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No. 10763137
United States Court of Appeals for the Ninth Circuit
United States v. Holmes
No. 10763137 · Decided December 22, 2025
No. 10763137·Ninth Circuit · 2025·
FlawFinder last updated this page Apr. 2, 2026
Case Details
Court
United States Court of Appeals for the Ninth Circuit
Decided
December 22, 2025
Citation
No. 10763137
Disposition
See opinion text.
Full Opinion
FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
UNITED STATES OF AMERICA, No. 22-10312
Plaintiff-Appellee, D.C. No.
5:18-cr-00258-
v. EJD-1
ELIZABETH A. HOLMES, ORDER AND
AMENDED
Defendant-Appellant. OPINION
UNITED STATES OF AMERICA, No. 22-10338
Plaintiff-Appellee,
D.C. No.
v. 5:18-cr-00258-
EJD-2
RAMESH SUNNY BALWANI,
Defendant-Appellant.
UNITED STATES OF AMERICA, Nos. 23-1040
23-1167
Plaintiff-Appellee,
D.C. No.
v. 5:18-cr-00258-
2 USA V. HOLMES
EJD-1
ELIZABETH A. HOLMES,
Defendant-Appellant.
UNITED STATES OF AMERICA, No. 23-1166
D.C. No.
Plaintiff-Appellee, 5:18-cr-00258-
EJD-2
v.
RAMESH "SUNNY" BALWANI,
Defendant-Appellant.
Appeal from the United States District Court
for the Northern District of California
Edward J. Davila, District Judge, Presiding
Argued and Submitted June 11, 2024
San Francisco, California
Filed February 24, 2025
Amended December 22, 2025
Before: Mary M. Schroeder, Jacqueline H. Nguyen, and
Ryan D. Nelson, Circuit Judges.
Order;
Opinion by Judge Nguyen
USA V. HOLMES 3
SUMMARY *
Criminal Law
The panel affirmed Elizabeth Holmes’s and Ranesh
“Sunny” Balwani’s convictions on numerous fraud charges,
their sentences, and the district court’s $452 million
restitution order, in a case in which Defendants defrauded
investors about the achievements of their company
Theranos’s blood-testing technology.
Defendants argued that the district court erred by
allowing former Theranos employees, who testified as lay
witnesses, to offer improper expert testimony. The panel
explained that if a witness offers an opinion that is based on
specialized knowledge, experience, training, or education
contemplated by Fed. Rule of Evidence 702, a party cannot
evade the Rule by labeling a witness “percipient.” And there
is no “on-the-job” exception to Rule 702. But the fact that a
witness’s testimony pertains to scientific matters, or conveys
opinions drawn from the witness’s own experiences with
such matters, does not automatically render it expert
testimony within the ambit of Rule 702. Considering each
of the challenged witnesses with these principles in mind,
the panel held that some aspects of the testimonies veered
into expert territory, but any error was harmless.
Holmes argued that a report prepared by the Center for
Medicare and Medicaid Services was irrelevant under
Federal Rule of Evidence 401 and should have been
excluded pursuant to Federal Rule of Evidence 403 because
*
This summary constitutes no part of the opinion of the court. It has
been prepared by court staff for the convenience of the reader.
4 USA V. HOLMES
there was a significant risk that the report would mislead the
jury. The panel held that the district court did not abuse its
discretion in finding that the report was relevant to Holmes’s
knowledge, intent, or state of mind, and in finding that the
probative value of the report was not substantially
outweighed by its potential for unfair prejudice.
Holmes argued that the district court abused its
discretion by allowing testimony that Theranos voided all
patient sample tests run on a device used in Theranos’s
clinical lab. Federal Rule of Evidence 407 provides that
when measures are taken that would have made an earlier
injury less likely to occur, evidence of subsequent measures
is not admissible to prove culpable conduct. The purpose of
Rule 407—to avoid punishing the defendant for efforts to
remedy safety problems—is not implicated in cases
involving subsequent measures in which the defendant did
not voluntarily participate. The panel held that the district
court did not clearly err in finding that the decision to void
was not voluntary, and did not abuse its discretion balancing
the risk of prejudice against the probative value of the
evidence.
Holmes argued that the district court violated her rights
under the Confrontation Clause of the Sixth Amendment
when it prohibited her from cross-examining a former
Theranos laboratory director on aspects of his post-Theranos
employment. The panel held that the district court did not
abuse its discretion in limiting the scope of the cross-
examination.
Holmes argued that the district court should have
admitted, as statements against interest under Federal Rule
of Evidence 804(b)(3), portions of deposition testimony
given by Balwani to the Securities and Exchange
USA V. HOLMES 5
Commission. The panel held that the district court correctly
recognized that the statements were not solidly inculpatory
and did not abuse its discretion in declining to admit these
statements.
Balwani argued that the indictment was constructively
amended in violation of his Fifth Amendment rights when
the government presented evidence concerning the accuracy
and reliability of Theranos tests run on conventional
technology even though the indictment only charged him
with misrepresentations concerning the accuracy and
reliability of tests run on proprietary technology. The panel
rejected this argument because the indictment plainly gave
Balwani notice that he was charged with misrepresenting the
accuracy of a non-exhaustive list of patient tests, regardless
of which type of device the tests were run on.
Balwani argued that his due process rights were violated
under Napue v. Illinois by the government’s failure to correct
allegedly false testimony given by two investor-
victims. The panel held that the Napue claim fails under
plain error review.
The panel held that the district court did not err in
applying the preponderance-of-the-evidence standard for
proving loss at sentencing. Regarding Defendants’
arguments concerning loss causation and the number of
victims, raised for the first time in letters pursuant to Federal
Rule of Appellate Procedure 28(j), the panel held that the
district court’s factual findings were not clearly erroneous.
Defendants argued that the district court erred by
awarding restitution based on investors’ total investments,
rather than the diminution in value of the shares after the
fraud came to light. The panel explained that, although the
district court properly identified the money invested as the
6 USA V. HOLMES
lost property, it should have also considered possible credits
against Defendants’ restitution obligation by accounting for
the residual value of the shares after the fraud came to
light. The panel concluded that any error was harmless
because the district court’s factual findings compel the
conclusion that the victims’ actual losses were equal to the
total amount of their investments.
COUNSEL
Kelly I. Volkar (argued), Robert Leach, Casey Boome,
Amani S. Floyd, and John C. Bostic, Assistant United States
Attorneys; Matthew M. Yelovich and Merry J. Chan, Chiefs,
Appellate Section, Criminal Division; Thomas A. Colthurst,
Martha Boersch, Ismail Ramsey, Stephanie M. Hinds, and
Craig H. Missakian, United States Attorneys; United States
Department of Justice, Office of the United States Attorney,
San Francisco, California; for Plaintiff-Appellee.
Amy M. Saharia (argued), Patrick J. Looby (argued), Kevin
M. Downey, Katherine A. Trefz, and Lance A. Wade,
Williams & Connolly LLP, Washington, D.C.; John D.
Cline, Law Office of John D. Cline, Seattle, Washington;
Jeffrey B. Coopersmith (argued), Corr Cronin LLP, San
Francisco, California; Aaron P. Brecher, Amy Walsh, and
Sachi Schuricht, Orrick Herrington & Sutcliffe LLP, Seattle,
Washington; Stephen A. Cazares and Amari L. Hammonds,
Orrick Herrington & Sutcliffe LLP, Los Angeles, California;
James A. Flynn, Orrick Herrington & Sutcliffe LLP,
Washington, D.C.; Mark S. Davies, White & Case,
Washington, D.C.; for Defendants-Appellants.
USA V. HOLMES 7
Brian T. Goldman, Daniel M. Sullivan, and Benjamin B.
Allen, Holwell Shuster & Goldberg LLP, New York, New
York; Donald M. Falk, Schaerr Jaffe LLP, San Francisco,
California; for Amicus Curiae National Association of
Criminal Defense Lawyers.
Kimberly K. Chemerinsky, Alston & Bird LLP, Los
Angeles, California; Paul N. Monnin and Danielle K.
Goldstein, Alston & Bird LLP, Atlanta, Georgia; for Amici
Curiae American Board of Criminal Lawyers, California
Attorneys for Criminal Justice, and Due Process Institute.
ORDER
The opinion filed on February 24, 2025 (Dkt. No. 88),
and reported at 129 F.4th 636, is amended. The amended
opinion will be filed concurrently with this Order.
The panel has unanimously voted to deny Balwani’s
petition for panel rehearing. Judge Nguyen and Judge
Nelson voted to deny the petition for rehearing en banc, and
Judge Schroeder so recommended. The full court was
advised of the petition for rehearing en banc, and no judge
has requested a vote on whether to rehear the matter en banc.
Fed. R. App. P. 40.
The petitions for panel rehearing and rehearing en banc,
Dkt. No. 92, are DENIED. Balwani’s motion for leave to
file a reply in support of the petition for rehearing en banc or
panel rehearing, Dkt. No. 100, is GRANTED.
8 USA V. HOLMES
OPINION
NGUYEN, Circuit Judge:
“[O]ne tiny drop changes everything.” That was the
vision shared by Elizabeth Holmes and Ramesh “Sunny”
Balwani, who set out in the mid-2000s to revolutionize
medical laboratory testing through a biotechnology
company called Theranos. In the early 2010s, Theranos
claimed that it could run fast, accurate, and affordable tests
with just a drop of blood drawn from the prick of a finger, in
contrast to traditional testing methods that require large
needles to draw blood from a vein.
Investors, health care professionals and companies, and
Silicon Valley spectators were captivated by the potential of
Theranos’s revolutionary technology. As a result, Holmes
and Balwani were able to establish relationships with major
companies, investors, and prominent figures, including high-
ranking members of the United States military.
But the vision sold by Holmes and Balwani was nothing
more than a mirage. In late 2015, news reporting revealed
internal struggles within the Theranos laboratory and the
limitations of its technology. The grandiose achievements
touted by Holmes and Balwani were half-truths and outright
lies. Theranos’s blood-testing device failed to deliver faster
and more accurate testing results than conventional
technology. Pharmaceutical companies never validated the
technology, as Holmes and Balwani had told investors.
Contrary to the rosy revenue projections shared with
investors and business partners, Theranos was running out
of money.
