Medical Practice Guidelines as Malpractice Safe Harbors: Illusion or Deceit?

Institute of Medicine, National Academies of Science, Clinical Practice Guidelines: Directions for a New Program , Field M. J. Lohr K. N. , eds. (Washington, D.C.: National Academies Press, 1990): At 38 (hereinafter cited as 1990 IOM Report).

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Id. (Hall), at 131.

Id., at 135.

Id., at 131.

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Id., at 342.

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Rosoff A. J. , “Evidence-Based Medicine and the Law: The Courts Confront Clinical Practice Guidelines,” Journal of Health Politics, Policy, and Law 26, no. 2 (2001): 327–368, at 343.

Id., at 340.

See Trail Allen , supra note 8, at 244; Hyams A. L. Shapiro D. W. Brennan T. A. , “Medical Practice Guidelines in Malpractice Litigation: An Early Retrospective,” Journal of Health Politics, Policy, and Law 21, no. 2 (1996): 289–313, at 307–308.

See Trail Allen , supra note 8, at 247.

See Hyams Shapiro Brennan , supra note 12, at 308.

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See Rosoff , supra note 10, at 335; Trail Allen , supra note 8, at 248.

See Hall , supra note 2, at 137–138.

Id.; Hyams Shapiro Brennan , supra note 12, at 308–310; Ayres J. D. , “The Use and Abuse of Medical Practice Guidelines,” Journal of Legal Medicine 15, no. 3 (1994): 421–443, at 422.

See Hyams Shapiro Brennan , supra note 12, at 308–310; Rosoff , supra note 10, at 340.

Todd J. S. , “Only Parameters Will Give MDs Needed Flexibility,” American Medical News, January 6, 1989, at 15.

See Rosoff , supra note 10, at 343.

See Begel , supra note 6, at 342.

Id., at 86; see Hyams Shapiro Brennan , supra note 12, at 306–307; Rosoff , supra note 10, at 343.

See Hall , supra note 2, at 135.

Kuc G. W. , “Comment: Practice Parameters as a Shield Against Physician Liability,” Journal of Contemporary Health Law & Policy 10, Spring (1994): 439–468, at 441.

See Trail Allen , supra note 8, at 245.

See Office of Technology Assessment, supra note 15, at 33.

Id.

See Ayres , supra note 18, at 429.

See Hall , supra note 2, at 143.

Id.

Id., at 436.

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Id., at 1903–1904.

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See 1990 IOM Report, supra note 1, at 6.

Id., at 15.

See Hyams Shapiro Brennan , supra note 12, at 309.

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H. R. 3590. Patient Protection and Affordable Care Act, 111th Cong., 2nd sess. (2010).

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Id.

Hall R. F. , “Right Question, Wrong Answer: A Response to Professor Epstein and the ‘Permititis’ Challenge,” Minnesota Law Review Headnotes 94 (Spring 2010): 50–84, at 75.

Keyhani S. Kim A. Mann M. Korenstein D. , “A New Independent Authority Is Needed to Issue National Health Care Guidelines,” Health Affairs 30, no. 2 (2011): 256–265, at 259–260; Sniderman A. D. Furberg C. D. , “Why Guideline-Making Requires Reform,” JAMA 301, no. 4 (2009): 429–431.

See Sniderman Furberg , supra note 49, at 430.

Id. (emphasis added).

Mendelson T. B. Meltzer M. Campbell E. G. Caplan A. L. Kirkpatrick J. N. , “Conflicts of Interest in Cardiovascular Clinical Practice Guidelines,” Archives of Internal Medicine 171, no. 6 (2011): 577–584; see Keyhani , supra note 48; Sniderman Furberg , supra note 49.

See Mendelson , supra note 52, at 577.

See Sniderman Furberg , supra note 49, at 429.

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See Sniderman Furberg , supra note 49, at 430.

See Mendelson , supra note 52, at 578.

Id.

Id., at 579.

See Sawka , supra note 46, at 33.

See Jost , supra note 55, at 332–333.

See Mendelson , supra note 52, at 578–579.

Ronn S. , “In the Lymelight: Law and Clinical Practice Guidelines,” Southern Medical Journal 102, no. 6 (2009): 626–630, at 627.

Id., at 627.

Id., at 628. See also Blumenthal R. , “Conn. Att'y Gen'l: Conflicts of Interest in Treatment Guidelines,” The Day, July 19, 2009, available at <http://www.theday.com/apps/pbcs.dll/article?AID=/20090719/OP05/307199960&template> (last visited April 4, 2012).

See Mendelson , supra note 52, at 580.

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See Avraham , supra note 67, at 29.

