Court Opinion

ID: 4567967
Source: CourtListenerOpinion
Date Created: 2020-09-22 22:30:09.991854+00
Date Added: 2024-06-11T08:46:35.094421
License: Public Domain

PUBLISHED

                       UNITED STATES COURT OF APPEALS
                           FOR THE FOURTH CIRCUIT

                                       No. 19-4656

UNITED STATES OF AMERICA,

                     Plaintiff – Appellee,

              v.

FELIX BRIZUELA, JR.,

                     Defendant – Appellant.

Appeal from the United States District Court for the Northern District of West Virginia, at
Clarksburg. Irene M. Keeley, Senior District Judge. (1:18-cr−00001-IMK-MJA-1)

Submitted: March 26, 2020                                         Decided: June 19, 2020

Before MOTZ, HARRIS, and QUATTLEBAUM, Circuit Judges.

Reversed and remanded for a new trial by published opinion. Judge Quattlebaum wrote the
opinion in which Judge Motz and Judge Harris joined.

Philip Urofsky, Washington, D.C., Shaina L. Schwartz, Sahand Farahati, SHEARMAN &
STERLING LLP, New York, New York, for Appellant. William J. Powell, United States
Attorney, Martinsburg, West Virginia, Sarah E. Wagner, OFFICE OF THE UNITED
STATES ATTORNEY, Clarksburg, West Virginia, for Appellee.
QUATTLEBAUM, Circuit Judge:

       Dr. Felix Brizuela operated a medical practice in West Virginia. Following

complaints about his opioid prescription-writing practices, Brizuela was investigated by

the United States Drug Enforcement Administration (“DEA”) and ultimately convicted of

15 counts of unlawfully distributing controlled substances, in violation of 21 U.S.C.

§ 841(a)(1), (b)(1)(C). He now appeals his conviction.

       Although Brizuela raises a host of arguments, we focus on his contention that, under

United States v. Kennedy, 32 F.3d 876 (4th Cir. 1994) and Federal Rule of Evidence 404(b),

the district court improperly admitted the testimony of patients whose treatment by

Brizuela was not the basis for any of the charges in the indictment. 1 For the reasons set

forth below, we agree with Brizuela that the testimony of the patients whose treatment was

not included in the indictment was not necessary to “complete the story” of the charged

offenses under Kennedy, and was not otherwise admissible under Rule 404(b). And

       1
         Brizuela also argues that allowing the government’s expert witness to testify that
each of the 21 prescriptions cited in the unlawful distribution charges were written “outside
the bounds of professional medical practice” violated Federal Rule of Evidence 704(b)
because the testimony constituted an inadmissible legal conclusion; that the district court
imposed an impermissible mandatory presumption by instructing the jury that “assisting
another in the maintenance of a drug habit is conduct that is not for a legitimate medical
purpose or is outside the bounds of professional medical practice.” J.A. 1684; that the
district court erred by not instructing the jury that, in order to convict him of unlawful
distribution under 21 U.S.C. § 841(a)(1), it must find that he knowingly or intentionally
acted outside the bounds of professional practice by writing the charged prescriptions; and
that there was not sufficient evidence to support his convictions under § 841(a)(1) because
no reasonable jury could find that the prescriptions cited in each charge were written
outside the bounds of professional medical practice. In light of our decision today, we need
not address these additional challenges to the verdict.

                                             2
because the government did not carry its burden of establishing that this error was harmless,

we vacate Brizuela’s conviction and remand for a new trial in accordance with this

decision.

       We do not lightly overturn the verdict of a federal jury whose members gave

substantial time and effort performing their civic duty during Brizuela’s trial. But

compliance with the Federal Rules of Evidence is important to ensure that trials are

conducted fairly. When, as here, evidence introduced in a trial deviates from those Rules

and causes prejudice, we are compelled to order a new trial.

                                             I.

       Brizuela is a Doctor of Osteopathic Medicine 2 and a board-certified neurologist who

operated a medical practice in Morgantown, West Virginia. He offered pain management

services, including prescribing patients opioid pain killers such as oxycodone and

oxymorphone. These drugs are Schedule II controlled substances under the Controlled

Substances Act (“CSA”), 21 C.F.R. § 1308.12(b)(1). Brizuela also worked at Advance

       2
         A doctor of osteopathic medicine (D.O.) is a licensed doctor who has graduated
from an American osteopathic medical school. Like a doctor of medicine (M.D.) who has
attended a conventional medical school, D.O.s complete residency training in their chosen
specialties and must pass the same licensing examination before they can treat patients and
prescribe medications. However, D.O. training emphasizes holistic patient treatment that
focuses on the musculoskeletal system—the body’s interconnected system of nerves,
muscles and bones. PATRICK WU & JONATHAN SIU, A BRIEF GUIDE TO OSTEOPATHIC
MEDICINE: FOR STUDENTS, BY STUDENTS 3 (American Association of Colleges of
Osteopathic Medicine 2d ed.) (2015).

                                             3
Healthcare, a clinic in Weirton, West Virginia that treated patients for opioid addiction by

prescribing them Suboxone, a medication designed to reduce opioid withdrawal symptoms

and the desire to use opioids. Suboxone is a Class III controlled substance because it

contains buprenorphine, another habit-forming opioid. See 21 C.F.R. § 1308.13(e)(2). 3

       Under federal law, every doctor who wishes to dispense controlled substances must

apply for and obtain a unique registration number (“DEA number”). See 21 U.S.C.

§ 822(a)(2). If a registered practitioner fails to comply with the CSA or the terms of

registration, their ability to prescribe certain classes of controlled substances can be

revoked or suspended. See 21 U.S.C. § 824.

