quoting from Schachtman, “WOE-fully Inadequate Methodology – An Ipse Dixit By Another Name” (May 1, 2012)).

4 See Charles Menzie, Miranda Hope Henning, Jerome Cura, Kenneth Finkelstein, Jack Gentile, James Maughan, David Mitchell, Stephen Petron, Bonnie Potocki, Susan Svirsky & Patti Tyler, “A weight-of-evidence approach for evaluating ecological risks; report of the Massachusetts Weight-of-Evidence Work Group,” 2 Human Ecological Risk Assessment 277, 279 (1996) (“although the term ‘weight of evidence’ is used frequently in ecological risk assessment, there is no consensus on its definition or how it should be applied”); Sheldon Krimsky, “The weight of scientific evidence in policy and law,” 95 Am. J. Pub. Health S129 (2005) (“However, the term [WOE] is applied quite liberally in the regulatory literature, the methodology behind it is rarely explicated.”); V. H. Dale, G.R. Biddinger, M.C. Newman, J.T. Oris, G.W. Suter II, T. Thompson, et al., “Enhancing the ecological risk assessment process,” 4 Integrated Envt’l Assess. Management 306 (2008) (“An approach to interpreting lines of evidence and weight of evidence is critically needed for complex assessments, and it would be useful to develop case studies and/or standards of practice for interpreting lines of evidence.”); Douglas L. Weed, “Weight of Evidence: A Review of Concept and Methods,” 25 Risk Analysis 1545 (2005) (noting the “lack of definition of the term weight of evidence, multiple uses of the term and a lack of consensus about its meaning, and the many different kinds of weights, both qualitative and quantitative which can be used in risk assessment”); R.G. Stahl Jr., “Issues addressed and unaddressed in EPA’s ecological risk guidelines,” 17 Risk Policy Report 35 (1998) (noting that U.S. Environmental Protection Agency’s guidelines for ecological weight-of-evidence approaches to risk assessment fail to provide guidance); Glenn W. Suter, Susan M. Cormier, “Why and how to combine evidence in environmental assessments: Weighing evidence and building cases,” 409 Sci. Total Env’t 1406, 1406 (2011) (noting arbitrariness and subjectivity of WOE “methodology”).

5 See Igor Linkov, Drew Loney, Susan Cormier, F. Kyle Satterstrom, and Todd Bridges, “Weight-of-evidence evaluation in environmental assessment: review of qualitative and quantitative approaches,” 407 Sci. Total Env’t 5199, 5203 (2009).

6 See, e.g., People v. Collier, 146 A.D.3d 1146, 1147-48, 2017 NY Slip Op 00342 (N.Y. App. Div. 3d Dep’t, Jan. 19, 2017) (rejecting appeal based upon defendant’s claim that conviction was against “weight of the evidence”); Venson v. Altamirano, 749 F.3d 641, 656 (7th Cir. 2014) (noting “new trial is appropriate if the jury’s verdict is against the manifest weight of the evidence”).

7 David L. Faigman, Christopher Slobogin & John Monahan, “Gatekeeping Science: Using the Structure of Scientific Research to Distinguish Between Admissibility and Weight in Expert Testimony,” 110 Northwestern L. Rev. 859, 865 (2016) (“An expert economist in an employment discrimination case who admittedly fails to control for a key variable such as seniority or wage structure in a regression analysis has committed a general error that should lead to exclusion by a judge… .”).

Posted in Causation, Rule 702, Scientific Evidence | Comments Off on Weight of the Evidence in Science and in Law

Samuel Tarry’s Protreptic for Litigation-Sponsored Publications

July 9th, 2017

Litigation-related research has been the punching bag of self-appointed public health advocates for some time. Remarkably, and perhaps not surprising to readers of this blog, many of the most strident critics have deep ties to the lawsuit industry, and have served the plaintiffs’ bar loyally and zealously for many years.¹^,²^,³^,⁴ And many of these critics have ignored or feigned ignorance of the litigation provenance of much research that they hold dear, such as Irving Selikoff’s asbestos research undertaken for the asbestos workers’ union and its legal advocates. These critics’ campaign is an exquisite study in hypocrisy.

For some time, I have argued that the standards for conflict-of-interest disclosures should be applied symmetrically and comprehensively to include positional conflicts, public health and environmental advocacy, as well as litigation consulting or testifying for any party. Conflicts should be disclosed, but they should not become a facile excuse or false justification for dismissing research, regardless of the party that sponsored it.⁵ Scientific studies should be interpreted scientifically – that is carefully, thoroughly, and rigorously – regardless whether they are conducted and published by industry-sponsored, union-sponsored, or Lord help us, even lawyer-sponsored scientists.