USA V. HOLMES 9
After a two-and-a-half-year investigation, a grand jury
returned an indictment against Holmes and Balwani. They
were tried separately in lengthy jury trials, and each was
convicted on numerous fraud charges. Holmes and Balwani
now bring several challenges to the district court’s decisions
at trial and sentencing. We affirm.
Factual Background
The Third Superseding Indictment (the “Indictment”)
charged Holmes and Balwani (collectively, “Defendants”)
with conspiracy to commit wire fraud against investors from
2010 to 2015 (Count 1), six wire fraud counts involving
investors who invested in Theranos in 2013 and 2014
(Counts 3 to 8), conspiracy to commit wire fraud against
patients from 2013 to 2016 (Count 2), and four wire fraud
counts involving patients (Counts 9 to 12).
A. Holmes Starts Theranos
Holmes founded Theranos in 2003 and served as its
Chief Executive Officer until 2018. Theranos aimed to
revolutionize medical laboratory testing through innovative
methods for drawing blood, testing blood, and interpreting
patient data. Holmes’s claimed goal was to create
technology to run blood tests on small samples of blood
drawn from a fingerstick.
Balwani, who was in a romantic relationship with
Holmes from 2004 to 2016, joined the company in 2009 and
was later appointed its President and Chief Operating
Officer. The precise division of responsibilities between
Holmes and Balwani was disputed at their respective trials.
But evidence offered at both showed that Balwani oversaw
operations in Theranos’s patient-testing lab and served as the
primary contact for Theranos’s relationships with retailers,
10 USA V. HOLMES
including Safeway and Walgreens. Both Holmes and
Balwani communicated with investors and business partners
on behalf of Theranos. And they were both informed of
Theranos’s financial position on a regular basis. Holmes
admitted that although not everyone directly reported
directly to her, “ultimately all roads” led to her as the CEO.
B. Theranos’s Technology
Theranos’s technology was structured around “three
core areas: the first was the chemistry or the assays; the
second was hardware; and the third was software.” One of
Theranos’s early developments was a miniaturized device
called the “Edison.” 1 The Edison was used in Theranos’s
clinical lab to test patient samples. While other devices,
including the “minilab” and the “4.0” (or “4s”), were in
development while Holmes ran Theranos, the Edison was
the only device developed by Theranos that was ever used to
test patient samples.
Theranos also developed proprietary “nanotainers” that
were used to collect blood samples from a fingerstick. These
nanotainers contrasted with traditional “vacutainers,” which
are used to collect higher volumes of blood from traditional
venous blood draws. Blood samples that were collected by
Theranos from a fingerstick using the nanotainer would be
tested on either the Edison device or a modified third-party
device.
Although Theranos developed 300 small-sample assays
during Holmes’s time at the company, only twelve assays
were ever run on the Edison. Other “general chemistry tests”
conducted by Theranos were run on third-party-
1
The “Edison” is also referred to as the “3.5” device, the “Edison 3.5”
device, or the “Theranos Proprietary System” (“TPS”).
USA V. HOLMES 11
manufactured machines. Theranos made various
modifications to third-party machines to run certain tests.
Theranos’s goal was to get as many tests to run on the Edison
as possible, and Holmes and Balwani pushed employees in
the clinical laboratory to do so despite their expressed
concerns about the Edison’s accuracy.
C. Scheme to Defraud Investors
In 2010, Theranos partnered with Walgreens to use
Theranos’s propriety device to conduct patient tests in
Walgreens’s retail pharmacies. After publicly launching its
testing services at Walgreens in the fall of 2013, Theranos
raised funds by offering shares to investors. Three investors
purchased C-1 shares in late 2013: Chris Lucas (Count 4),
John Bryan Tolbert (Count 5), and Alan Eisenman (Count
3). In 2014, Theranos offered C-2 shares to new investors:
Brian Grossman (Count 6), Lisa Peterson (Count 7), and
Daniel Mosley (Count 8). Theranos shares were not publicly
traded.
The Indictment alleged that, in procuring these
investments, Holmes and Balwani made materially false and
misleading statements to the investors, which generally fell
in the following categories: (A) the technological
capabilities of Theranos’s device; (B) Theranos’s financial
health; (C) technology demonstrations; (D) a purportedly
expanding relationship with Walgreens; (E) Theranos’s
work with the United States military; (F) the use of third-
party devices to test patients; and (G) pharmaceutical
companies’ purported validation of Theranos’s technology.
Theranos employees testified at both trials that the
Edison device consistently failed quality control checks and
was unable to provide accurate results. They conveyed their
concerns about the reliability of Theranos’s testing to
12 USA V. HOLMES
Holmes and Balwani in real time, but Holmes and Balwani
dismissed these concerns or shifted blame away from any
problems with the Theranos device.
One extensively litigated item of evidence was a report
prepared by the Center for Medicare and Medicaid Services
(“CMS”) (“the Report” or “the CMS Report”). CMS, the
federal agency responsible for overseeing blood testing
laboratories, conducted an unannounced inspection of
Theranos in late 2015. The CMS Report summarized the
findings from that inspection, including the conclusion that
deficiencies in Theranos’s clinical laboratory practices and
procedures presented “immediate jeopardy” to patient
health. The Report identified quality control failures within
the lab relating to tests that were run on the Edison device as
well as patient tests from modified, commercial third-party
devices.
One form of deception charged in the Indictment is
Theranos’s use of third-party devices to conduct patient
samples and tests. Theranos employees explained how
patient tests were run on machines that were commercially
available and manufactured by third parties. Some patient
tests were run on “modified” versions of the third-party
machines, while some tests were run on unmodified
versions. Multiple investors testified that Holmes and
Balwani misled them to believe that Theranos ran its tests
solely on devices manufactured by Theranos. The truth,
according to these investors, would have impacted their
investment decisions.
Holmes and Balwani took steps to conceal their use of
third-party devices. Employees testified that Theranos
would invite “VIP” guests, including investors, to observe
technological demonstrations of the Theranos device. These
USA V. HOLMES 13
VIP guests would be placed in a room with an Edison or
“minilab” and would be led to believe that the device was
running a sample of their blood. In reality, the device was
running a “null protocol” while some of the VIP samples
were surreptitiously run on third-party devices.
Holmes and Balwani also shared false financial
projections with investors. In the early 2010s, Theranos’s
business partnerships with pharmaceutical and retail
companies were failing to generate revenue. Theranos’s
Corporate Controller, Han Spivey, testified that Theranos
did not have any revenue in 2012 and 2013 and, in fact,
suffered $57 million and $92 million in net losses,
respectively. In November 2013, Balwani told Holmes that
Theranos was down to $15 million in cash, but the company
was spending up to $2 million weekly. In 2015, Theranos
reported only $1,944,948 in total income to the IRS. But
Holmes and Balwani painted a very different picture to
investors. For example, investor-victim Peterson testified at
Holmes’s trial that financial documents she received from
Holmes and Balwani showed that Theranos was projecting a
profit of $230 million by the end of 2015. And investor-
victim Grossman testified that, prior to his investment,
Holmes and Balwani told him that Theranos had generated
$200 million in revenue from the Department of Defense.
Theranos’s work with the military, and various false
representations Holmes and Balwani made to investors
about that work, was explored in significant detail at both
trials. General James Mattis testified at Holmes’s trial
regarding Theranos’s relationship with the military.
Although Theranos had developed a relationship with the
Department of Defense to explore the potential use of the
Edison device in combat settings, that application never
materialized. General Mattis testified that the Edison device
14 USA V. HOLMES
was never put into the field by the military, it was never
installed on a military medevac, and it was never used to
treat servicemembers on the battlefield. But multiple C-1
and C-2 investors testified that Holmes and Balwani led
them to believe otherwise. At Holmes’s trial, the
government introduced a recording of Holmes speaking to
investors on a call in December 2013 in which she made
various statements about Theranos’s partnership with the
military. 2 For instance, Holmes told investors that “we have
also been doing a lot of work for special operations
command in the context of missions in remote areas” and
that Theranos had “created a distributed system that can be
used in remote areas.”
Finally, the Indictment alleged that Holmes and Balwani
also misrepresented to investors the status of Theranos’s
partnerships with other companies, including retailers and
pharmaceutical companies. A Walgreens representative
testified that, while Holmes and Balwani were touting to
investors that Theranos’s partnership with Walgreens was
expanding, the partnership was actually contracting, and the
pilot program was not going as hoped. Walgreens’s decision
to reduce the number of stores launching Theranos’s testing
services was motivated in part by the high percentage of
blood draws that were being performed venously (a
traditional blood draw), rather than through a finger prick.
Theranos’s partnerships with pharmaceutical
companies—which began in 2008 and 2009 with the purpose
of conducting studies of the Theranos technology—quickly
soured. A representative of Pfizer testified that he believed
that Theranos’s answers to technical due diligence questions
2
As relevant to Balwani’s Napue claim, the government did not
introduce this recording at his trial.
USA V. HOLMES 15
were oblique, deflective, or evasive, and that after 2008,
Pfizer and Theranos had no meaningful business dealings.
But once again, Holmes and Balwani projected a very
different image to investors. Holmes admitted that she
personally affixed the logo of various pharmaceutical
companies, including Pfizer, GlaxoSmithKline, and
Schering-Plough, onto reports containing favorable
conclusions about Theranos’s device. In emails to
Walgreens, Holmes described these reports as representing
the pharmaceutical companies’ independent and technical
validation of the Theranos device. At trial, representatives
from these companies testified that they neither
independently validated the Theranos technology nor
authorized the use of their company logo on these reports.
These reports were shared with investors, who found it
significant that large, independent, third-party companies
were vouching for the technology.
D. Scheme to Defraud Patients
The Indictment further alleged that Holmes and Balwani
devised a scheme to defraud patients through advertisements
and marketing materials boasting about the accuracy, cost,
and reliability of Theranos’s blood testing services. Multiple
patients testified at the trials. One patient testified that an
HIV test she took through Theranos came back positive, but
two subsequent tests showed that she was in fact negative.
Another patient testified that she received incorrect results
from a Theranos blood test about her pregnancy. The
evidence linked Balwani to the transmission of these
inaccurate results, as well as the purchase of advertisements
for Theranos Wellness Centers in Arizona.
16 USA V. HOLMES
Procedural History
The district court severed Defendants’ trials based on
Holmes’s disclosure of Balwani’s abuse in their personal
relationship. Holmes was tried first in late 2021. Balwani
was then tried in early 2022. Each trial lasted nearly four
months.
