Reaching safe harbor – legal implications of clinical practice guidelines

As the nation moves further down the road toward “Accountable Care,” there has been an increasing emphasis on stricter compliance with national guidelines. Theoretically, adherence to clinical guidelines by providers would reduce care variation, decrease unnecessary costs, and improve quality (value). Physicians rightly worry about their own exposure (both legally and financially) if they elect to deviate from published guidelines. In this month’s column, three experts on this topic discuss safe harbor and legal risk for providers with respect to practice guidelines. We appreciate Dr. Adams’ willingness to write from the viewpoint of both a physician (faculty at the University of Michigan) and an attorney.

John I. Allen, M.D., MBA, AGAF, Special Section Editor

The Institute of Medicine defines clinical practice guidelines (CPGs) as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”¹ The origin of CPGs can be traced to the desire of physicians and the public to give and receive the best care possible, especially given increasing medical costs, newly developed expensive technologies, evolving modalities of health care delivery, and variation in the quality of care. CPGs are used by diverse stakeholders including patients, legislators and policy makers, insurance companies, litigators, health systems, and physicians, not only to make medical care efficient, but also to hold practitioners accountable across different practice and geographic settings.

Although CPGs may be beneficial to overall population health, they may not be the right approach for an individual patient.² However, there is a real concern among physicians that going against a CPG recommendation could potentially lead to litigation, especially in the setting of a negative outcome. So when, if ever, is it acceptable to go against CPG recommendations? In this article, we present a hypothetical case in which following guideline recommendations would potentially expose the patient to greater risks than intentionally choosing to deviate from guidelines. We then discuss the legal implications of this choice, and the challenges of using CPGs to establish the legal standard of care.

Case

A 24-year-old man, incarcerated, with no past medical history, presents to the emergency department with complaints of dysphagia and an inability to tolerate his oral secretions. The patient reports that he was attempting to swallow a packet of heroin of unknown quantity to hide evidence. A diagnosis of heroin packet impaction in the esophagus is made, and the gastroenterology service is consulted for urgent endoscopy.

Given current CPG recommendations advocating no role for endoscopy in removal of impacted cocaine and heroin,³ the astute gastroenterologist then discusses the case with the surgical service and presents options to the patient: either surgical removal of the impacted object via thoracotomy, or with upper endoscopy with the knowledge that the latter option would be against guidelines and present significant procedural risks, including possible death if the packet ruptures. The dilemma occurs when the patient insists against the surgical approach, makes an informed decision, and consents only to endoscopic removal. How should the gastroenterologist proceed? Will there be medicolegal ramifications of performing a procedure against CPG recommendations, especially if there are complications?

Discussion

With the emergence of health services research in the 1970s and 1980s, practitioners and policy makers began to recognize the existence of widespread practice variation in the provision of health care services. CPGs grew from this body of work in an attempt to encourage more standardized, quality care processes and control ballooning health care costs. Through the Omnibus Budget Reconciliation Act of 1989 (103 Stat. 2159), Congress created the precursor to today’s Agency for Healthcare Research and Quality to enhance the quality, appropriateness, and effectiveness of health care services through various means, including the development of CPGs. A quick search of today’s Agency for Healthcare Research and Quality National Guideline Clearinghouse reveals the existence of 260 gastroenterology-related guidelines from local and national professional societies, hospitals and health care centers, and governmental organizations. Whether and to what extent these guidelines should be used to establish the legal standard of care is a hotly debated topic among both legal and medical circles.

A medical professional liability claim is a civil claim of negligence. Negligence, in the legal sense, is defined as a breach of the “standard of conduct to which [one] must conform...[and] is that of a reasonable man under like circumstances.”⁴ To prove negligence on the part of a physician in a medical professional liability case, the plaintiff/patient must prove the required elements of the claim, as follows: 1) the existence of a duty of care, 2) breach of that duty, 3) actual and proximate causation, and 4) damages/harm.