Several years ago, a defense lawyer, Samuel Tarry, published a case series of industry-sponsored research or analysis, which grew out of litigation, but made substantial contributions to the scientific understanding of claimed health risks. See Samuel L. Tarry, Jr., “Can Litigation-Generated Science Promote Public Health?” 33 Am. J. Trial Advocacy 315 (2009). Tarry’s paper is a helpful corrective to the biased (and often conflicted) criticisms of industry-sponsored research and analysis by the lawsuit industry and its scientific allies and consultants. It an ocean of uninformative papers about “Daubert,” Tarry’s paper stands out and should be required reading for all lawyers who practice in the area of “health effects litigation.”

Tarry presented a brief summary of the litigation context for three publications that deserve to remembered and used as exemplars of important, sound, scientific publications that helped changed the course of litigations, as well as the scientific community’s appreciation of prior misleading contentions and publications. His three case studies grew out of the silicone-gel breast implant litigation, the latex allergy litigation, and the never-ending asbestos litigation.

1. Silicone

There are some glib characterizations of the silicone gel breast implant litigation as having had no evidentiary basis. A more careful assessment would allow that there was some evidence, much of it fraudulent and irrelevant. See, e.g., Hon. Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in the silicone gel breast implant litigation as “charlatans” and the litigation as largely based upon fraud). The lawsuit industry worked primarily through so-called support groups, which in turn funded friendly, advocate physicians, who in turn testified for plaintiffs and their lawyers in personal injury cases.

When the defendants, such as Dow Corning, reacted by sponsoring serious epidemiologic analyses of the issue whether exposure to silicone gel was associated with specific autoimmune or connective tissue diseases, the plaintiffs’ bar mounted a conflict-of-interest witch hunt over industry funding.⁶ Ultimately, the source of funding became obviously irrelevant; the concordance between industry-funded and all high quality research on the litigation claims was undeniable. Obvious that is to court-appointed expert witnesses⁷, and to a blue-ribbon panel of experts in the Institute of Medicine⁸.

2. Latex Hypersensitivity

Tarry’s second example comes from the latex hypersensitivity litigation. Whatever evidentiary basis may have existed for isolated cases of latex allergy, the plaintiffs’ bar had taken and expanded into a full-scale mass tort. A defense expert witness, Dr. David Garabrant, a physician and an epidemiologist, published a meta-analysis and systematic review of the extant scientific evidence. David H. Garabrant & Sarah Schweitzer, “Epidemiology of latex sensitization and allergies in health care workers,” 110 J. Allergy & Clin. Immunol. S82 (2002). Garabrant’s formal, systematic review documented his litigation opinions that the risk of latex hypersensitivity was much lower than claimed and not the widespread hazard asserted by plaintiffs and their retained expert witnesses. Although Garabrant’s review did not totally end the litigation and public health debate about latex, it went a long way toward ending both.

3. Fraudulent Asbestos-Induced Radiography

I still recall, sitting at my desk, my secretary coming into my office to tell me excitedly that a recent crop of silicosis claimants had had previous asbestosis claims. When I asked how she knew, she showed me the computer print out for closed files for another client. Some of the names were so distinctive that the probability that there were two men with the same name was minuscule. When we obtained the closed files from storage, sure enough, the social security numbers matched, as did all other pertinent data, except that what had been called asbestosis previously was now called silicosis.

My secretary’s astute observation was mirrored in the judicial proceedings of Judge Janis Graham Jack, who presided over MDL 1553. Judge Jack, however, discovered something even more egregious: in some cases, a single physician interpreted a single chest radiograph as showing either asbestosis or silicosis, but not both. The two, alternative diagnoses were recorded in two, separate reports, for two different litigation cases against different defendants. This fraudulent practice, as well as others, are documented in Judge Jack’s extraordinary, thorough opinion. See In re Silica Prods. Liab. Litig., 398 F. Supp. 2d 563 (S.D. Tex. 2005)⁹.

The revelations of fraud in Judge Jack’s opinion were not entirely surprising. As everyone involved in asbestos litigation has always known, there is a disturbing degree of subjectivity in the interpretation of chest radiographs for pneumoconiosis. The federal government has long been aware of this problem, and through the Centers for Disease Control and the National Institute of Occupational Safety and Health, has tried to subdue extreme subjectivity by creating a pneumoconiosis classification schemed for chest radiographs known as the “B-reader” system. Unfortunately, B-reader certification meant only that physicians could achieve inter-observer and intra-observer reproducibility of interpretations on the examination, but they were free to peddle extreme interpretations for litigation. Indeed, the B-reader certification system exacerbated the problem by creating a credential that was marketed to advance the credibility of some of the most biased, over-reading physicians in asbestos, silica, and coal pneumoconiosis litigation.

