TORTINI

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

The United States Government’s Role in the Asbestos Mess

January 31st, 2012

More Asbestos History

The role of the United States government in the asbestos mess is relatively unexplored historical territory. Anti-asbestos zealots, including the “Lobby,” and the plaintiffs bar, have demonized industry for the failure to control asbestos health hazards. The truth is very different. (The term, “the Lobby,” comes from the insightful article by the late Prof. Liddell: F. D. K. Liddell, “Magic, Menance, Myth and Malice,” 41 Ann. Occup. Hyg. 3 (1997). Liddell’s article should be required reading for all judges with an asbestos docket, as well as all policy makers and legislators who tackle asbestos issues.)

Back in 2007, Walter Olson, wrote an important essay on government and risk, “Dangerous When In Power” Reason (Mar. 2007). Olson later followed up on this theme at Point of Law, where he wrote about “The U.S. Navy and the asbestos calamity.” Olson published some observations I shared with him at the time:

“In the mid-1970s, amidst economic turmoil and declining military budgets, the US Navy found itself with a big problem. Payments to civilians under the FECA (Federal Employees Compensation Act), a statute that gives civilian employees of shipyards the equivalent of workers’ compensation benefits, came right out of the Navy’s budget for shipbuilding. The Navy had no insurance for FECA payments, and suddenly it found itself facing a large uptick in the number of claims made by civilians for asbestos-related injuries.

About the same time, many states adopted some version of strict product liability, some stricter than others. None was likely stricter than Pennsylvania’s version.

The FECA gives the government liens against any recovery in third-party actions. The JAG lawyers, faced with a blooming docket of FECA cases, started to encourage the workers compensation plaintiffs’ lawyers to file third-party actions. Indeed, in Philadelphia, the lawyers who stepped into the forefront of asbestos personal injury actions had been workers comp lawyers with a large FECA docket (Gene Locks; Joe Shein).

The cruel irony of the FECA (or workers’ comp) statutes is that the employer pays regardless of fault, that the employer can’t be sued in civil actions, and that the employer can recover ~80% of its payments from settlements or judgment proceeds from a civil defendant.

Ultimately, the plaintiffs’ bar found that recoveries and settlements were too certain to encumber themselves and their clients with government liens, and they stopped filing their FECA cases altogether.

The government’s role in fueling the explosion of asbestos civil actions has never, to my knowledge, been discussed in the media. When I was a young lawyer, my first trials were in defense of companies that were dragged into litigation over having sold asbestos products to the Navy, often pursuant to government specifications. These cases, filed in the late 1970s, up for trial in the mid-1980s, often had a letter in the claimant’s personnel file from the JAG officer, noting that the man had been diagnosed with asbestosis and urging him to seek legal counsel to consider a civil suit against the Navy’s suppliers. Unfortunately, I don’t have any of these documents anymore, but they may not be too difficult to obtain.

What a story is hidden away in those old files! Not only did the Navy know of the asbestos hazards, hide them from its civilian workers, but when those workers got sick, the Navy turned on its outside suppliers by encouraging its workers to sue the suppliers, while hiding behind the exclusive remedy provision of the FECA.”

The historical mythology of asbestos and its hazards was created in large measure with the active cooperation of the government and asbestos plaintiffs’ lawyers. The government, acting through the plaintiffs’ bar, was able to keep its weapons budgets intact, by minimizing its own losses on FECA payments. We should probably thus regard the asbestos litigation as an early form of the parens patriae suits that have become a commonplace.

In the late 1960s, some of the asbestos insulation manufacturers that were still in business, created their own mythology. In litigating the early, Navy-inspired, failure-to-warn claims, these insulation manufacturers advanced the unfounded view that the dangerousness of asbestos to end users was somehow not known before Dr. Irving Selikoff publicized the hazard, with his work in 1964. The insulators union’s publication, Asbestos Worker, shows an awareness of the hazard before then; indeed, the union’s appreciation of the hazard was in large measure the reason that the union approached Selikoff to conduct epidemiologic studies on their membership. The U.S. Navy was also well aware of the hazards (and thus did not need to be warned by anyone), as can be seen in an article entitled “Asbestosis” by Capt. H.M. Robbins & W.T. Marr in the October 1962 issue of the Navy’s Safety Review. See also Walter Olson, “Asbestos awareness pre-Selikoff,” (Oct. 19, 2007).

Recently, a defense expert witness, Dr. Dennis Paustenach, published an historical review on the evolution of knowledge about asbestos. Kara Franke & Dennis Paustenbach, “Government and Navy knowledge regarding health hazards of Asbestos: A state of the science evaluation (1900 to 1970),” 23(S3) Inhalation Toxicology 1 (2011) (available for download free of charge).

Here is the authors’ abstract:

“We evaluated dozens of published and unpublished documents describing the knowledge and awareness of both the scientific community and governmental entities, particularly the US Navy, regarding the health hazards associated with asbestos over time. We divided our analysis into specific blocks of time: 1900–1929, 1930–1959, and 1960–1970. By 1930, it was clear that high occupational exposure to asbestos caused a unique disease (asbestosis). Between about 1938 and 1965, a considerable amount of exposure and epidemiology data were collected by various scientific and government organizations. Between 1960 and 1970, mesothelioma was clearly linked to exposure to amphibole asbestos. Nonetheless, the Navy continued to require the use of asbestos-containing materials on ships, but also recommended that proper precautions be taken when handling asbestos. We concluded that the Navy was arguably one of the most knowledgeable organizations in the world regarding the health hazards of asbestos, and that it attempted to implement procedures that would minimize the opportunity for adverse effects on both servicemen and civilians. Finally, it is apparent from our research that through at least 1970, neither the military nor the private sector believed that the myriad of asbestos-containing products considered “encapsulated” (e.g. gaskets, brakes, Bakelite) posed a health hazard to those working with them.”

