TORTINI

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

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

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

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)

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.

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. SeeMore 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.  SeeThe 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.

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.” SeeThe 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. SeeDiscovery 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?

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.

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: junk food Google NgramWhat then about junk science?

The Rise of Junk Science - Google Ngram Viewer

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

Junk Science without smoothing

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 vs junk food

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

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.”)

“Judges and other lawyers must learn how to deal with scientific evidence and inference.”

March 1st, 2014

Late last year, a panel of 7th Circuit reversed an Administrative Law Judge (ALJ) who had upheld a citation and fine against Caterpillar Logistics, Inc. (Cat).  The panel, in a wonderfully succinct, but meaty decision by Judge Easterbrook, wrote of the importance of judges’ and lawyers’ learning to deal with scientific and statistical evidence. Caterpillar Logistics, Inc. v. Perez, 737 F.3d 1117 (7th Cir. 2013)

Pseudonymous MK, a worker in Cat’s packing department, developed epidcondylitis (tennis elbow).  Id. at 1118. OSHA regulations require employers to report injuries  “the work environment either caused or contributed to the resulting condition”. 29 C.F.R. § 1904.5(a). MK’s work required her to remove items from containers and place items in shipping cartons. The work was repetitive, but MK acknowledged that the work involved little or no impact or force.  Apparently, Cat gave some rather careful consideration to whether MK’s epidcondylitis was work related; it assembled a panel of three specialists in musculoskeletal disorders and two generalists to consider the matter.  The panel, relying upon NIOSH and AMA guidelines, rejected MK’s claim of work relatedness.  Both the NIOSH and the AMA guidelines conclude that repetitive motion in the absence of weight or impact does not cause epicondylitis. Id.

MK called an expert witness, Dr. Robert Harrison, a clinical professor of medicine, at the University of California, San Francisco.  Id. at 1118-1119.  Harrison unequivocally attributed MK’s condition to her work at Cat, but he failed to explain why no one else in Cat’s packing department ever developed the condition.  Id. at 1119.

Harrison acknowledged that epidemiologic evidence could confirm his opinion, but he dismissed such evidence as being able to disconfirm his opinion.  The ALJ echoed Dr. Harrison in holding epidemiologic evidence to be irrelevant:

“none of these [other] people are [sic] MK. Similar to the concept of the ‘eggshell skull’ plaintiff in civil litigation, you take your workers as they are.”

Id. at 1119-20, citing ALJ, at 2012 OSAHRC LEXIS 118 at *32.

Judge Easterbrook found this attempt to disqualify any opposing evidence to lie beyond the pale:

“Judges and other lawyers must learn how to deal with scientific evidence and inference.”

Id. (citing Jackson v. Pollion, 733 F.3d 786 (7th Cir. 2013).

Judge Easterbrook called out the ALJ for misunderstanding the nature of epidemiology and the role of statistics, in the examination of causation of health outcomes that have a baseline incidence or prevalence in the population:

“The way to test whether Harrison is correct is to look at data from thousands of workers in hundreds of workplaces—or at least to look at data about hundreds of worker-years in Caterpillar’s own workplace. Any given worker may have idiosyncratic susceptibility, though there’s no evidence that MK does. But the antecedent question is whether Harrison’s framework is sound, and short of new discoveries about human physiology only statistical analysis will reveal the answer. Any large sample of workers will contain people with idiosyncratic susceptibilities; the Law of Large Numbers ensures that their experience is accounted for. If studies of large numbers of workers show that the incidence of epicondylitis on jobs that entail repetitive motion but not force is no higher than for people who do not work in jobs requiring repetitive motion, then Harrison’s view has been refuted.”

Id. at 1120.

Judge Easterbrook acknowledged that Cat’s workplace evidence may have been a sample too small from which to draw a valid statistical inference, given the low base rate of epicondylitis in the general population.  Dr. Harrison’s and the ALJ’s stubborn refusal, however, to consider any disconfirming evidence, obviating the need to consider sample size and statistical power issues.

Finally,  Judge Easterbrook chastised the ALJ for dismissing Cat’s experience as irrelevant because many other employers will not have sufficient workforces or record keeping to offer similar evidence.  In Judge Easterbrook’s words:

“This is irrational. If the camera in a police car captures the events of a highspeed chase, the judiciary would not ignore that video just because other police cars lack cameras; likewise, if the police record an interrogation, courts will consider that information rather than wait for the day when all interrogations are recorded.”

Id. This decision illustrates why some commentators at places such as the Center for Progressive Reform get their knickers in a knot over the prospect of applying the strictures of Rule 702 to agency fact finding; they know it will make a difference.

