Articles Posted in FDA

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Stethoscope1-150x150Travis Thams, the whistleblower who filed a False Claims Act (“FCA”) lawsuit on behalf of the United States and 28 states, stands to receive a substantial portion of the $8 million settlement reached with his employer, Cardiovascular Systems, Inc. (“CSI”).

Thams was recruited to CSI to act as a District Sales Manager. He was responsible for selling the entire portfolio of CSI products.

CSI manufactures devices to treat peripheral artery disease (“PAD”). The devices in question are electrically driven and use a diamond-coated “crown” to sand away hard plaque within the arteries. As the crown “spins” at between 60,000 to 120,000 revolutions per minute within the artery, the plaque is effectively “sanded” away, and it restores blood flow.

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WhistleThe U.S. Department of Justice announced today that medical device manufacturer Medtronic Inc. has agreed to pay the federal government $2.8 million to settle a relator’s allegations of fraud brought under the False Claims Act against the Minnesota-based company. Medtronic allegedly caused a number of physicians, located throughout twenty states, to submit false claims to federal health care programs for a medical procedure known as “SubQ stimulation” between 2007 and 2011. As an investigational procedure, it was not eligible for reimbursement. United States ex rel. Nickel v. Medtronic, Inc. was filed in federal court in New York by Jason Nickell, a former Medtronic sales representative. The government subsequently elected to intervene in the case, leading to this settlement. For his role in helping to uncover the fraud, Nickell will receive $602,000.  Continue reading