April 1998 Bulletin

Pedicle screw:
1st cases naming Academy sent to local courts

The first 53 cases naming the Academy and two other medical organizations as defendants in the pedicle screw product liability litigation have been sent back to federal district courts from which they originated across the country. The local courts will supervise remaining discovery, decide pretrial motions and conduct individual trials.

They are part of more than 5,000 civil actions against manufacturers, physicians and medical associations which were previously consolidated for pretrial administration before Judge Louis Bechtle in the U.S. District Court for the Eastern District of Pennsylvania, Philadelphia. The Academy will be working closely with the other defendants in the 53 cases - including the Scoliosis Research Society and the North American Spine Society - to file motions for summary judgment in the local district courts. If the motions for summary judgment are not granted, the cases will be tried.

"The Academy’s motions for summary judgment will argue that there is no causal connection between the plaintiffs’ injury and anything the Academy did; precisely, that the speakers at Academy meetings did not, by their statements, fraudulently induce implanting physicians to use pedicle screw instrumentation," says Norman P. Jeddeloh, of Burditt & Radzius, Chtd., one of the Academy’s outside legal counsels. This argument is, in turn, based upon an earlier opinion by Judge Bechtle narrowing the scope of the claims against the medical associations which could be used to support a finding of fraud. According to Jeddeloh, to prove fraud under Judge Bechtle’s ruling, the plaintiffs must now show that physicians were induced to implant the pedicle screw because the speakers at a medical association seminar did not disclose their financial arrangements with manufacturers, did not disclose the FDA clearance status of the pedicle screw and did not disclose the risks and complications of using the pedicle screw.

Jeddeloh says that "if the physicians who implanted the device did not attend a medical association meeting where the device was discussed or if the physician would have implanted a pedicle screw regardless of a speaker’s nondisclosure of these so-called facts, there is no causation, and, therefore, no fraud."

The 53 cases involving the medical associations were among more than 300 cases that have been remanded to the local courts. The Academy is a defendant in about 500 cases and the Academy will seek summary judgment in each case. Thus far, the Academy’s legal expenses total more than $1.6 million, some of which are covered by insurance.

The Academy and other medical associations were first named defendants in the pedicle screw multidistrict litigation on Oct. 20, 1995. The plaintiffs allege that the medical associations and manufacturers conspired to promote and market the use of the pedicle screws by holding courses at which the pedicle screw was discussed. The medical associations deny they were involved in a conspiracy and contend they were holding educational meetings at which scientific information was discussed.

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