Abbott (NYSE:ABT) subsidiary St. Jude Medical must face a negligence lawsuit brought over its recalled Riata defibrillator leads after a federal judge ruled that the case is not pre-empted by federal rules.
Plaintiff Kristen Bull was implanted with a St. Jude implantable cardioverter defibrillator using Riata leads in November 2010, just a month before the company pulled the silicone-coated wires after finding that some of the internal conductors had worn through their insulation.
In November 2011 the company warned that the Riata leads appeared to fail more frequently than previously reported, leading to a Class I recall from the FDA. St. Jude settled a raft of Riata product liability lawsuits in February 2015, ahead of its $25 billion acquisition last year by Abbott.
Bull was in a plane on the tarmac in October 2015 when her ICD malfunctioned, firing six times, according to court documents. Her ICD was subsequently deactivated and explanted, but not before Bull experienced three insulation abrasions two external and one internal, according to the documents.
She first sued in March 2017 and later amended her compliant to a single negligence claim for failure to warn under Pennsylvania law. The company moved to dismiss in January, arguing that Bull’s claim was pre-empted because it failed to assert a claim that parallel’s federal law.
Judge Michael Baylson of the U.S. District Court for Eastern Pennsylvania disagreed July 12, ruling that Bull’s single claim can proceed.
“Plaintiff’s state law failure-to-warn claim identifies a state duty to warn physicians of risks inherent in medical devices that is parallel to St. Jude’s duty to comply with MDR reporting requirements with respect to the Riata ST Lead, a Class III medical device that has received premarket approval,” Baylson wrote. “The state law duty that forms the cause of action does not extend beyond that required of St. Jude under federal MDR regulations. As such, it parallels these federal requirements, and is not expressly preempted.”