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Canadian Judges’ Reference Manual on Scientific Evidence

July 24th, 2015

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

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

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

* * *

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

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

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


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

Manual at 14. These are laudable goals, indeed.

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

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

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

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

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

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

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. 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. 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.”)

Pennsylvania Workers Regain Their Right of Action in Tort against Employers for Latent Occupational Diseases

February 14th, 2014

Worker’s compensation legislation was part of great compromise in the rough-and-tumble battles between labor and management in the first few decades of the last century.  In virtually every state, employers had a common law duty to provide a reasonably safe workplace.  In tort litigation, however, employers enjoyed several powerful affirmative defenses:  contributory negligence, the fellow-servant rule, and assumption of risk.  Workers enjoyed increasingly sympathetic juries and generous damage awards.  Worker’s compensation statutes made recovery for most injuries a certainty, with schedules of damages that were deeply discounted from what might be had in a jury trial. In return for well-nigh absolute liability, employers gained certainty of outcome, reduction of administrative costs, and immunity to tort liability for all but intentional harms.

After World War II, tort law began to change dramatically.  Contributory negligence gave way to comparative negligence.  Assumption of risk defenses were curtailed, and the fellow-servant rule was severely modified or abandoned.  Labor was feeling buyers’ remorse over the workman’s compensation deal.

In 1965, the American Law Institute adopted § 402A which provided for “Special Liability of Seller of Product for Physical Harm to User or Consumer,” based upon concerns of unequal knowledge of defects and latent hazards of products sold to consumers. Liability followed for harm caused by a product irrespective of privity of contract or warranty, and even if “the seller has exercised all possible care in the preparation and sale of his product.” Restatement (Second), Torts § 402A (2)(a),(b) (1965).

Section 402A was inspired by tort cases in New Jersey and California, involving consumer products, but the Restatement was quickly, and unthinkingly, applied to sales made to large manufacturing employer-purchasers in which there was no real inequality of knowledge between seller and purchaser, or hidden or latent hazard in the product or material. (Think about how knowledgeable the United States Navy was about the hazards of asbestos insulation products it bought for ship building.) Section 402 became the vehicle for injured workers to ditch their capped damages in worker’s compensation court, and to put their cases back in front of juries, with the prospect of unlimited awards for non-economic damages.

In the workers’ compensation era, very few injured workers succeeded in making out intentional torts that would overcome their employers’ immunity to suit. Late last year, however, Pennsylvania workers regained their common law right to sue employers for negligence and other torts, for occupational diseases that manifest more than 300 weeks after last employment. Section 301(c)(2) of the Pennsylvania’s Workman’s Compensation Act, 77 P.S. § 411(2) removes these delayed manifested occupational disease claims from the scope of the Act. Since the Act’s inception, most courts have held that late manifestation (over 300 weeks) deprived the claimant of a recovery under the Act, but did not remove the employer’s immunity from suit. In an opinion issued in November 2013, Justice Todd, writing for herself and four other justices, held that the statute’s exclusion of late-manifesting occupational diseases (after 300 weeks) does not leave claimants without a remedy; the statute simply removes the latent disease cases from the purview of the Act, and returns them to the vicissitudes of common law litigation. Tooey v. AK Steel Corp., 81 A.3d 851 (2013).

The Tooey decision has profound implications for how occupational disease litigation claims will be litigated.  For decades, Pennsylvania juries were treated to a faux spectacle that suggested that plaintiffs, with claimed occupational diseases, were the “victims,” of remote suppliers’ failure to warn, when in reality their diseases were largely or totally the result of employer and employee negligence. Not only will plaintiffs sue their employers, but third-party vendors will seek contribution or indemnification from negligent employers. Employers will assert comparative negligence and assumption of risk defenses, which will give the lie to the plaintiffs’ claims of inadequate warnings from the remote suppliers.  Just possibly, Tooey will let the truth come out.

Styles of Judicial Opinion Writing

May 28th, 2013

Not Enough Original Words

You copy a little,
But not too much.
Some people say it’s degrading.

In Cojocaru v. British Columbia Women’s Hospital and Health Centre, the Supreme Court of Canada confronted an interesting question whether a litigant may challenge an adverse judgment on grounds that the trial judge plagiarized from the plaintiffs’ submissions.  Cojocaru (May 24, 2013).

In this complex medical malpractice case, the trial court issued its written judgment in 368 paragraphs, of which only 47 were discernibly original.  The overwhelming majority of the paragraphs, 321, were plagiarized from the plaintiffs’ submissions, without attribution.  The Supreme Court agreed that this degree of plagiarism raises a serious question whether the trial judge’s judgment should be set aside as not a truly independent evaluation of the facts and law.  Id. at para. 10-11.

