The American Journal of Law & Medicine is co-published with the American Society of Law, Medicine and Ethics. Mr. Moulton is the Executive Director of the American Society of Law, Medicine and Ethics. Additionally, Mr. Moulton served as an advisor to the Foundation for Informed Medical Decision Making, a non-profit foundation that creates decision aids for patient education. Mr. Moulton and Mrs. Staples King, however, submitted this article for review in blind format. The editorial staff completed its review and accepted this article without knowing who the authors were.

1 See, e.g., Jessica W. Berg et al., Informed Consent: Legal Theory and Clinical Practice vii-viii (2d ed. 2001); Katz, Jay, The Silent World of Doctor and Patient (Johns Hopkins University Press 2002)Google Scholar; Gatter, Ken Marcus, Protecting Patient-Doctor Discourse: Informed Consent and Deliberative Autonomy, 78 Or. L. Rev. 941, 950 (1999)Google ScholarPubMed; Wennberg, John E. & Peters, Philip G., Unwanted Variations in the Quality of Health Care: Can the Law Help Medicine Provide a Remedy/Remedies?, 37 Wake Forest L. Rev. 925, 925-941 (2002)Google Scholar.

2 While each state may have its own basic interpretation of each standard, they can easily be divided into the two groups based on their language and intent, with the exception of New Mexico and Minnesota, which have hybrid standards. For more information on the individual state standards please see Appendix A.

3 Tashman v. Gibbs, 556 S.E.2d 772, 777 (Va. 2002).

4 Canterbury v. Spence, 464 F.2d 772, 784 (D.C. Cir. 1972).

5 Center for the Evaluative Clinical Sciences, Dartmouth Medical School, Dartmouth Atlas Project Topic Brief: Preference-Sensitive Care 6 (2005), http://www.dartmouthatlas.org/topics/preference_sensitive.pdf.

6 Bogardus, Sidney T. et al., Perils, Pitfalls and Possibilities in Talking about Medical Risk, 281 JAMA 1037, 1039 (1999)CrossRefGoogle ScholarPubMed.

7 Center for the Evaluative Clinical Sciences, Dartmouth Medical School, The Dartmouth Atlas of Health Care 1998 21 (1998), available at http://www.dartmouthatlas.org/atlases/98Atlas.pdf; see also John E. Wennberg, Variation in Use of Medical Services Among Regions and Selected Academic Medical Centers: Is More Better?, Commonwealth Fund Rep., Dec. 2005, at 26, available at http://www.cmwf.org/usr_doc/874_wennberg_variation_medicaresvcs.pdf.

8 Feldman-Stewart, Deb et al., Practical Issues in Assisting Shared Decision-Making, 3 Health Expectations 46, 49 (2000)CrossRefGoogle ScholarPubMed.

9 See, e.g., Wennberg & Peters, supra note 1, at 937; see also Katz, supra note 1.

10 Kaplan, Robert M., Shared Medical Decision Making: A New Tool for Preventative Medicine, 26 Am. J. Prev. Med. 81, 81 (2003)CrossRefGoogle Scholar.

11 Id.

12 See, e.g., Katz, supra note 1, at 121-128, 227-228.

13 See, e.g., Bogardus et al., supra note 6, at 1037-41; Leydon, Geraldine M. et al., Cancer Patients’ Information Needs and Information Seeking Behavior: In Depth Interview Study, 320 Brit. Med. J. 909, 909-913 (2000)CrossRefGoogle Scholar; Woolf, Steven H. & Krist, Alex, The Liability of Giving Patients a Choice: Shared Decision Making and Prostate Cancer, 71 Am. Family Phys 1871, 871-72 (2005)Google ScholarPubMed.

14 See, e.g., Dunn, Andrew S. et al., Physician-Patient Discussions of Controversial Cancer Screening Tests, 20 Am. J. Preventive Med. 130, 133 (2001)CrossRefGoogle ScholarPubMed (finding that “a substantial number of physicians decide whether to screen patients for prostate and breast cancer without sufficiently involving patients in the decision”); Woolf & Krist, supra note 13, at 1871 (claiming that little shared medical decision making occurs in practice despite consensus among medical organizations on the benefits of this approach).

15 Woolf, Steven H., The Logic and Limits of Shared Decision Making, 166 J. Urology 244, 244 (2001)CrossRefGoogle ScholarPubMed; Woolf & Krist, supra note 13, at 1871-72.

16 Merenstein, Daniel, Winners and Losers, 291 JAMA 15, 15-16 (2004)Google ScholarPubMed.

17 Id. at 15.

18 Id.

19 Id.; U.S. Preventive Services Task Force, Screening for Prostate Cancer: Recommendation and Rationale, 137 Annals. Internal. Med. 915, 915 (2002)CrossRefGoogle Scholar.

20 U.S. Preventive Services Task Force, supra note 19, at 915.

21 Id.

22 Id.

23 Holmberg, Lars et al., A Randomized Trial Comparing Radical Prostatectomy with Watchful Waiting in Early Prostate Cancer, 347 New Eng. J. Med. 781, 787 (2002)CrossRefGoogle ScholarPubMed.

24 U.S. Preventive Services Task Force. supra note 19, at 915.

25 Id.

26 Id. at 916.

27 Merenstein, supra note 16, at 15.

28 Id.

29 Id.

30 Id.

31 Id.

32 Id.

33 Id.

34 Id.

35 See generally Restatement (Second) of Torts § 281 (1965) (discussing elements for a cause of action for negligence); Frank J. Vandal & Ellen Wertheimer, Torts: Cases and Problems 179-89 (Michie 1997) (discussing the concept of the standard of care owed to others related to negligence claims).

