A US District Court Judge in West Virginia denied the request by the medical device manufacturer, Medtronic, to dismiss a complaint filed by a 70-year old man, who alleged the manufacturer’s SynchroMed II pump was defective, DrugDeliveryBusiness.com reports.
In the complaint, the plaintiff alleges that Medtronic is negligent in manufacturing the medical device, which delivers an infusion of pain-relief medication, such as hydromorphone, in order to manage chronic pain. The pump was developed in order to minimize the risk of side effects more associated with oral pain medication.
The plaintiff had the SynchroMed II pump inserted in 2012 to treat back pain. But he claims the device stopped working in 2018. In September of that year, the plaintiff was admitted to the ER. He was experiencing severe muscle and joint pain, chills, sweats, anxiety, depression and severe diarrhea. His doctor recommended replacing the device’s pump. Ultimately, his surgeon discovered that the pump’s motor had stalled. The plaintiff sued Medtronic last year.
The judge ruled that Medtronic’s position that because of the fact that other jurisdictions accept FDA premarket authorization of a Class III medical device, it is exempt manufacturing defect lawsuits, has no standing; the Southern District of West Virginia does not accept the premarket authorization exemption.
The Judge’s decision was also influenced by the plaintiff’s inclusion of several warning letters, recalls and lawsuits concerning the pain-pump device in his claim.
Medtronic is no stranger to lawsuits when it comes to its SynchroMed II pump. In fact, two years ago, the company set aside $35 million for a compensation fund for those who claim they were harmed by the device.
The first problem with the device was documented over a decade ago, when in 2009, it was discovered that the pump’s battery can develop a filmy substance. When this occurs, the battery can malfunction and the device suddenly powers off. Consequently, when those with the pain pump are denied pain medication, they can develop withdrawal symptoms, and their pain can return. When the battery suddenly stops working, the device is supposed to trigger an alarm. However, the alarms failed to operate properly.
Medtronic, in 2011, issued a warning that there were 55 confirmed cases of faulty devices. And in one of those cases, one death resulted, which was attributed to withdrawal of the deceased’s pain medication, baclofen.
By 2013, four defects were found in the device, and by that same year, 14 deaths would be associated with the SynchroMed II pump.
Four years later, Medtronic agreed to stop manufacturing the SynchroMed II pump, after the U.S. Justice Dept. filed a legal complaint against the company. Ultimately, the FDA determined that Medtronic failed to correct violations found by the agency.
In 2017 Medtronic announced that for the SynchroMed II pumps manufactured between 2005-2010, 0.13% of the devices failed by month 72.
The device, which was also used for spinal spasticity, which affects those with multiple sclerosis, cerebral palsy, stroke, and other conditions, was recalled in 2019.