Spectranetics, a medical device maker, has agreed to settle a dispute with the Justice Department for $5 million after allegedly illegally importing unapproved medical devices. Specifically, the company has agreed to pay $4.9 million in civil damages and $100,000 in forefeiture to resolve the claims and will not face criminal charges. According to a Justice Department news release although Spectranetics will not face criminal prosecution, it has accepted responsibility for its actions. The company has also agreed to institute measures to prevent similar conduct and will cooperate in the Justice Department’s ongoing investigation.
Federal officials first began an investigation of Spectranetics on September 4, 2008 on suspiscion that the the company imported medical devices and provided them to physicians for use in patients without federal regulatory approval. Moreover, the Justice Department also alleged that Spectranetics conducted a clinical study that did not comply with federal regulatory requirements.
Spectranetics is best known for making medical laser devices used to clear blockages in coronary and leg arteries. The President and CEO of the company, Emile J. Geisenheimer, recently stated that he was pleased to solve the issues with the government.
recently named in the 2009 edition of Best Lawyer's In America, David Mittleman has been representing seriously injured people since 1985. A partner with Church Wyble PC—a division of Grewal Law PLLC—Mr. Mittleman and his partners focus on medical malpractice, wrongful death, car accidents, slip and falls, nursing home injury, pharmacy/pharmacist negligence and disability claims.