The Court proceeded to note that trial court judgments are “entitled” to a presumption of integrity and impartiality.  The defendants argued that any such presumption was vaporized by the “the extent of the copying, the quality of the copying, the lack of attribution for the copying, the nature of the case and the failure to fulfill the basic functions of reasons for judgment.” Id. at para. 52.

Although acknowledging that the trial court had copied over 87% of its judgment from the plaintiffs’ briefs, the Supreme Court held that the defendants had failed to rebut the presumption of judicial integrity and impartiality.  Id. at  para. 73.  Judicial plagiarism is, according to the Supreme Court, “a longstanding and accepted practice.” Id. at para 30.  The Court, however, acknowledged that excessive plagiarism “may raise problems.”  Id.

The Supreme Court rejected the notion that judges should express themselves in their own language, and that their reasons should be their “original” work product.  Id. at 31.  Copying, according to the Court, does not mean that plagiarist judges have failed to think about and resolve the issues before them.  Id.

The Court conceded that it was not “best practice for judges to bulk up their judgments with great swaths of borrowed material.”  If the carried the copying to excess (presumably much greater than 87%), the copying “may raise problems.”

Rules and prohibitions against plagiarism do not apply to judges, say the Canadian Supreme Court judges.  Id. at para. 32.  According to the high court, lack of originality is a virtue in a system that depends upon precedent.  “Judges are not selected, and are only rarely valued, because of their gift for original expression.”  Id. (quoting, with attribution, thankfully, Simon Stern, “Copyright Originality and Judicial Originality” 63 Univ. Toronto L. J. 1 (2013)).

The Supreme Court cited precedential support of its judgment that judges are too busy to think and write in their own words.  See id. at para. 37, 38 (citing English v. Emery Reimbold & Strick Ltd., [2002] EWCA Civ 605, [2002] 3 All E.R. 385 (holding that copying does not invalidate a court’s decision); id. at para. 41 (citing United States v. El Paso Natural Gas Co., 376 U.S. 651, 656 (1964) (noting that when trial judge “adopt[s] verbatim” the findings of fact submitted by counsel, “[t]hose findings, though not the product of the workings of the … judge’s mind, are formally his; they are not to be rejected out-of-hand, and they will stand if supported by evidence”).

The majority of the intermediate appellate court, the Court of Appeal, had held that the extent and nature of the plagiarism was “cogent evidence” of lack of the trial judge’s judicial integrity.  Although the Supreme Court rejected the conclusion that the trial judge had failed to make an independent decision, the Supreme Court did display some original, independent thought in upholding the defendants’ assignments of error.  The Supreme Court reversed the judgment for plaintiffs on the merits.  Id. at para. 76.

Judicial Verbosity – Too Many Original Words

There is a tradition in New Jersey appellate cases to never issue a short, succinct opinion when a long one is at hand.  Plaintiff Alison Rosenberg took Merck’s drug, Fosamax, for osteoperosis. After undergoing a tooth extraction, Rosenberg developed bone complications of her jaw.  She claimed that she developed osteonecrosis of the jaw (ONJ), and that this condition was caused by her use of Fosamax, and by Merck’s negligent failure to warn that Fosamax causes ONJ. Rosenberg et al. v. Merck Sharp & Dohme Corp., No. A-5271-10T3, 2013 WL 1187916 (N.J. Super. Ct. App. Div. Mar. 25, 2013) (per curiam).

Merck defended and affirmatively sought to show that Rosenberg did not have ONJ.  Its expert witness, Brent Ward, D.D.S., M.D., an expert in ONJ and in maxillofacial surgery, testified that Rosenberg suffered from osteomyelitis, not from ONJ.

At the end of the case, the trial judge instructed the jury to make findings:

“(1) whether plaintiff proved it was more likely than not that plaintiff had ONJ;

(2) whether plaintiff’s development of ONJ was a result of taking Fosamax; and

(3) whether Merck negligently failed to adequately warn about the risks of ONJ from Fosamax.”

The jury resolved the first question by finding that the plaintiff had not suffered from ONJ, and pursuant to the trial court’s instructions, ceased deliberations and notified the court of their final verdict, upon which judgment was entered.  The jury thus never reached the questions about ONJ and Merck’s liability.

Rosenberg, et vir., appealed, contending that the trial judge erred in excluding evidence of Merck’s 2010 change in its warning label, which impeded her attempt to impeach Dr. Ward on the relationship between Fosamax and ONJ.  The problem is that the excluded evidence was relevant only to an issue that the jury never reached.  Somehow the New Jersey Appellate Division managed to draw out its per curiam opinion to eleven pages, in its own words.