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Why Should the Supreme Court Take This Case
Xiulu Ruan, MD, December 25, 2020
INTRODUCTION
This case presents the Court with an opportunity to evaluate the federal regulation 21 C.F.R. Subsection 1306.04 and the related Supreme Court case, United States v. Moore, 423 U.S. 122, which was established in 1975. This regulation is confusing, and its applications by district and appellate courts are often inconsistent, or even conflicting.
The key phrase, “outside the usual course of professional practice,” derived from Subsection 1306.04 and Moore, is so vague that it essentially becomes whatever the paid government experts say it is. Not only is this standard subject to different expert opinions, but the Moore Case Law is subject to the caprice of the courts. Its equivocal uses have resulted in many healthcare professionals being unjustly convicted as drug “pushers.” This criminal standard has a chilling effect on clinicians who in good faith prescribe controlled medications to treat their patients. Under the present law, good faith and legitimate medical purposes are not even an allowable defense. This is unfair.
I respectfully make this plea to the Court: The misinterpretation and misapplication of Subsection 1306.04 and Moore’s “outside the usual course of professional practice” rendered my criminal proceedings fundamentally unfair and violated my due process rights.
FACTUAL BACKGROUND AND PROCEDURAL HISTORY
Physicians Pain Specialists of Alabama (PPSA) was founded by Dr. John Patrick Couch in 1998. Dr. Couch’s primary specialty was anesthesia; he achieved four medical board/subspecialty board certifications (Tr. 2/13/17, p. 5453-54). My primary specialty was physical medicine and rehabilitation; f achieved eight board/subspecialty board certifications (Tr. 2/14/17, p. 5644). Both Dr. Couch and myself were fellowship-trained interventional pain specialists (Tr. 2/13/17, p. 5451), (Tr. 2/14/17, p. 5640). In fact, I was the 81st physician in the nation and the second in the State of Alabama, who became board certified by the American Board of lnterventional Pain Physicians (Id., p. 5643).
When I first joined PPSA in 2003, it had only seven employees (Id,. 5674). To better serve patients of PPSA, Dr. Couch and I founded C&R Pharmacy in late 2010. By 2015, PPSA and C&R Pharmacy had close to 60 employees (Tr. 2/14/17, p. 5648). Despite its rapid growth, PPSA had always maintained its policies of “No Cash-Payments” and “All Patients Require Referrals” since its inception in 1998.
At the time of our arrest in May, 2015, PPSA had 8,000 active patients (Tr. 2/13/17. p. 5455-56), including 445 patients on spinal infusion pump therapy (Tr. 2/8/17, p. 4834). [In patients who had failed other conventional therapies and could not tolerate further opioid dosage increase due to side effects, we surgically implanted spinal infusion pumps to deliver minute amount of opioid directly into the spinal canal. This advanced therapy could provide improved pain control and reduce the overall systemic opioid dose by a factor of 100 to 200 (Tr. 2/15/17, p. 5944-45).]
Alf three versions of the Indictments alleged that Dr. Couch and I practiced not for a legitimate medical purpose and outside the usual course of professional practice, in violation of Controlled Substances Act (CSA). In the Second Superseding Indictment, it states:
“Ruan and Couch ran what was, in essence, a pill mill. Their primary method of pain management was writing multiple prescriptions for high doses of Schedule 11, Ill, IV Controlled Substances” (p. 8)
“Title 21, Code of Federal Regulations, Section 1306.04(a), states that a valid prescription for a Controlled Substance must be issued for a legitimate medial purpose by an individual practitioner acting in the usual course of his professional practice.” (Id., p. 4-5)
Both Dr. Couch and myself had filed pretrial motion (Doc;. 376 and Doc;. 374, respectively) seeking counts dismissal or some or the charges alleging our violation of CSA, for example, my motion specifically argued:
“The provisions of the CSA at issue here, 21 U.S.C. Subsections 841 and 846, violated the Due Process Clauses of the Fifth and Fourteenth Amendments of the United States Constitution, because those provisions are unconstitutionally vague…sections 641 and 640 or title Act are vague and constitutionally infirm, because the statutory framework, controlling regulatory authority, and case law fail to define the conduct proscribed by the Act with sufficient definiteness that a physician would know what conduct is prohibited and, therefore, encourages arbitrary and discriminatory enforcement.” (Doc. 374, p. 1).
Judge Granade denied our motions, and the jury trial began on January 4, 2017. However, there were many discrepancies between the Indictments and the actual trial presentation. To give one example, the Indictments repeatedly stated that we practiced not for a legitimate medical purpose, yet, in the prosecutor’s opening statement, Mr. Bodnar actually conceded that we practiced for a legitimate-medical purpose:
“A lot of patients that went to PPSA…had legitimate medical problems where pain medicine may have been appropriate. But just because there is legitimate medical need for controlled substances does not make the prescription legal if it is prescribed outside the usual course of professional practice.” (Tr. 1/5/17. p. 27)
“A lot of patients that came there were legitimate patients with legitimate pain…there were definitely some that were treated very appropriately in his office. There is no question of that, that there were certain cases where Dr. Ruan and Dr. Couch did a really good job for their patients…Most will have legitimate pain, and opioids and other pain killers for people with legitimate pain is in most cases for a legitimate medical purpose. But there has to be the second prong, was it also in the usual course of professional practice[?].” (Id., p. 45-46)
The above statements squarely show that we practiced for a legitimate medical purpose even in the government’s own eyes. Mr. Bodnar would not have said so had there been a scintilla of evidence showing the contrary.
After a seven-week jury trial, Dr. Couch was convicted on all of the Counts charged, while I was convicted on 15 Counts involving RICO, controlled substances, healthcare fraud and anti-kickback conspiracies, and substantive drug and money laundering Counts {I was acquitted of one substantive drug Count, namely Count 10). I was sentenced to 252 months imprisonment, four years supervised release and $15.239.369.93 restitution. Respecting my direct appeal, the Eleventh Circuit panel reversed and remanded on Count 16, affirming all other convictions. My petition for an en banc hearing was subsequently denied on November 4, 2020.
ANALYSIS
Vagueness of 21 C.F.R. Subsection 1306.04 and Its Conflicting Interpretations by District and Appellate Courts
Relevant Federal Law and Moore Case Law
Under the CSA, it is unlawful for “any person” knowingly and intentionally to distribute or dispense a controlled substance. 21 U.S.C.S. Subsection 841(a). Although the CSA makes exceptions to this prohibition for certain individuals who are registered as “practitioners” under the Act, such as physicians and pharmacists, this Court has held that these practitioners are still subject to criminal prosecution “when their activities fall outside the usual course of professional practice.” United States v. Moore (1975), 423 U.S. 122, 124, 96 S. Ct. 335, 46 L. Ed. 2d 333.
In Moore, the defendant, Dr. Moore, a physician, was convicted of violating 21 U.S.C.S. Subsection 841(a)(1) for prescribing large quantities of methadone to drug addicts and charging sliding scale fees based on the amount of methadone prescribed. The Court explained that even though the physician could be prosecuted for the relatively minor offense relating to issuing of prescriptions in violation of Subsection 829, he was not exempted from prosecution under Subsection 841(a)(1) for the significantly greater offense of acting as a drug “dealer.”
CSA, however, does not define what the “outside the usual course of professional practice” is. In fact CSA text does not even contain this term. CSA convictions rely on relevant regulations such as 21 C.F.R. Subsection 1306.04. In our case, United States v. Ruan, 966 F.3d 1101; 2020 U.S. App. LEXIS 21367 (11th Cir. 2020}, the Eleventh Circuit stated that “such prescriptions are only lawful if they are issued for a legitimate medical purpose in the usua1 course of the licensed healthcare professional’s professional practice.” (See 21 C.F.R. Subsection 1306.04) (Id., at 8)
Thus, the Eleventh Circuit explicitly expressed that the “usual course of professional practice” referred to should be of that Individual practitioner’s “usual course- of professional practice,” not someone else’s. Reasoning along this line, my “usual course of professional practice” in the capacity of a well-trained board certified interventional pain specialist ought to be different from that of government expert witnesses, such as Drs. David Greenberg and Tricia Aultman, because they were not pain management specialists. (Discussed later.)
