Man was rendered paraplegic after surgeons implanted a system that infuses pain medication into the spine. The U.S. Supreme Court refused to stop a lawsuit against Medtronic by a man who was rendered paraplegic after surgeons implanted a system that infuses pain medication into the spine.
In their ruling yesterday, the justices left intact a federal appeals court decision allowing the to go forward, Bloomberg News reports. The accuses Medtronic of failing to tell federal regulators about previous problems with the SynchroMed EL pump and catheter.
Medtronic argued that patients can’t use state law to sue device makers for allegedly violating a duty under federal law. The appeals court rejected that argument, allowing the suit brought by an Arizona man and his wife to proceed. (The man has since died, Bloomberg reports.)
In previous Supreme Court decisions, the justices have interpreted the federal law that governs medical-device approval
In previous Supreme Court decisions, the justices have interpreted the federal law that governs medical-device approval as limiting the types of suits patients can bring, according to Bloomberg News. In a 2008 ruling, the court said device makers can’t be subjected to additional requirements under state product-liability law, but that ruling left room for patients to sue under state rules that “parallel” federal requirements. The U.S. Circuit Court of Appeals for the 9th District said the claims by the plaintiffs met the test and could, therefore, go forward.
In 2013, the Wall Street Journal reported that 14 deaths have been linked to SynchroMed infusion systems, the majority occurring when patients implanted with the device either went into withdrawal or overdosed. Various models of the pump have been recalled over issues including patients accidentally being injected with drugs during a procedure, and because of blockages, which stop the flow of medication, and electrical, which can injure the patient. A 2008 recall occurred because the FDA found that the SynchroMed El Implantable Infusion Pumps stalled at an unusually high rate.