Last month two physicians, doctor John Couch and doctor Xiulu Ruan of Mobile, Alabama, pleaded not guilty to multiple charges of drug diversion. I have no personal knowledge of either Dr. John Couch or Dr. Xiulu Ruan, or of their case, having only read about the doctors in the media. What caught my attention was that the news report included a discussion of “medical necessity,” i.e., whether there was a “medical necessity for dispensing the controlled substance.” Medical necessity is not, however, the legal standard by which the crime is measured. Nor is malpractice. This is an issue I have devoted some time to while defending physicians charged with prescription drug crimes. Rather, “drug diversion” is a specific intent crime. To convict a doctor of drug diversion, the government must prove more than malpractice, and more than the absence of medical necessity.

The elements of the crime of drug diversion

Doctors Couch and Ruan had authority to prescribe controlled drugs by virtue of their DEA Registrations. Under 21 U.S.C. § 841(a)(1), it is generally agreed that the government must prove (1) that both doctors prescribed or dispensed a controlled substance, (2) that they acted knowingly and intentionally, and (3) that they did so other than for a legitimate medical purpose and in the usual course of his or her professional practice. See, e.g., United States v. Norris, 780 F2d 1207, 1209 (5th Cir. 1986); citing, U.S. v. Rosen, 582 F2d 1032, 1033 (5th Cir. 1978).

It is important to know, however, that the Controlled Substances Act (CSA), which is the statutory scheme passed by Congress, includes only the first two elements above. The third element,”legitimate medical purpose,” is rooted in an agency Rule promulgated by the Drug Enforcement Administration (DEA). See 21 C.F.R. 1306.04(a). That Rule provides that a controlled substance can be dispensed by a prescription “issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice.” 21 C.F.R. 1306.04(a); Norris, 780 F2d 1207,1209. Thus, lawyers defending doctors need to be careful that the agency’s Rule does not swallow the federal statute, watering down the criminal conviction standard.

Did the doctors “knowingly and intentionally” divert drugs?

Keeping the federal statute front and center, the question is whether Dr. John Couch or Dr. Xiulu Ruan intended to divert drugs, a specific intent crime. The DEA’s attorneys might very well prove that Dr. John Couch or Dr. Xiulu Ruan prescribed without medical necessity, or that they committed malpractice while prescribing, but more is required to prove the specific intent crime of drug diversion. The DEA’s attorneys must prove that doctors John Couch and Xiulu Ruan “knowingly and intentionally” diverted drugs to an illicit purpose. This is the burden of proof imposed upon the government, by the Congress, pursuant to 21 U.S.C. § 841(a)(1).