In Ruan v. United States (No. 24-1410, 6/27/22), https://www.supremecourt.gov/opinions/21pdf/20-1410_1an2.pdf, the Court addressed the mens rea requirement of the Controlled Substances Act as applied to physicians. From the syllabus:
Petitioners…are medical doctors licensed to prescribe controlled substances. Each was tried for violating 21 U. S. C. §841, which makes it a federal crime, “[e]xcept as authorized,…for any person knowingly or intentionally…to manufacture, distribute, or dispense…a controlled substance.” A federal regulation authorizes registered doctors to dispense controlled substances via prescription, but only if the prescription is “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 CFR §1306.04(a). At issue in [the] trials was the mens rea required to convict under §841 for distributing controlled substances not “as authorized.” [Petitioners] each contested the jury instructions pertaining to mens rea given at their trials, and each was ultimately convicted under §841 for prescribing in an unauthorized manner. Their convictions were separately affirmed by the Courts of Appeals.
Held: Section 841’s “knowingly or intentionally” mens rea applies to the statute’s “except as authorized” clause. Once a defendant meets the burden of producing evidence that his or her conduct was “authorized,” the Government must prove beyond a reasonable doubt that the defendant knowingly or intentionally acted in an unauthorized manner.
The decision was unanimous, but the rationale for the decision was not. Six Justices joined the majority opinion written by Justice Breyer; Justice Alito, joined by Justice Thomas and (partially) Justice Barrett, concurred in the result but rejected the majority’s reasoning, instead basing his opinion on “the distinction between the elements of an offense and an affirmative defense.” (All of which is bringing me back to my first year of law school and the only criminal law course I ever took.)
Both opinions are lengthy and complex. For a pithy analysis, see https://www.scotusblog.com/2022/06/subjective-intent-of-wrongdoing-required-to-convict-doctors-under-controlled-substances-act/. This commentary includes specific charges against the petitioners, not mentioned in either opinion (because they were not relevant to the question presented), which if proven will show that the petitioners truly were operating pill mills: One of them allegedly “issued more than 300,000 prescriptions for controlled substances over a four-year period [and] was one of the top prescribers in the nation of a type of fentanyl”; the other “is alleged to have sold controlled substances in exchange for cash – and even firearms sometimes – without performing any exam and documenting the encounters with falsified notes.” I doubt that they will fare any better at new trials with “subjective intent” jury instructions. Nevertheless, the Court’s articulation of the mens rea requirement for a Controlled Substances Act conviction is of great importance outside the pill mill context. Dr. Jeffrey Singer (a surgeon who filed an amicus brief, together with the Association of American Physicians and Surgeons, in support of the petitioners) put it this way at https://www.cato.org/blog/scotus-vacates-appeals-court-decision-ruan-vs-united-states-america:
Prescribing medications in an unusual manner, or a manner that falls outside the mainstream, might be a “standard of care” or malpractice issue, but should not be automatically considered a criminal issue. Approximately 20 percent of medications approved by the Food and Drug Administration (FDA) are legally prescribed “off‐label,” i.e., for different purposes than those for which the FDA approved them. The originators of off‐label uses fall outside the mainstream of prescribers, but they are not treated as criminals. And many off‐label uses are later approved by the FDA. This is one of the ways clinical medical science advances.
The lower court convictions of Drs. Ruan and Kahn treated what, at worst, could have been medical malpractice or standard of care violations as criminal matters….Cases and convictions like these have sent chills up the spines of other health care practitioners who are trying to help their patients in pain, causing many pain patients to be under‐treated or, worse, abandoned. Today’s Supreme Court decision was a victory for the “good faith” defense. But it was also a victory for physician autonomy, the patient‐doctor relationship, and patients in pain.
For the record, I think Dr. Singer took an overly generous view of Drs. Ruan and Kahn. Assuming the allegations of the indictments are true, what they did absolutely was (not “could have been”) malpractice; whether a properly instructed jury finds them criminally guilty remains to be seen. But his comments got me thinking about prosecutions of healthcare providers outside the controlled substances context. It does happen, and the implications are troubling. I found a comprehensive collection of cases and a thoughtful discussion of them in the American Journal of Roentgenology (really) at https://www.ajronline.org/doi/10.2214/ajr.179.2.1790331?mobileUi=0. The article particularly focuses on the case of a New York internist who was found guilty of “reckless endangerment of a patient and willful violation of New York's health laws” in connection with the death of a patient. (The prosecutor had unsuccessfully sought an indictment for manslaughter.) The judge sentenced the doctor to 52 weekends in prison, but after 6 weekends the sentence was commuted by then-governor Pataki. The article concludes as follows (footnotes omitted)
One medical-legal commentator has written: “Responsible physicians have nothing to fear from the criminal law...for a physician will not be held criminally liable for the death of a patient if that death is the result of a good-faith error of judgment or an inadvertent mistake. However, when physicians intentionally or recklessly disregard their patients' safety, they properly face criminal prosecution.” On the other hand, the General Council of the Medical Society of the State of New York contended the following: “The Medical Society strongly believes that it is a terrible policy to criminalize mistakes in professional judgment; it is just as inappropriate to criminalize a doctor's clinical judgment as it would be to criminalize a lawyer's tactical judgment.” Added the Executive Vice President of the American Medical Association: “Our concern is that mistakes of judgment should not be liable to criminal prosecution. Traditionally, errors in judgment are handled through peer review and malpractice. Society has been poorly served by [the action lodged against the New York internist].”
