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In Brief: Plaintiff pedicle screw comments

This article was originally published in The Gray Sheet

Executive Summary

Plaintiff pedicle screw comments: Plaintiffs' Legal Committee submits supplemental comments in response to the American Association of Neurological Surgeons' request for finalization of the agency's proposed reclassification of pedicle bone screws from Class III to Class II ("The Gray Sheet" June 9, I&W-10). AANS said results of a pedicle bone screw cohort study used by FDA to support its October 1995 downclassification proposal warrant immediate finalization of the rule. PLC states that AANS' petition "contains an extremely limited, one-sided account of the expert testimony before the" U.S. District Court in Philadelphia, which is overseeing multi-district pedicle bone screw liability proceedings, "and a skewed perspective on the court's ruling regarding the admissibility of the cohort study." PLC claims that the study is flawed because "those who designed and executed the cohort study made no effort to minimize selection bias, information bias, loss to follow-up bias, random error, or confounding error. Furthermore," PLC says "they failed to reveal significant conflicts of interest and they took steps to destroy material documents pertaining to the Study"...

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