United States v. Dr. James Heaton ( 2023 )


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  • USCA11 Case: 20-12568    Document: 71-1      Date Filed: 02/14/2023   Page: 1 of 46
    [PUBLISH]
    In the
    United States Court of Appeals
    For the Eleventh Circuit
    ____________________
    No. 20-12568
    ____________________
    UNITED STATES OF AMERICA,
    Plaintiff-Appellee,
    versus
    DR. JAMES HEATON,
    Defendant-Appellant.
    ____________________
    Appeal from the United States District Court
    for the Northern District of Georgia
    D.C. Docket No. 2:18-cr-00009-RWS-JCF-3
    ____________________
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    2                      Opinion of the Court               20-12568
    Before WILSON, JILL PRYOR, and HULL, Circuit Judges.
    HULL, Circuit Judge:
    After a jury trial, Dr. James Heaton appeals his convictions
    for 27 counts of aiding and abetting the acquisition of controlled
    substances by deception and 102 counts of unlawfully dispensing
    controlled substances. On appeal, Heaton argues that the jury
    instructions were improper and his statute of conviction, 
    21 U.S.C. § 841
    (a), was unconstitutionally vague. After review, and with the
    benefit of oral argument, we affirm Heaton’s convictions.
    I.    BACKGROUND
    Heaton was a family practice physician in the small town of
    Blairsville, Georgia. Heaton primarily treated geriatric patients,
    but over time the number of his patients declined. Heaton’s
    practice then saw an increasing number of chronic pain patients.
    This case involves the large volume of prescriptions for
    controlled substances that Heaton wrote for three pain patients:
    (1) Michael Gowder and (2) two women patients referred to here
    as T.G. and H.J.W. From 2013 through 2015, Heaton prescribed
    these three patients thousands of pain pills, including
    hydrocodone, oxycodone, and methadone.
    Gowder, who was a health care administrator, was not only
    Heaton’s so-called “pain patient,” but also was charged as a
    codefendant for his role in aiding and abetting Heaton’s unlawful
    dispensing of controlled substances and for Gowder’s acquiring
    controlled substances by deception. The jury found Gowder
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    20-12568                Opinion of the Court                           3
    guilty, and he did not appeal. This appeal involves only Heaton
    and his convictions.
    Below, we describe Heaton’s practice, his prior interactions
    with the Georgia Medical Board (“Medical Board”), his
    relationships with the three pain patients, and the federal
    investigation into his prescriptions for controlled substances.
    A.     Heaton’s Practice
    In the late 1990s, Heaton operated a general family practice
    and rented space to other doctors. In 2011 or 2012, Heaton moved
    his practice into a smaller office, where he saw an increasing
    number of younger patients and patients with chronic pain issues.
    As part of his practice, Heaton operated a sleep study
    business. Heaton rented the building for his practice from the
    Union General Hospital (the “Hospital”). Heaton also served as
    the medical director of the Hospital’s nursing home.
    B.     The Patient Pain Contracts
    In 2010, Heaton had a matter before the Medical Board. 1 In
    connection with that matter, Heaton provided the Medical Board
    with two forms that he reportedly gave to patients who were
    prescribed controlled substances for pain. Heaton informed the
    1The details of that matter were not presented in the trial evidence. The
    Medical Board has since changed its name to the Composite State Board of
    Medical Examiners.
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    4                            Opinion of the Court                     20-12568
    Medical Board that all of the pain patients at his clinic were
    required to fill out both forms.
    Heaton’s form contracts provided that patients agreed:
    (1) not to ask for prescriptions to be filled early, (2) not to ask for
    the dosage or frequency of medications to be increased, and (3) that
    any breach of the contract could result in the patient’s dismissal
    from Heaton’s practice. 2 Heaton’s records for Gowder, T.G., and
    H.J.W. did not contain these contracts.
    C.        Michael Gowder
    Gowder, Heaton’s codefendant, had been Heaton’s patient
    since the 1990s. While Gowder testified in his defense case, the
    government’s evidence about Heaton’s controlled substance
    prescriptions for Gowder, recounted below, came from other
    2   One of the forms was a patient pain contract, containing these terms:
    I, ____, understand, agree with, and will comply with the
    following rules pertaining to my medications.
    I will not ask for my medications to be filled early.
    I will not ask for the dosage or frequency of my medications to
    be increased.
    ....
    Any breech [sic] of this contract could result in my being
    dismissed as a patient from Blairsville [F]amily Practice.
    _______________                         ______________
    Patient                                 Physician
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    20-12568                 Opinion of the Court                            5
    witnesses, patients’ files, medical records, and the database records
    of the prescription drug monitoring program (“PDMP”).
    Starting in January 2012, Heaton prescribed Gowder 40 pills
    of hydrocodone 10 milligrams (mg) to treat Gowder’s back and leg
    pain.
    As outlined in detail later, the dosage, quantity, and potency
    of Gowder’s pain prescriptions increased over time. By June 2012,
    Heaton had increased Gowder’s monthly prescription to 120 pills
    of oxycodone 30 mg. From July 2012 to November 2012, Heaton
    prescribed Gowder two prescriptions per month, each for 120 or
    150 pills of hydrocodone 10 mg or oxycodone 30 mg. By 2013,
    Heaton was writing Gowder two or three prescriptions, each for
    150 pills of oxycodone, nearly every month.
    Gowder filled these prescriptions at pharmacies in Georgia,
    Tennessee, and North Carolina. 3
    On January 1, 2013, Gowder, who was a health care
    administrator, became the Hospital’s chief executive officer
    (“CEO”). That same day, Gowder increased Heaton’s salary as
    medical director of the Hospital’s nursing home by $1,000 a month.
    A Hospital employee testified that he saw Heaton at the nursing
    home “very infrequently.”
    3At this time, the PDMPs in Georgia, North Carolina, and Tennessee did not
    share information, so the pharmacists checking their state’s PDMP records
    would not have learned that Michael Gowder was filling multiple
    prescriptions for the same or similar drugs each month in different states.
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    6                         Opinion of the Court                   20-12568
    Nearly every month between May 2013 and June 2015,
    Heaton wrote Gowder two prescriptions, each for oxycodone 30
    mg. During that time period, Heaton also wrote Gowder a
    prescription for Percocet 10 mg most months. 4 For example, in
    January 2014, Heaton issued Gowder: (1) a prescription for 150 pills
    of oxycodone 30 mg on January 14th; and (2) prescriptions for 150
    pills of oxycodone 30 mg and 150 pills of Percocet 10 mg on January
    24th. In total, Heaton prescribed more than 15,000 pain pills to
    Gowder between January 2012 and June 2015.
    Lisa Kelley worked at Heaton’s office from the late 1990s to
    2015. Kelley testified that, to her knowledge, Gowder never paid
    for an office visit with Heaton. Kelley never collected a co-pay
    from Gowder, who did not make an appointment when he visited
    Heaton’s office.
    Instead, at least once a month, Gowder came through the
    back door of Heaton’s clinic at closing time and met with Heaton
    in his private office to pick up a prescription. On some of these
    visits, Gowder brought a check from the Hospital payable to
    Heaton, who deposited these checks in his personal account. From
    April 2013 to December 2015, while Gowder was the CEO, the
    Hospital issued checks totaling $342,500 to Heaton, some of which
    Gowder delivered personally.
    4   The Percocet contained oxycodone 10 mg mixed with Tylenol.
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    20-12568                   Opinion of the Court                          7
    In January 2014, Gowder, in his capacity as the Hospital’s
    CEO, purchased Heaton’s sleep clinic for $155,000. After this deal,
    Gowder instructed Hospital employees to reduce Heaton’s $3,200
    monthly rent for his office space by $1,000 because the sleep study
    was being housed there.
    D.     Patient-Witness T.G.
    Patient T.G. testified that she had struggled with drug
    addiction. T.G. expressly told Heaton that she was a former heroin
    abuser before she became his patient. T.G. had track marks on her
    arms where she injected heroin. At trial, T.G. showed these track
    marks to the jury.
    Prior to becoming Heaton’s patient, T.G. was prescribed
    pain medication after she broke her back in a car accident when she
    was 11 years old. When T.G. asked her original treating physician
    for a higher dose of pain pills, that physician refused to prescribe a
    stronger dose.
