Pedicle Screw Update
The following actions have occurred since the last report on the Pedicle Screw Multi-District Litigation now pending in Philadelphia. Overall, two important decisions were rendered by the presiding judge, Judge Louis C. Bechtle, with one in favor of the defendant associations and one against.
Defendants’ Motion Denied
On April 16, 1997, Judge Bechtle entered an Opinion and Order denying the defendants’ motion to dismiss the “Omni” amended complaints against them based on the First Amendment of the U.S. Constitution and other grounds and to stay all proceedings pending final appellate review of the issues raised by the Motion to Dismiss.
The defendant associations had asserted that their free speech rights to provide a forum for discussions about spinal fusion surgery involving pedicle fixation with bone screws were denied as a result of the state law tort claims. They also stated the Plaintiffs have failed to plead sufficient facts in support of their claims of fraud or conspiracy against the defendants. The Judge disagreed, noting that commercial speech is not afforded the same level of protection as other types of speech and he couldn’t determine from the limited evidence thus far presented whether the physicians were engaged in commercial speech or free speech, which is more fully protected. Consequently, he ruled that the Plaintiffs have the right to present their case.
AMA Joins Appeal
The AANS, the American Academy of Orthopaedic Surgeons (AAOS), and the other medical association defendants in the pedicle screw litigation (North American Spine Society and the Scoliosis Research Society), immediately acted to appeal Judge Bechtle’s denial of the First Amendment-based Joint Motion to Dismiss and asked the American Medical Association (AMA) to join them in that appeal. Legal counsel for the various groups felt that the AMA was in a unique position in an amicus brief to the court to explain how Continuing Medical Education (CME) functions and the role which industry has traditionally played in the development of new ideas and medical devices.
The whole basis of the Plaintiff’s complaint in this litigation is the assertion that the medical associations “conspired” with the medical device manufacturers by allowing the manufacturers to demonstrate and discuss at association meetings devices which had not been cleared by the FDA. If the Plaintiffs in this litigation are successful, it will have a dramatically chilling effect on CME programs for all of organized medicine. The AMA agreed to join the appeal, which was filed in June with the Federal Appeals Third Circuit Court in Philadelphia.
Plaintiffs’ Motion Denied
On May 5, 1997, Judge Bechtle entered an Opinion and Order denying the Plaintiffs’ motion to bar references to the FDA-sponsored “Historical Cohort Study of Pedicle Screw Fixation in Thoracic, Lumbar and Sacral Spinal Fusions” (Cohort Study). Among other things, the Cohort Study concluded that the use of pedicle screws was at least as safe and effective as other conventional forms of spinal fusion surgical treatments.
The Defendants stated they expect some defense experts to refer to the findings of the Cohort Study as one of several bases for their opinion. The Plaintiffs, on the other hand, sought to prevent the use of the Cohort Study as scientific evidence at trial on the basis it does not comply with the standards of good science.
After considerable review, the court did not agree that perceived weaknesses in the Cohort Study warranted its limitation or preclusion at trial. As a result, it denied the Plaintiffs’ motion to preclude use of the Cohort Study.
FDA Reclassification Sought
In a related action, on May 12, AANS President Edward L. Laws, Jr., MD, acting individually and on behalf of the AANS, submitted a Citizen’s Petition to the U.S. Food and Drug Administration asking that agency to act on its long-pending reclassification of the pedicle screw spinal systems from Class III to Class II. The feeling is that the FDA has been paralyzed by the Multi-District Litigation in Philadelphia, and needs to be reminded that the medical community needs to have timely decisions made on matters of this sort.
The petition was accepted by the FDA and given a docket number for future consideration. No date has been set for a decision.
Neurosurgery PAC Formed
A new national political action committee (PAC) for neurosurgeons has been established. Founded in April of this year, ANS PAC is dedicated to protecting the interests of neurological surgeons and their patients by backing candidates for federal office who support the goals of the neurosurgical community. “I have been involved in physician politics for over 20 years,” said Russell L. Travis, MD, Founding Chairman of the ANS PAC. “Until recently, I did not believe that neurosurgery needed a PAC. However, rapid political, social and economic changes are having a major impact on specialty medicine and Congress will continue to pass laws that affect how neurosurgeons practice. To ensure that our voice is heard, it is essential for neurosurgeons to participate in the political process. We think the ANS PAC is the vehicle to help us accomplish that goal.”
In addition to Dr. Travis, ANS PAC’s initial Board of Directors includes: George H. Koenig, MD, Vice-Chairman; Gary Dennis, MD, Secretary/Treasurer; and Katie O. Orrico, Assistant Secretary/Treasurer. Most of the money raised for the PAC will go directly to help elect candidates for federal office. It is a nonpartisan effort, that will contribute to both Republican and Democratic candidates who actively support the physician community, especially the concerns of the specialty care physicians and their patients.
For more information, write the ANS PAC at P.O. Box 136, Washington, DC 20044-0136, or call (202) 628-1996.
ANS PAC is an independent organization and not affiliated with either the AANS or CNS.
Stroke Management Workshops Begin
Last fall, the AANS joined with several other medical organizations to form the Brain Matters Stroke Initiative Coalition (formerly known as StART), a broad-based education effort by a consortium of organizations interested in stroke to educate the public and medical professionals about the need for immediate medical treatment for stroke. In addition to the AANS, the consortium includes the American Academy of Neurology, American Association of Neuroscience Nurses, American College of Radiology, American Heart Association, American Society of Neuroimaging, National Institute of Neurological Disorders and Stroke, as well as the National Stroke Association.
The first round of workshops have now been held in San Diego, Chicago, Dallas, Minneapolis, and Seattle to enthusiastic response. Six more are scheduled for the fall in Detroit, Memphis, San Francisco, Miami, Washington, DC and Denver. Neurosurgeons serving as faculty are Michael Horowitz, MD, Gaylan Rockswold, MD, and Marc Mayberg, MD. Steven Giannota, MD, was Course Director for the San Diego workshop. See page 40 for a complete listing of upcoming courses.
Course Overview
The “Acute Stroke Management Workshops” are designed to reach a multi-disciplinary audience and give a global view of the acute management of persons with stroke. The one-day sessions provide information on treatment plans for acute stroke centers, and directions for how health professionals can develop multi-disciplinary stroke teams and stroke emergency response systems in communities throughout the country. One of the purposes of the workshops is to foster the development of multi-disciplinary “stroke teams” throughout the country.
Registration
The workshops carry a $150 reservation fee which will be refunded to registrants upon completion of the workshop. Participants will earn 7.0 credit hours in Category 1 of the Physician’s Recognition Award of the American Medical Association. CEU credits for nurses will be available for the fall courses. A detailed brochure on the workshop, including a registration form, can be obtained from GEM Communications, which is coordinating workshop logistics on behalf of The Brain Matters Stroke Initiative. Call Suzanne Pereira at GEM Communications at (203)838-8812 or check the Acute Stroke Management Workshop page of the American Academy of Neurology’s web site at https://www.aan.com/public/smevent.html. (No longer valid as of 3/16/99.)
Funding for the coalition is provided by Genentech, Inc., Janssen Pharmaceutica, Inc., and Knoll Pharmaceutical Company.