The subject is well covered territory, but the article approaches its subject matter from the perspective of what was known by the United States Navy, which may well have been singlehandedly responsible for exposing the greatest number of men and women to asbestos in the United States. Back in the 1980s, Dr. Sam Forman covered a similar theme, but only through War War II. See Samuel A. Forman, “U.S. Navy Shipyard Occupational Medicine Through World War II,” 30 J. Occup. Med. 28 (1988).

The focus on the Navy is a welcome change from the conspiratorial histories of Brodeur, Castleman, Rosner, and others whose writings suggest that “industry,” more or less specifically defined, withheld material knowledge from its customers. In the case of the Navy, the withholding may have gone the other way around.

I leave it to readers to judge the bona fides and Franke and Paustenbach’s historical essay, but from my perspective, the article generally hits a more balanced and better supported view of the asbestos state of the art.

The article is, however, not without problems.

Here are some things that were either left out, or given incomplete or inadequate emphasis:

1. The Navy’s work rules that required asbestos insulation to be removed from its packaging on shore, before being taken on board ships. This work rule deprived ship-board workers of the benefit of warnings. (Whether package warnings could have made any difference to control exposures that required technical personnel with exposure measuring equipment is a whole other matter.)

2. The Navy had effective knowledge of working conditions through its ownership and control of the workplace. In this respect, the Navy’s knowledge of the hazards created in its shipyards was vastly greater than that of remote suppliers.

3. The Navy’s had no workers’ compensation budget per se. Money paid to civilian employees under the Federal Employees’ Compensation Act (FECA) came directly from the Navy’s general revenues. Navy legal counsel encouraged FECA plaintiffs’ counsel to sue the Navy’s vendors under emerging doctrines of strict liability. In some states, such as Pennsylvania and New Jersey, the vendors, sued in strict liability, often could not point to the Navy’s negligence as a defense because the Navy was immune from a civil suit.

There are historical nits to pick with Franke’s article, as well. Consider:

“the elevated risk of lung cancer was first formally discovered by Doll in 1955 (Doll, 1955).”

Id. at 2. What does it mean to discover something formally? Doll certainly did not present a mathematical proof, with Q.E.D. at the bottom line. The men who had lung cancer in Doll’s cohort also had asbestosis, and his study suggested that there was a relationship between the diffuse interstitial pulmonary fibrosis and lung cancer, and not necessarily an association with the lighter, more intermittent exposures sustained by insulators. Furthermore, although Doll’s cohort was impressive at the time, he had no control for smoking. This oversight was remarkable given that Doll was working on the epidemiology of smoking and lung cancer at the very time he published his cohort study of asbestos factory workers.

And consider the authors’ statement:

“Crocidolite was not frequently used in products … .”

Id. at 3 (citing Rachel Maines, Asbestos and Fire (New Brunswick 2005). The authors do not provide a specific page reference so it is difficult to evaluate their citation of Professor Maines. What is known, however, is that crocidolite was used in transite pipe and board products, as well as other products, used throughout the United States, including Navy shipyards. After Johns-Manville went into bankruptcy, shipyard workers miraculously experienced a sudden, permanent loss of memory about their use of JM products. A careful review of the pre-JM-bankruptcy testimony of key shipyard workers, however, shows that “big blue” was in Navy shipyards.

Posted in Historian Testimony, Sophisticated User | 4 Comments »

Discovery into the Origin of Historian Expert Witnesses’ Opinions

January 30th, 2012

As every trial lawyer in America knows, the Federal Rules of Civil Procedure were recently changed to protect expert witness draft reports and lawyer-expert witness communications from discovery. See Rule 26. Duty to Disclose; General Provisions Governing Discovery (amended effective December 2010).

In particular, Rule 26(b) (4)(B), and (C) provides:

(4)(B) Trial-Preparation Protection for Draft Reports or Disclosures. Rules 26(b)(3)(A) and (B) protect drafts of any report or disclosure required under Rule 26(a)(2), regardless of the form in which the draft is recorded.

(C) Trial-Preparation Protection for Communications Between a Party’s Attorney and Expert Witnesses. Rules 26(b)(3)(A) and (B) protect communications between the party’s attorney and any witness required to provide a report under Rule 26(a)(2)(B), regardless of the form of the communications, except to the extent that the communications:

(i) relate to compensation for the expert’s study or testimony;

(ii) identify facts or data that the party’s attorney provided and that the expert considered in forming the opinions to be expressed; or

(iii) identify assumptions that the party’s attorney provided and that the expert relied on in forming the opinions to be expressed.

In some ways, this amendment was a retrograde step. Although protecting drafts and communications from discovery helps ease the expense and inconvenience of working with expert witnesses, the amendment also serves to protect unscrupulous lawyers and expert witnesses who work in concert to present tendentious opinions.

In the sciences, tendentious opinions will ultimately be embarrassed by future facts, but in the field of history, the interpretative narratives are often unfalsifiable and malleable. Discovery into the creative process of historian expert witnesses’ opinions needs to be complete and thorough.