As for the “idiosyncratic gambit,” this argument is made all too frequently in tort cases, with similar lack of predicate.  Plaintiffs claim that there may be a genetic or epigenetic susceptibility in a very small subset of the population, and that epidemiologic studies may miss this small, sequestered risk.  Right, and the light in the refrigerator may stay on when you close the door.  Prove it!

The Infrequency of Bayesian Analyses in Non-Forensic Court Decisions

February 16th, 2014

Sander Greenland is a well-known statistician, and no stranger to the courtroom.  I first encountered him as a plaintiffs’ expert witness in the silicone gel breast implant litigation, where he testified for plaintiffs in front of a panel of court-appointed expert witnesses (Drs. Diamond, Hulka, Kerkvliet, and Tugwell).  Professor Greenland has testified for plaintiffs in vaccine, neurontin, fenfluramine, anti-depressant and other pharmaceutical cases.  Although usually on the losing side, Greenland has written engaging post-mortems of several litigations, to attempt to vindicate his positions he took, or deconstruct positions taken by adversary expert witnesses.

In one attempt to “correct the record,” Greenland criticized a defense expert witness for stating that Bayesian methods are rarely used in medicine or in the regulation of medicines. Sander Greenland, “The Need for Critical Appraisal of Expert Witnesses in Epidemiology and Statistics,” 39 Wake Forest Law Rev. 291, 306 (2004).  According to Greenland, his involvement as a plaintiff’s expert witness in a fenfluramine case allowed him to observe a senior professor in Yale University, who served as Wyeth’s statistics expert, make a “ludicrous claim,” id. (emphasis added), that

“the Bayesian method is essentially never used in the medical literature or in the regulatory environments (such as the FDA) for interpreting study results. . . .”

Id. (quoting from Supplemental Affidavit of Prof. Robert Makuch, App. Ex. 114, ¶5, in Smith v. Wyeth-Ayerst Labs., 278 F.Supp. 2d 684 (W.D.N.C. 2003)). Greenland criticizes Professor Makuch’s affidavit as “provid[ing] another disturbing case study of misleading expert testimony regarding current standards and practice.” 39 Wake Forest Law Rev. at 306.

“Ludicrous,” “disturbing,” “misleading,” and “demonstrably quite false”?  Really?

Greenland notes, as a matter of background, that many leading statisticians recommend and adopt Bayesian statistics.  Id. (citing works by Donald Berry, George Box, Bradley Carlin, Andrew Gelman James Berger, and others). Remarkably, however, Greenland failed to cite a single new or supplemental drug application, or even one FDA summary of safety or efficacy, or FDA post-market safety or efficacy review.  At the time Greenland was preparing his indictment, there really was little or no evidence of FDA’s embrace of Bayesian methodologies.  Six years later, in 2010, the agency did promulgate a guidance that set recommended practices for Bayesian analyses in medical device trials. FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials (February 5, 2010); 75 Fed. Reg. 6209 (February 8, 2010); see also Laura A. Thompson, “Bayesian Methods for Making Inferences about Rare Diseases in Pediatric Populations” (2010); Greg Campbell, “Bayesian Statistics at the FDA: The Trailblazing Experience with Medical Devices” (Presentation give by Director, Division of Biostatistics Center for Devices and Radiological Health at Rutgers Biostatistics Day, April 3, 2009).  Even today, Bayesian analysis remains uncommon at the U.S. FDA.

Having ignored the regulatory arena, Greenland purported to do a study of the biomedical journals, “to check the expert’s claim in detail.” 39 Wake Forest Law Rev. at 306. Greenland searched on the word “Bayesian” in the Journal of Clinical Oncology for issues published from 1994-2003, and “found over fifty publications that contain the word in that journal alone.” Greenland does not tell us why he selected this one journal, which was not in the subject matter area of the litigation in which he was serving as a partisan expert witness.  For most the time surveyed, the Journal of Clinical Oncology published 24 issues a year, and occasional supplements. Most volumes contained over 4,000 pages per year.  Finding 50 uses of the word “Bayesian” in over 40,000 pages hardly constitutes resounding evidence to support his charges of “ludicrous,” “misleading,” “disturbing,” and “quite false.”  Greenland further tells us looking at these 50 or so articles “revealed several,” which “had used Bayesian methods to explore statistically nonsignificant results.” 39 Wake Forest Law Rev. at 306-07 & n.61 (citing only one paper, Lisa Licitra et al., Primary Chemotherapy in Resectable Oral Cavity Squamous Cell Cancer: A Randomized Controlled Trial, 21 J. Clin. Oncol. 327 (2003)). So in over 40,000 pages, Greenland found “several” Bayesian analyses, apparently post hoc looks to explore results that did not achieve pre-specified levels of statistical significance. Given the historical evolution of Bayesian analyses at FDA, and Greenland’s own evidence, the posterior odds that Greenland was correct in his charges seem to be disturbingly low.

