United States v. Michael Kaplan , 836 F.3d 1199 ( 2016 )

FOR PUBLICATION
UNITED STATES COURT OF APPEALS
FOR THE NINTH CIRCUIT
UNITED STATES OF AMERICA, No. 15-10241
Plaintiff-Appellee,
D.C. No.
v. 2:13-cr-00377-
GMN-CWH-1
MICHAEL STANLEY KAPLAN, MD,
Defendant-Appellant. OPINION
Appeal from the United States District Court
for the District of Nevada
Philip M. Pro, District Judge, and
Gloria M. Navarro, Chief District Judge, Presiding
Argued and Submitted July 19, 2016
San Francisco, California
Filed September 9, 2016
Before: Susan P. Graber and Richard C. Tallman, Circuit
Judges, and Nancy G. Edmunds,* Senior District Judge.
Opinion by Judge Tallman
*
The Honorable Nancy G. Edmunds, Senior United States District
Judge for the Eastern District of Michigan, sitting by designation.
2 UNITED STATES V. KAPLAN
SUMMARY**
Criminal Law
The panel affirmed a conviction for conspiracy to commit
adulteration in violation of the Federal Food, Drug, and
Cosmetic Act, 21 U.S.C. § 331(k), with the intent to defraud
or mislead, in a case in which the defendant, a urologist,
reused single-use plastic needle guides during prostate biopsy
exams.
The panel held that a physician’s use of a consumable,
single-use device on a paying patient satisfies the “held for
sale” element under § 331(k), and that the district court, in
denying the defendant’s motion to dismiss the indictment, did
not err in determining that the defendant’s use of the needle
guides in the course of treating his urology patients
constituted a “sale” under § 331(k).
The panel held that there was sufficient evidence to
support the conviction that the defendant conspired to commit
adulteration in violation of § 331(k) and to support the special
finding that he intended to defraud his patients, the public,
the FDA, and the Nevada State Medical Board.
The panel held that the district court did not err in
rejecting the defendant’s requested jury instruction stating
that off-label use of an unadulterated device is not unlawful,
where the theory was already covered by the instructions.
The panel held that the district court did not plainly err in
**
This summary constitutes no part of the opinion of the court. It has
been prepared by court staff for the convenience of the reader.
UNITED STATES V. KAPLAN 3
refusing to give a “practice of medicine” exemption
instruction.
The panel held that because the indictment contained the
elements of the defendant’s fraud in adequate detail, he was
fairly informed of the charges against him, and that any error
in omitting the materiality element from the indictment was,
on this record, harmless.
The panel held that the defendant waived any challenge
to the jury instructions and special verdict form regarding
how the jury distinguished between a misdemeanor and a
felony conviction.
COUNSEL
Dennis P. Riordan (argued) and Donald M. Horgan, Riordan
& Horgan, San Francisco, California, for Defendant-
Appellant.
Elizabeth O. White (argued), Appellate Chief and Assistant
United States Attorney; Daniel G. Bogden, United States
Attorney; United States Attorney’s Office, Reno, Nevada; for
Plaintiff-Appellee.
4 UNITED STATES V. KAPLAN
OPINION
TALLMAN, Circuit Judge:
It is axiomatic that physicians are expected to do no harm.
When a physician breaches that duty and puts his own
interests above those of his patients, great harm can occur.
Though the regulation of the practice of medicine is delegated
to the states, when a physician misuses medical devices and
threatens public health, the physician may run afoul of the
Federal Food, Drug, and Cosmetic Act (“FDCA”). Doctor
Michael Kaplan, a Nevada urologist, entered that domain
when he decided to start reusing single-use plastic needle
guides during prostate biopsy exams.
Kaplan appeals his felony conviction for conspiracy to
commit adulteration in violation of 21 U.S.C. § 331(k) with
the intent to defraud or mislead. Kaplan challenges the
statute under which he was charged, the sufficiency of the
evidence, the denial of his proposed jury instructions, the
sufficiency of the indictment, and his enhanced sentence. For
all the reasons set forth below, we affirm.
I
In December 2010, Kaplan owned and operated two
urology clinics located in Henderson and Las Vegas, Nevada.
Kaplan worked at the clinic in Henderson, while his associate
Dr. Brian Golden worked out of the Las Vegas clinic. At
both offices the physicians regularly performed prostate
needle biopsies, a surgical procedure in which prostate tissue
is removed and examined for disease.
UNITED STATES V. KAPLAN 5
During a prostate biopsy, an ultrasound probe is inserted
into the patient’s rectum to locate the prostate. A hollow
needle is then injected through the rectal wall into the
prostate to gather the tissue sample. A needle guide, housing
the collection needle, stabilizes the needle throughout the
biopsy procedure. During the biopsy procedure, both the
inside and outside of the needle are contaminated with
various biological debris, including tissue, blood, and fecal
matter, along with any bacteria and viruses. When the
procedure is complete, the needle is pulled back into the
channel of the needle guide, bringing debris with it. Because
the procedure is bloody and dirty, patients take antibiotics at
the time of the biopsy to prevent infection.
Needle guides come in both single-use and reusable
forms. Reusable guides are made of stainless steel and can be
disinfected after every use. Single-use guides, however, are
made of plastic, which is prone to scratching by the needle,
creating crevices that can trap debris. The plastic guides
come in distinctive packaging and are accompanied by a
booklet clearly stating that they are sterile only for a single
use and are not to be reused. Before the conduct at issue,
Kaplan’s office used a reusable stainless-steel guide and
Golden’s office used single-use plastic guides.
Circumstances changed in December 2010, when
Kaplan’s ultrasound machine broke and a new one was
ordered. Kaplan was in a “tight crunch” and quickly ordered
a refurbished machine and requested another reusable
stainless-steel guide. Because a reusable stainless-steel guide
was not available for the new machine and the old stainless-
steel guide did not fit, sales representative Timothy Brandt
arranged to send single-use plastic guides to Kaplan’s office.
6 UNITED STATES V. KAPLAN
Office manager Mary Taylor called Brandt after the
Kaplan office received the plastic guides, because she was
concerned and upset that the guides were not reusable.
