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Washington Supreme Court Illustrates the Difference Between Frye and Rule 702

April 15th, 2013

Last month, the Washington Supreme Court decided a public and private nuisance case against a local utility for fear of future illnesses from exposure to electro-magnetic frequency radiation (EMF).  Lakey v. Puget Sound Energy, Inc., ___ Wn. 2d ___ , 2013 WL 865468 (Mar. 6, 2013).

The defendant utility and local municipality had moved for the exclusion of plaintiffs’ expert witnesses, under Frye v. United States, 54 App. D.C. 46, 293 F. 1013 (1923), and the Washington state version of Rule 702.  The plaintiff homeowners submitted declarations from two expert witnesses, Dr. De Kun Li and and Dr. David Carpenter.

Dr. Carpenter was the Director of the Institute for Health and the Environment at the University at Albany and a Professor of Environmental Health Sciences within the School of Public Health. He also has held the position of Dean of the School of Public Health at the University of Albany and the Director of the Wadsworth Center for Laboratories and Research of the New York State Department of Health.  Dr. Carpenter apparently has been active in testifying about EMF health issues.  See, e.g., Amended Declaration of David Carpenter (2011).

The trial court conducted a three-day Frye hearing, at which both sides offered expert witness testimony.  Plaintiffs called Carpenter, and the defendants called Dr. Nancy Lee, an epidemiologist, and Dr. Mark Israel, a professor at Dartmouth’s Geisel School of Medicine, and a specialist in the molecular and cellular biology of brain tumors.

At the hearing, Dr. Lee testified that Carpenter had failed to follow generally accepted epidemiologic methodology of considering all pertinent data.  Carpenter had “cherry picked”; his opinion selectively ignored studies that contradicted his conclusions.  Even among the studies that Carpenter had relied upon, he ignored data that undermined or contradicted his conclusion.  Slip op. at 6.  Furthermore, Carpenter ignored the toxicologic data and studies available. Id.  Among the studies ignored by Carpenter were the most recent, and most carefully conducted, studies. Id.  The trial court excluded Li and Carpenter, and the plaintiffs appealed.

Affirming the exclusion, the Supreme Court of Washington engaged in a curious two step.  The Court reversed the trial court’s exclusion on Frye grounds.  In Supreme Court’s view, the plaintiffs’ witnesses sufficiently deployed a generally accepted method when they waded into the field of epidemiology because epidemiology is generally accepted.  The Frye doctrine does not require that expert witnesses apply the established methodology well, reliably, or soundly.  The expert witnesses are immunized from exclusion by relying upon studies from a generally accepted discipline, no matter how poorly or selectively they have analyzed and interpreted these studies.  An expert witness’s errors in engaging with a particular scientific discipline that is in general considered generally accepted “go to the weight, not the admissibility, of the evidence unless the error renders the evidence unreliable.” Slip op. at 11.

Carpenter’s cherry-picking approach to data and studies, however, was properly excluded under Rule 702.  Carpenter’s approach vitiated the reliability of his opinion with the consequence of :

“seriously tainting his conclusions because epidemiology is an iterative science relying on later studies to refine earlier studies in order to reach better and more accurate conclusions. Carpenter refused to account for the data from the toxicological studies, which epidemiological methodology requires unless the evidence for the link between exposure and disease is unequivocal and strong, which is not the case here. Carpenter also selectively sampled data within one of the studies he used, taking data indicating an EMF-illness link and ignoring the larger pool of data within the study that showed no such link, Carpenter’s treatment of this data created an improper false impression about what the study actually showed.”

Slip op. at 12.

So that’s the difference between Frye and Rule 702!

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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

 

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Egilman Petition for Certiorari Denied

March 18th, 2013

Some will no doubt think that the Supreme Court’s decision in Egilman v. Conagra Foods Inc. was determined by the forces of class warfare and historical materialism more generally, but there it is:  certiorari denied in Order 12-697.

