Victims of unapproved spinal operations fight back.

About a thousand times a week somewhere in the United States a surgeon inserts two-inch metal screws into the walls of someone's spinal vertebrae. These so-called pedicle screws hold metal plates or rods firmly against the spinal column to help fuse together two or three pain-causing vertebrae. The operation is often successful and patients are grateful.

Sometimes the fusion fails, the screws bend or break, perhaps damaging nearby nerves in the spinal column, and the patient is in far worse condition than before the screws were inserted.

At this point, the patient may learn that the U.S. Food and Drug Administration (FDA) has never approved the use of screws in the spine, that the FDA has warned manufacturers to stop advertising screws for that use, and that many of the doctors who perform these operations have significant financial ties to the manufacturers of spine stabilization devices. These patients are not at all grateful, and they sue.

According to attorney Gary Eaton of Tulsa, Oklahoma, who chairs an ATLA litigation group subcommittee concentrating on spinal-screw litigation, several thousand people from all parts of the country joined class action suits against the manufacturers of spinal fixation systems that use screws. The class actions and about 60 individual cases were consolidated in federal multidistrict litigation in the Eastern District of Pennsylvania. In re Orthopedic Bone Screw Products Liability Litigation, No. MDL 1014 (E.D. Pa. consolidated Aug. 8, 1994).)

On February 22, 1995, Judge Louis Bechtle denied certification for the class but allowed the MDL to continue through pre-trial discovery. The cases will revert to district courts for trial.

When spinal screws break, slip, migrate, or have been poorly positioned by a surgeon, patients suffer excruciating pain. "It felt like someone was hanging on my spine all the time," said Barbara Ausmann of Westville, Pennsylvania, who had screws implanted in 1991. "I was at the point that if I didn't get help I would walk to [a] bridge and I would jump." Ausmann endured another operation to have the screws removed.

Before Frank Reynolds of Roxborough, Pennsylvania, underwent his spinal fusion operation in 1991, his surgeon told him he would be back at work in six weeks and he would "play tennis, basketball, and golf at full speed." Reynolds has never returned to work. He has pain in his right leg and numbness in his toes and genitals.

"Last night, I was awake all night in pain," he told a reporter. "I was lying in bed and could actually feel the screws." (Susan Fitzgerald, Spinal Screws Can Be a Pain in the Back, FDA Warns, Salt Lake Trib., Aug. 11, 1994, at C1.)

In addition to pain, victims suffer blood vessel injuries, infection, weakness or progressive paralysis in the legs, loss of bladder and bowel control, and wounds in the fusion mass that do not heal. They also face soft-tissue reactions to the implants, degeneration of neighboring areas of the spine, and "failed-back-surgery syndrome" (which commonly includes depression, frustration, hysteria, and hostility).

On December 20, 1994, the Public Citizen Health Research Group in Washington, D.C., published the results of an investigation of pedicle screw implantation. Public Citizen called for "a moratorium on most uses of bone screws in the spine until manufacturers can show that they are safe and effective." The research organization also urged the FDA to "immediately move for substantial criminal or civil penalties against each manufacturer that illegally promoted the pedicle screw systems."

Bone screws have been on the market for repair of long bone fractures (as in the arm or leg) since before the Medical Device Amendments Act of 1976. During the 1980s, some surgeons decided that bone screws, used with plates and rods, would aid fusion when the screws were placed through the pedicles or walls of the spinal vertebrae. Between 1979 and 1987 spinal fusion became the fastest growing spinal procedure in U.S. medicine, increasing 200 percent.

But the screws were never approved for spinal use by the FDA. The agency did, however, grant some investigational device exemptions for clinical testing of pedicle fixation systems (involving about 6,120 patients), but it refused to approve spinal screws except in those limited experiments.

Manufacturers nonetheless proceeded to advertise the pedicle systems, recruit doctors into training programs, and contribute anecdotal reports to the medical literature about successful experiences. As noted in Public Citizen's study, the devices were frequently modified without testing, and because they were not legally on the market, the manufacturers did not seek FDA approval for modifications. According to one prominent researcher, the high rate of modifications to the pedicle systems suggested that "the biomechanical input to their design may not always be adequate." (R.C. Mulholland, Pedicle Screw Fixation in the Spine, 76-B J. Bone Joint Surgery (Br) 517 (1994).)

FDA Warnings

On August 11, 1993, the FDA finally warned seven firms to stop promoting the screws for use in back surgery, or face possible seizure of products, injunction, or civil penalties. In response, the manufacturers asked the agency to reclassify the devices from Class III to Class II for some procedures. Class II devices could be approved by the FDA if they met prescribed performance standards. Class III devices lack sufficient performance data to establish standards.