Confusion and Vagueness of 21 C.F.R. Subsection 1306.04 and Why the Court Should Take the Instant Case In United States v. Davis (2019), 139 S. Ct. 2319; 204 L. Ed. 2d 757; 2019 U.S. LEXIS 4210, the Court held:
“(W]hen congress passes a vague law, the role of courts under the Constitution is not to fashion a new, clearer law to take its place, but to treat the law as a nullity and invite the Congress to try again…The doctrine prohibiting vague laws rests on the twin constitutional pillars of due process and separation of powers.”
“Vague laws contravene the first essential due process of law that statutes must give people of common intelligence fair notice of what the law demands of them…Vague statutes threaten to hand responsibility for defining crimes to relatively unaccountable police, prosecutors, and judges, eroding the people’s ability to oversee the creation of laws they are expect to abide.” (Id., at 766)
Lack of Statutory Definition of “Usual Course of Professional Practice” and “Legitimate Medical Purpose” and Conflicting Interpretation by the Fifth and Eleventh Circuits and District Courts
Neither “usual course of professional practice” nor “legitimate medical purpose” has any statutory definition. As mentioned before, CSA convictions rely on the languages used in related regulations, namely 21 C.F.R. Subsection 1306.04.
Unfortunately, this statute does not define these terms either. It is not even clear whether Subsection 1306.04 treated these terms as one element, i.e. “legitimate medical purpose,” or two elements, i.e. “legitimate medical purpose” and usual course of professional practice.” Most appellate courts and district courts interpreted Subsection 1306.04 as having two elements, but the Fifth Circuit, the predecessor of the Eleventh Circuit held differently. (See below.)
Remarkably, Subsection 1306.04 is stated in an affirmative tone: “for it to be effective [or valid] ” However, when a statement in a negative tone (e.g., “for it to be ineffective [or invalid]” was used by the district and appellate courts, either to secure or sustain convictions, the problem becomes messy. For example, in United States v. Rosen, 582 F.2d 1032; 1978 U.S. App. LEXIS 8109 (5th Cir. 1978), the Fifth Circuit stated:
“To Convict…in violation of 21 U.S.C.S 841(a)(1) that he did so other than for a legitimate medical purpose and in the usual course of professional practice.” (Id., at 1033) (Rosen Court Language, RCL)
By contrast, in United States v. Feldman, 2016 U.S. Dist. LEXIS 66868 (M.D. FL, 2016), the district court stated:
“Dr. Feldman prescribed controlled substances for other than legitimate medical purpose NOT in the usual course of professional practice.” (Id., at 5) (Feldman Court Language, FCL, emphasis added) Evidently, the Feldman Court considered Subsection 1306.04 offense involving two elements, unlike the Fifth Circuit. In its instruction on the element of offense for violation of 21 U.S.C. 841(a)(1), Modern Federal Jury Instruction (MFJI) states: “First…Second Third, that the defendant dispensed the drug other than for a legitimate medical purpose and NOT in the usual course of professional practice.”{[3]-[56] Modern Federal Jury Instruction-Criminal, 56.02 (Matthew Bender, June, 2020, emphasis added)}
MFJI explicitly uses FCL, not RCL. To argue that RCL and FCL are the same is to violate the Law of Non-Contradiction, which dictates that contradictory propositions cannot be both true at the same time and in the same sense, i.e., the two premises “A is B” and “A is not B” are mutually exclusive and therefore cannot be both true. The modifier “NOT” in FCL and MFJI makes it opposite in meaning respecting “usual course of professional practice” as in RCL. Since only one can be correct, and if I assume FCL and MFJI are correct, then RCL must be wrong.
The problem is obvious because both FCL and RCL are interpretations of the same regulation, namely 21 C.F.R. Subsection 1306.04, used in 21 U.S.C. 841(a)(1) convictions of healthcare professionals, and these opposing interpretations regarding the element of “outside the usual course of professional practice” indicate Subsection 1306.04 and its application is confusing because even courts could not interpret or apply it without contradiction.
Remarkably, the Fifth Circuit later dubbed RCL as an example of “single element offense” In United States v. Fuchs, 467 F.3d 889; 2006 U.S. App. Ll:XIS 25749 (5th Cir. 2006) (“Rosen listed as a single element of the offense that the dispensing be done other than for a legitimate medical purpose and in the usual course of professional practice.”) In other words, Subsection 1306.04 was interpreted as a single element offense in RCL, in contrast to the two-element offense, interpreted and applied by other appellate and district courts that were on the side of FCL.
In United States v. Orta-Posario, 469 Fed. Appx. 140; 2012 U.S. App. 496 Fed. Appx. 140; 2012 U.S. App. LEXIS 5569 (4th Cir. 2012), for example, the Fourth Circuit interpreted Subsection 1306.04 in a rather convoluted way: “In order to prosecute the Defendants…the Government must prove that the controlled substance was not prescrlbed ONLY’ for a legitimate medical purpose by an individual practitioner acting in the usual course of professional practice.’ 21 C.F.R. Subsection 1306.04 (a).” (Emphasis added.) The word “only” is not only unnecessary, but mistaken. (The above statement also contains RCL.)
Although most appellate and district courts used languages analogous to FCL, RCL was still frequently used Improperly by the Eleventh and Fifth Circuits as well as certain by district courts within these sister circuits. For example, in United States v. Craig, 2020 U.S. App. LEXIS 24468 (5th Cir. 2020), the Filth Circuit, without using the term “single element offense,” held, “Later cases in our court…have upheld convictions for ‘distributing a controlled substance under 21 U..S.C. Subsection 841’ when the Government proves: ‘(1)…(2)…and (3) that [the doctor] did so other than for a legitimate medical purpose and In the usual course of [the doctor’s] professional practice,’ e.g., United States v. Evans, 892 F.3d 692, 703 (5th Cir. 2018).” (Notice RCL was used in Craig.)
Further, RCL was cited by several district courts in the Fifth and Eleventh Circuits, e.g., United States v. Webman, 2014 U.S. Dist. 27504 (N.D. GA, 2014); United States v. Roland, 2016 U.S. Dist. LEXIS 196922 (N.D. GA, 2016); United States v. Ruble, 2016 U.S. Dist. LEXIS 58972 (S.O. GA, 2016); United States v. Buckingham, 2018 U.S. Dist. LEXIS 210350 (N.D. AL, 2018); United States v. Gayden 2018 U.S. Dist. LEXIS 233935 (M.D. FL, 2018).
Similarly, the Eleventh Circuit has used RCL in many of its appellate rulings, e.g., in 2020 alone, in United States v. Ignasiak, 808 Fed. Appx. 709; 2020 U.S. App. LEXIS 9774; United States v. Bacon, 809 Fed. Appx. 757; 2020 U.S. App. LEXIS 11514; United States v. lriele, 977 F.3d 1155; 2020 U.S. App. LEXIS 32102; and in our case, United States v. Ruan, 966 F.3d 1101; 2020 U.S. App. LEXIS 32102 (11th Cir. 2020) [“In order to secure a conviction for unlawfully dispensing under Subsection 841 (a)(1), the government must prove that the defendants ‘dispensed controlled substances for other than legitimate medical purpose in the usual course of professional practice.’ United States v. Azmat, 805 F.3d 1018, 1035 (11th Cir. 2015) (quoting Ignasiak, 667 F.3d at 1227)”).
The above quoted statement, literally, means that my practice was inside, rather than outside, the usual course of professional practice. Since the prosecutors had already explicitly conceded that our practice was “for legitimate medical purpose” (shown earlier), and the Eleventh Circuit cited Azmal using RCL and concluded that our practice was “in the usual course of professional practice,” my convictions, therefore, require reversal.
