No medical device or surgical procedure is free of risk. But the pedicle screw’s path to approval by the U.S. Food and Drug Administration (FDA) was surely one that required stamina, determination and patience for everyone involved. Its tortured regulatory history is held up as proof by both its supporters and detractors that the FDA needs to change the way it regulates medical devices.
Capping a three-year process, the FDA formally reclassified pedicle screw spinal systems to Class II from Class III for certain indications. The final rule, published in the July 27, 1998 issue of the Federal Register, states that sufficient information exists to demonstrate the safety and effectiveness of pedicle screw spinal systems, intended to provide immobilization and stabilization of spinal systems in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor and failed previous fusion (pseudoarthrosis).
The reclassification, however, does not include spinal systems intended for use in the cervical spine or in pediatric populations.
Historical Perspective
The FDA’s mission is to ensure the safety and efficacy of products it approves to be marketed in the United States, including all devices used in spinal surgery. The AANS fully supports this mission and has worked for many years in conjunction with the FDA, major spine societies, and medical device manufacturers to clarify standards for pedicle screws and other spinal-surgery devices.
The bone screw itself is a long-established, safe, and reliable medical device for use in many parts of the body, including the spine. The FDA approved the use of bone screws for general surgery – such as arm and leg operations – in 1985.
Pedicle screw fixation systems were developed in the 1960s by Canadian, American, and French surgeons who understood that, when operating from the back of the spine, the strongest fixation site on the vertebral bodies are through the pedicles. These surgeons found that pedicle screw fixation permitted greater correction of deformity and more rigid fixation than wires or hooks. Also important, the screw fixation spared adjacent health vertebrae that might otherwise become fused and further limit the patient’s flexibility.
Historically, the FDA has acknowledged that good medical practice requires physicians to use both devices and drugs in new ways (“off-label” uses) that the federal regulators did not initially envision. The FDA has respected the medical professional’s autonomy and expertise in determining the best treatment options for patients.
Despite the FDA’s viewpoint, the road to reclassification of the pedicle screw has been long and complex. It began on August 11, 1993, when the FDA sent letters to six manufacturers stating that they could not advertise or promote the use of bone screws as pedicle screws. The FDA did not ask the companies to stop manufacturing the screws, nor did it prohibit the use of them; it only stopped the promotion of them. According to a FDA representative, the use of bone screws in the pedicle represented a good method of enhancing spine fusions. But it didn’t have a sufficient number of patient reports in its files to authorize the advertisement of the screws for use in the spine.
So, the FDA approached a group of spine-related specialty societies and asked them for assistance in developing a research study that would correct this deficiency.
Such a study would help determine whether there was sufficient clinical data regarding the use of bone screws in the pedicles of the spine to warrant reclassification of the device to Class II – the regulatory classification currently applied to all other bone screws, and most other spinal fixation devices. Such classification would eventually allow these devices to be labeled and marketed for use in the pedicles. Also, it would allow timely regulatory clearances for a surgical method that had become, over the past several years, the standard of care in treating some patients with spinal disorders.
The study, called the “Historical Cohort Study of Pedicle Screw Fixation in Thoracic, Lumbar and Sacral Fusions” was organized by a Scientific Committee composed of spinal surgeons representing each of the six principal medical societies concerned with the spine: The American Association of Neurological Surgeons, the American Academy of Orthopedic Surgeons, the Scoliosis Research Society, the Congress of Neurological Surgeons, North American Spine Society, and the Scoliosis Research Society. The Spinal Implant Manufacturers Group, consisting of some 14 companies, agreed to underwrite the cost of the study.
The AANS was supportive of the study and encouraged neurosurgeons to participate. Applications to participate in the study were distributed to the membership via the Bulletin. “The FDA has offered surgeons who use pedicle screws an opportunity to assume responsibility for determining safety and efficacy for a defined and limited study population,” Bulletin readers were told. “If it is possible to acquire enough patients to analyze the information, the FDA may have no alternative but to stop the production and dissemination of pedicle screws. When the formal call goes out to surgeons who have used pedicle screws for spinal stabilization, you are urged to respond. Our combined participation is essential to the success of this study, and to the use of this cooperative approach for the resolution of similar problems in the future.” The participating surgeons were assured by the FDA of the confidentiality of their reports, in order to encourage fair reporting of both good and bad results.
