                                                                                  FILED
                                                                      United States Court of Appeals
                                       PUBLISH                                Tenth Circuit

                     UNITED STATES COURT OF APPEALS                         January 21, 2014

                                                                           Elisabeth A. Shumaker
                                     TENTH CIRCUIT                             Clerk of Court


UNITED STATES OF AMERICA,

             Plaintiff - Appellee,

v.                                                           No. 12-1239

GEORGE JOHN SCHULTE, a/k/a John
Schulte,

             Defendant - Appellant.




                    Appeal from the United States District Court
                            for the District of Colorado
                        (D.C. No. 1:10-CR-00455-WYD-1)


Thomas L. Kirsch, II, (Steffen N. Johnson, Washington, DC; Michael A. Skokna,
Andrew J. Yahkind, Benjamin L. Ellison, Chicago, Illinois, with him on the brief) of
Winston & Strawn LLP, Chicago, Illinois, for Defendant - Appellant

James C. Murphy, Assistant U.S. Attorney, (John F. Walsh, United States Attorney,
Jaime A. Pena, Tim R. Neff, Assistant U.S. Attorneys, with him on the brief) U.S.
Attorney’s Office, District of Colorado, Denver, Colorado, for Plaintiff - Appellee

Before KELLY, McKAY, and O'BRIEN, Circuit Judges.


O’BRIEN, Circuit Judge.


      John Schulte appeals from his conviction on one charge of making a false

statement to the government. See 18 U.S.C. § 1001(a). The charge alleged he made five
false statements during a voluntary interview with a United States Food and Drug

Administration (FDA) agent while a search warrant was being executed at the offices of

Schulte’s employer, Spectranetics. Schulte claims two of the charged statements were

not false, and therefore, cannot support the verdict as a matter of law. As to all five

statements, he contends the government failed to prove both his intent to supply false

information and the materiality of the statements to the government’s investigation. We

find no error and affirm.

                                     BACKGROUND

       Because the jury found Schulte guilty, we draw the facts from the evidence

presented at trial in the light most favorable to the government. United States v. Rufai,

732 F.3d 1175, 1188 (10th Cir. 2013). Schulte was the Chief Executive Officer of

Spectranetics, located in Colorado Springs, Colorado. The company primarily

developed, manufactured, and marketed laser-based medical devices for use in

procedures to remove blockage in coronary (heart) arteries and peripheral arteries

(usually located in the patient’s leg). Schulte was CEO from January 2003 through

October 2008. During this time, Spectranetics sought to expand its product line to

include devices made by other manufacturers which would provide a good fit with

Spectranetics’ products. To that end, Schulte and various other Spectranetics employees

engaged in discussions with manufacturing companies in the United States and abroad.

       Schulte’s statements concerned two potential product expansions. The first was a

guidewire designed to puncture through a severe artery blockage known as chronic total


                                                -2-
occlusion.1 The guidewire was designed and manufactured by a Japanese company,

Future Medical Design, Ltd. (FMD). The second product was a balloon angioplasty

catheter which was placed into an artery to expand its circumference to remove blockage.

This product was designed and manufactured by Bavarian Medizin Technologie (BMT)

in Germany.

A. FMD Guidewire

       The negotiations between Spectranetics and FMD began in early 2005 and

continued through the end of 2007. On at least three occasions, Schulte travelled to

Japan to meet with FMD President, Tsuyoshi Terashi, and was given guidewire samples

to bring back to the United States. The first visit occurred in July 2005, when Schulte

received a prototype coronary wire. In late September/early October 2005, FMD shipped

50 guidewires of various specifications to Spectranetics. Although FMD’s facilities and

products were approved by Japanese authorities, they had not been approved by the FDA.

Spectranetics planned to file the necessary information for such approval. Prior to filing

for approval, however, Schulte asked Dr. Bruce Murphy, one of Spectranetics’ advising

physicians, to evaluate the guidewires after he had used them in patients. Spectranetics

received a second shipment of ten peripheral guidewires in November 2005. These wires

were also sent to Dr. Murphy for evaluation. It is undisputed Murphy placed FMD’s

wires in five patients in November 2005, although the parties dispute whether he knew


       1
        A total occlusion of the artery is a blockage so severe that there is almost no
blood flow beyond the blockage.

                                               -3-
the product was not FDA-approved at that time. As reported to Schulte, the evaluation of

the guidewire was very positive.

