Clinical practice guidelines: The warped incentives in the U.S. healthcare system

American Journal of Law and Medicine

Volumn 37, Issue 1, 2011, Pages 7-40

  Avraham, Ronen ^a  

^a UNIVERSITY OF TEXAS AT AUSTIN   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

ARTICLE; CONFLICT OF INTEREST; ECONOMICS; EVIDENCE BASED MEDICINE; GOVERNMENT; HUMAN; LEGAL ASPECT; LEGAL LIABILITY; MALPRACTICE; ORGANIZATION AND MANAGEMENT; PRACTICE GUIDELINE; REIMBURSEMENT; UNITED STATES;

CONFLICT OF INTEREST; DEFENSIVE MEDICINE; EVIDENCE-BASED MEDICINE; GOVERNMENT AGENCIES; HUMANS; LIABILITY, LEGAL; MALPRACTICE; PRACTICE GUIDELINES AS TOPIC; PRIVATE SECTOR; REIMBURSEMENT MECHANISMS; UNITED STATES;

EID: 79958163648     PISSN: 00988588     EISSN: None     Source Type: Journal    
DOI: 10.1177/009885881103700101     Document Type: Article

References (227)

1. Patient Protection and Affordable Care Act, Pub. L. 111-148, 124 Stat. 119(2010) (to be codified as amended in scattered sections of the Internal Revenue Code and 42 U. S. C.).
2. The first attempt was scheduled for January 12, 2011.
3. See Robert Lowes, GOP Schedules House Vote to Repeal Healthcare Reform Law, MEDSCAPE MED. NEWS (Jan. 4, 2011), http://www.medscape.com/viewarticle/ 735209.
4. Michael D. Shear, Democrats Plan Attack on Republican Repeal Effort, N. Y. TIMES POL. & GOV'T BLOG (Jan. 6, 2011, 6:05 AM), http://thecaucus.blogs. nytimes.com/201l/Ol/06/democrats-plan-attack-on-republicanrepeal-effort/.
5. Another paradigmatic example of externalization is cesarean deliveries: When the doctor chooses vaginal delivery and harm materializes, he is frequently sued, whereas in the event of a cesarean delivery, the patient rarely sues. Arguably this happens not because cesarean deliveries never end in harm, but because either the harm is too minor to justify a legal suit or there is a latent harm with long-term effects that can hardly be traced back years later to the operation. The result is that most of the harms caused by cesarean deliveries are externalized to the patient, while most of the harms caused by vaginal deliveries are internalized to the doctor.
6. Ariel Porat, Offsetting Risks, 106 MICH. L. REV. 243, 265(2007).
7. See Philip K. Howard, Op-Ed., Why Medical Malpractice Is Off Limits, WALL ST. J. (Oct. 15, 2009, 10:29 PM), http://online.wsj.com/article/ SB10001424052970204488304574432853190155972.html;
8. U. S. DEP'T OF HEALTH & HUMAN SERVS., ADDRESSING THE NEW HEALTH CARE CRISIS: REFORMING THE MEDICAL LITIGATION SYSTEM 11(2003) (estimating that defensive medicine costs between $70 and $126 billion per year).
9. See STEPHEN KLAIDMAN, Coronary: A True Story of Medicine Gone Awry (2007) (detailing an FBI investigation which discovered that up to 50% of the 1, 000 bypasses a year at the Redding Medical Center in California were not medically justified). Atul Gawande recently documented how hospitals in McAllen, Texas perform offensive medicine to enrich themselves at the expense of the public. He pegged spending in McAllen at $14, 946 per Medicare enrollee per year, about twice as much as nearby and socio-demographically similar El Paso.
10. Atul Gawande, The Cost Conundrum: What a Texas Town Can Teach Us About Health Care, NEW YORKER (June 1, 2009), at 36.
11. Barack Obama, Pres., United States of America, Remarks by the President in Town Hall Meeting on Health Care (June 11, 2009) (transcript available at http://www.whitehouse.gov/the-press-office/Remarks-by-the-President-in-Town- Hall-Meeting-on-Health-Care-in-Green-Bay-Wisconsin/) ("[W]e should change the warped incentives that reward doctors and hospitals based on how many tests and procedures they do... even if those tests or procedures aren't necessary or result from medical mistakes.").
