The Illinois Medical Studies Act and Access to Underlying Research Data

In the course of the welding fume litigation, defense counsel sought underlying data and documentation from a study published by Dr. Brad Racette and others, on their observations of Alabama welders[1]. The Alabama study, with its duplicate publication, aroused counsel’s suspicion for several reasons, not the least of which was that plaintiffs’ counsel had participated in creating the study by providing their clients as participants at screenings to be conducted by Dr. Racette and his colleagues.  According to the disclosure in the Neurology article, the study was

“[s]upported by NIH grants K23NS43351 and NS41509, the Greater St. Louis Chapter of the American Parkinson’s Disease Association, and the Welder Health Fund. The Welder Health Fund was created by Gulf States Trial Attorneys to support medical–legal screening of welders for Parkinson disease. No author has taken any money personally related to this research.”

A little research showed that the referenced NIH grants were not for this specific study, which was a creation of the litigation industry d/b/a the Welder Health Fund.

Defense counsel directed subpoenas to both Dr. Racette and his institution, Washington University St. Louis, for the study protocol, underlying data, data codes, and statistical analyses.  After a long discovery fight, the MDL court largely enforced the subpoenas.  See, e.g., In re Welding Fume Prods. Liab. Litig., MDL 1535, 2005 WL 5417815 (N.D. Ohio Oct. 18, 2005) (upholding defendants’ subpoena for protocol, data, data codes, statistical analyses, and other things from Dr. Racette author of study on welding and parkinsonism).

Dr. Racette continued the controversy with a one-sided editorial in Neurology, which he wrote along with his legal counsel from the subpoena contest. Brad A. Racette, Ann Bradley, Carrie A. Wrisberg, and Joel S. Perlmutter, “The Impact of Litigation on Neurologic Research,” 67 Neurology 2124 (2006) [“Litigation Impact”]. Defense counsel wrote a response, which was limited due to the nature of the 400-word cap on letters to the editor. Nathan A. Schachtman, “The Impact of Litigation on Neurologic Research,” 69 Neurology 495 (2007).  A slightly more expansive response was published on the TortsProf blog. Schachtman, “Letter: Litigation and Research” (April 15, 2007).

The debate continued in October 2007, when Dr. Brad Racette and I were invited by the Committee on Science, Technology, and Law of the National Academies of Science to discuss litigation and compelled access to underlying research data.  Dr. Racette complained about how disruptive subpoenas were into the operation of his research.  The Committee members appeared unimpressed by the alleged burdens when they realized that Racette’s research grew out of medico-legal screenings organized, conducted, and paid for by plaintiffs’ lawyers, and that it had been over 30 years since the National Research Council urged scientists to plan proactively for sharing data from their research, and that current National Institutes of Health guidelines require such a plan[2]. Most members of the Committee expressed the view that nothing untoward had occurred with the subpoena of Dr. Racette’s underlying data.

The fight over Dr. Racette’s data had consequences in the courtroom.  Defense expert witnesses were able to see how Dr. Racette was able to generate the appearance of large increased prevalence of “parkinsonism” (idiosyncratically defined and ascertained), which appearance was at odds with the vast data from analytical epidemiologic studies from around the world. James Mortimer, Amy Borenstein, and Laurene Nelson, “Associations of welding and manganese exposure with Parkinson disease: Review and meta-analysis,” 79 Neurology 1174 (2012) (reporting a statistically significant decreased risk of Parkinson’s disease among welding tradesmen).  Remarkably, the plaintiffs’ counsel, who had sponsored the Alabama study, did not show the underlying Racette data and materials to their expert witnesses.  Within a short time after the subpoena was enforced, plaintiffs’ counsel mostly withdrew the epidemiologic component of their cases. Racette’s study ceased to play a major role in the plaintiffs’ claims. The debate over access to underlying data continues, both for clinical trials and for observational studies[3].

In “Litigation Impact,” Racette and colleagues offered specific remedial suggestions concerning the access of data.  One suggestion is to prohibit all data access categorically. Ironically, Racette’s suggestion run contrary to the widespread view that clinical trial data must be shared. Here is how Racette presents his suggestion:

“Stronger, more comprehensive federal legislation recognizing a research scholar privilege and ensuring that research data are uniformly protected against disclosure in all states is essential to advancing medical science.

Protections for study participants and researchers against disclosure of study data could be modeled after provisions such as those set forth in the Illinois Medical Studies Act. This Act specifically designates medical research study data and protocols as protected and prohibits the disclosure of research data obtained as part of a medical study.40,41 Enforcement includes a potential misdemeanor conviction for any person disclosing medical study data. Such legislation must strike a critical balance between the rights of industry to defend itself and the rights of researchers.”

Litigation Impact at 2128.

Is Racette correct that Illinois Medical Studies Act prevents disclosure of underlying research study data?