The study got underway in late 1993 and was completed in 1994. It reported on results from 314 surgeons who treated 3,498 patients. Approximately 87 percent of the surgeons participating in the study were orthopedic surgeons and 12 percent were neurological surgeons.
The Scientific Committee’s principal conclusion based on the study’s data was that pedicle screw fixation is as safe and effective as other means of achieving spinal fusion, both instrumented and non-instrumented, and that in some respects the results achieved with pedicle screws were clearly superior.
One of the Cohort Study’s most compelling findings was that patients whose treatment for degenerative spondy-lolisthesis included pedicle screws achieved successful fusion at a rate of 90 percent. That is a superior result compared to the 70 percent of patients in the control group, who achieved fusion but did not receive implants. With regard to spinal fractures, pedicle screws were shown to offer comparable safety and efficacy compared to surgical treatments using other internal fixation devices.
Based on these findings, and after an in-depth review and meta-analysis of the literature, the FDA Advisory Panel on Orthopedic and Rehabilitative Devices subsequently recommended that the pedicle screw be reclassified from its existing Class III designation to Class II. However, no action was forthcoming.
Spine surgeons were left with a widening gap between the state of medical science regarding the use of pedicle screws and the FDA’s approval of the promotion of those devices.
Litigation Filed
Casting a dark shadow over the reclassification process was a new threat arising in the courts. In December 1993, the ABC Network television show “20/20” broadcasted a segment that was highly critical of pedicle screws.
Following the “20/20” broadcast, thousands of lawsuits were filed across the country, almost all of which closely followed a format designed by the plaintiff ‘s lawyers in New Orleans, Louisiana, and Philadelphia, Pennsylvania. The plaintiffs alleged that the devices were inherently defective and that the use of what they described as “unapproved” devices was experimental and, therefore, malpractice. Not only were individual spine surgeons named as defendants, seven pedicle screw manufacturers and numerous distributors and hospitals were named, as well.
As a result of those filings, the Federal Courts formally designated the case as “multi-district litigation,” and assigned them all to Judge Louis Bechtle in Philadelphia for discovery and pre-trial handling. Judge Bechtle designated the lead plaintiff ‘s counsel as the Plaintiffs Legal Committee (PLC), with the responsibility for managing the prosecution of the cases, but denied the PLC’s motion to have the cases combined and certified as a Class II.
According to the PLC, the industry had subverted the FDA’s rules by using the physicians to help sell the pedicle screw and, in the process, patients were used as guinea pigs for an untested treatment.
As part of the discovery process for the litigation, plaintiffs’ attorneys attempted to obtain the names of the physicians and patients who had participated in the Cohort Study. Confidentiality is a key component of most research protocols, and patients and physicians participating in the Cohort Study were given that assurance of confidentiality as an inducement for their involvement and their reporting of all case results, both good and bad. The AANS had encouraged neurosurgeons to be part of the study believing their participation would be confidential.
Concerned about the potential chilling effect that the release of such information might have on future research, the AANS joined two other specialty societies – the American Academy of Orthopedic Surgeons and the North American Spine Society – in filing a successful “Motion to Intervene” to protect the confidentiality of this information.
The motion was granted, but within a matter of weeks, the AANS, CNS and the other associations were named as defendants. The PLC alleged that the associations had acted as “promotional centers” for the pedicle screw, engaged in “reckless, outrageous and wanton” promotion of hazardous spinal fixation devices, and “conspired with manufacturers for the illegal sale of dangerous medical devices.” The groups all strongly denied the charges.
Impact on Education and Patient Care
As educational and professional organizations, the medical societies were put in the unfortunate position of not being able to provide forums in which surgeons could openly discuss research and clinical issues relating to pedicle screw, or demonstrate newly-developed techniques for pedicle screw implantation for fear of being sued.
