USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 1 of 35

PUBLISHED

UNITED STATES COURT OF APPEALS FOR THE FOURTH CIRCUIT

No. 23-4467

UNITED STATES OF AMERICA,

Plaintiff – Appellee,

v.

ANITA LOUISE JACKSON,

Defendant – Appellant.

------------------------------

PHYSICIANS AGAINST ABUSE, INC.,

Amicus Supporting Appellant.

No. 23-4587

UNITED STATES OF AMERICA,

Plaintiff – Appellee,

v.

ANITA LOUISE JACKSON,

Defendant – Appellant.

------------------------------ USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 2 of 35

PHYSICIANS AGAINST ABUSE, INC.,

Amicus Supporting Appellant.

Appeal from the United States District Court for the Eastern District of North Carolina, at Raleigh. James C. Dever, III, District Judge. (5:21-cr-00259-D-1)

Argued: November 1, 2024 Decided: January 21, 2025

Before DIAZ, Chief Judge, AGEE, and BENJAMIN, Circuit Judges.

Affirmed by published opinion. Judge Agee wrote the opinion in which Chief Judge Diaz and Judge Benjamin joined.

ARGUED: Elliot Sol Abrams, CHESHIRE PARKER SCHNEIDER, PLLC, Raleigh, North Carolina, for Appellant. Katherine Twomey Allen, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C., for Appellee. ON BRIEF: Ripley E. Rand, WOMBLE BOND DICKINSON (US) LLP, Raleigh, North Carolina, for Appellant. Nicole M. Argentieri, Principal Deputy Assistant Attorney General, Lisa H. Miller, Criminal Division, UNITED STATES DEPARTMENT OF JUSTICE, Washington, D.C.; Michael F. Easley, Jr., United States Attorney, David A. Bragdon, Assistant United States Attorney, Appellate Chief, OFFICE OF THE UNITED STATES ATTORNEY, Raleigh, North Carolina, for Appellee. Eric O. Husby, HUSBY LAW, Land O Lakes, Florida, for Amicus Curiae.

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AGEE, Circuit Judge:

Dr. Anita Jackson appeals her convictions for various offenses arising from the

operation of her private medical practice in North Carolina. She raises multiple arguments

challenging her conviction for violating the Food, Drug, and Cosmetics Act (“FDCA”) by

holding for re-sale adulterated medical devices, in violation of

(k). Flowing

from her challenge to the FDCA conviction, she also asserts that the prejudicial spillover

effect of evidence introduced to support that count requires vacatur of her other

convictions. And, assuming her case is remanded for a new trial, she submits that the Court

should reassign the case to a different district judge. Separately, Jackson challenges her

convictions for two counts of aggravated identity theft, in violation of 18 U.S.C.

§§ 1028A(a)(1) and 2.

Finding no reversible error as to any of the challenged convictions, we affirm.

I.

Jackson is a board-certified otolaryngologist, commonly referred to as an ear, nose,

and throat physician. During the relevant timeframe, she ran a multi-location private

practice in Lumberton and Rockingham, North Carolina.1

1 We recount the facts established at trial in the light most favorable to the Government, as the prevailing party. United States v. Torrez,

(4th Cir. 2017). 3 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 4 of 35

At one time, Jackson was the leading Medicare biller in the nation for a procedure

known as balloon sinuplasty surgery, which treats chronic sinusitis.2 The procedure

consists of the doctor inserting a device through the patient’s nose into one or more of the

sinuses and inflating a small balloon to widen the cavity. The device Jackson used for this

procedure during the relevant timeframe was an Entellus XprESS Multi-Sinus Dilation

Tool (“Entellus” or “the device”). The insertable part of this device has a small tip, an

inflatable balloon, and a thin hollow metal tube. The balloon slides up and down the tube

and is inflated after it is placed in the patient’s sinus cavity. The rest of the Entellus remains

outside the patient’s body and consists of the slide mechanism for the balloon, a suction

port, and a light fiber that runs through the hollow tube to allow the physician to see into

the sinus during the procedure. The device also has small retractable parts that often come

into contact with and trap bodily fluids and hair from the patient during the procedure.

These parts are fragile and may break easily, particularly if the Entellus is reused. The

device was, accordingly, designed for single use and is labeled by the Food and Drug

Administration as being approved only for single use.

Physicians who perform sinuplasty surgeries can be reimbursed by Medicare. In

fact, this particular procedure does not require preapproval to submit a claim. Medicare

reimbursement levels for sinuplasty and other procedures factor in “three main parts: The

amount of time and effort it takes to provide service, the costs associated with that service

2 Medicare is a federal health insurance program for individuals aged 65 or older as well as for certain people with qualifying disabilities. 42 U.S.C. § 1395c. Physicians can be reimbursed for services provided to Medicare beneficiaries by applying for a national provider identifier and enrolling with the program to obtain billing privileges. 4 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 5 of 35

that the doctor will incur, and the costs that the[] doctor incurs for malpractice.” J.A. 1402.

This formula, which takes into account the cost of the equipment needed to perform the

procedure, was used to calculate Medicare’s reimbursement amounts for a sinuplasty using

the Entellus.

Becoming the nation’s leading Medicare biller for sinuplasty surgery was far from

happenstance, as Jackson’s employees recounted how she incentivized recruiting Medicare

patients to agree to the procedure. For her employees, Jackson tied work hours to surgery-

marketing efforts, set surgery quotas for her offices, and paid bonuses related to how many

sinuplasty procedures were performed. She encouraged employees to recruit patients

throughout the community, targeting rural localities and seeking out individuals likely to

have Medicare because it did not require preapproval for the procedure. Employees

testified, for example, that they were told to pitch balloon sinuplasty to potential patients

at locations like Wal-Mart parking lots, churches, barbershops, and doctor’s offices. In

addition, Jackson offered some potential patients financial enticements such as not

requiring any front payment or limiting fees to a $50 copayment rather than the higher

Medicare-directed copayment amounts. By agreeing to have the sinuplasty procedure,

patients could also receive free transportation to Jackson’s office and gift cards to local

stores.

In conjunction with these efforts to drum up new sinuplasty patients, Jackson

streamlined the process she followed before deeming a patient eligible for the procedure.

Early on, Jackson ordered diagnostic scans and considered alternative treatments before

performing the procedure. Later, Jackson would simply perform the procedure on a

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patient’s first visit, implementing what Jackson’s employees termed an “assembly line” to

“get to ‘yes’” for the sinuplasty to be performed, thereby skipping a bona fide assessment

of the patients’ medical condition, alternative treatments, or even determining whether the

procedure was medically appropriate. J.A. 1766, 1953–55.

