TORTINI

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

Vaccine Court Inoculated Against Pathological Science

October 25th, 2015

Richard I. Kelley, M.D., Ph.D., is the Director of the Division of Metabolism, Kennedy Krieger Institute, and a member of the Department of Pediatrics, in Johns Hopkins University. The National Library of Medicine’s Pubmed database shows that Dr. Kelley has written dozens of articles on mitochondrial disease, but none that concludes that thimerosal or the measles, mumps and rubella vaccine plays a causal role in causing autism by inducing or aggravating mitochondrial disease. In one article, Kelley opines:

“Large, population-based studies will be needed to identify a possible relationship of vaccination with autistic regression in persons with mitochondrial cytopathies.”

Jacqueline R. Weissman, Richard I. Kelley, Margaret L. Bauman, Bruce H. Cohen, Katherine F. Murray, Rebecca L. Mitchell, Rebecca L. Kern, and Marvin R. Natowicz, “Mitochondrial Disease in Autism Spectrum Disorder Patients: A Cohort Analysis,” 3 PLoS One e3815 (Nov. 26, 2008). Those large scale population-based studies to support the speculation of Kelley and his colleagues have not materialized since 2008, and meta-analyses and systematic reviews have dampened the enthusiasm for Kelley’s hypothesis.[1]

Special Master Denise K. Vowell, in the Federal Court of Claims, has now further dampened the enthusiasm for Dr. Kelley’s mitochondrial theories, in a 115 page opinion, written in support of rejecting Kelley’s testimony and theories that the MMR vaccine caused a child’s autism. Madariaga v. Sec’y Dep’t H.H.S., No. 02-1237V (Ct. Fed. Claims Sept. 26, 2015) Slip op. [cited as Madariaga].

Special Master Vowell fulsomely recounts the history of vaccine litigation, in which the plaintiffs have presented theories that the combination of thimerosal-containing vaccines and the MMR vaccine cause autism, or just the thimerosal-containing vaccines cause autism. Madariaga at 3. Both theories were tested in the crucible of litigation and cross-examination in a series of test cases. The first theory resulted in verdicts against the claimants, which were affirmed on appeal.[2] Similarly, the trials on the thimerosal-only claims uniformly resulted in decisions from the Special Masters against the claims.[3] The three Special Masters, hearing the cases, found that the vaccine-causation claims were not close cases, and were based upon unreliable evidence.[4] Madariaga at 4.[5]

In Madariaga, Special Master Vowell noted that Doctor Kelley had conceded the “absence of an association between the MMR vaccine and autism in large epidemiological studies.” Madariaga at 61. Kelley attempted to evade the force of his lack of evidence by retreating into a claim that “autistic regressions caused by the live attenuated MMR vaccine are rare events,” and an assertion that there are many inflammatory factors that can induce autistic regression. Madariaga at 61.

Special Master described the whole of Kelley’s testimony as “meandering, confusing, and completely unpersuasive elaboration of his unique insights and methods.” Madariaga at 66. Although it is clear from the Special Master’s opinion that Kelley was unbridled in his over-interpretation of studies, and perhaps undisciplined in his interpretation of test results, the lengthy opinion provides only a high-altitude view of Kelley’s errors. There are tantalizing comments and notes in the Special Master’s decision, such as one that reports that one study may have been over-interpreted by Kelley because he ignored the authors’ comment that their findings could be consistent with chance because of their multiple comparisons, and another that paper that failed to show statistical significance. Madariaga at 90 & n.160.

The unreliability of Kelley’s testimony appeared to be more than hand waving in the absence of evidence. He compared the child’s results on a four-hour fasting test, when the child had not fasted for four hours. When pressed about this maneuver, Kelley claimed that he had made calculations to bring the child’s results “back to some standard.” Madariaga at 66 & n.115.

Although the Special Master’s opinion itself was ultimately persuasive, the tome left me eager to know more about Dr. Kelley’s epistemic screw ups, and less about vaccine court procedure.


[1] See Vittorio Demicheli, Alessandro Rivetti, Maria Grazia Debalini, and Carlo Di Pietrantonj, “Vaccines for measles, mumps and rubella in children,” Cochrane Database Syst. Rev., Issue 2. Art. No. CD004407, DOI:10.1002/14651858.CD004407.pub3 (2012) (“Exposure to the MMR vaccine was unlikely to be associated with autism … .”); Luke E. Taylor, Amy L. Swerdfeger, and Guy D. Eslick, “Vaccines are not associated with autism: An evidence-based meta-analysis of case-control and cohort studies,” 32 Vaccine 3623 (2014) (“Findings of this meta-analysis suggest that vaccinations are not associated with the development of autism or autism spectrum disorder. Furthermore, the components of the vaccines (thimerosal or mercury) or multiple vaccines (MMR) are not associated with the development of autism or autism spectrum disorder.”).

[2] Cedillo v. Sec’y, HHS, No. 98-916V, 2009 WL 331968 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 89 Fed. Cl. 158 (2009), aff’d, 617 F.3d 1328 (Fed. Cir. 2010); Hazlehurst v. Sec’y, HHS, No. 03-654V, 2009 WL 332306 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 473 (2009), aff’d, 604 F.3d 1343 (Fed. Cir. 2010); Snyder v. Sec’y, HHS, No. 01-162V, 2009 WL 332044 (Fed. Cl. Spec. Mstr. Feb. 12, 2009), aff’d, 88 Fed. Cl. 706 (2009).

[3] Dwyer v. Sec’y, HHS, 2010 WL 892250; King v. Sec’y, HHS, No. 03-584V, 2010 WL 892296 (Fed. Cl. Spec. Mstr. Mar. 12, 2010); Mead v. Sec’y, HHS, 2010 WL 892248.

[4] See, e.g., King, 2010 WL 892296, at *90 (emphasis in original); Snyder, 2009 WL 332044, at *198.

[5] The Federal Rule of Evidence technically do not control the vaccine court proceedings, but the Special Masters are bound by the requirement of Daubert v. Merrell Dow Pharm., 509 U.S. 579, 590 (1993), to find that expert witness opinion testimony is reliable before they consider it. Knudsen v. Sec’y, HHS, 35 F.3d 543, 548-49 (Fed. Cir. 1994). Madariaga at 7.

On Amending Rule 702 of the Federal Rules of Evidence

October 17th, 2015

No serious observer or scholar of the law of evidence can deny that the lower federal courts have applied Daubert and its progeny, and the revised Federal Rule of Evidence 702, inconstantly and inconsistently, in their decisions to admit or exclude proffered expert witness opinion testimony. Opponents of trial court “gatekeeping” of expert witnesses applaud the lapses in hopes that the gates have been unhinged and that there will be “open admissions” for expert witness testimony. These opponents latch on to the suggestion that the Rules favor “liberal” admissibility with a libertine; they lose sight of the meaning of “liberal” that conveys enlightened, with an openness to progress and salutary change, and the claims of knowledge over blind faith.  Supporters of gatekeeping lament the courts’ inability or unwillingness to apply a clear statutory mandate that is designed to improve and ensure the correctness of fact finding in the federal courts. A few have decried the lawlessness of the courts’ evasions and refusals to apply Rule 702’s requirements.

Given the clear body of Supreme Court precedent, and the statutory revision to Rule 702, which was clearly designed to embrace, embody, enhance, and clarify the high Court precedent, I did not think that an amendment to Rule 702 was needed to improve the sorry state of lower court decisions. Professor David Bernstein and lawyer Eric Lasker, however, have made a powerful case for amendment as a way of awakening and galvanizing federal judges to their responsibilities under the law. David E. Bernstein & Eric G. Lasker,“Defending Daubert: It’s Time to Amend Federal Rule of Evidence 702,” 57 William & Mary L. Rev. 1 (2015) [cited below as Bernstein & Lasker].

