Medical device giant Medtronic (NYSE:MDT) lost a 9th Circuit Court of Appeals hearing, with a panel of judges ruling unanimously that a case against the medical device giant and its implantable pain pumps may proceed.
The case had been thrown out of court earlier this year when a federal judge dismissed the case of grounds of preemption, which holds that patients can’t sue medical device makers in state courts over products that went through the FDA’s most stringent review process, called pre-market approval.
The 9th Circuit’s 3-judge panel this week decided that plaintiff Richard Stengel, who had the pump implanted into his abdomen in 2000, could proceed with his negligence claims against Medtronic, Thomson Reuters reported.
Medtronic had landed a legal win in the case in April 2012 when the same 9th Circuit Court upheld a lower court’s decision to dismiss Stengel’s case on preemption grounds.
In July the court granted en banc rehearing of the case, meaning it would reconsider the decision in front of the entire court. Typically, the court will grant an en banc rehearing when the case concerns a matter of exceptional public importance, or the panel’s decision appears to conflict with a prior decision of the court.
During the en banc rehearing lawyers for the plaintiff argued that Medtronic had failed to properly provide product updates that would have allowed the FDA to earlier warn physicians and patients about potential issues with the SynchroMed programmable pain pump implants.
"If what should have occurred had occurred, an earlier warning would have gone out," patient lawyer Tom Cotter said in court.
According to the lawsuit, plaintiff Richard Stengel in 2000 began using Medtronic’s SynchroMed EL pain pump, an implanted device that delivers medication directly to the spine via an intrathecal catheter. In 2005, Stengel began developing symptoms of paralysis from an inflammation in his spine around the catheter tip.
The device and most of the inflammation were removed, "but not in time to prevent the granuloma from rendering Stengel permanently paraplegic," according to court documents.
The FDA approved the 1st SynchroMed pump in 1998 and later granted approval for the model used to treat Stengel. Medtronic later recalled that device in 2008.
Medtronic in November 2012 also initiated a recall of its SynchroMed II drug pumps after finding higher-than-expected rates of failure when the devices were used with "unapproved drugs." The company recommended that healthcare providers use the SynchroMed II only with the drugs approved on the device’s labeling.