In many cases, Jackson’s recruitment efforts left patients without understanding that

the proposed procedure was actually a surgery. Instead, it was described to them as a “sinus

spa” or “rinse.” J.A. 1749–50, 2045. Many patients were also unaware that the procedure

worked by having the balloon micro-fracture bones. And they were similarly unaware that

Jackson elected to perform the procedure using the same device on more than one patient.

Instead, patients were informed that a “small sterile balloon” would be used during the

procedure. S.J.A. 172.

When investigators searched Jackson’s offices, they discovered that aged, used

devices were being stored loose in drawers. Those conditions were typical. Employees

reported that many Entelluses used on patients were rusted and the retractable parts no

longer operated smoothly. After use, Jackson’s employees would wash the device using a

variety of cleaning methods because they were not given clear instructions for how to do

so. They lacked appropriate tools to assist in cleaning the devices’ hollow and delicate

parts, and they could not see many areas of an Entellus to ensure that it was clean, much

less sterile. Usually, employees would wash the device with tap water and soap while

gently scrubbing it so as not to break any of its parts. They would then place it in two

chemical solutions for around thirty minutes (well below the solutions’ recommended

cleaning times), rinse with tap water, and then leave the device to dry on top of a pad on

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the counters of exam rooms. Once dry, the Entelluses were put in drawers where they were

interspersed with other supplies. This process created a significant likelihood that some

reused devices still contained prior patients’ bodily fluids.

Jackson’s billing practices related to sinuplasty surgeries drew the attention of

federal investigators, and she was audited four times between 2016 and 2018. After a 2016

audit, Jackson was forced to repay over $30,000 in Medicare reimbursements because of

noncompliant (incomplete) recordkeeping. The 2016 audit did not cause Jackson to

implement better recordkeeping measures; instead, she and her employees began falsifying

documents to support her billing practices. The record shows that each time Jackson was

informed of an audit and asked to produce complete copies of her medical records

supporting various claims, she submitted altered records.3 Specifically, Jackson created

entirely new records, omitted incomplete records, and changed other records. In response

to one of the 2018 audits (the “2018 Palmetto audit”), Jackson submitted declarations

purporting to be from sinuplasty patients. The declarations represented that the patients had

chronic sinusitis and had been unsuccessfully treated with antibiotics before Jackson

performed the sinuplasty surgery. The declarations contained a statement representing the

truth and correctness of the contents, under penalty of perjury. Some of the declarations,

including those belonging to patients with the initials of L.J. and W.F., contained false

notarizations and forged signatures.

3 The opinion describes certain acts as Jackson’s own conduct, even when the record sometimes shows that the acts were performed at Jackson’s direction by those under her supervision. Given the way Jackson was charged and the applicable law, these distinctions are not meaningful in providing an overview of the offense conduct. 7 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 8 of 35

As a result of the audits and related investigations into Jackson’s practice, a grand

jury returned an indictment charging Jackson with an array of federal crimes. The twenty-

count superseding indictment alleged the following offenses:

• Count 1: violating

(k) by holding for resale adulterated medical devices, namely, the Entellus with which Jackson performed the sinuplasty surgeries; • Counts 2–11: violating the federal anti-kickback statute, 42 U.S.C. § 1320a-7b, by billing Medicare for procedures without advising patients of their copayment responsibilities and without collecting copayments from patients, as required by federal law; • Counts 12–14: making materially false statements, in violation of

(a)(2) and 2, during the course of the three 2017 to 2018 Medicare audits; • Counts 15–16: committing aggravated identity theft, in violation of 18 U.S.C. §§ 1028A(a)(1) and 2, by submitting forged and fabricated documents purportedly from patients L.J. and W.F. as part of Jackson’s response to the 2018 Palmetto audit described in Count 14; • Counts 17–19: committing mail fraud, in violation of

, 1349, and 2, relating to mailing falsified documents responding to the audits described in Counts 12 to 14; and • Count 20: conspiring to commit the federal offenses described in the prior counts, in violation of

.

During the multi-week trial that ensued, the jury heard evidence from multiple

witnesses, including Jackson’s employees and patients, as well as the designer of the

Entellus. In addition, Jackson testified in her defense. After the presentation of evidence,

the jury convicted Jackson on all charges, specifically finding that she acted with the intent

to defraud or mislead as to the FDCA violation (Count 1) and that she had obtained

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$4,794,039.31 as “gross proceeds traceable to the commission of the federal health care

offenses.” J.A. 3657.4

Jackson moved for a judgment of acquittal as to Counts 2 through 19 (but, notably,

not Count 1) and included a blanket cross-reference to “the entirety of her preserved

objections, submissions, legal arguments, motions, denials of said motions, requests, and

rights preserved in the trial record . . . as grounds for [a] motion for new trial.” J.A. 3674.

The district court denied these motions.

Jackson was sentenced to a below-Guidelines sentence of twenty-five years’

imprisonment and ordered to pay $5,726,218.26 in restitution.

Jackson noted a timely appeal, and the Court has jurisdiction under

.

II.

In this appeal, Jackson does not directly challenge seventeen of her convictions.5 As

to the FDCA conviction (Count 1) and aggravated identity theft convictions (Counts 15

and 16), she raises multiple arguments. Although Jackson also broadly contends that she is

4 Violating

(k) ordinarily carries a maximum sentence exposure of not more than one year’s imprisonment or a $1,000 fine, or both.

(a)(1). But if a person commits such a violation “with the intent to defraud or mislead,” then the statutory maximum increases to not more than three years’ imprisonment or a $10,000 fine, or both.

§ 333(a)(2). 5 In that regard, she does not raise any arguments specifically challenging the evidence related to her ten convictions for violating the federal anti-kickback statute (Counts 2–11), three convictions for making material false statements (Counts 12–14), three convictions for mail fraud (Counts 17–19), or one count of conspiracy to commit the other offenses (Count 20). 9 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 10 of 35

entitled to vacatur and remand for a new trial as to all of her convictions, those arguments

all flow solely from errors that she claims occurred as to Count 1, which she contends

prejudicially infected the rest of the trial.

We begin by considering Jackson’s challenge to Count 1, in which she was charged

with violating the FDCA. Two elements of the offense are undisputed—that the conduct at

issue involves a “device” as that term is defined in the FDCA, and that the devices had

been shipped in interstate commerce. The remaining elements are, in relevant part, that the

defendant (1) engaged in prohibited conduct with respect to the device, (2) while the device

was “held for sale (whether or not the first sale),” and (3) the prohibited conduct resulted

in the device “being adulterated.” § 331(k).6 The prohibited conduct set out above

encompasses “two distinct offenses,” the first relating to the label itself and potential

misbranding and the second—the conduct at issue here—relating to adulteration, which “is

concerned solely with deterioration or contamination of the commodity itself.” United

States v. Wiesenfeld Warehouse Co.,

, 89–90 (1964). The FDCA states that a

“device shall be deemed to be adulterated” “if it has been prepared, packed, or held under

insanitary conditions whereby it may have been contaminated with filth, or whereby it may

have been rendered injurious to health.”