The greater concern, however, was that the controversy surrounding pedicle screw was discouraging surgeons from recommending these devices when they were appropriate and that patients were not receiving appropriate treatment. In fact, according to an article published in the Journal of Spinal Disorders, (Vol. 8, No. 5), the process had a truly chilling effect upon a practice in Chicago during 1995. “It places a state-of-the art medical procedure under attack,” wrote the authors, “thereby affecting patient care in two ways. First, patient confusion has been fostered in terms of what the role of the FDA is in their care. This has resulted in some patients refusing an instrumented procedure and opting for a sub-optimal procedure. There also has been an overall increased anxiety in patients. Second, all 11 lawsuits (filed in Illinois at the time) have identical allegations relying on the FDA issues.”
The authors further noted that “two major Chicago-area hospitals have discontinued the use of these devices until reviewed by their Institutional Review Board. This review process is estimated to take approximately three months. Until this process has been completed, the community is unable to receive this state-of-the-art level of care.”
Media Coverage
Early on, the national media began covering the lawsuit and the FDA Cohort Study. To assure that media reports present a balanced view of the related issues, the AANS prepared background information on pedicle screw for reporters and appointed Stewart Dunsker, MD, current AANS Vice President and founding member of the AANS/CNS Section on Disorders of the Spine and Peripheral Nerves, as the official spokesperson on the pedicle screw issue. He also led the neurosurgical team supporting the FDA’s retrospective study on the use of the pedicle screw.
The Association’s key communication points were:
- The pedicle screw has proven to be a successful option for spine stabilization for specific types of conditions and has been a valuable tool for spine stabilization. When properly used, pedicle screws provide the same safety and efficacy as comparable internal fixation devices used to stabilize spine fractures. More than 300,000 patients have been treated with pedicle screw implants. Only 2,100 have participated in the related litigation, and the number of actual failures of the device, at most, is substantially less than 1 percent.
- When properly performed by qualified surgeons on appropriately selected patients, implantation of the pedicle screw is the best treatment for some spinal conditions. The Association was deeply concerned that the litigation and surrounding publicity has discouraged surgeons from recommending this procedure, and could prevent a growing number of patients from receiving the appropriate and proven treatment they need.
In a letter to the editor responding to an editorial about the litigation published in the Wall Street Journal, the AANS and CNS described the “guerilla litigation” and noted, “As surgeons specializing in spine care, we fear that the current controversy surrounding pedicle screws has begun to discourage surgeons from recommending these devices when they are appropriate and that a growing number of patients are not receiving this treatment as they should . . . The pedicle screw has become the standard of care for treatment of specific types of spinal conditions, promoting healing and liberating back-surgery patients from wearing uncomfortable body casts, often for months at a time. In some cases, it is the only fixation device that can be implanted to help the patient.”
Reclassification Back on the Front Burner
In the midst of this turmoil, the FDA, once again, raised the prospect of reclassifying the pedicle screw. On October 5, 1995, it issued a formal call for public comments regarding this action. The FDA believed that there was sufficient data available to take this step and that establishment of special controls would provide reasonable assurance of the safety and effectiveness of these implants.
The AANS, on behalf of its membership, responded to the FDA’s call for comments and, in a letter to D. Bruce Burling, Director of the FDA’s Center for Devices and Radiological Health, and 1995-96 AANS President Sidney Tolchin, MD, stated that the Association supported:
- The proposal of the FDA and the findings of the Orthopedic and Rehabilitation Devices Panel to reclassify certain pedicle screw systems to Class II;
- The proposal of the FDA to expand the uses of the device identified by the Panel to include pedicle screw spinal systems intended to provide immobilization and stabilization of spinal segments as an adjunct to fusion in the treatment of acute and chronic instabilities and deformities, including spondylolisthesis, fractures and dislocation, scoliosis, kyphosis and spinal tumors.
- The proposal of the FDA to establish one regulation for the pre-amendments and post-amendments device.
In its response, the Association also urged the FDA to encourage further outcome studies to determine full efficacy of the devices and patient selection criteria.
