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

Ninth Circuit Affirms Rule 702 Exclusion of Dr David Egilman in Diacetyl Case

June 20th, 2011

On June 17, 2011, the Ninth Circuit of the United States Court of Appeals affirmed a district judge’s decision to exclude Dr David S. Egilman from testifying in a consumer-exposure diacetyl case.  Newkirk v. Conagra Foods Inc. (9th Cir. 2011).

Plaintiff claimed to develop bronchiolitis obliterans from having popped and eaten an Homeric quantity of microwavable popcorn.  The case was thus a key test of “consumer” diacetyl exposure.  Another case, also involving Egilman, just finished a Daubert hearing in Colorado, last week.

To get the full “flavor” of this diacetyl case, you may have to read the district court’s opinion, which excluded Egilman and other witnesses, and entered summary judgment for the defense. Newkirk v. Conagra Foods, Inc., No. CV-08-273, 2010 WL 2680184 (E.D. Wash. July 2, 2010).

Plaintiff appealed, and so did Egilman.  (See attached Egilman Motion Appeal Diacetyl Exclusion 2011 and Egilman Declaration Newkirk Diacetyl Appeal 2011.)  In what some may consider scurrilous pleading, Egilman attacked the district judge for having excluded him from testifying.  If Egilman’s challenge to the trial judge was not bizarre enough, Egilman also claimed a right to intervene in the appeal by advancing the claim that the Rule 702 exclusion hurt his livelihood.  The following language is from paragraph 11 of Dr. Egilman’s declaration in support of his motion:

“The Daubert ruling eliminates my ability to testify in this case and in others. I will lose the opportunity to bill for services in this case and in others (although I generally donate most fees related to courtroom testimony to charitable organizations, the lack of opportunity to do so is an injury to me). Based on my experience, it is virtually certain that some lawyers will choose not to attempt to retain me as a result of this ruling. Some lawyers will be dissuaded from retaining my services because the ruling is replete with unsubstantiated pejorative attacks on my qualifications as a scientist and expert. The judge’s rejection of my opinion is primarily an ad hominem attack and not based on an actual analysis of what I said – in an effort to deflect the ad hominem nature of the attack the judge creates ‘straw man’ arguments and then knocks the straw men down, without ever addressing the substance of my positions.”

Egilman Declaration at Paragraph 11.

Egilman tempers his opinion about the prejudice he will suffer in front of judges in future cases.  Only judges who have not seen him before would likely be persuaded by Judge Peterson’s decision in Newkirk.  Those judges who have heard him testify before would, no doubt, see him for the brilliant crusading avenger that he is:

“This will generally not occur in cases heard before Judges where I have already appeared as a witness. For example a New York state trial judge has praised plaintiffs’ molecular-biology and public-health expert Dr. David Egilman as follows: ‘Dr. Egilman is a brilliant fellow and I always enjoy seeing him and I enjoy listening to his testimony . . . . He is brilliant, he really is.’ [Lopez v. Ford Motor Co., et al. (120954/2000; In re New York City Asbestos Litigation, Index No. 40000/88).]”

Egilman Declaration at p. 9 n. 2.

It does not appear as though Egilman’s attempt to intervene helped plaintiff before the Ninth Circuit, which may not have thought that he was as brilliant as the unidentified trial judge in Lopez.

The Newkirk case is interesting for several reasons.

First, the Circuit correctly saw that general causation must be shown before the plaintiff can invoke a differential etiology analysis.

Second, the Circuit saw that it is not sufficient that the substance in question can cause the outcome claimed; the substance must do so at the levels of exposure that were experienced by the plaintiff.  In Newkirk, even by consuming massive quantities of microwave popcorn, plaintiff had not shown exposure levels to diacetyl equivalent to the exposures among factory workers at risk for bronchiolitis obliterans.  The affirmance of the district court is a strong statement that exposure matters in the context of the current understanding of diacetyl causation.

Third, the Circuit was not intimidated or persuaded by the tactics of Dr David Egilman, expert witness.

Fourth, having dealt with the issues deftly, the Ninth Circuit issued a judgment from which there will be no appeal.

WLF Legal Backgrounder on Matrixx Initiatives

June 20th, 2011

In Matrixx Initiatives, Inc. v. Siracusano, ___ U.S. ___, ___ , 2011 WL 977060 (Mar. 22, 2011), the Supreme Court addressed a securities fraud case against an over-the-counter pharmaceutical company for speaking to the market about its rosy financial projections, but failing to provide information received about the hazards of the product.

