Conflicts of Interest, Footnote 17, and Scientific McCarthyism

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.

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