12. See Jonathan Gruber & Maria Owings, Physician Financial Incentives and Cesarean Section Delivery, 27 RAND J. ECON. 99, 120(1996) (suggesting physicians substituted csection delivery for normal delivery in order to make up for negative income shocks from decreased fertility rates);
13. Jerry Cromwell & Janet B. Mitchell, Physician-Induced Demand for Surgery, 5 J. HEALTH ECON. 293, 311-13(1986).
14. Such a safe harbor is part of the Obama Administration's drive to overhaul the medical malpractice system. Ricardo Alonso-Zaldivar, Obama Starts Drive for Medical Malpractice Reforms, STAMFORD ADVOCATE (Feb. 15, 2011, 11:41 AM), http://www.stamfordadvocate.com/news/article/Obama-starts-drive-for- medicalmalpractice-reforms-1014244.php.
15. For a recent summary of the proposals see Troven A. Brennan & Michelle M. Mello, Commentary, Incremental Health Care Reform, 301 JAMA 1814, 1815-16(2009).
16. By "optimal", I mean the socially optimal balance between safety, effectiveness, cost, and other relevant factors such as political or moral concerns.
17. Uwe E. Reinhardt et al., U. S. Health Care Spending in an International Context, 23 HEALTH AFF. 10, 10-12(2004).
18. See 42 U. S. C. § 1320a-7b (b) (2006).
19. See 42 U. S. C. §1395nn (2006).
20. In 2002, an FBI investigation of officials at the Redding Medical Center in California (also known as "little house of horrors") discovered that up to fifty percent of the 1, 000 bypasses a year (three times the normal rate for a facility its size) were not medically justified. The hospital eventually settled for more than $450 million with patients and the government.
21. See Paul Jacobs, Heart Surgeries Lead Hospital Into Difficulties, L. A. TIMES, July 31, 1980, B1 (reporting that doctors at Paramount General Hospital in California were "anxious to operate on almost anything").
22. See also KLAIDMAN, supra note 6, at 7-11 (reporting that officials from the Psychiatric Institutes of America in Texas bribed doctors for referrals; after an FBI investigation, some doctors were sent to jail and PIA paid $379 million in fines and settlements with plaintiffs who had been wrongly admitted to the psychiatric institution).
23. The law also needs to award the correct amount of damages. In what follows, I assume that courts can determine damages well. I focus on better defining negligence.
24. See Steve Shavell, FOUNDATIONS OF ECONOMIC ANALYSIS OF LAW 224-25(2004).
25. Id.
26. See David Hyman & Charles Silver, Medical Malpractice and Tort Reform: It's the Incentives, Stupid, 59 VAND. L. REV. 1085, 1090(2006)
27. (citing Troyen A. Brennan et al., Incidence of Adverse Events and Negligence in Hospitalized Patients, 324 NEW ENG. J. MED. 370, 371(1991) (noting that the likelihood of a claim was substantially higher when the injury was more severe)).
28. Id.
29. Id.
30. See id. at 1090-91.
31. See also FVLORIDA AGENCY FOR HEALTH CARE ADMIN., DIV. OF HEALTH QUALITY ASSURANCE, REPORTED HMO MALPRACTICE CLAIMS BY DISTRICT COMPARED TO REPORTED ADVERSE INCIDENTS 2007, available at http://www.fdhc.state.fl.us/SCHS/risk/ documents/2007HMOMalp.pdf (showing that in 2004 malpractice claims were only twenty-three percent of reported incidents). Since self-reported negligence numbers will almost certainly under-report the volume of negligence, the percentage of malpractice victims who filed a claim in the Florida study is probably much lower than these numbers suggest.
32. See Hyman & Silver, supra note 18, at 1090-91.
33. See Hyman & Silver, supra note 18, at 1113.
34. Id.
35. Id. at 1132.
36. Id. at 1123.
37. See David M. Studdert et al., Claims, Errors, and Compensation Payments in Medical Malpractice Litigation, 354 NEW ENG. J. MED. 2024(2006) (showing that the legal system performs well roughly three quarters of the time, on the basis of those awarded compensation (deserving and undeserving) of medical malpractice claims, and that the size of the harm is the most important predictor of outcome).
38. See Joseph King Jr., Causation, Valuation and Chance in Personal Injury Torts Involving Preexisting Conditions and Future Consequences, 90 YALE L. J. 1353, 1381-82(1981). About half of the states have adopted some variation of the doctrine.
