The U.S. Department of Justice announced on October 29, 2020 that Minnesota-based medical device maker Medtronic USA Inc. (“Medtronic”) has agreed to pay $8.1 million to resolve allegations that it violated the False Claims Act by paying kickbacks to induce… Read More
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Medical Device Manufacturer To Pay $18M To Settle Illegal Kickbacks Allegations
The U.S. Department of Justice announced on October 14, 2020 that medical device manufacturer Merit Medical Systems Inc. (“MMSI”) of South Jordan, Utah has agreed to pay $18 million to resolve allegations that the company caused the submission of false… Read More
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Study Finds Medical Device Manufacturers’ Payments To Physicians Influenced Their Device Selection
A study published on November 3, 2020 in JAMA Network entitled “Association Between Industry Payments to Physicians and Device Selection in ICD Implantation” concluded: “In this cross-sectional study, a large proportion of ICD or CRT-D implantations were performed by physicians… Read More
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Spine Surgeon And Medical Device Distributor Agree To Plead Guilty To Illegal Kickback Scheme
The U.S. Attorney’s Office for the District of Massachusetts announced on August 18, 2020 that a Missouri surgeon and Kansas medical device distributor have been charged and agreed to plead guilty to conspiring to pay and receive kickbacks aimed at… Read More
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Federal Appellate Court Reinstates Pelvic Mesh Lawsuit As Timely Filed
The United States Court of Appeals for the Sixth Circuit (“Federal Appellate Court”), in its opinion filed on August 13, 2020, stated, “Karla Parton appeals the district court’s dismissal of her product-liability suit against Johnson & Johnson and Ethicon, which… Read More
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Class I Recall Of Abdominal Stent Graft
The FDA has announced a Class I recall, the most serious type of recall, of all lots of Endologix Ovation iX Abdominal Stent Graft System manufactured from 2015 to the present, which involves 5,403 such medical devices. The Ovation iX… Read More
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Bayer Agrees To Pay $1.6 Billion To Resolve Approximately 35,000 Essure Claims
On August 20, 2020, Bayer announced that it has reached agreements with plaintiff law firms to resolve approximately 90% of the nearly 39,000 total filed and unfiled U.S. Essure™ claims involving women who allege device-related injuries. The settlements include all… Read More
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FDA Announces Voluntary Recall Of Two Coronary Catheters
The FDA announced on February 20, 2020 that Abbott has voluntarily recalled specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm… Read More
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Tenet Healthcare And An Affiliated Hospital Agree To Pay $1.41M For Allegedly Implanting Unnecessary Cardiac Monitors
The U.S. Department of Justice announced on February 11, 2020 that Tenet Healthcare Corporation and its affiliated hospital Desert Regional Medical Center (DRMC), a general medical and surgical hospital located in Palm Springs, California, have agreed to pay $1.41 million… Read More