36 Merenstein, supra note 16, at 15.

37 Id. at 15-16.

38 Tom L. Beauchamp & James F. Childress, Principles of Biomedical Ethics 12 (5th ed. 2001).

39 See id. at 12, 114-115, 176, 248.

40 Id. at 176; O’Neill, Onora, Autonomy and Trust in Bioethics 39 (Cambridge University Press 2002)CrossRefGoogle Scholar; Tauber, Alfred I., Sick Autonomy, 46 Persp. Biology & Med. 484, 488 (2003)CrossRefGoogle ScholarPubMed. See also Parascandola, Mark et al., Patient Autonomy and the Challenge of Clinical Uncertainty, 12 Kennedy Inst. Ethics J. 245, 245-247 (2002)CrossRefGoogle ScholarPubMed (discussing the challenges facing physicians in the face of clinical uncertainty about a patient's health).

41 Tauber, supra note 40, at 485.

42 Id.

43 Id.; see O’Neill, supra note 40, at 29-31 (discussing naturalistic philosophy of individuality arising from “civil or social liberty”).

44 Id. at 23.

45 Kukla, Rebecca, Conscientious Autonomy: Displacing Decisions in Health Care, 35 Hastings Ctr. Rep. 34, 35 (2005)Google ScholarPubMed.

46 Id.

47 Id.

48 Beauchamp & Childress, supra note 38, at 166.

49 Id.

50 Id.

51 Id.

52 Id. at 176.

53 Parascandola et al., supra note 40, at 248.

54 Id.; Beauchamp & Childress, supra note 38, at 12; Kukla, supra note 45, at 35; O’Neill, supra note 40, at 34; Tauber, supra note 40, at 485.

55 See Tauber, supra note 40, at 485-86.

56 Id. at 486.

57 Meisel, Alan & Kuczewski, Mark, Legal and Ethical Myths About Informed Consent, 156 Archives Internal Med. 2521, 2525CrossRefGoogle Scholar.

58 Gatter, supra note 1, at 946-48.

59 See, e.g., Mohr v. Williams, 104 N.W. 12, 14-15 (Minn. 1905).

60 See, e.g., Canterbury, 464 F.2d at 787; Tashman, 556 S.E.2d at 777.

61 Noah, Lars, Informed Consent and the Elusive Dichotomy Between Standard and Experimental Therapy, 28 Am. J.L. & Med. 361, 367 (2002)CrossRefGoogle ScholarPubMed.

62 Id. at 368.

63 Mohr, 104 N.W. at 14.

64 Restatement (Second) of Torts § 18 (2006). Claims for battery may also be brought in criminal proceedings as well as civil proceedings as a tort. Battery in the medical malpractice context is generally considered a tort, rather than a criminal act.

65 Mohr, 104 N.W. at 14.

66 Id. at 13.

67 Id. at 14.

68 Id. at 15; see also Gatter, supra note 1, at 947.

69 Schloendorff v. Soc’y of N.Y. Hosp., 105 N.E. 92 (N.Y. 1914).

70 Id. at 93.

71 Id.

72 Katz, supra note 1, at 68.

73 Id. at 70.

74 See id. at 69.

75 See id. at 68.

76 Gatter, supra note 1, at 950.

77 Natanson v. Kline, 350 P.2d 1093, 1106 (Kan. 1960).

78 See Katz, supra note 1, at 2.

79 Id. at 80-81.

80 See id. at 81.

81 See id. at 59.

82 Salgo v. Leland Stanford Jr., Univ. Bd. of Trs., 317 P.2d 170 (Cal. Dist. Ct. App. 1957).

83 Id. at 176.

84 Id. at 173-74.

85 Id. at 173.

86 Katz, supra note 1, at 61.

87 Id. (quoting Salgo, 317 P.2d at 176).

88 Salgo, 317 P.2d at 181.

89 Natanson, 350 P.2d at 1093.

90 Katz, supra note 1, at 70.

91 Natanson, 350 P.2d at 1106.

92 Id. at 1106.

93 Id. at 1103.

94 Katz, supra note 1, at 65.

95 Tashman, 556 S.E.2d at 777 (citing Dickerson v. Fatehi, 484 S.E.2d 880, 881 (1997), Rogers v. Marrow, 413 S.E.2d 344, 346 (Va, 1992), & Raines v. Lutz, 341 S.E.2d 194, 196 (Va. 1986)).

96 Id. See Appendix A for language from the rest of the physician-based states.

97 See id. at 777-779.

98 Id. at 777.

99 Merenstein, supra note 1, at 15-16.

100 See infra Appendix A (listing the twenty-five physician-based states as Alabama, Arkansas, Arizona, Colorado, Delaware, Florida, Idaho, Illinois, Indiana, Kansas, Kentucky, Maine, Michigan, Missouri, Montana, Nebraska, Nevada, New Hampshire, New York, North Carolina, South Carolina, Tennessee, Vermont, Virginia and Wyoming). See Appendix A for a more detailed description of the laws on a state-by-state basis.

