LITIGATION AND LEGISLATION UPDATE Litigation and legislation of particular interest to orthodontists will be reported under this section of the AMERICAN JOURNAL OF ORTIIODO,VTICSAND DENTOFACIAL ORTHOPEDICS. l~[anascripts for publication and readers" comments may be submitted to Ms. Sally A. Bowers, American Association of Orthodontists, 401 N. Lhzdbcrgh Blvd., St. Louis, MO 63141.
Reconditioning and reuse of orthodontic devices Thomas d. DiPasquale* St. Paul, Minn.
LEGAL LIABILITY CONSIDERATIONS A l l too often it is the courts that are called on to
reconcile conflicting or competing public policy interests. The proliferation of litigation has been particularly acute in the health care sector, and it is a subject of concern to all health care providers and medical device manufacturers. Although there have been few reported lawsuits involving reuse of disposable medical devices and, so far as is known, no such claims relating to reuse of orthodontic devices, this may be by virtue of a failure to recognize and causally link specific episodes of reuse with a particular adverse affect. Nevertheless, the fact that reuse is a practice driven by economic forces and surrounded by unresolved ethical issues and unknown medical risks creates a volatile legal atmosphere. If the orthodontic industry fails to resolve the issues raised by bracket reuse, the judiciary will almost inevitably fill the breach by resolving questions of liability for each of the major parties--the orthodontist, the manufacturer (and others in the manufacturer's distribution chain), and the reconditioner.
Orthodontic practitioner liability The orthodontic practitioner is most vulnerable to the risk of liability since he is most directly responsible for the quality of care rendered to patients. This liability can be premised on two grounds: (I) failure to obtain informed consent and (2) medical malpractice, that is, failure to meet the prevailing standard of medical care. Both are negligence-based theories. Generally speaking, absence of a patient's consent to a particular course of treatment or procedure may give rise to a cause of action for negligent nondisclosure of risks or even battery, that is, total absence of consent. *Senior Counsel for Minnesota Mining and Manufacturing Co. 811139061
The patient must establish that he was not properly informed of a risk inherent in the treatment, the undisclosed risk materialized in harm, and consent to the treatment would not have been given if the risk were disclosed. There are exceptions that will excuse nondisclosure. The exceptions include emergency situations, risks commonly known, and the therapeutic privilege, which permits withholding information if the disclosure would hinder treatment or cause psychologic or emotional distress to the patient. Many states have adopted the "patient-oriented" standard for informed consent. Typically, this standard requires the physician to disclose not only those risks that accepted standards of medical practice require to be disclosed, but also those risks and alternative treatments that a reasonable person in the patient's position would consider material or significant in deciding whether to accept or to reject the proposed treatment. Under this standard, a health care provider may be found liable if the jury concludes that a reasonable person in the patient's position would not have consented to treatment if the risks or alternative treatments had been disclosed. Did the orthodontist believe that the patient, if given a choice between treatment with new or used brackets, would have chosen used brackets? Was the orthodontist aware of any clinical studies that demonstrated reused brackets have the same safety and efficacy profile as new brackets? Did the orthodontist disclose to the patient that the manufacturer labeled the bi'ackets as 'single-use only'? These are among the questions that would be posed to an orthodontist in the course of a lawsuit, and it does not appear they could be easily answered. The AAO has recently published a new brochure on informed consent for the orthodontic patient. 7 Although it is quite thorough in its treatment of risks involved in orthodontic treatment, it is silent on the
285
286 Litigation and legislation update possibility of treatment with used brackets. If an orthodontist is reusing brackets, he or she should consider including a statement to that effect in the informed consent. The second negligence cause of action to which the practitioner is vulnerable is based on the failure to use reasonable care in the diagnosis and treatment of a patient. In the context of reuse, a patient may allege that the reuse of a single-use device constituted a departure from the standards of accepted orthodontic treatment and thus constituted malpractice. Given that reuse is a controversial practice not supported by controlled clinical studies, that reconditioners of brackets may not be in Compliance with regulatory requirements governing the manufacture of medical devices, and that most orthodontists do not use reconditioned brackets in their practice, it may not be too difficult to establish that treatment of patients with used brackets constitutes a departure from accepted clinical practice. In summary, the risk of malpractice claims may well offset, in the long run, the short-term cost savings obtained by bracket reuse.