Greenland tells us that the number of Bayesian analyses could be increased by looking at additional journals, and the Bayesian textbooks he cites.  No doubt this is true, as is his statement that respected statisticians, in prestigious journals, have called for Bayesian analyses to replace frequentist methods. Of course, increasing the scope of his survey, Greenland would be dramatically increasing the denominator of total journal papers with statistical methods.  Odds are that the frequency would remain very low.  Greenland’s empirical evidence hardly contradicts his bête noire for making the quoted purely descriptive statement about the infrequent use of Bayesian analysis in biomedical journals and in regulatory applications.

In lodging charges of ludicrousness, Greenland might have presented a more balanced view from more carefully conducted surveys of the biomedical literature, in the relevant time period.  See, e.g., J. Martin Bland & Douglas G. Altman, “Bayesians and frequentists,” 317 Brit. Med. J. 1151, 1151 (1998) (“almost all the statistical analyses which appear in the British Medical Journal are frequentist”); David S. Moore, “Bayes for Beginners? Some Reasons to Hesitate,” 51 The Am. Statistician 254, 254 (“Bayesian methods are relatively rarely used in practice”); J.D. Emerson & Graham Colditz, “Use of statistical analysis in the New England Journal of Medicine,” in John Bailar & Frederick Mosteler, eds., Medical Uses of Statistics 45 (1992) (surveying 115 original research studies for statistical methods used; no instances of Bayesian approaches counted); Douglas Altman, “Statistics in Medical Journals: Developments in the 1980s,” 10 Statistics in Medicine 1897 (1991); B.S. Everitt, “Statistics in Psychiatry,” 2 Statistical Science 107 (1987) (finding only one use of Bayesian methods in 441 papers with statistical methodology).

Perhaps the balance between frequentist and Bayesian analysis is shifting today, but when Professor Makuch made his affidavit in 2002 or so, he was clearly correct, factually and statistically.

In the legal arena, Bayesian analyses are frequently used in evaluating forensic claims about DNA, paternity, lead-isotopes, and other issues of identification.  Remarkably, Bayesian analyses play virtually no role in litigation of health effects claims, whether based upon medicines, or upon occupational or environmental exposures.  In searching Google scholar and Westlaw I found no cases outside of forensics. Citations to black-swan cases are welcomed.

“Dummkopf! You’re Fired” – Judge Posner on Expert Witness Gatekeeping

February 15th, 2014

“Equity is a roguish thing, for law we have a measure, know what to trust to. equity is according to the conscience of him that is chancellor, and as that is larger or narrower so is equity. ’Tis all one as if they should make the standard for the measure we call a foot, a chancellor’s foot. What an uncertain measure would this be. One chancellor has a long foot, another a short foot, a third an indifferent foot; ’tis the same thing in the chancellor’s conscience.”

John Selden, The Table Talk of John Selden (1689), at 61 (Samuel Harvey Reynolds, ed., Oxford 1892).

*  *  *  *  *  *  *  *

As Equity in days of old varied with the size of the Chancelor’s foot, today the quality of judicial gatekeeping of expert witness opinion testimony varies with the acumen of the trial judge in the area of the challenged witness’s expertise.  In Apple Inc. v. Motorola, Inc., 2012 WL 1959560 (N.D. Ill. 2012), the parties challenged each other’s damages expert witnesses under Federal Rule 702, only to find that the trial judge was considerably more astute than their expert witnesses. When it came to assessing the validity and reliability of the damages opinions, the trial judge was a veritable “big foot,” kicking the courthouse door closed to some dodgy damage calculations.

The Hon. Richard Posner is a judge of the United States Court of Appeals, for the Seventh Circuit.  Judge Posner is also an economist and a stalwart of law-and-economics jurisprudence. In Apple v. Motorola, Judge Posner sat by designation as a trial judge.   Instead of judging whether a trial judge had abused his or her discretion in admitting or excluding expert witness testimony, Judge Posner had to put his own discretion on the line. 

Judge Posner identified the biggest challenge in gatekeeping as:

“distinguish[ing] between disabling problems with the proposed testimony, which are a ground for excluding it, and weaknesses in the testimony, which are properly resolved at the trial itself on the basis of evidence and crossexamination.”