101 Canterbury, 464 F.2d at 772.

102 Id. at 787.

103 Mohr, 104 N.W. at 12.

104 See Canterbury, 464 F.2d at passim.

105 Id. at 776.

106 Id. at 778.

107 Id. at 780 (quoting Schloendorff, 105 N.E. at 93).

108 Id.

109 Id. at 784.

110 Id. at 784-85.

111 Id. at 785-87.

112 Id. at 786-87.

113 Id. at 787 (quoting Waltz, Jon R. & Scheuneman, Tomas W., Informed Consent to Therapy, 64 Nw. U.L. Rev. 628, 639-40 (1970)Google Scholar).

114 See Katz, supra note 1, at 74.

115 Scott v. Bradford, 606 P.2d 554 (Okla. 1979).

116 Id. at 559.

117 Id. at 558.

118 See id. at 559.

119 See id.

120 Bradford, 606 P.2d at 559 (emphasis in original).

121 See id. at 559.

122 Johnson v. Thompson, 971 F.2d 1487, 1499 (10th Cir. Okla. 1992); In re Baycol Prods. Litig., 2003 U.S. Dist. LEXIS 26846, at *22 (D. Minn. Feb. 25, 2003); Goss v. Okla. Blood Inst., 856 P.2d 998, 998 (Okla. Ct. App. 1990).

123 See, e.g., Masquat v. Maguire, 638 P.2d 1105 (Okla. 1981) (noting the lack of a causal link between unrevealed risk and injuries); Arena v. Gingrich, 733 P.2d 75, 79 (Or. Ct. App. 1987) (“[T]hat the test is subjective does not mean … that the only permissible determinants are the plaintiff's testimony and other evidence that pertains directly to the plaintiff's subjective choice”).

124 See Masquat, 638 P.2d at 1107.

125 See id. at 1105.

126 See id. at 1106.

127 Id. at 1107.

128 See id. at 1106-07; Arena, 733 P.2d at 78.

129 See Ashe v. Radiation Oncology Assocs., 9 S.W.3d 119, 122 (Tenn. 1999).

130 See id.; see also Piper, August Jr., Truce on the Battlefield: A Proposal for a Different Approach to Medical Informed Consent, J.L. Med. & Ethics 301, 304-05 (1994)CrossRefGoogle ScholarPubMed.

131 See Ashe, 9 S.W.3d at 122.

132 See Scott, 606 P.2d at 559; Macy v. Blatchford, 8 P.3d 204, 210 (Or. 2000).

133 See infra Part XI.

134 Canterbury, 464 F.2d at 786.

135 Id. at 787.

136 See Scott, 606 P.2d at 559.

137 See infra Appendix A (listing patient-based states to include Alaska, California, Connecticut, District of Columbia, Georgia, Hawaii, Iowa, Louisiana, Maryland, Massachusetts, Mississippi, New Jersey, North Dakota, Oklahoma, Ohio, Oregon, Pennsylvania, Rhode Island, South Dakota, Texas, Utah, Washington, West Virginia and Wisconsin. The remaining two states, Minnesotta and New Mexico, have hybrid standards). See Appendix A for a more detailed description of the laws on a state-by-state basis.

138 Wennberg & Peters, supra note 1, at 925.

139 See id.

140 Id. at 934.

141 Frosch, Dominick L. & Kaplan, Robert M., Shared Decision Making in Clinical Medicine: Past Research and Future Directions, 17 Am. J. Preventive Med. 285, 287 (1999)CrossRefGoogle ScholarPubMed.

142 See Deb Feldman-Stewart, et al., The Information Required by Patients with Earlystage Prostate Cancer in Choosing Their Treatment, 87 Bju Int’l 218, 220-23 (2001)CrossRefGoogle Scholar.

143 See generally Center for the Evaluative Clinical Sciences, supra note 7 (concluding that health care varies with geography).

144 See, e.g., Center for the Evaluative Clinical Sciences, Dartmouth Medical School, The Quality of Medical Care in the United States: A Report on the Medicare Program, The Dartmouth Atlas of Health Care 1999 (1999), available at http://www.dartmouthatlas.org/atlases/99Atlas.pdf; Wennberg, John E. & Gittelsohn, Alan, Small Area Variations in Health Care Delivery: A Population-based Health Information System Can Guide Planning and Regulatory Decision-making, 182 Science 1102 (1973)CrossRefGoogle Scholar.

145 Center for the Evaluative Clinical Sciences, supra note 5, at 3.

146 Id. at 11-15; Center for the Evaluative Clinical Sciences, supra note 7, at 107.

147 Center for the Evaluative Clinical Sciences, supra note 7, at 5.

148 Center for Evaluative Clinical Sciences, supra note 5, at 3.

149 See Center for the Evaluative Clinical Sciences, supra note 7, at 111-30 (for regions with below-average treatment rates for various procedures); see also Wennberg, supra note 7, at 2-3 (for data on the underuse of effective care).

150 Cf. Center for the Evaluative Clinical Sciences, supra note 7, at 38 (finding that the distribution of physician workforce in the United States did not change in any dramatic way from 1993-1996).

151 Wennberg, supra note 7, at 8.

152 Id. at 6-7.

153 Feldman-Stewart, supra note 8, at 47.

154 Id.

155 Id.

156 Id. at 46-47.

157 Id. at 47.

158 Id.

159 Wennberg, supra note 1, at 925.

160 See id. at 927-32.

161 Wennberg & Peters, supra note 9, at 927.

162 Id.

163 John E. Wennberg, Keynote Lecture at the Instit. for Health Care Improvement Nat’l Forum: Understanding Practice Patterns: A Focus on What the Quality Movement Can Do to Reduce Unwarranted Variations (Dec. 14, 2005) (transcript available at www.dartmouthatlas.org/atlases/lecture.shtm).

