Judge Louis Bechtle of the Eastern District of Pennsylvania issued an order in December in the pedicle screw litigation which provides a compromise between the plaintiffs' request for public release of the complete Pedicle Screw Cohort Study and the demands of the attorneys for the Academy, North American Spine Society (NASS), Scoliosis Research Society (SRS), and American Association of Neurological Surgeons (AANS) that the promised confidentiality of the study participants be honored. Judge Bechtle's order provides that all of the Cohort Study information may be used by the plaintiffs and publicly disclosed, but that the names and other personally identifying information of physicians who participated in the Cohort Study must be removed from the materials. Judge Bechtle made an exception for the names of the members of the Scientific Committee which conducted the study, the members of the U.S. Food and Drug Administration (FDA) Orthopaedic and Rehabilitation Devices Advisory Panel, and persons who made presentations or testified before the Advisory Panel on Aug. 20, 1993 and July 22, 1994. The plaintiffs expressed an intent to provide the Cohort Study information to the FDA as part of the public comment process on the agency's proposal to reclassify pedicle screws from class III to class II for two uses (AAOS Report, November 1995). Because the period for public comment on the FDA's reclassification proposal initially ended Jan. 2, 1996, and due to the time needed to properly make the Cohort Study ready for publication without the names of the participants, Judge Bechtle requested and the FDA extended the comment period to March 4. The Academy has submitted a statement to the FDA supporting the proposal.
In mid-January, the Orthopaedic Research and Education Foundation and Orthopaedic Trauma Association were named as defendants in the pedicle screw litigation, joining the Academy, NASS, SRS, and AANS. The suits contend the organizations were "Promotional Centers" for the use of pedicle screws and aided spinal implant manufacturers in promoting the use of the screws by, among other things, educational seminars and workshops. The Academy and others continue to vigorously defend the suits.