Much or most of the holding of the case is an unexceptional application of settled principles of securities fraud litigation in the context of claims against a pharmaceutical company with products liability cases pending.  The defendant company, however, attempted to import Rule 702 principles of scientific evidence into a motion to dismiss on the pleadings, with much confusion resulting among the litigants, the amici, and the Court.  The Supreme Court ruled unanimously to affirm the reinstatement of the complaint against the defendant.

I have written about this case previously: “The Matrixx – A Comedy of Errors,” and “Matrixx Unloaded,” and “The Matrixx Oversold,” and “De-Zincing the Matrixx.”

Now, with the collaboration of David Venderbush from Alston & Bird LLP, we have collected our thoughts to share in the form of a Washington Legal Foundation Legal Backgrounder, which is available for download at the WLF’s website.  Schachtman & Venderbush, “Matrixx Unbounded: High Court’s Ruling Needlessly Complicates Scientific Evidence Principles,” 26 (14) Legal Backgrounder (June 17, 2011).

The Fascinating Thing About History

June 16th, 2011

“There is something fascinating about science.  One gets such wholesale returns of conjecture out of such a trifling investment of fact.”

— Mark Twain, Life on the Mississippi 1883.

History is much more fun and profitable, because you can get in on the action, without any investment of fact.  The SEC ought to look into this.

Consider the historians of silicosis:

“In the postwar era, professionals, industry, government, and a conservative labor movement tried to bury silicosis as an issue.”

David Rosner & Gerald Markowitz, Deadly Dust:  Silicosis and the Politics of Occupational Disease in the Twentieth Century America 213 (Princeton 1991).

Now, I pick on Rosner and Markowitz because they pick on me, they are easy targets, and their writings are illustrative of what I believe is so wrong about importing historians’ broad, and sometimes glib, judgments into the courtroom.  Of course, Rosner and Markowitz have made themselves actors in various litigation efforts to advance their radical and Marxist views.  See Ronald Johnston & Arthur McIvor, “Workshop Handout:  Approaches and Methods in the History of Occupational and Environment Health,” presented at The Fourth Annual International Conference on the History of Occupational and Environmental Health (June 2010)(asking whether Rosner and Markowitz are not the best writing in the tradition of radical and Marxist approaches to the history of workers’ health).

Before World War II, there were notable, unfortunate large scale outbreaks of silicosis.  The silicosis outbreaks among workers in the Barre, Vermont, granite quarries and sheds, and of course, among  workers at the Gauley Bridge/Hawk’s Nest tunnel, are among the most notorious.

After WWII, the most notable outbreak was a fantasy and a fraud, created by plaintiffs’ counsel who conspired with reprobate physicians.  In re Silica Products Liab. Litig., 398 F.Supp. 2d 563 (S.D.Tex. 2005) (Jack, J.).

Occasionally, empirical evidence can be brought to bear to embarrass the glib generalizations that historians make.  Consider the claim, above, by Rosner & Markowitz that everyone (other than the heroic Leninist labor unions) sought to bury the issue of silicosis.

Well, we can obtain something of a reality check by measuring the number of publications in the National Library of Medicine’s database (PubMed) on silicosis.  A simply search on “silicosis,” with limits to each decade after the 1930s reveals a pattern that silicosis had not been buried at all:

Date Range                    Number of Articles from Keyword Search

1940 – 1949                      113

1950 – 1959                    1,421

1960 – 1969                    1,867

1970 – 1979                    1,178

1980 – 1989                       940

1990 – 1999                       882

2000 – 2009                      843

Considering the major post-War developments in the medical world, from antibiotics, poliomyelitis, tobacco-related cancers, and other chronic diseases, the continued interest in silicosis after World War II is remarkable.

I suppose that Rosner and Markowitz would discount the words of the Centers for Disease Control (CDC), because, after all, the CDC is part of government, which in turn is part of the conspiracy with medical professionals, industry, and non-Marxist labor union leaders, to bury the silicosis issues.  If you see through Rosner and Markowitz’ broad brush generalization, you might be interested to know that the CDC mentioned silicosis as among the ten great public achievements of the twentieth century.  CDC, “Ten Great Public Health Achievements – United States, 1900 – 1999,” 48(12) CDC Morbidity and Mortality Weekly Report 241 (April 02, 1999)(“Work-related health problems, such as coal workers’ pneumoconiosis (black lung), and silicosis — common at the beginning of the century — have come under better control.”).