Circuit Courts’ Differing Opinions Respecting “No Legitimate Medical Purpose” and “Outside the Usual Course of Professional Practice”
In United States v. Rottschaefer, 178 Fed. Appx. 145; 2006 U.S. App. LEXIS 10504 (3rd Cir. 2006), the Third Circuit held: “[There is considerable room to doubt whether the distinction between the ‘no legitimate medical reason’ and the ‘outside the usual course of professional practice’s standards’ is of any importance. Nelson 383 F.3d at 1231 [10th Cir. 2004}. Several courts have held that there is no difference-In the meanings of the statutory phrase, ‘in the usual course of professional practice’ and the regulation’s phrase, ‘legitimate medical purpose.’ United States v. Kirk, 584 F.2d 773, 784 (6th Cir. 1978)0; the Fourth Circuit of Appeals goes even further holding that the ‘without medical purpose’ standard that Rottschaefer challenges is ‘more strict than [the ‘outside the usual course of professional practice’s standard] required by Moore. United States v. Cuong, 18 F.2d 1132, 1138 (4th Cir.1994).”
“As the Nelson Observed: ‘ft is difficult to imagine circumstances In which a practitioner could have prescribed controlled substances within the usual course of professional practice but without a legitimate medical purpose. Similarly, it is difficult to imagine circumstances in which a practitioner could have prescribed controlled substances with a legitimate medical purpose and yet be outside the usual course of professional practice. 383 F.3d at 1231″‘
In United States v. Armstrong, 550 F.3d 382; 2008 U.S. App. LEXIS 25289 (5th Cir. 2008), the Fifth Circuit noted that the two clauses “legitimate medical purpose” and “usual course of professional practice” are often used interchangeably. (Id., at 395) It further acknowledged that “for other than legitimate medical purpose” places a heavier burden on the government than otherwise required to establish criminal liability than “outside the usual course of professional practice.” United States v. Mciver, 479 F.3d 550, 559 (4th Cir. 2006) (citing United States v. Alerre, 430 F.3d 681, 690-91 (4th Cir. 2005).
In our case, United States v. Couch, 2016 U.S. Dist. LEXIS 177947 (S.D. AL, 2016), Judge Granade denied our motions asking for dismissing some of the counts relating to CSA violations in the Second Indictment, where the vagueness of Subsection 841 (a)(1) and Subsection 846 was raised. In that motion, we specifically challenged the vagueness of the language “legitimate medical purpose” and “usual course of professional practice.” In denying our motion, Judge Granade stated:
“No case law is before the Court suggesting that courts have grappled with what qualifies as “not for a legitimate medical purpose” or “outside the usual course of professional practice.” Instead, cases have repeatedly upheld convictions for physicians who abused their exemption under the CSA.” (Id., at 4)
However, based on the widespread and long-standing history of the misinterpretation of 21 C.F.R. 1306.04 shown above, Judge Granade’s foregoing statement is inaccurate. Furthermore, the touted success of guilty convictions and affirmations based on the inconsistent and even contradictory interpretation and application of law runs afoul of the constitutional rights of the accused and renders the trial and appellate criminal proceedings fundamentally unfair.
The Court should take the instant case to revisit these discrepancies in the interpretation of 21 C.F.R. 1306.04 in CSA convictions and exercise its supervisory power to clarify and correct them for the lower courts so as to set a uniform standard in interpreting and applying this confusing federal law. This is the first reason that the Court should take the instant case.
The Prosecutor’s Concession of Our “Legitimate Medical Purpose” and Why My Convictions Should Be Reversed
On the aforementioned basis, namely that “not for a legitimate medical purpose” and “outside the usual course of professional practice” are used interchangeably and that the former is even considered a heavier burden than the latter, my convictions, then, require reversal because the prosecution had squarely conceded that we prescribed controlled medications for a legitimate purpose. Recall that, in his opening statement, Mr. Bodnar stated:
‘There were definitely some that were treated very appropriately …there were instances where Dr. Ruan and Dr. Couch did really a good job for their patients…And opioids…for people with legitimate pain is in most cases for a legitimate medical purpose. But there has to be the second prong, was it also in the usual course of professional practice[?]” (Tr. 1/5/17, p. 46)
When Mr. Bodnar stated “But there has to be the second prong…,” he implied that we had passed the first prong, namely “for a legitimate medical purpose.” Pursuant to the aforementioned criteria, we should never have been convicted for CSA violations. On the other hand, the Eleventh Circuit in its ruling of our direct appeal cited that we acted “not for a legitimate medical purpose” or its equivalent more than 20 times. The Eleventh Circuit’s opinion was at odds with the trial evidence presented, because our trial could not have presented evidence consistent with our practice acting “not for a legitimate medical purpose,” as Mr. Bodnar had conceded this in his opening statement.
Trial Court Provided Erroneous Jury Instruction Respecting Crime Element and Tailored Its Jury Instruction to the Prosecutor’s Opening Statement
On Day 1 of the trial, before the prosecutor gave his opening statement, Judge Granade gave the following jury instruction: “For each of those substantive counts…can be found guilty…first…second…third, that the defendant did not have a legitimate medical purpose in the usual course of professional practice for doing so.” (Tr. 1/5/17, p. 16)
I will refer this instruction as Version 1. In it there is the sentence, “did not have a legitimate medical purpose in the usual course or proress1ona1practice: which is the RCL. This Instruction is erroneous because it is diametrically opposite lo that of MFJI, which states:
“First…Second…Third, that the defendant dispensed the drug other than for a legitimate medical purpose and NOT in the usual course of medical practice.” {[3]-[5] Modern Federal Jury Instruction-Criminal, 56.02 (Matthew Bender, June, 2020)} (emphasis added)
This error is a serious one because it contradicts MFJI on the element of the offense. It shows that Judge Granade did not understand Subsection 1306.04 and she incorrectly stated the law when she gave the jury instruction, instructing the jury to find the defendants guilty, even if we practiced within the usual course of professional practice. This further shows that the language of Subsection 1306.04 is vague and confusing, even Judge Granade failed to correctly understand it, let alone properly apply ii.
Rule 24.1(a) of the Supreme Court states: “At its option, the Court may consider a plain error not among questions presented but evident from the record and otherwise within its jurisdiction to decide.”
In Silber v. United States (1962), 370 U.S. 717, 8 L. Ed. 798, 82 S. Ct. 1287, the Supreme Court held that “while ordinarily we do not take note of error not called to the attention of the Court of Appeals not properly raised here, that rule is not without exception. The Court has the power to notice a ‘plain error’ though it was not assigned.” (Citation omitted.) “In exceptional circumstances, especially in criminal cases, appellate courts, in the public interest, of their own, notice errors- to which no exception has been taken if the errors are obvious, or If they otherwise seriously affected the fairness, integrity, or public reputation of judicial proceedings.” (Citation omitted.)
Whether this error is “plain” enough is up to the Court; nonetheless, it is a serious error, especially considering that not only did Judge Granade fail to recognize it, but the Eleventh Circuit has been unable to recognize this decades-long error. The Court should use this instant case to (1) revisit this long-standing issue problematic interpretation and application of Subsection 1306.04 and (2) notice and correct the aforementioned jury instruction error by Judge Granade pursuant to Rule 24.1(a).
On Day 28 of the trial,’ Judge Granade gave the jury the following charge:
“The defendant can be found guilty of each offense only if all of the following facts are proved…one…two…three, the defendant did not have a legitimate medical purpose to do so or did not do so in the usual course of professional practice.” (Tr. 2/17/17, p, 6235)
“Thus a medical doctor has violated Section 841 when the government has proved beyond a reasonable doubt that the doctor’s actions were either not for a legitimate medical purpose or were outside the usual course of professional practice.” (Id., p. 6236)
I will refer to the above instructions as Version 2. Version 1 and Version 2 differ significantly: (a) the RCL in Version 1 was no longer seen in Version 2; (b) what replaced RCL was the statement, “the defendant did not have a legitimate medical purpose …or did not do so in the usual course of professional practice,” which resembled FCL and MFJI. This change happened after Judge Granade had heard Mr. Bodnar’s opening statement in which he had conceded that our practice at PPSA was for a legitimate medical purpose, and that the prosecution was after the second prong, “outside the usual course of professional practice.”
