A Post-Ruan Problem: Jury Instructions Tying "Usual Course of Medical Practice for a Legitimate Medical Purpose" to Standard of Care

In a recent post, I  briefly discussed the offense instruction in U.S. v. Romano--a post-Ruan illegal distribution case out of the Southern District of Ohio. I noted that the jury charge in Romano, "tied the concept of 'usual course of professional practice for a legitimate medical purpose'  to a 'standard of medical practice generally recognized and accepted in the State of Ohio.'"  I think this type of instruction, often used in the pre-Ruan era, should be considered improper in post-Ruan times. Although Ruan left many questions unsettled for now, the Supreme Court made it clear that no objective "reasonable physician" standard can constitutionally be superimposed onto the government's obligation to prove scienter beyond a reasonable doubt. Justice Breyer did say that criteria such as  "legitimate medical medical purpose" and  "usual course course of professional practice" were objective in nature and that the more unreasonable the defendant's beliefs and misunderstandings were, "especially as measured against objective criteria," the more likely it is that the jury will find that a defendant knew his conduct was unauthorized. But the Romano instruction risks having the jury equate "standard of care," a staple of civil malpractice cases, to "legitimate medical purpose" and "usual course of professional practice." Criminal defense practitioners in illegal distribution prosecutions of physicians and other medical professionals are all too familiar with government experts who are willing to testify that this or that particular practice or procedure by the defendant physician did not comport with a state or national standard of care. It is one thing to allow testimony of this type in order for the government to show how far a particular defendant deviated from the broad consensus of medical opinion and to further show how this deviation, in combination with other facts in the case, is circumstantial evidence of scienter. It is something different I believe to import this unexplained into the offense instruction.  The Ninth Circuit has long held that a physician defendant cannot be convicted of unlawful distribution merely by showing that he or she intentionally violated a standard of care. The government must also show that he or she acted without a legitimate medical purpose. I realize that the distinctions being discussed here can be extremely subtle in nature, but that is exactly why they can lead to jury confusion. For this reason, I much prefer the U.S. v. Saloumeh Rahbarvafaei Offense Instruction which referenced standards of care, but did so in the following context: "There are no specific guidelines in the law defining what is the usual course of professional practice or defining a legitimate medical purpose. Therefore, in determining whether the defendant acted outside the usual course of professional practice, you may consider the standards to which medical professionals generally hold themselves, including standards of care among medical professionals. However, any finding of criminal liability must ultimately depend on the mental sate of the defendant herself, not what a hypothetical 'reasonable' medical practitioner would do or intend. Because of the need for the government to prove the defendant's criminal intent, this case is different from a medical malpractice case."

(wisenberg)