On February 17, 1994, the FDA issued another warning, stating that "the law forbids manufacturers or others from labeling or promoting orthopedic screws approved for other uses as `pedicle screws.'"

But the agency took no action other than the warnings, and in July, 1994 an FDA medical advisory panel recommended that the agency grant the industry's request to reclassify, the screws. The FDA, however, has not yet acted on this recommendation.

"The FDA cannot approve the use of pedicle screws, because there is no evidence that there have ever been objective tests for their safety, and efficacy," said attorney Gregory Ramirez of Oxnard, California, cochair of ATLA's Orthopedic Implants Litigation Group.

"Instead, we have positive war stories, anecdotal accounts of successes by, certain surgeons. And many of these surgeons turn out to be members of the board or stockholders of the manufacturing company. I have seven clients paralyzed for life, living on morphine pumps because of these devices."

Doctors say pedicle screws and plates improve the chances for successful fusion and make it unnecessary for fusion patients to be immobilized in a body cast. Richard Balderston, a spine surgeon at Pennsylvania Hospital in Philadelphia who has performed about 800 operations with pedicle screws, reported that he did not consider them experimental because years of experience and published research showed that they are "safe to be used."

He pointed out that doctors often apply drugs and techniques in situations for which they are not specifically marketed and that insurance companies have been willing to pay for the operations.

It is not illegal for physicians to engage in off-label use of medical devices. However, according to the FDA, a physician who does so has the responsibility to base the decision on sound medical evidence and a firm, scientific rationale. The physician should undertake a full and frank discussion of such off-label use with the patient, explaining the benefits, drawbacks, and limitations of knowledge about the procedure, and making it clear that the use in question has not been approved by the FDA." (Food and Drug Administration, Update on the Regulatory Status of Pedicle Screws (Feb. 17, 1994).)

Joanne Mott, who codirected the Public Citizen study, reported that most patients were not told before surgery that the use of pedicle screws is an experimental procedure. She said that several patients did not even recall giving their consent to the implants.

"It was difficult to believe that any surgeon would place a stainless steel or titanium device into a human being without that person's informed consent, or that the doctor would explain the risks of such an invasive procedure when the patient was under the influence of medication," she said. "However, these complaints have been corroborated so often ...it is clear that a not insignificant number of surgeons have been misleading patients concerning the nature of their surgery.

"To subject a patient to a procedure without informed consent is practicing human experimentation," she said. "Informed consent is a cornerstone of medical ethics."

Corrupted Literature

The close relationship between manufacturers of the devices and surgeons who implant them was also explored in the Public Citizen study. Particularly troubling was the potential for corruption of the medical literature.

For example, there are nine major manufacturers in the field, and all make some use of medical advisory groups staffed by practicing physicians. Public Citizen focused on AcroMed Corp., one of the better known manufacturers whose founder and majority stockholder is Arthur Steffee, inventor of a pedicle screw fixation system. Public Citizen reported that each member of AcroMed's medical advisory panel was given a stock option agreement in exchange for serving as a member.

Public Citizen reported that the editor-in-chief of a leading journal in the field of spinal surgery is a shareholding member of the AcroMed panel. So are the deputy editor and three members of the associate editorial board. In fact, 18 of the 19 surgeons on Acromed's panel have published articles about pedicle screw fixation in peer-reviewed medical journals.

"[T]hese surgeons have been aggressive in efforts to saturate orthopedic journals with the merits of pedicle screw fixation," said Mott.

The collusion may involve more them medical literature, according to Ramirez. "Many hospitals are charging 250 percent markups on these devices. This is illegal, because markups on experimental devices are not permitted under federal regulations."

Also, Ramirez said, doctors get a bonus for performing pedicle screw operations. Because the operations involve implantation of "instrumentation," they are classified as "complicated procedures," adding a multiplier to the bill.

Mark Melkerson, who reviews orthopedic devices for the FDA, said that current studies show that spinal screws can be expected to break in about 5 percent of patients. That calculates to about 50 victims per week at present implant rates. The FDA estimates that 350,000 people may have already received the pedicle screw implants.

Patients living with failed screws in their bodies must decide whether to undergo surgery to have them extracted. Some of these people have formed support groups to share information and help each other. Regional groups exist in Illinois, New Mexico, North Carolina, Pennsylvania, and Washington and reportedly include upwards of 10,000 members.

Contacts are John Canterberry, Illinois, [phone]; Marty, Ward, New Mexico, [phone]; Lynn Tauxx, North Carolina, [phone]; Frank Reynolds, Pennsylvania, [phone]; and Keefe or Holly Swedeen, Washington, [phone].

A copy of Public Citizen's report, Public Citizen Health Research Group Investigation of Pedicle (Spinal) Screw Implantation, can be obtained by writing to 2000 P St., N.W., Washington, DC 20036 or calling [phone].