See Mendelson , supra note 52, citing Van Wyck D. Eckardt K. U. Uhlig K. Rocco M. Levin A. , “Response to 'Influence of Industry on Renal Guideline Development,” Clinical Journal of the American Society of Nephrology 2, no. 1 (2007): 13–14.

Id., at 581.

See Sniderman Furberg , supra note 49, at 429.

Id., at 430–431.

Id., at 430.

Tricoci P. Allen J. M. Kramer J. M. Califf R. M. Smith S. C. Jr. , “Scientific Evidence Underlying the ACC/AHA Clinical Practice Guidelines,” JAMA 301, no. 8 (2009): 831–841, at 832.

Id., at 832.

Id., at 831.

Id., at 835.

McAlister F. A. van Diepen S. Padwal R. S. Johnson J. A. Majumdar S. R. , “How Evidence-Based Are the Recommendations in Evidence-Based Guidelines?” PLoS Medicine 4, no. 8 (2007): E250 at e250.

Id.

IOM, Initial National Priorities for Comparative Effectiveness Research (Washington, D.C.: National Academies Press, 2009): At 30.

See Sawka , supra note 46, at 33.

See McAlister , supra note 78, at e250.

Mathews S. C. Provonost P. J. , “Physician Autonomy and Informed Decision Making: Finding the Right Balance for Patient Safety and Quality,” JAMA 300, no. 24 (2008): 2913–2915, at 2915.

Id.

See McAlister , supra note 78, at e250.

Chung K. C. Shauver M. J. , “Crafting Practice Guidelines in the World of Evidence-Based Medicine,” Plastic and Reconstructive Surgery 124, no. 4 (2009): 1349–1354, at 1350.

See Shaneyfelt , supra note 33, at 1904. See also Harpole L. H. Kelley M. J. Schreiber G. Toloza E. M. Kolimaga J. McCrory D. C. , “Assessment of the Scope and Quality of Clinical Practice Guidelines in Lung Cancer,” Chest 123, Supp. (2003): 7S–20S, at 17S and Hinds P. S. Gattuso J. S. Barnwell E. Cofer M. Kellum L. Mattox S. Norman G. Powell B. Randall E. Sanders C. , “Translating Psychosocial Research Findings into Practice Guidelines,” JONA 33, nos. 7–8 (2003): 397–403 at 397–398.

See Avraham , supra note 67, at 29.

Lin G. A. Redberg R. F. Anderson H. V. Shaw R. E. Milford-Beland S. Peterson E. D. Rao S. V. Werner R. M. Dudley R. A. , “Impact of Changes in Clinical Practice Guidelines on Assessment of Quality of Care,” Medical Care 48, no. 8 (2010): 733–738.

Id., at 734.

Id.

Harris J. , “Development, Use, and Evaluation of Clinical Practice Guidelines,” Journal Occupational & Environmental Medicine 39, no. 1 (1997): 23–34 (emphasis added); see also Chung Shauver , supra note 86; Murphy R. N. , “Legal and Practical Impact of Clinical Practice Guidelines on Nursing and Medical Practice,” Nurse Practitioner 22, no. 3 (1997): 138–148.

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See Hyams , supra note 12, at 295.

Id., at 292.

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See Rosoff , supra note 10, at 357.

See Rosoff , supra note 10, at 327.

Id.; Avraham , supra note 67.

See Rosoff , supra note 10, at 328.

See Keyhani , supra note 49, at 262.

See Hall , supra note 2, at 140.

See Keyhani , supra note 49, at 257.

See Avraham , supra note 67, at 31.

See Rosoff , supra note 10, at 328.

See Hall , supra note 2, at 131.

See Havighurst , supra note 2, at 789.

Institute of Medicine, “About the IOM,” available at <http://www.iom.edu/About-IOM.aspx> (last visited April 4, 2012).

See Rosoff , supra note 10, at 344; Begel , supra note 6, at 93–97. But see Mello M. M. Chandra A. Gawande A. A. Studdert D. M. , “National Costs of the Medical Liability System,” Health Affairs 29, no. 9 (2010): 1569–1577.

Mehlman M. J. Nance D. A. , Medical Injustice: The Case Against Health Courts (Washington, D.C.: American Association for Justice, 2007): At 7.

See Lin , supra note 89, at 735–736.

See Mello , supra note 111, at 660–661, 695, 701.

ABA Model Code of Professional Responsibility, Preliminary Statement, 1983, available at <http://www.law.cornell.edu/ethics/aba/mcpr/MCPR.HTM> (last visited April 4, 2012); ABA Model Rules for Professional Conduct, Preamble and Scope, at [14], available at <http://www.americanbar.org/groups/professional_responsibility/publications/model_rules_of_professional_conduct/model_rules_of_professional_conduct_preamble_scope.html> (last visited April 4, 2012).

See Mello , supra note 111, at 695.