Brandt told Taylor he had heard from a physician in
California that, with appropriate sterilization, the single-use
guides could be used two to three times before the guides
disintegrate. Brandt, however, testified that he was relying
only on the California physician’s information because he
was a lay person and “naive.” Brandt further testified that he
never advised Taylor to reuse the single-use guides, he did
not believe he was qualified to give such advice, and he never
instructed her on how to sterilize the guides.
By January 2011, because both clinics were using the
plastic guides, supplies were running short and additional
plastic guides were on backorder with the manufacturer.
Kaplan told Taylor and the medical assistant supervisor,
Martha Cortez, to tell the medical assistants to reuse the
plastic guides by cleaning them in the same manner as the
reusable stainless-steel guides. Taylor told a medical
assistant, in Kaplan’s presence, that because the single-use
guides were expensive, it would be “ridiculous” not to reuse
them. Kaplan and Taylor insisted on reusing the guides even
after the medical assistants pointed out that the packaging for
the plastic guides clearly stated that they were for single use
only.
No formal procedures for cleaning the single-use plastic
guides were ever provided, other than Kaplan’s instruction to
clean them with the same Cidex1 cleaning protocol used to
clean the stainless-steel guide. Using that protocol, the
1
Cidex is a liquid chemical sterilant, primarily composed of
glutaraldehyde, used to disinfect reusable medical devices.
UNITED STATES V. KAPLAN 7
medical assistants would first hold a guide under the sink to
rinse it with water and then use a wire with bristles, like a
pipe cleaner, or thin needle to clean the inside of the guide.
The guides were then submerged in Cidex for a period of
time. After transferring the guides to sterile water for some
time, the guides were placed on a sterile tray, ready to use in
the next biopsy.
There were many inconsistencies and safety issues
surrounding the Cidex cleaning protocol as implemented in
Kaplan’s office. The temperature of the water and the length
of time a guide spent in the initial rinse varied from medical
assistant to medical assistant. The amount of time the guides
spent in the Cidex also varied. Though Cortez, the
supervisor, testified that the Cidex was refreshed and replaced
“religiously,” the medical assistants did not know how often
the Cidex was replaced or whether the logs were updated;
they had never replaced the Cidex and had never checked the
Cidex with test strips or checked the temperature. Cortez
herself testified that she did not know that Cidex came with
test strips. The sterile water in which the guides were placed
at the end of the protocol was not changed frequently enough
to maintain sterility.
Finally, Kaplan’s office kept no record of how many
times a particular guide was reused. But all employees
estimated that the guides were reused three to five times.
Neither Kaplan, Taylor, Cortez, nor the medical assistants
informed patients that the guides were being reused.
During the time the medical assistants were instructed to
reuse the plastic guides, they observed blood and pinkish
water left in the guides. The pipe cleaner that the assistants
used to clean the stainless-steel guide was not designed to
8 UNITED STATES V. KAPLAN
clean the plastic guides and therefore did not reach fully
inside the plastic guides. Additionally, the pipe cleaner could
not reach into the scratches in the plastic created by the
needle during the biopsy procedure, and blood and fecal
matter became trapped in the guides. Assistants observed
brown scratches that did not come clean during the
disinfecting process. Cortez testified that she could tell the
difference between a new and used plastic guide because the
used guides were discolored.2
A month after Kaplan began reusing the single-use plastic
guides, Dr. Golden discovered the reuse. Golden
immediately contacted Taylor to tell her to stop the practice.
Taylor informed Golden that “if this was ever happening at
this office it’s not happening anymore.” Golden assumed that
the practice stopped. And Golden himself, who had always
used the plastic guides, never reused them.
At this time, Kaplan’s wife, Michelle Darquea Kaplan, an
attorney and the office administrator, learned that the plastic
guides were being reused. Mrs. Kaplan spoke to her husband,
who told her they reused the plastic needle guides just like
any other medical equipment in the office. After doing some
research and calling the company that made the disposable
guides, Mrs. Kaplan again spoke to Kaplan because she was
still confused as to whether the guides were reusable and why
Golden had contacted Taylor. Kaplan replied that he didn’t
know and that Golden was “always mad at me for
something. . . . He’s probably just trying to give me a hard
2
The medical assistants never reported to Kaplan, Taylor, or Cortez
that they were having trouble cleaning the plastic guides. One assistant
stated that she did not go to Kaplan or Taylor because she was afraid she
might get in trouble because “they already knew it was wrong.”
UNITED STATES V. KAPLAN 9
time or whatever.” Mrs. Kaplan then told her husband that
they should stop reusing the plastic guides, he agreed, and
Mrs. Kaplan told Taylor, the office manager, to instruct
everyone to stop using the guides. As of January 6, 2011,
Mrs. Kaplan believed that reuse had stopped.
The practice of reusing the needle guides, however, did
not stop. The medical assistants all testified that they were
never told by Kaplan or Taylor to stop reusing the plastic
guides. Reuse continued until March 2011, when Kaplan’s
own medical assistants reported him to the Nevada State
Medical Board (“Medical Board”). The Medical Board
immediately notified federal investigators and commenced its
own inquiry in response.
When Food and Drug Administration (“FDA”) Office of
Criminal Investigations special agents arrived on March 11,
2011, Kaplan readily admitted to reusing the guides.
However, Kaplan inconsistently claimed to the agents how
long reuse had lasted. First he insisted that reuse had ended
as early as January, when Dr. Golden called, then later stated
that it had lasted not beyond late February. When asked why
he reused the devices, Kaplan would say only that “he was
practicing cost-effective medicine and good patient care.”
The agents spoke to the medical staff the same day, and the
staff all reported that reuse was still ongoing at that time.
When agents spoke again to Kaplan later that same day,
Kaplan then stated that reuse had lasted only from December
21, 2010, to January 21, 2011.
A Medical Board representative also attended the FDA
agents’ interviews at Kaplan’s office. Kaplan’s medical
license was suspended by the Nevada State Medical Board on
10 UNITED STATES V. KAPLAN
March 14, 2011.3 In his representations to the Medical Board
in April 2011, Kaplan maintained that reuse had stopped in
January of 2011.