       Schulte again visited FMD in August 2006. At that time, he was given samples of

new peripheral guidewires to bring back with him for bench evaluation. Schulte’s third

visit to FMD’s facilities occurred in the summer of 2007; he returned with samples of the

newest design. Disagreements over pricing stalled negotiations, but even so,

Spectranetics submitted a 510(k) request for approval of the guidewires with the FDA

under the market name “Quick-Cross” guidewires. 2 (Appellant’s App’x. Vol. V at 1920-

21.) The FDA requested additional information to complete the approval process. When

Spectranetics did not respond, the FDA considered the 510(k) application withdrawn. In

October 2007, Spectranetics notified FMD it was cancelling further business dealings as

of January 1, 2008.



       2
         As Ashley Boam, branch chief for the FDA’s regulatory oversight of medical
devices, explained, “[m]edical devices are usually classified as Class I, Class II or Class
III, depending upon the level or risk that they pose to a patient.” (Appellant’s App’x Vol.
III at 1066.) Class I is the lowest risk and would include “bandages, gauze [and] tongue
depressors.” (Id.) While Class I devices do not need FDA approval before they can be
sold in the United States, Class II, moderate risk devices, and Class III, high risk devices
require FDA approval prior to being sold in the United States. The devices at issue here
are Class II. The common name of the FDA marketing application for Class II devices is
“called a 510(k), which is taken from the section of the statute that describes that type of
application.” (Id. at 1068.) If a manufacturer wants to study a Class II device in human
subjects and that device presents a significant risk to the patient, an investigational device
exemption (IDE) . . . approved by FDA is needed before that device can be used in
human patients.” (Id.) Spectranetics did not apply for an IDE before Murphy used the
wires in humans.


                                                -4-
B. BMT Balloon Catheter

      BMT manufactured medical devices for customers worldwide. Each device was

made to the customer’s specifications and then distributed under the customer’s label. In

2007, Schulte began negotiations with Knut Sauerteig, BMT’s managing director,

regarding a line of BMT balloon catheters. These catheters were not distributed in the

United States and the balloons under discussion were not approved in Europe or by the

FDA. In October 2007, BMT sent Spectranetics a shipment to be used in clinical studies

(used on human patients) prior to FDA approval. A Spectranetics employee developed a

one-page form entitled “BMT PTA Catheter Product Evaluation” to record the

physician’s comments. (Appellant’s App’x Vol. VIII at 3290.) By e-mail, Schulte

approved the form stating, “[O]n the money. I look forward to the results.” (Appellant’s

App’x Vol. III at 1282.)

      At the end of October, Schulte and others met with Sauerteig in Washington D.C.

They discussed the positive clinical evaluations from two physicians, Dr. Craig Walker

and Dr. Robert Gallino. Again, there was contradicting testimony as to whether the

doctors knew the devices were not approved in the United States. Negotiations between

the two companies continued into 2008, but were formally terminated in January 2009.

C. Internal Investigation

      On April 1, 2008, a former employee contacted the Spectranetics’ employee

hotline. He complained of unethical practices, including the use of unapproved German

and Japanese devices in patients. Emile Geisenheimer, chairman of Spectranetics Board


                                              -5-
of Directors, telephoned Schulte and told him about the allegations. Schulte denied any

use of the devices in humans and stated he had ordered the devices only for bench testing

in the United States. Spectranetics’ Board hired an outside law firm to conduct an

internal investigation to determine the truth of the allegations. Lawyers from the firm

interviewed Schulte and other Spectranetics employees over the next few months and

Schulte and Geisenheimer spoke frequently during the investigation. Schulte steadfastly

maintained the devices had not been used in human patients. In August 2008,

Spectranetics’ general counsel ended the Board’s investigation.

D. FDA Search Warrant

       In July 2008, three former employees and one current employee brought their

allegations to the FDA. The employees provided internal company e-mails and the BMT

evaluation forms as proof of Spectranetics’ illegal conduct under Schulte’s direction.

FDA investigator Dan Burke was assigned to lead the investigation. The employees’

information led to a search warrant which FDA executed on September 8, 2008.

