TORTINI

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The Outer Limits (and Beyond?) of Ex Parte Advocacy of Federal Judges

May 23rd, 2014

As every trial lawyer knows, people sometimes reveal important facts in curious ways, incorporated in their own biased narrative of events. Recently, I heard a recorded lecture about expert witnesses, by a plaintiffs’ lawyer, who revealed a damning fact about a judge. The lawyer clearly thought that this fact was commendatory, but in fact revealed another effort of scientific advocates and zealots to subvert the neutrality of federal judges. See In re School Asbestos Litigation, 977 F.2d 764 (3d Cir. 1992) (describing effort by plaintiffs’ lawyers and the late Dr. Irving Selikoff to corrupt state and federal judges with one-sided ex parte presentations of their views at the so-called Third-Wave Conference).

Anthony Z. Roisman is the Managing Partner of the National Legal Scholars Law Firm. This firm has a roster of affiliated law professors who serve as consultants for plaintiffs in environmental and tort cases. (Some other participants in this law firm include Jay M. Feinman, Lucinda M. Finley, Neil Vidmar, and Richard W. Wright.) Roisman has been active in various plaintiff organizations, including serving as the head of the ATLA Section on Toxic, Environmental & Pharmaceutical Torts (STEP).

Roisman lectures frequently for the American Law Institute on expert witness issues. Recently, I was listening to an mp3 recording of one of Roisman’s lectures on expert witnesses in environmental litigation. Given Roisman’s practice and politics, I was not surprised to hear him praise Judge Rothstein’s opinion that refused to exclude plaintiffs’ expert witnesses’ causation opinions in the PPA litigation. See In re Phenylpropanolamine Prod. Liab. Litig., 289 F. 2d 1230 (2003). What stunned me, however, was his statement that Judge Rothstein issued her opinion “fresh from a seminar at the Tellus Institute,” which he described as “organization set up by scientist trying to bring common sense to interpretation of science.”

Post hoc; ergo propter hoc?

Judge Rothstein’s PPA decision stands as a landmark of judicial gullibility. Judge Rothstein conducted hearings and entertaining extensive briefings on the reliability of plaintiffs’ expert witnesses’ opinions, which were based largely upon one epidemiologic study, known as the “Yale Hemorrhagic Stroke Project (HSP).” In the end, publication in a prestigious peer-reviewed journal proved to be a proxy for independent review: “The prestigious NEJM published the HSP results, further substantiating that the research bears the indicia of good science.” Id. at 1239 (citing Daubert II for the proposition that peer review shows the research meets the minimal criteria for good science). The admissibility challenges were refused.

Ultimately, the HSP study received much more careful analysis before juries, which uniformly returned verdicts for the defense. After one of the early defense verdicts, plaintiffs’ counsel challenged the defendant’s reliance upon underlying data in the HSP, which went behind the peer-reviewed publication, and which showed that the peer review failed to prevent serious errors. The trial court rejected the plaintiffs’ request for a new trial, and spoke to the significance of challenging the superficial significance of peer review of the key study relied upon by plaintiffs in the PPA litigation:

“I mean, you could almost say that there was some unethical activity with that Yale Study. It’s real close. I mean, I — I am very, very concerned at the integrity of those researchers.”

“Yale gets — Yale gets a big black eye on this.”

O’Neill v. Novartis AG, California Superior Court, Los Angeles Cty., Transcript of Oral Argument on Post-Trial Motions, at 46 -47 (March 18, 2004) (Hon. Anthony J. Mohr)

Roisman’s endorsement of the PPA decision may have been purely result-oriented jurisprudence, but what of his enthusiasm for the “learning” that Judge Rothstein received at the Tellus Institute. Tell us, what is this Tellus Institute?

In 2003, roughly contemporaneously with Judge Rothstein’s PPA decision, SKAPP published a jeremiad against the Daubert decision, with support from none other than the Tellus Group. See Daubert: The Most Influential Supreme Court Ruling You’ve Never Heard Of; A Publication of the Project on Scientific Knowledge and Public Policy, coordinated by the Tellus Institute (2003). The Tellus Institute website tells us very little specific detail about the Institute’s projects, other than stating some vague and pious goals. The alignment, however, of the Tellus Institute with David Michael’s SKAPP, which was created with plaintiffs’ lawyers’ funding, certainly seems like a dubious indicator of neutrality and scientific commitment. See “Skapp a Lot” (April 30, 2010).

We might get a better idea of the organization from the Tellus membership.

Richard Clapp and David Ozonoff are both regular testifiers for plaintiffs in so-called toxic tort and environmental litigation. In an article published about the time of the PPA decision, Clapp and Ozonoff acknowledged having benefited from discussions with colleagues at the Tellus Institute. See Richard W. Clapp & David Ozonoff, “Environment and Health: Vital Intersection or Contested Territory?” 30 Am. J. L. & Med. 189, 189 (2004) (“This Article also benefited from discussions with colleagues in the project on Scientific Knowledge and Public Policy at Tellus Institute, in Boston, Massachusetts.”).

In the infamous case of Selikoff and Motley and their effort to subvert the neutrality of Judge James M. Kelly in the school district asbestos litigation, the conspiracy was detected in time for a successful recusal effort. In re School Asbestos Litigation, 977 F.2d 764 (3d Cir. 1992). Unfortunately, in the PPA litigation, there was no disclosure of the efforts by the advocacy group, Tellus Institute, to undermine the neutrality of a federal judge.

Outside observers will draw their own inferences about whether Tellus was an “honest broker” of scientific advice to Judge Rothstein. One piece of evidence may be SKAPP’s website, which contains a page about Richard Clapp’s courtroom advocacy in the PPA litigation. Additional evidence comes from Clapp’s leadership role in Physicians for Social Responsibility, and his own characterization of himself as a healthcare professional advocate. Clapp, a member of Tellus, was an expert witness for plaintiffs in PPA cases.

Was Clapp present at the Tellus Institute meeting attended by Judge Rothstein? History will judge whether the Tellus Institute participated in corrupting the administration of justice.

Posted in Conflicts of Interest, Expert Witnesses, Rule 702 | Comments Off on The Outer Limits (and Beyond?) of Ex Parte Advocacy of Federal Judges

The Fallacy of Cherry Picking As Seen in American Courtrooms

May 3rd, 2014

After a long winter, the cherry trees are finally managing to blossom. Before we know it, it will be cherry-picking time.

Cherry picking is a good thing; right? Cherry picking yields cherries, and cherries are good. Selective cherry picking yields the best, ripest, sweetest, tastiest cherries. Cherry picking data no doubt yields the best, unbiased, unconfounded, most probative data to be had. Well, maybe not.

What could be wrong with picking cherries? At the end of the process you have cherries, and if you do it right, you have all ripe, and no rotten, cherries. Your collection of ripe cherries, however, will be unrepresentative of the universe of cherries, but at least we understand how and why your cherries were selected.

Elite colleges cherry pick the best high school students; leading law schools cherry pick the top college students; and top law firms and federal judges cherry pick the best graduates from the best law schools. Lawyers are all-too-comfortable with “cherry picking.” Of course, the cherry-picking process here has at least some objective criteria, which can be stated in advance of the selection.

In litigation, each side is expected to “cherry pick” the favorable evidence, and ignore or flyblow the contrary evidence. Perhaps this aspect of the adversarial system induces complacency in judges about selectivity in the presentation of evidence by parties and their witnesses. In science, this kind of adversarial selectivity is a sure way to inject bias and subjectivity into claims of knowledge. And even in law, there are limits to this adversarial system. Undue selectivity in citing precedent can land a lawyer in a heap of trouble. See Thul v. OneWest Bank, FSB, No. 12 C 6380, 2013 WL 212926 (N.D. Ill. Jan. 18, 2013) (failure to cite relevant judicial precedent constitutes an ethical offense)

In science, the development of the systematic review, in large measure, has been supported by the widespread recognition that studies cannot be evaluated with post hoc, subjective evaluative criteria. See generally Matthias Egger, George Davey Smith, and Douglas Altman, Systematic Reviews in Health Care: Meta-Analysis in Context (2001).

Farmers pick the cherries they want to go to market, to make money and satisfy customers. The harvesters’ virtue lies in knowing what to pick to obtain the best crop. The scientist’s virtue lies in the disinterested acquisition of data pursuant to a plan, and the evaluation of the data pursuant to pre-specified criteria.

The scientist’s virtue is threatened by motivations that are all-too human, and all-too common. The vice in science is wanting data that yields marketable publications, grants, promotions, awards, prizes, and perhaps a touch of fame. Picking data based upon a desired outcome is at the very least scientific fallacy if not scientific fraud. Cherry picking does not necessarily imply scienter, but in science, it is a strict liability offense.

The metaphor of cherry picking, mixed as it may be, thus gives us a label for fallacy and error. Cherry picking incorporates sampling bias, selection bias, confirmation bias, hasty generalization, and perhaps others as well. As explained recently, in Nature:

“Data can be dredged or cherry picked. Evidence can be arranged to support one point of view. * * * The question to ask is: ‘What am I not being told?’”

