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Confusing Regulatory and Litigation Standards for Showing Causation – More on Chantix

September 3rd, 2012

Before denying Pfizer’s Rule 702 challenges to the plaintiffs’ expert witnesses’ opinion testimony, the Chantix MDL court handed Pfizer a significant victory by holding that the company’s 2009 warnings were adequate as a matter of law. In re Chantix Products Liab. Litig., 2012 U.S. Dist. LEXIS 101780, *21 (Jul. 23, 2012). The MDL court assessed warnings in the full context of the learned intermediary setting, in which the prescribing physicians are the intended audience for the warnings. The court held that when the warning addresses the particular injury sustained by the plaintiff, the warning is adequate. Id. at *29-30 n.10. See Michelle Yeary, “Chantix Warnings Adequate As a Matter of Law” (July 31, 2012).

Perhaps the MDL Court felt that it needed to level the playing field by denying the defendant’s Rule 702 motions. In any event, I seem to be not alone in expressing dismay over the glib pronouncements of the Chantix MDL court’s Rule 702 opinion. See David Oliver, “Of Mice and Monkeys and Men” (Aug. 30, 2012) (noting the court’s indulgence in the extreme assumption that causation in one mammalian species justifies an inference that it will cause in others, including humans).

In “Open Admissions for Expert Witnesses in Chantix Litigation (Sept. 1, 2012),” I detailed much that went wrong in the gatekeeping in the Chantix litigation. Unfortunately, I only scratched at the surface.

CONFUSING REGULATORY ACTION WITH CAUSAL ASSESSMENTS

One of the more stunning aspects of the Chantix opinion is its holding that the plaintiffs’ expert witnesses need present opinions no more rigorous and warranted than would be required to justify FDA action. Memorandum Opinion and Order at 22-23, In re Chantix (Varenicline) Prod. Liab. Litig., MDL No. 2092, Case 2:09-cv-02039-IPJ Document 642 (N.D. Ala. Aug. 21, 2012)[hereafter cited as Chantix]. As I noted in the earlier post, this holding against the overwhelming weight of precedent on the issue. Judge Johnson relied heavily upon the Supreme Court’s decision in Matrixx Initiatives, but that decision carefully distinguished causal judgments in civil actions from regulatory action, at least for a while, before the Court conflated them in dictum.

To be sure, Judge Johnson, in the Chantix litigation, is not the first federal judge to conflate regulatory decision making with the sufficiency and reliability needed to establish medical causation in civil litigation. Judge Rakoff, confusing statistical significance probability with posterior probability attached to the causation issue, reached a similar conclusion in the Ephedra MDL. See In re Ephedra Prods. Liab. Litig., 393 F. Supp. 2d 181, 189 (S.D.N.Y. 2005) (relying upon FDA ban despite “the absence of definitive scientific studies establishing causation”).

The FDA could not be clearer that its labeling requirements do not bear on the civil tort standards of liability and causation. Back in 1979, the FDA stated that its “[l]abeling requirements will not affect adversely the civil tort liability of manufacturers, physicians, pharmacists, and other dispensers of prescription drug products.” 44 Fed. Reg. 40016, 40023 (FDA July 6, 1979) (addressing patient package inserts)
In terms of modifying drug warnings, the FDA requires that manufacturers address potential adverse events “as soon as there is reasonable evidence of a causal association with a drug; a causal relationship need not have been definitely established.” 21 C.F.R. § 201.57(c)(6)(i) (stating requirement for medications approved after June 30, 2001). For medications approved before July 1, 2001, the FDA requires that warnings be modified “as soon as there is reasonable evidence of an association of a serious hazard with a drug; a causal relationship need not have been proved.” Id. at § 201.80(e). See also “Labeling of Diphenhydramine Containing Drug Products for Over-the-Counter Human Use,” 67 Fed. Reg. 72,555, at 72,556 (Dec. 6, 2002) (“FDA’s decision to act in an instance such as this one need not meet the standard of proof required to prevail in a private tort action. . .. To mandate a warning or take similar regulatory action, FDA need not show, nor do we allege, actual causation.”)(citing Agent Orange, Glastetter, and Hollander).

SUPREME COURT OF THE UNITED STATES

Matrixx Initiatives, Inc. v. Siracuso, ___U.S. ___, 131 S. Ct. 1309, 1320 (2011) (regulatory and administrative agencies “may make regulatory decisions … based on post-marketing evidence that gives rise to only a suspicion of causation.)(internal citation omitted)

IUD v. API, 448 U.S. 607, 656 (1980)(“agency is free to use conservative assumptions in interpreting the data on the side of overprotection rather than underprotection.”)

First Circuit

In re Neurontin Mktg., Sales Practices, and Prod. Liab. Litig., 612 F. Supp. 2d 116, 136 (D. Mass. 2009) (‘‘It is widely recognized that, when evaluating pharmaceutical drugs, the FDA often uses a different standard than a court does to evaluate evidence of causation in a products liability action. Entrusted with the responsibility of protecting the public from dangerous drugs, the FDA regularly relies on a risk-utility analysis, balancing the possible harm against the beneficial uses of a drug. Understandably, the agency may choose to ‘err on the side of caution,’ … and take regulatory action such as revising a product label or removing a drug from the marketplace ‘upon a lesser showing of harm to the public than the preponderance-of-the-evidence or more-like-than-not standard used to assess tort liability.’’’)(internal citations omitted)

Sutera v. Perrier Group of Am., Inc., 986 F. Supp. 655, 667 (D. Mass. 1997)

Second Circuit

Mancuso v. Consolidated Edison Co., 967 F. Supp. 1437, 1448 (S.D.N.Y. 1997) (“recommended or prescribed precautionary standards cannot provide legal causation”; “[f]ailure to meet regulatory standards is simply not sufficient” to establish liability)

In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 781 (E.D.N.Y.1984)(“The distinction between avoidance of risk through regulation and compensation for injuries after the fact is a fundamental one.”), aff’d in relevant part, 818 F.2d 145 (2d Cir.1987), cert. denied sub nom. Pinkney v. Dow Chemical Co., 484 U.S. 1004 (1988)

Third Circuit

Gates v. Rohm & Haas Co., 655 F.3d 255 (3d Cir. 2011) (‘‘plaintiffs could not carry their burden of proof for a class of specific persons simply by citing regulatory standards for the population as a whole’’)

In re Schering-Plough Corp. Intron/Temodar Consumer Class Action, 2009 WL 2043604, at *13 (D.N.J. July 10, 2009)(“[T]here is a clear and decisive difference between allegations that actually contest the safety or effectiveness of the Subject Drugs and claims that merely recite violations of the FDCA, for which there is no private right of action.”)

Soldo v. Sandoz Pharm. Corp., 244 F. Supp. 2d 434, 543 (W.D. Pa. 2003) (“FDA is a regulatory agency whose mandate is to control which drugs are marketed in the United States and how they are marketed. FDA ordinarily does not attempt to prove that the drug in fact causes a particular adverse effect.”)