Judge Granade amended her jury instruction according to the prosecution’s presentation. Instead of using the RCL single element offense theory, Judge Granade instructed the Jury to consider both elements, either “did not have a legitimate medical purpose,” or “did not do so in the usual course of professional practice.”
The Moore Case Law Should Not Apply to My Case
Dr. Moore was convicted of violating 21 U.S.C.S. Subsection 841(a)(1) for allegedly prescribing large quantities of methadone to treat heroine addicts and charged sliding-scale fees based on the amount of methadone prescribed. In Moore, the government’s position was that Dr. Moore’s conduct was inconsistent with all accepted methods of treating addicts, i.e. he In fact operated as a drug “pusher.” The narrow sets of facts In Moore, according to this Court, determined that Dr. Moore was prosecuted under the steeper Subsection 841(a)(1), rather than Subsection 829.
Our case, however, is way different. Both defendants were fellowship-trained, multi-board certified interventional pain management physicians who had provided multidisciplinary pain management to patients suffering from chronic pain. There is a material difference between our case and Moore. There was ample evidence showing that PPSA utilized a multi-disciplinary approach in treating chronic pain. For example, my expert witness Dr. Jeff Gudin [fellowship-trained and quadruple-board certified in anesthesia, pain management, addiction medicine, and hospice and palliative care medicine (Tr. 2/10/17, p. 5159- 10)] testified:
“There wasn’t a single chart of Dr. Ruan’s I reviewed that did not include, what we call in the pain field, multimodal techniques. That means Dr. Ruan tried everything at hand…physical therapy and behavior therapy, injections…medicine that had nothing to do with opioids… So every chart contained numerous attempts at finding treatment other than opioids to manage the pain.” (Id., p. 5127-28)
Dr. Christopher Gharibo [fellowship-trained and double boarded in anesthesia and pain management and also an Associate Professor of Anesthesiology and Orthopedics at the New York School of Medicine (Tr. 2/15/17, p. 5932-33)] testified:
“I found Dr. Ruan’s treatment in many ways exemplary…lt was quite impressive and exemplary treatment…that’s evidence of somebody who is highly skilled…Dr. Ruan engaged in more advanced interventional therapies…encouraged them to have a drug delivery system implanted…where you can cut down the overall dosing…by a factor of 100 to 200” (Id., p. 5944-45).
Dr. Gharibo was appreciative that we made use of spinal infusion pumps in selected patients so as to cut down the overall opioid dosage patients received “by a factor of 100 to 200.” Dr. Gharibo also testified that, “Dr. Ruan’s care was clearly mufti modal and multi-disciplinary that it was clearly in the higher end of the standard of care.” (Id., p. 5945)
Dr. Couch’s expert witness, Professor Carol Warfield [a world renowned pain management expert, the Lowenstein Distinguished Professor of Anesthesia at Harvard Medical School under whom the pain management clinic of Beth Israel Hospital of Harvard Medical School was named (Tr. 2/8/17, p. 4661)] testified that Dr. Couch “used a number of nonopioid medications … lots of nerve blocks…various treatments in addition to opioids.” (ld., p. 4667.) She also opined: “[T]here were also a number of other treatments, which is very, very typical of a pain management center a combination of nerve blocks, epidural steroid injection, other type of medications along with opioids.” (Id., p. 4669)
Based on the above testimony, PPSA was completely distinguishable from Moore. The specific set of facts in Moore were lacking in our case, we should not have been indicted under CSA 841(a)(1), let alone being so convicted and affirmed by the Eleventh Circuit.
Moore’s “Outside the Usual Course of Professional Practice” Is Pliable and Insidious
Since there is no statutory definition of “outside the usual course of professional practice,” this standard can be easily manipulated by the prosecution. On the one hand, on its face, it sounds benign or harmless, but that is only a misconception. When this Court used the term “outside the usual course of professional practice” to prosecute Dr. Moore 45 years ago, it represented an element of crime used to penalize drug dealers and drug kingpins. It was based on a narrow set of facts, where Dr. Moore allegedly prescribed large quantities of methadone to drug addicts and charged sliding-scale fees based on the amount of methadone prescribed, i.e., Dr. Moore allegedly acted as a drug “pusher.” In other courts, “outside the usual course of professional practice,” unlike other crimes such as murder, rape, or bank robbery, with which the jurors are a lot more familiar, few jurors can truly appreciate the gravity of this term.
When courts used “outside the usual course of professional practice” to explain the criminal liability standard, namely “outside the usual course of professional practice,” the entire reasoning was circular, which would not help the jury to understand what exactly the criminal liability standard meant. Most significantly at my trial, the Moore’s language “outside the usual course of professional practice” was used equivocally to the disadvantage of the defendants. The vagueness of this term allows the government experts to say whatever they are paid to say. The prosecutorial strategy was to have the jury hear this term as often as possible. For example, in the direct examination Dr. David Greenberg alone. the jury heard “usual course of professional practice” more than 70 times (Tr. 1/12/17, p. 578-93).
Government’s Expert Testimony of My “Outside the Usual Course of Professional Practice” Was Unreliable
The prosecutors clearly knew the specific qualifications required for being a pain management specialist because they correctly placed the Pain Physician Criteria (PPC) in our First Superseding Indictment, which states:
“The discipline of pain medicine is an accepted and recognized medical subspecialty…Legitimate and qualified medical experts have specialized knowledge, education, training, and experience and utilize a multi-disciplinary approach…is recognized by state regulatory boards as a subspecialty of anesthesiology, physical medicine and rehabilitation, neurology, and psychiatry, which are recognized as primary specialties… Fellowship training programs exist for purpose of further education in the subspecialty of pain medicine, making graduates eligible for board certification in pain medicine.” (1st Superseding Indictment, p. 1)
Based on the PPG, neither Dr. Aultman nor Dr. Greenberg weren’t even board eligible. Dr. Aultman completed a residency in internal medicine, not in one of the four primary specialties listed above. She worked as a hospitalist in a local Hospital (Tr. 2/6/17, p. 4225). Dr. Greenberg had not undergone residency training in any specialty.
An irony appearing in Dr. Aultman’s resume (provided by the government) is that she listed a detailed section called “DEA Experience,” which stood out, spanning from page 1 to page 2 of a loosely typed 2-page document. Unlike other physicians who would provide their special expertise, board certifications, academic affiliations, and clinical publications, Dr. Aultman’s CV provided something like this:
DEA Experience
Dr. Aultman’s DEA experience became her marketable expertise, and she actually bragged about her success in prosecution of other healthcare professionals as if she were a prosecutor. On this basis, her “expert testimony” would always be biased and prejudicial. She had pocketed huge sums of money from DOJ/DEA, over $325,000 (Tr. 2/6/17, p. 4406). Ironically, the money Dr. Aultman brought in matched the amount that Dr. Greenberg had collected working for DOJ/DEA, $320,000 (Tr. 1/23/17, p. 801-02).
The prosecutors retained Drs. Greenberg and Aultman because they would be willing to say whatever was needed as long as they got paid.
Both the District Court and the Eleventh Circuit Relied Heavily on Dr. Greenberg’s Testimony to Secure and Sustain My Convictions
Dr. Greenberg was the leading government expert witness. He was on the witness stand for two full days (Tr. 2/16/17, p. 6024). He reviewed 20 PPSA patient files (Tr. 1/12/17, p. 591). He was the only government expert who had reviewed five patients of mine that carried substantive drug counts, namely Diane Greathouse, Kimberly Lowe, Erick Gist, Deborah Walker, and John Bosarge (Count 8, 9, 10. 11, and 12, respectively). The trial record dedicated to Dr. Greenberg’s testimony was just shy of 400 pages (Tr. 1/12/17, p. 556-719 and Tr. 1/13/17, p. 734-956).
