Managing Increasing Liability Risks Related to Opioid Prescribing
The increase in prescription opioid-related overdose deaths has increasingly led to liability and sanctions for physicians. For instance, in January 2010, Maurice Conte, MD was found negligent for prescribing a combination of Vicodin, Xanax, and Soma, which caused an overdose death, and was fined over $9 million.1 Conte, as the Medical Director of pain clinics, rarely saw patients and instead sold signed prescription pads to clinic owners, resulting in over 15,000 controlled-substance combination prescriptions.1 In February 2016, Hsiu-Ying Tseng, DO was sentenced to 30 years to life in prison after being found guilty of second-degree murder for 3 patient opioid overdose deaths.2 Tseng wrote 27,000 opioid prescriptions over 3 years, including for patients whom she knew exhibited problematic drug use.2
While liability can serve to deter physicians with reckless prescribing behaviors like Conte and Tseng, it may also discourage well-intentioned prescribers and compromise patient pain management.3 Yet our review of the growing body of case law4 and consideration of prescribing guidelines5, 6 suggests that opioid-prescribing liability threats can be reasonably managed. Providing an understanding of the legal frameworks and risk-limiting measures may counteract the potential chilling effect of recent cases and give physicians confidence that liability exposure need not be a barrier to appropriate opioid prescribing.
The most conventional form of liability opioid prescribers face is a medical malpractice lawsuit for an injury resulting from opioids prescribed, brought by the patient or patient’s family.3 If a case isn’t settled, determining whether the physician breached her duty of care is often a central point of contention.4 Courts, increasingly guided by now widely available opioid-prescribing guidelines,5, 6 look to what a “reasonable prudent physician” would have done in the same situation.3, 4
Courts have established certain negligent opioid-prescribing indicia, and those found guilty typically exemplify many such practices. For example, Conte prescribed over a prolonged period in quantities and frequencies that were far in excess of what is medically supportable failed to obtain patient medical histories or perform physical examinations and overlooked the cause of patient pain.1, 4 Other practices that contribute to negligence findings include failure to maintain accurate records of opioids prescribed and to take any action to limit opioid prescriptions for known-addicted patients.4
Opioid prescribers can be criminally charged under the federal Controlled Substances Act8 and state equivalents.7Under the Controlled Substances Act, the Drug Enforcement Administration is increasingly prosecuting physicians who knowingly and intentionally prescribe drugs outside of the usual course of medical practice or for non-legitimate medical purposes.8 According to the National Practitioner Data Bank, from 2011 to 2014, adverse actions by the Drug Enforcement Administration against physicians have quadrupled from 88 to 371 cases.9 In practice, courts often look to the “reasonable prudent physician” standard applied in negligence cases to determine “legitimate medical purpose” or “usual course of medical practice.”7
Physicians can also face homicide charges under state laws when opioids they prescribe result in overdose death.7 To be found guilty of lesser involuntary manslaughter, a physician typically must show a reckless indifference to the patient’s life.7 Murder charges require more blameworthy behavior on the part of the prescriber. For example, to be found guilty of second-degree murder like Tseng, a physician must act in conscious disregard of the life and safety of her patient.7 Despite being alerted by authorities over a dozen times that her patients had died, Tseng caused further fatalities by continuing to prescribe opioids in the same manner.2
State medical boards have wide latitude to oversee and discipline physicians, either in connection with legal charges or not. Inappropriate prescribing accounts for a substantial proportion of the 41% increase in adverse actions by medical boards against practitioners from 2004-2014.10 State medical boards investigate complaints initiated by patients, colleagues, or any concerned party.7 They also increasingly identify outlier prescribing practices from sources such as prescription drug monitoring programs, now available in 49 states.7 Unsurprisingly, Conte’s medical license was suspended soon after the overdose death for which he was later found negligent, and Tseng’s license was ultimately permanently revoked.
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-Y. Tony Yang, ScD, LLM, MPH, Marc R. Larochelle, MD, MPH, Rebecca L. Haffajee, JD, PhD, MPH
This article originally appeared in the March 2017 issue of The American Journal of Medicine.