Liability Implications of Innovative Drug Therapy: The Significance of Clinical Guidelines in Establishing the Legal Standard of Care

Abstract

The use of the clinical practice guideline (CPG) has become widespread in contemporary health care. For some health care providers, there may be a perceived “safe haven” from liability for strict compliance with a relevant CPG. Pointing to an objective standard, such as a CPG, the health care provider may feel secure in defending care that was provided to a patient, when called to account for a bad outcome. The benefit of any CPG is that it standardizes practice at an acceptably high level. The complimentary risk of a CPG is that it may stifle innovation based on newly discovered or newly appreciated data that were not considered when the CPG was developed. The trend in malpractice law is to recognize a CPG as relevant to the applicable standard of care, but not to equate a CPG with the standard of care. In fact, an outdated CPG may fail to reflect the standard of care, if new scientific or medical knowledge has been validated. The health care provider who adheres to an outdated CPG is at greater risk of liability than the health care provider who spurns the outdated CPG in favor of innovative practice based on valid new information. Innovation, as opposed to experimentation, is recognized as a necessary component of competent health care. The health care provider who adheres to outdated traditional medicine, spurning new developments validated by evidence, has clearly expanded exposure to liability.