Consider the consider the case of Barry Castleman, who has testified for decades for the asbestos litigation industry, on historical issues in asbestos personal injury cases. Back in 1986, when Castleman was still “researching” his opinions, he received a letter from plaintiffs’ lawyer, Tom Hart:

Mr. Barry Castleman January 9, 1986
1722 Linden Avenue
Baltimore, Maryland 21217

RE: Kenneth Lynch

Dear Barry:

As a follow-up to our conversation on January 6, 1986, I have reviewed our files and find that we do not have a file on Kenneth Lynch. Apparently I was provided with some of these papers indirectly. I seem to recall that the attorneys from California came to South Carolina and conducted the search for Kenneth Lynch’s papers.

We have not been eager to pursue this due to our understanding that Dr. Lynch was not convinced that asbestos was a cause of cancer. Despite his earlier publications, he remained personally reluctant to state that asbestos was causally related to the formation of cancers until some time in the late 1950’s or early 1960’s. This indecision on his part would be contrary to our best interests in the asbestos litigation and, accordingly, we have discouraged other counsel from exploring this further.

Since we do not have the specific documents you need, perhaps Marcia Hughes could provide them to you from Dick Gerry’s office in San Diego.

With best regards, I am

Very truly yours,

Thomas H. Hart, III

Dr. Lynch was a well-known South Carolina pathologist, who, along with Dr. William Smith, published a case report of lung cancer in a patient with asbestosis. See Kenneth M. Lynch & William A. Smith, “Pulmonary asbestosis III: carcinoma of lung in asbestosilicosis,” 23 Am. J. Cancer 56 (1935). Plaintiffs’ counsel were eager to over interpret this case report as showing an association, which was beyond the ability of a single, uncontrolled case to do.

The new Rule can be seen to have a few holes in it. Discovery is permitted into facts or data provided by counsel, and which were considered by the expert witness. Discovery is also permitted into the identity of assumptions given by the directing counsel, and relied upon by the expert witness. The letter from Hart to Castleman above, however, illustrates that important insights may result from suggestions, implicit or explicit, not to look at certain facts.

Posted in Conflicts of Interest, Historian Testimony, Trial Procedure, Underlying Data | No Comments »

Ethics and Statistics

January 21st, 2012

Chance magazine has started a new feature, the “Ethics and Statistics column, which is likely to be of interest to lawyers and to statisticians who work on litigation issues. The column is edited by Andrew Gelman. Judging from the Gelman’s first column, I think that the column may well become a valuable forum for important scientific and legal issues arising from studies used in public policy formulation, and in reaching conclusions that are the bases for scientific expert witnesses’ testimony in court.

Andrew Gelman is a professor of statistics and political science in Columbia University. He is also the director of the University’s Applied Statistics Center. Gelman’s inaugural column touches on some issues of great importance to legal counsel who litigate scientific issues involving scientific studies: access to underlying data in the studies that are the bases for expert witness opinions. See Andrew Gelman, “Open Data and Open Methods,” 24 Chance 51 (2011).

Gelman acknowledges that conflicts are not only driven by monetary gain; they can be potently raised by positions or causes espoused by the writer:

“An ethics problem arises when you are considering an action that

(a) benefits you or some cause you support,

(b) hurts or reduces benefits to others, and

(c) violates some rule.”

Id. at 51a.

Positional conflicts among scientists whose studies touch upon policy issues give rise to “the ethical imperative to share data.” Id. at 51c. Naming names, Professor Gelman relates an incident in which he wrote to an EPA scientist, Carl Blackman, who had presented a study on the supposed health effects of EMF radiation. Skeptical of how Blackman had analyzed data, Gelman wrote to Blackman to request his data to carry out additional, alternative statistical analyses. Blackman answered that he did not think these other analyses were needed, and he declined to share his data.

This sort of refusal is all too common, and typical of the arrogance of scientists who do not want others to be able to take a hard look at how they arrived at their conclusions. Gelman reminds us that:

“Refusing to share your data is improper… .”

* * * *

“[S]haring data is central to scientific ethics. If you really believe your results, you should want your data out in the open. If, on the other hand, you have a sneaking suspicion that maybe there’s something there you don’t want to see, and then you keep your raw data hidden, it’s a problem.”

* * * *

“Especially for high-stakes policy questions (such as the risks of electric power lines), transparency is important, and we support initiatives for automatically making data public upon publication of results so researchers can share data without it being a burden.”

Id. at 53.

To be sure, there are some problems with sharing data, but none that is insuperable, and none that should be an excuse for withholding data. The logistical, ethical, and practical problems of data sharing should now be anticipated long before publication and the requests for data sharing arrive.

Indeed, the National Institutes of Health requires data sharing plans to be part of a protocol for a federally funded study. See Final NIH Statement on Sharing Research Data (Feb. 26, 2003). Unfortunately, the NIH’s implementation and enforcement of its data-sharing policy is as spotty as a Damien Hirst painting. See “Seeing Spots” The New Yorker (Jan. 23, 2012).

Posted in Conflicts of Interest, Data Sharing, Rule 702, Scientific Evidence, statistical evidence | No Comments »

Tortini – Guilt-Free Pastry

January 16th, 2012

Well, I have blogged over 100 posts on Tortini. I have had the gratification of seeing some of these posts quoted, approvingly and disapprovingly, in print publications, as well as in other blogs. More important, the blog has put me in contact with some very interesting people, who have generously shared ideas, comments, and criticisms — all grist for my blogging mill.

