Schachtman Law » Rule 702

TORTINI

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

David Madigan’s Graywashed Meta-Analysis in Taxotere MDL

June 12th, 2020

Once again, a meta-analysis is advanced as a basis for an expert witness’s causation opinion, and once again, the opinion is the subject of a Rule 702 challenge. The litigation is In re Taxotere (Docetaxel) Products Liability Litigation, a multi-district litigation (MDL) proceeding before Judge Jane Triche Milazzo, who sits on the United States District Court for the Eastern District of Louisiana.

Taxotere is the brand name for docetaxel, a chemotherapic medication used either alone or in conjunction with another chemotherapy, to treat a number of different cancers. Hair loss is a side effect of Taxotere, but in the MDL, plaintiffs claim that they have experienced permanent hair loss, which was not adequately warned about in their view. The litigation thus involved issues of exactly what “permanent” means, medical causation, adequacy of warnings in the Taxotere package insert, and warnings causation.

Defendant Sanofi challenged plaintiffs’ statistical expert witness, David Madigan, a frequent testifier for the lawsuit industry. In its Rule 702 motion, Sanofi argued that Madigan had relied upon two randomized clinical trials (TAX 316 and GEICAM 9805) that evaluated “ongoing alopecia” to reach conclusions about “permanent alopecia.” Sanofi made the point that “ongoing” is not “permanent,” and that trial participants who had ongoing alopecia may have had their hair grow back. Madigan’s reliance upon an end point different from what plaintiffs complained about made his analysis irrelevant. The MDL court rejected Sanofi’s argument, with the observation that Madigan’s analysis was not irrelevant for using the wrong end point, only less persuasive, and that Sanofi’s criticism was one that “Sanofi can highlight for the jury on cross-examination.”[1]

Did Judge Milazzo engage in judicial dodging with rejecting the relevancy argument and emphasizing the truism that Sanofi could highlight the discrepancy on cross-examination? In the sense that the disconnect can be easily shown by highlight the different event rates for the alopecia differently defined, the Sanofi argument seems like one that a jury could easily grasp and refute. The judicial shrug, however, begs the question why the defendant should have to address a data analysis that does not support the plaintiffs’ contention about “permanence.” The federal rules are supposed to advance the finding of the truth and the fair, speedy resolution of cases.

Sanofi’s more interesting argument, from the perspective of Rule 702 case law, was its claim that Madigan had relied upon a flawed methodology in analyzing the two clinical trials:

“Sanofi emphasizes that the results of each study individually produced no statistically significant results. Sanofi argues that Dr. Madigan cannot now combine the results of the studies to achieve statistical significance. The Court rejects Sanofi’s argument and finds that Sanofi’s concern goes to the weight of Dr. Madigan’s testimony, not to its admissibility.34”[2]

There seems to be a lot going on in the Rule 702 challenge that is not revealed in the cryptic language of the MDL district court. First, the court deployed the jurisprudentially horrific, conclusory language to dismiss a challenge that “goes to the weight …, not to … admissibility.” As discussed elsewhere, this judicial locution is rarely true, fails to explain the decision, and shows a lack of engagement with the actual challenge.[3] Of course, aside from the inanity of the expression, and the failure to explain or justify the denial of the Rule 702 challenge, the MDL court may have been able to provide a perfectly adequately explanation.

Second, the footnote in the quoted language, number 34, was to the infamous Milward case,[4] with the explanatory parenthetical that the First Circuit had reversed a district court for excluding testimony of an expert witness who had sought to “draw conclusions based on combination of studies, finding that alleged flaws identified by district court go to weight of testimony not admissibility.”[5] As discussed previously, the widespread use of the “weight not admissibility” locution, even by the Court of Appeals, does not justify it. More important, however, the invocation of Milward suggests that any alleged flaws in combining study results in a meta-analysis are always matters for the jury, no matter how arcane, technical, or threatening to validity they may be.

So was Judge Milazzo engaged in judicial dodging in Her Honor’s opinion in Taxotere? Although the citation to Milward tends to inculpate, the cursory description of the challenge raises questions whether the challenge itself was valid in the first place. Fortunately, in this era of electronic dockets, finding the actual Rule 702 motion is not very difficult, and we can inspect the challenge to see whether it was dodged or given short shrift. Remarkably, the reality is much more complicated than the simple, simplistic rejection by the MDL court would suggest.

Sanofi’s brief attacks three separate analyses proffered by David Madigan, and not surprisingly, the MDL court did not address every point made by Sanofi.[6] Sanofi’s point about the inappropriateness of conducting the meta-analysis was its third in its supporting brief:

“Third, Dr. Madigan conducted a statistical analysis on the TAX316 and GEICAM9805/TAX301 clinical trials separately and combined them to do a ‘meta-analysis’. But Dr. Madigan based his analysis on unproven assumptions, rendering his methodology unreliable. Even without those assumptions, Dr. Madigan did not find statistical significance for either of the clinical trials independently, making this analysis unhelpful to the trier of fact.”[7]

This introductory statement of the issue is itself not particularly helpful because it fails to explain why combining two individual clinical trials (“RCTs”), each not having “statistically significant” results, by meta-analysis would be unhelpful. Sanofi’s brief identified other problems with Madigan’s analyses, but eventually returned to the meta-analysis issue, with the heading:

“Dr. Madigan’s analysis of the individual clinical trials did not result in statistical significance, thus is unhelpful to the jury and will unfairly prejudice Sanofi.”[8]

After a discussion of some of the case law about statistical significance, Sanofi pressed its case against Madigan. Madigan’s statistical analysis of each of two RCTs apparently did not reach statistical significance, and Sanofi complained that permitting Madigan to present these two analyses with results that were “not statistically very impressive,” would confuse and mislead the jury.[9]

“Dr. Madigan tried to avoid that result here [of having two statistically non-significant results] by conducting a ‘meta-analysis’ — a greywashed term meaning that he combined two statistically insignificant results to try to achieve statistical significance. Madigan Report at 20 ¶ 53. Courts have held that meta-analyses are admissible, but only when used to reduce the numerical instability on existing statistically significant differences, not as a means to achieve statistical significance where it does not exist. RMSE at 361–362, fn76.”

Now the claims here are quite unsettling, especially considering that they were lodged in a defense brief, in an MDL, with many cases at stake, made on behalf of an important pharmaceutical company, represented by two large, capable national or international law firms.

First, what does the defense brief signify by placing ‘meta-analysis’ in quotes. Are these scare quotes to suggest that Madigan was passing off something as a meta-analysis that failed to be one? If so, there is nothing in the remainder of the brief that explains such an interpretation. Meta-analysis has been around for decades, and reporting meta-analyses of observational or of experimental studies has been the subject of numerous consensus and standard-setting papers over the last two decades. Furthermore, the FDA has now issued a draft guidance for the use of meta-analyses in pharmacoepidemiology. Scare quotes are at best unexplained, at worst, inappropriate. If the authors had something else in mind, they did not explain the meaning of using quotes around meta-analysis.

Second, the defense lawyers referred to meta-analysis as a “greywashed” term. I am always eager to expand my vocabulary, and so I looked up the word in various dictionaries of statistical and epidemiologic terms. Nothing there. Perhaps it was not a technical term, so I checked with the venerable Oxford English Dictionary. No relevant entries.

Pushed to the wall, I checked the font of all knowledge – the internet. To be sure, I found definitions, but nothing that could explain this odd locution in a brief filed in an important motion:

gray-washing: “noun In calico-bleaching, an operation following the singeing, consisting of washing in pure water in order to wet out the cloth and render it more absorbent, and also to remove some of the weavers’ dressing.”

graywashed: “adj. adopting all the world’s cultures but not really belonging to any of them; in essence, liking a little bit of everything but not everything of a little bit.”

Those definitions do not appear pertinent.

Another website offered a definition based upon the “blogsphere”:

Graywash: “A fairly new term in the blogsphere, this means an investigation that deals with an offense strongly, but not strongly enough in the eyes of the speaker.”

Hmmm. Still not on point.

Another one from “Urban Dictionary” might capture something of what was being implied:

Graywashing: “The deliberate, malicious act of making art having characters appear much older and uglier than they are in the book, television, or video game series.”

Still, I am not sure how this is an argument that a federal judge can respond to in a motion affecting many cases.

Perhaps, you say, I am quibbling with word choices, and I am not sufficiently in tune with the way people talk in the Eastern District of Louisiana. I plead guilty to both counts. But the third, and most important point, is the defense assertion that meta-analyses are only admissible “when used to reduce the numerical instability on existing statistically significant differences, not as a means to achieve statistical significance where it does not exist.”

This assertion is truly puzzling. Meta-analyses involve so many layers of hearsay that they will virtually never be admissible. Admissibility of the meta-analyses is virtually never the issue. When an expert witness has conducted a meta-analysis, or has relied upon one, the important legal question is whether the witness may reasonably rely upon the meta-analysis (under Rule 703) for an inference that satisfies Rule 702. The meta-analysis itself does not come into evidence, and does not go out to the jury for its deliberations.

But what about the defense brief’s “only when” language that clearly implies that courts have held that expert witnesses may rely upon meta-analyses only to reduce “numerical instability on existing statistically significant differences”? This seems clearly wrong because achieving statistical significance from studies that have no “instability” for their point estimates but individually lack statistical significance is a perfectly legitimate and valid goal. Consider a situation in which, for some reason, sample size in each study is limited by the available observations, but we have 10 studies, each with a point estimate of 1.5, and each with a 95% confidence interval of (0.88, 2.5). This hypothetical situation presents no instability of point estimates, and the meta-analytical summary point estimate would shrink the confidence interval so that the lower bound would exclude 1.0, in a perfectly valid analysis. In the real world, meta-analyses are conducted on studies with point estimates of risk that vary, because of random and non-random error, but there is no reason that meta-analyses cannot reduce random error to show that the summary point estimate is statistically significant at a pre-specified alpha, even though no constituent study was statistically significant.

Sanofi’s lawyers did not cite to any case for the remarkable proposition they advanced, but they did cite the Reference Manual for Scientific Evidence (RMSE). Earlier in the brief, the defense cited to this work in its third edition (2011), and so I turned to the cited page (“RMSE at 361–362, fn76”) only to find the introduction to the chapter on survey research, with footnotes 1 through 6.

After a diligent search through the third edition, I could not find any other language remotely supportive of the assertion by Sanofi’s counsel. There are important discussions about how a poorly conducted meta-analysis, or a meta-analysis that was heavily weighted in a direction by a methodologically flawed study, could render an expert witness’s opinion inadmissible under Rule 702.[10] Indeed, the third edition has a more sustained discussion of meta-analysis under the heading “VI. What Methods Exist for Combining the Results of Multiple Studies,”[11] but nothing in that discussion comes close to supporting the remarkable assertion by defense counsel.

On a hunch, I checked the second edition of RMSE, published in the year 2000. There was indeed a footnote 76, on page 361, which discussed meta-analysis. The discussion comes in the midst of the superseded edition’s chapter on epidemiology. Nothing, however, in the text or in the cited footnote appears to support the defense’s contention about meta-analyses are appropriate only when each included clinical trial has independently reported a statistically significant result.

If this analysis is correct, the MDL court was fully justified in rejecting the defense argument that combining two statistically non-significant clinical trials to yield a statistically significant result was methodologically infirm. No cases were cited, and the Reference Manual does not support the contention. Furthermore, no statistical text or treatise on meta-analysis supports the Sanofi claim. Sanofi did not support its motion with any affidavits of experts on meta-analysis.

Now there were other arguments advanced in support of excluding David Madigan’s testimony. Indeed, there was a very strong methodological challenge to Madigan’s decision to include the two RCTs in his meta-analysis, other than those RCTs lack of statistical significance on the end point at issue. In the words of the Sanofi brief:

“Both TAX clinical trials examined two different treatment regimens, TAC (docetaxel in combination with doxorubicin and cyclophosphamide) versus FAC (5-fluorouracil in combination with doxorubicin and cyclophosphamide). Madigan Report at 18–19 ¶¶ 47–48. Dr. Madigan admitted that TAC is not Taxotere alone, Madigan Dep. 305:21–23 (Ex. B); however, he did not rule out doxorubicin or cyclophosphamide in his analysis. Madigan Dep. 284:4–12 (“Q. You can’t rule out other chemotherapies as causes of irreversible alopecia? … A. I can’t rule out — I do not know, one way or another, whether other chemotherapy agents cause irreversible alopecia.”).”[12]

Now unlike the statistical significance argument, this argument is rather straightforward and turns on the clinical heterogeneity of the two trials that seems to clearly point to the invalidity of a meta-analysis of them. Sanofi’s lawyers could have easily supported this point with statements from standard textbooks and non-testifying experts (but alas did not). Sanofi did support their challenge, however, with citations to an important litigation and Fifth Circuit precedent.[13]

This closer look at the actual challenge to David Madigan’s opinions suggests that Sanofi’s counsel may have diluted very strong arguments about heterogeneity in exposure variable, and in the outcome variable, by advancing what seems a very doubtful argument based upon the lack of statistical significance of the individual studies in the Madigan meta-analysis.

