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Further Musings on U.S. v. Harkonen

April 15th, 2013

Epistemic Crimes

In U.S. v. Harkonen, the government prosecuted a physician, company CEO, for issuing a press release that stated a clinical trial “demonstrated” benefit when the government believed that the clinical trial was inconclusive. No doubt the government was intent upon punishing what it thought was off-label promotion in the same press release, but the jury acquitted on the charge of misbranding, and convicted on the wire fraud count. The trial court denied post-trial motions, and recently, the United States Court of Appeals, for the Ninth Circuit, affirmed, in an unpublished per curiam opinion. United States v. Harkonen, No. 11-10209, No. 11-10242, 2013 WL 782354, 2013 U.S. App. LEXIS 4472 (9th Cir. March 4, 2013).

A Gedanken Experiment

An expert witness writes a report that X, a drug therapy, causes Y, a benefit in survival, for a disease, Z.

The expert witness sent his report by email, and regular mail, to counsel, who then served it upon his adversary. The report set out some of the support for the opinion, as follows.

The expert witness relied upon a randomized clinical trial, conducted with one primary and nine secondary endpoints. The multiple endpoints were chosen because of uncertainty of how the anticipated benefit would manifest. Mortality (survival), although obviously a very important endpoint, was not made primary endpoint because the scientists who conducted the trial did not anticipate sufficient deaths over the course of the trials to see a statistically significant benefit.

This clinical trial had surprising results. Although the trial did not show a difference on the primary endpoint, a composite defined in terms of various pulmonary functional changes or death, the trial did “demonstrate,” according to the witness, a survival benefit. Indeed, the survival benefit was clinically significant. Patients randomized to therapy experienced a 40% decrease in mortality, compared to those randomized to placebo. (p = 0.084). The expert witness pointed out, in his report, that the survival benefit was even stronger in a subgroup of the clinical trial, which consisted of the patients who had mild- to moderate-disease at the time of randomization. For this subgroup, the decrease in mortality was even more dramatic, 70%, p = 0.004. The witness’s report did not clearly label this subgroup as “post-hoc,” although a discerning reader might well have assessed it as such.

The expert witness was not relying upon only one clinical trial. His report identified an earlier trial, published in a leading clinical medical journal, which reported benefit from the drug, p < 0.001. This trial was extended, with continuing strong evidence of differential survival. In terms of survival at five years, the earlier trial showed survival in the therapy group at 77.8%, compared to 16.7% in the control groups, p = 0.009.

The expert witness’s report did not explicitly reference clinical experience, or the in vitro and in vivo mechanistic evidence that the therapy, X, plays a role in inhibiting processes that are clearly involved in producing the disease, Z. The expert witness could have written a stronger expert witness report with these references, but did not expect that this level of completeness was required. The expert witness did note that he would marshal the data in more detail at a later time. The expert witness further relied upon the assessment of the principal investigator of the later clinical, who had written that the benefit against mortality of X was “compelling,” and that the finding was “a major breakthrough.” The principal investigator of the trial noted that X was “the first treatment ever to show any meaningful clinical impact in this disease in rigorous clinical trials, and these results would indicate that [X] should be used early in the course of this disease in order to realize the most favorable long-term survival benefit.” The report went on to note, accurately, that there are no FDA-approved therapies for Z.

Adversary counsel, receiving this report, moved pursuant to Federal Rules of Evidence 702 and 703, to exclude the expert witness’s report and his opinions. The motion to exclude was made in advance of the deposition, and without a preliminary motion for more detail about the supporting data. In particular, the motion to exclude claimed that the expert witness was unjustified in concluding that a benefit had been “demonstrated,” as opposed to being merely suggested.

What would be the challenger’s chances of success on the Rule 702 motion? The outcome, Y, was not “statistically significant” at the conventional two-tail 5% (but would have been on a one-tail test). The subgroup that sported a p-value of 0.004 was not clearly marked as a post-hoc subgroup, although the challenger could discern that it was likely exploratory, and challenged it as uncorrected for multiple testing. The challenger, however, did not attempt to offer a modified p-value that took into account of multiple testing. The essence of this challenge was that the expert witness’s statement that a benefit had been “demonstrated” was not supported by sufficient evidence, and that the low p-value of 0.004 was not truly “significant” because the result emerged from an analysis that was not pre-planned.

My hunch, based upon published judicial opinions on both state and federal Rule 702 motions, is that many judges would allow the challenged expert witness to testify. There would be the usual judicial hand waving about the challenge’s going to the weight not the admissibility of the expert witness’s opinion. Perhaps an occasional judge might order additional discovery. I believe that most judges would not find that this expert witness had engaged in pathologically bad science such that the party proponent should be denied its expert witness.

Transmuting Disputed Causal Inferences Into Criminal Fraud

Instead of moving to exclude the expert witness’s opinion, why not turn the report over to the U.S. Attorney’s office to prosecute for wire or mail fraud? Even if a trial court were to brand the opinion “inadmissible,” that outcome would hardly suggest that the opinion was the kind of speech that could qualify as fraudulent under federal wire or mail fraud statutes. Branding a scientist as a fraudfeasor, however, was exactly the result reached in U.S. v. Harkonen, where the Ninth Circuit upheld a wire fraud conviction of a physician whose written statements would likely have been admissible in most federal courtrooms, under Federal Rule 702. As much as I would like to see more stringent gatekeeping of expert witness opinions, there is something unseemly about the government’s efforts here to criminalize scientific opinions with which it disagrees.

Dr. Harkonen has petitioned the Ninth Circuit for reconsideration, in a brief filed by attorneys, Mark Haddad and colleagues, of Sidley Austin. Petition for Rehearing En Banc (filed 29, 2013). The case raises important First Amendment and due process issues, which were addressed by the party and amici briefs before the Panel.

The case also raises the specter of prosecutions of scientists for speech in various contexts, including grant applications and reports, under the False Claims Act, for witness perjury for testimony in judicial, administrative, or legislative proceedings, or for wire or mail fraud for manuscript submissions to journals. On April 8th, Professor Robert Makuch, of Yale University, Professor Timothy Lash, of Emory University, and I filed an amicus brief, which addresses the government’s controversial branding statements “false as a matter of statistics.” The government has gone from one extreme of painting, broad brush, that statistical significance is not important or necessary (in Matrixx Initiatives Inc. v. Siracusano), to the other extreme that statistical significance is so important that a scientist who his opinion on causality on evidence the government believes is not statistically significant has committed fraud (in Harkonen). Both extreme positions are untenable.

