Medical Devices and DME

April 2, 2015

Medical device maker Medtronic plc and affiliated Medtronic companies,Medtronic Inc., Medtronic USA Inc., and Medtronic Sofamor Danek USA Inc., agreed to pay $4.41 million to resolve allegations they violated the False Claims Act by making false statements to the Department of Veterans Affairs and the Department of Defense regarding the country of origin of certain Medtronic products sold to the US.  Specifically, the government charged Medtronic with selling to the VA and DoD products it certified would be made in the US or other designated countries when in fact they were manufactured in China and Malaysia, which are prohibited countries under the Trade Agreements Act of 1979.  The allegations were first raised in a whistleblower lawsuit filed by three unidentified whistleblowers under the qui tam provisions of the False Claims Act. They will receive a whistleblower award of $749,700.  Whistleblower Insider

February 6, 2015

Minnesota-based medical device manufacturer Medtronic Inc. agreed to pay $2.8M to resolve allegations it violated the False Claims Act by causing physicians to submit false claims to federal health care programs for investigational medical procedures known as “SubQ stimulations” that were not reimbursable. According to the government, Medtronic improperly promoted the procedure and the use of its spinal cord stimulation devices for the procedure even though its safety and efficacy had not been established by the FDA. The charges were first raised in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by former Medtronic sales representative Jason Nickell. He will receive a whistleblower award of $602,000. DOJ

September 18, 2014

New York Attorney General Eric T. Schneiderman announced that 46 states and the District of Columbia have reach a settlement agreement with Minnesota-based company Medtronic to resolve claims under the False Claims Act that Medtronic improperly induced physicians to recommend Medtronic devices to treat cardiac rhythmic disease. New York led a national team composed of members from Oregon, Texas and California to negotiate the settlement. The federal government settled its matter in May of this year. The agreement requires Medtronic to pay the settling states $362,362 which will go to those states’ Medicaid programs. The matter was brought by a whistleblower, Adolfo Schroeder. NYAG

July 28, 2014

Vascular Solutions Inc (VSI), a Minneapolis-based medical device maker, agreed to pay $520,000 to resolve allegations that it violated the False Claims Act by marketing a product for sealing veins without FDA approval.  Specifically, the government charged that VSI marketed and sold its "Vari-Lase Short Kit" for treating perforator veins (which run deep in the leg muscle) even though the FDA approved the device only for treating surface (or superficial) veins.  DeSalle Bui, a former sales representative of VSI, will receive a whistleblower award in an undisclosed amount.  DOJ

May 28, 2014

Medical device manufacturer Medtronic Inc. agreed to pay $9.9M to resolve allegations under the False Claims Act that the company used various types of illegal kickbacks to induce physicians to use pacemakers and defibrillators made and sold by Medtronic. Among the the illegal inducements the government charged Medtronic with using were: 1) paying implanting physicians to speak at events intended to increase the flow of referral business; 2) developing marketing/business development plans for physicians at no cost; and 3) providing tickets to sporting events. The settlement stems from a whistleblower complaint filed by former Medtronic employee Adolfo Schroeder under the qui tam provisions of the False Claims Act. He will receive a whistleblower reward of approximately $1.73M. DOJ