Sanofi advanced two very strong points, first about the irrelevant outcome variable definitions used by Madigan, and second about the complexity of Taxotere’s being used with other, and different, chemotherapeutic agents in each of the two trials that Madigan combined.[14] The MDL court addressed the first point in a perfunctory and ultimately unsatisfactory fashion, but did not address the second point at all.

Ultimately, the result was that Madigan was given a pass to offer extremely tenuous opinions in an MDL on causation. Given that Madigan has proffered tendentious opinions in the past, and has been characterized as “an expert on a mission,” whose opinions are “conclusion driven,”[15] the missteps in the briefing, and the MDL court’s abridgement of the gatekeeping process are regrettable. Also regrettable is that the merits or demerits of a Rule 702 challenge cannot be fairly evaluated from cursory, conclusory judicial decisions riddled with meaningless verbiage such as “the challenge goes to the weight and not the admissibility of the witness.” Access to the actual Rule 702 motion helped shed important light on the inadequacy of one point in the motion but also the complexity and fullness of the challenge that was not fully addressed in the MDL court’s decision. It is possible that a Reply or a Supplemental brief, or oral argument, may have filled in gaps, corrected errors, or modified the motion, and the above analysis missed some important aspect of what happened in the Taxotere MDL. If so, all the more reason that we need better judicial gatekeeping, especially when a decision can affect thousands of pending cases.[16]

[1] In re Taxotere (Docetaxel) Prods. Liab. Litig., 2019 U.S. Dist. LEXIS 143642, at *13 (E.D. La. Aug. 23, 2019) [Op.]

[2] Op. at *13-14.

[3] “Judicial Dodgers – Weight not Admissibility” (May 28, 2020).

[4] Milward v. Acuity Specialty Prods. Grp., Inc., 639 F.3d 11, 17-22 (1st Cir. 2011).

[5] Op. at *13-14 (quoting and citing Milward, 639 F.3d at 17-22).

[6] Memorandum in Support of Sanofi Defendants’ Motion to Exclude Expert Testimony of David Madigan, Ph.D., Document 6144, in In re Taxotere (Docetaxel) Prods. Liab. Litig. (E.D. La. Feb. 8, 2019) [Brief].

[7] Brief at 2; see also Brief at 14 (restating without initially explaining why combining two statistically non-significant RCTs by meta-analysis would be unhelpful).

[8] Brief at 16.

[9] Brief at 17 (quoting from Madigan Dep. 256:14–15).

[10] Michael D. Green, Michael Freedman, and Leon Gordis, “Reference Guide on Epidemiology,” at 581n.89, in Fed. Jud. Center, Reference Manual on Scientific Evidence (3d ed. 2011).

[11] Id. at 606.

[12] Brief at 14.

[13] Brief at 14, citing Burst v. Shell Oil Co., C. A. No. 14–109, 2015 WL 3755953, at *7 (E.D. La. June 16, 2015) (Vance, J.) (quoting LeBlanc v. Chevron USA, Inc., 396 F. App’x 94, 99 (5th Cir. 2010)) (“[A] study that notes ‘that the subjects were exposed to a range of substances and then nonspecifically note[s] increases in disease incidence’ can be disregarded.”), aff’d, 650 F. App’x 170 (5th Cir. 2016). See “The One Percent Non-solution – Infante Fuels His Own Exclusion in Gasoline Leukemia Case” (June 25, 2015).

[14] Brief at 14-16.

[15] In re Accutane Litig., 2015 WL 753674, at *19 (N.J.L.Div., Atlantic Cty., Feb. 20, 2015), aff’d, 234 N.J. 340, 191 A.3d 560 (2018). See “Johnson of Accutane – Keeping the Gate in the Garden State” (Mar. 28, 2015); “N.J. Supreme Court Uproots Weeds in Garden State’s Law of Expert Witnesses” (Aug. 8, 2018).

[16] Cara Salvatore, “Sanofi Beats First Bellwether In Chemo Drug Hair Loss MDL,” Law360 (Sept. 27, 2019).

Posted in Meta-analysis, Rule 702, Rule 703, statistical evidence | Comments Off on David Madigan’s Graywashed Meta-Analysis in Taxotere MDL

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

June 5th, 2020

Legislative Initiatives – The Asbestos Fairness in Compensation Act

Over the years, Congress has considered various possible solutions to the problem of asbestos liability. One proposed reform bill, which bore the title “Asbestos Fairness in Compensation Act,” was specifically motivated by a concern about the quality of the expert opinions that fueled the asbestos litigation tsunami.[1] The Report by the Senate Judiciary Committee for this bill commented on its view of medical testimony in asbestos cases:

“Defendants’ rights are further compromised when courts lack the resources to monitor the medical evidence submitted by plaintiffs. A study by neutral academics showed that forty-one (41 %) percent of audited claims of alleged asbestosis or pleural disease were found by trust physicians to have either no disease or a less severe disease than alleged by the plaintiffs’ experts (for example, pleural disease rather than asbestosis).”[2]

A key part of the bill sought to establish a process to ensure that claims would be based upon sound medical science. As the Senate Report explained the legislative goal:

“4. Diagnostic and latency criteria

Asbestos claimants must meet diagnostic and latency criteria to be compensated by the Fund. The diagnostic criteria should reflect the typical components of a true medical diagnosis by a claimant’s doctor, including an in-person physical examination (or pathology in the case where the injured person is deceased) and a review of the claimant’s medical, smoking and exposure history by the doctor diagnosing an asbestos-related disease. These requirements ensure that the claimant will be given a meaningful diagnosis related to the claimant’s condition. The diagnosis must also include consideration of other more likely causes of the condition to ensure that asbestos exposure was the cause of any claimed nonmalignant disease (as opposed to other industrial dust exposure) or a substantial contributing factor in causing a malignant disease….”[3]

A number of the bill’s specific provisions sought to limit payments to only claimants who could qualify under properly validated medical criteria. This bill, like all those before it, died on the Hill.

The Health Care Quality Improvement Act of 1986

In 1986, Congress passed the Health Care Quality Improvement Act (“HCQIA”)[4], which was prompted by concerns that fear of litigation would deter hospitals, physicians and others from carrying out peer review of unprofessional conduct and from providing candid assessments to peer review bodies. The Act gave all participants in a qualifying “professional review action” immunity from being held liable in damages “under any law of the United States or of any State (or political subdivision thereof) with respect to the action.”[5] One of the immunized entities is a “professional review body,” a term defined by HCQIA to mean “a health care entity and the governing body or any committee of a health care entity which conducts professional review activity, and includes any committee of the medical staff of such an entity when assisting the governing body in a professional review activity.”[6] Moreover, another provision of the Act[7] provides immunity from damages to any person “providing information to a professional review body regarding the competence or professional conduct of a physician. . . .unless such information is false and the person providing it knew such information was false.”

The HCQIA has given rise to litigation over whether it protects professional review bodies from defamation cases involving litigation opinions. If medico-legal opinions are within the scope of the practice of medicine, then a potentially important method for curbing unscrupulous expert witnesses and false or exaggerated opinion testimony might consist of peer review actions through professional associations or state medical boards.

In Florida litigation, an intermediate appellate court held that the Florida Medical Association did not have immunity under the HCQIA for having provided procedures for pressing complaints against medical expert witnesses for unprofessional conduct.[8] The state law that might be invoked to curb meretricious testimony by licensed physicians, through professional associations or medical licensing boards, remains a hodge-podge.[9]

The American Bar Association’s Resolution Condemning Screenings and Calling For Impairment Criteria in Asbestos Litigation

Part of the impetus for federal legislative reform of asbestos litigation and its diagnostic gamesmanship came from an American Bar Association (ABA) recommendation of enacting impairment requirements for asbestos non-malignant personal injury cases.[10] Acting upon concerns of court dockets backlogged by unimpaired and false-positive and bogus asbestosis cases, many of which arose out of mass screenings, the ABA urged that limitations rules be relaxed so as not to require the filing of unimpaired cases and that compensation be limited to cases that have demonstrable objective evidence of physical impairment due to asbestosis. The ABA Report helped to instigate asbestos tort reform efforts in Congress, as well as several successful state legislative efforts.

State Tort Reform Acts for Reliable Diagnostic and Impairment Criteria in Asbestos and Silica Cases

While Congress floundered on litigation reform of the asbestos racket, several states enacted meaningful procedural and substantive changes to address some of the more abusive medical screening practices in asbestos and silica cases. Texas, Georgia, Florida, and Ohio have enacted remedial legislation that requires a demonstration of objective pulmonary impairment. In some instances, the tort reform measures specify that the diagnosing physician have a patient-physician relationship with the claimant. This requirement was aimed at chilling the efforts of itinerant, out-of-state screening physicians, whose conduct came under scrutiny in In re Silica.[11]

Daubert, Its Progeny, and Amended Rule of Evidence 702

The Supreme Court’s opinion in Daubert was not only a watershed in the analysis of expert evidence generally but also reflected specific concerns about expert testimony in the area of product liability litigation. Daubert itself was a pharmaceutical product liability case, as were Joiner and Kumho Tire. Medical causation is one of the key issues in every product liability case, and the pressure to produce an opinion, whether inculpatory or exculpatory, will occasionally distort a fragile epistemic foundation that will not support a conclusion with any certainty. In In re Silica, the prospect of creating a mass tort out of whole cloth seems to have had just such a distorting influence.[12]

As noted by Judge Jack, in making the reliability inquiry, the trial judge has the responsibility “to make certain that an expert … employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field.”[13] Typically, this requirement of “intellectual rigor” means that physicians proffering a diagnosis for litigation purposes must employ the same standards and practices in reaching that diagnosis that they would use in their regular, non-litigation practice of medicine.

Judge Jack was not writing on a completely blank slate in finding the silicosis diagnoses to be bogus in the MDL cases. A few years earlier, the Fourth Circuit affirmed the exclusion of a physician expert witness who insisted upon a “hands-on” examination in his medical practice, but who did not bother to examine the plaintiff personally in a case involving a failed spinal fusion.[14] Standing alone, the physician expert witness’s failure to conduct a physical examination might not have required exclusion, but the deviation from his own established, non-litigation practice provided a persuasive showing that the expert witness “did not employ in the courtroom the same methods that he employs in his own practice,” which required exclusion.[15]

A similar example of gatekeeping occurred in Ingram v. Solkatronic Chemical, Inc.,[16] where the trial judge excluded the testimony of a medical expert witness who opined that plaintiff had been injured by exposure to arsine gas. At his deposition, the expert witness “outlined his standard diagnostic protocol when called upon to evaluate a cause of a given physical ailment.”[17] The witness’s own protocol included taking a medical history, performing a physical examination, and determining what tests were required. This protocol starkly contrasted with the expert witness’s anemic litigation approach to diagnosis, which failed to include physical examinations or review of complete medical or occupational histories. Finding that the expert’s procedures “depart[ed] from his own established diagnostic standards,” the court excluded his testimony.[18]

[1] S. 852, 109^th Congress, 1^st Session, and Senate Judiciary Comm. Report (June 30, 2005).

[2] Id. at 21.

[3] Id. at 34.

[4] 42 U.S.C. §§ 11101, et seq.

[5] 42 U.S.C. § 11111(a)(1).

[6] 42 U.S.C. § 11151(11).

[7] 42 U.S.C. § 11111(a)(2)/

[8] Fullerton v. The Florida Med. Ass’n, 938 So.2d 587 (Fla. D. Ct. App. 2006). See also Adam Liptak, “Doctor’s Testimony Leads To a Complex Legal Fight,” N.Y. Times (June 20, 2004).