Bernstein and Lasker remind us that Rule 702 is a statute[1] that superseded inconsistent prior judicial pronouncements. The authors review many of the more egregious cases that ignore the actual text of Rule 702, while adverting to judicial gloss on the superseded rule, and even to judicial precedent and dicta pre-dating the Daubert case itself. Like the Papa Bear in the Berenstain Bear family, the authors show us how not to interpret a statute properly, through examples from federal court decisions.

The Dodgers’ Dodges

Questions about whether expert witnesses properly applied a methodology to the facts of a case are for the jury, and not the proper subject of gatekeeping.

As Bernstein and Lasker document, this thought- and Rule-avoidance dodge is particularly shocking given that the Supreme Court clearly directed close and careful analysis of the specific application of general principles to the facts of a case.[2] Shortly after the Supreme Court decided Daubert, the Third Circuit decided a highly influential decision in which it articulated the need for courts to review every step in expert witnesses’ reasoning for reliability. In re Paoli RR Yard PCB Litig., 35 F.3d 717, 745 (3d Cir. 1994). The Paoli case thus represents the antithesis of a judicial approach that asks only the 10,000 foot level question whether the right methodology was used; Paoli calls for a close, careful analysis of the application of a proper methodology to every step in the case. Id. (“any step that renders the analysis unreliable … renders the expert’s testimony inadmissible … whether the step completely changes a reliable methodology or merely misapplies that methodology”).

While the Paoli approach is unpopular with some judges who might prefer not to work so hard, the Advisory Committee heartily endorsed Paoli’s “any step” approach in its Note to the 2000 amendment. Bernstein & Lasker at 32. Bernstein and Lasker further point out that the Committee’s Report, Professor Dan Capra, acknowledged, shortly after the amendment went into effect, that the Paoli “any step” approach had a “profound impact” on the drafting of amended Rule 702. Bernstein & Lasker at 28.[3]

Having demonstrated the reasons, the process, and the substance of the judicial and legislative history of the revised Rule 702, Bernstein and Lasker are understandably incensed at the lawlessness of circuit and trial courts that have eschewed the statute, have ignored Supreme Court precedent, and have retreated to vague judicial pronouncements that trace back to before some or any of the important changes occurred in Rule 702.[4]

Let’s Cherry Pick and Weigh of the Evidence; Forget the Scale

Along with some courts’ insistence that trial judges may not examine the application of methods to the facts of a case, other courts, perhaps mindful of their citation practices, have endorsed “cherry picking” as a satisfactory methodology for partial expert witnesses to support their opinions. Id. at 35-36. Our law review authors also trace the influence of plaintiffs’ counsel, through their “walking around money” from the breast implant litigation, in sponsoring anti-Daubert, anti-gatekeeping conferences, at which prominent plaintiffs’ advocates and expert witnesses, such as Carl Cranor presented in favor of a vague “weight of the evidence” (WOE) approach to decision making. Id. at 39. Following these conferences, some courts have managed to embrace WOE, which is usually packaged as an abandonment of scientific standards of validity and sufficiency, in favor of selective review and subjective decisions. To do this, however, courts have had to ignore both Supreme Court precedent and the clear language of Rule 702. In Joiner, the high Court rejected WOE, over the dissent of a single justice,[5] but some of the inferior federal courts have embraced the dissent to the exclusion of the majority’s clear holding, as well as the incorporation of that holding into the revised Rule 702.[6] An interesting case of judicial disregard.

Other Dodges

The law review authors did not purport to provide an exhaustive catalogue of avoidance and evasion techniques. Here is one that is not discussed: shifting the burden of proof on admissibility to the opponent of the expert witness’s opinion:

“Testimony from an expert is presumed to be helpful unless it concerns matters within the everyday knowledge and experience of a lay juror.”

Earp v. Novartis Pharms., No. 5:11–CV–680–D, 2013 WL 4854488, at *3 (Sept. 11, 2013). See also Kopf v. Skyrm, 993 F.2d 374, 377 (4th Cir.1993); accord Koger v. Norfolk S. Ry. Co., No. 1:08–0909, 2010 WL 692842, at *1 (S.D.W.Va. Feb. 23, 2010) (unpublished).

Whence comes this presumption? Perhaps it is no more than a requirement for the opponent to object and articulate the flaws before the trial court will act. But the “presumption” sure looks like a covert shifting of the burden of proof for the requisite reliability of an expert witness’s opinion, which burden clearly falls on the proponent of the testimony.

The Proposed Amended Rule 702

There are several possible responses to the problem of the judiciary’s infidelity to basic principles, precedent, and legislative directive. Bernstein and Lasker advance amendments to the current Rule 702, as a blunt reminder that the times and the law have changed, really. Here is their proposed revision, with new language italicized, and deleted language shown to be struck:

“Rule 702. Testimony by Expert Witnesses

A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if the testimony satisfies each of the following requirements:

(a) the expert’s scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue;

(b) the testimony is based on sufficient facts or data that reliably support the expert’s opinion;

(c) the testimony is the product of reliable and objectively reasonable principles and methods; and

(d) the expert has reliably applied the principles and methods to the facts of the case and reached his conclusions without resort to unsupported speculation.

Appeals of district court decisions under this Rule are considered under the abuse-of-discretion standard. Such decisions are evaluated with the same level of rigor regardless of whether the district court admitted or excluded the testimony in question. This Rule supersedes any preexisting precedent that conflicts with any or all sections of this Rule.

Bernstein & Lasker at 44-45.

Before discussing and debating the changes, we should ask, “why change a fairly good statute just because lower courts evade its terms?” The corrupt efforts of SKAPP[7] to influence public and judicial policy, as well as the wildly one-sided Milward symposium,[8] which the authors discuss, should serve as a potent reminder that there would be many voices in the review and revision process, both from within plaintiffs’ bar, and from those sympathetic to the litigation industry’s goals and desires. Opening up the language of Rule 702 to revision could result in reactionary change, driven by the tort bar’s and allies’ lobbying. The result could be the evisceration of Rule 702, as it now stands. This danger requires a further exploration of alternatives to the proposed amendment.

Rule 702 has had the benefit of evolutionary change and development, which have made it better and also possibly burdened with vestigial language. To be sure, the rule is a difficult statute to draft, and while the authors give us a helpful start, there is many problems to be subdued before a truly workable working draft can be put be forward.

The first sentence’s new language, “the testimony satisfies each of the following requirements,” is probably already satisfied the use of “and” between the following numbered paragraphs. Given the judicial resistance to Rule 702, the additional verbiage could be helpful; it should be unnecessary. The conditionality of “if,” however, leaves the meaning of the Rule unclear when that condition is not satisfied. The Rule clearly signifies that “if” in the introductory sentence means “only if,” and the law and litigants would be better off if the Rule said what it means.

Proposed Subsection (b)

(b) the testimony is based on sufficient facts or data that reliably support the expert’s opinion;

The authors do not make much of a case for striking “sufficient.” There will be times when there are perfectly good facts and data supporting an expert witness’s opinion, in a completely reliable opinion, but the supporting facts and data do not support an epistemic claim of “knowledge,” because the support is indeterminate between the claim and many other competing hypotheses that might explain the outcome at issue. The reliably supporting facts and data may amount to little more than a scientific peppercorn, and really be too much of too little to support the claim. Deleting “sufficient” from subsection b could be a serious retrograde move, which will confuse the judiciary more than instruct it.