A. Holmes’s Conviction and Sentence
During Holmes’s trial, the government dismissed Count
9. The jury acquitted Holmes on the patient-related counts:
conspiracy (Count 2) and wire fraud (Counts 10–12). The
jury convicted Holmes of four investor-related counts: the
investor-related conspiracy (Count 1), and wire fraud
relating to three investor-victims (Counts 6–8). The jury
hung on the wire-fraud counts related to C-1 investors
(Counts 3–5).
At Holmes’s sentencing, the district court found that the
offense involved ten or more victims, resulting in a two-level
sentencing enhancement under United States Sentencing
Guidelines (“USSG”) § 2B1.1(b)(2). United States v.
Holmes (Holmes I), 2023 WL 149108, at *7–9 (N.D. Cal.
Jan. 10, 2023). It further found that the offense caused a loss
of $120 million, resulting in a 24-level enhancement under
§ 2B1.1(b)(1). Id. at *6–7. These calculations yielded a
sentencing range of 135 to 168 months. The district court
sentenced Holmes to 135 months of imprisonment.
B. Balwani’s Conviction and Sentence
The jury convicted Balwani of all counts: conspiracy to
commit wire fraud against Theranos investors (Count 1),
conspiracy to commit wire fraud against Theranos patients
(Count 2), investor wire fraud (Counts 3–8), and patient wire
fraud (Counts 9–12).
USA V. HOLMES 17
Based on the same findings of the number of victims and
the amount of the loss as in Holmes’s case, Balwani faced
the same sentencing range of 135 to 168 months. United
States v. Balwani, 2023 WL 2065045, at *15 (N.D. Cal. Feb.
16, 2023). The district court sentenced him to 155 months
of imprisonment. Id.
C. Restitution Order
The district court issued its restitution order in May
2023. United States v. Holmes, et al. (Holmes II), 673 F.
Supp. 3d 1049 (N.D. Cal. 2023). It first determined that the
twelve investors who had been induced by Defendants’ fraud
to invest in Theranos were “victims” under the Mandatory
Victims Restitution Act of 1996 (“MVRA”), 18 U.S.C.
§ 3663A. Id. at 1056. The district court found that the
“property” each victim “lost” was the money that each
invested in exchange for ownership shares in Theranos. Id.
at 1058. The district court credited the amount that Theranos
had already paid to three investors in civil settlements, but it
rejected the proposition that the residual value of the
Theranos shares qualified as “returned” property within the
meaning of § 3663A(b)(1)(B)(ii). Id. at 1057–58. The court
held Holmes and Balwani jointly and severally liable for
$452 million in restitution, including $397 million for the
twelve victims identified at sentencing and $54.5 million for
two other victims, Safeway and Walgreens. Id. at 1066.
Holmes and Balwani timely appealed, challenging their
convictions, sentences, and the restitution order.
Conviction Challenges
I. Expert Testimony
Holmes and Balwani argue that the district court erred
by allowing former Theranos employees, who testified as lay
18 USA V. HOLMES
witnesses, to offer improper expert opinions. We review the
district court’s determination of whether testimony is offered
as an expert or a lay witness for abuse of discretion. United
States v. Perez, 962 F.3d 420, 434 (9th Cir. 2020).
A. Legal Standard
Under Federal Rule of Evidence 701, a lay witness may
provide opinions “rationally based on the witness’s
perception” that are “not based on scientific, technical, or
other specialized knowledge within the scope of Rule 702.”
Fed. R. Evid. 701. Opinion testimony requiring special
“knowledge, skill, experience, training, or education” is
subject to the requirements of Federal Rule of Evidence 702,
Daubert v. Merrell Dow Pharmaceuticals, Inc., 509 U.S.
579 (1993), and the disclosure requirements of Federal Rule
of Criminal Procedure 16.
“[W]hether evidence is more properly offered by an
expert or a lay witness ‘depends on the basis of the opinion,
not its subject matter.’” Perez, 962 F.3d at 436 (quoting
United States v. Barragan, 871 F.3d 689, 704 (9th Cir.
2017)). If the basis of a witness’s opinion is “technical or
specialized knowledge,” then that opinion falls within Rule
702. Id. at 437. But if the basis of the opinion is “just
familiarity with the subjects,” then it is proper lay opinion
under Rule 701. Id.
Drawing that line is a particularly difficult task in a case
like this one. By the very nature of the underlying facts and
the alleged fraud, the testimony of percipient witnesses will
inevitably involve observations made in a scientific setting
and relate to scientific or technical concepts. But the fact
that a witness’s testimony pertains to scientific matters, or
conveys opinions drawn from the witness’s own experiences
with such matters, does not automatically render it expert
USA V. HOLMES 19
testimony within the ambit of Rule 702. Indeed, “[a] lay
witness’s opinion testimony necessarily draws on the
witness’s own understanding, including a wealth of personal
information, experience, and education, that cannot be
placed before the jury.” United States v. Gadson, 763 F.3d
1189, 1208 (9th Cir. 2014). A lay witness’s opinion is
permissible so long as it is not “based on scientific, technical,
or other specialized knowledge.” Fed. R. Evid. 701
(emphasis added).
By the same token, the “mere percipience of a witness to
the facts on which he wishes to tender an opinion does not
trump Rule 702.” United States v. Figueroa-Lopez, 125 F.3d
1241, 1246 (9th Cir. 1997). In other words, there is no “on-
the-job” exception to Rule 702. See id. at 1247. The fact
that a witness personally observes a matter does not take the
witness’s opinion about that matter outside the scope of Rule
702 if that opinion is the product of “specialized
knowledge.” Id. at 1246. Thus, as we explained in
Figueroa-Lopez, if a witness offers an opinion that is based
on specialized knowledge, experience, training, or education
contemplated by Rule 702, a party cannot evade the Rule by
labeling a witness “percipient.” See id. at 1243. But the
converse is also true—an opinion is not automatically
deemed “expert” within the meaning of Rule 702 merely
because it is offered by a lay witness drawing on their own
unique experiences or personal knowledge.
With these principles in mind, we consider each of the
challenged witnesses in turn.
B. Dr. Kingshuk Das
Holmes argues that the district court erroneously allowed
Dr. Kingshuk Das, who worked as a laboratory director at
Theranos, to offer expert opinion testimony. Das began
20 USA V. HOLMES
working at Theranos in March of 2016. Holmes hired him
to review and respond to the CMS Report, a task that became
Das’s near “sole responsibility.” In carrying out this role,
Das had many conversations with Holmes about the CMS
Report, the company’s response to its findings, and
Theranos’s quality control data from Edison tests run in
2014 and 2015.
Das testified that, in responding to the CMS Report, he
was involved in Theranos’s performance of Patient Impact
Assessments (PIAs)—one of two retrospective analyses of
the Edison. According to Das, the PIAs were “descriptions
of [Theranos’s] assessment on [its] evaluation of whether
these tests led to potential for patient harm.” To perform
these assessments, Das reviewed three categories of
Theranos documents: validation reports for tests performed,
quality control results and reports, and patient test result
distributions and calculations. The PIAs were sent to CMS
as part of Theranos’s response to CMS’s deficiency findings.
Over Holmes’s objection, the government introduced the
PIA concerning Theranos’s proprietary Edison device. That
document states, and Das confirmed, that the Theranos
“laboratory conducted an expanded retrospective analysis
for 2014 and 2015 [quality control] data,” with the goal of
“see[ing] how far the poor performance extended.” Based
on that comprehensive analysis, the laboratory concluded
that “there [was] a possible patient impact for every test
reported from the laboratory’s TPS 3.5 [Edison]
instruments.” Das confirmed that, based on the data
analyzed in the PIA, he found the Edison “unsuitable for
clinical use.”
Das further testified that he conveyed these results and
conclusions to Holmes. While Theranos was preparing its
USA V. HOLMES 21
response to CMS, Das shared with Holmes his concerns that,
based on “the validation data,” he believed that “these
instruments apparently were not performing from the very
beginning.” Das then explained that, when he raised these
issues, Holmes attributed the poor results to laboratory
control failures rather than an issue with the device itself—
an explanation that Das found unsatisfying.
Holmes claims that “[t]he government’s examination of
Das was an ‘end-run around Rule 702 and Daubert.’” See
In re: Taxtore (Docetaxel) Prods. Liab. Litig., 26 F.4th 256,
264 (5th Cir. 2022). The PIA and Das’s opinions about
Theranos’s quality control data, according to Holmes,
“rested on sophisticated data analysis based on extensive
scientific training.” In response, the government argues that
Das properly testified as a percipient witness because he
merely described the job he was hired to do, and the PIA is
not expert testimony but rather an admission by Theranos—
and, by extension, Holmes—that there were serious
reliability issues with the Edison device.
The government’s argument is misplaced. As we
explained, there is no “on-the-job” exception to Rule 702.
That Das described personal observations made while
performing his job would not take his testimony outside the
scope of Rule 702 if Das offered opinions that relied on
specialized knowledge, training, or skill. See Figueroa-
Lopez, 125 F.3d at 1246. And there is little doubt that the
PIA and Das’s opinions concerning the suitability of the
Theranos device for clinical use were based on specialized
knowledge. Das testified that he reviewed data collected by
Theranos (i.e., validation reports, quality control data, and
patient test result distributions and calculations), conducted
a comprehensive retrospective analysis of this data, and
reached conclusions about the Edison device based on this
22 USA V. HOLMES
statistical analysis. In his conversations with Holmes, Das
used “terms of the validation data in describing that these
instruments apparently were not performing from the very
beginning.” Das’s conclusion, reached after a
comprehensive statistical analysis and interpretation of the
results, was clearly based on highly specialized knowledge.
Moreover, the district court recognized before trial that
the “Six Sigma” data analysis—the second retrospective
analysis of the Edison that Das conducted—would have
approached expert witness territory. Holmes argues, and the
government does not refute, that the analysis contained in
the PIA was not meaningfully different from the Six Sigma
data analysis in terms of the specialized training or
knowledge required to reach the resulting opinions. We
therefore conclude that certain aspects of Das’s testimony,
including the PIA, and Das’s accompanying opinions about
the Edison device, amounted to expert opinions. To the
extent that the government used Das’s testimony to prove
that there were significant problems with the accuracy and
reliability of the Edison device, Rule 702 required that Das’s
opinions be subject to Daubert scrutiny.