       Burke, along with 30-40 officers from the FDA and other federal agents, arrived

unannounced at Spectranetics offices at approximately 9:15 a.m. The first hour was

“chaotic.” (Appellant’s App’x Vol. V at 2257.) After immediate business concerns were

addressed, Schulte and other key employees agreed to be interviewed. Burke conducted

Schulte’s interview in the presence of Special Agent Rob Cruz and Spectranetics’

corporate counsel. Although Cruz and general counsel were both called out of the

interview at certain times, they were present for much of the questioning. According to


                                               -6-
Burke’s testimony, Schulte said: he was never supplied FMD guidewires while in Japan

and did not physically carry guidewires with him when he returned to the United States;

he was not aware his staff or consultants provided FMD guidewires to Bruce Murphy for

use in human patients; he never physically provided BMT balloons to Dr. Robert Gallino

or Dr. Craig Walker for use in human patients; and when asked if “this testing [was] done

by rogue employees,” Schulte said, “I don’t know.” (Appellant’s App’x Vol. V at 2221,

2223-24, 2225, 2227.) When shown the BMT evaluation forms with the testing results,

Schulte said “he had never seen the forms before.” (Id. at 2225-26.)

        Because Burke did not feel Schulte was being truthful, he provided Schulte an

advisement form containing the language of 18 U.S.C. § 1001(a) which states, in relevant

part:

        [W]hoever, in any matter within the jurisdiction of the executive,
        legislative, or judicial branch of the Government of the United States,
        knowingly and willfully -- . . . . makes any materially false, fictitious, or
        fraudulent statement or representation . . . . shall be fined under this title
        [and] imprisoned not more than 5 years. . . .

This was followed by a sentence reading: “I have read and understand the provisions and

penalties of this law.” (Appellant’s App’x Vol. VIII at 3281.) Schulte read the form and

signed it. He told Burke he did not want to change any of his statements.

        Later that day, Schulte called Chairman Geisenheimer. Schulte was “distraught”

and said he had been reviewing his e-mails and realized his statements to the FDA agents

were not accurate. (Appellant’s App’x Vol. VI at 2341.) Geisenheimer told him to

immediately contact the federal agents to correct the record and to get his own lawyer.


                                                  -7-
Geisenheimer testified “it was incredible to me that one needs to review their e-mails to

know whether they were knowledgeable of facts.” (Id. at 2341.) According to

Geisenheimer:

       Schulte’s statements about those balloons and wires changed from not
       having any knowledge of it to certainly believing that they were never used
       in humans, to acknowledging that they were imported, and if anything, this
       was a misdemeanor, that the doctors knew about it, that . . . senior
       colleagues, executives of the company knew about it, and it’s common in
       the industry because these were low technology devices, et cetera.

(Id. at 2358-59.) Geisenheimer, however, said the use of unapproved devices was not

common in the industry; he had “never encountered it before in [his] 40 years in the

medical device industry.” (Id. at 2359.)

E. Schulte’s Corrections

       Schulte, through his attorneys, provided three letters correcting his interview

statements. On September 9, 2008, his attorneys faxed a letter to Burke. It said, in part:

“In thinking about the questions you asked concerning guidewires, Mr. Schulte promptly

went back to check his records. This further review has refreshed Mr. Schulte’s

recollection that in early July[] 2005, Mr. Schulte returned from FMD with a single

demonstration sample.” (Appellant’s App’x Vol. VIII at 3304.) The second letter, sent

on September 22, 2008, attached an e-mail chain showing Schulte’s knowledge of the

proposed BMT evaluation form. The letter said:

       Mr. Schulte believes Special Agent Burke showed Mr. Schulte the same or
       similar versions of this form, which had handwriting as though the forms
       had been filled out in whole or in part.



                                               -8-
       To clarify, Mr. Schulte still does not believe he had ever seen the
       completed forms before the interview. . . . Based on Mr. Schulte’s
       subsequent review of this matter, however, it appears he had seen an earlier
       version of the form which did not bear the handwriting on the forms
       Special Agent Burke displayed.

(Id. at 3305-06.) The third letter, dated January 16, 2009, was sent to the Assistant

United States Attorney. It explained Schulte’s files “suggest[ed] that Mr. Schulte brought

a small number of FMD guidewires into the United States on two additional occasions,”

in August 2006 and early July 2007. (Id. at 3308.)

                               PROCEDURAL HISTORY

       Schulte and others were charged in a twelve-count indictment alleging: (1)

conspiracy to defraud the United States; (2) false statements; (3) introduction and receipt

of adulterated and misbranded devices into interstate commerce; and (4) aiding and

abetting. After 15 days of trial, the jury acquitted him on all counts except Count II, false

statements. On that charge, the jury unanimously agreed Schulte knew at least one of the

following statements he made was false:

       Statement One, Schulte told Special Agent Burke that he was never given
       FMD guidewires while in Japan and did not physically carry any with him
       when returning to the United States.