The revised subsection also fails to address the integrity of the facts and data, and the validity of how the data were generated. To be sure, Rule 703 could pick up some of the slack, but Rule 703 is often ignored, and even when invoked, that rule has its own drafting and interpretation problems. SeeGiving Rule 703 the Cold Shoulder” (May 12, 2012); “RULE OF EVIDENCE 703 — Problem Child of Article VII” (Sept. 19, 2011). Also missing is an acknowledgment that the facts or data must often be analyzed in some way, whether by statistical tests or some other means. And finally, there is the problem in that reliable does not necessarily connote valid or accurate. Subsection (b) thus seems to cry out for additional qualification, such as:

“the testimony is based on sufficient facts or data, reliably, accurately, and validly ascertained, and analyzed, which facts or data reliably and validly support the expert’s opinion”

Proposed Subsection (c)

Bernstein and Lasker propose modifying this subsection to inject “and objectively reasonable” before “principles and methods.” The authors do not explain what objectively reasonable principles and methods encompass, and they qualification does seem self-explanatory. Perhaps they are calling for principles and methods that are “generally accepted,” and otherwise justified as warranted to produce accurate, true results? Is so, that might be a helpful addition.

Proposed Subsection (d)

Here the authors bolster the language of the subsection with a prohibition against using unsupported speculation. OK; but would supported or inspired or ingenious speculation be any better? Subsection (a) speaks of knowledge, and it should be obvious that the expert witness’s opinion has an epistemic warrant to be something more than a mere subjective opinion.

Whether Bernstein and Lasker have opened a can or a Concordat of Worms remains to be seen.


[1] The authors provide a great resource on the legislative history of attempts to revise 702, up to and including the 2000 revision. The 2000 revision began with a proposed amendment from the Advisory Committee in April 1999. The Standing Committee on Rules of Practice and Procedure approved the proposal, and forwarded the proposed amendment to the Judicial Conference, which approved the amendment without change in September 1999. The Supreme Court ordered the amendment in April 2000, and submitted the revised rule to Congress. Order Amending the Federal Rules of Evidence, 529 U.S. 1189, 1195 (2000). The revised Rule 702 became effective on December 1, 2000. See also Bernstein & Lasker at 19 n. 99 (citing Edward J. Imwinkelried, “Response, Whether the Federal Rules of Evidence Should Be Conceived as a Perpetual Index Code: Blindness Is Worse than Myopia,” 40 Wm. & Mary L. Rev. 1595, 1595-98 (1999) (noting and supporting the Supreme Court’s interpretation and application of the Federal Rules of Evidence as a statute, and subject to the judicial constraints on statutory construction). For a strident student’s pro-plaintiff view of the same legislative history, see Nancy S. Farrell, “Congressional Action to Amend Federal Rule of Evidence 702: A Mischievous Attempt to Codify Daubert v. Merrell Dow Pharmaceuticals, Inc.”, 13 J. Contemp. Health L. & Pol’y 523 (1997).

[2] General Electric Co. v. Joiner, 522 U.S. 136 (1997) (reviewing and analyzing individual studies’ internal and external validity, and rejecting plaintiffs’ argument that only the appropriateness of the methodology in the abstract was subject of gatekeeping); Kumho Tire Co. v. Carmichael, 526 U.S. 137, 156-57 (1999) (“stressing that district courts must scrutinize whether the principles and methods employed by an expert have been properly applied to the facts of the case”) (quoting what was then the proposed advisory committee’s note to Rule 702, Preliminary Draft of Proposed Amendments to the Federal Rules of Civil Procedure and Evidence: Request for Comment, 181 F.R.D. 18, 148 (1998)).

[3] citing Stephen A. Saltzburg, Edwin J. Imwinkelried, & Daniel J. Capra, “Keeping the Reformist Spirit Alive in Evidence Law,” 149 U. Pa. L. Rev. 1277, 1289-90 (2001). The authors note that other circuits have embraced the Paoli “any steps” approach. Bernstein & Lasker at 28 at n. 152 (citing Paz v. Brush Engineered Materials, Inc., 555 F.3d 383, 387-91 (5th Cir. 2009); McClain v. Metabolife Int’l, Inc., 401 F.3d 1233, 1245 (11th Cir. 2005); Dodge v. Cotter Corp., 328 F.3d 1212, 1222 (10th Cir. 2003); Amorgianos v. Nat’l R.R. Passenger Corp., 303 F.3d 256, 267 (2d Cir. 2002) (quoting In re Paoli, 35 F.3d at 746).

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

[5] General Electric Co. v. Joiner, 522 U.S. 136, 146-47 (1997) (holding that district court had the “discretion to conclude that the studies upon which the experts relied were not sufficient, whether individually or in combination, to support their conclusions that Joiner’s exposure to PCB’s contributed to his cancer”). Other federal and state courts have followed Joiner. See Allen v. Pa. Eng’g Corp., 102 F.3d 194, 198 (5th Cir. 1996) (“We are also unpersuaded that the ‘weight of the evidence’ methodology these experts use is scientifically acceptable for demonstrating a medical link between Allen’s EtO exposure and brain cancer.”). For similar rejections of vague claims that weak evidence add up to more than the sum of its parts, see Hollander v. Sandoz Pharm. Corp., 289 F.3d 1193, 1216 n.21 (10th Cir. 2002); Magistrini v. One Hour Martinizing Dry Cleaning, 180 F. Supp. 2d 584, 608 (D.N.J. 2002); Caraker v. Sandoz Pharm. Corp., 188 F. Supp. 2d 1026, 1040 (S.D. Ill. 2001); Siharath v. Sandoz Pharm. Corp., 131 F. Supp. 2d 1347, 1371 (N.D. Ga. 2001), aff’d sub nom. Rider v. Sandoz Pharm. Corp., 295 F.3d 1194 (11th Cir. 2002); Merck & Co. v. Garza, 347 S.W.3d 256, 268 (Tex. 2011); Estate of George v. Vt. League of Cities & Towns, 993 A.2d 367, 379-80 (Vt. 2010).

[6] Milward v. Acuity Specialty Products Group, Inc., 639 F.3d 11, 17-18 (1st Cir. 2011) (reversing the exclusion of expert witnesses who embraced WOE). Milward has garnered some limited support in a few courts, as noted by Bernstein and Lasker; see In re Fosamax (Alendronate Sodium) Prods. Liab. Litig., Nos. 11-5304, 08-08, 2013 WL 1558690, at *4 (D.N.J. Apr. 10, 2013); Harris v. CSX Transp., Inc., 753 S.E.2d 275, 287-89, 301-02 (W. Va. 2013).

[7]SKAPP A LOT” (April 30, 2010).

[8]Milward Symposium Organized by Plaintiffs’ Counsel and Witnesses” (Feb. 13, 2013); [http://perma.cc/PW2V-X7TK].

Woodside on Access to Underlying Research Data

October 10th, 2015

Access to underlying data and materials, source codes, and other research materials is a two-edged sword. Many scientists who hold forth on the issue, including some prominent plaintiffs’ expert witnesses, have been extremely critical of the pharmaceutical and other industries for not sharing underlying data of their research. On the other hand, some of the same people have resisted sharing data and information when the litigants have sought access to these materials to understand or to challenge the published conclusions and analyses.[1]

Dr. Frank Woodside, of Dinsmore & Shohl, kindly sent me a copy of his recent law review article, written with a colleague, which advocates for full disclosure of underlying research data when research becomes material to the outcome of litigation.[2] Frank C. Woodside & Michael J. Gray, “Researchers’ Privilege: Full Disclosure,” 32 West. Mich. Univ. Cooley L. Rev. 1 (2015). The authors make the case that the so-called researcher’s privilege has little or no support in federal or state law. My previous posts have largely supported this view, at least for research that has been published, and especially for research that is being relied upon by testifying expert witnesses in pending litigation. As Lord Chancellor Hardwicke put the matter, “the public has a right to every man’s evidence,”[3] and scientists should not be immune to the requirement of giving and sharing their evidence.

