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). SeeThe 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). SeeJohnson 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).

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

June 8th, 2020

Claims under Federal and State Racketeering Acts And Other Civil Remedies

There are three types approaches to civil remedies a defendant might pursue to inhibit the flow of false claims in products cases. First, a defendant could seek to take on the entire procedure by which these claims have been developed and focus broadly on the alliance between plaintiffs’ lawyers and their medical accomplices.  The Federal Racketeering Act, RICO, offers the most likely avenue of attack for such a wide-ranging approach. Indeed, this was the approach that the CSX Railroad took in seeking redress from fraudfeasor radiologist Dr. Ray Harron and his lawsuit industry collaborators.[1] Second, the product liability defendant could select a limited number of bogus claims and file suit related specifically to those claims.  Third, the product liability defendant can seek remedies in the specific cases, after prevailing, for bad faith filings or improper conduct by lawyers.

A Challenge under RICO to the Broad Pattern Of Misconduct By Plaintiffs’ Lawyers And Their Medical Collaborators

The federal RICO statute allows a private plaintiff damaged by a “pattern of racketeering activity” to sue those involved in conducting the affairs of an enterprise through a pattern of such unlawful conduct.[2]  One of the central aspects of RICO is that it provides a civil remedy for misconduct that would otherwise be subject only to criminal sanctions.  On the other hand, to qualify for such unique remedies, a plaintiff must satisfy a number of difficult, technical requirements under the RICO statute.

While a substantial and complex body of case law has developed under RICO, the following are the main issues that bear on the viability of such a claim against the lawyers and medical professionals who are responsible for allegedly bogus claims, such as were seen in the Silica MDL:

  • The existence of repeated instances of the misconduct on which the RICO claim is predicated;
  • A showing that there has been a pattern or practice of such misconduct;
  • Proof that a person has conducted the affairs of an enterprise engaged in interstate commerce through the pattern of racketeering activity.[3]

Putting aside the various – and significant – technical issues, a product liability defendant must meet three fundamental requirements of persuasion before a court will likely allow it to proceed, namely showing that the pattern of false claims the product liability defendant confronts:

(1) falls well outside the normal bounds of litigation misconduct (given that courts are all too accustomed to experts whose testimony conveniently favors their respective sides);

(2) is such a wide-ranging problem that it cannot properly be addressed on a case-by-case basis like most issues of bad faith litigation conduct; and

(3) raises issues that are susceptible of judicial, rather than legislative, redress.

The Predicate Offense

The most central requirement for a RICO plaintiff is the identification of an illegal “predicate act” within the meaning of RICO – that is, an illegal action which, taken together with other instances of similar conduct, constitutes a “pattern” of racketeering activity.  The statute contains a long list of enumerated predicate offenses, one of which must occur in a “pattern” over a sufficiently long period of time for there to be a valid claim under RICO.  While there are several candidates, the most promising theory here is that the plaintiffs’ lawyers have engaged in repeated acts of bribing witnesses to provide false and/or misleading testimony at depositions and at trial — in particular, the medical professionals whose diagnoses are the linchpin of the false claims, such as those seen in the Silica MDL.[4]  It is also possible that the product liability defendant could bring a RICO case based on predicate acts of mail and wire fraud.

“Bribery” of Witnesses; Obstruction of Justice; Witness Tampering

In defining “racketeering activity,”[5] the federal RICO statute expressly refers to certain offenses that pertain to the administration of justice, including obstruction of justice,[6] witness tampering,[7] and bribery.[8]  These statutes, however, only apply to offenses committed in the course of federal proceedings.

On the other hand, Section 1961(1)(A), of the federal criminal code, also refers to “bribery. . . .chargeable under State law and punishable for imprisonment for more than one year. . . .”  There is substantial authority to the effect that “bribery” is a generic designation and does not limit predicate acts to state laws that are specifically labeled as bribery.  Rather, a court need only determine whether the alleged misconduct is the type of activity which falls within a general description of bribery.[9]  Product liability defendants may well have a claim that the dealings between plaintiffs’ lawyers and the physicians involved in medical screenings involve an ongoing course of what can properly be viewed as bribes to witnesses to submit materially false evidence in violation of state law.  Several points support this position.

There is authority under state law that payments to witnesses to provide favorable testimony do in fact constitute bribery.[10]  For example, the Texas Penal Code provides that:[11]

“(a) A person commits an offense if, with intent to influence the witness, he offers, confers, or agrees to confer any benefit on a witness or prospective witness in an official proceeding[[12]] or coerces a witness or prospective witness in an official proceeding:

(1) to testify falsely;

(2) to withhold any testimony, information, document, or thing… .”

Similarly, Mississippi, another jurisdiction where screening activities have taken place with some abandon, has enacted a prohibition against “bribery to induce perjury” which provides as follows:

“Every person who shall, by the offer of any valuable consideration, attempt, unlawfully and corruptly, to procure any other person to commit willful and corrupt perjury as a witness in any cause, matter, or proceeding in or concerning which such other person might by law be examined as a witness, shall, upon conviction, be punished by imprisonment in the penitentiary not exceeding five years.”[13]

In the silica MDL cases, Judge Jack’s opinion did not specifically find that a corrupt payment was made on any particular occasion.  Rather than describing the exchange of a specific envelope of cash, the silica MDL opinion described an ongoing course of corrupt remuneration paid to medical professionals who were all too willing to bend their opinions and subvert medical standards.  Any attempt to characterize such a pattern of behavior as witness bribery must answer two basic questions:

(1) are the medical witnesses being paid for expert services, rather than the content of their testimony; and

(2) would awarding relief in this case establish a wide-ranging precedent under which legitimate experts would be chilled from rendering opinions and litigants’ access to the courts correspondingly restricted.

There seems no good reason to excuse the collaboration of lawyers and expert witnesses that results in the procurement of convenient, false, and exaggerated testimony from the laws that condemn tendering false evidence.

The proof problem, however, for situations in which the illicit payments take more subtle forms, such as “fees” for hired experts as opposed to envelopes of money for lay witnesses, may become intractable. In practice, it will be easier to persuade a court to consider the payments made for favorable diagnoses (such as silicosis in the silica MDL) as bribes if the evidence shows that the hired physicians’ testimony was perjured. Perjured testimony would certainly encourage courts to permit juries to consider whether the witness payments were for the substance of testimony, rather than for disinterested professional services. Furthermore, a showing of perjury would reduce any judicial concern that the litigation would chill legitimate expert witness opinion testimony, especially in novel contexts.

The federal bribery statute specifically carves out payment of reasonable fees to expert witnesses.[14]  But expert witnesses clearly have no immunity from the prohibitions against accepting compensation for the substance of testimony.  The proof problems for expert witnesses are differentially greater than they are with lay witnesses.  The basic requirement of truthful testimony, however, is a constant.  Notwithstanding that expert witnesses are entitled to fair compensation for their expertise, judicial concerns over the corrupting influence of excessive fees and testifying date back to the 19th century.

The difficulty in showing that the procured opinion testimony was deliberately false may be mitigated in cases such as the claimed silicosis cases in the silica MDL by showing that the opinions were given with full knowledge that they were insufficient under professional standards and scientific, medical principles. Furthermore, there is the matter of physicians reading the same X-ray in two, inconsistent ways. In any event, under the federal RICO statute (as opposed to the analogous state RICO statutes) showing perjury in a state court proceeding will not be enough to state a valid claim.  A showing of perjury, however, combined with the other aspects of the relationship between the plaintiffs’ lawyers and their cooperating medical screeners may support an inference of bribery, which in turn may serve as a predicate offense for RICO liability.

Fraud

GAF’s claims of frauds discussed[15] earlier focused on the claim that asbestos plaintiffs’ lawyers focused had committed RICO predicate acts of mail fraud,[16] and wire fraud,[17] by submitting fraudulent claims for payment.  Much of the GAF litigation focused on arguments about whether GAF’s successive complaints satisfied the requirement of Federal Rule of Civil Procedure 9(b) that allegations of fraud be pled “with particularity.”

Although Judge Jack’s thorough opinion showed that fraud claims certainly had a basis in fact in the context of the silica MDL, that litigation illustrates a central problem; namely, how can a defendant prosecute a civil fraud or RICO case when it knew that the claims were bogus, litigated the soundness of the diagnoses, and prevailed by having the diagnoses excluded. Detrimental reliance is, of course, a key general element of any fraud claim.  In the case brought by GAF, this issue was resolved in favor of GAF, but based on GAF’s argument that it had relied on fraudulent affidavits in connection with settlements of cases.  Thus, in essence, GAF adequately pleaded that it had relied on the fraudulent misstatements.[18]

Notwithstanding the general requirement that a fraud claim plead detrimental (and reasonable) reliance, there is authority that would support a RICO claim even if the RICO plaintiff did not rely on the fraudulent representations.[19] The reliance of a third party, such as a court or a jury may satisfy the reliance requirement.