Tarry’s third example is a study conducted under the leadership of the late Joseph Gitlin, at Johns Hopkins Medical School. With funding from defendants and insurers, Dr. Joseph Gitlin conducted a concordance study of films that had been read by predatory radiologists and physicians as showing pneumoconiosis. The readers in his study found a very low level of positive films (less than 5%), despite their having been interpreted as showing pneumoconiosis by the litigation physicians. See Joseph N. Gitlin, Leroy L. Cook, Otha W. Linton, and Elizabeth Garrett-Mayer, “Comparison of ‘B’ Readers’ Interpretations of Chest Radiographs for Asbestos Related Changes,” 11 Acad. Radiol. 843 (2004); Marjorie Centofanti, “With thousands of asbestos workers demanding compensation for lung disease, a radiology researcher here finds that most cases lack merit,” Hopkins Medicine (2006). As with the Sokol hoax, the practitioners of post-modern medicine cried “foul,” and decried industry sponsorship, but the disparity between courtroom and hospital medicine was sufficient proof for most disinterested observers that there was a need to fix the litigation process.

Meretricious Mensuration¹⁰ – Manganese Litigation Example

Tarry’s examples are important reminders that corporate sponsorship, whether from the plaintiffs’ lawsuit industry or from manufacturing industry, does not necessarily render research tainted or unreliable. Although lawyers often confront exaggerated or false claims, and witness important, helpful correctives in the form of litigation-sponsored studies, the demands of legal practice and “the next case” typically prevent lawyers from documenting the scientific depredations and their rebuttals. Sadly, unlike litigations such as those involving Bendectin and silicone, the chronicles of fraud and exaggeration are mostly closed books in closed files in closed offices. These examples need the light of day and a fresh breeze to disseminate them widely in both the scientific and legal communities, so that all may have a healthy appreciation for the value of appropriately conducted studies generated in litigation contexts.

As I have intimated elsewhere, the welding fume litigation is a great example of specious claiming, which ultimately was unhorsed by publications inspired or funded by the defense. In the typical welding fume case, plaintiff claimed that exposure to manganese in welding fume caused Parkinson’s disease or manganism. Although manganism sounds as though it must be a disease that can be caused only by manganese, in the hands of plaintiffs’ expert witnesses, manganism became whatever ailment plaintiffs claimed to have suffered. Circularity and perfect definitional precision were achieved by semantic fiat.

The Sanchez-Ramos Meta-Analysis

Manganese Madness was largely the creation of the Litigation Industry, under the dubious leadership of Dickie Scruggs & Company. Although the plaintiffs enjoyed a strong tail wind in the courtroom of an empathetic judge, they had difficulties in persuading juries and ultimately decamped from MDL 1535, in favor of more lucrative targets. In their last hurrah, however, plaintiffs retained a neurologist, Juan Sanchez-Ramos, who proffered a biased, invalid synthesis, which he billed as a meta-analysis¹¹.

Sanchez-Ramos’s meta-analysis, such as it was, provoked professional disapproval and criticism from the defense expert witness, Dr. James Mortimer. Because the work product of Sanchez-Ramos was first disclosed in deposition, and not in his Rule 26 report, Dr. Mortimer undertook belatedly a proper meta-analysis.¹² Even though Dr. Mortimer’s meta-analysis was done in response to the Sanchez-Ramos’s improper, tardy disclosure, the MDL judge ruled that Mortimer’s meta-analysis was too late. The effect, however, of Mortimer’s meta-analysis was clear in showing that welding had no positive association with Parkinson’s disease outcomes. The MDL 1535 resolved quickly thereafter, and with only slight encouragement, Dr. Mortimer published a further refined meta-analysis with two other leading neuro-epidemiologists. See James Mortimer, Amy Borenstein, and Lorene Nelson, “Associations of welding and manganese exposure with Parkinson disease: Review and meta-analysis,” 79 Neurology 1174 (2012). See also “Manganese Meta-Analysis Further Undermines Reference Manual’s Toxicology Chapter” (Oct. 15, 2012).

1 See, e.g., David Michaels & Celeste Monforton, “Manufacturing Uncertainty Contested Science and the Protection ofthe Public’s Health and Environment,” 95 Am. J. Pub. Health S39, S40 (2005); David Michaels & Celeste Monforton, “How Litigation Shapes the Scientific Literature: Asbestos and Disease Among Automobile Mechanics,” 15 J. L. & Policy 1137, 1165 (2007). Michaels had served as a plaintiffs’ paid expert witness in chemical exposure litigation, and Monforton had been employed by labor unions before these papers were published, without disclosure of conflicts.

2 Leslie Boden & David Ozonoff, “Litigation-Generated Science: Why Should We Care?” 116 Envt’l Health Persp. 121, 121 (2008) (arguing that systematic distortion of the scientific record will result from litigation-sponsored papers even with disclosure of conflicts of interest). Ozonoff had served as a hired plaintiffs’ expert witnesses on multiple occasion before the publication of this article, which was unadorned by disclosure.