William J. Sutherland, David Spiegelhalter & Mark Burgman, “Policy: Twenty tips for interpreting scientific claims,” 503 Nature 335, 337 (2013).

Cherry picking in the orchard may be a good thing, but in the scientific world, it refers to the selection of studies or data within studies to yield results desired results, however misleading or counterfactual. See Ben Goldacre, Bad Science 97-99 (2008). The selective use of evidence is not a fallacy unique to science. Cherry picking is widely acknowledged to seriously undermine the quality of public debate See Gary Klass, “Just Plain Data Analysis: Common Statistical Fallacies in Analyses of Social Indicator Data” (2008). See generally Bradley Dowden, “Fallacies,” in James Fieser & Bradley Dowden, eds., Internet Encyclopedia of Philosophy.

The International Encyclopedia of Philosophy describes “cherry picking” as a fallacy, “a kind of error in reasoning.” Cherry-picking the evidence, also known as “suppressed evidence,” is:

“[i]ntentionally failing to use information suspected of being relevant and significant is committing the fallacy of suppressed evidence. This fallacy usually occurs when the information counts against one’s own conclusion. * * * If the relevant information is not intentionally suppressed but rather inadvertently overlooked, the fallacy of suppressed evidence also is said to occur, although the fallacy’s name is misleading in this case.”

Bradley Dowden, “Suppressed Evidence,” International Encyclopedia of Philosophy (Last updated: December 31, 2010). See also “Cherry picking (fallacy),” Wikipedia (describing cherry picking as the pointing to data that appears to confirm one’s opinion, while ignoring contradictory data).

In 1965, in his landmark paper, Sir Austin Bradford Hill described some important factors to consider in determining whether a clear-cut association, beyond that which we would attribute to chance, was a causal association. Hill, Austin Bradford Hill, “The Environment and Disease: Association or Causation?” 58 Proc. Royal Soc’y Med. 295, 295 (1965).

One of the key Hill factors is, of course, consistent, replicated results. Surely, an expert witness should not be permitted to manufacture a faux consistency by conducting a partial review. In birth defects litigation, the problem of “cherry picking” is so severe that one of the leading professional societies concerned with birth defects has issued a position paper to remind its members, other scientists, and the public that “[c]ausation determinations are made using all the scientific evidence”:

“Causation determinations are made using all the scientific evidence. This evidence is derived from correctly interpreted papers that have been published in the peer-reviewed literature. Unpublished data may be useful if available in sufficient detail for an evaluation and if derived from a source that is known to use reliable internal or external review standards. A National Toxicology program report would be an example of an unpublished source that is typically reliable. All available papers are considered in a scientific deliberation; selective consideration of the literature is not a scientific procedure.”

The Public Affairs Committee of the Teratology Society, “Teratology Society Public Affairs Committee Position Paper Causation in Teratology-Related Litigation,” 73 Birth Defects Research (Part A) 421, 422 (2005) (emphasis added).

* * * * * *

Cherry picking is a main rhetorical device for the litigator. Given the pejorative connotations of “cherry picking,” no one should be very surprised that lawyers and judges couch their Rule 702 arguments and opinions in terms of whether expert witnesses engaged in this fulsome fruitful behavior.

The judicial approach to cherry picking is a just a little schizophrenic. Generally, in the context of exercising its gatekeeping function for expert witnesses, the elimination of cherry picking is an important goal. Lust v. Merrell Dow Pharmaceuticals, Inc., 89 F.3d 594, 596-98 (9th Cir. 1996) (affirming exclusion of Dr. Done in a Chlomid birth defects case; district court found that “Dr. Done has seen fit to ‘pick and chose’ [sic] from the scientific landscape and present the Court with what he believes the final picture looks like. This is hardly scientific.”) (internal citation omitted); Barber v. United Airlines, Inc., 17 Fed. Appx. 433, 437 (7th Cir. 2001) (holding that a “selective use of facts fails to satisfy the scientific method and Daubert”). See also Crawford v. Indiana Harbor Belt Railroad Co., 461 F.3d 844 (7th Cir. 2006) (affirming summary judgment in disparate treatment discharge case, and noting judicial tendency to require “comparability” between plaintiffs and comparison group as a “natural response to cherry-picking by plaintiffs”); Miller v. Pfizer, Inc., 196 F. Supp. 2d 1062, (D. Kan. 2002) (excluding, with aid of independent, court-appointed expert witnesses, a party expert witness, David Healy, who failed to reconcile the fact that other research is contrary to his conclusion), aff’d, 356 F.3d 1326 (10th Cir.), cert denied, 125 S. Ct. 40 (2004).

In Ellis v. Barnhart, the Eighth Circuit affirmed a district court’s reversal of an Administrative Law Judge for “cherry picking” the record in a disability case. 392 F.3d 988 (8th Cir. 2005). Clearly cherry picking was a bad thing for a judicial officer to do when charged with the administration of justice. Several years later, however, the Eighth Circuit held that a trial court erred in excluding an expert witness for having offered an opinion that ignored the witness’s own prior, contrary opinions, a key National Institutes of Health clinical trial, and multiple other studies. The adversary’s charges of “cherry picking” were to no avail. Kuhn v. Wyeth, Inc., 686 F.3d 618, 633 (8th Cir. 2012) (“There may be several studies supporting Wyeth’s contrary position, but it is not the province of the court to choose between the competing theories when both are supported by reliable scientific evidence.”), rev’g Beylin v. Wyeth, 738 F.Supp. 2d 887, 892 (E.D.Ark. 2010) (MDL court) (Wilson, J. & Montgomery, J.) (excluding proffered testimony of Dr. Jasenka Demirovic who appeared to have “selected study data that best supported her opinion, while downplaying contrary findings or conclusions.”).

But wait, the court in Kuhn did not cite its own published opinion on cherry picking in Ellis. Some might say that the Circuit cherry picked its own precedents to get to a desired result. Anthony Niblett, “Do Judges Cherry Pick Precedents to Justify Extralegal Decisions?: A Statistical Examination,” 70 Maryland L. Rev. 234 (2010) (reviewing charges of cherry picking, and examining data [cherry picked?] from California).

The situation in the federal trial courts is chaotic. Most of the caselaw recognizes the fallacy of an expert witness’s engaging in ad hoc selection of studies upon which to rely. Federal courts, clear on their gatekeeping responsibilities and aware of the selection fallacy, have condemned cherry-picking expert witnesses. Judge Lewis Kaplan, in the Southern District of New York, expressed the proper judicial antipathy to cherry picking:

“[A]ny theory that fails to explain information that otherwise would tend to cast doubt on that theory is inherently suspect,” and “courts have excluded expert testimony ‘where the expert selectively chose his support from the scientific landscape.’”

In re Rezulin Prod. Liab. Litig., 369 F. Supp. 2d 398, 425 & n.164 (S.D.N.Y. 2005) (citation omitted).

Judge Breyer, of the Northern District of California, expressed similar sentiments in ruling on Rule 702 motions in the Celebrex personal injury litigation:

“these experts ignore the great weight of the observational studies that contradict their conclusion and rely on the handful that appear to support their litigation-created opinion.”

In re Bextra & Celebrex Mktg. Sales Pracs. & Prods. Liab. Litig., 524 F. Supp. 2d 1166, 1181 (N.D. Cal. 2007). The “cherry-picking” of favorable data “does not reflect scientific knowledge, is not derived by the scientific method, and is not ‘good science.’” Id. at 1176.

Other illustrative federal cases include:

In re Bausch & Lomb, Inc., 2009 WL 2750462 at *13-14 (D.S.C. 2009) (“Dr. Cohen did not address [four contradictory] studies in her expert reports or affidavit, and did not include them on her literature reviewed list [. . .] This failure to address this contrary data renders plaintiffs’ theory inherently unreliable.”)

Rimbert v. Eli Lilly & Co., No. 06-0874, 2009 WL 2208570, *19 (D.N.M. July 21, 2009) )(“Even more damaging . . . is her failure to grapple with any of the myriad epidemiological studies that refute her conclusion.”), aff’d, 647 F.3d 1247 (10th Cir. 2011) (affirming exclusion but remanding to permit plaintiff to find a new expert witness)

LeClercq v. The Lockformer Co., No. 00C7164, 2005 WL 1162979, at *4, 2005 U.S. Dist. LEXIS 7602, at *15 (N.D. Ill. Apr. 28, 2005) (“failure to discuss the import of, or even mention … material facts in [expert] reports amounts to ‘cherry-pick[ing]’ … and such selective use of facts fail[s] to satisfy the scientific method and Daubert.”) (internal citations and quotations omitted)

Contractors Ass’n of E. Pa. Inc. v. City of Philadelphia, 893 F. Supp. 419, 436 (E.D. Pa., 1995) (holding that expert witness opinion was unreliable when witness’s conclusions rested on incomplete factual data)

Galaxy Computer Servs. Inc. v. Baker, 325 B.R. 544 (E.D. Va. 2005) (excluding expert witness when witness relied upon incomplete data in reaching a valuation assessment).

