Medtronic (NYSE:MDT) last week reportedly agreed to create a settlement fund worth some $35 million to compensate those who say they were harmed by the SynchroMed II intrathecal drug pump.
The settlement involves about 500 people who claimed harm came from use of the pain-fighting pump, represented by three law firms that are negotiating individual settlements. A master settlement was dated in April of this year, but the Minneapolis Star Tribune reported that at least one plaintiff has not yet received funds.
“Over the years, Medtronic has reached various agreements resolving certain claims related to the SynchroMed infusion system. Terms of those agreements are confidential,” Medtronic spokeswoman Michelle Claypool told the newspaper. “These agreements are a compromise between the parties of disputed claims that avoids the costs and disruptions of continued litigation and is in no way an admission of liability or wrongdoing by Medtronic.”
The implantable pain-fighting 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.
There were 55 confirmed cases of the devices failing as of May 32, 2011, Medtronic said back then, including one death attributed to baclofen withdrawal syndrome.
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.
In a letter dated April 2017 sent to European doctors, Medtronic updated the numbers for pumps with batteries made from March 2005 through December 2010. The company said there was a 0.13% cumulative probability for pump failure at 72 months due to the issue.
Shares of MDT were up +0.2% at $107.56 per share in mid-morning trading today.