Kaplan then hired a law firm and put together a public
relations team. The public relations team decided to publish
an advertisement in the Las Vegas Review-Journal,
explaining Kaplan’s conduct. To do so they interviewed
everyone involved in Kaplan’s medical practice. Kaplan told
the team that he had ordered his staff to stop reuse on January
6, 2011. But all the staff interviewed told the team that they
were never ordered to stop reusing the plastic guides. The
one staff member who stated that reuse lasted only one to two
weeks later testified that she was pressured to do so by
Taylor.
Despite the results of the medical assistants’ interviews,
the advertisement that the public relations team ultimately
published asserted that reuse of the plastic guides ended on
January 6, 2011, less than three weeks after the new
ultrasound machine was put into service. It was established
at trial, however, that, based on their investigation, the FDA
agents estimated that between January 7, 2011, the date that
the reuse was alleged to have stopped, and March 11, 2011,
Kaplan used 67 guides for 94 procedures.4 Kaplan’s
3
In its original administrative complaint, the Medical Board alleged
several charges, including malpractice. Later, the Medical Board
reinstated Kaplan’s license, and then amended the complaint to drop the
malpractice count and add a count alleging failure to properly supervise
medical assistants.
4
For the period between December 10, 2010, the date the new
machine was purchased, and March 11, 2011, the agents estimated that
Kaplan used 51 guides for 123 procedures.
UNITED STATES V. KAPLAN 11
published advertisement further asserted that he reused the
guides because he had been instructed that “it was perfectly
safe to do so.”
On October 2, 2013, a grand jury in Nevada returned a
two-count indictment; the one count relevant to this appeal
charged Kaplan with conspiracy under 18 U.S.C. § 371 to
commit adulteration in violation of 21 U.S.C. §§ 331(k),
333(a)(2), and 351(a)(2)(A).5 In addition to the relevant
testimony recounted above, at trial both sides offered expert
testimony regarding whether the guides were adulterated; that
is, whether the guides were held under insanitary conditions
such that they may have become contaminated. See
21 U.S.C. § 351(a)(2)(A). The government established that
there were no data on whether the single-use plastic guides
were reusable, and that the Cidex label clearly indicated that
it was not to be used to reprocess single-use devices.
Furthermore, the government expert testified that, without
testing, it was not possible to determine whether cleaning and
sterilization of a single-use device was effective.
The defense expert acknowledged that the cleaning
procedure was imperfect, but speculated that the risk of
infection in Kaplan’s patients was between one in one trillion
and one in one hundred trillion. The defense expert
nonetheless admitted that he was the primary author of an
article that advised “do not reuse items labeled for single
use,” had conducted no experiments to determine if the
plastic guides could safely be reused, and was not actually
advocating for reuse of the single-use plastic guides.
5
The other count charged Kaplan with making a false statement to a
government agency, on which the petit jury found him not guilty. That
count is not before us on appeal.
12 UNITED STATES V. KAPLAN
On September 25, 2014, after a nine-day jury trial
presided over by now-retired District Judge Philip M. Pro,
Kaplan was found guilty of conspiring to commit
adulteration. The jury expressly found that Kaplan acted with
the intent to defraud or mislead, thereby convicting Kaplan of
a felony. At sentencing on May 5, 2015, Chief District Judge
Gloria Navarro calculated an advisory guidelines sentencing
range of 31–41 months’ imprisonment based on the felony
conviction and varied upward from that range to impose 48
months’ imprisonment. Final judgment was entered on May
7, 2015, and this timely appeal followed. We have
jurisdiction under 28 U.S.C. § 1291.
II
Before we can decide whether there was sufficient
evidence to convict Kaplan of the conspiracy, we must first
determine whether his conduct can be criminally prosecuted
under the FDCA. Section 331(k) prohibits “the doing of any
. . . act with respect to . . . [a] drug [or] device . . . if such act
is done while such article is held for sale . . . after shipment
in interstate commerce and results in such article being
adulterated.” 21 U.S.C. § 331(k). A device is adulterated if
it is “held under insanitary conditions whereby it may have
been contaminated with filth, or . . . rendered injurious to
health.” Id. § 351(a)(2)(A). This case turns on the
interpretation of “held for sale” in § 331(k); can a doctor’s
use of a device in the course of treating a patient be
considered a “sale” under the statute? Before trial, Kaplan
moved to dismiss the indictment on the ground that his use of
the guides in treating patients was not covered by the “held
for sale” provision of § 331(k). Based on the report and
recommendation of the magistrate judge, the district court
UNITED STATES V. KAPLAN 13
held otherwise and ruled that “held for sale” included a
physician’s use of a device in treating patients. We agree.
This is an issue of first impression and requires us to
interpret § 331(k) of the FDCA. We review questions of
statutory construction de novo, J & G Sales Ltd. v. Truscott,
473 F.3d 1043, 1047 (9th Cir. 2007), and hold that the district
court did not err in determining that Kaplan’s use of the
guides in the course of treating his urology patients
constituted a “sale” under § 331(k).
A
To interpret a statute, “we look first to the plain meaning
of the text.” Transwestern Pipeline Co. v. 17.19 Acres of
Prop. Located in Maricopa Cty., 627 F.3d 1268, 1270 (9th
Cir. 2010). When words in a statute are not defined, they
“will be interpreted as taking their ordinary, contemporary,
common meaning.” Id. (quoting Perrin v. United States,
444 U.S. 37, 42 (1979)). Courts examine “not only the
specific provision at issue, but also the structure of the statute
as a whole, including its object and policy.” United States v.
Williams, 659 F.3d 1223, 1225 (9th Cir. 2011) (quoting
Children’s Hosp. & Health Ctr. v. Belshe, 188 F.3d 1090,
1096 (9th Cir. 1999)). The FDCA is to be interpreted broadly
in order to protect public health. See United States v. Article
of Drug (Bacto-Unidisk), 394 U.S. 784, 798 (1969)
(“Congress fully intended that the Act’s coverage be as broad
as its literal language indicates . . . .”).
