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VIEWS & REVIEWS: Brad A. Racette, Ann Bradley, Carrie A. Wrisberg, and Joel S. Perlmutter The impact of litigation on neurologic research Neurology 2006; 67: 2124-2128 [Abstract] [Full text] [PDF]

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The impact of litigation on neurologic research

Nathan A. Schachtman   (2 April 2007)

Reply from the Authors

Brad A. Racette, Ann Bradley, Carrie A. Wrisberg, Joel S. Perlmutter   (2 April 2007)

The impact of litigation on neurologic research 2 April 2007
Nathan A. Schachtman, McCarter & English, LLP 1735 Market Street, Mellon Bank Center, Suite 700. Philadelphia, PA 19103-7501 Send Correspondence to journal: Re: The impact of litigation on neurologic research nschachtman{at}mccarter.com Nathan A. Schachtman	Racette et al complain that litigation interferes with scientific research. [1] Unfortunately, their article offers a one-sided, incomplete picture of the interaction between scientific research and the law, and their proposals are ill-considered. Although the authors complain about the expense incurred in responding to subpoenas for data underlying their Alabama study, they fail to disclose that the welder screenings for their study were funded by plaintiffs' attorneys as part of an effort to solicit personal-injury clients. [2] Defendants served subpoenas to obtain the study's underlying data only after plaintiffs' counsel heavily relied on the study in the litigation. Contrary to their minimal disclosure, the authors were not disinterested researchers inadvertently caught up in litigation. The authors collaborated with plaintiffs' counsel so closely that counsel invoked litigation privileges to cloak the work in secrecy. The authors also fail to mention that much of the cost of complying with the subpoenas resulted from their own actions. The subpoenas were served with offers to redact individual identifiers, reimburse reasonable expenses, and to agree to non-disclosure and non-publication of data. The authors spurned these offers, and filed briefs seeking to block all access. The Court, after carefully weighing all parties' interests, required production of limited, redacted data, with compensation for reasonable expenses, as originally offered. The costs complained of were largely self-inflicted. Basic norms of science favor openness and discourage secrecy in research. The scientific community has increasingly demanded transparency from investigators. Many leading journals require raw data and questionnaires to be submitted, either in peer-review or upon acceptance. Research funded by the NIH is subject to federal law that makes underlying data subject to public disclosure,[3] and the National Research Council has urged sharing research data, especially when relevant to public policy.[4] As demonstrated in the welding cases, judges appropriately have discretion to protect researchers' legitimate interests, while ensuring that litigants can discover and examine studies that may be offered against them. The authors' proposals would chill participation by outstanding senior academic physicians and create vacuums in courtrooms, which will be filled by less-qualified witnesses. The proposals undermine physicians' civic obligations to provide their expertise, properly compensated, to all participants in the judicial system.[5] Finally, the authors' vague proposal to limit industry-sponsored support for specific projects threatens to prevent companies from funding research, a demand often made by the very plaintiffs' lawyers who supported Dr. Racette's work. References 1. Racette BA, Bradley A, Wrisberg CA, Perlmutter JS. The impact of litigation on neurologic research. Neurology 2006;67:2124-2128. 2. Racette BA, Tabbal SD, Jennings D, Good L, Perlmutter JS, Evanoff B. Prevalence of parkinsonism and relationship to exposure in a large sample of Alabama welders. Neurology 2005;64:230-235. 3. Public Law 105-277 (1999)(requiring the Office of Management and Budget to promulgate regulations that required federal agencies awarding research contracts to ensure that "all data produced under a federal award will be made available to the public"); see also OMB Circular A-110, Uniform Administrative Requirements for Grants and Agreements with Institutions of Higher Education, Hospitals, and Other Non-Profit Organizations, Federal Register 64:5684 (Feb. 4, 1999). 4. Fienberg SE, Martin ME, Straf ML. Sharing Research Data. Washington DC: National Academies Press, 1985. 5. American College of Physicians. Guidelines for the Physician Expert Witness. Ann Intern Med 1990;113:789. Disclosure: Nathan A. Schachtman is a member of McCarter & English LLP, Philadelphia, PA. Mr. Schachtman, in his capacity as legal counsel for welding defendants, was responsible for serving the subpoenas discussed in the editorial piece by Drs. Racette and Perlmutter, and their legal counsel. He has prepared and tried hundreds of cases involving epidemiologic data, involving various disease outcomes, including neurological diseases and disorders. The opinions in this letter are his, and not necessarily those of his clients or his firm.
