Medtronic Corporation and Executives Agree to Consent Decree to Resolve Allegations of Food, Drug and Cosmetic Act Violations
Medical device manufacturer Medtronic Corporation and two of its top executives have agreed to resolve allegations that they violated various provisions of the federal Food, Drug and Cosmetic Act (FDCA) with regard to the company’s SynchroMed infusion pump. At the request of the U.S. 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 in interstate commerce that are adulterated because they were not manufactured in accordance with current good manufacturing processes.
“The proposed consent decree will require Medtronic and its leadership to commit to making changes in their process that will benefit the American public by ensuring that their products are safe and effective for patients,” said Principal Deputy Assistant Attorney General Benjamin C. Mizer of the Justice Department’s Civil Division. “The Department of Justice will not permit medical device manufacturers to shirk their responsibility to ensure that the devices that patients rely upon are safe.”
The defendants design, manufacture and distribute the SynchroMed II implantable infusion pump system, which is used to deliver medication to treat cancer, chronic pain and severe spasticity. Medical devices such as the Medtronic’s SynchroMed system are required to comply with FDA’s quality system (QS) regulations. The complaint alleges that Medtronic repeatedly failed to correct violations of the QS regulations with regard to the SynchroMed II.
The FDA conducted multiple inspections of Medtronic Neuromodulation’s manufacturing facilities in Columbia Heights, Minnesota, between 2006 and 2013. These inspections revealed significant violations of the QS regulations, many of which related to design controls, complaint handling, and corrective and preventive action. Those regulations ensure that when a device is found to have malfunctioned or caused serious injury to a patient, the complaint is thoroughly investigated and necessary validated design changes are implemented. The problems that the FDA observed with the SynchroMed II pump could result in an over- or under-infusion of medication for patients.
Under the terms of the agreement, which must be approved by the court, Medtronic and the two individual defendants have agreed to stop manufacturing, designing and distributing new SynchroMed II pump systems except in extraordinary cases, such as when a treating physician certifies that a SynchroMed II pump is medically necessary for an individual patient’s treatment. The proposed consent decree also requires Medtronic to retain an expert to help Medtronic correct its regulatory violations. Medtronic may not resume distributing the SynchroMed II pump system until it receives permission from the FDA.
“We will continue to work with the Food and Drug Administration and our partners at the Consumer Protection Branch of the Department of Justice to identify and remedy instances in which medical technology manufacturers in Minnesota fail to adhere to best practices,” said U.S. Attorney Andrew M. Luger of the District of Minnesota. “As an industry leader, Medtronic and its executives must adhere to the high-quality manufacturing processes required under the FDCA.”
The matter is being handled by the Civil Division’s Consumer Protection Branch, the U.S. Attorney’s Office of the District of Minnesota and the FDA’s Office of Chief Counsel.