A federal judge in Missouri has blocked an effort by Medtronic (NYSE:MDT) to dismiss a lawsuit alleging that the failure of one of its infusion pumps caused “severe and permanent injuries.”


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.

Source: Mass Device

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