Dr. Greenberg’s testimony played a central role in securing and sustaining my convictions. His testimony was repeatedly referenced in the government’s brief by the DOJ Appellate Attorney, Sonja M. Ralston (dated October, 221 2018); In fact, it was cited 78 times (61 times in the text and 17 times in the footnotes). In its decision on my direct appeal .(United States v. Ruan, 966 F. 3d 1011; 2020 U.S. App. LEXIS 21367) (11th Cir. 2020), the Eleventh Circuit extensively cited Dr. Greenberg’s testimony in the Section of Discussion of Sufficiency relating to my substantive drug dispensing Counts 8, 9, 11, and 12, filling more than a dozen pages of the record (Id., at 49-63).
Dr. Greenberg Was Unqualified as a Pain Expert and His Testimony Was Unreliable
Dr. Greenberg admitted twice in his direct testimony that he did not have any residency training (Tr. 1/12/17, p. 563; Id., p. 564); yet, on cross-examination, he claimed he had done some pain procedures in his “residency.” (Tr. 1/13/17, p. 903). He admitted he was not board certified in pain medicine or pain management (Id., p. 784). He admitted that he .did not treat lower back pain or phantom limb pain (Id., p. 801). He also admitted that he had received about $320,000 for working for the DOJ/DEA as witness or consultant (Id.. p. 801). In addition, he admitted that he lied under oath when he testified in a State Court in Arizona in 2012 (Id., p. 848-49), and that he lied under oath in the instant trial (Id., p. 858). After completing his testimony, he told the prosecutors that he was just diagnosed to have dementia (Tr. 1/17/17, p. 965). Most remarkably, he told the prosecutors himself that he was unreliable and his facts were unreliable (Id., p. 964).
Inconsistencies, misinterpretations, contradictions, and errors were replete in Dr. Greenberg’s testimony. In fact, the prosecutors ended up filing a motion (under seal) over the weekend seeking a judicial order to disqualify Dr. Greenberg and his testimony on the ground of his “mental incompetency” (Id., p. 964). The motion states:
“At several points during both his direct and cross-examinations, Dr. Greenberg was confused about what material he had reviewed…This confusion appeared more pronounced toward the end of each day. Dr. Greenberg also appeared to struggle when asked to perform certain tasks…According to Dr. Greenberg, he received a call from his wife during lunch break on January 13, 2017…she informed him that test results showed he had early onset Alzheimer’s disease…Dr. Greenberg explained that he had been tested for dementia ‘two weeks ago’…He explained that he had been in denial until ‘he learned his fate’ from his wife…” (Motion Name, p. 2-3)
It also appeared that the prosecutors had negotiated with my counsel regarding some “damage control” measures. According to the email from my counsel Mr. Knizley to Dr. Couch’s counsel Mr. Sharman and others on January 15, 2017, the prosecutors appeared to have proposed:
“The plan of the government will be to strike the testimony and therefore exclude any effective closing argument about the witness, giving up the counts he talked about. They believe the strength of the rest of the case can prevail. Also they want a jury admonition by the court that the witness was a nut and we did not know it…”
Undeniably, all parties including Judge Granade knew that Dr. Greenberg and his testimony were unreliable. However, instead of throwing out Dr. Greenberg’s unreliable testimony, Judge Granade kept it and submitted it to the jury for deliberation.
Admission of Dr. Greenberg’s Legal Conclusion of Violated Rule 704(a) and the Equivocal Uses of Moore’s “Outside the Usual Course of Professional Practice”
In Commodores Entm’t Corp. v. McClary, 879 F.3d 1114; 2018 U.S. App. LEXIS 518 (11th Cir. 2018), the Eleventh Circuit held that, according to the Federal Rules of Evidence (Fed. R. Evid.) Rule 704(a), “Experts may not testify to the legal implication of conduct or tell the jury what result to reach. Rather, the court must be the jury’s own source of law, and questions of law are not subject to expert testimony. Courts must remain vigilant against the admission of legal conclusions, and an expert witness may not substitute for the court in charging the jury regarding the applicable law. Thus, a district court must take adequate steps to protect against the danger that an expert’s opinion would be accepted as a legal conclusion.
In United States v. Diaz, 876 F.3d 1194; 2017 U.S. App. LEXIS (9th Cir. 2017), the Ninth Circuit, however, allowed the government expert’s uses of phrases such as “outside the usual course of professional practice” and “legitimate medical purpose.” It reasoned that “these phrases were used in their ordinary, everyday sense and do not ‘have a separate, distinct and specialized’ legal significance apart from common parlance.”
To me, that is exactly the root of the problem with the Moore language, “outside the usual course of professional practice.” Essentially, these phrases have been used by the courts equivocally. For example, when examined for admissibility, the court would argue it in their “ordinary” and “everyday sense” usefulness, thus justifying its admission. Once admitted, these “ordinary” statements morph into “crime-element containing” or “legal conclusion-reaching” statements that equate them to the criminal liability standard used to penalize drug kingpins.
The ploy of using such language equivocally by the courts allowed the government experts to improperly infuse the jury with the term “outside the usual course of professional practice” during their testimony, therefore, conditioned the jurors’ minds to falsely conclude that the physicians practiced “outside the usual course of professional practice,” even though the jury was never clearly instructed as to what the term really entailed.
Had the language been clear-cut and specific such as those in the crime elements of murder, bank robbery. or kidnapping, it would have been obvious that such language drawing legal conclusions by experts would not be allowed. This Is precisely why the Moore language “outside the usual course of professional practice” is so insidious and deceiving, and courts have misused and even abused It in unfairly prosecuting physicians who provided needed medical care to their patients, in violation of the accused’s due process rights. This Is one of the most important reasons why the Court should take the instant case to revisit the 45 year-old Moore Case law, examining the problems associated with equivocal use of Moore’s language “outside the usual course of professional practice.” As shown below, this term was a catchall phrase at my trial.
Examples of Low-Threshold at Which “Outside the Usual Course of Professional Practice” Was Used at Trial
In direct examination of Dr. Greenberg by Ms. Griffin regarding the care rendered ta my patient Deborah Walker (Count 11):
Q You didn’t notice any initialing on the lab report to show that Dr. Ruan had reviewed the lab report showing the inconsistencies?
A No, I didn’t see that.
Q Would that be outside the usual course of professional practice, rather than just a mistake to inquire about the inconsistent drug test?
A Yes…(Tr. 1/12/17, p. 640).
Regarding the care rendered to Diane Greathouse (Count 8):
Q And was that prescribing outside the usual course of professional practice?
A Yes, absolutely. (Id_. p. 651)
Regarding the care rendered to patient Kimberly Lowe (Count 9):
Q Did you determine there were any referrals to a psychiatrist or any kind of physical therapy? A No…
Q Is that outside the usual course of professional practice for the pain clinic?
A Yes, I would say so. Absolutely. (Id., p. 641)
Dr. Greenberg criticized me extensively on my care to patient John Bosarge (Count 12), taking seven pages of trial transcript (Tr. 1/12/17 ,p. 615-622). Mr. Bosarge was referred to me by Dr. Regina Benjamin [the former Surgeon General of the United States (Tr. 1/13/17, p. 872)] for his lower back pain and knee pain. Mr. Bosarge had history of 11 right knee surgeries and one left knee surgery for severe gouty arthritis. He also had colon cancer and history of partial colon resection. Dr. Greenberg’ chief criticism was that I put him on butorphanol without first detoxing him off his opioids, and that butorphanol was a poor choice of drug because it would increase cardiac workload, in view of Bosarge’s high blood pressure. The following dialogue occurred during direct examination of Dr. Greenberg by Ms. Griffin:
Q …[H]e was given …butorphanol?
A Yeah.
Q And the controlled substance opioids, is that right?
A Yes; that’s correct. And that was without recommended detoxification…prior to being put on the butorphanol.
Q [H]ave you determined if his treatment by Dr. Ruan was outside the usual course of professional practice?
A Most definitely it was outside the usual course of professional practice. The package insert is full of all types of warnings…(ld, p. 621-22)
Q Does it have any impact on the heart?
A Yes, it does. That particular medication increases the amount of work that the heart has to perform…
Q So that would be outside the usu.al course of professional practice?
A Yes, outside the usual course of professional practice (Id., p. 619).