3 Lennart Hardell, Martin J. Walker, Bo Walhjalt, Lee S. Friedman, and Elihu D. Richter, “Secret Ties to Industry and Conflicting Interest in Cancer Research,” 50 Am. J. Indus. Med. 227, 233 (2007) (criticizing “powerful industrial interests” for “undermining independent research on hazard and risk,” in a “red” journal that is controlled by allies of the lawsuit industry). Hardell was an expert witness for plaintiffs in mobile phone litigation in which plaintiffs claimed that non-ionizing radiation caused brain cancer. In federal litigation, Hardell was excluded as an expert witness when his proffered opinions were found to be scientifically unreliable. Newman v. Motorola, Inc., 218 F. Supp. 2d. 769, 777 (D. Md. 2002), aff’d, 78 Fed. Appx. 292 (4th Cir. 2003).

4 See David Egilman & Susanna Bohme, “IJOEH and the Critique of Bias,” 14 Internat’l J. Occup. & Envt’l Health 147, 148 (2008) (urging a Marxist critique that industry-sponsored research is necessarily motivated by profit considerations, and biased in favor of industry funders). Although Egilman usually gives a disclosure of his litigation activities, he typically characterizes those activities as having been for both plaintiffs and defendants, even though his testimonial work for defendants is minuscule.

5 Kenneth J. Rothman, “Conflict of Interest: The New McCarthyism in Science,” 269 J. Am. Med. Ass’n 2782 (1993).

6 See Charles H. Hennekens, I-Min Lee, Nancy R. Cook, Patricia R. Hebert, Elizabeth W. Karlson, Fran LaMotte; JoAnn E. Manson, and Julie E. Buring, “Self-reported Breast Implants and Connective- Tissue Diseases in Female Health Professionals: A Retrospective Cohort Study, 275 J. Am. Med. Ass’n 616-19 (1998) (analyzing established cohort for claimed associations, with funding from the National Institutes of Health and Dow Corning Corporation).

7 See Barbara Hulka, Betty Diamond, Nancy Kerkvliet & Peter Tugwell, “Silicone Breast Implants in Relation to Connective Tissue Diseases and Immunologic Dysfunction: A Report by a National Science Panel to the Hon. Sam Pointer Jr., MDL 926 (Nov. 30, 1998).” The court-appointed expert witnesses dedicated a great deal of their professional time to their task of evaluating the plaintiffs’ claims and the evidence. At the end of the process, they all published their litigation work in leading journals. See Barbara Hulka, Nancy Kerkvliet & Peter Tugwell, “Experience of a Scientific Panel Formed to Advise the Federal Judiciary on Silicone Breast Implants,” 342 New Engl. J. Med. 812 (2000); Esther C. Janowsky, Lawrence L. Kupper., and Barbara S. Hulka, “Meta-Analyses of the Relation between Silicone Breast Implants and the Risk of Connective-Tissue Diseases,” 342 New Engl. J. Med. 781 (2000); Peter Tugwell, George Wells, Joan Peterson, Vivian Welch, Jacqueline Page, Carolyn Davison, Jessie McGowan, David Ramroth, and Beverley Shea, “Do Silicone Breast Implants Cause Rheumatologic Disorders? A Systematic Review for a Court-Appointed National Science Panel,” 44 Arthritis & Rheumatism 2477 (2001).

8 Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (Institute of Medicine) (Wash. D.C. 1999).

9 See also Lester Brickman, “On the Applicability of the Silica MDL Proceeding to Asbestos Litigation, 12 Conn. Insur. L. J. 289 (2006); Lester Brickman, “Disparities Between Asbestosis and Silicosis Claims Generated By Litigation Screenings and Clinical Studies,” 29 Cardozo L. Rev. 513 (2007).

10 This apt phraseology is due to the late Keith Morgan, whose wit, wisdom, and scientific acumen are greatly missed. See W. Keith C. Morgan, “Meretricious Mensuration,” 6 J. Eval. Clin. Practice 1 (2000).

11 See Deposition of Dr. Juan Sanchez-Ramos, in Street v. Lincoln Elec. Co., Case No. 1:06-cv-17026, 2011 WL 6008514 (N.D. Ohio May 17, 2011).

12 See Deposition of Dr. James Mortimer, in Street v. Lincoln Elec. Co., Case No. 1:06-cv-17026, 2011 WL 6008054 (N.D. Ohio June 29, 2011).

Posted in Asbestos, Causation, Conflicts of Interest, Meta-analysis, Rule 702, Scientific Evidence, Scientific Misconduct | Comments Off on Samuel Tarry’s Protreptic for Litigation-Sponsored Publications