(a)(2)(A).

6 The statutory text prohibits the act of or causing of “[t]he alteration, mutilation, destruction, obliteration, or removal of the whole or any part of the labeling of, or the doing of any other act with respect to, a food, drug, device, tobacco product, or cosmetic, if such act is done while such article is held for sale (whether or not the first sale) after shipment in interstate commerce and results in such article being adulterated or misbranded.” § 331(k). 10 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 11 of 35

Jackson raises several arguments aimed at undermining her conviction on Count 1,

asserting alternatively that problems with the indictment require dismissal of the charge

outright or that trial errors require vacatur of the conviction and remand for a new trial. As

reflected in the analysis that follows, most of Jackson’s arguments are raised here for the

first time on appeal. The fact that she failed to preserve those issues affects our standard of

review, as outlined below.

In broad terms, Jackson presses the following arguments: (1) the Entellus devices

were not “held for sale,” as required to violate § 331(k); (2) her actions were protected

under

, which she claims insulates certain physician conduct that would

otherwise violate § 331(k) so long as it occurs within a legitimate doctor-patient

relationship; (3) the Government relied on a defective theory of per se adulteration arising

from re-use of a device labeled for single use; (4) she should have been permitted to

demonstrate her cleaning and sanitation process as part of her defense; (5) she should have

been permitted to introduce documentary evidence about the prevalence of re-using single-

use devices and proper sanitization as part of her defense; (6) the jury should not have been

instructed that it was “irrelevant” that none of her patients were harmed or that she believed

the device was clean; and (7) the Government made an improper “Golden Rule” argument

during closing argument. We address each of these contentions in turn.7

7 We further note that we have considered Jackson’s brief in full even though it lodges a number of arguments that we do not directly engage. We reject those arguments without further discussion, primarily because they plainly lack merit on their face or are subsumed within discussed arguments. 11 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 12 of 35

A.

Jackson posits that the indictment was deficient, the jury instructions erroneous, and

the evidence insufficient to support the verdict. She argues that each of these alleged errors

permitted the element of § 331(k) requiring that the device be “held for sale” to be satisfied

by conduct falling outside the scope of that statutory language. In sum, Jackson asserts that,

at most, she held the Entelluses for use during sinuplasty surgeries and that they were not

“held for sale” to her patients. Her rationale is that she did not hold the devices for sale

because ownership of or title to an Entellus never transferred to the patient as a part of the

procedure. In her view, because “re-use” falls outside the scope of holding the device “for

sale,” the indictment should have been dismissed because it did not charge her with conduct

that the statute prohibits. She further asserts that this mismatch between the statutory

language and her conduct carried forward to the jury instructions, which stated that “[t]he

phrase ‘held for sale’ includes a single-use device that a doctor used in the course of treating

a Medicare patient. A device is ’held for sale’ at the time the holder of the device, including

a doctor, intends it to be sold or used in the course of treating a Medicare patient.”

J.A. 3515. For the same reasons, she asserts the trial record is insufficient to support her

conviction.

Because Jackson makes each of these arguments centered on the Entellus being

“held for sale” for the first time on appeal, we apply plain-error review. See Puckett v.

United States,

, 134–35 (2009) (stating that appellate courts review

“unpreserved claim[s] of trial error” for plain error). Before proceeding with that review,

however, we briefly discuss our basis for concluding that she failed to preserve any

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argument with respect to whether the Entellus was “held for sale.” Jackson first maintains

that she preserved her argument related to the indictment by moving to dismiss Count 1 for

failure to state an offense. Reviewing Jackson’s arguments in support of that motion reveals

that she asserted three reasons why Count 1 should be dismissed. First, she claimed that

§ 331(k) was “[u]nconstitutionally [v]oid for [v]agueness,” J.A. 138, because it failed to

adequately notify individuals when a device is left in sufficiently unsanitary conditions so

as to be deemed “adulterated.” Second, she argued the indictment did not sufficiently allege

her intent to defraud or mislead her patients. Third, she claimed that the indictment did not

allege that she failed to engage in a permitted off-label use of the Entellus. None of these

arguments challenges any aspect of the “held for sale” element of § 331(k), let alone

reflects some variant of the specific grounds she raises on appeal about this element. We

therefore reject her contention that her motion to dismiss the indictment was sufficient to

preserve the issue she now brings before the Court.8 As for the jury instructions on this

8 Jackson also points out that the district court mentioned United States v. Kaplan,

(9th Cir. 2016), during its bench ruling denying her motion as to Count 1, asserting that because Kaplan addressed the “held for sale” argument, the district court’s reference to that decision shows that the issue is preserved. While it’s true that the district court mentioned Kaplan, Jackson’s argument is unpersuasive when considering the actual bench ruling and Kaplan decision in context. In that ruling, the district court noted in passing that “[o]ne case that wasn’t cited in the papers,” but which had been “informative to [it] in connection with this entire topic is [Kaplan because] the Court there did address some of the same issues.” J.A. 626. But at no time during its ruling did the district court specifically mention—in the context of referencing Kaplan or otherwise—the element of a device being “held for sale.” Kaplan discusses several issues relating to § 331(k), including two issues that were raised in her motion to dismiss the indictment, namely, a physician’s off-label use of a single-use device and the sufficiency of an indictment’s allegations about intent to defraud and mislead. See Kaplan, 836 F.3d at 1210–12. (Continued) 13 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 14 of 35

matter, Jackson did not object to them and instead expressed that she was “satisfied with”

the instructions to which she did not object. J.A. 3401. So that part of her argument likewise

was never brought before the district court. Lastly, Jackson did not move for judgment of

acquittal on a basis remotely related to whether the Entellus was “held for sale,” so she also

failed to preserve that component of her argument.

The Supreme Court set out the standard for plain-error review in United States v.

Olano,

(1993). First, there must be an error.

at 732–33. Second, the error

“must be clear or obvious, rather than subject to reasonable dispute.” Puckett,

(citing Olano,

). “Third, the error must have affected the appellant’s

substantial rights, which in the ordinary case means he must demonstrate that it ‘affected

the outcome of the district court proceedings.’”

(quoting Olano,

).

Fourth, even when “the above three prongs are satisfied, the court of appeals has the

discretion to remedy the error—discretion which ought to be exercised only if the error

seriously affect[s] the fairness, integrity or public reputation of the judicial proceedings.”

