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Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 1

November 12th, 2012

In Matrixx Initiatives, Inc. v. Siracusano, 131 S.Ct. 1309 (2011), the Supreme Court, speaking through Justice Sotomayor, wandered into a discussion whether statistical significance was necessary for a determination of the causality of an association:

“We note that courts frequently permit expert testimony on causation based on evidence other than statistical significance. See, e.g., Best v. Lowe’s Home Centers, Inc., 563 F. 3d 171, 178 (6^th Cir 2009); Westberry v. Gislaved Gummi AB, 178 F. 3d 257, 263–264 (4^th Cir. 1999) (citing cases); Wells v. Ortho Pharmaceutical Corp., 788 F. 2d 741, 744–745 (11^th Cir. 1986). We need not consider whether the expert testimony was properly admitted in those cases, and we do not attempt to define here what constitutes reliable evidence of causation.”

Id. at 1319.

As I have pointed out previously, the Court’s citation to these three cases was jarring for their irrelevance, and for the questionable scholarship involved.

The first two cases cited involved differential etiology to assess specific causation, not general causation. As most courts have recognized, this assessment strategy requires that general causation has already been established. See, e.g., Hall v. Baxter Healthcare, 947 F. Supp. 1387 (D. Ore. 1996). These cases did not, therefore, even touch on the use of statistical significance to establish general causation. There was no statistical analysis in those cases, and nothing to judge significant or insignificant.

The citation to the third case, Wells, is noteworthy because the case has nothing to do with adverse event reports or the lack of statistical significance. Wells involved a claim of birth defects caused by the use of spermicidal jelly contraceptive, which had been the subject of several studies, one of which at least yielded a statistically significant increase in detected birth defects over what was expected. Wells v. Ortho Pharmaceutical Corp., 615 F. Supp. 262 (N.D. Ga. 1985), aff’d and rev’d in part on other grounds, 788 F.2d 741 (11^th Cir.), cert. denied, 479 U.S.950 (1986). Wells could thus hardly be an example of a case in which there was a judgment of causation based upon a scientific study that lacked statistical significance in its findings. Of course, finding statistical significance is just the beginning of assessing the causality of an association; Wells was notorious for its poor assessment of all the determinants of scientific causation.

As I pointed out in Matrixx Unloaded, the citation to Wells was remarkable because the Wells decision has been widely criticized for its failure to evaluate the entire evidentiary display, as well as for its failure to rule out bias and confounding in the studies relied upon by the plaintiff.[i]

A few years later, another case in the same judicial district against the same defendant for the same product resulted in the grant of summary judgment. Smith v. Ortho Pharmaceutical Corp., 770 F. Supp. 1561, 1582 (N.D. Ga. 1991) (supposedly distinguishing Wells on the basis of more recent studies). Some legal scholars have been content to point out that the science had matured with the passage of time, from the point that there was sufficient evidence to support plaintiffs’ case (in Wells) to the point that the evidence was so overwhelmingly adverse to plaintiffs that summary judgment for the defense was appropriate (in Smith). While this suggestion has the virtue of simplicity, it fails to look at what really happened in Wells, and to analyze the evidence in front of the Wells court.

Another remarkable aspect of the Supreme Court’s citation to Wells is that the case, and all it stands for, was overruled sub silentio by the Supreme Court’s own decisions in Daubert, Joiner, Kumho Tire, and Weisgram. And if that did not kill the concept, then there was the simple matter of a supervening statute: the 2000 amendment of Rule 702, of Federal Rules of Evidence. Citing a case as jurisprudentially dead and discredited as Wells could have been sloppy scholarship and lawyering. The principle of charity, however, suggests it was purposeful, and that is a frightful prospect.

Katie Wells was conceived sometime in the month of October 1980. Her mother was using the defendant’s product, Ortho-Gynol Contraceptive Jelly, with its active ingredient, a non-ionic surfactant called p-diisobutylphenoxypolyethoxyethanol or octoxynol-9, from July until mid-November 1980. Defendant Ortho had manufactured and marketed this product since 1950, without any warning that the product causes birth defects. 615 F. Supp. at 268-69. Ortho’s defense consisted in denying general and specific causation, and noting that in the fall of 1980, “no published reports or studies had concluded that spermicides cause birth defects,” and that “it had received no other complaints nor had access to any other evidence suggesting a link between its Product and birth defects.” 615 F. Supp. at 269.

Key issues in Wells were whether the state of the art required a warning on product in 1980, when used, and whether, as of the time of the trial in 1984, plaintiffs could establish cause in fact.

The district judge, Judge Marvin Shoob, heard the case as the trier of fact. Both sides waived their rights to a jury trial in part because of the number of witnesses could not be accommodated within the time scheduled for the trial. Given that the plaintiffs called so many redundant witnesses, a reasonable observer may suspect that the plaintiffs wanted a bench trial. Perhaps there was something about the relationship between Katie’s mother and father to give plaintiffs’ counsel pause. Katie’s father, Mr. Gary Wells, was not a party; only her mother was claiming economic damages. Perhaps Katie’s father’s admitted substantial use of illegal, recreational drugs, pushed plaintiffs to make this choice. Katie’s mother admitted to using only therapeutic drugs, Decadron for bronchitis, and Amoxicillin during her pregnancy, but her father admitted to using LSD, amphetamines, methaqualone, and marijuana. Id. at 269. The defense probably agreed, hoping to avoid an unduly sympathetic jury, and to gain a more analytical decision maker.

Jurisdiction in Wells was based upon diversity of citizenship; the court was bound to apply Georgia law under controlling choice-of-law precedent. Georgia law requires plaintiffs to prove medical causation “reasonable degree of medical certainty.” See Parrott v. Chatham County Hospital Authority, 145 Ga.App. 113, 115, 243 S.E.2d 269 (1978); Robertson v. Emory University Hospital, 611 F.2d 604, 608 n. 13 (5th Cir.1980); Watson v. United States, 346 F.2d 52, 54 (5th Cir.1965), cert. denied, 382 U.S. 976 (1966). 615 F. Supp. at 295. Plaintiffs, under Georgia law, must show more than a “bare possibility” of causation, as well as ruling out other theories that are equally plausible. Id. (citing Maddox v. Houston County Hospital Authority, 158 Ga.App. 283, 284, 279 S.E.2d 732 (1981)).

According to Georgia law of negligence, a manufacturer must exercise reasonable care to warn of dangers of which it has “actual or constructive knowledge,” when the product was sold and delivered. Id. (citations omitted).

In deciding this case, Judge Shoob began defensively, on thin ice, by declaring that he had to make a “legal” decision, not a medical decision. Id. at 266. This defensive prelude was curious because Georgia law clearly imported “knowledge” into both the duty to warn, and into resolution of the causal issue. The requisite knowledge could come only from the scientific evidence that the parties tried to marshal. The defensive prelude was also curious because, as we shall see, Judge Shoob allowed the plaintiffs’ expert witnesses to opine about their subjective perceptions that warnings should be required upon suspicion of harm.

It bears pointing out that, as in Ferebee, Federal Rule of Evidence 702 or 703 is never mentioned in Judge Shoob’s decision. There appears to have been no defense challenges to the qualifications or the “helpfulness” of any of the plaintiffs’ witnesses. There are no challenges to any expert witness’s qualifications. There are no Frye challenges discussed.

On re-reading Judge Shoob’s opinion, the most salient feature is the absence of any discussion of the “point estimates” of association or “effect size” in any of the studies discussed. Similarly, Judge Shoob fails to mention the extent of the random error in any study, either in the form of p-values of in confidence intervals. There is an occasional hint that studies are too small to yield meaningful findings, but no power calculations or assessments are provided, and no alternative hypotheses specified. There is no consideration of multiple comparisons, which may have diluted the usual interpretation of significance probability. Judge Shoob failed to engage in the scientific studies or the evidence, which was offered to him as the trier of fact.

