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.


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]


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.


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”).

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.