39. See Torry Weigand, Loss of Chance in Medical Malpractice: A Look at Recent Developments, 70 DEF. COUNS. J. 301, 302-03(2003).
40. Thomas C. Schelling, The Life You Save May Be Your Own, in PROBLEMS IN PUBLIC EXPENDITURE ANALYSIS 127, 129 (Samuel B. Chase ed. 1968).
41. See Deborah A. Small & George Loewenstein, Helping a Victim or Helping the Victim: Altruism and Identifiabilty, 26 J. RISK AND UNCERTAINTY 5, 5(2003) (showing that "subjects were more willing to compensate others who lost money when the losers had already been determined" and people contributed more to a charity for a pre-selected family than when told that the family would be selected later).
42. Id. at 5-6.
43. See Deborah A. Small & George Loewenstein, The Devil You Know: The Effect of Identifiability on Punitiveness, 18 J. BEHAV. DECISION MAKING 311, 311-18(2005) (showing that "people are more punitive toward identified wrongdoers than toward equivalent, but unidentified, wrongdoers").
44. It is theoretically possible that the increased harshness and increased sympathy towards identifiable others is in fact the "accurate" level of harshness and sympathy. This would indicate that people's judgment of the statistical victims and statistic perpetrators is actually what is distorted.
45. Baruch Fischhoff, Hindsight ≠ Foresight: The Effect of Outcome Knowledge on Judgment Under Uncertainty, 1 J. EXP. PSYCH. 288(1975).
46. See Jeffrey J. Rachlinski, A Positive Psychological Theory of Judging in Hindsight, 65 U. CHI. L. REV. 571, 598(1998) (explaining that defendants who take a higher level of care only have to pay for precautions, not additional damages). (Pubitemid 128443620)
47. Id. at 610-20.
48. See DAN B. DOBBS, THE LAW OF TORTS § 242(2006). Over the last few decades, however, some courts have allowed risk-utility proof to override what they consider suboptimal medical custom.
49. See, e.g., Helling v. Carey, 519 P.2d 981 (Wash. 1974).
50. See James A. Henderson Jr. & John A. Siliciano, Universal Health Care and the Continued Reliance on Custom in Determining Medical Malpractice, 79 CORNELL L. REV. 1384, 1389-1400(1994).
51. RICHARD POSNER, AN AFFAIR OF STATE: THE INVESTIGATION, IMPEACHMENT, AND TRIAL OF PRESIDENT CLINTON 147(1999).
52. See, e.g., Joseph Sanders, From Science to Evidence: The Testimony on Causation in the Bendectin Cases, 46 STAN. L. REV. 1, 37-39(1993).
53. Michelle M. Mello et al., "Health Courts" and Accountability for Patient Safety, 84 MILBANK Q. 459, 478-82(2006).
54. See, e.g., Elena A. Gates, New Surgical Procedures: Can Our Patients Benefit While We Learn?, 176 AM. J. OBSTETRICS & GYNECOLOGY 1293, 1293-96(1997).
55. Michael D. Cabana et al., Why Don't Physicians Follow Clinical Practice Guidelines?: A Framework for Improvement, 282 JAMA 1458, 1461-62(1999).
56. See id.
57. Gideon Parchomovsky & Alex Stein, Torts and Innovation, 107 MICH. L. REV. 285, 305-06(2008).
58. Paul H. Keckley, Evidence Based Medicine in Managed Care: A Survey of Current and Emerging Strategies, 6 MEDSCAPE GEN. MED. 56, 56 (footnote omitted).
59. See also AGENCY FOR HEALTHCARE RESEARCH AND QUALITY, CLOSING THE QUALITY GAP: A CRITICAL ANALYSIS OF QUALITY IMPROVEMENT STRATEGIES 1(2004), available at http://www.ahrq.gov/clinic/epc/qgapfact.pdf.
60. Peter H. Schuck, FDA Preemption of State Tort Law in Drug Regulation: Finding the Sweet Spot, 13 ROGER WILLIAMS U. L. REV. 73, 97-98(2008).
61. This should not be read broadly as an indictment against the entire legal system, but more specifically to the inability of the courts to efficiently regulate procedures in quicklyevolving medical fields when the only checks against their decisions require considerable time.
