Perspective: Law and Medicine – Practice Guidelines

Question: A 45-year-old woman consulted her family physician for a breast lump. She has no family history of breast cancer and no other risk factors. The physician was unable to palpate the mass, so he reassured the patient and scheduled a follow-up appointment in 6 weeks. Patient forgot her appointment, but returned a year later complaining of an enlarging mass, which proved to be malignant. Which of the following statements is best?

A. The physician is justified in asking the patient to return for a repeat exam, as this can be shown to constitute customary standard of care.

B. National clinical practice guidelines require a screening mammogram in this case.

C. The physician will definitely prevail by relying on the latest practice guideline as a shield against a lawsuit.

D. Patient will win simply by choosing a different supporting guideline.

E. Clinical guidelines are just that, a guide, and carry no legal significance.

Answer: A. As no mass was palpated in this low-risk patient, whether the physician should have immediately ordered a mammogram would depend on factors such as family history, menstrual history, chest radiation, and age. The defense expert will testify that scheduling a recheck in 6 weeks in lieu of an immediate mammogram meets the legal standard of care. Additionally, the physician will attempt to use the recent national practice guidelines on screening mammography (age 50 and older, as opposed to the older guidelines that recommended screening starting at age 40) as exculpatory evidence. The plaintiff may refer to other guidelines, although her best arguments are that in her case, mammography would have been diagnostic, not screening, and that she should have received a reminder regarding her missed appointment.

Practice guidelines are defined by the Institute of Medicine as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." Some 2,000 guidelines have been developed by medical organizations and governmental agencies, as well as insurance carriers, managed care organizations, and others. These guidelines purport to define the best evidence-based medicine. If they are arrived at by consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards (Pollard v. Goldsmith). On the other hand, guidelines become less credible if they primarily are written to reduce health care costs.

Practice guidelines have been variously described as recipes, parameters, and rudimentary road maps, and physicians have been slow to adopt them, including those promulgated by authoritative federal organizations such as the Agency for Healthcare Research and Quality.

Notwithstanding their limitations, guidelines should not be dismissed as having no legal significance. They are usually allowed into evidence, much like textbooks and scientific articles, as an exception to the hearsay rule of evidence (learned treatise exception). However, some jurisdictions such as Maryland have ruled them inadmissible as evidence in courts of law. At the other extreme, states such as Maine allow doctors to elect to be covered by practice guidelines, with such compliance constituting evidence against any allegation of negligence.

Practice guidelines are double-edged swords, as they may be used in some jurisdictions either to exculpate or inculpate, i.e., exonerating or implicating the doctor. Both plaintiff and defense attorneys are increasingly confronting guideline issues. Still, the proliferation of practice guidelines has tended to increase, not decrease, the use of medical experts. Guidelines frequently are written to underscore a minimal rather than an ordinary or customary standard. Negligence is about breaching an objective customary standard, and guidelines may meet, exceed, or even fall below that standard. Both the plaintiff and defendant are required to produce experts to legally establish what constitutes standard as opposed to substandard care.

Medical standards are issues of fact that are ultimately determined by the jury, not the judge. It is highly unusual therefore for a judge in a jury trial to decide what constitutes the proper standard.

This column, "Law and Medicine," regularly appears in Internal Medicine News, an Elsevier publication. Dr. Tan is professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: A 45-year-old woman consulted her family physician for a breast lump. She has no family history of breast cancer and no other risk factors. The physician was unable to palpate the mass, so he reassured the patient and scheduled a follow-up appointment in 6 weeks. Patient forgot her appointment, but returned a year later complaining of an enlarging mass, which proved to be malignant. Which of the following statements is best?

A. The physician is justified in asking the patient to return for a repeat exam, as this can be shown to constitute customary standard of care.

B. National clinical practice guidelines require a screening mammogram in this case.

C. The physician will definitely prevail by relying on the latest practice guideline as a shield against a lawsuit.

D. Patient will win simply by choosing a different supporting guideline.

E. Clinical guidelines are just that, a guide, and carry no legal significance.

Answer: A. As no mass was palpated in this low-risk patient, whether the physician should have immediately ordered a mammogram would depend on factors such as family history, menstrual history, chest radiation, and age. The defense expert will testify that scheduling a recheck in 6 weeks in lieu of an immediate mammogram meets the legal standard of care. Additionally, the physician will attempt to use the recent national practice guidelines on screening mammography (age 50 and older, as opposed to the older guidelines that recommended screening starting at age 40) as exculpatory evidence. The plaintiff may refer to other guidelines, although her best arguments are that in her case, mammography would have been diagnostic, not screening, and that she should have received a reminder regarding her missed appointment.

Practice guidelines are defined by the Institute of Medicine as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." Some 2,000 guidelines have been developed by medical organizations and governmental agencies, as well as insurance carriers, managed care organizations, and others. These guidelines purport to define the best evidence-based medicine. If they are arrived at by consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards (Pollard v. Goldsmith). On the other hand, guidelines become less credible if they primarily are written to reduce health care costs.