Manufacturer liability The usual "deep pockets" of the manufacturer make it a likely defendant in the case of an injured orthodontic patient. However, the manufacturer's liability risks are more remote than those of the orthodontist because of the intervening conduct of the reconditioning firm. General theories of product liability--strict liability, breach of warranty and negligence--would be asserted against the manufacturer. A patient would encounter difficulty in establishing strict liability or breach of warranty because of the need, in both causes of action, to establish that the bracket was defective when it left the manufacturer's hands. In addition to these difficulties of proof, it may well be concluded that the manufacturer's duty to the ultimate consumer (the patient) was discharged when the warning against reuse was conveyed to the informed intermediary (the orthodontist). Recently, some bracket suppliers have expanded their warnings against reuse by including language to the effect that neither the physical properties of the bracket nor patient safety can be assured with a reused bracket and, further, the manufacturer assumes no liability for injuries associated with reuse. The manufacturer has a right to assume that this warning will be heeded and failure to do so would probably result in forfeiture of the orthodontist defendant's right to assert a third-party claim against the manufacturer for contribution or indemnity. Despite what has been said, there are liability risks for the manufacturer. If the manufacturer is aware or
Am. J. Orthod. Dentofac. Orthop. September 1992
should have been aware that brackets are being reused, it is conceivable that a court would impose an obligation to perform additional product testing to assure safe use even for the unintended purpose of reuse. Further, in the absence of bracket traceability or some discernible indicator of reuse, it may be quite difficult to establish that a particular bracket had indeed been reconditioned and reused, although establishing that an orthodontist did use reconditioned brackets in his practice would not be difficult given the broad range of discovery in civil litigation. Thus the added duty to test and the potential legal and insurance costs (which assumedly will be passed on to the customer) must be added to the costbenefit equation when considering whether reuse makes economic sense.
Reconditioner liability The liability theories described previously with respect to a manufacturer's liability apply equally to reconditioners, but prevailing against a reconditioner in a product suit would be a much easier task. Whereas original bracket manufacturers have established comprehensive systems of control and approval for the design, manufacture, quality assurance, and release of single-use brackets to help assure product safety and reliability, the degree of such controls exercised by reconditioning firms is certainly variable and may be lacking entirely. This fact alone goes a long way in explaining the cost savings that can be passed on to a purchaser of reconditioned brackets. In any event, the absence of these accepted quality assurance practices would allow a claimant to establish negligence with relative ease. Further, the apparent noncompliance with FDA regulatory requirements--from failure to submit to the product approval process to noncompliance with good manufacturing practices and medical device reporting regulations~would constitute negligence per se in most, if not all, jurisdictions. Failure to meet these legal requirements would create an impression of irresponsible conduct that would be difficult for the reconditioner to overcome in a products case and could even result in punitive damages, s One is left to ~,vonder whether the firms that recondition brackets are insured against product liability claims. Failure to obtain such insurance would achieve significant reductions in the costs of doing business, but at the same time would result in compromising the legal rights of both purchasers and patients. In the absence of insurance, any judgment against a reconditioner by an orthodontist, patient, or original bracket manufacturer is likely to go unsatisfied. Certainly an orthodontist has the right to request a certificate of insurance evidencing products liability insurance cover-
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age from suppliers, though such a request is probably seldom made. The absence o f developed case law involving reused medical devices makes the legal liability issue almost as murky as the medical, scientific, and ethical issues. However, what has been described here does not require the development o f new legal principles, but rather is based on the law o f product liability and medical malpractice as it exists in most states today. In conclusion, orthodontic bracket reuse is a practice driven by the desire to reduce costs, but these cost savings may well be illusory. The legal consequences of bracket reuse to the orthodontic industry are not readily quantifiable, but will no doubt be part of the ultimate cost-benefit determination if the practice continues. Costs associated with the diminished reputation of the industry and orthodontists must also be considered. In the long run, the costs o f bracket reuse may well exceed any perceived short-term benefits.
Litigation and legislation update
287
REFERENCES 1. Regan D, van Noort R, O'Keefe C. The effects of recycling on the tensile bond strength of new and clinically used stainless steel orthodontic brackets: an in vivo study. Br J Orthod 1990;17(2):137-45. 2. Maijer R, Smith DC. Biodegradation of the orthodontic bracket system. AM J ORTHODDtLVI'OFACORTttOP 1987;91(4):352. 3. Harris EF, Newman SM, Nicholson JA. Nitinol arch wire in a simulated oral environment: changes in mechanical properties. AM J ORTHODDEr~rOFACORTHOP1988;93(6):508-13. 4. Lew KK, Djeng SK. Recycling ceramic brackets. J Clin Orthod 1990;24:44-7. 5. FDA Compliance Policy Guide 7124.16, 1981. 6. FDA Compliance Policy Guide 7124.28, 1987. 7. Your orthodontic treatment: informed consent for the orthodontic patient. St. Louis: American Association for Orthodontists, 1990. 8. Boardman TA, DiPasquale TJ. Product liability implications of regulatory compliance or noncompliance. In: The medical device industry: science, technol~y and regulation in a competitive environment. New York: Marcel Dekker, 1990:387-97.