The agency established a 180-day period for public comments, after which it would publish a final regulation to reclassify the devices. Unfortunately, that did not happen.
By May 1997, frustrated by the FDA’s reluctance or unwillingness to finalize the proposed reclassification of pedicle screw systems, the AANS, acting through then-President Edward R. Laws, Jr., MD, filed a Citizen’s Petition with the FDA requesting that the reclassification be made final. Under the FDA’s regulations, the agency was required to respond to Dr. Laws’ Petition within 180 days. When it failed to do so, the AANS followed up with repeated demands that the FDA follow its own regulations and finalize the reclassification.
Though the medical associations were taking an aggressive stance in fighting the litigation, at least one of the device manufacturers decided to settle out of court. On October 17, 1997, over the objections of Sofamor-Danek and a number of other plaintiffs, Judge Bechtle approved a settlement by AcroMed in the amount of $100 million. The objecting plaintiffs complained that they would be forced to unfairly accept small compensation for their injuries under the AcroMed settlement. Those plaintiffs, as well as Sofamor-Danek, appealed Judge Bechtle’s approval of the AcroMed settlement to the Third Circuit Court. Final approval was put off until the spring of 1998.
Finally, Reclassification
On July 27, 1998, the FDA finally took action. When all the data was viewed in conjunction with the medical literature and the MDR and FDA’s MedWatch surveillance data, no new issues relating to the safety or effectiveness of pedicle screw spinal systems were raised. Therefore, the agency had concluded that the data provided valid scientific evidence that certain special controls, in conjunction with the general controls applicable to all devices, would provide a reasonable assurance of the safety and effectiveness of pedicle screw spinal systems for L5 – S1 use, and for use at other levels for the treatment of degenerative spondylolisthesis with objective evidence of neurologic impairment.
The ruling supported the use of pedicle screw spinal systems when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion for the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar and sacral spine: degenerative spondylolisthesis with objective evidence of neurologic impairment, fractures, dislocations, scoliosis, kyphosis, spinal tumors, and failed previous fusion (pseudarthrosis).
The classification and reclassification does not carry over to pedicle screw spinal systems intended for use in the cervical spine, which are considered post-amendments Class III devices for which premarket approval is required. In addition, all valid scientific evidence reviewed by the panel and FDA were obtained from skeletally mature populations. To date, the safety and effectiveness of pedicle screw spinal systems in pediatric populations are post-amendments Class III devices for which premarket approval is required.
Under the reclassification, pedicle screw spinal systems must comply with the following special controls:
- Compliance with material standards;
- Compliance with mechanical testing standards;
- Compliance with biocompatibility standards; and
- Labeling which contains the following two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
According to AANS President Russell L. Travis, MD, “The reclassification was a direct result of the Association’s insistence that the reclassification be made final. I want to thank Dr. Laws, in particular, for keeping this issue front and center with the FDA. Without his persistence we might still be waiting for the FDA to act.”
AANS Dismissed from Litigation
On the heels of reclassification, things also began to move along with the Multi-District Litigation in Philadelphia. Presiding Judge Louis Bechtle granted the Defendant Associations’ Motions to dismiss many of the elements of the Plaintiffs’ initial claims. Early in 1998, he had begun remanding the cases back to the District Courts in which they had been originally filed, for ultimate resolution or trial. Then, working in conjunction with the other medical association defendants, the AANS filed Motions for Summary Judgement in many of those cases, which resulted in five decisions being entered — dismissing all claims against the association defendants.
In August, after the entry of those five decisions, and as a result of related negotiations, the Plaintiffs’ attorneys agreed to dismiss the AANS and the other associations from all the remaining pedicle screw suits. The litigation will continue against the device manufacturers and implanting surgeons who are charged with individual malpractice.
In addition, the PLC is appealing some of Judge Bechtle’s earlier rulings dismissing various aspects of the litigation. Those appeals, however, should not directly affect the AANS.
