The Consequences of Truth

Many in the medical and legislative fields are discussing the advisability of laws that will shield medical professionals' explanations and apologies following medical errors from being admitted in court. Such laws, some say, would encourage open discussions between medical caregivers and their patients, possibly diffusing the anger that patients feel when they discover a medical mistake on their own. And when less angry, a patient is less likely to file a lawsuit or to refuse to settle a claim in a reasonable manner.

Few states, however, have instituted compulsory medical error admissions. William M. Sage et al., The Relational Regulatory Gap: A Pragmatic Information Policy For Patient Safety and Medical Malpractice, 59 Vand. L. Rev. 1263 (2006) (noting that four states recently passed legislation requiring patients to be informed when they were the victim of medical errors). One state that has is New Jersey, which, in 2004, enacted the Patient Safety Act, N.J.S.A. 26:2H-12.23 (PSA). This landmark legislation changed the way medical errors are dealt with in New Jersey by creating a legal duty to immediately disclose medical errors to patients who are harmed by them. N.J.S.A. 26:2H-12.25.

The Law in New Jersey

Under the PSA, when the patient is a victim of a serious preventable adverse event, he or she must be informed no later than the end of the episode of care; or, if discovery occurs after the end of the episode of care, in a timely fashion. N.J.S.A. 26:2H-12.25(d). A “serious preventable adverse event” is any adverse event that is preventable and results in death, loss of a body part, or disability or loss of bodily function either lasting more than seven days, or that is still present at the time of discharge. N.J.S.A. 26:2H-12.25(a). In addition to requiring adverse events to be reported to the victims of medical malpractice, the PSA also requires health care providers to report medical errors to the New Jersey Department of Health and Human Services (the Department). N.J.S.A. 26:2H-12.25(c).

On Jan. 24, 2008, the Department enacted regulations that gave teeth to the notification and reporting requirements of the Act. As of March 3, 2008 (for hospitals), Aug. 30, 2008 (for ambulatory care facilities, home health care agencies and hospice providers), and March 3, 2009, (for nursing homes and assisted living facilities), health care providers have five business days after discovery of a serious preventable adverse event to notify the Department that a preventable adverse event has occurred. N.J.A.C. 8:43E-10.1, N.J.A.C. 8:43E-10.6(b). The notification requires the inclusion of specific categories of information, including: 1) the date and time the event occurred; 2) a brief description of the event; 3) a statement about the impact of the event on the health of the patient; 4) the date and time the facility became aware of the event; 5) how the event was discovered; 6) the immediate corrective actions the facility took to eliminate or reduce the adverse impact of the event on the patient; and 7) what steps were taken to prevent the occurrence of future similar events. N.J.A.C. 8:43E-10.6(c). Failure to comply with these reporting requirements results in a fine of $1,000 a day. N.J.A.C. 8:43E-3.4(14).

Medical providers have 24 hours after the discovery of a serious preventable adverse event to notify a patient that it has occurred. N.J.A.C. 8:43E-10.7(b). Patients are to be notified in person if they are still at the facility or by telephone or by certified mail if they are not. N.J.A.C. 8:43E-10.7(c). Disclosure to a patient must be accompanied by documentation in the patient's medical chart which indicates: 1) that the disclosure was made; 2) the time, date and individuals present when the disclosure was made; and 3) the name of the person to whom the disclosure was made. N.J.A.C. 8:43E-10.7(f). Medical providers failing to disclose a serious preventable adverse event to a patient are subject to a fine of $1,000 if the event was also not disclosed to the Department of Health and Senior Services, but $5,000 if they reported the event to department, N.J.A.C. 8:43E-3.4(15).

As one commentator observed, by compelling the disclosure and reporting of medical errors, the PSA is forcing a change in the culture of health care in New Jersey. Postscript on Health Care Dispute Resolution: Conflict Management and the Role of Culture, supra, at 1053. It stands to reason that this health care culture change will impact medical malpractice litigation.

Ethical Disclosure Mandates Inadequate to Compel Disclosures

Under the American Medical Association Code of Ethics, physicians have an ethical obligation to advise a patient when they commit consequential acts of medical malpractice where “a patient suffers significant medical complications that may have resulted from the physician's mistake or judgment.” Am. Med. Ass'n Code of Medical Ethics A-02 Edition, E-8.12 Patient Information, 77. Similarly, the American College of Physicians Ethics Manual mandates disclosure of errors if disclosure of this information is “material to the patient's well-being.” Lois Snyder & Cathy Leffler, Ethics Manual, Fifth Edition, 142 Ann Intern Med 560, 563. Finally, the Joint Commission requires that patients be informed of unanticipated results that differ from the expected outcome in a significant way when a medical error occurs at a hospital. Joint Comm'n on Accreditation of Health Care Orgs., Revisions to Joint Commission Standards in Support of Patient Safety and Medical/Health Care Error Reduction 12 (2001).