“Pattern Of Racketeering Activity” 

Apart from the requirement of showing that predicate acts have occurred, a complaint under RICO must plead the existence of “a pattern of racketeering activity.”[20]  The RICO statute defines a “pattern of racketeering activity” as requiring a showing of “at least two acts of racketeering activity” committed within a 10-year period.  Most courts recognize that a “pattern” usually means more than two, with some courts requiring plaintiffs to show “continuity plus relationship” between or among the predicate acts to establish a “pattern of racketeering activity.”[21] The Supreme Court has stated that RICO plaintiffs can show “continuity plus relationship” for purposes meeting the RICO statutory RICO’s “pattern of racketeering activity” requirement by establishing a nexus between the defendant’s predicate acts.[22]

A plaintiff can establish the nexus by showing that “the criminal acts have the same or similar purposes, results, participants, victims, or methods of commission, or otherwise are interrelated by distinguishing characteristics and are not isolated events.”[23] The continuity element is basically a temporal connection, satisfied by showing “the predicates themselves amount to, or . . . otherwise constitute a threat of continuing racketeering activity.”[24] RICO plaintiffs can meet their burden by alleging and proving that either

(1) that the defendant’s predicate acts or offenses were part of the defendant’s regular way of doing business;[25] or

(2) that “a series of related predicates extend[ed] over a substantial period of time.”[26]

The Supreme Court has made clear that the proper focus is on long-term criminal conduct, and stated that “[predicate] acts extending over a few weeks or months and threatening no future criminal conduct [would] not satisfy [the continuity] requirement.”[27]  The federal circuits have continued to disagree about how to apply this mandate.

To succeed on a RICO claim, a product liability defendant must show that the pattern of activity with which it is concerned satisfies the continuity requirement inherent in the statutory reference to a “pattern of racketeering activity.”  The misconduct must have taken place over a significant period of time and over a wide number of cases; it must be ongoing and constitute a basic method of doing business for those involved.

Conducting the Affairs of the “Enterprise” Through the Pattern of Racketeering Activity

A complaint under RICO must also allege that a person has “conduct[ed]” the affairs of an enterprise engaged in interstate commerce through the pattern of racketeering activity.

Distinction between the Enterprise and the Pattern Of Racketeering Activity

An enterprise is a group of persons or entities associating together for the common purpose of engaging in a course of conduct.[28] Under the federal RICO statute, the enterprise may be a legal entity or “any union or group of individuals associated in fact although not a legal entity.”[29] A confederacy of individuals or entities may be a valid “associat[ion] in fact” enterprise.  But “[t]he plaintiff alleging an association-in-fact enterprise must adduce evidence demonstrating ‘an ongoing organization, formal or informal, and . . . evidence that the various associates function as a continuing unit.’ ”[30]  As one of the Circuits has stated, such an “associat[ion] in fact” enterprise:[31]

(1) must have an existence separate and apart from the pattern of racketeering,

(2) must be an ongoing organization and

(3) its members must function as a continuing unit as shown by a hierarchical or consensual decision making structure.

In considering the plaintiffs’ counsel’s racket in the Silica MDL as a protential RICO case, we must assess whether the network of silica plaintiffs’ lawyers and the cooperating medical screeners can properly be characterized as an “enterprise” within the meaning of RICO. Although the corrupt nature of the enterprise was apparent to Judge Jack, a RICO case will require particularity in pleading and proof of the cross-ties between the participants in the scheme. Beyond the evidence proffered in the Rule 702 hearing in In re Silica, a RICO plaintiff would have to develop further the ongoing relationships between plaintiffs’ counsel and the screening and sham-diagnosing physicians by showing their collaboration in and through professional organizations, joint efforts to influence legislation, and other activities, to define the nature and scope of their enterprise.[32]

Remedies

There are two types of remedies that might be available based on the RICO claim.  First, the plaintiff could seek the consequential damages incurred as a result of the pattern of racketeering activity.  Second, the plaintiff could seek equitable relief, including an injunctive to halt the illegal conduct.

Damages — Under section 1964(c) a RICO plaintiff must be “injured in his business or property” and “shall recover threefold the damages he sustains and the cost of the suit, including a reasonable attorney’s fee . . .”  “[T]he plaintiff only has standing if, and can only recover to the extent that, he has been injured in his business or property.”[33]    To seek consequential damages under RICO, an aggrieved product manufacturer would have to prove that the pattern of illegal behavior has imposed reasonably quantifiable costs.

In cases where the product liability defendant already prevailed, the defendant could seek the costs of defending the action.  Although the issue is not finally settled, there is strong authority for the proposition that litigation costs can be awarded under RICO notwithstanding the general rule that parties bear their own court costs.[34]  This rule is particularly appropriate in cases in which the predicate acts directly increased the difficulty and cost of defense.

If a product liability claim proceeded to jury verdict in favor of the plaintiff, the product manufacturer could not seek damages until it obtained relief from judgment. A final judgment in favor of plaintiff would bar, under the doctrine of res judicata, any RICO claim for the misconduct that went into obtaining the verdict.

Equitable Relief – The product liability defendant might also seek an injunction against a continuation of the pattern of racketeering activity in which the lawyers and medical professionals have engaged.  Whether Section 1964(c) authorizes equitable remedies for private litigants is an issue that has divided courts.[35]

Filing Suit against Lawyers and Physicians Involved in Particular Bogus Claims or Groups of Claims

State Fraud and Malicious Prosecution Actions

A defendant facing perjurious testimony in a line of improper product liability cases might also consider filing a test case against those responsible for a particular bogus claim or group of claims.  Although a single test case might seem to be easier endeavor than a broad RICO action, that is not necessarily true, due to the difference in the legal theories available.  As noted above, RICO and its state counterparts are notable for the fact that they allow civil remedies for misconduct proscribed by criminal law.

To prevail in a suit alleging malicious prosecution of a civil claim, in Texas for instance, a plaintiff must establish the following elements:

“(1) the institution or continuation of civil proceedings against the plaintiff;

(2) by or at the insistence of the defendant;

(3) malice in commencement of the proceedings;

(4) lack of probable cause for the proceeding;

(5) termination of the proceedings in defendant’s favor; and

(6) special damages.”[36]

Texas courts have made clear that “a plaintiff must suffer a special injury before recovering for malicious prosecution of a case.”[37]  A party is deemed to have suffered special damages when there is “some physical interference with a party’s person or property in the form of an arrest, attachment, injunction, or sequestration.”[38]

State-law based fraud claims raise the difficulties of proof of detrimental reliance discussed above in the context of RICO; namely, whether the product liability defendant must demonstrate that it detrimentally relied on the fraudulent conduct it alleges.  Some of the RICO case law promisingly suggests that third-party’s reliance will suffice, but there is a dearth of precedent for most states’ common law fraud. A number of states have adopted their own state analogues of the federal RICO statute. One potential advantage of proceeding under state RICO is that obstruction of justice may, in some states, serve as a predicate offense, without having to demonstrate bribery.

 Common Law Negligence Actions against Testifying Physicians

Although the harm arising from misleading opinion testimony can be substantial and readily foreseen, the law of most states gives testifying expert witnesses immunity from suit for negligently false or misleading testimony.[39]  More recent cases have prohibited parties from suing their adversaries’ expert witnesses, but have permitted parties to sue their own expert witnesses.[40]

In 1984, New Jersey took a big step towards permitting actions against adversarial expert witnesses by allowing a suit against an “impartial expert,” jointly appointed by the parties to render a binding asset valuation.  The New Jersey Supreme Court, in reversing a summary judgment for the expert, held that such an expert witness has no immunity from claims for breach of agreement, for breach of fiduciary duty, and for negligence.[41]

The Texas Supreme Court has allowed a man involuntarily committed to proceed with a negligence action against the psychiatrist who served as an expert witness for his children.[42] In decades since these narrow exceptions, there has been little movement on reducing the immunity that expert witnesses enjoy for incorrect testimony, negligently or even recklessly given.

Actions or Motions to Disqualify Testifying Expert Witnesses from Participating in Future Proceedings

Under the laws of most states, there is no opportunity to bar an expert witness from participating in future litigation endeavors on the basis of his past derelictions of duty.  The closest remedy to such prospective prohibition is a professional sanction such as licensure suspension or revocation, which would be readily discovered and used to impeach the offending expert witness in future cases.  As we have seen, such a sanction is quite rare in the United States.