    In September 2010, T.G. became Heaton’s patient. During
    T.G.’s first visit, Heaton prescribed her 120 pills of Lortab 10 mg.5
    Heaton never told T.G. that the drugs could be habit-forming or
    dangerous, and he never conducted a urine screen. Although
    Heaton checked a bulging disk in T.G.’s neck, he never conducted
    a full physical examination of T.G.
    5 The Lortab   10 mg contained hydrocodone 10 mg mixed with Tylenol.
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    8                       Opinion of the Court                 20-12568
    T.G. sometimes asked Heaton for refills on her pain
    medication before her prescriptions ran out. When T.G. asked
    Heaton for a refill, she would pick it up from his house or his office.
    In July 2011, Heaton began to prescribe T.G. 90 pills of
    methadone 10 mg. By October 2012, Heaton had increased T.G.’s
    prescription to 150 pills of methadone 10 mg.
    T.G. was using methamphetamine and drinking heavily
    while being prescribed pain medications by Heaton. Over a
    five-month period, T.G. was arrested for driving under the
    influence (“DUI”) three times. She served a four-month sentence
    for her third DUI.
    T.G. testified that: (1) she told Heaton that she had been to
    jail and that she was arrested for multiple DUIs, but (2) Heaton
    never warned her that she was at risk of an overdose after going
    without opiates for so long or that it was dangerous to consume
    alcohol while taking her pain medication.
    In June 2014, after T.G. was released from jail, Heaton even
    prescribed her the same amount of pain medication that he had
    prescribed before she was incarcerated (150 pills of methadone 10
    mg).
    To make matters even worse, Heaton and T.G. had a sexual
    relationship that began before T.G. became Heaton’s patient and
    continued during the time Heaton was prescribing her controlled
    substances. Heaton and T.G. often would have sex when T.G.
    asked for an early refill before her prescriptions ran out. T.G.
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    20-12568                   Opinion of the Court                            9
    testified that she had sex with Heaton at his house or his office after
    hours. At trial, T.G. identified Heaton’s bedroom from pictures
    introduced by the government.
    After T.G. was arrested for violating her probation, she
    began to cooperate with law enforcement. At the request of law
    enforcement, T.G. texted Heaton in January 2016 and asked for a
    prescription for controlled substances. Heaton responded: “Can
    only write controlled substances at office visit, rules have changed,
    has to be documented, it’s crazy now.” T.G. explained that, when
    she had texted Heaton in the past, he would write her a
    prescription.
    E.     Patient-Witness H.J.W.
    Patient H.J.W. became Heaton’s patient starting in May
    2014. At H.J.W.’s first appointment, H.J.W. asked Heaton to
    prescribe hydrocodone and Heaton wrote a monthly prescription
    for 60 pills of Lortab 7.5 mg 6 to H.J.W. to treat her lower abdominal
    pain (eventually diagnosed as Crohn’s disease and fibromyalgia).
    In August 2014, H.J.W. visited Heaton again, complaining of knee
    and back pain. At H.J.W.’s request, Heaton doubled her monthly
    dose to 120 pills of Lortab 7.5 mg.
    In October 2014, Heaton prescribed H.J.W. cough syrup
    after she presented with a sore throat. Heaton also issued H.J.W.
    a prescription for 120 pills of Lortab 7.5 mg, but he did not inform
    6 The Lortab   7.5 mg contained hydrocodone 7.5 mg mixed with Tylenol.
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    10                          Opinion of the Court                        20-12568
    H.J.W. about any risks associated with taking Lortab (which
    contains hydrocodone) and cough syrup at the same time. In
    December 2014, at H.J.W.’s request, Heaton later increased her
    monthly dosage to 120 pills of Lortab 10 mg.
    H.J.W. began to buy hydrocodone pills off the street a year
    after she started seeing Heaton. In March 2015, H.J.W. told
    Heaton that she had begun buying pills from other people. Heaton
    responded that H.J.W. “could not do that” because (1) buying pills
    off the street was illegal and (2) Heaton could not regulate H.J.W.’s
    medications if he did not know the dosage she was taking. Heaton
    said that H.J.W. could continue with her pain medication or switch
    to Suboxone 7 if she wanted to stop taking her pain medication.
    At Heaton’s urging, H.J.W. signed a document, which stated
    “I will get my meds from only Dr. Heaton.” The document also
    stated, “will titrate down” and was initialed by Heaton.
    In March 2015, Heaton noted in H.J.W.’s patient file that she
    was receiving seven Lortab 10 mg a day and that he would “work
    her down one a day every two weeks” until H.J.W. was no longer
    taking Lortab. In April 2015, Heaton noted that he had reduced
    H.J.W.’s prescription to five Lortab 10 mg a day.
    Starting in May 2015, however, Heaton switched H.J.W.’s
    medication from Lortab 10 mg to the more potent oxycodone 15
    mg, prescribing her 120 pills of oxycodone 15 mg. Heaton never
    7   Suboxone is a medication-assisted treatment for opioid addiction.
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    20-12568                 Opinion of the Court                          11
    referred H.J.W. to a specialist or insisted that she seek drug
    treatment.
    F.     Patient-Witness H.B.W.
    Patient H.B.W. testified as a government witness.8
    H.B.W.’s testimony was admitted pursuant to Federal Rule of
    Evidence 404(b) to show Heaton’s intent to commit the charged
    crimes.
    H.B.W. was Heaton’s pain patient from March 2011 to
    January 2012. At her first appointment, H.B.W. told Heaton that
    she was struggling with parenthood and owning a business.
    Heaton prescribed Xanax to H.B.W. to treat her anxiety. H.B.W.
    eventually became addicted to Xanax and began to buy it off the
    street. While H.B.W. was Heaton’s patient, she and Heaton had a
    sexual relationship that lasted from mid-2011 until January 2012.
    H.B.W.’s husband filed a complaint against Heaton with the
    Medical Board, which investigated Heaton’s prescribing practices
    and his sexual affair with H.B.W. In May 2014, Heaton told a
    Medical Board investigator that he had prescribed controlled
    substances to H.B.W. but claimed that his sexual relationship with
    her began after he “terminated her” as a patient.
    At some point H.B.W. and her husband stopped
    communicating with the Medical Board’s investigator. In July
    8 Two of Heaton’s former patients have the initials “H.W.,” so we refer to
    these patients using their middle initials.
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    12                       Opinion of the Court                   20-12568
    2014, the Medical Board closed Heaton’s case with no disciplinary
    action. The Medical Board, however, issued a letter of concern to
    Heaton regarding its “boundary with patients” rule, which
    prohibits physicians from having sexual relationships with their
    patients.
    G.     Federal Investigation
    In July 2015, Drug Enforcement Administration (“DEA”)
    Agent Jason Allen began to investigate suspected drug diversion in
    Blairsville, Georgia after Dr. George David Gowder was arrested
    trying to fill fraudulent prescriptions. George David Gowder is the
    brother of Heaton’s codefendant Michael Gowder, the Hospital’s
    CEO. 9 Agent Allen began to investigate Heaton after learning that
    Heaton issued Michael Gowder numerous prescriptions for
    oxycodone 30 mg.
    In September 2015, Agent Allen and a Medical Board
    investigator met with Heaton. At this meeting, the Medical Board
    investigator subpoenaed Heaton’s patient file for Michael Gowder.
    Agent Allen, who reviewed this patient file, stated that it was “very
    light” compared to a typical patient file.
    A few weeks later, Agent Allen served a DEA subpoena on
    Heaton for this same Michael Gowder file, which now contained
    9 Before Heaton and Michael Gowder’s trial, George David Gowder pled
    guilty to unlawfully dispensing controlled substances and was sentenced to
    eighteen months’ imprisonment. After trial, Michael Gowder was sentenced
    to a term of imprisonment of one year and one day.
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    20-12568               Opinion of the Court                        13
    two MRI reports from 2011 and 2015 and a radiology report from
    2006. Agent Allen did not see any of these reports in this file when
    Heaton provided it to the Medical Board.
    During his investigation, Agent Allen interviewed T.G.,
    who was wearing a short sleeve shirt and “had very obvious track
    marks” on both arms.
    In March 2016, Heaton was arrested. During the arrest,
    Agent Allen accompanied Heaton to his bedroom so that Heaton
    could change his clothes. Agent Allen told Heaton that his
    bedroom matched a description given by one of his patients.