The claim seems dubious, but the Act is hardly a model of clarity:

Sec. 8-2101. Information obtained. All information, interviews, reports, statements, memoranda, recommendations, letters of reference or other third party confidential assessments of a health care practitioner’s professional competence, or other data of the Illinois Department of Public Health, local health departments, the Department of Human Services (as successor to the Department of Mental Health and Developmental Disabilities), the Mental Health and Developmental Disabilities Medical Review Board, Illinois State Medical Society, allied medical societies, health maintenance organizations, medical organizations under contract with health maintenance organizations or with insurance or other health care delivery entities or facilities, tissue banks, organ procurement agencies, physician-owned insurance companies and their agents, committees of ambulatory surgical treatment centers or post-surgical recovery centers or their medical staffs, or committees of licensed or accredited hospitals or their medical staffs, including Patient Care Audit Committees, Medical Care Evaluation Committees, Utilization Review Committees, Credential Committees and Executive Committees, or their designees (but not the medical records pertaining to the patient), used in the course of internal quality control or of medical study for the purpose of reducing morbidity or mortality, or for improving patient care or increasing organ and tissue donation, shall be privileged, strictly confidential and shall be used only for medical research, increasing organ and tissue donation, the evaluation and improvement of quality care, or granting, limiting or revoking staff privileges or agreements for services, except that in any health maintenance organization proceeding to decide upon a physician’s services or any hospital or ambulatory surgical treatment center proceeding to decide upon a physician’s staff privileges, or in any judicial review of either, the claim of confidentiality shall not be invoked to deny such physician access to or use of data upon which such a decision was based.
(Source: P.A. 92-644, eff. 1-1-03.)

Ill.Ann.Stat. ch. 735 § 5 (Code of Civil Procedure)/8–2101, et seq. (Medical Studies).

Racette’s suggestion that the Act protects the underlying data from research studies is not supported by reliable precedent.  Plaintiffs’ lawyers, including lawyers who worked with Dr. Racette in the welding litigation, have objected to discovery on the basis of the Act, but the objections were apparently not further litigated. See Videotape Deposition of Paul A. Nausieda, M.D. in Boren v. A.O. Smith Corp., Circuit Court of Illinois, Third Judicial Circuit (Dec. 22, 2004).

The Act itself has no ostensible connection to protecting the underlying data in an epidemiologic study.  Niven v. Siquiera, 109 Ill. 2d 357, 487 N.E.2d 937 (1985) (“the purpose of the Act is to encourage candid and voluntary studies and programs used to improve hospital conditions and patient care or to reduce the rates of death and disease”); Matviuw v. Johnson, 70 Ill. App.3d 481, 486, 388 N.E.2d 795, 799 (1st Dist. 1979). The Act protects peer-review or quality-control committees that supervise overall medical care with a view to improving the quality and standard of care, and reducing morbidity and mortality of patients. The privilege is designed to permit persons to speak freely to committees, and to protect their self-evaluative deliberations. Id.; Walker v. Alton Memorial Hospital Ass’n, 91 Ill. App.3d 310, 314, 414 N.E.2d 850, 853 (5th Dist. 1980). For a document to fall within the scope of the Act, it must be “generated specifically for the use of a peer-review committee.” Webb v. Mt. Sinai Hospital and Medical Center of Chicago, Inc., 807 N.E.2d 1026, 1033 (Ill. App. Ct. 2004)(internal citation omitted).

Given the language of the Act, and its interpretation in the Illinois courts, it is not surprising that attempts to assert the statutory privilege to defeat research subpoenas have failed.

In Andrews v. Eli Lilly & Co., Inc., 97 F.R.D. 494 (N.D. Ill. 1983), the district judge quashed a subpoena that sought production of records from research that was exploring the association between maternal use of diethylstilbestrol and daughters’ development of adenocarcinoma of the vagina. In granting the motion to quash, the district judge acknowledged that the Medical Studies Act protected the records from disclosure. Id. at 500. The party seeking discovery, argued that the Illinois statute was limited to hospital peer review.  The district court acknowledged that the purpose of the Act was to ensure confidentiality of the peer-review process, but that the “plain language” of the statute did not limit protected material to that used for peer review. Id. at 500 n.19. In any event, Andrews was stripped of any precedential force when it was vacated by the United States Court of Appeals.   Deitchman v. E.R. Squibb & Sons, Inc., 740 F.2d 556 (7th Cir. 1984).

In the Orthopedic Bone Screw MDL, plaintiffs sought research study documents from the Scoliosis Research Society. Invoking the Illinois Medical Studies Act, the Society moved for a protective order to prevent disclosure of the names of physicians and patients who participated in “The Pedicle Screw Cohort Study,” and the disclosure of documents from that study. In re Orthopedic Bone Screw Prods. Liab. Litig., MDL No. 1014, 1996 WL 34394351 (E.D. Pa. Feb. 14, 1996), app. dism’d, 94 F.3d 110 (3d Cir. 1996). The Society claimed that the Act provided an unconditional confidentiality for all data and related information underlying a “a medical study.” Id. at *2.