The next day, in cross-examination, it was revealed butorphanol was not prescribed by me; it was prescribed by Dr. Benjamin (Tr. 1/13/17, p. 873-74). In the above testimony, Dr. Greenberg determined for the jury that my practice was “outside the usual course of professional practice.” He directly introduced the crime element, “outside the usual course of professional practice” prong, to substitute the jury’s legal conclusion, in violation of Rule 704(a). What made all this possible is the pliable and amorphous criminal liability standard, “outside the usual course of professional practice” from Moore.
Based on the above examples, “outside the usual course of professional practice” was used as an “everyday sense” catchall phrase. When such a pliable or essentially nonexistent standard is used, the accused is at the greatest disadvantage, because the “outside the usual course of the professional practice,” the criminal liability standard for prosecution under CSA 841 becomes whatever the paid government experts say it is.
The constitutional guarantee of the presumption of innocence is completely destroyed with the use of this catchall phrase, “outside the usual course of the professional practice,” because physicians prosecuted would need to take the stand to repute the government experts’ false testimony, line by line, sentence by sentence, to explain to the jury how they practiced in good faith to help their patients, and to defend every milligram of controlled medication that they prescribed in helping their patients. Thus, the government’s burden to prove the defendants’ guilt becomes the defendants’ burden to prove their innocence. Once convicted under Moore’s “outside the usual course of professional practice” criminal standard, the physicians would inevitably be subject to cruel penalties under the CSA 841(a). This is fundamentally unfair.
“Outside the Usual Course of Professional Practice” Was Improperly Elicited by the Use of Leading Questions in Violation of Rule 611 (c)
All of the foregoing sample testimony where the legal conclusion of “outside the usual course of professional practice” was elicited through improper use of leading questions. Leading questions are those that suggest a specific answer to the question and seek a “yes” or a “no” response. Rule 611(c) of Fed. R. Evid states “Leading questions should not be used on direct examinations except as necessary to develop witness’s testimony. “(Federal Court Rules, 2019)
Examining the rulings made by Judge Granade reveals a strange pattern. In the early phase of the trial when the prosecutors were the examining attorneys, Judge Granade largely allowed to prosecutors to lead. Later on, she started to reverse herself. In fact, she gave two admonitions against using leading questions. Both admonitions were to the defense counsel: “[B]but I won’t allow you to lead them.”(Tr. 1/25/17, p. 2472); “[But don’t lead her…(Tr. 2/13/17, p. 5397).
The first three objections occurred during Mr. Bodnar’s direct examination of the first government witness, DEA Diversion Investigator Susannah Herkert:
Q Fentanyl does not have a legitimate medical purpose, doesn’t it?
A Yes.
Mr. Knizley: Objection. Leading.
The Court: Overruled.
Q In your experience have you seen any pill mills with a cash transaction for over $20,000 worth of fentanyl?
Mr. Knizley: Objection. Leading.
The Court: Overruled
Q How about large volumes of the 60 and 80 OxyContin?
A Yes.
Mr. Knizley: Objection. Leading.
The Court: overruled (Tr. 1/5/17, p. 167-69)
Despite knowing that Rule 611(c) prohibits leading questions in direct examination, Judge Granade successively made erroneous, self-contradictory rulings, three in a row, to the first set of properly raised objections. These rulings sent a biased message to the prosecutors, signaling to them that their misconduct was condoned. At the same time, another subtext was sent to the defense: Don’t humiliate yourself by raising such questions as they would be overruled.
Thus, at the beginning of the trial, Judge Granade’s erroneous rulings clearly and arrogantly set a tone against the defense counsel, discouraging them from raising further objections to leading questions inappropriately utilized by the prosecutors. An additional harmful effect is that these rulings might have also sent a false impression to the jury, to imply that the defense counsel was perhaps unprincipled and desperate, who would try anything just to slow down the prosecutorial progression.
As a consequence, leading questions in direct examinations by the prosecutors became pervasive, persistent, and pronounced.
They were largely used to deliberately mislead the Jury by poisoning their minds with prejudicial and false testimony that could not have been brought to court without using leading questions. This rampant use of leading questions branched out from the first string of faulty rulings shown above.
Take for example the second leading question of the above: “In your experience have you seen any pill mills with a cash transaction for over $20,000 worth of fentanyl?” This question contains extremely prejudicial and false information and it could not be simply rephrased using open-ended questions. It implied that PPSA was in “cash transactions for $20,000 worth of fentanyl,” when Mr. Bodnar knew this was false because he had admitted in his opening statement that PPSA was not a “cash pay” clinic. (Tr. 1/5/17, p. 28) (“PPSA was not a cash pay only. In fact, they wouldn’t accept that.”)
When an insurance company pays for a branded product such as a medication, most of its cost is paid toward the proprietary right of that medication, rather than the material or the compound Itself. For example, considering Subsys, it is an uniquely patented sublingual spray system on which the company had spent a lot of money in its research and development, conducting clinical trials, getting FDA approval, obtaining patent right, and others, that ultimately makes Subsys an expensive drug. So the expression of “pill mills” with a cash transaction for over $20,000 worth al fentanyl” is ludicrous. Such exceedingly prejudicial testimonies via inappropriate leading questions from the prosecutors were commonplace during the government presentation.
Judge Granade’s rulings on objections raised to leading questions in direct examination revealed a disturbing pattern of inconsistency. For example, over a dozen times she overruled the defendant’s properly raised objections. (Tr. 1/6/17, p. 167; Id. p. 168; Id., p. 169; Tr. 1/19/17, p. 76; Id., p. 197; Tr. 1/24/17, p. 2454; Tr. 1/25/17, p. 2595; Tr. 1/26/17, p. 2975; Id., p. 2981; Tr. 1/30/17, p. 3369; Id., p. 3479; Id., p. 3488; Tr. 2/1/17, p. 3790)
In contrast, there was not a single ruling of “overruled” to more than a dozen objections raised by prosecutors to leading questions used in direct examination by the defense counsel (Tr. 27/17, p. 4501; Id., p. 4613; Id., p. 4653; Tr. 2/8/17, p. 4820; Tr. 2/9/17, p. 4948; Id:, p. 5064; Tr. 2/10/17, p. 5130; Id., p. 5224; Id., p. 5226; Id., p. 5630; Id., p. 5631; Tr. 2/13/17, p. 5388; Id., p. 5473).
The stark difference indicates a strong partiality, especially seen in light of Judge Grenade’s unilateral admonition to the defense counsel against the use of leading questions in direct-examination.
Both the Seventh Circuit and the Eleventh Circuit downplayed the harm of using leading questions, opining that most of the competent lawyers can rephrase a leading question to elicit the desired testimony [United States v. Coleman, 914 F.3d 508; 2019 U.S.. App. LEXIS 2196 (7th Cir. 2019); United States v. Roy 855 F.3d 1133; 2017 U.S. App. LEXIS 7354 (11th Cir. 2017)), but this argument does not apply to the crime-element-containing leading questions shown earlier in Dr. Greenberg’s direct examination. Those questions specifically adopted the crime element in 21 C.F.R. 1306.04 and Moore, i.e. “outside the usual course of professional practice,” and they could not have been rephrased and elicited using open-ended questions.
For this reason, such questions are extremely prejudicial because they were Introduced Into the court under the guise of “common sense language” but subsequently were used equivocally to mean crime element or legal conclusion to substitute the jury’s judgment. Such calculated misconduct by the prosecutors and their government expert witnesses, together with Judge Granade partial condoning and indulgence violated Rt.lie 704(a) and Rule 611(c) as well as my due process rights.
