In a ruling issued yesterday, the U.S. Supreme Court has allowed a lawsuit to go forward against medical device maker Medtronic. The suit was brought by a man who was rendered paraplegic after the implantation of a pump system that infuses pain medication into the spine.
In the ruling, the justices left intact a federal appeals court decision that allowed the suit to go forward, Bloomberg News reports. The suit accuses Medtronic of failing to tell federal regulators about previous problems with the SynchroMed EL pump and catheter.
Medtronic argued that patients cannot 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 earlier decisions, the justices interpreted the law governing 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 the ruling left open the possibility that patients could 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 in the Medtronic case met the test and could go forward.
Last year the Wall Street Journal reported that 14 deaths have been linked to SynchroMed infusion systems. The majority of the deaths occurred when patients with the device either went into withdrawal or overdosed SynchronMed El Implantable Infusion pumps have been recalled for a variety of issues. Some patients have accidentally been injected with drugs during a refill procedure and in other instances blockages stopped the flow of medication. Some units had electrical shorts, which can injure the patient. The 2008 recall occurred because the FDA found that SynchroMed pumps stalled at an unusually high rate.