Criticism for Both St. Jude Medical and FDA over Defective St. Jude ICD Batteries

October 20, 2017, 9:00AM. By Gordon Gibb

Washington, DCA troubling report that ran in The New York Times back in April shed a dark shadow on defective St. Jude cardiac defibrillators and the batteries that powered them. St Jude ICD and CRT-D device lawsuits have alleged further than the original manufacturer of the medical devices, St. Jude Medical, downplayed reports of device failure for years. And it’s not just St. Jude lawsuit plaintiffs making that allegation; so too, is the US Food and Drug Administration (FDA), according to The New York Times (04/13/17).

What complicates the story is the acquisition, this past January, of St. Jude Medical by Abbott Laboratories for $25 billion. The St. Jude recall, which happened in October of last year, involved some 400,000 St Jude defibrillators (200,000 of them in the US alone) but occurred under St. Jude’s watch, before Abbott acquired the manufacturer.

The warning letter issued by the FDA on April 17 of this year pulled no punches, suggesting that St. Jude Medical played down the failure of some batteries in various models of its defibrillators and shipped the units for years with a known defect before recalling the medical devices a year ago this October.

There was more. The FDA accused St. Jude Medical of dropping the ball when it came to sharing with its own management team and medical advisory board that battery failures had contributed to the death of a patient. The FDA further cited St. Jude Medical for making an insufficient effort to remedy problems that precipitated the delayed St. Jude recall.

The New York Times reported that of the 400,000 defective St Jude cardiac defibrillators recalled globally, 841 were returned to St. Jude Medical for analysis as the batteries had run out of power prematurely. With a normal lifespan of four to five years, the batteries are designed to gently alert the patient that the battery is nearing the end of life, so steps can be taken to have the battery replaced before power runs out and the defibrillator fails entirely, putting the life of the patient in jeopardy. As of this past January, the FDA said, two patients had died when their defibrillators failed.

The manufacturer of the batteries had confirmed that a problem related to the formation of lithium crystals was determined to be the cause of the battery failures. Specifically, the formation of crystals was found to short the battery, and trigger its premature demise.

The New York Times
reported that battery problems were reported by physicians at Duke University in 2014, with medical teams from the University of Illinois also reporting failures in batteries supplied to St. Jude Medical by Greatbatch, now known as Integer Holdings, the following year. In 2015, it was reported that St. Jude Medical addressed the problem in new defibrillators manufactured from that point forward, but failed to undertake a St. Jude recall of older devices, or issue any communication to the medical community as to the problems with the older defibrillators until October of last year.

A retired cardiologist, interviewed by The New York Times, was not pleased by the course of events on behalf of innocent patients. “What bothers me most about this is that the doctors and the patients weren’t told about the potential” for failure, said Dr. Robert G. Hauser, an advocate for improved safety in medical devices. “And clearly this is for St. Jude’s benefit. They can sell products rather than scrapping it.”

That said, Hauser suggested the blame extends beyond St. Jude, to the federal regulator itself, suggesting that the FDA “should have been in there years ago, looking at all the raw data in order to determine if the incidence was low enough to allow these devices to be shipped and implanted,” Hauser said.

A spokeswoman for the FDA said the agency did not insist on an earlier recall because it was relying on information the company had provided at the time. But while the agency now says the company misrepresented the risk, Angela Stark of the FDA said, “I don’t think we can speculate on how that might have changed the decision,” almost three years ago now.

The St. Jude recall of October, 2016 includes St. Jude defibrillators in the Fortify, Unify and Assura lines. Stark, of the FDA said back in April in comments published in The New York Times that nearly 200,000 patients in the US had received a defibrillator associated with the St. Jude recall.

It has been reported that surgical procedures required to remove defective defibrillators can pose an increase in risk, when compared against the initial implantation. Batteries approaching the end of their designated lifespans can be replaced with little fuss. However attempting to remove, and replace a defective defibrillator can put the patient at risk.

Such is the ongoing fodder for St. Jude ICD and CRT-D device lawsuits.