In the courtroom, CPGs are sometimes used to help define the standard of care against which the reasonableness of the physician’s actions will be judged. Under current legal practice, CPGs can be used as evidence of the standard of care, but are not considered definitive evidence. If admitted, they are considered along with other forms of evidence relevant to defining the standard of care, including expert witness testimony. Ultimately, the fact finder (generally the jury) must determine what weight to give each piece of evidence. Furthermore, under legal tenets governing the admissibility of evidence, CPGs generally can be admitted only under an exception to the hearsay rule (called the “learned treatise” exception), usually through a qualified expert witness who can vouch for the guidelines as a “reliable authority.”⁵ This, of course, raises the thorny question of which guidelines are authoritative enough to serve this role. Furthermore, multiple studies have shown poor adherence with CPGs, calling into question whether they can really be upheld as outlining prevailing medical practice. Indeed, some scholars have suggested that CPGs represent “an ideal of optimal care, rather than prevailing medical custom.”⁵

There has been continued debate in legal and policy circles since the early 1990s regarding so-called safe harbor legislation, which would give CPGs a pre-emptive effect that either precludes opposing testimony regarding the standard of care or shifts the burden of proof to the opposing party. There is debate as well regarding whether this should be an affirmative defense only available to physicians, or should be available to plaintiffs as a “sword,” in addition to a defensive “shield.”⁵ Indeed, several states (including Maine, Minnesota, Vermont, and Florida) have instituted demonstration projects designed to test this as a possible solution to the medical liability crisis. The overall consensus is that these programs have been largely unsuccessful in meeting their stated goals. Reasons posited for this lack of success include lack of physician buy-in (including lack of support from organizations such as the American Medical Association), use of safe harbor as a rebuttable defense, and shortcomings of available guidelines. To this last point, clinical guidelines may provide conflicting recommendations, which can muddy the waters when determining standards of care for negligence purposes. Guidelines also may be biased by the interests of the issuing organizations, or be constructed without methodologic rigor. Recent efforts such as the Grading of Recommendations Assessment, Development and Evaluation approach to guideline development seek to bolster guideline quality and trustworthiness.⁶ However, methodologically rigorous guideline development processes are by nature more time intensive, and may delay dissemination of critical guidance to expeditiously address the needs of clinicians on the front lines of medical care. Weighing these practical issues, different gastroenterology specialty societies use varying processes for guideline development that ultimately may lead to inconsistent recommendations of varying quality. In addition, guidelines often are written to establish national, not local, standards of care. Finally, as a rebellion against so-called “cookie-cutter” medicine, there has been increased emphasis in recent years on personalized medicine and shared decision making,⁷ which runs counter to the standardized approach typically espoused by guidelines.

A recent study examining closed liability claims in Oregon to determine the effects of hypothetical safe harbor legislation in that state found that the results of only 1% of 266 reviewed claims from 2002 to 2009 would have been changed by safe harbor legislation.⁸ This may reflect the protective effect of guidelines in suppressing filing of meritless claims. Thus, the investigators concluded that, although safe harbor legislation may not significantly impact the medical liability claims landscape, it may have a secondary effect of improving patient safety by encouraging guideline adherence in appropriate cases.

So, how do gastroenterologists best protect themselves when intentionally deviating from guideline recommendations? The answer is simple: documentation. The more carefully physicians document their decision making, including guidelines referenced, options discussed with the patient (including risks and benefits of each), and specific reasons for taking a particular approach (including patient preferences and unique circumstances), the more protected they ultimately will be.⁹ The most contentious legal issues arise when there is a paucity of documentation, so the physician is forced to recollect a decision-making process that occurred often years earlier to defend the reasonableness of the care provided.

Conclusions

Although CPGs often are designed for the general patient population, exceptions should be made in specific patient cases. When not adhering to guidelines, the practitioner often faces increased scrutiny if complications occur and legal action is pursued. We recommend documenting the discussion with the patient in as much detail as possible, as well as explaining in the medical record the rationale for the clinical decision. As physicians, our duty is to do no harm. This principle should guide the clinician in reaching a sound clinical decision, especially when contemplating a clinical approach at odds with guideline recommendations.

Disclaimer

The clinical scenario featured in this article is a hypothetical one, used to illustrate the type of clinical dilemmas gastroenterologists may face in daily practice with respect to clinical practice guidelines. Furthermore, the earlier discussion is intended as general commentary, and does not constitute legal advice in individual cases. Do not act or rely on information contained in this article without first seeking the advice of a personal attorney.

References

1. Institute of Medicine. Clinical practice guidelines we can trust. National Academies Press, Washington, D.C.; 2011.

2. Yapali, S., Talaat, N., Lok, A.S. Management of hepatitis B: our practice and how it relates to the guidelines. Clin Gastroenterol Hepatol. 2014;12:16-26.