(cleaned up) (emphasis in original).

Notably, only one circuit court has confronted the merits of this particular “held for

sale” issue in a directly analogous context, and it has rejected Jackson’s argument. In

United States v. Kaplan,

(9th Cir. 2016), the Ninth Circuit rejected the

argument that a physician merely held for “use” (and not for “sale”) single-use devices

Based on the above, we decline Jackson’s invitation to infer from the district court’s invocation of Kaplan that it was doing so to reject an argument the court did not mention and Jackson never made. 14 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 15 of 35

used during biopsy exams.

. The Ninth Circuit held that § 331(k)’s requirement

that the allegedly adulterated device be “‘held for sale’ included a physician’s use of a

device in treating patients.” Id. In doing so, it relied on the statutory text and the purpose

of the FDCA, noting that the statute “is to be interpreted broadly in order to protect public

health.” Id. It also recounted the reasoning of other courts that had interpreted this phrase,

recognizing that it “extends to physicians using both drugs and devices in the treatment of

patients” given the commercial nature of a physician’s treatment of patients. Id. at 1209.

Agreeing with this reasoning, the Ninth Circuit described the doctor–patient relationship

as setting up a “sale” of services, with the device being part and parcel of those services.

Id. at 1210 (a “physician [is] engaged in the business of providing medical services in

exchange for payment: a commercial actor in a commercial setting, using a commercial

product”). The Ninth Circuit also placed particular significance on the “single-use nature”

of the device at issue in that case, observing that such devices are “meant to be ‘consumed’

in the course of treating a patient—just like a drug.” Id. It then elaborated:

Once the single-use device is used or consumed there is nothing left to be done with the device. It no longer possesses a functional purpose in the medical practice and, rather than giving the used device to the patient, the doctor disposes of it. Therefore, when a physician uses a disposable device on a patient, the device is “held for sale” within the meaning of the FDCA provided that there is a commercial relationship between the doctor and the patient and that the device is one that is meant to be ‘consumed’ in the process.

Id.

While acknowledging the common-sense persuasiveness of the Ninth Circuit’s

reasoning and the body of caselaw from other courts on which it rests, we do not ultimately

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need to determine whether we would hold the same. Even were we to assume that Kaplan

was wrongly decided and that Jackson can demonstrate error, her argument fails at the

second prong of plain-error review—she cannot show a clear or obvious, i.e., a “plain,”

error. See Olano,

(“‘Plain’ is synonymous with ‘clear’ or, equivalently,

‘obvious.’”). In discussing this prong, the Supreme Court has recognized that, “[a]t a

minimum, court[s] of appeals cannot correct [unpreserved] error pursuant to Rule 52(b)

unless the error is clear under current law.”

Thus, we have previously recognized that

“[a]n error is plain ‘if the settled law of the Supreme Court or this circuit establishes that

an error has occurred.’” United States v. Carthorne,

(4th Cir. 2013)

(quoting United States v. Maxwell,

(4th Cir. 2002) (citation omitted)).

Applying this understanding of what constitutes “plain” error to this case, we

observe that it’s not “obvious” that Jackson’s conduct falls outside the meaning of “held

for sale” as it is used in § 331(k). Neither the Supreme Court nor we have taken a position

on this issue, placing it outside the ordinary circumstances in which we would conclude

error is “plain.” And we have previously recognized that a “district court does not commit

plain error by following the reasoning of another circuit” “where we have yet to speak

directly on a legal issue and other circuits are split.” United States v. Strieper,

(4th Cir. 2012) (citing United States v. Rouse,

, 263–64 (4th Cir.

2004)); cf. United States v. Alli-Balogun,

(2d Cir. 1995) (per curiam) (stating,

“we do not see how an error can be plain error when the Supreme Court and this court have

not spoken on the subject, and the authority in other circuit courts is split”). If a position in

line with one side of an existing sister-circuit split cannot cause error to be plain, a fortiori,

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a position in line with the sole circuit court to address an issue cannot be obviously wrong.

In short, where the only circuit court to address the issue goes against the defendant, as

does a substantial body of case law across courts addressing underlying points that the

circuit court relied on, any error by the district court in this case was not “plain.” Accord

United States v. Green,

(4th Cir. 2021) (recognizing that an error is

“clear” or “obvious” when, even though there is no binding precedent from the Supreme

Court or the Fourth Circuit, circuit courts of appeals “have uniformly taken a position”

contrary to the district court’s).

We therefore reject Jackson’s assertion that the conduct relied on to support the

indictment and her conviction falls outside the scope of § 331(k) because it does not involve

the device being “held for sale.”

B.

Jackson next argues that the district court erred by failing to recognize that

protects physicians from being prosecuted under § 331(k) for off-label use of

medical devices that occur within a doctor–patient relationship. That central premise forms

the basis of another multi-faceted assertion of error: (1) that the district court should have

dismissed the indictment for failure to allege that the relied-on conduct occurred outside a

doctor–patient relationship, (2) that the court abused its discretion by rejecting her

proposed jury instruction that “[i]n order to find [her] guilty of the [FDCA] offense . . . [it]

must find that the defendant was not acting within the scope of . . . a legitimate doctor-

patient relationship when she re-used the medical device at issue in this case,” J.A. 238;

and (3) that the court should have entered a judgment of acquittal because insufficient

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evidence existed to prove that Jackson acted outside of a legitimate doctor–patient

relationship.9

All three facets of this argument rest on a fundamental misunderstanding of the

relationship between §§ 396 and 331(k). Moreover, adopting Jackson’s position would

thwart congressional intent and create a huge loophole in the FDCA. See United States v.

Regenerative Sciences, LLC,

(D.C. Cir. 2014) (observing that

“classifying [acts prohibited by other provisions of the FDCA] as the practice of medicine”

for purposes of § 396 would “create an enormous gap in the FDCA’s coverage”). The mere

fact that the individual charged is a physician cannot be sufficient to prohibit prosecution

under § 331(k). On its face, § 331(k) prohibits certain conduct, regardless of the individual

who engages in that conduct. So, nothing in § 331(k) itself suggests that it would not apply

to a physician who engaged in the proscribed conduct.

Although § 396 protects a doctor’s ability to practice medicine by limiting how the

FDCA is to be applied to them, the statute does not apply to the circumstances presented

here. In that regard, the statute provides:

Nothing in [the FDCA] shall be construed to limit or interfere with the authority of a health care practitioner to prescribe or administer any legally marketed device to a patient for any condition or disease within a legitimate health care practitioner-patient relationship. This section shall not limit any existing authority of the Secretary to establish and enforce restrictions on the sale or distribution, or in the labeling, of a device that are part of a determination of substantial equivalence, established as a condition of approval, or promulgated through regulations. Further, this section shall not

9 Our standards of review for this issue vary based on whether Jackson has preserved the precise challenge, but we need not delve into that because we conclude under any standard of review that there is no error of the sort she alleges. 18 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 19 of 35

change any existing prohibition on the promotion of unapproved uses of legally marketed devices.

