A case that tested the FDA's authority over imported parts for medical device manufacturing is nearly complete with former Spectranetics ($SPNC) CEO John Schulte being sentenced to a year of probation and a $5,000 fine.
Schulte, who left the medical laser manufacturer in 2008 after a probe into the company's practices was initiated by the FDA and other authorities, was convicted of only one count of lying to federal investigators. He was acquitted, after a 5-week trial, of about a dozen other charges ranging from defrauding the government to smuggling unapproved medical devices into the country, reports The Colorado Springs Gazette. Schulte could have received up to three years in prison and a fines of up to $250,000. Prosecutors sought two years in jail and three years of probation.
The indictment alleges that Schulte and others imported unapproved devices and avoided FDA oversight. It said they concealed their actions not only from the FDA and the Department of Homeland Security, but also from internal investigators at Spectranetics.
Two other former Spectranetics executives, Trung Pham and Obinna Adighije, also had all federal charges dropped against them, according to the story. Hernan Ricuarte, a consultant to the company, pleaded guilty in August to participating in the alleged scheme by sending an email to a Spectranetics employee that suggested using bogus invoices for non-FDA approved catheter guidewires. Spectranetics itself settled the investigation in 2009 when it paid $5 million in penalties and forfeitures, according to the Gazette.
- read the Gazette story
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