Legal Perspective: Licensing and Liability Issues Regarding the Use of Oral Appliances in the Treatment of Obstructive Sleep Apnea

As the science of disordered sleep develops, the public is becoming increasingly aware of how large a segment of the population suffers from obstructive sleep apnea (OSA). As discussed extensively in this issue of Sleep and Breathing, one of the many treatments for OSA makes use of an oral appliance (OA) that positions the patient's jaw in a manner that maintains the integrity of the patient's posterior airway space during sleep.[1] Because of the nature of OA therapy, certain aspects of this treatment may fall within the scope of practice of physicians, and certain aspects may fall within the scope of practice of dentists. From a legal standpoint, two main concerns arise in this context: compliance with local licensing requirements, and issues of professional liability.

Each jurisdiction has laws that define the scope of practice of licensed health professionals within that jurisdiction. With respect to OA therapy, a number of licensing concerns apply. For example, the diagnosis of OSA, and the prescription, construction, fitting, placement, and adjustment of an OA may, based on the jurisdiction in which the conduct occurs, be restricted to either physicians or dentists. Practitioners should be aware of the limitations of their own jurisdiction before undertaking a treatment of OSA involving the use of an OA.

Liability issues applicable to this course of treatment come in several stripes. For example, each jurisdiction may provide for civil and criminal penalties for violations of the licensing statutes. In addition, a health-care practitioner may be exposed to malpractice liability where a course of treatment is undertaken in violation of the licensing statute,[2] or otherwise does not satisfy the applicable standard of care.[3] A number of factors comprise the standard of care for a given course of treatment, but as a general rule, the conduct expected of a reasonably prudent practitioner of the profession is used as a baseline measure.[4]