[9] See, e.g., Sandeep K. Narang & Stephan R. Paul, “Expert Witness Participation in Civil and Criminal Proceedings,” 139 Pediatrics e1 (2017); Robert A. Bitterman, “Halting inappropriate expert witness testimony – Part I: Professional associations’ efforts to police ‘experts’,” Relias Media (Jan. 1, 2007); Robert A. Bitterman, “Halting Inappropriate Expert Witness Testimony — Part II: Efforts of State Medical Boards and State Medical Societies to Police ‘Experts’,” Relias Media (Feb. 1, 2007); Robert A. Bitterman, “Halting inappropriate expert witness testimony ? Part III: Tort reform to prevent not-so-expert opinions,” Relias Media (Mar. 1, 2007).

[10] See ABA Commission on Asbestos Litigation, Report to the House of Delegates (Report No. 302) (February 2003).

[11] For discussion of some of the state legislative reform, see Mark A. Behrens, “What’s New in Asbestos Litigation?” 28 Rev. Litig. 501 (2009); Jeb Barnes, “Rethinking the Landscape of Tort Reform: Legislative Inertia and Court-Base Tort Reform in the Case of Asbestos,” 28 The Justice System J. 157 (2007); Jeb Barnes, Dust-Up: Asbestos Litigation and the Failure of Commonsense Policy Reform (2011).

[12] In re Silica Prods. Liab. Litig., 398 F.Supp. 2d 563 (S.D. Tex. 2005).

[13] Id. at 621, quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999).

[14] Cooper v. Smith & Nephew, Inc., 259 F.3d 194, 203 (4^th Cir. 2001).

[15] Id.

[16] 2005 WL 3544244 (N.D. Okla., Dec. 28, 2005),

[17] Id. at *13.

[18] Id. at *14. See also Goebel v. Denver and Rio Grande Western Railroad Co., 346 F.3d 987, 998 (10^th Cir. 2003) (upholding admissibility of opinion of medical expert witness who “followed ‘standard medical procedure in evaluating and diagnosing’ [plaintiff]”) (internal quotations omitted); Fitzgerald v. Smith & Nephew Richards, Inc., 1999 WL 1489199 (D. Md., Dec. 30, 1999), aff’d, 11 Fed. Appx. 335, 339 (4^th Cir. 2001) (excluding opinion of medical expert who testified that clinical judgment requires personal contact with patient, but who failed to examine the plaintiff or review her complete medical history; finding that the expert “did not undertake his medical review and formulate his opinions with ‘intellectual rigor’”); Wooley v. Smith & Nephew Richards, Inc., 67 F. Supp. 2d 703, 709 (S.D. Tex. 1999) (excluding testimony of medical expert witness who had not examined plaintiff, and who relied on his review of medical records selected by plaintiff’s counsel; concluding that “no expert orthopedic surgeon would attempt to make an accurate and complete diagnosis as to the probable cause of postoperative spinal injury without interviewing or examining the patient or considering the entirety of a patient’s records”).

Posted in Expert Witnesses, Rule 702 | Comments Off on Legal Remedies for Suspect Medical Science in Products Cases – Part Three

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

June 3rd, 2020

The Federal Multi-District Silicosis Proceedings Before Judge Janis Jack

One of the most significant developments in the role of scientific and medical evidence gatekeeping under Rule 702, and the Supreme Court’s decision in Daubert,[1] was the 2005 opinion of Judge Janis Graham Jack in the multi-district silicosis litigation.[2] Judge Jack’s lengthy opinion addresses a variety of procedural issues, including subject matter jurisdiction over some of the cases, but Her Honor’s focus was “whether the doctors who diagnosed Plaintiffs with silicosis employed a sufficiently reliable methodology for their testimony to be admissible” and “whether Plaintiffs’ counsel should be sanctioned for submitting unreliable diagnoses and failing to fully comply with discovery orders.” Judge Jack held that thousands of diagnoses of silicosis were radically flawed and could not be treated as proper science or medicine, and she imposed sanctions against plaintiffs’ lawyers in the cases over which she had subject matter jurisdiction.

In summary, Judge Jack held that to pass the minimum reliability analysis under Daubert, a diagnosis of silicosis requires:

“(1) an adequate exposure to silica dust with an appropriate latency period,

(2) radiographic evidence of silicosis, and

(3) the absence of any good reason to believe that the radiographic findings are the result of some other condition (i.e., a differential diagnosis).

* * * * *

As discussed above, these three criteria are universally accepted, as demonstrated by learned treatises and experts in the field. It is the implementation of these criteria in these cases which ranged from questionable to abysmal.”[3]

With respect to the first criterion, evidence of “adequate exposure to silica dust with an appropriate latency period,” the court concluded that “[t]he ‘exposure histories’ (or ‘work histories’) were virtually always taken by people with no medical training, who had significant financial incentives to find someone positive for exposure to silica (or asbestos, depending on which type of suit the employing law firm was seeking to file).”[4] The court went on to state that:

“[t]hese ‘histories’ were devoid of meaningful details, such as the duration and intensity of exposure, which are critical to determining whether someone has sufficient exposure, dosage and latency to support a reliable diagnosis.”[5]

Judge Jack, who had been a registered nurse before going to law school and becoming a lawyer, was clearly concerned that the medical “histories were taken by receptionists [at medical screening companies allied with plaintiffs’ counsel] with no medical training.”[6] The head of one of the screening companies “testified that the doctors who worked for his screening company simply relied upon the abbreviated work histories that [the screening company] supplied them.”[7] As a former nurse, Judge Jack was probably more than a little put off by the screening company executive’s explanation that “to ask the doctor to take a work history in our field would be like asking [the defense attorney questioning him] to wash my car. I mean it’s . . . very beneath him.”[8] Judge Jack rejected this approach entirely, and found that legitimate doctors would find it necessary to take the occupational history themselves:

“This type of thorough, detailed, physician-guided work/exposure history is the kind of history that experts in the field of occupational medicine insist upon when diagnosing silicosis. It is therefore the type of history required by the Federal Rules for these diagnoses to be admissible. Cf. Allen v. Pennsylvania Eng’g Corp., 102 F.3d 194, 198 (5^th Cir. 1996)… .”[9]

The second required predicate for an admissible diagnosis of silicosis was an appropriate radiographic finding – a so-called “B-read,” which is simply the interpretation of a physician, who has passed a certifying proficiency examination given by the National Institute of Occupational Health, for evaluating chest films for pneumoconiosis, using a standardized scale and notations. Judge Jack discerned, contrary to the approach taken by some of the plaintiffs’ lawyers and certain doctors, that a positive B-read was not “a talisman that would dispel any doubts about the diagnoses as a whole.”[10] A positive B-read simply is not sufficient alone to support a silicosis diagnosis.

Judge Jack noted that a consensus report of the American College of Occupational and Environmental Medicine rejected the use of a B-read alone as sufficient to support a diagnosis of pneumoconiosis, and emphasized the views of one testifying physician that the “ILO guidelines, by their express terms, [were] ‘not supposed to be used for designation of disease or determining compensation.’ ”[11] But even apart from rejecting the concept that a positive B-read was by itself a sufficient basis for a diagnosis of silicosis, Judge Jack fundamentally criticized the manner in which the X-rays at issue were conducted.

The B-reader system was not originally established for use in litigation, but as part of a coal workers’ surveillance program to determine whether a worker should be transferred to a low-dust environment. And under this surveillance program, the worker is not transferred until at least two B-readers agree on a positive read. But in most of these MDL cases, a single positive B-read was deemed sufficient by plaintiffs’ hired witnesses to establish a diagnosis of silicosis.[12]

Judge Jack also stressed that the methodology followed by the B-readers did “not correspond to the ILO’s recommended methodology for applying the ILO classification system, because according to ILO guidelines:

“When classifying radiographs for epidemiological purposes it is essential that the reader does not consider any information about the individuals concerned other than the radiographs themselves. Awareness of supplementary details specific to the individuals themselves can introduce bias into the results.”[13]

In the cases before her, Judge Jack found that it was obvious that the so-called B-reader was “acutely aware of the precise disease he is supposed to be finding on the X-rays. In these cases, the doctors repeatedly testified that they were told to look for silicosis, and the doctors did as they were told.”[14] Business pressures had obviously corrupted the diagnostic process, and resulted in improbable consistency in finding silicosis in whomever plaintiffs’ lawyers signed up for litigation.

This corrupt consistency, and obediency to retaining plaintiffs’ counsel, which led to Judge Jack’s approval of the testimony from the hearings that advanced the notion that some degree of blinding is needed to assure the integrity of the diagnostic process. When the radiographic films come from a mass screening, the readers should be confronted with films known to be negative through multiple, independent evaluations.

The third criterion given by Judge Jack for an admissible diagnosis of silicosis, was a proper “differential diagnosis,” which consisted of a showing of “the absence of any good reason to believe that the positive radiographic findings are the result of some other condition.”[15]

One of the physicians whose diagnoses were challenged claimed that this ruling out of other explanations for a radiographic pattern was not required for diagnosing silicosis, but Judge Jack found that this self-serving opinion was contradicted by the major textbooks in the field, by the physicians who showed up to testify in the hearings, and even by the plaintiffs’ own briefs. Judge Jack adverted to the language of Daubert to note that one factor to be considered in the “reliability” of an expert witness’s opinion was its general acceptance in the relevant scientific community.[16] The self-validating views of plaintiffs’ expert witnesses simply were not generally accepted in any legitimate segment of the medical profession. And thus Judge Jack found that, in the MDL cases, the plaintiffs’ expert witnesses’ failure to exclude other alternative causes of the radiographic findings clearly was not generally accepted in the field of occupational medicine, and that their opinions did not satisfy the requirements of Rule 702.[17] A proper differential diagnosis required what was lacking across the board in the cases, namely “a thorough occupational/exposure history and medical history,” as well as a social history that included travel destinations.[18]

In addition to Judge Jack’s carefully reasoned conclusions about the diagnostic “process” used by the challenged expert witnesses, Her Honor was presented with additional evidence of the egregious infirmity of the challenged diagnoses:

– The willingness of one doctor to render opinions on 1,239 plaintiffs in the MDL when he was admittedly not a qualified B-reader, not an expert in silicosis treatment, not qualified to read X-rays or CT scans, did no physical examinations, simply took whatever histories had been given to him by the plaintiffs’ lawyers, and spent a negligible amount of time reviewing each of the plaintiffs’ files. The doctor testified that his practice consists almost entirely of litigation consulting and that he charges $600 per hour for that work.

– Another doctor’s abandonment of about 3,700 diagnoses under the scrutiny generated by the hearings before Judge Jack.

– The fact that 1,587 claimants who had previously been listed as having asbestosis, with no reference to silica disease, had their diagnoses changed to silicosis, with no reference to asbestos disease. These diagnoses were produced rapidly and in large groups.

– The fact that a purported epidemic of silicosis apparently began abruptly in early 2001, when plaintiffs’ lawyers turned their attention to this alternative to asbestos litigation, and the fact that many of the silicosis claimants were recycled asbestosis clients of the plaintiffs’ firms.

The specific facts before Judge Jack may seem extreme, but the same or similar abuses have been commonplace in asbestos litigation for a long time before they were outed in the silicosis MDL. The crucial holdings of In re Silica go beyond the serious depravity of the expert witnesses involved.

Raymark v. Stempel

In 1990, one now defunct asbestos product manufacturer, Raymark Industries, Inc. (“Raymark”), deluged with dubious lawsuits, brought RICO and other claims against medical professionals, lawyers, and claimants.[19] Raymark based its allegations on deceptions that led it to settle an asbestos personal injury class action.

In ruling upon defendants’ motions to dismiss, the district court found that defendant medical screeners had disregarded standards set by the American Thoracic Society and reported that workers had asbestos-related “injuries” even thought the radiographic interpretations had no clinical significance. The court stated that the screening program had produced a “steady flow of faulty claims” and was a “fraud on the court.”[20] The court thus refused to dismiss Raymark’s claims based on common law fraud and RICO violations.[21]

Owens Corning Fiberglass Bankruptcy Proceedings

The efforts to curtail frivolous asbestos claims also include the motion by Credit Suisse in the Owens Corning bankruptcy for leave to file an adversary complaint against certain physicians who reported chest radiographs as positive for asbestos-related diseases. This motion was granted conditionally on the agreement of Credit Suisse to indemnify Owens Corning for any potential ensuing liability, but then was withdrawn when Credit Suisse declined to provide such assurance.

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

[2] In re Silica Products Liab.Litig., 398 F.Supp. 2d 563 (S.D.Tex. 2005) (“In re Silica”).

[3] In re Silica. at 622 (internal citations and footnote omitted).

[4] In re Silica, at 622 -23.

[5] Id.

[6] Id.

[7] Id.

[8] Id.

[9] In re Silica, at 623-34.