Up till now, I have not made my blog interactive; I have not set up the blog to permit comments from readers. I have avoided this level of on-line, immediate interactivity with my readers mostly to avoid the pressure of having to monitor the blog closely. As the quasi-publisher, I feel a responsibility to make sure that the comments were legitimate “fair comment,” and not defamatory rubbish, or worse.

Recently, Professor Deborah Mayo posted a good portion of my post, The Continuing Saga of Bad-Faith Assertions of Conflicts of Interest on her blog. The post attracted the attention of a critic who described my post with a mixed metaphor: “meretricious garbage.” I responded on Mayo’s website, but the exchange made me realize that there are plusses and minuses to opening up a blog to comments.

I think for my part, I will continue Tortini as I have been doing. If I have given offense, personally, professionally, or intellectually, I invite you to write to me. Let me know whether you are willing to have me post your comments. I am certainly open to posting opposing points of view on Tortini.

Posted in Uncategorized | No Comments »

Beware the Academic-Publishing Complex!

January 11th, 2012

Today’s New York Times contains an important editorial on an attempt by some congressmen to undermine access to federally funded research. See Michael B. Eisen, “Research Bought, Then Paid For” New York Times (January 11, 2012). Eisen’s editorial alerts us to this attempt to undo a federal legal requirement that requires federally funded medical research be made available, for free, on the National Library of Medicine’s Web site (NLM).

As a founder of the Public Library of Science (PLoS), which is committed to promoting and implementing the free distribution of scientific research, Eisen may be regarded as an “interested” ora biased commentator. Such a simple-minded ascription of bias would be wrong. The PLoS has become an important distribution source of research results in the world of science, and competes with the publishing oligarchies: Elsevier, Springer, and others. The articles of the sort that PLoS makes available for free are sold by publishers for $40 or more. Subscriptions from these oligarchical sources are often priced in the thousands of dollars per year. Eisen’s simple and unassailable point is that the public, whether the medical profession, patients and citizens, students and teachers, should be able to read about the results of research funded with their tax monies.

“[I]f the taxpayers paid for it, they own.”

The United States government and its employees do not enjoy copyright protections for their creative work (and they do not), neither should their contractors.

Public access is all the more important given that the mainstream media seems so reluctant or unable to cover scientific research in a thoughtful and incisive way.

The Bill goes beyond merely unraveling a requirement of making published papers available free of charge at the NLM. The language of the Bill, H.R.3699, the Research Works Act, creates a false dichotomy between public and private sector research:

“SEC. 2. LIMITATION ON FEDERAL AGENCY ACTION.

No Federal agency may adopt, implement, maintain, continue, or otherwise engage in any policy, program, or other activity that—

(1) causes, permits, or authorizes network dissemination of any private-sector research work without the prior consent of the publisher of such work … .”

Work that is conducted in private or in state universities, but funded by the federal taxpayers, cannot be said to be “private” in any meaningful sense. The public’s access to this research, as well as its underlying data, is especially important when the subject matter of the research involves issues that are material to public policy and litigation disputes.

Who is behind this bailout for the private-sector publishing industry? Congressman Darrell Issa (California) introduced the Bill, on December 16, 2011. The Bill was cosponsored by Congresswoman Carolyn B. Maloney, the Democratic representative of New York’s 14th district. Oh Lord, Congresswoman Maloney represents me! NOT. How humiliating to be associated with this regressive measure.

This heavy-handed piece of legislation was referred to the House Committee on Oversight and Government Reform. Let us hope it dies a quick death in committee. See Michael Eisen, “Elsevier-funded NY Congresswoman Carolyn Maloney Wants to Deny Americans Access to Taxpayer Funded Research” (Jan. 5, 2012).

Posted in Conflicts of Interest, Data Sharing, Peer Review | No Comments »

The Will to Ummph

January 10th, 2012

It has become très chic to criticize and dismiss the concept of statistical significance.

The new Reference Manual on Scientific Evidence contains a sly reference and endorsement to a book by the two would-be statistics experts who submitted an amicus brief to the Supreme Court in Mattrix Initiatives v. Siracusano:

“For a hypercritical assessment of statistical significance testing that nevertheless identifies much inappropriate overreliance on it, see Stephen T. Ziliak & Deidre N. McCloskey, The Cult of Statistical Significance (2008).”

Michael D. Green, D. Michael Freedman, and Leon Gordis, ” Reference Guide on Epidemiology” 549, 579, in Federal Judicial Center and National Research Council, Reference Manual on Scientific Evidence (3d ed. 2011).

The Reference Manual authors are, in fact, hypo-critical of the rhetoric of Ziliak and McCloskey. I have previously written at some length of these authors’, and brief writers’, submission to the Supreme Court, and their subsequent harrumph in Significance. See The Matrixx Oversold; Matrixx Unloaded; The Matrixx – A Comedy of Errors; Matrixx Galvanized – More Errors, More Comedy About Statistics; and Ziliak Gives Legal Advice — Puts His Posterior On the Line (June 2, 2011).

To date, I have not addressed Ziliak and McCloskey’s book-length treatment of statistical significance, and their demonization of Sir Ronald Fisher, their beatification of William Gossett, and the need for a measure of “ummph: The Cult of Statistical Significance. Thankfully, Professor Deborah Mayo, a professor of statistics and philosophy, has delivered the coup de grâce to Ziliac & McCloskey, in her interesting and timely blog, Error Statistics Philosophy. See, e.g., Part 2 Prionvac: The Will to Understand Power (October 3, 2011); and Part 3: Prionvac: How the Reformers Should Have done Their Job (October 4, 2011).

