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Clinical Practice Guidelines: The Warped Incentives in the U.S. Healthcare System

Published online by Cambridge University Press:  06 January 2021

Ronen Avraham
Ronen Avraham*
Affiliation:
University of Texas at Austin
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Abstract

The healthcare system is sick. The players are incentivized to maximize their own benefit and externalize their costs onto the other parties. This paper examines the warped incentives that underlie the system. The tort system, lacking expertise and slow to adapt, is unable to overcome cognitive biases to adequately solve the problems. Clinical practice guidelines could pose a solution, but not as they are currently developed. Guidelines promulgated by healthcare associations are infected by a web of conflicts of interest with every player in the industry. Government agencies, and their revolving doors, are underfunded and also subject to the industry's web of conflicts. Even if adequate guidelines could consistently be produced, state legislatures and courts have been unwilling and unable to substantially incorporate guidelines into the legal landscape. Lastly, this article proposes a private regulation regime that could be a solution which would align all of the players' incentives to society's interests.

Type
Article
Information
American Journal of Law & Medicine , Volume 37 , Issue 1 , March 2011 , pp. 7 - 40
Copyright
Copyright © American Society of Law, Medicine and Ethics and Boston University 2011

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References

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. See Robert Lowes, GOP Schedules House Vote to Repeal Healthcare Reform Law, Medscape Med. News (Jan. 4, 2011), http://www.medscape.com/viewarticle/735209.

3 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/2011/01/06/democrats-plan-attack-on-republicanrepeal-effort/.

4 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.

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6 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. Gawande, Atul, The Cost Conundrum: What a Texas Town Can Teach Us About Health Care, New Yorker (June 1, 2009)Google Scholar, at 36.

7 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.”).

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9 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-medical-malpractice-reforms-1014244.php. For a recent summary of the proposals see Brennan, Troven A. & Mello, Michelle M., Commentary, Incremental Health Care Reform, 301 JAMA 1814, 1815-16 (2009)CrossRefGoogle ScholarPubMed.

10 By “optimal,” I mean the socially optimal balance between safety, effectiveness, cost, and other relevant factors such as political or moral concerns.

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12 See 42 U.S.C. § 1320a-7b(b) (2006).

13 See 42 U.S.C. §1395nn (2006).

14 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. 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”). 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).

15 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.

16 See Steve Shavell, Foundations of Economic Analysis of Law 224-25 (2004).

17 Id.

18 See Hyman, David & Silver, Charles, Medical Malpractice and Tort Reform: It's the Incentives, Stupid, 59 Vand. L. Rev. 1085, 1090 (2006)Google Scholar (citing Brennan, Troyen A. et al., Incidence of Adverse Events and Negligence in Hospitalized Patients, 324 New Eng. J. Med. 370, 371 (1991)CrossRefGoogle ScholarPubMed (noting that the likelihood of a claim was substantially higher when the injury was more severe)).

19 Id.

20 Id.

21 See id. at 1090-91. See also Florida 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. See Hyman & Silver, supra note 18, at 1090-91.

22 See Hyman & Silver, supra note 18, at 1113.

23 Id.

24 Id. at 1132.

25 Id. at 1123.

26 See Studdert, David M. et al., Claims, Errors, and Compensation Payments in Medical Malpractice Litigation, 354 New Eng. J. Med. 2024 (2006)CrossRefGoogle ScholarPubMed (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).

27 See King, Joseph Jr., Causation, Valuation and Chance in Personal Injury Torts Involving Preexisting Conditions and Future Consequences, 90 Yale L.J. 1353, 1381-82 (1981).CrossRefGoogle Scholar About half of the states have adopted some variation of the doctrine. See Weigand, Torry, Loss of Chance in Medical Malpractice: A Look at Recent Developments, 70 Def. Couns. J. 301, 302-03 (2003).Google Scholar

28 Schelling, Thomas C., The Life You Save May Be Your Own, in Problems in Public Expenditure Analysis 127, 129 (Chase, Samuel B. ed. 1968).Google Scholar

29 See Small, Deborah A. & Loewenstein, George, Helping a Victim or Helping the Victim: Altruism and Identifiabilty, 26 J. Risk and Uncertainty 5, 5 (2003)CrossRefGoogle Scholar (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).