Practice guidelines have been variously described as recipes, parameters, and rudimentary road maps, and physicians have been slow to adopt them, including those promulgated by authoritative federal organizations such as the Agency for Healthcare Research and Quality.

Notwithstanding their limitations, guidelines should not be dismissed as having no legal significance. They are usually allowed into evidence, much like textbooks and scientific articles, as an exception to the hearsay rule of evidence (learned treatise exception). However, some jurisdictions such as Maryland have ruled them inadmissible as evidence in courts of law. At the other extreme, states such as Maine allow doctors to elect to be covered by practice guidelines, with such compliance constituting evidence against any allegation of negligence.

Practice guidelines are double-edged swords, as they may be used in some jurisdictions either to exculpate or inculpate, i.e., exonerating or implicating the doctor. Both plaintiff and defense attorneys are increasingly confronting guideline issues. Still, the proliferation of practice guidelines has tended to increase, not decrease, the use of medical experts. Guidelines frequently are written to underscore a minimal rather than an ordinary or customary standard. Negligence is about breaching an objective customary standard, and guidelines may meet, exceed, or even fall below that standard. Both the plaintiff and defendant are required to produce experts to legally establish what constitutes standard as opposed to substandard care.

Medical standards are issues of fact that are ultimately determined by the jury, not the judge. It is highly unusual therefore for a judge in a jury trial to decide what constitutes the proper standard.

This column, "Law and Medicine," regularly appears in Internal Medicine News, an Elsevier publication. Dr. Tan is professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].

Question: A 45-year-old woman consulted her family physician for a breast lump. She has no family history of breast cancer and no other risk factors. The physician was unable to palpate the mass, so he reassured the patient and scheduled a follow-up appointment in 6 weeks. Patient forgot her appointment, but returned a year later complaining of an enlarging mass, which proved to be malignant. Which of the following statements is best?

A. The physician is justified in asking the patient to return for a repeat exam, as this can be shown to constitute customary standard of care.

B. National clinical practice guidelines require a screening mammogram in this case.

C. The physician will definitely prevail by relying on the latest practice guideline as a shield against a lawsuit.

D. Patient will win simply by choosing a different supporting guideline.

E. Clinical guidelines are just that, a guide, and carry no legal significance.

Answer: A. As no mass was palpated in this low-risk patient, whether the physician should have immediately ordered a mammogram would depend on factors such as family history, menstrual history, chest radiation, and age. The defense expert will testify that scheduling a recheck in 6 weeks in lieu of an immediate mammogram meets the legal standard of care. Additionally, the physician will attempt to use the recent national practice guidelines on screening mammography (age 50 and older, as opposed to the older guidelines that recommended screening starting at age 40) as exculpatory evidence. The plaintiff may refer to other guidelines, although her best arguments are that in her case, mammography would have been diagnostic, not screening, and that she should have received a reminder regarding her missed appointment.

Practice guidelines are defined by the Institute of Medicine as "systematically developed statements to assist practitioner and patient decisions about appropriate health care for specific clinical circumstances." Some 2,000 guidelines have been developed by medical organizations and governmental agencies, as well as insurance carriers, managed care organizations, and others. These guidelines purport to define the best evidence-based medicine. If they are arrived at by consensus of an authoritative body of experts, courts will tend to view them as reflective, though not necessarily dispositive, of customary medical standards (Pollard v. Goldsmith). On the other hand, guidelines become less credible if they primarily are written to reduce health care costs.

Practice guidelines have been variously described as recipes, parameters, and rudimentary road maps, and physicians have been slow to adopt them, including those promulgated by authoritative federal organizations such as the Agency for Healthcare Research and Quality.

Notwithstanding their limitations, guidelines should not be dismissed as having no legal significance. They are usually allowed into evidence, much like textbooks and scientific articles, as an exception to the hearsay rule of evidence (learned treatise exception). However, some jurisdictions such as Maryland have ruled them inadmissible as evidence in courts of law. At the other extreme, states such as Maine allow doctors to elect to be covered by practice guidelines, with such compliance constituting evidence against any allegation of negligence.

Practice guidelines are double-edged swords, as they may be used in some jurisdictions either to exculpate or inculpate, i.e., exonerating or implicating the doctor. Both plaintiff and defense attorneys are increasingly confronting guideline issues. Still, the proliferation of practice guidelines has tended to increase, not decrease, the use of medical experts. Guidelines frequently are written to underscore a minimal rather than an ordinary or customary standard. Negligence is about breaching an objective customary standard, and guidelines may meet, exceed, or even fall below that standard. Both the plaintiff and defendant are required to produce experts to legally establish what constitutes standard as opposed to substandard care.

Medical standards are issues of fact that are ultimately determined by the jury, not the judge. It is highly unusual therefore for a judge in a jury trial to decide what constitutes the proper standard.

This column, "Law and Medicine," regularly appears in Internal Medicine News, an Elsevier publication. Dr. Tan is professor of medicine and former adjunct professor of law at the University of Hawaii. This article is meant to be educational and does not constitute medical, ethical or legal advice. It is adapted from the author’s book, "Medical Malpractice: Understanding the Law, Managing the Risk" (2006). For additional information, readers may contact the author at [email protected].