The MDL court denied the plaintiffs’ motion to enforce, but rejected the claim that the Act created a privilege that applied in the case. Id. at *3 (citing the predominant federal interest in determining whether a state court privilege applied, and the lack of Illinois interests in a choice of law analysis).

In another multi-district litigation, Pfizer sought peer reviewer and editorial comments from the Journal of the American Medical Association, on articles and manuscripts of studies involving its COX-2 inhibitor medications, Bextra and Celebrex.  In re Bextra & Celebrex Mktg. Sales Practices & Prod. Liab. Litig., Case No. 08 C 402, 2008 U.S. Dist. LEXIS 21098; 2008 WL 4345158 (N.D. Ill. Mar. 14, 2008). The Journals asserted privileges, including a statutory privilege under the Illinois Medical Studies Act. Id. at *10-12. The federal district court ruled that the privilege appeared not to apply to manuscripts, articles, peer reviewer and editorial comments:

“The Medical Studies Act, 735 ILCS 5/8-2101, provides that [a]ll information, interviews, reports, statements, memoranda, recommendations, letters of reference or third party confidential assessments of a health care practitioner’s professional competence, or other data …  of allied medical societies . . . used in the course of internal quality control or of medical study for the purpose of reducing morbidity or mortality, or for improving patient care or increasing organ and tissue donation, shall be privileged, strictly confidential and shall be used only for medical research, increasing organ and tissue donation, the evaluation and improvement of quality care, or granting, limiting or revoking staff privileges or agreements for services . . . . 735 ILCS 5/8-2101. The purpose of the Act is to ‛ensure that members of the medical profession can maintain effective professional self-evaluation and to improve the quality of healthcare’.

To that end, the Act clearly protects from disclosure information gathered in the course of a peer review, but only if it is used in connection with a program or study designed to improve internal quality control or patient care, or to reduce morbidity and mortality. Putting aside the question of whether the Journals would qualify as ‛allied medical societies’, the Court is not persuaded that the specific information identified in the subpoenas fits within this definition. In her declaration, Dr. DeAngelis represented that JAMA ‛publishes scientific articles, commentaries, and news involving all fields of medicine, including medical research, significant clinical observations, diagnostic and therapeutic developments, legal and social matters of interest to  physicians, and issues of medical ethics’; JAMA’s motto, she said, is ‛to promote the science and art of medicine and the betterment of the public health’. DeAngelis Declaration, PP12-13. A lofty goal – but one that far transcends the provisions of the Medical Studies Act. The Act protects from disclosure documents only when ‛used in the course of internal quality control or of medical study for the purpose of reducing morbidity or mortality, or for improving patient care or increasing organ and tissue donation’; surely not everything published in JAMA and AIM – or everything considered for publication – can fairly be described this way. And, on the limited record before it, the Court cannot say that all of the documents requested in the subpoenas can be either.”

Id. at *11-14.

Racette’s suggestion that the Illinois Medical Studies Act can provide guidance with respect to research subpoenas is wrong on the law, facts, and policy of the need for data sharing. The public, and its members, remain entitled to every man’s evidence. See Lord Hardwicke’s Speech on Lord Orford’s Bill (May 25, 1742), quoted in George Harris, The Life of Lord Chancellor Hardwicke; with Selections from His Correspondence, Diaries, Speeches, and Judgments, Vol. 2, at 8 (1847).

[1] See Brad A. Racette, S.D. Tabbal, D. Jennings, L. Good, J.S. Perlmutter, and Brad Evanoff, “Prevalence of parkinsonism and relationship to exposure in a large sample of Alabama welders,” 64 Neurology 230 (2005); Brad A. Racette, et al., “A rapid method for mass screening for parkinsonism,” 27 Neurotoxicology 357 (2006).

[2] See National Institutes of Health, Final Statement on Sharing Research Data (Feb. 26, 2003); Stephen E. Fienberg, et al., eds. Committee on National Statistics, National Research Council, Sharing Research Data (1985); Eleanor Singer, chair, Panel on Data Access for Research Purposes, National Research Council, Expanding Access to Research Data: Reconciling Risks and Opportunities (2005).  See also National Academy of Sciences Committee on Ensuring the Utility and Integrity of Research Data in a Digital Age, Ensuring the Integrity, Accessibility, and Stewardship of Research Data in the Digital Age (2009).

[3] See, e.g., Jesse A Berlin, Sandra Morris, Frank Rockhold, Lisa Askie, Davina Ghersi, and Joanne Waldstreicher, “Bumps and bridges on the road to responsible sharing of clinical trial data,” 11 Clinical Trials 7 (2014); Rebecca Kush & Michel Goldman, “Fostering Responsible Data Sharing through Standards,” 370 New Engl. J. Med. 2163 (June 5, 2014); Jerome P. Reiter & Satkartar K. Kinney, “Sharing Confidential Data for Research Purposes: A Primer,” 22 Epidemiology 632 (2011).

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