       Statement Two, Schulte told Special Agent Burke that the FMD guidewires
       provided to physicians were not provided for use in human patients.

       Statement Three, Schulte told Special Agent Burke that he was not aware
       that FMD guidewires were provided to [Dr. Bruce Murphy] by members of
       his staff or by [a consultant] for use inside human patients.

       Statement Four, Schulte told Special Agent Burke that he did not know that
       [Dr. Craig Walker] or [Dr. Robert Gallino] [was] supplied BMT balloons


                                                -9-
      by employees to use inside human patients.

      Statement Five, Special Agent Burke showed Schulte a copy of the
      evaluation forms entitled “BMT PTA Catheter Product Evaluation,” and
      Schulte told Special Agent Burke that he had never seen the forms.

(Appellant’s App’x Vol. I at 101-02 (capitalization modified and numbering added).)

Because neither party requested a special verdict form, the jury did not specify which

statement or statements it unanimously found to be false.

      Schulte filed a post-trial motion seeking a judgment of acquittal or a new trial. He

claimed there was insufficient evidence to prove Statements Four and Five were false.

He further argued there was insufficient evidence to show any statement was material to

the investigation or that he knowingly made a false statement. The motion was denied.

                                     DISCUSSION

      Schulte contends the government failed to prove his intent to supply false

information and the materiality of the information to the government’s investigation. We

disagree.

      To convict Schulte under § 1001, the government must prove:

      First, the defendant made a false statement or representation to the
      government, specifically as detailed in Count Two of the Indictment.

      Second, the defendant made the statement knowing it was false.

      Third, the defendant made the statement willfully, that is deliberately,
      voluntarily and intentionally.

      Fourth, the statement was made in a matter within the jurisdiction of the
      Executive Branch of the United States.



                                              - 10 -
       And [F]ifth, the statement was material to the United States Food and Drug
       Administration.

(Appellant’s App’x Vol. VII at 3043-44.)

A. False Statement

           1. Preservation

       On appeal, Schulte argues Statements Four and Five were based “on a legally

deficient theory of liability—one that violates both § 1001 and the First Amendment.”

(Appellant’s Br. at 16.) The government claims Schulte did not raise this error below.

Instead, he merely claimed there was insufficient evidence to prove these statements were

false. Therefore, according to the government, our review must be for plain error.

United States v. DeChristopher, 695 F.3d 1082, 1091 (10th Cir. 2012) (“Defendant did

not raise this specific argument in his Rule 29 motion, meaning we review it only for

plain error.”).

       We agree with the government. In his motion for acquittal or a new trial, Schulte

argued the government failed to prove his statements were false. Regarding Statement

Five, Schulte’s argument to the district court consisted of the following sentence:

“Because there is absolutely no evidence that Schulte had ever seen the completed,

handwritten BMT Evaluation Forms, Statement Five was not false.” (Appellant’s App’x

Vol. I at 249.) He made no mention of the First Amendment or any other constitutional

argument. As to Statement Four, Schulte claimed, “Burke’s subjective interpretation of

what Schulte’s responses to other questions meant cannot support proof of falsity beyond



                                              - 11 -
a reasonable doubt.” (Id. at 248). He never argued Statements Four and Five should not

have gone to the jury because of a legal error.

       The legal analysis of his argument to the district court varies significantly from his

argument on appeal—and has significant consequences. If Statements Four or Five were

merely unsupported by the evidence, Schulte’s conviction will stand if there was

sufficient evidence demonstrating any one of his remaining statements were false (and

otherwise within the requirements of the statute). See Griffin v. United States, 502 U.S.

46, 56-57 (1991) (quoting Turner v. United States, 396 U.S. 398, 420 (1970) (“[W]hen a

jury returns a guilty verdict on an indictment charging several acts in the conjunctive . . .

the verdict stands if the evidence is sufficient with respect to any one of the acts

charged.”). On the other hand, if it was legal error to submit Statements Four or Five to

the jury, then Schulte’s conviction must be vacated as it could be based on a statement

which did not qualify under the statute. Griffin, 502 U.S. at 59.