The FDCA’s overall purpose is to protect consumers from
dangerous products. United States v. Sullivan, 332 U.S. 689,
696 (1948). Congress’s specific intent in enacting § 331(k)
was “to extend the Act’s coverage to every article” in
14 UNITED STATES V. KAPLAN
interstate commerce until it reaches “the ultimate consumer,”
the patient. Id. at 697; see also United States v. Evers,
643 F.2d 1043, 1049 (5th Cir. 1981) (“The flow of commerce
begins with the manufacturer of the drug and ends with the
consumer, that is, the patient.”).
In construing the meaning of “held for sale” under
§ 331(k), several courts have held that the phrase extends to
physicians using both drugs and devices in the treatment of
patients. See United States v. Rhody Dairy, L.L.C., 812 F.
Supp. 2d 1239, 1244 (W.D. Wash. 2011) (“[S]everal cases
have held that drugs and devices used in the treatment of
patients are ‘held for sale’ by doctors as part of the
distribution process.”); see also Evers, 643 F.2d at 1050(“Doctors holding drugs for use in their practice are clearly
one part of the distribution process, and doctors may therefore
hold drugs for sale within the meaning of section 301(k) of
the Act.”); United States v. Diapulse Corp. of Am., 514 F.2d
1097, 1098 (2d Cir. 1975) (per curiam) (“Such devices, used
in the treatment of patients, may properly be considered ‘held
for sale’ within the meaning of the [FDCA], 21 U.S.C.
§ 331(k).”); United States v. Device Labeled “Cameron
Spitler Amblyo-Syntonizer”, 261 F. Supp. 243, 246 (D. Neb.
1966) (holding that a physician was not exempt from the
requirements of the FDCA when he used misbranded devices
in the treatment of his patients even though he did not sell the
devices in the commercial sense). The statements made in
these cases, however, are quite conclusory and offer little
guidance.
In the only case from our circuit addressing the “held for
sale” provision, we concluded that “held for sale” does not
reach homemade products distributed in a noncommercial
setting at no cost to the recipients. United States v. Geborde,
UNITED STATES V. KAPLAN 15
278 F.3d 926, 928 (9th Cir. 2002). Geborde, who was not a
physician, made his own recreational drugs and distributed
them free of charge. Id. at 927. The government charged
Geborde under § 331(k), alleging that “held for sale” included
this type of distribution because it covered any conduct in
which a drug is not held for personal consumption. Id. at
931. In rejecting that argument, we emphasized “that the
phrase ‘held for sale’ plainly contemplates a sale.” Id. at 932.
Notably, in construing the term “held for sale” we focused on
“commercial transactions, commercial actors, and
commercial products” but did not define the term more
specifically. Id. at 931. Geborde’s conduct was not a sale
under this definition because Geborde was a noncommercial
actor, in a noncommercial setting, distributing homemade
drugs completely free of charge. Id. at 931–32; see also
Rhody Dairy, 812 F. Supp. 2d at 1244 (noting that the
distinguishing factor in Geborde was the noncommercial
nature of the transaction).
B
In applying § 331(k) to Kaplan’s conduct, Kaplan argues
that the phrase “held for sale” must be interpreted narrowly
and cannot be read to mean “held for use.” Because title and
possession of the guides were not transferred to patients,
Kaplan argues that there was no sale and thus that his use of
the guides during prostate biopsies falls outside the scope of
the statute. Such an argument, however, is in direct
contravention to out-of-circuit caselaw stating that a
physician’s use of a device on a patient is covered by the
statutory phrase “held for sale.” See Evers, 643 F.2d at 1050;
Diapulse Corp., 514 F.2d at 1098; Rhody Dairy, 812 F. Supp.
2d at 1244; Cameron Spitler, 261 F. Supp. at 246.
16 UNITED STATES V. KAPLAN
Kaplan’s reliance on Geborde to distinguish these cases
is misplaced. We did not hold that a sale in the strict sense
must occur. Rather, we focused more generally on the
commercial nature of the transaction, actors, and products.
Geborde, 278 F.3d at 931. The district court in this case,
therefore, properly focused on the commercial nature of
Kaplan’s business, a medical practice operated for profit,
reasoning that patients who paid Kaplan for the medical
services he performed were also paying for the cost of
products used in the course of treatment, including biopsies,
and that the patients were therefore the ultimate consumers of
the guides. Kaplan is a physician engaged in the business of
providing medical services in exchange for payment: a
commercial actor in a commercial setting, using a
commercial product. We hold that his use of the plastic
guides is covered by the “held for sale” provision of
§ 331(k).6
The single-use nature of the guides is particularly critical
to our decision. A single-use device is meant to be
“consumed” in the course of treating a patient—just like a
drug. Once the single-use device is used or consumed there
is nothing left to be done with the device. It no longer
possesses a functional purpose in the medical practice and,
rather than giving the used device to the patient, the doctor
disposes of it. Therefore, when a physician uses a disposable
device on a patient, the device is “held for sale” within the
meaning of the FDCA provided that there is a commercial
6
Contrary to Kaplan’s argument, the rule of lenity is inapplicable.
See Warren v. Crabtree, 185 F.3d 1018, 1023 (9th Cir. 1999) (“The
simple existence of some statutory ambiguity is not sufficient to warrant
application of that rule, for most statutes are ambiguous to some degree.”
(internal quotation marks and ellipsis omitted)).
UNITED STATES V. KAPLAN 17
relationship between the doctor and the patient and that the
device is one that is meant to be “consumed” in the process.7
This interpretation of “held for sale” comports with
Congress’s intent that the FDCA be interpreted broadly, see
Bacto-Unidisk, 394 U.S. at 798, and the intent of § 331(k) to
protect the ultimate consumer, the patient, from dangerous
products, see Sullivan, 332 U.S. at 696. Even a physician can
make a product dangerous for a patient if the product is
utilized improperly.