    Heaton responded that patients came over to his house from time
    to time.
    II.    INDICTMENT & TRIAL
    In March 2019, a second superseding indictment charged
    Heaton with 1 count of conspiracy to unlawfully distribute and
    dispense controlled substances, in violation of 
    21 U.S.C. §§ 841
    (b)(1)(C), 843, & 846 (Count 1); 102 substantive counts of
    unlawful dispensing of controlled substances to Gowder (Counts
    2-76) and to T.G. and H.J.W. (Counts 104-130), all in violation of
    
    21 U.S.C. § 841
    (a)(1), (b)(1)(C); and 27 counts of aiding and abetting
    Gowder’s acquisition of controlled substances by deception, in
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    14                       Opinion of the Court                    20-12568
    violation of 
    21 U.S.C. § 843
    (a)(3) and 
    18 U.S.C. § 2
     (Counts
    77-103). 10
    As to the 102 substantive § 841(a) counts, the indictment
    alleged that Heaton unlawfully prescribed controlled substances
    to: (1) Michael Gowder from May 1, 2013, to June 16, 2015 (Counts
    2-76); (2) T.G. from September 16, 2014, to August 18, 2015
    (Counts 104-115); and (3) H.J.W. from October 15, 2014, to
    September 11, 2015 (Counts 116-130).
    During Heaton and Michael Gowder’s eight-day jury trial,
    the government presented thirteen witnesses and overwhelming
    evidence of Heaton’s unlawful dispensation of controlled
    substances.    The government’s witnesses included former
    employees of Heaton’s practice and the Hospital, Agent Allen, two
    Medical Board investigators, three of Heaton’s patients (T.G.,
    H.J.W., and H.B.W.), and an expert witness on pain management.
    The evidence also included hundreds of pages of patient files,
    medical records, prescription documents, charts from the PDMP
    databases, and photographs.
    While the above evidence covers Heaton’s interactions with
    the Medical Board and his patients, we now outline the expert
    10During Heaton’s criminal proceedings, the trial court dismissed more than
    seventy counts from the second superseding indictment. At the trial court’s
    direction, the government prepared a “dummy” indictment, which omitted
    the dismissed charges. This dummy indictment was submitted to the jury
    during deliberations. The counts referenced in this opinion are as numbered
    in the dummy indictment.
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    20-12568              Opinion of the Court                     15
    testimony about how Heaton prescribed pain pills for no legitimate
    medical purpose and outside the scope of professional practice.
    A.    Dr. Gary Kaufman
    The government called Dr. Gary Kaufman as an expert
    witness. Dr. Kaufman, a board-certified physician in pain medicine
    and neurosurgery, ran a pain management clinic in Brunswick,
    Georgia for thirteen years. He reviewed the patient files and
    PDMP records for eleven of Heaton’s patients, including Michael
    Gowder, T.G., and H.J.W. Dr. Kaufman described the Medical
    Board’s rules governing the prescription of controlled substances
    and explained how Heaton did not follow them.
    Dr. Kaufman testified that the Medical Board has adopted
    “commonsense” rules of professional conduct that all physicians
    must follow. Under these rules, “unprofessional conduct”
    includes: (1) failing to maintain appropriate records for patients
    being prescribed controlled substances; (2) having personal or
    sexual relationships with patients; and (3) prescribing controlled
    substances to known or suspected drug abusers in the absence of a
    substantial justification.
    Additionally, the Medical Board requires that physicians:
    (1) obtain a patient’s medical history, conduct a physical
    examination, and receive informed consent before prescribing pain
    medications; (2) obtain or make a diligent effort to obtain a
    patient’s prior medical records; (3) create a treatment plan;
    (4) determine whether conservative treatment, including non-
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    16                     Opinion of the Court               20-12568
    controlled medicines, is appropriate before prescribing opioids;
    (5) have a treatment agreement with the patient if the patient is
    prescribed hydrocodone, oxycodone, or similar substances for
    longer than ninety days; (6) monitor a patient’s use of the
    controlled substances by randomly checking bodily fluids (i.e.,
    urine screens) at least four times a year; and (7) create a record
    showing evaluation and monitoring of the patient and the rationale
    for continuing or modifying the therapy.
    Dr. Kaufman explained that the treatment of pain can
    constitute a legitimate medical purpose for prescribing controlled
    substances. But if a doctor determines that a patient is abusing the
    medication, the issuance of pain medications is no longer
    legitimate, and the doctor must make an appropriate referral for
    treatment of substance abuse.
    The Medical Board requires doctors who prescribe
    controlled substances to “document everything.” Dr. Kaufman
    observed: “If it’s not written, it didn’t happen.”
    Based on his review of Heaton’s patient files for Michael
    Gowder, T.G., and H.J.W., Dr. Kaufman testified that Heaton
    regularly: (1) failed to conduct credible physical examinations;
    (2) did not monitor patient compliance with prescribed
    medications; (3) did not review PDMP records; (4) did not obtain
    prior medical records relating to pain complaints; and (5) did not
    properly document the prescriptions that he issued to these
    patients.
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    20-12568               Opinion of the Court                      17
    According to Dr. Kaufman, the physical exams documented
    in Heaton’s files were not “authentic” because (1) Heaton
    repeatedly failed to fill out important blanks in the electronic
    template, and (2) Heaton copied and pasted the same information
    on the templates for the completed parts of the template, even
    though that information likely would have changed from visit to
    visit. Ultimately, after reviewing all of the patient files and
    prescriptions, Dr. Kaufman opined that Heaton prescribed pain
    medications to Michael Gowder, T.G., and H.J.W. without a
    legitimate medical purpose and outside the usual course of
    professional practice.
    Here’s what Dr. Kaufman specifically testified about based
    on his review of Heaton’s patient files for Gowder, T.G., and
    H.J.W. and the prescriptions that Heaton wrote to each of these
    patients.
    B.    Dr. Kaufman as to Prescriptions for Michael Gowder
    Even though Heaton wrote more than 100 prescriptions for
    Michael Gowder, Heaton’s patient file for Gowder usually did not
    document those prescriptions with any notation in the file about
    what he had prescribed. Heaton’s records for Gowder accounted
    for only five of these prescriptions.
    Dr. Kaufman explained that more than 100 prescriptions to
    Michael Gowder were missing from Heaton’s records.
    Significantly too, apart from two MRI reports, Heaton’s patient file
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    18                     Opinion of the Court                20-12568
    for Gowder did not contain prior records of Gowder’s pain
    complaints or indicate that Heaton attempted to get those records.
    The PDMP records showed that Heaton prescribed
    hydrocodone 10 mg to Gowder for six months from January 2012
    to June 2012. However, the first note in Heaton’s file for Gowder
    relating to controlled substances was dated June 12, 2012. In this
    June 12, 2012 note, Heaton wrote that he planned to prescribe
    Gowder 120 pills of oxycodone 30 mg to treat Gowder’s back pain.
    While Dr. Kaufman did not doubt Gowder was experiencing back
    pain from his previous back surgery, Dr. Kaufman testified that this
    pain did not provide Heaton with a legitimate medical reason to be
    prescribing 120 pills of oxycodone 30 mg.
    In July and August 2012, Heaton continued to issue the same
    prescription for 120 pills of oxycodone 30 mg to Gowder without
    noting in Gowder’s file that he had collected Gowder’s medical
    history, conducted a physical exam, or monitored Gowder’s
    compliance with the prescribed medications. From September to
    December 2012, Heaton wrote Gowder monthly prescriptions for
    120 pills and then 150 pills of oxycodone 30 mg.
    In sum, in 2012, Heaton increased the dosage, strength, and
    quantity of Gowder’s monthly medications from 40 pills of
    hydrocodone 10 mg in January 2012 to 150 pills of oxycodone 30
    mg in December 2012, without documenting why he was
    increasing Gowder’s medications.         Heaton also routinely
    prescribed “extra” or early prescriptions to Gowder for a 30-day
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    20-12568                 Opinion of the Court                            19
    supply of 120 or 150 pills of oxycodone 30 mg roughly every 2
    weeks. 11
    In January 2013, Heaton also started to issue Gowder
    prescriptions for 150 pills of Percocet 10 mg. Heaton noted that he
    was prescribing Percocet to treat Gowder’s “breakthrough pain.”