       As the Supreme Court explained:

       Jurors are not generally equipped to determine whether a particular theory
       of conviction submitted to them is contrary to law – whether, for example,
       the action in question is protected by the Constitution, is time barred, or
       fails to come within the statutory definition of the crime. When, therefore,
       jurors have been left the option of relying upon a legally inadequate theory,
       there is no reason to think that their own intelligence and expertise will
       save them from that error. Quite the opposite is true, however, when they
       have been left the option of relying upon a factually inadequate theory,
       since jurors are well equipped to analyze the evidence.




                                                  - 12 -
Id.3

       In his reply brief, Schulte argues he alerted the court to the “essential issue,” and

therefore, his failure to specifically define the error does not result in forfeiture.

(Appellant’s Reply Br. at 4.) However, we see nothing in Schulte’s district court brief

which would put either the district court or the government on notice of a claim of “legal

error,” as described by the Supreme Court in Griffin, as opposed to the failure to adduce

sufficient evidence of falsity. Therefore, we review Schulte’s claim of legal error for

plain error. He must “demonstrate (1) error that is (2) plain, (3) affects substantial rights,

and (4) seriously affects the fairness, integrity, or public reputation of judicial

proceedings.” DeChristopher, 696 F.3d at 1091.




       3
        The Supreme Court also distinguished legal error from insufficiency of the
evidence as follows:
      In one sense “legal error” includes inadequacy of evidence – namely, when
      the phrase is used as a term of art to designate those mistakes that it is the
      business of judges (in jury cases) and of appellate courts to identify and
      correct. In this sense “legal error” occurs when a jury, properly instructed
      as to the law, convicts on the basis of evidence that no reasonable person
      could regard as sufficient. But in another sense – a more natural and less
      artful sense – the term “legal error” means a mistake about the law, as
      opposed to a mistake concerning the weight or the factual import of the
      evidence. . . . [W]e are using “legal error” in the latter sense.

Griffin, 502 U.S. at 59.




                                                 - 13 -
           2. Legal Error – Fundamental Ambiguity

       Whether the question itself is unable to legally support a perjury or false statement

conviction depends on whether it contains a “fundamental ambiguity.” United States v.

Strohm, 671 F.3d 1173, 1178 (10th Cir. 2011). “We review claims that a question is

fundamentally ambiguous de novo.” Id. at 1179.4

       A question is fundamentally ambiguous in narrow circumstances. To
       qualify, the question must lack ‘a meaning about which men of ordinary
       intellect could agree, nor one which could be used with mutual
       understanding by a questioner and answerer unless it were defined at the
       time it were sought and offered as testimony.’ That is, the question itself is
       excessively vague, making it impossible to know—without guessing—the
       meaning of the question and whether a witness intended to make a false
       response.

Id. at 1179 (quoting United States v. Farmer, 137 F.3d 1265, 1269 (10th Cir. 1998)).

“The purpose of the rule of fundamental ambiguity is three-fold, namely, to (1) preclude

convictions grounded on surmise or conjecture; (2) prevent witnesses from unfairly

bearing the risks of inadequate examination; and (3) encourage witnesses to testify (or at

least not discourage them from doing so).” Farmer, 137 F.3d at 1269. “Fundamental

ambiguity is the exception, not the rule. Id. “Given the nature of language, in hindsight,



       4
         While our precedent addresses perjury convictions, courts routinely apply the
fundamental ambiguity analysis to analogous charges for various types of false
statements. See, e.g., United States v. Brooks, 681 F.3d 678, 706 (5th Cir. 2012) (false
natural gas price reporting), cert. denied, 133 S. Ct. 839 (2013); United States v. Sarwari,
669 F.3d 401, 407 (4th Cir. 2012) (false statement on passport application); United States
v. Mubayyid, 658 F.3d 35, 61 (1st Cir. 2011) (false statement to FBI agent), cert. denied,
132 S. Ct. 2378 (2012); United States v. Ahmed, 472 F.3d 427, 433 (6th Cir. 2006) (false
statement of federal employment application).

                                               - 14 -
many questions could be susceptible to differing interpretations. Simply plumbing a

question for post hoc ambiguity will not defeat a perjury conviction where the evidence

demonstrates the defendant understood the question in context and gave a knowingly

false answer.” Strohm, 671 F.3d at 1178.