The argument that defining “held for sale” in this manner
impermissibly interferes with a physician’s ability to treat
patients is foreclosed by United States v. Regenerative Scis.,
LLC, 741 F.3d 1314 (D.C. Cir. 2014). There, physicians
removed stem cells from patients, cultured them in a mixture
with antibiotics, and then reinjected them into the patients to
treat orthopedic conditions. Id. at 1318. In the suit alleging
that the stem cell mixture was misbranded and adulterated
under the FDCA, the physicians argued that the FDA was
improperly attempting to regulate the practice of medicine by
regulating the stem cell procedure. Id. at 1319. The court
noted, however, that “the FDA does not claim that the
procedures used to administer the Mixture are unsafe; it
claims that the Mixture itself is unsafe.” Id. Similarly, in
Kaplan’s case the government is not alleging that the biopsy
procedure is unsafe, but rather that the guides themselves are
7
We need not decide at this time whether “held for sale”
encompasses services donated free of charge or devices that are part of a
physician’s general office equipment, such as an MRI machine or
examination table. Additionally, we also decline to consider here whether
the reusable stainless-steel guide, an item that can be properly and safely
reused, could be considered “held for sale” under § 331(k). We leave
those questions for another day.
18 UNITED STATES V. KAPLAN
unsafe. Kaplan’s “arguments about the practice-of-medicine
exemption are therefore wide of the mark.” Id.
Finally, Kaplan’s claim that his reuse of the single-use
guides is merely off-label use is similarly unavailing. Off-
label use allows a physician to use drugs or devices regulated
by the FDCA for a purpose not approved by the FDA. See
Evers, 643 F.2d at 1049 (holding that a physician’s off-label
use of chelating agents to treat circulatory disorders in
patients, though potentially dangerous, was permissible off-
label use). The purpose of this exception is to allow
physicians the freedom to manage the care of their patients.
See Buckman Co. v. Plaintiffs’ Legal Comm., 531 U.S. 341,
350 (2001) (noting that off-label use is “an accepted and
necessary corollary of the FDA’s mission to regulate in this
area without directly interfering with the practice of
medicine” and the FDA cannot interfere with a physician’s
off-label use of a device in a “legitimate health care
practitioner-patient relationship.” (quoting 21 U.S.C. § 396)).
Kaplan’s argument that his reuse of the single-use guides
was merely a permissible off-label use that cannot be
criminally prosecuted fails for two reasons: the allegations of
adulteration and the purpose of the off-label use. First, off-
label use does not immunize a physician who uses adulterated
products. Though off-label use “allow[s] physicians to
prescribe . . . lawful drugs for unapproved uses,” Evers,
643 F.2d at 1049, off-label use of adulterated products is
beyond the scope of the privilege. While a physician may
exercise professional judgment in the off-label use of
unadulterated products, nothing in the FDCA or caselaw
UNITED STATES V. KAPLAN 19
suggests that the use of adulterated products is ever
permissible.8
Second, Kaplan’s stated purpose for reusing the guides
was “cost-effective medicine,” and there is no evidence in the
record to suggest that this cost savings was passed on to the
patients or that the practice in any way benefitted the patients.
The benefits, if any, of reusing the single-use guides seem to
be confined to cost savings for Kaplan and had nothing to do
with Kaplan’s management of patient care. The argument
that Kaplan used professional judgment for some legitimate
off-label purpose fails.
Therefore, we hold that a physician’s use of a
consumable, single-use device on a paying patient satisfies
the “held for sale” element under 21 U.S.C. § 331(k). The
district court did not err in denying the motion to dismiss the
indictment.
III
Though we have established that Kaplan’s conduct is
covered by the element “held for sale” under 21 U.S.C.
8
In upholding the determination that Kaplan’s conduct is covered by
§ 331(k), it is appropriate to highlight briefly the difference between
malpractice and criminal behavior. While criminal acts by a physician
against a patient nearly always constitute malpractice, only a fraction of
malpractice acts rise to the level of a crime. Evers’ patients may have
been able to bring a malpractice action against him because his care fell
below prevailing professional standards, see Evers, 643 F.2d at 1045,
1053, but a criminal charge could not be sustained because he used
unadulterated products in a permissible way. By contrast, not only could
Kaplan’s patients bring a putative malpractice action, Kaplan’s alleged
conduct can also be criminally charged under § 331(k).
20 UNITED STATES V. KAPLAN
§ 331(k), he was not charged with the substantive offense.
The government instead charged Kaplan with conspiracy to
commit adulteration in violation of § 331(k), and Kaplan
challenges the sufficiency of the evidence convicting him of
that crime. We review the sufficiency of the evidence de
novo. United States v. Sullivan, 522 F.3d 967, 974 (9th Cir.
2008) (per curiam).
A
“There is sufficient evidence to support a conviction if,
‘viewing the evidence in the light most favorable to the
prosecution, any rational trier of fact could have found the
essential elements of the crime beyond a reasonable doubt.’”
Id. (quoting Jackson v. Virginia, 443 U.S. 307, 319 (1979)).
In reviewing the sufficiency of the evidence, “[t]he test is
whether the evidence and all reasonable inferences which
may be drawn from it, when viewed in the light most
favorable to the government, sustain the verdict.” United
States v. Terry, 911 F.2d 272, 278 (9th Cir. 1990) (quoting
United States v. Soto, 779 F.2d 558, 560 (9th Cir. 1986)).
“[A]ny conflicts in the evidence are to be resolved in favor of
the jury’s verdict.” United States v. Alvarez-Valenzuela,
231 F.3d 1198, 1201–02 (9th Cir. 2000).
To prove a conspiracy under 18 U.S.C. § 371, the
government must establish three elements: “(1) an agreement
to engage in criminal activity, (2) one or more overt acts
taken to implement the agreement, and (3) the requisite intent
to commit the substantive crime.” Sullivan, 522 F.3d at 976(quoting United States v. Montgomery, 384 F.3d 1050, 1062
(9th Cir. 2004)). An agreement to commit a crime “can be
explicit or tacit, and can be proved by direct or circumstantial
evidence, including inferences from circumstantial evidence.”
UNITED STATES V. KAPLAN 21
United States v. Loveland, 825 F.3d 555, 557 (9th Cir. 2016).
Proof of the underlying substantive crime, however, does not,
without more, prove the existence of a conspiracy. United
States v. Lennick, 18 F.3d 814, 819 (9th Cir. 1994).