O’Neal v. Dep’t of the Army, 852 F. Supp. 327, 333 (M.D. Pa. 1994) (administrative risk figures are “appropriate for regulatory purposes in which the goal is to be particularly cautious [but] overstate the actual risk and, so, are inappropriate for use in determining” civil liability)

Wade-Greaux v. Whitehall Laboratories, Inc., 874 F. Supp. 1441, 1464 (D.V.I.) (“assumption[s that] may be useful in a regulatory risk-benefit context … ha[ve] no applicability to issues of causation-in-fact”), aff’d, 46 F.3d 1120 (3d Cir. 1994)

Fourth Circuit

Meade v. Parsley, No. 2:09-cv-00388, 2010 U.S. Dist. LEXIS 125217, * 25 (S.D.W. Va. Nov. 24, 2010) (‘‘Inasmuch as the cost-benefit balancing employed by the FDA differs from the threshold standard for establishing causation in tort actions, this court likewise concludes that the FDA-mandated [black box] warnings cannot establish general causation in this case.’’)

Dunn v. Sandoz Pharm. Corp., 275 F. Supp. 2d 672, 684 (M.D.N.C. 2003) (FDA “risk benefit analysis” “does not demonstrate” causation in any particular plaintiff).

Fifth Circuit

Johnson v. Arkema Inc., 2012 WL ______ (5th Cir. June 20, 2012) (per curiam) (affirming exclusion of expert witness who relied upon regulatory pronouncements; noting the precautionary nature of such statements, and the absence of specificity for the result claimed at the exposures experienced by plaintiff)

Allen v. Pennsylvania Eng’g Corp., 102 F.3d 194, 198-99 (5th Cir. 1996)(“Scientific knowledge of the harmful level of exposure to a chemical, plus knowledge that the plaintiff was exposed to such quantities, are minimal facts necessary to sustain the plaintiffs’ burden in a toxic tort case”; regulatory agencies, charged with protecting public health, employ a lower standard of proof in promulgating regulations than that used in tort cases)

Cano v. Everest Minerals Corp., 362 F. Supp. 2d 814, 825 (W.D. Tex. 2005) (noting that a product that “has been classified as a carcinogen by agencies responsible for public health regulations is not probative of” common-law specific causation);

Burleson v. Glass, 268 F.Supp. 2d 699, 717 (W.D. Tex. 2003) (“the mere fact that [the product] has been classified by certain regulatory organizations as a carcinogen is not probative on the issue of whether [plaintiff’s] exposure . . . caused his . . . cancers”), aff’d, 393 F.3d 577 (5th Cir. 2004)

Newton v. Roche Labs., Inc., 243 F. Supp. 2d 672, 677, 683 (W.D. Tex. 2002) (“Although evidence of an association may. . .be important in the scientific and regulatory contexts. . ., tort law requires a higher standard of causation.”)(FDA’s precautionary decisions on labeling are not a determination of causation of specified adverse events)

Molden v. Georgia Gulf Corp., 465 F. Supp. 2d 606, 611 (M.D. La. 2006) (“regulatory and advisory bodies make prophylactic rules governing human exposure based on proof that is reasonably lower than that appropriate in tort law”)

Sixth Circuit

Nelson v. Tennessee Gas Pipeline Co., 243 F.3d 244, 252-53 (6th Cir. 2001)(exposure above regulatory levels is insufficient to establish causation)

Stites v Sundstrand Heat Transfer, Inc., 660 F. Supp. 1516, 1525 (W.D. Mich. 1987) (rejecting use of regulatory standards to support claim of increased risk, noting the differences in goals and policies between regulation and litigation)

Baker v. Chevron USA Inc., 680 F. Supp. 2d 865, 880 (S.D. Ohio 2010) (“[t]he mere fact that Plaintiffs were exposed to [the product] in excess of mandated limits is insufficient to establish causation”; rejecting Dr. Dahlgren’s opinion and its reliance upon a “one-hit” or “no threshold” theory of causation in which exposure to one molecule of a cancer-causing agent has some finite possibility of causing a genetic mutation leading to cancer, a theory that may be accepted for purposes of setting regulatory standards, but as reliable scientific knowledge; ‘‘regulatory agencies are charged with protecting public health and thus reasonably employ a lower threshold of proof in promulgating their regulations’’)

Eighth Circuit

Glastetter v. Novartis Pharms. Corp., 107 F. Supp. 2d 1015, 1036 (E.D. Mo. 2000) (“[T]he [FDA’s] statement fails to affirmatively state that a connection exists between [the drug] and the type of injury in this case. Instead, it states that the evidence received by the FDA calls into question [drug’s] safety, that [the drug] may be an additional risk factor. . .and that the FDA had new evidence suggesting that therapeutic use of [the drug] may lead to serious adverse experiences. Such language does not establish that the FDA had concluded that [the drug] can cause [the injury]; instead, it indicates that in light of the limited social utility of [the drug for the use at issue] and the reports of possible adverse effects, the drug should no longer be used for that purpose.”) (emphasis in original), aff’d, 252 F.3d 986, 991 (8th Cir. 2001) (FDA’s precautionary decisions on labeling are not a determination of causation of specified adverse events; “methodology employed by a government agency results from the preventive perspective that the agencies adopt”)(“The FDA will remove drugs from the marketplace upon a lesser showing of harm to the public than the preponderance-of-the-evidence or the more-like-than-not standard used to assess tort liability . . . . [Its] decision that [the drug] can cause [the injury] is unreliable proof of medical causation.”)

Wright v.Williamette Indus., Inc., 91 F.3d 1105, 1107 (8th Cir. 1996)

Nelson v. Am. Home Prods. Corp., 92 F. Supp. 2d 954, 958 (W.D. Mo. 2000) (FDA’s precautionary decisions on labeling are not a determination of causation of specified adverse events)

National Bank of Commerce v. Associated Milk Producers, Inc., 22 F. Supp. 2d 942, 961 (E.D.Ark. 1998), aff’d, 191 F.3d 858 (8th Cir. 1999)

Junk v. Terminix International Co., 594 F. Supp. 2d 1062, 1071 (S.D. Iowa 2008) (“government agency regulatory standards are irrelevant to [plaintiff’s] burden of proof in a toxic tort cause of action because of the agency’s preventative perspective”)

Ninth Circuit

Lopez v. Wyeth-Ayerst Labs., Inc., 1998 WL 81296, at *2 (9th Cir. Feb. 25, 1998) (FDA’s precautionary decisions on labeling are not a determination of causation of specified adverse events)

Tenth Circuit

Hollander v. Shandoz Pharm. Corp., 95 F. Supp. 2d 1230, 1239 (W.D. Okla. 2000) (distinguishing FDA’s threshold of proof as lower than appropriate in tort law), aff’d in relevant part, 289 F.3d 1193, 1215 (10th Cir. 2002)

Mitchell v. Gencorp Inc., 165 F.3d 778, 783 n.3 (10th Cir. 1999) (state administrative finding that product was a carcinogen was based upon lower administrative standard than tort standard)

In re Breast Implant Litig., 11 F. Supp. 2d 1217, 1229 (D.Colo. 1998)

Eleventh Circuit

Rider v. Sandoz Pharm. Corp., 295 F.3d 1194, 1201 (11th Cir. 2002)(FDA may take regulatory action, such as revising warning labels or withdrawing drug from the market ‘‘upon a lesser showing of harm to the public than the preponderance-of-the-evidence or more-likely-than-not standard used to assess tort liability’’)(“A regulatory agency such as the FDA may choose to err on the side of caution. Courts, however, are required by the Daubert trilogy to engage in objective review of the evidence to determine whether it has sufficient scientific basis to be considered reliable.”)