Notwithstanding the failure to consider important rules of evidence, and the scientific evidence, Judge Shoob appreciated that there was a failure of proof on the part of the plaintiffs:

“Although some of the studies suggested a connection between spermicides and birth defects, overall the studies failed to show conclusively whether or not the spermicide caused any or all of the birth defects suffered by Katie Wells.”

Id. at 266. How then did Ortho loose?

(to be continued).

[i] See, e.g., James L. Mills and Duane Alexander, “Teratogens and ‘Litogens’,” 15 New Engl. J. Med. 1234 (1986); Samuel R. Gross, “Expert Evidence,” 1991 Wis. L. Rev. 1113, 1121-24 (1991) (“Unfortunately, Judge Shoob’s decision is absolutely wrong. There is no scientifically credible evidence that Ortho-Gynol Contraceptive Jelly ever causes birth defects.”). See also Editorial, “Federal Judges v. Science,” N.Y. Times, December 27, 1986, at A22 (unsigned editorial) (“That Judge Shoob and the appellate judges ignored the best scientific evidence is an intellectual embarrassment.”); David E. Bernstein, “Junk Science in the Courtroom,” Wall St. J. at A 15 (Mar. 24,1993) (pointing to Wells as a prominent example of how the federal judiciary had embarrassed American judicial system with its careless, non-evidence based approach to scientific evidence); Bert Black, Francisco J. Ayala & Carol Saffran-Brinks, “Science and the Law in the Wake of Daubert: A New Search for Scientific Knowledge,” 72 Texas L. Rev. 715, 733-34 (1994) (lawyers and leading scientist noting that the district judge “found that the scientific studies relied upon by the plaintiffs’ expert were inconclusive, but nonetheless held his testimony sufficient to support a plaintiffs’ verdict. *** [T]he court explicitly based its decision on the demeanor, tone, motives, biases, and interests that might have influenced each expert’s opinion. Scientific validity apparently did not matter at all.”) (internal citations omitted); Troyen A. Brennan, “Untangling Causation Issues in Law and Medicine: Hazardous Substance Litigation,” 107 Ann. Intern. Med. 741, 744-45 (1987) (describing the result in Wells as arising from the difficulties created by the Ferebee case; “[t]he Wells case can be characterized as the court embracing the hypothesis when the epidemiologic study fails to show any effect”). Kenneth R. Foster, David E. Bernstein, and Peter W. Huber, eds., Phantom Risk: Scientific Inference and the Law 28-29, 138-39 (MIT Press 1993) (criticizing Wells decision); Hans Zeisel & David Kaye, Prove It With Figures: Empirical Methods in Law and Litigation § 6.5, at 93(1997) (noting the multiple comparisons in studies of birth defects among women who used spermicides, based upon the many reported categories of birth malformations, and the large potential for even more unreported categories); id. at § 6.5 n.3, at 271 (characterizing Wells as “notorious,” and noting that the case became a “lightning rod for the legal system’s ability to handle expert evidence.”).

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Evidence-Based Specific Causation

November 7th, 2012

In the last post, I discussed an important article by Professors Davidson and Guzelian, on the legal implications of evidence-based medicine (EBM). Terence M. Davidson & Christopher P. Guzelian, “Evidence-based Medicine (EBM): The (Only) Means for Distinguishing Knowledge of Medical Causation from Expert Opinion in the Courtroom,” 47 Tort Trial & Ins. Practice L. J. 741 (2012) [cited as Davidson].

Their criticism of the deficiencies in current gatekeeping practice cries out for reform of much current judicial practice. Education of the judiciary in EBM would be helpful to both plaintiffs and defendants in civil cases, as well as prosecutors and defendants in criminal cases. I will leave for another day a discussion of whether the boundary between knowledge and “mere opinion” is so easily discernible.

Although the authors’ call for EBM in judicial decisions is timely and needed, I noted my dissent to their assessment of one defense expert witness’s specific causation opinion in the hormone therapy litigation. Davidson and Guzelian criticize one district judge for having admitted the challenged testimony of a defense expert witness, Dr. Blaustein, who opined that (1) estrogen + progesterone combination post-menopausal hormone replacement therapy (CHRT) has not been shown to cause breast cancer, and (2) there is no generally accepted method for determining a cause of a woman’s breast cancer. Cross v. Wyeth Pharms., Inc., CASE NO.: 8:06-cv-429-T-23AEP, 2011 U.S. Dist. LEXIS 89078; 2011 WL 3498305 (M.D. Fla. 2011) (Merryday, J.).

Here is how Davidson & Guzelian put the matter:

“Blaustein also opined that there is no generally accepted method for diagnosing specific medical causation—that is, whether a medical intervention or treatment, even if it is known to generally cause a result ‘X’ (e.g., breast cancer), caused a particular patient’s result ‘X’. Blaustein’s statement, accepted by the judge as befitting of presentation to the jury, is ‘simply false’.”

The claim that Blaustein’s statement is “simply false” is pretty strong for both general and specific causation, and partially explains my initial dissent. The prestige of the Women’s Health Initiative (WHI), a large, randomized, clinical meta-trial of CHRT, with its finding of an increased risk for breast cancer among women, certainly has made Dr. Blaustein’s opinion on general causation a distinctly minority view. There are, however, some careful authors who have challenged the findings of the WHI on grounds of internal and external validity. See, e.g., Samuel Shapiro, Richard Farmer, Helen Seaman, J. C. Stevenson, “Does hormone replacement therapy cause breast cancer? An application of causal principles to three studies: part 2. The Women’s Health Initiative: estrogen plus progestogen,” 37 J. Family Planning & Reproductive Health Care 165, 165 (2011) (“HRT with estrogen plus progestogen may or may not increase the risk of breast cancer, but the WHI did not establish that it does.”). In any event, given the state of the science, most defendants would hedge their position on general causation even if they stopped short of saying it was not established. Still, the validity concerns may cause us to have some doubts that the conclusions drawn from the WHI and other studies are truly “knowledge.”

Professor Guzelian has persuaded me that their indictment of Blaustein’s opinion on specific causation is correct, at least technically. There are, to be sure, a few genetic causes of breast cancer, such as the BrCa 1, and 2, genes, which can cause breast cancer, and which, if present in a particular woman, would constitute an adequate description of the cause of that woman’s cancer. Blaustein claimed that there is no generally accepted method for attributing an individual woman’s breast cancer to known causes, and Davidson and Guzelian are correct that Blaustein’s claim is, therefore, “simply false.”

Given how cursory and conclusory the trial court’s opinion is, Davidson and Guzelian’s derision is, however, relatively uncharitable. We can probably credit the plaintiff’s counsel with sufficient entrepreneurial savvy to have not pressed the claims of a woman who had a known genetic cause of breast cancer. And we can similarly credit the defense counsel with sufficient intelligence not to have overlooked the presence of such a gene if it were present.

With genetic causes taken out of the equation, Blaustein’s opinion seems fairly unremarkable. Even if the criticism of the trial court’s refusal to preclude Dr. Blaustein’s testimony on general causation were correct under Federal Rule of Evidence 702, Davidson and Guzelian have failed to make their case against the trial court, and Dr. Blaustein, on specific causation.

Here is what Davidson and Guzelian have to say about Blaustein’s specific causation opinion:

“EBM has documented and catalogued the best practices regarding how to diagnose whether generally applicable evidence-based conclusions hold for specific patients.⁵¹ Moreover, even if in a specific case it were plausible to assert that it is impossible to reach a specific causation conclusion for a particular patient’s condition using the scientific method, that is very different than saying that there is no scientific method for analyzing specific causation. According to EBM’s strictures, Blaustein’s proposed blanket denial of the possibility of specific causation should have been precluded from his testimony.⁵²”

Davidson at 757. The footnotes in this passage are to the section of an article on evidence-based toxicology, which deals with attribution of an adverse drug reaction. Philip Guzelian et al., “Evidence-Based Toxicology: A Comprehensive Framework for Causation,” 24 Human & Experimental Toxicol. 161, 190-91 (Table 9) (2005) (presenting “an overview of evidence-based specific causation diagnostic criteria”). Putting aside the very substantial differences between cancer causation and the general run of adverse drug reactions, we can see that the proposed criteria for specific causation in the referenced article contain this extremely important criterion:

“No good alternative candidate (unexplained exacerbation or recurrence of underlying illness).”

