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

Judicial Dodgers – Reassigning the Burden of Proof on Rule 702

May 13th, 2020

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

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

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

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

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

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

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

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


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

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

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

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

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

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

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

[8]  Id.

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

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

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

Judicial Dodgers – The Crossexamination Excuse for Denying Rule 702 Motions

May 11th, 2020

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

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

“Vigorous cross-examination, presentation of contrary evidence, and careful instruction on the burden of proof are the traditional and appropriate means of attacking shaky but admissible evidence.”[3]

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[10]  Id. at 11 n.5.

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

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

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

Should Federal Rule of Evidence 702 Be Amended?

May 8th, 2020

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

Dark Money, Scott Augustine, and Hot Air

April 11th, 2020

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

[9]  See

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