United States v. Michael Kaplan

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.