       In other words, a fundamental ambiguity cannot be the basis for a false statement

conviction because a person cannot knowingly give a false reply to a question that defies

interpretation despite its context. Thus, the context of the question is “critically

important.” Farmer, 137 F.3d at 1269. The situation in Farmer is instructive. There, the

defendant, while a witness at a pretrial hearing, had the following exchange with the

prosecutor:

       Q. Prior to your coming to testify here today, did you speak to anyone
       about your testimony here today?

       A. No, just the attorney asked me if I would-you know, verifying that I
       would come.

       Q. When was that?

       A. Well, I called the office this morning, which I didn't speak with him. Oh,
       I did too. I spoke with an investigator, a federal investigator.

                ****

       Q. Have you talked to Mr. McMahon, the Defendant about your testimony
       here today?

       A. No.

       Q. When is the last time you talked to Mr. McMahon?

       A. I talked to him-well, I believe it was yesterday. I am not real sure. It was


                                                - 15 -
       yesterday or the day before. He called and I talked to him briefly on the
       phone.

Id. at 1266-67 (emphasis added). In a later interview, she told an investigator she had

spoken with McMahon about her testimony on the day prior to the pretrial hearing. She

was charged and convicted of perjury based on her testimony at the pretrial hearing.

       The defendant challenged her conviction based on the ambiguity of the

prosecutor’s questions. She claimed she understood the prosecutor’s use of the phrase

“here today” to refer to whether she had spoken with McMahon on the day of the pretrial

hearing, and thus answered the question truthfully. Id. at 1267. Although we did not

decide whether the question was fundamentally ambiguous or merely arguably

ambiguous, we found it impossible to discern whether “here today” referred to either

when she “talked” to the defendant or to her “testimony.” Id. at 1270. The context of the

exchange was the key to our decision to reverse her conviction. Read in its entirety, the

context of the questions and answers was consistent with her understanding of the

question, not the government’s interpretation. See id. at 1270.

       Considering Burke’s questions “in light of the testimony as a whole,” the

questions leading to Statements Four and Five were not fundamentally ambiguous. Id. at

1269. Agent Burke testified as follows: after he and Schulte covered Schulte’s

background, they discussed the FMD project. Schulte said the FMD guidewires were not

provided to physicians for use in human patients by members of his staff or by a

consultant. Turning to the BMT project, Schulte said he was currently in negotiations



                                              - 16 -
with a company in Germany. Burke asked Schulte if there were any BMT balloons on

site. He replied there may have been at one time for “use in glass models.” (Appellant’s

App’x Vol. V at 2224.) Burke continued:

       I asked him if he ever physically provided BMT balloons to Dr. Robert
       Gallino or Dr. Craig Walker for use in human patients, and he said that he
       had not. But he added that he recalled that they were possibly, those
       doctors were possibly at Spectranetics on site for use in glass models, to use
       those in glass models.
       ....
       I showed him the forms, and we went over the forms. He said he had never
       seen the forms before.
       ....
       I asked him . . . does this look like . . . these products were used in humans,
       and he said, yes, it did. He acknowledged that based on the responses, it
       looked like the balloons were in fact used in humans.
       ....
       He . . . again said he had never seen the forms before.
       ....
       He said that . . . other personnel were in charge of the BMT project. And
       then I asked him, well, then, was this testing done by rogue employees?
       And I remember him very distinctly saying I don’t know.

(Id. at 2225-27.)

       Burke explained he “didn’t differentiate if [the form] was filled out or not filled

out. It was the form. . . . [Schulte] said he had never seen it before.” (Id. at 2234.)

When again asked about the use of BMT balloons in human patients, Burke said:

       [B]ased on my questioning, particularly involving the BMT PTA catheter
       evaluation forms, . . . I asked him if the testing was done by rogue
       employees. And he said, I don’t know. And so what was conveyed to me
       was that he did not know that Craig Walker and Rob Gallino were supplied
       these . . . BMT balloons by employees for use in human patients.

(Id. at 2237-38.)



                                               - 17 -
       Burke’s testimony was not the only evidence establishing the context of the

interview. Memorandums and notes of the interview were also presented. These notes

reflect, prior to the questions about the evaluation forms, Schulte had affirmatively stated

he had not provided the BMT balloons for use in patients. According to Cruz’s notes:5

       Schulte was asked if BMT balloons were provided to doctors, and he
       claimed “No.”
       Schulte was shown a[n] evaluation form used by SPECTRANETICS for
       doctors to fill out and asked if he was aware of the form. He claimed “No
       he was not.”

(Appellant’s App’x Vol. VIII at 3288) (emphasis added).