Dwyer v. Sec’y of Health & Human Servs., No. 03-1202V, 2010 WL 892250, at *14 (Fed. Cl. Spec. Mstr. Mar. 12, 2010)(recommending rejection of thimerosal autism claim)(“In general, respondent’s experts provided more responsive answers to such questions. Respondent’s experts were generally more careful and nuanced in their expert reports and testimony. In contrast, petitioners’ experts were more likely to offer opinions that exceeded their areas of expertise, to “cherry-pick” data from articles that were otherwise unsupportive of their position, or to draw conclusions unsupported by the data cited… .”)

Holden Metal & Aluminum Works, Ltd. v. Wismarq Corp., No. 00C0191, 2003 WL 1797844, at *2 (N.D. Ill. Apr. 3, 2003) (“Essentially, the expert ‘cherrypicked’ the facts he considered to render his opinion, and such selective use of facts failed to satisfy the scientific method and Daubert.”) (internal citation omitted).

Flue-Cured Tobacco Cooperative Stabilization Corp. v. EPA, 4 F. Supp. 2d 435, 459 – 60 (M.D.N.C. 1998) (finding that EPA’s selection of studies for inclusion in a meta-analysis to be “disturbing,” and that agency’s selective, incomplete inclusion of studies violated its own guidelines for conducting risk assessments), rev’d on other grounds, 313 F.3d 852, 862 (4th Cir. 2002) (Widener, J.) (holding that the issuance of the report was not “final agency action”)

Fail-Safe, LLC v. AO Smith Corp., 744 F. Supp. 2d 870, 889 (E.D. Wis. 2010) (“the court also finds the witness’s methodology unreliable because of how Dr. Keegan uniformly treated all evidence that undermined his underlying conclusion: unwarranted dismissal of the evidence or outright blindness to contrary evidence. … In fact, it is readily apparent that Dr. Keegan all but ‘cherry picked’ the data he wanted to use, providing the court with another strong reason to conclude that the witness utilized an unreliable methodology. * * * Dr. Keegan’s two reports are rich with examples of his ‘cherry picking’ of the evidence.”)

As noted, however, there are federal trial courts that are all too willing to suspend judgment and kick the case to the jury. Here is a sampler of cases that found cherry picking to be an acceptable methodology, or at least a methodology sufficient to require that the case be submitted to the finder of fact.

In Berg v. Johnson & Johnson, the district court noted the defendants’ argument that proffered testimony is unreliable because witness “cherry-picked” data in order to form an opinion solely for purposes of litigation. 940 F.Supp. 2d 983, 991-92 (D.S.D. 2013). The trial judge, however, was not willing to look particularly closely at what was excluded or why:

“The only difference between his past and present research seems to exist in how he categorized his data. Defendants label this ‘cherry-picking’. The court views it as simply looking at the existing data from a different perspective.”

Id. Of course, expert witnesses on opposite sides look at the case from different perspectives, but the question begged was whether the challenged expert witness had categorized data in an unprincipled way. Other cases of this ilk include:

United States v. Paracha, 2006 WL 12768, at *20 (S.D. N.Y. Jan. 3, 2006) (rejecting challenge to terrorism expert witness on grounds that he cherry picked evidence in conspiracy prosecution involving al Queda)

In re Chantix (Varenicline) Products Liab. Litig., 889 F. Supp. 2d 1272, 1288 (N.D. Ala. 2012) (“Why Dr. Kramer chose to include or exclude data from specific clinical trials is a matter for cross-examination, not exclusion under Daubert.“)

Bouchard v. Am. Home Prods. Corp., 2002 WL 32597992 at *7 (N.D. Ohio May 24, 2002) (“If Bouchard believes that [the expert]… ignored evidence that would have required him to substantially change his opinion, that is a fit subject for cross-examination, not a grounds for wholesale rejection of an expert opinion.”)

In re Celexa & Lexapro Prods. Liab. Litig., 927 F. Supp. 2d 758, 2013 WL 791780, at *5, *7, *8 (E.D. Mo. 2013) (Sippel, J.) (rejecting challenge to David Healy in antidepressant suicide case)

Allen v. Takeda Pharms., MDL No. 6:11-md-2299, No. 12-cv-00064, 2013 WL 6825953, at *11 (W.D. La. Dec. 20, 2013) (challenged expert witness in Actos litigation sufficiently explained his choices to be exonerated from charges of cherry picking)

In re NuvaRing Prods. Liab. Litig., No. 4:08–MD–1964 RWS, 2013 WL 791787 (E.D. Mo. Mar. 4, 2013) (“As to cherry picking data, the Eighth Circuit has recently made clear that such allegations should be left for crossexamination.”)

McClellan v. I-Flow Corp., 710 F. Supp. 2d 1092, 1114 (D. Ore. 2010) (“Defendants are correct that plaintiffs’ experts must elucidate how the relevant evidence lends support to their opinions by explaining…..”) (rejecting cherry picking but denying Rule 702 challenge based in part upon alleged cherry picking)

Rich v. Taser Internat’l, Inc., No. 2:09–cv–02450–ECR–RJJ, 2012 WL 1080281, at *6 (D. Nev. March 30, 2012) (noting the objection to cherry picking but holding that it was an issue for cross-examination)

In re Urethane Antitrust Litig., No. 04-1313-JWL, MDL No. 1616, 2012 WL 6681783, at *3 (D. Kan. Dec. 21, 2012) (allowing expert testimony that “certain events are consistent with collusion”; “the extent to which [an expert] considered the entirety of the evidence in the case is a matter for cross-examination.”)

In re Titanium Dioxide Antitrust Litig., No. RDB-10-0318, 2013 WL 1855980, 2013 U.S. Dist. LEXIS 62394 (D. Md. May 1, 2013) (rejecting Rule 702 cherry-picking challenge to an expert who cherry picked; witness’s selection of documents upon which to rely from a record that exceeded 14 million pages was not unreliable. “ If important portions of the record were overlooked, then the Defendants may address that issue at trial.”)

STATE COURTS

The situation in state courts is similarly chaotic and fragmented.

In Lakey v. Puget Sound Energy, Inc., the Washington Supreme Court resoundingly rejected “cherry picking” by expert witnesses in a public and private nuisance case against a local utility for fear of future illnesses from exposure to electro-magnetic frequency radiation (EMF). Lakey v. Puget Sound Energy, Inc., 176 Wn.2d 909 (2013). The court held that the plaintiffs’ expert witnesses’ cherry-picking approach to data and studies was properly excluded under Rule 702. Their selective approach vitiated the reliability of his opinion with the consequence of :

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

Id.; see also “Washington Supreme Court Illustrates the Difference Between Frye and Rule 702” (April 15, 2013).

Other state Supreme Courts have recognized and rejected the gerrymandering of scientific evidence. Betz v. Pneumo Abex LLC, 2012 WL 1860853, *16 (May 23, 2012 Pa. S. Ct.)(“According to Appellants, moreover, the pathologist’s self-admitted selectivity in his approach to the literature is decidedly inconsistent with the scientific method. Accord Brief for Amici Scientists at 17 n.2 (“‘Cherry picking’ the literature is also a departure from ‘accepted procedure’.”)); George v. Vermont League of Cities and Towns, 2010 Vt. 1, 993 A.2d 367, 398 (Vt. 2010)(expressing concern about how and why plaintiff’s expert witnesses selected some studies to include in their “weight of evidence” methodology. Without an adequate explanation of selection and weighting criteria, the choices seemed “arbitrary” “cherry picking.”); Bowen v. E.I. DuPont de Nemours & Co., 906 A.2d 787, 797 (Del. 2006) (noting that expert witnesses cannot ignore studies contrary to their opinions).

Lower state courts have also quashed the cherry-picking harvest. Scaife v. AstraZeneca LP, 2009 WL 1610575, at *8 (Del. Super. June 9, 2009) (“Simply stated, the expert cannot accept some but reject other data from the medical literature without explaining the bases for her acceptance or rejection.”); see also In re Bextra & Celebrex Prod. Liab. Litig., No. 762000/2006, 2008 N.Y. Misc. LEXIS 720, at *47 (Sup. Ct. N.Y. Co. Jan 7, 2008) (stating that plaintiffs must show that their experts “do not ignore contrary data”).

The Nebraska Supreme Court appears to recognize the validity of considering the existence of cherry-picking in expert witness gatekeeping. In practice, however, that Court has shown an unwillingness to tolerate close scrutiny into what was included and excluded from the expert witness’s consideration. King v. Burlington No. Santa Fe Ry, ___N.W.2d___, 277 Neb. Reports 203, 234 (2009)(noting that the law does “not preclude a trial court from considering as part of its reliability inquiry whether an expert has cherry-picked a couple of supporting studies from an overwhelming contrary body of literature,” but ignoring the force of the fallacious expert witness testimony by noting that the questionable expert witness (Frank) had some studies that showed associations between exposure to diesel exhaust or benzene and multiple myeloma).

“Of all the offspring of time, Error is the most ancient, and is so old and familiar an acquaintance, that Truth, when discovered, comes upon most of us like an intruder, and meets the intruder’s welcome.”

