July 22, 1996
Editor
Wall Street Journal
200 Liberty Street
New York, NY 10281
Dear Sir:
Max Boot’s editorial (“A Screwy Way to Treat Companies”) in the July 16, 1996, edition described how a medical device manufacturer, Sofamor Danek, faces possible extinction due to an all too familiar scenario — guerrilla litigation by avaricious attorneys. The American Association of Neurological Surgeons (AANS) and Congress of Neurological Surgeons (CNS) are deeply concerned about this “mass tort” litigation surrounding pedicle screws for several reasons, not the least of which are its profound impact on patient care and the future of medical research.
First, 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. As correctly noted by Mr. Boot, 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.
Second, as part of the discovery process for the current litigation, plaintiffs attorneys attempted to obtain the names of the physicians and patients who participated in a pedicle screw research study sponsored by the Food and Drug Administration (FDA). We are concerned about the potential chilling effect that the release of such information might have on future research. Confidentiality is a key component of most research protocols and patients and physicians were given that assurance of confidentiality as an inducement for their involvement and their reporting of all case results, both good and bad.
As a measure of that concern, the AANS and several other medical associations filed a successful Motion to Intervene in the pending multi-district litigation with the United States District Court for the Eastern District of Pennsylvania to protect the confidentiality of this information. Within a matter of weeks, our Societies — as well as the others — were suddenly named as defendants in hundreds of suits by patients who received pedicle screw implants and now are claiming personal injuries. It was alleged that we have 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,” charges we all strongly deny.
Now, as educational and professional organizations, the AANS and CNS are in the unfortunate position of not being able to provide forums in which neurosurgeons may openly discuss research and clinical issues relating to pedicle screw and demonstrate newly-developed techniques for pedicle screw implantation for fear of being sued.
Our Societies are typical: we publish journals, sponsor workshops, and allow medical device manufacturers to exhibit at our scientific meetings. Unfortunately, the plaintiffs’ attorneys have judged this activity to be of a conspiratorial nature. As a consequence, medical associations, medical schools and medical device manufacturers could face the specter of financial ruin or worse.
We are not speaking out as apologists for the pedicle screw or any manufacturer. If scientific evidence showed that the pedicle screw was unsafe or ineffective, neurosurgeons would not use it. If some individuals have been truly injured then they deserve recompense. However, absent evidence to the contrary, we deeply regret that some of our patients may soon lose access to a valuable medical device because of the inaction of regulators and the greed of hungry litigators.
Charles Rich, MD
President
The American Association of Neurological Surgeons
Stephen J. Haines, MD
President
Congress of Neurological Surgeons