Nevertheless, any error in admitting these opinions was
harmless. To the extent that Holmes is now challenging
Das’s qualifications as an expert, we conclude he was
qualified. See id. at 1247. Based on his extensive experience
working in clinical laboratories, Das would have easily
qualified as an expert to deliver the disputed opinion
testimony. See United States v. Holguin, 51 F.4th 841, 855–
56 (9th Cir. 2022) (finding error in admitting expert
testimony harmless and recognizing that “[e]xperience
alone” could be reliable basis for certain expert testimony).
“[T]he failure formally to go through the usual process—
USA V. HOLMES 23
although an error—was clearly harmless.” Figueroa-Lopez,
125 F.3d at 1247.
Holmes also stresses that Daubert required the district
court to scrutinize the reliability of Das’s opinions under
Rule 702. 3 It is not likely however that the admission of
Das’s opinion testimony affected the jury’s verdict, given
the weight of other evidence against Holmes. The standard
of harmlessness for evidentiary errors in this circuit is clear.
See United States v. Charley, 1 F.4th 637, 651 (9th Cir.
2021). “Evidentiary errors ‘are not harmless unless it is
more probable than not that the erroneous admission of the
evidence did not affect the jury’s verdict.’” Id. (quoting
United States v. Hill, 953 F.2d 452, 458 (9th Cir. 1991)).
Holmes objects to Das’s opinions concerning the accuracy
and reliability of the Edison device, but his was not isolated
testimony on that subject. Multiple former Theranos
employees reported similar problems with the technology,
and Das’s testimony was essentially cumulative of theirs.
Das’s testimony was relevant to misrepresentations
concerning the technological capabilities of the device, but
such misrepresentations constituted only one of numerous
types of misrepresentations to investors that the government
3
Holmes also argues a discovery violation based on the government’s
failure to disclose Das as an expert. See Fed. R. Crim. P. 16. “[A]
violation of Rule 16 does not itself require reversal, or even exclusion of
the affected testimony.” Figueroa-Lopez, 125 F.3d at 1247. The
discovery violation must have resulted in prejudice to the defendant’s
substantial rights. United States v. Basinger, 60 F.3d 1400, 1407 (9th
Cir. 1995). Holmes was aware of the substance of Das’s testimony as
early as February 2021. And as Holmes recognizes, the substance of
Das’s scientific opinions largely overlapped with that of Dr. Stephen
Master, who was timely disclosed. On these facts, any untimely
disclosure did not result in prejudice.
24 USA V. HOLMES
alleged and presented evidence to prove. The government
offered evidence that Holmes misrepresented Theranos’s
financial status, its reliance on third-party testing devices, its
partnerships with Walgreens and the military, and
pharmaceutical companies’ purported validation of
Theranos’s technology. Das’s testimony about the
technology’s unreliability was not essential to proving any
of these misrepresentations.
Moreover, after the district court permitted the
government to call Das as a percipient witness, Holmes
never requested a Daubert hearing to test the reliability of
his testimony. Nor did she object when Das offered the
opinions she now challenges. Only when the court admitted
the PIA itself did Holmes raise a Rule 702 objection. There
was no reversible error by the district court.
C. Dr. Adam Rosendorff and Dr. Mark Pandori
Balwani challenges certain testimony given by two other
former Theranos laboratory directors—Dr. Adam
Rosendorff and Dr. Mark Pandori. Both testified that there
were problems with Theranos’s laboratory tests. During
Rosendorff’s tenure, he developed concerns about the
systemic inaccuracy of the Theranos device, specific tests
offered to patients, management’s unwillingness to perform
proper proficiency testing as required by federal regulations,
and the pressure he felt to explain problematic results when
patients and physicians complained.
Like Rosendorff, Pandori testified that the “failure rate
of the controls on the Edisons was notably higher than what
[he] would see on the assay equipment with which [he] had
familiarity.” Pandori detailed his experience with the
proficiency testing at Theranos, which he described as a
regulatory requirement that was meant to be “a neutral way
USA V. HOLMES 25
to ascertain the quality of [a] test.” His concern stemmed
from the fact that the proficiency tests were performed on
third-party devices, whereas actual patient samples were run
on Theranos-manufactured devices. And when the same
tests were run on Theranos devices and third-party devices,
the significant differences in the results led him to question
the accuracy of Theranos’s device.
We conclude that, as with Das, some aspects of these
witnesses’ testimonies veered into expert territory. A prime
example is Rosendorff’s explanation of hemolysis.
Rosendorff testified that hemolysis is the “bursting of red
blood cells,” which can happen “when you collect the
blood.” Rosendorff explained that damage to the red blood
cells can cause “whatever is inside of the red blood cells [to]
get[] into the sample, and it can really interfere with the
detection of a lot of different things.” This, according to
Rosendorff, interfered with the ability of the Theranos
devices to read the sample, thereby affecting the accuracy
and reliability of the tests. Rosendorff further explained that
hemolysis was more common in Theranos fingerstick
samples rather than standard vein samples. This is plainly
expert opinion within the meaning of Rule 702 because a lay
person without specialized scientific training or education
would not know what hemolysis means, why it more
commonly occurs when blood is collected from via a
fingerstick rather than a venous blood draw, or how it can
interfere with the accuracy of test result. See United States
v. Finley, 301 F.3d 1000, 1008, 1013 (9th Cir. 2002)
(describing expert testimony as that which goes “beyond the
common knowledge of the average layman”). The fact that
Rosendorff personally observed a relationship between
hemolysis and the accuracy of certain Theranos tests would
26 USA V. HOLMES
not remove this testimony from the ambit of Rule 702. See
Figueroa-Lopez, 125 F.3d at 1246.
Similarly, Pandori’s testimony about the results of
Theranos’s proficiency testing constituted expert opinion.
Pandori explained that Theranos conducted proficiency
testing by running certain tests on third-party machines, and
then ran the same tests on Theranos devices, and compared
the results. Pandori explained that the third-party machines
were “extraordinarily vetted methodolog[ies],” meaning
“one might feel very confident that a [third-party] method
will give an accurate result.” Pandori then testified that there
were “large differences” between the third party and
Theranos testing. He specifically stated that “you would
need to be an expert to appreciate the differences because
the differences don’t look large.” By Pandori’s own
explanation, a lay person would not know whether the
differences in the results were significant.
These opinions required the witnesses to draw on their
respective specialized experience and background in clinical
labs. The government’s questions illustrate the expert nature
of these opinions because they called on the witnesses to
compare the quality control issues experienced at Theranos
with quality control issues at other labs and to explain why
problems were worse at Theranos. Only one with
specialized experience in clinical laboratory science could
understand whether the problems suffered at Theranos were
unique or particularly problematic—an average lay person
without that background would not be able to opine on
Theranos’s problems relative to other laboratories.
Still, any error in permitting Rosendorff’s or Pandori’s
testimonies was harmless for the same reason the
erroneously admitted testimony in Figueroa-Lopez was
USA V. HOLMES 27
harmless. See 125 F.3d at 1247. Rosendorff testified as to
his medical background and qualifications to serve as
laboratory director. Rosendorff completed medical school,
a fellowship in basic science research in a laboratory,
worked as a post-doctoral fellow at Harvard University in a
laboratory, completed specialized training in laboratory
medicine, and oversaw laboratory testing at a children’s
hospital for five years. Pandori received a doctoral degree
and was trained as a public health microbiologist at the
California Department of Public Health. He worked as a
postdoctoral research fellow at Harvard University School
of Medicine and became an instructor of medicine there.
Pandori then served as the chief microbiologist at the San
Francisco Department of Public Health Laboratory, which
was a Clinical Laboratory Improvement Amendments
(“CLIA”)-certified diagnostic laboratory that ran blood tests.
Both Rosendorff and Pandori would have easily qualified as
experts, and their extensive experiences allowed them to
draw reliable conclusions about problems with Theranos’s
device and testing services. See Holguin, 51 F.4th at 855
(“The Rules Advisory Committee has explicitly recognized
that ‘the application of extensive experience’ is a ‘method’
that can reliably support expert testimony.” (quoting Fed. R.
Evid. 702 advisory committee’s note to 2000 amendment)). 4
Thus, because the facts of this case demonstrate that
Rosendorff and Pandori would have met all the requirements
under Rule 702 and Daubert, any error in admitting their
testimonies was harmless.
4
Additionally, Balwani failed to object to the vast majority Rosendorff’s
testimony, including instances where he expressed concerns about the
accuracy of certain tests and problems in the laboratory. Even if certain
portions of his testimony were erroneously admitted, it is unlikely they
materially affected the impact of Rosendorff’s testimony in its entirety.
28 USA V. HOLMES
D. Erika Cheung
Balwani argues that Erika Cheung, a former Theranos
laboratory associate, also offered expert testimony in
violation of Rule 702.
Cheung was hired immediately after graduating college.
During her time at Theranos, Cheung ran test samples on the
Edison device and became familiar with which types of tests
each device ran. Cheung was responsible for running quality
controls, which she described as “essentially a check that
you have to do before you run the patient samples.”
According to Cheung, in “[quality control], you have a
known concentration of a particular test.” The known
sample is put into the machine, which “gives . . . an answer”
that should reflect the known value of the sample or a value
“in some acceptable range.” Cheung explained that quality
control testing “gives you some level of confidence that all
of the parts and pieces of the system are working properly.”
Cheung testified, and documentary evidence presented
by the government corroborated, that the Edison device
frequently failed these quality control checks. Cheung
eventually concluded that the Theranos blood testing devices
were “highly unreliable” because quality controls were
failing with such high frequency across multiple tests.
Although devices that failed quality control were not used
for patient testing, Cheung nevertheless harbored concerns
about the accuracy of patient tests. Over Balwani’s Rule 702
objection, Cheung explained that “if you just extrapolate out
essentially the percentage of failures that are happening
across the system, even if we change the device, there’s
something still going on that is causing one out of four
failures of every single test that we do on this . . . system.”
USA V. HOLMES 29
Balwani argues that Cheung’s testimony concerning the
capabilities and accuracy of the Theranos technology
constituted impermissible expert opinions. Even though
Cheung did not have any relevant expertise or special
statistical training, Balwani nevertheless contends that
because Cheung’s opinions about quality control were
derived from her on-the-job training at Theranos, her
testimony falls within Rule 702 pursuant to Figueroa-Lopez.
