Medical Devices and DME

March 23, 2018

Massachusetts-based medical device manufacturer Alere Inc. agreed to pay $33.2 million to resolve allegations that Alere violated the False Claims Act by causing hospitals to submit false claims to Medicare, Medicaid, and other federal healthcare programs by knowingly selling unreliable point-of-care diagnostic testing devices marketed under the trade name Triage. According to the government, Alere received customer complaints that put it on notice that certain devices it sold produced erroneous results that had the potential to create false positives and false negatives that adversely affected clinical decision-making. Nonetheless, the company failed to take appropriate corrective actions until FDA inspections prompted a nationwide product recall in 2012. The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by Amanda Wu, who formerly worked for Alere as a senior quality control analyst. She will receive a whistleblower award of roughly $5.6 million from the proceeds of the government's recovery. DOJ

March 8, 2018

Massachusett’s-based Abiomed, Inc. agreed to pay $3.1 million to settle claims of violating the False Claims Act and Anti-Kickback Statute by purchasing lavish meals for physicians in order to induce them to use Abiomed’s Impella line of heart pumps. The allegations originated in a whistleblower lawsuit filed under the qui tam provisions of the False Claims Act by a former Abiomed employee. The whistleblower will receive an award of $542,500 from the proceeds of the government’s recovery. DOJ (MA)

January 23, 2018

California medical device company DJO Global Inc. agreed to pay $7.62 million to resolve allegations that its Minnesota subsidiary Empi Inc. submitted false claims to TRICARE for excessive, unnecessary transcutaneous electrical nerve stimulation electrodes that TRICARE beneficiaries did not need or use. TENS is a therapy that uses low-voltage electrical current for pain relief. DOJ

September 20, 2017

New Jersey-based durable medical equipment supplier R&V Medical Supplies LLC and its former owner Victor Saul agreed to pay $220,000 to settle charges of violating the False Claims Act by engaging in a scheme to defraud Medicare by billing for equipment not properly authorized by a physician or not actually provided. DOJ (EDPA)