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SOFAMOR DANEK GROUP v. CLINTON

December 6, 1994

SOFAMOR DANEK GROUP, Inc., Plaintiff,
v.
J. JARRETT CLINTON, et. al., Defendants.



The opinion of the court was delivered by: GLADYS KESSLER

 I. Introduction and Procedural History

 This action for declaratory and injunctive relief is brought under the Administrative Procedure Act, 5 U.S.C. § 701 et. seq., the Federal Advisory Committee Act (FACA), 5 U.S.C. app. 2 § 1 et. seq., and the Freedom of Information Act (FOIA), 5 U.S.C. § 552. *fn1" Plaintiff Sofamor Danek, through wholly-owned subsidiaries, develops and manufactures prescription medical devices used in spinal surgery. Defendant Department of Health and Human Services (HHS) -- through the Agency for Health Care Policy and Research (AHCPR), the Forum for Quality and Effectiveness in Health Care (Forum), and the Expert Panel on Low Back Problems in Adults (Low Back Panel) -- has completed development of a Clinical Practice Guideline (CPG) on low back problems (Low Back CPG).

 In brief, Plaintiff seeks to bar Defendants from publishing, disseminating, or in any way relying on the CPG for Acute Low Back Pain, on the grounds that the CPG has been generated by an expert panel convened and operated in violation of the public-access requirements of the Federal Advisory Committee Act.

 Plaintiff filed its Complaint on May 24, 1994. On July 18, 1994, Defendants answered. On August 1, 1994, Plaintiff filed its Motion for Summary Judgment, and Defendants filed their Cross-Motion for Summary Judgment on August 12, 1994. On September 16, 1994, Plaintiff filed an Unopposed Motion to Expedite Consideration of This Matter, and, after Defendants filed a Notice that the Low Back CPG was scheduled to be distributed on December 8, 1994, Plaintiff filed a Motion for Preliminary Injunction as well as a Request for Expedited Hearing. Defendants filed their Opposition to Plaintiff's Motion for Preliminary Injunction on November 30, 1994.

 Because the Court finds that the Cross-Motions for Summary Judgment can be decided on the papers and on the case file in its entirety, and that consequently no oral hearing is necessary, the Court denies Plaintiff's Request for an Expedited Hearing (33-1).

 Accordingly, this matter is now before the Court upon Plaintiff's Motion for Preliminary Injunction (2-2); Defendants' Motion for Summary Judgment (15-1); and Plaintiff's Motion for Summary Judgment (27-1). The Court has considered the Motions, Oppositions, Replies, and the case file in its entirety, as well as the case law relevant to this action.

 For the reasons stated below, Plaintiff's Motions for Preliminary Injunction and for Summary Judgment shall be denied, and Defendants' Motion for Summary Judgment shall be granted.

 II. Statement of Facts2

 The Agency for Health Care Policy and Research (AHCPR) is an agency of the United States Public Health Service, Department of Health and Human Services. Congress established the AHCPR in the Omnibus Budget Reconciliation Act of 1989 (OBRA), Pub. L. No. 101-239, § 901, 103 Stat. 2189 (1989), which amended the Public Health Service Act, 42 U.S.C. §§ 1301 - 1395ccc. *fn3" Congress intended the AHCPR to improve the quality, appropriateness, and effectiveness of health care services, and to improve access to such services. 42 U.S.C. § 299(b). To carry out that objective, Congress directed the AHCPR to facilitate development of CPGs, guidelines that would establish parameters for diagnosing, treating, managing, and preventing selected conditions. 42 U.S.C. § 2(a).

 Congress required that the CPGs be based on a comprehensive review of the best scientific research and professional judgment and that they be presented in formats appropriate for use by physicians, health care practitioners and providers, medical educators, and medical review organizations. 42 U.S.C. § 299b-1(b). The AHCPR defines clinical practice guidelines (CPGs) as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." AHCPR Program Note (August 1993) at 1, Attached as Exhibit 1 to Defendants' Motion for Summary Judgment.

 Congress in the OBRA also established the Forum for Quality and Effectiveness in Health Care (Forum). Through the Forum, the AHCPR oversees the development, periodic review and updating of the CPGs. 42 U.S.C. § 299b. Based on the guidelines produced, the Forum oversees development of medical review criteria, standards of quality, and performance measures which assist health care providers to assess or review the provision of health care. AHCPR Program Note, supra, at 1.

 Congress directed the AHCPR to develop CPGs through the establishment and operation of panels of medical experts and consumers. 42 U.S.C. § 299b-2. The AHCPR facilitates the development of CPGs in two ways: it either itself convenes multidisciplinary private-sector panels of experts and health care consumers, or it contracts with public or private nonprofit organizations to convene panels of experts. AHCPR Program Note, supra, at 2.

 On March 18, 1991, the AHCPR announced in the Federal Register that it was establishing a panel of experts and health care consumers to develop clinical practice guidelines for low back disorders and related conditions and invited nominations of qualified individuals to serve as chairperson(s) and as panel members. 52 Fed. Reg. 11452 (March 18, 1991).

 On April 22, 1992, Dr. James Mason, Assistant Secretary for Health at HHS announced the formation of an AHCPR sponsored 23-member panel of private-sector health care experts and consumers to develop clinical practice guidelines for diagnosing and treating low back problems.

 On July 24, 1992, the AHCPR announced in the Federal Register that a public meeting would be held on September 16, 1992 to receive comments and information pertaining to the development of the clinical practice guidelines on Low Back Problems. 57 Fed. Reg. 32991 (July 24, 1992).

 Sofamor Danek, by letter from its counsel dated November 1, 1993, informed the AHCPR that it believed the Expert Panels convened to develop clinical practice guidelines, including the Low Back Problems Panel, were advisory committees subject to the procedures and requirements of the Federal Advisory Committee Act (FACA), 5 U.S.C. App. 2.

 In a letter to Sofamor Danek dated November 10, 1993, Dr. Jarrett Clinton, then the Administrator of AHCPR, stated that the clinical practice guideline panels are not advisory committees within the meaning of FACA and therefore not subject to FACA's procedural requirements. Representatives of Sofamor Danek and the Department of Health and Human Services met on March 28, 1994. By letter dated April 29, 1994, Beverly Dennis, the Deputy General Counsel at HHS, informed counsel for Sofamor Danek that it continued to be HHS's opinion that the clinical guideline panels are not advisory committees within the meaning of FACA.

 After more than two years of work and study, the Low Back Problems Panel has now completed the development of the CPG on low back problems. Along with the CPGs, the AHCPR will publish and disseminate a Quick Reference Guide for Physicians and a Patient's Guide. The AHCPR will publish and disseminate the CPG on low back problems and its accompanying documents without charge to physicians, health care practitioners and providers, medical educators, and medical review organizations. The CPG on low back problems will also be available through the AHCPR Publications Clearinghouse. Individuals or organizations may call a toll-free number or write the Clearinghouse, and the Clearinghouse will send the CPG, the Clinician's Guide, or the Patient Guide to the requestor without charge. ...


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