3. ASGE Standards of Practice Committee. Management of ingested foreign bodies and food impactions. Gastrointest Endosc. 2011;73:1085-91.

4. Restatement (Second) of torts: liability for physical & emotional harm § 283 (1965). Mello MM. Of swords and shields: the role of clinical practice guidelines in medical malpractice litigation. 149 U. Pa. L. Rev. 645 2000-2001.

6. Ransohoff, D.F., Pignone, M., Sox, H.C. How to decide whether a clinical practice guideline is trustworthy. JAMA. 2013;309:139-40.

7. Ubel, P.A. Medical facts versus value judgments – toward preference-sensitive guidelines. N Engl J Med. 2015;26:2475-6.

8. Kachalia, A., Little, A., Isavoran, M., et al. Greatest impact of safe harbor rules may be to improve patient safety, not reduce liability claims paid by physicians. Health Aff (Millwood). 2014;33:59-66.

9. Rex, D.K. Avoiding and defending malpractice suits for postcolonoscopy cancer: advice from an expert witness. Clin Gastroenterol Hepatol. 2013;11:768-73.

Dr. Oza is in the division of gastroenterology and liver diseases, Yale New Haven Medical Center, New Haven, Conn; Dr. El-Dika is in the division of gastroenterology, hepatology and nutrition, Ohio State University–Wexner Medical Center, Columbus; Dr. Adams is in the division of gastroenterology, department of medicine, University of Michigan Medical School, and Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor.

As the nation moves further down the road toward “Accountable Care,” there has been an increasing emphasis on stricter compliance with national guidelines. Theoretically, adherence to clinical guidelines by providers would reduce care variation, decrease unnecessary costs, and improve quality (value). Physicians rightly worry about their own exposure (both legally and financially) if they elect to deviate from published guidelines. In this month’s column, three experts on this topic discuss safe harbor and legal risk for providers with respect to practice guidelines. We appreciate Dr. Adams’ willingness to write from the viewpoint of both a physician (faculty at the University of Michigan) and an attorney.

John I. Allen, M.D., MBA, AGAF, Special Section Editor

The Institute of Medicine defines clinical practice guidelines (CPGs) as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”¹ The origin of CPGs can be traced to the desire of physicians and the public to give and receive the best care possible, especially given increasing medical costs, newly developed expensive technologies, evolving modalities of health care delivery, and variation in the quality of care. CPGs are used by diverse stakeholders including patients, legislators and policy makers, insurance companies, litigators, health systems, and physicians, not only to make medical care efficient, but also to hold practitioners accountable across different practice and geographic settings.

Although CPGs may be beneficial to overall population health, they may not be the right approach for an individual patient.² However, there is a real concern among physicians that going against a CPG recommendation could potentially lead to litigation, especially in the setting of a negative outcome. So when, if ever, is it acceptable to go against CPG recommendations? In this article, we present a hypothetical case in which following guideline recommendations would potentially expose the patient to greater risks than intentionally choosing to deviate from guidelines. We then discuss the legal implications of this choice, and the challenges of using CPGs to establish the legal standard of care.

Case

A 24-year-old man, incarcerated, with no past medical history, presents to the emergency department with complaints of dysphagia and an inability to tolerate his oral secretions. The patient reports that he was attempting to swallow a packet of heroin of unknown quantity to hide evidence. A diagnosis of heroin packet impaction in the esophagus is made, and the gastroenterology service is consulted for urgent endoscopy.

Given current CPG recommendations advocating no role for endoscopy in removal of impacted cocaine and heroin,³ the astute gastroenterologist then discusses the case with the surgical service and presents options to the patient: either surgical removal of the impacted object via thoracotomy, or with upper endoscopy with the knowledge that the latter option would be against guidelines and present significant procedural risks, including possible death if the packet ruptures. The dilemma occurs when the patient insists against the surgical approach, makes an informed decision, and consents only to endoscopic removal. How should the gastroenterologist proceed? Will there be medicolegal ramifications of performing a procedure against CPG recommendations, especially if there are complications?