[10] In re Silica, at 625 – 26.

[11] Id. at 626 – 27 (internal quotes omitted).

[12] Id. at 626.

[13] Id.

[14] Id. at 627.

[15] Id. at 629.

[16] Id. at 629 – 30 (citing Daubert, 509 U.S. at 593-94; Pipitone v. Biomatrix, Inc., 288 F.3d 239, 246 (5^th Cir. 2002) (upholding admissibility under Rule 702 when a physician’s “elimination of various alternative causes. . . .were [sic] based on generally accepted diagnostic principles related to these conditions”).

[17] Id. at 629 – 30.

[18] Id. at 630 – 32 (coccidioidomycosis is endemic to some parts of the United States and resembles silicosis radiographically).

[19] Raymark Indus., Inc. v. Stemple, 1990 WL 72588 (D. Kan., May 30, 1990).

[20] 1990 WL 72588 at *2, *8, *18, *22.

[21] See Nathan Schachtman, “Medico-Legal Issues in Occupational Lung Disease Litigation,” 27 Sem. Roentgenology 140 (1992) (discussing Semple in greater detail). It is unclear how Stemple was ultimately resolved. The court’s docket does not indicate whether this case was dismissed, voluntarily, involuntarily, as a result of settlement, or otherwise. The clerk of the court reported that this case was sealed under court order.

Posted in Asbestos, Expert Witnesses, Rule 702, Silica | Comments Off on Legal Remedies for Suspect Medical Science in Products Cases – Part Two

Judicial Dodgers – Rule 702 Tie Does Not Go to Proponent

June 2nd, 2020

The Advisory Committee notes to the year 2000 amendment to Federal Rule of Evidence 702 included a comment:

“A review of the case law after Daubert shows that the rejection of expert testimony is the exception rather than the rule. Daubert did not work a ‘seachange over federal evidence law’, and ‘the trial court’s role as gatekeeper is not intended to serve as a replacement for the adversary system’.”[internal citation omitted]

In stating its review of the caselaw, perhaps the Committee was attempting to allay the anxiety of technophobic judges. But was the Committee also attempting to derive an “ought” from an “is”? Before the Supreme Court decided Daubert in 1993, virtually every admissibility challenge to expert witness opinion testimony failed. The trial courts were slow to adapt and to adopt the reframed admissibility standard. As the Joiner case illustrated, some Circuits were even slower to permit trial judges the discretion to assess the validity vel non of expert witnesses’ opinions.

The Committee’s observation about the “exceptional” nature of exclusions was thus unexceptional as a description of the case law before and shortly after Daubert was decided. And even if the Committee were describing a normative view, it is not at all clear how that view should translate into a ruling in a given case, without a very close analysis of the opinions at issue, under the Rule 702 criteria. In baseball, most hitters are thrown out at first base, but that fact does not help an umpire one whit in calling a specific runner “safe” or “out.” Nonetheless, courts have repeatedly offered the observation about the exceptional nature of exclusion as both an explanation and a justification of their opinions to admit testimony.[1] The Advisory Committee note has thus mutated into a mandate to err on the side of admissibility, as though deliberately committing error was a good thing for any judge to do.[2] First rule: courts shall not err, not intentionally, recklessly, or negligently.

Close Calls and Resolving Doubts

Another mutant offspring of the “exception, not the rule” mantra is that “[a]ny doubts regarding the admissibility of an expert’s testimony should be resolved in favor of admissibility.”[3] Why not resolve the doubts and rule in accordance with the law? Or, if doubts remain, then charge them against the proponent who has the burden of showing admissibility? Unlike baseball, in which a tie goes to the runner, in expert witness law, a tie goes to the challenger because the defender of the motion has failed to show a preponderance in favor of admissibility. A better mantra: “exclusion when it is the Rule.”

Some courts re-imagine the Advisory Committee’s about exceptional exclusions as a recommendation for admitting Rule 702 expert witness opinion testimony as a preferred outcome. Again, that interpretation reverses the burden of proof and makes a mockery of equal justice and scientific due process.

Yet another similar judicial mutation is the notion that courts should refuse Rule 702 motions when they are “close calls.”[4] Telling the litigants that the call was close might help assuage the loser and temper the litigation enthusiasms of the winner, but it does not answer the key question: Did the proponent carry the burden of showing admissibility? Residual doubts would seem to weigh against the proponent.

Not all is lost. In one case, decided by a trial court within the Ninth Circuit, the trial judge explicitly pointed to the proponent’s failure to identify his findings and methodology as part of the basis for exclusion, not admission, of the challenged witness’s opinion testimony.[5] Difficulty in resolving whether the Rule 702 predicates were satisfied worked against, not for, the proponent, whose burden it was to show those predicates.

In another case, Judge David G. Campbell, of the District of Arizona, who has participated in the Rules Committee’s deliberations, showed the way by clearly stating that the exclusion of opinion testimony was required when the Rule 702 conditions were not met:

“Plaintiffs have not shown by a preponderance of the evidence that [the expert witness’s] causation opinions are based on sufficient facts or data to which reliable principles and methods have been applied reliably… .”[6]

Exclusion followed because the absent showings were “conditions for admissibility,” and not “mere” credibility considerations.

Trust Me, I’m a Liberal

One of the reasons that the Daubert Court rejected incorporating the Frye standard into Rule 702 was its view that a rigid “general acceptance” standard “would be at odds with the ‘liberal thrust’ of the Federal Rules.”[7] Some courts have cited this “liberal thrust” as though it explained or justified a particular decision to admit expert witness opinion testimony.[8]

The word “liberal” does not appear in the Federal Rules of Evidence. Instead, the Rules contain an explicit statement of how judges must construe and apply the evidentiary provisions:

“These rules shall be construed to secure fairness in administration, elimination of unjustifiable expense and delay, and promotion of growth and development of the law of evidence to the end that the truth may be ascertained and proceedings justly determined.”[9]

A “liberal” approach, construed as a “let it all in” approach would be ill-designed to secure fairness, eliminate unjustifiable expense and time of trial, or lead to just and correct outcomes. The “liberal” approach of letting in opinion testimony and let the jury guess at questions of scientific validiy would be a most illiberal result. The truth will not be readily ascertained if expert witnesses are permitted to pass off hypotheses and ill-founded conclusions as scientific knowledge.

Avoiding the rigidity of the Frye standard, which was so rigid that it was virtually never applied, certainly seems like a worthwhile judicial goal. But how do courts go from the Justice Blackmun’s “liberal thrust” to infer a libertine “anything goes”? And why does liberal not connote seeking of the truth, free of superstitions? Can it be liberal to permit opinions that are based upon fallacious or flawed inferences, invalid studies, or cherry-picked data sets?

In reviewing the many judicial dodges that are used to avoid engaging in meaningful Rule 702 gatekeeping, I am mindful of Reporter Daniel Capra’s caveat that the ill-advised locutions used by judges do not necessarily mean that their decisions might not be completely justifiable on a carefully worded and reasoned opinion that showed that Rule 702 and all its subparts were met. Of course, we could infer that the conditions for admissibility were met whenever an expert witness’s opinions were admitted, and ditch the whole process of having judges offer reasoned explanations. Due process, however, requires more. Judges need to specify why they denied Rule 702 challenges in terms of the statutory requirements for admissibility so that other courts and the Bar can develop a principled jurisprudence of expert witness opinion testimony.

[1] See, e.g., In re Scrap Metal Antitrust Litig., 527 F.3d 517, 530 (6th Cir. 2008) (“‘[R]ejection of expert testimony is the exception, rather than the rule,’ and we will generally permit testimony based on allegedly erroneous facts when there is some support for those facts in the record.”) (quoting Advisory Committee Note to 2000 Amendments to Rule 702); Citizens State Bank v. Leslie, No. 6-18-CV-00237-ADA, 2020 WL 1065723, at *4 (W.D. Tex. Mar. 5, 2020) (rejecting challenge to expert witness opinion “not based on sufficient facts”; excusing failure to assess factual basis with statement that “the rejection of expert testimony is the exception rather than the rule.”); In re E. I. du Pont de Nemours & Co. C-8 Pers. Injury Litig., No. 2:18-CV-00136, 2019 WL 6894069, at *2 (S.D. Ohio Dec. 18, 2019) (committing naturalistic fallacy; “[A] review of the case law … shows that rejection of the expert testimony is the exception rather than the rule.”): Frankenmuth Mutual Insur. Co. v. Ohio Edison Co., No. 5:17CV2013, 2018 WL 9870044, at *2 (N.D. Ohio Oct. 9, 2018) (quoting Advisory Committee Note “exception”); Wright v. Stern, 450 F. Supp. 2d 335, 359–60 (S.D.N.Y. 2006)(“Rejection of expert testimony, however, is still ‘the exception rather than the rule,’ Fed.R.Evid. 702 advisory committee’s note (2000 Amendments)[.] . . . Thus, in a close case the testimony should be allowed for the jury’s consideration.”) (internal quotation omitted).

[2] Lombardo v. Saint Louis, No. 4:16-CV-01637-NCC, 2019 WL 414773, at *12 (E.D. Mo. Feb. 1, 2019) (“[T]he Court will err on the side of admissibility.”).

[3] Mason v. CVS Health, 384 F. Supp. 3d 882, 891 (S.D. Ohio 2019).

[4] Frankenmuth Mutual Insur. Co. v. Ohio Edison Co., No. 5:17CV2013, 2018 WL 9870044, at *2 (N.D. Ohio Oct. 9, 2018) (concluding “[a]lthough it is a very close call, the Court declines to exclude Churchwell’s expert opinions under Rule 702.”); In re E. I. du Pont de Nemours & Co. C-8 Pers. Injury Litig., No. 2:18-CV-00136, 2019 WL 6894069, at *2 (S.D. Ohio Dec. 18, 2019) (suggesting doubts should be resolved in favor of admissibility).

[5] Rovid v. Graco Children’s Prod. Inc., No. 17-CV-01506-PJH, 2018 WL 5906075, at *13 (N.D. Cal. Nov. 9, 2018), app. dism’d, No. 19-15033, 2019 WL 1522786 (9th Cir. Mar. 7, 2019).

[6] Alsadi v. Intel Corp., No. CV-16-03738-PHX-DGC, 2019 WL 4849482, at *4 -*5 (D. Ariz. Sept. 30, 2019).

[7] Daubert v. Merrell Dow Pharms., Inc. 509 U.S. 579, 588 (1993).

[8] In re ResCap Liquidating Trust Litig., No. 13-CV-3451 (SRN/HB), 2020 WL 209790, at *3 (D. Minn. Jan. 14, 2020) (“Courts generally support an attempt to liberalize the rules governing the admission of expert testimony, and favor admissibility over exclusion.”)(internal quotation omitted); Collie v. Wal-Mart Stores East, L.P., No. 1:16-CV-227, 2017 WL 2264351, at *1 (M.D. Pa. May 24, 2017) (“Rule 702 embraces a ‘liberal policy of admissibility’, under which it is preferable to admit any evidence that may assist the factfinder[.]”); In re Zyprexa Prod. Liab. Litig., 489 F. Supp. 2d 230, 282 (E.D.N.Y. 2007); Billone v. Sulzer Orthopedics, Inc., No. 99-CV-6132, 2005 WL 2044554, at *3 (W.D.N.Y. Aug. 25, 2005) (“[T]he Supreme Court has emphasized the ‘liberal thrust’ of Rule 702, favoring the admissibility of expert testimony.”).

[9] Federal Rule of Evidence Rule 102 (“Purpose and Construction”) (emphasis added).

Posted in Evidence, Rule 702, Scientific Evidence | Comments Off on Judicial Dodgers – Rule 702 Tie Does Not Go to Proponent

Judicial Dodgers – Weight not Admissibility

May 28th, 2020

Another vacuous response to a methodological challenge under Rule 702 is to label the challenge as “going to the weight, not the admissibility” of the challenged expert witness’s testimony. Of course, a challenge may be solely focused upon the expert witness’s credibility, such as when an expert witness testifies on many occasions only for one side in similar disputes, or for one whose political commitments render him unable to acknowledge the bona fides of any studies conducted by the adversarial parties.[1] If, however, the Rule 702 challenge stated an objection to the witness’s methodology, then the objection would count against both the opinion’s weight and its admissibility. The judicial “weight not admissibility” label conveys the denial of the challenge, but it hardly explains how and why the challenge failed under Rule 702. Applying such a label without addressing the elements of Rule 702, and how the challenged expert witness satisfied those elements, is often nothing less than a failure of judging.