Apple Inc. v. Motorola, Inc., 2012 WL 1959560, *1. Posner cites old caselaw, arguably superseded by the current Rule 702, for the chestnut that:

“the judge should not exclude evidence simply because he or she thinks that there is a flaw in the expert’s investigative process which renders the expert’s conclusions incorrect. The judge should only exclude the evidence if the flaw is large enough that the expert lacks ‘good grounds’ for his or her conclusions.”

Id. (quoting In re Paoli R.R. Yard PCB Litigation, 35 F.3d 717, 746 (3d Cir.1994)). Of course, flawed reasoning or methodology is the essence of what deprives anyone from making an claim to knowledge; this little chestnut is not very nourishing.

Judge Posner does better in “operationalizing” Kumho Tire for making the distinction between flaws that weaken, and those that vitiate, the epistemic bases for opinions.  Whether an expert witness “employs in the courtroom the same level of intellectual rigor that characterizes the practice of an expert in the relevant field” is a key test for determining on which side of the distinction a challenged opinion falls. Id. at *2 (quoting Kumho Tire Co. v. Carmichael, 526 U.S. 137, 152 (1999)).

“The Kumho principle implies that an expert witness must provide reasons for rejecting alternative hypotheses ‘using scientific methods and procedure’ and the elimination of those hypotheses must be founded on more than ‘subjective beliefs or unsupported speculation, … .’ ”

Id. at *8 (internal citations omitted).

Posner tempers, and dilutes, Kumho by qualifying the Kumho principle to require a testifying expert to use the same approach as used in the relevant field “if it is feasible for him to do so.” Id. at *3. It is always feasible, but rarely seen, for an expert witness to profess insufficient knowledge, facts, or data to give an opinion. Posner goes further and rewrites the statute, Rule 702, which was designed to keep uncertainty from being masqueraded as certainty:

“when the plaintiff has done his best to prove damages his inability to dispel uncertainty concerning the accuracy of his claim is not fatal. But if an expert witness fails to conduct a responsible inquiry that would have been feasible to conduct, his failure cannot be excused by reference to the principle that speculation is permitted in the calculation of damages; that permission presupposes the exhaustion of feasible means of dispelling uncertainty. Uncertainty is a bad; it is tolerated only when the cost of eliminating it would exceed the benefit.”

Id. at *5.  Sometimes the best efforts to eliminate uncertainty will leave us uncertain.  And the issue of acceptable uncertainty is not necessarily tied to the cost of eliminating it.

Nevertheless, Posner goes on to identify multiple unreasonable assumptions, alternative inferences, missing data, and flawed methods that vitiated most of the opinions before him in Apple v. Motorola.

Judge Posner applies the Kumho principle in the context of damages with a series of counterfactual Gedanken experiments.  He asks what if the plaintiff’s expert witness were working for the defendant (and vice versa), and charged with ascertaining the lowest cost to avoid infringing the plaintiff’s patent.  If the expert submitted the most expensive approach, or an extremely speculative, answer, the defendant would indeed fire the expert: “Dummkopf! You’re fired.” Id. at *9. And if the expert offered unverified evidence that came from an interested, adverse party, the expert’s opinion would again be worthy of no consideration.

Judge Posner is at home in the world of assessing economic damages, and as a “Chancellor,” he proved to have a very big foot indeed. The parties’ expert witnesses came up short on almost every damages opinion examined.

Not all evidentiary issues can be resolved by Judge Posner’s economic reductionism as neatly as the damages issues in this patent infringement case.  Posner’s approach is less satisfying in the context of health effects litigation, where expert witnesses will often have the option of proclaiming inadequate knowledge or method to ascertain general or specific causation.  Still Posner’s Gedanken experiments are contagious.  Suppose we were confronted with a birth defect case in which plaintiffs claimed that the mother’s use of a medication in early pregnancy caused the child’s birth defect.  It is generally conceded that most such birth defects have no known cause, but the plaintiffs’ expert witnesses contend that they have conducted a differential etiology and ascribed causation of the baby’s defect to the mother’s use of the defendant’s   medication.  Suppose there was a serious economic (or life-and-death) consequence to the expert’s opinion.  If the defect were drug-induced, there was no surgical or other correction, but if the defect were “idiopathic,” it could be readily repaired surgically.  Would the expert witness, acting as a treating physician, withhold the treatment because he was “reasonably medically certain” that the defect was caused by the drug?  I don’t think so.  Dr. Dummkopf, you’re fired!

The opinions, statements, and asseverations expressed on Tortini are my own, or those of invited guests, and these writings do not necessarily represent the views of clients, friends, or family, even when supported by good and sufficient reason.