Seven people were implanted with St. Jude Medical defibrillators after the devices were recalled from the market, but neither regulators nor the company are saying whether those patients have been informed.
A warning letter the U.S. Food and Drug Administration sent last week noted that Little Canada-based St. Jude Medical — which was acquired by Abbott Laboratories in January for about $25 billion — somehow allowed the seven to be implanted with recalled defibrillators that contained lithium-chemistry batteries that carry a low risk of sudden premature depletion.
The FDA's letter said government inspectors were not satisfied with how the company handled problems with devices made at its Sylmar, Calif., plant. Inspectors said the company repeatedly disregarded signs that its defibrillator batteries could deplete prematurely, and disregarded its own policies in fixing cybersecurity holes in its at-home monitoring products.
One stock analyst said the warning is likely to create a public-relations "black eye" for Chicago-based Abbott, and may delay FDA approvals for other Abbott products, such as defibrillators that are compatible with magnetic-resonance imaging scanners, which were expected to be approved later this year.
The FDA warning letter said the defibrillators were subject to a worldwide recall on Oct. 11, 2016, yet seven of them were implanted into patients between Oct. 14 to Oct. 26, after being under the control of St. Jude Medical personnel in the U.S.
An FDA official said Abbott sent notification letters about the recall to its "affected customers." Asked whether the letters were sent to the seven patients, or just to their doctors, the FDA official said the question should be directed to Abbott.
An Abbott spokesman later wrote that the company was not providing any further answers about the issue beyond its initial statement, which said most of the alleged problems took place before Abbott bought the company, but that Abbott is taking the matter seriously. Abbott is slated to hold its quarterly earnings call with investors on Wednesday.
Although sudden battery depletion would not be an immediately life-threatening event for most defibrillator patients, the issue is concerning for patients whose defibrillators are also used as pacemakers, doctors say. Authorities recommend patients with the recalled defibrillator models — Fortify, Fortify Assura, Quadra Assura, Unify, Unify Assura and Unify Quadra — manufactured before May 2015 should consult with their doctors about what to do next, if anything.
More information is available at sjm.com, including a lookup tool where patients can enter their device serial number to see if they're affected by the battery issue.
In an investors' note, Wells Fargo stock analysts said Abbott is likely to meet a 15-day deadline to file a response to the FDA's concerns, and that the company is likely to resolve the whole matter in as little as nine months. But until the FDA is satisfied with Abbott's corrective actions, the government agency said it will not approve new premarket application (PMA) products made at the Sylmar plant, including two highly anticipated MRI-safe defibrillators.
While the issue may generate some negative publicity for Abbott, the analysts said, it's unlikely to create a civil liability problem for the company because of the legal doctrine known as "pre-emption."
"Medical device products approved under the PMA pathway by the FDA are pre-empted from civil lawsuits," the Wells Fargo note said. "As such, we believe that [Abbott's] product liability risk is likely limited and manageable."
Joe Carlson • 612-673-4779