Disclosure of medical errors is not only ethically mandated, it is consistent with the fiduciary nature of the physician-patient relationship, since in most instances, disclosure of errors will be help the patient to understand why unexpected problems have developed. Some commentators have suggested that since patients need information about errors to make decisions about their medical care, disclosure of malpractice is part of a physician's duty to provide a patient with informed consent. Thomas H. Gallagher, Wendy Levinson, Disclosing Medical Errors to Patients: a Status Report in 2007,177(3) Can Med Assn J 265 (2007).

In theory, physicians agree that they have an ethical obligation to disclose medical errors. One study suggests that between 70% and 90% of the physician population believes that doctors should disclose errors to patients. Kathleen M. Mazor et al., Communicating with Patients about Medical Errors, 164 Arch Intern Med 1690, 1692 (2004). In another study, 97% of the faculty and resident population surveyed indicated that they would disclose medical errors that caused minor harm, and 93% indicated that they would disclose an error causing major harm. Lauris Kaldjian, et al., Disclosing Medical Errors to Patients: Attitudes and Practices of Physicians and Trainees, 22(7) J Gen Intern Med 988-96 (2007). This being the case, one would expect physicians, nearly universally, to report medical errors to their patients. However, research does not bear this theory out. For example, one study revealed that only 24% of residents surveyed reported the medical errors they committed to their patients. Albert Wu, et al., Do House Officers Learn from Their Mistakes? 12 Quality & Safety Health Care 221, 224 (2003). Another study estimated that, nationwide, physicians are only disclosing errors to patients about 1/3 of the time. Robert J. Blendon et al., Views of Practicing Physicians and the Public on Medical Errors, 347 New. Eng. J. Med. 1933, 1935 (2002).

In next month's newsletter we will look at some of the reasons why medical error reporting falls below the hoped-for standard, what the law's effects on med-mal suit outcomes may be and how New Jersey's compulsory medical error reporting law may ultimately help the medical profession nationwide.

John Ratkowitz, a member of this newsletter's Board of Editors, is a partner in Roseland, NJ's, Starr, Gern, Davison & Rubin, P.C. He specializes in complex litigation, with an emphasis in medical malpractice and can be reached by e-mail at: [email protected].

Many in the medical and legislative fields are discussing the advisability of laws that will shield medical professionals' explanations and apologies following medical errors from being admitted in court. Such laws, some say, would encourage open discussions between medical caregivers and their patients, possibly diffusing the anger that patients feel when they discover a medical mistake on their own. And when less angry, a patient is less likely to file a lawsuit or to refuse to settle a claim in a reasonable manner.

Few states, however, have instituted compulsory medical error admissions. William M. Sage et al., The Relational Regulatory Gap: A Pragmatic Information Policy For Patient Safety and Medical Malpractice, 59 Vand. L. Rev. 1263 (2006) (noting that four states recently passed legislation requiring patients to be informed when they were the victim of medical errors). One state that has is New Jersey, which, in 2004, enacted the Patient Safety Act, N.J.S.A. 26:2H-12.23 (PSA). This landmark legislation changed the way medical errors are dealt with in New Jersey by creating a legal duty to immediately disclose medical errors to patients who are harmed by them. N.J.S.A. 26:2H-12.25.

The Law in New Jersey

Under the PSA, when the patient is a victim of a serious preventable adverse event, he or she must be informed no later than the end of the episode of care; or, if discovery occurs after the end of the episode of care, in a timely fashion. N.J.S.A. 26:2H-12.25(d). A “serious preventable adverse event” is any adverse event that is preventable and results in death, loss of a body part, or disability or loss of bodily function either lasting more than seven days, or that is still present at the time of discharge. N.J.S.A. 26:2H-12.25(a). In addition to requiring adverse events to be reported to the victims of medical malpractice, the PSA also requires health care providers to report medical errors to the New Jersey Department of Health and Human Services (the Department). N.J.S.A. 26:2H-12.25(c).

On Jan. 24, 2008, the Department enacted regulations that gave teeth to the notification and reporting requirements of the Act. As of March 3, 2008 (for hospitals), Aug. 30, 2008 (for ambulatory care facilities, home health care agencies and hospice providers), and March 3, 2009, (for nursing homes and assisted living facilities), health care providers have five business days after discovery of a serious preventable adverse event to notify the Department that a preventable adverse event has occurred. N.J.A.C. 8:43E-10.1, N.J.A.C. 8:43E-10.6(b). The notification requires the inclusion of specific categories of information, including: 1) the date and time the event occurred; 2) a brief description of the event; 3) a statement about the impact of the event on the health of the patient; 4) the date and time the facility became aware of the event; 5) how the event was discovered; 6) the immediate corrective actions the facility took to eliminate or reduce the adverse impact of the event on the patient; and 7) what steps were taken to prevent the occurrence of future similar events. N.J.A.C. 8:43E-10.6(c). Failure to comply with these reporting requirements results in a fine of $1,000 a day. N.J.A.C. 8:43E-3.4(14).