In this case, the government must show that (1) Kaplan
agreed with others to hold the single-use plastic guides in an
adulterated state in violation of 21 U.S.C. § 331(k)—that is,
in insanitary conditions such that the guides may have been
contaminated, see id. § 351(a)(2)(A); (2) Kaplan and others
took acts in furtherance of that agreement; and (3) Kaplan and
others had the intent to adulterate the guides. In order to
sustain the felony conviction, the government also had to
show that Kaplan acted with the intent to defraud or mislead.
See id. § 333(a)(2). Evidence of intent to defraud can be
circumstantial and may be inferred from misrepresentations
and omissions. United States v. Rogers, 321 F.3d 1226, 1230
(9th Cir. 2003). Considering the evidence in the light most
favorable to the government and the jury’s verdict, there was
sufficient evidence to convict Kaplan of the felony of
conspiracy to violate 21 U.S.C. § 331(k) with the intent to
defraud.
B
First, the government provided sufficient evidence that
Kaplan and Taylor agreed to reuse the guides in an
adulterated state. When the clinic noticed that it was running
short of guides, Kaplan explicitly told Taylor and Cortez to
instruct the medical assistants to reuse the single-use guides
and to employ the Cidex cleaning protocol. Taylor told a
medical assistant, in Kaplan’s presence, that it would be
“ridiculous” not to reuse the guides considering the cost.
Kaplan, Taylor, and Cortez instructed the medical assistants
22 UNITED STATES V. KAPLAN
to clean and reuse the devices despite the medical assistants’
protests that the packaging for the devices labeled them for
single use. Finally, after being notified by Golden that reuse
had to stop, Taylor spoke with Kaplan but neither of them
decided to stop. Taking the evidence in the light most
favorable to the government, there was sufficient evidence for
a rational trier of fact to determine that Kaplan agreed with
others to nonetheless reuse the devices after employing the
Cidex cleaning protocol.
Second, the evidence clearly established, and Kaplan does
not dispute, that after he and Taylor told the medical
assistants to clean and reuse the guides the medical assistants
did so. Therefore, Kaplan caused an act to be committed in
furtherance of the agreement.
Third, there was sufficient evidence to show that Kaplan
and others intended to hold the devices in an adulterated state.
This is a closer question because, as Kaplan notes, the
difficulty with the intent element is that an agreement to
intend to reuse the devices is not the same as an agreement to
intend to hold the devices in an adulterated state.
Additionally, proof of actual adulteration is not relevant to
showing that Kaplan intended to adulterate the devices. See
Lennick, 18 F.3d at 819.
According to Kaplan, the government must show that he
intended to adulterate the devices but cannot do so because
Kaplan thought that the disinfection protocol was working
and that the guides were not insanitary or contaminated.
Kaplan urges us to declare that the government must show
that the guides were in fact contaminated and that Kaplan
intended to use them in that state. The argument proves too
much. The record established that Kaplan intended to reuse
UNITED STATES V. KAPLAN 23
the guides following the Cidex cleaning protocol, though he
possessed no evidence that such a protocol would actually
work, based apparently on Brandt’s hearsay statement that a
California physician said it would work, and with no
guidance to the medical assistants on how to clean the guides
properly.9 And there was sufficient evidence—testimony of
actual blood, stains, scratches, discoloration, and expert
testimony—to show that, after the lax Cidex cleaning
protocol, the devices were being held under insanitary
conditions and may have been contaminated.10 The guides’
packaging clearly declared they were not to be reused and the
Cidex label clearly warned that it was not to be used to clean
disposable devices.
Kaplan may not have intended the guides to be
contaminated when he reused them, but he intended to put
them through the Cidex cleaning protocol that had never been
tested on single-use guides. There is a reasonable probability
that the Cidex cleaning protocol as actually employed left the
single-use guides in an insanitary condition that may have
contaminated them, leaving them adulterated. Therefore,
because Kaplan intended to put the guides through an
9
Kaplan argues that his reuse of a single-use device cannot be
adulteration because the “FDA does not know if [the guides] can be
cleaned and disinfected effectively because no data exist.” However, this
argument works against Kaplan as well. Because there are no data to
show that the guides can be cleaned, there is a possibility the guides were
adulterated; that is to say, they may have been kept in insanitary
conditions. Given the known risk of infection from the biopsy procedure,
proceeding in this manner exposed his patients to a much greater risk of
harm with no notice to them of this increased danger.
10
That no patient contracted an acute infection is not dispositive. The
patients were, after all, already taking antibiotics at the time of the
procedure.
24 UNITED STATES V. KAPLAN
inappropriate cleaning protocol, he intended to put the guides
through a procedure that left them adulterated. That is
sufficient to constitute criminal intent to support the
conspiracy conviction.
Moreover, Kaplan’s claim of ignorance as to the
adulterated state of the guides is unavailing. The evidence
showed that he ordered reuse despite the protest of his
medical assistants. In January, Dr. Golden called Taylor to
tell the Kaplan clinic to stop reusing the guides, and Dr.
Kaplan was aware of that conversation. When questioned by
his wife regarding reuse, Kaplan stated that Golden was “just
trying to give me a hard time.” Her research confirmed the
risk. But after that, no medical assistant was ever instructed
to stop reusing the guides. Kaplan was repeatedly made
aware of the problems with reusing the guides, knew that the
guides should not be reused, and persisted in reusing the
guides anyway for several weeks thereafter. His continued
reuse of potentially adulterated guides was unquestionably
intentional, and the jury reasonably concluded that Kaplan
possessed the sufficient intent to support a conspiracy
conviction.
Finally, in order to constitute a felony offense rather than
simply a misdemeanor, the government had to prove that
Kaplan intended to defraud or mislead. The government
provided evidence that clearly established that Kaplan and his
staff did not disclose reuse to his patients, and that Kaplan
and his public relations team attempted to conceal the truth
from the public, the Nevada State Medical Board, and the
FDA, by stating that reuse ended in January 2011, when in
fact reuse continued into March. Those misrepresentations
about when reuse stopped are indicative of his consciousness
of guilt. Office Manager Taylor even pressured an employee
UNITED STATES V. KAPLAN 25
to lie about the extent of reuse. Though the evidence that
Kaplan and his public relations team were attempting to hide
his tracks is circumstantial evidence of his intent, a
reasonable jury could find on this record that he was acting
with the intent to defraud and mislead.