    Dr. Kaufman, however, testified that (1) Percocet can treat
    “breakthrough pain” that arises when a long-acting medication
    wears off too soon, but (2) oxycodone 30 mg was not a long-acting
    medication, so Gowder did not need a prescription for
    breakthrough pain.
    By May 2013, Heaton each month was prescribing Gowder
    two prescriptions, each for 150 pills of oxycodone 30 mg, and one
    prescription for 150 pills of Percocet 10 mg. Dr. Kaufman explained
    that Heaton in effect was prescribing Gowder the equivalent of a
    daily dose of 450 milligram morphine, or a milligram morphine
    equivalent (“MME”) of 450. Under these circumstances, Dr.
    Kaufman would have suspected that Gowder was a drug addict or
    was diverting his medication.
    On June 13, 2013, Heaton noted in the file that he had
    prescribed 120 pills of oxycodone 30 mg to Gowder. The PDMP
    records, however, showed that since January 2013 Heaton had
    11 Gowderalso obtained “extra” prescriptions for 120 pills of hydrocodone 10
    mg in August 2012 and 150 pills of Percocet 10 mg throughout 2013, 2014, and
    2015.
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    20                     Opinion of the Court                20-12568
    written Gowder multiple prescriptions, each for 150 pills of
    oxycodone 30 mg.
    In 2014, Heaton documented only one office visit for
    Gowder, despite the Medical Board’s requirement to see a patient
    who is taking opioids once every three months. Dr. Kaufman
    testified that Heaton’s note for that one 2014 visit was “deceptive”
    because Heaton indicated he was treating Gowder using
    “conservative measures” without acknowledging the extensive
    pain medication being prescribed to Gowder.
    From June 18, 2014 to July 16, 2014, Heaton issued Gowder
    three oxycodone prescriptions, each for 150 pills of oxycodone 30
    mg, and one prescription for 150 pills of Percocet 10 mg. In effect,
    Heaton was prescribing Gowder the equivalent of 885 MME per
    day, a “very high” daily dose that would kill the average person,
    but that an addicted person might be able to consume. Dr.
    Kaufman testified that: (1) it was generally recommended that
    physicians in general practice not prescribe more than 50 or 100
    MME per day; and (2) Dr. Kaufman had never prescribed a patient
    more than 500 MME a day and only prescribed 250 MME to 5 or
    10 patients in his entire career.
    Dr. Kaufman also reviewed records from Gowder’s visits
    with two specialists in 2015. During a visit with a cardiologist in
    June 2015, Gowder reported “some increasing low back pain” over
    the past three to four months. In December 2015, Gowder saw a
    neurologist and reported numbness and moderate-to-severe pain.
    Dr. Kaufman explained that this amount of pain would not have
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    20-12568               Opinion of the Court                        21
    warranted the pain medications that Heaton prescribed to
    Gowder.
    C.     Dr. Kaufman as to Prescriptions for T.G.
    Turning to T.G., Dr. Kaufman explained that Heaton did
    not document in T.G.’s patient file that he: (1) took a complete
    medical history from T.G.; (2) conducted an adequate physical
    examination; (3) obtained informed consent; (4) monitored T.G.’s
    compliance with her prescribed medications; (5) tried to acquire
    T.G.’s prior records; or (6) diagnosed her pain. Although T.G.’s
    patient file included some early prescriptions, Heaton did not
    document all of the many prescriptions that he wrote to T.G.
    During T.G.’s first visit in September 2010, Heaton
    prescribed her 60 pills of Lortab 5 mg without obtaining her prior
    medical records or providing informed consent. Dr. Kaufman
    testified that Heaton’s records for this visit contained a “very, very
    suboptimal amount of information” about Heaton’s physical
    examination of T.G. and an “inadequate” medical history. In
    October 2010, Heaton increased T.G.’s prescription to 90 pills of
    Lortab 5 mg.
    Over the next six months, Heaton increased the quantity
    and potency of T.G.’s monthly pain medication from 90 pills of
    Lortab 5 mg in October 2010 to 90 pills of oxycodone 10 mg in
    March 2011. Heaton did not document T.G.’s response to the
    medication or indicate that he had conducted a “definitive”
    physical examination. Although T.G. consistently reported muscle
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    22                       Opinion of the Court                   20-12568
    spasms, Heaton did not treat that issue, prescribing controlled
    substances instead.
    In May 2011, Heaton gave T.G. an early prescription for
    oxycodone 10 mg after she reported that her medications were
    stolen. Heaton noted “Meds stolen at work,” without verifying
    whether T.G.’s medications were actually stolen. Dr. Kaufman
    testified that physicians must be “very strict” and should not
    replace medicines without a “real reason.”
    In July 2011, Heaton changed T.G.’s prescription to 90 pills
    of methadone 10 mg, noting in her file that she could not afford
    oxycodone and “was on methadone in New Jersey.” As a result of
    switching to methadone, T.G.’s daily MME increased from 45 to
    240, which was “way above the dangerous level.” 12 Dr. Kaufman
    testified that Heaton increased T.G.’s prescription “for no apparent
    reason except that she went to New Jersey and it was cheaper.”
    In October 2012, Heaton increased T.G.’s monthly
    prescription for methadone 10 mg from 120 pills to 150 pills
    without explanation.
    In June 2014, Heaton noted that T.G. had gotten a DUI.
    Heaton, however, prescribed T.G. the same monthly prescription
    for 150 pills of methadone 10 mg that he had issued to her before
    she went to jail without warning T.G. that she could die if she
    12 Dr. Kaufman testified that hydrocodonehas the same potency as morphine,
    oxycodone is one and a half times as strong as morphine, and methadone is
    eight times as strong as morphine.
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    20-12568               Opinion of the Court                        23
    continued to drink and use opioids. According to Dr. Kaufman,
    this prescription put T.G. at “extreme risk” and was “very
    dangerous.” Dr. Kaufman testified that Heaton failed to follow the
    Medical Board’s requirements and that his practices went “way
    beyond poor recordkeeping.”
    D.    Dr. Kaufman as to Prescriptions for H.J.W.
    Regarding H.J.W., Dr. Kaufman expressed similar concerns
    about Heaton’s prescribing practices, starting with H.J.W.’s first
    visit in May 2014. During this visit, Heaton prescribed 60 pills of
    Lortab 7.5 mg to H.J.W., without obtaining an adequate medical
    history, getting records from her prior doctors, or trying alternative
    therapies.
    In October 2014, Heaton prescribed H.J.W. cough syrup and
    120 pills of Lortab 7.5 mg. Dr. Kaufman explained that these two
    drugs should never be prescribed together because they are
    dangerous and prone to abuse.
    In March 2015, Heaton noted in H.J.W.’s file that “[t]he
    Lortab is down to seven a day.” Dr. Kaufman testified that he was
    unsure how H.J.W.’s prescription “got to that level” since Heaton
    had not properly documented what prescriptions he gave to
    H.J.W. in her patient file.
    At this point, Dr. Kaufman testified that it was “fair to say”
    that Heaton suspected H.J.W. had developed an addiction to her
    medication. Dr. Kaufman testified that Heaton: (1) properly told
    H.J.W. she should either reduce her dosage or enter drug
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    24                     Opinion of the Court                20-12568
    rehabilitation; and (2) began to decrease H.J.W.’s medication from
    seven pills of Lortab 10 mg per day in March 2015 to five pills of
    Lortab 10 mg per day in April 2015.
    Then, in May 2015, Heaton prescribed H.J.W. 120 pills of
    oxycodone 15 mg, which increased her morphine equivalent from
    50 to 90 MME for “no clear-cut reason.” While Dr. Kaufman
    agreed that H.J.W.’s diseases might have justified the medication
    in a different setting, it was dangerous and medically inappropriate
    for Heaton to sharply increase her prescription when Heaton
    believed that she was abusing her medication.
    E.    Rule 29 Motion, Defense, and Verdict
    At the close of the government’s evidence, Heaton moved
    for judgment of acquittal under Federal Rule of Criminal
    Procedure 29, which the district court denied.
    Heaton’s defense was that he was only a “bad note-taker,”
    and not a “drug dealer.” Heaton did not testify, but he did call two
    witnesses: (1) Shane Mobley, who testified to Heaton’s practices
    and policies at his sleep clinic; and (2) Dr. Alan Sanders, who
    testified to his own family practice in Blairsville, Georgia.