       Schulte claims Burke’s testimony shows, as to Statement Four, he was never asked

directly whether any employees had supplied balloons to Drs. Gallino or Walker. He was

asked whether “rogue” employees had done the testing. Therefore, he truthfully replied

he did not know. As to Statement Five, Schulte maintains because Burke did not

distinguish between the completed and uncompleted forms, he truthfully stated he had

never seen the completed forms. But this ignores the contextual evidence.

       If the jury accepted Cruz’s notes, whether Schulte had seen that particular form

before was not the question. While Schulte’s interpretation of the question may not be

unreasonable, it changes the actual question from whether he was aware of “the form” to

whether he was aware of “this completed form.” And even accepting this interpretation,

the evidence showing he had approved the form, and the later conversations discussing


       5
       Burke did not testify as to the specific question he asked Schulte when he
produced the evaluation form.

                                               - 18 -
the reactions of the doctors after using the BMT balloon shows he was “aware” of the

completed form. Similarly, given Schulte’s denials of any knowledge of the clinical use

of the BMT balloons, Burke’s use of the term “rogue” employee does not obfuscate the

meaning of his question. In light of Schulte’s previous statements, if an employee had

initiated the testing it would necessarily have been a “rogue” employee.

       Thus, the questions could be mutually understood by Burke and Schulte within the

context in which they were asked. We do not diminish the importance of “clear, precise

questioning” as a foundation for a false statement or perjury charge. Strohm, 761 F.3d at

1178. In this case, however, it was a question for the jury whether Schulte interpreted the

questions as he claimed. See Farmer, 137 F.3d at 1269 (“[I]n most instances, the

meaning of a prosecutor’s question and the truthfulness of a defendant's answer are best

left to the jury.”). There was no error, let alone plain error in the district court’s denial of

Schulte’s motions for acquittal and for a new trial based on fundamental ambiguity.

B. Sufficiency of the Evidence

       Even if there was no legal error, Schulte argues the government failed: (1) to

present sufficient evidence Statements Four and Five were false; (2) to prove any of his

statements were made with intention of providing false information; and (3) to prove any

statement was material to the FDA investigation. To determine whether evidence is

sufficient to support a conviction, we review all the evidence in the light most favorable

to the government to determine whether a reasonable jury might find the defendant guilty

beyond a reasonable doubt. United States v. Migliaccio, 34 F.3d 1517, 1521 (10th Cir.


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1994). Because his conviction will be affirmed if any one of Schulte’s statements meets

each element of the charge, for the sake of brevity we address only Statement Four.

          1. Sufficient Evidence Schulte Knew Statement Four Was False.

       Schulte maintains the government did not negate his reasonable interpretation of

Burke’s question. An arguably ambiguous question is one which contains more than one

reasonable interpretation. Strohm, 671 F.3d at 1181. When a question is arguably

ambiguous, “a witness can still intend, and in fact give, a response that was literally

false.” Strohm, 671 F.3d at 1181. We review a conviction based on an arguably

ambiguous question to determine whether the government presented evidence sufficient

to negate the defendant’s alleged understanding of the question. Id.

       Schulte relies on United States v. Migliaccio, where the government accused a

doctor of “using incorrect medical terminology” in order to mislead a government agency

to receive payment. 34 F.3d at 1523. The doctor argued the relevant medical terms and

the reporting requirements were ambiguous, that his interpretations were reasonable, and

his reasonable compliance therefore negated his intent to deceive. We said:

       In cases arising under 18 U.S.C. § 1001, which criminalizes making false
       statements to a government agency, the government bears the burden to
       negate any reasonable interpretations that would make a defendant’s
       statement factually correct where reporting requirements are
       ambiguous. . . . It necessarily follows that, where the evidence supports a
       defendant’s position, the jury must be instructed concerning reasonable
       interpretations of ambiguous requirements and the government’s ensuing
       burden.

Id. at 1325 (citations omitted). We reversed and remanded for a new trial.



                                               - 20 -
       Schulte does not claim the jury instructions were flawed, but challenges the

sufficiency of the evidence negating his reasonable interpretation of Burke’s question.

Burke asked if Schulte did not provide the balloons, was it done by rogue employees?

Schulte said he didn’t know. Schulte claims he answered truthfully because Burke only

used the term “rogue employees” and Schulte did not remember any of his employees

providing the BMT balloons to doctors at the time he answered the question. We find the

evidence is sufficient for the jury to conclude he knew his answer was false.

