It is illegal for any person to distribute or dispense a controlled drug “except as permitted by this subchapter,” according 21 USC 841. Yesterday’s Supreme Court heard how language in the Controlled Substances Act applies to doctors accused of prescribing opioid pain medicine “outside the ordinary course of professional-medical practice.” Patients and doctors should be concerned about this issue. It is because criminal prosecutions for deviating from the Drug Enforcement Administration’s (DEA) medically acceptable guidelines can have a chilling affect on pain treatment.
The CSA permits physicians holding DEA registrations with the right to prescribe controlled substances. A CSA regulation states that a prescription must be valid for a medical reason and issued by a practitioner in his normal practice. Justice Samuel Alito said that the expression “knowingly” or “intentionally” can’t be taken to mean deviations from this ambiguous standard. Justice Stephen Breyer disagreed.
Regardless of whether Alito or Breyer is right on that point, most of the justices seemed to agree that “the presumption of scienter”—some degree of intent or knowledge—applies when the government seeks to imprison doctors based on their prescribing practices. Justice Neil Gorsuch observed that the CSA does NOT explicitly mandate that a doctor be required to “knowingly and intentionally” depart from accepted medical practices. But, you could argue that “the exception clause must have some mens rea element, as it is what differentiates lawful behavior from illegal.”
Eric Feigen was defending Federal Government’s position about how the CSA should affect prescribers. However, even Feigen conceded to that fact. Feigen claimed that it is the right test to determine if a physician “sincerely attempted” to practice recognizable forms of medicine.
Contrary, the U.S. Court of Appeals of the 11th Circuit ruled that a physician’s good faith belief that he dispensed a control substance during his normal professional practice was irrelevant to the issue of whether he had violated the CSA. The 11th Circuit rejected appeal by a Mobile, Alabama pain specialist for prescribing opioids in a way that was not consistent with accepted practice. It didn’t matter, according to the 11th Circuit AllWhether XiuluRuan the defendant truly believed he was doing exactly what a doctor should do.
This is just one of the two cases involving doctors convicted for drug trafficking. The Supreme Court will be reviewing them both. The U.S. Court of Appeals, 10th Circuit, ruled that a doctor’s good faith does not affect the issue of whether prescriptions were made in the “usual course of professional practice.” This case must be decided “objectively.” This case concerns Shakeel Kahn (a Wyoming physician) who was sentenced for 25 years.
Justice Brett Kavanaugh clearly was concerned about the consequences of these decisions. He observed that “the doctor could have violated this objective standard but may have legitimately thought the standard was slightly different” while questioning Beau Brindley who represented Kahn. Kavanaugh stated that Brindley’s arguments were not valid in these circumstances and suggested that the doctor should be sentenced to 20 years imprisonment.
Kavanaugh said that the phrase “legitimate medicinal purpose” is “very vague in my estimation,” and “reasonable people can disagree.” Kavanaugh asked Feigen about his belief that these cases are often dominated by two experts who differ on the conduct of defendants. Kavanaugh asked him, “Do you go to jail for twenty years if you get on the wrong end of a close-call?”
Gorsuch emphasized this point. He stated, “Even though this case is very close,” that the individual was “unable to protect himself against any mens rea requirement. This person will be subject to basically a regulatory offense, which can result in 20 to life imprisonment.”
Justice Clarence Thomas also highlighted the fact that physicians can face severe criminal sanctions for violating DEA registration conditions. According to Thomas, “If you violate the terms of your DEA registration, you can lose your medical license.” “So it’s regulatory. Here, there isn’t that intermediate step—that is, that you lose your registration that allows you to prescribe certain drugs. Instead, it’s folded into the underlying criminal violation….My concern [is]It seems that we are doing both, which can lead to some very severe criminal sanctions.
Brindley claimed that criminal liability should only apply to doctors who have clearly stopped practicing medicine, and are instead involved in drug dealing. This distinction was made by the Court, he said. Gonzales v. Oregona 2005 ruling that disapproved of an attempt to revoke DEA registrations of physicians who had prescribed assisted suicide drugs. According to the Court, “The statute as well as our case law strongly support the conclusion Congress regulates medical practices insofar that it prohibits doctors from using their prescription writing powers for illicit drug trafficking and dealing as commonly understood.” The statute does not intend to regulate medicine in general.
Brindley stated that while a doctor may fail to provide the proper care for patients and could be charged with malpractice or violation of state medical regulations, Brindley did not argue that such a physician is “engaged.”[d]In illicit drug dealing and trafficking, as currently understood.” He stated that the government allows doctors to be convicted if they misunderstand their obligations, but not for drug dealing as commonly understood. The government has many mechanisms to help patients protect themselves from those who are unable or unwilling to follow the standards of care. This is not Section 841’s function. Under Section 841, the question isn’t whether a doctor has a poor record but whether he or she was selling drugs. A good faith determination must therefore be solely based upon the genuineness of the doctor’s intent in writing the prescription.
Feigen warned doctors that this standard leaves them free to determine what medically is appropriate regardless of their colleagues’ opinions. Brindley pointed out that even though the government may present evidence that prescriptions are clearly contrary to established practice, it is still possible for the government to show that doctors made incorrect decisions. Brindley explained that “all of objective evidence” will prove your case to be insane and you’ll likely get convicted. It’s the fact.
Feigen described government’s preferred testing as “an objective”, which he called “an objective”.
Honest effort standard” and “a kind of extremely objectively grounded mens’ rea,” in this manner: “You cannot be convicted as long you tried to make a genuine medical diagnosis.” You can make reasonable errors about the legitimate purposes of medical treatment.
Gorsuch seemed skeptical: “‘An honest effort.’ You see, that’s not what I know. Yet, I am able to define ‘knowing’ as well as ‘intentional.
Lawrence Robbins (the attorney for Ruan) argued, like Brindley that Ruan should not be convicted of violating 21 USC 841 unless it can prove that the doctor’s prescriptions were written without good-faith medical purposes. Robbins suggested that the Court could decide that an “honest efforts” standard makes the most sense. However, the Court should also recognize the subjective aspect of such a rule, as opposed to the way that the government presents it.
Feigen quoted the jury instruction in 1975’s case United States v. MooreThe case involved Moore, a doctor who prescribed large amounts of methadone to patients, without providing them with proper physical exams or instructions. He also charged fees based on the amount of methadone prescribed and not fees for services rendered. A footnote was added by the Court to note that Moore had not made an honest effort to provide detoxification according with accepted standards of medical practice.
Robbins claimed that Feigen misunderstood to call this objective. The defendant stated that he had only tried to find a solution for a problem and the jury believed him. That is an subjective question. He did he really try? The jury disapproved of his claim that he had done so because he used a novel method. But the jury did not say, “Well, a reasonable physician wouldn’t do this.” A doctor objectively rational wouldn’t do this. No. It was not.
Chief Justice John Roberts stated repeatedly that standards for pain treatment and opioid prescribing are uncontested and clear. Robbins acknowledged that ongoing discussions about the best way to balance the risks and benefits are still being held, which places doctors in a dangerous position. What is the best amount of medication for someone with a particular type of disability? Robbins stated. Robbins said, “The truth is that there’s no such book. That’s what is the problem.”