PHILADELPHIA — A federal judge has denied a motion to dismiss a lawsuit against St. Jude Medical Inc., alleging a cardiac defibrillator implant created a risk to patients.
Judge Michael M. Baylson issued the ruling on July 12 in the U.S. District Court for the Eastern District of Pennsylvania. The motion to dismiss was denied because the amended complaint "adequately states a claim that the Riata ST Lead was defective on a failure to warn theory," Baylson wrote in his ruling.
Kristen Bull filed the lawsuit on March 15, 2017, against St. Jude, which manufactures the heart implant, alleging it was aware of risks involved with the Riata ST Lead, which was part of the device. She claims that St. Jude failed to warn her physicians or to disclose problems fully to the Food & Drug Administration (FDA).
The component part was known to malfunction, of which the defendants were aware, she claimed in her lawsuit. The plaintiff alleged in her lawsuit that the component created a danger to patients, according to court documents.
There were more than 8,000 complaints involving the Riata and Durata lead models between 2002 and 2009, according to a St. Jude spreadsheet provided during an investigation by the Food and Drug Administration (FDA).
The FDA discovered that it only had less than half of the complaints in its adverse events database, meaning that St. Jude did not report certain complaints.
The components were eventually recalled in 2011.
Bull alleged she had an implantable cardiac defibrillator (ICD) that had the Riata component in it in 2010 and was on a plane in 2015 when her ICD malfunctioned, causing her to be taken to and admitted to the hospital.
"Plaintiff alleges that if St. Jude had made timely and complete MDR reports of all adverse events that it was aware of prior to the implantation of her ICD on November 1, 2010, her physicians would not have chosen to implant an ICD using Riata ST Leads, and instead would have chosen another such device using different leads, Baylson wrote. "This sufficiently alleges a claim that if she had been warned about the deficiencies with the Riata ST Lead, then she would have avoided being injured by it. Plaintiff is not required to make any further allegations at the pleading stage."
Baylson denied the motion to dismiss.