    On cross-examination, Dr. Sanders testified that, when
    prescribing pain medications, he documents “everything [he]
    do[es]” with pain patients and takes “elaborate notes” about his
    appointment with pain patients in compliance with the Medical
    Board’s requirements. Dr. Sanders explained that the State of
    Georgia made it “pretty easy” for physicians to prescribe controlled
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    20-12568                 Opinion of the Court                   25
    substances and that physicians could “be safe” in prescribing
    controlled substances in compliance with the Medical Board’s
    rules.
    Michael Gowder testified in his own defense that, despite
    some compliance issues, the sleep clinic became profitable the year
    after the Hospital purchased it from Heaton. At the close of
    evidence, Heaton renewed his Rule 29 motion, which the district
    court denied as to Counts 2-130 and reserved ruling as to Count 1.
    In closing argument, Heaton’s counsel argued that Gowder,
    T.G., and H.J.W. all suffered from pain and that Heaton prescribed
    them pain medications for a legitimate medical purpose and within
    the scope of professional practice.
    The jury convicted Heaton on the substantive § 841(a) and
    § 843 Counts 2-130 and acquitted him on the conspiracy Count 1.
    The district court sentenced Heaton to 72 months’ imprisonment
    on his § 841(a) convictions in Counts 2-76 (Gowder) and his
    § 841(a) convictions in Counts 104-130 (T.G. and H.B.W.), to run
    concurrently, and concurrent 42-month sentences on his § 843
    aiding and abetting convictions in Counts 77-103 (Gowder).
    III.    JURY INSTRUCTIONS
    Heaton challenges the district court’s jury instructions. We
    set forth the instructions and then Heaton’s claims.
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    26                      Opinion of the Court                 20-12568
    A.     The District Court’s Jury Instructions
    The district court charged the jury that Heaton could be
    found guilty of his § 841(a) crimes only if all of these facts were
    proved beyond a reasonable doubt:
    (1) Dr. Heaton knowingly and intentionally
    dispensed oxycodone or hydrocodone; and
    (2) Dr. Heaton’s dispensing of the oxycodone and/or
    the hydrocodone was outside the usual course of
    professional practice or for no legitimate medical
    purpose.
    Heaton does not dispute that he knowingly and intentionally
    dispensed oxycodone and hydrocodone.             At trial Heaton
    contended (1) his dispensing was not “outside the usual course of
    professional practice” and (2) his prescriptions were issued for a
    “legitimate medical purpose.”
    The district court charged the jury that whether Heaton
    dispensed the controlled substances “outside the usual course of
    professional practice”: (1) is to be determined by the jury “based on
    the totality of the evidence presented concerning the accepted
    standard of professional practice in the State of Georgia at the time
    of the crime” and (2) is “to be judged objectively.” (Emphasis
    added).
    The district court further charged that “Heaton’s good faith
    belief that he dispensed a controlled substance in the usual course
    of professional practice is not a defense to the charge if he dispensed
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    20-12568                  Opinion of the Court                            27
    the controlled substances ‘outside the usual course of professional
    practice.’”
    The district court also instructed that, “[w]hether Dr.
    Heaton dispensed the controlled substances ‘for no legitimate
    medical purpose’ does depend on his subjective belief.” (Emphasis
    added).
    We now turn to Heaton’s challenges to the jury charges.
    B.     Instructions as to the Elements of a § 841(a) Offense
    Heaton argues that the district court erred because its jury
    instruction used “or,” instead of “and,” in setting forth the elements
    of a § 841(a) offense. Heaton contends that § 841(a) requires the
    government to prove that he prescribed medication both “outside
    the course of professional practice” and “for no legitimate medical
    purpose.” 13
    Some background about § 841(a) is helpful. The Controlled
    Substances Act (“CSA”) makes it unlawful, “[e]xcept as
    authorized[,] . . . for any person knowingly or intentionally . . . to
    manufacture, distribute, or dispense . . . a controlled substance,”
    such as opioids. 
    21 U.S.C. § 841
    (a)(1) (emphasis added). In turn,
    the CSA expressly authorizes medical “practitioner[s]” to dispense
    Schedule II and Schedule III substances with a “prescription.” 
    Id.
    13 We review de novo whether a challenged jury instruction misstated the law.
    United States v. Melgen, 
    967 F.3d 1250
    , 1259 (11th Cir. 2020).
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    28                        Opinion of the Court                     20-12568
    § 829(b). 14   Practitioners who seek to dispense controlled
    substances must register with the Attorney General. Id. § 822(a)(2).
    The key statutory terms—“controlled substance,” “dispense,”
    “distribute,” “practitioner,” and “prescription”—are defined either
    by statute, see id. § 802(6), (10), (11), (21), or by regulation, see 
    21 C.F.R. § 1306.04
    (a) (2022).
    The CSA’s regulations, promulgated by the Attorney
    General, specify that, “[a] prescription for a controlled substance to
    be effective must be issued for a legitimate medical purpose by an
    individual practitioner acting in the usual course of his professional
    practice.” 
    21 C.F.R. § 1306.04
    (a). As provided by regulation, a
    prescription is only authorized when a doctor issues it “for a
    legitimate medical purpose . . . acting in the usual course of his
    professional practice.” 
    Id.
    In United States v. Abovyan, this Court concluded that a
    doctor violates § 841(a) if he prescribes controlled substances either
    (1) for no legitimate medical purpose or (2) outside the usual
    course of professional practice. 
    988 F.3d 1288
    , 1308 (11th Cir.
    2021). In Abovyan, the defendant physician requested an
    instruction stating, inter alia, that the government must prove
    14 Oxycodone and methadone are Schedule II controlled substances.    
    21 C.F.R. § 1308.12
    (b)(l)(xi), (c)(15). Hydrocodone was reclassified from a Schedule III
    controlled substance to a Schedule II controlled substance, effective October
    6, 2014. 
    Id.
     § 1308.12(b)(l)(vi); Schedules of Controlled Substances:
    Rescheduling of Hydrocodone Combination Products from Schedule III to
    Schedule II, 
    79 FR 49661
    -01 (Aug. 22, 2014).
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    20-12568                Opinion of the Court                        29
    beyond a reasonable doubt that the defendant was acting as a drug
    dealer, not a doctor. 
    Id.
     This Court held that the district court did
    not abuse its discretion in refusing to give this instruction because
    “the law requires only that the jury find the doctor prescribed a
    drug [(1)] not for a legitimate medical purpose or [(2)] not in the
    usual course of professional practice.” 
    Id.
     (emphasis added and
    quotation marks omitted).
    Similarly, in United States v. Tobin, this Court recognized
    that “a distribution [of prescription drugs] is unlawful if 1) the
    prescription was not for a legitimate medical purpose or 2) the
    prescription was not made in the usual course of professional
    practice.” 
    676 F.3d 1264
    , 1282 (11th Cir. 2012) (quotation marks
    omitted), abrogated on other grounds by United States v. Davila,
    
    569 U.S. 597
    , 
    133 S. Ct. 2139 (2013)
    .
    As the government points out, the plain language of 
    21 C.F.R. § 1306.04
    (a) demonstrates that the jury instruction here
    correctly used “or” in defining the elements of a § 841(a) offense.
    Under § 1306.04(a), a prescription for a controlled substance is
    effective if it is issued “for a legitimate medical purpose by an
    individual practitioner acting in the usual course of his professional
    practice.” 
    21 C.F.R. § 1306.04
    (a) (emphases added). Put simply,
    the regulation has two requirements for a prescription to be
    effective: (1) “a legitimate medical purpose” . . . (2) by a
    practitioner “acting in the usual course of his professional practice.”
    
    Id.
     Conversely, a prescription for controlled substances is unlawful
    if it is issued (1) without a legitimate medical purpose or (2) by the
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    30                        Opinion of the Court                      20-12568
    physician acting outside the usual course of professional practice.
    See 
    id.
     Thus, both requirements must be satisfied to make a
    prescription authorized.
    For all of these reasons, we reject Heaton’s challenge to the
    “or” portion of the jury charge. Aboyvan, 988 F.3d at 1308; see also
    Tobin, 
    676 F.3d at 1282
    .
