July 1996 AAOS Report

Judge to review pedicle screw cohort study records, drops some claims

In June, Judge Louis C. Bechtle of the Eastern District of Pennsylvania issued several significant rulings in the multidistrict litigation involving pedicle screws. On June 6, Judge Bechtle ordered the U.S. Food and Drug Administration (FDA) to submit the identities of all physicians who participated in the pedicle screw Cohort Study to him for an in camera review, along with the physicians' financial disclosure documents. An in camera review means that only the judge may review the documents. In issuing this order, Judge Bechtle indicated that the purpose of his in camera review "will be to determine if there are material discrepancies between the financial disclosure statements [made by the physicians participating in the Cohort Study] and the other available information of record developed through discovery, and if so, how many physicians are affected." After he determines the facts, Judge Bechtle will convene a hearing to determine any future course of action. The judge did not appoint an accountant to perform the review as had been requested by the PLC. In a related matter, the FDA indicated in a May 6 letter to Judge Bechtle that its ongoing audit of the Cohort Study will be released in summary form at an undetermined future date. The FDA indicated that the fact-finding aspect of its audit of the Cohort Study is complete, and that the agency is reviewing and evaluating the significance of the information gathered. On June 24, Judge Bechtle dismissed the fraud on the marketplace claim presented by the PLC and the PLC withdrew its enterprise liability claim against the defendants. In addition, initial oral arguments on the Academy and others' motion to dismiss were held. The court took the arguments under advisement. Oral arguments will continue throughout the summer on other phases of defendants' motions to dismiss.


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