REFERENCES

• 1 Schmidt-Nowara W, Lowe A, Wiegand L. Oral appliances for the treatment of snoring and obstructive sleep apnea: A review.  Sleep. 1995;  18 501-510
• 2 Keeton W. Page. Prosser and Keeton on the Law of Torts, § 36, 5^th ed. 18: West, 1984 . 
• 3 See, e.g., Snead v. United States, 595 F Supp. 658, 663 (D.D.C. 1984)
• 4 See, e.g., Raines v. Lutz, 231 Va 110 (1986). Other courts measure the standard based upon ``the ordinary and accepted standards [and] skill of the average member'' of the profession. See, e.g., Mann et al. v. United States, 904 F.2d 1 (2d Cir. 1990)
• 5 Schmidt-Nowara W. Recent developments in oral appliance therapy of sleep disordered breathing. J. Sleep and Breathing 1999 3: 103-106
• 6 Kan Stat § 65-1422 (1998) . 
• 7 225 ILCS 25/17 (1999) . 
• 8 See, e.g., D.C. Code § 2-3301.2 (1999) (District of Columbia); Ky. Rev. Stat. § 313.010 (1998) (Kentucky); Mass. Gen. Laws ch. 112, § 50 (1999) (Massachusetts); N.H. Rev. Stat. § 317-A:20 (1999) (New Hampshire); N.Y. Educ. Law § 6601 (Consol. 1999) (New York); N.C. Gen. Stat. § 90-29 (1999) (North Carolina); Ohio Rev. Code § 4715.01 (1999); Okla. Stat. tit. 59, § 328.19 (1999) (Oklahoma); P.R. Laws tit. 20, § 92 (1997) (Puerto Rico); S.D. Codified Laws § 36-6A-28 (2000) (South Dakota); Tenn. Code § 63-5-108 (1999) (Tennessee)
• 9 225 ILCS 25/17. 
• 10 Similar limitations are found in the dental practice acts of Alabama, Ala. Code § 34-9-6 (1999); Arkansas, Ark. Code § 17-82-102 (1999); California, Cal. Bus. & Prof. Code § 1625 (1999); Colorado, Colo. Rev. Stat. § 12-35-110 (1999); Delaware, Del. Code tit. 24, § 1121 (1999); District of Columbia, D.C. Code § 2-3301.2; Florida, Fla. Stat. § 4666.003 (1999); Hawaii, Haw. Rev. Stat. § 448-1 (1999); Idaho Code § 54-901 (1999); Indiana, Ind. Code § 25-14-1-23 (1999); Kansas, Kan. Stat. § 65-1422; Kentucky, Ky. Rev. Stat. § 313.010; Maine, Me. Rev. Stat. tit. 32, § 1081 (1998); Maryland, Md. Code, Health Occ. § 4-101 (1999); Massachusetts, Mass. Gen. Laws ch. 112, § 50; Minnesota, Minn. Stat. § 150A.05 (1999); Mississippi, Miss. Code § 73-9-3 (2000); Missouri, Mo. Rev. Stat. § 332.071 (1999); Montana, Mont. Code § 37-4-101 (1999); Nebraska, Neb. Rev. Stat. § 71-183 (1999); Nevada, Nev. Rev. Stat. § 631.215 (2000); New Hampshire, N.H. Rev. Stat. § 317-A:20; New Jersey, N.J. Rev. Stat. § 45:6-19 (1999); New Mexico, N.M. Stat. § 61-5A-4 (2000); New York, N.Y. Educ. Law § 6601; North Carolina, N.C. Gen. Stat. § 90-29; North Dakota, N.D. Cent. Code § 43-28-01 (2000); Ohio Rev. Code § 4715.01; Oklahoma, Okla. Stat. tit. 59, § 328.19; Pennsylvania, 63 Pa. Cons. Stat. § 121 (1999); Puerto Rico, P.R. Laws tit. 20, § 92; Rhode Island, R.I. Gen. Laws § 5-31.1-1 (1999); South Carolina, S.C. Code § 40-15-70 (1998); South Dakota, S.D. Codified Laws § 36-6A-26; Tennessee, Tenn. Code § 63-5-108; Texas, Tex. Occ. Code § 251.003 (2000); Utah Code § 58-69-102 (1999); Vermont, Vt. Stat. tit. 26, § 721 (2000); Virgin Islands, V.I. Code tit. 27, § 61 (1999); Virginia, Va. Code § 54.1-2700 (1999); Washington, Wash. Rev. Code § 18.32.020 (1999); West Virginia, W. Va. Code § 30-4-2 (2000); Wisconsin, Wis. Stat. § 447.01 (1999); and Wyoming, Wyo. Stat. § 33-15-114 (1999).  
• 11 Schmidt-Nowara W., Meade T., Hays M. Treatment of snoring and obstructive sleep apnea with a dental orthosis.  Chest . 1991;  99 1378-1385
• 12 24 Del. C § 1130. 
• 13 Kan. Stat. § 65-1423 . 
• 14 225 ILCS 25/17 . 