Woodside and Gray have updated the scholarship in this area, and their article should be consulted in any ongoing discovery, subpoena, or Freedom of Information Act (FOIA) battle. Their discussion of the evolving case law under FOIA is especially timely. Despite the strong presumption in favor of disclosure under FOIA,[4] and President Obama’s pronouncements[5] about a new era in FOIA openness and transparency, the government’s compliance is at an all-time low. See Ted Bridis, “Obama administration sets new record for withholding FOIA requests,” PBS News Hour (Mar. 18, 2015). Court decisions have made clear that researchers cannot refuse to produce underlying data simply “because disclosure would diminish the researchers’ ability to publish their results in prestigious journals.”[6] And yet the National Institute of Environmental Health and Safety continues in its aggressive resistance to disclosure of underlying data, often by invoking FOIA exemption number four. In my cases, I have seen the NIEHS resort to this exemption that protects documents that reveal “[t]rade secrets and commercial or financial information obtained from a person and privileged or confidential,”[7] even when the research in question was conducted by academic researchers funded by the NIEHS.


[1] See, e.g., Enoch v. Forest Research Institute, Inc., N.J. Law Div. Hudson Cty., Civ. Div. L-3896-14, Order Granting Defendants’ Motion to Compel Production of Documents Necessary to Verify the Validity and Accuracy of a Study by Plaintiffs’ Expert, Anick Berard, Ph.D. (Oct. 9, 2015) (Jablonski, J.) (ordering plaintiffs to “produce the documents sought by the Forest defendants to verify the validity and accuracy of the study known as “Berard et al., Sertraline Use During Pregnancy and the Risk of Major Malformations, Am. J. Obstet. Gynecol. (2015), doi 10.1016/j.ajog.2015.01.034, namely the study’s SAS source codes and the specific generalized estimating equation models that were used to generate Table 2 of the study”).

[2] And I should thank Dr. Woodside and Mr. Gray for their generous citations to your humble blogger’s posts on this subject.

[3] Debate in the House of Lords on the Bill to Indemnify Evidence, 12 Hansard’s Parliamentary History of England, 675, 693, May 25, 1742, quoted in 8 Wigmore on Evidence at 64, § 2192 (3d ed. 1940).

[4] See S. REP. No. 89-813, at 3 (1965) (the purpose of FOIA is to “establish a general philosophy of full agency disclosure . . . and to provide a court procedure by which citizens and the press may obtain information wrongfully withheld”).

[5] See Executive Order, Memorandum, 74 Fed. Reg. 4685 (Jan. 21, 2009).

[6] See Burka v. U.S. Dep’t of Health and Human Serv., 87 F.3d 508, 515 (D.C. Cir. 1996).

[7] See 5 U.S.C. § 552(b)(4).

The C-8 (Perfluorooctanoic Acid) Litigation Against DuPont, part 1

September 27th, 2015

The first plaintiff has begun her trial against E.I. Du Pont De Nemours & Company (DuPont), for alleged harm from environmental exposure to perfluorooctanoic acid or its salts (PFOA). Ms. Carla Bartlett is claiming that she developed kidney cancer as a result of drinking water allegedly contaminated with PFOA by DuPont. Nicole Hong, “Chemical-Discharge Case Against DuPont Goes to Trial: Outcome could affect thousands of claims filed by other U.S. residents,” Wall St. J. (Sept. 13, 2015). The case is pending before Chief Judge Edmund A. Sargus, Jr., in the Southern District of Ohio.

PFOA is not classified as a carcinogen in the Integrated Risk Information System (IRIS), of the U.S. Environmental Protection Agency (EPA). In 2005, the EPA Office of Pollution Prevention and Toxics submitted a “Draft Risk Assessment of the Potential Human Health Effects Associated With Exposure to Perfluorooctanoic Acid and Its Salts (PFOA),” which is available at the EPA’s website. The draft report, which is based upon some epidemiology and mostly animal toxicology studies, stated that there was “suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential.”

In 2013, The Health Council of the Netherlands evaluated the PFOA cancer issue, and found the data unsupportive of a causal conclusions. The Health Council of the Netherlands, “Perfluorooctanoic acid and its salts: Evaluation of the carcinogenicity and genotoxicity” (2013) (“The Committee is of the opinion that the available data on perfluorooctanoic acid and its salts are insufficient to evaluate the carcinogenic properties (category 3)”).

Last year, the World Health Organization (WHO) through its International Agency for Research on Cancer (IARC) reviewed the evidence on the alleged carcinogenicity of PFOA. The IARC, which has fostered much inflation with respect to carcinogenicity evaluations, classified as PFOA as only possibly carcinogenic. See News, “Carcinogenicity of perfluorooctanoic acid, tetrafl uoroethylene, dichloromethane, 1,2-dichloropropane, and 1,3-propane sultone,” 15 The Lancet Oncology 924 (2014).

Most independent reviews also find the animal and epidemiologic unsupportive of a causal conclusion between PFOA and any human cancer. See, e.g., Thorsten Stahl, Daniela Mattern, and Hubertus Brunn, “Toxicology of perfluorinated compounds,” 23 Environmental Sciences Europe 38 (2011).

So you might wonder how DuPont lost its Rule 702 challenges in such a case, which it surely did. In re E. I. du Pont de Nemours & Co. C-8 Pers. Injury Litig., Civil Action 2:13-md-2433, 2015 U.S. Dist. LEXIS 98788 (S.D. Ohio July 21, 2015). That is a story for another day.

David Faigman’s Critique of G2i Inferences at Weinstein Symposium

September 25th, 2015

The DePaul Law Review’s 20th Annual Clifford Symposium on Tort Law and Social Policy is an 800-plus page tribute in honor of Judge Jack Weinstein. 64 DePaul L. Rev. (Winter 2015). There are many notable, thought-provoking articles, but my attention was commanded by the contribution on Judge Weinstein’s approach to expert witness opinion evidence. David L. Faigman & Claire Lesikar, “Organized Common Sense: Some Lessons from Judge Jack Weinstein’s Uncommonly Sensible Approach to Expert Evidence,” 64 DePaul L. Rev. 421 (2015) [cited as Faigman].

Professor Faigman praises Judge Jack Weinstein for his substantial contributions to expert witness jurisprudence, while acknowledging that Judge Weinstein has been a sometimes reluctant participant and supporter of judicial gatekeeping of expert witness testimony. Professor Faigman also uses the occasion to restate his own views about the so-called “G2i” problem, the problem of translating general knowledge that pertains to groups to individual cases. In the law of torts, the G2i problem arises from the law’s requirement that plaintiffs show that they were harmed by defendants’ products or environmental exposures. In the context of modern biological “sufficient” causal set principles, this “proof” requirement entails that the product or exposure can cause the specified harms in human beings generally (“general causation”) and that the product or exposure actually played a causal role in bringing about plaintiffs’ specific harms.

Faigman makes the helpful point that courts initially and incorrectly invoked “differential diagnosis,” as the generally accepted methodology for attributing causation. In doing so, the courts extrapolated from the general acceptance of differential diagnosis in the medical community to the courtroom testimony about etiology. The extrapolation often glossed over the methodological weaknesses of the differential approach to etiology. Not until 1995 did a court wake to the realization that what was being proffered was a “differential etiology,” and not a differential diagnosis. McCullock v. H.B. Fuller Co., 61 F.3d 1038, 1043 (2d Cir. 1995). This realization, however, did not necessarily stimulate the courts’ analytical faculties, and for the most part, they treated the methodology of specific causal attribution as general acceptance and uncontroversial. Faigman’s point that the courts need to pay attention to the methodological challenges to differential etiological analysis is well taken.