Charles MacKay, Extraordinary Popular Delusions and the Madness of Crowds (1841)

Posted in Causation, Rule 702 | Comments Off on The Fallacy of Cherry Picking As Seen in American Courtrooms

On The Quaint Notion That Gatekeeping Rules Do Not Apply to Judges

April 27th, 2014

In In re Zurn Pex Plumbing Prods. Liab. Litig., 644 F.3d 604 (8th Cir. 2011), the United States Court of Appeals for the Eighth Circuit rejected the defendant’s argument that a “full and conclusive” Rule 702 gatekeeping procedure was required before a trial court could certify a class action under the Federal Rules. The Circuit remarked that “[t]he main purpose of Daubert exclusion is to protect juries from being swayed by dubious scientific testimony,” an interest “not implicated at the class certification stage where the judge is the decision maker.” Id. at 613.

Surely, one important purpose of Rule 702 is to protect juries against dubious scientific testimony, but judges are not universally less susceptible to dubious testimony. There are many examples of judges being misled by fallacious scientific evidence, especially when tendentiously presented by advocates in court. No jury need be present for dubious science testimony + “zealous” advocacy to combine to create major errors and injustice. See, e.g., Wells v. Ortho Pharmaceutical Corp., 615 F. Supp. 262 (N.D. Ga. 1985)(rendering verdict for plaintiffs after bench trial), aff’d and rev’d in part on other grounds, 788 F.2d 741 (11^th Cir.), cert. denied, 479 U.S.950 (1986); Hans Zeisel & David Kaye, Prove It With Figures: Empirical Methods in Law and Litigation § 6.5 n.3, at 271 (1997) (characterizing Wells as “notorious,” and noting that the case became a “lightning rod for the legal system’s ability to handle expert evidence.”). Clearly Rule 702 does not exist only to protect juries.

Nemo iudex in causa sua! Perhaps others should judge the competence of judges’ efforts at evaluating scientific evidence. At the very least, within the institutional framework of our rules of civil procedure and evidence, Rule 702 creates a requirement of structured inquiry into expert opinion testimony before the court. That gatekeeping inquiry, and its requirement of a finding, subject to later appellate review and to public and professional scrutiny, are crucial to the rendering of intellectual due process in cases that involve scientific and technical issues. The Eighth Circuit was unduly narrow in its statement of the policy bases for Rule 702, and their applicability to class certification.

The case of Obrey v. Johnson, 400 F.3d 691 (9th Cir. 2005) provides another cautionary tale about the inadequacies of judges in the evaluation of scientific and statistical evidence. The plaintiff, Mr. Obrey, sued the Navy on a claim of race discrimination in promoting managers at the Pearl Harbor Naval Shipyard. The district court refused plaintiff’s motion to admit the testimony of a statistician, Mr. James Dannemiller, President of the SMS Research & Marketing Services, Inc. The district court also excluded much of plaintiff’s anecdotal evidence, and entered summary judgment. Id. at 691 – 93.

On appeal, Obrey claimed that Dannemiller’s report showed “a correlation between race and promotion.” Id. at 693. This vague claim seemed good enough for the Ninth Circuit, which reversed the district court’s grant of summary judgment and remanded for trial.

The Ninth Circuit’s opinion does not tell us what sort of correlation was supposedly shown by Mr. Dannemiller. Was it Pearson’s r? Or Jaspen’s multi-serial coefficient? Spearman’s ρ? Perhaps Kendall’s τ? Maybe the appellate court was using correlation loosely, and Mr. Dannemiller had conducted some other sort of statistical analysis. The district court’s opinion is not published and is not available on Westlaw. It is all a mystery. More process is due the litigants and the public.

Even more distressing than the uncertainty as to the nature of the correlation is that the Ninth Circuit does not tell us what the correlation “effect size” was, or whether the correlation was statistically significant. If the Circuit did not follow strict hypothesis testing, perhaps it might have told us the extent of random error in the so-called correlation. The Circuit did not provide any information about the extent or the precision of the claim of a “correlation”; nor did the Circuit assess the potential for bias or confounding in Mr. Dannemiller’s analysis.

Indeed, the Ninth Circuit seemed to suggest that Mr. Dannemiller never even showed a correlation; rather the court described Mr. Dannemiller as having opined that there was “no statistical evidence in these data that the selection process for GS-13 through GS-15 positions between 1999 and 2002 was unbiased with respect to race.” Id. at 694. Reading between the lines, it seems that the statistical evidence was simply inconclusive, and Mr. Dannemiller surreptitiously shifted the burden of proof and offered an opinion that the Navy had not ruled out bias. The burden, of course, was on Mr. Obrey to establish a prima facie case, but the appellate court glossed over this fatal gap in plaintiff’s evidence.

On appeal, the Navy pressed its objections to the relevance and reliability of Mr. Dannemiller’s opinions. Brief of the Navy, 2004 WL 1080083, at *1 (April 7, 2004). There seemed to be no dispute that Mr. Dannemiller’s “study” was based entirely upon “statistical disparities,” which failed to take into account education, experience, and training. Mr. Dannemiller appeared to have simplistically compared race make up of the promoted workers, ignoring the Navy’s showing of the relevancy of education, experience, and training. Id. at *13, 18.

The Ninth Circuit not only ignored the facts of the case, it ignored its own precedents. See Obrey v. Johnson, 400 F.3d at 696 (citing and quoting from Coleman v. Quaker Oats Co., 232 F.3d 1271, 1283 (9th Cir. 2000) (“Because [the statistics] failed to account for many factors pertinent to [the plaintiff], we conclude that the statistics are not enough to take this case to trial.”). The court, in Obrey, made no effort to distinguish its treatment of the parties in Coleman, or to justify its decision as to why the unspecified, unquantified, mysterious statistical analysis of Mr. Dannemiller sufficed under Rule 702. The Circuit cryptically announced that “Obrey’s evidence was not rendered irrelevant under Rule 402 simply because it failed to account for the relative qualifications of the applicant pool.” Obrey, 400 F.3d at 695. Citing pre-Daubert decisions for the most part (such as Bazemore), the Ninth Circuit persuaded itself that Rule 702 requires nothing more than simple relevancy. Had the Circuit taken even a cursory look at Bazemore, it would have seen that the case involved a much more involved multiple regression than whatever statistical analysis Mr. Dannemiller propounded. And the Ninth Circuit would have seen that even the Bazemore decision acknowledged that there may be

“some regressions so incomplete as to be inadmissible as irrelevant… .”

478 U.S. 385, 400 n.10 (1986). It is difficult to imagine a discrimination claim analysis more incomplete than one that did not address education, training, and experience.

Sadly, neither the Navy’s nor Mr. Obrey’s brief, 2004 WL 545873 (Feb. 4, 2004) provided any discussion of the nature, quality, findings, or limits of Mr. Dannemiller’s statistical analysis. The Navy’s brief referred to Mr. Dannemiller as a “purported” expert. His resume, available online, shows that Mr. Dannemiller studied history as an undergraduate, and has a master’s degree in sociology. He is the president of SMS Research, a consulting company.

The taxpayers deserved better advocacy from the Department of Justice, and greater attention to statistical methodology from its appellate judges. See ATA Airlines, Inc. v. Federal Exp. Corp., 665 F.3d 882, 888-96 (2011) (Posner, J.) (calling for lawyers and judges to do better in understanding and explaining, in plain English, the statistical analyses that are essential to their cases). Judges at level need to pay greater attention to the precepts of Rule 702, even when there is no jury around to be snuckered.

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Duty of Objectivity for Expert Witnesses – Up North and Abroad

April 19th, 2014

In the United States, we talk of the requirements for admissibility of expert witness opinion testimony; proffered testimony must be relevant and reliable. If the requirements go unsatisfied, the legal consequence is usually limited to the preclusion of the expert witness’s challenged opinion. If the opinion is necessary to support the sponsoring party’s claim or defense, the further legal consequence may be the entry of judgment adverse to the retaining party.

A few states have permitted a party to sue its own expert witness for “expert malpractice,” committed in the scope of the witness’s engagement as an expert witness. See, e.g., LLMD of Michigan Inc. v. Jackson-Cross Co., 740 A.2d 186 (Pa. 1991). Fewer states permit the adverse party to sue its adversary’s expert witness. Davis v. Wallace, 565 S.E.2d 386 (W. Va. 2002).

In the United Kingdom and Canada, courts impose duties directly upon expert witnesses themselves. The following enumeration is frequently cited as setting forth the independent duties, owed to the court, by expert witnesses:

“1. Expert evidence presented to the Court should be, and should be seen to be, the independent product of the expert uninfluenced as to form or content by the exigencies of litigation.

2. An expert witness should provide independent assistance to the Court by way of objective unbiased opinion in relation to matters within his expertise. An expert witness in the High Court should never assume the role of an advocate.)

3. An expert witness should state the facts or assumption upon which his opinion is based. He should not omit to consider material facts which could detract from his concluded opinion.

4. An expert witness should make it clear when a particular question or issue falls outside his expertise.

5. If an expert’s opinion is not properly researched because he considers that insufficient data is available, then this must be stated with an indication that the opinion is no more than a provisional one. In cases where an expert witness who has prepared a report could not assert that the report contained the truth, the whole truth and nothing but the truth without some qualification, that qualification should be stated in the report.