The Flawed Application of a Generally Accepted Methodology

If a meretricious expert witness by pretense or ignorance invokes a standard methodology but does so in a flawed or distorted, or in an invalid way, then there will be a clear break in the chain of inferences from data to conclusion. The clear language of Rule 702 should render such an expert witness’s conclusion inadmissible. Some courts, however, retreat into a high level of generality about the method used rather than inspecting the method as applied. For example, a court might look at an expert witness’s opinion and correctly find that it relied upon epidemiology, and that epidemiology is a generally accepted discipline concerned with identifying causes. The specific detail of the challenge may have shown that the witness had relied upon a study that was thoroughly flawed,[2] or that the witness relied upon an epidemiologic study of a type that cannot support a causal inference.[3]

Rule 702 and the Supreme Court’s decision in Joiner make clear that the trial court must evaluate the expert witness’s application of methodology and whether it actually supports valid inferences leading to the witness’s claims and conclusions.[4] And yet, lower courts continue to characterize the gatekeeping process as “hands off” the application of methodology and conclusions:

“Where the court has determined that plaintiffs have met their burden of showing that the methodology is reliable, the expert’s application of the methodology and his or her conclusions are issues of credibility for the jury.”[5]

This rejection of the clear demands of a statute has infected even the intermediate appellate United States Court of Appeals. In a muddled application of Rule 702, the Third Circuit approved admitting expert witness testimony in a case, explaining “because [the objecting party / plaintiff] objected to the application rather than the legitimacy of [the expert’s] methodology, such objections were more appropriately addressed on cross-examination and no Daubert hearing was required”).[6] Such a ruling in the Third Circuit is especially jarring because it violates not only the clear language of Rule 702, but also established precedent within the Circuit that holds that “any step that renders the analysis unreliable . . . renders the expert’s testimony inadmissible. This is true whether the step completely changes a reliable methodology or merely misapplies that methodology.”[7]

The Eight Circuit seems to have set itself up stridently against the law by distinguishing between scientific methodologies and their applications, and holding that “when the application of a scientific methodology is challenged as unreliable under Daubert and the methodology itself is otherwise sufficiently reliable, outright exclusion of the evidence in question is warranted only if the methodology was so altered by a deficient application as to skew the methodology itself.”[8]

The Ninth Circuit similarly has followed this dubious distinction between methodology in the abstract and methodology as applied. In City of Pomona, the Circuit addressed the admissibility of an expert witness whose testing deviated from protocols. Relying upon pre-2000 Ninth Circuit case law, decided before the statutory language of Rule 702 was adopted, the court found that:

“expert evidence is inadmissible where the analysis is the result of a faulty methodology or theory as opposed to imperfect execution of laboratory techniques whose theoretical foundation is sufficiently accepted in the scientific community to pass muster under Daubert.”[9]

The Eleventh Circuit has similarly disregarded Rule 702 by adverting to an improvised distinction between validity of methodology and flawed application of methodology.[10]

Cherry Picking and Inadequate Bases

Most of the Circuits of the United States Court of Appeals have contributed to the mistaken belief that “[a]s a general rule, questions relating to the bases and sources of an expert’s opinion affect the weight to be assigned that opinion rather than its admissibility.”[11] Clearly, such questions can undermine the admissibility of an expert witness’s opinion under Rule 702, and courts need to say why they have found the challenged opinion to have had a “sufficient basis.” For example, in the notorious Milward case, the First Circuit, citing legally invalid pre-Daubert decisions, stated that “when the factual underpinning of an expert’s opinion is weak it is a matter affecting the weight and credibility of the testimony − a question to be resolved by the jury.”[12]

After Milward, the Eighth Circuit followed suit in a hormone replacement therapy case. An expert who ignored studies was excluded by the district court, but the Court of Appeals found an abuse of discretion, holding that the sufficiency of an expert’s basis is a question of weight and not admissibility.[13]

These rulings elevate form over substance by halting the gatekeeping inquiry at an irrelevant, high level of abstraction, and finding that the challenged expert witness was doing something “sciencey,” which is good enough for government work. The courts involved evaded their gatekeeping duties and ignored the undue selectivity in reliance materials and the inadequacy and insufficiency of the challenged expert witness’s factual predicate. The question is not whether expert witnesses relied upon “scientific studies,” but whether their causal conclusions and claims are well supported, under scientific standards, by the studies upon which they relied.

Like the covert shifting of the burden of proof, or the glib assessment that the loser can still cross-examine in front of the jury,[14] the rulings discussed represent another way that judges kick the can on Rule 702 motions. Despite the confusing verbiage, these judicial rulings are a serious deviation from the text of Rule 702, as well as the Advisory Committee Note to the 2000 Amendments, which embraced the standard articulated in In re Paoli, that

“any step that renders the analysis unreliable . . . renders the expert’s testimony inadmissible. This is true whether the step completely changes a reliable methodology or merely misapplies that methodology.”[15]

On a positive note, some courts have recognized that responding with the conclusory assessment of a challenge’s going to weight not admissibility is a delegation of the court’s gatekeeping duty to the jury.[16]

In 2018, Professor Daniel Capra, the Reporter to the Rules Committee addressed the “weight not admissibility dodge” at length in his memorandum to the Rules Committee:

“Rule 702 clearly states that these are questions of admissibility, but many courts treat them as questions of weight. The issue for the Committee is whether something/anything can be done about these wayward decisions.”[17]

The Reporter charitably noted that the problem could be in the infelicitous expression of some courts that short-circuit their analyses by saying “I see the problems, but they go to the weight of the evidence.”[18] Perhaps these courts meant to say that they had found that the proponent of the challenged expert witness testimony had shown admissibility by a preponderance, and that what non-disqualifying problems remained should be taken up on cross-examination.[19] The principle of charity, however, cannot exonerate federal judges from exercising the dodge repeatedly in the face of clear statutory language. Indeed, the Reporter reaffirmed the Rules Committee’s substantive judgment that questions of sufficient basis and reliable application of methodology are admissibility issues:[20]

“It is hard to see how expert testimony is reliable if the expert has not done sufficient investigation, or has cherry-picked the data, or has misapplied the methodology. The same ‘white lab coat’ problem − that the jury will not be able to figure out the expert’s missteps − would seem to apply equally to basis, methodology and application.”

Although the Reporter opined that some authors may have overstated judicial waywardness, he found the judicial disregard of the requirements of Rule 702(b) and (d) incontrovertible.[21]

Professor Capra restated his conclusions a year later, in 2019, when he characterized broad statements such as such as “challenges to the sufficiency of an expert’s basis raise questions of weight and not admissibility” as “misstatement[s] made by circuit courts in a disturbing number of cases… .”[22] Factual insufficiency and unreliable application of methodology are, of course, also credibility and ethical considerations, but they are the fact finders’ concern only after the proponent has shown admissibility by a preponderance of the evidence. Principled adjudication requires judges to say what they mean and mean what they say.

[1] See also Cruz-Vazquez v. Mennonite Gen. Hosp. Inc., 613 F.3d 54 (1st Cir. 2010) (reversing exclusion of an expert witness who was biased in favor of plaintiffs in medical cases and who was generally affiliated with plaintiffs’ lawyers; such issues of personal bias are for the jury in assessing the weight of the expert witness’s testimony). Another example would be those expert witnesses whose commitment to Marxist ideology is such that they reject any evidence proffered by manufacturing industry as inherently corrupt, while embracing any evidence proffered by labor or the lawsuit industry without critical scrutiny.

[2] In re Phenylpropanolamine (PPA) Prods. Liab. Litig., MDL No. 1407, 289 F. Supp. 2d 1230 (W.D. Wash. 2003) (Yale Hemorrhagic Stroke Project).

[3] Cook v. Rockwell Internat’l Corp., 580 F. Supp. 2d 1071, 1098 (D. Colo. 2006) (“Defendants next claim that Dr. Clapp’s study and the conclusions he drew from it are unreliable because they failed to comply with four factors or criteria for drawing causal interferences from epidemiological studies: accounting for known confounders … .”), rev’d and remanded on other grounds, 618 F.3d 1127 (10th Cir. 2010), cert. denied, ___ U.S. ___, 133 S.Ct. 22 (2012). For another example of a trial court refusing to see through important qualitative differences between and among epidemiologic studies, see In re Welding Fume Prods. Liab. Litig., 2006 WL 4507859, *33 (N.D. Ohio 2006) (reducing all studies to one level, and treating all criticisms as though they rendered all studies invalid)

[4] General Electric Co. v. Joiner, 522 U.S. 136 (1997).

[5] Proctor & Gamble Co. v. Haugen, 2007 WL 709298, at *2 (D. Utah 2007); see also United States v. McCluskey, 954 F.Supp.2d 1227, 1247-48 (D.N.M. 2013) (“the trial judge decides the scientific validity of underlying principles and methodology” and “once that validity is demonstrated, other reliability issues go to the weight − not the admissibility − of the evidence”); Murphy-Sims v. Owners Ins. Co., No. 16-CV-0759-CMA-MLC, 2018 WL 8838811, at *7 (D. Colo. Feb. 27, 2018) (“Concerns surrounding the proper application of the methodology typically go to the weight and not admissibility[.]”).

[6] Walker v. Gordon, 46 F. App’x 691, 696 (3rd Cir. 2002).

[7] In re Paoli R.R. Yard PCB Litig., 35 F.3d 717, 745 (3d Cir. 1994).

[8] United States v. Gipson, 383 F.3d 689, 696 (8th Cir. 2004)(relying upon pre-2000 authority for this proposition).

[9] City of Pomona v. SQM N.Am. Corp. 750 F.3d 1036, 1047 (9th Cir. 2014).

[10] Quiet Tech. DC-8, Inc. v. Hurel-Dubois UK Ltd., 326 F.3d 1333, 1343 (11th Cir. 2003).

[11] Puga v. RCX Sols., Inc., 922 F.3d 285, 294 (5th Cir. 2019). See also United States v. Hodge, 933 F.3d 468, 478 (5th Cir. 2019)(“As a general rule, questions relating to the bases and sources of an expert’s opinion affect the weight to be assigned that opinion rather than its admissibility and should be left for the jury’s consideration.”); MCI Communications Service Inc. v. KC Trucking & Equip. LLC, 403 F. Supp. 3d 548, 556 (W.D. La. 2019); Coleman v. United States, No. SA-16-CA-00817-DAE, 2017 WL 9360840, at *4 (W.D. Tex. Aug. 16, 2017); Alvarez v. State Farm Lloyds, No. SA-18-CV-01191-XR, 2020 WL 734482, at *3 (W.D. Tex. Feb. 13, 2020)(“To the extent State Farm wishes to attack the ‘bases and sources’ of Dr. Hall’s opinion, such questions affect the weight to be assigned to that opinion rather than its admissibility and should also be left for the jury’s consideration.”)(internal quotation and citation omitted); Patenaude v. Dick’s Sporting Goods, Inc., No. 9:18-CV-3151-RMG, 2019 WL 5288077, at *2 (D.S.C. Oct. 18, 2019) (“More fundamentally, each of these arguments goes to the factual basis of the report, … and it is well settled that the factual basis for an expert opinion generally goes to weight, not admissibility.”); Wischermann Partners, Inc. v. Nashville Hosp. Capital LLC, No. 3:17-CV-00849, 2019 WL 3802121, at *3 (M.D. Tenn. Aug. 13, 2019) (“[A]rguments that Pinkowski’s opinions are unreliable because he failed to review other relevant information and ignored certain facts bear on the factual basis for Pinkowski’s opinions, and, therefore, go to the weight, rather than the admissibility, of Pinkowski’s testimony.”).

[12] Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11, 22 (1st Cir. 2011) (internal citations omitted), cert. denied sub nom., U.S. Steel Corp. v. Milward, 132 S. Ct. 1002 (2012).