Government’s Creation of the Straw Man –Our Prescribing “Holy Trinity” and Imputing It to Our “Outside the Usual Course of Professional Practice”
Using “Holy Trinity” to Prejudice against the Defendants, the Government Introduced It to Represent An Addictive Cocktail
It is well recognized that the Christian Dogma of Holy Trinity, namely the Father, the Son, and the Holy Ghost, is a sacred unity that is worshipped by nearly all Christians. In my trial, the prosecutors intended it to mean an addictive cocktail of controlled substances. At the time of my arrest in May, 2015t there was only one reference in the PubMed database (the most authoritative scientific database), namely the article by Matthias Forrester entitled “Ingestion of Hydrocodone, Carisoprodol, and Alprazolam in combinations reported to Texas Poison Center,” published in April, 2011, in the Journal of Addictive Disease. In this paper, the combination of Hydrocodone, Carisoprodol, and Alprazolam was defined as “Holy Trinity,’ or “Houston Cocktail,” or “Trio.” This definition was cited in cases such as United States v. Geralt, 682 Fed. Appx. 394; 2017 U.S. App. LEXIS 4326 (6th Cir. 2017); United States v. Shelton, 369 F. Supp. 3d 824; 2019 U.S. Dist. LEXIS 28191 (2019); and United States v. lfediba, 2019 U.S. Dist. LEXIS 202017 (2019).
The Government Hired Dr. Sprague to Expand the Definition of “Holy Trinity” in Literature for Our Prosecution
In the Summer of 2016, one year after our arrest, the prosecutors Informed the defense that they would use Dr. Jon E. Sprague as their expert witness, who would testify on the danger of “Holy Trinity.” Dr. Sprague was associated with the Ohio Attorney General’s Center for Future of the Forensic Sciences.
In September 2016, about 16 months after our arrest, an article entitled “The Pharmacology and Toxicology of the “Holy Trinity,” by Joseph Horsfall and Jon E. Sprague, appeared online in a journal called “Basic & Clinical Pharmacology.” [Prior to this, Dr. Sprague had published a few dozen articles, but none involving any opioid, benzodiazepine, or carisoprodol. Horsfall had never published anything under PubMed.]
The definition of “Holy Trinity” in the Horsfall and Sprague paper was expanded; it included any opioid (not just hydrocodone), any benzodiazepine (not just alprazolam), and carisoprodol. The only paper they cited to support the definition of their newly expanded definition was the Forrester paper. Therefore, for the first time, a new but expanded definition of “Holy Trinity” appeared in medical literature. This new definition was introduced into our trial by DEA Diversion Investigator Susannah Herkert {Tr. 1/6/17, p. 122).
Under this new definition, more PPSA patients could be labeled as “Holy Trinity” recipients. (This was the purpose of the Sprague’s publication.) Nevertheless, even under the expanded “Holy Trinity,” only a very small fraction of PPSA patients received “Holy Trinity,” for example, about 5.2% of Dr. Couch’s patients received such combination prescriptions (Tr. 1/7/17, p. 392-93).
None from PPSA Side Knew What “Holy Trinity” Meant and Government Witnesses Testified It Was A Slang or Law Enforcement Term
There was no evidence that any PPSA patient or staff member ever used the term “Holy Trinity.” I testified that I had never heard of “Holy Trinity” in a pain clinic. Professor Warfield, a world-class pain expert under whom ‘the Pain Management Center at Beth Israel Hospital of Harvard Medical School was named (Tr. 2/8/17, p. 4661), testified that she had no idea what it meant other than its spiritual meaning (Tr. 2/8/17, p. 4702). Even cooperating government witness, Gary Douthitt, a former patient of mine, who was later unrelatedly charged with a felony for heroin trafficking, said he had no Idea what “Holy Trinity” meant (Tr. 1/30/17, p. 3448).
Several government witnesses testified that “Holy Trinity” was a slang term, or rather a law enforcement term, for example, Dr. Aultman acknowledged that il was a slang term (Tr. 2/6/17, p. 4370). DEA Agent Paul Short admitted that “Holy Trinity” was a slang word (Tr. 1/9/17, p. 390). Deputy Shawn Kelley told the jury that “Holy Trinity” was a “law enforcement term and they (PPSA staff and patients) would not use it.” (Tr. 1/20/17, p. 1806). Even Mr. Bodnar incidentally acknowledged that DEA Agent Paul Short’s working at DEA to be Short’s basis for being familiar with the term “Holy Trinity” in Paul Short’s direct examination by Mr. Bodnar (Tr. 1/9/17/, p. 350) (“Q: Based .on your experience working at DEA, are you familiar with a name for that drug combination? A: It’s often referred to as ‘Holy Trinity’.”)
Nothing Medically Wrong with “Holy Trinity” and Its Admission Was Repeatedly Objected to by the Defense
There is 11othing wrong medically to use such combinational drug therapy. Professor Warfield testified: “That Is absolutely within the usual course of professional practice…you can call it a cocktail…it’s done very commonly to treat anything,” (Tr. 2/8/17, p. 4706) Even government witnesses Dr. Aultman and DEA Diversion Investigator Herkert testified that there was nothing intrinsically wrong in prescribing such a drug combination (Tr. 1/30/17, p. 3276; Tr. 1/6/17, p. 145).
The defense counsel vehemently objected to its admission first during Herkert’s direct examination by Bodnar:
Q And is there a term for that type of — cocktail?
A Yes, it’s considered a drug cocktail, or the Holy Trinity.
Mr. Essig: Your Honor, I am going to object to that testimony.
The Court: On what ground?
Mr. Essig: There’s no relevance shown to this case whatsoever.
The Court: Overruled (Tr. 1/6/17, p. 121)
Another timely objection was raised during the sidebar discussion, where my counsel Mr. Gordon Armstrong repeatedly argued that “Holy Trinity” was a government argument:
“If you look at it…that’s purely argument…We think that’s inappropriate. We think that’s extremely prejudicial, it’s argument. It’s not in the data as cocktail. That’s government’s assertion…That’s not a medical term and that’s not in the data. That’s argument by the government. So we would object to that.” (Tr. 1/9/17, p. 251)
Counsel’s argument is not evidence. [Showan v. Pressdee, 922 F.3d 1211; 2019 U.S. App. LEXIS 12754 (11th Cir. 2019); United States v. Ganji, 880 F.3d 760; 2018 U.S. App. LEXIS 2279 (5th Cir. 2018)]. In fact, in Judge Granade’s preliminary jury instruction, she actually gave an admonition that “the statements, the arguments, and the questions by the lawyers are not evidence.” (Tr. 1/5/17, p. 8) Yet, Judge Granade contradicted herself when she improperly admitted “Holy Trinity” as evidence over the defense counsel’s correctly raised objections.
Massive “Holy Trinity” Related Testimonies Were Admitted over Defendant’s Objections
Judge Granade, in blatant partiality, overruled the above correctly raised objections. Massive testimonies related to “Holy Trinity” poured into trial court. The following government witnesses testified on “Holy Trinity”: DEA Diversion Investigator Susannah Herkert (Tr. 1.6/17, p. 121-22, Id., p. 173-74); DEA Analyst Paul Short (Tr. 1/9/17, p. 350-54); Deputy Patrick Shawn Kelley (Tr. 1/29/17, p. 1806-07); medical expert witness Rahul Vohra (Tr. 1/23/17, p. 2192-93, Tr. 1/24/17, p. 2434); United Healthcare representative Doug Moore (Tr. 1/25/17, p. 2633-34, Id., p. 2643); former PPSA nurse practitioner Bridgette Parker (Tr. 2/1/17, p. 3827); and medical expert witness Dr. Tricia Aultman (Tr. 2/6/17, p. 4253-54, Id., p. 4272-75, Id., p. 4278, Id., 4280, Id.. p. 4283-84, ld., p. 4287-88, Id., p. 4290, Id., p. 4292, Id., p. 4295).
The following examples are taken from Or. Aultman’s direct examination by Bodnar. This examination took place on Day 19 of the trial, with Dr. Aultman being government witness No. 56. The first three questions were related to Or. Couch’s patient Ms. Brenda Ward and the last question was related to my patient Ms. Sandra Wimberly.
Q So did she receive the Holy Trinity on this date?
A Yes, sir. (Tr. 2/6/17, p. 4278)
Q Even after being told she might be doctor shopping, she still received the Holy Trinity?
A Right.
Q Is that within the usual course of practice?
A No, sir. (Id., 4280)
Q Does she again continues month after month to get the Holy Trinity?
A Yes, sir. (Id.)
Q And here does it show with the Klonopin, the Soma, and the Opana that she is still receiving the Holy Trinity?