Reply from the Authors 2 April 2007
Brad A. Racette, Washington University School of Medicine 660 South Euclid Ave., Box 8111, St. Louis, MO 63110, Ann Bradley, Carrie A. Wrisberg, Joel S. Perlmutter Send Correspondence to journal: Re: Reply from the Authors racetteb{at}neuro.wustl.edu Brad A. Racette, et al.	We appreciate Mr. Schachtman’s interest in our recent article. However, it is important to point out the errors included in his letter. Mr. Schachtman inaccurately alleges that we provided “minimal disclosure” and collaborated with plaintiffs' counsel.[6] As originally disclosed in our article, [2] our University was paid by attorneys to perform medical screenings in Alabama of patients exposed to welding. The data that we collected was subsequently retrospectively examined and the results published. There was no funding or collaboration with attorneys as to any aspect of the design, execution, or publication of the study. Furthermore, Mr. Schachtman suggests that plaintiffs counsel's invocation of privileges for patients who did not file lawsuits proves an illicit collaboration between plaintiffs’ counsel and our research team. Various legal privileges protect patient medical data. [7] Pleadings filed in the multidistrict litigation indicate that none of the Alabama patients we examined became plaintiffs in the multidistrict litigation. The patient data demanded by the welding defendants' subpoenas related entirely to patients who were not plaintiffs in the underlying litigation. Counsel for these patients who did not file suit legitimately asserted litigation privileges to protect their medical data. Seeking protection of applicable privileges is procedural for lawyers and not evidence of a conspiracy. Mr. Schachtman stretches credibility by asserting that much of the cost of complying with subpoenas resulted from our “own actions”. His suggestion that we could have avoided litigation costs and simply complied with his clients subpoenas is, and was, an unacceptable outcome, in a case where neither the University nor its researchers are parties or designated experts. He and his clients’ primary interest in this research are to discredit it in a court of law; which is neither the forum nor the outcome we could abide willingly. Mr. Schachtman's clients served subpoenas, found by a United States District Judge to be overbroad and burdensome. A few examples included: copies of all patient videos; all grant applications by study authors; all drafts of the published version of the study; all editor and peer review comments to drafts of the study; and all data analyses outputs. [2,6] Failing to object to these unreasonable requests would have consumed greater resources, jeopardized patient confidentiality, and further delayed future research. Mr. Schachtman naively equates the peer-review system and scientific openness with legal review of data by medical experts paid large sums of money to discredit research. The former advances science and brings needed treatments to patients. The intent of the latter frequently is to intimidate scientists from pursuing new avenues of research that might prove detrimental to one side of a lawsuit. Reasonable limitations on access to researchers’ time and data would prevent investigators from abandoning promising research leads. However, researchers must also take responsibility for their actions and decide if their own personal gain trumps patients’ interests. Despite Mr. Schachtman’s claims to the contrary, it is reasonable to expect that a researcher avoid personal financial conflicts when conducting research. We owe our patients acknowledgement of the problem and correction of this abusive system. References 6. United States District Court for the Northern District of Ohio Eastern Division. MDL#1535, 2007. 7. See, e.g.,10 A.L.R. 4th 552, Physician-patient privilege as extending to patient's medical or hospital records, Wakefield WE. 2007. 8. United States District Court for the Eastern District of Missouri, Eastern Division, 4:05MC165SNL, 2005. Disclosure: The authors report no conflicts of interest.