St. Jude Medical Slow in Reacting and Removing Faulty DefibrillatorsApr 17, 2017
St. Jude Medical responded to a warning letter issued by the U.S. Food and Drug Administration (FDA) by recalling an allegedly faulty medical device. The warning issued April 12, 2017 states that during an inspection of the facility located in Sylmar, California on February 7, through February 17, 2017, investigators from the FDA determined that the facilities that manufacture the Fortify, Unity, Assura (including Quadra) defibrillators were not compliant with FDA standards.
Defibrillator Recall Details
Defibrillators supply an electric shock to return the heart to a normal pace when it is not beating properly, the New York Times reports. Nearly 400,000 defibrillators were recalled with orders from the FDA for the manufacturer to provide a plan for correcting its reporting on the device problems within 15 days.
It was also discovered by the FDA, that St. Jude, that was acquired by Abbott Laboratories in January, also neglected to tell its own management and a medical advisory board that the battery problems had led to the death of a patient, reports the Times.
Product liability attorneys at Parker Waichman LLP are actively reviewing potential lawsuits regarding allegedly defective medical devices including St. Jude defibrillators.
Faulty defibrillators as well as other implanted devices are especially problematic because removing them may often be riskier than keeping them in. When St. Jude announced the recall in October, the FDA advised that doctors closely monitor their patients' devices for any malfunctions. Stating that problem may not be widespread, the FDA warned that "patients could be at greater risk of complications from the surgical procedure required to replace the device."
The FDA said that of the nearly 400,000 devices sold worldwide that were involved in the recall, 841 were returned to the company for analysis because the battery had died unexpectedly. As of January, two people had died because their defibrillators failed to work, the FDA said. Dozens of others had suffered adverse effects.
Angela Stark, an FDA spokeswoman said that nearly 200,000 people in the U.S. have a defibrillator affected by the recall.
Lithium Battery Clusters Allegedly Cause Short-Circuits
In 2014, physicians at Duke University reported two cases of battery problems with the defibrillators and another group at the University of Illinois did so in 2105 concluding that lithium in the battery was forming clusters and causing it to short-circuit. St. Jude fixed the problem in new defibrillators that same year, but it did not recall the older devices or alert doctors or patients about the potential problem until October. Subsequently, doctors continued implanting the old devices in patients, reports the Times.
Dr. Robert G. Hauser, a retired cardiologist who campaigns for improved safety of medical devices said, "What bothers me most about this is that the doctors and the patients weren't told about the potential" for failure.' Dr. Hauser added, "And clearly this is for St Jude's benefit. They can sell products rather than scrapping [them]."
He also criticized the FDA for not having investigated St. Jude sooner. "They 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," said D. Hauser.
St. Jude's Financials
According to The Minneapolis Star Tribune, which reported on the device last fall, defibrillators accounted for nearly a third of St. Jude's sales in 2015, or about $1.6 billion. In January, St. Jude was acquired by Abbott for $25 billion.
Abbot remarked it was reviewing the warning letter and that it was committed to addressing the problems raised by the agency. "We have a strong history and commitment to product safety and quality," the company said.
Ms. Stark, the FDA spokeswoman, reacted to questions on why the agency had not insisted on an earlier recall, with a statement that it was relying on information the company had provided at the time. While the agency may have misrepresented the risk, Ms. Stark said, "I don't think we can speculate on how that might have changed the decision almost two years ago."
According to the letter, St. Jude understated the problem by concluding that reports about failing batteries were "unconfirmed" even though the battery manufacturer concluded that the lithium clusters were the culprit. The company did not include these "unconfirmed" cases when it calculated the likelihood that the devices would malfunction, making it appear that the problem was less serious than it was, the FDA said.
The FDA also found that St. Jude knew of a patient's death in 2014 but did not disclose it to St. Jude Medical management or a medical advisory board. "Both presentations stated there was no serious injury or death directly related to lithium cluster formations," the letter said.
In 2011, a unit of Boston Scientific (another defibrillator manufacturer) pleaded guilty to federal criminal charges and paid nearly $300 million in fines after it was revealed, in part because of Dr. Hauser's efforts, that it had allowed some of its defibrillators to be implanted in patients even though the company knew the devices might short-circuit, reports the Times.
Have You Been Injured by a St. Jude Defibrillator?
If you or someone you know has sustained injury associated with a defibrillator, you may be eligible for valuable compensation. Parker Waichman personal injury law firm offers free, no-obligation case evaluations. We urge you to contact us at 1-800-YOURLAWYER (1-800-968-7529).