30 Id. at 5-6.

31 See Small, Deborah A. & Loewenstein, George, The Devil You Know: The Effect of Identifiability on Punitiveness, 18 J. Behav. Decision Making 311, 311-18 (2005)CrossRefGoogle Scholar (showing that “people are more punitive toward identified wrongdoers than toward equivalent, but unidentified, wrongdoers”).

32 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.

33 Fischhoff, Baruch, Hindsight ≠ Foresight: The Effect of Outcome Knowledge on Judgment Under Uncertainty, 1 J. Exp. Psych. 288 (1975).Google Scholar

34 See Rachlinski, Jeffrey J., A Positive Psychological Theory of Judging in Hindsight, 65 U. Chi. L. Rev. 571, 598 (1998)CrossRefGoogle Scholar (explaining that defendants who take a higher level of care only have to pay for precautions, not additional damages).

35 Id. at 610-20.

36 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. See, e.g., Helling v. Carey, 519 P.2d 981 (Wash. 1974).

37 See Henderson, James A. Jr. & Siliciano, John A., Universal Health Care and the Continued Reliance on Custom in Determining Medical Malpractice, 79 Cornell L. Rev. 1384, 1389-1400 (1994).Google ScholarPubMed

38 Richard Posner, An Affair of State: The Investigation, Impeachment, and Trial of President Clinton 147 (1999).

39 See, e.g., Sanders, Joseph, From Science to Evidence: The Testimony on Causation in the Bendectin Cases, 46 Stan. L. Rev. 1, 37-39 (1993).CrossRefGoogle ScholarPubMed

40 Mello, Michelle M. et al., “Health Courts” and Accountability for Patient Safety, 84 Milbank Q. 459, 478-82 (2006).CrossRefGoogle ScholarPubMed

41 See, e.g., Gates, Elena A., New Surgical Procedures: Can Our Patients Benefit While We Learn?, 176 Am. J. Obstetrics & Gynecology 1293, 1293-96 (1997).CrossRefGoogle ScholarPubMed

42 Cabana, Michael D. et al., Why Don't Physicians Follow Clinical Practice Guidelines?: A Framework for Improvement, 282 JAMA 1458, 1461-62 (1999).CrossRefGoogle ScholarPubMed

43 See id.

44 Parchomovsky, Gideon & Stein, Alex, Torts and Innovation, 107 Mich. L. Rev. 285, 305-06 (2008).Google ScholarPubMed

45 Keckley, Paul H., Evidence Based Medicine in Managed Care: A Survey of Current and Emerging Strategies, 6 Medscape Gen. Med. 56, 56 (footnote omitted)Google Scholar. 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.pdfGoogle Scholar.

46 Schuck, Peter H., FDA Preemption of State Tort Law in Drug Regulation: Finding the Sweet Spot, 13 Roger Williams U. L. Rev. 73, 97-98 (2008).Google Scholar

47 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 quickly-evolving medical fields when the only checks against their decisions require considerable time.

48 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. Wennberg, John E., Dealing with Medical Practice Variations: A Proposal for Action, 3 Health Aff. 6, 9 (1984)CrossRefGoogle Scholar.

49 See Perfetto, Eleanor M. & Morris, Lisa Stockwell, Agency for Health Care Policy and Research Clinical Practice Guidelines, 30 Annals of Pharmacotherapy 1117, 1119 (1996).CrossRefGoogle ScholarPubMed

50 Lohr, Kathleen N. et al., Health Policy Issues and Applications for Evidence-Based Medicine and Clinical Practice Guidelines, 46 Health Pol. 1, 7 (1998).CrossRefGoogle ScholarPubMed

51 See U.S. Dep't Health & Human Servs., Agency for Healthcare Research & Quality, National Guideline Clearinghouse, www.guideline.gov.

52 The Cochrane Collaboration, http://www.cochrane.org (last visited Jan. 27, 2011); Trip Database, http://www.tripdatabase.com (last visited Jan. 27, 2011).

53 The American College of Physicians considers guidelines “automatically withdrawn or invalid 5 years after publication.” See Qaseem, Amir et al., Screening for Osteoporosis in Men: A Clinical Guideline from the American College of Physicians, 148 Annals of Internal Med. 680, 683 (2008).CrossRefGoogle ScholarPubMed

54 See Michael D. Cabana et al., supra note 42, at 1458.

55 Id. at 1460.

56 Id.

57 Id.

58 See Rosoff, Arnold J., Evidence-Based Medicine and the Law: The Courts Confront Clinical Practice Guidelines, 26 J. Health Pol., Pol’y & L. 327, 330 (2001).CrossRefGoogle ScholarPubMed See also Rosoff, Arnold J., On Being a Physician in the Electronic Age: Peering into the Mists at Point-&-Click Medicine, 46 St. Louis U. L.J. 111, 116 (2002)Google Scholar (“[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.”).

