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Wednesday, January 29, 2014

FDA Law Blog Reminder from Tenth Circuit Regarding Making False Statements to the Government

Tenth Circuit Affirms False Statement Conviction: Lesson Learned

By Anne K. Walsh
While the mid-Atlantic region was paralyzed under 4 to 8 inches of snow, it was business as usual for the Tenth Circuit Court of Appeals in Colorado.  On January 21, 2014, the court issued an opinion affirming the felony conviction of John Schulte, former CEO of The Spectranetics Corporation, for making a false statement to the government. 
The woes of the company date back to 2008, when a former employee alleged that it was marketing unapproved devices brought into the country illegally.  The company’s Board of Directors ordered an internal investigation, but the investigation did not result in any finding of wrongdoing.  Later that year, the government learned of the same allegations brought to the Board, and quickly executed a search warrant.  It was during this search that Schulte voluntarily agreed to provide an interview to federal law enforcement agents.  The statements he made during that interview five and a half years ago continue to haunt him today.
As readers may recall (see our previous post here), the company entered into a settlement with the government in 2009 in which it agreed to pay a $5 million civil penalty.  The government decided not to criminally prosecute the company, and instead allowed the company to enter into a non-prosecution agreement that required cooperation in the government’s ongoing criminal investigation of certain individuals, including Schulte.
In 2010, the government indicted Schulte on twelve separate counts, but after a four-week jury trial in 2012, a jury acquitted him of all but one of those counts: making false statements under 18 U.S.C. § 1001.  The court’s sentence was lenient, requiring only one year of probation, a $5000 fine, and 100 hours of community service.  (The court rejected the government’s sentencing request for two years of prison and three years of probation.) 
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