6. If, after exchange of reports, an expert witness changes his view on a material matter having read the other side’s expert’s report or for any other reason, such change of view should be communicated (through legal representatives) to the other side without delay and when appropriate to the Court.

7. Where expert evidence refers to photographs, plans, calculations, analyses, measurements, survey reports or other similar documents, these must be provided to the opposite party at the same time as the exchange of reports.”

National Justice Compania Naviera S.A. v. Prudential Assurance Co. Ltd., (“The Ikarian Reefer”), [1993] 2 Lloyd’s Rep. 68 at 81-82 (Q.B.D.), rev’d on other grounds [1995] 1 Lloyd’s Rep. 455 at 496 (C.A.)(embracing the enumeration of duties).

It is unclear, however, what the consequences of breach of these duties are. Often the sponsoring party may be complicit in the breach, and the harm will be to the court and the adverse party.

In the United States, perhaps the heavy lifting of judicial gatekeeping, required by Federal Rule of Evidence 702, might be assisted in recognizing these independent duties of expert witnesses.

The duties of expert witnesses, set out in the The Ikarian Reefer, have been generally accepted by courts in Ontario and throughout Canada. See, e.g., Frazer v. Haukioja, 2008 CanLII 42207, at ¶141 (O.S.C.) (Moore, J.) (quoting from Ikarian Reefer). The Ontario court system decided not to leave compliance with these duties to chance or instructions from counsel. Starting in 2010, Ontario’s New Rule 4.1 of its Rules of Civil Procedure went into effect to define explicitly the duties of an expert witness:

RULE 4.1 DUTY OF EXPERT

4.1.01 (1)

It is the duty of every expert engaged by or on behalf of a party to provide evidence in relation to a proceeding under these rules,

(a) to provide opinion evidence that is fair, objective and non-partisan;

(b) to provide opinion evidence that is related only to matters that are within the expert’s area of expertise; and

Duty Prevails

The duty stated in the Ontario Rule 4.1 trumps any contractual or positional obligations expert witnesses may owe to the parties that engaged them. Remarkably, the Ontario courts do not leave to chance whether expert witnesses will understand and act upon their mandated obligations. Ontario Rule 53, subrule 53.03(2.1), requires expert witnesses to submit signed acknowledgment forms (Form 53, below), which recite their understand of their duties.

FORM 53

Courts of Justice Act

ACKNOWLEDGMENT OF EXPERT’S DUTY

1. My name is _______________________________ (name). I live at

___________________ (address), in the __________________ (name of city) of _________________________ (name of province/state).

2. I have been engaged by or on behalf of ___________________ (name of party/parties) to provide evidence in relation to the above-noted court proceeding.

3. I acknowledge that it is my duty to provide evidence in relation to this proceeding as follows:

a. To provide opinion evidence that is fair, objective and non-partisan;

b. To provide opinion evidence that is related only to matters that are within my area of expertise; and

c. To provide such additional assistance as the court may reasonably require, to determine a matter in issue.

4. I acknowledge that the duty referred to above prevails over any obligation which I may owe to any party by whom or on whose behalf I am engaged.

Date: ___________________ ___________________________ (signature)

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Relative Risk of Two in Medical Malpractice Cases

April 14th, 2014

Counsel for plaintiffs and defendants in toxic tort cases are well aware of the need to show a sufficiently large relative risk, greater than two, to have sufficient evidence to satisfy the burden of proof on proximate causation between a known causal exposure and a specific plaintiff’s injury. As Judge Jack Weinstein wrote 30 years ago, “[a] government administrative agency may regulate or prohibit the use of toxic substances through rulemaking, despite a very low probability of any causal relationship. A court, in contrast, must observe the tort law requirement that a plaintiff establish a probability of more than 50% that the defendant’s action injured him. … This means that at least a two-fold increase in incidence of the disease attributable to Agent Orange exposure is required to permit recovery if epidemiological studies alone are relied upon.” In re Agent Orange Product Liab. Litig., 597 F. Supp. 740, 785, 836 (E.D.N.Y. 1984), aff’d 818 F.2d 145, 150-51 (2d Cir. 1987)(approving district court’s analysis), cert. denied sub nom. Pinkney v. Dow Chemical Co., 487 U.S. 1234 (1988).

In toxic tort cases, the risk ratio at issue allegedly results from a higher incidence of the disease in exposed persons compared to the incidence in unexposed persons. A similar risk ratio issue occurs in medical malpractice cases when a healthcare provider negligently fails to administer a therapy, or fails to administer a therapy in a timely fashion, to the detriment of the plaintiff. In instances in which the therapy is almost always efficacious, the risk ratio of a bad patient outcome will be very high, and the corresponding probability that the bad outcome would have been avoided by proper or timely therapy will be close to 100 percent. On the other hand, for some therapies, even timely administration is efficacious in a limited number of cases, less often than the 50-plus percent of cases that would support a proximate cause opinion between the allegedly negligent failure to administer therapy and the patient’s bad health outcome.

Unfortunately, the relative risk issue goes unlitigated in many cases, in New York and elsewhere. One recurring malpractice claim involves the alleged failure to administer clot-busting drugs to ischemic stroke patients. One such drug, tissue plasminogen activator (t-PA), which was approved by the Food and Drug Administration in 1996, can substantially reduce brain damage if administered within three hours of stroke onset. Even if administered within the crucial therapeutic time window, however, t-PA will benefit only about 30 percent of patients, and there is no medical “fingerprint”that identifies who has benefitted from the t-PA. In Samaan v. St. Joseph Hospital, 670 F.3d 21 (1st Cir. 2012), the First Circuit acted on its gatekeeping responsibilities to perscrutate the risk evidence and found that it fell short of what is required by Federal Rule of Evidence 702, and the “more likely than not” standard for civil cases. See also Smith v. Bubak, 643 F.3d 1137, 1141–42 (8th Cir.2011) (rejecting relative benefit testimony and suggesting in dictum that absolute benefit “is the measure of a drug’s overall effectiveness”); Young v. Mem’l Hermann Hosp. Sys., 573 F.3d 233, 236 (5th Cir.2009) (holding that Texas law requires a doubling of the relative risk of an adverse outcome to prove causation), cert. denied, ___ U.S. ___, 130 S.Ct. 1512 (2010).

Samaan and the cases cited by the First Circuit are hardly unique; the size of the relative risk issue has helped the defense prevail in other t-PA and similar malpractice cases around the country. Kava v. Peters, 450 Fed.Appx. 470, 478-79 (6th Cir. 2011) (affirming summary judgment for defendants when plaintiffs expert witnesses failed to provide clear testimony that plaintiff specific condition would have been improved by timely administration of therapy); Bonesmo v. The Nemours Foundation, 253 F.Supp. 2d 801, 809 (D.Del. 2003); Joshi v. Providence Health System of Oregon Corp., 342 Or. 152, 156, 149 P. 3d 1164, 1166 (2006) (affirming directed verdict for defendants when expert witness testified that he could not state, to a reasonable degree of medical probability, beyond 30%, that administering t-PA, or other anti-coagulant would have changed the outcome and prevented death); Ensink v. Mecosta County Gen. Hosp., 262 Mich.App. 518, 687 N.W.2d 143 (Mich.App. 2004) (affirming summary judgment for hospital and physicians when patient could not greater than 50% probability of obtaining a better result had emergency physician administered t-PA within three hours of stroke symptoms); Merriam v. Wanger, 757 A.2d 778, 2000 Me. 159 (2000) (reversing judgment on jury verdict for plaintiff on grounds that plaintiff failed to show that defendant failure to act were, more likely than not, a cause of harm). In Michigan, the holding of the t-PA and similar medical malpractice cases has been codified by statute:

“In an action alleging medical malpractice, the plaintiff has the burden of proving that he or she suffered an injury that more probably than not was proximately caused by the negligence of the defendant or defendants. In an action alleging medical malpractice, the plaintiff cannot recover for loss of an opportunity to survive or an opportunity to achieve a better result unless the opportunity was greater than 50%.”

Mich. Comp. Laws § 600.2912a(2) (2009). But see O’Neal v. St. John Hosp. & Med. Ctr., 487 Mich. 485, 791 N.W.2d 853 (Mich. 2010) (affirming denial of summary judgment when failure to administer therapy (not t-PA) in a timely fashion more than doubled the risk of stroke). In one unpublished Kentucky case, involving t-PA, the court seemed to acknowledge the general principle, but became confused as to whether 30 percent, was a reasonable probability. Lake Cumberland, LLC v. Dishman, 2007 WL 1229432, *5 (Ky. Ct. App. 2007) (unpublished) (citing without critical discussion an apparently innumerate opinion of expert witness Dr. Lawson Bernstein).

Despite the success of medical malpratice defense counsel in litigating dispositive motions in t-PA cases, the issue seems to go unnoticed in New York cases. For instance, in Gyani v. Great Neck Medical Group, a stroke victim sued on various allegations of medical malpractice, including failure to administer t-PA. N.Y. S.Ct. for Nassau Cty, 2011 WL 1430037 (April 4, 2011). The trial court denied summary judgment on proximate cause grounds, and noted that

“[t]he plaintiffs’ expert ultimately opines that the failure to administer t-PA allowed Gyani’s stroke to go untreated and progress to the point of her being locked-in permanently which would not have happened had t-PA been administered.”