Id. Specific causation in a breast cancer case falls outside this criterion because most cases of breast cancer (with the exception of the genetic cases mentioned above) have no identifiable risk factor. Dr. Blaustein’s opinion on specific causation — that there is no generally accepted method for attributing breast cancer to exogenous cause(s) — seems then exactly on point, even on the EBM criteria for specific causation urged by the authors.

In Cross, the trial court does not provide any insight into the basis for the plaintiffs’ challenge to Blaustein’s specific causation opinion, and I am aware of none. The trial court does not give us any particulars of the plaintiff’s use of CHRT or development of breast cancer, and there is no suggestion that she had an extraordinarily high risk (say > 10-fold increase, which I have never seen reported, in any event).

The plaintiffs did not attempt to infer causation from risk. Perhaps they thought better of it, or perhaps one of their testifying epidemiologists, Dr. Graham Colditz, refused to support such an inference:

“Knowledge that a factor is associated with increased risk of disease does not translate into the premise that a case of disease will be prevented if a specific individual eliminates exposure to that risk factor. Disease pathogenesis at the individual level is extremely complex. As Rose stated, a preventive measure that brings large benefits to the community offers little to each participating individual [3]. Accordingly, epidemiology must be harnessed to identify the population level strategies that will reduce the burden of illness.”

Graham A. Colditz, “From epidemiology to cancer prevention: implications for the 21st Century,” 18 Cancer Causes Control 117, 118 (2007). Professor Colditz’ view is hardly unique; there are many similar refusals to base an inference of specific causation upon an increased risk, whether or not that increased risk is quantified as a relative risk greater than two. The late David Freedman, who was the co-author of the chapters on statistics in all three editions of the Reference Manual on Scientific Evidence, was also a naysayer when it came to transmuting risk into cause:

“The scientific connection between specific causation and a relative risk of two is doubtful. *** Epidemiologic data cannot determine the probability of causation in any meaningful way because of individual differences.”

David Freedman & Philip Stark, “The Swine Flu Vaccine and Guillaine-Barré Syndrome: A Case Study in Relative Risk and Specific Causation,” 64 Law & Contemporary Problems 49, 61 (2001).

The plaintiffs’ challenge to Blaustein’s claim that there was no “generally accepted” method for specific causal attribution took the form of advancing their own “method”: differential diagnosis. At face value, the plaintiffs’ use of differential diagnosis to advance a claim of specific causation is “simply false.” There was no dispute about diagnosis, and no differential diagnosis at issue. Unfortunately, courts have permitted lawyers to corrupt the meaning of differential diagnosis and contend that it covers something akin to differential etiology.

Davidson and Guzelian, in their reference back to an earlier article on evidence-based toxicology, embrace differential etiology as a method of specific case attribution. I agree that there is really no dispute about the logically validity of such reasoning, generally. The logic of differential etiology is simple. If you can specify all the known causes of a disease, and eliminate all but one cause, then you have ruled in the specific cause. Logically, this is an iterative disjunctive syllogism, also known as the process of elimination. The syllogism requires an exhaustive statement of disjuncts, with the negation of all but one:

A v B v C v D

~A and ~B and ~ C.

Therefore, D.

In “The Adventure of the Beryl Coronet,” Sir Arthur Conan Doyle had his famous detective, Sherlock Holmes, articulate this method in ordinary English, with a bit more flair:

“It is an old maxim of mine that when you have excluded the impossible, whatever remains, however improbable, must be the truth.”

Arthur Conan Doyle, The Penguin Complete Sherlock Holmes 315 (Penguin 1981). The process of elimination was a mainstay of Holmes’ forensic thought:

“Eliminate all other factors, and the one which remains must be the truth.”

“The Sign of the Four,” chap. 1 (“The Science of Deduction”), in Arthur Conan Doyle, The Penguin Complete Sherlock Holmes at 92 (Penguin 1981).

The problem of course is, for a disease such as breast cancer, is that one of the disjuncts has been, and will remain, for some time: the proposition that this case is “idiopathic” or “sporadic.” The plaintiffs in Cross did not advance any plausible method for eliminating this disjunct. As a result, they can never arrive at a conclusion that CHRT was a cause of Ms. Cross’s breast cancer. The closest they can get to their desired conclusion with this “method,” once they have eliminated genetic causes, is a conclusion that:

The case is idiopathic OR the case resulted from CHRT.

This conclusion is not really a conclusion at all, but an indeterminate statement, which would be quite unhelpful to the trier in deciding the case. Furthermore, as the case is described by the trial court’s opinion, the plaintiffs did not even attempt a quantification of the probability of each of these two disjuncts. Thus, the plaintiffs failed to offer any substantial evidence that a jury could believe to find in their favor on specific causation. The trial court was correct to reject the challenge to Dr. Blaustein’s specific causation opinion, but the court should have granted the defendants’ challenge to the plaintiffs’ expert witnesses, who had no method at all on the crucial element of specific causation.

Interestingly, one of the plaintiffs’ better arguments against Dr. Blaustein was that he was, as a clinician, unqualified to opine on causation. Cross, *9. The trial court did not elaborate on the argument other than to point out that plaintiffs had emphasized that Dr. Blaustein relied upon his “unquantifiable and untested clinical experience.” Cross, *10. The courts have been remarkably resistant to the argument that physicians are generally unqualified to interpret scientific evidence of causation. Sadly, there is a good deal of empirical evidence to show that physicians are not particularly well trained in statistics or in interpreting clinical research. See, e.g., Donna Windish, Stephen Huot, and Michael Green, “Medicine Residents’ Understanding of the Biostatics and Results in the Medical Literature,” 298 J. Am. Med. Ass’n 1010, 1010 (2007) (“Most residents in this study lacked the knowledge in biostatistics to interpret many of the results in published clinical research.”).

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Egilman’s Allegations Against McDonald and His Epidemiologic Research Are Baseless

October 20th, 2012

Dr. David Egilman has been trash-talking the epidemiologic studies of Quebec asbestos miners and millers for so long that most sensible people have tuned out his diatribe. The studies attacked by Egilman were done under the supervision of a capable epidemiologist, J. Corbett McDonald, Emeritus Professor of McGill University, in Montreal. McDonald is now in his late 90’s, but remains active as a Honorary Professorial Research Fellow at the National Heart & Lung Institute, in the Imperial College of London (UK).

McDonald’s studies showed a significant fiber-type differential in mesothelioma causation. Even though his studies have been corroborated by the work of researchers from around the world, McDonald’s studies remain among the largest, and best-conducted. As such, the McDonald work has always stuck in the craw of Selikoff and his co-conspirators who have tried to politicize the science of fiber-type differential.

Irving Selikoff died 20 years ago, but his political heirs have continued to prosecute the reputation of scientists (Doll, McDonald, Wagner, and others) who dared to disagree with Selikoff dogma. Egilman has often led the charge against McDonald, in publications and ultimately in an ethics complaint to McDonald’s former employer, McGill University. This complaint was then used by Egilman’s trial lawyer supporters to impugn the studies that are anathema to their mission to squeeze every last possible cent from the asbestos fiasco. See, e.g., Shein Law Center, Ltd., “McGill University Asbestos Study under Attack” (Feb. 12, 2012) (republishing Egilman’s attack on McDonald’s studies).

In response to Egilman’s scurrilous attacks upon McDonald and his work, McGill University undertook a formal investigation of the allegations. In a report prepared by the University’s Research Integrity Officer, Abraham Fuks, the Egilman allegation were found to be baseless and unsupported. Consultation Report to Dean David Eidelman (Sept. 23, 2012). The Report’s Conclusions and Recommendations decisively rebuffed the Egilman complaint:

“Following review of the documentation presented, the data available in the published literature, and materials available at the University, I was unable to find any support for these allegations. The financial support from the industry was acknowledged in publications and there is no evidence to suggest that the sponsors influenced the data analyses or the conclusions. In fact, JCM [J.Corbett McDonald] noted an excess of lung cancers in asbestos workers in the earliest papers and reports and this could not have been a happy outcome for the asbestos companies. JCM’s findings and conclusions have been replicated by other groups and their robustness has endured many critical analyses and legal inquiries. In fact, the recent statement by the combined epidemiology societies notes the gradient of toxicities of different types of asbestos fibers and refers to this as the current consensus, thus corroborating what the McGill group foreshadowed almost forty years ago.