§ 396. In discussing this provision, the Supreme Court has recognized that it protects “off-

label” usage of medical devices, which it understood to mean “use of a device for some

purpose other than that for which it has been approved by the FDA.” Buckman Co. v.

Plaintiffs’ Legal Comm.,

(2001).

The principal problem with Jackson’s argument is that she equates the sort of off-

label usage that § 396 is designed to protect with the holding for sale of an adulterated

device, an action not protected by the statute. Section 396 protects only physicians who

“prescribe or administer any legally marketed device” (emphasis added). The FDCA bars

adulterated devices from the stream of commerce entirely, so they cannot be lawfully sold.

(a), (c). They therefore are not legally marketed devices within the meaning

of § 396. Judge Rotenberg Educ. Ctr., Inc. v. U.S. FDA,

(D.C. Cir. 2021).

And while off-label use is “an accepted and necessary corollary of the FDA’s mission to

regulate in this area without directly interfering with the practice of medicine,” Buckman

Co.,

, holding adulterated devices for sale is not.

Once again, the Ninth Circuit’s decision in Kaplan addressed and rejected the view

Jackson espouses of how §§ 331(k) and 396 operate. And on this point, we expressly agree

with its conclusion that “[w]hile a physician may exercise professional judgment in the off-

label use of unadulterated products, nothing in the FDCA or caselaw suggests that the use

of adulterated products is ever permissible.”

; accord United States v. Cal.

19 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 20 of 35

Stem Cell Treatment Ctr., Inc.,

(9th Cir. 2024).10 Section 396 simply

does not cover the type of conduct at issue in the charged violation of § 331(k) proven at

trial here. We therefore reject Jackson’s argument to the contrary.

C.

Allied with her defective § 396 theory, Jackson also argues that her § 331(k)

conviction cannot stand because it is grounded in a faulty theory that re-use of a device

labeled for single use constitutes per se adulteration. In her view, “FDA-mandated labels

do not have the force of law as to doctors’ use of devices” and “it cannot be a per se

violation of the FDCA for a doctor to use a device in a manner different from the way its

manufacturer intended as provided on the label—including reusing a device labeled as a

‘single use’ device.” Opening Br. 45, 47. She contends that because the indictment, jury

instructions, and evidence were directed to show that she was liable based on this flawed

theory, the Court should vacate her conviction and dismiss the charges.11

We reject Jackson’s argument because it misunderstands the basis for her

conviction. In short, her conviction followed statutory requirements and is not based on the

theory she claims as the Government’s basis for her prosecution. To the contrary, the theory

10 As was true in Kaplan, we note that the record before us contains no evidence that Jackson “used professional judgment for some legitimate off-label purpose” when deciding to engage in the conduct at issue in Count 1. Kaplan,

. While this bolsters our conclusion that the district court did not err in deeming § 396 irrelevant to Jackson’s culpability under § 331(k), it is not essential to our holding. 11 The only part of this argument Jackson preserved relates to the district court’s acceptance and rejection of jury instructions, which we review for abuse of discretion. See United States v. Campbell,

(4th Cir. 2020). We review the unpreserved parts of the argument for plain error. Puckett, 556 U.S. at 134–35.

20 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 21 of 35

for holding Jackson liable was that she “held for sale” an adulterated device—exactly as

§ 331(k) envisions. That fact is borne out in both the superseding indictment and the jury

instructions, as well as how the Government prosecuted the case.

For example, the superseding indictment repeatedly cited and quoted § 331(k) and

§ 351(a)(2)(A)’s statutory language about when a violation occurs and when a medical

device is adulterated. In connecting that statutory language to Jackson’s alleged violation,

the indictment described why the Entellus could not be cleaned effectively or sterilized. It

also described the conditions in Jackson’s practice that caused the device to be adulterated.

This language does not suggest that mere off-label use such as re-use of a device labeled

for single use was a per se basis for charging Jackson with violating § 331(k).

The jury instructions similarly tracked the statutory language for what constitutes a

§ 331(k) violation and adulteration. At no time was the jury instructed that it could convict

Jackson solely based on her re-use of a device labeled for single use. Indeed, the only time

the instructions mentioned that the device was labeled for “single-use” is in the context of

finding Jackson’s intent to defraud—an add-on finding to the threshold determination that

Jackson had violated § 331(k). That instruction provided the example that “if [the jury]

f[ou]nd beyond a reasonable doubt that [Jackson] did not disclose to a patient that she was

reusing a single-use . . . device that she had used on a different patient and that one of her

reasons for doing so was to enrich herself, then the Government has proven an intent to

defraud and mislead.” J.A. 3516. This finding about Jackson’s intent became relevant only

21 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 22 of 35

after the jury’s initial determination that the device was adulterated and that Jackson had

violated § 331(k).12

To be sure, that the Entellus was labeled for single use came up at trial. And rightly

so, as it was relevant background information. But the testimony at trial centered on why

the device had been labeled for single use, not on the fact that it was labeled so. Parallel

with evidence about the Entelluses’ labeling, the Government developed a thorough case

about what happened to the device after its first use and the risks associated with attempting

to clean a used device and then reusing it. And the totality of that evidence was directly

relevant to the issue before the jury—whether Jackson had “do[ne] any other act with

respect to” the device while it was being “held for sale” that “result[ed] in such [device]

being adulterated.” § 331(k). In addition, evidence about the Entellus’s single-use label

was relevant to establishing how Medicare reimbursed doctors for performing a sinuplasty

procedure on patients, and it supported the Government’s theory about Jackson’s profit

12 The district court rejected Jackson’s proposed instruction that “the re-use by a licensed physician of a . . . medical device labeled by the manufacturer as a single-use device is not, in and of itself, unlawful.” J.A. 241. A district court abuses its discretion in rejecting a proposed instruction only if the proffered instruction was “(1) A correct statement of the law; (2) Not substantially covered by the instructions given by the district court; and (3) Involved some point so important that the failure to give the instruction seriously impaired the defendant’s defense.” Campbell,

. The instructions the district court gave properly counseled the jury on the elements of § 331(k), thereby ensuring that the jury’s verdict was properly focused on whether the Entelluses were adulterated and “held for sale” along with the other elements of the offense. As discussed elsewhere in this opinion, Jackson’s proposed instruction did not target the elements of § 331(k), nor did it tread necessary new ground relevant to that determination. As such, applying the above test, we conclude the district court did not abuse its discretion in declining to give the proposed instruction. 22 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 23 of 35

motive for engaging in the prohibited conduct. But again, it was not the single-use labeling

that formed the basis for finding that the Entelluses were adulterated.