Posted in Causation, Rule 702, statistical evidence | Comments Off on Further Musings on U.S. v. Harkonen

Gatekeeping in Allen v. Martin Surfacing — Postscript

April 11th, 2013

Back in November 2012, I wrote a review and analysis of a district court’s handling of Rule 702 challenges to expert witness opinions, in a case involving a tragic ALS death, Allen v. Martin Surfacing, 263 F.R.D. 47 (D. Mass. 2009). See Bad Gatekeeping or Missed Opportunity – Allen v. Martin Surfacing (Nov. 30, 2012).

I received correspondence from one of the plaintiffs’ expert witnesses, Dr. Marcia Ratner, who was not entirely happy with my discussion of the Allen case. Suffice it to say, on the medico-legal issues, we do not have much common ground for agreement. Dr. Ratner, however, asked me to update my post by noting two facts:

1. First, plaintiffs’ counsel had asked her to testify that solvent fumes, including toluene, had caused Mr. Allen’s ALS, and she refused. She was unwilling to acquiesce in their request, and she testified only about acceleration of onset.

2. Second, Dr. Ratner objected to my including the colorful comments about her brush with the law. My report was factual and documented, but I am sympathetic. Dr. Ratner would have me note that she is a registered Republican and a staunch defender of Second Amendment rights; her arrest result when she “inadvertently stepped into a liberal trap when [she] came down [to Massachusetts] from Vermont.”

As a lawyer, I am indeed sympathetic to anyone who has truly stepped into a trap. As for the Allen case, the matter settled, and so there never was a chance to see how a jury would react to the various theories in the case. More important, there never was appellate judicial review of the gatekeeping efforts.

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UC Davis Daubert Symposium

March 28th, 2013

Earlier this month, I wrote about a Symposium on Daubert at the University of California Davis School of Law. The UC Davis Law Review has now published the proceedings of the Symposium, including a transcript of the direct and cross-examinations of the mock expert witnesses:

Symposium — The Daubert Hearing: From All the Critical Perspectives

Edward J. Imwinkelried, “Introductions”
Hypothetical (Basis for the Mock Daubert Hearing)
Transcript of the Mock Daubert Hearing
David L. Faigman, “The Daubert Revolution and the Birth of Modernity: Managing Scientific Evidence in the Age of Science”
Edward J. Imwinkelried, “A Trial Advocacy Postscript to the Daubert Hearing”

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U.C. Davis Symposium on the “Daubert” Hearing

March 11th, 2013

Professor David Faigman’s recent article, “The Daubert Revolution and the Birth of Modernity: Managing Scientific Evidence in the Age of Science,” 102 U.C. Davis Law Rev. 101 (2013), notes that the paper grew out of informal remarks given at a recent symposium. A little Googling quickly turned up the Symposium Site on the University of California, Davis, website. Like Professor Faigman’s paper, this symposium is a valuable contribution to the art and learning of what Rule 702 hearings should, and should not, be.

The symposium, The Daubert Hearing — From All the Critical Perspectives (March 2, 2012) described itself:

Pretrial practice has long been the center of gravity in modern litigation. The vast majority of cases never go to trial. Instead, after pretrial discovery and in limine motions, the cases settle. The Supreme Court’s celebrated 1993 decision in Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S. 579, has solidified that trend. In Daubert, the Court abandoned the traditional general acceptance standard for the admissibility of scientific testimony and announced a new empirical validation test. Throughout the country counsel began basing pretrial in limine motions on Daubert to target opposition expert testimony. In criminal cases, defense counsel started challenging the prosecution’s forensic evidence identifying the accused as the perpetrator. In civil tort cases, defense counsel filed motions attacking the plaintiff’s evidence on general causation. When counsel won these motions, the opposition lacked sufficient evidence to go to trial. The hearing on the pretrial Daubert motion became the centerpiece of the litigation.

This symposium will begin with a demonstration Daubert hearing. After the demonstration, all the participants will deliver remarks, giving their perspective on the law and tactics of Daubert hearings. In addition, there will be expert academic commentary by Professor David Faigman of U.C. Hastings School of Law, the lead author of the popular treatise, MODERN SCIENTIFIC EVIDENCE.

The symposium featured a list of distinguished speakers:

Hon. James M. Rosenbaum

Robert G. Smith

Bert Black

Professor David L. Faigman

Professor Edward Imwinkelried

Dr. William A. Toscano, Jr.

Dr. Sander Greenland

The symposium’s hypothetical is available on line, and the symposium itself, which was video recorded, is available for viewing at the UC Davis website.

The scientists who role-played as expert witnesses, Drs. Toscano and Greenland, were obviously pushed to articulate certain positions that they did not personally subscribe to. Still, their true colors managed to show, and to influence the mock hearing. For instance, Dr. Toscano stated several times that causation is very difficult to prove, and in so stating, he managed to convey the impression that he had a personal, subjective higher bar for causal claims than the rest of the scientific community. This approach is a common rookie mistake for defense counsel and their expert witnesses, and it should be avoided. There are plenty of good examples of causal relationship that have been established with epidemiology, and the defense expert should be prepared to identify them, and to explain why in some cases, the causal relationships required more exacting evidence. The other glaring error in the defense presentation was that the exact methodological error was not made clear through Dr. Toscano’s testimony although the defense lawyer, Mr. Smith, explored the gaps and leaps of faith in his cross-examination of Dr. Greenland. In this setting, the defense expert witness’s focus is on the methodological inadequacies of the plaintiffs’ witness, not on why he rejected the causal claim.

Dr. Greenland was his inimitable self, even going so far as to talk into his magic marker under the impression that it was a microphone. Who knows; perhaps it was, but it also wrote on the white board. More telling was that Dr. Greenland embraced a probabilistic conception of causation, which he explained was essentially a bet on the correct result. This metaphor seems fatally defective. A bet is a bet, but you cannot call the bet until you have actual evidence of who won. It may be lovely that Dr. Greenland, or some other expert witness, is willing to place the bet, perhaps with odds, but this metaphor fails to take causal inference out of the subjective realm. Along with his betting metaphor, Greenland emphasized that the causation decision is driven by a cost-benefit analysis of Type I and II errors. The slippery slide into substituting the precautionary principle for causal analysis was obvious.

On the plaintiffs’ side, Bert Black, an apostate defense lawyer, did a very good job of portraying the shenanigans used by plaintiffs’ lawyers to avoid and evade gatekeeping. Statistical significance is not necessary; epidemiology is not necessary; Bradford Hill factors are not necessary; therefore, I can show causation without much of anything. Black illustrated nicely how the focus is redirected to other cases, such as when someone from a drug company wrote an improvident article that concludes causation from case reports alone. Or cases involving signature diseases, or acute outbreaks, for which causal relations were discerned and embraced by scientists on the basis of very informal epidemiologic studies or even case series (which someone characterized as anecdata).

