A 70-year-old man may proceed with a lawsuit claiming that Medtronic’s SynchroMed II infusion pump is defective and that the company was negligent in manufacturing it.
A U.S. District Court judge in West Virginia last week denied Medtronic’s motion to dismiss the lawsuit brought by John David Brumfield, who claims that the pump in the SynchroMed II device he had implanted in 2012 to treat back pain stopped delivering the pain medication hydromorphone in 2018.
Brumfield went to the emergency room in September 2018 complaining of severe muscle and joint pain, chills, sweats, anxiety, depression and severe diarrhea. His doctor recommended replacing the device’s pump, and the surgeon found the pump’s motor had stalled, according to the court order. Brumfield sued Medtronic in 2020 and Medtronic filed for dismissal.
Judge Robert C. Chambers ruled against both of Medtronic’s arguments for dismissal. While other jurisdictions accept that FDA premarket authorization of a Class III medical device exempts its manufacturer from manufacturing defect lawsuits, the Southern District of West Virginia does not, Chambers wrote in his order.
Chambers also noted that Brumfield’s claim details several warning letters, recalls and lawsuits concerning the SynchroMed II Device and identifies those which may have affected the device Brumfield had implanted.
SynchroMed II has been dogged by troubles — so many that Medtronic agreed in 2019 to create a settlement fund worth some $35 million to compensate those who say they were harmed by it.
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.
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 concerning 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.
Medtronic did not immediately respond to a request for comment on Chambers’ order.