       The DEA began investigating Brizuela after it received complaints from a

pharmacist, the West Virginia Board of Pharmacy and the mother of one of Brizuela’s

patients about Brizuela’s opioid prescription-writing practices. To corroborate these

claims, the DEA used the West Virginia Controlled Substances Monitoring Program, a

       3
         While currently regulated, opioids have been in the United States since its early
days, with Benjamin Franklin taking them to deal with bladder stones and Alexander
Hamilton receiving them after his fatal duel with Aaron Burr. Letter from Benjamin
Franklin to M. Le Veillard (Sept. 5, 1789), in 3 THE LIFE OF BENJAMIN FRANKLIN,
WRITTEN BY HIMSELF, 438 (John Bigelow ed., 1902); DAVID COURTWRIGHT, DARK
PARADISE: A HISTORY OF OPIATE ADDICTION IN AMERICA 40, 44 (2009). The first
documentation of widespread opioid addiction in the United States occurred during the
Civil War. During that period, the administration of morphine—an opioid—to injured
soldiers led to an addiction known as “the Army disease.” Nat Hentoff, The Treatment of
Patients, THE NEW YORKER 45 (June 26, 1965). In 1914, Congress passed the first federal
law aimed at curbing the distribution of opioids for non-medical or non-scientific uses. Id.
at 46. Although additional restrictions were placed on the use and prescribing of opioids
over the next century, opioid use and abuse continued. Currently, opioids account for more
than half of all overdose deaths in the United States. NATIONAL INSTITUTE ON DRUG
ABUSE, WEST VIRGINIA: OPIOID-INVOLVED DEATHS AND RELATED HARMS 2 (2020).
                                             4
database that records prescriptions for controlled substances. Upon reviewing the

prescriptions associated with Brizuela’s DEA number, agents confirmed that Brizuela was

prescribing “very unusual . . . dangerous cocktails” of opioids and other drugs. J.A. 215–

16.

       As a result, federal and state investigators executed a search warrant to obtain patient

files, medical charts, insurance documents and other materials from Brizuela’s

Morgantown practice. Among the items seized were pre-signed, blank prescriptions from

Brizuela’s prescription pad as well as sheets from his prescription pad that had been dated

and filled out with the type of controlled substance to be prescribed, but not signed. On the

day of the raid, Brizuela voluntarily surrendered his authority to prescribe Schedule II

controlled substances, including oxycodone. Notably, Brizuela told investigators that he

was relieved to give up his Schedule II prescribing authority because the patients receiving

Schedule II drugs from him were “pill-seekers and addicts” that he no longer wished to

treat. J.A. 223–24.

       Federal investigators also reviewed 404 patient files seized from the Morgantown

office to evaluate whether Brizuela subjected his opioid-prescribed patients to regular urine

drug tests. Such tests help ensure that patients are taking the prescribed opioids, abstaining

from illegal drugs or other illicit substances and not diverting opioids to other users. An

“inconsistent” urine test—a test showing the presence of street drugs, drugs not prescribed

by the doctor or such a low level of the prescribed opioid as to suggest that it is being

diverted to another person—alerts a doctor to at least reconsider, or possibly stop,

prescribing that patient opioids. When federal investigators reviewed Brizuela’s patient

                                              5
files, they found that 253—or about 63%—contained at least one inconsistent urine drug

screen test, and 170—or about 42%—contained multiple inconsistent urine drug screens.

Moreover, emails between Brizuela and the testing lab showed that he prescribed opioids

to his patients prior to, and sometimes without ever, receiving the results of urine drug

screens tests. In one email, Brizuela warned the lab that that the lack of timely test results

“is going to get us in trouble . . . .” J.A. 762.

       A federal grand jury indicted Brizuela on 21 counts of distributing controlled

substances outside the bounds of professional medical practice, each related to specific

prescriptions written for five of Brizuela’s patients, in violation of 21 U.S.C. §§ 841(a)(1),

(b)(1)(C); 4 one count of conspiracy to distribute controlled substances outside the bounds

of professional medical practice, in violation of 21 U.S.C. §§ 841(a)(1), (b)(1)(E)(i),

(b)(1)(E)(iii), 846; and 16 counts of illegal remuneration in violation of the federal anti-

kickback statute, in violation of 42 U.S.C. §§ 1320a-7b(b)(1)(B). 5 The conspiracy charge

was later dismissed at the government’s request.

       The case proceeded to trial. The government called two of the five patients whose

treatments were the subject of the indictment to testify about the prescriptions they received

       4
         See United States v. Moore, 423 U.S. 122, 124 (1975) (holding “that registered
physicians can be prosecuted under § 841 when their activities fall outside the usual course
of professional practice”); see also United States v. Tran Trong Cuong, 18 F.3d 1132, 1137
(4th Cir. 1994) (“[A] licensed physician who prescribes controlled substances outside the
bounds of his professional medical practice is subject to prosecution and is no different
than a large-scale pusher.”)
       5
        Because the jury acquitted Brizuela of the kickback charges, we have not described
the evidence related to the prosecution or defense of those charges.
                                                    6
from Brizuela. It also called four of Brizuela’s other patients to testify, although none of

Brizuela’s charges related to their treatment.

       The government also called Robin Price and Louis Tennant, two of Brizuela’s

former receptionists, to testify about the operation of the Morgantown office. They testified

that, although opioid prescriptions are usually not supposed to be refilled without regular

in-person evaluations, Brizuela often went months without seeing patients to whom he was

prescribing controlled substances. Tennant also stated that she routinely took Brizuela’s

prescription pad home, filled out patients’ refill prescriptions and brought the prescriptions

to the office for Brizuela to sign. According to Tennant, she completed around 500

prescriptions a month under this process, but never observed Brizuela comparing the

prescriptions she completed with patients’ medical charts.

