Federal Government Crack-Down on Health Care Fraud During Fiscal 2014 Results in $3.3 Billion in Judgments and Settlements

Crack-Down on Health Care Fraud Results in $3.3B in 2014

Crack-Down on Health Care Fraud Results in $3.3B in 2014

A joint report issued by the U.S. Department of Justice and the U.S. Department of Health and Human Services shows that during the fiscal year 2014, the federal government netted $3.3 billion in judgments and settlements related to health care fraud allegations.

The report details high-profile actions taken against such medical device giants as Boston Scientific and its Guidant subsidiaries, Abbott Laboratories, Inc., Genzyme Corp., CareFusion Corp., Medtronic, Smith & Nephew and Omni Surgical L.P. (also known as Spine 360), according to JDSupra Business Advisor (JDSupra). [Read more…]

Medtronic Reaches Financial Agreement with the Government Over False Claims Act Violation

Medtronic Reaches Financial Agreement with the Government

Medtronic Reaches Financial Agreement with the Government

On Thursday, the U.S. Department of Justice announced that it had reached an agreement with Medtronic, Inc. for violation of the False Claims Act. The medical device maker will pay $4.4 million to settle the allegations.

The violation centers on false statements made by Medtronic concerning the sale of medical equipment to the U.S. Department of Defense and the U.S. Department of Veteran Affairs during an eight-year period from January 2007 to September 2014. During that time, the medical device maker claimed the equipment was manufactured in the United States when they had actually been made in China and Malaysia, according to NASDAQ. [Read more…]

Medtronic Settles Whistleblower Allegations over SubQ Stimulation for $2.8 Million

Medtronic Settles Whistleblower Allegations

Medtronic Settles Whistleblower Allegations


Medtronic has reached a $2.8 million settlement with the United States to resolve allegations under the False Claims Act that it caused false claims to be submitted over SubQ stimulation. According to a news release from the Department of Justice (DOJ), the company promoted the procedure despite knowing that its safety and efficacy had not been established by the U.S. Food and Drug Administration (FDA).

“Today’s settlement demonstrates our commitment to ensure that beneficiaries of federal health care plans, including Medicare recipients and military families, receive medical treatments that have been proven safe and effective,” said Acting Assistant Attorney General Joyce R. Branda of the Justice Department’s Civil Division in the release. “Targeting chronic pain patients with a medical procedure that lacks evidence of clinical efficacy wastes the country’s health care resources.” [Read more…]

FDA Issues Safety Warning on Use of Bone Graft Devices in Patients Under 18

FDA Issues Safety Warning on Use of Bone Graft Devices

FDA Issues Safety Warning on Use of Bone Graft Devices


In a safety communication addressed to healthcare providers, patients, and parents and guardians, the Food and Drug Administration is warning that bone graft devices containing recombinant proteins or synthetic peptides can cause serious injury when used in patients under age 18.

Certain recombinant proteins and synthetic peptides mimic natural bone growth substances and these may be added to a device that is surgically implanted in a patient with a bone defect to promote new bone growth or to replace or heal existing bone. The FDA has approved devices such as Medtronic Infuse for orthopedic and dental use only in patients over the age of 18 who have finished growing (skeletal mature). The labeling for each product provides the specific indications for use. The FDA has not evaluated the safety and effectiveness of these devices in patients under age 18, whose skeletons are considered immature. Any product that affects bone growth could negatively impact skeletal development by altering normal bone formation and growth, especially if implanted near open growth plates, the FDA explains. [Read more…]

Class I recall issued on Medtronic SynchroMed drug infusion pumps

Class I recall issued on Medtronic SynchroMed drug infusion pumpsA Class I recall has been issued on Medtronic’s SynchroMed II drug infusion pumps.

The recall was deemed necessary after the manufacturer admitted that the motor can stall on the devices, especially when they’re used to dispense unapproved drug treatments. The recall includes SynchroMed II infusion pumps manufactured from May 1998 until November 2012. They were distributed from April 1999 until November 2012.

A Class I recall from the Food and Drug Administration means that use of a medical device or drug will likely result in serious injuries or death.

The recall includes the following SynchroMed drug infusion pumps: SynchroMed II, models 8637-40 and 8637-20 (The SynchroMed II Pump is supplied in 20 ml or 40 ml reservoir sizes.) and the SynchroMed EL, models 8626-10, 8626L-10, 8626-18, 8626L-18, 8627-10, 8627L-10, 8627-18, 8627L-18. [Read more…]