62 Pages Posted: 4 Aug 2013 Last revised: 6 Mar 2014
Date Written: August 3, 2013
Uncertainty pervades medical practice. Rapid scientific advances and substantial patient heterogeneity in both treatment responses and value preferences make it impossible for even the most knowledgeable practitioner to confidently identify the “right” option for every patient. Uncertainty is particularly acute when a physician deliberately deviates from generally accepted practices in an attempt to improve patient care. Unlike drug and device manufacturers, innovative physicians are not subject to mandatory public regulation by the FDA or any other government agency. The question of how to regulate physician behavior thus largely falls to the tort system. Innovation by definition involves a departure from customary practice, so adherence to custom in defining the legal standard of care essentially requires physicians to solely bear the liability costs of novel interventions. This regime protects patients from unnecessary risks associated with untested treatments, but may also unduly deter physicians from tailoring individualized treatment plans that address patients’ particular needs and circumstances.
This Article proposes a fiduciary framework for regulating medical uncertainty and physician innovation. The proposed approach mandates close scrutiny of the decision-making process but deference to the substance of medical decisions. Under this model, a physician should be held liable for failing to act in her patient’s best interests, taking into account the patient’s unique clinical condition and value preferences. Within these constraints, however, patients should have the freedom to choose – and assume the associated risks and uncertainties – from among a range of reasonable alternatives. If a physician satisfactorily discharges her fiduciary disclosure duties, she should be shielded from liability for providing an innovative treatment that rationally advances the patient’s interests. This legal scheme strikes a desirable balance that respects patient autonomy, minimizes unnecessary risk, and encourages medical progress.
Keywords: medical malpractice, innovation, uncertainty, fiduciary duties
Suggested Citation: Suggested Citation
Laakmann, Anna B., Medical Uncertainty and Physician Innovation (August 3, 2013). Lewis & Clark Law School Legal Studies Research Paper No. 2013-17. Available at SSRN: https://ssrn.com/abstract=2305679 or http://dx.doi.org/10.2139/ssrn.2305679