Mayo’s “will to understand power” is a nice play on Nietzsche, and a rebuke of Ziliak and McCloskey’s strident call for a measure of “ummph.” Most of their argument is beside the point for the current practice of epidemiology, which insists upon reporting a measure of “effect” size, as well as statistical precision in a confidence interval. The Reference Manual‘s citation to Ziliak & McCloskey’s book thus badly misses the point and the errors of the book’s criticisms of significance.

Mayo’s posts should remove any sense of need or desire to obtain and read Ziliac & McCloskey’s book. You can safely wait until Cult shows up in on the discount rack, or in the recycling pile.

Posted in statistical evidence | No Comments »

Defendants’ Petition for Certiorari in Milward – DENIED

January 9th, 2012

The Supreme Court reported this morning that the defendants petition for certiorari in U.S. Steel Corp. v. Milward, Docket No.. 11-316, was denied.

While unfortunate for the parties involved, the denial was not a surprise. The Supreme Court does not sit to review factual errors and distortions, such as those that pervaded the First Circuit’s decision below. Furthermore, most of the justices are at sea when it comes to scientific evidence, as shown by Justice Sotomayor’s incredible discussion of causal concepts, in Mattrix Initiatives v. Siracusano, ___ U.S. ___, 131 S.Ct. 1309 (2011). See “Matrixx Unloaded.”

Indeed, there were great dangers involved in seeking this discretionary review in the Supreme Court. As I have written, the SKAPP-a-lites have larded up the most recent edition of the Reference Manual on Scientific Evidence with language that could easily be marshaled in favor of a loosey-goosey interpretation of Rule 702. See “Reference Manual on Scientific Evidence v3.0 – Disregarding Study Validity in Favor of the ‘Whole Gamish’.”

What is needed is not Supreme Court review, but a thorough dismemberment of the philosophy behind the Circuit’s decision in Milward, and the wayward, or the Milward, trend towards anything goes in the latest edition of the Reference Manual on Scientific Evidence. See “Milward — Unhinging the Courthouse Door to Dubious Scientific Evidence.”

It was shame and humiliation that drove the Daubert decision in the Supreme Court, and ultimately the revision of Federal Rule of Evidence 702. When the Courts suddenly realized that the scientific community was looking at their aberrant judgments, they changed up. The silicone gel breast implant litigation illustrates the phenomenon of how the courts react to the medical and scientific communties’ condemnation.

The Milward decision calls for a similar collateral attack on the unprincipled use of so-called “weight of the evidence” thinking. Some evidence, after all, is a mere feather’s weight, and not an appropriate basis for a scientific conclusion.

FW: Defendants’ Petition for Certiorari in Milward – DENIED

Inbox
x

Nathan A. Schachtman

11:37 AM (12 minutes ago)

to me

From: Nathan A. Schachtman [mailto:Nathan@SchachtmanLaw.com]
Sent: Monday, January 09, 2012 11:22 AM
To: ‘Nathan A. Schachtman’
Subject: Defendants’ Petition for Certiorari in Milward – DENIED

The Supreme Court reported this morning that the defendants petition for certiorari in U.S. Steel Corp. v. Milward, Docket No.. 11-316, was denied.

http://www.supremecourt.gov/opinions/10pdf/09-1156.pdf

http://schachtmanlaw.com/matrixx-unloaded/

What is needed is not Supreme Court review, but a thorough dismemberment of the philosophy behind the Circuit’s decision in Milward, and the wayward, or the Milward, trends towards anything goes in the latest edition of the Reference Manual on Scientific Evidence. See “Milward — Unhinging the Courthouse Door to Dubious Scientific Evidence.”

http://schachtmanlaw.com/milward-unhinging-the-courthouse-door-to-dubious-scientific-evidence/

The courts need to be made to feel ashamed of their judgments with respect to scientific matters.

It was the shame and humiliation of Bendectin litigation and others that moved the Court in Daubert, and later Joiner.

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Posted in Rule 702, Scientific Evidence | No Comments »

The Continuing Saga of Bad-Faith Assertions of Conflicts of Interest

December 28th, 2011

Conflicts of interest (COI), real or potential, have become a weapon used to silence the manufacturing industry in various scientific debates and discussions. Other equally “interested” parties, labor unions, advocacy groups, and consultants to the other industry – the litigation industry – have used conflicts and ethical claims to silence the manufacturing industry and to engage in unfettered false scientific speech. The public, unwilling and untrained to look at evidence on the merits, is conditioned to accepting an allegation of COI as the end of the discussion on scientific issues.

Recently, journalist Shannon Brownlee criticized the FDA for its suggestion that the agency was having difficulty in finding experts who cleared the agency’s conflict-of-interest prohibitions. Brownlee explicitly contended that she could easily find “unbiased” scientists who could advise the agency on drug and device issues.

Shannon Brownlee, “Is There an Independent Unbiased Expert in the House” (Aug. 3, 2011).

Indeed, Brownlee sent FDA Commissioner Margaret Hamburg a list of allegedly neutral experts who could advise the agency. Brownlee gave everyone on her list a clean bill of ethical health, and has published the list on multiple occasions, both on the website Healthnewsreview.org, and a few years ago, in the British Medical Journal: Jeanne Lenzer & Shannon Brownlee, “Is there an (unbiased) doctor in the house?” 337 Brit. Med. J. 206 (2008).