       Tennant and Price said that Brizuela’s patients travelled from as far away as

Virginia, Maryland and Ohio to receive opioid prescriptions. They described how some

patients who came into the office looked “stoned,” “high” or “glassy-eye[d],” and how they

could become hostile if they did not quickly receive their refill prescriptions. J.A. 503, 573.

Tennant also testified that she overheard patients discuss selling their prescriptions and that

Brizuela was aware of such information. And Price noted that urine drug test results would

often sit unreviewed on Brizuela’s desk, while patients continued to receive opioid

prescriptions. Price also stated that as far as she knew, those urine tests were the only way

that Brizuela monitored whether his patients were using their controlled substances

properly.

                                              7
       In addition, the government called Debbie Shepard, the Executive Director of the

West Virginia Board of Osteopathic Medicine. Testifying not as an expert but as head of

the state governing body, Shepard explained that the Board received a complaint from the

mother of one of the patients whose treatment was included in the charges against Brizuela.

She also explained that in West Virginia, osteopathic doctors are prohibited from either

pre-signing prescription pads or prescribing controlled substances if the doctor knows or

has reason to know that a patient is abusing or diverting controlled substances. Shepard

also testified that physicians are required to properly document patient treatment—

including the in-person examination and other justifications for prescribing a controlled

substance—and to self-report any violations of the rules. She stated that Brizuela did not

self-report any violations to the West Virginia Board of Osteopathic Medicine relating to

the charged activity.

       The government also called Dr. Patrick Marshalek, a specialist in psychiatry and

addiction medicine. As the medical director of West Virginia University’s Chestnut Ridge

Center, he treats patients with opioid use disorders and has experience treating patients

with chronic pain. Marshalek was admitted as an expert in pain management without

objection.

       Marshalek described the medical standards for doctors prescribing controlled

substances. He stated that doctors must thoroughly assess patients by exploring their

history and performing in-person, physical evaluations to identify whether they have

legitimate pain or are simply seeking drugs. They must, Marshalek opined, also assess

whether the medical benefits of prescribing a patient opioids outweigh the patient’s unique

                                            8
risk factors, and must then discuss those risks with patients to receive informed consent for

a course of treatment.

       Marshalek testified that doctors must closely monitor patients’ use of controlled

substances by utilizing options such as urine drug tests and pill counts to ensure patients

are using the correct amount of medication. He also told the jury that doctors who become

aware that their patients are abusing or misusing opioid prescriptions must intervene and

alter the patient’s treatment. For example, according to Marshalek, a doctor could stop

administering the drug and refer the patient to addiction treatment or could continue

prescribing the drug with increased monitoring. Marshalek testified that, if patients

continue to abuse the drugs, doctors should stop prescribing them because the patient is a

danger to themselves and others.

       Marshalek reviewed the files of the five patients who received the prescriptions

charged in Brizuela’s 21 unlawful distribution counts. He also reviewed each patient’s

prescription data on the West Virginia Board of Pharmacy’s Prescription Monitoring

Program database and memoranda of interviews with the patients and their families. After

discussing Brizuela’s treatment of each patient, he opined that each of the charged

prescriptions were issued outside the bounds of professional medical practice.

       In response, Brizuela called Dr. Bruce Nicholson, an anesthesiologist with a

specialty in chronic and acute pain management, and the Director of the Division of Pain

Medicine for the Lehigh Valley Health Network. Nicholson testified that upon reviewing

the files of the five patients who received the prescriptions charged in the indictment, all

21 of the prescriptions listed in the unlawful distribution charges were issued within the

                                             9
bounds of professional medical practice. Nicholson said that while there is no standard,

“concrete way” to treat a patient’s chronic pain, J.A. 1157, Brizuela “adhered to the

standard of care” in issuing the charged prescriptions, and “practiced within the guidelines

of his medical professional competency and capabilities.” J.A. 1160. Brizuela also testified,

largely consistent with the opinions offered by Dr. Nicholson.

       After a seven-day trial, the jury found Brizuela guilty of fifteen counts of

distribution of controlled substances outside the bounds of professional medical practice,

but acquitted him of six distribution counts and all sixteen counts of illegal remuneration

in violation of the federal anti-kickback statute. Later, the district court sentenced Brizuela

to 48 months in prison and 3 years of supervised release.

       Brizuela timely filed his notice of appeal. This Court has jurisdiction under 28

U.S.C. § 1291.

                                              II.

       Brizuela argues the district court erred by admitting the testimony of patients who

Brizuela treated, but whose treatment was not the basis for his criminal charges. Because

this is a challenge to an evidentiary ruling, we review for an abuse of discretion. United

States v. Faulls, 821 F.3d 502, 508 (4th Cir. 2016). “A court has abused its discretion if its

decision is guided by erroneous legal principles or rests upon a clearly erroneous factual

finding.” United States v. Johnson, 617 F.3d 286, 292 (4th Cir. 2010) (internal quotation

marks omitted).

                                              10
       With that standard of review in mind, we turn to the testimony of the patients whose

treatment was not included in the indictment. The 21 prescriptions charged in Brizuela’s

indictment were written for five patients. Only two of these patients testified at trial.

However, the government also called four other patients who Brizuela treated, but whose

prescriptions were not the basis for any of the charges in the indictment, to testify at trial.

       Before trial, the government filed a notice under Federal Rule of Evidence 404(b),

alerting the district court and Brizuela of its intent to introduce the testimony of those four

other patients. It argued that this evidence was admissible under Kennedy because it was

“necessary to complete the story of the crime on trial.” J.A. 91 (quoting Kennedy, 32 F.3d

at 886). Specifically, the government argued that this testimony provides “[e]vidence that

[Brizuela] consistently failed to follow generally recognized procedures,” which “tends to

show that in prescribing drugs he was not acting as a healer but a seller of wares.” J.A. 91

(quoting United States v. Alerre, 430 F.3d 681, 691 (4th Cir. 2005)). It claimed that this

testimony could be used “[t]o prove the criminal violation” because it “show[ed] the extent

and severity of [Brizuela’s] violation of a professional norm.” J.A. 91. Alternatively, the

government also argued that the testimony was admissible under Rule 404(b)(2) because

it showed that Brizuela did not issue the 21 prescriptions charged in the indictment due to

a mistake or accident. 6 The district court overruled Brizuela’s objection and allowed the

government to introduce the testimony.