Thus, I find no warrant to initiate further investigations of the allegations that we have received.

Id. at 13-14.

* * * * *

b. Did the asbestos industry launch its research programs with its own interests in mind?

To frame the question in those terms is to invite the obvious answer. Indeed, the documents made available during the many years of legal discovery make it clear that by supporting JCM and his group, and for that matter, the group at Mt Sinai led by Dr. Selikoff, the asbestos companies hoped to develop information that would vindicate their claims that asbestos, in certain forms and treated in certain ways, could continue to be used with safety. This is not surprising as such. One must acknowledge that other sources of support were not as readily available as they ought to have been and moreover, the researchers were aware of the pitfalls of the relationship they had accepted. It is all the more important to recognize that the research by JCM and other groups throughout the world generated the information that led to the near complete disappearance of the asbestos industry in the developed world and the universal recognition of the toxicity of the product. It is also clear that the industry attempted to misuse the research data to its own purposes in policy debates throughout the world and in setting standards for occupational exposures. However, it was these very same studies that permitted and permeated the litigation and policy statements clarifying the toxicity of the product.

c. Did McGill University collude with the asbestos industry in promoting the use of asbestos and in opposing the recommendations of the UICC?

These are amongst the allegations leveled at the University, albeit with no documentation or plausible evidence. The review of the materials described previously lends no credence to these allegations and claims.

Id. at 14.

Although the report falls into the trap of adopting the accusers’ loose language, such as condemning all companies through its use of term “the industry,” the report exculpates Professor McDonald for the alleged “collusion,” as well as the “industry” for attempting to manipulate his publications. The advocacy uses or misuses of the Quebec studies by one or another companies seem mild in comparison with the distortions of the anti-asbestos zealots and their trial lawyer friends.

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“Trust Me” Rules of Evidence

October 18th, 2012

Stating what should be obvious, Judge Posner noted that the “[l]aw lags science, it does not lead it.” Rosen v. Ciba Geigy, 78 F.3d 316, 319 (7th Cir. 1996). Science as a method and a process has long ago moved away from authoritative pronouncements. Since 1663, the Royal Society has sported the motto: “Nullius in verba.” When confronted with a pamphlet entitled “100 Authors against Einstein,” Albert Einstein quipped “if I were wrong, one would have been enough.” See Remigio Russo, 18 Mathematical Problems in Elasticity 125 (1996) (quoting Einstein). Disputes in science are resolved with data, from high-quality, reproducible experimental or observational studies, not with appeals to the prestige of the speaker.

Almost 20 years ago, the Supreme Court, in Daubert v. Merrell Dow Pharms., Inc., 509 U.S. 579 (1993), redirected the course of the federal system of evidence, which had exalted expert witness opinion over knowledge. The Court attempted to put expert witness testimony on the same footing as knowledge, or true justified belief, as required by the plain language of Rule 702. The Court’s leadership culminated in today’s revised Federal Rule of Evidence 702.

Many rules of evidence, however, remain mired in the “trust me” authoritarian regime of subjective opinion. Recently, the Committee on Rules of Practice and Procedure has approved draft amendments to three rules with built-in “trustworthiness” elements:

· Rules 803(6) (Records of a Regularly Conducted Activity),

· FRE 803(7) (Absence of a Record of a Regularly Conducted Activity), and

· FRE 803(8) (Public Records).

Public comment on the draft rules closes on February 13, 2012. The amendments are designed to make clear that the party against whom the business or public record is offered must show the untrustworthiness of the record to keep the record out of evidence. These exceptions to the rule against hearsay are problematic because medical records and governmental reports may be larded with subjective opinions that would never pass Rule 702 scrutiny.

There is something peculiar about this aspect of the federal rules and its insistence that a party, facing the admission of evidence, must show the absence of trustworthiness. These exceptions to the rule against hearsay, dealing with public and business records, are not alone in employing trustworthiness of the source as a proxy for the truth. For many years, Rule 703 was viewed as an exception to the rule against hearsay, with the predicate to admissibility being the reliance by a party’s expert witness. The changes wrought by Daubert made this interpretation of Rule 703 untenable, and today, the text of the rule ensures against this once popular evidentiary fallacy. In hindsight, the use of a party’s hired witness to provide the predicate for admissibility seems a fairly primitive move within the Federal Rules of Evidence.

This pending revision to the Federal Rules of Evidence ignores another trustworthiness-based rule, Rule 803(18), which creates limited admissibility for “statements in learned treatises, periodicals, or pamphlets.” This rule does require the proponent to present expert witness testimony to qualify the source, or to seek judicial notice of “learnedness,” which has been interpreted to be a proxy for trustworthiness and knowledge. As such, the rule represents a major gap in the requirement that the proponent of scientific testimony show its epistemic warrant. Statements in treatises or periodicals are often made in conclusory fashion, without a complete explication of their bases. See Schachtman, “Further Unraveling of the Learned Treatise Exception” (Sept. 29, 2010); “The New Wigmore on Learned Treatises” (Sept. , 2011); and “Unlearning The Learned Treatise Exception” (Aug. 21, 2010).

Even within the current framework of judicial decisions interpreting Rule 702, courts still struggle when faced with appeals to authority, especially in the field of clinical medicine. Courts have a difficult time getting past: “Trust me, I am a physician.” See, e.g., Mueller v. Auker, No. 11-35351, ___ F.3d ___, 2012 WL 3892960 at *8 (9th Cir. Sept. 10, 2012) (noting that “clinical instinct” is a generally accepted method of decision making by physicians). The evidence-based worldview continues to challenge, confound, and confuse judges.

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Union of Concerned Scientists on Criticism and Personal Attacks on Scientists

October 12th, 2012

The Union of Concerned Scientists (UCS) has produced a glossy pamphlet with a checklist of how scientists may respond to criticism and personal attacks. See UCS – Science in an Age of Scrutiny: How Scientists Can Respond to Criticism and Personal Attacks (2012).

The rationale for this publication is described at the UCS website. The UCS notes that scientists are under a great deal of scrutiny, and “attack,” especially when their research is at the center of contentious debate over public policy. According to the UCS, scientists are “sometimes attacked by individuals who do not like the research results. These attacks can take multiple forms—emails, newspaper op-eds, blogs, open-records requests, even subpoenas—but the goals are the same: to discredit the research by discrediting the researcher.

I am all for protecting scientists and researchers from personal attacks. The UCS account, however, seems a bit narcissistic. The UCS is making an ad hominem attack on the putative attackers for what they claim is an ad hominem attack on the researchers. What if the so-called attackers don’t care a bit about discrediting the researchers, but only the research?

The “even subpoenas” got my attention. Subpoenas have been propounded for good reason, and with good effect, on litigation-related research. See, e.g., In re Welding Fume Prods. Liab. Litig., MDL 1535, 2005 WL 5417815 (N.D. Ohio Aug. 8, 2005) (upholding defendants’ subpoena for documents and things from Dr. Racette author of study on welding and parkinsonism). The UCS has thus attacked motives of lawyers charged with protecting their clients from dubious scientific research; I suppose we could return the epithet and declare that the UCS goal is to discredit the process of compelling data sharing by discrediting the motives of the persons seeking data sharing.

Subpoenas served upon independent researchers, whose work bears on the issues in litigation, are a valid part of the litigation discovery process. Litigants, especially defendants who are involuntarily before a tribunal by compulsory process, are entitled to “every man’s evidence.”

