Dr. Ruan Requests Support For Another Writ

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Xiulu Ruan, MD; 66857019

F.C.I. Oakdale 1, Eva 2

P.O. Box 5000, Oakdale, LA 71463

Re: Request for Amicus Brief for Our Upcoming Petition for Writ of Certiorari (Case Number: to be assigned soon)

March 18, 2023

Jane M. Orient, MD, Executive Director Association of American Physicians and Surgeons

1601 N. Tucson Blvd. Suite 9, Tucson AZ 85716-3450

Dear Dr. Orient:

Dr. Couch and I need your help! Pain physicians need your help! Millions of people living in pain need your help!

On June 27, 2022, in a 9:0 decision, the Supreme Court handed down Xiulu Ruan v. U.S., 142 S. Ct. 2730 (“Ruan II”). Ruling in my favor the Court vacated and remanded my case back to the Eleventh Circuit. The Court, however, did not expressly invalidate its earlier precedent, U.S. v. Moore, 423 U.S. 122 (1975). This is problematic.

For close to five decades, Moore (1975) has been the Court’s seminal case law in prosecuting clinicians as drug traffickers under the Controlled Substances Act (CSA) Section 841. The Moore Court, unfortunately, erred when it ruled: “Registered physicians can be prosecuted under the Section 841, when, as here, their activities fell ‘outside the usual course of professional practice’ [‘OUCPP’].”  Based on today’s standard in Ruan II, the above OUCPP Ruling was plain error because it failed to consider the guilty intention or “mens rea” respecting OUCPP (discussed in detail in the attached essay).

Moore (1975) is also self-contradictory: While the Court implicitly authorized the Moore’s Jury Instruction, which contained the phrase “other than in good faith” that served as the requisite “mens rea” at Dr. Moore’s trial, the Court’s OUCPP Ruling, however, mentioned no “mens rea,” thus negating the “mens rea” it had endorsed in Moore’s Jury Instruction. Consequently, Moore (1975) violated the Law of Non-Contradiction, which dictates that the two opposing propositions cannot be both true at the same time in the same sense. (The two premises, “A is B” and “A is not B,” are mutually exclusive and collectively exhaustive and therefore cannot be both true at the same time.)

On my direct appeal, I cited Moore to support my “good faith” or the lack of “mens rea.” The Eleventh Circuit rejected it, citing Moore’s OUCPP Ruling:”This rule reflects the Supreme Court’s decision in U.S. v. Moore, 423 U.S.122 (1975), the first case by the Supreme Court establishing that physicians can be prosecuted for violating the Controlled Substances Act ‘when their activities fall outside the usual course of professional practice.’ Id. at 124″ (U.S. v. Ruan, 966 F.3d 1101, 1166-67) (11th Cir. 2020). This predicament is caused by the Moore Court’s simultaneously embracing two opposing propositions.

In addition, Moore (1975) erroneously acquiesced to a novel prosecution model, the prototype of prosecuting physicians as drug traffickers under Section 841, namely by combining the CSA 841(a) statute with 21 C.F.R. Section 1306.04(a), together with Moore (1975). Today, this compound criminal liability standard has the following appearance:

“It is generally ‘unlawful for any person knowingly or intentionally … to manufacture, distribute, or dispense, or posses with intent to manufacture, distribute, or dispense, a controlled substance.’ 21 U.S.C. Section 841(a). A medical professional’s prescription of a controlled substance is lawful only if ‘issued for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.’ 21 C.F.R. Section 1306.04; See also United States v. Moore, 423 U.S. 122,

124” (U.S. v. Lague, 971 F.3d 1093 (9th Cir. 2020)).

This compound criminal standard contains multiple fatal flaws . I will briefly mention one here: The violation of Section 1306.04 is akin to a civil infringement, not a felony offense. There is no rational connection between violating Section 1306.04 and violating Section 841 (discussed in detail in the attached essay).

Indeed in U.S. v. Howen, 2022 U.S. Dist. LEXIS 236721 (E.D. Ca. 2022), the Government filed a civil suit against defendant pharmacist Howen and defendant pharmacies for knowingly violating Section 1306.04. The court opined: “Section 1306.04(a) explicitly subjects pharmacists to CIVIL PENALTIES if they ‘knowingly’ fill an invalid prescription [.]’ See 21 C.F.R. Section 1306.04(a)” (2022 U.S. Dist. LEXIS 14) (emphasis added).