Brownlee tells us that journalists from respectable print media, including the New York Times, and the Wall Street Journal, have requested the list, apparently to contact the “unbiased” experts to help investigate news stories about drugs and medical devices. What the gullible may not appreciate is that the list fallaciously is based upon only one exclusionary criterion: having consulted for the pharmaceutical industry. The list omits other important COI exclusionary criteria, such as having consulted for the litigation industry, or having taken erroneous, unwarranted, and ideologically driven positions on scientific issues.

What litigation industry? Brownlee may have missed the fact that plaintiffs’ lawyers represent a huge financial interest in obtaining compensation for others, with 40 percent of the proceeds going to themselves. This litigation industry thrives, even with Dickie Scruggs in prison, and Stanley Chesley in disrepute.

In today’s litigation environment, with aggregation of claims in federal multi-district cases, plaintiffs’ counsel stand to profit in the billions from scientific positions espoused by their expert witnesses.

Who are the litigation industry expert witnesses on Brownlee’s list? Here are some obvious candidates:

Peter R. Breggin, MD, psychiatrist, clinical psychopharmacologist, independent author and scientist; Founder and Director Emeritus, International Center for the Study of Psychiatry and Psychology

Adriane Fugh-Berman, MD, Professor, Department of Physiology and Biophysics, Georgetown University Medical Center; Director, PharmedOut.org

Curt Furberg, MD, PhD, Professor of Public Health Sciences, Wake Forest University School of Medicine

Joseph Glenmullen, MD, Clinical instructor in psychiatry, Harvard Medical School

Bruce Psaty, MD, PhD, Professor, Medicine & Epidemiology, University of Washington Cardiovascular Health Research Unit

Also on the list were well-known anti-industry zealots, who focus almost exclusively on the manufacturing industry, while ignoring or endorsing the excesses and unwarranted claims of the litigation industry:

Lisa Bero, PhD, Professor, University of California, San Francisco U.S.

Sheldon Krimsky, PhD, Tufts University & Council for Responsible Genetics

Sidney Wolfe, MD, Director, Health Research Group of Public Citizen.

Now some people may claim that the litigation industry consultants, and the anti-industry zealots, take their positions not to please their sponsors, or to pursue lucrative opportunity, but because they fervently believe the positions that they take. But then why not give the pharmaceutical industry consultants the same benefit of the doubt? Indeed, why not move beyond COI allegations to creating lists of scientists and physicians who have demonstrated proficiency in advancing evidence-based judgments that have withstood the test of time?

This anti-industry hypocrisy manifests not only in assertions of conflicts of interest, but also in calls for industry to disclose all underlying data from industry-funded or sponsored studies, while taking a protectionist stance on all other underlying data.

Let’s hope that in 2012, industry fights back, and evidence regains its primary role in resolving scientific disputes.

Posted in Conflicts of Interest, Scientific Evidence | No Comments »

A Rule of Completeness for Statistical Evidence

December 23rd, 2011

Witnesses swear to tell the “whole” truth, but lawyers are allowed to deal in half truths. Given this qualification on lawyers’ obligation of truthfulness, the law prudently modifies the law of admissibility for writings to permit an adverse party to require that written statements are not yanked out of context. Waiting days, if not weeks, in a trial to restore the context is an inadequate remedy for these “half truths.” If a party introduces all or part of a writing or recorded statement, an adverse party may ” require the introduction, at that time, of any other part — or any other writing or recorded statement — that in fairness ought to be considered at the same time.” Fed. R. Evid. 106 (Remainder of or Related Writings or Recorded Statements). See also Fed. R. Civ. Pro. Rule 32(a)(4) (rule of completeness for depositions).

This “rule of completeness” has its roots in the common law, and in the tradition of narrative testimony. The Advisory Committee notes to Rule 106 comments that the rule is limited to “writings and recorded statements and does not apply to conversations.” The Rule and the notes ignore that the problematic incompleteness might be in the form of mathematical or statistical evidence.

Confidence Intervals

Consider sampling estimates of means or proportions. The Reference Manual on Scientific Evidence (2d ed. 2000) urges that:

“[w]henever possible, an estimate should be accompanied by its standard error.”

RMSE 2d ed. at 117-18.

The new third edition dilutes this clear prescription, but still conveys the basic message:

“What is the standard error? The confidence interval?

An estimate based on a sample is likely to be off the mark, at least by a small amount, because of random error. The standard error gives the likely magnitude of this random error, with smaller standard errors indicating better estimates.”

RMSE 3d ed. at 243.

The evidentiary point is that the standard error, or the confidence interval (C.I.), is an important component of the sample statistic, without which the sample estimate is virtually meaningless. Just as a narrative statement should not be truncated, a statistical or numerical expression should not be unduly abridged.

Of course, the 95 percent confidence interval is the estimate (the risk ratio, the point estimate) plus or minus 1.96 standard errors. By analogy to Rule 106, lawyers should insist that the confidence interval, or some similar expression of the size of the standard error, be provided at the time that the examiner asks about, or the witness gives, the sample estimate. There are any number of consensus position papers, as well as guidelines for authors of papers, which specify that risk ratios should be accompanied by confidence intervals. Courts should heed those recommendations, and require parties to present the complete statistical idea – estimate and random error – at one time.