Dr. Egilman still has the option of suing the district judge for alleged defamation, or plaintiffs’ counsel for breach of an implied contract.  Stay tuned.

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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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New York Breathes Life Into Frye Standard – Reeps v. BMW

March 5th, 2013

In Lumpenepidemiology, I detailed how one federal judge, the Hon. Helen Berrigan, was willing to “just say no” to bad epidemiology and bad science, and to shut an expert witness’s attempt to distort and subvert scientific methodology.  Judge Berrigan closely examined the plaintiffs’ claim that a mother’s ingestion of Paxil caused a child’s heart defect, and found the proffered expert witness testimony to fail legal and scientific standards. Frischhertz v. SmithKline Beecham Corp., 2012 U.S. Dist. LEXIS 181507 (E.D.La. 2012).  The plaintiffs’ key expert witness, Dr. Shira 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.  Id. at *13 (citing Chamber v. Exxon Corp., 81 F. Supp. 2d 661 (M.D. La. 2000), aff’d, 247 F.3d 240 (5th Cir. 2001).

Frischhertz was decided in December 2012, the same month that another trial judge, right here in New York City, caught Dr. Shira Kramer in the commission of similar lumpenepidemiology, in Reeps v. BMW of North America, LLC, New York S.Ct., Index No. 100725/08 (New York Cty. Dec. 21, 2012) (York, J.).   See William Ruskin, “Frye Decision in BMW Case Results in Exclusion of Plaintiff’s Experts” (Jan. 17, 2013). Reeps was also a birth defects case.  Debra Reeps claimed that during the first trimester of her pregnancy, she was exposed to gasoline fumes from a fuel-line leak in her BMS 525i. She also claimed that her son’s adverse birth outcomes (which included severe mental retardation, severe cerebral palsy, and a congenital heart defect) were caused by her inhalation of gasoline fumes.  Heading the plaintiffs’ team of expert witnesses in support of these claims, Epidemiologist Shira Kramer opined that all of the boy’s problems were caused by the mother’s exposure to unleaded gasoline fumes.

Kramer’s opinions read like the Berenstain Bears’ guide to epidemiology.  She asserted that gasoline vapors and  its constituents (toluene, benzene, solvents, etc.), individually or collectively, cause “birth defects” generally, and Sean Reeps’ defects specifically.  Kramer also asserted that she used a “weight-of-evidence assessment,” which included a consideration of Bradford Hill’s criteria for judging causality. BMW moved to exclude plaintiffs’ witnesses, including Kramer, on grounds that the witnesses’ evidence and methods were “novel, unorthodox, unreliable and not generally accepted in the relevant scientific communities.”  Reeps slip op. at 5.  The number of ways that Kramer’s opinions ran afoul of New York law of expert witness opinions is remarkable.

Animal Studies

The animal studies found no relevant adverse birth effects, even at high gasoline fume exposure levels.  Kramer and her posse nonetheless cited animal studies involving cancer, miscarriage, and anemia for the general claim that gasoline fumes causes birth defects, as though such defects could all be lumped together.

Case Reports

Kramer relied upon two published papers of case reports in which women were exposed to leaded gasoline and then gave birth to children with malformations.  Given that the exposures reported were to leaded gasoline, the case reports were dubious in the first instance.  Furthermore, the reported defects were not even the same as those experienced by Sean Reeps.  Although the court seemed willing to engage in a discussion of what these case reports might offer towards a synthesis of all evidence, it ultimately recognized that, pace Raymond Wolfinger, plural of anecdote is not data.  “Courts have recognized that … case reports are not generally accepted in the scientific community on questions of causation.” Slip op. at 17 (quoting from Heckstall v. Pincus, 19 A.D.3d 203, 205, 797 N.Y.S.2d 445 (1st Dept. 2005)).