Discussion

With the emergence of health services research in the 1970s and 1980s, practitioners and policy makers began to recognize the existence of widespread practice variation in the provision of health care services. CPGs grew from this body of work in an attempt to encourage more standardized, quality care processes and control ballooning health care costs. Through the Omnibus Budget Reconciliation Act of 1989 (103 Stat. 2159), Congress created the precursor to today’s Agency for Healthcare Research and Quality to enhance the quality, appropriateness, and effectiveness of health care services through various means, including the development of CPGs. A quick search of today’s Agency for Healthcare Research and Quality National Guideline Clearinghouse reveals the existence of 260 gastroenterology-related guidelines from local and national professional societies, hospitals and health care centers, and governmental organizations. Whether and to what extent these guidelines should be used to establish the legal standard of care is a hotly debated topic among both legal and medical circles.

A medical professional liability claim is a civil claim of negligence. Negligence, in the legal sense, is defined as a breach of the “standard of conduct to which [one] must conform...[and] is that of a reasonable man under like circumstances.”⁴ To prove negligence on the part of a physician in a medical professional liability case, the plaintiff/patient must prove the required elements of the claim, as follows: 1) the existence of a duty of care, 2) breach of that duty, 3) actual and proximate causation, and 4) damages/harm.

In the courtroom, CPGs are sometimes used to help define the standard of care against which the reasonableness of the physician’s actions will be judged. Under current legal practice, CPGs can be used as evidence of the standard of care, but are not considered definitive evidence. If admitted, they are considered along with other forms of evidence relevant to defining the standard of care, including expert witness testimony. Ultimately, the fact finder (generally the jury) must determine what weight to give each piece of evidence. Furthermore, under legal tenets governing the admissibility of evidence, CPGs generally can be admitted only under an exception to the hearsay rule (called the “learned treatise” exception), usually through a qualified expert witness who can vouch for the guidelines as a “reliable authority.”⁵ This, of course, raises the thorny question of which guidelines are authoritative enough to serve this role. Furthermore, multiple studies have shown poor adherence with CPGs, calling into question whether they can really be upheld as outlining prevailing medical practice. Indeed, some scholars have suggested that CPGs represent “an ideal of optimal care, rather than prevailing medical custom.”⁵

There has been continued debate in legal and policy circles since the early 1990s regarding so-called safe harbor legislation, which would give CPGs a pre-emptive effect that either precludes opposing testimony regarding the standard of care or shifts the burden of proof to the opposing party. There is debate as well regarding whether this should be an affirmative defense only available to physicians, or should be available to plaintiffs as a “sword,” in addition to a defensive “shield.”⁵ Indeed, several states (including Maine, Minnesota, Vermont, and Florida) have instituted demonstration projects designed to test this as a possible solution to the medical liability crisis. The overall consensus is that these programs have been largely unsuccessful in meeting their stated goals. Reasons posited for this lack of success include lack of physician buy-in (including lack of support from organizations such as the American Medical Association), use of safe harbor as a rebuttable defense, and shortcomings of available guidelines. To this last point, clinical guidelines may provide conflicting recommendations, which can muddy the waters when determining standards of care for negligence purposes. Guidelines also may be biased by the interests of the issuing organizations, or be constructed without methodologic rigor. Recent efforts such as the Grading of Recommendations Assessment, Development and Evaluation approach to guideline development seek to bolster guideline quality and trustworthiness.⁶ However, methodologically rigorous guideline development processes are by nature more time intensive, and may delay dissemination of critical guidance to expeditiously address the needs of clinicians on the front lines of medical care. Weighing these practical issues, different gastroenterology specialty societies use varying processes for guideline development that ultimately may lead to inconsistent recommendations of varying quality. In addition, guidelines often are written to establish national, not local, standards of care. Finally, as a rebellion against so-called “cookie-cutter” medicine, there has been increased emphasis in recent years on personalized medicine and shared decision making,⁷ which runs counter to the standardized approach typically espoused by guidelines.

A recent study examining closed liability claims in Oregon to determine the effects of hypothetical safe harbor legislation in that state found that the results of only 1% of 266 reviewed claims from 2002 to 2009 would have been changed by safe harbor legislation.⁸ This may reflect the protective effect of guidelines in suppressing filing of meritless claims. Thus, the investigators concluded that, although safe harbor legislation may not significantly impact the medical liability claims landscape, it may have a secondary effect of improving patient safety by encouraging guideline adherence in appropriate cases.

So, how do gastroenterologists best protect themselves when intentionally deviating from guideline recommendations? The answer is simple: documentation. The more carefully physicians document their decision making, including guidelines referenced, options discussed with the patient (including risks and benefits of each), and specific reasons for taking a particular approach (including patient preferences and unique circumstances), the more protected they ultimately will be.⁹ The most contentious legal issues arise when there is a paucity of documentation, so the physician is forced to recollect a decision-making process that occurred often years earlier to defend the reasonableness of the care provided.