Additionally, the government offered sufficient evidence
to support the contention that this was done in an effort to
enrich Kaplan and save him money. As Taylor stated, the
expense of the reusable guides was “ridiculous.” And the
only reason Kaplan offered to FDA agents to explain reuse
was that he was practicing “cost-effective medicine.”
Viewing the evidence in the light most favorable to the
government and in support of the jury’s verdict, there was
sufficient evidence to support the conviction that Kaplan
conspired to commit adulteration in violation of 21 U.S.C.
§ 331(k) and to support the special finding that Kaplan
intended to defraud his patients, the public, the FDA, and the
Medical Board. We will not overturn the jury’s verdict.
IV
Kaplan also appeals the exclusion of two proposed jury
instructions: one on “off-label use” and the other on the
“practice of medicine.”11 In the course of drafting the jury
instructions, Kaplan attempted to introduce these instructions
11
The two instructions proposed the following: (1) that off-label use
is approved by the FDA, a physician is not required to follow the
manufacturer’s label, and therefore reuse of a single-use device is not per
se unlawful; and (2) that the FDA does not have the authority to interfere
with a physician’s health care practices within a legitimate physician-
patient relationship.
26 UNITED STATES V. KAPLAN
because he feared that the jury would determine that reuse of
a single-use device was a per se violation of the law. The
trial judge rejected these arguments because the court
believed that the jury instructions as they were written
sufficiently advised the jury that this was not a strict liability
offense. Kaplan contends that the absence of the requested
instruction allowed the government to improperly suggest at
closing argument that reuse of the single-use guides was per
se adulteration.
We review the wording of jury instructions for an abuse
of discretion, but review de novo “[w]hether jury instructions
omit or misstate elements of a statutory crime or adequately
cover a defendant’s proffered defense.” United States v.
Christensen, No. 08-50531, 2015 WL 11120665, at *13 (9th
Cir. July 8, 2016). Because Kaplan’s instructions were
offered to cover his preferred defense, we review them de
novo. See id.We must determine whether the instructions, viewed as a
whole, “were misleading or inadequate to guide the jury’s
deliberation.” United States v. Moore, 109 F.3d 1456, 1465
(9th Cir. 1997) (en banc) (quoting United States v. Perez,
989 F.2d 1111, 1114 (9th Cir. 1993)). “Jury instructions,
even if imperfect, are not a basis for overturning a conviction
absent a showing that they prejudiced the defendant.”
Christensen, 2015 WL 11120665, at *13. “A defendant is not
entitled to any particular form of instruction, nor is he entitled
to an instruction that merely duplicates what the jury has
already been told.” United States v. Lopez-Alvarez, 970 F.2d
583, 597 (9th Cir. 1992). A judge need not include proposed
instructions that are “not necessary to explain to the jury the
legal effect of the theory of the defense.” Id.UNITED STATES V. KAPLAN 27
First, as Kaplan himself states, the “theory of the case was
. . . that he never agreed to use, and did not use, adulterated
devices in his treatment of patients.” Kaplan further argues
that the “cornerstone” of this defense was that off-label use of
a single-use device was not illegal. However, the district
court properly noted that the instructions did not improperly
permit the jury to find that reuse of the guides was a per se
violation of § 331(k). Kaplan’s legal theory was ultimately
that the devices were not adulterated, and the instructions
state explicitly that the jury had to determine whether the
devices were adulterated. Therefore, there is no need for a
jury instruction stating that off-label use of an unadulterated
device is not unlawful, the theory was already covered by the
instructions, and the district court did not err in rejecting
Kaplan’s “off-label use” instruction.12
Second, Kaplan did not object when the district court
rejected his “practice of medicine” instruction. Whether we
review for plain error, Fed. R. Crim. P. 30(d) and 52(b), or
whether we consider the argument to have been litigated
adequately, see, e.g., United States v. Chhun, 744 F.3d 1110,
1119 (9th Cir. 2014), the result is the same. The district court
declined to give this instruction, noting “there could not be a
12
Kaplan highlights a brief statement in the government’s closing
argument that implied that reuse is equivalent to adulteration and attributes
it to the court’s failure to accept his jury instruction. However, the
government repeatedly agreed that this was not a strict liability offense.
The government’s theory actually relied heavily on the manner in which
Kaplan cleaned and reused the guides and the fact that these particular
guides were not suited to reuse because they would become
adulterated—not the mere fact that they were reused. This brief statement
during closing arguments by the government therefore did not prejudice
Kaplan.
28 UNITED STATES V. KAPLAN
practice of medicine exemption which provided that he could
use . . . adulterated stuff.”
We hold that the district court properly rejected Kaplan’s
proposed jury instructions because his proposed “theory of
the case” instructions merely duplicated what the jury was
already told, and there was no plain error in the district
court’s refusal to give the “practice of medicine” instruction.
V
Before trial, Kaplan moved to dismiss count one of the
indictment for failure to allege that he acted with the intent to
defraud or mislead. The district court denied the motion and
adopted the magistrate judge’s recommendation noting that,
because the indictment cited to the specific provision,
21 U.S.C. § 333(a)(2), and contained enough factual
allegations, Kaplan was sufficiently notified that he was
charged with a felony. Kaplan continues to argue here that
the indictment was insufficient. We review the sufficiency of
an indictment de novo. United States v. Enslin, 327 F.3d 788,
793 (9th Cir. 2003).
“An indictment is sufficient if it contains the elements of
the charged crime in adequate detail to inform the defendant
of the charge . . . .” United States v. Buckley, 689 F.2d 893,
896 (9th Cir. 1982). In judging the sufficiency of the
indictment we look to “whether the indictment adequately
alleges the elements of the offense and fairly informs the
defendant of the charge, not whether the Government can
prove its case.” Id. at 897. The court must look at the
indictment as a whole, include facts which are necessarily
implied, and construe it according to common sense. Id. at
899.