[13] Kuhn v. Wyeth, Inc., 686 F.3d 618, 633 (8th Cir. 2012): Kuhn v. Wyeth, Inc., 686 F.3d 618, 633 (8th Cir. 2012), rev’g Beylin v. Wyeth, 738 F.Supp. 2d 887, 892 (E.D.Ark. 2010) (MDL court) (Wilson, J. & Montgomery, J.) (excluding proffered testimony of Dr. Jasenka Demirovic who appeared to have “selected study data that best supported her opinion, while downplaying contrary findings or conclusions.”); see United States v. Finch, 630 F.3d 1057 (8th Cir. 2011) (the sufficiency of the factual basis for an expert’s testimony goes to credibility rather than admissibility, and only where the testimony “is so fundamentally unsupported that it can offer no assistance to the jury must such testimony be excluded”); Katzenmeier v. Blackpowder Prods., Inc., 628 F.3d 948, 952 (8th Cir. 2010)(“As a general rule, the factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility, and it is up to the opposing party to examine the factual basis for the opinion in cross-examination.”); Paul Beverage Co. v. American Bottling Co., No. 4:17CV2672 JCH, 2019 WL 1044057, at *2 (E.D. Mo. Mar. 5, 2019) (admitting challenged opinion testimony without addressing the expert witness’s basis or application of methodology, following Eighth Circuit’s incorrect statement in Nebraska Plastics, Inc. v. Holland Colors Americas, Inc., 408 F.3d 410, 416 (8th Cir. 2005) that “[a]s a general rule, the factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility, and it is up to the opposing party to examine the factual basis for the opinion in cross-examination[,]”). See also “The Fallacy of Cherry Picking As Seen in American Courtrooms” (May 3, 2014).

[14] See “Judicial Dodgers – Reassigning the Burden of Proof on Rule 702” (May 13, 2020); “Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions” (May 11, 2020).

[15] Fed. R. Evid. 702, Advisory Note (quoting In re Paoli RR Yard PCB Litig., 35 F.3d 717, 745 (3d Cir. 1994)).

[16] See Nease v. Ford Motor Co., 848 F.3d 219, 231 (4th Cir. 2017) (“For the district court to conclude that Ford’s reliability arguments simply ‘go to the weight the jury should afford Mr. Sero’s testimony’ is to delegate the court’s gatekeeping responsibility to the jury.”).

[17] Daniel J. Capra, Reporter’s Memorandum re Forensic Evidence, Daubert and Rule 702, at 1-2 (Apr. 1, 2018)

[18] Id. at 43.

[19] Id. at 43, 49-50.

[20] Id. at 49-50.

[21] Id. at 52.

[22] Daniel J. Capra, Reporter, Reporter’s Memorandum re Possible Amendments to Rule 702, Advisory Comm. on Evidence Rules, Minutes of Meeting at 23 (May 3, 2019).

Posted in Rule 702, Uncategorized | Comments Off on Judicial Dodgers – Weight not Admissibility

Judicial Dodgers – Reassigning the Burden of Proof on Rule 702

May 13th, 2020

Explaining the denial of a Rule 702 motion in terms of the availability of cross-examination is just one among several dodges that judges use to avoid fully engaging with Rule 702’s requirements.[1] Another dodge involves shifting the burden of proof on admissibility from the proponent of the challenged expert witness to the challenger. This dodgewould appear to violate well-established law.

The Supreme Court, in deciding Daubert, made clear that the question whether an expert witness’s opinion was admissible was governed under the procedure set out in Federal Rule of Evidence 104(a).[2] The significance of placing the Rule 702 issues under the procedures set out in Rule 104(a) is that the trial judge must make the admissibility determination, and that he or she is not bound by the rules of evidence. The exclusion of the admissibility determination from the other rules of evidence means that trial judges can look at challenged expert witnesses’ relied-upon materials, and other facts, data, and opinions, regardless of these materials’ admissibility. The Supreme Court also made clear that the admissibility of an expert witness’s opinion testimony should be shown “by a preponderance of proof.”[3] Every court that has directly addressed the burden of proof issue in a Rule 702 challenge to expert witness testimony has clearly assigned that burden to the proponent of the testimony.[4]

Trial courts intent upon evading gatekeeping responsibility, however, have created a presumption of admissibility. When called upon to explain why they have denied Rule 702 challenges, these courts advert to the presumption as an explanation and justification for the denial.[5] Some courts even manage to discuss the burden of proof upon the proponent, and a presumption of admissibility, in almost the same breath.[6]

In his policy brief for amending Rule 702, Lee Mickus traces the presumption innovation to Borawick v. Shay, a 1995 Second Circuit decision that involved a challenge to hypnotically refreshed (or created) memory.[7] In Borawick, the Court of Appeals held that the plaintiff’s challenge turned upon whether Borawick’s testimony was competent or admissible, and that it did not involve the “the admissibility of data derived from scientific techniques or expert opinions.”[8] Nevertheless, in dicta, the court observed that “by loosening the strictures on scientific evidence set by Frye, Daubert reinforces the idea that there should be a presumption of admissibility of evidence.”[9]

Presumptions come in different forms and operate differently, and this casual reference to a presumption in dictum could mean any number of things. A presumption of admissibility could mean simply that unless there is a challenge to an expert witness’s opinion, the opinion is admissible.[10] The presumption could be a bursting-bubble (Thayer) presumption, which disappears once the opponent of the evidence credibly raises questions about the evidence’s admissibility. The presumption might be something that does not disappear, but once the admissibility is challenged, the presumption continues to provide some evidence for the proponent. And in the most extreme forms, the (Morgan) presumption might be nothing less than a judicially artful way of saying that the burden of proof is shifted to the opponent of the evidence to show inadmissibility.[11]

Although Borawick suggested that there should be a presumption, it did not exactly hold that one existed. A presumption in favor of the admissibility of evidence raises many questions about the nature, definition, and operation of the presumption. It throws open the question what evidence is needed to rebut the presumption. For instance, may a party whose expert witness is challenged not defend the witness’s compliance with Rule 702, stand on the presumption, and still prevail?

There is no mention of a presumption in Rule 702 itself, or in any Supreme Court decision on Rule 702, or in the advisory committee notes. Inventing a presumption, especially a poorly described one, turns the judicial discretion to grant or deny a Rule 702 challenge into an arbitrary decision.

Most importantly, given the ambiguity of “presumption,” a judicial opinion that denies a Rule 702 challenge by invoking a legal fiction fails to answer the question whether the proponent of the expert witness has carried the burden of showing that all the subparts of Rule 702 were satisfied by a preponderance of the evidence. While judges may prefer not to endorse or disavow the methodology of an otherwise “qualified” expert witness, their office requires them to do so, and not hide behind fictional presumptions.

1

[1] “Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions” (May 11, 2020).

[2] Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 592 n.10 (1993).

[3] Id., citing Bourjaily v. United States, 483 U. S. 171, 175-176 (1987).

[4] Barrett v. Rhodia, Inc., 606 F.3d 975, 980 (8th Cir. 2010) (quoting Marmo v. Tyson Fresh Meats, Inc., 457 F.3d 748, 757 (8th Cir. 2006)); Beylin v. Wyeth, 738 F. Supp. 2d 887 (E.D. Ark. 2010) (MDL court) (Wilson, J. & Montgomery, J.); Pride v. BIC Corp., 218 F.3d 566, 578 (6th Cir. 2000); Reece v. Astrazeneca Pharms., LP, 500 F. Supp. 2d 736, 742 (S.D. Ohio 2007).

[5] See, e.g., Cates v. Trustees of Columbia Univ. in City of New York, No. 16CIV6524GBDSDA, 2020 WL 1528124, at *6 (S.D.N.Y. Mar. 30, 2020) (discussing presumptive admissibility); Price v. General Motors, LLC, No. CIV-17-156-R, 2018 WL 8333415, at *1 (W.D. Okla. Oct. 3, 2018) (“[T]here is a presumption under the Rules that expert testimony is admissible.”)(internetal citation omitted); Powell v. Schindler Elevator Corp., No. 3:14cv579 (WIG), 2015 WL 7720460, at *2 (D. Conn. Nov. 30, 2015) (“The Second Circuit has made clear that Daubert contemplates liberal admissibility standards, and reinforces the idea that there should be a presumption of admissibility of evidence.”); Advanced Fiber Technologies (AFT) Trust v. J & L Fiber Services, Inc., No. 1:07-CV-1191, 2015 WL 1472015, at *20 (N.D.N.Y. Mar. 31, 2015) (“In assuming this [gatekeeper] role, the Court applies a presumption of admissibility.”); Crawford v. Franklin Credit Mgt. Corp., 08-CV-6293 (KMW), 2015 WL 13703301, at *2 (S.D.N.Y. Jan. 22, 2015) (“[T]he court should apply ‘a presumption of admissibility’ of evidence” in carrying out the gatekeeper function.); Martinez v. Porta, 598 F. Supp. 2d 807, 812 (N.D. Tex. 2009) (“Expert testimony is presumed admissible”).

[6] S.E.C. v. Yorkville Advisors, LLC, 305 F. Supp. 3d 486, 503-04 (S.D.N.Y. 2018) (“The party seeking to introduce the expert testimony bears the burden of establishing by a preponderance of the evidence that the proffered testimony is admissible. There is a presumption that expert testimony is admissible … .”) (internal citations omitted).

[7] Borawick v. Shay, 68 F.3d 597, 610 (2d Cir. 1995), cert. denied, 517 U.S. 1229 (1996).

[8] Id.

[9] Id. (referring to Frye v. United States, 293 F. 1013 (D.C.Cir.1923)).

[10] In re Zyprexa Prod. Liab. Litig., 489 F. Supp. 2d 230, 282 (E.D.N.Y. 2007) (Weinstein, J.) (“Since Rule 702 embodies a liberal standard of admissibility for expert opinions, the assumption the court starts with is that a well-qualified expert’s testimony is admissible.”).

[11] See, e.g., Orion Drilling Co., LLC v. EQT Prod. Co., No. CV 16-1516, 2019 WL 4273861, at *34 (W.D. Pa. Sept. 10, 2019) (after declaring that “[e]xclusion is disfavored” under Rule 702, the court flipped the burden of production and declared the opinion testimony admissible, stating “Orion has not established that incorporation of the data renders Ray’s opinion unreliable.”).

Posted in Expert Witnesses, Rule 702 | Comments Off on Judicial Dodgers – Reassigning the Burden of Proof on Rule 702

Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions

May 11th, 2020

In my last post,[1] I praised Lee Mickus’s recent policy paper on amending Rule 702 for its persuasive force on the need for an amendment, as well as a source for helping lawyers anticipate common judicial dodges to a faithful application of the rule.[2] There are multiple dodges used by judicial dodgers, and it behooves litigants to recognize and anticipate them. In this post, and perhaps future ones, I elaborate upon the concerns that Mickus documents.

One prevalent judicial response to the Rule 702 motion is to kick the can and announce that the challenge to an expert witness’s methodological shenanigans can and should be addressed by crossexamination. This judicial response was, of course, the standard one before the 1993 Daubert decision, but Justice Blackmun’s opinion kept it alive in frequently quote dicta:

“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.”[3]

Justice Blackmun, no doubt, believed he was offering a “helpful” observation here, but the reality is quite different. Traditionally, courts allowed qualified expert witnesses to opine with wild abandon, after showing that they had the very minimal qualifications required to do so in court. In the face of this traditional judicial lassitude, “[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof” were all a litigant could hope to accomplish in litigation. Furthermore, the litany of remedies for “shaky but admissible evidence” fails to help lower court judges and lawyers sort shaky but admissible evidence from shaky and inadmissible evidence.

Perhaps even more to the point, cases at common law “traditionally” did not involve multivariate logistic regression, structural equation models, propensity score weighting, and the like. Juries did just fine on whether Farmer Brown had exercised due care when he ran over his neighbor’s cow with his tractor, or even when a physician opined that a child was born 350 days after the putative father’s death was sired by the testator and entitled to inherit from “dad.”

Mickus is correct that a trial judge’s comment that the loser of a Rule 702 motion is free to cross-examine is often a dodge, an evasion, or an outright failure to engage with the intricacies of a complex methodological challenge.[4] Stating that the “traditional and appropriate means of attacking shaky but admissible evidence” remain available is a truism, and might be offered as judicial balm to the motion loser, but the availability of such means is hardly an explanation or justification for denying the Rule 702 motion. Furthermore, Justice Blackmun’s observation about traditional means was looking back at an era when in most state and federal court, a person found to be minimally qualified, could pretty much say anything regardless of scientific validity. That was the tradition that stood in active need of reform when Daubert was decided in 1993.