Medical providers have 24 hours after the discovery of a serious preventable adverse event to notify a patient that it has occurred. N.J.A.C. 8:43E-10.7(b). Patients are to be notified in person if they are still at the facility or by telephone or by certified mail if they are not. N.J.A.C. 8:43E-10.7(c). Disclosure to a patient must be accompanied by documentation in the patient's medical chart which indicates: 1) that the disclosure was made; 2) the time, date and individuals present when the disclosure was made; and 3) the name of the person to whom the disclosure was made. N.J.A.C. 8:43E-10.7(f). Medical providers failing to disclose a serious preventable adverse event to a patient are subject to a fine of $1,000 if the event was also not disclosed to the Department of Health and Senior Services, but $5,000 if they reported the event to department, N.J.A.C. 8:43E-3.4(15).

As one commentator observed, by compelling the disclosure and reporting of medical errors, the PSA is forcing a change in the culture of health care in New Jersey. Postscript on Health Care Dispute Resolution: Conflict Management and the Role of Culture, supra, at 1053. It stands to reason that this health care culture change will impact medical malpractice litigation.

Ethical Disclosure Mandates Inadequate to Compel Disclosures

Under the American Medical Association Code of Ethics, physicians have an ethical obligation to advise a patient when they commit consequential acts of medical malpractice where “a patient suffers significant medical complications that may have resulted from the physician's mistake or judgment.” Am. Med. Ass'n Code of Medical Ethics A-02 Edition, E-8.12 Patient Information, 77. Similarly, the American College of Physicians Ethics Manual mandates disclosure of errors if disclosure of this information is “material to the patient's well-being.” Lois Snyder & Cathy Leffler, Ethics Manual, Fifth Edition, 142 Ann Intern Med 560, 563. Finally, the Joint Commission requires that patients be informed of unanticipated results that differ from the expected outcome in a significant way when a medical error occurs at a hospital. Joint Comm'n on Accreditation of Health Care Orgs., Revisions to Joint Commission Standards in Support of Patient Safety and Medical/Health Care Error Reduction 12 (2001).

Disclosure of medical errors is not only ethically mandated, it is consistent with the fiduciary nature of the physician-patient relationship, since in most instances, disclosure of errors will be help the patient to understand why unexpected problems have developed. Some commentators have suggested that since patients need information about errors to make decisions about their medical care, disclosure of malpractice is part of a physician's duty to provide a patient with informed consent. Thomas H. Gallagher, Wendy Levinson, Disclosing Medical Errors to Patients: a Status Report in 2007,177(3) Can Med Assn J 265 (2007).

In theory, physicians agree that they have an ethical obligation to disclose medical errors. One study suggests that between 70% and 90% of the physician population believes that doctors should disclose errors to patients. Kathleen M. Mazor et al., Communicating with Patients about Medical Errors, 164 Arch Intern Med 1690, 1692 (2004). In another study, 97% of the faculty and resident population surveyed indicated that they would disclose medical errors that caused minor harm, and 93% indicated that they would disclose an error causing major harm. Lauris Kaldjian, et al., Disclosing Medical Errors to Patients: Attitudes and Practices of Physicians and Trainees, 22(7) J Gen Intern Med 988-96 (2007). This being the case, one would expect physicians, nearly universally, to report medical errors to their patients. However, research does not bear this theory out. For example, one study revealed that only 24% of residents surveyed reported the medical errors they committed to their patients. Albert Wu, et al., Do House Officers Learn from Their Mistakes? 12 Quality & Safety Health Care 221, 224 (2003). Another study estimated that, nationwide, physicians are only disclosing errors to patients about 1/3 of the time. Robert J. Blendon et al., Views of Practicing Physicians and the Public on Medical Errors, 347 New. Eng. J. Med. 1933, 1935 (2002).

In next month's newsletter we will look at some of the reasons why medical error reporting falls below the hoped-for standard, what the law's effects on med-mal suit outcomes may be and how New Jersey's compulsory medical error reporting law may ultimately help the medical profession nationwide.

John Ratkowitz, a member of this newsletter's Board of Editors, is a partner in Roseland, NJ's, Starr, Gern, Davison & Rubin, P.C. He specializes in complex litigation, with an emphasis in medical malpractice and can be reached by e-mail at: [email protected].