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From Health Law Daily, April 28, 2015

Medtronic deflates and suspends manufacturing of infusion pump under consent decree

By Bryant Storm, J.D.

Medtronic Corporation and two of the medical device manufacturer’s executives agreed to a consent decree to resolve allegations that they violated the federal Food, Drug, and Cosmetics Act (FDC Act) (21 U.S.C. §301) by selling adulterated SynchroMed® infusion pumps. The Department of Justice (DOJ) filed a complaint and a proposed consent decree in federal court on Monday, April 27, 2015, alleging that the SynchroMed infusion pumps were being distributed into interstate commerce despite the fact that they were not manufactured in compliance with current good manufacturing processes. Under the consent decree, Medtronic will suspend design, distribution, and manufacturing of the device at issue.

SynchroMed. According to a DOJ press release, the SynchroMed II implantable infusion pump system is used to deliver medication to treat cancer, chronic pain, and severe spasticity. Medtronic’s SynchroMed II system is required to comply with the FDA’s quality system (QS) regulations.

Complaint. According to the complaint, multiple FDA investigations, between 2006 and 2013, revealed that Medtronic’s manufacturing facilities were producing the SynchroMed II system without adequate design validation procedures, risk analyses, or documentation. The investigations also identified failures in the establishment and maintenance of “procedures for verifying the device design.” The complaint further alleges that Medtronic received several notices that the practices did not comply with federal regulations. The problems that the FDA discovered with the SynchroMed II pump presented a risk of over- or under-infusion of medication for patients. The manufacturer received warning letters related to the FDA after inspections in 2006, 2007, and 2012. Despite Medtronic’s promises to correct the manufacturing failures, the complaint alleges that the manufacturer persisted in its regulatory violations. The complaint asserts that without restraint through a permanent injunction, Medtronic will continue to violate manufacturing standards with respect to its SynchroMed II device.

Consent Decree. Under the consent decree, Medtronic agreed to suspend the manufacture, design, and distribution of the SynchroMed II system. The suspension will be in effect until the FDA determines that Medtronic’s manufacturing facilities have returned to compliance with the QS regulations. Under the decree, Medtronic must retain an expert to conduct inspections of the manufacturing operations and assist the manufacturer in correcting the noncompliance. Medtronic is also obligated to develop a work plan based upon the expert’s findings. There are some exceptions to the suspension of the manufacturer of the SynchroMed II system. For example, in the case of a medical emergency where a treating physician certifies a patient’s need for the device, Medtronic may provide a SynchroMed II device.

Companies: Medtronic Corporation

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