       As discussed above, there was an abundance of evidence contradicting Schulte’s

faulty memory. Numerous witnesses testified about their conversations with Schulte

regarding the clinical use of the BMT balloons, including Sauerteig, who testified the

shipment of balloons was sent because Schulte wanted to test them in clinical studies

before reaching a supply agreement. Moreover, Schulte had been specifically questioned

about the same issues during the recent internal investigation and had several

conversations with Spectranetics’ Board Chairman Geisenheimer on this subject. Finally,

he had approved an evaluation form to assess physicians’ reactions to the product.

Geisenheimer testified that he found Schulte’s forgetfulness incredible. It appears the

jury agreed.

       In addition, the term “rogue employees” was used only after Schulte stated he did

not provide the balloons for clinical use. In the context of Burke’s questions and

Schulte’s previous answers, “rogue” could only be understood to mean employees who




                                              - 21 -
had acted without Schulte’s permission and against the company’s policies. Thus, unlike

Migliaccio, the evidence sufficiently negated Schulte’s explanation.

       Schulte also claims his “prompt and voluntary recantations,” precluded a finding

he knowingly and willingly provided false statements to the FDA. (Appellant’s Br. at 42

n.9.) According to Schulte, as he became aware of the inaccuracies in his statements to

Burke, he corrected and clarified his statements. He asserts “[i]t is not plausible that

Schulte would willfully give false information to the Government, only to turn around

and correct those errors only days later.” (Id. at 42.) However, even though Schulte

testified he remembered the clinical use of the devices when he “corrected” his

statements in September 2008, none of his “prompt recantations” included an admission

he knew his employees gave the BMT balloons to the doctors at his direction. In sum,

the record contains sufficient evidence to support the jury’s determination that, beyond a

reasonable doubt, Statement Four was deliberately false.6

           2. Whether Statement Four Was Material to the Investigation

       Schulte also maintains the government’s evidence was insufficient to show his

statements were material to the investigation. “[T]o establish ‘materiality’ under § 1001,

the government must show that the statement had ‘a natural tendency to influence, or [be]

capable of influencing, the decision of the decisionmaking body to which it was

addressed.’” United States v. Gordon, 710 F.3d 1124, 1144-45 (10th Cir.), (quoting


       6
        Because we find the evidence sufficient to support his conviction, we need not
address Schulte’s lenity argument.

                                               - 22 -
United States v. Gaudin, 515 U.S. 506, 509 (1995)) cert. denied, 134 S. Ct. 617 (2013).

Materiality is a mixed question of law and fact. Gaudin, 515 U.S. at 511-12.

       “Deciding whether a statement is ‘material’ requires the determination of at least

two subsidiary questions of purely historical fact: (a) ‘what statement was made?’ and

(b) ‘what decision was the agency trying to make?’” Id. at 512. Schulte contends his

statements were not material because Burke had already reviewed the e-mails and the

decision to investigate Spectranetics had already been made. In addition, Burke had

already decided who he wanted to interview. Thus, in Schulte’s view, his statements did

not have the capacity to influence any government decision.

       This argument fails to account for the nascent quality of the investigation. As

Burke testified, he had received information from the whistleblowers and was trying to

confirm the information he received and learn the “scope” of the questionable activities.

(Appellant’s App’x Vol. V at 2229.) The FDA, charged with protecting citizens’ health,

was trying to ascertain the number and type of unapproved devices placed into human

patients. Schulte’s statements misdirected the focus of the investigation from a company

policy soliciting clinical trials to the possible, but unknown activities of individual

employees. See Gordon, 710 F.3d at 1145 (statement by attorney that he had no

knowledge of potentially illegal conduct “could have influenced the agency’s decision on

how to craft its investigative focus”); see also United States v. Oldbear, 568 F.3d 814,

825 (10th Cir.2009) (holding that a false statement made to an FBI agent that the

defendant had “no information” regarding the matter under investigation was “material”


                                                - 23 -
under § 1001(a)(2) because the statement related to an issue important to the underlying

investigation). “[F]or testimony to be material, it need not have an actual effect; it

merely must be capable of influenc[e].” See United States v. Hasan, 609 F.3d 1121, 1140

(10th Cir. 2010) (quotation marks omitted). Given Schulte’s position in the company and

his ability to explain the purpose and use of the devices prior to FDA approval, the jury

was provided sufficient evidence to find, beyond a reasonable doubt, Schulte’s statements

could have influenced the agency.

       AFFIRMED.




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