       6
         On appeal, the government makes two additional admissibility arguments for the
first time. First, it argues that the testimony of McCabe, Haraczy, Lively and Walker was
necessary because Brizuela asserted at trial that the government “cherry-picked” the five

                                              11
       Amy McCabe was the first patient whose treatment was not part of the indictment

to testify. She stated that both she and her husband are recovering opioid addicts and former

patients of Brizuela. She testified that when she started seeing Brizuela for her migraine

headaches, he never asked for medical records or conducted any tests to determine their

cause. Despite this, and her history with opioid addiction, Brizuela prescribed McCabe and

her husband opioid pain medication. She testified that she twice failed her urine drug tests

and, on one of her failed screenings, Brizuela wrote that she was at risk for sudden death.

However, she said that Brizuela neither directly discussed her failed drug screens nor

warned her of her risk of death. Instead, he continued to prescribe her the same opioids.

       Next, Brennan Haraczy testified about his treatment by Brizuela. Like McCabe, his

treatment was not the basis for any of Brizuela’s charges. Haraczy said Brizuela prescribed

him oxycodone, an opioid pain medication, for a pinched nerve in his shoulder. Haraczy

testified that Brizuela did not warn him of the addiction risk posed by taking opioids or the

dangers of mixing oxycodone with other types of drugs. Within the first month, Haraczy

became physically dependent on the medication. He testified that he sometimes took up to

patients and 21 prescriptions cited in the indictment to make their case J.A. 196, 1744.
Second, the government argues that their testimony is also admissible under Rule 404(b)
to rebut Brizuela’s good-faith defense. See United States v. Hurwitz, 459 F.3d 463, 476
(4th Cir. 2006) (“[A] doctor’s good faith generally is relevant to a jury's determination of
whether the doctor acted outside the bounds of medical practice or with a legitimate
medical purpose when prescribing narcotics.”). Because these arguments were not
presented to or considered by the district court, we do not consider them now. Hodges v.
Thompson, 311 F.3d 316, 320 n. 3 (4th Cir. 2002) (citation omitted); see also Wratchford
v. S. J. Groves & Sons Co., 405 F.2d 1061, 1063 (4th Cir. 1969) (“Ordinarily, of course, a
party should not be allowed to change the theory of his case after trial . . . .”).

                                             12
15 pills at once, at times mixing the oxycodone with marijuana, Xanax, Ativan and anxiety

medication that he got off the street. Even so, Brizuela never, according to Haraczy,

indicated that there was a problem with his urine drug screen tests. Haraczy also explained

that his monthly in-person evaluations only lasted “[a] couple of minutes, at tops.” J.A.

612. He stated that it took him three years after he stopped seeing Brizuela to get clean of

opioids, and that he “lost everything” because of his addiction. J.A. 615.

       The government also questioned Haraczy about Brizuela’s treatment of his deceased

mother. When Brizuela objected, the government argued that Haraczy’s testimony about

Brizuela’s treatment of his mother was “part of the picture” of the crimes on trial because

his mother was “[a]nother patient dependent.” J.A. 611. The district court allowed this

testimony as “background information concerning the course of [Brizuela’s medical]

practice . . . .” J.A. 611. Haraczy then testified that his mother was so physically dependent

on the opioids that Brizuela prescribed that “[s]he would be sick” if she did not take them.

J.A. 610.

       Finally, Jennifer Lively and her wife, Donna Walker, testified about the treatment

they received from Brizuela. Like McCabe and Haraczy, their treatment was not the basis

for any of the charges in the indictment. Although Brizuela prescribed both Lively and

Walker a combination of opioids and Xanax, they each stated that Brizuela did not warn

them about the risk of addiction or discuss what drug combinations could be dangerous.

Lively testified that she became so physically dependent on her oxycodone that she would

get “deathly sick” if she did not take it. J.A. 661. On one occasion, her withdrawal

symptoms were so bad that she had to be put on life support. Walker said that when she

                                             13
called Brizuela from the hospital to talk about Lively’s condition, he “cussed [her] out

several times.” J.A. 681. Lively and Walker testified that they witnessed a doctor from the

hospital tell Brizuela over the telephone that Lively “was in withdrawals due to the

medication” Brizuela prescribed her. J.A. 668. Upon Lively’s release, she said Brizuela

continued to prescribe her oxycodone and Xanax without ever mentioning her time in the

hospital or discussing her addiction.

       Lively and Walker also testified more generally about their interactions with

Brizuela. Lively testified that Brizuela told her about internet posts claiming that he was

“a bad physician” and that “if anybody wanted pills to go to him.” J.A. 669, 680. Walker

also noted that Brizuela once “threw a temper tantrum” and “stomped his feet in the middle

of his . . . office” when she asked to change prescriptions because of the way it made her

feel. J.A. 678. She also told the jury that she once witnessed him “cuss[] out” a nurse. J.A.

679.

