After years of uncorrected problems, and repeated inspections and warnings from the Food and Drug Administration (FDA), Medtronic Corp. has entered an agreement with the Justice Department that halts the sale of most of the company’s SynchroMed infusion pumps.
The consent decree will resolve allegations that Medtronic and two of its executives violated provisions of the federal Food, Drug and Cosmetic Act (FDCA). According to the Justice Department, the pumps were not manufactured in accordance with current good manufacturing processes. Some SynchroMed pumps deliver an over- or under-infusion of medication.
Acting at the request of the FDA, the Justice Department filed a legal complaint and the proposed consent decree in the U.S. District Court for the District of Minnesota. The complaint alleges that Medtronic, S. Omar Ishrak, chief executive officer, and Thomas M. Tefft, senior vice president, have been distributing medical devices that are considered adulterated under the FDCA. The complaint alleges that Medtronic repeatedly failed to correct violations of quality system (QS) regulations.
Between 2006 and 2013, the FDA conducted a number of inspections of Medtronic Neuromodulation’s manufacturing facilities in Columbia Heights, Minnesota. According to the Justice Department press release, the “[d]efendants are well aware that their practices violate the Act.” The FDA “repeatedly warned defendants, both orally and in writing,” about violations that needed correction.
The FDA inspections revealed serious QS violations, many of them related to Medtronic’s design controls, complaint handling, and corrective and preventive actions. These regulations are intended to ensure that when a device malfunctions or causes serious injury to a patient, the incident is thoroughly investigated and necessary design changes are implemented. Since 2006, some SynchroMed pumps were recalled because they could lose battery power and the pump would fail, The Associated Press (AP) reports. Other pumps released too much or too little medication, endangering patients.
SynchroMed implantable drug pumps are prescribed for patients with cancer, chronic pain and severe muscle spasms who do not respond to oral medications or who experience severe side effects when taking them, the Justice Department press release explains. The implanted pump delivers a drug solution to the area surrounding the spinal cord.
A consent decree is a type of legal settlement in which a company agrees to court-ordered actions without admitting fault or guilt. A consent decree must be approved by the court before it can go into effect. Under the terms of the consent decree, Medtronic and the two individual defendants have agreed to halt the design, manufacture, and distribution of SynchroMed II pump systems except in extraordinary cases, for example, when a physician certifies that a SynchroMed II pump is medically necessary for a patient’s treatment, according to the Justice Department. Under the agreement, Medtronic must hire an outside expert to help correct the problems. The consent decree remains in effect until the FDA determines Medtronic has corrected the pump’s problems.