Plaintiff Carissa Sullivan, who has cerebral palsy and spastic quadriplegia, claims that the SynchroMed II infusion pump she had implanted in 2011 failed in 2015, causing injuries from withdrawal of the drug baclofen. Baclofen is used to control spasticity. Sullivan claims she needed pump replacement surgery.
SynchroMed is designed to administer a programmed amount of medication into the intrathecal space of the spine. Patients receiving intrathecal baclofen could develop baclofen withdrawal syndrome, which can lead to a life-threatening condition. Sullivan alleges her baclofen withdrawal was caused by manufacturing defects that caused the pump’s motor to stall or seize. Withdrawal from the drug also left her with an inability to void through her urethra, impaired speech, an uncontrollable stutter and panic attacks, she claims.
Sullivan sued Medtronic under Missouri state law. Medtronic argued that Sullivan’s claims are preempted by the 1976 Medical Device Amendments to the Food, Drug and Cosmetic Act, according to the order by Judge Catherine D. Perry of U.S. District Court for the Eastern District of Missouri. Medtronic also argued that Sullivan failed to state plausible claims for relief. Perry denied Medtronic’s motion, finding that the claims are not preempted and that they meet
federal pleading requirements.
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.
Medtronic did not immediately respond to a request for comment.