St. Jude Medical (NYSE:STJ) will face claims that it failed to warn patients about problems with its Riata defibrillator leads before it yanked the devices in 2010, after a federal judge shot down a bid to dismiss the failure-to-warn claims.
Judge James Selna of the U.S. District Court for Central California previously allowed claims for negligence and liability for manufacturing defects, according to court documents, but had ruled that the failure-to-warn claims were deficient and failed to claim a link between the allegedly failed warnings and any injuries.
When St. Jude pulled the devices off of shelves in 2010 it cited issues with "externalized conductors as a result of inside-out abrasion." The FDA did not issue a recall notice on the device at the time. The company issued another warning on the devices in November 2011 and the FDA gave the Riata leads Class I recall status later that year after St. Jude said the defibrillator leads failed more frequently than previously reported.
A group of plaintiffs sued St. Jude last year, alleging that the heart wires were defective and led to injuries or death for more than 30 patients. Plaintiff Gene Knoppel, for example, alleged that the Riata lead he was implanted with in February 2005 had to be replaced in December 2011 after he’d suffered more than 60 shocks caused by the leads’ alleged defects between May and July 2011.
Since his initial ruling on the failure-to-warn claims, the plaintiffs in the 5 consolidated lawsuits have cured their deficiencies, Selna ruled last week. A St. Jude spokeswoman told MassDevice.com in an email that the company plans “to continue to vigorously defend these cases.”
First, the judge wrote, it’s reasonable to infer that abrasion caused perforation of the leads.
"It is plausible that wires, implanted in the human body to conduct electrical impulses, when stripped of the insulation to contain and isolate the electrical current, could cause tissue perforation, whether as a result of the escaping electrical current or the escaping wires themselves," Selna wrote.
A June 2009 FDA inspection, which in part examined a St. Jude spreadsheet of data from all complaints the company had received since 2002, showed that "perforation events" rose from 2% in 2002 to 8% in 2008, according to the documents. That inspection also prompted the FDA to observe that a report from St. Jude to the federal watchdog agency "did not include all information that was reasonably known to the manufacturer," according to the records.
"Significantly, review of a number of complaint files revealed although the complainants reported adverse events as ‘perforations,’ those events were not reported as ‘perforations’ to the FDA. Moreover, the FDA identified 2 instances of known perforation events that, without any explanation, were reported to the FDA a number of years after they were required to be reported," Selna wrote. "Subsequent inspections revealed that perforation events described in medical literature were not reported to the FDA. The FDA also identified problems with accurate reporting of rates of occurrence based on erroneous calculations and/or misclassification of contributing causes. Given that the specific examples of incorrect reporting represented only a sample, it is fair to infer that an exhaustive review would identify more deficiencies. Taken together, these allegations support inferences regarding defendant’s knowledge of adverse events as well as the reasonable inference that more accurate and timely reporting of adverse events, especially of perforation events, could have led Knoppel’s physicians to forego the implantation of a Riata Lead in Knoppel in 2005."