Reconditioning and reuse of orthodontic devices Thomas d. DiPasquale* St. Paul, Minn.
LEGAL LIABILITY CONSIDERATIONS A l l too often it is the courts that are called on to
reconcile conflicting or competing public policy interests. The proliferation of litigation has been particularly acute in the health care sector, and it is a subject of concern to all health care providers and medical device manufacturers. Although there have been few reported lawsuits involving reuse of disposable medical devices and, so far as is known, no such claims relating to reuse of orthodontic devices, this may be by virtue of a failure to recognize and causally link specific episodes of reuse with a particular adverse affect. Nevertheless, the fact that reuse is a practice driven by economic forces and surrounded by unresolved ethical issues and unknown medical risks creates a volatile legal atmosphere. If the orthodontic industry fails to resolve the issues raised by bracket reuse, the judiciary will almost inevitably fill the breach by resolving questions of liability for each of the major parties--the orthodontist, the manufacturer (and others in the manufacturer's distribution chain), and the reconditioner.
Orthodontic practitioner liability The orthodontic practitioner is most vulnerable to the risk of liability since he is most directly responsible for the quality of care rendered to patients. This liability can be premised on two grounds: (I) failure to obtain informed consent and (2) medical malpractice, that is, failure to meet the prevailing standard of medical care. Both are negligence-based theories. Generally speaking, absence of a patient's consent to a particular course of treatment or procedure may give rise to a cause of action for negligent nondisclosure of risks or even battery, that is, total absence of consent. *Senior Counsel for Minnesota Mining and Manufacturing Co. 811139061
The patient must establish that he was not properly informed of a risk inherent in the treatment, the undisclosed risk materialized in harm, and consent to the treatment would not have been given if the risk were disclosed. There are exceptions that will excuse nondisclosure. The exceptions include emergency situations, risks commonly known, and the therapeutic privilege, which permits withholding information if the disclosure would hinder treatment or cause psychologic or emotional distress to the patient. Many states have adopted the "patient-oriented" standard for informed consent. Typically, this standard requires the physician to disclose not only those risks that accepted standards of medical practice require to be disclosed, but also those risks and alternative treatments that a reasonable person in the patient's position would consider material or significant in deciding whether to accept or to reject the proposed treatment. Under this standard, a health care provider may be found liable if the jury concludes that a reasonable person in the patient's position would not have consented to treatment if the risks or alternative treatments had been disclosed. Did the orthodontist believe that the patient, if given a choice between treatment with new or used brackets, would have chosen used brackets? Was the orthodontist aware of any clinical studies that demonstrated reused brackets have the same safety and efficacy profile as new brackets? Did the orthodontist disclose to the patient that the manufacturer labeled the bi'ackets as 'single-use only'? These are among the questions that would be posed to an orthodontist in the course of a lawsuit, and it does not appear they could be easily answered. The AAO has recently published a new brochure on informed consent for the orthodontic patient. 7 Although it is quite thorough in its treatment of risks involved in orthodontic treatment, it is silent on the
285
286 Litigation and legislation update possibility of treatment with used brackets. If an orthodontist is reusing brackets, he or she should consider including a statement to that effect in the informed consent. The second negligence cause of action to which the practitioner is vulnerable is based on the failure to use reasonable care in the diagnosis and treatment of a patient. In the context of reuse, a patient may allege that the reuse of a single-use device constituted a departure from the standards of accepted orthodontic treatment and thus constituted malpractice. Given that reuse is a controversial practice not supported by controlled clinical studies, that reconditioners of brackets may not be in Compliance with regulatory requirements governing the manufacture of medical devices, and that most orthodontists do not use reconditioned brackets in their practice, it may not be too difficult to establish that treatment of patients with used brackets constitutes a departure from accepted clinical practice. In summary, the risk of malpractice claims may well offset, in the long run, the short-term cost savings obtained by bracket reuse.