Monetary Sanctions against Attorneys

Both state and federal law contain a variety of remedies for improper litigation conduct, including Federal Rule of Civil Procedure 11, 28 U.S.C. § 1927, and the inherent supervisory powers of the court, and others, to address improper litigation expert witness conduct. Historically, these three approaches have not provided any meaningful remedy against meretricious expert witness testimony.

Conclusion

Encouraged by legal counsel, and fueled by partisan zeal or desire to shape public policy through the workings of tort law, expert witnesses have shaped and distorted the law.  The imposition of a reliability standard in Federal Rule of Evidence 702 has ameliorated the situation a bit in federal court, at least when federal district judges are willing to make the effort to understand the science and examine the testimony for its logical and scientific gaps and errors.  The situation in many state courts is not so sanguine, and there are situations in all courts where more serious remedies than simple exclusionary rules are needed.  The law is catching up with the magnitude of the problem created by the prosecution of mass torts, with fortunes at stake.  The solutions will take creativity and persistence from those aggrieved by bogus science and bad medicine in the courtroom.


[1]  CSX Transp., Inc. v. Peirce, 974 F. Supp. 2d 927 (N.D. W. Va. 2013), app. dism’d sub nom. CSX Transport., Inc. v. Gilkison (4th Cir. Nov. 6, 2014).

[2]  18 U.S.C. § 1962(c).

[3] Section 1962 contains other prohibitions against racketeering activity.  However, the prohibition in § 1962(c) referred to above is the most plausible avenue for relief in the present context.

[4] While the plaintiffs themselves are likely encouraged to give false or unfounded testimony, the medical professionals are a more appropriate subject of attention, for both substantive and tactical reasons.

[5]  18 U.S.C. § 1961(1)(B).

[6]  18 U.S.C. § 1503.

[7]  18 U.S.C. § 1512.

[8]  18 U.S.C. § 201.

[9] “The state law felony offenses listed in § 1961(1)(A) are included by generic designation, and the test for determining whether particular acts fit into the generic category of predicate offense is whether the complaint alleges the type of activity generally known or characterized in the proscribed category.”  Heden v. Hill, 937 F. Supp. 1230 (S.D. Texas 1996) (citing United States v. Forsythe, 560 F.2d 1127, 1137 (3d Cir.1977)).

[10] 18 U.S.C. § 201 criminalizes “bribery of public officials and witnesses” in federal proceedings.  This language lends further credence to the conclusion that transferring improper benefits to witnesses in exchange for favorable testimony constitutes “bribery” within the meaning of the RICO statute.

[11]  Texas Penal Code § 36.05, entitled “tampering with witness,” makes such undue influence on witnesses punishable by a prison term of not less than two years.

[12] The phrase “official proceeding” is no longer defined in the statute.  A 1993 amendment to the Texas Penal Code deleted the prior definition, which would have been broad enough to encompass civil cases brought in state court, as well as a variety of other contexts.

[13]  Mississippi Statute § 97-9-65.  This statute cross-references the Mississippi RICO law.

[14] 18 U.S.C. § 201(d) (“Bribery of public officials and witnesses).” Similarly, Texas and Mississippi both have rules that allow payment of reasonable expert fees in their Rules of Professional Conduct.  See V.T.C.A., Govt. Code T. 2, Subt. G App. A, Art. 10, § 9, Rule 3.04 (a lawyer may pay “a reasonable fee for the professional services of an expert witness.”); MS R.P.C. Rule 3.4 Comment (“it is not improper to pay a witness’s expenses or to compensate an expert witness on terms permitted by law.  The common law rule in most jurisdictions is that it is improper to pay an occurrence witness any fee for testifying and that it is improper to pay an expert witness a contingent fee.”)

[15]  “Legal Remedies for Suspect Medical Science in Products Cases – Part One” (June 2, 2020).

[16]  18 U.S.C. § 1341.

[17]  18 U.S.C. § 1343.

[18]  See G-I Holdings, Inc. v. Baron & Budd, 238 F.Supp. 2d 521, 539-40, 542-43 (S.D.N.Y. 2002).

[19]  See, e.g., Ideal Steel Supply Corp. v. Anza, 373 F.3d 251, 262-63 (2d Cir. 2004) (“a plaintiff who is injured as a proximate result of RICO predicate acts of fraud need not prove his own reliance, rather than that of a third party… .”); Procter & Gamble Co. v. Amway Corp., 242 F.3d 539 (5th Cir. 2001) (upholding RICO claim by Procter & Gamble against competitors that disseminated rumors that plaintiff was linked to Satanism, although plaintiff had in no way relied upon those rumors); City of New York v. Cyco.Net, Inc., 2005 WL 174482 (S.D.N.Y., Jan. 27, 2005).

[20]  18 U.S.C. § 1961(5).

[21]  See Sedima, S.P.R.L. v. Imrex Co., 473 U.S. 479, n.14 (1985).

[22]  H.J. Inc. v. Northwestern Bell Telephone Co., 492 U.S. 229, 239, 251 (1989.

[23]  Id. at 240.

[24]  Id.

[25]  Id. at 240-42.  Such allegations established an “open-ended” pattern.

[26]  Id. at 242.  Such allegations establish a “closed-ended” pattern.

[27]  Id.

[28]  United States v. Turkette, 452 U.S. 576, 583 (1981).

[29]  18 U.S.C. § 1961(4) (emphasis added).

[30] Whelan v. Winchester Prod. Co., 319 F.3d 225 (5th Cir. 2003)(quoting Turkette, 452 U.S. at 583).

[31]  Crowe v. Henry, 43 F.3d 198, 205 (5th Cir. 1995).

[32]  See, e.g., State Farm Mut. Auto. Ins. Co. v. Giventer, 212 F.Supp. 2d 639 (N.D. Tex. 2002) (rejecting RICO claim by automobile insurer defrauded into paying claims when plaintiff failed to an enterprise of plaintiffs’ lawyers and chiropractic clinics).

[33]  Sedima S.P.R.L. v. Imrex Co., 473 U.S. 479, 496 (1985).

[34]  See, e.g., Malley-Duff & Assocs., Inc. v. Crown Life Ins. Co., 792 F.2d 341, 354-55 (3d Cir. 1986), aff’d, 483 U.S. 143 (1987); Stochastic Decisions Inc. v. DiDomenico, 995 F.2d 1158, 1167 (2d Cir. 1993). On the other hand, a court may be reluctant to award litigation costs with respect to claims that have not yet been resolved.

[35]  Compare Nat’l Org. for Women, Inc. v. Scheidler, 267 F.3d 687 (7th Cir. 2001) (private equitable relief available), with Religious Technology Ctr. v. Wollersheim, 796 F.2d 1076 (9th Cir. 1986) (private equitable relief unavailable).

[36]  Fuqua v. Graber, 158 S.W.3d 635, 638 (Tex. Ct. App. 2005), quoting Tex. Beef Cattle Co. v. Green, 921 S.W.2d 203, 207-08 (Tex. 1996).

[37]  Tex. Beef Cattle, 921 S.W.2d at 208-09.

[38]  Id. at 209, citing Sharif-Munir-Davidson Dev. Corp. v. Bell, 788 S.W.2d 427, 430 (Tex. App. 1990). Similarly, the elements of a tort of malicious prosecution is Mississippi are: “(1) the institution of a proceeding (2) by, or at the insistence of the defendant (3) the termination of such proceedings in the plaintiff’s favor (4) malice in instituting the proceedings and (5) the suffering of injury or damage as a result of the prosecution.”  Williams v. Jungle, — So. 2d – , 2005 WL 43721 (Miss. Jan. 11, 2005), citing McClinton v. Delta Pride Catfish, Inc., 792 So. 2d 968, 973 (Miss. 2001).  All of the elements must be proven by a preponderance of the evidence.  See Williams, — So. 2d, 2005 WL 43721 at *1, citing Van v. Grand Casinos of Mississippi, Inc., 724 So. 2d 889, 891 (Miss. 1998).

[39]  See, e.g., Briscoe v. LaHue, 460 U.S. 325 (1983)(noting that expert witnesses have absolute immunity for harm caused to opposing parties from incorrect or misleading testimony).

[40]  See, e.g., LLMD of Michigan, Inc. v. Jackson-Cross Co., 740 A.2d 186, 191 (Pa. 1999) (holding that a party may sue its expert witness for negligence); Murphy v. A.A. Mathews, 841 S.W. 2d 671, 682 n.11 (Mo. 1992).

[41]  Levine v. Wiss & Co., 97 N.J. 242, 478 A.2d 397, 402 (1984).

[42]  James v. Brown, 637 S.W.2d 914 (Texas 1982) (per curiam).

