October 1995 AAOS Report

Plantiffs seek names from Pedicle Screw Cohort Study; Academy prepared to challenge

The Academy has received information that plaintiff attorneys in the pedicle screw multidistrict litigation in Philadelphia are seeking to obtain the names of physicians who participated in the Pedicle Screw Cohort Study. A Scientific Committee composed of representatives of the Academy, the North American Spine Society, the Scoliosis Research Society, the American Association of Neurological Surgeons, and the Congress of Neurosurgeons conducted the Cohort Study in 1993-1994 at the request of the U.S. Food and Drug Administration. According to Academy president James W. Strickland, MD, "The confidentially of physician and patient names is integral to the integrity of most research protocols, and an assurance of confidentiality was given to orthopaedic and neurological surgeons who participated in the Pedicle Screw Cohort Study. The Academy stands ready to take all appropriate legal actions to block the release of the names of the physicians from the Cohort Study." Other organizations on the Scientific Committee are similarly concerned about this breach of established research protocol.


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