The Union of Concerned Scientists seem either unduly sensitive or cavalier and careless in their generalization about the goals of lawyers who propound subpoenas. The goal is typically not to discredit the researcher. The personality, reputation, and position of the researcher are irrelevant; it’s about the data.

The Federal Judicial Center’s Manual for Complex Litigation describes subpoenas for researchers’ underlying data and materials at some length. See Fed. Jud. Center, Manual for Complex Litigation § 22.87 (4th ed. 2004). The Manual acknowledges that the federal courts have protected unpublished research from discovery, but that courts permit discovery of underlying data and materials from studies that have been published. Federal Rule of Civil Procedure 45(c)(3)(B)(ii) allows courts to enforce subpoenas against non-parties, on a showing of “substantial need for the testimony that cannot be otherwise met without undue hardship,” and on assurance that the subpoenaed third parties “will be reasonably compensated.” Manual at 444-45. The federal courts have recognized that litigants’ need to obtain, examine, and re-analyze data underlying research studies used to by their adversaries against them. Although the researchers have interests that should be protected in the discovery process, such as their claims “for protection of confidentiality, intellectual property rights, research privilege, and the integrity of the research,” these claims must be balanced against the necessity of the evidence in the litigation process. Id.

Of course, when the research is sponsored by litigants, whether by financial assistance or by assisting in recruiting study participants, and is completed, “courts generally require production of all data; for pending studies, courts often require disclosure of the written protocol, the statistical plan, sample data entry forms, and a specific description of the progress of the study until it is completed. Id.

Some have argued that the scientific enterprise should be immune from the rough and tumble of legal discovery because its essential collaborative nature is threatened by the adversarial interests at play in litigation. Professor George Olah, in accepting his Nobel Prize in Chemistry, rebutted this sentiment:

“Intensive, critical studies of a controversial topic always help to eliminate the possibility of any errors. One of my favorite quotation is that by George von Bekessy (Nobel Prize in Medicine, 1961).

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

George A. Olah, “My Search for Carbocations and Their Role in Chemistry,” Nobel Lecture (Dec. 8, 1994), quoting George von Békésy, Experiments in Hearing 8 (N.Y. 1960). The UCS should rejoice for its intellectual enemies. “Out of life’s school of war: What does not destroy me, makes me stronger.” Friedrich Nietzsche, The Twilight of the Idols Maxim 8 (1899).

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Hop on Pop Redux – Watson Case

October 3rd, 2012

Last month, Maxwell Kennerly of the Beasley Firm in Philadelphia posted about the Watson case in his blog. See Max Kennerly, “The Science And Law Behind The $7 Million Microwave Popcorn Lung Jury Verdict” (Sept. 20, 2012). This case has attracted a lot of attention, as it well should. See “It’s Alimentary, My Dear Watson” (Sept. 20, 2012); and “Good’s Expert Witness Opinion Not Good Enough in Tenth Circuit” (Sept. 8, 2012).

Kennerly is correct that we should not lump the Watson case with other frivolous cases, such as the infamous McDonald’s hot-coffee spill case. I suppose people can debate whether McDonald’s sold their coffee at too-high a temperature, but most civilized people can agree that McDonald’s makes bad coffee, and that everyone should be careful what they put between their legs, regardless of temperature.

Watson represents a paradigmatic tort case, involving exposure and diagnostic issues common to many toxic tort cases. Mr. Watson was a mega-consumer of microwavable popcorn, flavored with diacetyl. We can assume for discussion that diacetyl can cause bronchiolitis obliterans in factory workers who are exposed at relatively high levels. There are, however, other causes, as well as idiopathic cases. Two uncertainties overlapped in the Watson case: diagnosis and exposure assessment. A treating physician pondered a differential diagnosis between hypersensitivity pneumonitis (HP) and bronchiolitis obliterans (BO). As a carpet cleaner, Watson had occupational exposures that might well have caused HP. Indeed, in August 2006, an open lung biopsy requested by his treating physicians, by pathologists at University Hospital, at the University of Colorado, interpreted Watson’s lung pathology as HP. In 2010, Professor Eugene Mark, a well-known pulmonary pathologist at Harvard Medical School, interpreted the pathology as “in keeping with hypersensitivity pneumonitis.” Although Dr. Mark was consulting for the defense in this case, he is not a frequent testifier, and his few forays have been almost always for plaintiffs in asbestos cancer cases. To my understanding, none of the pathologists testified at the trial.

Despite the pathology report, Watson’s treating physician, Dr. Cecile Rose, advocated that the correct diagnosis was BO. She wrote a letter to NIOSH, and other federal agencies, in which advanced her diagnosis, although she did not mention the hospital pathology. Regulators and lawyers became involved. NIOSH measurements of diacetyl in Watson’s home were below the level of detection. Another set of diacetyl measurements taken by Watson’s legal team reported levels close to that of the industrial workers who sustained BO from workplace exposure to diacetyl. The plaintiffs’ expert witnesses relied upon these measurements suggesting high exposure. Just before trial, the defense renewed its Rule 702 motion, challenging the plaintiffs’ exposure level evidence. The defendant’s motion sought preclusion of the plaintiffs’ expert witnesses’ reliance upon data generated by an Innova Model 1312 Photoacoustic Multi-Gas Monitor. The court denied this motion, with leave to raise it at trial, and also precluded mention of the testing in front of the jury until the evidentiary matter is resolved. Order of June 22, 2012. I do not know how the court handled this important evidentiary issue at trial, and no analysis of the case is possible until this part of the story is told.

What can be said now, hypothetically, is that if the plaintiffs had no reliable evidence of high exposure, there was precious little in the exposure data to support Watson’s treating physician’s argument for BO, over HP. The treating clinician did not settle on the BO diagnosis until she had the dubious exposure data. The pathology reports consistently favored the HP diagnosis.

Watson is the third consumer diacetyl case litigated to date. The Newkirk case resulted in the 702 exclusion of plaintiffs’ expert witness, Dr. Egilman. Newkirk v. ConAgra Foods, Inc., 727 F. Supp. 2d 1006 (E.D.Wash. 2010), aff’d, 438 Fed.Appx. 607 (9th Cir. 2011). See also Egilman v. ConAgra Foods, Inc., No. 10-35667, U.S. Court of Appeals for the Ninth Circuit (Sept. 5, 2012; unpublished memorandum) (refusing personal appeal of expert witness who claimed defamation and “wrongful exclusion” by district court). A second case was tried to a jury verdict for the defense, and the appellate court upheld the judgment for the defense. Khoury v. Conagra Foods, Inc., 368 S.W.3d 189 (Mo. Ct. App. 2012).

Kennerly argues that Watson had proof! Referring to “evidence” as “proof” is a hyperbolic conceit of lawyers; I am sure have used the expression, as well. Outside the legal world, proofs and demonstrations are the work of geometers and mathematicians; factual propositions are usually more modestly shown or suggested by evidence. The “proof” that Kennerly cites is the testimony of Watson’s treating physician, Dr. Cecile Rose, MD, MPH, “a published expert and researcher of occupational pulmonary diseases,” who testified that the basis for her opinion:

“relates mainly to the fact that his lung disease has stabilized with the cessation of use of the product and exposure to the inhalants related with that product. The fact that there was no other causal explanation for his lung condition and the fact that the clinical findings in his lung disease were similar to those that occurred in workers who were exposed to butter flavoring also support that opinion.”

This is the same Dr. Rose who wrote to several federal regulatory agencies, to present a tendentiously abridged clinical case report of a patient with BO, who consumed thousands of bags of microwave diacetyl-flavored popcorn. Even with the serious omissions of information, and the problematic exposure measurements, Dr. Rose hedged in her attribution:

“It is difficult to make a causal connection based on a single case report. We cannot be sure that this patient’s exposure to butter flavored microwave popcorn from daily heavy preparation has caused his lung disease. However, we have no other plausible explanation. Given the public health implications of this possibility, we wanted to alert you to our concerns.”

