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TORTINI

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

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.

Posted in Causation, Expert Witnesses, Risk and Risk Factor, Rule 702 | Comments Off on Relative Risk of Two in Medical Malpractice Cases

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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