       On appeal, Brizuela argues that the district court erred in admitting the testimony of

these four patients under the “Kennedy doctrine,” which allows courts to admit evidence

of uncharged acts or crimes if they are “necessary to complete the story of the crime on

trial.” Kennedy, 32 F.3d at 885 (internal alteration and citation omitted). He claims that the

admission of this evidence constituted an “unduly expansive interpretation of Kennedy”

that “eviscerates the protections intended to be conferred through Rule 404(b)’s general

prohibition on the introduction of other crimes, wrongs, or acts.” Appellant’s Opening

Brief at 14. Brizuela argues that the government introduced the testimony as propensity

evidence because it “did not relate in any way to his treatment of those patients charged in

                                             14
the indictment,” and was “introduced solely to create an impression before the jury that

[he] had a gaggle of allegedly pill-addicted patients.” Appellant’s Opening Brief at 18.

       After considering these arguments and the government’s responses, we agree with

Brizuela that the district court abused its discretion in admitting the challenged testimony

under Kennedy’s “complete the story” doctrine. We also reject the government’s

alternative argument that the evidence was properly admitted under Fed. R. Evid. 404(b)(2)

to show that Brizuela’s violations were not the result of accident or mistake. Last, we

conclude that the government did not meet its burden of establishing that the district court’s

error was harmless.

                                             A.

       Federal Rule of Evidence 404(b) prohibits admitting evidence of another “crime,

wrong, or other act . . . to prove a person’s character in order to show that on a particular

occasion the person acted in accordance with the character.” Fed. R. Evid. 404(b)(1). Such

“propensity evidence is excluded because it might ‘overpersuade’ a jury and cause them to

‘prejudge one with a bad general record.’” United States v. Queen, 132 F.3d 991, 995 (4th

Cir. 1997) (quoting Michelson v. United States, 335 U.S. 469, 475–76 (1948)). But the

Rule allows the admission of evidence of other acts or crimes if used to prove “motive,

opportunity, intent, preparation, plan, knowledge, identity, absence of mistake, or lack of

accident.” Fed. R. Evid. 404(b)(2).

       Critically, however, “not all prior ‘bad act’ evidence is encompassed by Rule

404(b).” United States v. McBride, 676 F.3d 385, 396 (4th Cir. 2012). Instead, the rule is

“only applicable when the challenged evidence is extrinsic, that is, separate from or

                                             15
unrelated to the charged offense.” United States v. Bush, 944 F.3d 189, 195 (4th Cir. 2019)

(internal quotations omitted). In contrast, acts that are a part of, or “intrinsic to, the alleged

crime do not fall under Rule 404(b)’s limitations on admissible evidence.” Id. at 195–96.

(quoting United States v. Chin, 83 F.3d 83, 87–88 (4th Cir. 1996)).

       When, as here, we are tasked with determining whether uncharged conduct is

intrinsic to the charged offenses, we have consistently held that such conduct is intrinsic,

and not barred by Rule 404(b), when it “arose out of the same . . . series of transactions as

the charged offense, . . . or is necessary to complete the story of the crime on trial.” 7

Kennedy, 32 F.3d at 886 (quoting United States v. Towne, 870 F.2d 880, 886 (2d Cir. 1989)

(internal alteration omitted); United States v. Sutherland, 921 F.3d 421, 430 (4th Cir. 2019),

cert. denied, 140 S. Ct. 1106 (2020); McBride, 676 F.3d at 396; United States v. Palacios,

677 F.3d 234, 245 (4th Cir. 2012); United States v. Basham, 561 F.3d 302, 326 (4th Cir.

2009); United States v. Siegel, 536 F.3d 306, 316 (4th Cir. 2008); United States v. Stitt, 250

F.3d 878, 887 (4th Cir. 2001); see also United States v. Denton, 944 F.3d 170, 186 (4th

Cir. 2019); United States v. Lipford, 203 F.3d 259, 265 (4th Cir. 2000). 8 Our “complete the

       7
          Although not argued here, we have also held that that evidence of uncharged acts
is “intrinsic,” and not prohibited by Rule 404(b), when the charged and uncharged conduct
“are inextricably intertwined.” Bush, 944 F.3d at 196 (citation omitted). But because
neither the district court’s decision, nor Brizuela’s appeal, raise the related “inextricably
intertwined” doctrine, we need not address its applicability to the challenged testimony.
       8
          These holdings are consistent with the approach embraced by a number of our
sister circuits. See, e.g., United States v. Quinones, 511 F.3d 289, 309 (2d Cir. 2007);
United States v. Price, 329 F.3d 903, 906 (6th Cir. 2003); Lockett v. Anderson, 230 F.3d
695, 709 n. 24 (5th Cir. 2000); United States v. Ramsdale, 61 F.3d 825, 830 (11th Cir.
1995). However, as Brizuela notes, other circuits have criticized or done away with similar

                                               16
story” decisions reflect case-by-case, fact-based analyses. But to illustrate how uncharged

conduct may or may not “complete the story” of charged offenses, we describe two of our

prior decisions.

       In Kennedy—this Court’s seminal case on the “complete the story” doctrine— the

defendant was charged with conspiracy to distribute, and possession with the intent to

distribute, cocaine. Kennedy, 32 F.3d at 881. At trial, the district court admitted testimony

describing Kennedy’s drug distribution activities with suppliers not named in his federal

indictment. Id. at 885. On appeal, Kennedy argued that the testimony constituted

impermissible “other crimes” evidence under Fed. R. Evid. 404(b) because it described a

separate conspiracy that involved different people and fell outside the conspiracy time

period charged in the indictment. Id. We rejected this argument, holding that the testimony

“constituted predicate evidence necessary to provide context to the [federally charged] drug

distribution scheme . . . ” because it “proved Kennedy’s participation in drug distribution

activities, and addressed Kennedy’s sources for the cocaine that he supplied . . . during the

charged conspiracy period.” Id. at 885–86. Additionally, we held that the testimony “served

as evidence of a subset of the charged conspiracy—Kennedy's own distribution network—

that helped the jury to understand how Kennedy's group obtained its cocaine and how that

group related to and became part of the bigger [drug] conspiracy.” Id. at 886. As a result,

“completes the story” or “inextricably intertwined” theories of intrinsic evidence. See, e.g.,
United States v. Bowie, 232 F.3d 923, 929 (D.C. Cir. 2000); United States v. Gorman, 613
F.3d 711, 719 (7th Cir. 2010); United States v. Green, 617 F.3d 233, 248 (3rd Cir. 2010).