From the court’s opinion, it would appear that defense counsel never pressed beyond this conclusory opinion, devoid of quantified relative risk. Behind the curtain of “ultimate” opinion is an expert without a meaningful basis for his opinion. It is time to pull the curtain.

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Asymmetries in the Law Between the Pursuer and the Defender

April 5th, 2014

There are some important asymmetries in the law. A single defendant is at risk of collateral estoppel, but each individual plaintiff will claim independence lack of privity with the rest of the herd. Similarly, a defendant in a mass tort may be bound by its cross-examination of a now unavailable witness, but plaintiffs may be able to disavow a previous plaintiff’s examination even though there was a common representation.

Plaintiffs have sought discovery of confidential consulting expert witnesses of a defendant in multi-district litigation, while successfully evading discovery of their own consulting expert witnesses. Again plaintiffs’ success turns on the lack of privity between and among the many plaintiffs, or because plaintiffs’ counsel indulge the fiction that they were not acting in their role as attorney for claimants.

Expert witnesses for plaintiffs accuse scientists who testify for a defendant of “conflicts of interest,” but conveniently ignore and fail to disclose their own. See “More Hypocrisy Over Conflicts of Interest” (Dec. 4, 2010) (Arthur Frank and Barry Castleman); James Coyne, “Lessons in Conflict of Interest: The Construction of the Martyrdom of David Healy and The Dilemma of Bioethics,” 5 Am. J. Bioethics W3 (2005).

Plaintiffs often seek to use evidence of lobbying or “rent-seeking” by defendants. See Bruce R. Parker and Jennifer Lilore, “Application of the Noerr-Pennington Doctrine to Drug and Medical Device Litigation,” Rx for the Defense 2 (Fall 1995) (“Typically, plaintiffs will argue that the petitioning activity was designed to minimize or eliminate regulations pertaining to safety and efficacy in order to maximize profits. Plaintiffs’ counsel often assert that such conduct is reckless and supports an award of punitive damages.”). See, e.g., Ruth v. A.O. Smith Corp., 2006 WL 530388 at *13 (N.D. Ohio Feb. 27, 2006); In re Welding Fume Prods. Liab. Litig., No. 1:03–CV–17000, MDL no. 1535, 2010 WL 7699456, *93 (June 4, 2010) (“Trial Template for Welding Fume MDL Cases”; summarizing previous Noerr-Pennington ruling in this MDL, and rejecting defendants’ motion, in part, to bar use of defendants’ petitioning governmental and quasi-governmental entities to consider scientific studies and arguments concerning “threshold limit values,” despite constitutional protection of speech).

Of course, the plaintiffs’ bar lobbies as an organized entity, and perhaps its activities should be imputed to all members of the relevant organizations. Mutuality might chill plaintiffs’ enthusiasm for attacking defendants for their efforts to influence policy. The plaintiffs’ bar is, after all, the litigation industry. A few weeks ago, the Association of Trial Lawyers of America (ATLA), now operating under the pseudonym American Association of Justice (AAJ), issued a press release (Mar. 13, 2014), praising a proposed FDA regulation that would undermine preemption defenses for manufacturers of generic pharmaceuticals. The press release conveniently omitted that the proposed regulation praised was one that plaintiffs helped craft. Paul Berard, “Trial lawyers helped FDA with rule opening generic drug firms to lawsuits” Wash. Examiner (Mar. 27, 2014).

Last week, the FDA in response to a Congressional inquiry, acknowledged that high-level officials of the agency met with plaintiffs’ lawyer, Ed Blizzard, and regulatory counsel for ATLA-AAJ, Sarah Rooney, and ATLA’s lobbyist, Michael Forscey. See Jeff Overley, “FDA Chief Questioned Over Staff Meeting With Trial Lawyers,” Law360, New York (Mar. 28, 2014). The meeting was calendared, in February 2013, at the FDA as a follow up to the Supreme Court’s decision in Pliva v. Mensing, which held that FDA regulations preempted state liability claims against makers of generic drugs. The FDA participated through high-level officials, including its chief counsel, and policy advisors. Congressman Kevin Yoder interrogated FDA Commissioner Margaret Hamburg as to why a private session with plaintiffs’ lawyers and lobbyists, who are in the litigation business. The news accounts did not provide an explanation why the plaintiffs’ litigation lobbyists could not have submitted their comments publicly. Mr. Blizzard’s and the ATLA’s lobbying snow storm was, however, registered on the FDA’s public calendar for February 11-15, 2013.

Jim Beck documents that this is not first time that the plaintiffs’ bar has lobbied for their fee-generating activities with the FDA, for rules that fostered their litigation product. See “The More Things Change, The More They Remain The Same” (April 3, 2014). Perhaps when the plaintiffs next make their argument that the FDA is captured by industry, courts should take judicial notice that the plaintiffs’ bar has a great deal of influence as well.

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What Happens When Historians Have Bad Memories

March 15th, 2014

Well when patients have poor recall of their medical treatments, signs, and symptoms, physicians say that they are poor historians. Can one say that about Barry Castleman, plaintiffs’ standard bearer on asbestos state-of-the-art issues?

Back in March 2011, I wrote about a memorandum, dated November 5, 1979, apparently written by Castleman to Dr. Irving Selikoff, “Defense Attorneys’ Efforts to Use Background Files of Selikoff-Hammond Studies to Avert Liability.” See “The Selikoff – Castleman Conspiracy” (Mar. 13, 2011). A year later, defense counsel, in a Delaware jury trial before Judge John Parkins, Jr., confronted Castleman with the memorandum. The exchange was short:

“Q. So, between 1971 and 1992, you’ve had many exchanges with Dr. Selikoff; is that correct?

A. Yes.

Q. And you once asked him to conceal some of the research that he might have done on the 1964 study; is that correct?

A. No. What you’re referring to is a memorandum that doesn’t have any signature and it doesn’t have any letterhead, and was produced in cross-examination about two years ago in a trial. And I have no memory of this document.”

Carlton v. Crane Co., et al., No. 10C-08-216, Delaware Superior Court, New Castle Cty., at p. 152 (June 11, 2012).

After Castleman testified, Judge Parkins issued an order to show cause whether the examining defense counsel violated the rules of professional conduct in his examination of Castleman. Defense counsel filed a thorough rebuttal to the suggestion that he lacked a good-faith basis for having asked questions about the 1979 memorandum. See Defendant Crane Co.’s Response to Order to Show Cause, Transaction ID 44889066 (June 19, 2012).

In responding to the Order to Show Cause, defense counsel marshaled past testimony given by Castleman, about the memorandum. In the following 2010 testimony, Castleman acknowledged that he might well have written the memorandum, and that the memorandum reflected contemporaneous concerns of plaintiffs’ counsel Ron Motley and Motley’s requests to Castleman to communicate with Selikoff:

“Q. And you actually wrote a letter to Dr. Selikoff in 1979 wherein you told him Ron Motley, the plaintiffs’ lawyer I work for, knows that you got some information about insulators who said they knew about the hazards of asbestos in the ’40s and ’50s, please don’t let that get out?

A. That is a gross mischaracterization of what I wrote to Dr. Selikoff.

Q. Tell me what the letter said.

A. The memo showed up last summer for the first time. I hadn’t seen this thing or didn’t even remember it. It showed up in cross-examination at some trial last summer. It’s dated 1979 and it — it’s not on any letterheads and not signed, but it looks like something I might have written. I had testified a total of one time at the time I wrote this and I conveyed to Dr. Selikoff one of the plaintiffs’ lawyers with whom I had been in contact, this guy, Motley, was concerned that Selikoff’s medical research records might contain a questionnaire that would include information asking the workers when they first heard that asbestos work was dangerous. And Motley — I conveyed to Selikoff — I am basically conveying Motley’s concern and was saying that if such a thing was turned over to defense counsel, they would use this to get people’s cases dismissed. . . .”

See Transcript of Castleman Testimony, at 753-55, in Farag v. Advance Auto Parts, No. 431525 California Superior, Los Angeles Cty. (Dec. 1, 2010). Castleman’s testimony further supports the authenticity and his authorship of memorandum, when he explained that he had agreed to communicate with Selikoff because Motley was experiencing a “paranoid fit” over the possibility of the defendants’ obtaining information that would support their defenses of contributory negligence and assumption of risk Id. at 756.

In a Madison County, Illinois, case in 2010, Castleman testified at deposition in a way that appeared to accept his authorship of the memorandum, and his active collaboration with Motley to suppress defendants’ access to discovery of information about the insulators’ knowledge of asbestos hazards:

“Q: Okay. Now, obviously, but you asked Dr. Selikoff, you said, [i]t strikes me as most important to hold these files confidential and resist efforts to get them released to the defendants. Isn’t that true?

A: Yes. I felt that medical research was not something that should just be – – I mean, again, the date of this memo is 1979. I had testified in a total of one trial in my whole life by that time. I was not at all familiar with the legal system. I was very concerned about what Motley told me, because I thought it would jeopardize Selikoff’s ability to do epidemiology studies on workers and identify occupational health hazards, not just with asbestos but with all kinds of things.”