UNITED STATES V. KAPLAN 29
That the indictment referred to the particular statute,
21 U.S.C. § 333(a)(2), rather than explicitly stating that
Kaplan was being charged with the felony of intent to
defraud, does not render the indictment invalid. Common
sense dictates that Kaplan was adequately informed of the
charge against him where the indictment alleged the specific
conduct that constituted fraud: that Kaplan concealed reuse
from patients and made false representations to the FDA, the
public, and the Medical Board regarding the extent of reuse
of the guides for his own enrichment.
Kaplan further argues that the indictment failed to allege
the element of materiality in charging him with the intent to
defraud and that the government failed to argue materiality at
trial. Kaplan is correct; an allegation in the indictment stating
that the facts concealed from patients were material
omissions may have been necessary. See Neder v. United
States, 527 U.S. 1, 20 (1999). “[T]he well-settled meaning of
‘fraud’ require[s] a misrepresentation or concealment of
material fact.” Id. at 22.
But Kaplan seems only to be arguing that the words “and
it was material” had to appear in the indictment and be
presented to the jury. Such an “omission of an element is an
error that is subject to harmless-error analysis.” Id. at 15.
And an error is harmless when an omitted element is
supported by uncontroverted evidence. Id. at 18. We
therefore must ask “whether the record contains evidence that
could rationally lead to a contrary finding with respect to the
omitted element.” Id. at 19. Kaplan does not argue, nor
could he, that failing to inform patients that he was reusing
single-use plastic devices in their prostate biopsies was not
material. Therefore, omitting the element of “materiality” in
the indictment was harmless error.
30 UNITED STATES V. KAPLAN
Because the indictment contained the elements of
Kaplan’s fraud in adequate detail, he was fairly informed of
the charges against him. Additionally, any error in omitting
the materiality element from the indictment, on this record,
was harmless. The district court did not err in refusing to
dismiss the indictment.
VI
Finally, Kaplan contends that the jury instructions and
verdict form defined the offense as a misdemeanor, and not
a felony, and he was therefore improperly sentenced for a
felony conviction under 21 U.S.C. § 333(a)(2). However,
Kaplan waived any challenge to the jury instructions and
special verdict form regarding how the jury distinguished
between a misdemeanor and a felony conviction. A party
forfeits a right when it fails to make a timely assertion of that
right and waives a right when it is intentionally relinquished
or abandoned. United States v. Olano, 507 U.S. 725, 733
(1993). “Forfeited rights are reviewable for plain error, while
waived rights are not.” United States v. Perez, 116 F.3d 840,
845 (9th Cir. 1997) (en banc). Waiver of a jury instruction
occurs when a party considers “the controlling law, or
omitted element, and, in spite of being aware of the
applicable law, proposed or accepted a flawed instruction.”
Id. (“If [a party] has both invited the error, and relinquished
a known right, then the error is waived and therefore
unreviewable.”).
The trial judge specifically asked both parties during the
instruction conference to take a hard look at how the jury
instructions distinguished between a misdemeanor conviction
and a felony conviction. The judge separated the jury
instructions into two parts: (1) an instruction on what was
UNITED STATES V. KAPLAN 31
required to convict Kaplan of the conspiracy to commit
adulteration, and (2) a separate instruction on the intent to
defraud element necessary to make the offense a felony. The
judge particularly noted that he did not explicitly use the
terms “misdemeanor” and “felony” because he felt that they
were not helpful to the jury and that the instructions were
self-explanatory. The intent to defraud instruction was also
included on the jury verdict form as a separate special finding
to be made by the jury.
Objections during the editing process were few, and
Kaplan affirmatively approved the instructions on several
occasions. At a key point in the discussions, Kaplan’s
attorney explicitly stated, “I think the verdict form handles
the intent to defraud.” Furthermore, in asking the court to
modify the intent to defraud instruction to add the term
“beyond a reasonable doubt,” which the court did, Kaplan
affirmatively approved the instruction: “[W]hen I took a look
at the verdict form I didn’t have a problem with it, except that
I think it needs to say . . . beyond a reasonable doubt . . . .”
Kaplan characterizes what happened at trial as the
submission of “the conspiracy charge to the jury on
instructions defining the offense as a misdemeanor.” At
sentencing, Kaplan’s newly retained counsel objected to a
felony sentence for a misdemeanor conviction. However, the
contention that the instructions submitted to the jury defined
the offense only as a misdemeanor is belied by the judge’s
own explanation of the instructions to “look . . . carefully as
to how I dealt with . . . distinguishing . . . what we would call
a felony and misdemeanor.” Kaplan’s sentencing counsel
cannot rewrite the record to avoid what is clearly a well-
supported felony conviction by the jury based on proper jury
32 UNITED STATES V. KAPLAN
instructions and a verdict form affirmatively approved by
Kaplan’s trial counsel.
Because the arguments now pressed on appeal do not
change the fact that Kaplan’s trial counsel waived any
objection to the jury instructions and verdict form as they
relate to the felony conviction, we find the claim waived and
decline to reach the issue.
VII
At one point, Kaplan bragged that the volume of his
successful medical practice made him the “McDonald’s of
Urology.” But the evidence showed that, instead of
protecting the safety of his patients, Kaplan took shortcuts to
keep pumping patients through his clinic. Greed overcame
his concern for patient care. And his practice of reusing
single-use plastic needle guides on prostate biopsy patients
brought them into contact with dangerous products,
threatened public health, and breached § 331(k) of the FDCA.
A physician’s use of a consumable device on a patient is
covered by the “held for sale” provision of 21 U.S.C.
§ 331(k), and there was sufficient evidence to support the
jury’s verdict that Kaplan engaged in a conspiracy to violate
§ 331(k). The district court did not err in denying Kaplan’s
proposed jury instructions or in holding that the indictment
sufficiently charged him with a felony. Finally, Kaplan
waived any objection to how the jury instruction and special
verdict form distinguished between a misdemeanor and
felony conviction.
AFFIRMED.