Conclusions

Although CPGs often are designed for the general patient population, exceptions should be made in specific patient cases. When not adhering to guidelines, the practitioner often faces increased scrutiny if complications occur and legal action is pursued. We recommend documenting the discussion with the patient in as much detail as possible, as well as explaining in the medical record the rationale for the clinical decision. As physicians, our duty is to do no harm. This principle should guide the clinician in reaching a sound clinical decision, especially when contemplating a clinical approach at odds with guideline recommendations.

Disclaimer

The clinical scenario featured in this article is a hypothetical one, used to illustrate the type of clinical dilemmas gastroenterologists may face in daily practice with respect to clinical practice guidelines. Furthermore, the earlier discussion is intended as general commentary, and does not constitute legal advice in individual cases. Do not act or rely on information contained in this article without first seeking the advice of a personal attorney.

References

1. Institute of Medicine. Clinical practice guidelines we can trust. National Academies Press, Washington, D.C.; 2011.

2. Yapali, S., Talaat, N., Lok, A.S. Management of hepatitis B: our practice and how it relates to the guidelines. Clin Gastroenterol Hepatol. 2014;12:16-26.

3. ASGE Standards of Practice Committee. Management of ingested foreign bodies and food impactions. Gastrointest Endosc. 2011;73:1085-91.

4. Restatement (Second) of torts: liability for physical & emotional harm § 283 (1965). Mello MM. Of swords and shields: the role of clinical practice guidelines in medical malpractice litigation. 149 U. Pa. L. Rev. 645 2000-2001.

6. Ransohoff, D.F., Pignone, M., Sox, H.C. How to decide whether a clinical practice guideline is trustworthy. JAMA. 2013;309:139-40.

7. Ubel, P.A. Medical facts versus value judgments – toward preference-sensitive guidelines. N Engl J Med. 2015;26:2475-6.

8. Kachalia, A., Little, A., Isavoran, M., et al. Greatest impact of safe harbor rules may be to improve patient safety, not reduce liability claims paid by physicians. Health Aff (Millwood). 2014;33:59-66.

9. Rex, D.K. Avoiding and defending malpractice suits for postcolonoscopy cancer: advice from an expert witness. Clin Gastroenterol Hepatol. 2013;11:768-73.

Dr. Oza is in the division of gastroenterology and liver diseases, Yale New Haven Medical Center, New Haven, Conn; Dr. El-Dika is in the division of gastroenterology, hepatology and nutrition, Ohio State University–Wexner Medical Center, Columbus; Dr. Adams is in the division of gastroenterology, department of medicine, University of Michigan Medical School, and Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor.

As the nation moves further down the road toward “Accountable Care,” there has been an increasing emphasis on stricter compliance with national guidelines. Theoretically, adherence to clinical guidelines by providers would reduce care variation, decrease unnecessary costs, and improve quality (value). Physicians rightly worry about their own exposure (both legally and financially) if they elect to deviate from published guidelines. In this month’s column, three experts on this topic discuss safe harbor and legal risk for providers with respect to practice guidelines. We appreciate Dr. Adams’ willingness to write from the viewpoint of both a physician (faculty at the University of Michigan) and an attorney.

John I. Allen, M.D., MBA, AGAF, Special Section Editor

The Institute of Medicine defines clinical practice guidelines (CPGs) as “statements that include recommendations intended to optimize patient care that are informed by a systematic review of evidence and an assessment of the benefits and harms of alternative care options.”¹ The origin of CPGs can be traced to the desire of physicians and the public to give and receive the best care possible, especially given increasing medical costs, newly developed expensive technologies, evolving modalities of health care delivery, and variation in the quality of care. CPGs are used by diverse stakeholders including patients, legislators and policy makers, insurance companies, litigators, health systems, and physicians, not only to make medical care efficient, but also to hold practitioners accountable across different practice and geographic settings.

Although CPGs may be beneficial to overall population health, they may not be the right approach for an individual patient.² However, there is a real concern among physicians that going against a CPG recommendation could potentially lead to litigation, especially in the setting of a negative outcome. So when, if ever, is it acceptable to go against CPG recommendations? In this article, we present a hypothetical case in which following guideline recommendations would potentially expose the patient to greater risks than intentionally choosing to deviate from guidelines. We then discuss the legal implications of this choice, and the challenges of using CPGs to establish the legal standard of care.