62. For example, a study published in the early 1980s described how in Maine, the likelihood of a woman having a hysterectomy by the time she reached age seventy varied from twenty to seventy percent in different hospital markets. In Iowa, the likelihood that a man who reached the age of eighty-five would have had a prostatectomy varied from fifteen to sixty percent in different areas. In Vermont, children who had undergone a tonsillectomy varied from eight to seventy percent depending on geographic area. John E. Wennberg, Dealing with Medical Practice Variations: A Proposal for Action, 3 HEALTH AFF. 6, 9(1984).
63. See Eleanor M. Perfetto & Lisa Stockwell Morris, Agency for Health Care Policy and Research Clinical Practice Guidelines, 30 ANNALS OF PHARMACOTHERAPY 1117, 1119(1996).
64. Kathleen N. Lohr et al., Health Policy Issues and Applications for Evidence-Based Medicine and Clinical Practice Guidelines, 46 HEALTH POL. 1, 7(1998).
65. See U. S. Dep't Health & Human Servs., Agency for Healthcare Research & Quality, National Guideline Clearinghouse, www.guideline.gov.
66. THE COCHRANE COLLABORATION, http://www.cochrane.org (last visited Jan. 27, 2011);
67. TRIP DATABASE, http://www.tripdatabase.com (last visited Jan. 27, 2011).
68. The American College of Physicians considers guidelines "automatically withdrawn or invalid 5 years after publication. " See Amir Qaseem et al., Screening for Osteoporosis in Men: A Clinical Guideline from the American College of Physicians, 148 ANNALS OF INTERNAL MED. 680, 683(2008).
69. See Michael D. Cabana et al., supra note 42, at 1458.
70. Id. at 1460.
71. Id. 57 Id.
72. See Arnold J. Rosoff, Evidence-Based Medicine and the Law: The Courts Confront Clinical Practice Guidelines, 26 J. HEALTH POL., POL'Y & L. 327, 330(2001).
73. See also Arnold J. Rosoff, On Being a Physician in the Electronic Age: Peering into the Mists at Point-s-Click Medicine, 46 ST. LOUIS U. L. J. 111, 116(2002) ("[P]hysicians may be wary of following CPGs for fear that the patient care actions they take to comply with CPGs may expose them to liability because of the way CPGs relate, or fail to relate, to traditional legal principles measuring the adequacy of physician performance by reference to standard professional practice.").
74. See Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 332-33.
75. Andrew L. Hyams et al., Medical Practice Guidelines in Malpractice Litigation: An Early Retrospective, 21 J. HEALTH POL., POL'Y & L. 289(1996).
76. See id. at 295.
77. See Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 341.
78. See Hyams et al., supra note 60, at 296.
79. Id.
80. Id.
81. Id.
82. Id. at 310.
83. See also Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 352;
84. Michelle M. Mello, Of Swords and Shields: The Role of Clinical Practice Guidelines in Medical Malpractice Litigation, 149 U. PA. L. REV. 645, 665(2001). (Pubitemid 33656781)
85. See Ronen Avraham & William M. Sage, Legal Models for Assuring the Quality of CPGs 49-59 (July 2010) (unpublished manuscript) (on file with author).
86. Rosoff notes that even if a CPG had information relevant to other elements of medical malpractice like causation, damages, and prognosis, "it is hard to see how a court could make use of this information without the accompanying testimony of a medical expert witness." Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 332. Nevertheless, as discussed herein, courts and legislatures have made little progress in the use of CPGs for establishing the standard of care without the mouthpiece of expert witness testimony.
87. See supra Parts B.l.i-ii.
88. Hyams et al., supra note 60, at 293. Of course, state courts vary significantly in their rules for admissibility.
89. See, e.g., Hinlicky v. Dreyfuss, 848 N. E.2d 1285, 1290 (N. Y. 2006) (allowing guidelines into evidence over hearsay objection but only to show the steps the physician had in fact taken, not for proof of the matter asserted).
90. Avraham & Sage, supra note 68.
91. See Mello, supra note 67, at 660.
92. Hyams et al., supra note 60, at 295.
93. Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 329.
94. Mello, supra note 67, at 680.
95. There are two possible exceptions to this general rule that courts do not examine the bases for guidelines. First, some cases distinguish between medical guidelines and the guidelines applied by insurance companies in utilization reviews.
96. See Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 338, for a short discussion of the difference between medical practice guidelines and utilization review guidelines made by some academics. Second, the Hyams et al. study did find that guidelines written by the American College of Obstetrics and Gynecology (ACOG) were relied upon in a plurality of successful cases.