    C.     Instructions as to § 841(a)’s Mens Rea Requirement
    Next, Heaton argues that the jury instructions as to the
    mens rea requirement ran afoul of the Supreme Court’s recent
    decision in Ruan v. United States, 597 U.S. ----, 
    142 S. Ct. 2370 (2022)
    (“Ruan”). Heaton argues that the district court erred in instructing
    the jury to apply an objective standard to the “outside the usual
    course of professional practice” requirement. 15 We first discuss the
    Supreme Court’s Ruan decision and how Ruan error did occur here
    15 We reject the government’s contention that we should not consider
    Heaton’s Ruan argument in his direct appeal because he failed to file a timely
    motion under United States v. Durham, 
    795 F.3d 1329
    , 1330 (11th Cir.
    2015) (en banc) (holding that an appellant may raise a new issue based on an
    intervening Supreme Court decision that overrules binding precedent). This
    contention ignores that: (1) oral argument in Heaton’s direct appeal was set
    for December 2021, (2) Heaton timely suggested Ruan would affect his direct
    appeal by filing a motion to continue oral argument after the Supreme Court
    granted certiorari in Ruan, and (3) this Court continued Heaton’s case to await
    the Supreme Court’s decision in Ruan. After Ruan was decided in 2022, this
    Court ordered supplemental briefing. Under these particular circumstances,
    we are not persuaded by the government’s claim.
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    20-12568                 Opinion of the Court                          31
    as to the mens rea requirement. We then evaluate whether it was
    harmless.
    1. Ruan Error
    In Ruan,� the defendant physicians were convicted of
    violating § 841(a)(1) by “dispensing controlled substances not ‘as
    authorized.’” 597 U.S. at ----, 142 S. Ct. at 2375. One of the
    defendants requested a jury instruction “requir[ing] the
    government to prove that he subjectively knew that his
    prescriptions fell outside the scope of his prescribing authority.” Id.
    at ----, 142 S. Ct. at 2375. The district court rejected that instruction,
    and this Court affirmed. Id. at ----, 142 S. Ct. at 2376.
    Reversing, the Supreme Court held that the § 841(a)
    statute’s “knowingly or intentionally” mens rea applied to the
    statute’s “except as authorized” clause. Id. at ----, 142 S. Ct. at 2376.
    The Supreme Court instructed that: “After a defendant produces
    evidence that he or she was authorized to dispense controlled
    substances, the Government must prove beyond a reasonable
    doubt that the defendant knew that he or she was acting in an
    unauthorized manner, or intended to do so.” Id. at ----, 142 S. Ct.
    at 2375.
    In Ruan, the Supreme Court reasoned that: (1) it is generally
    presumed that “Congress intends to require a defendant to possess
    a culpable mental state”; (2) a scienter requirement in a statute (like
    § 841(a)’s “knowingly or intentionally” language) typically
    modifies the statutory term “that separate[s] wrongful from
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    32                        Opinion of the Court                      20-12568
    innocent acts”; (3) the statutory clause in question—“outside the
    usual course of professional practice”—plays a critical role in
    separating a defendant’s wrongful from innocent conduct; and
    (4) § 841(a)’s scienter requirement applies to that critical statutory
    clause. Id. at ----, 142 S. Ct. at 2377–78 (quotation marks omitted).
    The Supreme Court further emphasized that the terms here are not
    the kind it has held fall outside the scope of scienter requirements.
    Id. at ----, 142 S. Ct. at 2378. The Supreme Court also noted that
    “[t]he Government . . . can prove knowledge of a lack of
    authorization through circumstantial evidence.” Id. at ----, 142 S.
    Ct. at 2382. The Supreme Court declined to address whether any
    error in the jury instructions was harmless. Id. at ----, 142 S. Ct. at
    2382.
    Here similarly, the jury was instructed that “[w]hether Dr.
    Heaton dispensed the controlled substances ‘outside the usual
    course of professional practice’ is to be judged objectively.” 16
    Because this instruction allowed the jury to convict Heaton
    without considering whether he knowingly or intentionally issued
    16To the extent Heaton challenges the jury instruction as to the mens rea for
    dispensing controlled substances for a legitimate medical purpose, that
    argument lacks merit. The jury was properly instructed that whether Heaton
    prescribed controlled substances for a legitimate medical purpose “depend[ed]
    on his subjective belief.” There was no Ruan error as to the legitimate medical
    purpose part of the charge.
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    20-12568                   Opinion of the Court                              33
    prescriptions outside the usual course of professional practice, it
    was erroneous under Ruan.17
    2. Harmless Error
    This brings us to whether the Ruan error—as to “outside the
    usual course of professional practice”—was harmless.
    Jury instructions are subject to harmless error review.
    United States v. Seabrooks, 
    839 F.3d 1326
    , 1332 (11th Cir. 2016).
    The government, however, has the burden to prove harmless
    error. See Neder v. United States, 
    527 U.S. 1
    , 15, 
    119 S. Ct. 1827
    ,
    1837 (1999).
    “An error is harmless if the reviewing court is satisfied
    beyond a reasonable doubt that the error complained of did not
    contribute to the verdict obtained.” Seabrooks, 
    839 F.3d at
    1332–
    33 (quotation marks omitted). Stated another way: “Is it clear
    beyond a reasonable doubt that a rational jury would have found
    the defendant guilty absent the error?” Neder, 
    527 U.S. at 18
    , 119
    17 InAbovyan, there was no mens rea challenge to the jury instructions and
    thus no Ruan error. Abovyan’s holding—that a doctor violates § 841(a) if the
    “legitimate medical purpose” or “outside the scope of professional practice”
    requirement is met—remains binding precedent, which is why we follow
    Abovyan earlier. See United States v. Archer, 
    531 F.3d 1347
    , 1352 (11th Cir.
    2008) (explaining that “a prior panel’s holding is binding on all subsequent
    panels unless and until it is overruled or undermined to the point of abrogation
    by the Supreme Court or by this court sitting en banc,” but “the Supreme
    Court decision must be clearly on point” (quotation marks omitted)). Further,
    even without Abovyan, we explained earlier why the § 1306.04(a) regulation
    has two requirements.
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    34                         Opinion of the Court                       20-12568
    S. Ct. at 1838; see also Delaware v. Van Arsdall, 
    475 U.S. 673
    , 681,
    
    106 S. Ct. 1431
    , 1436 (1986) (“[A]n otherwise valid conviction
    should not be set aside if the reviewing court may confidently say,
    on the whole record, that the constitutional error was harmless
    beyond a reasonable doubt.”).
    As noted earlier, the district court did charge that the
    government must prove beyond a reasonable doubt that Heaton
    subjectively knew he was dispensing pain medication for no
    legitimate medical purpose. But there was no special verdict form
    here, and the district court properly charged “or” as to “outside the
    usual course of a professional practice.” Thus, we must assume
    that the jury verdict could have been based on Heaton’s dispensing
    outside the usual course of professional practice “judged
    objectively.” 18
    Nevertheless, we readily conclude that the government
    presented overwhelming evidence that Heaton subjectively knew
    18 Here, the district court suggested that a special verdict form be submitted to
    the jury on the two requirements, but Heaton declined. We note, as a general
    matter, that the use of a special verdict form is often a good practice. In a
    special verdict form, the jury can specify whether the defendant’s prescriptions
    were issued for no legitimate medical purpose, outside the usual course of
    professional practice, or both. Therefore, we can more readily determine the
    basis for the jury verdict.
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    20-12568                    Opinion of the Court                                35
    his conduct fell outside the usual course of his professional
    practice. 19 We recount the many ways that Heaton knew that.
    The Medical Board’s rules for prescribing controlled
    substances are well established and not disputed. For starters, Dr.
    Kaufman testified that the Medical Board had adopted
    “commonsense” rules that all physicians must follow, and Dr.