McClain v. Metabolife Internat’l, Inc., 401 F.3d 1233, 1248-1250 (11th Cir. 2005)(ephedra)( “[U]se of FDA data and recommendations raises a more subtle methodological issue in a toxic tort case. The issue involves identifying and contrasting the type of risk assessment that a government agency follows for establishing public health guidelines versus an expert analysis of toxicity and causation in a toxic tort case.’’)

Siharath v. Sandoz Pharm. Corp., 131 F. Supp. 2d 1347, 1370 (N.D. Ga. 2001)(“The standard by which the FDA deems a drug harmful is much lower than is required in a court of law. The FDA’s lesser standard is necessitated by its prophylactic role in reducing the public’s exposure to potentially harmful substances.”)

In re Seroquel Products Liab. Litig., 601 F. Supp. 2d 1313, 1315 (M.D. Fla. 2009)(noting that administrative agencies “impose[] different requirements and employ[] different labeling and evidentiary standards” because a “regulatory system reflects a more prophylactic approach” than the common law)

STATES

New York

Parker v. Mobil Oil Corp., 7 N.Y.3d 434, 450, 857 N.E.2d 1114, 1122, 824 N.Y.S.2d 584 (N.Y. 2006) (“standards promulgated by regulatory agencies as protective measures are inadequate to demonstrate legal causation”)

In re Bextra & Celebrex, 2008 N.Y. Misc. LEXIS 720, *20, 239 N.Y.L.J. 27 (2008) (characterizing FDA Advisory Panel recommendations as regulatory standard and protective measure).

Ohio

Valentine v. PPG Industries, Inc., 821 N.E.2d 580, 597-98 (Ohio App. 2004), aff’d, 850 N.E.2d 683 (Ohio 2006).

Pennsylvania

Betz v. Pneumo Abex LLC, 44 A. 3d 27 (Pa. 2012).

Texas

Exxon Corp. v. Makofski, 116 S.W.3d 176, 184-85 (Tex. App. 2003)

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Open Admissions for Expert Witnesses in Chantix Litigation

September 1st, 2012

Chantix is medication that helps people stop smoking. Smoking kills people, but make a licensed drug and the lawsuits will come.

Earlier this month, Judge Inge Prytz Johnson, the MDL trial judge in the Chantix litigation, filed an opinion that rejected Pfizer’s challenges to plaintiffs’ general causation expert witnesses. Memorandum Opinion and Order, In re Chantix (Varenicline) Products Liability Litigation, MDL No. 2092, Case 2:09-cv-02039-IPJ Document 642 (N.D. Ala. Aug. 21, 2012)[hereafter cited as Chantix].

Plaintiffs claimed that Chantix causes depression and suicidality, sometimes severe enough to result in suicide, attempted or completed. Chantix at 3-4. Others have written about Judge Johnson’s decision. See Lacayo, “Win Some, Lose Some: Recent Federal Court Rulings on Daubert Challenges to Plaintiffs’ Experts,” (Aug. 30, 2012).

The breadth and depth of error of the trial court’s analysis, or lack thereof, remains, however, to be explored.

STATISTICAL SIGNIFICANCE

The Chantix MDL court notes several times that the defendant “harped” on this or that issue; the reader might think the defendant was a music label rather than a pharmaceutical manufacturer. One of the defendant’s chords that failed to resonate with the trial judge was the point that the plaintiffs’ expert witnesses relied upon statistically non-significant results. Here is how the trial court reported the issue:

“While the defendant repeatedly harps on the importance of statistically significant data, the United States Supreme Court recently stated that ‘[a] lack of statistically significant data does not mean that medical experts have no reliable basis for inferring a causal link between a drug and adverse events …. medical experts rely on other evidence to establish an inference of causation.’ Matrixx Initiatives, Inc. v. Siracsano, 131 S.Ct. 1309, 1319 (2011).”

Chantix at 22.

Well, it was only a matter of time before the Supreme Court’s dictum would be put to this predictably erroneous interpretation. See “The Matrixx Oversold” (April 4, 2011).

Matrixx involved a motion to dismiss the complaint, which the trial court granted, but the Ninth Circuit reversed. No evidence was offered; nor was any ruling that evidence was unreliable or insufficient at issue. The Supreme Court affirmed the Circuit on the issue whether pleading statistical significance was necessary. Matrixx Initiatives took this position in the hopes of avoiding the merits, and so the issue of causation was never before the Supreme Court. A unanimous Supreme Court held that because FDA regulatory action does not require reliable evidence to support a causal conclusion, pleading materiality for a securities fraud suit does not require an allegation of causation, and thus does not require an allegation of statistically significant evidence. Everything that the Court said about statistical significance and causation was obiter dictum, and rather ill-considered dictum at that.

The Supreme Court thus wandered far beyond its holding to suggest that courts “frequently permit expert testimony on causation based on evidence other than statistical significance.” Matrixx Initiatives, Inc. v. Siracsano, 131 S.Ct. 1309, 1319 (2011) (citing Wells v. Ortho Pharm. Corp., 788 F.2d 741, 744-745 (11th Cir.1986)). But the Supreme Court’s citation to Wells, in Justice Sotomayor’s opinion, failed to support the point she was trying to make, or the decision that the trial court announced in Chantix.

Wells involved a claim of birth defects caused by the use of spermicidal jelly contraceptive. At least one study reported a statistically significant increase in detected birth defects over the expected rate. 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). Wells is not an example of a case in which an expert witness opined about causation in the absence of a scientific study with statistical significance. Of course, finding statistical significance is just the beginning of assessing the causality of an association; the Wells case was and remains notorious for the expert witness’s poor assessment of all the determinants of scientific causation, including the validity of the studies relied upon.

The Wells decision was met with severe criticism in the 1980s. The decision was widely criticized for its failure to evaluate the entire evidentiary display, as well as for its failure to rule out bias and confounding in the studies relied upon by the plaintiff. See, e.g., James L. Mills and Duane Alexander, “Teratogens and ‘Litogens’,” 15 New Engl. J. Med. 1234 (1986); Samuel R. Gross, “Expert Evidence,” 1991 Wis. L. Rev. 1113, 1121-24 (1991) (“Unfortunately, Judge Shoob’s decision is absolutely wrong. There is no scientifically credible evidence that Ortho-Gynol Contraceptive Jelly ever causes birth defects.”). See also Editorial, “Federal Judges v. Science,” N.Y. Times, December 27, 1986, at A22 (unsigned editorial); David E. Bernstein, “Junk Science in the Courtroom,” Wall St. J. at A 15 (Mar. 24,1993) (pointing to Wells as a prominent example of how the federal judiciary had embarrassed the American judicial system with its careless, non-evidence based approach to scientific evidence). A few years later, another case in the same judicial district, against the same defendant, for the same product, resulted in the grant of summary judgment. Smith v. Ortho Pharmaceutical Corp., 770 F. Supp. 1561 (N.D. Ga. 1991) (supposedly distinguishing Wells on the basis of more recent studies).

Neither the Justices in Matrixx Initiatives nor the trial court in Chantix can be excused for their poor scholarship, or their failure to note that Wells was overruled sub silentio by the Supreme Court’s own subsequent decisions in Daubert, Joiner, Kumho Tire, and Weisgram. And if the weight of precedent did not kill the concept, then there is the simple matter of a supervening statute: the 2000 amendment of Rule 702, of Federal Rules of Evidence.