A Yes, sir. (Id., p. 4288)
First, none of the prescriptions described above met the true definition of “Holy Trinity” based on the original paper by Forrester, because none of the above was the hydrocodone, alprazolam, and carisoprodol combination. Under the new, expanded definition, however, Mr. Bodnar was able to put the label “Holy Trinity” on these prescriptions.
Second, Dr. Aultman concluded that the alleged prescribing “Holy Trinity” was “outside the usual course of professional practice,” namely the crime element itself in 21 C.F.R 1306.04. In other words, Dr. Aultman drew a legal conclusion for the jury to substitute’s the jury’s own, in violation of Rule 704(a).
Third, the introduction of “Holy Trinity” and “outside the usual course of professional practice” were done with the improper use of leading questions. This is actually a good example to show how rampant the prosecutorial leading questions were used, as a result of Judge Granade’s erroneous rulings on such questions. The testimony of “Holy Trinity” as well as the improper uses of leading questions started with DEA Diversion Agent Susannah Herkert, government witness No. 1, and were continuing during the examination of Dr. Aultman, government witness No. 56. This gives an idea how pervasive the prosecutors’ uses of leading questions were and how hard the prosecutors pushed along the line of “Holy Trinity.”
Trial Court Violated Multiple Federal Court Rules by Improperly Admitting “Holy Trinity” Related Testimony
Judge Granade violated Rule 104(b), Rule 401, 402, and 403. Rule 104(b) dictates that the relevancy of an item of evidence depends upon the existence of a particular preliminary fact. Thus when a spoken statement is relied upon to prove a notice to X, it is without probative value unless X heard it. (Federal Court Rules, 2019) The admission of “Holy Trinity” related evidence violated Rule 104(b), as none of the PPSA physicians, staff members, even patients knew what “Holy Trinity” meant In a clinical setting, because it was a “slang term,” or a “law enforcement term,” or a government argument, and thus it does not have ahy probative value namely it is devoid of any relevance, just as what was objected to by defense counsel (Tr. 1/6/17, p. 121) (“There is no relevance shown to this case whatsoever.”) Because of the Irrelevance, its admission violated Rule 401 and 402, both of which require the admitted evidence to be relevant.
It also violated Rule 403 due to its unduly prejudicial effects: the Holy Trinity is strictly a Christian doctrine, and when this term was used by the government, to mean an addictive cocktail being “illegally” prescribed to PPSA patients, at a criminal trial in a Federal Court of Southern District of Alabama, one of the most conservative regions In the nation, the overall prejudicial impact cannot be fully assessed.
Further, its admission by the improper use of leading questions in direct examinations violated Rule 611(c), and the admission of crime-element containing language, i.e. “outside the usual course of professional practice” by Dr. Aultman also violated Rule 704 (a), which prohibits admission of expert testimony that draws a legal conclusion for the jury.
Mischaracterization of Trial Evidence Respecting “Holy Trinity” by the Appellate Court and Egregious Government Misconduct Violated My Due Process Rights
Judge Coogler mischaracterized the trial evidence respecting the “Holy Trinity.” In his 137-page Opinion, he mentioned “Holy Trinity’1 twice — once at the beginning in the Trial Evidence section, the other at the end in the Restitution Calculation section. In the former, he wrote:
“The combination of these three types of drugs – which the government referred to as the “Holy Trinity” at trial — is popular among substance abusers because of its euphoric effect, yet It is highly addictive and can increase the chances of user’s death.” (Ruan, 2020 U.S. App. LEXIS 32102, at 8-9)
Judge Coogler downplayed what the prosecution had done in presenting “Holy Trinity” related testimonies to the jury. In our case, “Holy Trinity” was essentially a straw man deliberately created by the government for our prosecution. Using their inflammatory rhetoric, the prosecutors effectively demolished their straw man before the jury, as though it had “proven” their case that we practiced “outside the usual course of professional practice.” The government went so far as to hire Dr. Sprague to alter and expand the definition of “Holy Trinity” In medical literature (16 months after our arre.st) to aid the prosecution. Judge Granade, over the defendants’ vigorous objections, improperly admitted massive testimonies of “Holy Trinity,” and allowed the government’s unqualified medical experts, e.g., Dr. Aultman, to give expert testimony insinuating our alleged prescribing of “Holy Trinity” to be “outside the usual course of professional practice.” Judge Coogler’s mischaracterization of trial evidence dissembled what really had happened at court and was at odds with what the jury had seen and heard at trial. “Holy Trinity” related testimonies were admitted as major and substantial evidence of our alleged acting “outside the usual course of professional practice,” completely unlike what Judge Coogler lightly referenced to in his Opinion.
Again the insidious and deceiving nature of the Moore language, “outside the usual course of professional practice” is evident when considering its use in association with “Holy Trinity” in my case. As a result of the lack of statutory definition of “outside of the usual course of professional practice,” anything could be painted to be “outside the usual course of practice.” In other words, this criminal liability standard from Moore could be easily manipulated and exploited by the government. All the prosecutors ever needed was to pay some government “experts” to say whatever was necessary. The district court kept a blind eye, allowing “outside the usual course of professional practice” to be used equivocally in court. As a result, I was deprived of my due process rights and my criminal proceedings were fundamentally unfair. I respectfully make this plea to the Court to review these Issues and to reverse my convictions.
- Trial Court Egregiously Abdicated Its Gatekeeping Role in Admitting Expert Testimony of “Outside the Usual Course of Professional Practice, Justifying Plain Error Review by the Court Pursuant to Rule 24.1(a)
Rule 24.1(a) of the Supreme Court of the United States states: “At Its option, however, the Court may consider a plain error not among the questions presented but evident from the record and otherwise within its jurisdiction to decide.”
In Silber v. United States (1962), 370 U.S. 717, 8 L. Ed. 2d 798, 82 S. Ct. 1287, the Supreme Court held, “While ordinarily we do not take note error not called to the attention of the Court of Appeals not properly raised here, that rule is not without exception. The Court has power to notice a ‘plain error” though it was not assigned. (Citation omitted.) “In exceptional circumstances, appellate courts may notice errors if the errors are obvious, or if they otherwise seriously affected the fairness, integrity or public reputation of judicial proceedings.” (Citation omitted.)
The trial error committed by Judge Granade in keeping Dr. Greenberg’s unreliable, legal-conclusion drawing testimony could not be plainer. Rule 702 of Fed. R. Evid. provides: A witness who is qualified as an expert witness by knowledge, skill, experience, training or education may testify in the form of an opinion. (Federal Court Rules, 2019) In Daubert v. Merrell Dow Pharms., Inc. (1993), 509 U.S. 579, 125 L. ED. 2d 469, 113 S. Ct. 2786, this Court held that under Rule 702, the trial judge must ensure that any and all scientific testimony or evidence admitted is not only relevant, but reliable (Id., at 589)
Dr. Greenberg failed both prongs of the Daubert. First he was unqualified as I have shown earlier [lll(E)(3)]. Based on the government’s own information, the Pain Physician Criteria in my First Superseding Indictment, Dr. Greenberg was not even board eligible. Judge Granade however, ignored his lack of qualification and abdicated his gatekeeping role and violated the Daubert Rule and Rule 702.
Dr. Greenberg’s testimony was unreliable even according to Dr. Greenberg’s own words, when he confessed to the prosecutors he was not reliable and his facts were not reliable. Even the prosecutors had filed a motion seeking a court order to throw his testimony out of court on the ground of incompetency; nevertheless, Judge Granade kept his testimony and also submitted it to the jury for deliberation. Judge Granade blatantly abandoned her role as a neutral gatekeeper in violation of the Daubert Rule and Rule 702.
Such egregious error in violation of Daubert and Rule 702 could not be plainer. Undeniably, this has seriously affected my rights as well as the fairness, integrity, and public reputation of judicial proceedings. The Court should use the instant case to re emphasize its power to notice a plain error that has been missed or ignored by the appellate court. l respectfully plead for a plain error review by the Supreme Court pursuant to Rule 24.1(a).