In sum, Jackson’s argument ignores large swaths of the Government’s case and

myopically focuses on and takes out of context one component of admitted evidence to

argue that a theory of per se adulteration from re-use led to her conviction. Based on the

totality of the record, including the language of the superseding indictment and the jury

instructions, we reject this argument.

D.

Jackson also argues that the district court improperly curtailed her ability to present

her defense when it prohibited her from introducing a video she recorded in which she

demonstrated how she cleaned the Entellus. She maintains that the district court mistakenly

believed that she wanted to testify as an expert witness when her purpose was to offer lay

testimony about “how she cleaned and sanitized the device[],” so that the jury would hear

her side of the story. Opening Br. 54.

The record presents a different picture of why the district court disallowed this

evidence. The night after Jackson began to testify at trial, her attorneys disclosed for the

first time their intent to introduce a video recording the following day when Jackson

resumed her testimony. The video would depict Jackson demonstrating her cleaning

methods, taking culture samples from the device, and then handing over the samples for

testing. Initially, Jackson explained to the court that she wanted to introduce the video as

background evidence for introducing her testimony both about her cleaning methods and

about the results of the culture tests. The Government objected, and the district court agreed

23 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 24 of 35

with the Government, observing that this request was a “blatant violation of Rule 16 and

[the court’s] scheduling order,” J.A. 3078, and was “an effort to have [Jackson] testify as

an expert” without following the pre-trial process, J.A. 3079. Jackson then shifted gears,

asking the court if it would permit a silent version of the video recording to play while

Jackson testified about it as “an example of how she washes [the device].” J.A. 3080. The

district court denied that request too, observing “there’s a process of reviewing information

or videos like this in a timely fashion. And to produce it the night before—in the middle of

testimony . . . . No lawyer has tried to do this, and it’s because it’s patently improper.”

J.A. 3080.

Jackson’s arguments on appeal fail to grapple with the fundamental ground of

untimeliness that the district court relied on when denying admission of the video,

regardless of whether it was classified as expert testimony or not. Because Jackson

requested discovery from the Government, Federal Rule of Criminal Procedure

16(b)(1)(A)(ii) required Jackson to allow inspection of any evidence she wished to use in

her “case-in-chief at trial.” The district court’s scheduling order required Jackson to make

her Rule 16(b) disclosures by July 2022—six months before Jackson did so. S.A. 2.

District courts have broad discretion “in all rulings related to the admission and

exclusion of evidence, and this Court will not reverse the decision to exclude such evidence

absent abuse of that discretion.” United States v. Holmes,

(4th Cir.

2012). We see no abuse of discretion in the district court’s refusal to reward Jackson for

24 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 25 of 35

her disregard of the court’s scheduling order. We reject Jackson’s evidentiary challenge

to the exclusion of her video evidence.13

E.

Jackson’s second evidentiary argument relates to the district court’s exclusion of

certain documents about disinfection and sterilization from the Centers for Disease Control

and Prevention (“CDC”). Though their specifics vary, the documents generally discuss

sterilization techniques for medical equipment. One such document, titled “Reuse of

Single-Use Medical Devices,” recounts that “[a]pproximately 20 to 30% of U.S. hospitals

reported that they reuse at least one type of single-use device.” J.A. 3638. When ruling on

their admissibility, the district court excluded them as hearsay and rejected Jackson’s

argument that they were nonetheless admissible to show their effect on her and thereby had

the potential to negate a finding that she intended to defraud her patients.

13 Jackson contends the district court’s conduct rose beyond an improper evidentiary ruling and amounted to a constitutional violation by infringing her ability to present a “complete defense.” See United States v. Smith,

(4th Cir. 2006) (recognizing that the Fifth and Sixth Amendments guarantee an accused “a meaningful opportunity to present a complete defense”). But we have never held that this right entitles a criminal defendant to introduce whatever evidence she wants in her defense. And unfavorable evidentiary rulings rarely take on constitutional dimensions. See, e.g., United States v. Perkins,

(4th Cir. 1991) (“[The defendant] cannot transform the exclusion of . . . evidence into constitutional error by arguing that he was deprived of his right to present a defense. The right to present a defense is clearly fundamental, but in the exercise of this right, the accused, as is required of the [Government], must comply with established rules of procedure and evidence designed to assure both fairness and reliability in the ascertainment of guilt and innocence.” (cleaned up)). Here, we observe that nothing specific about the video calls into question Jackson’s ability to present a “complete defense.” At trial, Jackson was able to describe at some length her cleaning practices, as were her employees. She was also able to make related arguments to the jury. As such, we also reject the constitutional component of this argument. 25 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 26 of 35

On appeal, Jackson again asserts that these documents were admissible for a purpose

other than for their truth, i.e., for their effect on her. She contends that had this evidence

been admitted, the jury “may well have had a reasonable doubt as to whether [she] had a

reason to cover up her re-use of devices, and thus may have acquitted her of the adulteration

offense[.]” Opening Br. 55.

Assuming, without deciding, that the evidence was admissible, we conclude that

any purported error was harmless. To prove nonconstitutional error harmless, “the

Government must demonstrate that the error did not have a ‘substantial and injurious effect

or influence in determining the jury’s verdict.’” United States v. Curbelo,

(4th Cir. 2003) (quoting Kotteakos v. United States,

(1946)). “An

appellate court does not inquire into whether absent the error sufficient evidence existed to

convict, but rather whether we believe it highly probable that the error did not affect the

judgment.” United States v. Ibisevic,

(4th Cir. 2012) (internal quotation

marks and citation omitted). So, to affirm, we “must be able to ‘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.’”

(citation omitted). We

have the requisite “fair assurance” here. The CDC documents provide scant support for the

propositions Jackson uses them to advance. None of them address the disinfection or

sterilization of the Entellus or a similar device. And the document about re-use of single-

use devices likewise does not mention this device as one that is reused by other medical

providers. At bottom, the documents do not show that this device could be sterilized

effectively or that Jackson was justified in believing that they could be. For this reason, we

26 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 27 of 35

conclude it is “highly probable that [their exclusion] did not affect the judgment.” Ibisevic,

(quotation marks and citation omitted).

F.

Next, Jackson asserts the district court prejudiced her case by instructing the jury

that it was “irrelevant” that no patient was harmed.14 The instructions she challenges were

given in response to objected-to questioning during her testimony (i.e., not immediately

before deliberations). Though the specific instructions vary, in each instance, the district

court returned the jury’s attention to the Government’s burden with respect to the § 331(k)

violation, cautioning them, for example, that evidence that no patients were harmed as a

result of Jackson’s methods “is irrelevant. . . . The United States does not have to prove in

Count 1 that a single patient got sick because of the defendant’s process.” J.A. 3167.

