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

2. Cal Chaney, JD Presentation Focus: Definitions Practice Guidelines in Legislation Practice Guidelines in Litigation Potential Liability to Drafters of Practice Guidelines Recommendations for Drafting Practice Guidelines

3. Cal Chaney, JD For purposes of this presentation: Medical Guidelines = Practice Guidelines = Clinical Policies = Health Care Guidelines = Clinical Guidelines = Protocol

4. Cal Chaney, JD 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.”

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

6. Cal Chaney, JD 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.

7. Cal Chaney, JD Legislative Guidelines Designed to “reduce health care costs by eliminating defensive medicine;” and To protect doctors from fallacious litigation.

8. Cal Chaney, JD The Maine Medical Liability Demonstration Project: Using Practice Guidelines as an Affirmative Defense

9. Cal Chaney, JD 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.

10. Cal Chaney, JD 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.

11. Cal Chaney, JD The Maine Medical Liability Demonstration Project developed guidelines in four medical specialties: Emergency Medicine Anesthesiology Radiology Obstetrics/Gynecology

12. Cal Chaney, JD The Maine Medical Liability Demonstration Project was: Experimental; Not used in litigation for various reasons; and Sunsetted after five years, and renewed.

13. Cal Chaney, JD LITIGATION

14. 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.

15. Cal Chaney, JD Practice guidelines may be used to: 1. 1. Establish the standard of care by which the defendant physician’s actions will be measured; 2. 2. Contribute toward determining what that standard should be; or 3. 3. Impeach the testimony of the other party’s expert witnesses.

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

17. Cal Chaney, JD 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.

18. Cal Chaney, JD Practice guidelines are not likely to be the only factor in determining a physician’s liability. Other factors will be considered including: 1. 1. Patient variations; 2. 2. Geographic considerations; and 3. 3. Accepted practice of the medical community that varies from the practice guideline.

19. Cal Chaney, JD 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.

20. Cal Chaney, JD There are few major studies in the United States on the use of practice guidelines in litigation.

21. Cal Chaney, JD 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.

22. Cal Chaney, JD 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.

23. Cal Chaney, JD 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.

24. Cal Chaney, JD POTENTIAL LIABILITY RESULTING FROM DRAFTING PRACTICE GUIDELINES

25. Cal Chaney, JD For liability to result, the practice guidelines would have to: 1. 1. Recommend an unreasonable course of action or eliminate from consideration a reasonable course of action; 2. 2. Be a necessary cause of the harm; that is that harm would not have occurred without it.

26. Cal Chaney, JD To avoid liability, the drafters of practice guidelines must ensure that: 1. 1. The guidelines are reviewed and updated regularly; 2. 2. Reasonable care is taken in their development to reflect the current medical knowledge; 3. 3. The guidelines emphasize the importance of professional judgment; and 4. 4. The standards established in the policy are not the result of coercion of any kind including financial incentives.

27. Cal Chaney, JD Recommendations for Preventing Practice Guidelines From Being Used Against Physicians In Malpractice Litigation: 1. 1. Practice guidelines should be written or approved by physicians. 2. 2. Clinical evidence should be the foundation of practice guidelines. 3. 3. Practice guidelines should take into account the variations in practice pattern, disease presentation, patient characteristics (age, gender, medications, current diseases, etc.) 4. 4. Guidelines must be carefully reviewed from the perspective of a plaintiff’s attorney. 5. 5. Practice guidelines should be easily accessible to the physicians affected by them.