Former federal judge James Rosenbaum presided magisterially, and cowardly denied the cross-motion Rule 702 challenges. In his comments after the mock, Judge Rosenbaum revealed his conception of the gatekeeping process as essentially a determination that the witness is competent. Of course this is not the law, and much more is required than to determine that the witness is minimally qualified. Professor Faigman respectfully chastised the judge for ignoring the statute and the caselaw.

One of the more interesting dialogues in the discussions after the mock centered on the harm to an expert witness’s reputational interests from the gatekeeping process. To be sure there can be such harm, but as Professional Faigman pointed out, the potential for such harm cannot intimidate judges from ruling on the facts and law before them. I believe though that expert witnesses should be aware of the potential for this sort of harm from their testimonial adventures, and should require certain contractual assurances from the lawyers who engage them. For instance, expert witnesses should insist upon whether such challenges are possible in the jurisdiction, what the standards are, and whether they will have an opportunity to speak to the challenges. The expert witnesses should insist upon prompt notification of all such challenges, and upon prompt receipt of all briefs and affidavits that challenge the validity or reliability of their opinions, as well as an opportunity to be heard on their responses.

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Professor Faigman on the Dual Goals of the Daubert Revolution

March 9th, 2013

Academic commentators on Daubert and its progeny tend to fall into two camps: acolytes and heretics. The acolytes have generally supported the changes brought about by Daubert and the ultimate statutory embrace of active expert witness gatekeeping. The heretics have maintained a rearguard action against Daubert, and Rule 702; they have tried to undermine gatekeeping at every turn.

Among the chief acolytes is David Faigman, whose books and articles have contributed substantially to the discussions and debates about the law of scientific evidence and expert witnesses. Professor Faigman’s recent article is an important contribution to the law review literature on Daubert. David L. Faigman, “The Daubert Revolution and the Birth of Modernity: Managing Scientific Evidence in the Age of Science,” 102 U.C. Davis Law Rev. 101 (2013) [“Revolution”]. It is well worth reading.

Professor Faigman declares himself “a fan” of Daubert, and embraces the revolution in expert witness law heralded by the Supreme Court’s 1993 decision. Id. at 103. He emphasizes that the decision, quickly approaching its 20th anniversary, was truly revolutionary in how the federal courts engaged with expert witness opinion testimony, and that the consequences of the revolution are still taking shape. Id.

Faigman acknowledges that Daubert and its progeny, and the statutory embrace of gatekeeping in Rule 702, at the end of the last millennium, were important developments in ensuring the epistemic warrant of federal courts’ judgments. Some authors, hostile to the gatekeeping enterprise, have suggested that this aspect of Daubert resulted from persistent pressures from the defense bar and industry to limit plaintiffs’ access to the courts. Faigman does not address such suggestions, and I believe that they are cynical and incorrect. The federal courts, by the mid-1980’s, were deeply embarrassed by the scientific community’s opprobrium, meted out over notorious decisions, such as Wells v. Ortho Pharmaceutical Corp., 615 F. Supp. 262 (N.D. Ga. 1985), aff’d and rev’d in part on other grounds, 788 F.2d 741 (11th Cir.), cert. denied, 479 U.S.950 (1986). See also In re Air Crash Disaster at New Orleans, 795 F.2d 1230, 1234 (5th Cir. 1986) (“Our message to our able trial colleagues: it is time to take hold of expert testimony in federal trials.”). Daubert and its progeny were, in my view, the judicial response to the scientific community’s criticisms.

Faigman’s thesis in this paper, however, lies elsewhere. He argues that the Supreme Court’s excursions into expert evidence law, in Daubert and in the later cases, were intended primarily to give trial courts greater control over their dockets by being able to excluding dubious testimony and to grant summary dispositions. Revolution at 104 Scientific verisimilitude was secondary to docket control. Id. at 105.

Faigman’s thesis is plausible and should be taken seriously. The first three cases in the “Revolution,” Daubert, Joiner, and Kumho Tire, were all tort cases with “mass tort” overtones. Daubert was one of many Bendectin cases. Joiner was a case involving occupational PCB exposures. If the tenuous scientific opinions were deemed “admissible,” there were sure to be many more such cases. And Kumho Tire was a case involving dubious allegations of a defect in a tire, the sort of allegations that plague American industry because they are so easy to manufacture, and so costly to defend.

Faigman builds an impressive case for the proposition that the justices really were trying to give trial courts managerial power to control their own dockets by filtering out essential, but deficient, expert witness testimony. Id. at 118. After all, if the Supreme Court were really interested in improving judicial use of scientific evidence, why would it have created an abuse of discretion standard for reviewing Rule 702 determinations? The abuse standard signals that decisions either way are tolerable if they are accompanied by the right verbiage and procedural steps.

Faigman also points out that the abuse-of-discretion standard deprives the appellate courts of any meaningful review of the validity of scientific opinion testimony. The claims and conclusions advanced by expert witnesses in individual cases will often be of interest and importance to scientists, policy makers, plaintiffs, defendants, beyond the confines of the individual case. The appellate courts are in a better position to ascertain validity questions, and maintain consistency in them, as a matter of law. Freed of the pressures of trial courts, and with input from amici curiae, the appellate court can evaluate validity issues more deliberately with a view to harmonizing competing factors across many cases. The scientific issues are, in any event, often non-case specific, or they have the tendency to recur in many cases of the same type. Id. at 131.

Faigman’s thesis sheds light upon who the heretics are, and why they have worked so hard to undermine expert witness gatekeeping. At stake is not only greater scientific validity, but also summary disposition of litigation rent-seeking. Rule 702 gatekeeping challenges judges and commentators to identify their priorities: commitment to scientific principles or to litigation as an alternative to regulation and legislation on behalf of a special constituency.

There are some ironies inherent in Faigman’s thesis. The trial bench has been reluctant to exercise its gatekeeping function as a method of docket control. Instead, it has moved towards greater use of pre-trial consolidations in multi-district litigations to achieve economies of scale. The MDL trend, however, has its problems. Placing responsibility for expert witness gatekeeping in the MDL court may be counter to its “pre-trial” rationale of the MDL statute. Furthermore, exercising gatekeeping across hundreds or thousands of cases heightens and highlights the anxieties, fears, distaste, and institutional incompetence for deciding scientific issues. The move toward MDL handling has had the apparent result of diluting the gatekeeping mandate and reducing the use of summary dispositions.

