St. Jude pulled the silicone-coated Riata and Riata ST leads in 2010 after finding that some of the internal conductors had worn through their insulation, a failure that could result in patients receiving unwanted shocks. 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. The company settled a raft of Riata product liability lawsuits in February 2015, ahead of its $25 billion acquisition early this year by Abbott.
The latest Riata lawsuit, filed in April the U.. District Court for Northern California by Richard Connelly, alleged that the leads that were first implanted in 2003 malfunctioned last November as he slept, shocking him an estimated 16 to 20 times and causing “irreparable harm to his heart, body, and mind,” according to Townsville community legal advice. Connelly alleged strict liability for manufacturing defect and failure to warn, negligence per se and negligence, according to the documents.
St. Jude moved to have the case dismissed, arguing that three of his claims are expressly preempted, one is impliedly preempted and all are insufficiently pled.
Although Judge Edward Davila agreed with the company about the failure-to-warn and negligence per se, he declined to dismiss the manufacturing defect and negligence claims, according to the documents.
“Connelly’s complaint identifies specific facts from an internal St. Jude audit, three FDA enforcement actions, two Dear Doctor letters, and the 2011 Class I recall of the Riata Leads. Together, this evidence suggests that St. Jude violated the requirements contained in the applicable PMAs. Connelly has also demonstrated a plausible connection between the alleged manufacturing defects and his injuries,” Davila wrote. “Having found that Connelly has adequately stated non-preempted claims for manufacturing defects, the court also finds that Connelly’s negligence claim is sufficient to survive St. Jude’s motion to dismiss.”
But because Connelly’s leads were implanted in 2003, before St. Jude allegedly became aware of problems with Riata in 2005, Avila ruled that Connelly failed to prove his failure-to-warn claim.
“None of these allegations suggest that St. Jude failed to report known adverse events before Connelly’s Riata leads were implanted in 2003. Connelly’s allegation that St. Jude knew of defects ‘[n]o later than 2005 and likely sooner’ ‘ is insufficient because Connelly provides no factual basis for his claim that St. Jude knew of defects in Riata leads, but failed to report them to the FDA, before 2005. As such, the court finds that Connelly has failed to establish a causal connection between Connelly’s injuries and St. Jude’s failure to warn,” Avila wrote, dismissing the claim but giving the plaintiff a chance to amend his complaint by Sept. 8.
As for the negligence-per-se claim, the judge ruled that it was preempted because they are impliedly preempted because the federal government has exclusive authority to enforce the requirements of the Food, Drug & Cosmetics Act.