Not so. Figueroa-Lopez does not stand for the proposition
that testimony given by a percipient witness is “expert”
merely because the testimony concerns a matter that a
witness learned about at her job. See 125 F.3d at 1244, 1247.
Figeroa-Lopez involved officers who offered an
interpretation of a specific set of facts based on an
application their prior law enforcement training and
experience that were completely unrelated to those facts.
See 125 F.3d at 1246. In contrast, Cheung testified about her
training at Theranos for the purpose of explaining what she
understood that training to mean, not for the purpose of
applying that training to reach conclusions about an
unrelated set of facts.
Importantly, Balwani does not argue that any scientific
expertise is required to know whether a given sample passed
or failed quality control. Had Cheung testified as to the
mechanics or operation of the Edison device, or how the
device generated quality control results, that may have
hewed closer to expert testimony. But Cheung only testified
that she ran samples in the Theranos device and that the
device indicated that those samples failed quality control.
Balwani himself described this as nothing more than
“scan[ning] barcodes, load[ing] samples into cartridges and
machines, and then ‘hit[ting] start.’” Such testimony
resembles that offered in United States v. Jimenez-Chaidez,
30 USA V. HOLMES
96 F.4th 1257, 1267–68 (9th Cir. 2024), where we found that
an FBI agent appropriately testified as a lay witness when
the agent used software to extract information from a cell
phone. The agent did not testify as to the mechanics of the
software, but rather testified as to the report that the software
produced. Id. The agent’s testimony about the report was
“based on his perception and not specialized knowledge.”
Id. at 1267. Similarly, Cheung’s testimony did not require
specialized knowledge.
Moreover, it takes no special knowledge, training, or
education to infer that when a device consistently fails
measures designed to test the accuracy of the device, the
device may in fact suffer from accuracy issues. To borrow
the district court’s analogy, if a certain model of a toaster
consistently burned bread or short-circuited when run on
regular settings, and those problems consistently manifested
across multiple toasters of the same model, a lay person
using the toaster could reasonably reach the conclusion that
there is a problem with the design or manufacturing of the
toaster. Similarly, Cheung could offer lay opinion testimony
that repeated quality control problems with the Edison
device signaled a problem with the device.
We therefore conclude that the district court did not
abuse its discretion in admitting Cheung’s testimony about
quality control problems that led her to question the accuracy
and reliability of the Theranos device as lay opinion.
II. CMS Report
The CMS Report was the subject of intense litigation
below. The district court denied Holmes’s pre-trial motion
in limine to exclude the Report, rejecting her arguments that
its probative value was substantially outweighed by its risk
of unfair prejudice. Over Holmes’s renewed objection at
USA V. HOLMES 31
trial, the government introduced the CMS Report into
evidence during its direct examination of Das. After Das’s
testimony, Holmes moved to strike the report and Das’s
related testimony, which the district court denied.
On appeal, Holmes argues that the CMS Report was
irrelevant under Federal Rule of Evidence 401 first, because
the Report was issued in January 2016—after the alleged
misrepresentations to investors took place—and second,
because the Report made no findings as to whether
Theranos’s technology was in fact accurate or reliable.
Holmes further argues that the Report should have been
excluded pursuant to Federal Rule of Evidence 403 because
there was a significant risk that the Report would mislead the
jury. We review the district court’s decision as to the
admissibility of the Report for an abuse of discretion. See
Figueroa-Lopez, 125 F.3d at 1244. Under this standard, we
will only reverse a district court’s decision if the decision
“(1) illogical, (2) implausible, or (3) without support in
inferences that may be drawn from the facts in the record.”
United States v. Hinkson, 585 F.3d 1247, 1262 (9th Cir.
2009) (en banc) (quotation omitted).
First, the district court did not abuse its discretion in
finding that the CMS Report was relevant to questions about
Holmes’s state of mind, intent, and knowledge regarding the
alleged misrepresentations about the accuracy and reliability
of Theranos’s blood tests. As the district court recognized,
the Report and the related testimony were probative of
Holmes’s knowledge of the state of Theranos’s clinical
laboratory in late 2015, when the CMS inspection occurred,
and early 2016, when the Report was received by Theranos.
The Report therefore makes it more likely that Holmes also
knew about the condition of the lab during the charging
period even if Holmes did not receive the Report itself until
32 USA V. HOLMES
after the alleged misrepresentations were made. See United
States v. Bibo-Rodriguez, 922 F.2d 1398, 1400 (9th Cir.
1991) (recognizing that subsequent acts may raise an
inference of prior knowledge); United States v. Nelson, 137
F.3d 1094, 1106–07 (9th Cir. 1998) (same); United States v.
Boulware, 384 F.3d 794, 805 (9th Cir. 2004) (“Evidence is
relevant if it has ‘any tendency to make the existence of any
fact that is of consequence to the determination of the action
more probable or less probable than it would be without the
evidence.’” (quoting Fed. R. Evid. 401) (emphasis added)).
Second, the district court did not abuse its discretion in
finding that the probative value of the CMS Report was not
substantially outweighed by its potential for unfair
prejudice. “A district court’s decision to exclude or admit
evidence under [Rule] 403 is reviewed ‘with considerable
deference.’” United States v. Hankey, 203 F.3d 1160, 1167
(9th Cir. 2000) (quoting United States v. Cordoba, 194 F.3d
1053, 1063 (9th Cir. 1999)).
With the benefit of extensive briefing and oral argument,
the district court fully and carefully considered Holmes’s
arguments and declined to exclude the CMS Report on three
separate occasions: first, in denying Holmes’s motion in
limine to exclude the Report, again in deferring ruling on
Holmes’s proposed redactions to the Report and its cover
letter, and finally, in denying her motion to strike the Report.
The district court’s decision to admit the Report certainly
does not “lie[] beyond the pale of reasonable justification
under the circumstances.” United States v. Hollis, 490 F.3d
1149, 1153 (9th Cir. 2007) (quoting Harman v. Apfel, 211
F.3d 1172, 1175 (9th Cir. 2000)).
Importantly, the district court implemented appropriate
safeguards to minimize the risk of unfair prejudice to
USA V. HOLMES 33
Holmes by instructing the jury that its limited purpose was
to show Holmes’s state of mind and that she could not be
found guilty merely because she may have violated
regulations or industry standards. Holmes cites United
States v. Wolf, 820 F.2d 1499 (9th Cir. 1987), to argue that
jury instructions are not always curative of prejudice
associated with evidence of regulatory violations. But
unlike the instruction in Wolf, which vaguely described the
regulations at issue as “background evidence,” 820 F.2d at
1505, the instructions given by the district court here
explicitly informed the jury that any CLIA violations
reported by CMS were not independently relevant of
Holmes’s guilt. Nothing in the record rebuts the “strong[]
presum[ption] that the jury followed the court’s instruction.”
United States v. Ubaldo, 859 F.3d 690, 704 (9th Cir. 2017).
In sum, the district court did not err in admitting the CMS
Report as evidence of Holmes’s knowledge, intent, or state
of mind.
III. Voiding Results
Holmes also argues that the district court abused its
discretion by allowing Das to testify that Theranos voided
all patient tests run on the Edison. That testimony, Holmes
claims, is evidence of a “subsequent remedial measure” that
Theranos took out of “an abundance of caution.” As such, it
should have been excluded under Federal Rule of Evidence
407, which provides that “[w]hen measures are taken that
would have made an earlier injury or harm less likely to
occur, evidence of the subsequent measures is not admissible
to prove . . . culpable conduct.” Fed. R. Evid. 407. We
assume, without deciding, that Theranos’s decision to void
results of patient tests run on the Edison constitutes a
34 USA V. HOLMES
“measure” within the meaning of the Rule. 5 We
nevertheless find that the district court did not abuse its
discretion in admitting this evidence.
“The purpose of Rule 407 is not implicated in cases
involving subsequent measures in which the defendant did
not voluntarily participate.” In re Aircrash in Bali,
Indonesia, 871 F.2d 812, 817 (9th Cir. 1989). Rule 407 is
meant to avoid “‘punish[ing]’ the defendant for his efforts to
remedy his safety problems,” so the rule does not
contemplate exclusion of evidence that the defendant took
actions that it was legally obligated to take. Id. The central
issue here is whether Theranos’s decision to void tests was
truly “voluntary.” Because this issue goes to the
admissibility of the voiding evidence under Rule 407, it is a
preliminary question for the district court to decide. Fed. R.
Evid. 104(a). Where a preliminary question turns on a
question of fact, it must be established by a preponderance
of the evidence, and the district court’s fact-finding on that
question is subject to clear error review. See Bourjaily v.
United States, 483 U.S. 171, 175–76 (1987).
When the district court overruled Holmes’s Rule 407
objection and allowed Das to testify regarding the voiding,
it implicitly found that the decision to void was not
voluntary. As Holmes’s counsel recognized prior to Das’s
testimony, there was evidence in the record that could
support a finding either way on the voluntariness issue. And
“[w]here there are two permissible views of the evidence,
the factfinder’s choice between them cannot be clearly
5
The government urges us to conclude that “Theranos’s internal analysis
leading to the voiding” is not a “measure” protected by Rule 407. But
we reach the same conclusion regardless of whether voiding results is a
“remedial measure” rather than an “internal analysis.”
USA V. HOLMES 35
erroneous.” United States v. Working, 224 F.3d 1093, 1102
(9th Cir. 2000) (en banc) (quotation omitted).
Additionally, the district court carefully balanced the risk
of prejudice against the probative value of the evidence
pursuant to Rule 403. 6 The district court reasonably
concluded that this evidence is highly probative of Holmes’s
knowledge and state of mind because the decision to void
every single patient test result generated by the Edison is an
admission by Theranos, and by extension Holmes, that the
test results were, and always had been, unreliable, despite
Holmes’s representations to investors saying exactly the
opposite. Moreover, the district court reasonably concluded
that the government proffered adequate evidence linking
Holmes’s 2016 conduct and the charged conduct, where
investor-victims testified that in 2016, Holmes
“downplayed” the CMS inspection and kept investors in the
dark regarding the seriousness of the problems with
Theranos’s tests. We cannot say that the district court’s
decision to admit the evidence of voiding is so illogical,
implausible, or without support in the record as to constitute
an abuse of discretion. See Hinkson, 585 F.3d at 1251.