To be sure, this is nothing like the McDonald’s coffee-spill case. This is a case of questioned and questionable science. Kennerly is correct; there is nothing frivolous about the Watson case. If the diagnosis were correct, and the exposure measurements were accurate, this case would raise very serious public concerns for consumer exposure to diacetyl. If the antecedents of the BO diagnosis are incorrect, then the judicial system has been snookered, again. The view from over 2,600 kilometers away suggests that the antecedent conditions were unlikely.

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Siracusano Dicta Infects Daubert Decisions

September 22nd, 2012

Gatekeeping is sometimes intellectually challenging, but the challenge does not excuse sloppy thinking. Understandably, judges will sometimes misunderstand the relevant science. The process, however, allows the public and the scientific community to see what is happening in court cases, rather than allowing the critical scientific reasoning to be hidden in the black box of jury determinations. This transparency can and should invite criticism, commentary, corrections, and consensus, when possible.

Bad legal reasoning is much harder to excuse. The Supreme Court, in Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309 (2011), unanimously affirmed the reversal of a trial court’s Rule 12(b)(6) dismissal of a securities fraud class action. The corporate defendant objected that the plaintiffs failed to plead statistical significance in alleging causation between Zicam and the loss of the sense of smell. The Supreme Court, however, made clear that causation was not required to make out a claim of securities fraud. It was, and would be, sufficient for the company’s product to have raised sufficient regulatory concerns, which in turn would bring regulatory scrutiny and action that would affect the product’s marketability.

The Supreme Court could have disposed of the essential issue in a two page per curiam opinion. Instead the Court issued an opinion signed by Justice Sotomayor, who waxed carelessly about causation and statistical significance, which discussion was not necessary to the holding. Not only was Justice Sotomayor’s discussion obiter dicta, but the dicta were demonstrably incorrect. Matrixx Unloaded (Mar. 29, 2011).

The errant dicta in Siracusano has already led one MDL court astray:

“While the defendant repeatedly harps on the importance of statistically significant data, the United States Supreme Court recently stated that ‘[a] lack of statistically significant data does not mean that medical experts have no reliable basis for inferring a causal link between a drug and adverse events …. medical experts rely on other evidence to establish an inference of causation.’ Matrixx Initiatives, Inc. v. Siracsano, 131 S.Ct. 1309, 1319 (2011).”

Memorandum Opinion and Order at 22, In re Chantix (Varenicline) Products Liability Litigation, MDL No. 2092, Case 2:09-cv-02039-IPJ Document 642 (N.D. Ala. Aug. 21, 2012)[hereafter cited as Chantix]. See Open Admissions for Expert Witnesses in Chantix Litigation.

It was only a matter of time before the Supreme Court’s dictum would be put to this predictably erroneous interpretation. See “The Matrixx Oversold” (April 4, 2011). Within two weeks, the error in Chantix propagated itself in another MDL case, with another trial court succumbing to the misleading dicta in Justice Sotomayor’s opinion. See Memorandum in Support of Separate Pretrial Order No. 8933, Cheek v. Wyeth Pharm. Inc. (E.D.Pa. Aug. 30, 2012)(Bartle, J.).

In Cheek, Judge Harvey Bartle rejected a Rule 702 challenge to plaintiffs’ expert witness’s opinion. I confess that I do not know enough about the expert witness’s opinion or the challenge to assess Judge Bartle’s conclusion. Judge Bartle, however, invoked the Matrixx decision for the dubious proposition that:

“Daubert does not require that an expert opinion regarding causation be based on statistical evidence in order to be reliable. Matrixx Initiatives, Inc. v. Siracusano, 131 S. Ct. 1309, 1319 (2011). In fact, many courts have recognized that medical professionals often base their opinions on data other than statistical evidence from controlled clinical trials or epidemiological studies. Id. at 1320.”

Cheek at 16. The Cheek decision is a welter of non-sequiturs. The fact that in some instances statistical evidence is not necessary is hardly a warrant to excuse the lack of statistical evidence in every case. The truly disturbing gaps in reasoning, however, are not scientific, but legal. Siracusano was not a “Daubert” opinion; and Siracusano does not, and cannot, support the refusal to inquire whether statistical evidence was necessary in a causation opinion, in main part because causation was not at issue in Siracusano.

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Bipartisan Junk Science – Pork-Barrel Causation

September 19th, 2012

Despite the hand waving and finger pointing, junk science is embraced by both political parties in the United States, when it suits their purposes. Both parties want to have God and science on their sides.

Congress created September 11th Victim Compensation Fund, 49 USC § 40101, also known as the James Zadroga 9/11 Health and Compensation Act (P.L. 111-347) (signed into law in January 2011). The Act was a touching acknowledgement of the dedication and sacrifices of first responders to the World Trade Center and Pentagon victims of an Islamic jihad. Being a victim, however, implies that the harm to be compensated was caused by the attack and its consequences. The New York politicians soon learned that causality can be turned into a very malleable concept.

The law allocated over $4 billion for medical screening and treatment of fire fighters, policemen, emergency responders, and survivors. Most of the covered conditions were acute onset respiratory and mental disorders caused by gases, fumes, dusts, and stresses, to which the workers were exposed. The law also made the director of CDC’s National Institute for Occupational Safety and Health (NIOSH), the head of a World Trade Center Health Program, which could add new conditions to the list of compensable diseases, based upon a review of scientific evidence.

In September 2011, several New York congressmen and Senators petitioned the director, citing flimsy or non-existent scientific evidence, to add cancer to the list. Senators Kirsten Gillibrand (D-NY) and Charles Schumer (D-NY), and Representatives Carolyn Maloney (D-NY), Jerrold Nadler (D-NY), Peter King (R-NY), Charles Rangel (D-NY), Nita Velazquez (D-NY), Michael Grimm (R-NY), and Yvette Clark (D-NY), made their request, citing R. Zeig-Owens, M. Webber, C.B. Hall, et al., “Early assessment of cancer outcomes in New York City firefighters after the 9/11 attacks: an observational cohort study,” 378 Lancet 898 (2011).

This is pork barrel politics masquerading as sympathy for putative victims. The Zeig-Owens study reported a non-statistically significant standardized incidence ratio for all cancer, of either 1.10 (95% CI 0.98–1.25), with a comparison group of the generalized U.S. male population, or 1.19 (95% CI 0.96–1.47), with unexposed firefighters as a comparison group, and corrected for possible surveillance bias. Of course, given that there is no disease of cancer, the composite end point is not particularly meaningful.

Here are the authors’ (including Dr. Prezant’s) published interpretation of the data:

“We reported a modest excess of cancer cases in the WTC-exposed cohort. We remain cautious in our interpretation of this finding because the time since 9/11 is short for cancer outcomes, and the reported excess of cancers is not limited to specific organ types. As in any observational study, we cannot rule out the possibility that effects in the exposed group might be due to unidentified confounders.”

Zeig-Owens, at 898. The Zeig-Owens study did not support any conclusions of causality between the workers’ exposures in 2001, and any type of cancer. See NIOSH Report Sets Up Run on September 11th Victim Compensation Fund by Non-Victims.

The WTC Health Program director requested recommendations from the program’s Scientific – Technical Advisory Committee (STAC), whether to add cancer generally, or any particular kind of cancer, to the Zadroga Act’s list of compensable conditions. In April 2012, the STAC made its recommendations, essentially relying upon likely exposures, without any consideration of individual dose, duration, latency, and without any serious consideration of the available epidemiologic evidence.

The STAC claimed that the Lancet study reported statistically significant excesses of cancer; it did not. The Committee also failed to come to grips with the biological implausibility of excess rates of solid malignant tumors presenting within less than a decade since exposure:

“Given that cancer latencies for solid tumors average 20 years or more, it is noteworthy that the published FDNY study of fire fighters showed a statistically significant excess in all-site cancer with only 7 years of follow-up.”

In June 2012, NIOSH director, Dr. Howard, reported that he was inclined to accept the STAC’s recommendation, but held open a public comment period. See Anemona Hartocollis, “Sept. 11 Health Fund Given Clearance to Cover Cancer,” N.Y. Times (June 8, 2012). Not surprising, given the political pressure, the WTC Health Program director promulgated his final rule to include 50 types of cancer, including many that occurred less often than expected in the Zeig-Owens study.