New Action
Despite the reclassification of the pedicle screw, and the release of the Medical Association defendants from the three-year litigation, the Plaintiff ‘s Legal Committee recently filed a “Motion for Order Requiring Disclosure of Additional Confidential Information and For Court Appointment of an Expert Witness with Respect to the Historic Cohort Study of Pedicle Screw Fixation.” The PLC is seeking, once again, to obtain the disclosure of the names of the physician-participants in the Cohort Study and to appoint an expert to audit the findings of the study.
Under the PLC’s proposal, the court-appointed auditor would perform a site visit at each of the of the 315 participating study sites, which are the medical offices of the participant-researchers. The auditor would not only review the adequacy of the responses provided, but would also be required to check all of the physicians’ other files to cross-verify that patients were properly included in the study. In the process, all of the names of the physician-researchers would be, of necessity, released. In addition, the identities of countless patients would be disclosed along with their complete medical records.
As the Bulletin went to press, the AANS, the American Academy of Orthopedic Surgeons, North American Spine Society, and the Scoliosis Research Society, had filed a Memorandum, asking Judge Bechtle to reject the motion, citing the associations’ original concerns about patient and physician confidentiality as well as the on the medical practices of the named orthopedic surgeons and neurosurgeons. Judge Bechtle’s decision is pending.
In the meantime, a legal precedent has been set, according to AANS General Counsel Russell Pelton, who served as Liaison Counsel for all of the medical associations. “Medical societies must be free to provide forums for the discussion of evolving medical treatment. The pedicle screw litigation threatened that process. It had a profound impact on patient care and the future of medical research. We believe that the process we followed in seeking protection against this mass tort litigation established some legal precedent that will protect other associations from similar legal problems in the future.”
In a further attempt to prevent the implementation of the down classification, on August 28, 1998, the PLC sued the FDA seeking to enjoin the reclassification of pedicle screws. The PLC’s suit alleges that the FDA based its actions on false statements from manufacturers and fatal defects in the Cohort Study, and that the agency violated Federal Law in the way it handled the down classification. The case has been assigned to Judge Bechtle and no action has yet taken place.
HIGHLIGHTS OF PEDICLE SCREW RECLASSIFICATION
- Pedicle screw has been reclassified by the FDA from a Class III to a Class II device.
- Pedicle screw is now clinically APPROVED for use as an adjunct to fusion in the treatment of:
- Acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine
- Fractures
- Dislocation
- Degenerative spondylolisthesis with objective evidence of neurologic impairment
- Scoliosis
- Kyphosis
- Spinal tumors
- Failed previous fusion (pseudarthrosis)
- Pedicle screw is NOT APPROVED for use:
- In the cervical spine
- In pediatric populations
WHAT DO THE FDA CLASSIFICATIONS MEAN
Class I – General Controls. Means the device is used in a simple, low-risk way, for which safety and effectiveness are relatively easy to determine. FDA pre-market approval and/or performance standards are not necessary. Crutches, canes and wheelchairs are Class I devices.
Class II – Performance Standards. Means that the FDA has enough information about a device, such as a bone screw and plate, to establish a performance standard, but not enough information to establish general controls to assure safety and effectiveness. Examples of Class II devices include intramedullary nails, bone screws and plates when used for long bone fractures, and cemented hip replacements.
When the pedicle screw was reclassified to this level it became clinically approved for use in fusions in the treatment of instabilities and deformities in the spine, including fractures dislocations, spondylolisthesis, scoliosis, kyphosis and spinal tumors. The FDA’s reclassification simply provided regulatory clearance to sell and advertise these screws as the standard of care in treating selected patients with these kinds of disorders.
Class III – Pre-market Approval. Means that existing information is insufficient for establishing general controls and performance standards that could assure the safety and effectiveness of a device. Class III devices are generally considered investigational but also include new applications of an existing device that pose a potential risk. In short, more research is needed to determine when, where, and how the device should be used.
Initially, the bone screw was placed in this category, which allowed for its use, by a physician in any bone in the body to help the patient. However, it was not approved for use in any specific bone and a manufacture was barred from advertising the screw for use in the pedicle.