Four medical associations based in the Chicago suburbs are trying to shield themselves from hundreds of lawsuits filed in a massive product-liability battle over a device used in spine surgery.
At issue is whether the groups acted improperly in sponsoring meetings and publishing articles in which the controversial device-called the pedicle screw-was discussed.
The societies contend it's a matter of free speech and cite the need to disseminate information about medical options. Plaintiffs have charged them with nothing less than a nationwide conspiracy to illegally market an unsafe medical device.
None of the 800 to 1,000 cases (including 27 originally filed in Illinois) has yet gone to trial. The four medical groups-the Rosemont, Ill.-based North American Spine Society, Scoliosis Research Society and American Academy of Orthopaedic Surgeons, and the Park Ridge, Ill.-based American Association of Neurological Surgeons-are embroiled in a pretrial bid to be dismissed from the cases.
A decision is expected soon from a federal judge in Philadelphia, where the lawsuits have been consolidated. If they are not dismissed, the doctors' groups say they face possible bankruptcy if they are eventually found liable.
The legal free-for-all could yield hundreds of millions of dollars in actual and punitive damages. Both sides are bracing for a constitutional showdown.
"The First Amendment-they're trying to erode that with this issue," says Eric J. Meuhlbauer, executive director of the North American Spine Society, a defendant whose membership is composed of orthopedic and neurological surgeons. If the physician groups are included in the lawsuits, he said, "it's going to chill people from doing research, and it's going to eventually hurt patients."
Since 1995, the four local groups have been among more than two dozen defendants in conspiracy lawsuits over the pedicle screw-a metal implant used with rods or plates to attach vertebrae in order to aid bone grafts or promote fusion.
A common technique. Before the 1940s, bone screws were used by surgeons to heal arm and leg injuries. About 30 years ago, their use in spine surgery became commonplace, Meuhl-bauer said. About 40,000 back surgeries annually in the U.S. involve pedicle screws.
But in 1993, an expose by the ABC-TV program "20/20" detailed post-surgical complications-including spinal fractures and spinal fluid leakage-in some patients, allegedly related to the pedicle screw. At that point, patients began suing surgeons and manufacturers of the device, including Cleveland-based AcroMed Corp. and Memphis, Tenn.-based Sofamor Danek Group.
The spine society's attorney, Shawn Collins, points out that the current wave of conspiracy lawsuits departs from the pure product-liability cases of the early 1990s: "The real flood started to happen in October 1995. The (later lawsuits) named not only the manufacturers but*.*.*.*medical societies, doctors who spoke and wrote in support of the use of pedicle screws, hospitals all over the country who taught the implanting of these pedicle screws (and) magazine editors who wrote articles. It was an absolute kitchen-sink approach."
Collins notes that in 1976, amendments to the U.S. Food, Drug and Cosmetics Act required the federal government to approve the marketing of certain medical devices classified as being of "high risk" to patients.
High risk. The marketing of all bone screws designed before the 1976 amendments are exempt from federal oversight, but newer pedicle screw designs are classified as "high risk" by the Food and Drug Administration, and marketing them is prohibited.
However, it's only the marketing of the devices that's banned, not their use-so pedicle screws, including those of newer design, continue to be used in surgery.
Plaintiffs' lawyers charge that manufacturers and medical groups have skirted the marketing prohibition. Indeed, a 1995 Illinois lawsuit states, "The . . . associations which participated in the . . . conspiracy did so, in part, because they recognized that they could capitalize on the manufacturers' interest in promoting (the) devices through the associations by obtaining significant financial compensation and remuneration from manufacturers."
That lawsuit, involving a patient operated on at LaGrange (Ill.) Memorial Hospital, charges that the spine society received $600,000 from manufacturers for holding scientific meetings in which presentations were given on the pedicle screw; the American Academy of Orthopaedic Surgeons received $815,562, and the Scoliosis Research Society was paid $440,000 by manufacturers. Neither LaGrange Memorial nor the surgeon who performed the operation is a defendant in the case.
Although not named in the LaGrange Memorial lawsuit, the American Association of Neurological Surgeons is charged in other lawsuits with receiving $80,000 from pedicle screw manufacturers.
Arnold Levin, a Philadelphia attorney who heads a committee of lawyers for the plaintiffs, said, "This is absolutely the most important thing. (The associations) were partners in this (with the manufacturers)."
Neither the American Academy of Orthopaedic Surgeons nor the Scoliosis Research Society would comment.
However, David F. Fardon, a Knoxville, Tenn., orthopedic surgeon and president of the spine society, said, "What we've been doing is not secretive or anything that the right of free speech doesn't allow us to do." He said the payments were for exhibit space and other fees associated with medical conventions at which manufacturers commonly display their wares, and he said every exhibitor pays the same price.
"If Americans can't participate in courses and research and development projects because of the legal climate, then either it's not going to get done or it's going to be taken overseas," he argued.
But the four medical groups could have more immediate concerns if they remain as defendants.
"We are not a deep-pockets organization," said a spokeswoman for the neurological association, adding that the 5,000-member group's annual budget is about $11 million. "We would be out of business" if found guilty of conspiracy and held liable for large monetary penalties.
But Levin isn't budging. "(They) have First Amendment privileges, but not when they become agents of the manufacturers and aid and abet the sale of an unapproved device."