                                             17
we held that the testimony “did not constitute ‘other crimes’ evidence under Rule 404(b)”

because it “served to complete the story of the crime on trial.” Id. at 886 (citation omitted).

       In contrast, in United States v. McBride, 676 F.3d 385, 389–90 (4th Cir. 2012),

McBride was charged with possession of cocaine with the intent to distribute, stemming

from a 2009 drug sale at the Nu Vibe Club in Clarendon County, South Carolina. At trial,

the government elicited testimony—over McBride’s Rule 404(b) objection—describing a

2008 encounter during which a confidential police informant attempted to purchase crack

cocaine from McBride at his residence. See id. at 390–91. On appeal, we rejected the

argument that the 2008 encounter arose out of the same series of transactions as, or

completed the story of, his possession of cocaine at the club in 2009. Id. at 396. We

explained “nothing that occurred at McBride’s residence in January 2008 was necessary to

‘complete the story’ of the crimes alleged at the club.” Id. Instead, the evidence was

“relevant primarily to establish McBride’s character as a ‘drug dealer’” and constituted

“the very type of evidence that the limitation imposed by Rule 404(b) was designed to

exclude.” Id. at 398.

       While there are other cases in which we have applied this principle, these two

decisions illustrate that for evidence of uncharged conduct to be admissible to “complete

the story” of a charged offense, the evidence must be probative of an integral component

of the crime on trial or provide information without which the factfinder would have an

incomplete or inaccurate view of other evidence or of the story of the crime itself. For

example, in Kennedy, the evidence proved the defendant’s involvement with the charged

conspiracy, explained to the jury where the conspiracy sourced its cocaine and

                                              18
demonstrated how Kennedy’s network fit into the larger drug distribution operation.

Kennedy, 32 F.3d at 885–86. In contrast, the challenged evidence in McBride was simply

another drug deal that was never connected, and did not add any information to, the drug

crimes for which McBride was charged. McBride, 676 F. 3d at 396.

       And importantly, these decisions also make clear that evidence must be “necessary”

to “complete the story” of the charged offense. Kennedy, 32 F.3d at 885. This requires a

hard look to ensure that there is a clear link or nexus between the evidence and the story of

the charged offense, and that the purpose for which the evidence is offered is actually

essential. Otherwise, the “complete the story” doctrine might be used to disguise the type

of propensity evidence that Rule 404(b) is meant to exclude.

                                             B.

       With this background in mind, we turn to the testimony of McCabe, Haraczy, Lively

and Walker. From our review of the record, their testimony was not necessary to “complete

the story” of the charged offenses and, therefore, described conduct that was extrinsic to

the offenses for which Brizuela was charged. First, the testimony does not describe acts

that “arose out of the same . . . series of transactions as the charged offense[s] . . . .”

Kennedy, 32 F.3d at 885 (citation omitted). Under the CSA and accompanying regulations,

registered doctors are prohibited from writing a prescription for controlled substances if

the prescription is not “issued for a legitimate medical purpose by an individual practitioner

acting in the usual course of his professional practice.” United States v. Hurwitz, 459 F.3d

463, 475 (4th Cir. 2006) (quoting 21 C.F.R. § 1306.04(a) (2006)). Accordingly, a doctor

“knowingly . . . issuing such a purported prescription shall be subject to the penalties

                                             19
provided for violations” of § 841. See id. (emphasis added, internal alterations omitted).

An unlawful distribution violation under § 841 is, therefore, charged by citing a specific

prescription. Each of Brizuela’s § 841 charges properly identified a different prescription

that he wrote for one of five patients.

       For each of these charges, the “transaction” in question was Brizuela writing the

specific prescription listed in that count of the indictment. Significantly, the challenged

testimony of the four other patients did not reference or encompass any of the 21

prescriptions listed in the indictment. Thus, none of the acts they described arose from the

same transaction, series of transactions or single criminal episode as the charged offenses.

The district court indicated as much when, for example, it allowed Haraczy to testify about

Brizuela’s treatment of his mother. In that instance, it warned the jury that “there’s been

no charge in this indictment” related to Brizuela’s treatment of her, and that it was only to

serve as “background information concerning the course of [Brizuela’s medical] practice

. . . .” J.A. 611. Importantly, the warning did not connect the testimony to the charged

offenses.

       Second, none of the conduct described by these four patients was “necessary to

complete the story of the crime[s] on trial.” Kennedy, 32 F.3d at 885 (internal alteration

and citation omitted). The testimony did not, for example, offer facts that were necessary

to prove a specific element of a charged offense or provide information that was essential

to understanding how the offense was committed. Instead, the testimony offered new

patient stories that were neither the basis for, nor necessary to prove, any of Brizuela’s

charges. These new stories constituted “overkill” or “piling-on” by the prosecution, which

                                             20
invited the jury “to find guilt by association or as result of a pattern,” rather than examining

whether sufficient evidence supported a conviction under each count in the indictment.

United States v. Tran Trong Cuong, 18 F.3d 1132, 1142 (4th Cir. 1994).

       The government insists—as it did below—that the challenged testimony completed

the story of Brizuela’s § 841 charges by providing “evidence that [Brizuela] consistently

failed to follow generally recognized procedures,” which “tends to show that in prescribing

drugs he was not acting as a healer but a seller of wares.” J.A. 91 (quoting United States v.

