ROANOKE TIMES
Copyright (c) 1996, Roanoke Times
DATE: Saturday, December 7, 1996 TAG: 9612090057
SECTION: VIRGINIA PAGE: C-3 EDITION: METRO
SOURCE: SANDRA BROWN KELLY STAFF WRITER
MORE THAN 100 SOUTHWEST Virginians have filed claims against the company's bone screw devices, used in spinal surgery.
A Cleveland company facing about 4,000 lawsuits involving use of its bone screws in spinal fusion surgery has given preliminary agreement to a settlement of $100million in cash, plus the proceeds from its insurance.
More than 100 Southwest Virginia residents are among the persons with claims against the company, AcroMed Corp., based on information compiled by the People Against Pedicle Screws, a Roanoke Valley back surgery support group.
AcroMed's devices were used by at least two orthopedic surgeons who practiced at Carilion Roanoke Memorial Hospital and by surgeons at the University of Virginia and in a Raleigh, N.C., hospital. The AcroMed products had not been approved by the Food and Drug Administration for use in spine surgery.
AcroMed and the Plaintiffs' Legal Committee, the group a Philadelphia district court judge put in place to handle the consolidated suits, have until Jan. 6 to submit the formal class settlement agreement, said lawyer Arnold Levin of Philadelphia. The schedule for notifying claimants and for a hearing to approve the settlement will be set after that hearing.
Levin said Friday he couldn't estimate how much each person suing might receive because each claim will have to evaluated individually. Guidelines for assessing the cases still have to be worked out, he said.
The suits grew out of problems that occurred when doctors used screws and plates to hold the spine stable to encourage the fusion of a bone graft and the vertebrae. Screws were inserted into the pedicles, the sturdy side pillars of the vertebrae in a patient's backbone, in what was considered an experimental procedure.
Several group lawsuits were filed after many patients had problems with the devices breaking. Pedicle screws were the subject of a ``20/20'' television show in 1993, and the number of such surgeries dropped.
The settlement is expected to end all suits involving AcroMed devices, which in addition to the 4,000 against the company include another 2,000 suits against doctors and distributors.
Similar suits against other medical device manufacturers are still pending. These include claims against Sofmar Danek of Memphis, Tenn., whose products were used at Columbia Lewis-Gale Medical Center in Salem by surgeons from Lewis-Gale Clinic. Lewis-Gale had a specialty spine clinic for several years, but closed it after a number of lawsuits were filed against one of the surgeons, Dr. Eric Korsh.
Korsh has won one of the suits, another ended in a hung jury, and others still are active.
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