Castleman Deposition Transcript at 26, in Luna v. A.W. Chesterton, Inc., et al., No. 08-L-619, Circuit Court of Madison County, Illinois (July 12, 2010). See also Transcript of Testimony of Barry Castleman at 377, in Benton v. John Crane, Inc., No. 109661/02, Supreme Court of the State of New York, New York County (Oct. 14, 2011) (testifying in response to questions about the memorandum that “I go on to say in the next sentence that it might impair Selikoff’s ability to obtain the cooperation of unions and workers in other studies. . . .”).

In response to this offer of proof for the good-faith basis to inquire about the memorandum, Judge Parkins withdrew the rule to show cause.

==============================

I have been to Madison County, Illinois, only a couple of times. Some years ago, I had a deposition in Granite City, a double misnomer; it is neither a city, nor does it have any granite. Some might say that the county court house, not far away, in Edwardsville, Illinois, has also been a misnomer at times.

A recent trial suggests that the truth will sometime come out in a Madison County trial. Local media coverage of the trial reported that Barry Castleman testified early in the proceedings, and that he denied writing the conspiratorial 1979 memorandum. See Heather Isringhausen Gvillo, “Plaintiffs expert denies writing letter to asbestos researcher during Madison County trial” (Feb. 21, 2014) (reporting on Brian King, individually and as special administrator of the estate of Tom King vs. Crane Co.) Actually the text of the article makes clear that Castleman did not deny writing the memorandum; rather, he testified that he had no memory of having written it. “I have no memory of writing this and I don’t recognize it.” Id. On February 28, 2014, distancing themselves from Castleman’s poor memory for his own writings, the jury in the King case rejected the plaintiffs’ claims. Gvillo, “Defense verdict reached in asbestos trial” (Mar. 3, 2014).

Castleman’s lapse of memory is perhaps convenient, and maybe even a disability in someone who aspires to be an historian. In addition to being a “poor historian” of his own career, which was financed by plaintiffs’ counsel, Castleman appears to have taken direction from Ron Motley and his partners, on where to look, and where not to look, for historical support for the plaintiffs’ version of the state of the art. See “Discovery into the Origin of Historian Expert Witnesses’ Opinions” (Jan. 30, 2012).

There are steps that could be taken to shore up the authenticity of the Castleman-Selikoff memorandum. A subpoena to the Selikoff document archive might be in order. Since everyone loves a conspiracy, why not convene a grand jury to inquire into an ongoing conspiracy to suppress evidence?

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A Black Swan Case – Bayesian Analysis on Medical Causation

March 15th, 2014

Last month, I posted about an article that Professor Greenland wrote several years ago about his experience as a plaintiffs’ expert witness in a fenfluramine case. “The Infrequency of Bayesian Analyses in Non-Forensic Court Decisions (Feb. 16, 2014).” Greenland chided a defense expert for having declared that Bayesian analyses are rarely or never used in analyzing clinical trials or in assessments of pharmaco-epidemiologic data. Greenland’s accusation of ludicrousness appeared mostly to blow back on him, but his stridency for Bayesian analyses did raise the question, whether such analyses have ever moved beyond random-match probability analyses in forensic evidence (DNA, fingerprint, paternity, etc.) or in screening and profiling cases. I searched Google Scholar and Westlaw for counter-examples and found none, but I did solicit references to “Black Swan” cases. Shortly after I posted about the infrequency of Bayesian analyses, I came across a website that was dedicated to collecting legal citations of cases in which Bayesian analyses were important, but this website appeared to confirm my initial research.

Some months ago, Professor Brian Baigrie, of the Jackman Humanities Institute, at the University of Toronto, invited me to attend a meeting of an Institute working group on The Reliability of Evidence in Science and the Law. The Institute fosters interdisciplinary scholarship, and this particular working group has a mission statement close to my interests:

“The object of this series of workshops is to formulate a clear set of markers governing the reliability of evidence in the life sciences. The notion of evidence is a staple in epistemology and the philosophy of science; the notion of this group will be the way the notion of ‘evidence’ is understood in scientific contexts, especially in the life sciences, and in judicial form as something that ensures the objectivity of scientific results and the institutions that produce these results.”

The Reliability of Evidence in Science and the Law. The faculty on the working group represent disciplines of medicine (Andrew Baines), philosophy (James R. Brown, Brian Baigrie), and law (Helena Likwornik, Hamish Stewart), with graduate students in the environmental science (Amy Lemay), history & philosophy of science and technology (Karolyn Koestler, Gwyndaf Garbutt ), and computer science (Maya Kovats).

Coincidentally, in preparation for the meeting, Professor Baigrie sent me links to a Canadian case, Goodman v. Viljoen, which turned out to be a black swan case! The trial court’s decision, in this medical malpractice case focused mostly on a disputed claim of medical causation, in which the plaintiffs’ expert witnesses sponsored a Bayesian analysis of the available epidemiologic evidence; the defense experts maintained that causation was not shown, and they countered with the unreliability of the proffered Bayesian analysis. The trial court resolved the causation dispute in favor of the plaintiffs, and their witnesses’ Bayesian approach. Goodman v. Viljoen, 2011 ONSC 821 (CanLII), aff’d, 2012 ONCA 896 (CanLII). The Court of Appeals’ affirmance was issued over a lengthy, thoughtful dissent. The Canadian Supreme Court denied leave to appeal.

Goodman was a medical practice case. Mrs. Goodman alleged that her obstetrician deviated from the standard of care by failing to prescribe corticosteroids sufficiently early in advance of delivery to avoid or diminish the risk of cerebral palsy in her twins. Damages were stipulated, and the breach of duty turned on a claim that Mrs. Goodman, in distress, called her obstetrician. Given the decade that passed between the event and the lawsuit, the obstetrician was unable to document a response. Duty and breach were disputed, but were not the focus of the trial.

The medical causation claim, in Goodman, turned upon a claim that the phone call to the obstetrician should have led to an earlier admission to the hospital, and the administration of antenatal corticosteroids. According to the plaintiffs, the corticosteroids would have, more probably than not, prevented the twins from developing cerebral palsy, or would have diminished the severity of their condition. The plaintiffs’ expert witnesses relied upon studies that suggested a 40% reduction and risk, and a probabilistic argument that they could infer from this risk ratio that the plaintiffs’ condition would have been avoided. The case thus raises the issue whether evidence of risk can substitute for evidence of causation. The Canadian court held that risk sufficed, and it went further, contrary to the majority of courts in the United States, to hold that a 40% reduction in risk sufficed to satisfy the more-likely-than-not standard. See, e.g., Samaan v. St. Joseph Hosp., 670 F.3d 21 (1st Cir. 2012) (excluding expert witness testimony based upon risk ratios too small to support opinion that failure to administer intravenous tissue plasminogen activator (t-PA) to a patient caused serious stroke sequelae); see also “Federal Rule of Evidence 702 Requires Perscrutations — Samaan v. St. Joseph Hospital (2012)” (Feb. 4, 2012).

The Goodman courts, including the dissenting justice on the Ontario Court of Appeals, wrestled with a range of issues that warrant further consideration. Here are some that come to mind from my preliminary read of the opinions:

1. Does evidence of risk suffice to show causation in a particular case?

2. If evidence of risk can show causation in a particular case, are there requirements that the magnitude of risk be quantified and of a sufficient magnitude to support the inference of causation in a particular case?

3. The judges and lawyers spoke of scientific “proof.” When, if ever, is it appropriate to speak of scientific proof of a medical causal association?

4. Did the judges incorrectly dichotomize legal and scientific standards of causation?

5. Did the judges, by rejecting the need for “conclusive proof,” fail to articulate a meaningful standard for scientific evidence in any context, including judicial contexts?

6. What exactly does the “the balance of probabilities” mean, especially in the face of non-quantitative evidence?

7. What is the relationship between “but for” and “substantial factor” standards of causation?

8. Can judges ever manage to define “statistical significance” correctly?

9. What is the role of “common sense” in drawing inferences by judges and expert witnesses in biological causal reasoning? Is it really a matter of common sense that if a drug did not fully avert the onset of a disease, it would surely have led to a less severe case of the disease?

10. What is the difference between “effect size” and the measure of random or sampling error?

11. Is scientific certainty really a matter of being 95% certain, or is this just another manifestation of the transposition fallacy?

12. Are Bayesian analyses acceptable in judicial settings, and if so, what information about prior probabilities must be documented before posterior probabilities can be given by expert witnesses and accepted by courts?

13. Are secular or ecological trends sufficiently reliable data for expert witnesses to rely upon in court proceedings?

14. Is the ability to identify biological plausibility sufficient to excuse the lack of statistical significance and other factors that are typically needed to support the causality of a putative association?

15. What are the indicia of reliability of meta-analyses used in judicial proceedings?

16. Should courts give full citations to scientific articles that are heavily relied upon as part of the requirement that they publicly explain and justify their decisions?

