“The government contends that St. Jude knowingly caused the submission of false claims and failed to inform the FDA with critical information about prior injuries and a death which, had the FDA been made aware, would have led to a recall.” These words from Acting United States Attorney Jonathan Lenzer merely scratch the surface of the horrors inflicted on unwitting patients by a company that continued to sell faulty heart defibrillators after they knew there was a problem with the devices.
Surgically implanted heart defibrillators are one of the last lines of defense for patients whose irregular heart rhythms put them at an increased risk of heart attack. The devices constantly monitor the patient’s heartbeat and if an irregularity is detected they will deliver a small shock to correct the issue. This, of course, assumes that there is enough power in the device’s battery to do so.
In 2016 it became apparent that some of the batteries used in St. Jude defibrillators were depleting too quickly and leaving patients who believed their batteries had sufficient charges without a critical lifeline. Some died while others were left feeling dizzy and bordering on loss of consciousness until emergency medical assistance could arrive.
The company finally took the step of warning the medical community against the continued use of their defibrillators later that year. Some 350,000 patients were affected worldwide, and the company recommended that doctors remotely monitor their patients and their devices to check functionality and determine whether additional action needed to be taken.
Allegations in the government’s lawsuit against St. Jude include the possibility that the company knew that there could be issues with its batteries as early as 2013 yet failed to warn anyone about the possible fault and concealed that information from regulators. They submitted an application to change the design of the defibrillator in 2014 but stated that “no serious injury, permanent harm or deaths have been reported associated with this issue,” yet the government maintained that the company knew of at least one death associated with the device, as well as two serious injuries.
It is worth noting that St. Jude Medical, Inc – the company involved in knowingly selling faulty defibrillators to heart patients – has absolutely no affiliation with or relation to the St. Jude Children’s Research Hospital.