    Sanders, a defense witness, testified that it was “pretty easy” to
    prescribe controlled substances and that physicians could “be safe”
    in prescribing controlled substances in compliance with the
    Medical Board’s rules. As Dr. Kaufman testified, those Medical
    Board rules for prescribing the pain medications here require
    physicians, like Heaton, to: (1) obtain a patient’s prior medical
    history as to pain; (2) conduct a physical examination; (3) monitor
    a patient’s compliance with use of the controlled substances by
    randomly checking bodily fluids (i.e., urine screens) four times a
    year; (4) document all prescriptions issued; (5) receive informed
    consent; (6) create a treatment plan; (7) refrain from sexual
    relationships with patients; (8) refrain from prescribing to known
    or suspected drug abusers; (9) obtain a treatment agreement with
    a patient if the patient is prescribed hydrocodone, oxycodone, or
    19The government contends that Heaton’s challenge to the mens rea used in
    the district court’s jury instructions is, at most, reviewable for plain error
    because at trial he did not raise a timely objection to this jury instruction about
    “outside the usual course of professional practice.” We assume—without
    deciding—that Heaton properly preserved this Ruan issue for appeal given
    that any error in the jury instruction was harmless.
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    36                     Opinion of the Court                20-12568
    similar substances for longer than ninety days; and (10) maintain
    appropriate records for patients receiving controlled substances.
    After reviewing Heaton’s patient files, Dr. Kaufman testified
    how Heaton regularly failed to comply with the Medical Board’s
    rules. According to Dr. Kaufman, Heaton regularly: (1) failed to
    obtain prior medical records relating to pain complaints; (2) did not
    conduct credible physical examinations; (3) did not monitor patient
    compliance with prescribed medications; and (4) did not properly
    document the prescriptions that he issued to these patients.
    Heaton’s own files prove he knew he was not following the
    Medical Board’s rules. Here’s just some of the many examples
    shown in the files.
    As to Michael Gowder, Heaton repeatedly violated the
    Medical Board’s requirement to “document everything.” Even
    though Heaton began to prescribe Gowder pain medications in
    January 2012, he did not note in Gowder’s patient file that he was
    prescribing Gowder pain medication until June 2012. As Dr.
    Kaufman testified and the PDMP records show, Heaton
    documented only 5 of the more than 100 prescriptions he issued to
    Gowder.
    Heaton did not document in Gowder’s patient file that he:
    (1) obtained Gowder’s medical history; (2) conducted a physical
    examination; or (3) monitored compliance with Gowder’s
    prescribed medications. Heaton’s patient file for Gowder also did
    not contain prior records of Gowder’s pain complaints or indicate
    that Heaton attempted to get those records. After the Medical
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    20-12568                 Opinion of the Court                            37
    Board subpoenaed this file, Heaton supplemented the file with
    Gowder’s MRI and radiology reports, indicating that Heaton was
    aware that his patient file for Gowder was incomplete.
    Further, Heaton continued to prescribe Gowder pain
    medications despite clear signs that Gowder was abusing his
    medication. By May 2013, Heaton was prescribing Gowder such a
    high daily dose that Dr. Kaufman would have suspected that
    Gowder was a drug addict or was diverting his medication. Yet,
    Heaton continued to increase the potency of Gowder’s pain
    medications and routinely provided Gowder with “extra” or early
    prescriptions for pain pills roughly every two weeks. By mid-2014,
    Heaton was prescribing Gowder a “very high” daily dose that
    would kill the average person, but an addicted person might be able
    to consume.20
    As for T.G., the government’s evidence proved that
    Heaton’s prescribing practices went “way beyond poor
    recordkeeping,” including evidence of a prohibited sexual
    relationship with a patient. Heaton knew his sexual relationship
    with T.G. fell outside the usual course of professional practice
    because the Medical Board had already warned him that such a
    relationship was prohibited. In July 2014, the Medical Board issued
    20 Although Heaton purportedly issued this pain medication to treat Gowder’s
    back pain, Gowder reported only moderate back pain and numbness to other
    providers. Dr. Kaufman explained that this amount of pain would not have
    warranted the pain medications that Heaton prescribed to Gowder.
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    38                     Opinion of the Court               20-12568
    Heaton a letter of concern regarding its “boundary with patients”
    rule, which prohibits physicians from having sexual relationships
    with their patients. Months later, Heaton began to write T.G. the
    prescriptions charged in Counts 104-115, which were issued from
    October 15, 2014, to September 11, 2015—all while he was having
    a sexual relationship with T.G. Accordingly, Heaton’s sexual
    relationship with T.G., despite receiving a warning from the
    Medical Board, proved that Heaton knew his prescriptions to T.G.
    fell outside the usual course of professional practice.
    In addition, Heaton continued to increase the potency of
    T.G.’s pain medications without documenting T.G.’s response to
    the medication or conducting a full physical examination. As Dr.
    Kaufman testified, Heaton increased T.G.’s prescription to 90 pills
    of methadone 10 mg in July 2011 “for no apparent reason except
    that she went to New Jersey and it was cheaper.”
    Heaton ignored obvious red flags that T.G. was abusing her
    medication. Before T.G. became Heaton’s patient, she informed
    Heaton that she had abused heroin. However, after T.G. was
    arrested for three DUIs and spent time in jail, Heaton continued to
    prescribe 150 pills of methadone 10 mg to her, even though T.G.
    told him that she spent four months in jail for her third DUI.
    Heaton did not even warn T.G. that it was dangerous to consume
    alcohol while taking her pain medication.
    Turning to H.J.W., Heaton prescribed pain medications to
    her in flagrant violation of the Medical Board’s rules. During
    H.J.W.’s first appointment, Heaton prescribed 60 pills of Lortab 7.5
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    20-12568               Opinion of the Court                      39
    mg to her, without obtaining an adequate medical history, getting
    her prior medical records, or trying alternative therapies. In March
    2015, Heaton noted in H.J.W.’s file that “[t]he Lortab is down to
    seven a day,” but Dr. Kaufman was unsure how H.J.W.’s
    prescription “got to that level” because Heaton had not properly
    documented H.J.W.’s prescriptions in her patient file.
    Just two months later, in May 2015, Heaton sharply
    increased the strength of H.J.W.’s prescription just two months
    after H.J.W. told Heaton that she was buying pills from other
    people. Dr. Kaufman explained that it was dangerous and
    medically inappropriate for Heaton to increase H.J.W.’s
    prescription when Heaton believed that she was abusing her
    medication.
    Finally, Heaton’s own interactions with the Medical Board
    confirm Heaton subjectively knew he was not prescribing pursuant
    to professional practices. Although Heaton informed the Medical
    Board that he obtained patient contracts from every pain patient,
    his files for Michael Gowder, T.G., and H.J.W. did not contain
    these contracts. In fact, Heaton’s records did not contain any
    patient agreements with Gowder or T.G. As for H.J.W., Heaton
    asked her to sign a handwritten agreement, which stated that
    H.J.W. would only get her pain medications from Heaton, who
    would “titrate down” her pain medication. Heaton violated his
    own handwritten agreement when he increased H.J.W.’s
    prescription just two months later.
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    40                        Opinion of the Court                      20-12568
    Heaton failed to take any action after T.G. and H.J.W.
    violated the terms of the pain contracts that he provided to the
    Medical Board. Heaton filled T.G.’s prescription early without
    documenting a “real reason” after T.G. asked him to replace a
    prescription. Heaton also prescribed 60 pills of Lortab 7.5 mg
    to H.J.W. upon her request and increased her dosage of pain
    medications twice after she asked him to do so. Heaton’s failure to
    act when he knew these patients had violated the terms of his own
    patient pain agreements showed that Heaton knew the
    prescriptions to these patients were issued outside the usual course
    of professional practice.
    In short, we are satisfied that (1) this evidence extensively
    proved beyond a reasonable doubt that Heaton subjectively knew
    his prescriptions to Michael Gowder, T.G., and H.J.W. were issued
    outside the usual course of professional practice, and (2) a jury
    would have found Heaton guilty absent the error.21 There is no
    21 Heaton  also argues that the evidence at trial was insufficient to show that
    the prescriptions he issued to Michael Gowder, T.G., and H.J.W. had no
    legitimate medical purpose. We review de novo whether the evidence is
    sufficient to support a conviction, taking all evidence and drawing all
    reasonable inferences in the light most favorable to the government.
    Abovyan, 988 F.3d at 1302.
    Based on the evidence discussed throughout this opinion, we conclude
    that the trial evidence amply showed Heaton’s prescriptions in Counts 2-76
    and 104-130 were issued for no legitimate medical purpose.
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    20-12568                Opinion of the Court                         41
    basis in this trial record for concluding that the jury would have
    acquitted Heaton had it been properly instructed.