CONFUSING REGULATORY ACTION WITH CAUSAL ASSESSMENTS

The Supreme Court in Matrixx Initiatives was careful to distinguish causal judgments from regulatory action, but then went on in dictum to conflate the two. The trial judge in Chantix showed no similar analytical care. Judge Johnson held that the asserted absence of statistical significance was not a basis for excluding plaintiffs’ expert witnesses’ opinions on general causation. Her Honor adverted to the Matrixx Initiatives dictum that the FDA “does not apply any single metric for determining when additional inquiry or action is necessary.” Matrixx, 131 S.Ct. at 1320. Chantix at 22. Judge Johnson noted

“that ‘[n]ot only does the FDA rely on a wide range of evidence of causation, it sometimes acts on the basis of evidence that suggests, but does not prove, causation…. the FDA may make regulatory decisions against drugs based on postmarketing evidence that gives rise to only a suspicion of causation’. Matrixx, id. The court declines to hold the plaintiffs’ experts to a more exacting standard as the defendant requests.”

Chantix at 23.

In the trial court’s analysis, the difference between regulatory action and civil litigation fact adjudication is obliterated. This, however, is not the law of the United States, which has consistently acknowledged the difference. See, e.g., IUD v. API, 448 U.S. 607, 656 (1980)(“agency is free to use conservative assumptions in interpreting the data on the side of overprotection rather than underprotection.”)

As the Second Edition of the Reference Manual on Scientific Evidence (which was the out-dated edition cited by the court in Chantix) explains:

“[p]roof of risk and proof of causation entail somewhat different questions because risk assessment frequently calls for a cost-benefit analysis. The agency assessing risk may decide to bar a substance or product if the potential benefits are outweighed by the possibility of risks that are largely unquantifiable because of presently unknown contingencies. Consequently, risk assessors may pay heed to any evidence that points to a need for caution, rather than assess the likelihood that a causal relationship in a specific case is more likely than not.”

Margaret A. Berger, “The Supreme Court’s Trilogy on the Admissibility of Expert Testimony,” in Reference Manual On Scientific Evidence at 33 (Fed. Jud. Ctr. 2d. ed. 2000).

CONCLUSIONS VS. METHODOLOGY

Judge Johnson insisted that the “court’s focus was solely on the principles and methodology, not on the conclusions they generate.” Chantix at 9. This insistence, however, is contrary to the established law of Rule 702.

Although the United States Supreme Court attempted, in Daubert, to draw a distinction between the reliability of an expert witness’s methodology and conclusion, that Court soon realized that the distinction was flawed. If an expert witness’s proffered testimony is discordant from regulatory and scientific conclusions, a reasonable, disinterested scientists would be led to question the reliability of the testimony’s methodology and its inferences from facts and data, to its conclusion. The Supreme Court recognized this connection in General Electric v. Joiner, and the connection between methodology and conclusions was ultimately incorporated into a statute, the revised Federal Rule of Evidence 702:

“[I]f scientific, technical or other specialized knowledge will assist the trier of fact to understand the evidence or to determine a fact in issue, a witness qualified as an expert by knowledge, skill, experience, training or education, may testify thereto in the form of an opinion or otherwise, if

the testimony is based upon sufficient fact or data,

the testimony is the product of reliable principles and methods; and

the witness has applied the principles and methods reliably to the facts.”

When the testimony is a conclusion about causation, the Rule 702 directs an inquiry into whether that conclusion is based upon sufficient fact or data, and whether that conclusion is the product of reliable principles and methods. The court’s focus should indeed be on the conclusion as well the methodology claimed to generate the conclusion. The Chantix MDL court thus ignored the clear mandate of a statute, Rule 702(1), and applied dictum from Daubert, superseded by Joiner, and an Act of Congress. The ruling is thus legally invalid to the extent it departs from the statute.

EPIDEMIOLOGY

For obscure reasons, Judge Johnson sought to deprecate the need to rely upon epidemiologic studies, whether placebo-controlled clinical trials or observational studies. See Chantix at 25 (citing Rider v. Sandoz Pharm. Corp., 295 F.3d 1194, 1198-99 (11 Cir.2002)). Of course, the language cited in Rider came from a pre-Daubert, pre-Joiner, case, Wells v. Ortho Pharm. Corp., 788 F.2d 741, 745 (11th Cir.1986) (holding that “a cause-effect relationship need not be clearly established by animal or epidemiological studies”). This dubious legal lineage cannot support the glib dismissal of the need for epidemiologic evidence.

WEIGHT OF THE EVIDENCE (WOE)

According to Judge Johnson, plaintiffs’ expert witness Shira Kramer considered all the evidence relevant to Chantix and neuropsychiatric side effects, in what Kramer described as a “weight of the evidence” analysis. Chantix at 26. In her report, Kramer had written that determinations about the weight of evidence are “subjective interpretations” based upon “various lines of scientific evidence. Id. (citing and quoting Kramer’s report). Kramer also claimed that every scientist “brings a unique set of experiences, training and expertise …. Philosophical differences exist between experts…. Therefore, it is not surprising that differences of opinion exist among scientists. Such differences of opinion are not necessarily evidence of flawed scientific reasoning or methodology, but rather differences in judgment between scientists.” Id.

Without any support from scientific literature, or the Reference Manual on Scientific Evidence, Judge Johnson accepted Kramer’s explanation of a totally subjective, unprincipled approach as a scientific methodology. Not surprisingly, Judge Johnson cited the First Circuit’s embrace of a similar vacuous embrace of a WOE analysis in Milward v. Acuity Specialty Products Group, Inc. 639 F.3d 11, 22 (1st Cir. 2011). Chantix at 51.

CHERRY PICKING

Judge Johnson noted, contrary to her earlier suggestion that Shira Kramer had considered all the studies, that Kramer had excluded data from her analysis. Kramer’s basis for excluding data may have been based upon pre-specified exclusionary principles, or they may have been completely ad hoc, as were the lack of weighting principles in her WOE analysis. In its gatekeeping role, however, the trial court expressed complete indifference to Kramer’s selectivity in excluding data. “Why Dr. Kramer chose to include or exclude data from specific clinical trials is a matter for cross-examination.” Chantix at 27. This indifference is an abdication of the court’s gatekeeping responsibility.

POWER

The trial court attempted to justify its willingness to mute defendant’s harping on statistical significance by adverting to the concept of statistical power:

“Oftentimes, epidemiological studies lack the statistical power needed for definitive conclusions, either because they are small or the suspected adverse effect is particularly rare. Id. [Michael D. Green et al., “Reference Guide on Epidemiology,” in Reference Manual on Scientific Evidence 333, 335 (Fed. Judicial Ctr. 2d ed. 2000)… .

Chantix at 29 n.16.

To be fair to the trial court, the Reference Manual invited this illegitimate use of statistical power because it, at times, omits the specification that statistical power requires not only a level of statistical significance to be attained, but also a specified alternative hypothesis to assess power. See Power in the Courts — Part One; Power in the Courts — Part Two. The trial court offered no alternative hypothesis against which any measure of power was to be assessed.

Judge Johnson did not report any power analyses, and she certainly did not report any quantification of power or lack thereof against some specific alternative hypothesis. Judge Johnson’s invocation of power was just that – power used arbitrarily, without data, evidence, or reason.