Manufacturer liability The usual "deep pockets" of the manufacturer make it a likely defendant in the case of an injured orthodontic patient. However, the manufacturer's liability risks are more remote than those of the orthodontist because of the intervening conduct of the reconditioning firm. General theories of product liability--strict liability, breach of warranty and negligence--would be asserted against the manufacturer. A patient would encounter difficulty in establishing strict liability or breach of warranty because of the need, in both causes of action, to establish that the bracket was defective when it left the manufacturer's hands. In addition to these difficulties of proof, it may well be concluded that the manufacturer's duty to the ultimate consumer (the patient) was discharged when the warning against reuse was conveyed to the informed intermediary (the orthodontist). Recently, some bracket suppliers have expanded their warnings against reuse by including language to the effect that neither the physical properties of the bracket nor patient safety can be assured with a reused bracket and, further, the manufacturer assumes no liability for injuries associated with reuse. The manufacturer has a right to assume that this warning will be heeded and failure to do so would probably result in forfeiture of the orthodontist defendant's right to assert a third-party claim against the manufacturer for contribution or indemnity. Despite what has been said, there are liability risks for the manufacturer. If the manufacturer is aware or
Am. J. Orthod. Dentofac. Orthop. September 1992
should have been aware that brackets are being reused, it is conceivable that a court would impose an obligation to perform additional product testing to assure safe use even for the unintended purpose of reuse. Further, in the absence of bracket traceability or some discernible indicator of reuse, it may be quite difficult to establish that a particular bracket had indeed been reconditioned and reused, although establishing that an orthodontist did use reconditioned brackets in his practice would not be difficult given the broad range of discovery in civil litigation. Thus the added duty to test and the potential legal and insurance costs (which assumedly will be passed on to the customer) must be added to the costbenefit equation when considering whether reuse makes economic sense.
Reconditioner liability The liability theories described previously with respect to a manufacturer's liability apply equally to reconditioners, but prevailing against a reconditioner in a product suit would be a much easier task. Whereas original bracket manufacturers have established comprehensive systems of control and approval for the design, manufacture, quality assurance, and release of single-use brackets to help assure product safety and reliability, the degree of such controls exercised by reconditioning firms is certainly variable and may be lacking entirely. This fact alone goes a long way in explaining the cost savings that can be passed on to a purchaser of reconditioned brackets. In any event, the absence of these accepted quality assurance practices would allow a claimant to establish negligence with relative ease. Further, the apparent noncompliance with FDA regulatory requirements--from failure to submit to the product approval process to noncompliance with good manufacturing practices and medical device reporting regulations~would constitute negligence per se in most, if not all, jurisdictions. Failure to meet these legal requirements would create an impression of irresponsible conduct that would be difficult for the reconditioner to overcome in a products case and could even result in punitive damages, s One is left to ~,vonder whether the firms that recondition brackets are insured against product liability claims. Failure to obtain such insurance would achieve significant reductions in the costs of doing business, but at the same time would result in compromising the legal rights of both purchasers and patients. In the absence of insurance, any judgment against a reconditioner by an orthodontist, patient, or original bracket manufacturer is likely to go unsatisfied. Certainly an orthodontist has the right to request a certificate of insurance evidencing products liability insurance cover-
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age from suppliers, though such a request is probably seldom made. The absence o f developed case law involving reused medical devices makes the legal liability issue almost as murky as the medical, scientific, and ethical issues. However, what has been described here does not require the development o f new legal principles, but rather is based on the law o f product liability and medical malpractice as it exists in most states today. In conclusion, orthodontic bracket reuse is a practice driven by the desire to reduce costs, but these cost savings may well be illusory. The legal consequences of bracket reuse to the orthodontic industry are not readily quantifiable, but will no doubt be part of the ultimate cost-benefit determination if the practice continues. Costs associated with the diminished reputation of the industry and orthodontists must also be considered. In the long run, the costs o f bracket reuse may well exceed any perceived short-term benefits.
Litigation and legislation update
287
REFERENCES 1. Regan D, van Noort R, O'Keefe C. The effects of recycling on the tensile bond strength of new and clinically used stainless steel orthodontic brackets: an in vivo study. Br J Orthod 1990;17(2):137-45. 2. Maijer R, Smith DC. Biodegradation of the orthodontic bracket system. AM J ORTHODDtLVI'OFACORTttOP 1987;91(4):352. 3. Harris EF, Newman SM, Nicholson JA. Nitinol arch wire in a simulated oral environment: changes in mechanical properties. AM J ORTHODDEr~rOFACORTHOP1988;93(6):508-13. 4. Lew KK, Djeng SK. Recycling ceramic brackets. J Clin Orthod 1990;24:44-7. 5. FDA Compliance Policy Guide 7124.16, 1981. 6. FDA Compliance Policy Guide 7124.28, 1987. 7. Your orthodontic treatment: informed consent for the orthodontic patient. St. Louis: American Association for Orthodontists, 1990. 8. Boardman TA, DiPasquale TJ. Product liability implications of regulatory compliance or noncompliance. In: The medical device industry: science, technol~y and regulation in a competitive environment. New York: Marcel Dekker, 1990:387-97.