One disreputable lawyer trick is to present incomplete confidence intervals. Plaintiffs’ counsel, for instance, may inquire into the upper bound of a confidence interval, and attempt to silence witnesses when they respond with both the lower and upper bounds. “Just answer the question, and stop volunteering information not asked.” Indeed, some unscrupulous lawyers have been known to cut off witnesses from providing the information about both bounds of the interval, on the claim that the witness was being “unresponsive.” Judges who are impatient with technical statistical testimony may even admonish witnesses who are trying to make sure that they present the “whole truth.” Here again, the completeness rule should protect the integrity of the fact finding by allowing, and requiring, that the full information be presented at once, in context.

Although I have seen courts permit the partial, incomplete presentation of statistical evidence, I have yet to see a court acknowledge the harm from failing to apply Rule 106 to quantitative, statistical evidence. One court, however, did address the inherent error of permitting a party to emphasize the extreme values within a confidence interval as “consistent” with the data sample. Marder v. G.D. Searle & Co., 630 F.Supp. 1087 (D.Md. 1986), aff’d mem. on other grounds sub nom. Wheelahan v. G.D.Searle & Co., 814 F.2d 655 (4th Cir. 1987)(per curiam).

In Marder, the plaintiff claimed pelvic inflammatory disease from a IUD. The jury was deadlocked on causation, and the trial court decided to grant the defendant’s motion for directed verdict, on grounds that the relative risk involved was less than two. Id. at 1092. (“In epidemiological terms, a two-fold increased risk is an important showing for plaintiffs to make because it is the equivalent of the required legal burden of proof—a showing of causation by the preponderance of the evidence or, in other words, a probability of greater than 50%.”)

The plaintiff sought to resist entry of judgment by arguing that although the relative risk was less than two, the court should consider the upper bound of the confidence interval, which ranged from 0.9 to 4.0. Id. So in other words, the plaintiff argued that she was entitled to have the jury consider and determine that the actual value was actually 4.0.

The court, fairly decisively, rejected this attempt to isolate the upper bound of the confidence interval:

“The upper range of the confidence intervals signify the outer realm of possibilities, and plaintiffs cannot reasonably rely on these numbers as evidence of the probability of a greater than two fold risk. Their argument reaches new heights of speculation and has no scientific basis.”

The Marder court could have gone further by pointing out that the confidence interval does not provide a probability for any value within the interval.

Multiple Testing

In some situations, completeness may require more than the presentation of the size of the random error, or the width of the confidence interval. When the sample estimate arises from a study with multiple testing, presenting the sample estimate with the confidence interval, or p-value, can be highly misleading if the p-value is used for hypothesis testing. The fact of multiple testing will inflate the false-positive error rate.

Here is the relevant language from Kaye and Freedman’s chapter on statistics, in the Reference Manual (3d ed.):

“4. How many tests have been done?

Repeated testing complicates the interpretation of significance levels. If enough comparisons are made, random error almost guarantees that some will yield ‘significant’ findings, even when there is no real effect. To illustrate the point, consider the problem of deciding whether a coin is biased. The probability that a fair coin will produce 10 heads when tossed 10 times is (1/2)¹⁰ = 1/1024. Observing 10 heads in the first 10 tosses, therefore, would be strong evidence that the coin is biased. Nonetheless, if a fair coin is tossed a few thousand times, it is likely that at least one string of ten consecutive heads will appear. Ten heads in the first ten tosses means one thing; a run of ten heads somewhere along the way to a few thousand tosses of a coin means quite another. A test—looking for a run of ten heads—can be repeated too often.

Artifacts from multiple testing are commonplace. Because research that fails to uncover significance often is not published, reviews of the literature may produce an unduly large number of studies finding statistical significance.¹¹¹ Even a single researcher may examine so many different relationships that a few will achieve statistical significance by mere happenstance. Almost any large dataset—even pages from a table of random digits—will contain some unusual pattern that can be uncovered by diligent search. Having detected the pattern, the analyst can perform a statistical test for it, blandly ignoring the search effort. Statistical significance is bound to follow.

There are statistical methods for dealing with multiple looks at the data, which permit the calculation of meaningful p-values in certain cases.¹¹² However, no general solution is available… . In these situations, courts should not be overly impressed with claims that estimates are significant. …”

RMSE 3d ed. at 256-57.

When a lawyer asks a witness whether a sample statistic is “statistically significant,” there is the danger that the answer will be interpreted or argued as a Type I error rate, or worse yet, as a posterior probability for the null hypothesis. When the sample statistic has a p-value below 0.05, in the context of multiple testing, completeness requires the presentation of the information about the number of tests and the distorting effect of multiple testing on preserving a pre-specified Type I error rate. Even a nominally statistically significant finding must be understood in the full context of the study.

Many texts and journals recommend that the Type I error rate not be modified in the paper, as long as readers can observe the number of multiple comparisons that took place and make the adjustment for themselves. Most jurors and judges are not sufficiently knowledgeable to make the adjustment without expert assistance, and so the fact of multiple testing, and its implication, are additional examples of how the rule of completeness may require the presentation of appropriate qualifications and explanations at the same time as the information about “statistical significance.”

Posted in Scientific Evidence, statistical evidence | No Comments »

The Integrity of Facts in Judicial Decisions

December 21st, 2011

One of the usual tasks of an appellate judge’s law clerk is to read the record – the entire record. In my clerking experience, the law clerk who had the assignment for a case in which the judge was writing an opinion was responsible for knowing every detail of the record. The judge believed that fidelity to the factual record was an absolute.

