United States v. Schulte, 2014 U.S. App. LEXIS 1079

Schulte, CEO of Spectranetics, was convicted of one count of making false statements to the FDA under 18 U.S.C. § 1001(a) during a post-search interview in 2008.
The five challenged statements concerned unapproved FMD guidewires and unapproved BMT balloons used in human patients, with disputes over whether such use occurred and who authorized it.
Spectranetics pursued negotiations with FMD (Japan) for a guidewire and with BMT (Germany) for balloons; some devices were tested in humans without FDA approval.
Internal investigation and external FDA investigation followed allegations of unethical device use; Schulte initially denied knowledge but later provided corrections and letters.
The district court admitted all five statements to the jury; Schulte challenged Statements Four and Five as legally defective and/or factually insufficient.
The panel affirmed the conviction, addressing whether the questions were properly submitted, whether the statements were false, and whether they were material.

Issue	Plaintiff's Argument	Defendant's Argument	Held
Whether Statements Four and Five were legally permissible	Schulte argued legal error due to fundamental ambiguity or First Amendment concerns.	Government contends no legal error; adequate factual basis to support falsity.	No error; proper submission to jury.
Sufficiency of evidence that Statement Four was false	Reasonable interpretation could render the statement true; argues ambiguity negates falsity.	Evidence shows Schulte knew balloons were used in humans or possibly occurred; misstatement deliberate.	Sufficient evidence that Statement Four was knowingly false.
Materiality of the statements to the FDA investigation	Statements did not influence the agency’s decision because focus was already set on other factors.	False statements could have steered investigation and focus toward rogue actions by employees.	Statements were material; capable of influencing the investigation.

Griffin v. United States, 502 U.S. 46 (U.S. 1991) (conjunctive counts; overwhelming evidence needed for legality of perjury theory)
United States v. Strohm, 671 F.3d 1173 (10th Cir. 2011) (fundamental ambiguity and interpretation in false-statement cases)
Farmer, 137 F.3d 1265 (10th Cir. 1998) (contextual interpretation essential to assess ambiguity)
United States v. Migliaccio, 34 F.3d 1517 (10th Cir. 1994) (ambiguous reporting requirements negate falsity unless government negates reasonable interpretations)
United States v. Gaudin, 515 U.S. 506 (U.S. 1995) (materiality requires the statement to have a natural tendency to influence a decision)