CONFIDENCE INTERVALS

As with the invocation of statistical power, the trial also invoked the concept of confidence intervals to suggest that such intervals provide a more refined approach to assessing statistical significance:

“A study found to have ‘results that are unlikely to be the result of random error’ is ‘statistically significant’. Reference Guide on Epidemiology, supra, at 354. Statistical significance, however, does not indicate the strength of an association found in a study. Id. at 359. ‘A study may be statistically significant but may find only a very weak association; conversely, a study with small sample sizes may find a high relative risk but still not be statistically significant.’ Id. To reach a ‘more refined assessment of appropriate inferences about the association found in an epidemiologic study’, researchers rely on another statistical technique known as a confidence interval’. Id. at 360.”

Chantix at 30 n.17. True, true, but immaterial. The trial court, again, never carries through with the direction given by the Reference Manual. Not a single confidence interval is presented. No confidence intervals are subjected to this more refined assessment. Why have more refined assessments when even the cruder assessments are not done?

OPEN ADMISSIONS IN SCHOOL OF EXPERT WITNESSING

The trial court somehow had the notion that all it had to do was state that every disputed fact and opinion went to the weight not the admissibility, and then pass to a presumably more scientifically literate jury. To be sure, the court engaged in a good deal of hand waving, going through the motions of deciding a contested issues. Not only did the Judge Johnson smash poor Pfizer’s harp, Her Honor unhinged the gate that federal judges are supposed to keep. Chantix declares that it is now open admissions for expert witnesses testifying to causation in federal cases. This is a judgment in search of an appeal.

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Canadian Remedy for American Taliban

August 29th, 2012

A few years ago, Quebec introduced a very interesting religious education program for public school. The Province’s Ethics and Religious Culture (“ERC”) Program, which went into effect in 2008, requires that children learn facts about the many different religions practiced in the Canada. The intent and the content of the ERC program was to maintain neutrality between faiths, and to help children understand the beliefs of others in the Province.

Two parents of school children sought to have their children removed from the education program on the ground that their children’s “freedom of religion” was infringed by their having to learn facts about other religions. The challenge might seem peculiar because nothing in the ERC Program kept the children from practicing their own faith, or the faith of their parents thrust upon them; nor did the Program require them to practice any faith, or cult for that matter.

The briefs of the parents and of organized churches, however, made clear what the gravaman of the complaint was. Being required to learn about other faiths (and cults) would undermine the parents’ claims that their faith was the “one true faith,” and would lead to the children’s rejection of their parents’ faith. The school system, by opening children’s eyes to the existence of many different faiths, making competing claims to truth and understanding, would interfere with the parents’ “obligation” to indoctrinate the Catholic faith in their children by causing their children to question their faith. Maybe more to the point, but unstated, the education program would not just cause children to question their faith, but rather it would allow the children to see that the existence of competing faiths undermined any claim to Truth in one. All the faiths might take on an arbitrary and capricious appearance.

Now if the parents believed that their Catholic faith was somehow privileged and True, it would have been a relatively simple matter to teach their children the how and why of their own religious beliefs. We would think that the children would be inoculated against the heretical views of the diverse religions practiced in Canada. Perhaps the parents’ anxiety, and their resort to pleadings, reveals some insecurity about their faith’s ability to withstand critical scrutiny. Better to put off the day of reckoning until the brainwashing of the children is complete.

On February 17, 2012 the Supreme Court of Canada upheld Quebec’s Ethics & Religious Culture Program, in S.L. v. Commission scolaire des Chênes, 2012 SCC 7. The Court held that the parents, whose names are not revealed (due to shame?), and their children suffered no infringement of their freedom of religion. Accepting that the parents were sincere in their professions of faith, the Court unanimously held that the ERC Program did not interfere with those beliefs. Parents in Canada remain free to do their best to indoctrinate their children in parental religious beliefs, whether those beliefs be Protestant, Catholic, Muslim, Jewish, Jain, Scientology, Satanic, Astrological, or even Pastafarian.

Merely causing children to open their eyes and compare religions in a factual way is not an infringement of the Canadian Charter of Rights and Freedoms. Learning about the diversity of faiths is not a restraint of the free exercise of religion. The Supreme Court of Canada noted that the ERC Program maintained neutrality in presenting facts about religion and morals.

Refusing to accept that the ERC Program interfered with parental “obligations” to inculcate and indoctrinate their own faith was perhaps non-empirical. The parents’ claim is not implausible, and it might well be true. The Court’s holding ignored that neutrality was the LAST thing the litigious parents wanted in matters of religion. The parents, S.L. and D.J., took their anonymous children out of public school, and placed them in Catholic schools, where they can have their children indoctrinated without scrutiny or appeal to law or reason.

Indeed, let’s hope that it is true that teaching facts about competing faiths, which cannot all be equally correct, might lead to some epistemic humility and even skepticism. Surely that would be welcomed. We have something here to learn from our northern neighbor. Teaching “anthropology of religion” in the United States might have great benefits to break the stranglehold of cults on our politics. The Quebec ERC Program would be a step in moving from a faith-based to an evidence-based world. American Taliban beware.

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Extraordinary Claims Require Extraordinary Evidence – Cold Fusion

August 18th, 2012

According to the font of knowledge, Wikipedia, the oft-quoted expression, “An extraordinary claim requires extraordinary proof,” is due to Macello Truzzi. See Marcello Truzzi, “On the Extraordinary: An Attempt at Clarification,” 1(1) Zetetic Scholar 11 (1978). I certainly recall hearing a similar statement from Carl Sagan, who popularized the expression on his PBS specials. But Pierre-Simon Laplace, in his Bayesian phase, stated the matter best, over two centuries ago:

“The weight of evidence for an extraordinary claim must be proportioned to its strangeness.”

Martin Fleischmann and his associate, B. Stanley Pons, might have avoided some embarrassment if they had taken Laplace’s maxim to heart. With a very low posterior probability, they needed an extraordinary likelihood ratio to make their claimed outcome of “cold fusion” credible.

In March 1989, Fleischmann and Pons held a news conference to announce their illusory discovery of so-called “cold fusion.” The immediate reaction from many in the media was uncritical acclaim. Fleischmann and Pons made the front page of major newspapers, and the covers of the then popular weekly news magazines (Time and Newsweek). The media frenzy was clearly justified if the claim were true. Their spectacular claim invited attempts at replication, but no amount of wish bias could make dream into fact. Scientists from around the world, including the American Physical Society and from the United States Department of Energy, in short order, put Fleischmann and Pons’ claim to rest.

Martin Fleischmann died earlier this month, and the New York Times published a lengthy obituary. Douglas Martin, Martin Fleischmann, Seeker of Cold Fusion, Dies at 85, N.Y. Times A18 (Aug. 12, 2012). Not surprisingly, the Times focused on the “cold fusion” fiasco, and the discredited research claim of Fleischmann and Pons. The obituary quoted Richard Petrasso, a Massachusetts Institute of Technology physicist who, in a 1991 interview, expressed his initial conviction that Fleischmann and Pons’ work was an “absolute fraud,” but later softened in noting that the two scientists “probably believed in what they were doing.” William J. Broad, “Cold-Fusion Claim Is Faulted on Ethics as Well as Science, ” New York Times (Mar. 17, 1991).

Petrasso was probably correct, but his interpretation, while charitable, highlights the power of wish and confirmation biases in science. Fleischmann was a capable, well-trained scientist. He received his doctorate from the University of London, held respectable academic appointments, and was elected a fellow of the Royal Society. He had over 240 articles published in journals. While social constructivists anguish over corporate influence in science, a great deal of really bad science receives a pass because wish and confirmation biases are so commonplace. The Times quoted Fleischmann as saying, in 2009, that “unless we get fusion to work in some fashion, we are doomed, aren’t we?” Perhaps his sense of doom helped make his slippery evidence easier to accept. According to the obituary, Fleischmann and Pons planned their experimental approach while hiking in Utah. Whiskey was involved.