The procedural and the validity goals of Daubert are quite independent. Validity may have been, as Faigman argues, a secondary goal for the Justices, but it was a worthy goal in and of itself. I believe Professor Faigman would agree. In describing the Supreme Court’s path on validity, Faigman notes that there were two competing models of expert witness admissibility determinations that vied for acceptance: Frye, and then Daubert. Id. at 105. He likens Frye to nose counting among the “relevant” scientific community for support of the witness’s methodology. All a trial judge need do is identify the relevant community and then to count the noses. Daubert represented a possible alternative:

“to charge judges with the responsibility to consider the methods and principles underlying proffered expert opinion and have them make the validity determination.”

Id. at 105. Making trial judges responsible for warranting the validity of scientific evidence, and ultimately all expert witness opinion testimony, was one of the important changes that resulted in the Revolution and its embrace of “good grounds” or epistemic validity:

“[p]roposed testimony must be supported by appropriate validation.”

Daubert v. Merrell Dow Pharm., 509 U.S. 579, 590 (1993)

Professor Faigman correctly observes that, although lawyers and lower court judges have obsessed over the so-called Daubert factors, the actual holding of Daubert was “the requirement that an expert’s testimony pertain to ‘scientific knowledge’ establishes a standard of evidentiary reliability.” Revolution at 111 (quoting Daubert, 509 U.S. at 590). Despite the improvident dictum about focus on methodology and not on conclusions, the Supreme Court, in Daubert, had made clear that there are necessary implications of Rule 702’s requirement that expert witness testimony relate to specialized “knowledge”:

“This entails a preliminary assessment of whether the reasoning or methodology underlying the testimony is scientifically valid and of whether that reasoning or methodology properly can be applied to the facts in issue.”

Daubert, 509 U.S. at 592-93.

Professor Faigman writes to point out the erroneous interpretations and distortions of Daubert, its progeny, and Rule 702:

“The holding of Daubert is the requirement that judges find as a preliminary fact that the methods and principles underlying proffered expert testimony are sufficiently valid to support that testimony. The four ‘Daubert factors’ were offered as guidelines to help courts assess expert testimony.”

Revolution at 114.

Faigman’s writing is a useful reminder to those judges and commentators who would simplify and abridge the entire gatekeeping project into one or another dictum found in Daubert (or Joiner or Kumho Tire), and who ignore the actual holding of the cases, or the mandate of the subsequent statute. For those writers who try to evade the difficult scientific determinations and discriminations inherent in evaluating causal claims and other scientific opinions, Faigman reminds us that Justice Breyer, in his concurrence in Joiner, was not shy about pointing out that gatekeeping:

“will sometimes ask judges to make subtle and sophisticated determinations about scientific methodology and its relation to the conclusions an expert witness seeks to offer.”

General Electric Company v. Joiner, 522 U.S. 136, 118 S. Ct. 512, 520 (1997) (Breyer, J., concurring). I take Faigman’s essay as an eloquent importuning of the judiciary to heed Justice Breyer, to stop whining, and to start learning.

It is a measure of Professor Faigman’s concern for the accuracy and validity of scientific testimony that he cannot bring himself to address a third way: ignore validity, reliability, sufficiency, and simply allow expert witnesses to battle out.

This third way was what really prevailed before Daubert in much of civil litigation over health effects. The Frye rule was rarely if ever applied to such cases, and most states excepted the opinion testimony of physicians, in any event. Before Frye, we had whatever was dished up by ready, willing, able (and sufficiently glib) testifiers. To be sure, expert witnesses had to be qualified, but the threshold was astonishingly low. In Pennsylvania, for instance, the standard is that the putative “expert” must have “a reasonable pretense of expertise.” See, e.g., Ruzzi v. Butler Petroleum Co., 527 Pa. 1, 9-10 (1991); Kuisis v. Baldwin-Lima-Hamilton Corp.,457 Pa. 321, 319 A.2d 914 (1974)(“the witness must have a reasonable pretension to specialized knowledge on the subject under investigation”). The federal courts were not far behind. Ferebee v. Chevron Chem. Co., 552 F. Supp. 1297 (D.D.C. 1982), aff’d, 736 F.2d 1529 (D.C. Cir.), cert. denied, 469 U.S. 1062 (1984).

Indeed, there is a pervasive, reactionary movement afoot, among judges and academic commentators to return to the wild, woolly days, celebrated in Ferebee’s famous dictum:

“On questions … which stand at the frontier of current medical and epidemiological inquiry, if experts are willing to testify that such a link exists, it is for the jury to decide whether to credit such testimony.”

Ferebee, 736 F.2d at 1534. This third way then is simply to delegate to the expert witnesses themselves to assess the “weight of the evidence,” and offer up their opinions, without any scrutiny from the courts as to the validity or sufficiency of the bases for those opinions. This retrograde step is not just the stuff of naive law student musings. See, e.g., Note, “Admitting Doubt: A New Standard for Scientific Evidence,” 123 Harv. L. Rev. 2021 (2010). Reactionaries in the Academy and in the judiciary are intent to reduce gatekeeping to a weak test of relevancy, without any determination of content validity.

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Milward Symposium Organized By Plaintiffs’ Counsel and Witnesses

February 16th, 2013

The criticisms of corporate free speech are motivated, at bottom, over hostility to the views that would likely flow from corporate speech. In this age, it is a marvel that there is such hostility to free expression of ideas. We should be much more focused on validity and factual accuracy of arguments than on sponsorship. Sometimes, even the most biased sources manage to stumble upon the truth.

Still, sponsorship remains a major debating point for those who cannot or will not take the time to evaluate the merits of an issue. The Center for Progressive Reform (CPR) is, like many American corporations, a nonprofit organization, but it aspires to be a “research and educational organization.” The CPR’s principal aims deal with protecting health and safety against occupational and environmental harms. These are laudable goals even if the CPR is predictably a voice of entrenched interest groups, such as the litigation industry, also known as the plaintiffs’ tort bar.

One of the CPR’s key activities is “[d]efending clean science from political or corporate interference.” The CPR raises interesting questions about what is “clean,” and what is “dirty” science, and whether it is willing to defend science from all political and corporate interference, or only that interference with which it disagrees.