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

June 7th, 2020

Requirements Imposed By State Licensing Boards and Medical Professional Societies

The involvement of medical professionals in disciplining physicians for dubious litigation testimony, whether through state licensing authorities or voluntary medical associations, raises some difficult questions:

  1. Does a physician’s rendering an opinion on a medical issue in litigation, such as diagnosing silicosis, asbestosis, welding-induced encephalopathy, or fenfluramine-related cardiac injury, constitute the “practice of medicine” within the meaning of state law regulating the practice of medicine?
  1. If a physician deviates from the standard of care in rendering such an opinion, either negligently or intentionally, what remedies are available, and to whom?
  1. How should we consider the partitioning of the diagnostic process, when an essential part of the diagnosis is provided by physicians who do not testify at trial, such as radiologists who conduct screenings for lawyers?
  1. What professional standards have been adopted by the medical profession (or licensing agencies or others) for giving testimony in litigation on medical subjects?
  1. Are the views of professional associations such as the American Medical Association properly invoked by litigants?

The record of medical boards and professional societies’ efforts to curb abusive medico-legal testimony is uneven.[1] In one closely followed case, the North Carolina Medical Board revoked a physician’s license on the basis of finding of “unprofessional conduct” in the form of testimony given in a medical malpractice case. The Board found that Dr. Lustgarten had misrepresented the applicable standard of care and accused one of the malpractice defendants of having intentionally falsified medical records without a good faith basis.[2]

A reviewing trial court reversed the finding of misrepresentation of the standard of care, but agreed that Lustgarden had wrongly asserted the defendant’s fabrication of records, and modified the revocation to a one year suspension.[3] On appeal to the North Carolina Court of Appeals, the court held that the Board had the power to suspend or revoke a physician’s license for “unprofessional conduct,” and that providing expert witness testimony was a form of practicing medicine subject to peer review and discipline. Upon reviewing the factual record, however, the Court of Appeals held that the lower court’s finding was unsupported:

“Dr. Lustgarten did not actually state that the defendant had ‘falsified’ a medical record or use the terms ‘liar’ or ‘lying’ to describe the other physician or his conduct. Rather, these terms were introduced by the attorneys representing the defendant.”

Dr. Lustgarten had couched his opinion as a “difficulty believing” the defendant’s record notations, in the appellate court’s view did not merit the sanctions imposed. Although such licensure suspensions or revocations for “testimonial misadventures” remain rare, the Lustgarten case illustrates that Medical Boards have the power to police medico-legal testimony.[4]

Medical societies, although voluntary, may have considerable influence on teaching and hospital privileges and positions.  Most medical societies have shown no interest in taking disciplinary action against members on the basis of testimony given while serving as expert witnesses.[5] One notable exception is the American Association of Neurological Surgeons (AANS).  In 1996, the AANS suspended member Dr. Donald Austin over negligent testimony given as an expert witness in a medical malpractice action.  Dr. Austin, claiming substantial loss in revenues from work as an expert witness, sued the association.  The federal district court dismissed Dr. Austin’s claims, and the Seventh Circuit of the U.S. Court of Appeals affirmed.[6]

Involvement in Litigation as the “Practice of Medicine”

The “practice of medicine” is generally defined and regulated by state statutes.[7] The terms of the respective state statutes vary significantly, but certain of the statutes, or regulations adopted under them, define what constitutes the “practice of medicine,” and some of these provisions expressly address the subject of expert testimony.

The relevant Utah statute was interpreted in an asbestos products case, in which the defendants asserted that:

“the physician who rendered the diagnoses and the technician who administered the pulmonary function tests did so without the required licenses.  Indeed, contend Defendants, these tests and diagnoses were not by treating physicians licensed in Utah, but by a physician who traveled to Utah with the sole purpose of generating asbestos claims at motels.  Consequently, assert Defendants, these diagnoses and tests are flawed, unreliable, untrustworthy and illegal and should, therefore, be inadmissible under Utah law governing the admissibility of expert testimony and under Utah’s public policy.  Moreover, contend Defendants, without these diagnoses, Plaintiffs have no proof of medical causation and, as a result, their claims must be dismissed.”[8]

The Utah asbestos plaintiffs invoked the following statutory exemption from the medical licensure requirement of the Utah statute, which permits an expert witness to provide testimony, in Utah, without a Utah license.[9] The Utah trial court rejected plaintiffs’ reliance upon the statutory exemption, essentially because the doctor in question had rendered diagnostic reports rather than simply testifying in a court proceeding.  The court thus concluded that the doctor had in fact:

“practiced medicine in Utah, without a licence [sic], and [that] these practices resulted in the diagnostic reports that now serve as the basis for Plaintiffs’ law suits.”[10]

Since a case cannot be brought unless the plaintiff has first been diagnosed with a compensable condition, the court’s conclusion as a practical matter means that Utah plaintiffs must first be diagnosed by Utah physicians, or at least by a physician with a current temporary or other license to practice in the state.  More important, the opinion necessarily implies that a medico-legal diagnosis of diseases such as asbestosis or silicosis must comply with the professional standards applicable to medical opinions.

A decision from a Seattle area trial court sustained a challenge similar to the Utah challenge to an expert witness proffered by plaintiffs’ firm Brayton Purcell. Judge Sharon Armstrong considered defendants’ challenge to a physician who participated in union screenings of plaintiffs.[11] The physician in question examined and diagnosed the plaintiffs, and recommended treatment, in Washington State, where he was not licensed. The physician in question also relied upon radiographic interpretations form unregistered and uncertified technicians and radiologists, who had used unregistered and uncertified equipment.

Judge Armstrong dismissed the complaint, without prejudice. Accepting the “tainted” evidence generated by the unlicensed practice of medicine would contravene public policy.[12] Although the challenged physician had committed a criminal offense under Washington law, Judge Armstrong did not refer the matter to the King County prosecutor.

In sum, there is support for the proposition that medical screenings, as well as the actual diagnoses of disease, constitute the “practice of medicine” subject to state regulation.  One extraordinary but distinguishable case from the Fourth Circuit suggests that a notorious screening physician, the late Dr. Ray Harron, did not have a patient-physician relationship such that a patient injured as a result of the screening could sue him for malpractice.[13] The plaintiff had received a chest X-ray in a mass screening that resulted from a law firm solicitation. West Virginia radiologist, Dr. Ray Harron, who gained much international notoriety from Judge Jack’s review of his professional misdeeds, read the chest films and suggested that the plaintiff might have lung cancer. Plaintiff’s counsel, however, failed to alert his client. The Court of Appeals affirmed a dismissal of the case on the grounds that there was no patient-physician relationship under West Virginia law.  The per curiam decision does not reveal whether the American Medical Association ethical and practice guidelines, discussed more fully below, were raised in support of the plaintiff’s claim.

Standards of Conduct Adopted by the American Medical Association And Other Professional Associations

The American Medical Association (“AMA”) has adopted a variety of ethical standards for expert testimony that are directly relevant to the issues of abusive medico-legal activities and testimony. Although the AMA’s ethical standards have not been invoked frequently in the reported cases,[14] they provide useful guidance on a number of issues concerning appropriate standards for physician participation in litigation.

To begin with, the AMA has endorsed the proposition that testimony on medical subjects, at least by physicians, constitutes the practice of medicine.  AMA Provision H-265.993, concerning “Peer Review of Medical Expert Witness Testimony,” states that:[15]

“AMA policy is that: (1) the giving of medico-legal testimony by a physician expert witness be considered the practice of medicine, and (2) all medico-legal expert witness testimony given by a physician should be subject to peer review.”

Furthermore, the AMA has adopted standards on the basis for, and quality of, testimony by physicians that at least generally mirrors the types of requirements imposed by courts which have followed Daubert Rule 702 standards.  Code provision E-9.07, concerning “Medical Testimony,” states in part that:

“When physicians choose to provide expert testimony, they should have recent and substantive experience or knowledge in the area in which they testify, and be committed to evaluating cases objectively and to providing an independent opinion. Their testimony should reflect current scientific thought and standards of care that have gained acceptance among peers in the relevant field. If a medical witness knowingly provides testimony based on a theory not widely accepted in the profession, the witness should characterize the theory as such. Also, testimony pertinent to a standard of care must consider standards that prevailed at the time the event under review occurred.

All physicians must accurately represent their qualifications and must testify honestly. Physician testimony must not be influenced by financial compensation; for example, it is unethical for a physician to accept compensation that is contingent upon the outcome of litigation.