This brand of historical generalizations does not belong in courtrooms.

Conflicts of Interest, Footnote 17, and Scientific McCarthyism

June 12th, 2011

In Exxon Shipping Co. v. Baker, 554 U.S. 471, 501 (2008) – the Exxon Valdez case – the Supreme Court struck down a $2.5 billion punitive damage award.  Justice Souter wrote the opinion for a fragmented court, in a 5-3 decision, with several concurrences.  There are many interesting aspects to the case, including a curious statement with a more curious footnote.  Justice Souter wrote:

“We are aware of no scholarly work pointing to consistency across punitive awards in cases involving similar claims and circumstances.17

In the corresponding footnote, Justice Souter explained:

“The Court is aware of a body of literature running parallel to anecdotal reports, examining the predictability of punitive awards by conducting numerous “mock juries,” where different “jurors” are confronted with the same hypothetical case. See, e.g., C. Sunstein, R. Hastie, J. Payne, D. Schkade, W. Viscusi, Punitive Damages: How Juries Decide (2002); Schkade, Sunstein, & Kahneman, Deliberating About Dollars: The Severity Shift, 100 Colum. L.Rev. 1139 (2000); Hastie, Schkade, & Payne, Juror Judgments in Civil Cases: Effects of Plaintiff’s Requests and Plaintiff’s Identity on Punitive Damage Awards, 23 Law & Hum. Behav. 445 (1999); Sunstein, Kahneman, & Schkade, Assessing Punitive Damages (with Notes on Cognition and Valuation in Law), 107 Yale L.J. 2071 (1998). Because this research was funded in part by Exxon, we decline to rely on it.”

Professor Sunstein, then at University of Chicago, of course now serves in President Obama’s administration.  Professor Kahneman is a Nobel Laureate.  Professor Viscusi has been one of the most prolific writers about and investigators of punitive damages.  Justice Souter’s footnote could easily be interpreted to impugn the integrity of their research by virtue of their corporate sponsorship.

The footnote was curious in large part because Exxon won the case, which leaves open why Justice Souter went out of his way to call into question research that supported his concern about the vagaries of punitive damage awards.  Having in large measure adopted an approach urged by the Exxon-sponsored studies, Justice Souter’s disclaimer seems rather disingenuous.  Perhaps Justice Souter was simply acknowledging that the Court was aware of the work, and for sake of appearances, wanted to note that the Court had reached its decision independently of the litigant-sponsored studies.

There was nothing underhanded done by Exxon; the studies disclosed their funding source.

Since the Exxon Valdez case, expert witnesses, litigants, and courts have pointed to footnote17 inappropriately to suggest that party-sponsored studies should be disregarded without consideration of their merits.

For almost a century, litigants have invoked social science research designed to influence court’s decisions about “legislative facts” or policy.  Such research is very different from research studies upon which expert witnesses rely when appearing before trial courts and juries, responsible for finding facts.

Footnote 17 was thus torn from its context of using social science research to shape policy, and extended to apply to scientific studies that are relied upon by expert witnesses at the trial court level.  Overlooking this distinction, Judge Jack Weinstein jumped on the issue when he commented on sponsorship of pharmaceutical companies’ clinical trials, and generalized (without any reliable scientific basis) that the “commercial bias found in today’s research laboratories means studies are often lacking in essential objectivity, with the potential for misinformation, skewed results or cover-ups….”  In re Zyprexa Prod. Liab. Litig., 253 F.R.D. 69, 106-08 (E.D.N.Y. 2008) (citing Exxon).

A new front of “Scientific McCarthyism” has opened.  This intolerance toward corporate sponsorship has been going on for some time.  Journal editors and industry critics have been using the “conflicts of interest” mantra to impugn industry-sponsored studies, and to impose greater burdens on the publication of such studies than required for federally funded studies.  Curiously, the same journal editors have stuck their heads in the sand when it comes to studies sponsored by plaintiffs’ counsel, or conducted by scientists who are consultants to, or witnesses for, plaintiffs’ counsel in tort cases.