The American litigation industry is represented by a highly politicized “corporation,” the American Association for Justice (AAJ), previously known by the more revealing name, Association of Trial Lawyers of America (ATLA®). The AAJ describes itself as a corporation, or a “collective,” that supports plaintiff trial lawyers as their “collective voice … on Capitol Hill and in courthouses across the nation … .” The Robert A. Habush Foundation is endowed by the AAJ, and serves as an educational mission. Through the Habush Foundation, the AAJ funds educational programs, “think tanks,” and writing projects designed to influence judges, law professors, lawyers, and the public, on issues of importance to the AAJ: “the civil justice system and individual rights” for bigger, better, and more profitable litigation outcomes.

Of the two organizations, the CPR, and the AAJ/ATLA, the CPR has the more disinterested stance, in theory. The AAJ may be a “not-for-profit,” but it represents the interests of one of the most powerful, and wealthiest, interest groups in American society — the plaintiffs’ bar.

Last May, the CPR sponsored a symposium in Washington D.C. on one of the most controversial, and reactionary decisions involving federal gatekeeping of expert witness testimony, Milward v. Acuity Specialty Products Group, Inc., 664 F.Supp. 2d 137 (D. Mass. 2009), rev’d, 639 F.3d 11 (1st Cir. 2011), cert. denied, U.S. Steel Corp. v. Milward, ___ U.S. ___, 2012 WL 33303 (2012). The CPR’s interest in the Milward decision is clear. One of CPR’s member “scholars,” Carl Cranor, was a partisan expert witness in Milward. The trial court had excluded Cranor’s testimony; a panel of the First Circuit of the Court of Appeals reversed and ordered that Cranor and the plaintiffs’ other expert witnesses be heard at trial. See Milward — Unhinging the Courthouse Door to Dubious Scientific Evidence (Sept. 2, 2011); WOE-fully Inadequate Methodology – An Ipse Dixit By Another Name (May 2, 2012). The Milward decision embraced a vacuous methodology sometimes called “weight of the evidence” (WOE) or “inference to the best explanation,” which had been previously rejected by other Circuits, as well as by the United States Supreme Court, in General Electric Co. v. Joiner, 522 U.S. 136 (1997).

The agenda for the symposium, “Toxic Tort Litigation after Milward v. Acuity Specialty Products,” reflects the CPR’s role, in conjunction with the Wake Forest Journal of Law and Public Policy, in sponsoring the event. The connection between the CPR and Wake Forest Law School may not be obvious. CPR board member, Sid Shapiro, is a law professor at Wake Forest. Shapiro and CPR member Thomas McGarity presented at the symposium. So did Professor Steve Gold, who has been an enthusiastic cheerleader for the Milward decision. Law professors Michael Green and Joseph Sanders also presented. There was only one practicing lawyer involved in the symposium, Texas plaintiffs’ lawyer, Steve Jensen, of Allen Stewart, P.C. Mr. Jensen is a past chair of the AAJ’s Section on Toxic, Environmental, and Pharmaceutical Torts.

No defense counsel participated.

The proceedings of the Milward symposium will be published in an upcoming issue (volume 3, no. 1) of the Wake Forest Journal of Law and Public Policy. This issue is scheduled to include papers from the presenters, along with one additional author, Carl Cranor.

The website of the Wake Forest Journal of Law & Policy describes the symposium:

In Milward v. Acuity Products, 639 F.3d 11 (1st Cir. 2011), the First Circuit became the first court – either federal or state – to allow a “weight of the evidence” methodology for assessing causation in a toxic tort case. The plaintiff had alleged that exposure to defendant’s benzene-containing products caused his rare leukemia (Acute Promyelocytic Leukemia (“APL”)). His expert witness, a leading toxicologist and expert on benzene, surveyed five lines of scientific evidence from the peer-reviewed literature, and concluded the available evidence, taken as a whole, supported the inference that benzene exposure can cause APL. The lower court, following a common post-Daubert approach, excluded the testimony “because no one line of evidence supported a reliable inference of causation, [and] an inference of causation based on the totality of the evidence was unreliable.” The First Circuit rejected this “atomistic” approach, noting that the district court did not have the authority to exclude evidence because reasonable experts may disagree about what it means.

This symposium will explore the implications of Milward for toxic tort litigation in the federal and state courts, including whether it correctly applies Daubert v. Merrell Dow Pharmaceuticals, Inc., 509, U.S. 579 (1993). * * * Speakers are invited to comment on any aspect on Milward that they find interesting and important, including the following issues:

What role does the weight of the evidence methodology play in scientific risk assessment, and what are the implications of this role for tort litigation?

Should well-founded testimony based on a weight of the evidence methodology be admissible in toxic tort litigation? Does the Restatement of Torts (Third) § 28 cmt. c concerning the role of scientific judgment in adjudicating general causation support the admissibility of such testimony?

Does the reliance of regulatory agencies, such as EPA, on a weight of the evidence methodology for purposes of regulating toxic chemicals support the result in Milward? Or are there differences in the legal and policy judgments being made by regulators and judges that distinguish regulatory agencies from courts?

What are the legal and policy implications of Milward for the future of toxic tort litigation?

The Journal also notes the sponsorship of the CPR, and, in a cryptic paragraph, reports that

“CPR thanks the Robert L. Habush Foundation for its support of the symposium.”

Most casual readers will not likely recognize the Habush foundation for what it is: an arm of AAJ/ATLA. I suppose it was too painful for Wake Forest or the CPR to acknowledge openly that the litigation industry itself supported this symposium. Some may find irony in the CPR’s past criticism of Citizens United v. Federal Election Commission, 558 U.S. 310 (2010), when its current status as a conduit for litigation industry money to support scholarship in that industry’s interests. See Daniel Farber, “Of the Corporations, By the Corporations, For the Corporations? The Meaning of the Citizens United Decision” (Jan. 21, 2010).

Professor Steve Gold’s paper, “When Certainty Dissolves into Probability: A Legal Vision of Toxic Causation for the Post-Genomic Era,” has been posted at the Social Science Research Network. Steve Jensen’s contribution to the symposium has been published as well, in the AAJ’s trade journal. Steve Baughman Jensen, “Reframing the Daubert Issue in Toxic Tort Cases,” Trial (Feb. 2013).

Posted in Conflicts of Interest, Expert Witnesses, Rule 702 | Comments Off on Milward Symposium Organized By Plaintiffs’ Counsel and Witnesses

Reanalysis of Epidemiologic Studies – Not Intrinsically WOEful

December 27th, 2012

A recent student law review article discusses reanalyses of epidemiologic studies, an important, and overlooked topic in the jurisprudence of scientific evidence. Alexander J. Bandza, “Epidemiological-Study Reanalyses and Daubert: A Modest Proposal to Level the Playing Field in Toxic Tort Litigation,” 39 Ecology L. Q. 247 (2012).

