United States v. Anita JacksonUnited States v. Anita Jackson
PHYSICIANS AGAINST ABUSE, INC., Amicus Supporting Appellant.
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.
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
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
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
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
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
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
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.
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
21 U.S.C. § 331(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
18 U.S.C. §§ 1035(a)(2) and2 , 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) and2 , 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
18 U.S.C. §§ 1341 ,1349 , and2 , 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
18 U.S.C. § 371 .
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
$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
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
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
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
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, 556 U.S. 129, 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
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
matter, Jackson did not object to them and instead expressed that she was satisfied with the instructions to which she did not object.
The Supreme Court set out the standard for plain-error review in United States v. Olano, 507 U.S. 725 (1993). First, there must be an error. Id. at 732–33. Second, the error must be clear or obvious, rather than subject to reasonable dispute. Puckett, 556 U.S. at 135 (citing Olano, 507 U.S. at 734). 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.’ Id. (quoting Olano, 507 U.S. at 734). 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. Id. (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, 836 F.3d 1199 (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.
used during biopsy exams. Id. at 1208. The Ninth Circuit held that
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.
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
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,
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
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, 996 F.3d 176, 185 (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
B.
Jackson next argues that the district court erred by failing to recognize that
evidence existed to
All three facets of this argument rest on a fundamental misunderstanding of the relationship between
Although
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
change any existing prohibition on the promotion of unapproved uses of legally marketed devices.
The principal problem with Jackson‘s argument is that she equates the sort of off-label usage that
Once again, the Ninth Circuit‘s decision in Kaplan addressed and rejected the view Jackson espouses of how
Stem Cell Treatment Ctr., Inc., 117 F.4th 1213, 1220 (9th Cir. 2024).10 Section 396 simply does not cover the type of conduct at issue in the charged violation of
C.
Allied with her defective
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
for holding Jackson liable was that she “held for sale” an adulterated device—exactly asFor example, the superseding indictment repeatedly cited and quoted
The jury instructions similarly tracked the statutory language for what constitutes a
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.”
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
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,
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, 670 F.3d 586, 598 (4th Cir. 2012). We see no abuse of discretion in the district court‘s refusal to reward Jackson for 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
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, 343 F.3d 273, 278 (4th Cir. 2003) (quoting Kotteakos v. United States, 328 U.S. 750, 776 (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, 675 F.3d 342, 350 (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.” Id. (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 conclude it is “highly probable that [their exclusion] did not affect the judgment.” Ibisevic, 675 F.3d at 350 (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
Jackson‘s argument misapprehends what
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, 90 F.4th 651, 671 (4th Cir. 2024) (quoting United States v. Al-Maliki, 787 F.3d 784, 795 (6th Cir. 2015)); accord United States v. Moreno, 947 F.2d 7, 8 (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, 937 F.3d 1329, 1340 (11th Cir. 2019) (quoting Burrage v. Harrell, 537 F.2d 837, 839 (5th Cir. 1976)).
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
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, 90 F.4th at 671.
* * * *
Having rejected each of Jackson‘s arguments as to Count 1, we affirm her conviction for violating
III.
Jackson next challenges her convictions for aggravated identity theft, in violation of
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, 599 U.S. 110 (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
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 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, 593 U.S. 503, 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
when a defendant “uses” another‘s identifying information “in relation to” another qualifying offense. United States v. O‘Lear, 90 F.4th 519, 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, 599 U.S. at 114. 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. Id. 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. Id. The provider‘s “fraud” thus related to identifying the type
The Government charged the Dubin defendant with aggravated identity theft based on the submitted paperwork bearing the name of the patient. Id. at 114-15. But the Supreme Court held that
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, 87 F.4th 644, 648 (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
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
IV.
For the reasons set forth above, we affirm all of Jackson‘s convictions.
AFFIRMED
Notes
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