    3. Ruan II
    Before concluding, we recognize that this Court concluded
    on remand from the Supreme Court’s decision in Ruan that: (1) the
    jury instructions “inadequately conveyed the required mens rea to
    authorize conviction under § 841(a)”; and (2) the error in that case
    was not harmless. United States v. Ruan, 
    56 F.4th 1291
    , 1298 (11th
    Cir. 2023) (“Ruan II”). The trial evidence in Ruan II, however, was
    nothing like the evidence in Heaton’s case.
    On remand, this Court observed that: (1) both defendants
    presented expert evidence about the appropriate standard of care;
    (2) Dr. Ruan “introduced witnesses who testified to his practices
    and procedures at the clinic to guard against abuse”; (3) Dr. Ruan
    testified in his own defense “about how he always centered the
    patient’s medical needs;” (4) Dr. Couch introduced “lay witnesses
    who testified to his activities at the clinic”; (5) Dr. Couch “testified
    to his activities at the clinic”; and (6) both Dr. Ruan and Dr. Couch
    testified that they believed their actions were in accord with the
    applicable standard of care. 
    Id.
     Even if the jury in Ruan II believed
    the doctor defendants’ testimony about their beliefs, our Court
    pointed out that the jury could still have convicted them “if [the
    jury] found that a reasonable doctor would not have believed the
    conduct was in accord with the appropriate standard.” 
    Id.
     We
    reasoned that “a properly instructed jury may not have convicted
    the defendants had it known that Dr. Ruan’s and Dr. Couch’s
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    42                         Opinion of the Court                      20-12568
    subjective beliefs that they were acting properly was a defense to
    these charges.” 
    Id.
    This case is materially different than Ruan II. Unlike the
    physicians in Ruan II, Heaton did not testify in his own defense,
    nor did Heaton call any expert witnesses to testify that his practices
    complied with professional practices. Even though Heaton called
    two lay witnesses (Mobley and Dr. Sanders), neither witness
    testified about Heaton’s activities at his clinic—much less that they
    complied with professional practices. Of course, neither testified
    that Heaton, or any doctor for that matter, could reasonably
    believe Heaton’s practice complied. 22 In light of all the
    overwhelming evidence of Heaton’s subjective knowledge
    recounted above, we are well satisfied that the jury would have
    convicted Heaton had it been properly instructed.
    IV.     VAGUENESS
    Heaton also argues that § 841 is unconstitutionally vague as
    applied to him. He contends that the phrase “in the usual course
    of his professional practice” lacks a standard defining when a
    physician’s prescribing practices become unlawful. 23
    22 Gowder  did testify in his own defense about his interactions with Heaton.
    After Heaton’s defense rested, Gowder (1) testified that he “didn’t have a clue”
    what Heaton put in his charts, and (2) gave no testimony about the usual
    course of professional practices for doctors or Heaton’s subjective belief.
    We review de novo whether a criminal statute is unconstitutionally vague.
    23
    United States v. Wayerski, 
    624 F.3d 1342
    , 1347 (11th Cir. 2010).
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    20-12568                   Opinion of the Court                              43
    Where a vagueness challenge does not involve the First
    Amendment, our Court must determine whether the statute at
    issue, as applied to the facts of the case, “fails to provide people of
    ordinary intelligence a reasonable opportunity to understand what
    conduct it prohibits or it authorizes or even encourages arbitrary
    and discriminatory enforcement.” United States v. Wayerski, 
    624 F.3d 1342
    , 1347 (11th Cir. 2010) (quotation marks omitted). A
    criminal statute is not required to “define every factual situation
    that may arise.” United States v. Biro, 
    143 F.3d 1421
    , 1430 (11th
    Cir. 1998). There is a “strong presumption that statutes passed by
    Congress are valid.” Wayerski, 
    624 F.3d at 1347
    .
    In United States v. Collier, this Court held that § 841(a) is not
    unconstitutionally vague as applied to physicians. 
    478 F.2d 268
    ,
    270–72 (5th Cir. 1973). 24
    In Collier, a physician appealed his § 841(a)(1) conviction for
    dispensing methadone while acting outside the usual course of
    professional practice. Id. at 270. Affirming the conviction, this
    Court rejected the physician’s arguments (1) that the phrase “in the
    course of his professional practice” did not give physicians notice
    as to what conduct violates the statute, and (2) that “statutes
    affecting medical practice [must] delineate the precise
    24 In Bonnerv. City of Prichard, 
    661 F.2d 1206
    , 1209 (11th Cir. 1981) (en banc),
    this Court adopted as precedent the decisions of the former Fifth Circuit
    handed down prior to October 1, 1981.
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    44                     Opinion of the Court                20-12568
    circumstances constituting       the     bounds    of    permissible
    practice.” 
    Id.
     at 270–72.
    In so ruling, our Court concluded that § 841(a) is not
    unconstitutionally vague because it restricts a physician to
    “dispensing or prescribing drugs in the bona fide treatment of a
    patient’s disease” and does not “under the guise of treatment”
    permit a physician to “distribute drugs to an addict.” Id. at 272.
    Indeed, the phrase—“usual course of his professional practice”—
    gives physicians a certain latitude of available options. Id. at 270–
    72.
    Here, Heaton raises essentially the same argument that our
    Court rejected in Collier—that the phrase “the usual course of his
    professional practice” lacks a standard defining when a physician’s
    prescribing practices become unlawful. See id.
    Heaton attempts to distinguish his case from Collier on the
    basis that Collier was decided before the relevant case law devolved
    into a “state of muddled confusion.” He contends that existing case
    law provides insufficient guidance as to the applicable mens rea and
    standard of care for § 841(a) offenses involving physicians.
    We are unpersuaded. Our Court has identified specific
    examples of “condemned behavior” by physicians that violates
    § 841(a), including (1) prescribing an excessive quantity of
    controlled substances; (2) issuing large numbers of such
    prescriptions; (3) failing to physically examine patients;
    (4) prescribing controlled drugs at intervals inconsistent with
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    20-12568               Opinion of the Court                       45
    legitimate medical treatment; and (5) issuing prescriptions for
    drugs that had no logical relationship to the treatment of the
    patient’s alleged condition. See United States v. Rosen, 
    582 F.2d 1032
    , 1035–36 (5th Cir. 1978); see also United States v. Joseph, 
    709 F.3d 1082
    , 1104 (11th Cir. 2013) (affirming physician’s § 841(a)
    conviction where evidence showed he prescribed an inordinate
    amount of controlled substances, he conducted inadequate
    physical examinations, and many of the combinations of prescribed
    drugs were not medically necessary), overruled on other grounds
    by Ruan, 597 U.S. ----, 
    142 S. Ct. 2370
    ; Abovyan, 988 F.3d at 1305
    (affirming physician’s § 841(a) conviction where evidence showed
    he prescribed controlled substances for pain/withdrawal when
    patients did not have pain/withdrawal and he failed to conduct
    adequate physical examinations).
    Tellingly too, the Supreme Court’s Ruan decision clarified
    the mens rea that should be incorporated into jury instructions for
    § 841(a) offenses. 597 U.S. at ----, 142 S. Ct. at 2376. The Supreme
    Court determined that (1) § 841(a)’s “knowingly or intentionally”
    mens rea applies to the critical terms in the statute and (2) the
    government must prove that the defendant physician subjectively
    knew that his conduct fell outside the usual course of professional
    conduct. Id. at ----, 142 S. Ct. at 2376. We have no reason to depart
    from our precedent in Collier.
    Likewise, we reject Heaton’s argument that § 841 is
    unconstitutionally vague because the CSA does not define the
    phrases “legitimate medical purpose” and “usual course of
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    46                         Opinion of the Court                20-12568
    professional practice.” These phrases do not require statutory or
    regulatory definitions. Rather, they are phrases reasonably
    understandable by a physician and their factual application will
    necessarily entail a case-by-case analysis. See Collier, 
    478 F.2d at
    270–72; Biro, 
    143 F.3d at 1430
    . For the above reasons, we conclude
    § 841(a) is not unconstitutionally vague as applied to physicians.
    V.     CONCLUSION
    We affirm Heaton’s convictions. 25
    AFFIRMED.
    25   Heaton does not appeal his 72-month sentence.