This decision ignores appropriate scientific methodology for reaching causal conclusions. Worse than its intellectual shabbiness, the decision insults the true victims of the jihad terrorism.

The rule is effective October 12, 2012.

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The Supreme Court’s Unsteady Gatekeeping Pre-Daubert

September 8th, 2012

Some writers assert that the United States Supreme Court did not wade into the troubled waters of medical causation and expert witness testimony until it decided Daubert v. Merrell Dow Pharmaceuticals, 509 U.S. 579 (1993). Actually, the Court swam in these stormy waters in admiralty and FELA cases, at least up through the 1950’s.

In 1953, Mr. Sentilles, a marine engineer, was thrown to the deck of his ship, and washed off deck, by a wave. He became ill with tuberculosis, and he brought a person injury action (for “maintenance and cure”) against vessel owner. Inter-Caribbean Shipping Corp. v. Sentilles, 256 F.2d 156 (5th Cir. 1958). The vessel owner defended on the theory that the plaintiff’s diabetes pre-disposed him to TB, and that the plaintiffs’ expert witnesses were equivocal in their conclusions of causality or aggravation. The jury nonetheless found for the plaintiff.

The judgment entered on a jury verdict for the seaman was reversed by the Fifth Circuit, which found the plaintiffs’ expert witnesses’ testimony inadequate to support submission of the case to the jury:

“The rule as to the medical testimony respecting causation which is required to take a case to a jury has been thus stated:

It appears to be well settled that medical testimony as to the possibility of a causal relation between a given accident or injury and the subsequent death or impaired physical or mental condition of the person injured is not sufficient, standing alone, to establish such relation. By testimony as to possibility is meant testimony in which the witness asserts that the accident or injury `might have’, `may have’, or `could have’ caused, or `possibly did’ cause the subsequent physical condition or death or that a given physical condition (or death) `might have,’ `may have,’ or `could have’ resulted or `possibly did’ result from a previous accident or injury — testimony, that is, which is confined to words indicating the possibility or chance of the existence of the causal relation in question and does not include words indicating the probability or likelihood of its existence.”

Id. (internal citations omitted).

The Supreme Court granted a writ of certiorari, heard argument, and reversed the Court of Appeals. Sentilles v. Inter-Caribbean Shipping Corp., 361 U.S. 107 (1959). In announcing the Court’s opinion, Justice Brennan voiced the remarkable doctrine that the jury could find reasonable probability when the expert witnesses could not:

“The jury’s power to draw the inference that the aggravation of petitioner’s tubercular condition, evident so shortly after the accident, was in fact caused by that accident, was not impaired by the failure of any medical witness to testify that it was in fact the cause. Neither can it be impaired by the lack of medical unanimity as to the respective likelihood of the potential causes of the aggravation, or by the fact that other potential causes of the aggravation existed and were not conclusively negated by the proofs. The matter does not turn on the use a of particular form of words by the physicians in giving their testimony. The members of the jury, not the medical witnesses, were sworn to make a legal determination of the question of causation. They were entitled to take all the circumstances, including the medical testimony into consideration. Though this case involves a medical issue, it is no exception to the admonition that, ‘It is not the function of a court to search the record for conflicting circumstantial evidence in order to take the case away from the jury on a theory that the proof gives equal support to inconsistent and uncertain inferences. The focal point of judicial review is the reasonableness of the particular inference or conclusion drawn by the jury. * * * The very essence of its function is to select from conflicting inferences and conclusions that which it considers most reasonable. * * * Courts are not free to reweigh the evidence and set aside the jury verdict merely because the jury could have drawn different inferences or conclusions or because judges feel that other results are more reasonable.’”

Id. at 109-10. Justice Brennan thus ignored equally venerable precedent that juries are not free to speculate, and he failed to consider how the jury in this case could reach a determination in the face of conflicting evidence, and without ruling out alternative causes.

Sentilles was decided before the enactment of the Federal Rules of Evidence, and there was no challenge to the plaintiff’s expert witnesses’ testimony under the Frye doctrine. Another crucial difference, of course, is that Sentilles was an isolated case, not likely to recur frequently in the federal courts. With the rise of product liability law, and the emergence of epidemiology as a basis for inferring causality, the federal courts would soon see mass exposure situations resulting in mass torts. Dubious expert witness testimony resulting in dubious judgments of causation would attain much greater notoriety, for the expert witnesses, for the trial bar, and for the courts that tolerated the results.

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David Egilman’s Methodology for Divining Causation

September 6th, 2012

If the Method Yields An Erroneous Conclusion, then the Method is Wrong

David Stephen Egilman wanted very much to testify in a diacetyl case. One judge, however, did not think that this was such a good idea, and excluded Dr. Egilman’s testimony. Newkirk v. Conagra Foods, Inc. 727 F.Supp. 2d 1006 (E.D. Wash. 2010).

Egilman was so distraught by being excluded that he sought to file a personal appeal to the United States Court of Appeal. See “Declaration of David Egilman, M.D., M.P.H., in Support of Opposition to Motion for Order to Show Cause Why Appeal Should Not Be Dismissed for Lack of Standing.” (Attached: Egilman Motion Appeal Diacetyl Exclusion 2011 and Egilman Declaration Newkirk Diacetyl Appeal 2011.)

Egilman improvidently, if not scurrulously, attacked the district judge for having excluded Egilman’s proffered testimony. If Egilman’s attack on the trial judge were not sufficiently odd, Egilman also claimed a right to intervene in the appeal by advancing the claim that the Rule 702 exclusion hurt his livelihood. Here is how Egilman put the matter:

“The Daubert ruling eliminates my ability to testify in this case and in others. I will lose the opportunity to bill for services in this case and in others (although I generally donate most fees related to courtroom testimony to charitable organizations, the lack of opportunity to do so is an injury to me). Based on my experience, it is virtually certain that some lawyers will choose not to attempt to retain me as a result of this ruling. Some lawyers will be dissuaded from retaining my services because the ruling is replete with unsubstantiated pejorative attacks on my qualifications as a scientist and expert. The judge’s rejection of my opinion is primarily an ad hominem attack and not based on an actual analysis of what I said – in an effort to deflect the ad hominem nature of the attack the judge creates ‘straw man’ arguments and then knocks the straw men down, without ever addressing the substance of my positions.”

Egilman Declaration at ¶ 11.

The Ninth Circuit, unmoved by the prospect of an impoverished Dr. Egilman, denied his personal appeal, and affirmed the district court’s exclusion. Newkirk v. Conagra Foods, Inc., 438 Fed. Appx. 607 (9th Cir. 2011).

In his appellate papers, Egilman did not stop at simply citing his pecuniary interest. With no sense of false shame or modesty, Egilman recited what a wonderful expert witness he has been. Egilman suggested that courts have been duly impressed by his views on the scientific assessment of causation:

“My views on the scientific standards for the determination of cause-effect relationships (medical epistemology) have been cited by the Massachusetts Supreme Court (Vassallo v. Baxter Healthcare Corporation, 428 Mass. 1 (1998)):

‘Although there was conflicting testimony at the Oregon hearing as to the necessity of epidemiological data to establish causation of a disease, the judge appears to have accepted the testimony of an expert epidemiologist that, in the absence of epidemiology, it is “sound science…. to rely on case reports, clinical studies, in vivo tests and animal tests.” The judge may also have relied on the affidavit of the plaintiff’s epidemiological expert, Dr. David S. Egilman, who identified several examples in which disease causation has been established based on animal and clinical case studies alone to demonstrate that “doctors utilize epidemiological data as one tool among many”.’”

Egilman Declaration at p.5-6.

We may excuse Dr. Egilman, a non-lawyer, for incorrectly referring to a non-existent court. Massachusetts does not have a “Supreme Court,” but the quoted language did indeed come from the Supreme Judicial Court of Massachusetts, in Vassallo v. Baxter Healthcare Corporation, 428 Mass. 1, 12, 696 N.E.2d 909, 917 (1998).

