Kirk Bledsoe sued Medtronic in Indiana state court in 2017 after the company’s Synchromed II pain pump, which Bledsoe had implanted in 2011, failed on two occasions and had to be removed. Bledsoe claimed the pump had design and manufacturing defects and that Medtronic failed to notify him that the pump had been recalled 10 times between March 2008 and March 2017, even though Medtronic representatives were present on two occasions when Bledsoe was examined.
The pump continued to malfunction until it stalled completely in 2016, when it was removed, according to the judge’s order.
The SynchroMed II pump has a history of customer complaints and recalls. The pumps are used primarily to treat chronic pain or severe spinal or cerebral spasticity. The initial issue with the device, reported in July 2009, relates to the formation of a filmy substance within the pump battery that can lead the device to shut down suddenly, causing a patient’s pain and symptoms to return or triggering withdrawal symptoms. Returned product analysis proved the failed devices’ alarms functioned as designed, Medtronic said at the time.
Medtronic confirmed 55 cases of the devices failing as of May 32, 2011, including one death attributed to baclofen withdrawal syndrome. The company reached a $35 million settlement in April 2019 with about 500 people who claimed they had been harmed by it.
In 2015, after the U.S. Justice Dept. filed a legal complaint against Medtronic in relation to the issues with the SynchroMed II pump, Medtronic agreed to halt production of the devices after the FDA reported that the company failed to correct violations found by the agency.
Judge Theresa Springmann ruled on Friday that Bledsoe could not sue the company under Indiana law for the alleged design defect or the recall notifications, but that Medtronic must face Bledsoe’s claim of a manufacturing defect.
Medtronic argued that Bledsoe did not cite a specific federal regulation that was violated or show how the company’s violation of a federal requirement and caused his injury. The judge was not persuaded.
“To prevail on his claim, the plaintiff will ultimately have to specify a violation of a particular federal requirement and will have to prove that his injury was the direct and proximate cause of that violation,” Springmann wrote in Friday’s order. “However, such a requirement is not imposed at this point in the
proceedings. Therefore, to the extent the plaintiff’s complaint alleges that his injuries were
caused by a manufacturing defect in the production of his medical device and that the defect was
caused by a violation of the federal requirements, his claim is properly pled and not preempted.”