WASHINGTON D.C. — The U.S. government is suing Medtronic, the Minnesota medical manufacturing giant, for failing to obey federal laws.
The U.S. Attorney General’s office filed a lawsuit in federal court against Medtronic earlier this month. They are asking for a permanent injunction against the company, which means they want the court to order Medtronic to shape up its operations. Since 2006, the FDA has found Medtronic in violation of federal laws that deal with quality system regulation. Specifically, the company is violating laws that ensure medical devices and products are safely and effectively made, packed, stored, and installed.
The lawsuit was filed shortly after the FDA banned Medtronic from manufacturing the SynchroMed II Implantable Infusion Pump towards the end of April. Citing the failure to meet the quality system regulations mentioned earlier, the company is banned from manufacturing, designing, or distributing the device.
The FDA inspects medical manufacturer facilities on a regular basis. In this case, government inspections have found Medtronic in violation of various quality control regulations in 2006, 2007, 2011, 2012, and 2014. The fact that the government has to resort to a lawsuit means the FDA does not believe Medtronic has or will take any steps to fix its operations so that medical products are safely and properly made. The company has been fully aware of the problems and failures to pass inspection, but has not made any effort to change. If the court rules in favor of the government, Medtronic will have to stop manufacturing specific medical devices and shipping them.
Implantable Infusion Pumps at Issue
The medical device most at risk here (i.e. the one in which many violations occurred) is the Medtronic SynchroMed II implantable infusion pumps. These pumps are used to store and deliver medication at specific programmable rates and times. It is most often used to deliver pain and other medication used to treat metastatic cancer.
The device has been subject to many lawsuits and a Class I recall in 2012, so it is disconcerting that Medtronic is not doing everything it can to ensure the device is made properly. The recall occurred after it was determined the pump’s performance suffered negatively if unapproved drugs were used with it. The failure rate jumped from 2.4 percent to 7 percent when unapproved drugs were used. Pump failure means it would pump irregularly, the motor stalled, or the drugs were not delivered. Improper drug delivery or lack of delivery can lead to death depending on the patient’s condition.
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