Faigman also claims, however, that in advancing “differential etiologies, expert witnesses were inventing wholesale an approach that had no foundation or acceptance in their scientific disciplines:

 “Differential etiology is ostensibly a scientific methodology, but one not developed by, or even recognized by, physicians or scientists. As described, it is entirely logical, but has no scientific methods or principles underlying it. It is a legal invention and, as such, has analytical heft, but it is entirely bereft of empirical grounding. Courts and commentators have so far merely described the logic of differential etiology; they have yet to define what that methodology is.”

Faigman at 444.[1] Faigman is correct that courts often have left unarticulated exactly what the methodology is, but he does not quite make sense when he writes that the method of differential etiology is “entirely logical,” but has no “scientific methods or principles underlying it.” Afterall, Faigman starts off his essay with a quotation from Thomas Huxley that “science is nothing but trained and organized common sense.”[2] As I have written elsewhere, the form of reasoning involved in differential diagnosis is nothing other than the iterative disjunctive syllogism.[3] Either-or reasoning occurs throughout the physical and biological sciences; it is not clear why Faigman declares it un- or extra-scientific.

The strength of Faigman’s claim about the made-up nature of differential etiology appears to be undermined and contradicted by an example that he provides from clinical allergy and immunology:

“Allergists, for example, attempt to identify the etiology of allergic reactions in order to treat them (or to advise the patient to avoid what caused them), though it might still be possible to treat the allergic reactions without knowing their etiology.”

Faigman at 437. Of course, not only allergists try to determine the cause of an individual patient’s disease. Psychiatrists, in the psychoanalytic tradition, certain do so as well. Physicians who use predictive regression models use group data, in multivariate analyses, to predict outcomes, risk, and mortality in individual patients. Faigman’s claim is similarly undermined by the existence of a few diseases (other than infectious diseases) that are defined by the causative exposure. Silicosis and manganism have played a large role in often bogus litigation, but they represent instances in which a differential diagnosis and puzzle may also be an etiological diagnosis and puzzle. Of course, to the extent that a disease is defined in terms of causative exposures, there may be serious and even intractable problems caused by the lack of specificity and accuracy in the diagnostic criteria for the supposedly pathognomonic disease.

As for whether the concept of “differential etiology” is ever used in the sciences themselves, a few citations for consideration follow.

Kløve & D. Doehring, “MMPI in epileptic groups with differential etiology,” 18 J. Clin. Psychol. 149 (1962)

Kløve & C. Matthews, “Psychometric and adaptive abilities in epilepsy with differential etiology,” 7 Epilepsia 330 (1966)

Teuber & K. Usadel, “Immunosuppression in juvenile diabetes mellitus? Critical viewpoint on the treatment with cyclosporin A with consideration of the differential etiology,” 103 Fortschr. Med. 707 (1985)

G.May & W. May, “Detection of serum IgA antibodies to varicella zoster virus (VZV)–differential etiology of peripheral facial paralysis. A case report,” 74 Laryngorhinootologie 553 (1995)

Alan Roberts, “Psychiatric Comorbidity in White and African-American Illicity Substance Abusers” Evidence for Differential Etiology,” 20 Clinical Psych. Rev. 667 (2000)

Mark E. Mullinsa, Michael H. Leva, Dawid Schellingerhout, Gilberto Gonzalez, and Pamela W. Schaefera, “Intracranial Hemorrhage Complicating Acute Stroke: How Common Is Hemorrhagic Stroke on Initial Head CT Scan and How Often Is Initial Clinical Diagnosis of Acute Stroke Eventually Confirmed?” 26 Am. J. Neuroradiology 2207 (2005)

Qiang Fua, et al., “Differential Etiology of Posttraumatic Stress Disorder with Conduct Disorder and Major Depression in Male Veterans,” 62 Biological Psychiatry 1088 (2007)

Jesse L. Hawke, et al., “Etiology of reading difficulties as a function of gender and severity,” 20 Reading and Writing 13 (2007)

Mastrangelo, “A rare occupation causing mesothelioma: mechanisms and differential etiology,” 105 Med. Lav. 337 (2014)


[1] See also Faigman at 448 (“courts have invented a methodology – differential etiology – that purports to resolve the G2i problem. Unfortunately, this method has only so far been described; it has not been defined with any precision. For now, it remains a highly ambiguous idea, sound in principle, but profoundly underdefined.”).

[2] Thomas H. Huxley, “On the Education Value of the Natural History Sciences” (1854), in Lay Sermons, Addresses and Reviews 77 (1915).

[3] See, e.g.,Differential Etiology and Other Courtroom Magic” (June 23, 2014) (collecting cases); “Differential Diagnosis in Milward v. Acuity Specialty Products Group” (Sept. 26, 2013).

Let Me Not Be Frank With You – Frank Subpoena Quashed

August 19th, 2015

In June 2015, Honeywell International Inc. subpoenaed non-party witness Dr. Arthur Frank, to produce documents and to testify, in Yates v. Ford Motor Co., et al., No. 5:12-cv-752-FL (E.D.N.C.). Although Dr. Frank is a “prolific plaintiffs’ expert” witness, he was not retained in Yates. Dr. Frank thus moved to quash the subpoena in the district where he was served, and the matter ended up on the docket of Judge Gerald J. Pappert. Frank v. Honeywell Int’l, Inc., No. 15-mc-00172, 2015 U.S. Dist. LEXIS 106453, 2015 BL 260668 (E.D. Pa. Aug. 12, 2015) [cited below as Yates]. See also Steven M. Sellers, “Asbestos Expert Tops Honeywell in Subpoena Battle,” BNA Bloomberg Law (Aug. 18, 2015).

Back in 2009, Dr. Frank lobbied the National Cancer Institute (“NCI”), and succeeded in having the NCI change its website and “Fact Sheets” about the supposed cancer risks among auto mechanics from exposure to asbestos in repairing brakes. The NCI had proposed describing any increased risk of mesothelioma or lung cancer among brake repairman as “controversial,” and not supported by the available evidence. Dr. Frank, who routinely testifies for the litigation industry that the risk is certain, known, and substantial, believed the NCI statement would be “misleading, erroneous, and contrary to the public health.” Frank believed that the NCI was basing its evaluation upon studies that were “unreliable,” and so set out to lobby the NCI. As a result of his telephoning and letter writing campaign, the NCI eliminated citations to two studies deemed unreliable (or inconvenient) to Dr. Frank, and adopted the following Frank-approved language:

“Studies into the cancer risk experienced by automobile mechanics exposed to asbestos through brake repair are limited, but the overall evidence suggests that there is no safe level for asbestos exposure.”

Yates at *4.

Operating in cahoots with, and under the guidance of asbestos plaintiffs’ counsel, Frank wrote to the NCI, of course mindful to run a draft of his correspondence past his litigation industry members. Plaintiffs’ counsel made various suggestions that Frank adopted. Yates at *5-7.

Frank objected to the subpoena on grounds that it:

(1) was too broad and unduly burdensome, as well as intended to harass;

(2) sought communications protected by attorney-client privilege; and

(3) sought the opinion of an unretained expert witness, contrary to Federal Rule of Civil Procedure 45(d)(3)(B)(ii).

The court quashed Honeywell’s subpoena only on grounds of burden, Rule 45(d)(3)(A), and did not reach Frank’s other arguments. Yates at *8.