Jackson contends these instructions erroneously prohibited her “from showing that the

devices were not adulterated,” “that she had no motive to—and thus did not—adulterate

the devices . . . or otherwise scheme to cover up the fact that she was using dirty devices,”

and that they “misinformed the jury about how they should consider evidence related to

adulteration.” Opening Br. 60.

Jackson’s argument misapprehends what § 331(k) required of the Government. As

the statutory definition makes clear, the district court was correct when it instructed that

14 Alongside this argument, Jackson asserts that the district court abused its discretion by instructing the jury that it was “irrelevant” that “Jackson believed the devices were clean.” Opening Br. 58. But none of her cited examples contained such an instruction. Instead, the context of each statement shows that the Government’s objection and the district court’s instructions centered on whether Count 1 requires proof of actual harm to a patient. 27 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 28 of 35

§ 331(k) did not require proof of actual harm to patients for a jury to find that the Entellus

had been adulterated. Section 351(a)(2)(A) states that a device “shall be deemed to be

adulterated” if it is “held under insanitary conditions whereby it may have been

contaminated by filth, or whereby it may have been rendered injurious to health.”

(Emphases added). A device can satisfy this definition without causing someone actual

harm; it is sufficient that the potential for contamination or injury exist. Thus, the district

court was well within its discretion to instruct the jury to that effect.

G.

Jackson’s final challenge to this count contends that reversible error occurred during

the Government’s closing argument as a result of an impermissible “Golden Rule”

argument. An invitation “urg[ing] jurors to identify individually with the victim” is an

improper “Golden Rule” closing argument. United States v. Huskey,

(4th

Cir. 2024) (quoting United States v. Al-Maliki,

(6th Cir. 2015)); accord

United States v. Moreno,

(1st Cir. 1991) (observing that improper “golden

rule” arguments “encourage[] the jury to depart from neutrality and to decide the case on

the basis of personal interest and bias rather than on the evidence”). “A golden-rule

objection typically arises when a lawyer asks jurors to place themselves in the plaintiff’s

position with respect to the calculation of damages,” with “[t]he rationale for prohibiting

such an argument [being] that the jury’s sympathy will be unfairly aroused, resulting in a

disproportionate award of damages.” Ermini v. Scott,

(11th Cir. 2019)

(quoting Burrage v. Harrell,

(5th Cir. 1976)).

28 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 29 of 35

Jackson asserts that two portions of the Government’s closing argument violated

this precept. In suggesting that every patient would prefer a sterile device to an adulterated

one, the Government asked, “Which one would you want? . . . . If you could have a device

that had been here fully coated and contaminated with another person’s blood and mucous,

or you could have that perfectly pristine device, which one would you want? Which one

would you choose?” J.A. 3418. The Government then “add[ed] another factor to [the

juror’s] choice,” observing that the unused device was “completely sterile” and posed “zero

risk that another human’s bodily fluids would get inside your body . . . . Would that impact

your decision?” J.A. 3418.

Assuming, without deciding, that these statements constitute an impermissible

“Golden Rule” argument, we conclude that they were not prejudicial in context and

therefore do not require reversal. We will reverse a conviction based on an improper

closing argument only when the impropriety “so prejudicially impacted the defendant’s

substantial rights as to deprive him of a fair trial.” United States v. Webb,

(4th Cir. 2020) (quotations and citation omitted). And here our review is further

constrained by the plain-error standard because Jackson neither lodged a contemporaneous

objection nor moved for judgment of acquittal on this ground in the district court.15 See

15 Jackson argues that she did not need to object to preserve her Golden Rule argument. But our decisions say only that parties need not object contemporaneously— raising the issue at the end of closing statements will do. Werner v. Upjohn Co.,

(4th Cir. 1980); Leathers v. Gen. Motors Corp.,

, 1085–86 (4th Cir. 1976). We do not read our decisions in Werner and Leathers to free Jackson from any obligation to present the Golden Rule issue to the district court. 29 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 30 of 35

Jackson has not met her burden. The allegedly improper argument consists of three

lines in a closing argument that spans some thirteen pages devoted just to Count 1. Quite

apart from these brief references, the jury had overwhelming evidence supporting

Jackson’s culpability. Indeed, Jackson admitted to reusing Entelluses, and it’s undisputed

that she did not inform her patients that she did so. Other evidence supported the jury’s

conclusion that Jackson’s re-use and cleaning methods nonetheless “adulterated” the

device. And still more evidence supported the jury’s finding that by reusing the devices,

Jackson profited by billing Medicare in full for the sinuplasty procedure that factored in

the full price of a new device. Jackson profited handsomely from her approach. On this

record, we cannot discern that Jackson’s substantial rights were impacted and, absent that

showing of prejudice, reversal is not warranted. See Huskey,

.

****

Having rejected each of Jackson’s arguments as to Count I, we affirm her conviction

for violating

(k).16

III.

Jackson next challenges her convictions for aggravated identity theft, in violation of

18 U.S.C. §§ 1028A(a)(1) and 2, which formed Counts 15 and 16 of the superseding

indictment. This offense imposes a mandatory consecutive two-year term of imprisonment

if an individual has been convicted of other qualifying offenses and, during or in relation

16 Because we affirm this conviction, we reject Jackson’s argument that errors relating to Count 1 require vacatur of her other convictions. 30 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 31 of 35

to those offenses, the defendant “knowingly transfers, possesses, or uses, without lawful

authority, a means of identification of another person.” § 1028A(a)(1), (b)(2); see United

States v. Abdelshafi,

(4th Cir. 2010) (recounting the four elements of

this offense).

The superseding indictment charged that Jackson aided and abetted in aggravated

identity theft by manufacturing backdated declarations purporting to be from two patients,

using their names and, most importantly, their forged signatures. Jackson then submitted

those declarations as part of her responses to the 2018 Palmetto audit.

After the jury convicted Jackson, the Supreme Court decided Dubin v. United States,

(2023), which clarified what it meant to “use” an individual’s identity “in

relation to” another qualifying offense. Arguing that Dubin invalidated her convictions,

Jackson moved for a judgment of acquittal or a new trial as to Counts 15 and 16. The

district court denied her motion. It concluded that the concerns present in Dubin about

when a defendant’s “use” of another’s identifying information is sufficiently close to the

qualifying offense to be deemed “in relation to” to it were not at issue in this case. In the

court’s view, the requisite hook between the identity theft and qualifying other offense

existed here because Jackson had forged the patients’ signatures on declarations purporting

to be from those patients and then submitted them as part of the false statements that

constituted the qualifying other offense (making false statements relating to health care

matters).