59 See Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 332-33.

60 Hyams, Andrew L. et al., Medical Practice Guidelines in Malpractice Litigation: An Early Retrospective, 21 J. Health Pol., Pol’y & L. 289 (1996).CrossRefGoogle ScholarPubMed

61 See id. at 295.

62 See Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 341.

63 See Hyams et al., supra note 60, at 296.

64 Id.

65 Id.

66 Id.

67 Id. at 310. See also Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 352; Mello, Michelle M., Of Swords and Shields: The Role of Clinical Practice Guidelines in Medical Malpractice Litigation, 149 U. Pa. L. Rev. 645, 665 (2001).CrossRefGoogle Scholar

68 See Ronen Avraham & William M. Sage, Legal Models for Assuring the Quality of CPGs 49-59 (July 2010) (unpublished manuscript) (on file with author).

69 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. See supra Parts B.1.i-ii.

70 Hyams et al., supra note 60, at 293. Of course, state courts vary significantly in their rules for admissibility. 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).

71 Avraham & Sage, supra note 68.

72 See Mello, supra note 67, at 660.

73 Hyams et al., supra note 60, at 295.

74 Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 329.

75 Mello, supra note 67, at 680.

76 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. 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. Hyams et al., supra note 60, at 296.

77 Mello, supra note 67, at 680.

78 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.”).

79 Id. at 353.

80 Or. Rev. Stat. Ann. § 413.011(1)(e) (West Supp. 2010).

81 LeCraw, Linda L., Use of Clinical Practice Guidelines in Medical Malpractice Litigation, 3 J. Oncology Prac. 254, 254 (2007).CrossRefGoogle ScholarPubMed

82 Id.

83 U.S. Gov't Accountability Office, Medical Malpractice: Maine's Use of Practice Guidelines to Reduce Costs 3 (1993) [hereinafter GAO Report].

84 Id.

85 Me. Rev. Stat. Ann. tit. 24, §§ 2971-2979 (1989) (repealed in 1999).

86 LeCraw, supra note 81.

87 Zonana, Howard, Commentary, When Is a Practice Guideline Only a Guideline?, 36 J. Am. Acad. Psychiatry L. 302, 303 (2008).Google ScholarPubMed

88 LeCraw, supra note 81 (citing GAO Report, supra note 83, at 2, 5).

89 See Trail, William R. & Allen, Brad A., Government Created Medical Practice Guidelines: The Opening Of Pandora's Box, 10 J.L. & Health 231, 247-48 (1995).Google Scholar

90 Id.

91 Id.

92 Id. at 245-46.

93 See Platt, Bruce D., 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)Google Scholar.

94 Florence Kavaler & Allen D. Spiegel, Risk Management in Health Care Institutions 251 (2d ed. 2003).

95 Kinney, Eleanor D., Medical Malpractice Reform in the 1990s: Past Disappointments, Future Success?, 20 J. Health Pol., Pol’y & L. 99, 111 (1995) (citing Fla. Stat. Ann. § 408.02 (West 1993)).CrossRefGoogle ScholarPubMed

96 Id. at 110.

97 Id. (citing 1992 Vt. Acts & Resolves 160).

98 LeCraw, supra note 81 (citing Ky. Rev. Stat. Ann. §§ 216B.145, 342.035 (Michie 1995); Md. Code Ann., Health-Gen. §§ 19-1601—19-1606 (West 1993)).

99 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. See discussion infra Parts II.B & III.

