DOJ Files Injunction Against Medtronic
On April 27, 2015, the Consumer Protection Branch of the Department of Justice filed an injunction in the U.S. District Court for the District of Minnesota against the medical device manufacturer Medtronic. The DOJ is seeking a court order to prohibit the company from manufacturing, labeling and distributing SynchroMed II implantable infusion pumps. The Department of Justice filed the action following several failed attempts to force Medtronic to follow FDA regulations concerning medical devices.
Medtronic Signs Consent Decree
On the same day the injunction was filed, executives for Medtronic signed a 27-page consent decree, agreeing to the DOJ’s demands and taking the Synchromed pumps off the market. As long as the court approves the decree, Medtronic will no longer sell the Synchromed pumps, except under special circumstances, such as when a treating physician certifies that a SynchroMed pump is medically necessary. Medtronic must hire an expert to correct its regulatory violations and may not resume distribution of the product until the FDA allows it.
Medtronic’s Many Run-ins with the FDA
Medtronic has a long history of flouting government regulations. The DOJ’s injunction request states that from February through April 2013, the FDA conducted an inspection of a Medtronic manufacturing facility. During the inspection, the FDA found several violations of FDA regulations related to the manufacture of the SynchroMed II implantable infusion pump. Among the many violations, the government determined that that Medtronic failed to establish and maintain adequate design validation procedures to ensure that devices conform to user needs and intended users. The government also found in its inspection that Medtronic violated regulations related to complaint handling and corrective and preventive actions.
In prior inspections of May 2012, January 2011, January 2007, and June 2006, the FDA repeatedly observed violations of FDA’s quality regulations similar to those found in the April 2013 inspection. Warning letters were issued to the company following each such inspection. However, the company failed to improve or address the FDA violations. Based on the several violations of regulations, the SynchroMed pumps have been deemed “adulterated” because they were not manufactured in accordance with current good manufacturing processes.
What Exactly is Wrong with the SynchroMed II Infusion Pump?
According to the DOJ’s website, “The problems that the FDA observed with the SynchroMed II pump could result in over- or under-infusion of medication for patients.” This could result in serious injury to pump users. The SynchroMed II is an implantable device that delivers medication into the intrathecal space according to instructions programmed by a physician. The pump is connected to a thin piece of tubing that is implanted under the skin. The first iteration of the device came on the market in 1988 and has a long history of failure. The FDA has received hundreds of complaints against the device.
On January 14, 2011, the FDA issued a Class I recall for the device because its use could result in the “unintended injection of drugs or fluids into the patient’s subcutaneous tissue at the pump pocket site instead of the pump.”FDA Class I recalls are the most serious level of recall available. On June 3, 2013, the FDA issued another Class I recall for the device, stating that there was a possibility for unintended delivery of medication during the priming bolus procedure, which could result in patients receiving drugs at an unintentionally high rate of infusion into the cerebrospinal fluid. The FDA states this could result in serious injury, including death.
Have You Been Affected by a Faulty SynchroMed II Infusion Pump?
If you have suffered serious injury as a result of a defective SynchroMed II infusion pump, Ashcraft & Gerel’s experienced defective device practice group is here to help. There are significant legal hurdles in pursuing cases against device manufacturers. However, Ashcraft & Gerel has a long track record of success in similar cases and has the expertise to take on large, corporate defendants, including General Electric, and Boehringer Ingelheim. To learn more about your rights, contact our medical device lawyers online or by calling 800-829-7037 today for a free and confidential consultation.