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Are there risks in continuing education?
J OrolMaxillofac Surg 56:l 123, 1998
Are There
Risks
in Continuing
Although we are all aware of the recent rash of lawsuits that have involved the manufacturers of Prop&t-Teflon TMJ implants and silicone breast implants, as well as the surgeons who placed them, there has been less publicized litigation occurring in the past few years that has even more far-reaching implications. Starting in 1994, not only have thousands of product liability lawsuits been brought against the manufacturers of the orthopedic pedicle bone screw, but also about 400 lawsuits have been brought against a number of medical associations, claiming that they have conspired with the manufacturers to promote the use of these devices, in violation of Federal law, by conducting manufacturer-supported seminars. Such litigation challenges the ability of a professional society to present continuing education courses in which a medical device is discussed if it might be construed as promotion of a non-Food and Drug Administration (FDA)-approved, or “off-label” use. This clearly threatens one of the fundamental tenets of continuing education, the ability to talk freely about clinical topics with our peers. Although, to date, most of the lawsuits against the medical societies have been dismissed, there are still a number of concerns that need to be considered by all associations and societies when presenting continuing education programs. The First question is whether one can consider a society-sponsored program about the use of a device for a purpose other than for what it was approved by the FDA as promotional. This question arose with the pedicle screw because it was approved only for treating spondylolisthesis. The answer can be found in the landmark decision of Judge Tom Stewart Jackson in the case of Coleman z, Danek Medical et al, when he stated that the surgeon’s decision to use pedicle screws “was not based on anything that he had heard (or not heard) at any seminars, but rather was based on his own medical judgment, which was, in turn, based primarily on his own personal assessment of what he considered the relevant medical literature and available information relative to the devices.” Another important issue is to consider whether a manufacturer’s exhibit at a society meeting or educational seminar constitutes promotion of that manufacturer’s product by the society. Although every effort should be made to avoid exhibitors using such meetings as a forum to promote off-label use of their
Education?
product, their presence clearly does not imply society approval of either their product or its usage. The final question is whether a society or a speaker is obligated to note the FDA classification of a device discussed at an educational program. Legal opinion indicates that the government cannot impose an obligation on anyone to provide information about the position of regulatory authorities when they are merely engaged in expressing their opinions or exchanging information with their colleagues. The FDA can regulate whether one can legally use a device or advertise the product, but it cannot prohibit one from providing or receiving information about it. Despite the relatively low risk of litigation, the fact that it can and does happen makes it important for associations and societies to take whatever steps are necessary to avoid this possibility. In a recent article, Shawn Collins, a trial lawyer who represents one of the medical association defendants in the pedicle screw litigation, discusses some of the precautions to be taken. First, irrespective of past disclosure requirements, it is imperative that attendees at continuing education programs are fully apprised when an offlabel device is being discussed. Second, it is essential that the audience is informed about any relationship the speaker has with the manufacturer. Although ACCME and the ADA’s Continuing Education Recognition Program require this, enforcement is the real issue. Despite the fact that this is generally a standard procedure with large organizations, it is something that is often forgotten by smaller societies that do not follow the specific ACCME and ADA guidelines. In addition, it is essential to have proper insurance coverage to protect your organization should any continuing education-related lawsuits ever arise. The ever-increasing emphasis on continuing education is a definite indication of its importance to our profession and to the patients that we serve. Therefore, the current legal situation should not be construed as a deterrent to its continuation. By taking the proper precautions, we can avoid future problems and assure our ongoing ability to learn about new advances and to provide the public with the best care possible. DANIEL
1123
M.
LASKIN
Are There
Risks
in Continuing
Although we are all aware of the recent rash of lawsuits that have involved the manufacturers of Prop&t-Teflon TMJ implants and silicone breast implants, as well as the surgeons who placed them, there has been less publicized litigation occurring in the past few years that has even more far-reaching implications. Starting in 1994, not only have thousands of product liability lawsuits been brought against the manufacturers of the orthopedic pedicle bone screw, but also about 400 lawsuits have been brought against a number of medical associations, claiming that they have conspired with the manufacturers to promote the use of these devices, in violation of Federal law, by conducting manufacturer-supported seminars. Such litigation challenges the ability of a professional society to present continuing education courses in which a medical device is discussed if it might be construed as promotion of a non-Food and Drug Administration (FDA)-approved, or “off-label” use. This clearly threatens one of the fundamental tenets of continuing education, the ability to talk freely about clinical topics with our peers. Although, to date, most of the lawsuits against the medical societies have been dismissed, there are still a number of concerns that need to be considered by all associations and societies when presenting continuing education programs. The First question is whether one can consider a society-sponsored program about the use of a device for a purpose other than for what it was approved by the FDA as promotional. This question arose with the pedicle screw because it was approved only for treating spondylolisthesis. The answer can be found in the landmark decision of Judge Tom Stewart Jackson in the case of Coleman z, Danek Medical et al, when he stated that the surgeon’s decision to use pedicle screws “was not based on anything that he had heard (or not heard) at any seminars, but rather was based on his own medical judgment, which was, in turn, based primarily on his own personal assessment of what he considered the relevant medical literature and available information relative to the devices.” Another important issue is to consider whether a manufacturer’s exhibit at a society meeting or educational seminar constitutes promotion of that manufacturer’s product by the society. Although every effort should be made to avoid exhibitors using such meetings as a forum to promote off-label use of their
Education?
product, their presence clearly does not imply society approval of either their product or its usage. The final question is whether a society or a speaker is obligated to note the FDA classification of a device discussed at an educational program. Legal opinion indicates that the government cannot impose an obligation on anyone to provide information about the position of regulatory authorities when they are merely engaged in expressing their opinions or exchanging information with their colleagues. The FDA can regulate whether one can legally use a device or advertise the product, but it cannot prohibit one from providing or receiving information about it. Despite the relatively low risk of litigation, the fact that it can and does happen makes it important for associations and societies to take whatever steps are necessary to avoid this possibility. In a recent article, Shawn Collins, a trial lawyer who represents one of the medical association defendants in the pedicle screw litigation, discusses some of the precautions to be taken. First, irrespective of past disclosure requirements, it is imperative that attendees at continuing education programs are fully apprised when an offlabel device is being discussed. Second, it is essential that the audience is informed about any relationship the speaker has with the manufacturer. Although ACCME and the ADA’s Continuing Education Recognition Program require this, enforcement is the real issue. Despite the fact that this is generally a standard procedure with large organizations, it is something that is often forgotten by smaller societies that do not follow the specific ACCME and ADA guidelines. In addition, it is essential to have proper insurance coverage to protect your organization should any continuing education-related lawsuits ever arise. The ever-increasing emphasis on continuing education is a definite indication of its importance to our profession and to the patients that we serve. Therefore, the current legal situation should not be construed as a deterrent to its continuation. By taking the proper precautions, we can avoid future problems and assure our ongoing ability to learn about new advances and to provide the public with the best care possible. DANIEL
1123
M.
LASKIN