164 See McGlynn, Elizabeth A. et al., The Quality of Health Care Delivered to Adults in the United States, 348 N. Engl. J. Med., 2635, 2641-44 (2003)CrossRefGoogle ScholarPubMed (indicating that on average, Americans receive about half of recommended medical care processes).

165 See Lane v. Candura, 376 N.E.2d 1232, 1233 (Mass. App. Ct. 1978).

166 See Wennberg & Peters, supra note 9, at 925-41; see also O’Connor, Annette M. et al., Modifying Unwarranted Variations in Health Care: Shared Decision Making Using Patient Decision Aids, Health Aff. (Web Exclusive) 63, 63-72 (2004)CrossRefGoogle Scholar; Interview by Ben Moulton with Jack E. Wennberg, Co-Founder and Senior Policy Advisor of the Foundation for Informed Medical Decision Making (2006).

167 See Wennberg, supra note 164, at 9-14 (noting that doctors may treat patients with chronic hip, knee, and back conditions in more than one way).

168 Wennberg & Peters, supra note 9, at 928.

169 Id.

170 Id.

171 Center for the Evaluative Clinical Sciences, supra note 5, at 11-15.

172 Wennberg & Peters, supra note 9, at 928.

173 Bhatnagar, Viba & Kaplan, Robert, Treatment Options for Prostate Cancer: Evaluating the Evidence, 71 Am. Fam Physician 1915, 1915 (2005)Google ScholarPubMed.

174 Id. at 1916, 1918.

175 Id.

176 Id. at 1920.

177 Id.

178 Id.

179 See Bogardus et al., supra note 6, at 1037-41.

180 Wennberg, supra note 164, at 9.

181 Id.

182 Wennberg & Peters, supra note 9, at 930 (citing Center for the Evaluative Clinical Sciences, Dartmouth Medical School, The Quality of Medical Care in the United States: A Report on the Medicare Program, The Dartmouth Atlas of Health Care 1999 (1999), available at http://www.dartmouthatlas.org/atlases/atlas_series.shtm).

183 Wennberg, supra note 164, at 10 (citing Center for the Evaluative Clinical Sciences, Dartmouth Medical School, The Quality of Medical Care in the United States: A Report on the Medicare Program, The Dartmouth Atlas of Health Care 1999 (1999), available at http://www.dartmouthatlas.org/atlases/atlas_series.shtm).

184 See id.

185 Id. at 11.

186 Wennberg & Peters, supra note 1, at 932.

187 Frosch & Kaplan, supra note 141, at 287; see also Feldman-Stewart, Deb et al., The Information Required by Patients With Early-Stage Prostate Cancer in Choosing Their Treatment, 87 BJU Int’l 218, 220-221 (2001)CrossRefGoogle ScholarPubMed.

188 Feldman-Stewart et al., supra note 8, at 49.

189 Id.

190 Id. An Index of Agreement was used to determine substantial agreement between patients and the threshold was set at 67% agreement. Id.

191 Canterbury, 464 F.2d at 787 (quoting Waltz, Jon R. & Scheuneman, Thomas W., Informed Consent to Therapy, 64 Nw. U. L. Rev. 628, 640 (1970)Google Scholar).

192 Frosch & Kaplan, supra note 141, at 286.

193 See supra Part V.

194 Id.

195 Wennberg, supra note 164, at 7.

196 See id.

197 O’Connor et al., supra note 167, at 63.

198 Center for the Evaluative Clinical Sciences, supra note 7, at 21.

199 Reed Abelson, Side Effects: A Stent Epidemic; Heart Procedure is Off the Charts in an Ohio City, N.Y. Times, Aug. 18, 2006, at A1.

200 Id.

201 Id.

202 Id.

203 Id.

204 Id.

205 Id.

206 Id.

207 Id.

208 Id.

209 Center for the Evaluative Clinical Sciences, supra note 7, passim.

210 Feldman-Stewart, supra note 8, at 49.

211 See infra notes 212-213 and accompanying text.

212 See Feldstein, Paul J., Health Policy Issues: an economic perspective on Health Reform 38–46 (Health Administration Press & AUPHA Press 1999)Google Scholar; Miller, Tracy E. & Horowitz, Carol R., Disclosing Doctors’ Incentives: Will Consumers Understand and Value the Information?, 19 Health Affairs 149, 149-155 (2000)CrossRefGoogle ScholarPubMed; Frank, Richard G., Behavioral Economics and Health Economics (Nat’l Bureau of Econ. Research, Working Paper No. 10881, 2004)CrossRefGoogle Scholar.

213 Christensen, Kate T., Ethically Important Distinctions Among Managed Care Organizations, 23 J.L. Med. & Ethics 223, 224 (1995)CrossRefGoogle ScholarPubMed; Nadler, Eric S. et al., Does a Year Make a Difference? Changes in Physician Satisfaction and Perception in an Increasingly Capitated Environment, 107 Am. J. Med. 38, 38 (1999)CrossRefGoogle Scholar (discussing capitation as financial incentive for physicians).