100 H.R. 1290, 81st Leg. Sess. (Tx. 2009).

101 Jacobson, Peter D., Commentary, Transforming Clinical Practice Guidelines Into Legislative Mandates: Proceed with Abundant Caution, 299 JAMA 208, 209 (2009).Google Scholar

102 Id. at 209-10. 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).

103 N.J. Stat. Ann. § 2A:53A-30 et seq. (West 2001). See Brief of Texas et al. as Amici Curiae Supporting Respondents, Aetna Health, Inc. v. Davila, 542 U.S. 200 (2004) (No. 02-1845). See also Ariz. Rev. Stat. § 20-3153 (LexisNexis 2011); Cal. Civ. Code § 3428 (West 2011); Ga. Code Ann. § 51-1-48 (2000); La. Rev. Stat. Ann. § 22:2085 (2011); Me. Rev. Stat. tit. 24-A, § 4313 (1999); Okla. Stat. tit. 36, § 6593 (2000); Tex. Civ. Prac. & Rem. Code Ann. § 88.002 (West 2005); Wash. Rev. Code § 48.43.545 (2000); W. Va. Code § 33-25C-7 (2010).

104 Aetna Health, Inc. v. Davila, 542 U.S. 200, 223 (2004).Google Scholar

105 See, e.g., Tex. Civ. Prac. & Rem. Code Ann. § 88.0015 (West 2005) (limiting applicability of statute to insurance plans not regulated under ERISA). See also Humiston, David M. & Toto, James A., Department, Practice Tips: The Prognosis for the Managed Care Liability Act after Davila, 28 L.A. Lawyer 12, 12 (2005).Google Scholar

106 Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 352.

107 See Sharkey, Catherine M., Products Liability Preemption: An Institutional Approach, 76 Geo. Wash. L. Rev. 449, 495 (2008).Google Scholar

108 Rachlinski, supra note 34, at 609.

109 For example, the FDA changed its policy during the second Bush administration regarding its ability to determine preemption. See Epstein, Richard A., Why the FDA Must Preempt Tort Litigation: A Critique of Chevron Deference and a Response to Richard Nagareda, 1 J. Tort. L. 5 (2006).Google Scholar

110 In the U.S., one cannot sue the FDA or any other agency for a wrong decision within its discretion. See Epstein, supra note 109, at 3, nn.6-7.

111 Id. at 22 (arguing agencies have incentives to regulate in an overly risk-adverse fashion because of self-interest).

112 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.”).

113 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). See Price-Anderson Act of 1957, 42 U.S.C. § 2210 (2006); National Childhood Vaccine Injury Act of 1986, 42 U.S.C. §§ 300aa-1—300aa-34 (2006).

114 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). See, e.g., Colo. Rev. Stat. Ann. § 13-21-403(1)(b) (West 2010); Ind. Code § 34-20-5-1(2) (1999); Kan. Stat. Ann. § 60-3304(a) (2005); N.J. Stat. Ann. § 2A:58C-4 (West 2000); Tenn. Code Ann. § 29-28-104 (2000); Tex. Civ. Prac. & Rem. Code Ann. § 82.007(a) (West 2005); Utah Code Ann. § 78-15-6(3) (West 2005). By and large, neither the Restatement Second nor the Third allow for a complete defense. See Restatement (Second) of Torts § 288C (1965); Restatement (Third) of Torts: Products Liability § 4 (1998).

115 Shekelle, Paul G. 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).CrossRefGoogle ScholarPubMed

116 Id. at 1462.

117 See Alonso-Zaldivar, supra note 9 (listing malpractice reforms that could be funded under President Obama's grant proposal).

118 Sheryl Gay Stolberg & Robert Pear, Obama Open to Reining in Medical Malpractice Suits, N.Y. Times, June 15, 2009, at A14.

119 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.

120 Healthy Americans Act, S. 391, 111th Cong. (2009).

121 Mello, supra note 67, at 651 (quoting Merz, Stephen M., Clinical Practice Guidelines: Policy Issues and Legal Implications, 19 Joint Comm’n J. on Quality Improvement 306, 307 (1993)).CrossRefGoogle ScholarPubMed

122 GAO Report, supra note 83.

123 Mello, supra note 67, at 651.

124 Even in Michigan the doctrine is just for pharmaceuticals. See Mich. Comp. Laws Ann. § 600.2946(5) (West 2010).

125 See Epstein, supra note 109; Schuck, supra note 46; Sharkey, Catherine, What Riegel Portends for FDA Preemption of State Law Products Liability Claims, 103 Nw. U. L. Rev. 437 (2009).Google Scholar

126 See Van Tassel, Katharine, 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).Google ScholarPubMed

127 See Daniel R. Longo et al., Hospital Patient Safety: Characteristics of Best-Performing Hospitals, J. Healthcare Mgmt., May 2007, at 195-200.