Alerre, 430 F.3d 681, 691 (4th Cir. 2005)). Therefore, it claims that the testimony was

necessary “[t]o prove the criminal violation” because it “showed the extent and severity of

[Brizuela’s] violation of a professional norm.” J.A. 91.

       It is certainly true that in prosecuting doctors for unlawfully distributing controlled

substances under § 841, the government must prove “beyond a reasonable doubt that the

doctor was acting outside the bounds of professional medical practice.” Alerre, 430 F.3d

at 690 (internal quotation marks omitted). And we have previously allowed “evidence that

a physician consistently failed to follow generally recognized procedures [] to show that in

prescribing drugs he was not acting as a healer but as a seller of wares.” Id. at 691. But

neither Alerre nor any other case identified by the government allow admitting the

testimony of patients whose treatment was not the basis for a defendant’s § 841 charges,

or permit admitting uncharged acts that are not necessary to the stories of the prescriptions

                                              21
cited in a § 841 charge. 9 See Alerre, 430 F.3d at 691; United States v. McIver, 470 F.3d

550, 561 (4th Cir. 2006).

       As stated above, a doctor’s violation of § 841 is prescription specific, and writing a

prescription only violates § 841 if, in doing so, the doctor strays from bounds of

professional medical practices in treating that specific patient. See Tran Trong Cuong, 18

F.3d at 1142; United States v. Singh, 54 F.3d 1182, 1187 (4th Cir. 1995). Therefore, the

relevant “story” for a § 841 offense is whether in writing the cited prescription, the

defendant doctor was treating the patient receiving the prescription within the bounds of

professional medical practices.

       Here, the government did not sufficiently connect the treatment of McCabe,

Haraczy, Lively and Walker to the stories of the 21 prescriptions charged in the indictment.

It simply claimed that their testimony “shows the extent and severity of [Brizuela’s]

violation of a professional norm.” J.A. 91. This is not enough. Kennedy and our subsequent

“complete the story” decisions require that the context provided by uncharged acts do more

than simply show the “extent” and “severity,” of alleged violations. Instead, they must

“complete the story of the crime[s] on trial.” Kennedy, 32 F.3d at 885 (emphasis added).

       9
         In Alerre, the defendants were charged with conspiring to unlawfully distribute
controlled substances, and the government’s expert witness was permitted to review 88
randomly selected patient charts and opine that the defendants did not adhere to generally
accepted medical standards in treating those patients. Alerre, 430 F.3d at 686. While “[i]t
is well established that when seeking to prove a conspiracy, the government is permitted
to present evidence of acts committed in furtherance of the conspiracy even though they
are not all specifically described in the indictment,” see, e.g. United States v. Palacios, 677
F.3d 234, 245 (4th Cir. 2012) (citation omitted); United States v. Janati, 374 F.3d 263, 270
(4th Cir. 2004), Brizuela did not face a conspiracy charge at trial.
                                              22
To hold otherwise would not only misapply Kennedy, but would also render Rule 404(b)

virtually toothless. In the absence of a clear link between other-acts testimony and the

stories of the specific crimes on trial, the evidence cannot be admitted under Kennedy’s

“complete the story” doctrine.

       Finally, our precedent requires that uncharged acts must be “necessary” to complete

the stories of the charged offenses. See e.g. Kennedy, 32 F.3d at 885. The government failed

to directly address this necessity requirement below or on appeal. It certainly did not

establish the testimony of McCabe, Haraczy, Lively and Walker was probative to an

integral component of the crimes on trial or provided information without which the jury

would have an incomplete or inaccurate view of other evidence or of the story of the

charged crimes. Accordingly, for all of these reasons, the challenged testimony does not

fall within Kennedy’s “complete the story” doctrine and is not otherwise intrinsic to

Brizuela’s § 841 offenses.

                                            C.

       We turn now to the government’s alternative admissibility argument. In its pretrial

Rule 404(b) notice, the government argued that if the challenged testimony was not

admissible as intrinsic evidence under Kennedy, it was otherwise admissible under Rule

404(b)(2) because it showed that Brizuela did not issue the 21 charged prescriptions due to

a mistake or accident. While the district court did not directly address the merits of this

alternative argument, the government reiterates it on appeal.

       Rule 404(b)(1) prohibits the admission of extrinsic evidence of a defendant's other

crimes or bad acts to show that the defendant acted in conformity to those prior actions.

                                            23
But other-acts evidence may be admitted if offered for a permissible purpose under Rule

404(b)(2). That subsection provides a non-exhaustive list of permitted purposes, which

allow evidence of other acts or crimes to be admitted to prove “motive, opportunity, intent,

preparation, plan, knowledge, identity, or absence of mistake or accident.” Queen, 132 F.3d

at 994 (quoting Fed. R. Evid. 404(b)(2)).

       “The government bears the burden of establishing that evidence of a defendant's

prior bad acts is admissible for a proper purpose.” United States v. Hall, 858 F.3d 254, 266

(4th Cir. 2017). To meet this burden, the government must satisfy a four-prong test:

       First, [t]he evidence must be relevant to an issue, such as an element of an
       offense, and must not be offered to establish the general character of the
       defendant. Second, [t]he act must be necessary in the sense that it is probative
       of an essential claim or an element of the offense. Third, [t]he evidence must
       be reliable. And fourth, the evidence's probative value must not be
       substantially outweighed by confusion or unfair prejudice in the sense that it
       tends to subordinate reason to emotion in the factfinding process.

Hall, 858 F.3d at 266 (internal quotation marks and citations omitted). Here, the

government cannot carry this burden.

       To begin with, the government did not explain why the absence of a mistake or

accident was probative of an essential element of the charged offenses. Moreover, at trial,

Brizuela never asserted he wrote any of the 21 prescriptions charged in the indictment due

to a mistake or an accident. To the contrary, he argued his conduct was appropriate and in

the best interest of his patients. Since neither mistake nor accident was an issue below,

evidence purportedly speaking to those issues is not relevant to or probative of an essential

element of the charged offenses.