Organized medicine, including state and specialty societies, and medical licensing boards can help maintain high standards for medical witnesses by assessing claims of false or misleading testimony and issuing disciplinary sanctions as appropriate… .”[16]

Similarly, AMA Code provision H-265.994, “Expert Witness Testimony,” states, among other relevant provisions, that:

“(2) Our AMA is on record that it will not tolerate false testimony by physicians and will assist state, county and specialty medical societies to discipline physicians who testify falsely by reporting its findings to the appropriate licensing authority… .”[17]

While the AMA has no power to require physicians to comply with its pronouncements, the Association has stated that its official policy is for all physicians who serve as expert witness in medical liability litigation should affirm in writing their intent to adhere to AMA principles for giving expert witness testimony.[18]

The AMA policies, guidances, and principles, if followed, would go a long way towards reducing abusive screenings and meretricious testimony.


[1]  See generally David B. Resnik, “Punishing Medical Experts for Unethical Testimony: A Step in the Right Direction or a Step too Far?” 4 J. Philosophy, Science & Law 45 (2004); Juan Carlos B. Gomez, “Silencing the Hired Guns: Ensuring Honesty in Medical Expert Testimony Through State Legislation,” 26 J. Legal Med. 385 (2005); Robert S. Peck & John Vail, “Blame It on the Bee Gees: The Attack on Trial Lawyers and Civil Justice,” 51 N. Y. L. Sch. L. Rev. 323 (2006-2007).

[2]  In re Gary James Lustgarten, M.D., Opinion and Order (March 30, 2004).

[3]  Lustgarten v. North Carolina Med. Bd., Wake Cty. Super. Ct. N. C., No. 02 CVS 12218 (Apr. 18, 2005).

[4]  In re Gary James Lustgarten, MD, 177 N.C. App. 663, 629 S.E.2d 886 (2006). See generally John M. Luce, “The Development of Professional Standards for Physician Expert Witnesses in Medical Malpractice Litigation in the United States,” Unpublished MS (2014); Ronald M. Sandgrund, Scott F. Sullan, Leslie A. Tuft, and Jennifer A. Seidman, “Crossing the Separation of Powers Threshold: Legislative and Regulatory Control of Expert Testimony,” 37 The Colorado Lawyer 27 (May 2008); Nadia N. Sawicki, “A Theory of Discipline for Professional Misconduct” (Mar. 3, 2009).

[5]  See Opinion of Bill Lockyer, Attorney General of the State of California, and Gregory L. Gonot, Deputy Attorney General dated April 28, 2004, which stated, in a medical malpractice context, that “[w]hen a physician testifies as an expert in a civil proceeding regarding the applicable standard of medical care and whether the defendant has breached that standard, the physician may not, on the basis of his or her testimony, be held liable in a subsequent tort action brought by the adverse party, but may be subject to professional discipline by the Medical Board of California if the testimony constitutes unprofessional conduct.”

[6]  Austin v. American Association of Neurological Surgeons, 253 F.3d 967 (7th Cir. 2001). See Wood, “Professional Oversight of Expert Testimony – Austin v. American Association of Neurological Surgeons,” 7 Virtual Mentor – Ethics J. Am. Med. Ass’n (2005).

[7]  See generally 61 Am. Jur. 2d § 25.

[8]  In re Asbestos Cases of Brayton Purcell v. Asbestos Defendants, Case No. 010900863, Op. at 1-2 (Dist. Ct. of the Third Judicial Dist. for Salt Lake Cty., Utah) (Jan. 25, 2005) [Brayton op.]

[9]  Utah Code Ann. § 58-67-305.

[10]  Brayton op. at 3.

[11]  In re Certain Asbestos Cases (ACR XXIV Cases), No. 89-2-18455-9 SEA (Superior Court for King County, Washington) Order Granting Summary Judgment (Oct.15, 2002) (Hon. Sharon Armstrong).

[12]  See Nickila v. Board of Chiropractic Examiners, 862 P.2d 555 (Or. App. 1993) (affirming sanctions issued by Board of Chiropractic Examiners, against petitioner, for participating in an X-ray procedure while his license was suspended; rejecting petitioner’s argument that he was not practicing medicine because he acted in concert with or through other practitioners); West Virginia Radiologic Technology Board of Examiners v. Darby, 427 S.E.2d 486 (W. Va. 1993) (holding regulations prohibiting unlicensed persons from practicing radiologic technology also prevented licensed medical practitioner from employing unlicensed technician; “If a person is found taking X-rays without a license, the Board can enjoin that individual from engaging in further practice pursuant to W.Va. Code 30-23-12”); Nelson v. Palmquist, 363 N.W.2d 570, 572 (S.D. 1985) (holding defendant practiced chiropractic without a license when he examined and interpreted X-rays; defendant engaged in “diagnosis” in violation of the South Dakota statute); People v. Allied Medical Clearing House Incorporated, 285 N.Y.S.2d 439, 493-94 (N.Y. Sup. Ct. 1967) (holding evaluation by defendant of X-rays of litigants, taken at labs under contract with defendant constituted practice of medicine without a license); Chiropractic Association of New York, Inc. v. Hilleboe, 227 N.Y.S.2d 309, 313 (N.Y. Sup. Ct. 1961) (“When in this state a man whether he calls himself a chiropractor or something else, diagnoses the case of one who comes to him for help as requiring an X-ray and either takes the X-ray himself or sends the one seeking help to someone else to take the X-ray, he is practicing medicine within the meaning of section 6501, subdivision 4. . . .”); Smith v. State Board of Medicine of Idaho, 259 P.2d 1033, 1038 (Idaho 1953) (“The conclusion is inevitable, therefore, that appellant in performing surgery — though classified by him as only minor — using drugs, and diagnosing by the use of X-ray, was, as found by the learned trial court, practicing medicine and surgery without a license; therefore, he was violating the law.”).

[13]  Adams v. Harron, 1999 WL 710326 (4th Cir. 1999) (per curiam)

[14]       See, e.g., Piscopo v. Secretary of Health and Human Services, 66 Fed.Cl. 49, 52 (Court of Federal Claims 2005); Doe v. Secretary of Health and Human Services, 2004 WL 3321202, *22 n.40 (Court of Federal Claims, Office of the Special Masters, Oct. 5, 2004).

[15]  Res. 221, I-97; Reaffirmed: BOT Rep. 18, I-98; Reaffirmation A-99; Reaffirmation, A-00.

[16]  Code provision E-9.07, “Medical Testimony,” issued December 2004.

[17]  See H-265.992, “Expert Witness Testimony”[17]; H-265.997, “AMA-ABA Statement on Interprofessional Relations for Physicians and Attorneys”; D-265.997, “False Testimony”; D-265.994, “Expert Witness Affirmation”; 265.995, “Physician Testimony Related to Tobacco and Health”; D-490.989, “Expert Witness Testimony by Physicians on Behalf of Tobacco Companies.”

[18]  See H-265.990, “Expert Witness Affirmation,” which provides that “AMA policy is that all physicians, serving as expert witnesses in medical liability litigation, voluntarily sign an expert witness affirmation explicitly stating that they will adhere to the AMA’s principles guiding expert witness testimony. (Res. 7, A-04).”

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, 109th Congress, 1st 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 (4th 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 (10th 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 (4th 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”).

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 (5th 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 (5th 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.

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

June 2nd, 2020

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

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

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

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

GAF’s Litigation against the Asbestos Lawsuit Industry

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

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

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

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

And GAF complained that:

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

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

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

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

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

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

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

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

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

Federal and State Prosecutions against Physicians and Screening Companies

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

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

The Pennsylvania Silicosis Litigation Cock Up

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

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

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

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

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

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

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

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

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


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

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

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

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

[5]  Fourth Amended Complaint, ¶ 61.

[6]   18 U.S.C. § 1961, et seq.

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

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

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

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

ACGIH TLVs Lack Scientific Integrity & Transparency – The Mica NIC

June 2nd, 2020

The American Conference of Governmental Industrial Hygienists (ACGIH®) is a non-profit corporation established in 1938, to advance occupational and environmental health.  The corporation’s motto, included in its logo, hubristically announces:  “Defining the Science of Occupational and Environmental Health.”

Philosophers of science may demur from “the” in “the Science,” as well as from the intellectual arrogance in suggesting that this private organization has any such ability to commandeer the complex social nature of scientific knowledge. And yet, in the small area of setting permissible exposure limits to potential environmental or occupational toxic substances, the ACGIH is in the business of “defining” safety. Starting in 1941, the group started to review and recommend “exposure limits.” In 1956, the group coined (literally and figuratively) the term “threshold limit values” (TLVs®), and started to publish documentation for its recommended values.

From the beginning, the ACGIH has asserted that TLVs® are not standards; rather they are guidelines for use, with other information, in determining safe levels of workplace and environmental exposure. The ACGIH maintains that its TLVs are based upon published, peer-reviewed scientific studies in industrial hygiene, toxicology, occupational medicine, and epidemiology, without consideration for economic or technical feasibility.