These are some of the questions that come to mind from my first read of the Goodman case. The trial judge attempted to explain her decision in a fairly lengthy opinion. Unfortunately, the two judges, of the Ontario Court of Appeals, who voted to affirm, did not write at length. Justice Doherty wrote a thoughtful dissent, but the Supreme Court denied leave to appeal. Many of the issues are not fully understandable from the opinions, but I hope to be able to read the underlying testimony before commenting.

Thanks to Professor Baigrie for the reference to this case.

Posted in Causation, Scientific Evidence, statistical evidence | Comments Off on A Black Swan Case – Bayesian Analysis on Medical Causation

The Rise and Rise of Junk Science

March 8th, 2014

Many authors attribute the term “junk science” to Peter Huber and his use of it in the term in his book, Galileo’s Revenge: Junk Science In The Courtroom (1991). As important as Huber’s book was to raising judicial consciousness to what was going on in courtrooms around the United States, the phrase “junk science” clearly predates Huber’s book.

Lawrence Hubert and Howard Wainer note that the phrase appears to have been in use by the early 1980’s, and sugggest that the first use of the pejorative phrase occurred in a Reagan administration white paper. Lawrence Hubert and Howard Wainer, A Statistical Guide for the Ethically Perplexed 460 (Boca Raton 2013). The document cited by Hubert and Wainer notes:

“Another way in which causation often is undermined – also an increasingly serious problem in toxic tort cases – is the reliance by judges and juries on non-credible scientific or medical testimony, studies or opinions. It has become all too common for “experts” or “studies” on the fringes of, or even well beyond the outer parameters of mainstream scientific or medical views, to be presented to juries as valid evidence from which conclusions may be drawn. The use of such invalid scientific evidence (commonly referred to as “junk science”) has resulted in findings of causation which simply cannot be justified or understood from the standpoint of the current state of credible scientific and medical knowledge. Most importantly, this development has led to a deep and growing cynicism about the ability of tort law to deal with difficult scientific and medical concepts in a principled and rational way.”

United States Dep’t of Justice, Tort Policy Working Group, Report of the Tort Policy Working Group on the causes, extent and policy implications of the current crisis in insurance availability and affordability at 35 (Report No. 027-000-01251-5) (Wash.DC 1986). So according to the Justice Department authors, “junk science” was already in common use by 1986. We really would not expect linguistic creativity in such a document.

Whence comes the phrase “junk science”? Clearly, the phrase is an analogue of “junk food,” food that fills but fails to nourish. Here is the Google ngram of the emergence of the phrase “junk food,” which shows the phrase took off in common use shortly before 1970: What then about junk science?

With a little tweaking of Google’s smoothing function, this search can be run to reveal more about the low end of the curve.

This chart suggests that there was very small flurry of usage in the first half of the 1970s, with a re-emergence around 1982 or so, and then a re-introduction in 1985, with a steady increase every since.

Here is how “junk science” compares to “junk food” (with more smoothing to the curve added):

Junk science seems to have overtaken junk food in books, at any rate.

Of course, “junk science” is an epithet to be hurled at science that the speaker dislikes. It has an emotive content, but its persistence reflects that it has an epistemic content as well. “Junk science” is science that lacks an epistemic warrant, and pretends to be something that it is not. Honest scientists, engaged in hypothesis-generating work, should not be defamed as junk scientists, but the boundary between hypothesis generation and conclusion mongering is often blurred by advocate scientists of all political persuasions.

There are many synonyms for junk science, which has been with us ever science gained prestige and persuasiveness over religious pronouncements about the real world. To avoid the politicization of the term “junk science,” here are some alternatives:

advertising

alternative medicine

alchemy

anti-vaccination movements

aroma therapy

astrology

baloney

blackguardism

blood letting

bogus science

bullshit

bunk

bunkum

cargo cult science

clinical ecology

cold fusion

creationism

cult

denialism

dodgy data

error

faith-based science

flim-flam

flotsam and jetsam

fraud

free-energy devices

fuzzy thinking

homeopathy

ignorance

intelligent design

junk science

Lysenkoism

magical thinking

magnetic therapy

miracles

misrepresentation

New Age science

nonsense on stilts

N rays

nostrums

not even wrong

paranormal phenomena

pathological science

phrenology

political science

propaganda

pseudoscience

pseudosymmetry

quackademic

parapsychology

quackery

rubbish

shamanism

spiritualism

voodoo science

Posted in Scientific Evidence | Comments Off on The Rise and Rise of Junk Science

Judicial Notice of Untruths

March 3rd, 2014

Judicial notice is a procedure for admitting facts the truth of which are beyond dispute. A special kind of magically thinking occurs when judges take judicial notice of falsehoods, myths, or lies.

In the federal judicial system, Federal Rule of Evidence 201 addresses judicial notice of adjudicative facts, and provides:

(b) Kinds of Facts That May Be Judicially Noticed. The court may judicially notice a fact that is not subject to reasonable dispute because it:

(1) is generally known within the trial court’s territorial jurisdiction; or

(2) can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned.

Procedurally, Rule 201 provides that a court must take judicial upon the request of a party who has supplied any needed basis for the fact to be noticed. A court may take notice sua sponte. Rule 201(c)(1), (2).

In the Chantix litigation, counsel for Pfizer challenged plaintiffs’ expert witness, Curt Furberg, on Rule 702 grounds. According the MDL judge, the Hon. Inge Prytz Johnson, Pfizer asserted that Furberg’s proferred testimony because the FDA approved Chantix as safe and effective. In re Chantix (Varenicline) Prods. Liab. Litig., 889 F. Supp. 2d 1272, 1285 n.8 (N.D. Ala. 2012). Citing no authority or text, Judge Johnson announced that “[a]pproval by the FDA is not evidence of the safety of a medication.” Id.

To be sure, safety issue can sometimes arise after initial approval, but before the FDA or the manufacturer and sponsor of the medication can react to the new safety data. The sweeping statement, however, that the FDA’s approval is not any evidence of safety seems bereft of factual support and common sense.

Judge Johnson went on, however, to invent supporting evidence out of thin air:

“The court takes judicial notice of such things as that at one time, thalidomide was used for morning sickness in pregnant women. Unfortunately, 10,000 children were born with birth defects from it before it was banned. And 50 years elapsed before doctors understood why thalidomide caused limbs to disappear. See e.g. http://www.nytimes.com/2010/03/16/science/16limb.html?pagewanted=all. Similarly, the fact that the FDA at one time approved Vioxx did not prevent the same being removed from the market due to growing concerns that it increased the risk of heart attacks and strokes. http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm103420.htm. Hence, initial approval by the FDA is not proof of the safety of a medication.”

The point about the FDA’s approval not constituting evidence of safety may simply be sloppy writing and reasoning. In the quote above, perhaps Her Honor merely meant to say that initial approval is not evidence that a medication is safe in view of later obtained data that were not available to the FDA on its review of the new drug application. If so, fair enough, but the sweeping statement that the initial approval is no evidence of safety ignores the considerable time, cost, and energy that goes into the FDA’s review of safety before agency approves marketing.

More egregious, however, is Judge Johnson’s taking judicial notice of the marketing of thalidomide as though it had some relevancy and probative value for her claim about the inefficacy of the FDA’s safety reviews.[1] Consider the recent review of the FDA’s handling of thalidomide by Margaret Hamburg, M.D., Commissioner of the U. S. Food and Drug Administration:

“Fifty years ago, the vigilance of FDA medical officer Dr. Frances Kelsey prevented a public health tragedy of enormous proportion by ensuring that the sedative thalidomide was never approved in the United States. As many remember, in the early 1960’s, reports were coming in from around the world of countless women who were giving birth to children with extremely deformed limbs and other severe birth defects. They had taken thalidomide. Although it was being used in many countries, Dr. Kelsey discovered that it hadn’t even been tested on pregnant animals.”

Margaret Hamburg, “50 Years after Thalidomide: Why Regulation Matters” (Feb. 7, 2012).

Judge Johnson took judicial notice of a non-fact. The FDA never approved thalidomide for use in the United States, back in the 1950s or 1960s.[2]

[1] Judge Johnson’s fantastical history of the FDA was recently cited by plaintiffs’ counsel in the Zoloft birth defects litigation. See Plaintiffs’ Opposition to Defendants’ Motion to Exclude the Testimony of Anick Berard, Ph.D., at 13 (Filed Feb. 24, 2014), in In re Zoloft (sertraline hydrochloride) Prods. Liab. Litig., Case 2:12-md-02342-CMR Document 713.

[2] Judge Johnson’s errant history may have resulted from her European perspective of the thalidomide tragedy. Judge Inge Prytz Johnson immigrated from Denmark, where she was born and educated. She became a U.S. citizen in 1978, and a state court judge one year later. In 1998, she was nominated by President Clinton to the Northern District of Alabama. In October 2012, Judge Johnson assumed senior status. See Kent Faulk, “U.S. District Judge Inge Johnson goes into semi-retirement” (Oct. 19, 2012) (quoting Judge Johnson as saying that “One thing I like about my job is I don’t have to take sides.”)

Posted in Causation, Scientific Evidence, Trial Procedure | Comments Off on Judicial Notice of Untruths

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