A California family doctor was prosecuted for second-degree murder in connection with the death of an 11-month-old child at a small, isolated community hospital. https://www.law.uh.edu/healthlaw/perspectives/bioethics/980213NegligenceHomicide.html. After the prosecution rested, the judge dismissed the case on the grounds that the evidence presented was insufficient to support a conviction. https://www.law.uh.edu/healthlaw/perspectives/bioethics/980224CalPhys.html. The author of the cited articles discusses the negative impact of such prosecutions:
Although there is a clear public policy interest in protecting the health of children and ensuring they receive proper health care, it is unclear whether such a prosecution serves these policy goals. Because physicians are under both legal and ethical duties to promote the best interests of their patients it appears unlikely their actions could meet the criteria necessary to establish implied malice except in extreme cases, where explicit intent would also be apparent. Both the American and California Medical Associations have recognized that in the event prosecutions of this sort were to become common, they would have a significant chilling effect on the willingness of physicians to practice medicine.
Prosecutors should consider the likely unintended consequences of their actions, i.e., long term deterrence of physicians from practicing in remote and underserved areas due to the lack of support services. It would be contrary to good public policy if criminal prosecutions, which were intended to promote the best interests of children but proved misguided in practice, actually had the effect of reducing the medical care available to children and thus potentially increasing unnecessary suffering and deaths.
Finally, in a recent case that I personally found very disturbing, a Tennessee nurse was found guilty of gross neglect of an impaired adult and negligent homicide after a medication error led to the death of a patient. https://www.npr.org/sections/health-shots/2022/03/25/1088902487/former-nurse-found-guilty-in-accidental-injection-death-of-75-year-old-patient. She faced up to 6 years in prison, but the judge “granted Vaught a judicial diversion, which means her conviction will be expunged if she completes a three-year probation.” https://www.npr.org/sections/health-shots/2022/05/13/1098867553/nurse-sentenced-probation.
The reaction of nurses to this prosecution and conviction was one of great alarm – properly so, in my opinion. The American Nurses Association said,
We are deeply distressed by this verdict and the harmful ramifications of criminalizing the honest reporting of mistakes. Health care delivery is highly complex. It is inevitable that mistakes will happen, and systems will fail. It is completely unrealistic to think otherwise. The criminalization of medical errors is unnerving, and this verdict sets into motion a dangerous precedent. There are more effective and just mechanisms to examine errors, establish system improvements and take corrective action. The non-intentional acts of Individual nurses like RaDonda Vaught should not be criminalized to ensure patient safety. The nursing profession is already extremely short-staffed, strained and facing immense pressure – an unfortunate multi-year trend that was further exacerbated by the effects of the pandemic. This ruling will have a long-lasting negative impact on the profession.
Physicians are equally alarmed, as am I. So I close this post by quoting at some length from https://www.boston.com/news/health/2022/03/28/a-bad-scary-precedent-local-doctors-react-to-nurses-conviction-in-accidental-death-case/:
Last week a nurse was convicted of two felonies for a fatal drug error in 2017, a ruling that Dr. Megan Ranney called “chilling on so many levels.”
The associate dean of the Brown University School of Public Health said on Twitter she was working in the emergency room when news of the ruling broke. She wrote Saturday that she and her co-workers kept talking about it, and that it spurred worries from her nurse friends that “it could have been any of [them]. Especially in the last 2 years.”….
“Negligence is not ok. That’s why [medical malpractice] exists,” Ranney tweeted. “But there’s a huge gap between malpractice and HOMICIDE charges. This sets a bad & scary precedent.” Ranney also pointed out that a culture of safety is dependent on change happening in systems that allow errors to slip through – something not achieved by scapegoating the individual. “The error that led to this tragic death was real. But a version of this skipped-safety-step happens every day across the country,” Ranney wrote.
[The charges against the nurse] stemmed from allegations that she didn’t properly monitor [a patient] after injecting her with the wrong drug. Vaught had injected Murphey with a powerful paralyzer, vecuronium, instead of the prescribed sedative, Versed, [as a result of which the patient died].
Dr. Jeremy Faust, an emergency physician at Brigham and Women’s Hospital, pointed to the alphabetic similarities of the two drugs and said in a blog post that “similar alphabetical errors probably occur all the time,” and that it hit close to home for him. Earlier in his career, a patient was given Rocuronium, a paralytic, as opposed to Rocephin, an antibiotic, Faust wrote Friday. In that case the error was caught quickly, and the patient suffered no consequences.
Faust said while this kind of serious error is rare, it is not impossible and could happen to anyone. They also may be preventable, but Faust says it’s more complicated than it may sound. For example, Faust says adding more alarms or hoops to jump through to get medications is not the answer – healthcare providers encounter hundreds of alarms a day, he noted, and there are times when they need to access medicines quickly. Logistics shouldn’t hinder that ability, he said. Better labeling…is an easier fix, according to Faust….
Ranney echoed [the American Nurses Association’s] concerns on Twitter, saying that nurses, and healthcare providers in general, are “constantly” working at the edges of their capacity. “Most of all: healthcare workers are already hurting. Esp in light of the last 2 years…this verdict will doubtless send more folks out of bedside care,” she wrote.