Beginning in the 1980s, “the Lobby”[1] started to throw brushback pitches at the ACGIH to bully the organization out of positions that the Lobby thought were too comforting to manufacturing industry.[2]  The result was a dramatic shift in the ACGIH’s perspective. The bullying created a “white-hat” bias that operates as a one-way ratchet to push the ACGIH always to lower TLVs, regardless whether there was a scientific warrant for doing so. Efforts to curb ACGIH overreach by litigation have generally failed. The TLVs have becoming increasingly controversial and non-evidence-based.[3]

What follows is what a hypothetical stakeholder might submit in response to a recent ACGIH Notice of Intended change for its TLV for mica dust. Like other mineral dusts, mica when inhaled in large quantities over long time periods, causes a pneumoconiosis. Documenting a “reasonable safe” level requires studies with adequate quantification of exposure. I will leave the reader to decide whether the ACGIH has that evidence in hand, based upon the following.

[1]  F.D.K. Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997); seeThe Lobby Lives – Lobbyists Attack IARC for Conducting Scientific Research” (Feb. 19, 2013).

[2]  Barry I. Castleman & Grace E. Ziem, “Corporate influence on threshold limit values,” 13 Am. J. Indus.  Med. 531 (1988); Grace Ziem & Barry I. Castleman, “Threshold limit values: historical perspectives and current practice,” 31 J. Occup. Med. 910 (1989); S.A. Roach & S.M. Rappaport, “But they are not thresholds:  a critical analysis of the documentation of Threshold Limit Values,” 17 Am. J. Indus. Med. 727 (1990).

[3]  Philip E. Karmel, “The Threshold Limit Values Controversy,” N.Y. L. J. (Jan. 3, 2008).

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

These comments are in response to the proposed change in the ACGIH® TLV® for Mica, as explained in the ACGIH “Mica: TLV® Chemical Substances Draft Documentation, Notice of Intended Change” (“NIC”).  For the reasons stated below, the change in the Mica TLV-TWA (time-weighted average) in the NIC is not warranted and the existing Mica TLV should not be changed.

The ACGIH® TLVs® are important non-governmental standards, largely because a number of government entities incorporate TLVs by reference into regulations and thus give TLVs the force of law.[4]  For example, some states and Canadian provinces simply adopt TLVs as state or provincial occupational exposures levels, and some states have established “maximum allowable ambient concentrations” or similar limits on “toxic air contaminants” based entirely or in part on TLVs.  The U.S. Mine Safety and Health Administration (MSHA) uses the 1973 ACGIH TLV for crystalline silica (quartz) as a legally enforceable permissible exposure level.[5]  The U.S. Occupational Health and Safety Administration (OSHA) Hazard Communication Standard requires that ACGIH TLVs be disclosed in required Safety Data Sheets.  The process by which the ACGIH develops TLVs is critically important, and furthermore, given the regulatory and legal significance of the ACGIH TLVs, the ACGIH has the burden to support proposed changes in TLVs by an adequate process, which includes transparency and evidence sufficient to support any proposed change.

The flaws in the ACGIH TLV setting process are well known and the subject of several publications, most recently in paper titled “142 ACGIH Threshold Limit Values® established from 2008-2018 lack consistency and transparency.”

The following specific comments address the ACGIH’s process disclosed in the ACGIH’s NIC in support of its proposed change for the TLV-TWA for mica, which illustrate the process problem — the ACGIH NIC for the proposed Mica TLV-TWA change does not support the change proposed by the ACGIH.   Again, the ACGIH TLVs have regulatory and legal significance; therefore, the ACGIH should not make TLV changes arbitrarily and capriciously.  Instead, the changes should be made pursuant to a transparent process, and the ACGIH should support the proposed changes with the weight of the available evidence, and the evidence in support of and the reasons for the proposed change should be publicly disclosed.  It has not done that in this case, and its own NIC makes it clear that it has not:

  1. There is no evidence that “mica is an important cause of disabling occupational pneumoconiosis” as stated in the NIC. 

The NIC provides no citation or other supporting evidence for this conclusion; it merely states the conclusion as “fact” and a premise for the proposed change.[6] The NIC fails to estimate the number of workers currently potentially exposed to mica in the U.S. (or elsewhere), what industries these workers work in, what forms of mica these workers may be exposed to, what levels of respirable mica these workers may be exposed to, and to what extent pneumoconiosis caused by the inhalation of respirable mica exists.[7]

  1. The NIC proposes to materially lower the TLV for mica, but, other than noting that there are “nine different major species”, does not adequately address the mineralogical differences between the different species of mica, makes no attempt to assess the potential adverse health effects for the different species of mica, does not examine the “dose-response” data (as inadequate as it is) for the different species of mica, and so on. 

The “Chemical and Physical Properties” section of the NIC suggests the wide variety of materials that fall within the general term “mica”.  In spite of this, the ACGIH appears to have ignored differences and concluded that the TLV for “mica” as a general category of substances should be applicable to all forms of mica, with no support for this conclusion in the NIC.[8]

  1. The human studies (sic) cited in the NIC are inadequate to support a decision to change the mica TLV and do not support the mica TLV proposed.

The first cited study involved four employees in a muscovite milling plant, with an alleged exposure to respirable mica (as muscovite) dust between 1.86 and 5.77 mg/m3.

The second cited study involved a (one) South African man who worked in a mica milling factory.  As noted in the NIC, “[q]uantitative exposure data were not reported.”

The third cited study involved a (one) 65-year old who worked in the rubber industry for 40 years, where he was exposed to numerous dusts, including mica.  There was no exposure data reported.

The fourth study involved a (one) 62-year old woman allegedly exposed to “pure mica” for seven years; no quantitative exposure data were available.

The NIC cites the case of a worker who bagged mica flake for 36 years.  In this case, there were, apparently, two dust samples taken – one at the time of a medical exam of the worker at age 54, total dust of 0.2 mg/m3 — and one taken 17 years earlier – 0.7 mg/m3.  The bulk mica samples disclosed 7.1% to 8.4% silica (presumably, respirable crystalline silica as quartz).  The reference to the silica content of the “bulk samples” suggests that there was no analysis of the material collected in the two air samples taken.

The NIC cites the case of two British men who worked as “grinders of imported muscovite,” one starting in 1957. The “workplace dust concentrations were not quantified.”

The next paper cited in the NIC was from 1940 and involved employees who were exposed to the dust caused by “mica-scrap” grinding.  There was actually an attempt to quantify mica exposures (the data from before 1940), but it was done by particle count.  The NIC notes that the available information regarding mica health effects may be “limited by potential uncertainty converting from mppcf (million particles per cubic foot) to mg/m3 (which might not apply to all dust exposure scenarios).”  The difficulties associated with converting from mppcf to mg/m3 are well known in the cases of minerals far more extensively studied than mica (e.g., crystalline silica as quartz).  In addition to the conversion factor issue, there are other concerns raised by relying upon a paper published in 1940 to support a TLV today, such as, the quality of the sampling, the quality of the chest x-rays, and issues with the classification of the chest x-rays.  With that said, the NIC noted that “[n]one of the workers exposed at less than 10 mppcf (1.8 mg/m3), irrespective of employment duration, developed pneumoconiosis.”

The remaining studies cited in the NIC are similar.  But, to close this section of the comments, I will refer to the last study, a study of 71 South African workers employed in mica milling.  Twelve personal and static samples were taken during the course of the study.  The results of the personal samples indicated a range of respirable dust (or was it mica?) between 0.4 to 1.68 mg/m3.  The radiologic examination disclosed that 19 of the 71 workers had changes consistent with one or more of asbestos, silica and/or mica.  “The specific dust concentrations to which the individuals presenting with lung changes were exposed were not reported.”

The ACGIH is proposing a reduction in the mica TLV based on the studies as described in the NIC.  We submit that this is a process and transparency problem – there is simply no way to conclude that a reduction in the mica TLV is warranted based on the Human Studies (the “evidence”) cited in the NIC.  In most cases, the Human Studies are simply case reports involving one, two, or a few people, with no quantitative exposure data.  The studies with exposure data are inadequate, i.e., date from before 1940, and among other things measured exposure as mppcf, with one study literally including two samples.  Given the legal and regulatory significance of ACGIH TLVs, the evidence cited in support of the change in the mica TLV, and the reasonable conclusion that can be drawn from the evidence cited, should exceed some threshold and meet some burden.  The evidence in the NIC is grossly insufficient to support the proposed change.