Citing local Eastern District of Pennsylvania precedent, Judge Pappert noted that a claim of undue burden is resolved by considering several factors:

“(1) relevance of the requested materials,

(2) the party’s need for the documents,

(3) the breadth of the request,

(4) the time period covered by the request,

(5) the particularity with which the documents are described,

(6) the burden imposed, and

(7) the recipient’s status as a non-party.”

Yates at *12.

Honeywell was easily able to show the relevance of Frank’s lobbying shenanigans. Plaintiffs’ counsel have used the Frank-approved NCI website language to cross-examine defense expert witnesses, in asbestos personal injury cases.

Judge Pappert was not persuaded that Honeywell needed the requested discovery because Frank had given much of the material before, and he had previously acknowledged his working in concert with plaintiffs’ lawyers to change the NCI statement.

Honeywell thus had the evidence it needed to rehabilitate defense expert witnesses challenged with the Frank-approved NCI language. The court thus left the discovery into Frank’s ex parte lobbying activities for a case in which Frank was actually a retained expert witness, which surely will be soon. Judge Pappert exercised restraint by not addressing Frank’s improvident claim of attorney-client privilege and involuntarily servitude as an expert witness.

Frank’s lawyer, John O’Riordan, was quoted by the BNA as chastizing Honeywell:

“What the auto industry, Honeywell and others are trying to do is attack Dr. Frank personally, and what they tried to do was improper. … If they think he was wrong as a matter of science, the answer is to come back with good science.”

Steven M. Sellers, “Asbestos Expert Tops Honeywell in Subpoena Battle,” BNA Bloomberg Law (Aug. 18, 2015).

O’Riordan’s response is rather disingenuous, given that plaintiffs’ counsel in asbestos cases exploit the imprimatur of the NCI in its Frank-approved statement to challenge defense expert witnesses. This game is not about science, it is about name dropping and authority-based decision making, the antithesis of science.

Publication of Two Symposia on Scientific Evidence in the Law

August 2nd, 2015

The Journal of Philosophy, Science & Law bills itself as an on-line journal for the interdisciplinary exploration of philsophy, science, and law. This journal has just made its “Daubert Special” issue available at its website:

Jason Borenstein and Carol Henderson, “Reflections on Daubert: A Look Back at the Supreme Court’s Decision,” 15 J. Philos., Sci. & Law 1 (2015)

Mark Amadeus Notturno, “Falsifiability Revisited: Popper, Daubert, and Kuhn,” 15 J. Philos., Sci. & Law 5 (2015)

Tony Ward, “An English Daubert? Law, Forensic Science and Epistemic Deference,” 15 J. Philos., Sci. & Law 26 (2015)

Daniella McCahey & Simon A. Cole, “Human(e) Science? Demarcation, Law, and ‘Scientific Whaling’ in Whaling in the Antarctic” 15 J. Philos., Sci. & Law 37 (2015)

Back in January 30 – 31, 2015, the Texas Law Review called for a Conference on Science Challenges for Law and Policy, to focus on issues arising at intersection of science and law, with particular focus on issues arising in criminal justice, bioethics, and the environment. The Conference schedule is still available here. Conference papers addressed the nature of scientific disputes, the role of expertise in resolving such disputes, and the legal implementation and management of scientific knowledge. Some of the Conference papers are now available in the symposium issue of the 2015 Texas Law Review:

Rebecca Dresser, “The ‘Right to Try’ Investigational Drugs: Science and Stories in the Access Debate,” 93 Tex. L. Rev. 1631

David L. Faigman, “Where Law and Science (and Religion?) Meet,” 93 Tex. L. Rev. 1659 (2015)

Jennifer E. Laurin, “Criminal Law’s Science Lag: How Criminal Justice Meets Changed Scientific Understanding,” 93 Tex. L. Rev. 1751 (2015)

Elizabeth Fisher, Pasky Pascual & Wendy Wagner, “Rethinking Judicial Review of Expert Agencies,” 93 Tex. L. Rev. 1681 (2015)

Sheila Jasanoff, “Serviceable Truths: Science for Action in Law and Policy,” 93 Tex. L. Rev. 1723 (2015)

Thomas O. McGarity, “Science and Policy in Setting National Ambient Air Quality Standards: Resolving the Ozone Enigma,” 93 Tex. L. Rev. 1783 (2015)

Jennifer L. Mnookin, “Constructing Evidence and Educating Juries: The Case for Modular, Made-In-Advance Expert Evidence About Eyewitness Identifications and False Confessions,” 93 Tex. L. Rev. 1811 (2015)

California Actos Decision Embraces Relative-Risk-Greater-Than-Two Argument

July 28th, 2015

A recent decision of the California Court of Appeal, Second District, Division Three, continues the dubious state and federal practice of deciding important issues under cover of unpublished opinions. Cooper v. Takeda Pharms. America, Inc., No. B250163, 2015 Cal. App. Unpub. LEXIS 4965 (Calif. App., 2nd Dist., Div. 3; July 16, 2015). In Cooper, plaintiff claimed that her late husband’s bladder cancer was caused by defendant’s anti-diabetic medication, Actos (pioglitazone). The defendant moved to strike the expert witness testimony in support of specific causation. The trial judge expressed serious concerns about the admissibility of plaintiff’s expert witnesses on specific causation, but permitted the trial to go forward. After a jury returned its verdict in favor of plaintiff, the trial court entered judgment for the defendants, on grounds that the plaintiff lacked admissible expert witness testimony.

Although a recent, large, well-conducted study[1] failed to find any meaningful association between pioglitazone and bladder cancer, there were, at the time of trial, several studies that suggested an association. Plaintiff’s expert witnesses, epidemiologist Dr. Alfred Neugut and bladder oncologist Dr. Norm Smith interpreted the evidence to claim a causal association, but both conceded that there were no biomarkers that allowed them to attribute Cooper’s cancer to pioglitazone. The plaintiff also properly conceded that identifying a cause of the bladder cancer was irrelevant to treating the disease. Cooper, 2015 Cal. App. Unpub. LEXIS 4965, at *13. Specific causation was thus determined by the so-called process of differential etiology, with the ex ante existence of risk substituting for cause, and using risk exposure in the differential analysis.

The trial court was apparently soured on Dr. Smith’s specific causation assessment because of his poor performance at deposition, in which he demonstrated a lack of understanding of Cooper’s other potential exposures. Smith’s spotty understanding of Cooper’s actual and potential exposures and other risks made any specific causation assessment less than guesswork. By the time of trial, Dr. Smith and plaintiff’s counsel had backfilled the gaps, and Smith presented a more confident analysis of Cooper’s exposures and potentially competing risks.

Cooper had no family history of bladder cancer, no alcohol consumption, and no obvious exposure to occupational bladder carcinogens. His smoking history would account for exposure to a known bladder carcinogen, cigarette smoke, but Cooper’s documented history was of minor tobacco use, and remote in time. Factually, Cooper’s history was suspect and at odds with his known emphysema. Based upon this history, along with their causal interpretation of the Actos bladder cancer association, and their quantitative assessment that the risk ratio for bladder cancer from Actos was 7.0 or higher for Mr. Cooper (controlled for covariate, potential confounders), the plaintiff’s expert witnesses opined that Actos was probably a substantial factor in causing Mr. Cooper’s bladder cancer. The court did not examine the reasonableness of Dr. Smith’s risk ratios, which seem exorbitant in view of several available meta-analyses.[2]

The court stated that under the applicable California law of “substantial factor,” the plaintiff’s expert witness, in conducting a differential diagnosis, need not exclude every other possible cause of plaintiff’s disease “with absolute certainty.” Cooper, at *41-42. This statement leaves unclear and ambiguous whether the plaintiff’s expert witness must (and did in this case) rule out other possible causes with some level of certitude less than “absolute certainty,” such as reasonable medical certainty, or perhaps reasonable probability. Dr. Smith’s testimony, as described, did not attempt to go so far as to rule out smoking as “a cause” of Cooper’s bladder cancer; only that the risk from smoking was a lower order of magnitude than that for Actos. In Dr. Smith’s opinion, the discrepancy in magnitude between the risk ratios for smoking and Actos allowed him to state confidently that Actos was the most substantial risk.