In the Daubert case itself, the Ninth Circuit, speaking through Judge Kozinksi, avoided the methodological issues raised by Shanna Swan’s reanalysis of Bendectin epidemiologic studies, by assuming arguendo its validity, and holding that the small relative risk yielded by the reanalysis would not support a jury verdict of specific causation. Daubert v. Merrell Dow Pharm., Inc., 43 F.3d 1311, 1317–18 (9th Cir. 1995).

There is much that can, and should, be said about reanalyses in litigation and in the scientific process, but Bandza never really gets down to the business at hand. His 36 page article curiously does not begin to address reanalysis until the bottom of the 20th page. The first half of the article, and then some, reviews some time-worn insights and factoids about scientific evidence. Finally, at page 266, the author introduces and defines reanalysis:

“Reanalysis occurs ‘when a person other than the original investigator obtains an epidemiologic data set and conducts analyses to evaluate the quality, reliability or validity of the dataset, methods, results or conclusions reported by the original investigator’.”

Bandza at 266 (quoting Raymond Neutra et al., “Toward Guidelines for the Ethical Reanalysis and Reinterpretation of Another’s Research,” 17 Epidemiology 335, 335 (2006).

Bandza correctly identifies some of the bases for judicial hostility to re-analyses. For instance, some courts are troubled or confused when expert witnesses disagree with, or reevaluate, the conclusions of a published article. The witnesses’ conclusions may not be published or peer reviewed, and thus the proffered testimony fails one of the Daubert factors. Bandza correctly notes that peer review is greatly overrated by judges. Bandza at 270. I would add that peer review is an inappropriate proxy for validity, a “test,” which reflects a distrust of the unpublished. Unfortunately, this judicial factor ignores the poor quality of much of what is published, and the extreme variability in the peer review process. Judges overrate peer review because they are desperate for a proxy for validity of the studies relied upon, which will allow them to pass their gatekeeping responsibility on to the jury. Furthermore, the authors’ own conclusions are hearsay, and their qualifications are often not fully before the court. What is important is the opinion of the expert witness who can be cross-examined and challenged. See “FOLLOW THE DATA, NOT THE DISCUSSION.” What counts is the validity of the expert witness’s reasoning and inferences.

Bandza’s article, which by title advertises itself to be about re-analyses, gives only a few examples of re-analyses without much detail. He notes concerns that reanalyses may impugn the reputation of published scientists, and burden them with defending their data. Who would have it any other way? After this short discussion, the article careens into a discussion of “weight of the evidence” (WOE) methodology. Bandza tells us that the rejection of re-analyses in judicial proceedings “implicitly rules out using the weight-of-the-evidence methodology often appropriate for, or even necessary to, scientific analysis of potentially toxic substances.” Bandza at 270. This argument, however, is one sustained non-sequitur. WOE is defined in several ways, but none of the definitions require or suggest the incorporation of re-analyses. Re-analyses raise reliability and validity issues regardless whether an expert witness incorporates them into a WOE assessment. Yet Bandza tells us that the rejection of re-analyses “Implicitly Ignores the Weight-of-the-Evidence Methodology Appropriate for the Scientific Analysis of Potentially Toxic Substances.” Bandza at 274. This conclusion simply does not follow from the nature of WOE methodology or reanalyses.

Bandza’s ipse dixit raises the independent issue whether WOE methodology is appropriate for scientific analysis. WOE is described as embraced or used by regulatory agencies, but that description hardly recommends the methodology as the basis for a scientific, as opposed to a regulatory, conclusion. Furthermore, Bandza ignores the ambiguity and variability of WOE by referring to it as a methodology, when in reality, WOE is used to describe a wide variety of methods of reasoning to a conclusion. Bandza cites Douglas Weed’s article on WOE, but fails to come to grips with the serious objections raised by Weed in his article to the use of WOE methodologies. Douglas Weed, “Weight of Evidence: A Review of Concept and Methods,” 25 Risk Analysis 1545, 1546–52 (2005) (describing the vagueness and imprecision of WOE methodologies). See also “WOE-fully Inadequate Methodology – An Ipse Dixit By Another Name.”

Bandza concludes his article with a hymn to the First Circuit’s decision in Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11 (1st Cir. 2011). Plaintiffs’ expert witness, Dr. Martyn Smith claimed to have performed a WOE analysis, which in turn was based upon a re-analysis of several epidemiologic studies. True, true, and immaterial. The re-analyses were not inherently a part of a WOE approach. Presumably, Smith re-analyzed some of the epidemiologic studies because he felt that the data as presented did not support his desired conclusion. Given the motivations at work, the district court in Milward was correct to look skeptically and critically at the re-analyses.

Bandza notes that there are procedural and evidentiary safeguards in federal court against unreliable or invalid re-analyses of epidemiologic studies. Bandza at 277. Yes, there are safeguards but they help only when they are actually used. The First Circuit in Milward reversed the district court for looking too closely at the re-analyses, spouting the chestnut that the objections went to the weight not the admissibility of the evidence. Bandza embraces the rhetoric of the Circuit, but he offers no description or analysis of the liberties that Martyn Smith took with the data, or the reasonableness of Smith’s reliance upon the re-analyzed data.

There is no necessary connection between WOE methodologies and re-analyses of epidemiologic studies. Re-analyses can be done properly to support or deconstruct the conclusions of published papers. As Bandza points out, some re-analyses may go on to be peer reviewed and published themselves. Validity is the key, and WOE methodologies have little to do with the process of evaluating the original or the re-analyzed study.

Posted in Causation, Data Sharing, Expert Witnesses, Rule 702, Scientific Evidence | Comments Off on Reanalysis of Epidemiologic Studies – Not Intrinsically WOEful

Litmus Tests

December 27th, 2012

Rule 702 is, or is not, a litmus test for expert witness opinion admissibility. Relative risk is, or is not, a litmus test for specific causation. Statistical significance is, or is not, a litmus test for reasonable reliance upon the results of a study. It is relatively easy to find judicial opinions on either side of the litmus divide. Compare National Judicial College, Resource Guide for Managing Complex Litigation at 57 (2010) (Daubert is not a litmus test) with Cryer v. Werner Enterprises, Inc., Civ. Action No. 05-S-696-NE, Mem. Op. & Order at 16 n. 63 (N.D. Ala. Dec. 28, 2007) (describing the Eleventh Circuit’s restatement of Rule 702’s “litmus test” for the methodological reliability of proffered expert witness opinion testimony).

