Three former executives of device company Spectranetics have been indicted on charges involving a scheme to import unapproved medical devices into the U.S.
Former Spectranetics execs face charges
Former CEO George “John” Schulte, 62, of Wellesley, Mass., was arrested Monday. Obinna “Larry” Adighije, 50, of Encinitas, Calif., who was vice president of business development, and Trung Pham, 37, a former business development manager who lives in Colorado Springs, Colo., are expected to surrender to authorities Wednesday.
Also facing charges and an arrest warrant is Hernan Ricaurte, 41, of Ladera Ranch, Calif., a representative of a Florida consulting company that helped Spectranetics identify sourcing partners. Ricaurte is out of the country, according to the U.S. attorney's office in Denver, which is handling the case with the Food and Drug Administration.
Spectranetics, a Colorado Springs-based company that sells laser systems for use in surgeries, agreed last year to pay $5 million and cooperate with investigators to resolve its civil and criminal liability in the matter.
The indictment includes e-mails in which the defendants make arrangements to secure guide wires from a company in Japan and balloon catheters from a German company. In others, the defendants arrange evaluations on patients by cooperating physicians. In some of the messages allegedly sent by Schulte and Ricaurte, the Japanese company is asked to alter invoices and packaging to avoid taxes and regulatory scrutiny.
The four defendants are charged with conspiracy, false statements, importation violations, and introduction and receipt of adulterated and misbranded medical devices.
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