Having estimated the smoking-related increased risk to somewhere between 0 and 100%, with the Actos increased risk at 600% or greater, Dr. Smith was able to present an admissible opinion that Actos was a substantial factor. Of course, this all turns on the appellate court’s acceptance of risk, of some sufficiently large magnitude, as evidence of specific causation. In the Cooper court’s words:

“The epidemiological studies relied on by Dr. Smith indicated exposure to Actos® resulted in hazard ratios for developing bladder cancer ranging from 2.54 to 6.97.18 By demonstrating a relative risk greater than 2.0 that a product causes a disease, epidemiological studies thereby become admissible to prove that the product at issue was more likely than not responsible for causing a particular person’s disease. “When statistical analyses or probabilistic results of epidemiological studies are offered to prove specific causation . . . under California law those analyses must show a relative risk greater than 2.0 to be ‘useful’ to the jury. Daubert v. Merrell Dow Pharmaceuticals Inc., 43 F.3d 1311, 1320 (9th Cir.), cert. denied 516 U.S. 869 (1995) [Daubert II]. This is so, because a relative risk greater than 2.0 is needed to extrapolate from generic population-based studies to conclusions about what caused a specific person’s disease. When the relative risk is 2.0, the alleged cause is responsible for an equal number of cases of the disease as all other background causes present in the control group. Thus, a relative risk of 2.0 implies a 50% probability that the agent at issue was responsible for a particular individual’s disease. This means that a relative risk that is greater than 2.0 permits the conclusion that the agent was more likely than not responsible for a particular individuals disease. [Reference Manual on Scientific Evidence (Federal Judicial Center 2d ed. 2000) (“Ref. Manual”),] Ref. Manual at 384, n. 140 (citing Daubert II).” (In re Silicone Gel Breast Implant Prod. Liab. Lit. (C.D. Cal. 2004) 318 F.Supp.2d 879, 893; italics added.) Thus, having considered and ruled out other background causes of bladder cancer based on his medical records, Dr. Smith could conclude based on the studies that it was more likely than not that Cooper’s exposure to Actos® caused his bladder cancer. In other words, because the studies, to varying degrees, adjusted for race, age, sex, and smoking, as well as other known causes of bladder cancer, Dr. Smith could rely upon those studies to make his differential diagnosis ruling in Actos®—as well as smoking—and concluding that Actos® was the most probable cause of Cooper’s disease.”

Cooper, at *78-80 (emphasis in the original).

Of course, the epidemiologic studies themselves are not admissible, regardless of the size of the relative risk, but the court was, no doubt, speaking loosely about the expert witness opinion testimony that was based upon the studies with risk ratios greater than two. Although the Cooper case does not change California law’s facile acceptance of risk as a substitute for cause, the case does base its approval of plaintiff’s expert witness’s attribution as turning on the magnitude of the risk ratio, adjusted for confounders, as having exceeded two. The Cooper case leaves open what happens when the risk that is being substituted for cause is a ratio ≤ 2.0. Some critics of the risk ratio > 2.0 inference have suggested that risk ratios greater than two would lead to directed verdicts for plaintiffs in all cases, but this suggestion requires demonstrations of both the internal and external validity of the studies that measure the risk ratio, which in many cases is in doubt. In Cooper, the plaintiff’s expert witnesses’ embrace of a high, outlier risk ratio for Actos, while simultaneously downplaying competing risks, allowed them to make out their specific causation case.


[1] James D. Lewis, Laurel A. Habel, Charles P. Quesenberry, Brian L. Strom, Tiffany Peng, Monique M. Hedderson, Samantha F. Ehrlich, Ronac Mamtani, Warren Bilker, David J. Vaughn, Lisa Nessel, Stephen K. Van Den Eeden, and Assiamira Ferrara, “Pioglitazone Use and Risk of Bladder Cancer and Other Common Cancers in Persons With Diabetes,” 314 J. Am. Med. Ass’n 265 (2015) (adjusted hazard ratio 1.06, 95% CI, 0.89-1.26).

[2] See, e.g., R.M. Turner, et al., “Thiazolidinediones and associated risk of bladder cancer: a systematic review and meta-analysis,” 78 Brit. J. Clin. Pharmacol. 258 (2014) (OR = 1.51, 95% CI 1.26-1.81, for longest cumulative duration of pioglitazone use); M. Ferwana, et al., “Pioglitazone and risk of bladder cancer: a meta-analysis of controlled studies,” 30 Diabet. Med. 1026 (2013) (based upon 6 studies, with median follow-up of 44 months, risk ratio = 1.23; 95% CI 1.09-1.39); Cristina Bosetti, “Cancer Risk for Patients Using Thiazolidinediones for Type 2 Diabetes: A Meta-Analysis,” 18 The Oncologist 148 (2013) (RR = 1.64 for longest exposure); Shiyao He, et al., “Pioglitazone prescription increases risk of bladder cancer in patients with type 2 diabetes: an updated meta-analysis,” 35 Tumor Biology 2095 (2014) (pooled hazard ratio = 1.67 (95% C.I., 1.31 – 2.12).

Ramazzini Serves Courtroom Silica Science Al Dente

July 25th, 2015

Collegium Ramazzini styles itself as an “independent, international academy.” The Collegium Ramazzini was founded in 1982, by the late Irving Selikoff and others to serve as an advocacy forum for their pro-compensation and aggressive regulation views on social and political issues involving occupational and environmental health.

The Collegium is a friendly place where plaintiffs’ expert witnesses, consultants, and advocates never have to declare their conflicts of interest.[1] Last year, in October 2014, the Collegium conducted a conference on silica health issues, entitled “Silica Three Hundred Years Later: Occupational Exposure, Medical Monitoring, and Regulation.”

The silica session was chaired by Christine Oliver, one of plaintiff’s key expert witnesses in Allen v. Martin Surfacing, 263 F.R.D. 47 (D. Mass. 2009). SeeBad Gatekeeping or Missed Opportunity – Allen v. Martin Surfacing” (Nov. 30, 2012). The purported goal of the session was

“to shine a light on silica as a persistent and dangerous threat to the health of exposed workers worldwide,” focusing on the following issues:

“1) Occupational silica exposures, new and old;

2) silica as a recognized human lung carcinogen and its interaction with other lung carcinogens such as tobacco smoke;

3) the role of silica and silicosis in tuberculosis;

4) issues relevant to medical surveillance of silica-exposed workers as set forth in OSHA’s proposed silica standard;

5) the role of the US Government in protecting the health of silica-exposed workers; and

6) international variability in addressing the threat to worker health posed by silicosis.”