Further, the term “OUCPP” in the context of Section 1306.04 differs in meaning from “OUCPP” in the context of Moore (1975). The former contemplates a civil infringement such as in Howen, while the latter represents a felonious offense per Moore’s OUCPP Ruling. Through the equivocal usage of the term “OUCPP” introduced by Moore (1975), a false causal connection between the two was established even though there was no rational connection between them. Thus innocuous conduct such as OUCPP in violation of Section 1306.04 became notorious felonious offense under Section 841.

For close to five decades innumerable clinicians including physicians, surgeons, licensed nurse practitioners and physician assistants, podiatrists, dentists, pharmacists, etc., have been prosecuted under this erroneous criminal standard as well as under Moore’s OUCPP Ruling. (Moore’s other serious errors were discussed in detail in the attached essay.)

Congress designed separate CSA provisions (Section 841, 842, and 843) for different purposes. Indeed the District of Columbia Circuit reasoned that the “broad outline strongly suggests that Congress intended to deal with registrants primarily through a system of administrative controls … and reserving the severe penalties provided in Section 841 for those seeking to avoid regulation entirely by not registering.” (U.S. v. Moore, 505 F.2d 426, 430 (D.C. Cir. 1974))

Following Moore (1975), almost all clinicians charged with “overprescribing” were prosecuted under Section 841, as though Section 842 and 843 had never existed. This practice violated the basic interpretive canon admonished by the Court in Rubin (138 S. Ct. 816) for it rendered 842 and 843 provisions nonsensical and superfluous, thus at odds with Congress’s intention.

Although the Howen Court in California treated the violation of Section 1306.04 as a civil infringement, the Eleventh Circuit, however, pushed it all the way to the other end, treating it like an act of “drug dealing.” For example, in U.S. v. Mencia, 2021 U.S. App. LEXIS 17160 (11th Cir. 2021), the Eleventh Circuit elaborated: “When does a physician stop acting as a doctor and start acting as a “drug pusher[?]” The answer under the Act is when he prescribes controlled substances outside the course of his professional practice or without a legitimate medical purpose.” (2021 U.S. App. LEXIS 40-41)

Shocking, isn’t it? That’s how pliable and insidious 21 C.F.R. Section 1306.04 could be. Its interpretation depends entirely on the caprice of the courts. A violation of it, a civil infringement per a federal court in California, can become a felonious offense of drug trafficking per the Court of Appeals for the Eleventh Circuit in Atlanta. Does this make any sense at all?

In the past two years, tons of illicitly manufactured fentanyl have been smuggled in across the open southern border with minimal government intervention. By contrast, Dr. Couch and I, in our capacity as fellowship-trained, multi-board certified interventional pain specialists, received sentencing enhancement for collectively prescribing FORTY GRAMS of fentanyl -­ during four and half years in treating our patients at Physicians’ Pain Specialists of Alabama, a tertiary interventional pain clinic that had been in practice for 17 years with more than 8,000 active patients (when the Government shut it down in 2015).

In a recent article, “The Misinformed & Misguided Prescription Abuse Prevention Act: A Response to Delfino,” by Robert Capodilupo and Jacob James Rich, published in “Yale Law and Policy Review” — Inter Alia (Spring 2023), the authors pointed out that, while opioid prescribing has declined over the past decade, total opioid deaths have skyrocketed because of a spike in illicit opioid overdoses. They cautioned that the proposed Prescription Abuse Prevention Act by Delfino may create a harmful “chilling effect,” further deterring physicians from prescribing needed pain medicines to treat patients.

Capodilupo and Rich also explained that the drastically increased opioid mortality over the past a few years was mostly due to illicitly manufactured fentanyl, not prescription fentanyl, noting that, by August 2017, the CDC had formally removed fentanyl from the definition of prescription opioid mortality. They predicted that further reduction in opioid prescribing may exacerbate opioid overdoses by orienting pain patients and recreational users to illicit alternatives such as heroin and illicit fentanyl.

The Court should use this petition to re-examine the fatally flawed criminal standard presented, which, for decades, has resulted in enormous harm to clinicians, patients, and our society — a tragedy and disgrace never intended by Congress .

Thank you wholeheartedly in advance for your attention and kind help. We look forward to seeing your Brief of Amicus Curiae in connection with our certiorari.

Sincerely,

Xiulu Ruan, MD