Government Spanks Medtronic Over Pain Pump

The FDA has stopped fooling around and on April 27, 2015 asked the U.S. Justice Department to file a complaint and proposed consent decree with a federal judge regarding Medtronic plc’s SynchroMed drug infusion system and the Neuromodulation quality system.

“Adulterated” Devices

The complaint alleges that Medtronic, its Chief Executive Officer Omar Ishrak and Senior Vice President Thomas Tefft, have been distributing medical devices in interstate commerce that are adulterated because they were not manufactured in accordance with current good manufacturing processes.

“Defendants are well aware that their practices violate the [Food, Drug and Cosmetic] Act, ” states the government filing. “FDA has repeatedly warned defendants, both orally and in writing, about their violative conduct.”

The company and government have agreed to resolve the allegations through the consent decree and Medtronic will be legally required to hire an outside expert to help correct the problems before manufacturing and selling any more of the devices. The decree outlines steps the company must take to address the FDA’s expectations. The company says its efforts are focused on “the implementation of design changes to address issues the company has previously communicated, and on enhancing the Neuromodulation quality system. The agreement also includes a defined process by which Medtronic can continue to provide physicians with access to the infusion system for patients.”

Repeated Warnings

The FDA issued the company three warning letters about quality control and manufacturing problems at its drug pump facility in Columbia Heights, Minnesota, between 2006 and 2013. The government said FDA inspectors visited the plant five times over that period. The inspections revealed significant violations of the quality system (QS) regulations, many of which related to design controls, complaint handling, and corrective and preventive action.

Medical devices such as the SynchroMed system are required to comply with FDA’s QS regulations. The complaint alleges that Medtronic repeatedly failed to correct QS regulations violations.

Treating Chronic Pain

The infusion pumps are implanted devices used primarily to treat chronic, intractable pain, severe spasticity and cancer. The medication is delivered through a catheter directly to the intrathecal space surrounding the spinal cord. Some Synchromed pumps had to be recalled because they could lose battery power and fail, endangering patients. In other cases, the devices could cause patients to receive too much or too little medication.

No Recalls

The company said there is no requirement to retrieve any Medtronic products and patients do not need to change their current course of therapy, have the pump removed, or take any other action as a result of this agreement.

“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.”