Medtronic, Inc. Hit with a Consent Decree for Repeatedly Failing to Correct Manufacturing Problems with its Synchromed II Implantable Infusion Pump Systems

Medtronic, Inc. Hit with a Consent Decree for Pump Systems

Medtronic Hit w/Consent Decree for Pump Systems

The U.S. Food and Drug Administration (FDA) has filed a consent decree against Medtronic. Inc., and two of the company’s officers – S. Omar Ishrak and Thomas M. Tefft – for repeatedly failing to correct violations relating to the manufacture of Synchromed II Implantable Infusion Pump Systems. The agency announced the legal action against the medical device maker on Monday.

The Synchromed II Implantable Infusion Pump Systems deliver medication to treat primary or metastatic cancer, chronic pain and severe spasticity. The device was approved by the FDA in 2004, and problems with the manufacture of the systems came to light in 2006. These problems can result in over- or under-infusion or a delay in therapy for patients. The FDA said in a press release on the agency’s website that the violations occurred at Medtronic’s Neuromodulation facilities in Columbia Heights, Minnesota, where the Synchromed II Implantable Infusion Pump Systems are made. [Read more…]

FDA Files Consent Decree Against Medtronic, Halting Sales of SynchroMed Implantable Drug Pumps

FDA Files Consent Decree, Halting Sales of SynchroMed Pumps

FDA Files Consent Decree, Halting Sales of SynchroMed Pumps

On Tuesday, the Food and Drug Administration (FDA) announced the filing of a consent decree against medical device maker Medtronic, Inc., and two of the company’s officers, CEO S. Omar Ishrak and senior vice president Thomas M. Tefft, for their repeated failure to correct violations related to the manufacture of the SynchroMed II Implantable Infusion Pump Systems. These pumps deliver medication to treat primary or metastatic cancer, chronic pain, and severe spasticity.

The violations occurred at Medtronic’s Neuromodulation facilities in Columbia Heights, Minnesota, where the pumps are manufactured, according to the FDA. The consent decree cites violations of the quality system (QS) regulation for medical devices, “which requires manufacturers to have processes in place to assure that the design, manufacture and distribution of a device allows for its safe use.” [Read more…]

Medtronic Must Stop Sales of Most SynchroMed Implantable Drug Pumps

Medtronic Stops Sales of SynchroMed Implantable Drug Pump

Medtronic Stops Sales of SynchroMed Implantable Drug Pump

Medical device manufacturer Medtronic Corporation and two of its top executives have reached an agreement with the Justice Department to resolve allegations that they violated provisions of the federal Food, Drug and Cosmetic Act  (FDCA) with respect to the company’s SynchroMed infusion pump. Medtronic must stop most sales of its implantable drug pumps after years of uncorrected problems.

At the request of the Food and Drug Administration (FDA), the Justice Department today filed a complaint and a proposed consent decree in the U.S. District Court for the District of Minnesota. The complaint alleges that Medtronic, its chief executive officer, S. Omar Ishrak, and its senior vice president, Thomas M. Tefft, have been distributing medical devices that are deemed adulterated because they were not manufactured in accordance with current good manufacturing processes, according to a press release from the Justice Department. [Read more…]

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…]