Inexpensive, limitless energy attracted a great deal of attention. Unfortunately, many science and health claims do not elicit prompt attempts at replication, and the public and the scientific communities are often willing to accept claims at face value. They would be prudent to heed Laplace’s dictum. I can think of any number of litigation claims which evaded expert witness gatekeeping because of violations of Laplace’s guidance.

As for Fleischmann’s death, the obituary in the Times probably suffices to prove the fact.

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The Dow-Bears Debate the Decline of Daubert

August 10th, 2012

Last month, I posted a short screenplay about how judicial gatekeeping of expert witnesses has slackened recently. See “Daubert Approaching the Age of Majority” (July 17, 2012).

Dr. David Schwartz, of Innovative Science Solutions, has adapted the screenplay to the cinematic screen, and directed a full-length feature movie, The Daubert Will Set Your Client Free, using text-to-talk technology. Dr. Schwartz is not only a first-rate scientist, but he is also an aspiring film maker and artist.

OK; full-length is only a little more than 90 seconds, but you may still enjoy our movie-making debut. And it is coming to a YouTube screen near you, now.

Posted in Expert Witnesses, Rule 702, Scientific Evidence, statistical evidence | Comments Off on The Dow-Bears Debate the Decline of Daubert

Eighth Circuit Holds That Increased Risk Is Not Cause

August 4th, 2012

The South Dakota legislature took it upon itself to specify the “risks” to be included in the informed consent required by state law for an abortion procedure:

(1) A statement in writing providing the following information:
* * *
(e) A description of all known medical risks of the procedure and statistically significant risk factors to which the pregnant woman would be subjected, including:
(i) Depression and related psychological distress;
(ii) Increased risk of suicide ideation and suicide;
* * *

S.D.C.L. § 34-23A-10.1(1)(e)(i)(ii). Planned Parenthood challenged the law on constitutional grounds, and the district court granted a preliminary injunction against the South Dakota statute, which a panel of the Eight Circuit affirmed, only to have that Circuit en banc reverse and remand the case for further proceedings. Planned Parenthood Minn. v. Rounds, 530 F.3d 724 (8th Cir. 2008) (en banc).

On remand, the parties filed cross-motions for summary judgment. The district court held that the so-called suicide advisory was unconstitutional. On the second appeal to the Eight Circuit, a divided panel affirmed the trial court’s holding on the suicide advisory. 653 F.3d 662 (8th Cir. 2011). The Circuit, however, again granted rehearing en banc, and reversed the summary judgment for Planned Parenthood on the advisory. Planned Parenthood Minnesota v. Rounds, Slip op. July 24, 2012 (en banc)[Slip op.].

In support of the injunction, Planned Parenthood argued that the state’s mandatory suicide advisory violated women’s abortion rights and physicians’ free speech rights. The en banc court rejected this argument, holding that the required advisory was “truthful, non-misleading information,” which did not unduly burden abortion rights, even if it might cause women to forgo abortion. See Planned Parenthood of Southeastern Pennsylvania v. Casey, 505 U.S. 833, 882-83 (1992).

Risk ≠ Cause

Planned Parenthood’s success in the trial court turned on its identification of risk (or increased risk) with cause, and its expert witness evidence that causation had not been accepted in the medical literature. In other words, Planned Parenthood argued that the advisory required disclosure of a conclusive causal “link” between abortion and suicide or suicidal ideation. See 650 F. Supp. 2d 972, 982 (D.S.D. 2009). The en banc court, on the second appeal, sought to save the statute by rejecting Planned Parenthood’s reading. The court parsed the statute to suggest that the term “increased risk” is more precise and limited than the umbrella term of “risk,” standing alone. Slip op. at 6. The statute does not define “increased risk,” which the en banc court noted had various meanings in medicine. Id. at 7.

Reviewing the medical literature, the en banc court held that the term “increased risk” does not refer to causation but to a much more modest finding of “a relatively higher probability of an adverse outcome in one group compared to other groups—that is, to ‘relative risk’.” Id. The en banc majority seemed to embroil itself in some considerable semantic confusion. One the hand, the majority, in a rhetorical rift proclaimed that:

“It would be nonsensical for those in the field to distinguish a relationship of ‘increased risk’ from one of causation if the term ‘risk’ itself was equivalent to causation.”

Id. at 9. The majority’s nonsensical labeling is, well, … nonsensical. There is a compelling difference in assessment of risk and causation. Risk is an ex ante concept, applied before the effect has occurred. Assessment or attribution of causation takes place after the effect. Of course, there is a sense of risk or “increased risk,” which is epistemologically more modest, but that hardly makes the more rigorous use of risk as an ex ante cause, nonsensical.

The majority, however, is not content to leave the matter alone. Elsewhere, the en banc court contradicts itself, and endorses a view that risk = causation. For instance, in citing to a civil action involving a claimed causal relationship between Bendectin and a birth defect, the Eighth Circuit reduces risk to cause. See Slip op. at 26 n. 9 (citing Brock v. Merrell Dow Pharms., Inc., 874 F.2d 307, 312 , modified on reh’g, 884 F.2d 166 (5th Cir. 1989)). The en banc court’s “explanatory” parenthetical explains the depths of its confusion:

“explaining that if studies establish, within an acceptable confidence interval, that those who use a pharmaceutical have a relative risk of greater than 1.0—that is, an increased risk—of an adverse outcome, those studies might be considered sufficient to support a jury verdict of liability on a failure-to-warn claim.”

This reading of Brock is wrong on two counts. First, the Fifth Circuit, in Brock, and consistently since, has required the relative risk greater than 1.0 to be statistically significant at the conventional significance probability, as well as other indicia of causality, such as the Bradford Hill factors. So Brock and its progeny did not confuse or conflate risk with cause, or dilute the meaning of cause such that it could be satisfied by a mere showing of an increased relative risk.

Second, Brock itself made a serious error in interpreting statistical significance and confidence intervals. The Bendectin studies at issue in Brock were not statistically significant, and the confidence intervals did not include a measure of no association (relative risk = one). Brock, however, in notoriously incorrect dicta claimed that the computation of confidence intervals took into account bias and confounding as well as sampling variability. Brock v. Merrill Dow Pharmaceuticals, Inc., 874 F.2d 307, 311-12 (5th Cir. 1989)(“Fortunately, we do not have to resolve any of the above questions [as to bias and confounding], since the studies presented to us incorporate the possibility of these factors by the use of a confidence interval.”)(emphasis in original). See, e.g., David H. Kaye, David E. Bernstein, and Jennifer L. Mnookin, The New Wigmore – A Treatise on Evidence: Expert Evidence § 12.6.4, at 546 (2d ed. 2011); Michael O. Finkelstein, Basic Concepts of Probability and Statistics in the Law 86-87 (2009)(criticizing the over-interpretation of confidence intervals by the Brock court); Schachtman, “Confidence in Intervals and Diffidence in the Courts” (Mar. 4, 2012).