The Massachusetts court’s suggestion that there was conflicting testimony at the “Oregon hearing,” about the need for epidemiologic evidence is itself rather bizarre. The Oregon hearing was the Rule 702 hearing before Judge Jones, of the District of Oregon. Judge Jones appointed four technical advisors to assist him in ruling on the defendants’ motions to exclude plaintiffs’ causation opinions. One of the appointed advisors was an epidemiologist. More important, the plaintiffs’ counsel presented the testimony of an epidemiologist, Dr. David Goldsmith. The Massachusetts court did not, and indeed, could not cite the Oregon District Court’s opinion, or the underlying record, for any suggestion that epidemiologic testimony was not needed to show a causal relationship between silicone breast implants and the development of autoimmune disease. See Hall v. Baxter Healthcare Corp., 947 F. Supp. 1387 (D. Or. 1996). Judge Jones made his views very clear: epidemiology was needed, but lacking, in the plaintiffs’ case. The argument that epidemiology was unnecessary came from Dr. Egilman’s report, and the plaintiffs’ counsel’s briefs.

There is more, however, to the disingenuousness of Dr. Egilman’s citation to the Vassallo case. The Newkirk court, in receiving his curious affidavit, would not likely know that Vassallo was a silicone gel breast implant case, and one may suspect that Dr. Egilman wanted to keep the Ninth Circuit uninformed of his role in the silicone litigation. If Dr. Egilman submitted an affidavit in connection with the so-called Oregon hearings, which took place during the summer of 1996, it was not a particularly important piece of evidence. Egilman is not mentioned by name in the Hall decision, even though the district court clearly rejected the plaintiffs’ witnesses and affiants, in their efforts to make a case for silicone as a cause of autoimmune disease.

A few months after the Oregon hearings, Judge Weinstein, in the fall of 1996, along with other federal and state judges, held a “Daubert” hearing on the admissibility of expert witness opinion testimony in breast implant cases, pending in New York state and federal courts. Plaintiffs’ counsel suggested that Egilman might testify, but ultimately he was a no show. After the New York hearings, Judge Weinstein granted, sua sponte, partial summary judgment against all plaintiffs’ claims of systemic immune-system injury. In re Breast Implant Cases, 942 F. Supp. 958 (E.&S.D.N.Y. 1996).

At the New York hearings, plaintiffs’ counsel again attempted to make an epidemiologic case, and once again called Dr. David Goldsmith. Marshaling the evidentiary display that Egilman would have presented had he shown up in New York, Dr. Goldsmith’s testimony did not go well. At one point, Judge Weinstein interrupted and offered his interim assessment of Dr. Goldsmith and the plaintiffs causation case:

THE COURT: Why are you presenting this witness, for epidemiological purposes?

MR. GORDON: That’s correct.

THE COURT: And I can tell you for epidemiological purposes, based on the only testimony I have seen, he doesn’t meet my standard of anybody who can be helpful to a jury, not because he isn’t a great epidemiologist, I’m sure he is, but because the data he is relying on admittedly is almost useless. I’m not going to go forward with a trial on this kind of haphazard abstract without any basic definition or explication.

Transcript at p.159:7-18, from Nyitray v. Baxter Healthcare Corp., CV 93-159 (E.D.N.Y. Oct. 9, 1996)(pre-trial hearing before Judge Jack Weinstein, Justice Lobis, and Magistrate Cheryl Pollak). In his semi-autobiographical writings, Judge Jack B. Weinstein elaborated upon his published breast-implant decision, with a bit more detail about how he viewed the plaintiffs’ expert witnesses. Judge Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation” 2009 Cardozo L. Rev. de novo 1, 14 (2009) (describing plaintiffs’ expert witnesses in silicone litigation as “charlatans”; “[t]he breast implant litigation was largely based on a litigation fraud. … Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”)

When Judge Weinstein began to create a process for the selection of Rule 706 court-appointed expert witnesses, plaintiffs’ counsel rushed to have Judge Pointer take control over the process. Because Judge Pointer believed that there must be some germ of validity in the plaintiffs’ case, the plaintiffs were hoping that his courtroom, the center of MDL 926, would be a more favorable forum than Judge Weinstein’s withering skepticism. Ultimately, Judge Pointer, through a select nominating committee, appointed appointed expert witnesses, in the fields of toxicology, immunology, rheumology, and epidemiology. MDL 926 Order No. 31 (Appointment of Rule 706 Expert Witnesses).

Each of the four witnesses prepared, presented, and defended his or her own report, but all the reports soundly rejected plaintiffs’ causation theories. Laural L. Hooper, Joe S. Cecil, and Thomas E. Willging, Neutral Science Panels: Two Examples of Panels of Court-Appointed Experts in the Breast Implants Product Liability Litigation (Fed. Jud. Ctr. 2001).

In the United Kingdom, the British Minister of Health ordered an independent review of the breast implant controversy, which led to the formation of the Independent Review Group (IRG) to evaluate the causal claims that were being made by claimants and advocates. The IRG concluded that there was no demonstrable risk of connective tissue disease from silicone breast implants. Independent Review Group, Silicone Breast Implants: The Report of the Independent Review Group 8, 22-23 (July 1998).

In 1999, The Institute of Medicine delivered its assessment of the safety of silicone breast implants. Again, the plaintiffs’ theories were rejected. Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (1999).

Still, Egilman persisted. As late as 2000, Egilman was posting his breast-implant litigation report at his Brown University website. His conclusion, however awkwardly worded, was clear enough:

“Although a prospective, large epidemiological study investigating atypical symptoms and disease would clearly contribute to underestimating of the strength of association between silicone breast implants and disease, the available epidemiologic evidence is suggestive of a causal association for silicone breast implants and atypical connective tissue diseases and scleroderma.”

David S. Egilman, “Breast Implants and Disease” (2000) (“For purposes of this report SBI induced disease is considered an iatrogenic environmental disease.”) (<http://209.67.232.40/brown/implants/sbi.html> lasted visited on Mar. 28, 2000).

Sometime after 2000, Egilman developed a sensitivity to being associated with the plaintiffs’ side of the silicone litigation. In 2009, Dr. Laurence Hirsch, published an article critical of Egilman’s disclosures of conflicts of interest, in some of his published articles. Hirsch struck a sensitive nerve in mentioning Egilman’s involvement in the breast implant litigation:

“Egilman reports having testified for plaintiffs in legal cases involving asbestosis, occupational lung disease, beryllium poisoning, silicone breast implants and connective tissue disease (characterized as the epitome of junk science91), selective serotonin reuptake inhibitor and suicide risk, atypical antipsychotics and metabolic changes, and selective COX-2 inhibitors and cardiovascular disease, an amazing breadth of medical expertise.”

Laurence J. Hirsch, “Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals,” 84 Mayo Clin. Proc. 811, 815 (2009).

Egilman apparently besieged Dr. Hirsch and the Mayo Clinic Proceedings with his protests, and it seems that he was able to induce the author or the journal into a “correction”:

“Dr Egilman has not testified in court in breast implant and connective tissue disease, or in antidepressant or antipsychotic drug cases.”

Laurence J. Hirsch, “Corrections,” 85 Mayo Clin. Proc. 99 (2010). But this correction is itself incorrect because Dr. Egilman testified over the course of three days, in court, in the same Vassallo v. Baxter Healthcare case he holds up as having embraced his causal “principles.” The Vassallo case involved allegations that silicone had caused systemic autoimmune disease, an allegation that was ultimately shown to be meritless by the MDL court’s neutral expert witnesses, as well as the Institute of Medicine.

Perhaps this history helps explain Dr. Egilman’s coyness in what he told the Newkirk appellate court about his involvement in the Vassallo case. More likely is that Dr. Egilman understands, all too well, the logical implications of his being wrong in the breast implant litigation. If his vaunted method leads to an erroneous conclusion, then the method must be wrong. It is a simple matter of modus tollens.

Posted in Causation, Expert Witnesses, Rule 702, Scientific Evidence | Comments Off on David Egilman’s Methodology for Divining Causation