On appeal, Jackson does not challenge the denial of her motion for judgment of

acquittal. Instead, she relies on Dubin to make two different arguments: that Dubin

31 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 32 of 35

rendered the superseding indictment and the jury instructions deficient because it requires

a specific finding—by the grand jury and the petit jury, respectively—that the alleged

misuse of the victim’s identity was what made the qualifying offense criminal. Because the

grand jury did not so find as part of Counts 15 or 16, she contends the Court should vacate

those convictions and remand for the district court to dismiss those charges. Alternatively,

because the jury instructions did not require the jury to make this finding before convicting

her, she asserts the Court should vacate those convictions and remand to permit a new trial.

Because Jackson did not raise either of these challenges in the district court, we

review for plain error. See Greer v. United States,

, 507–08 (2021).17 Jackson

has not met her burden of showing any error, let alone an obvious one.

In Dubin, the Supreme Court “clarified the scope of the statute prohibiting

aggravated identity theft” by resolving a circuit split (which we were not part of) about

17 Jackson acknowledges that she did not preserve a challenge to the relevant jury instructions, but she maintains that her general pretrial challenge to the sufficiency of the indictment preserved her challenge to the indictment. We disagree. When Jackson moved to dismiss Counts 15 and 16 of the indictment, she asserted that the charges were unconstitutionally vague. Her only argument in support of that conclusion challenged the allegations addressing the element of the offense that the identity theft occurred without the lawful authority of the person whose identity was used. Simply put, her argument challenging these charges in the district court did not bear even passing resemblance to the challenge she now raises. And even though Jackson did not have the benefit of Dubin’s precise language at the time she moved to dismiss the indictment, the arguments she made in her pretrial motion are far removed from the sorts of concerns addressed in that decision, which concern different elements of the offense. Moreover, once Dubin was decided, Jackson filed a post-judgment motion that did not raise the types of arguments she now raises concerning the indictment. Under these circumstances, we readily conclude that Jackson did not preserve the challenge to the indictment that she brings before us, so plain-error review is appropriate.

32 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 33 of 35

when a defendant “uses” another’s identifying information “in relation to” another

qualifying offense. United States v. O’Lear,

, 532–33 (6th Cir. 2024). The

defendant in Dubin conducted certain psychological tests on a patient and then submitted

claims to Medicaid for reimbursement. Dubin,

. That paperwork referred

to the patient by name and described the procedures performed, but fraudulently inflated

the amount to be reimbursed by misrepresenting the qualifications of the person performing

the procedures.

Unlike this case, the patient’s signature did not appear on the

paperwork. And while the patient’s name appeared on the provider-submitted paperwork,

services had been performed on that named patient.

The provider’s “fraud” thus related

to identifying the type and dates of services identified for reimbursement, not the identity

or existence of any particular patient.

The Government charged the Dubin defendant with aggravated identity theft based

on the submitted paperwork bearing the name of the patient.

at 114–15. But the Supreme

Court held that § 1028A(a)(1) does not cover such conduct, observing identity theft

offenses occur “when the defendant’s misuse of another person’s means of identification

is at the crux of what makes the conduct criminal,” i.e., when the means of identification

is “used in a manner that is fraudulent or deceptive . . ., [which] can often be succinctly

summarized as [deception about] ‘who’ is involved.” Id. at 113, 132. The “use” in Dubin

was not in “relation to” the healthcare fraud because the “crux” of the defendant’s

qualifying offense was that the “fraud was in misrepresenting how and when services were

provided to a patient, not who received the services.” Id. at 132 (emphasis in original). The

33 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 34 of 35

Fifth Circuit has since helpfully summarized the disconnect between the underlying fraud

and the identity theft that motivated the Supreme Court’s holding—

In Dubin, the Supreme Court identified a mismatch between the ‘crux’ of the predicate felony—overbilling Medicaid by misrepresenting Person A’s qualifications—and the § 1028A conviction that the government argued the predicate felony supported—the incidental use of Person B’s name and Medicaid ID on the billing statement. Because the billing statement was rendered fraudulent by the misrepresentation about Person A, and not by the misrepresentation about Person B, Person B’s means of identification was not used ‘in relation to’—that is, central to, the predicate offense of fraud.

United States v. Croft,

(5th Cir. 2023).

At the outset, then, we note that Dubin did not alter our understanding of the

elements of the aggravated identity theft offense or require additional factual findings in

each prosecution. Instead, it clarified the scope of the “use” and “in relation to” elements

in cases, requiring a narrower reading than the Fifth Circuit had previously permitted. We

therefore reject Jackson’s contention that the indictment and jury instructions were

inherently defective because Dubin requires a specific factual finding in every case that the

use of the means of identification was “the crux” of what made the qualifying offense

criminal.

Nor do we discern any reason to believe that Dubin undercuts the factual basis on

which Jackson was charged or convicted. The “crux” of Jackson’s fraud was in submitting

falsified paperwork as part of a Medicaid audit. But crucially, for § 1028A purposes, that

falsified paperwork contained the two declarations that then formed the basis of the

aggravated identity theft counts. And “who” created and signed those declarations was

essential to the qualifying offense’s fraud—Jackson submitted them claiming that they

34 USCA4 Appeal: 23-4467 Doc: 90 Filed: 01/21/2025 Pg: 35 of 35

were declarations signed by her patients supporting what they represented and thus

supporting her responses to the audit. Instead, the declarations were not the patients’

representations at all, nor did they bear the patients’ real signatures. Rather, it was Jackson

(or those under her direction) who both crafted the declarations purporting to be from her

patients and attested to those representations by forging the patients’ signatures.

Thus, unlike the circumstances in Dubin, the circumstances here present a classic

case of identity theft, falling cleanly within the aggravated identity theft statute’s scope. At

bottom, the facts in Dubin differ significantly from this case, and the concerns the Supreme

Court targeted there are not implicated here. See, e.g., United States v. Gladden,

(11th Cir. 2023) (concluding that no Dubin-like mismatch existed where the

defendant used others’ identities “to continue refilling prescriptions in their names,”

making that forgery “the heart of” the fraudulent practice of billing for medically

unnecessary prescriptions). We reject Jackson’s contention that the indictment or

instructions were deficient in view of Dubin’s clarifying language about the scope of the

offense. Discerning no error—plain or otherwise—with Jackson’s convictions for

aggravated identity theft (Counts 15 and 16), we affirm them.

IV.

For the reasons set forth above, we affirm all of Jackson’s convictions.

AFFIRMED

35