Not so for other appellate judges. See, e.g., Jacoby, “Judicial Opinions as “Minefields of Misinformation: Antecedents, Consequences and Remedies,” University Public Law and Legal Theory Working Papers Paper 35 (N.Y. 2006).

Some important cases turn on facts misunderstood or misrepresented by appellate courts. A few days ago, Kyle Graham blogged about a startling discovery in the Summers v. Tice case, which is covered in every first-year torts class. Kyle Graham, “Summers v. Tice: The Rest of the Story” (Dec. 1, 2011).

Summers v. Tice, 33 Cal.2d 80, 199 P.2d 1 (1948), is a leading California tort law case that shifted the burden of proof on causation to the two defendants. The rationale for shifting the burden was the gross negligence of both defendants, and the plaintiff’s faultless inability to identify which of the two defendants, Simonson or Tice, was responsible for shooting the plaintiff with a shotgun in their ill-fated quail hunt.

Professor Graham did something unusual: he actually read the record of the bench trial. It turns out that the facts were different from, and much more interesting than, those presented by the California Supreme Court. Simonson admitted shooting Summers, and implicated Tice. Tice denied shooting. The trial judge resolved credibility issue against Tice, although it seems to have been a close issue.

More important, Tice testified that his gun was loaded with No. 6 shot, whereas Simonson had used No. 7.5 shot. Summers admitted that the pellets had been given to him after his medical treatment, but he could not find them at the time of trial. Had he kept the pellets, Summers would have been able to distinguish between the gunfeasors.

Spoliation anyone? Missing evidence? Adverse inference?

Even if the trial judge was unimpressed with Tice’s denial of having discharged his shotgun, Tice’s lack of credibility could not turn into affirmative evidence that he had used number 7.5 shot, as had Simonson. This was a contested issue, on which the plaintiff could have adduced evidence. The plaintiff’s failure to do so was the result of his own post-accident carelessness (or worse) in not keeping important evidence. Tice’s testimony on the size of the shot in his gun was undisputed, even if the trial court thought that he was not a credible witness.

Thus, on the real facts, the shifting of the burden of proof, on the rationale that the plaintiff was without fault for his inability to produce evidence against Summers or Tice, was quite unjustified. The plaintiff was culpable for the failure of proof, and there was no affirmative evidence that the two potential causative agents were indistinguishable. The defendants were not in a better position than the plaintiff to identify who had been the cause of plaintiff’s wounds.

The trial court’s credibility assessment of Tice, for having denied a role in shooting, did not turn the absence of evidence into affirmative evidence that both defendants used the same size pellets in their shotguns. What makes for a great law school professor’s hypothetical was the result of an obviously fallacious inference, and a factual fabrication, borne of sloppy judicial decision making.

We can see a similar scenario play out in the New Jersey decisions that reversed directed verdicts in asbestos colorectal cancer cases. Landrigan v. Celotex Corp., 127 NJ. 404, 605 A2d 1079 (1992); Caterinicchio v. Pittsburgh Corning Corp., 127 NJ. 428, 605 A.2d 1092 (1992). In both cases, the trial courts directed verdicts, assuming arguenda that asbestos can cause colorectal cancer (a dubious proposition), on the ground that the low relative risk cited by plaintiffs’ expert witnesses (about 1.5) was factually insufficient to support a verdict for plaintiffs on specific causation. Indeed, the relative risk suggested that the odds were about 2 to 1 in defendants’ favor that the plaintiffs’ colorectal cancers were not caused by asbestos.

The intermediate appellate courts affirmed the directed verdicts, but the New Jersey Supreme Court reversed and remanded both judgments on curious grounds. According to the Court, there were other probative factors that the juries could have used to make out specific causation:

“Dr. Wagoner did not rely exclusively on epidemiological studies in addressing that issue. In addition to relying on such studies, he, like Dr. Sokolowski, reviewed specific evidence about decedent’s medical and occupational histories. Both witnesses also excluded certain known risk factors for colon cancer, such as excessive alcohol consumption, a high-fat diet, and a positive family history. From statistical population studies to the conclusion of causation in an individual, however, is a broad leap, particularly for a witness whose training, unlike that of a physician, is oriented toward the study of groups and not of individuals. Nonetheless, proof of causation in toxic-tort cases depends largely on inferences derived from statistics about groups.”

Landrigan, 127 N.J. at 422. The NJ Supreme Court held that the plaintiffs’ failure to show a relative risk in excess of 2.0 was not fatal to their cases, when there was other evidence that the jury could consider, in addition to the relative risks.

Well, actually there was no expert witness support for the assertion. Completely absent from the evidentiary displays in both the Landrigan and Caterinicchio cases was any evidence, apart from plaintiffs’ expert witnesses’ hand waving, that a higher relative risk existed among the subcohort of asbestos insulators who had had heavier exposure or who had concomitant pulmonary disease. There was no evidence that those exposed workers who lacked “excessive alcohol consumption, a high-fat diet, and a positive family history” had any increase risk. Indeed, the Selikoff study relied upon extensively by plaintiffs’ expert witnesses failed to make any adjustment for the noted risk factors, as well as for the greater prevalence of smoking histories among the insulators than among the unexposed comparator population. The Court turned the absence of evidence into the factual predicate for its holding that defendants were not entitled to judgment.

Now that’s judicial activism.

Posted in Rule 702, Scientific Evidence | No Comments »

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