December 1995 AAOS Report

Physician names in Pedicle Screw Cohort Study "inadvertently" released by FDA

Despite a court order expressly prohibiting their release, the U.S. Food and Drug Administration (FDA) in late October "inadvertently" released to plaintiffs' counsel the identity of some or all of the physicians who participated in the Pedicle Screw Cohort Study. The court had ordered the FDA to release the Master File containing all information from the cohort study to plaintiffs' counsel, but with the participating physician names specifically deleted. Upon discovering that the plaintiffs had received the physician names, Judge Louis Bechtle ordered that plaintiffs not to use, duplicate, or release any of the confidential information they had obtained. Counsel for the Academy, North American Spine Society (NASS), Scoliosis Research Society (SRS), and the American Association of Neurological Surgeons (AANS) had already moved to intervene in this matter to protect the identity of the physicians from further dissemination, but have filed an emergency motion intended to speed the resolution of this matter. Also, on Nov. 15, the House Committee on Commerce conducted hearings to review the FDA's role in providing plaintiffs with the physician names in this case. The Academy, NASS, SRS, and AANS will continue to diligently pursue all reasonable available measures to protect the names of the physicians involved in the cohort study.


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