A federal appeals court has affirmed the conviction of the former head of a medical device company on charges of making false statements to the U.S. Food and Drug Administration.
John Schulte, the former chief executive officer of Spectranetics Corp. in Colorado Springs, was convicted in 2012 on one count of making false statements but acquitted on 11 other counts, including conspiracy, in a case alleging the company illegally brought in unapproved devices from foreign manufacturers. He was sentenced to one year of probation.
Schulte had appealed the judgment entered by U.S. District Judge Wiley Daniel of Colorado. He asserted legal error, claiming he misunderstood the agent’s questions. He also claimed that two of the statements at issue weren’t false and that federal prosecutors had failed to prove he intended to lie or that his statements were material to their investigation.
The U.S. Court of Appeals for the Tenth Circuit on Tuesday disagreed with Schulte’s argument that the FDA agent’s questions were ambiguous. The court found that his statements weren’t true and that all were material to the investigation.
“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,” the panel wrote.
Schulte’s attorney, Thomas Kirsch, a partner at Chicago’s Winston & Strawn, did not return a call for comment, and Jeffrey Dorschner, a spokesman for the U.S. attorney’s office in Denver, which prosecuted the case, declined to comment.
Spectranetics makes laser medical devices used to remove blockages in arteries. Schulte was CEO until 2008, when the FDA, acting on tips from former employees, executed a search warrant of his company’s offices.
In 2010, Schulte, along with two other former executives and a representative of Spectranetics, was charged with conspiring to obstruct the FDA and U.S. Customs and Border Protection by importing medical devices into the United States that hadn’t been cleared or approved by federal authorities.
Spectranetics previously reached a $5 million settlement in the case and agreed to cooperate.
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