97. Hyams et al., supra note 60, at 296.
98. Mello, supra note 67, at 680.
99. Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 329 ("[I]n deciding what weight to accord to CPGs, [courts] may find it useful, even necessary, to distinguish between those that are based on EBM and those that are not.").
100. Id. at 353.
101. OR. REV. STAT. ANN. § 413. 011 (l) (e) (West Supp. 2010).
102. Linda L. LeCraw, Use of Clinical Practice Guidelines in Medical Malpractice Litigation, 3 J. ONCOLOGY PRAC. 254, 254(2007).
103. Id.
104. U. S. GOV'T ACCOUNTABILITY OFFICE, MEDICAL MALPRACTICE: MAINE'S USE OF PRACTICE GUIDELINES TO REDUCE COSTS 3(1993) [hereinafter GAO REPORT].
105. Id.
106. ME. REV. STAT. ANN. tit. 24, §§ 2971-2979(1989) (repealed in 1999).
107. LeCraw, supra note 81.
108. Howard Zonana, Commentary, When Is a Practice Guideline Only a Guideline?, 36 J. AM. ACAD. PSYCHIATRY L. 302, 303(2008).
109. LeCraw, supra note 81
110. (citing GAO REPORT, supra note 83, at 2, 5).
111. See William R. Trail & Brad A. Allen, Government Created Medical Practice Guidelines: The Opening Of Pandora's Box, 10 J. L. & HEALTH 231, 247-48(1995).
112. Id.
113. Id.
114. Id. at 245-46.
115. See Bruce D. Platt, A Summary of the Health Care and Insurance Reform Act of 1993: Florida Blazes the Trail, 21 FLA. ST. U. L. REV. 483, 494 (citing 1993 Fla. Laws 657, 696).
116. FLORENCE KAVALER & ALLEN D. SPIEGEL, RISK MANAGEMENT IN HEALTH CARE INSTITUTIONS 251 (2d ed. 2003).
117. Eleanor D. Kinney, Medical Malpractice Reform in the 1990s: Past Disappointments, Future Success?, 20 J. HEALTH POL., POL'Y at L. 99, 111(1995)
118. (citing FLA. STAT. ANN. § 408.02 (West 1993)).
119. Id. at 110.
120. Id. (citing 1992 Vt. Acts & Resolves 160).
121. LeCraw, supra note 81
122. (citing KY. REV. STAT. ANN. §§ 16B. 145, 342.035 (Michie 1995);
123. MD. CODE ANN., Health-Gen. §§ 19-1601-19-1606 (West 1993)).
124. The crucial missing aspect of these projects was that there is no justification for awarding doctors liability protection, unless, as is discussed more fully below, the guidelines are created under a system in which incentives progress towards creating safer, more cost effective procedures.
125. See discussion infra Parts II. B & III.
126. H. R. 1290, 81st Leg. Sess. (Tx. 2009).
127. Peter D. Jacobson, Commentary, Transforming Clinical Practice Guidelines Into Legislative Mandates: Proceed with Abundant Caution, 299 JAMA 208, 209(2009).
128. M Id. at 209-10.
129. See, e.g., MASS. GEN. LAWS ch. 176G, § 40(2002) (requiring insurance plans to provide benefits for hormone replacement therapy for peri-and post-menopausal women, as well as outpatient contraceptive services).
130. N. J. STAT. ANN. § 2A:53A-30 et seq. (West 2001).
131. See Brief of Texas et al. as Amici Curiae Supporting Respondents, Aetna Health, Inc. v. Davila, 542 U. S. 200(2004) (No. 02-1845).
132. See also ARIZ. REV. STAT. § 20-3153 (LexisNexis 2011);
133. CAL. CIV. CODE § 3428 (West 2011);
134. GA. CODE ANN. § 51-1-48(2000);
135. LA. REV. STAT. ANN. § 22:2085(2011);
136. ME. REV. STAT. tit. 24-A, § 4313(1999);
137. OKLA. STAT. tit. 36, § 6593(2000);
138. TEX. CIV. PRAC. & REM. CODE ANN. § 88. 002 (West 2005);
139. WASH. REV. CODE § 48.43.545(2000);
140. W. VA. CODE § 33-25C-7(2010).
141. Aetna Health, Inc. v. Davila, 542 U. S. 200, 223(2004).
142. See, e.g., TEX. CIV. PRAC. & REM. CODE ANN. § 88. 0015 (West 2005) (limiting applicability of statute to insurance plans not regulated under ERISA).