Exposure Assessment

The chemical components in gasoline, blamed by Kramer, make up no more than two percent of gasoline vapor. Reeps, slip at 6. One of plaintiffs’ expert witnesses asserted, without measurements, that Debra Reeps experienced atmospheric concentrations of gasoline at least 1,000 p.p.m.  Plaintiffs claimed that this level of exposure was tantamount to recreational solvent abuse, in an attempt to rely upon studies of solvent exposure at very high levels. BMW showed that the witnesses’ speculation was unfounded and implausible.  The fuel-line leak would have to leak about a gallon per mile driven to generate 1,000 p.p.m. in the passenger compartment.  Id. at 8.

Teratology Principles

Because certain structures, organs, and tissues in a developing embryo or fetus form at predictable stages of pregnancy, the science of teratology plays close attention to when the exposure to the putative teratogen occurred in the time course of a pregnancy.  Late exposures to known teratogens cannot very well explain harms that can result only from exposure early in pregnancy.  Similarly, early exposures cannot explain harms that arise only out of teratogenic exposures.  Debra Reeps’ claimed gasoline exposure occurred in her first trimester.  Despite Dr. Shira Kramer’s efforts, the neurological deficits and injuries in Sean Reeps thus cannot be explained by his mother’s early term exposures, even if gasoline fumes had the claimed teratogenic properties.

Ipse Dixit

Debra Reeps had a history of herpes simplex infection, which could explain her son’s cerebral palsy.  Slip op. at 7.  Dr. Kramer asserted that there were no alternative causes.

Epidemiology

Apparently no analytical epidemiologic study (either cohort or case-control) found an association between gasoline fume exposure in pregnancy and Sean Reeps’ birth defects. Kramer attempted to claim that the “[f]ailure to detect a statistical association does not establish that there is no association between an exposure and an outcome.”  Slip op. at 15.  Absence of evidence may not show evidence of absence, but it also does not show evidence of harm.

In one episode of Seinfeld, Jerry Seinfeld chides a rental car clerk for not honoring a reservation.  “You know how to take the reservation; you just don’t know how to hold the reservation.  And that’s really the most important part.”  Scientific methodology is similar to making reservations.  Anyone can claim to be following Sir Austin Bradford Hill’s causal criteria, but actually applying the criteria faithfully is really what the “methodology” is all about.  The abridged form favored by Dr. Kramer is indeed unorthodox, novel, unreliable, invalid, and unacceptable, scientifically and legally, as Justice York found in Reeps.  In essence, the plaintiffs argued that all their expert witnesses need show is that they are aware of proper methodologies, not that they actually used the methodologies properly.  Shira Kramer, and the other plaintiffs’ expert witnesses, offered a pastiche of a method, in the hopes that this would be sufficient.  Absent was a systematic review, and a proper analysis of the evidence. The Reeps case rejoined:  the law requires the real thing.

New York’s adherence to a Frye standard creates a potential roadblock to meaningful gatekeeping.  If an expert witness could evade gatekeeping by simply claiming to be following epidemiologic methods, regardless of how badly, that witness could undermine the interests of the justice system in weeding out speculative, unreliable, or invalid opinions.  The New York Court of Appeals demonstrated its unwillingness to tolerate such evasions.  See, e.g., Parker v. Mobil Oil Corp., 7 N.Y.3d 434, 857 N.E.2d 1114, 824 N.Y.S.2d 584 (2006) (excluding testimony of Dr. Bernard Goldstein, and dismissing leukemia (AML) claim based upon claimed low-level benzene exposure from gasoline) , aff’g 16 A.D.3d 648 (App. Div. 2d Dep’t 2005).

In Reeps, Justice York makes clear that it is the “plaintiff’s burden to prove the methodology applied to reach the conclusions will not be rejected by specialists in the field.”  Slip op. at 11.  The trial court recognized that a Frye hearing in New York must determine whether plaintiffs’ expert witnesses are faithfully applying a methodology, such as the Bradford Hill criteria, or whether they are they are “pay[ing] lip service to them while pursuing a completely different enterprise.”  Id.  To be sure, litigants might not welcome this level of scrutiny for their expert witnesses.  Justice York’s recognition that the court must examine a proffered opinion to determine whether it “properly relates existing data, studies or literature to the plaintiff’s situation, or whether, instead, it is connected to existing data only by the ipse dixit of the expert,” carries with it, an acknowledgment that New York law, like federal Rule 702, requires an assessment of the validity and sufficiency of the evidence and inferences that make up an expert witness’s opinions.  Id. (internal quotations omitted).