Mickus is also certainly correct that the whole point of judicial gatekeeping is that the presentation of vive voce testimony before juries is not an effective method for revealing shaky, inadmissible opinion testimony. A few courts have acknowledged that cross-examination in front of a jury is not an appropriate justification for admitting methodologically infirm expert witness opinion testimony. In the words of Judge Jed Rakoff, who served on the President’s Council of Advisors on Science and Technology,[5] addressed the limited ability of cross-examination in the context of forensic evidence:

“Although effective cross-examination may mitigate some of these dangers, the explicit premise of Daubert and Kumho Tire is that, when it comes to expert testimony, cross-examination is inherently handicapped by the jury’s own lack of background knowledge, so that the Court must play a greater role, not only in excluding unreliable testimony, but also in alerting the jury to the limitations of what is presented.”[6]

Judge Rakoff’s point is by no means limited to forensic evidence, and it has been acknowledged more generally by Professor Daniel Capra, the Reporter to the Advisory Committee on Evidence Rules:

“the key to Daubert is that cross-examination alone is ineffective in revealing nuanced defects in expert opinion testimony and that the trial judge must act as a gatekeeper to ensure that unreliable opinions don’t get to the jury in the first place.”[7]

Juries do not arrive at the court house knowledgeable about statistical and scientific methods; nor are they prepared to spend weeks going over studies to assess their quality, and whether an expert witness engaged in cherry picking, misapplying methodologies, or insufficient investigation.[8] In discussing the problem of expert witnesses’ overstating the strength of their opinions, beyond what is supported by evidence, the Reporter stressed the limits and ineffectiveness of remedial adversarial cross-examination:

“Perhaps another way to think about cross-examination as a remedy is to compare the overstatement issue to the issues of sufficiency of basis, reliability of methodology, and reliable application of that methodology. As we know, those three factors must be shown by a preponderance of the evidence. The whole point of Rule 702 — and the Daubert-Rule 104(a) gatekeeping function — is that these issues cannot be left to cross-examination. The underpinning of Daubert is that an expert’s opinion could be unreliable and the jury could not figure that out, even given cross-examination and argument, because the jurors are deferent to a qualified expert (i.e., the white lab coat effect). The premise is that cross-examination cannot undo the damage that has been done by the expert who has power over the jury. This is because, for the very reason that an expert is needed (because lay jurors need assistance) the jury may well be unable to figure out whether the expert is providing real information or junk. The real question, then, is whether the dangers of overstatement are any different from the dangers of insufficient basis, unreliability of methodology, and unreliable application. Why would cross-examination be insufficient for the latter yet sufficient for the former?

It is hard to see any difference between the risk of overstatement and the other risks that are regulated by Rule 702. When an expert says that they are certain of a result — when they cannot be — how is that easier for the jury to figure out than if an expert says something like ‘I relied on four scientifically valid studies concluding that PCB’s cause small lung cancer’. When an expert says he employed a ‘scientific methodology’ when that is not so, how is that different from an expert saying “I employed a reliable methodology” when that is not so?”[9]

The Reporter’s example of PCBs and small lung cancer was an obvious reference to the Joiner case, in which the Supreme Court held that the trial judge had properly excluded causation opinions. The Reporter’s point goes directly to the cross-examination excuse for not shirking the gatekeeping function. In Joiner, the Court held that gatekeeping was necessitated when cross-examination was insufficient in the face of an analytical gap between methodology and conclusion.[10] Indeed, such gaps are or should be present in most well-conceived Rule 702 challenges.

The problem is not only that juries defer to expert witnesses. Juries lack the competence to assess scientific validity. Although many judges are lacking in such competence, at least litigants can expect them to read the Reference Manual on Scientific Evidence before they read the parties’ briefs and the expert witnesses’ reports. If the trial judge’s opinion evidences ignorance of the Manual, then at least there is the possibility of an appeal. It will be a strange day in a stranger world, when a jury summons arrives in the mail with a copy of the Manual!

The rules of evidence permit expert witnesses to rely upon inadmissible evidence, at least when experts in their field would do so reasonably. To decide whether the reliance is reasonable requires the decision maker go outside the “proofs” that would typically be offered at trial. Furthermore, the decision maker – gatekeeper – will have to read the relied-upon study and data to evaluate the reasonableness of the reliance. In a jury trial, the actual studies relied upon are rarely admissible, and so the jury almost never has the opportunity to read them to make its own determination of reasonableness of reliance, or of whether the study and its data really support what the expert witness draws from it.

Of course, juries do not have to write opinions about their findings. They need neither explain nor justify their verdicts, once the trial court has deemed that there is the minimally sufficient evidence to support a verdict. Juries, with whatever help cross-examination provides, in the absence of gatekeeping, cannot deliver anything approaching scientific due process of law.

Despite Supreme Court holdings, a substantially revised and amended Rule 702, and clear direction from the Advisory Committee, some lower courts have actively resisted enforcing the requirements of Rule. 702 Part of this resistance consists in pushing the assessment of the reliability of the data and assumptions used in applying a given methodology out of the gatekeeping column and into the jury’s column. Despite the clear language of Rule 702, and the Advisory Committee Note,[11] some Circuits of the Court of Appeals have declared that assessing the reliability of assumptions and data is not judges’ work (outside of a bench trial).[12]

As Seinfeld has taught us, rules are like reservations. It is not enough to make the rules, you have to keep and follow them. Indeed, following the rule is really the important part.[13] Although an amended Rule 702 might include a provision that “we really mean this,” perhaps it is worth a stop at the Supreme Court first to put down the resistance.

[1] “Should Federal Rule of Evidence 702 Be Amended?” (May 8, 2020).

[2] Lee Mickus, “Gatekeeping Reorientation: Amend Rule 702 to Correct Judicial Misunderstanding about Expert Evidence,” Washington Legal Foundation Critical Legal Issues Working Paper No. 217 (May 2020).

[3] Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, 596 (1993).

[4] See, e.g., AmGuard Ins. Co. v. Lone Star Legal Aid, No. CV H-18-2139, 2020 WL 60247, at *8 (S.D. Tex. Jan. 6, 2020) (“[O]bjections [that the expert could not link her experienced-based methodology to her conclusions] are better left for cross examination, not a basis for exclusion.”); Powell v. Schindler Elevator Corp., No. 3:14cv579 (WIG), 2015 WL 7720460, at *2 (D. Conn. Nov. 30, 2015) (“To the extent Defendant argues that Mr. McPartland’s conclusions are unreliable, it may attack his report through cross examination.”); Wright v. Stern, 450 F. Supp. 2d 335, 359–60 (S.D.N.Y. 2006) (“In a close case, a court should permit the testimony to be presented at trial, where it can be tested by cross-examination and measured against the other evidence in the case.”) (internal citation omitted). See also Adams v. Toyota Motor Corp., 867 F.3d 903, 916 (8th Cir. 2017) (affirming admission of expert testimony, reiterating the flexibility of the Daubert inquiry and emphasizing that defendant’s concerns could all be addressed with “[v]igorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof”); Liquid Dynamics Corp. v. Vaughan Corp., 449 F.3d 1209, 1221 (Fed. Cir. 2006) (“The identification of such flaws in generally reliable scientific evidence is precisely the role of cross-examination.” (internal citation omitted)); Carmichael v. Verso Paper, LLC, 679 F. Supp. 2d 109, 119 (D. Me. 2010) (“[W]hen the adequacy of the foundation for the expert testimony is at issue, the law favors vigorous cross-examination over exclusion.”); Crawford v. Franklin Credit Mgt. Corp., 08-CV-6293 (KMW), 2015 WL 13703301, at *6 (S.D.N.Y. Jan. 22, 2015) (“In light of the ‘presumption of admissibility of evidence,’ that opportunity [for cross-examination] is sufficient to ensure that the jury receives testimony that is both relevant and reliable.”) (internal citation omitted).

Even the most explicitly methodological challenges are transmuted into cross-examination issues by refusnik courts. For instance, cherry picking is reduced to a credibility issue for the jury and not germane to the court’s Rule 702 determination. In re Chantix Prods. Liab. Litig., 889 F. Supp. 2d 1272, 1288 (N.D. Ala. 2012) (finding that an expert witness’s deliberate decision not to rely upon clinical trial data merely “is a matter for cross-examination, not exclusion under Daubert”); In re Urethane Antitrust Litig., 2012 WL 6681783, at *3 (D.Kan.) (“The extent to which [an expert] considered the entirety of the evidence in the case is a matter for cross-examination.”); Bouchard v. Am. Home Prods. Corp., 2002 WL 32597992, at *7 (N.D. Ohio) (“If the plaintiff believes that the expert ignored evidence that would have required him to substantially change his opinion, that is a fit subject for cross-examination.”). Similarly, courts have by ipse dixit made flawed application of what a standard methodological into merely a credibility issue to be explore by cross-examination rather than by judicial gatekeeping. United States v. Adam Bros. Farming, 2005 WL 5957827, at *5 (C.D. Cal. 2005) (“Defendants’ objections are to the accuracy of the expert’s application of the methodology, not the methodology itself, and as such are properly reserved for cross-examination.”); Oshana v. Coca-Cola Co., 2005 WL 1661999, at *4 (N.D. Ill.) (“Challenges addressing flaws in an expert’s application of reliable methodology may be raised on cross-examination.”).

[5] President’s Council of Advisors on Science and Technology, Report to the President on Forensic Science in Criminal Courts: Ensuring Scientific Validity of Feature-Comparison Methods (Sept. 2016).

[6] United States v. Glynn, 578 F. Supp. 2d 567, 574 (S.D.N.Y. 2008) (Rakoff, J.)

[7] Daniel J. Capra, Reporter, Advisory Comm. on Evidence Rules, Minutes of Meeting at 23 (May 3, 2019) (comments of the Reporter).

[8] Daniel J. Capra, Reporter’s Memorandum re Forensic Evidence, Daubert and Rule 702 at 50 (April 1, 2018) (identifying issues such as insufficient investigation, cherry-picking data, or misapplying standard methodologies, as examples of a “white lab coat” problem resulting from juries’ inability to evaluate expert witnesses’ factual bases, methodologies, and applications of methods).

[9] Daniel J. Capra, Reporter, Advisory Comm. on Evidence Rules, Minutes of Meeting at 10-11 (Oct. 1, 2019) (comments of the Reporter on possible amendment of Rule 702) (internal citation to Joiner omitted).

[10] Id. at 11 n.5.

[11] See In re Paoli RR Yard PCB Litig., 35 F.3d 717, 745 (3d Cir. 1994) (calling for a close, careful analysis of the application of a proper methodology to every step in the case; “any step that renders the analysis unreliable renders the expert’s testimony inadmissible whether the step completely changes a reliable methodology or merely misapplies that methodology”).

[12] See, e.g., City of Pomona v. SQM North Am. Corp., 750 F.3d 1036, 1047 (9th Cir. 2014) (rejecting the Paoli any-step approach without careful analysis of the statute, the advisory committee note, or Supreme Court decisions); Manpower, Inc. v. Ins. Co. of Pa., 732 F.3d 796, 808 (7th Cir. 2013) (“[t]he reliability of data and assumptions used in applying a methodology is tested by the adversarial process and determined by the jury; the court’s role is generally limited to assessing the reliability of the methodology – the framework – of the expert’s analysis”); Bonner v. ISP Techs., Inc., 259 F.3d 924, 929 (8th Cir. 2001) (“the factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility, and it is up to the opposing party to examine the factual basis for the opinion in cross-examination”).

[13] Despite the clarity of the revised Rule 702, and the intent to synthesize Daubert, Joiner, Kumho Tire, and Weisgram, some courts have insisted that nothing changed with the amended rule. See, e.g., Pappas v. Sony Elec., Inc., 136 F. Supp. 2d 413, 420 & n.11 (W.D. Pa. 2000) (opining that Rule 702 as amended did not change the application of Daubert within the Third Circuit) (“The Committee Notes to the amended Rule 702 cite and discuss several Court of Appeals decisions that have properly applied Daubert and its progeny. Among these decisions are numerous cases from the Third Circuit. See Committee Note to 2000 Amendments to Fed. R.Evid. 702. Accordingly, I conclude that amended Rule 702 does not effect a change in the application of Daubert in the Third Circuit.”). Of course, if nothing changed, then the courts that take this position should be able to square their decisions with text of Rule 702, as amended in 2000.

Posted in Expert Witnesses, Rule 702, Uncategorized | Comments Off on Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions

Should Federal Rule of Evidence 702 Be Amended?

May 8th, 2020

Almost 27 years have passed since the United States Supreme Court issued its opinion in Daubert.[1] The holding was narrow. The Court reminded the Bar that Federal Rule of Evidence 702 was a statute, and that courts were thus bound to read it as a statute. The plain language of Rule 702 had been adopted by the Court in 1972, and then enacted by Congress, to be effective on July 1, 1975. Absent from the enacted Rule 702 was the “twilight zone” test articulated by a lower federal court in 1923.[2] In the Daubert case, the defense erroneously urged the application of the twilight zone test. In the post-modern way, the plaintiffs urged the application of no test.[3] The Court held simply that the twilight zone test had not been incorporated in the statutory language of Rule 702. Instead, the Court observed that the plain language of the statute imposed “helpfulness” and epistemic requirements for admitting expert witness opinion testimony.