214 Feldstein, supra note 212, passim.

215 Center for the Evaluative Clinical Sciences, supra note 7, passim.

216 Id.

217 Wennberg & Peters, supra note 1, at 929.

218 See Wennberg, John E. & Gittelsohn, Alan, Small Area Variations in Health Care Delivery: A Population-Based Health Information System Can Guide Planning and Regulatory Decision-Making, 182 Science 1102 (1973)CrossRefGoogle Scholar (finding regional variations in health care).

219 Karen R. Sepucha et al., Policy Support for Patient-Centered Care: The Need for Measurable Improvements in Decision Quality, Health Affairs, Oct. 7 2004, http://content.healthaffairs.org/cgi/reprint/hlthaff.var.128v1.; Center for the Evaluative Clinical Sciences, supra note 7, passim.

220 Huntington, Beth & Kuhn, Nettie, Communication Gaffes: A Root Cause of Malpractice Claims, 16 Baylor U. Med. Center Proc. 157,157-160 (2003)CrossRefGoogle ScholarPubMed (attributing these problems to lack in physician communication); Vincent, Charles et al., Why Do People Sue Doctors? A Study of Patients and Relatives Taking Legal Action, 343 The Lancet 1609, 1609 (1994)CrossRefGoogle ScholarPubMed (discussing reasons patients take legal actions against doctors).

221 Piper, supra note 130, at 302.

222 Id.

223 Graskemper, Joseph P., The Standard of Care in Dentistry: Where Did It Come From? How Has It Evolved?, 135 J. Am. Dental Ass’n 1449, 1453-54 (2004)CrossRefGoogle ScholarPubMed.

224 Id.

225 See Merenstein, supra note 16, at 15-16.

226 Id.

227 Frosch & Kaplan, supra note 141, at 286.

228 Nadler et al., supra note 214, at 38.

229 Guadagnoli, Edward & Ward, Patricia, Patient Participation in Decision-Making, 47 Soc. Sci. & Med. 329, 332 (1998)CrossRefGoogle ScholarPubMed.

230 See supra pp. 446-448.

231 Id.

232 Id.

233 Id.

234 Canterbury, 464 F.2d at 788.

235 See supra pp. 446-448.

236 Bogardus et al., supra note 6, at 1039.

237 Id.; Woolf, supra note 15, at 244.

238 Frosch & Kaplan, supra note 141, at 287.

239 Id.

240 Teno, Joan et al., Preferences for Cardiopulmonary Resuscitation: Physician-Patient Agreement and Hospital Resource Use, 10 J. Gen. Internal Med. 179, 180 (1995)CrossRefGoogle ScholarPubMed; Woolf, supra note 15, at 244.

241 Teno et al., supra note 240, at 180.

242 Id. at 179.

243 Id. at 184; Frosch & Kaplan, supra note 141, at 287.

244 Teno et al., supra note 240, at 182-83.

245 Frosch & Kaplan, supra note 141, at 287; see supra pp. 2, 6.

246 Piper, supra note 130, at 303.

247 Id.

248 Id.

249 See id.

250 Bogardus et al., supra note 6 (discussing how doctors should approach informing patients of medical risks and the confusion surrounding their duty).

251 Katz, supra note 1, at 80 (citing McMullen v. Vaughn, 227 S.E.2d 40 (Ga. 1976); Woolley v. Henderson, 418 A.2d 1123 (Me. 1980); Bly v. Rhodes 222 S.E.2d 783 (Va. 1976)).

252 Id. at 80-82.

253 Katz, Jay, Informed Consent – A Fairy-Tale?: Law's Vision, 39 U. Pitt. L. Rev. 137, 174 (1977)Google ScholarPubMed.

254 See Office of Program and Policy Information, Division of Cancer Prevention and Control, Centers for Disease Control and Prevention, State Laws Relating to Breast Cancer: Legislative Summary, January 1949 to May 2000 (2000) 3, available at http://www.cdc.gov/cancer/breast/pdf/BCLaws.pdf.

255 Id.

256 See id. The patient-based states are California, Louisiana, Maryland, Minnesota, Pennsylvania and Texas. The physician-based states are Florida, Kansas, Kentucky, Maine, Michigan, Montana, New York and Virginia.

257 See id.

258 See Coulter, Angela, Editorial, Patient Information and Shared Decision-Making in Cancer Care, 89 Brit. J. Cancer S15, S15 (Supp. 1 2003)CrossRefGoogle ScholarPubMed.

259 See id. at S15-S16; Coulter, Angela & Cleary, Paul D., Patients’ Experiences with Hospital Care in Five Countries, 20 Health Affairs 244, 247-48 (2001)CrossRefGoogle ScholarPubMed; Grol, Richard et al., Patients in Europe Evaluate General Practice Care: An International Comparison, 50 Brit. J. Gen. Prac. 882, 884-86 (2000)Google Scholar.

260 See Coulter, supra note 260, at S15; Coulter & Cleary, supra note 259, at 247-48; Grol et al., supra note 259, at 884.

261 See Coulter, supra note 260, at S15; Coulter & Cleary, supra note 259, at 247-48; Grol et al., supra note 259, at 884.

262 See Coulter, supra note 260, at S15; Coulter & Cleary, supra note 259, at 247-48; Grol et al., supra note 259, at 884.

263 Braddock, Clarence H. et al., How Doctors and Patients Discuss Routine Clinical Decisions, 12 J. Gen. Internal Med. 339, 340 (1997)Google ScholarPubMed.