The “litmus test“ is one sorry, overworked metaphor. Perhaps its appeal has to do with a vague collective memory that litmus paper is one of those “things of science,” which we used in high school chemistry, and never had occasion to use again. Perhaps, litmus tests have the appeal of “proofiness.”

The reality is different. The litmus test is a semi-quantitative test for acidity or alkalinity. Neutral litmus is purple. Under acidic conditions, litmus turns red; under basic conditions, it turns blue. For some time, scientists have used pH meters when they want a precise quantification of acidity or alkalinity. Litmus paper is a fairly crude test, which easily discriminates moderate acidity from alkalinity (say pH 4 from pH 11), but is relatively useless for detecting an acidity at pH or 6.95, or alkalinity at 7.05.

So what exactly are legal authors trying to say when they say that some feature of a test is, or is not, a “litmus test”? The litmus test is accurate, but not precise at the important boundary at neutrality. The litmus test color can be interpreted for degree of acidity or alkalinity, but it is not the preferred method to obtain a precise measurement. Saying that a judicial candidate’s views on abortion are a litmus test for the Senate’s evaluation of the candidate makes sense, given the relative binary nature of the outcome of a litmus test, and the polarization of political views on abortion. Apparently, neutral views or views close to neutrality on abortion are not a desideratum for judicial candidates. A cruder, binary test is exactly what is desired by politicians.

The litmus test that is used for judicial candidates does not seem to work so well when used to describe scientific or statistical inference. The litmus test is well understood, but fairly obsolete in modern laboratory practice. When courts say things, such as statistical significance is not a litmus test for acceptability of a study’s results, clearly they are correct because measure of random error is only one aspect of judging a body of evidence for, or against, an association. Yet courts seem to imply something else, at least at times:

statistical significance is not an important showing in making a case that an exposure is reliably associated with a particular outcome.

Here courts are trading in half truths. Statistical significance is quantitative, and the choice of a level of significance is not based upon immutable law. So like the slight difference between a pH of 6.95 and 7.05, statistical significance tests have a boundary issue. Nonetheless, a consideration of random error cannot be dismissed or overlooked on the theory that significance level is not a “litmus test.” This metaphor obscures and attempts to excuse sloppy thinking. It is time to move beyond this metaphor.

Posted in Rule 702, Scientific Evidence, statistical evidence | Comments Off on Litmus Tests

Lumpenepidemiology

December 24th, 2012

Judge Helen Berrigan, who presides over the Paxil birth defects MDL in New Orleans, has issued a nicely reasoned Rule 702 opinion, upholding defense objections to plaintiffs expert witnesses, Paul Goldstein, Ph.D., and Shira Kramer, Ph.D. Frischhertz v SmithKline Beecham EDLa 2012 702 MSJ Op.

The plaintiff, Andrea Frischhertz, took GSK’s Paxil, a selective serotonin reuptake inhibitor (SSRI), for depression while pregnant with her daughter, E.F. The parties agreed that E.F. was born with a deformity of her right hand. Plaintiffs originally claimed that E.F. had a heart defect, but their expert witnesses appeared to give up this claim at deposition, as lacking evidential support.

Adhering to Daubert’s Epistemiologic Lesson

Like many other lower federal courts, Judge Berrigan focused her analysis on the language of Daubert v. Merrell Dow Pharmaceuticals Inc., 509 U.S. 579 (1993), a case that has been superseded by subsequent cases and a revision to the operative statute, Rule 702. Fortunately, the trial court did not lose sight of the key epistemological teaching of Daubert, which is based upon Rule 702:

“Regarding reliability, the [Daubert] Court said: ‘the subject of an expert’s testimony must be “scientific . . . knowledge.” The adjective “scientific” implies a grounding in the methods and procedures of science. Similarly, the word “knowledge” connotes more than subjective belief or unsupported speculation’.”

Slip Op. at 3 (quoting Daubert, 509 U.S. at 589-590).

There was not much to the plaintiffs’ expert witnesses’ opinion beyond speculation, but many other courts have been beguiled by speculation dressed up as “scientific … knowledge.” Dr. Goldstein relied upon whole embryo culture testing of SSRIs, but in the face overwhelming evidence, Dr. Goldstein was forced to concede that this test may generate hypotheses about, but cannot predict, human risk of birth defects. No doubt this concession made the trial court’s decision easier, but the result would have been required regardless of Dr. Goldstein’s exhibition of truthfulness at deposition.

Statistical Association – A Good Place to Begin

More interestingly, the trial court rejected the plaintiffs’ expert witnesses’ efforts to leapfrog finding a statistically significant association to parsing the so-called Bradford Hill factors:

“The Bradford-Hill criteria can only be applied after a statistically significant association has been identified. Federal Judicial Center, Reference Manual on Scientific Evidence, 599, n.141 (3d. ed. 2011) (“In a number of cases, experts attempted to use these guidelines to support the existence of causation in the absence of any epidemiologic studies finding an association . . . . There may be some logic to that effort, but it does not reflect accepted epidemiologic methodology.”). See, e.g., Dunn v. Sandoz Pharms., 275 F. Supp. 2d 672, 678 (M.D.N.C. 2003). Here, Dr. Goldstein attempted to use the Bradford-Hill criteria to prove causation without first identifying a valid statistically significant association. He first developed a hypothesis and then attempted to use the Bradford-Hill criteria to prove it. Rec. Doc. 187, Exh. 2, depo. Goldstein, p. 103. Because there is no data showing an association between Paxil and limb defects, no association existed for Dr. Goldstein to apply the Bradford-Hill criteria. Hence, Dr. Goldstein’s general causation opinion is not reliable.”

Slip op. at 6.

The trial court’s rejection of Dr. Goldstein’s attempted end run is particularly noteworthy given the Reference Manual’s weak-kneed attempt to suggest that this reasoning has “some logic” to it. The Manual never articulates what “logic” commends Dr. Goldstein’s approach; nor does it identify any causal relationship ever established with such paltry evidence in the real world of science. The Manual does cite several legal cases that excused or overlooked the need to find a statistically significant association, and even elevated such reasoning into legally acceptable, admissibility method. See Reference Manual on Scientific Evidence at 599 n. 141 (describing cases in which purported expert witnesses attempted to use Bradford Hill factors in the absence of a statistically significant association; citing Rains v. PPG Indus., Inc., 361 F. Supp. 2d 829, 836–37 (S.D. Ill. 2004); ); Soldo v. Sandoz Pharms. Corp., 244 F. Supp. 2d 434, 460–61 (W.D. Pa. 2003). The Reference Manual also cited cases, without obvious disapproval, which completely dispatched with any necessity of considering any of the Bradford Hill factors, or the precondition of a statistically significant association. See Reference Manual at 599 n. 144 (citing Cook v. Rockwell Int’l Corp., 580 F. Supp. 2d 1071, 1098 (D. Colo. 2006) (“Defendants cite no authority, scientific or legal, that compliance with all, or even one, of these factors is required. . . . The scientific consensus is, in fact, to the contrary. It identifies Defendants’ list of factors as some of the nine factors or lenses that guide epidemiologists in making judgments about causation. . . . These factors are not tests for determining the reliability of any study or the causal inferences drawn from it.“).

