Should a medication error result in a criminal prosecution and imprisonment? Let’s explore the nuances of this ethically complex intersection of law and medicine.
On March 25, 2022, a Tennessee jury convicted a former nurse, RaDonda Vaught, of reckless homicide and abuse of an impaired adult after she incorrectly injected vecuronium (Norcuron) instead of Versed into a 75-year-old patient. (As clinicians know, vecuronium is a powerful neuromuscular blocker used during general anesthesia or for critically ill patients when mechanical ventilation is necessary.) This tragic error resulted in the patient’s death. Apart from having her license revoked and being fired by Vanderbilt University Medical Center, she could have been sentenced for up to 12 years in prison for the medication error. Instead, the judge sentenced her to supervised probation for three years on May 13, 2022.
Testimony at Ms. Vaught’s trial revealed that the error was made possible by the nurse being able to “override” an automated dispensing cabinet (ADC). She initially typed the letters “VE” to obtain the ordered Versed, but when the ADC did not dispense Versed, she overrode the system, retyped “VE,” and the ADC dispensed the fatal dose of vecuronium. Trial testimony revealed that the nurses at Vanderbilt “routinely” override the medication carts when attempting to obtain a prescribed medication.
Whether Vanderbilt needs to reconsider its medication delivery system is beyond the scope of this article. However, it points to the salient issue: medication errors are virtually always flawed system problems rather than an aberrant nurse, physician, advanced practice provider, or pharmacist.
The entire medical community (as well as all others) was stunned by the landmark Institute of Medicine (IOM) report, To Err Is Human: Building a Safer Health System (National Academies Press, 2000). In large measure, this IOM report paved the way for the patient safety movement at both the federal and state levels. Perhaps the most important takeaway from the IOM report is that the estimated 44,000 to 98,000 deaths per year from medical errors (not just medication) were typically a result of flawed systems.
If a system is flawed to the point where it permits medication errors, is it fair or just to punish a single health care practitioner? Why not fix the system and incorporate fail-safe measures and redundancies learned from human factors engineering?
The medical community could learn from the Federal Aviation Administration’s Aviation Safety Reporting System (ASRS), which is a confidential and nonpunitive voluntary reporting system of adverse occurrences and near misses. Not having actionable data because a practitioner chose not to disclose a medication error due to a fear of loss of a license, a job, and possible criminal conviction is a missed opportunity to correct a system in need of repair.
High-profile criminal charges and convictions likely have an adverse effect on practitioners and health care facilities making voluntary disclosures when adverse events, especially patient deaths, occur.
According to an internationally recognized pioneer in the area of medication safety, Michael Cohen, RPh, MS, ScD (hon), president emeritus and founder of the Institute for Safe Medication Practices (ISMP), “Information about the cause and nature of medication errors is important. Yet even when no patient harm occurs after a medication error, health care practitioners won’t want to risk disciplinary action for their involvement, and may just choose to hide an incident under the rug.” Consequently, valuable information is forever lost that could prevent future adverse events.
Dr. Cohen’s sentiments are echoed by the American Nurses Association (ANA) in a statement responding to Vaught’s criminal conviction: “ANA believes that the criminalization of medical errors could have a chilling effect on reporting and process improvement” (Nursing World
, Mar. 23, 2022, https://bit.ly/3KeHJJi
One of the witnesses at Vaught’s trial, Ramona Smith, an investigator with the Tennessee Bureau of Investigation, testified that “Vanderbilt Medical Center carried a heavy burden of responsibility in this matter.” Yet interestingly no charges were brought against Vanderbilt even though it failed to report the fatal medication error to the Tennessee Department of Health and the Centers for Medicare & Medicaid Services. Additionally, a physician at Vanderbilt listed the cause of death as “natural.” (Vanderbilt settled with the former patient’s family for an undisclosed amount.)
Unfortunately, Ms. Vaught’s case is not the first time that medication errors have been treated as criminal homicides and will likely not be the last. Several years ago an overly aggressive district attorney in Denver, CO, charged three nurses with criminally negligent homicide after a fatal dose of penicillin was administered to a newborn who immediately went into cardiac arrest and died.
On behalf of ISMP, which is considered one of the leading organizations regarding medication safety, Dr. Cohen provided expert testimony for one of the nurses, who pled not guilty. Dr. Cohen analyzed all the relevant medical information and found that there were myriad errors in a broken system that allowed for the lethal dose of penicillin: the obstetrician who ordered the drug was covering for another obstetrician; the covering obstetrician did not need to prescribe penicillin for the pregnant mom (who had had a sexually transmitted infection more than 10 years prior); the pharmacy made a 10-fold error in dispensing; and a drug reference book contained inaccurate information regarding whether the medication could be given intravenously instead of intramuscularly.
These were only some of the system’s errors that ISMP identified. Dr. Cohen noted that “by reconstructing how the system failures contributed to the tragic outcome, the jury was able to understand how the flawed system allowed the nurse to make such an error.” The nurse in this case was found not guilty, but criminal conviction is clearly not a path any practitioner wants to travel down.
Treating Unintentional Error
The question remains: is criminal prosecution the correct approach to an unintentional error? If we have learned anything about medication errors, it is that they are system problems.
This prompts the question: is it fair to criminally scapegoat a single health care practitioner? There are important societal goals, such as making the medication delivery system safer. Perhaps, using the legal system to punish those involved with medication errors is not the most enlightened approach to enhance safety.
In this instance, the legal profession can learn from the Hippocratic Oath: Primum non nocere (First, do no harm).
Mr. Horowitz is Of Counsel at Arnall Golden Gregory LLP. His practice involves regulatory compliance concerning skilled nursing facilities, hospices, and home health agencies. He previously served as Assistant Regional Counsel at the U.S. Department of Health and Human Services and represented the Centers for Medicare & Medicaid Services. Disclosure: The author previously served as the Director of Clinical and Legal Affairs for ISMP.