264 Id. at 339.

265 Id.

266 Id. at 342.

267 Id. at 344.

268 Id.

269 Id.

270 Id.

271 Katz, supra note 1, at xiii-xxi. Wennberg & Peters, supra note 1, at 937; see also Coulter, Angela, Editorial, Shared Decision-making: The Debate Continues, 8 Health Expectations 95–96 (2005)CrossRefGoogle ScholarPubMed.

272 See Woolf, Steven H. et al., Promoting Informed Choice: Transforming Health Care to Dispense Knowledge for Decision Making, 143 Annals Internal Med. 293, 293 (2005)CrossRefGoogle ScholarPubMed (discussing the procedural and structural changes necessary to implement and difficulties in implementing shared decision-making in routine practice).

273 See Charles, Cathy et al., Shared Decision-making in the Medical Encounter: What Does It Mean? (Or it Takes at Least Two to Tango), 44 Soc. Sci. & Med. 681, 687 (1997)CrossRefGoogle Scholar.

274 See generally Whitney, Simon N. et al., A Typology of Shared Decision Making, Informed Consent, and Simple Consent, 140 Annals Internal Med. 54 (2004)CrossRefGoogle ScholarPubMed (distinguishing shared decision-making from the traditional legal doctrine of informed consent).

275 See Scott, 606 P.2d at 557.

276 See Charles, supra note 273, at 684 (suggesting that the requirements of share decision-making include interventions that not only provide patients with information, but also with a way of thinking about treatment decision-making that helps patients focus on key issues and evaluate relevant options).

277 Id. at 687.

278 See supra Part IV.B.2.a.

279 See supra Parts V.A, V.A.3.

280 Center for the Evaluative Clinical Sciences, supra note 7, at 170-177; Feldman-Stewart, supra note 8, at 46-54.

281 One possible way of identifying minimally invasive, highly effective care is through the United States Preventative Services Task Force, which has created a system of evaluating medical treatments for invasiveness and effectiveness. See U.S. Preventative Services Task Force (USPSTF), http://www.ahrq.gov/clinic/uspstfix.htm (last visited May 1, 2006).

282 Charles, Cathy et al., Treatment Decision Aids: Conceptual Issues and Future Directions, 8 Health Expectations 114, 114 (2005)CrossRefGoogle ScholarPubMed.

283 Foundation for Informed Medical Decision-Making, Decision Support and Shared Decision-Making, http://www.fimdm.org/decision_sdms.php (last visited August 30, 2006); see also Health Dialog, www.healthdialog.com (last visited August 30, 2006).

284 Id. For more information on how decision aids are created, see Foundation for Informed Medical Decision-Making, Decision Aids and Shared Decision-Making, Program Development and Updates, Foundation Procedures for Development of Decision Aids, www.fimdm.org/decision_sdms.php (last visited August 30, 2006).

285 Foundation for Informed Medical Decision-Making, supra note 283.

286 Id.

287 Id.

288 O’Connor, Annette et al., Decision Aids for Patients Facing Health Treatment or Screening Decisions: Systemic Review, 319 BMJ 731, 732-733 (1999)CrossRefGoogle ScholarPubMed.

289 Woolf et al., supra note 272, at 296.

290 Id.

291 See Bogardus et al., supra note 6, at 1039-40.

292 See id. at 141.

293 Dartmouth Hitchcock Medical Center, Center for Shared Decision-Making, http://www.dhmc.org/webpage.cfm?site_id=2&org_id=108&gsec_id=0&sec_id=0&item_id=2486 (last visited Aug. 30, 2006).

294 Ottawa Health Research Institute, A-Z Inventory of Decision Aids, http://decisionaid.ohri.ca/AZinvent.php (last visited Aug. 30, 2006).

295 Id. We will discuss the importance of evaluating decision aids through methods like the CREDIBLE criteria in later in this section.

296 See Health Dialog, Collaborative Care, www.healthdialog.com/hd/Core/CollaborativeCare/CCToolsResources.htm (last visited August 30, 2006).

297 See Health Dialog Awards, http://www.healthdialog.com/hd/Ancillary/Aboutus/awards.htm (last visited Oct. 11, 2006) (listing awards Health Dialog's communications materials have received).

298 See Health Dialog History, http://www.healthdialog.com/hd/Ancillary/Aboutus/history.htm (last visited Oct. 11, 2006).

299 Interview with Jack E. Wennberg, supra note 167.

300 See Foundation for Informed Medical Decision-Making, supra note 283.

301 See id.

302 See id.

303 See id.

304 Interview by Ben Moulton with Floyd J. Fowler Jr., President of the Foundation for Informed Medical Decision Making (2006).

305 The Cochrane Collaboration, Library Introduction, http://www.cochrane.org/reviews/clibintro.htm (last visited October 14, 2006).

306 Id.

307 See Frosch & Kaplan, supra note 141, at 291.

308 See O’Connor et al., supra note 167, at 64.

309 See id.

310 Frosch, supra note 141, at 287; McCabe, Pamela J. & Kalpin, Penny, Bold Voices in Progressive Care Using Shared Decision Making to Implement Evidence-Based Practice in Progressive Care, 25 Critical Care Nurse 76, 76 (2005)CrossRefGoogle ScholarPubMed; O’Connor et al., supra note 141, at 63-64.

