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The Legal Implications of Practice Guidelines. Cal Chaney, JD April 12, 2002. Presentation Focus:. Definitions Practice Guidelines in Legislation Practice Guidelines in Litigation Potential Liability to Drafters of Practice Guidelines Recommendations for Drafting Practice Guidelines.

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The Legal Implications of Practice Guidelines

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The Legal Implicationsof Practice Guidelines

  • Cal Chaney, JD

  • April 12, 2002


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Presentation Focus:

  • Definitions

  • Practice Guidelines in Legislation

  • Practice Guidelines in Litigation

  • Potential Liability to Drafters of Practice Guidelines

  • Recommendations for Drafting Practice Guidelines


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For purposes of this presentation:

  • Medical Guidelines = Practice Guidelines = Clinical Policies = Health Care Guidelines = Clinical Guidelines = Protocol


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1990, the Institute of Medicine defined practice guidelines as “systemically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances.”


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Practice guidelines developed by organizations such as ACEP have no specific legal authority and in no way are legally binding.


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Practice Guidelines can have potential legal significance by:

  • Being the basis for legislation/regulation of difficult clinical or medico-ethical activities;

  • Forming the best basis of expert evidence in medical malpractice cases.


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Legislative Guidelines

  • Designed to “reduce health care costs by eliminating defensive medicine;” and

  • To protect doctors from fallacious litigation.


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The Maine Medical Liability Demonstration Project: Using Practice Guidelines as an Affirmative Defense


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PROBLEM

  • The cost of health care delivery was skyrocketing because physicians were practicing defensive medicine, ordering unnecessary tests, procedures, and consultations to establish an unassailable record in the event of litigation.


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SOLUTION

  • In 1989, business, labor, and health care interests in the state of Maine formed a coalition and established guidelines and legislation that had wide physician acceptance.

  • The resulting legislation established standards of care that negate the need for medical expert testimony. The guidelines could not be used by the plaintiff.


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The Maine Medical Liability Demonstration Project developed guidelines in four medical specialties:

  • Emergency Medicine

  • Anesthesiology

  • Radiology

  • Obstetrics/Gynecology


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The Maine Medical Liability Demonstration Project was:

  • Experimental;

  • Not used in litigation for various reasons; and

  • Sunsetted after five years, and renewed.


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LITIGATION


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In common law legal systems such as the United States, plaintiffs claiming negligence and malpractice must prove:

  • The plaintiff was owed a duty of care (as in a patient-doctor relationship);

  • This duty was breached by failure to provide the required standard of care; and

  • The plaintiff was harmed by this failure.


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Practice guidelines may be used to:

  • Establish the standard of care by which the defendant physician’s actions will be measured;

  • Contribute toward determining what that standard should be; or

  • Impeach the testimony of the other party’s expert witnesses.


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Expert witnesses review the medical records and testify as to the standard of care a physician should meet in a particular circumstance.


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The current trend in the U.S. is to hold physicians to a national standard of care; however, standards of care can be established by state law and may vary from locale to locale.


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Practice guidelines are not likely to be the only factor in determining a physician’s liability. Other factors will be considered including:

  • Patient variations;

  • Geographic considerations; and

  • Accepted practice of the medical community that varies from the practice guideline.


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Practice guidelines may be used to impose liability on hospitals and other health care institutions for failure to require or enforce the accepted standards on its physicians.


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There are few major studies in the United States on the use of practice guidelines in litigation.


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Harvard School of Public Health Study (1995)

  • The Study reviewed 259 randomly selected insurance company malpractice claims.

  • The Study surveyed 960 medical malpractice attorneys about their use of practice guidelines in litigation.


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The Study found that practice guidelines were significant or used in evidence in only seventeen or (6%) of the surveyed cases.

  • Four cases -- practice guidelines were used to exonerate the physician.

  • Twelve cases -- practice guidelines were used to prove the physician’s negligence.


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Practice Guidelines (continued)

  • More than 27% of the attorneys reported that a practice guideline had influenced their decision to settle a case.

  • 22% stated that a practice guideline had influenced the trier of fact in a case in the previous year.

  • 26% reported that practice guidelines had influenced their decision not to take a case in the previous year.

  • 31% reported that a practice guideline influenced their decision to take a case in the previous year.

  • 38% of defense attorneys reported that practice guidelines had been important in more than one case in the previous year.


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POTENTIAL LIABILITYRESULTING FROM DRAFTING PRACTICE GUIDELINES


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For liability to result, the practice guidelines would have to:

  • Recommend an unreasonable course of action or eliminate from consideration a reasonable course of action;

  • Be a necessary cause of the harm; that is that harm would not have occurred without it.


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To avoid liability, the drafters of practice guidelines must ensure that:

  • The guidelines are reviewed and updated regularly;

  • Reasonable care is taken in their development to reflect the current medical knowledge;

  • The guidelines emphasize the importance of professional judgment; and

  • The standards established in the policy are not the result of coercion of any kind including financial incentives.


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Recommendations for Preventing Practice Guidelines From Being Used Against Physicians In Malpractice Litigation:

  • Practice guidelines should be written or approved by physicians.

  • Clinical evidence should be the foundation of practice guidelines.

  • Practice guidelines should take into account the variations in practice pattern, disease presentation, patient characteristics (age, gender, medications, current diseases, etc.)

  • Guidelines must be carefully reviewed from the perspective of a plaintiff’s attorney.

  • Practice guidelines should be easily accessible to the physicians affected by them.


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