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The Lobby Lives – Lobbyists Attack IARC for Conducting Scientific Research

February 19th, 2013

“[A]n anti-asbestos lobby, based in the Mount Sinai School of Medicine of the City University of New York, promoted the fiction that asbestos was an all-pervading menace, and trumped up a number of asbestos myths for widespread dissemination, through media eager for bad news.”

This statement was not the ranting of an industrialist whose company was bankrupted by asbestos personal injury cases; nor was it the complaint of an industry scientist, dismayed at a body of research that showed his industry’s product to be harmful.  The statement was made by one of the most independent, thoughtful scientists who has worked on asbestos health effects, the late Doug Liddell, of the Department of Epidemiology and Biostatistics, in McGill University.  F.D.K. Liddell, “Magic, Menace, Myth and Malice,” 41 Ann. Occup. Hyg. 3, 3 (1997).

Although Professor Liddell died in 2003,  the “Lobby” lives and thrives.  Witness the article published earlier this month, in The Lancet.   David Holmes, “IARC in the dock over ties with asbestos industry,” 381 Lancet 359 (2013).   A Scientist at the International Agency for Research on Cancer (IARC), Valerie McCormack, accepted an invitation to present data at a scientific conference in Kiev, Russia, on chrysotile asbestos risk assessment and management.  McCormack’s decision set off a firestorm of protest from various sources, claiming that the Russian scientists were in “cahoots” with the Russian asbestos industry.

The Lancet article presents a muddled account of the issues, but a persistent reader may make out several supposed concerns of the “Lobbyists.” First, the Lobbyists objected on grounds that an earlier version of the paper to be delivered by McCormack, “Estimating the asbestos-related lung cancer burden from mesothelioma mortality,” was too favorable to chrysotile in relation to commercial amphibole asbestos. (The Lancet fails to mention that McCormack’s paper has since been published, with co-authorship by some distinguished scientists.  See Valerie McCormack, Julian Peto, G. Byrnes, K. Straif, and P. Boffetta, “Estimating the asbestos-related lung cancer burden from mesothelioma mortality,” 106 Brit. J. Cancer 575 (2012).)

Second, the Lobbyists objected to IARC’s decision to collaborate on a study of Russian miners and millers, with Evgeny Kovalevkiy. The study, entitled  “Historical cohort study of cancer mortality following exposure to chrysotile asbestos at the Uralasbest plant in Asbest, Russian Federation” is supported by the Russian Scientific Research Institute of Occupational Health (SRIOH), which supports the continued mining and exporting of chrysotile asbestos.  Especially vexing to the Lobbyists, Kovalevskiy has personally advocated public policy that encourages the continued use of chrysotile.  In the words of three American political scientists who sent a letter of protest to the IARC:

“Kovalevskiy is a leading promoter of use of chrysotile asbestos. He testified before the Supreme Court of Brazil in August 2012, as witness on behalf of the Brazilian Chrysotile Institute.  He testified that there is no evidence whatsoever to justify banning the use of chrysotile asbestos; that he opposes placing chrysotile asbestos on the Rotterdam Convention’s List of Hazardous Substances; that, in the past, harm to health was caused by the use of amphibole asbestos and excessive, prolonged exposure levels to chrysotile asbestos, but that, today, chrysotile asbestos is causing no harm to health in Russia. We consider that it is unacceptable that a scientist, who is a promoter of chrysotile asbestos use, should be a lead scientist on an IARC research project regarding chrysotile asbestos.”

“IARC in the dock” at 360 (quoting letter signed by Richard Lemen, Arthur Frank, and Barry Castleman).  The Lancet article conveniently omits any reference to the remunerative and unremunerative work by these gentlemen for the American anti-asbestos litigation industry.