                                             24
       With good reason, we defer to the evidentiary judgments of district court judges

who work on the front lines of trials like the one before us now. But despite this deference,

it is our responsibility to ensure that evidentiary judgments are not based on erroneous legal

principles. In that regard, our review of this record reveals that the testimony about

uncharged conduct was neither necessary to complete the story of the charged offenses,

nor proper to show mistake or accident under Rule 404(b)(2). Consequently, we conclude

that the district court abused its discretion in admitting the testimony of McCabe, Haraczy,

Lively and Walker at trial.

                                             D.

       However, our determination that the district court abused its discretion in admitting

the challenged testimony does not end our inquiry. Under Federal Rule of Criminal

Procedure 52(a), once we determine that the district court erred, we will not vacate the

conviction if the error was harmless. An error is harmless if “we can say with fair assurance,

after pondering all that happened without stripping the erroneous action from the whole,

that the judgment was not substantially swayed by the error.” McBride, 676 F.3d at 400

(internal quotation marks and citation omitted). In making this determination, the question

is not “whether we believe that irrespective of the error there was sufficient untainted

evidence to convict but, more stringently, whether we believe it highly probable that the

error did not affect the judgment.” Id. (quoting United States v. Ince, 21 F.3d 576, 583 (4th

Cir. 1994)).

       Critically, the government—as the beneficiary of the error—bears the burden of

establishing that the error was harmless. United States. v. Curbelo, 343 F.3d 273 (4th Cir.

                                             25
2003). Despite that, the government did not even argue in its brief that the admission of the

testimony about uncharged conduct, if in error, was harmless. While we may address the

issue on our own initiative, United States v. Peay, 972 F. 2d 71, n* (4th Cir. 1992) (Luttig,

J. concurring), 10 we should avoid doing so when, as here, the question of harmless error is

close. See United States v. Pryce, 938 F. 2d 1343, 1348 (D.C. Cir. 1991) (addressing

harmless error despite government’s failure to argue the issue in its brief because the record

was straightforward and its harmlessness was beyond reasonable debate).

       To be sure, there was significant evidence of Brizuela’s guilt aside from the

evidence of uncharged conduct. Among that evidence was the fact that, although only two

of the five patients whose treatment was the subject of the indictment testified, the

government’s expert detailed the treatment of all five patients. Further, the government

       10
          A different, but related, question is whether the government’s failure to argue
harmless error waives the issue. While this Court has not addressed this issue head on, we
have indicated, albeit in dicta, that such a failure may waive harmless error review. See
United States v. Hall, 858 F.3d 254, 280 n. 8 (4th Cir. 2017) and Thomas v. Berryhill, 916
F.3d 307, 314 n. 7 (4th Cir. 2019). But we have also explained that harmless error, under
Rule 52, is a standard of review. United States v. Massenburg, 564 F.3d 337, 345 & n. 3
(4th Cir. 2009) (discussing the “plain error standard of review” and the “harmless error
standard of review”). And “[o]ur case law is clear that ‘parties cannot waive the proper
standard of review by failing to argue it’ or by consenting to an incorrect standard.” United
States v. Venable, 943 F.3d 187, 192 (4th Cir. 2019) (quoting Sierra Club v. United States
Dep’t of the Interior, 899 F.3d 260, 286 (4th Cir. 2018)); see also United States v. Williams,
641 F.3d 758, 770‒773 (6th Cir. 2011) (Thapar, J., concurring) (stating that “courts of
appeals, . . . routinely hold that standards of review are not waivable,” and compiling cases
from various circuits). These cases, along with Peay, suggest that, since a standard of
review determines how an appellate court reviews an issue and not whether it reviews it, it
cannot be waived. Because we resolve the question of harmless review on the
government’s failure to carry its burden of showing harmless error, we need not resolve
this waiver issue today.

                                             26
offered compelling testimony from an expert, the head of the state regulatory body and

Brizuela’s former employees supporting its theory that Brizuela’s treatment of those five

patients was outside the bounds of professional medical practice. Finally, the district court

issued a limiting instruction concerning the uncharged conduct which, the jury’s split

verdict suggests, minimized the prejudice of the court’s error.

       But the record also supports the argument that the error was not harmless. From a

sheer numerical standpoint, twice as many patients testified about uncharged conduct as

those who testified about charged conduct. And aside from the numbers, the testimony of

the patients whose treatment was not charged was sympathetic and dramatic. Also, the

fundamental issue presented by each § 841 charge—whether Brizuela’s conduct was

outside the bounds of medical practice—is not, by its very nature, subject to a clear-cut

answer. Thus, because there was conflicting expert witness testimony on this fundamental

issue, the evidence of uncharged conduct could have tipped the scales in favor of the

government on the counts of conviction. Finally, the split verdict indicates the case was

close, perhaps so much so that the erroneously admitted evidence was the deciding factor

in securing Brizuela’s convictions.

       On this record, reasonable minds could differ on the question of harmless error.

Facing that close question, we decline to find the error was harmless on our own initiative

and will not “relieve the government from the consequences of its failure to raise the issue

of harmlessness on appeal.” United States v. Giovannetti, 928 F.2d 225, 227 (7th Cir.

1991). Instead, we conclude that the government did not carry its burden of establishing

                                             27
that the district court’s error was harmless and Brizuela’s convictions must, therefore, be

vacated.

                                             III.

       We dispense with oral argument because the facts and legal contentions are

adequately presented in the materials before this Court and argument would not aid the

decisional process. For the foregoing reasons, the decision of the district court is

                                     REVERSED AND REMANDED FOR A NEW TRIAL.

                                             28