143. See also David M. Humiston & James A. Toto, Department, Practice Tips: The Prognosis for the Managed Care Liability Act after Davila, 28 L. A. LAWYER 12, 12(2005).
144. Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 352.
145. See Catherine M. Sharkey, Products Liability Preemption: An Institutional Approach, 76 GEO. WASH. L. REV. 449, 495(2008).
146. Rachlinski, supra note 34, at 609.
147. For example, the FDA changed its policy during the second Bush administration regarding its ability to determine preemption. See Richard A. Epstein, Why the FDA Must Preempt Tort Litigation: A Critique of Chevron Deference and a Response to Richard Nagareda, J. TORT. L. 5(2006).
148. In the U. S., one cannot sue the FDA or any other agency for a wrong decision within its discretion.
149. See Epstein, supra note 109, at 3, nn. 6-7.
150. Id. at 22 (arguing agencies have incentives to regulate in an overly risk-adverse fashion because of self-interest).
151. See, e.g., Brief for the United States of America as Amicus Curiae Supporting Respondent at 16, Colacicco v. Apotex, Inc., 432 F. Supp. 2d 514 (E. D. Pa. 2006) (No. 05-CV-05500-MMB) ("FDA seeks to encourage the optimal level of use in light of reasonable safety concerns, by requiring scientific evidence that establishes an association between a drug and a particular hazard before warning of that association on a drug's labeling.").
152. Few cases exist where Congress decided to replace state tort law with a complete regulatory regime that was viewed as optimal regulation. Examples of this occurring include workers' compensation, automobile accidents, nuclear energy (Price-Anderson Nuclear Industries Indemnity Act), and child vaccines (The National Childhood Vaccine Injury Act of 1986).
153. See Price-Anderson Act of 1957, 42 U. S. C. § 2210(2006);
154. National Childhood Vaccine Injury Act of 1986, 42 U. S. C. §§ 300aa-l-300aa-34(2006).
155. Michigan alone provides for a complete regulatory compliance defense, subject only to a fraud-on-the-agency exception; a handful of other states offer manufacturers various forms of more limited protection. MICH. COMP. LAWS ANN. § 600. 2946 (5) (West 2000).
156. See, e.g., COLO. REV. STAT. ANN. § 13-21-403 (1) (b) (West 2010);
157. IND. CODE § 34-20-5-1 (2) (1999);
158. KAN. STAT. ANN. § 60-3304 (a) (2005);
159. N. J. STAT. ANN. § 2A:58C-4 (West 2000);
160. TENN. CODE ANN. § 29-28-104(2000);
161. TEX. CIV. PRAC. & REM. CODE ANN. § 82. 007 (a) (West 2005);
162. UTAH CODE ANN. § 78-15-6 (3) (West 2005).
163. By and large, neither the Restatement Second nor the Third allow for a complete defense. See RESTATEMENT (SECOND) OF TORTS § 288C (1965);
164. RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 4(1998).
165. Paul G. Shekelle et al., Validity of the Agency for Healthcare Research and Quality Clinical Practice Guidelines: How Quickly Do Guidelines Become Outdated?, 286 JAMA 1461, 1464-65(2001).
166. Id. at 1462.
167. See Alonso-Zaldivar, supra note 9 (listing malpractice reforms that could be funded under President Obama's grant proposal).
168. Sheryl Gay Stolberg & Robert Pear, Obama Open to Reining in Medical Malpractice Suits, N. Y. TIMES, June 15, 2009, at A14.
169. MAX BAUCUS, U. S. SENATE COMMITTEE ON FINANCE, CALL TO ACTION: HEALTH REFORM 2009 75(2008), available at http://finance.senate.gov/healthreform2009/ finalwhitepaper.pdf.
170. Healthy Americans Act, S. 391, 111th Cong. (2009).
171. Mello, supra note 67, at 651
172. (quoting Stephen M. Merz, Clinical Practice Guidelines: Policy Issues and Legal Implications, 19 JOINT COMM'N J. ON QUALITY IMPROVEMENT 306, 307(1993)).
173. GAO REPORT, supra note 83.
174. Mello, supra note 67, at 651.
175. Even in Michigan the doctrine is just for pharmaceuticals.
176. See MICH. COMP. LAWS ANN. § 600. 2946 (5) (West 2010).
177. See Epstein, supra note 109;
178. Schuck, supra note 46;
179. Catherine Sharkey, What Riegel Portends for FDA Preemption of State Law Products Liability Claims, 103 NW. U. L. REV. 437(2009).