The en banc majority’s discussion of the studies of abortion and suicidality make clear that the presence of bias and confounding in a study may prevent inference of causation, but they do not undermine the conclusion that the studies show an increased risk. A conclusion that the body of epidemiologic studies was inconclusive, and that it failed to “to disentangle confounding factors and establish relative risks of abortion compared to its alternatives,” did not, therefore, render the suicide advisory about risk or increased risk unsupported, untruthful, or misleading. Slip op. at 20. Indeed, the en banc court provided an example, outside the context of abortion, to illustrate its meaning. The en banc court’s use of the example of prolonged television viewing and “increased risk” of mortality suggests that the court took risk to mean any association, no matter how likely it was the result of bias or confounding. See id. at 10 n. 3 (citing Anders Grøntved, et al., “Television Viewing and Risk of Type 2 Diabetes, Cardiovascular Disease, and All-Cause Mortality, 305 J. Am. Med. Ass’n 2448 (2011). The en banc majority held that the advisory would be misleading only if Planned Parenthood could show that the available epidemiologic studies conclusively ruled out causation. Slip op. at 24-25.

The Suicide Advisory Has Little Content Because Risk Is Not Cause

The majority decision clarified that the mandatory disclosure does not require a physician to inform a patient that abortion causes suicide or suicidal thoughts. Slip op. at 25. The en banc court took solace in its realization that physicians’ reviewing the available studies could provide a disclosure that captures the difference between risk, relative risk, and causation. In other words, physicians are free to tell patients that this thing called increased risk is not concerning because the studies are highly confounded, and they do not show causation. Id. at 25-26. Indeed, it would be hard to imagine an ethical physician telling patients anything else.

Dissent

Four of the Eight Circuit judges dissented, pointing to evidence that the South Dakota legislators intended to mandate a disclosure about causality. Slip op. at 29. Putting aside whether the truthfulness of the suicide advisory can be saved by reverting to a more modest interpretation of risk or of increased risk, the dissenters appear to have the better argument that the advisory is misleading. The majority, however, by driving its wedge between causation and increased risk have allowed physicians to explain that the advisory has little or no meaning.

NOCEBO

The nocebo effect is the dark side of the placebo effect. As pointed out recently in the Journal of the American Medical Association, nocebos can induce harmful outcomes because of the expectation of injury from the “psychosocial context or therapeutic environment” affecting patients’ perception of their health. Luana Colloca & Damien Finniss, “Nocebo Effects, Patient-Clinician Communication, and Therapeutic Outcomes,” 307 J. Am. Med. Ass’n 567, 567 (2012). It is fairly well accepted that clinicians can inadvertently prejudice health outcomes by how they frame outcome information to patients. Colloca and Finniss note that the negative expectations created by nocebo communication can take place in the process of obtaining informed consent.

Unfortunately, there is no discussion of nocebo effects in the Eight Circuit’s decision. Planned Parenthood might well consider the role the nocebo effect has on the risk-benefit of an informed consent disclosure about a risk that really is not a risk, or is not a risk in the sense that it is a factor that will result in the putative cause, but rather only something that is under study and which cannot be separated from many confounding factors. Surely, physicians in South Dakota will figure out how to give truthful, non-misleading disclosures that incorporate the mandatory suicide advisory, as well as the scientific evidence.

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Statistical Significance – Will Judicial Notice Substitute for An Expert Witness?

July 23rd, 2012

Do litigants in civil and criminal proceedings need statistical expert witnesses to present statistical analyses? Or, can lawyers take the data that are in evidence, and present their own statistical analyses?

Surely, lawyers could add figures to arrive at a sum, which is relevant to the issues in dispute. Some lawyers and judges might be able to take model assumptions, and compare two means or two proportions, to show that they the statistics did not likely come from the same populations. Indeed, some lawyers may be able to do such analyses better than some expert witnesses, but this begs the question: is it legally permissible?

In In re Pfizer Inc. Securities Litig., 584 F.Supp. 2d 621 (S.D.N.Y. 2008), defendant Pfizer filed a motion to dismiss a securities class action complaint. The court found that Pfizer’s motion would require it to interpret statistical significance, and that it could not accept the parties’ non-expert assertions of the meaning of the concept; nor could the court take judicial notice of the meaning:

“The Court declines to take judicial notice of the meaning of statistical significance or of the data interpretations proffered by Defendants in the context of this motion practice. Rule 201 of the Federal Rules of Evidence provides that courts may only take notice of facts ‘either (1) generally known . . . or (2) capable of accurate and ready determination by resort to sources whose accuracy cannot reasonably be questioned’. Fed. R. Evid. 201(b). While statistical significance may have certain characteristics capable of general abstraction, it is far beyond the scope of Rule 201 to accept as fact the particular definitions of statistical significance proffered by Defendants as either facts generally known or as drawn from sources whose accuracy cannot reasonably be questioned. It is one thing to take notice of the fact that an author has written that 5% is the threshold for statistical significance. It is quite another thing entirely to use that 5% figure as a basis for rejecting the significance of complicated medical studies.”

Id. at 634. Similarly, the court refused to look at specific studies and conclude that they failed to find a statistically significant association between Celebrex and cardiovascular adverse events:

“A motion to dismiss a complaint is not an appropriate vehicle for determination as to the weight of the evidence, expert or otherwise. Clearly, the Court cannot take judicial notice that the three studies show a lack of any statistically significant link between Celebrex/Bextra and adverse cardiovascular events because that supposed fact is neither generally known nor capable of accurate and ready determination by reference to unquestionably accurate sources. Moreover, the Court cannot determine as a matter of law whether such links were statistically insignificant because statistical significance is a question of fact.”

Id. at 635.

In Bristol-Myers Squibb v. AIU Insurance Co., et al., Cause No. A-145,672, Jefferson County, 58th Judicial District, Texas, plaintiff’s counsel made a Batson challenge to the defendants’ exercise of peremptory challenges. See Daily Transcript in (May 13, 1997). Not having expected the defense counsel to exercise their peremptory challenges in an apparently discriminatory fashion, the plaintiff’s counsel did not have a statistician ready to analyze the pattern of challenges. One of the plaintiff’s counsel presented the analysis in his oral argument to the court. The venire panel was made up of 49 persons, 18 black, and 31 white. The defense exercised 6 of their 7 peremptory challenges to black veniremen. Based upon these numbers, plaintiff’s counsel presented a calculation of the probability that defense counsel would have exercised their challenges in such an extreme fashion if they made their choices independent of race. The defense objected to plaintiff’s counsel’s calculations, but the trial court overruled the objection and noted that the laws of probability were subject to judicial notice. Id. at 828-30.

The Texas trial court found a prima facie case of discrimination, and permitted plaintiff’s counsel to cross-examine defense counsel about their peremptory and selection decisions. Id. at 858. The case settled shortly afterwards. See also Andrew T. Berry, “Selecting Jurors,” 24 Litigation 8, 9 (Fall 1997)(“For example, in a recent (unreported) large civil case in the Southwest, the defendants successfully defeated a Batson challenge to their use of 85 percent of their peremptory challenges against protected class members. The successful defense? That the two dozen eminent counsel …, given less than a quarter-hour to exercise their peremptories were simply too disorganized to have struck jurors in violation of Batson.”)

