Medtronic ($MDT) is again fighting a suit brought on by a patient who says he was left paralyzed by the company's SynchroMed pain pump, claiming the injury could have been avoided if Medtronic had been quicker to report problems to the FDA.
A judge dismissed the lawsuit earlier this year but granted a rehearing in July, dragging the medical device giant back into the courtroom, Courthouse News reports.
In the lawsuit, Richard Stengel claims that a faulty SynchroMed pump left him paralyzed, and that Medtronic dragged its feet in informing the FDA about manufacturing problems with the implant. Had the company immediately reported the issues plaguing the pumps, doctors and patients could have steered clear of the devices and Stengel's injury would never have happened, his lawyer contends.
Medtronic maintains that it complied with federal regulations, and its attorney says the suit basically amounts to the plaintiffs asking for the company to issue a warning above and beyond what is required by the law.
Ninth Circuit Chief Judge Alex Kozinski will have final say on whether Stengel's suit is revived. Even if the claims fall by the wayside, Medtronic still faces concerns over the pumps. Over the summer, the FDA slapped Medtronic with a warning letter over SynchroMed production, saying it fell short of fully addressing the risk of corrosion in the devices. Last year, the company warned customers that some SynchroMed units had faulty batteries.
- read the Courthouse News story