Supreme Court Makes Important Decision for Scienter in Drug Cases: Ruan
This case present a general scienter provision of knowingly or intentionally dispensing controlled substances as authorized.
Ruan's Supreme Court Syllabus
Petitioners Xiulu Ruan and Shakeel Kahn 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).
An issue in the trials of Ruan and Kahn was the men's rea required to convict under 841 for distributing controlled substances not “as authorized.” Ruan and Kahn each contested the jury instructions pertaining to men's rea, 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” men's 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.
(a) Criminal law generally seeks to punish conscious wrongdoing. Thus, when interpreting criminal statutes, the Court “start[s] from a longstanding presumption . . . that Congress intends to require a defendant to possess a culpable mental state.” Rehaif v. United States, 588 U. S. __, __. This culpable mental state, known as scienter, refers to the degree of knowledge necessary to make a person criminally responsible for his or her acts. See ibid.
The presumption of scienter applies even when a statute does not include a scienter provision, and when a statute does “includ[e] a general scienter provision,” “the presumption applies with equal or greater force” to the scope of that provision. Ibid. The Court has accordingly held that a word such as “knowingly” modifies not only the words directly following it, but also those other statutory terms that “separate wrongful from innocent acts.” Id., at __.
Here, 841 contains a general scienter provision of “knowingly or intentionally.” And in 841 prosecutions, authorization plays a “crucial” role in separating innocent conduct from wrongful conduct. United States v. X-Citement Video, Inc., 513 U. S. 64, 73. Moreover, the regulatory language defining an authorized prescription is “ambiguous” and “open to varying constructions,” Gonzales v. Oregon, 546 U. S. 243, 258, meaning that prohibited conduct (issuing invalid prescriptions) is “often difficult to distinguish” from acceptable conduct (issuing valid prescriptions). United States v. United States Gypsum Co., 438 U. S. 422, 441. A strong scienter requirement helps reduce the risk of “over-deterrence,” i.e., punishing conduct that lies close to, but on the permissible side of, the criminal line. Ibid.
The statutory provisions at issue here are also not the kind to which the Court has held the presumption of scienter does not apply. Section 841 does not define a regulatory or public welfare offense that carries only minor penalties. Cf. Rehaif, 588 U. S., at__; Staples v. United States, 511 U. S. 600, 618–619. Nor is the “except as authorized” clause a jurisdictional provision. Cf. Rehaif, 588 U. S., at __. Pp. 5– 8.
(b) Analogous precedent reinforces the Court’s conclusion here. In Liparota v. United States, 471 U. S. 419, United States v. X-Citement Video, 513 U. S. 64, and Rehaif v. United States, 588 U.S. __, the Court interpreted statutes containing a general scienter provision (“knowingly”), and considered what mental state applied to a statutory clause that did not immediately follow the “knowingly” provision. In all three cases, the Court held that “knowingly” modified the statutory clause in question because that clause played a critical role in separating a defendant’s wrongful from innocent conduct. See Liparota, 471 U.S., at 426; X-Citement Video, 513 U. S., at 72–73; Rehaif, 588 U. S., at __. As in those cases, the Court today concludes that 841’s mens rea applies to the “[e]xcept as authorized” clause, which serves to separate a defendant’s wrongful from proper conduct. Pp. 8–9.
(c) Neither the Government’s nor the concurrence’s contrary arguments are convincing. First, the Government and the concurrence correctly note that the statutory clauses in the cases just described set forth elements of an offense. Here, the Government and the concurrence say, 841’s “[e]xcept as authorized” clause does not set forth an element of the offense. In support, they point to a separate statutory provision—885. Section 885 says that the Government need not “negative any exemption or exception . . . in any complaint, information, indictment, or other pleading or in any trial,” and that “the burden of going forward with the evidence with respect to any such exemption or exception shall be upon the person claiming its benefit,” not upon the prosecution. But even assuming that lack of authorization is unlike an element in these two ways, 885 has little or nothing to do with scienter requirements. Section 885 simply absolves the Government of having to allege, in an indictment, the inapplicability of every statutory exception in each Controlled Substances Act prosecution. Section 885 also shifts the burden of production—but not the burden of persuasion—regarding statutory exceptions to the defendant, thereby relieving the Government of having to disprove, at the outset of every prosecution, the inapplicability of all exceptions.
Section 885 thus does not provide a basis for inferring that Congress intended to do away with, or weaken, ordinary and longstanding scienter requirements. At the same time, the factors discussed above— the language of 841; the crucial role authorization plays in distinguishing morally blameworthy conduct from socially necessary conduct; the serious nature of the crime and its penalties; and the vague, highly general regulatory language defining the scope of prescribing authority—all support applying normal scienter principles to the “except as authorized” clause. And the Government does not deny that, once a defendant satisfies his burden of production under 885 by invoking the authorization exception, the Government must then prove lack of authorization by satisfying the ordinary criminal law burden of proof—beyond a reasonable doubt.
The Government also offers a substitute mens rea standard. Instead of applying the statute’s “knowingly or intentionally” language to the authorization clause, the Government instead asserts that the statute implicitly contains an “objectively reasonable good-faith effort” or “objective honest-effort standard.” Brief for United States 16–17. But 841 uses the words “knowingly or intentionally,” not “good faith,” “objectively,” “reasonable,” or “honest effort.” And the Government’s standard would turn a defendant’s criminal liability on the mental state of a hypothetical “reasonable” doctor, rather than on the mental state of the defendant himself or herself. The Court has rejected analogous suggestions in other criminal contexts. See Elonis v. United States, 575 U. S. 723. And the Government is wrong to assert that the Court effectively endorsed its honest-effort standard in United States v. Moore, 423 U.S. 122, as that case did not address mens rea at all. Nor does United States v. Yermian, 468 U.S. 63, support the Government here, as that case dealt with a jurisdictional clause, to which the presumption of scienter does not apply.
