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FDA Consent Decree Halts Most Sales of Infusion Pump

Posted on in FDA

The United States Food and Drug Administration (FDA) announced this week that the agency has filed a consent decree against a medical device manufacturer for repeatedly failing to correct identified violations related to an implantable drug infusion pump. A consent decree is a type of legal settlement in which the manufacturer agrees to follow the court-ordered directives without acknowledgement of fault or guilt. The decree will remain in force until regulators are convinced that the company has addressed and fixed the identified issues.

The SychroMed II Implantable Infusion Pump System is a device designed to deliver medication necessary for the treatment of cancer, chronic pain, and sever spasticity. Medtronic, the manufacturer of the device, says that more 230,000 patients have used a SynchroMed system since it was developed more than 25 years ago. However, inspections by the FDA in 2006 and 2013 identified “significant violations” of federal regulations, including issues related to handling complaints and corrective actions. A warning letter from the FDA in 2012 noted the devices' propensity to stall and subsequently fail to deliver the needed medication.

Finally, in 2013, Medtronic officially notified doctors of several potential problems with the device, revealing that 14 deaths had been associated with the pump. In response, Class 1 recalls were issued to correct the problems, along with promises from the maker to correct the problems. The FDA continued to pursue the action which was made official this week as “defendants are well aware that their practices violate the [Food, Drug, and Cosmetic] Act,” the filing stated. Despite numerous warnings, the administration was not convinced the manufacturer had taken the necessary corrective steps.

The consent decree, expected to be signed by a federal judge in Minnesota, requires Medtronic to halt manufacturing, designing, and distributing new SynchroMed II devices. Limited exceptions may be made in cases of extreme medical necessity. In the meantime, Medtronic must retain a third-party expert to aid in its development and planning of a course of corrective action. Once the provisions in the consent decree are met, the FDA will permit manufacturing and sales of the device to resume, but compliance audit will be required going forward.

If you have been injured by a poorly designed medical device or a device that has failed due to poor quality control, you may be entitled to collect compensation for your injuries. Contact an experienced defective medical device attorney in Waukegan today. We will review your case and work with you every step of the way.

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