the legal implications of practice guidelines

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The Legal The Legal Implications Implications of of Practice Practice Guidelines Guidelines Cal Chaney, JD April 12, 2002

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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. - PowerPoint PPT Presentation

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Page 1: The Legal  Implications of  Practice  Guidelines

The Legal The Legal ImplicationsImplications

of of Practice Practice

GuidelinesGuidelines

Cal Chaney, JDApril 12, 2002

Page 2: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

Presentation Focus:Presentation Focus:

• Definitions• Practice Guidelines in Legislation• Practice Guidelines in Litigation• Potential Liability to Drafters of

Practice Guidelines• Recommendations for Drafting

Practice Guidelines

Page 3: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

For purposes of this presentation:For purposes of this presentation:

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

Page 4: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

1990, the Institute of Medicine 1990, the Institute of Medicine defined practice guidelines as defined practice guidelines as

“systemically developed “systemically developed statements to assist statements to assist

practitioner and patient practitioner and patient decisions about appropriate decisions about appropriate

health care for specific clinical health care for specific clinical circumstances.”circumstances.”

Page 5: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

Practice guidelines developed Practice guidelines developed by organizations such as by organizations such as

ACEP have no specific legal ACEP have no specific legal authority and in no way are authority and in no way are

legally binding.legally binding.

Page 6: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

Practice Guidelines can have Practice Guidelines can have potential legal significance by: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.

Page 7: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

Legislative GuidelinesLegislative Guidelines

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

• To protect doctors from fallacious litigation.

Page 8: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

The Maine Medical Liability The Maine Medical Liability Demonstration Project: Using Demonstration Project: Using

Practice Guidelines as an Practice Guidelines as an Affirmative DefenseAffirmative Defense

Page 9: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

PROBLEMPROBLEMThe 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.

Page 10: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

SOLUTIONSOLUTION• 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.

Page 11: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

The Maine Medical Liability The Maine Medical Liability Demonstration Project developed Demonstration Project developed

guidelines in four medical specialties:guidelines in four medical specialties:

• Emergency Medicine

• Anesthesiology

• Radiology

• Obstetrics/Gynecology

Page 12: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

The Maine Medical Liability The Maine Medical Liability Demonstration Project was:Demonstration Project was:

• Experimental; • Not used in litigation for various

reasons; and • Sunsetted after five years, and

renewed.

Page 13: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

LITIGATIONLITIGATION

Page 14: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

In common law legal systems such as the In common law legal systems such as the United States, plaintiffs claiming negligence United States, plaintiffs claiming negligence

and malpractice must prove: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.

Page 15: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

Practice guidelines may be used to:Practice guidelines may be used to:

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

2. Contribute toward determining what that standard should be; or

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

Page 16: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

Expert witnesses review the Expert witnesses review the medical records and testify as medical records and testify as

to the standard of care a to the standard of care a physician should meet in a physician should meet in a

particular circumstance.particular circumstance.

Page 17: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

The current trend in the U.S. is The current trend in the U.S. is to hold physicians to a to hold physicians to a

national standard of care; national standard of care; however, standards of care however, standards of care can be established by state can be established by state

law and may vary from locale law and may vary from locale to locale.to locale.

Page 18: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

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

will be considered including:will be considered including:

1. Patient variations;

2. Geographic considerations; and

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

Page 19: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

Practice guidelines may be Practice guidelines may be used to impose liability on used to impose liability on hospitals and other health hospitals and other health

care institutions for failure to care institutions for failure to require or enforce the require or enforce the

accepted standards on its accepted standards on its physicians.physicians.

Page 20: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

There are few major studies in There are few major studies in the United States on the use the United States on the use

of practice guidelines in of practice guidelines in litigation.litigation.

Page 21: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

Harvard School of Public Health Harvard School of Public Health Study (1995)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.

Page 22: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

The Study found that practice The Study found that practice guidelines were significant or used guidelines were significant or used

in evidence in only seventeen or in evidence in only seventeen or (6%) of the surveyed cases.(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.

Page 23: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

Practice Guidelines (continued)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.

Page 24: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

POTENTIAL LIABILITYPOTENTIAL LIABILITY

RESULTING FROM RESULTING FROM

DRAFTING PRACTICEDRAFTING PRACTICE

GUIDELINES GUIDELINES

Page 25: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

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

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

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

Page 26: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

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

1. The guidelines are reviewed and updated regularly;

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

3. The guidelines emphasize the importance of professional judgment; and

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

Page 27: The Legal  Implications of  Practice  Guidelines

Cal Chaney, JD

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

1. Practice guidelines should be written or approved by physicians.

2. Clinical evidence should be the foundation of practice guidelines.

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

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

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