February 1, 2013
Volume 77, Number 2
Oregon Safe Harbor Study Results: Is There Hope for Improved Medical Liability Transparency Through Use of Guidelines?
Christopher M. Burkle, M.D., J.D. Committee on Professional Liability
Malpractice reform advocates suggest that medical care consistent with established practice guidelines may serve as a “safe harbor” to protect physicians from medical malpractice litigation. Last year, the state of Oregon completed work on a federally funded study exploring potential improvements to both patient safety and the medical liability system through implementation of medical practice guidelines. The study evaluated whether adoption of guidelines may provide greater clarity of the standard of care expected of practitioners while affording liability protection (safe harbor) when followed.1
The concept of safe harbor legislation is not new. In 1990, Maine adopted legislation applying practice guidelines to four high-liability-risk specialties (anesthesiology, emergency medicine, OB/GYN and radiology).2 Under the state’s plan, compliance with guidelines could be pleaded by providers alone (“one sided” use) as a defense against a malpractice claim. Since enactment, only one provider in Maine has asserted a guideline defense. Following Maine’s initiative, the states of Minnesota, Vermont and Florida passed similar medical liability guideline legislation in the 1990s.2 Minnesota, like Maine, only allows for “one sided” use (the health care provider may provide guideline adherence as a defense to a claim) whereas Vermont and Florida permit both the defendant and plaintiff to bring forth evidence of compliance, or lack thereof, with guideline use. To date, neither Minnesota nor Florida has issued any specific medical care guidelines.2
Concern for the effectiveness of safe harbor use is not reflected by the paucity of legislative history alone. Some have suggested that guidelines are ineffective in large part due to a lack of enthusiasm among practitioners for what is viewed as “cookbook medicine,” concerns that no two patients behave the same way and failure of some guidelines to fall within the boundaries of scientific evidence, as well as medical biases among guideline drafters.2
Following ratification of the Patient Protection and Affordable Care Act (PPACA), Oregon was awarded one such Medical Liability & Safety Planning Grant by the Agency for Healthcare Research and Quality (AHRQ) in 2010 to evaluate potential benefits to patient safety tied to use of legal “safe harbors.”3
The specific objectives set out by the Oregon study included: 1) setting priorities to review patient injuries and medical liability claims; 2) testing a hypothesis that a legal safe harbor would reduce patient injuries or alter the course of a medical liability claim; 3) planning the evaluation of the impact of any future potential safe harbor legislation; and 4) soliciting input from stakeholders as to whether the information gained would serve value in implementing safe harbor legislation in Oregon. As part of their feasibility analysis, 907 closed claims reported to a single liability insurance provider between 2002 and 2009 were reviewed.1,3 Among those, reviewers identified 133 claims where an existing medical guideline would apply to the medical management of the patient. These findings are shown in Table 1.
The study found that only a small proportion (5 percent) of claims would have been avoided if the physicians had followed the guidelines (Table 1). Using the guidelines, around
10 percent of claims would have been resolved more quickly. The study estimated that with adoption of safe harbor legislation, medical liability costs in Oregon in 2008 would have dropped only by 5 percent to approximately $76 million.1 An additional concern voiced was that many separate guidelines (143) were required in analyzing the 133 closed claims, with the most frequently used guideline only applied in five clinical situations.3
The consensus among groups representing medical malpractice attorneys and insurers, as well as health care providers, was that safe harbor legislation was not a priority at the time and that they had mixed feelings as to the feasibility of safe harbor guideline implementation into the complex clinical setting involving patient care.1 Greater interest in
future safe harbor legislation was voiced by a group of 2,000 health care practitioners queried1 (Table 2).
While Oregon’s results suggested that safe harbor legislation may help to further patient safety initiatives, they would have little impact (5 percent decline in total liability costs) on stemming high medical liability costs in the state.1 If implementation were possible, it would require additional planning to ensure that practitioners supported state-endorsed evidence-based guidelines as a community standard of care.
Continued evaluation by Oregon as well as other states will determine both the future feasibility and impact that safe harbor legislation may have in improving patient safety while benefiting physicians through a more transparent medical liability system. However, the current study suggests that medical liability protection is limited.
Christopher M. Burkle, M.D., J.D. is
Assistant Professor of Anesthesiology, Mayo Clinic, Rochester, Minnesota
1. Smith J. AHRQ Medical Liability & Patient Safety Planning Grant: final progress report. Oregon Health Policy & Research website. http://www.oregon.gov/OHA/OHPR/RSCH/Pages/Doc_Rep_Present.aspx#Medical_Liability_Reports. Published June, 2012. Accessed December 4, 2012.
2. Mehlman MJ. Medical practice guidelines as malpractice safe harbors: illusion or deceit? J Law Med Ethics. 2012;40:(2):286-300.
3. Crider, LM. The State of Oregon’s medical liability closed claim file analysis. Oregon Health Policy & Research website. http://www.oregon.gov/oha/OHPR/PSDM/Att_A.pdf. Accessed December 4, 2012.