• 15 Alabama, Ala. Code § 34-9-6 ; Arkansas, Ark. Code § 17-82-105; California, Cal. Bus. & Prof. Code § 1625; Colorado, Colo. Rev. Stat. § 12-35-110; Connecticut, Conn. Gen. Stat. § 20-122a; Delaware, 24 Del. Code § 1130; District of Columbia, D.C. Code § 2-3301.2; Florida, Fla. Stat. § 4666.003; Georgia, Ga. Code § 43-11-17; Hawaii, Haw. Rev. Stat. § 448-1; Illinois, 225 ILCS 25/17; Indiana, Ind. Code § 25-14-1-23; Iowa, Ia. Code § 153.13; Kansas, K.S. § 65-1422; Kentucky, Ky. Rev. Stat. § 313.010; Maine, 32 Me. Rev. Stat. § 1081; Massachusetts, Mass. Gen. Laws Ch. 112, § 50; Minnesota, Minn. Stat. § 150A.05; Missouri, § 332.071 R.S. Mo.; Montana, Mont. Code § 37-4-101; Nebraska, R.R.S. Neb. § 71-183; New Hampshire, N.H. Rev. Stat. § 317-A:20; New Mexico, N.M. Stat. § 61-5A-4; New York, NY Law Educ. § 6601; North Carolina, N.C. Gen. Stat. § 90-29; North Dakota, N.D. Cent. Code § 43-28-02; Ohio, ORC § 4715.01; Oklahoma, Okla. Stat. tit. 59, § 328.19; Pennsylvania, 63 Pa. Cons. Stat. § 121; Puerto Rico, P.R. Laws tit. 20 § 92; Rhode Island, R.I. Gen. Laws § 5-31.1-1; South Dakota, S.D. Codified Laws § 36-6A-32; Tennessee, Tenn. Code § 63-5-108; Texas, Tex. Occ. Code § 251.003; Vermont, Vt. Stat. tit. 2b, § 721; Virgin Islands, V.I. Code tit. 27 § 61; Virginia, Va. Code § 54.1-2711; Washington, Wash. Rev. Code § 18.32.020; West Virginia, W. Va. Code § 30-4-2; Wisconsin, Wis. Stat. § 447.01; and Wyoming, Wyo. Stat. § 33-15-114 . 
• 16 Ala. Code § 34-9-7; Ark. Code § 17-82-102; Cal. Bus. & Prof. Code § 1626; Conn. Gen. Stat. § 20-123; Del. Code tit. 24, § 1134; Fla. Stat. § 4666.002; Ga. Code § 43-11-22; Haw. Rev. Stat. § 448-1; Idaho Code § 54-930; 225 ILCS 25/17; Ind. Code § 25-14-1-22; Iowa Code § 153.14; Kan. Stat. § 65-1423; 32 Me. Rev. Stat. § 1081; Md. Code, Health Occ. § 4-102; Miss. Code § 73-9-3; Mont. Code § 37-4-103; Neb. Rev. Stat. § 71-183.01; Nev. Rev. Stat. § 631.390; N.H. Rev. Stat. § 317-A:20; N.J. Stat. § 45:6-19; N.M. Stat. § 61-5A-5; N.C. Gen. Stat. § 90-29; N.D. Cent. Code § 43-28-02; Okla. Stat. tit. 59, § 328.19; Or. Rev. Stat. § 679.025; 63 Pa. Cons. Stat. § 121; R.I. Gen. Laws § 5-31.1-37; S.C. Code § 40-15-110; Tenn. Code § 63-5-109; Tex. Occ. Code § 251.004; Vt. Stat. tit. 26, § 721; V.I. Code tit. 27, § 61; Va. Code § 54.1-2701; Wash. Rev. Code § 18.32.030; W. Va. Code § 30-4-2; Wis. Stat. § 447.03; and Wyo. Stat. § 33-15-115 . 
• 17 U.S. Dep't of Health and Human Services, Public Health Service, National Institutes of Health, National Heart, Lung and Blood Institute NIH Pub No. 95-3798, Facts about Sleep Apnea (1995) . 
• 18 Pack A. Obstructive Sleep Apnea. Advances in Internal Medicine 39:517-566. The primary diagnostic tool for evaluating whether a patient has OSA is the in-laboratory polysomnography (``PSG''). A PSG consists of a battery of tests, including electrocardiogram, electroencephalogram, electromyogram, and electrooculogram. The patient's respiration is also measured in a variety of ways during a PSG
• 19 Among the various nonsurgical methods used to treat OSA are pharmacotherapy, continuous positive airway pressure (``CPAP''), and OAs. Several surgical methods have been used to correct OSA, such as removal of the tonsils and adenoids, removal of the uvula and associated tissues, surgical adjustment of the mandible, and tracheostomy. Pack, A. Obstructive Sleep Apnea. Advances in Internal Medicine 39:517-566. See also U.S. Dep't of Health and Human Services, Public Health Service, National Institutes of Health, National Heart, Lung and Blood Institute NIH Pub. No. 95-3803, Sleep Apnea: Is Your Patient at Risk? (1995)
• 20 Barsh L. Dentistry's role in the recognition and treatment of sleep-breathing disorders: the need for cooperation with the medical community.  CDA Journal . 1998;  26 591-598
• 21 Ala. Code § 34-9-5 . 
• 22 Ind. Code § 35-50-2-1 . 
• 23 225 ILCS 60/3.5 . 
• 24 225 ILCS 25/8.5 . 
• 25 Liang B. Assessing Medical Malpractice Jury Verdicts: A Case Study of an Anesthesiology Department. 7 Cornell J of Law and Pub. Policy 121, at n. 14
• 26 Keeton. supra note 3 at § 32 . 
• 27 Id. 
• 28 Liang. supra note 27 at nn 14, 41 . 
• 29 Metcalf v. United States, Civ A. No. 87-0138, 1990 U.S. Dist. LEXIS 2236 (Mar. 1, 1990) . 
• 30 Butts v. Watts, 290 S.W. 2d 777 (Ky. 1956) . 
• 31 See, e.g., Sewell v. United States, 629 F. Supp. 448 (W.D. La. 1986), Phillips v. United States, 566 F. Supp. 1, 14 (D.C. S.C. 1981)
• 32 Keeton. supra note 3 at § 32 . 
• 33 See, e.g., Cross v. Hutenlocher, 82 A.2d 952, 954 (Conn. 1981) .