  1. The NIC for mica does not disclose any evidence to support the proposed TLV of a TWA of 0.1 mg/m3

The comparison to OSHA’s notice of proposed rulemaking for occupational exposure to respirable crystalline silica (RCS) is instructive.  The supporting documentation sets forth a preliminary quantitative risk assessment outlining life-time risks for various disease end points associated with occupational exposure to RCS at various levels.  The preliminary quantitative risk assessment disclosed all of the underlying studies and methodology, sufficient to allow a reader to understand the basis for the risk assessment conclusions and agree or disagree with the conclusions.  Based on the risks (and other factors not considered by the ACGIH) set forth in the documentation, OSHA proposed a PEL (permissible exposure level) for RCS.

By contrast, the ACGIH simply contends for its proposed mica TLV: “Consequently, a TLV-TWA of 0.1 mg/m3 measured as respirable fraction (containing no asbestos and <1% crystalline silica) is recommended.”  The materials preceding “[c]consequently”, which in normal reading would be expected to support the conclusion following, are not a risk assessment or anything similar to one, and in no way even superficially support the conclusion – the recommendation – stated.[9]  Therefore, the ACGIH proposed a TLV-TWA of 0.1. The NIC materials do not support a TLV of 0.1 mg/m3, any more than they support a TLV of 0.0001 or 10.  It cannot be stated too emphatically that the NIC is devoid of any evidence to support any TLV, including the recommended TLV-TWA of 0.1 mg/m3.

Of course, the ACGIH TLV process is not a federal rulemaking.  And readers should be aware of the ACGIH Position Statement regarding TLVs (“TLVs … are not quantitative levels of risk at different exposure levels…”). But the same Position Statement notes that “TLVs®…represent conditions under which ACGIH® believes that nearly all workers may be repeatedly exposed without adverse health effects.”  So, presumably, the ACGIH concluded that its proposed mica TLV was that level, and yet there is simply no evidence in the NIC to support that conclusion.  Given the regulatory and legal significance of TLVs, the process of establishing TLVs should have some basis in science and evidence.

References

ACGIH® TLV/BEI® Position Statement, available at: https://www.acgih.org/tlv-bei-guidelines/policies-procedures-presentations/tlv-bei-position-statement

ACGIH® TLV/BEI® Policy Statement, available at: https://www.acgih.org/tlv-bei-guidelines/policies-procedures-presentations/tlv-bei-policy-statement

30 C.F.R. § 56.5001 (MSHA exposure to airborne contaminants)

29 C.F.R. § 1910.1200 (OSHA Hazard Communications)

D. Davies & R. Cotton, “Mica pneumoconiosis,” 40 Br. J. Indus. Med. 22 (1983)

Subhabrata Moitra, “Mica pneumoconiosis: a neglected occupational lung disease – letter,” 6 The Lancet Respir. Med. e39 (2018), available at: https://www.thelancet.com/journals/lanres/article/PIIS2213-2600(18)30178-4/fulltext

Notice of Proposed Rule Making (NPRM) for Occupational Exposure to Respirable Crystalline Silica, 56 Fed. Reg. 56273 (Sept. 12, 2013)

Knut R. Skulburg, “Mica pneumoconiosis – a literature review,” 11 Scand. J. Work & Envt’l Health 65 (1985)

Carl J. Smith & Thomas A. Perfetti, “142 ACGIH Threshold Limit Values® (TLV®s) established from 2008-2018 lack consistency and transparency,” 3 Toxicol. Research & Application 1 (2019)


[4] ACGIH states that TLVs are not intended to be legal standards, but the ACGIH recognizes the broad use of TLVs and should reasonably anticipate that TLVs will be used in ways beyond the scope of the legal disclaimers that the ACGIH publishes.

[5] 30 C.F.R. 56.5001

[6] The problems cited by Moitra — illegally operated mica mines exploiting vulnerable populations to work without protections in India and some African countries — speak to the need to eliminate illegal mining and protect vulnerable populations from exploitation, not the adequacy or inadequacy of any TLV.

[7] By comparison, see the OSHA documentation for the NPRM for Occupational Exposure to Respirable Crystalline Silica published September 12, 2013.  The citation to the 1985 Skulberg article (in “Major Sources of Exposure”) is inadequate on its face in 2020; the article summarizes world mica use from 1905-1981, and provides no information regarding use post-1981.  Likewise, the citation to the “Campaign for Safe Cosmetics” does not provide information on occupational exposure.

[8] The case of crystalline silica again provides a useful contrast.  There is no ACGIH TLV for “crystalline silica,” which as a general term includes many polymorphs.

[9] Actually, the materials that precede “consequently” explicitly refute the conclusion stated by the ACGIH (the TLV-TWA of 0.1 mg/m3) — “the published literature has established an association between mica exposure and pneumoconiosis typically at concentrations in the range of 1-6 mg/m3,”  and “no cases were observed among workers exposed to mica dusts at concentrations of 1.8 mg/m3 or less….”

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).

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 alsoThe Fallacy of Cherry Picking As Seen in American Courtrooms” (May 3, 2014).

[14]  SeeJudicial 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).

SKAPPOLOGY

May 26th, 2020

The Genetic Literacy Project (GLP) asks:

“Who is David and who is Goliath in the lobbying battle over agricultural biotechnology? Activists? Agro-business? In a commitment to transparency, the GLP has mined 5 years of data to help the public understand the funding network that shapes the biotechnology debate.”

The amount of money flowing into the campaign against genetically modified organisms (GMOs) is astonishing, but it does not stop the hypocritical complaints against industry’s sponsorship of studies to help show the safety of GMOs. In a recent on-line article, the GLP has published charts to map contributions from not-for-profit non-governmental organizations to anti-biotechnology advocacy groups. Close to a billion dollars ($850M) flowed into the coffers of these organizations from 2012 to 2016. The GLP’s work on tracking this funding is commendable for bringing balance to the debate about the effect of corporate money on health and environmental issues. Corporate includes the lawsuit industry and the advocacy industries.

Well actually, it would be a wonderful world if the GLP’s tracking were unnecessary. In one such alternative universe, people would ask to examine the evidence for and against claims, and they would have a healthy respect for uncertainty.

Studies funded by parties are routinely relied upon in litigation, and they are often pivotal in how courts decide significant claims of environmental or occupational harm.[1] Unfortunately, the sponsorship of studies by plaintiffs’ counsel, third-party litigation funding entities, and advocacy groups is often obscured or hidden.

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

I recently happened upon an article of interest in an obscure journal, by a well-known author.[2]  The author, John C. Bailar, formerly an Editor-in-Chief of the Journal of the National Cancer Institute, was  professor emeritus in the University of Chicago’s Department of Public Health Sciences. He died in September 2016. Bailar was a graduate of the Yale University medical school, and also held a doctorate in statistics.

There is nothing ground breaking in Bailar’s article, but it is a nice summary of the ways that errors can creep into the scientific literature, short of actual fabrication or falsification of data.[3] It is also worth reading because it is an article that comes from one of the several Coronado Conferences, sponsored by an advocacy organization that has fraudulently concealed its funding, The Project on Scientific Knowledge and Public Policy, aka SKAPP.

To be sure, authors of SKAPP-funded articles have invariably cited their funding from SKAPP, and Bailar was no exception. Bailar made the following acknowledgements:

“Support for this paper was provided by The Project on Scientific Knowledge and Public Policy (SKAPP) at The George Washington University School of Public Health and Health Services. It is revised from a paper presented at SKAPP’s March 2006 Coronado Conference “Truth and Advocacy: The Quality and Nature of Litigation and Regulatory Science.” The papers from that conference will be published elsewhere.”[4]

The acknowledgement of support was rather anemic by SKAPP standards.  Most SKAPP-funded articles recited something closer to the following provided by David Michaels, who headed up SKAPP and worked as an expert witness for the litigation industry, until becoming the Administrator of the Occupational Health & Safety Administration, in President Obama’s administration:[5]

“DM [David Michaels] and CM [Celeste Monforton] are employed by the George Washington University School of Public Health and Health Services as part of the Project on Scientific Knowledge and Public Policy (SKAPP). Their salaries, in part, are funded by the Common Benefit Litigation Expense Trust, a fund established pursuant to a court order in the Silicone Gel Breast Implant Products Liability litigation. SKAPP’s funding is unrestricted; its funders are not given advance notice or the opportunity to review or approve any documents produced by the project. PL [Peter Lurie] is with Public Citizen’s Health Research Group.”

Michaels’ statement was perhaps a little more forthcoming, but few scientists or lay persons would know that his salary, and support, came from plaintiffs’ lawyers as part of an active litigation effort. Although Michaels claimed that the funding was unrestricted, like Big Tobacco funding, the sponsor, plaintiffs’ counsel, created a substantial selection effect in choosing beneficiaries who would deliver its pre-approved message. The Common Benefit Trust may sound like an eleemosynary, public-spirited, organization, with the imprimatur of the federal court system.  It was not.