Back in 1993, Ken Rothman referred to this anti-industry as the “new McCarthyism in science.” Kenneth J. Rothman, “Conflict of interest: the new McCarthyism in science,” 269 J. Am. Med. Ass’n 2782 (1993).  The McCarthyites were undeterred.  The anti-industry journals pushed forward by increasing the burdens on industry sponsored studies, especially on pharmaceutical clinical trials.  See, e.g., Catherine D. DeAngelis, P. B. Fontanarosa, and A. Flanagin, “Reporting financial conflicts of interest and relationships between investigators and research sponsors 286 J. Am. Med. Ass’n 89 (2001)

Courageously, some scientists fought for science to be judged on its merits.  See Thomas P. Stossel, “Has the hunt for conflicts of interest gone too far?” 336 Brit. Med. J. 476 (2008); Nature Publishing Group, “Nothing to see here: based on one company’s past poor publishing practices, a top-tier medical journal misguidedly stigmatizes any paper from industry,” 26 Nature Biotechnol. 476 (2008); Kenneth J. Rothman & S. Evans, “Extra scrutiny for industry funded trials: JAMA’s demand for an additional hurdle is unfair–and absurd, 331 Brit. Med. J. 1350 (2005), and 332 Brit. Med. J. 151 (2006) (erratum).

Professor Stossel and others created an organization, ACRE – The Association of Clinical Researchers and Educators, to defend legitimate interactions between Physicians and Industry. ACRE has spoken out against the lopsided demonization of the pharmaceutical industry, and the lionizing of the industry’s critics.

The anti-industry prejudice seemed to jump the shark when a gaggle of plaintiffs’ expert witnesses published a “case study” of publication abuses allegedly perpetrated by Merck.  Some of the authors were paid expert witnesses in litigation against Merck, but this unseemly conflict of interest did not seem to disturb the journal’s editors.  J. S. Ross, K. P. Hill, David S. Egilman, and Harlan M. Krumholz, “Guest authorship and ghostwriting in publications related to rofecoxib: a case study of industry documents from rofecoxib litigation. 299 J. Am. Med. Ass’n 1800 (2008); Catherine D. DeAngelis & P.B. Fontanarosa, “Impugning the integrity of medical science: the adverse effects of industry influence,” 299 J. Am. Med. Ass’n 1833 (2008).

Along with Ken Rothman, another bold voice has cried out against the unfairness and partiality of journals’ conflict-of-interest rules and policies.  Laurence J. Hirsch, “Conflicts of Interest, Authorship, and Disclosures in Industry-Related Scientific Publications: The Tort Bar and Editorial Oversight of Medical Journals,” 84 Mayo Clin. Proc. 811 (2009).  Dr. Hirsch published a strongly worded commentary that journals’ concerns are often poorly disguised prejudices against industry.  Many of the journals in question rarely or never fuss over the obvious conflicts of interest created by the “profit motive” of researchers who want to climb the academic ladder, increase their salaries, enlarge their budgets, extend their influence, travel to organizational conferences, bolster their prestige, win more grants, enhance their reputations, or advance their political goals or ideologies.

Dr Hirsch uses the publication by Ross, Hill, Egilman, and Krumholz as an example of the double standard.  Their publication in the Journal of the American Medical Association was accompanied by an anemic disclosure that they had been consultants to the plaintiffs in Vioxx litigation, but they neglected to mention that they had actually testified for plaintiffs, and had earned thousands of dollars for their efforts.

Dr Hirsch published a correction last year in which he noted that “Dr Egilman has not testified in court in breast implant and connective tissue disease, or in antidepressant or antipsychotic drug cases.”  Laurence J. Hirsch, “Corrections,” 85 Mayo Clin. Proc. 99 (2010).  This correction was curious because Dr Egilman had testified in a breast implant case:  Vasallo v. Baxter Healthcare, tried in Massachusetts, in the late 1990s.  The Vassallo case involved allegations that silicone had caused systemic disease, an allegation that was ultimately shown to be meritless.

Judge Jack B. Weinstein, “Preliminary Reflections on Administration of Complex Litigation.” Cardozo Law Review DeNovo 1, 14 (2009) (“[t]he breast implant litigation was largely based on a litigation fraud. …  Claims—supported by medical charlatans—that enormous damages to women’s systems resulted could not be supported.”)

The medical profession, the courts, and the public are seriously misled by the obsession with conflicts of interest, on either side.  The obsession allows a disclosed or undisclosed conflict of interest to substitute for the much harder work of considering the merits of a study.