180. See Katharine Van Tassel, Hospital Peer Review Standards and Due Process: Moving From Tort Doctrine Toward Contract Principles Based On Clinical Practice Guidelines, 36 SETON HALL L. REV. 1179, 1189-90(2006).
181. See Daniel R. Longo et al., Hospital Patient Safety: Characteristics of Best-Performing Hospitals, J. HEALTHCARE MGMT., May 2007, at 195-200.
182. Thomas McGinn et al., Decreasing Mortality for Patients Undergoing Hip Fracture Repair Surgery, 31 JOINT COMM'N J. ON QUALITY & PATIENT SAFETY 304, 305(2005).
183. Id. at 306.
184. See About TapRooT, TapRooT, http://www.taproot.com/about.php (last visited Jan. 27, 2011).
185. Zonana, supra note 87, at 303.
186. Daniel Kessler & Mark McClellan, Do Doctor's Practice Defensive Medicine?, 111 Q. J. ECON. 353, 371-72(1996).
187. Zonana, supra note 87, at 303.
188. See Richard Amerling et al., Guidelines Have Done More Harm Than Good, 26 BLOOD PURIFICATION 73(2008).
189. Pierluigi Tricoci et al., Scientific Evidence Underlying the ACC/AHA Clinical Practice Guidelines, 301 JAMA 831, 833(2009). The study categorized its lowest level of acceptable evidence as indicating little to no objective empirical evidence for the recommended action.
190. See Press Release, Connecticut Attorney General's Office, Attorney General's Investigation Reveals Flawed Lyme Disease Guideline Process, IDSA Agrees to Reassess Guidelines, Install Independent Arbiter (May 1, 2008), http://www.ct.gov/ag/cwp/view.asp?a=2795&q=414284.
191. COUNCIL OF MED. SPECIALTY SOC'YS, NEW CODE FOR INTERACTIONS WITH COS. (2010), available at http://www.cmss.org/uploadedFiles/Site/CMSS-Policies/ CMSS%20Code%20for%20lnteractions %20with%20Companies%204-19-10.pdf (last visited Jan. 6, 2011). The council includes thirty-four medical societies with 650, 000 members, which make up the vast majority of providers in the United States.
192. See ABOUT CMSS, http://www.cmss.org/About/Default.aspx (last visited Jan. 7, 2011) at 19. More generally, one 2002 cross study involving 192 guideline authors found that fiftyeight percent of the authors surveyed had received financial support to perform clinical research, and thirty-eight percent had served as employees or consultants for a pharmaceutical company.
193. See Niteesh K. Choudhry et al., Relationships Between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry, 287 JAMA 612, 614(2002).
194. Id. at 612. Interestingly, even the authors of the study had attended events sponsored by or received money from pharmaceutical companies.
195. Id.
196. Quigley v. Jobe, 851 P.2d 236, 238 (Colo. Ct. App. 1992).
197. See Agency for Healthcare Research and Quality, Web Site Disclaimers (June 20, 2003), http://www.ahrq.gov/news/disclaim.htm. The AMA calls its guidelines "parameters" to emphasize the discretion left with the doctors and further suggests that all guidelines contain disclaimers renouncing any implied intention to replace doctors' discretion.
198. Mark R. Chassin, Standard of Care in Medicine, 25 INQUIRY 437(1988).
199. See also AM. PSYCH. ASS'N, PRACTICE GUIDELINE FOR THE TREATMENT OF PATIENTS WITH ALZHEIMER'S DISEASE AND OTHER DEMENTIAS 7 (2d ed. 2007) (explaining that "the APA Practice Guidelines are not intended to be construed or to serve as a standard of medical care").
200. For example, in Quigley v. Jobe, a Colorado court of appeals refused to accept a CPG written by liability insurers of the doctor because it was created "by a private insurance company as part of an insurance contract and did not reflect a generally recognized standard of care within the medical profession. "
201. Quigley, 851 P.2d, at 238.
202. See also Parchomovsky & Stein, supra note 44.
203. The contours of the proposal are laid out in full in Ronen Avraham, Private Regulation, 34 HARV. J. L. & PUB. POL'Y (forthcoming).