311 See Natanson, 350 P.2d at 1104.

312 Cruzan v. Dir., Mo. Dept. of Health, 497 U.S. 261, 278 (1990).

313 Gonzales v. Oregon, 126 S. Ct. 904 (2006).

314 Id. at 904.

315 Teno et al., supra note 240, at 183-84.

316 See id. at 184-85.

317 Canterbury, 464 F.2d at 787 (citing Jon R. Waltz & Thomas W. Scheuneman, Informed Consent to Therapy, 64 Nw.U. L. Rev. 628, 639-40 (1970)).

318 Guadagnoli & Ward, supra note 229, at 332 (1998).

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323 Guadagnoli & Ward, supra note 229, at 332; Kaplan, Sherrie H. et al., Assessing the Effects of Physician-Patient Interactions on the Outcomes of Chronic Disease, 27 Med. Care S110, S118-19 (Supp. 1989)CrossRefGoogle ScholarPubMed.

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325 Brody et al., supra note 322, at 510. The ‘p’ value associated with each result indicates the level of statistical significance. Typically, statistically significant results must have a 95% or higher probability that the results in the given data did not occur by chance. A ‘p’ value of .05 signifies that there is a 95% probability that the finding of these results did not occur by chance. Generally, in order to have statistical signicance, ‘p’ must be less than or equal to .05.

326 Morris, J. & Royle, G., Choice of Surgery for Early Breast Cancer: Pre and Postoperative Levels of Clinical Anxiety and Depression in Patients and Their Husbands, 74 Brit. J. Surgery 1017, 1018 (1987)CrossRefGoogle ScholarPubMed.

327 Id.

328 Webber, Gail C., Patient Education: A Review of the Issues, 28 Med. Care 1089, 1099 (1990)CrossRefGoogle ScholarPubMed.

329 Kaplan, supra note 323, at S119-120; Mendonca, P. & Brehm, S., Effects of Choice on Behavioral Treatment of Overweight Children, 1 J. Soc. Clinical Psychol. 343, 343-358 (1983)CrossRefGoogle Scholar; Schulman, Beryl A., Active Patient Orientation and Outcomes in Hypertensive Treatment, 17 Med. Care 267, 270 (1979)CrossRefGoogle ScholarPubMed.

330 Shulman, supra note 329, at 269-270.

331 Id. at 271-72.

332 Kaplan, supra note 323, at S120.

333 Id.

334 Id.

335 Guadagnoli & Ward, supra note 229, at 332.

336 Id.; Kaplan, supra note 323, at S118-19.

337 Coulter, supra note 322, at 265.

338 Id. at 268.

339 Keating, Nancy L. et al., Treatment Decision Making in Early-Stage Breast Cancer: Should Surgeons Match Patients’ Desired Level of Involvement?, 20 J. Clinical Oncology 1473, 1473 (2002)Google ScholarPubMed.

340 Id. at 1476.

341 Id. at 1475.

342 Id. at 1476.

343 Id. at 1475-76.

344 Id. at 1476.

345 Id.

346 Id.

347 Huntington & Kuhn, supra note 220, at 160; Vincent et al., supra note 220, at 1613; Woolf et al., supra note 272, at 298.

348 Bernat & Peterson, supra note 321, at 87.

349 Center for the Evaluative Clinical Sciences, supra note 5, at 5.

350 Id.

351 Feldstein, supra note 212, at 115-19.

352 Center for the Evaluative Clinical Sciences, supra note 144, at 226.

353 Silveira, Maria J. & Feudtner, Chris, Letter to the Editor, Shared Medical Decision-Making, 293 JAMA 1058, 1058 (2005)Google Scholar; Woolf et al., supra note 272, at 295; Woolf & Krist, supra note 13, at 1871.

354 Woolf et al., supra note 74, at 294-95.

355 See Woolf & Krist, supra note 13, at 1871-72.

356 Braddock et al., supra note 263, at 339-345; Woolf et al., supra note 272, at 295; Woolf & Krist, supra note 13, at 1871.

357 Foundation for Informed Medical Decision Making, Research Agenda, http://www.fimdm.org/research_agenda.php (last visited October 18, 2006).

358 Woolf & Krist, supra note 13, at 1871.

359 Center for the Evaluative Clinical Sciences, supra note 144, at 226-27.

360 See Woolf et al., supra note 347, at 295; see also David Blumenthal, Decisions, Decisions: Why the Quality of Medical Decisions Matters, Health Aff. (Web exclusive) VAR 124, VAR 126-127 (2004).

361 Huntington & Kuhn, supra note 220, at 157.

362 Vincent et al., supra note 220, at 1612 (finding the breakdown of those for whom some form of communication would have prevented a lawsuit to be as follows: explanation and apology 37%; admission of negligence 14%; listened and not treated as neurotic 5%; and honesty 4%).

363 Huntington & Kuhn, supra note 220, at 157.

364 Center for the Evaluative Clinical Sciences, supra note 5, at 6.

365 The Cochrane Collaboration, http://www.cochrane.org (last visited Oct. 18, 2006); Health Dialog, http://www.healthdialog.com/hd (last visited Oct. 18, 2006); The Ottawa Health Research Institute, http://decisionaid.ohri.ca/index.html (last visited Oct. 18, 2006).

366 Barry, Michael J., Health Decision Aids to Facilitate Shared Decision Making in Office Practice, 136 Annals Internal Med. 127, 133 (2002)CrossRefGoogle ScholarPubMed (noting that the cost effectiveness of shared decision making has not been studied).

367 Coulter, supra note 322, at 263; Feldman-Stewart et al., supra note 8, at 52.

368 Woolf et al., supra note 272, at 295; see also Center for Information Therapy, http://www.informationtherapy.org (last visited March 29, 2006).

