On May 20, 2015, Physicians’ Pain Specialists of Alabama (PPSA). an interventional pain management clinic located in Mobile, Alabama, which had been in practice for over 17 years, was raided and shut down by the Government. Dr. John Patrick Couch and I (physician owners of PPSA) were arrested. The Second Superseding Indictment returned in April 2016 charged us with more than twenty felonies, including Nine conspiracies and Thirteen substantive offenses.
Following a seven-week jury trial in 2017, at which over 500 exhibits had been admitted and more than 80 witnesses had testified, we were convicted of all the charges (except for one subs1antive drug offense of mine). Dr. Couch was sentenced to 20 years in prison; I was sentenced to 21 years in prison due to my role as an “undisputed leader” of our “criminal enterprises .” Together we made history by becoming the first group of physicians in the country that have been convicted as “gangsters,”
We appealed all the way to the Supreme Court (“the Court”). In 2021.the Court granted my petition and consolidated it with that of Dr. Shakeel Kahn’s. The consolidated case attracted significant public interest more than a dozen parties submitted Briefs of Amicus Curiae to the Court. The Brief of Amici Curiae written by Association of American Physicians and Surgeons (a national physician organization founded in 1943) and Jeffrey A. Singer, M.D. stated:
“Lengthy incarceration without proving criminal intent is tyrannical. A 21-yearimprisonment for medicating pain deters all physicians against fully treating patients who suffer. Undertreatment of pain inevitably results when a robust good faith defense is denied. Dr. Ruan acted in good faith as shown by an unsuccessful undercover sting operation against him, but that evidence and testimony by supportive patients were all withheld from the jury. In addition, the jury was misled that Dr. Ruan could have called anyone he wanted as a witness. He was not allowed to. (Brief of Amici Curiae Association of American Physicians and Surgeons and Jeffrey A. Singer, M.D., in Support of Petitioner, December 27. 2021, p. 2)
The Brief Amicus Curiae of Physicians Against Abuse (PAA) stated:
“No other country criminalizes physician behavior like the federal prosecutors have done in the U.S….Doctors are just a ‘sitting duck’ for these federal prosecutors who raid medical offices and unlike the career drug pusher on the streets who gets caught and charged with one or two counts, federal prosecutors pile up count after count because doctors are required to keep records and those records are used against them in these out of control prosecutions against physicians. (Brief Amicus Curiae of Physicians Against Abuse un Support of Petitioner, December 27, 2021.p. 3)
“This formula has made U.S. the only country in the world mass incarcerating physicians. This is not because all the criminal doctors miraculously reside in the United States, but rather, because there is something significantly wrong in the manner federal prosecutors have been allowed to litigate these cases as if they are in the “Wild West. (Id.,p. 2)
Indeed, physicians of this great nation have become anathema of the society – as a consequence of Government’s scapegoating of physicians. By relentlessly vilifying prescription opioids and blaming physicians’ prescribing having caused the “opioid crisis,” the Government can easily go after any physician it chooses, convicting him as a “drug pusher” and sentencing him as a “drug lord.” Not only is there “something significantly wrong in the manner federal prosecutors have been allowed to litigate these cases,” but this type of abusive persecution has actually been glorified and rewarded.
Fatal Flaws in the Criminal Standard Used to Prosecute Physicians as “Drug Pushers” under Section 841
The contemporary, hybrid criminal standard contains three components: (1} the CSA 841 statute,(2) the Federal Regulation, 21C.F.R. Section 1306.04,and (3) the Court’s Caselaw, U.S. v. Moore.423 U.S. 122 (1975). See U.S.v. Lague, 971 F.3d 1032 (9th Cir. 2020). Each of the three components has its own flaws.Iwill st.ilrt with the Court’s seminal Caselaw Moore.
Selected Major Flaws in Moore.
In 1975, the Government brought Dr. Moore’s case to the Supreme Court Dr. Moore was a physician who had been convicted as a •drug pusher'” under Section 841 for overprescribing methadone in treating heroin addicts. Dr. Moore appealed his convictions. arguing that he was a registered physician, a •registrant.• who should not have been prosecuted under Section 841, the severest CSA provision designed to punish nonregistered drug traffickers. The District of Columbia Circuit agreed with Dr. Moore and vacated his convictions. The Government appealed, and the Court agreed to hear the case.
On December 7, 1975, the Court handed down U.S. v. Moore, 423 U.S. 122, holding that Registered physicians can be prosecuted under Section 841.when their activities fall outside the usual course of professional practice .”
The most fatal flaw of Moore’s Ruling is that it completely eliminated the Government’s burden to prove a require guilty intention (mens rea). On June 27, 2022, the Court handed down Xiulu Ruan v. U.S., 142 S. Ct 2370 (“Ruan”), holding that section 841’s ‘knowingly or intentionally’ mens 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.”
In City of Huntington v.Amerisource Bergan Drug Group, 609 F.Supp. 3d 408 (S.D. WV. 2022), a case related to thousands of other lawsuits filed throughout the country in connection with the •opioid crisis,, experts on both sides agreed that over the past two decades and even during the peak of the opioid prescribing, the overwhelming majority of doctors were acting i11 good faith:
A great majority of cases of well-intended clinicians trying to follow what they understood, what they had been told, was the right way to treat patients “doctors who prescribed more opioids in accordance with the changing standard of care were acting reasonably based on the information available.