6
We reject Holmes’s assertion that we must apply de novo review
because the district court failed to explicitly perform any Rule 403
balancing. In overruling Holmes’s objection, “it is clear from the record
that the district court implicitly made the necessary finding.” United
States v. Ramirez-Jiminez, 967 F.2d 1321, 1326 (9th Cir. 1992). The
parties’ motions in limine concerning the voiding evidence addressed
Rule 403 considerations, the district court entertained oral argument on
those motions, and it acknowledged the Rule 403 considerations in its
order deferring ruling on the motions. The record is sufficient for us to
conclude that “the court considered [Rule 403’s] requirements before
admitting the evidence.” United States v. Lillard, 354 F.3d 850, 855 (9th
Cir. 2003). We therefore review the district court’s decision for an abuse
of discretion.
36 USA V. HOLMES
IV. Rosendorff Cross-Examination
Holmes argues that the district court violated her rights
under the Confrontation Clause of the Sixth Amendment
when it prohibited her from cross-examining Rosendorff on
certain aspects of his post-Theranos employment. As the
laboratory director at Theranos, Rosendorff was
“responsible for ensuring that the tests that come out of a lab
are appropriate for patient care,” which included monitoring
the accuracy of tests.
Holmes sought to cross-examine Rosendorff about his
employment at three different companies after he left
Theranos, which she claimed “bore directly on Rosendorff’s
credibility and competence.” The district court allowed
cross-examination as to Rosendorff’s employer at the time
of trial, PerkinElmer, but prohibited further questioning as
to the other employers. At the time of trial, PerkinElmer was
under investigation by the same CMS investigators who had
conducted the inspection of the Theranos laboratory. The
district court permitted Holmes’s counsel “to probe any
issues of bias that may exist” regarding Rosendorff’s
personal stake in the PerkinElmer investigation.
The district court’s ruling was well within its discretion.
See United States v. Larson, 495 F.3d 1094, 1101 (9th Cir.
2007) (en banc) (setting forth the standard of review for a
Confrontation Clause challenge to the district court’s
“limitation on the scope of questioning within a given area”).
Holmes was allowed to question Rosendorff about the
personal consequences attached to the pending CMS
investigation at PerkinElmer, which was adequate to expose
Rosendorff’s stake in cooperating with CMS. Id.
(identifying the relevant issue as whether “the exclusion of
USA V. HOLMES 37
evidence left the jury with sufficient information to assess
the credibility of the witness” (quotation omitted)).
Holmes argues that evidence of problems elsewhere
would have bolstered her defense that Rosendorff’s
incompetence obscured any problems in the lab from her.
Even assuming this is true, “[di]strict courts have
‘considerable latitude even with admittedly relevant
evidence in rejecting that which is cumulative.’” United
States v. Shih, 73 F.4th 1077, 1097 (9th Cir. 2023) (quoting
Hamling v. United States, 418 U.S. 87, 127 (1974)).
Holmes’s cross-examination of Rosendorff lasted nearly
four-and-half trial days, during which Holmes thoroughly
attacked Rosendorff’s competence. The Confrontation
Clause does not require more. See United States v. Weiner,
578 F.2d 757, 766 (9th Cir. 1978) (per curium) (“The court
in its discretion may limit cross-examination in order to
preclude repetitive questioning, upon determining that a
particular subject has been exhausted, or to avoid extensive
and time-wasting exploration of collateral matters.”). 7
Therefore, the district court did not abuse its discretion
in limiting the scope of Holmes’s cross-examination into
Rosendorff’s post-Theranos employment. 8
7
Holmes argues that Rosendorff’s employment at another company,
uBiome, was relevant to show Rosendorff’s motive to testify favorably
for the government. But the uBiome criminal investigation centered on
billing practices, not the reliability of its tests. And Rosendorff was not
a target of that investigation. Any relevance of this evidence would have
been marginal.
8
Holmes also argues that the government “opened the door” when it
elicited testimony that the problems Rosendorff experienced at Theranos
were worse than expected based on experience at other labs. But the
38 USA V. HOLMES
V. Balwani’s Statement Against Interest
During trial, Holmes moved to admit excerpts of
deposition testimony given by Balwani to the Securities and
Exchange Commission (“SEC”), under Federal Rule of
Evidence 804(b)(3), as statements against interest. On
appeal, Holmes argues that the following statements should
have been admitted:
A: Around 2010, when we started engaging
with the retail pharmacies, Safeway and
Walgreens, I started building a financial
model with the help initially from Safeway
and Walgreens that I owned . . . until I left the
company.
Q: By saying you owned, you mean you
were the person responsible for the
company’s financial projections as you just
described?
A: Financial model.
***
Q: Was there anyone else from Theranos
who was working on the model while you
were working on it?
A: I don’t think so . . . . Nobody with direct
access to the model. I don’t think anybody
else modified it.
district court struck that question and answer from the record and
instructed the jury to disregard it. Holmes does not persuasively explain
why that instruction was inadequate. See United States v. Saelee, 51
F.4th 327, 345 (9th Cir. 2022) (citing United States v. Parks, 285 F.3d
1133, 1139 (9th Cir. 2002)).
USA V. HOLMES 39
Q: [Holmes] was generally familiar with the
kinds of inputs that went into the financial
model?
A: She may have been at some point, but I
was revving the model and adding so many
assumptions that she may not be familiar with
all of them or even most of them.
***
Q: Did she ever edit the model?
A: To the best of my knowledge, no.
We conclude that the district court did not abuse its
discretion in declining to admit these statements.
Under the exception to the rule against hearsay for
statements against penal interest, the proponent of the
statement must show “(1) the declarant is unavailable as a
witness; (2) the statement so far tended to subject the
declarant to criminal liability that a reasonable person in the
declarant’s position would not have made the statement
unless he believed it to be true; and (3) corroborating
circumstances clearly indicate the trustworthiness of the
statement.” United States v. Paguio, 114 F.3d 928, 932 (9th
Cir. 1997). Neither party disputes that Balwani was
unavailable after invoking his Fifth Amendment privilege
against self-incrimination. To satisfy the second element,
the prior statements must “solidly inculpate” the declarant—
mere speculation that the statement may have subjected the
declarant to criminal liability will not suffice. United States
v. Monaco, 735 F.2d 1173, 1176 (9th Cir. 1984).
The district court correctly recognized that Balwani’s
statements were not solidly inculpatory because “[it] is . . .
not a crime to take ownership over the creation of a financial
40 USA V. HOLMES
model.” Even if a reasonable person in Balwani’s position
knew that Theranos’s “financial projections” were in the
SEC’s crosshairs, he did not clearly or unequivocally take
responsibility for those projections. To the contrary, when
the government asked if he was the person responsible for
the company’s “financial projections,” Balwani clarified that
he was responsible for the “financial model.” Balwani
admitted to owning the financial model while expressly
disclaiming responsibility for the financial projections, with
the latter being the primary interest of the SEC and U.S.
Attorney’s Office. See United States v. Oropeza, 564 F.2d
316, 325 (9th Cir. 1977) (disagreeing that a hearsay
statement was exculpatory of the defendant where the co-
conspirator “averred that [the defendant] was not involved
in the heroin distribution scheme, that the .357 magnum
pistol belonged to [the co-conspirator], and that [the
defendant] never ‘possessed’ the pistol” because the
“statement was merely a general assertion of [the
defendant’s] innocence rather than an assertion of [the co-
conspirator’s] own culpability”); United States v. Lynch, 903
F.3d 1061, 1072–74 (9th Cir. 2018) (finding the statement
that “[Defendant] didn’t know anything about this deal” not
admissible under Rule 804(b)(3) because “[s]tating the
negative, that another person does not know about a crime,
hardly inculpates the declarer, and certainly neither ‘so far’
nor so clearly that a reasonable person would not say so if
the statement were false” (quotation omitted)).
We therefore conclude that the district court did not
abuse its discretion in declining to admit these statements.
VI. Constructive Amendment
Balwani argues that the district court violated his Fifth
Amendment rights by constructively amending the
USA V. HOLMES 41
Indictment. Specifically, Balwani claims that evidence
concerning the accuracy and reliability of Theranos tests run
on conventional technology constructively amended the
Indictment, which, according to Balwani, only charged him
with misrepresentations concerning the accuracy and
reliability of Theranos tests run on proprietary technology.
Upon de novo review, we reject this argument. 9
Under the Fifth Amendment, “a court cannot permit a
defendant to be tried on charges that are not made in the
indictment against him.” United States v. Miller, 471 U.S.
130, 143 (1985) (quotation omitted).
Discrepancies between an indictment and
evidence presented at trial amount to a
constructive amendment in two general
situations: first, when “there is a complex set
of facts distinctly different from those set
forth in the charging instrument” such that
the defendant lacked notice; and second,
when “the crime charged was substantially
altered at trial, so that it was impossible to
9
We generally review allegations of constructive amendment de novo.
United States v. Bhagat, 436 F.3d 1140, 1145 (9th Cir. 2006). The
government argues for plain error review because Balwani did not object
at trial. We decline to do so because, as the district court recognized in
its order denying Balwani’s motion for release pending appeal, it
considered the substance of this argument, including Balwani’s
interpretation of the scope of the indictment, in its prior order denying
his motion in limine. See United States v. Valera-Rivera, 279 F.3d 1174,
1177 (9th Cir. 2002) (recognizing that issue is preserved for appeal
where substance was “thoroughly explored” in district court (quoting
United States v. Palmer, 3 F.3d 300, 304 (9th Cir. 1993))).
42 USA V. HOLMES
know whether the grand jury would have
indicted for the crime actually proved.”
United States v. Lopez, 4 F.4th 706, 727–28 (9th Cir. 2021)
(quoting United States v. Von Stoll, 726 F.2d 584, 586 (9th
Cir. 1984)). Balwani describes this case as the first kind: By
presenting evidence concerning the inaccuracy of Theranos
tests run on conventional technology, the government
presented a complex set of facts distinctly different from
those set forth in the indictment.
We begin our analysis of Balwani’s constructive
amendment claim by determining what the Indictment may
be fairly read to charge. In so doing, we are guided by the
principle that the purpose of an indictment is “to provide the
defendant with fair notice of the charges against him and to
ensure that the defendant is not placed in double jeopardy.”
United States v. Luong, 965 F.3d 973, 985 (9th Cir. 2020).