369 Woolf et al., supra note 272, at 295.

370 Frank, supra note 212, at 8; see also Inst. of Med., Crossing the Quality Chasm: A New Health System for the Twenty-First Century 32 (National Academies Press 2001).

371 Frank, supra note 212, at 8.

372 Feldman-Stewart et al., supra note 8, at 47-49.

373 Bogardus et al., supra note 6, at 1037; Woolf et al., supra note 272, at 295.

374 Bogardus et al., supra note 6, at 1037-1041.

375 See Fischoff, Baruch, Risk Perception and Communication Unplugged: Twenty Years of Progress, 15 Risk Analysis 137, 1937-45 (1995)CrossRefGoogle Scholar; Fischoff, Baruch et al., Risk Perception and Communication, 14 Ann. Rev. Pub. Health 183, 186-190 (1993)CrossRefGoogle Scholar.

376 Bogardus et al., supra note 6, at 1040; Tversky, Amos & Kahneman, Daniel, Availability: A Heuristic For Judging Frequency And Probability, 5 Cognitive Psychol. 207, 207-32 (1973)CrossRefGoogle Scholar.

377 Bogardus et al., supra note 6, at 1040; Frank, supra note 212, at 14-20.

378 Feldman-Stewart et al., supra note 8, at 47.

379 O’Connor et al., supra note 288, at 733; Woolf et al., supra note 272, at 295-298.

380 Green, Michael J. et al., Effect of a Computer-Based Decision Aid on Knowledge, Perceptions, and Intentions about Genetic Testing for Breast Cancer Susceptibility, 292 JAMA 442, 445-449 (2004)CrossRefGoogle ScholarPubMed; Hunter, A.G.W. et al., A Randomized Trial Comparing Alternative Approaches To Prenatal Diagnosis Counseling In Advanced Maternal Age Patients, 67 Clinical Genetics 303, 303 (2005)CrossRefGoogle ScholarPubMed.

381 Woolf et al., supra note 272.

382 Katz, supra note 1, at 168-75.

383 Coulter, supra note 322, at 264.

384 Katz, supra note 1, at 204-05.

385 Levinson et al., supra note 320, at 533; Leydon, Geraldine M. et al., Cancer Patients’ Information Needs and Information Seeking Behaviour: In Depth Interview Study, 320 BMJ 909, 911, 913 (2000)CrossRefGoogle ScholarPubMed.

386 Levinson et al., supra note 385, at 532.

387 Id.

388 Id. at 531-35; Woolf & Krist, supra note 13, at 1872.

389 Teno et al., supra note 240, at 183-84.

390 See infra Part X.

391 Kilmartin, Dara J. et al., Commentary: Sympathetic Ophthalmia Risk Following Vitrectomy: Should We Counsel Patients? , 84 Brit. J. Opthalmology, 448, 448-49 (2000)CrossRefGoogle Scholar.

392 See supra notes 36-37 and accompanying text.

393 Meisel, Alan & Kuczewski, Mark, Legal and Ethical Myths About Informed Consent, 156 Archives Internal Med., 2521, 2525 (1996)CrossRefGoogle ScholarPubMed.

394 Bogardus et al., supra note 6, at 1039.

395 Feldman-Stewart et al., supra note 8, at 49.

396 Bhatnagar, Vibha & Kaplan, Robert M., Treatment Options for Prostate Cancer: Evaluating the Evidence, 71 Am. Fam. Physician, 1915, 1918 (2005)Google ScholarPubMed.

397 Center for the Evaluative Clinical Sciences, supra note 7, at 18.

398 Feldman-Stewart et al., supra note 8, at 48-49.

399 Feldman-Stewart et al., supra note 142, at 221.

400 Id.

401 See id. at 222.

402 Bernat & Peterson, supra note 321, at 88; Meisel & Kuczewski, supra note 393.

403 Feldman-Stewart et al., supra note 142, at 218-223.

404 Foundation for Informed Medical Decision-Making, www.fimdm.org (last visited Aug. 30, 2006); Health Dialog, www.healthdialog.com (last visited Aug. 30, 2006).

405 Wennberg, supra note 164, at 15.

406 See, e.g., Rosoff, Arnold J., Evidence-Based Medicine and the Law: The Courts Confront Clinical Practice Guidelines, 26 J. Health Pol. Pol’y & L. 327 (2001)CrossRefGoogle ScholarPubMed.

407 See National Committee for Quality Assurance, NCQA Report Cards, http://hprc.ncqa.org/menu.asp (last visited August 30, 2006).

408 Wennberg, supra note 7, at 15.

409 Id.

410 Id.

411 See O’Connor, Annette M. et al., Decision Aids for People Facing Health Treatment or Screening Decisions, 1 Cochrane Database Systematic Revs. 1 (2003)Google Scholar, available at http://decisionaid.ohri.ca/docs/Cochrane_Review.pdf (evaluating over two hundred decision aids using the CREDIBLE criteria).

412 Ottawa Health Research Institute, CREDIBLE Criteria, http://decisionaid.ohri.ca/cred.html (last visited Mar. 15, 2006).

413 Center for the Evaluative Clinical Sciences, supra note 5, at 6.

414 Coulter, supra note 322, at 268; Feldman-Stewart et al. supra note 8, at 53.

415 Coulter, supra note 322, at 263-64.

416 Feldman-Stewart et al. supra note 8, at 52.