There Is No Logical Connection between Violation of Section 21 C.F.R. 1306.04 and Violation of CSA Section 841.
CSA 841 statute was designed to punish nonregistered drug pushers; it does not contain the word “registrant(s)” such as “physician(s)” or “pharmacist(s)” within the Section 841 statute. The Federal Regulation Section 1306.04 attempts to tie registrants’ conduct to Section 841 statute. Section 1306.04(a) provides: •A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual prescriber acting in the usual course of his professional practice.(Sentence A)…An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of Section 309 of the Act (21 U.S.C. 829), and the person knowingly fining such a prescription as well as the person issuing rt. shall be subject to the penalties provided for violation of the provisions of law relating to controlled substances. (Sentence B)”
Sentence B explicitly states that noncompliance of Section 1306.04 would lead to violation of Section 309, which relates to 21 U.S.C. 829, the punishment of which is provided for in Section 842, which is civil in nature.
As seen, the violation of Section 1306.04, even if knowingly is a civil violation, certainly not a felonious offense. Therefore, there is no rational or causal connection between the violation of Section 1306.04 and the violation of Section 841.
It is critical to realize that the meaning of OUCPP in the context of Section 1306.04 noncompliance differs materially from OUCPP in the context of Moore. The former contemplates a civil violation as seen in the above cases, and the latter represents drug trafficking under Section 841 as a result of the stipulated Moore’s Ruling. Therefore, it is only through the equivocal usage of the term, “outside the usual course of professional practice” (OUCPP), that a false connection between the noncompliance of Section 1306.04 and the violation of Section 841 is established. As a consequence, innocuous conduct such OUCPP in violation of Section 1306.04 becomes notorious felonious offense under Section 841.The Arbitrary Opioid Conversion Ratios of the Drug Conversion Tables (Previously Called Drug Equivalency Tables) In the Federal Sentencing Guidelines Manual Violated the Fifth Amendment and the Eighth Amendment.
Following a decade-long massive prosecution of physicians, the prescription opioid volume has dropped to the bottom low, but the opioid overdose deaths have soared to all-time high. The inference is plain and simple: Illicit opioid use without medical supervision is the real scourge; physicians, exercising their trained clinical judgment when prescribing needed opioids to treat their patients in pain, not only help patients’ pain and suffering, but also save their lives.
In 2021 more than 100,000 people died of drug overdose, where 64% involved illicitly manufactured opioids. (https://www.cdc.gove/drugoverdose/fatal/dashboard/index.htrnl) Prescription opioids accounted for a small fraction, i.e. 15.7% of opioid overdose deaths. (Id.) The most common culprit is illicit fentanyl. (Id.) The Sentencing Commission, however, continues to ignore this crucial fact By deliberately conflating illicit fentanyl overdose mortality with prescription opioid overdose mortality, the Sentencing Commission is able to continue its political agenda of vilifying prescription opioids and scapegoating of prescribing physicians. It is critical to distinguish the prescription fentanyl mortality from the illicit fentanyl mortality. The former is tiny, whereas the latter is huge. In fact, the CDC finally acknowledged this crucial difference, and in August 2017, it formally removed fentanyl from the definition of prescription opioid mortality. (See Annual Surveillance Report of Drug Related Risks and Outcomes, CDC, at 35 (2017)). The current OCT, however, do not distinguish prescription fentanyl from illicit fentanyl.
Fentanyl, when prescribed by physicians and used under physicians’ medical supervision, is both effective and safe. This conclusion is consistent with the CDC’s conclusion and decision mentioned earfier. A large-scale study conducted in Finland also supports this conclusion. Ojanpera and co-workers assessed the fatal toxicity index (FTI) of 70 medications during three discrete years (2005, 2009, and 2013) in Finland. FTI is the absolute number of fatal poisonings caused by a particular drug divided by its consumption figure in Finland. The higher the FTI, the more likely fatal drug poisonings were to occur. Their findings were published in 2016 in the International Journal of Legal Medicine.” (DOI 10.1007/s00414-016-13588 March 17, 2016)
Conclusion: (1) the true culprit that has caused the drastic increase of opioid overdose mortality in recent years is the use of illicitly manufactured opioid(s) without medical supervision, a predictable consequence of the “Chilling Effect• of Government’s massive prosecution of physicians; (2) pain management physicians not only help patients’ pain and suffering but save their lives; (3) the Sentencing Commission’s arbitrary opioid conversion ratios in OCT have punished physicians, as a class, more harshly than they have punished illicit drug dealers; this violated the Equal Protection Clause and Due Process Clause of the Fifth Amendment and the Cruel and Unusual Punishment Clause of the Eighth Amendment; and (4) prescription opioids should convert to only a small fraction of heroin equivalents.
Brief Amicus Curiae of PAA so concluded: “In analyzing the root cause of the near 99% success rate of convictions against physicians, PAA concluded that what it all boiled down to was a prosecutor with a hunch hiring an expert using the deep pockets of the government, often not in the same field as the accused physician, to criminalize behavior of the accused physician.” (Brief Amicus Curiae of Physicians Against Abuse. p. 2).