“[A]n indictment is not to be read in a technical manner, but
is to be construed according to common sense with an
appreciation of existing realities.” United States v.
Anderson, 532 F.2d 1218, 1222 (9th Cir. 1976).
In support of the constructive amendment claim,
Balwani distinguishes the Indictment’s background
references to Theranos’s “blood testing services” from the
charging allegations that only identify “Theranos
technology.” But parsing out the charging allegations from
the background allegations in the way that Balwani proposes
is not the most logical way to read the Indictment. The
Indictment includes multiple statements that refer not
specifically to Theranos’s proprietary analyzer, but rather to
Theranos and its “testing services” or “technology” more
generally. Importantly, the Indictment also alleges that, as
part of their scheme to defraud investors, Holmes and
USA V. HOLMES 43
Balwani “represented to investors that Theranos conducted
its patients’ tests using Theranos-manufactured analyzers;
when, in truth, Holmes and Balwani knew that Theranos
purchased and used for patient testing third party,
commercially-available analyzers.” In other words, Balwani
was charged with misrepresenting the capabilities of
Theranos’s testing services, and as part of the fraud against
investors, those services included tests run on conventional
technology. Applying basic transitive rules, the Indictment
can be fairly read to charge Balwani with misrepresenting
the accuracy of tests run on conventional technology.
Both the government and Balwani ascribe significance
to the Indictment’s inclusion of a list of specific tests for
which Theranos was unable to consistently produce accurate
and reliable results. The government argues that the list
includes assays that were not run (and were never run) on
Theranos technology, including the HIV test, meaning that
the reliability of tests run on conventional technology was
squarely at issue in the Indictment. On the other hand,
Balwani argues that the reference to HIV testing cuts in his
favor because, at the time of the Indictment, the government
(incorrectly) believed that HIV tests were conducted using
proprietary rather than conventional technology. We decline
Balwani’s invitation to inject a subjective component into
the constructive amendment analysis because the primary
consideration is not what the government believes, but rather
the notice that an indictment fairly and objectively gives to
the defendant. Luong, 965 F.3d at 985 (finding an
indictment sufficient where it named the charges against the
defendant even though it did not identify facts for every
single element of the charge); see also Simpson v. United
States, 289 F. 188, 189 (9th Cir. 1923) (recognizing that
indictment is sufficient if “[i]ts meaning is plain” and “a
44 USA V. HOLMES
person of ordinary intelligence could not be misled as to the
nature of the charge”). The Indictment plainly gave Balwani
notice that he was charged with misrepresenting the
accuracy of a non-exhaustive list of patient tests, regardless
of which type of device the tests were run on, especially
when viewed alongside the Indictment’s allegation that he
and Holmes fraudulently used conventional machines to run
patient tests.
Therefore, Balwani’s constructive amendment claim
fails.
VII. Napue Challenge
Balwani brings a claim under Napue v. Illinois, 360 U.S.
264 (1959), that his due process rights were violated by the
government’s failure to correct allegedly false testimony
given by two investor-victims, John Bryan Tolbert and Chris
Lucas. According to Balwani, Tolbert’s and Lucas’s
testimonies inaccurately describe Holmes’s representations
regarding Theranos’s military relationships made on a
December 2013 investor phone call. Applying plain error
review, we reject this claim.
A. Plain error review applies to Balwani’s Napue
challenge.
Balwani failed to contemporaneously object to the
aspects of Lucas’s and Tolbert’s testimonies that he now
argues are false. Nor did he attempt to argue that, once those
witnesses testified, playing the tape of the recording was
necessary to impeach their credibility, refresh their
recollections, or correct false testimony. See United States
v. Castillo, 181 F.3d 1129, 1132 (9th Cir. 1999) (recognizing
that “impeachment by contradiction permits courts to admit
extrinsic evidence that specific testimony is false, because
USA V. HOLMES 45
contradicted by other evidence”). Indeed, Balwani raised
this Napue claim for the first time after trial, at his bail
motion before the district court.
Balwani nevertheless argues that the issue is preserved
because his attempts to introduce the recording prior to the
witnesses’ testimonies put the district court “on notice” of
the same Napue arguments he raises now. We disagree.
Before Tolbert testified, the government signaled that it
would not introduce the recording. Invoking the best
evidence rule and the rule of completeness, Balwani urged
the district court to allow him to play portions of the
recording during cross-examination. But these arguments
did not sufficiently bring to the district court’s attention the
substance of his Napue claim. 10 We therefore review the
Napue claim for plain error. See United States v. Bingham,
653 F.3d 983, 995 (9th Cir. 2011) (holding that a Napue
claim is reviewed for plain error when it was not raised at
trial). Plain error is found where there is “(1) error, (2) that
was clear or obvious, (3) that affected substantial rights, and
(4) that seriously affected the fairness, integrity, or public
reputation of the judicial proceedings.” United States v.
Romero-Avila, 210 F.3d 1017, 1022 (9th Cir. 2000).
10
We are also not persuaded that the district court’s rejection of
Balwani’s best evidence and rule of completeness arguments precluded
Balwani from using the recording to impeach Tolbert or Lucas or
otherwise raising Napue claims. To the contrary, the district court left
open the possibility of introducing the tape at a later point, stating in its
ruling that it “[did]n’t see grounds to allow the defense at this time to
put” the tape in.
46 USA V. HOLMES
B. Balwani’s Napue claim fails under plain error
review.
In Napue, the Supreme Court held that a prosecutor
violates a defendant’s due process rights by eliciting or
failing to correct false testimony.
To establish a Napue violation, a defendant
must show: (1) that the testimony was
actually false, (2) that the government knew
or should have known that it was false, and
(3) that the testimony was material, meaning
there is a “reasonable likelihood that the false
testimony could have affected the judgment
of the jury.”
United States v. Renzi, 769 F.3d 731, 751 (9th Cir. 2014)
(quoting United States v. Houston, 648 F.3d 806, 814 (9th
Cir. 2011)). Balwani argues that three statements by Tolbert
and Lucas are false, each of which is discussed below. We
conclude that the challenged statements are not so clearly or
obviously false such that Balwani has demonstrated plain
error.
First, Balwani fails to establish the falseness of Lucas’s
testimony that Holmes told him that the “technology was
being used in the Middle East and . . . on the battlefield.”
Even if this testimony is inconsistent with Holmes’s
statements in the recording, that is insufficient to
demonstrate actual falsity. Lucas testified that he had
regular contact with Holmes between 2006 and 2013 leading
up to his investment and that Holmes provided updates on
Theranos’s business activities during these conversations.
Balwani has not negated the possibility that Holmes
discussed Theranos’s relationship with the military with
USA V. HOLMES 47
Lucas in one of these other conversations. Thus, Balwani
cannot show that Lucas’s statement is actually false.
Second, Balwani argues that Tolbert gave false
testimony when he testified that “Holmes had claimed that
Theranos’ military work would advance, in a ‘broadening of
the[] [company’s] business opportunities.’” Once again,
Balwani has failed to show that this testimony is false.
Although Holmes said on the call that Theranos had paused
some of its military programs, she also stated that she
anticipated continuing Theranos’s work with the military:
“[W]e will proceed with the pharmaceutical and military
business in leveraging some of this infrastructure and the
resources from it that we’re building out now.” Moreover,
Tolbert did not testify that Holmes herself said the military
work would “broaden” Theranos’s business opportunities.
Rather, Tolbert testified that he perceived Theranos’s work
with the military as broadening Theranos’s business
opportunities as compared to Theranos’s work in 2006.
Thus, this testimony is not “false” and cannot form the basis
of a Napue violation.
Third, Balwani argues that Tolbert’s testimony that
Holmes said Theranos devices were “employed on the
medevac helicopters” and “being used to kind of improve
survival rates” on the December 2013 phone call was false
and misleading. Balwani is technically correct: On the
December 2013 call, Holmes never explicitly said that
Theranos devices were actively employed by the military or
used on the battlefield, so Tolbert’s testimony that Holmes
did say that is in fact “actually false.” According to Balwani,
this created a “false impression” that Holmes definitively
stated that the military was currently using Theranos devices
on the battlefield. See Dickey v. Davis, 69 F.4th 624, 636
(9th Cir. 2023).
48 USA V. HOLMES
Tolbert’s testimony as to Holmes’s statements on the
December 2013 call may have been inaccurate. Although
the record is unclear whether the testimony was anything
more than a mistaken recollection, we assume without
deciding that the government had a duty to correct the
inaccurate statement. Regardless, however, Balwani’s
Napue claim fails under plain error review because the
testimony did not seriously affect Balwani’s substantial
rights. See United States v. Alli, 344 F.3d 1002, 1007–08
(9th Cir. 2003). Significantly, the jury heard similar
testimony from at least two other witnesses that Holmes
misrepresented the use of the device on medivac helicopters.
Further, any effect of the misstatement on Tolbert’s
testimony is mitigated by the fact that Tolbert admitted
during cross examination that he did not remember Holmes’s
exact words during the call. And despite Balwani
continually criticizing the government for not playing the
recording of the call, Balwani did not attempt to use the
recording to impeach Tolbert. Thus, because there was
ample evidence in the record to convict Balwani, the
government’s failure to correct Tolbert’s testimony did not
affect Balwani’s substantial rights. Balwani’s Napue claim
therefore fails under plain error review.
Sentencing Challenges
Defendants argue that the district court erroneously
applied the lower standard of preponderance of the evidence
for proving loss at sentencing, rather than the higher standard
of clear and convincing evidence. This argument is
foreclosed by our recent decision in United States v. Lucas,
101 F.4th 1158, 1163 (9th Cir. 2024) (en banc), where we
held that “clear and convincing evidence is not required for
factual findings under the Guidelines, even when potentially
large enhancements are at stake.” The district court
USA V. HOLMES 49
therefore did not err in applying the preponderance-of-the-
evidence standard.
After Lucas, both Holmes and Balwani filed letters
pursuant to Federal Rule of Appellate Procedure 28(j),
arguing for the first time that the district court’s findings on
loss causation and number of victims do not satisfy the
preponderance-of-the-evidence standard because there was
no evidence introduced at trial as to five of the ten investors.
Ordinarily, we do not consider arguments raised for the first
time in a 28(j) letter. See Kilpatrick v. Kijakazi, 35 F.4th
1187, 1195 n.1 (9th Cir. 2022). But even on the merits, the
argument fails.