Posted in Conflicts of Interest, Expert Witnesses, Scientific Misconduct | Comments Off on The Lobby Lives – Lobbyists Attack IARC for Conducting Scientific Research

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:

  1. 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?
  2. 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?
  3. 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?
  4. 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

The Dubious Origins of the Linear No Threshold Model of Carcinogenesis

January 10th, 2013

Most regulation of chemical exposures for causing cancer outcomes is based upon a linear no-threshold exposure-response (LNT) model.  This model informs risk assessments and policy judgments in the United States, Europe, and throughout the world.  If the LNT model were offered to support only precautionary principle judgments, then we might excuse the pretensions of LNT advocates.  The authors of LNT models, environmentalists, and a cadre of anti-industry scientists (“The Lobby”) are not willing, however, to be understood to be offering mere prudential guidance.  They claim that they are offering scientific conclusions, worthy of being taken seriously, as knowledge.

Passing off prudence, aesthetics, and hostility to industrialization as science is a deception that takes place virtually every day in the front pages of the lay media, in scientific journals, as well as in the Federal Register.  Implicit in the stridency of the Lobby is a desire to impose an often impossible burden upon industry to prove that there is no increased risk at miniscule exposures, and to challenge negative results with claims of inadequate power.

Professor Calabrese, in the current issue of the University of Chicago Law Review, has traced a source of the deception behind LNT to a series of events tied to the United States nuclear weapons program during World War II.  Edward J. Calabrese, “US Risk Assessment Policy: A History of Deception — A Response to Arden Rowell, Allocating Pollution,” 79 U. Chi. L. Rev. 985 (2012).   In 1927, Hermann J. Muller, a radiation geneticist, discovered that X-ray radiation caused mutation of fruit fly germ cells. The importance of health outcomes from radiation exposure led to Muller’s service as an advisor to the Manhattan Project during World War II.  In 1946, Muller received the Nobel Prize in medicine, for his work in genetics.

Professor Calabrese points out that Muller so thoroughly dismissed threshold models of radiation mutagenicity in his Nobel address, that the LNT became accepted dogma in the regulatory and scientific agencies of the United States government, and later, around the world.   Edward J. Calabrese, “Muller’s Nobel Prize Lecture: when ideology prevailed over science,” 126 Toxicol. Sci. 1 (2012).   What Professor Calabrese adds to the historical narrative is that Muller was aware of high quality research that undermined the LNT, when he announced in his Nobel lecture that there was no evidence for thresholds.  In the 1950’s, Muller continued to use his influence to advance the LNT model of radiation-induced carcinogenesis with the National Academies of Science Biological Effects of Atomic Radiation (“BEAR I”) Committee.

Professor Calabrese has provided an important cautionary tale about how scientific beliefs take hold and are propagated.  Muller’s influence and the rise of the LNT model is a recurring tale of the role of power, persuasion, and prestige in claiming scientific truths. It is not just about money.  Conflicts of interest involving professional honors, institutional recognition, friendships, intellectual commitments, and investigative “zeal,” which are often much greater threats to the integrity of science and medical research than receipt of payments.  See Richard S. Saver, “Is It Really All about the Money? Reconsidering Non-Financial Interests in Medical Research,”  40 J. Law, Med. & Ethics (2012).

If Professor Calabresse is right in his historical analysis, Muller achieved his goal of protecting his discovery from challenge by a selective presentation of the relevant data at a crucial moment in the formation of scientific thinking about mutagenesis. The rise and fall of the LNT model carries with it an important lesson to judicial gatekeepers.  Unlike the audience of Muller’s Nobel speech, lawyers and judges can, and must, insist upon a declaration of all materials considered so that they can determine whether an expert witness has proffered an opinion based upon a thorough, complete review of the relevant data.

Posted in Conflicts of Interest, Expert Witnesses | Comments Off on The Dubious Origins of the Linear No Threshold Model of Carcinogenesis

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