Finally, the Government argues that requiring it to prove that a doctor knowingly or intentionally acted not “as authorized” will allow bad-apple doctors to escape liability by claiming idiosyncratic views about their prescribing authority. But the Court has often rejected this kind of argument, see, e.g., Rehaif, 588 U. S., at , and does so again here. Pp. 9–15.
(d) The Court of Appeals in both cases evaluated the jury instructions relating to mens rea under an incorrect understanding of 841’s scienter requirements. On remand, those courts may address whether the instructions complied with the mens rea standard set forth here, as well as whether any instructional error was harmless. P. 15.
966 F. 3d 1101 and 989 F. 3d 806, vacated and remanded.
How Does the Ruan Case Work?
Substantive Application of Ruan
The holding of Ruan requires the government in a § 841 prosecution to prove that the doctor knew that the conduct of dispensing a controlled substance was unauthorized. Once the defendant established that he was authorized to dispense controlled substance under the CSA, the government must prove that the conduct at issue was “unauthorized” to obtain a conviction under § 841. The government may prove this burden by circumstantial evidence by establishing that the conduct was not for a “legitimate medical purpose” or in the “usual course” of “professional practice.” Ruan, at 2382.
Procedural Application of Ruan
A Ruan claim is best made at either the direct appeal or the motion to vacate stage if those are available to an accused person. These types of claims are significantly more difficult if attempted in a 2241 and as of right now we don't believe that it is proper in a 2255.
We do believe that the holding in Ruan can be retroactively applied to first in-time 2255 motions or appeals for the same reasons that Rehaif and Taylor are retroactive on first in-time 2255 motions.
Further, while every case is different, we suggest that claimants on plea cases evaluate whether a claim of voluntariness of the plea is a better claim to make than ineffective assistance of counsel as there is established caselaw that supports the idea that lawyers cannot and should not be required to anticipate changes in caselaw.
In 2008, Dr. Ignasiak was charged with multiple counts of health care fraud and unlawful dispensing of controlled substances in violation of 21 U.S.C. 841(a)(1). Following a lengthy procedural history, Dr. Ignasiak filed a timely 28 U.S.C. 2255 motion in 2021, arguing in part that his counsel was ineffective for failing to advise him of the elements necessary for the government to prove the 841(a)(1) counts. The 2255 motion was fully briefed as of May 2021.
Then, in June 2022, the Supreme Court issued its decision in Ruan involving the mens rea requirement for doctors to be convicted of unlawful dispensing under 841(a)(1). Dr. Ignasiak hired the Law Office of Jeremy Gordon to seek leave to amend his pending 2255 motion to include a claim under Ruan.
The Firm filed a motion for leave to amend Dr. Ignasiak’s 2255 motion to add a claim that his guilty pleas to the 841 convictions cannot be supported by an adequate factual basis following the Supreme Court’s decision in Ruan. Since the statute of limitations had already expired on filing new claims, the Firm argued that Ruan announced a new rule of substantive law that applies retroactively to cases on collateral review. This argument was bolstered by the Eleventh Circuit’s recent decision in Seabrooks which held the same for Rehaif and 922(g) convictions.
On August 17, 2022, the government filed its response to Dr. Ignasiak’s motion for leave to amend. The government conceded that Ruan is applicable to Dr. Ignasiak’s case and that the court should grant the motion to amend. Specifically, the government noted:
Although the Supreme Court was silent on the issue of whether the holding of Ruan was retroactive and no federal court has yet to decide the issue, it is the government’s current position that Ruan announced a new rule of substantive law that would apply retroactively to direct appeals and initial 2255 motions . . . This means that under 28 U.S.C. 2255(f)(3), any Ruan claim in an initial 2255 motion must be filed by June 27, 2023.
After the government filed its response, the United States District Court for the Northern District of Florida granted Dr. Ignasiak’s motion to amend and directed the government to file its response on the merits of the Ruan claim.
While the government’s concession may sound like a minor victory, it has major implications. The Supreme Court decided Rehaif in 2019. It took the Eleventh Circuit until 2022 to finally hold the decision retroactively applicable to 2255 motions. The government’s concession here that Ruan is also retroactively applicable is a significant step in paving the way for others to seek Ruan relief on direct appeal or initial 2255 motion.
I wanted to share this case to inform those who may be impacted by the Court’s decision in Ruan that now is the time to file for relief. If you are a doctor who was convicted of 21 U.S.C. 841, the clock is now ticking to file for Ruan relief if you are in your initial 2255 proceeding. If you are past your direct appeal and 2255 stage, relief may still be available but the procedural process will be a bit more complicated.
A brief collection of recent decisions involving the SCOTUS Ruan case
United States v. Nikparvar-Fard, No. CR 18-101-1, 2022 WL 2974715 (E.D. Pa. July 26, 2022) (Approving without deciding that the “as authorized” clause involved in Ruan is the same for prosecutions under 21 U.S.C. Sec. 856 cases)
United States v. Kraynak, No. 4:17-CR-00403, 2022 WL 3161907 (M.D. Pa. Aug. 8, 2022) (Evidence at trial was sufficient to establish that D knew he was prescribing outside the scope of ordinary medical practice in violation of 841)
United States v. Hoover, No. 2:18-CR-00188, 2022 WL 2826421 (W.D. Pa. July 20, 2022) (Compassionate release was not appropriate procedural vehicle to assert innocence under Ruan post-conviction and D should have filed a habeas claim)