It took another two Supreme Court decisions to flesh out the epistemic requirements for expert witnesses’ opinions,[4] and a third decision in which the Court told the Bench and Bar that the requirements of Rule 702 are “exacting.”[5] After the Supreme Court had added significantly to Rule 702’s helpfulness and knowledge requirements, the Advisory Committee revised the rule in 2000, to synthesize and incorporate these four Supreme Court decisions, and scholarly thinking about the patho-epistemology of expert witness opinion testimony. The Committee revised Rule 702 again in 2011, but only on “stylistic” issues, without any intent to add to or subtract from the 2000 rule.

Not all judges got the memo, or bothered to read and implement the revised Rule 702, in 2000. At both the District Court and the Circuit levels, courts persisted, and continue to persist, in citing retrograde decisions that predate the 2000 amendment, and even predate the 1993 decision in Daubert. Even the Supreme Court, in a 2011 opinion that did not involve the interpretation of Rule 702, was misled by a Solicitor General’s amicus brief, into citing one of the most anti-science, anti-method, post-modern, pre-Daubert, anything-goes decisions.[6] The judicial resistance to Rule 702 is well documented in many scholarly articles,[7] by the Reporter to the Advisory Committee,[8] and in the pages of this and other blogs.

In 2015, when evidence scholar David Bernstein argued that Rule 702 required amending,[9] I acknowledged the strength of his argument, but resisted because of what I perceived to be the danger of opening up the debate in Congress.[10] Professor Bernstein and lawyer Eric Lasker detailed and documented the many judicial dodges and evasions engaged in by many judges intent upon ignoring the clear requirements of Rule 702.

A paper published this week by the Washington Legal Foundation has updated and expanded the case for reform made by Professor Bernstein five years ago. In his advocacy paper, lawyer Lee Mickus has collated and analyzed some of the more recent dodges, which will depress the spirits of anyone who believes in evidence-based decision making.[11] My resistance to reform by amendment is waning. The meaning and intent of Rule 702 has been scarred over by precedent based upon judicial ipse dixit, and not Rule 702.

Mickus’s paper, like Professor Bernstein’s articles before, makes a persuasive case for reform, but this new paper does not evaluate the vagaries of navigating an amendment through the Advisory Committee, the Supreme Court, and Congress. Even if the reader is not interested in the amendment process, the paper can be helpful to the advocate in anticipating dodgy rule denialism.

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

[2] Frye v. United States, 54 App. D.C. 46, 293 F. 1013 (1923).

[3] See “The Advocates’ Errors in Daubert” (Dec. 28, 2018).

[4] General Electric Co. v. Joiner, 522 U.S. 136 (1997); Kumho Tire Co. v. Carmichael, 526 U.S. 137 (1999).

[5] Weisgram v. Marley Co., 528 U.S. 440, 455 (2000) (Ginsberg, J.) (unanimous decision).

[6] Matrixx Initiatives, Inc. v. Siracusano, 563 US 27, 131 S.Ct. 1309, 1319 (2011) (citing Wells v. Ortho Pharmaceutical Corp., 615 F. Supp. 262, 298 (N.D. Ga. 1985), aff’d and rev’d in part on other grounds, 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S.950 (1986)). See “Wells v. Ortho Pharmaceutical Corp. Reconsidered – Part 1”; “Part 2”; “Part 3”; “Part 4”; “Part 5”; and “Part 6”.

[7] David E. Bernstein & Eric Lasker, “Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702,” 57 Wm. & Mary L. Rev. 1 (2015); David E. Bernstein, “The Misbegotten Judicial Resistance to the Daubert Revolution,” 89 Notre Dame L. Rev. 27 (2014).

[8] See Daniel J. Capra, Reporter’s Memorandum re Forensic Evidence, Daubert and Rule 702 at 52 (April 1, 2018) (“[T]he fact remains that some courts are ignoring the requirements of Rule 702(b) and (d). That is frustrating.”).

[9] David E. Bernstein & Eric Lasker, “Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702,” 57 Wm. & Mary L. Rev. 1 (2015).

[10] “On Amending Rule 702 of the Federal Rules of Evidence” (Oct. 17, 2015).

[11] Lee Mickus, “Gatekeeping Reorientation: Amend Rule 702 to Correct Judicial Misunderstanding about Expert Evidence,” Washington Legal Foundation Critical Legal Issues Working Paper No. 217 (May 2020).

Posted in Expert Witnesses, Rule 702 | Comments Off on Should Federal Rule of Evidence 702 Be Amended?

Dark Money, Scott Augustine, and Hot Air

April 11th, 2020

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dodgy Data Duck Daubert Decisions

March 11th, 2020

Judges say the darndest things, especially when it comes to their gatekeeping responsibilities under Federal Rules of Evidence 702 and 703. One of the darndest things judges say is that they do not have to assess the quality of the data underlying an expert witness’s opinion.

Even when acknowledging their obligation to “assess the reasoning and methodology underlying the expert’s opinion, and determine whether it is both scientifically valid and applicable to a particular set of facts,”[1] judges have excused themselves from having to look at the trustworthiness of the underlying data for assessing the admissibility of an expert witness’s opinion.

In McCall v. Skyland Grain LLC, the defendant challenged an expert witness’s reliance upon oral reports of clients. The witness, Mr. Bradley Walker, asserted that he regularly relied upon such reports, in similar contexts of the allegations that the defendant misapplied herbicide to plaintiffs’ crops. The trial court ruled that the defendant could cross-examine the declarant who was available trial, and concluded that the “reliability of that underlying data can be challenged in that manner and goes to the weight to be afforded Mr. Walker’s conclusions, not their admissibility.”[2] Remarkably, the district court never evaluated the reasonableness of Mr. Walker’s reliance upon client reports in this or any context.

In another federal district court case, Rodgers v. Beechcraft Corporation, the trial judge explicitly acknowledged the responsibility to assess whether the expert witness’s opinion was based upon “sufficient facts and data,” but disclaimed any obligation to assess the quality of the underlying data.[3] The trial court in Rodgers cited a Tenth Circuit case from 2005,[4] which in turn cited the Supreme Court’s 1993 decision in Daubert, for the proposition that the admissibility review of an expert witness’s opinion was limited to a quantitative sufficiency analysis, and precluded a qualitative analysis of the underlying data’s reliability. Quoting from another district court criminal case, the court in Rodgers announced that “the Court does not examine whether the facts obtained by the witness are themselves reliable – whether the facts used are qualitatively reliable is a question of the weight to be given the opinion by the factfinder, not the admissibility of the opinion.”[5]

In a 2016 decision, United States v. DishNetwork LLC, the court explicitly disclaimed that it was required to “evaluate the quality of the underlying data or the quality of the expert’s conclusions.”[6] This district court pointed to a Seventh Circuit decision, which maintained that “[t]he soundness of the factual underpinnings of the expert’s analysis and the correctness of the expert’s conclusions based on that analysis are factual matters to be determined by the trier of fact, or, where appropriate, on summary judgment.”[7] The Seventh Circuit’s decision, however, issued in June 2000, several months before the effective date of the amendments to Federal Rule of Evidence 702 (December 2000).

In 2012, a magistrate judge issued an opinion along the same lines, in Bixby v. KBR, Inc.[8] After acknowledging what must be done in ruling on a challenge to an expert witness, the judge took joy in what could be overlooked. If the facts or data upon which the expert witness has relied are “minimally sufficient,” then the gatekeeper can regard questions about “the nature or quality of the underlying data bear upon the weight to which the opinion is entitled or to the credibility of the expert’s opinion, and do not bear upon the question of admissibility.”[9]

There need not be any common law mysticism to the governing standard. The relevant law is, of course, a statute, which appears to be forgotten in many of the failed gatekeeping decisions:

Rule 702. Testimony by Expert Witnesses

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if:

(a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data;

(c) the testimony is the product of reliable principles and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the case.

It would seem that you could not produce testimony that is the product of reliable principles and methods by starting with unreliable underlying facts and data. Certainly, having a reliable method would require selecting reliable facts and data from which to start. What good would the reliable application of reliable principles to crummy data?

The Advisory Committee Notes to Rule 702 hints at an answer to the problem:

“There has been some confusion over the relationship between Rules 702 and 703. The amendment makes clear that the sufficiency of the basis of an expert’s testimony is to be decided under Rule 702. Rule 702 sets forth the overarching requirement of reliability, and an analysis of the sufficiency of the expert’s basis cannot be divorced from the ultimate reliability of the expert’s opinion. In contrast, the ‘reasonable reliance’ requirement of Rule 703 is a relatively narrow inquiry. When an expert relies on inadmissible information, Rule 703 requires the trial court to determine whether that information is of a type reasonably relied on by other experts in the field. If so, the expert can rely on the information in reaching an opinion. However, the question whether the expert is relying on a sufficient basis of information—whether admissible information or not—is governed by the requirements of Rule 702.”

The answer is only partially satisfactory. First, if the underlying data are independently admissible, then there may indeed be no gatekeeping of an expert witness’s reliance upon such data. Rule 703 imposes a reasonableness test for reliance upon inadmissible underlying facts and data, but appears to give otherwise admissible facts and data a pass. Second, the above judicial decisions do not mention any Rule 703 challenge to the expert witnesses’ reliance. If so, then there is a clear lesson for counsel. When framing a challenge to the admissibility of an expert witness’s opinion, show that the witness has unreasonably relied upon facts and data, from whatever source, in violation of Rule 703. Then show that without the unreasonably relied upon facts and data, the witness cannot show that his or her opinion satisfies Rule 702(a)-(d).

[1] See, e.g., McCall v. Skyland Grain LLC, Case 1:08-cv-01128-KHV-BNB, Order (D. Colo. June 22, 2010) (Brimmer, J.) (citing Dodge v. Cotter Corp., 328 F.3d 1212, 1221 (10th Cir. 2003), citing in turn Daubert v. Merrill Dow Pharms., Inc., 509 U.S. 579, 592-93 (1993).

[2] McCall v. Skyland Grain LLC Case 1:08-cv-01128-KHV-BNB, Order at p.9 n.6 (D. Colo. June 22, 2010) (Brimmer, J.)

[3] Rodgers v. Beechcraft Corp., Case No. 15-CV-129-CVE-PJC, Report & Recommendation at p.6 (N.D. Okla. Nov. 29, 2016).

[4] Id., citing United.States. v. Lauder, 409 F.3d 1254, 1264 (10th Cir. 2005) (“By its terms, the Daubert opinion applies only to the qualifications of an expert and the methodology or reasoning used to render an expert opinion” and “generally does not, however, regulate the underlying facts or data that an expert relies on when forming her opinion.”), citing Daubert v. Merrill Dow Pharms., Inc., 509 U.S. 579, 592-93 (1993).

[5] Id., citing and quoting United States v. Crabbe, 556 F. Supp. 2d 1217, 1223
(D. Colo. 2008) (emphasis in original). In Crabbe, the district judge mostly excluded the challenged expert witness, thus rendering its verbiage on quality of data as obiter dicta). The pronouncements about the nature of gatekeeping proved harmless error when the court dismissed the case on other grounds. Rodgers v. Beechcraft Corp., 248 F. Supp. 3d 1158 (N.D. Okla. 2017) (granting summary judgment).

[6] United States v. DishNetwork LLC, No. 09-3073, Slip op. at 4-5 (C.D. Ill. Jan. 13, 2016) (Myerscough, J.)

[7] Smith v. Ford Motor Co., 215 F.3d 713, 718 (7th Cir. 2000).

[8] Bixby v. KBR, Inc., Case 3:09-cv-00632-PK, Slip op. at 6-7 (D. Ore. Aug. 29, 2012) (Papak, M.J.)

[9] Id. (citing Hangarter v. Provident Life & Accident Ins. Co., 373 F.3d 998, 1017 (9th Cir. 2004), quoting Children’s Broad Corp. v. Walt Disney Co., 357 F.3d 860, 865 (8th Cir. 2004) (“The factual basis of an expert opinion goes to the credibility of the testimony, not the admissibility, and it is up to the opposing party to examine the factual basis for the opinion in cross-examination.”).

Posted in Evidence, Expert Witnesses, Rule 702, Rule 703, Underlying Data | Comments Off on Dodgy Data Duck Daubert Decisions