Case

A 24-year-old man, incarcerated, with no past medical history, presents to the emergency department with complaints of dysphagia and an inability to tolerate his oral secretions. The patient reports that he was attempting to swallow a packet of heroin of unknown quantity to hide evidence. A diagnosis of heroin packet impaction in the esophagus is made, and the gastroenterology service is consulted for urgent endoscopy.

Given current CPG recommendations advocating no role for endoscopy in removal of impacted cocaine and heroin,³ the astute gastroenterologist then discusses the case with the surgical service and presents options to the patient: either surgical removal of the impacted object via thoracotomy, or with upper endoscopy with the knowledge that the latter option would be against guidelines and present significant procedural risks, including possible death if the packet ruptures. The dilemma occurs when the patient insists against the surgical approach, makes an informed decision, and consents only to endoscopic removal. How should the gastroenterologist proceed? Will there be medicolegal ramifications of performing a procedure against CPG recommendations, especially if there are complications?

Discussion

With the emergence of health services research in the 1970s and 1980s, practitioners and policy makers began to recognize the existence of widespread practice variation in the provision of health care services. CPGs grew from this body of work in an attempt to encourage more standardized, quality care processes and control ballooning health care costs. Through the Omnibus Budget Reconciliation Act of 1989 (103 Stat. 2159), Congress created the precursor to today’s Agency for Healthcare Research and Quality to enhance the quality, appropriateness, and effectiveness of health care services through various means, including the development of CPGs. A quick search of today’s Agency for Healthcare Research and Quality National Guideline Clearinghouse reveals the existence of 260 gastroenterology-related guidelines from local and national professional societies, hospitals and health care centers, and governmental organizations. Whether and to what extent these guidelines should be used to establish the legal standard of care is a hotly debated topic among both legal and medical circles.

A medical professional liability claim is a civil claim of negligence. Negligence, in the legal sense, is defined as a breach of the “standard of conduct to which [one] must conform...[and] is that of a reasonable man under like circumstances.”⁴ To prove negligence on the part of a physician in a medical professional liability case, the plaintiff/patient must prove the required elements of the claim, as follows: 1) the existence of a duty of care, 2) breach of that duty, 3) actual and proximate causation, and 4) damages/harm.

In the courtroom, CPGs are sometimes used to help define the standard of care against which the reasonableness of the physician’s actions will be judged. Under current legal practice, CPGs can be used as evidence of the standard of care, but are not considered definitive evidence. If admitted, they are considered along with other forms of evidence relevant to defining the standard of care, including expert witness testimony. Ultimately, the fact finder (generally the jury) must determine what weight to give each piece of evidence. Furthermore, under legal tenets governing the admissibility of evidence, CPGs generally can be admitted only under an exception to the hearsay rule (called the “learned treatise” exception), usually through a qualified expert witness who can vouch for the guidelines as a “reliable authority.”⁵ This, of course, raises the thorny question of which guidelines are authoritative enough to serve this role. Furthermore, multiple studies have shown poor adherence with CPGs, calling into question whether they can really be upheld as outlining prevailing medical practice. Indeed, some scholars have suggested that CPGs represent “an ideal of optimal care, rather than prevailing medical custom.”⁵

There has been continued debate in legal and policy circles since the early 1990s regarding so-called safe harbor legislation, which would give CPGs a pre-emptive effect that either precludes opposing testimony regarding the standard of care or shifts the burden of proof to the opposing party. There is debate as well regarding whether this should be an affirmative defense only available to physicians, or should be available to plaintiffs as a “sword,” in addition to a defensive “shield.”⁵ Indeed, several states (including Maine, Minnesota, Vermont, and Florida) have instituted demonstration projects designed to test this as a possible solution to the medical liability crisis. The overall consensus is that these programs have been largely unsuccessful in meeting their stated goals. Reasons posited for this lack of success include lack of physician buy-in (including lack of support from organizations such as the American Medical Association), use of safe harbor as a rebuttable defense, and shortcomings of available guidelines. To this last point, clinical guidelines may provide conflicting recommendations, which can muddy the waters when determining standards of care for negligence purposes. Guidelines also may be biased by the interests of the issuing organizations, or be constructed without methodologic rigor. Recent efforts such as the Grading of Recommendations Assessment, Development and Evaluation approach to guideline development seek to bolster guideline quality and trustworthiness.⁶ However, methodologically rigorous guideline development processes are by nature more time intensive, and may delay dissemination of critical guidance to expeditiously address the needs of clinicians on the front lines of medical care. Weighing these practical issues, different gastroenterology specialty societies use varying processes for guideline development that ultimately may lead to inconsistent recommendations of varying quality. In addition, guidelines often are written to establish national, not local, standards of care. Finally, as a rebellion against so-called “cookie-cutter” medicine, there has been increased emphasis in recent years on personalized medicine and shared decision making,⁷ which runs counter to the standardized approach typically espoused by guidelines.

