August 1996 AAOS Report

Plantiffs drop OREF, OTA from pedicle screw case

On June 28, the Orthopaedic Research and Education Foundation (OREF) and Orthopaedic Trauma Association (OTA) received word that the Plaintiffs Legal Committeee (PLC) had dropped them from the multidistrict litigation (MDL) involving the pedicle screw. Judge Louis C. Bechtle, presiding judge in the MDL based in Philadelphia, entered an order dropping OTA and OREF on July 11. The PLC claimed that while these two organizations had been properly joined in the MDL, the relationship of OREF and OTA with the alleged pedicle screw conspiracy was "sufficiently attentuated" to justify their dismissal. On July 25, Judge Bechtle heard additional oral arguments on the conspiracy and concert of action allegations. As before, the court took these arguments on why certain defendants, including the remaining medical societies, should be dismissed under advisement. In addition, on August 8, the Third Circuit Court of Appeals in Philadelphia is scheduled to hear arguments from the Scoliosis Research Society (SRS) that Judge Bechtle should not have allowed the PLC to use certain information from the Pedicle Screw Cohort Study to make comments to the FDA on the agency's proposed reclassification of the pedicle screw from Class III to Class II. This information included data on specific physicians who participated in the Cohort Study, but not the names of the physicians. In February, the Third Circuit had denied an emergency motion by SRS to stay the use of this confidential material. The PLC submitted this confidential material, along with its own extensive comments on the proposed reclassification, to the FDA in early March.


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