Recently, the Collegium updated its website to provide PDF files of some of the conference presentations:

Carol H. Rice, “Silica – old, new and emerging uses result in worker exposure

Arthur L. Frank, “Silica as a lung carcinogen

Rodney Ehrlich, “Silica in the head of the snake. Silica, gold mining, and tuberculosis in southern Africa

Christine Oliver, “Medical surveillance for silica-related disease: the Collegium responds to OSHA’s proposed rulemaking,”

Gregory R. Wagner, “US Government role in recognizing, reducing, and regulating silica risk: 80 years and counting

Sverre Langard, “Silicosis 300 years after Ramazzini: Eradication in some countries, increased incidence in others

A poster session chaired by Melissa McDiarmid and Carol Rice, revealingly titled “Sustainable Work 2020 – an advocacy platform for Horizon 2020,” followed. Casey Bartrem asked whether “Asbestos-induced lung cancer in Germany: is the compensation practice in accordance with the epidemiological findings?” Odds are that this presentation was a brief for greater compensation. Xaver Baur of Germany, presented on the “Ethics in the applied sciences: The challenge of preventing corporate influence over public health regulation,” but remarkably no one presented on the challenge of preventing the litigation and compensation industry’s influence over public health regulation.

You won’t find any cutting-edge science in the linked slides, but you will find some interesting revelations. Sverre Langard’s presentation makes the dramatic point that silicosis has been declining, despite the hand waving of OSHA Administrator David Michaels, and the histortions of Rosner and Markowitz. Consider Langard’s slide, based upon CDC data:

CDC Siicosis vs Asbestosis Mortality Over Time

And consider the admissions of Arthur Frank, veteran plaintiffs’ expert witness, who acknowledged that:

“until very recently it [silica] was not recognized as a carcinogen.”

True to form, Dr. Frank blamed Selikoff and his other teachers at Mt. Sinai Hospital in New York City, where he trained:

“At Mount Sinai I did not get trained that silica was a carcinogen”

Well, even a scurry of blind squirrels sometimes find their nuts!


[1][1] Some of the names on the list of Fellows and Emeritus Fellows reads like a “Who’s Who” of testifying expert witnesses, consultants, and advocates for the litigation industry:

Henry A. Anderson, Barry Castleman, David C. Christiani, Carl F. Cranor, Devra Lee Davis , John M. Dement, Arthur Frank, Bernard D. Goldstein, Howard Frumkin, Lennart Hardell, Peter F. Infante, Joseph LaDou, Philip Landrigan, Richard A. Lemen, Barry S. Levy, Roberto G. Lucchini, Steven B. Markowitz, Myron A. Mehlman, Ronald L. Melnick, Donna Mergler, Albert Miller, Franklin E. Mirer, Herbert L. Needleman, L. Christine Oliver, David M. Ozonoff, Carol H. Rice, Kenneth D. Rosenman, Sheldon W. Samuels, Ellen K. Silbergeld, Peter D. Sly, Martyn Thomas Smith, Colin L. Soskolne, Leslie Thomas Stayner, Daniel T. Teitelbaum, Laura Welch

Canadian Judges’ Reference Manual on Scientific Evidence

July 24th, 2015

I had some notion that there was a Canadian version of the Reference Manual on Scientific Evidence in the works, but Professor Greenland’s comments in a discussion over at Deborah Mayo’s blog drew my attention to the publication of the Science Manual for Canadian Judges [Manual]. See “‘Statistical Significance’ According to the U.S. Dept. of Health and Human Services (ii),Error Statistics Philosophy (July 17, 2015).

The Manual is the product of the Canadian National Judicial Institute (NJI), which is an independent, not-for-profit group that is committed to educating Canadian judges. The NJI’s website describes the Manual:

“Without the proper tools, the justice system can be vulnerable to unreliable expert scientific evidence.

* * *

The goal of the Science Manual is to provide judges with tools to better understand expert evidence and to assess the validity of purportedly scientific evidence presented to them. …”

The Chief Justice of Canada, Hon. Beverley M. McLachlin, contributed an introduction to the Manual, which was notable for its frank admission that:

[w]ithout the proper tools, the justice system is vulnerable to unreliable expert scientific evidence.

****

Within the increasingly science-rich culture of the courtroom, the judiciary needs to discern ‘good’ science from ‘bad’ science, in order to assess expert evidence effectively and establish a proper threshold for admissibility. Judicial education in science, the scientific method, and technology is essential to ensure that judges are capable of dealing with scientific evidence, and to counterbalance the discomfort of jurists confronted with this specific subject matter.”

Manual at 14. These are laudable goals, indeed.

The first chapter of the Manual is an overview of Canadian law of scientific evidence, “The Legal Framework for Scientific Evidence,” by Canadian law professors Hamish Stewart (University of Toronto), and Catherine Piché (University of Montreal). Several judges served as peer reviewers.

The second chapter, “Science and the Scientific Method,” contains the heart of what judges supposedly should know about scientific and statistical matters to serve as effective “gatekeepers.” Like the chapters in the Reference Manual on Scientific Evidence, this chapter was prepared by a scientist author (Scott Findlay, Ph.D., Associate Professor of Biology, University of Ottawa) and a lawyer author (Nathalie Chalifour, Associate Professor of Law, University of Ottawa). Several judges, and Professor Brian Baigrie (University of Toronto, Victoria College, and the Institute for the History and Philosophy of Science and Technology) provided peer review. The chapter attempts to cover the demarcation between science and non-science, and between scientific and other expert witness opinion. The authors describe “the” scientific method, hypotheses, experiments, predictions, inference, probability, statistics and statistical hypothesis testing, data reliability, and related topics. A subsection of chapter two is entitled “Normative Issues in Science – The Myth of Scientific Objectivity,” which suggests a Feyerabend, post-modernist influence at odds with the Chief Justice’s aspirational statement of goals in her introduction to the Manual.

Greenland noted some rather cavalier statements in Chapter two that suggest that the conventional alpha of 5% corresponds to a “scientific attitude that unless we are 95% sure the null hypothesis is false, we provisionally accept it.” And he pointed elsewhere where the chapter seems to suggest that the coefficient of confidence that corresponds to an alpha of 5% “constitutes a rather high standard of proof,” thus confusing and conflating probability of random error with posterior probabilities. Some have argued that these errors are simply an effort to make statistical concepts easier to grasp for lay people, but the statistics chapter in the FJC’s Reference Manual shows that accurate exposition of statistical concepts can be made understandable. The Canadian Manual seems in need of some trimming with Einstein’s razor, usually paraphrased as “Everything should be made as simple as possible, but no simpler.[1] The razor should certainly applied to statistical concepts, with the understanding that pushing to simplify too aggressively can sometimes result in simplistic, and simply wrong, exposition.

Chapter 3 returns to more lawyerly matters, “Managing and Evaluating Expert Evidence in the Courtroom,” prepared and peer-reviewed by prominent Canadian lawyers and judges. The final chapter, “Ethics of the Expert Witness,” should be of interest to lawyers and judges in the United States, where the topic is largely ignored. The chapter was prepared by Professor Adam Dodek (University of Ottawa), along with several writers from the National Judicial Institute, the Canadian Judicial Council, American College of Trial Lawyers, Environment Canada, and notably, Joe Cecil & the Federal Judicial Center.

Weighing in at 228 pages, the Science Manual for Canadian Judges is much shorter than the Federal Judicial Center’s Reference Manual on Scientific Evidence. Unlike the FJC’s Reference Manual, which is now in its third edition, the Canadian Manual has no separate chapters on regression, DNA testing and forensic evidence, clinical medicine and epidemiology. The coverage of statistical inference is concentrated in chapter two, but that chapter has no discussion of meta-analysis, systematic review, evidence-based medicine, confounding, and the like. Perhaps there will soon be a second edition of the Science Manual for Canadian Judges.


[1] See Albert Einstein, “On the Method of Theoretical Physics; The Herbert Spencer Lecture,” delivered at Oxford (10 June 1933), published in 1 Philosophy of Science 163 (1934) (“It can scarcely be denied that the supreme goal of all theory is to make the irreducible basic elements as simple and as few as possible without having to surrender the adequate representation of a single datum of experience.”).