January 1996 Bulletin

Pedicle screw suits name Academy, others

More than 20 law suits have been filed in numerous federal district court jurisdictions against the Academy on behalf of plaintiffs alleging injuries resulting from spinal surgeries utilizing pedicle screws.

In two suits in the New York District federal district court-Fine v. Danek Medical, Inc., et. al, and Donin v. Danek Medical Inc., et. al-the charges arise from the implantation of the Cotrel-Dubousset spinal fixation system manufactured by Sofamor.

In these cases, the Academy, North American Spine Society, Scoliosis Research Society, CICD-USA, Texas Scottish Rite Hospital, and Groupe International Cotrel-Dubousset were named as defendants for their role as "Promotional Centers." The suit also names spinal implant manufacturers, regulatory consultants, and product promoters. (Sixteen individual orthopaedic surgeons are defendants.)

The suits charge the "Promotional Centers" with illegal marketing and promotional activities. The suits allege that "the Promotional Centers failed to exercise reasonable care in disseminating, marketing materials that (a) marketed and promoted pedicle screw devices, including the Cotrel-Dubousset system, in violation of FDA (U.S. Food and Drug Administration) regulations; (b) made false claims of the benefits of such devices; or (c) made false claims of the potential risks of such devices." The suits also allege "the Promotional Centers organized, advertised, sponsored and/or taught seminars or workshops advocating pedicle screw spine plate fixation systems, including the Cotrel-Dubousset system." The Academy and other defendants will vigorously defend these suits.

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