There's never really a good place to have a medical emergency, but sitting on an airplane is certainly far from ideal, as Kristen Bull knows all too well.
Bull was on an airplane on the tarmac at a South Carolina airport in October 2015 when her implanted cardioverter defibrillator (ICD) malfunctioned and fired six times. She was taken to the Grand Strand Regional Medical Center, however, the hospital was not equipped to deactivate the device, which was manufactured by St. Jude Medical and used the company's Riata ST lead. A St. Jude representative came to the hospital the next morning to deactivate Bull's ICD, and she was placed in a Life Vest, according to court documents.
St. Jude recalled the Riata and Riata ST pacing leads in 2011, attracting a significant amount of criticism over current postmarket surveillance systems in the United States, not to mention lawsuits. St. Jude finally settled most of its lawsuits related to the leads in 2015, agreeing to pay up to $14.25 million to settle roughly 950 cases and claims, including lawyer fees and administrative expenses.
Bull filed a lawsuit against the company, which is now part of Abbott, in March 2017, alleging that St. Jude Medical committed negligence by failing to warn her physicians about risks inherent in the Riata ST lead. She claims that the company was aware of instances in which the device malfunctioned, creating a danger to patients, but did not inform FDA about all of these instances.
The company filed a motion to dismiss the lawsuit in January, in which it argued 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, and ruled on July 12 that the negligence case can proceed.