Court Opinion

ID: 9370698
Source: CourtListenerOpinion
Date Created: 2023-02-14 17:00:29.53753+00
Date Added: 2024-06-11T17:16:23.187263
License: Public Domain

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                                                              [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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               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.