In many ways, the past year has been one of ambiguity for the field of neurosurgery. Socioeconomic issues have created both controversy and opportunity for neurosurgeons like never before and research and development are bringing forth medical technologies and treatments that were unimaginable even 15 years ago. As President of the AANS, I am frequently asked, “What is the AANS doing for neurosurgeons to help them cope with the forces now threatening the future of neurosurgery?”
I can assure you that your professional society has become a true leader and advocate for the field of neurosurgery. Over the past year, the AANS has risen to face some of our biggest challenges yet — the proposed changes in practice expense reimbursement by the Health Care Finance Administration (HCFA), the pedicle screw litigation, and increased competition from other specialties — to name just a few. What the future holds for neurosurgery, we cannot be sure, but through the work of such organizations like the AANS, we can certainly try to manage influences over different facets and prepare for whatever changes lie ahead.
Elsewhere in this issue of the Bulletin, you’ll be reading about our efforts in responding to the practice expense issue and the marketing communications initiative we developed to increase the visibility of neurosurgeons in the public arena. In this, my last President’s Message, I wish to focus on the work that the AANS has done in area of the pedicle screw litigation.
Litigation Background
The AANS has long supported the efficacy of pedicle screw fixation in appropriate cases. That support remains strong today. In 1993, we cooperated with the Food and Drug Administration (FDA) and several prominent medical associations in conducting the retrospective Cohort Study. That study, involving more than 300 surgeons and 3,000 patients, was the most comprehensive study of the use of pedicle fixation ever conducted. While its methodology may not have been perfect, its conclusion that pedicle screw systems are efficacious in the reconstruction of certain types of diseased and damaged spines was an important contribution to the literature.
Following the broadcast of the 20/20 television show that severely criticized (in our view, unfairly) pedicle screws and the resulting explosion of litigation, Judge Louis Bechtle in Philadelphia was designated as the multi-district judge who would coordinate all pedicle screw cases filed in the federal courts. Because the results of the FDA-sponsored Cohort Study so undermined the plaintiffs’ basic contention that pedicle screws are inherently dangerous and unsafe, the Plaintiffs’ Legal Committee (PLC) attempted to attack that study and its participants in an effort to discredit its results.
The AANS’s first involvement in that litigation was to take the lead in blocking Judge Bechtle’s imminent disclosure of the names of the participant surgeons and perhaps their patients. That data had been submitted by participating surgeons under an assurance of confidentiality by the FDA. It was not until the intervention of the medical associations, led by the AANS, that Judge Bechtle appreciated the sensitivity of the confidentiality of those medical records.
In due course, the AANS and many other additional parties were drawn into the litigation as defendants in complaints alleging a broad-ranging conspiracy to promote the products of the manufacturers. Our attorney was selected as the liaison counsel for all of the medical associations in that litigation and has taken the lead role in coordinating the efforts of not only those associations but also a wider range of defendants with similar interests. That has resulted in a close coordination of defense efforts and the elimination of duplication of efforts by the law firms representing the associations.
Another important step we took to ensure that the resources of the AANS were appropriately marshaled behind the defense was to appoint a blue-ribbon task force of prominent neurosurgeons, chaired by David Cahill, MD, to prepare an analysis of the scientific and medical issues involved. That report has been completed, and, I understand, has been extremely useful to our attorneys in responding to the issues raised in the litigation.
Motion to Dismiss
Our attorneys, working in conjunction with counsel for the other associations, filed a comprehensive motion to dismiss the “Omni” complaints last year. In August, Judge Bechtle granted that motion to dismiss, but gave the plaintiffs leave to refile with amended complaints. Many (although not all) chose to do so, which led to renewed motions to dismiss filed by counsel for the associations. Those motions were based on deficiencies of the amended complaints in the allegations of the alleged conspiracy and in asserting some causation between the associations’ activities and the injuries to each particular plaintiff. In addition, First Amendment protections were asserted with respect to anything taught or discussed at association- sponsored meetings.
The renewed motion to dismiss was argued before Judge Bechtle on February 7,1997, and he is expected to rule soon. Counsel for the AANS is optimistic that we will be dismissed from the litigation at some stage prior to remand of the cases for trial, whether through this motion or a subsequent one.
The Future for Pedicle Screws
You may have heard that one of the manufacturers, AcroMed, entered into a settlement agreement with the PLC. That settlement is being implemented by the creation of a class of patients who received AcroMed devices. The AANS and the other medical associations were not parties to that agreement and had no voice in its terms. We are, however, indirect beneficiaries in that all litigation against the associations based on AcroMed devices will be dismissed with prejudice. We believe that it is both unfortunate and inappropriate for medical associations, such as the AANS, to be forced to defend this type of litigation. We will continue to defend not only the integrity of the AANS, but also the efficacy of pedicle screw fixation systems in appropriate cases and the rights of our members to use those systems where, in their judgment, it is in the best interests of their respective patients.