204. See RESTATEMENT (THIRD) OF TORTS: LIABILITY FOR PHYSICAL HARM § 16(2005);
205. RESTATEMENT (THIRD) OF TORTS: PRODUCTS LIABILITY § 4(1998). In several states, when a product manufacturer complies with a federal or state regulatory standard, it entitles the manufacturer to a "rebuttable presumption" against a finding of negligence or product defect.
206. See Copyright Act of 1976, 17 U. S. C. § 102(2006)
207. (codifying the holding in Baker v. Selden, 101 U. S. 99(1879)).
208. One problem with providing IP protection to guidelines is that firms that develop truly innovative and important procedures could hold out for exorbitant licensing prices. This would be especially bothersome because so much medical development is cumulative, building on previous work. The short time frame of protection discussed above would be one mitigation technique. Another could be frequent and expensive renewal fees.
209. In 1996 Congress added this last element into the patent law landscape by expressly depriving patent holders of any remedy against healthcare practitioners who violate a patent. Remedy is still available in actions against non-clinicians. Aaron S. Kesselheim & Michelle M. Mello, Medical-Process Patents: Monopolizing the Delivery of Health Care, 355 N. ENGL. J. MED. 2036, 2037(2006). Not enforcing IP protection against practitioners could provide an incentive for them to free-ride. Thus, hospitals may choose not to pay for the guidelines but simply to adopt them. This problem could be mitigated by granting immunity to providers who purchase guidelines and tailoring the sui-generis approach to prevent it. Yet, because it may be so hard to detect violations in practice, such a regime might not be a strong enough protection. If this became an issue, the additional step of requiring providers to purchase guidelines in the free market could be adopted.
210. See, e.g., Lewis v. Am. Cyanamid Co., 715 A.2d 967 (N. J. 1998).
211. Steven Shavell, The Judgment Proof Problem, 6 INT'L REV. L. & ECON. 45, 55(1986).
212. Steven Shavell, Minimum Asset Requirements and Compulsory Liability Insurance as Solutions to the Judgment-Proof Problem, 36 RAND J. ECON. 63, 65(2005).
213. See Jennifer Arlen & W. Bentley MacLeod, Malpractice Liability for Physicians and Managed Care Organizations, 78 N. Y. U. L. REV. 1929, 1940(2003);
214. Jennifer Arlen & W. Bentley MacLeod, Torts, Expertise and Authority: Liability of Physicians and Managed Care Organizations, 36 RAND J. ECCON. 494(2005).
215. Arlen & MacLeod, Malpractice Liability, supra note 150, at 1934.
216. See id. at 1962, 1966, 2005.
217. Davila, 542 U. S. at 204.
218. David Hyman et al., Do Defendants Pay What Juries Award?: Post-Verdict Haircuts in Texas Medical Malpractice Cases, 1988-2003, 4 J. EMPIRICAL LEGAL STUDIES 3(2007) (showing that doctors' liability is effectively capped under the current regime because plaintiffs do not recover more than the policy limit, which in itself is strategically set by the insurance companies).
219. U. S. Dep't Health & Human Servs., Agency for Healthcare Research & Quality, Clinical Practice Guidelines Archive, http://www.ahrq.gov/CLINIC/ cpgarchv. htm (last visited Jan. 26, 2011).
220. Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 350.
221. INSTITUTE OF MEDICINE, COMMITTEE ON QUALITY OF HEALTH CARE IN AMERICA, TO ERR IS HUMAN 26 (Linda T. Kohn et al. eds., 2000).
222. Id. at 30.
223. Id.
224. 5Julie Weed, If All Doctors Had More Time to Listen, N. Y. TIMES, June 7, 2009, at B1 (describing an alternative system where a doctor treats fewer patients for much longer visits, including house calls, thus lowering costs by treating many problems preventatively and reducing the need to refer patients to specialists).
225. Kevin Sack, For Two Health Care Systems, a Priceless Presidential Testimonial, N. Y. TIMES PRESCRIPTIONS BLOG (Sept. 10, 2009, 7:26 PM), http://prescriptions.blogs.nytimes.com/2009/09/10/for-two-health-care-systems-a- pricelesspresidential-testimonial/.
226. Kaiser Permanente, Frequently Asked Questions About Our Medical Care, https://members.kaiserpermanente.org/kpweb/faqmedcare/entrypage.do (last visited Jan. 26, 2011).
227. See supra notes 54-57 and accompanying text.