June 1998 Bulletin

Academy, SRS, NASS dismissed from pedicle cases

The Academy, Scoliosis Research Society and North American Spine Society won summary judgment motions in the first three pedicle cases to reach local federal district courts early last month.

The first summary judgment was awarded May 1 in U.S. District Court, Southern District of Mississippi, Jackson Division in the case of Mary Coleman, et al., vs Danek Medical, Inc. et al. It was one of 53 suits naming the medical associations that were remanded to the local courts by Judge Louis Bechtle in the U.S. District Court for the Eastern District of Pennsylvania, Philadelphia where more than 5,000 civil actions against manufacturers, physicians and medical associations had been consolidated for pretrial proceedings. The Academy is a defendant in about 500 cases.

The plaintiffs allege the medical associations engaged in a "conspiracy to defraud by active concealment." The suit alleged the medical associations conspired with manufacturers of bone screws to conduct continuing medical education seminars designed to promote pedicle screw fixation.

Attorneys for the medical associations argued that there is no causal connection between the plaintiffsí injury and anything the associations did or was said at their continuing medical education seminars.

In the motions for a summary judgment, attorneys for the medical associations said that "abundant evidence has demonstrated that pedicle screw fixation is safe and effective, and the standard of care, for many patients. Since at least 1992, the FDA has acknowledged that pedicle fixation with screws has been 'considered to be the standard of care by the surgical community.'"

The attorneys pointed out that an orthopaedic surgeon designated by the plaintiffs "testified that bone screws used in the pedicles are not per se defective" and are often used by his colleagues. Numerous orthopaedic surgeons and neurologic surgeons deposed in the litigation said the same thing.

Bruce Senter, MD, Colemanís spine surgeon, said in a deposition that he was not misled or duped by anything that was or was not said at any CME seminar. The medical associationsí attorneys said Dr. Senter was well aware of possible risks, complications and benefits "long before" he attended any CME seminars at which this procedure was discussed. The attorneys said, ìDr. Senter testified that the speakers at the seminars he attended discussed the risks and complications of spinal fusion surgery using pedicle fixation with screws, and, if anything, were 'more conservative' than he was."

In Jeanette Wade, et al. vs Danek Medical, Inc., Harold Young, MD, Wadeís spine surgeon did not attend any of the medical associationsí seminars and, therefore, could have been duped by the medical associations. Wade sued the medical associations; bone screw manufacturers; various doctors, none of whom treated the plaintiff; and a hospital, where the plaintiff has never been; but did not sue Dr. Young.

To prove the claim that the medical associations engaged in a conspiracy to defraud by active concealment, the plaintiffs had to prove both civil conspiracy and fraud by active concealment. The medical associations' attorneys said the plaintiffs provided no evidence that the medical associations agreed with bone screw manufacturers (or anyone else) to conceal any fact from or to defraud the physicians. To the allegation of active concealment, the attorneys said the plaintiffs cannot prove what was disclosed at the seminars, much less what was omitted.

The attorneys also said the FDA status of bone screw labeling and the financial relationships between the medical associations, seminar speakers and bone screw manufacturers were not material and nondisclosure or concealment does not support a claim of fraud.

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