In the welding fume MDL 1535, the plaintiffs persisted in challenges to a particular industry-funded, published epidemiologic study, which reported findings of no increased risks for Parkinson’s disease and parkinsonism among non-shipyard Danish welders. Jon Fryzek, J. Hansen, S. Cohen, J. Bonde, et al., “A cohort study of Parkinson’s disease and other neurodegenerative disorders in Danish welders,” 47 J. Occup. & Envt’l Med. 466 (2005). Plaintiffs’ counsel went to the extreme of traveling to Denmark, with one of their expert witnesses in tow, to analyze the underlying data for this study. Upon returning to the United States, the plaintiffs moved to bar reliance upon the Fryzek study, on the theory that the statistical analysis concerning the article’s finding of no statistically significant difference in the age of onset was incorrect. In support of their argument, one of the plaintiff’s counsel, a law professor who was assisting plaintiffs in the welding fume litigation, submitted an affidavit in support of the motion in limine to bar defense witness’s testimony. See Affidavit of Theodore Eisenberg, in In re Welding Fume Products Liability Litigation, Case No.: 1:03-cv-17000, MDL No. 1535, Document 1862 Filed 08/07/2006.

Eisenberg’s affidavit reported analyses of the Danish data, apparently based upon work done by an unnamed “programmer” at the Danish Cancer Society. The affidavit included truncated computer program output, without identification of the statistical tests, or of the statistical software, used. Eisenberg interpreted the p-value result of the attached statistical analysis to show that there was a statistically significant difference in the age of onset of Parkinson’s disease between welders and non-welders.

The defense opposed the motion on grounds that Eisenberg’s affidavit was an ethically impermissible attempt by a lawyer in the case to present an expert witness opinion. The defense also countered substantively with an affidavit from one of its expert witnesses, who analyzed the affidavit and realized that Eisenberg and the anonymous programmer had not presented the complete software output from their analyses, and that they had used a different test from that used in the published paper. Eisenberg’s affidavit therefore had not identified an error in the published paper. Declaration of Timothy L. Lash (Sept. 11, 2006), filed in In re Welding Fume Products Liability Litigation, Case No.: 1:03-cv-17000, MDL No. 1535. The trial court denied the plaintiff’s motion to bar reliance upon the Fryzek study, without comment on the propriety of Eisenberg’s affidavit.

The MTBE mass tort litigation gave rise a peculiar instance in which a trial court held that a real estate value appraiser had departed from the level of intellectual rigor used in assessing property value changes, claimed to have resulted from a gas station’s pollution of the ground water in a small town in Orange County, New York. The witness opined that the plaintiffs’ property suffered a 15% decline in market value, but he failed to identify the methods he used to arrive at his opinion. In re Methyl Tertiary Butyl Ether (“MTBE”) Prods. Liab. Litig., 2008 U.S. Dist. LEXIS 44216 (S.D.N.Y. June 4, 2008)(Scheindlin, J.). The expert witness did explain that there were so few sales in the affected town that he could not use regression analysis, and that it was thus necessary to look at “trend data on sales by sub-markets, sales/list price analysis and days on the market comparisons.” Id. at *5. Even so, the trial court could not otherwise discern what method the witness did use:

“In this case, I am unable to discern any method — much less a reliable method — that Langer used to reach his conclusion that the value of plaintiffs’ property decreased by fifteen percent because of MTBE contamination. Rather, Langer has merely compiled market data and then offered his conclusions, yet he has failed to explain the relationship between the two.”

Id. at *11.

Although the expert witness’s departure from the professional standard of care rendered his opinion inadmissible, the trial court decided that the would-be expert witness could still testify as a fact witness to the facts that he had collected about sales trends in the affected community and elsewhere. According to the court, the statistics gathered by this witness were relevant, and the plaintiffs’ counsel could argue plausible inferences to the jury, from the sales figures. Id. at *16-17. The court thus remarkably permitted the plaintiffs’ counsel to provide the statistical analysis that his designated expert witness had failed to give in a legally reliably form.

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Copywrongs – Plagiarism in the Law

July 20th, 2012

Previously I have written about the ethical and practical issues involved in lawyers’ plagiarism. See also Copycat – Further Thoughts. Professor Douglas E. Abrams, of the University of Missouri School of Law, has written an interesting article on issues raided by lawyers’ plagiarism, “Plagiarism in Lawyers’ Advocacy: Imposing Discipline for Conduct Prejudicial to the Administration of Justice,” which is due out next year in the Wake Forest Law Review. For now, a draft is available from the Social Science Research Network for download.

Abrams details some recent cases in which counsel were chastised for copying published material, prior judicial opinions, and other counsel’s briefs. There is still a lot of gray areas. Abrams does not deal with legal forms. However flattering it is for judges to adopt language from lawyers’ briefs, is it plagiarism for them to do so? Does a judge commit plagiarism by adopting language wholesale from a lawclerk’s draft? Does a senior lawyer commit plagiarism by leaving off the names of junior lawyers and lawclerks, who contributed portions of the brief? Does it matter if the senior lawyer’s writing is an article for publication rather than a brief to the court? If a lawyer takes language from another’s brief, and uses it in an article, does she commit plagiarism? If a lawyer discovers plagiarism committed by another lawyer, is there an ethical obligation to report the plagiarizer?

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Discovery of Statistician Expert Witnesses

July 19th, 2012

This post has been updated and superseded by “Discovery of Retained, Testifying Statistician Expert Witnesses (Part 1) (June 30, 2015).“

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Daubert Approaching the Age of Majority

July 19th, 2012

PLAINTIFF LAWYER: WHY DID YOU FILE THE DAUBERT?

DEFENSE LAWYER: THE DAUBERT WILL SET MY CLIENT FREE.

PLAINTIFF LAWYER: THE DAUBERT WILL COST YOUR CLIENT A LOT OF MONEY WHICH COULD COMPENSATE YOUR VICTIMS.

DEFENSE LAWYER: THE DAUBERT WILL BAR YOUR EXPERTS AND GIVE US THE SUMMARY JUDGMENT.

PLAINTIFF LAWYER: YOU WILL LOSE THE DAUBERT.

DEFENSE LAWYER: NO; WE WILL WIN THE DAUBERT BECAUSE YOU DO NOT HAVE THE BRADFORD HILL.

PLAINTIFF LAWYER: THE BRADFORD HILL ARE NINE THINGS. WHICH ONE ARE YOU TALKING ABOUT?

DEFENSE LAWYER: I AM TALKING ABOUT ALL NINE.

PLAINTIFF LAWYER: NO, WE HAVE THE BRADFORD HILL LOCKED UP.

DEFENSE LAWYER: BUT YOU DO NOT HAVE ANY OF THE NINE.

PLAINTIFF LAWYER: THE BRADFORD HILL SAYS NONE OF THE NINE IS NECESSARY; THEREFORE WE HAVE ALL SATISFIED.

DEFENSE LAWYER: BUT WAIT; YOU DO NOT EVEN GET TO THE BRADFORD HILL. YOUR P-VALUE IS TOO LOW.

PLAINTIFF LAWYER: I AM THE PLAINTIFF LAWYER. I CANNOT BE TOO RICH, TOO POWERFUL, OR HAVE TOO HIGH A P-VALUE.

DEFENSE LAWYER: NO; YOU NEED TO SHOW STATISTICAL SIGNIFICANCE BEFORE YOU GET TO THE BRADFORD HILL.

PLAINTIFF LAWYER: STATISTICAL SIGNIFICANCE IS NOT A LITMUS TEST; SO I HAVE THAT SATISFIED AS WELL.

DEFENSE LAWYER: YOU DON’T KNOW WHAT YOU’RE TALKING ABOUT.

PLAINTIFF LAWYER: YOU NEED TO KEEP UP WITH THE CASE LAW. LET’S GO PICK A JURY.

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