128 McGinn, Thomas et al., Decreasing Mortality for Patients Undergoing Hip Fracture Repair Surgery, 31 Joint Comm’n J. on Quality & Patient Safety 304, 305 (2005).CrossRefGoogle ScholarPubMed

129 Id. at 306.

130 See About TapRooT, TapRooT, http://www.taproot.com/about.php (last visited Jan. 27, 2011).

131 Zonana, supra note 87, at 303.

132 Kessler, Daniel & McClellan, Mark, Do Doctor's Practice Defensive Medicine?, 111 Q. J. Econ. 353, 371-72 (1996).CrossRefGoogle Scholar

133 Zonana, supra note 87, at 303.

134 See Amerling, Richard et al., Guidelines Have Done More Harm Than Good, 26 Blood Purification 73 (2008).CrossRefGoogle ScholarPubMed

135 Tricoci, Pierluigi et al., Scientific Evidence Underlying the ACC/AHA Clinical Practice Guidelines, 301 JAMA 831, 833 (2009).CrossRefGoogle ScholarPubMed The study categorized its lowest level of acceptable evidence as indicating little to no objective empirical evidence for the recommended action.

136 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.

137 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%20Interactions%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. 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 fifty-eight 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. See Choudhry, Niteesh K. et al., Relationships Between Authors of Clinical Practice Guidelines and the Pharmaceutical Industry, 287 JAMA 612, 614 (2002).CrossRefGoogle ScholarPubMed

138 Id. at 612. Interestingly, even the authors of the study had attended events sponsored by or received money from pharmaceutical companies. Id.

139 Quigley v. Jobe, 851 P.2d 236, 238 (Colo. Ct. App. 1992).

140 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. Chassin, Mark R., Standard of Care in Medicine, 25 Inquiry 437 (1988).Google Scholar 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”).

141 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.” Quigley, 851 P.2d, at 238. See also Parchomovsky & Stein, supra note 44.

142 The contours of the proposal are laid out in full in Ronen Avraham, Private Regulation, 34 Harv. J.L. & Pub. Pol’y (forthcoming).

143 See Restatement (Third) of Torts: Liability for Physical Harm § 16 (2005); 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.

144 See Copyright Act of 1976, 17 U.S.C. § 102 (2006) (codifying the holding in Baker v. Selden, 101 U.S. 99 (1879)).Google Scholar

145 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.

146 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. Kesselheim, Aaron S. & Mello, Michelle M., Medical-Process Patents: Monopolizing the Delivery of Health Care, 355 N. Engl. J. Med. 2036, 2037 (2006).CrossRefGoogle ScholarPubMed 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.

147 See, e.g., Lewis v. Am. Cyanamid Co., 715 A.2d 967 (N.J. 1998).

148 Shavell, Steven, The Judgment Proof Problem, 6 Int’l Rev. L. & Econ. 45, 55 (1986).CrossRefGoogle Scholar

149 Shavell, Steven, Minimum Asset Requirements and Compulsory Liability Insurance as Solutions to the Judgment-Proof Problem, 36 RAND J. Econ. 63, 65 (2005).Google Scholar

150 See Arlen, Jennifer & MacLeod, W. Bentley, Malpractice Liability for Physicians and Managed Care Organizations, 78 N.Y.U. L. Rev. 1929, 1940 (2003)Google Scholar; Arlen, Jennifer & MacLeod, W. Bentley, Torts, Expertise and Authority: Liability of Physicians and Managed Care Organizations, 36 RAND J. Econ. 494 (2005).Google ScholarPubMed

151 Arlen & MacLeod, Malpractice Liability, supra note 150, at 1934.

152 See id. at 1962, 1966, 2005.

153 Davila, 542 U.S. at 204.

154 Hyman, David 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)CrossRefGoogle Scholar (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).

155 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).

156 Rosoff, Evidence-Based Medicine and the Law, supra note 58, at 350.

157 Institute of Medicine, Committee on Quality of Health Care in America, To Err is Human 26 (Linda T. Kohn et al. eds., 2000).

158 Id. at 30.

159 Id.

160 Julie 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).

161 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-priceless-presidential-testimonial/.

162 Kaiser Permanente, Frequently Asked Questions About Our Medical Care, https://members.kaiserpermanente.org/kpweb/faqmedcare/entrypage.do (last visited Jan. 26, 2011).

163 See supra notes 54-57 and accompanying text.