Was Bailar influenced by his source of funding?  His topic would have permitted him many examples from the annals of science or litigation, but interestingly one of the few examples Bailar chose to give details about was a scientific dispute between the semiconductor industry and Richard Clapp, who was acting as an expert witness in litigation against that industry.  Although Clapp used a study design known to be inaccurate and biased, Bailar touted Clapp’s research over that sponsored by members of the industry.  Richard Clapp, in addition to have been an expert witness for the litigation industry on many occasions, also happened to have been a member of the SKAPP’s advisory committee. Hmmm.

Whence comes SKAPP funding?  SKAPP trades on most readers’ lack of familiarity with how “common benefit funds” are established.  They sound like some sort of disembodied charitable trust, such as the Pew. In fact, the silicone common benefit trust was nothing more than a funding device for mass federal litigation involving silicone breast implants. Ironically, the funding came from a litigation in which one leading judge described plaintiffs’ expert witnesses as “charlatans,” and the litigation claims as largely based upon fraud.[6] Cynics might believe that Bailar’s choice of Clapp versus the semiconductor industry, regardless of the merits, was driven by a desire to please SKAPP & Clapp.

The common benefit fund for the silicone-gel breast implant litigation was created by Order 13, “Establishing Plaintiffs’ Litigation Expense Fund to Compensate and Reimburse Attorneys for Services Performed and Expenses Incurred for Common Benefit.” The late Judge Sam Pointer, appointed to preside over MDL 926, In re Silicone Gel Breast Implants Products Liability Litigation, Master File No. CV 92-P-10000-S, entered the order on July 23, 1993.  Some of the pertinent terms of Order 13 illustrate how it was supposed to operate:

This order is entered in order to provide for the fair and equitable sharing among plaintiffs of the cost of special services performed and expenses incurred by attorneys acting for the common benefit of all plaintiffs.

  1. Plaintiffs’ Litigation Expense Fund to be Established. Plaintiffs’ National Liaison Counsel … are directed to establish an interest-bearing account to receive and disburse funds as provided in this order.

***

  1. Assessment.

(a)    All plaintiffs and their attorneys who, after this date, either agree — for a monetary consideration — to settle, compromise, dismiss, or reduce the amount of a claim or, with or without a trial, recover a judgment for monetary damages or other monetary relief, including both compensatory and punitive damages, with respect to a breast implant claim are hereby assessed:

(1)    5% of the “gross monetary recovery,” if the agreement is made or the judgment is entered after this date and before November 1, 1993, or

(2)    6% of the “gross monetary recovery,” if the agreement is made or the judgment is entered after October 31, 1993.

Defendants are directed to withhold this assessment from amounts paid to plaintiffs and their counsel, and to pay the assessment into the fund as a credit against the settlement or judgment.  ***

  1. Disbursements.

(a)    Payments may be made from the fund to attorneys who provide services or incur expenses for the joint and common benefit of plaintiffs in addition to their own client or clients.  Attorneys eligible are not limited to Plaintiffs’ National Liaison Counsel and members of Plaintiffs’ National Steering Committee, but include, for example, other attorneys called upon by them to assist in performing their responsibilities, State Liaison Counsel, and other attorneys performing similar responsibilities in state court actions in which the presiding state-court judge has imposed similar obligations upon plaintiffs to contribute to the fund.

(b)    Payments will be allowed only to compensate for special services performed, and to reimburse for special expenses incurred, for the joint and common benefit of all plaintiffs.

***

(c)    No amounts will be disbursed without review and approval by a committee of federal and state judicial officers to be designated by the court.  The committee may, however, utilize the services of a special master to assist in this review, and may authorize one or more of its members to act for the committee in approving particular types of applications for disbursement.

(d)    If the fund exceeds the amount needed to make payments as provided in this order, the court will order an refund to those who have contributed to the fund.  Any such refund will be made in proportion to the amount of the contributions.”

For a while, a defense lawyer, representing the defendants in the silicone MDL, participated in discussions concerning MDL 926 Order 13 funds, until the plaintiffs’ lawyers decided that his services were not needed, and excluded him from discussions of the use of the monies. The reality is that the plaintiffs’ lawyers in the silicone litigation were able to bamboozle the slim oversight committee into approving a propaganda campaign against Daubert gatekeeping, and that recipients of the plaintiffs’ lawyers’ largesse were able to misrepresent their funding as though it were from a federal court.

There are further ironies connected with the silicone common benefit trust.  First, the silicone litigation was effectively over when the court-appointed expert witnesses’ reports that announced that the plaintiffs’ expert witnesses lacked sound scientific evidence to support conclusions of causation.  SKAPP’s website reports that its activities started around 2002, by which time both the court-appointed witnesses, as well as the British Ministry of Health, and the Institute of Medicine’s select committee had reported that there was no basis for the plaintiffs’ causal claims in litigation.[7] The second irony is that SKAPP, through its sponsorship of various research and writing projects, had made the recipients of SKAPP money, by the terms of Order 13, agents of the silicone plaintiffs’ lawyers and their clients. Recipients of SKAPP funding who did not disclose that their support or salaries come from the coffers of plaintiffs’ counsel were engaged in misleading their readers and the scientific and legal communities.

I have written often in the past about SKAPP as an agent of plaintiffs’ counsel in mass tort litigation.[8] The concern is not new, but it has continuing significance because of the asymmetrical standard advanced by the lawsuit industry and its scientific advisors who seek to disqualify manufacturing industry and its scientific advisors from participating in scientific debate and argument about various health claims.[9]


[1]  See, e.g., Leaf River Forest Prods. v. Ferguson, 662 So. 2d 648, 657 (Miss. 1995) (litigation involving defense expert witness’s reliance upon dioxin studies funded by defendant paper mills); Maurer v. Heyer-Schulte Corp., No. Civ. A. 92-3485, 2002 WL 31819160 at *3 (E.D. La. Dec. 13, 2002) (granting defendant’s summary judgment against plaintiff’s claim that breast implants caused her harm; citing defendants’ sponsored epidemiologic studies showing no causal link, including epidemiologic study conducted in Sweden); Nat’l Res. Def. Council v. Evans, 232 F. Supp. 2d 1003, 1013 (N.D. Cal. 2002) (“commend[ing] defendants’ sponsorship of independent scientific research…”); FTC v. Pantron I, Corp., 1991 U.S. Dist. LEXIS 21858 (C.D. Cal. Sept 6, 1991) (finding study funded by defendants met “basic and fundamental requirements for scientific validity and reliability”).

[2]  John C. Bailar, “How to distort the scientific record without actually lying: truth, and the arts of science,” 11 European J. Oncol. 217 (2006).

[3]  Id. at 218.

[4]  Id. at 223.

[5]  David Michaels, Celeste Monforton & Peter Lurie, “Selected science: an industry campaign to undermine an OSHA hexavalent chromium standard,” 65 Envt’l Health 5 (2006).

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

[7]   Independent Review Group, Silicone Breast Implants: The Report of the Independent Review Group 8, 22-23 (July 1998) (concluding that there was no demonstrable risk of connective tissue disease from silicone breast implants); Stuart Bondurant, Virginia Ernster, and Roger Herdman, eds., Safety of Silicone Breast Implants (1999) (rejecting plaintiffs’ theories and litigation claims of systemic disease).

[8]   “SKAPP A LOT” (April 30, 2010); “Manufacturing Certainty” (Oct. 25, 2011); “David Michaels’ Public Relations Problem” (Dec. 2, 2011); “Conflicted Public Interest Groups” (Nov. 3, 2013). See also Walter Olson, Schools for Misrule: Legal Academia and an Overlawyered America 121-22 (2011); David E. Bernstein & Eric G. Lasker, “Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702,” 57 William & Mary L. Rev. 1, 39 & n.211 (2015); Ted Frank, “Daubert Debate,” Overlawyered (July 5, 2003); Peter Nordberg, “Bernstein on SKAPP (part 1),” Daubert on the Web (Jul)y 02, 2003).

[9]   Consider the media hysteria over former President Obama’s nomination of Dr. Robert Califf, to serve as Chair of the Food and Drug Administration.[9] The criticism was based upon his having served as the founding director of the Duke Clinical Research Institute, which received funding directly from pharmaceutical companies. The Senate confirmed Califf (89 to 4), but the controversy highlights the hypocrisy in play. Brady Dennis, “Senate confirms Robert Califf as new FDA commissioner,” Wash. Post (Feb. 24, 2016).

The opinions, statements, and asseverations expressed on Tortini are my own, or those of invited guests, and these writings do not necessarily represent the views of clients, friends, or family, even when supported by good and sufficient reason.