We review factual findings made at the sentencing phase
for clear error. United States v. Buenrostro-Torres, 24 F.3d
1173, 1174 (9th Cir. 1994). The thrust of Holmes’s
argument—which Balwani adopts—is that the government
did not introduce evidence at trial that five out of the ten
investor-victims relied on any alleged misrepresentation
when they made their investment. But this argument rests
on the faulty premise that the district court was limited to
admissible trial evidence. “In making factual
determinations, a sentencing judge is generally not restricted
to evidence that would be admissible at trial.” United States
v. Egge, 223 F.3d 1128, 1132 (9th Cir. 2000). The test is
whether the evidence bears “sufficient indicia of reliability
to support its probable accuracy.” Id. (quoting United States
v. Hopper, 27 F.3d 378, 382 (9th Cir. 1994)).
Here, in finding that ten investors qualified as victims—
and whose investments were relevant for loss purposes—the
district court relied on trial testimony, prior sworn testimony
given by witnesses to the SEC, and FBI memoranda
summarizing statements made by investors in interviews.
50 USA V. HOLMES
See Holmes I, 2023 WL 149108, at *9; Balwani, 2023 WL
2065045, at *9–10. There is no basis to conclude that this
evidence lacked sufficient indicia of reliability. Because the
district court’s factual findings are not clearly erroneous, we
affirm Defendants’ sentences.
Joint Challenge to Restitution Order
Finally, we address the district court’s restitution order
requiring Defendants to pay $452 million to fourteen victims
under the MVRA. See Holmes II, 673 F. Supp. 3d at 1065–
66. Defendants argue that the district court erred by
awarding restitution based on investors’ total investments,
rather than the diminution in value of the shares after the
fraud came to light. We review de novo “the legality of a
restitution order” as well as “the district court’s ‘valuation
methodology.’” United States v. Gagarin, 950 F.3d 596, 607
(9th Cir. 2020) (quoting United States v. Berger, 473 F.3d
1080, 1104 (9th Cir. 2007)). “If ‘the order is within statutory
bounds,’ then the restitution calculation is reviewed for
abuse of discretion, with any underlying factual findings
reviewed for clear error.” Id. (quoting United States v.
Galan, 804 F.3d 1287, 1289 (9th Cir. 2015)).
The MVRA provides instructions for calculating
restitution “in the case of an offense resulting in damage to
or loss or destruction of property of a victim of the offense.”
18 U.S.C. § 3663A(b)(1). In such cases, the offender must
“return the property to the owner,” id. § 3663A(b)(1)(A), or
if return of the property lost by the victim is “impossible,
impracticable, or inadequate,” the offender must pay the
victim “an amount equal to . . . the value of the property”
less “the value (as of the date the property is returned) of any
part of the property that is returned,” id. § 3663A(b)(1)(B).
USA V. HOLMES 51
The district court determined that the twelve investors
who were induced by Defendants’ fraud to invest in
Theranos were “victims” under the MVRA. 11 Holmes II,
673 F. Supp. 3d at 1055–56. It next concluded that the
“property” that these victims “lost” within the meaning of
the statute was the money that they invested in the company.
Id. at 1058. Relying on Dura Pharmaceuticals, Inc. v.
Broudo, 544 U.S. 336 (2005), Defendants argue that the
relevant lost “property” was not the money that each victim
invested, but rather the victim’s ownership interest in
Theranos.
In Dura Pharmaceuticals, the Supreme Court considered
a claim of securities fraud under the Securities Exchange Act
§ 10(b), which requires a plaintiff to show both economic
loss and loss causation. Id. at 338. The Court rejected the
proposition that a plaintiff alleging a claim of fraud on the
market could establish these elements merely by showing
that she paid an inflated price for a security in reliance on the
integrity of the market. Id. The Court reasoned that merely
purchasing securities at a fraudulently inflated price does not
establish economic loss because “at the moment the
transaction takes place, the plaintiff has suffered no loss; the
inflated purchase payment is offset by ownership of a share
that at that instant possesses equivalent value.” Id. at 342
(emphasis removed). Furthermore, even if the plaintiff sells
the securities at a loss, this does not necessarily establish loss
causation, because the lower price may reflect factors
unrelated to the misrepresentations. Id. at 343.
11
These represent the same twelve investors whose losses had been
included in the district court’s loss calculation under USSG
§ 2B1.1(b)(2) at sentencing.
52 USA V. HOLMES
We do not read Dura Pharmaceuticals to support the
proposition that the victims here suffered no loss under the
MVRA. Defendants’ reliance on Dura Pharmaceuticals
conflates the concept of economic loss with property loss,
and the MVRA speaks in terms of the latter. See 18 U.S.C.
§ 3663A(b)(1) (directed toward cases involving “loss or
destruction of property of a victim” (emphasis added)).
Under the plain text of the MVRA, the victims need not
necessarily have suffered an economic loss in order to have
suffered a loss of property. This reading is consistent with
the Supreme Court’s decision in Robers v. United States, 572
U.S. 639 (2014), a case involving fraudulent loan
applications to banks. The Court determined that “the
property the banks lost” under the MVRA was “the money
they lent to” the defendant, not the economic loss the banks
suffered when they ultimately sold the houses at foreclosure
sales for less than the banks were owed. Id. at 642; see also
id. at 640–41 (“In our view, the statutory phrase ‘any part of
the property’ refers only to the specific property lost by a
victim . . . . Therefore, no ‘part of the property’ is ‘returned’
to the victim until the collateral is sold and the victim
receives money from the sale.”).
We find more merit in Defendants’ argument that they
are entitled to credit for the residual value of a victim’s
investment under the MVRA. The district court rejected this
contention, reasoning that the MVRA only authorizes offsets
for “property that is returned.” 18 U.S.C.
§ 3663A(b)(1)(B)(ii). The district court reasoned that
because the lost “property” was the money invested, no
money was returned, and the residual value of the investment
would not justify a reduction in the restitution award. But
Robers clearly stated that the MVRA “provides room for
credits against an offender’s restitution obligation to prevent
USA V. HOLMES 53
double recovery to the victim.” 572 U.S. at 645 (cleaned
up); see also id. (“These provisions [of the MVRA] would
seem to give a court adequate authority to count, as part of
the restitution paid, the value of collateral previously
received but not sold.”).
The district court’s failure to discount the restitution
value by the residual value of the shares is at odds with the
well-settled principle that “[a] district court may not order
restitution such that victims will receive an amount greater
than their actual losses; to do so is plain error.” United States
v. Rizk, 660 F.3d 1125, 1137 (9th Cir. 2011). This limitation
stems from the basic premise that “[t]he purpose of
restitution is to put the victim back in the position he or she
would have been but for the defendant’s criminal conduct,”
United States v. Gossi, 608 F.3d 574, 581 (9th Cir. 2010),
not to provide a windfall.
Thus, although the district court properly identified the
money invested as the lost property, it should have also
considered possible credits against Defendants’ restitution
obligation—given that the victims still owned their Theranos
shares—by accounting for the residual value of the shares
after the fraud came to light. See United States v. Zolp, 479
F.3d 715, 719 (9th Cir. 2007) (“[W]hen the court confronts
a ‘pump-and-dump’ scheme involving an otherwise
legitimate company” and “the stock continues to have
residual value after the fraudulent scheme is revealed, the
court may not assume that the loss inflicted equals the full
pre-disclosure value of the stock; rather, the court must
disentangle the underlying value of the stock, inflation of
that value due to the fraud, and either inflation or deflation
of that value due to unrelated causes.”).
54 USA V. HOLMES
But we find that any error by the district court was
harmless because the district court’s factual findings compel
the conclusion that the victims’ actual losses were equal to
the total amount of their investments. Most importantly, the
court found that the victims were “[un]able to liquidate their
shares” after the fraud came to light. Holmes II, 673 F. Supp.
3d at 1059. In other words, for restitution purposes, the
victims were never able to recover any amount of residual
value that the stock may have retained. One investor who
testified at both trials explained that he had no opportunity
to sell his stock “once the cascade of negative publicity was
unleashed” and that “there was never a legitimate
opportunity from the company or from a third party to buy
my stock.” The evidence Holmes and Balwani cite—which
suggests, at best, that there was some opportunity to sell
shares to some parties at some unidentified time—is not
enough to render the district court’s finding clearly
erroneous.
The significant difference in sentencing loss versus
restitution was driven in part by the district court’s
determination that although investors were unable to sell
their shares and that their shares ultimately became
worthless, our case law, including Zolp, required the court to
give Defendants credit for the residual value of the shares for
the purpose of loss calculation under USSG § 2B1.1. Cf.
Holmes I, 2023 WL 149108, at *4; Balwani, 2023 WL
2065045, at *4. As we just explained, the investors’ inability
to sell their shares effectively meant that they lost out on any
residual or inherent value in those shares, which justifies
restitution in the full amount of each investment to make the
victim “whole.” It does not necessarily follow that the same
reasoning must be applied for loss calculation at sentencing,
which focuses on actions of the criminal defendant. See
USA V. HOLMES 55
United States v. Leonard, 529 F.3d 83, 93 (2d Cir. 2008)
(finding that the “district court erred in not deducting from
the purchase price the actual value of” illiquid securities).
The investors’ inability to resell their shares would justify
awarding them the full value of their investment for purposes
of restitution, as that amount made them “whole,” while the
inability to sell shares would not necessarily require an offset
of residual value for purpose of the court’s punitive
assessment of the defendant’s conduct. See United States v.
Crandall, 525 F.3d 907, 916 (9th Cir. 2008).
We therefore affirm the district court’s restitution order
in its entirety.
AFFIRMED.
Plain English Summary
FOR PUBLICATION UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT UNITED STATES OF AMERICA, No.
Key Points
01FOR PUBLICATION UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT UNITED STATES OF AMERICA, No.
03Davila, District Judge, Presiding Argued and Submitted June 11, 2024 San Francisco, California Filed February 24, 2025 Amended December 22, 2025 Before: Mary M.
04HOLMES 3 SUMMARY * Criminal Law The panel affirmed Elizabeth Holmes’s and Ranesh “Sunny” Balwani’s convictions on numerous fraud charges, their sentences, and the district court’s $452 million restitution order, in a case in which Defendant
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FOR PUBLICATION UNITED STATES COURT OF APPEALS FOR THE NINTH CIRCUIT UNITED STATES OF AMERICA, No.
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