Shira Kramer Takes Her Lumpings

The plaintiffs’ other key expert witness, Dr. Shira Kramer, was a more sophisticated and experienced obfuscator. Kramer attempted to provide plaintiffs with a necessary association by “lumping” all birth defects together in her analysis of epidemiologic data of birth defects among children of women who had ingested Paxil (or other SSRIs). Given the clear evidence that different birth defects arise at different times, based upon interference with different embryological processes, the trial court discerned this “lumping” of end points to be methodologically inappropriate. Slip op. at 8 (citing Chamber v. Exxon Corp., 81 F. Supp. 2d 661 (M.D. La. 2000), aff’d, 247 F.3d 240 (5th Cir. 2001) (unpublished).

Without her “lumping”, Dr. Kramer was left with only a weak, inconsistent claim of biological plausibility and temporality. Finding that Dr. Kramer’s opinion had outrun her headlights, Judge Berrigan, excluded Dr. Kramer as an expert witness, and granted GSK summary judgment.

Merry Christmas!

Posted in Causation, Expert Witnesses, Rule 702, Scientific Evidence, statistical evidence | Comments Off on Lumpenepidemiology

Egilman Petitions the Supreme Court for Review of His Own Exclusion in Newkirk v. Conagra Foods

December 13th, 2012

Last year, the Ninth Circuit of the United States Court of Appeals affirmed a district judge’s decision to exclude Dr David S. Egilman from testifying in a consumer-exposure diacetyl case. Newkirk v. Conagra Foods Inc., 438 Fed.Appx. 607 (9th Cir. 2011). The plaintiff moved on, but his expert witness could not let his exclusion go.

To get the full “flavor” of this diacetyl case, read the district court’s opinion, which excluded Egilman and other witnesses, and entered summary judgment for the defense. Newkirk v. Conagra Foods, Inc., 727 F. Supp. 2d 1006 (E.D. Wash. July 2, 2010). Here is the language that had Dr. Egilman popping mad:

“In other parts of his reports and testimony, Dr. Egilman relies on existing data, mostly in the form of published studies, but draws conclusions far beyond what the study authors concluded, or Dr. Egilman manipulates the data from those studies to reach misleading conclusions of his own. See Daubert I, 509 U.S. at 592–93, 113 S.Ct. 2786.”

727 F. Supp. 2d at 1018.

This language, cut Dr. Egilman to the kernel, and provoked him to lodge a personal appeal to the Ninth Circuit, based in part upon the economic harm done to his litigation consulting and testimonial practice. (See attached Egilman Motion Appeal Diacetyl Exclusion 2011 and Egilman Declaration Newkirk Diacetyl Appeal 2011.) Not only did the exclusion hurt Dr. Egilman’s livelihood, but also his eleemosynary endeavors:

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

Egilman Declaration in Newkirk at Paragraph 11.

The Ninth Circuit affirmed Dr. Egilman’s exclusion, Newkirk v. Conagra Foods, Inc., 438 Fed. Appx. 607 (9th Cir. 2011). See “Ninth Circuit Affirms Rule 702 Exclusion of Dr David Egilman in Diacetyl Case.

This year, the Ninth Circuit dismissed his personal appeal for lack of standing. Egilman v. Conagra Foods, Inc., 2012 WL 3836100 (9th Cir. 2012). Previously, I suggested that the Ninth Circuit had issued a judgment from which there will be no appeal. I may have been mistaken. Last week, counsel for Dr. Egilman filed a petition for certiorari in the United States Supreme Court. Smarting from the district court’s attack on his character and professionalism, Dr. Egilman is seeking the personal right to appeal an adverse Rule 702 ruling. The Circuit split, which Dr. Egilman hopes will get him a hearing in the Supreme Court, involves the issue whether he, as a non-party witness, must intervene in the proceedings in order to preserve his right to appeal:

“Whether a nonparty to a district court proceeding has a right to appeal a decision that adversely affects his interest, as the Second, Sixth, and D.C. Circuits hold, or whether, as six other circuit courts hold, the nonparty must intervene or otherwise participate in the district court proceedings to have a right to appeal.”

Egilman Pet’n Cert Newkirk v Conagra SCOTUS at 5 (Dec. 2012). Of course there is also a split among courts about Dr. Egilman reliability.

And who represents Dr. Egilman? Counsel of record is Alexander A. Reinert, who teaches at Cardozo Law School, here in New York. Dr. Egilman and Reinert have published several articles together, within the scope of Dr. Egilman’s litigation-oriented practice.[i] In the past, I have commented upon Reinert’s work. See, e.g., Schachtman, “Confidence in Intervals and Diffidence in the Courts” (May 8, 2012 ) (Arthur H. Bryant & Alexander A. Reinert, “The Legal System’s Use of Epidemiology,” 87 Judicature 12, 19 (2003)(“The confidence interval is intended to provide a range of values within which, at a specified level of certainty, the magnitude of association lies.”) (incorrectly citing the first edition of Rothman & Greenland, Modern Epidemiology 190 (Philadelphia 1998)). It should be interesting to see what mischief Egilman & Reinert can make in the Supreme Court.

[i] David S. Egilman & Alexander A. Reinert, “Corruption of Previously Published Asbestos Research,” 55 Arch. Envt’l Health 75 (2000); David S. Egilman & Alexander A. Reinert,“Asbestos Exposure and Lung Cancer: Asbestosis Is Not Necessary,” 30 Am. J. Indus. Med. 398 (1996); David S. Egilman & Alexander A. Reinert, “The Asbestos TLV: Early Evidence of Inadequacy,” Am. J. Indus. Med. 369 (1996); David S. Egilman & Alexander A. Reinert,“The Origin and Development of the Asbestos Threshold Limit Value: Scientific Indifference and Corporate Influence,” 25 Internat’l J. Health Serv. 667 (1995).

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