A recent study examining closed liability claims in Oregon to determine the effects of hypothetical safe harbor legislation in that state found that the results of only 1% of 266 reviewed claims from 2002 to 2009 would have been changed by safe harbor legislation.⁸ This may reflect the protective effect of guidelines in suppressing filing of meritless claims. Thus, the investigators concluded that, although safe harbor legislation may not significantly impact the medical liability claims landscape, it may have a secondary effect of improving patient safety by encouraging guideline adherence in appropriate cases.

So, how do gastroenterologists best protect themselves when intentionally deviating from guideline recommendations? The answer is simple: documentation. The more carefully physicians document their decision making, including guidelines referenced, options discussed with the patient (including risks and benefits of each), and specific reasons for taking a particular approach (including patient preferences and unique circumstances), the more protected they ultimately will be.⁹ The most contentious legal issues arise when there is a paucity of documentation, so the physician is forced to recollect a decision-making process that occurred often years earlier to defend the reasonableness of the care provided.

Conclusions

Although CPGs often are designed for the general patient population, exceptions should be made in specific patient cases. When not adhering to guidelines, the practitioner often faces increased scrutiny if complications occur and legal action is pursued. We recommend documenting the discussion with the patient in as much detail as possible, as well as explaining in the medical record the rationale for the clinical decision. As physicians, our duty is to do no harm. This principle should guide the clinician in reaching a sound clinical decision, especially when contemplating a clinical approach at odds with guideline recommendations.

Disclaimer

The clinical scenario featured in this article is a hypothetical one, used to illustrate the type of clinical dilemmas gastroenterologists may face in daily practice with respect to clinical practice guidelines. Furthermore, the earlier discussion is intended as general commentary, and does not constitute legal advice in individual cases. Do not act or rely on information contained in this article without first seeking the advice of a personal attorney.

References

1. Institute of Medicine. Clinical practice guidelines we can trust. National Academies Press, Washington, D.C.; 2011.

2. Yapali, S., Talaat, N., Lok, A.S. Management of hepatitis B: our practice and how it relates to the guidelines. Clin Gastroenterol Hepatol. 2014;12:16-26.

3. ASGE Standards of Practice Committee. Management of ingested foreign bodies and food impactions. Gastrointest Endosc. 2011;73:1085-91.

4. Restatement (Second) of torts: liability for physical & emotional harm § 283 (1965). Mello MM. Of swords and shields: the role of clinical practice guidelines in medical malpractice litigation. 149 U. Pa. L. Rev. 645 2000-2001.

6. Ransohoff, D.F., Pignone, M., Sox, H.C. How to decide whether a clinical practice guideline is trustworthy. JAMA. 2013;309:139-40.

7. Ubel, P.A. Medical facts versus value judgments – toward preference-sensitive guidelines. N Engl J Med. 2015;26:2475-6.

8. Kachalia, A., Little, A., Isavoran, M., et al. Greatest impact of safe harbor rules may be to improve patient safety, not reduce liability claims paid by physicians. Health Aff (Millwood). 2014;33:59-66.

9. Rex, D.K. Avoiding and defending malpractice suits for postcolonoscopy cancer: advice from an expert witness. Clin Gastroenterol Hepatol. 2013;11:768-73.

Dr. Oza is in the division of gastroenterology and liver diseases, Yale New Haven Medical Center, New Haven, Conn; Dr. El-Dika is in the division of gastroenterology, hepatology and nutrition, Ohio State University–Wexner Medical Center, Columbus; Dr. Adams is in the division of gastroenterology, department of medicine, University of Michigan Medical School, and Institute for Healthcare Policy and Innovation, University of Michigan, Ann Arbor.