Inspectors with the U.S. Food and Drug Administration on Wednesday slapped St. Jude Medical with a warning letter accusing the medical device maker of failing to properly investigate problems with the batteries in its implantable defibrillators and the cybersecurity of its at-home monitoring equipment.
The inspectors said that company officials systematically underestimated the true risks facing heart-device patients, even after one person died in 2014. Further, seven patients were implanted with defibrillators after St. Jude recalled more than 400,000 of the devices. On cybersecurity, the letter said the company failed to prove that it made sure a recent software patch would fix potential vulnerabilities before rolling it out to the public.
"We have reviewed your response and conclude that it is not adequate," said the FDA warning letter to St. Jude, using language contained in many such letters. "You should take prompt action to correct the violations addressed in this letter. Failure to promptly correct these violations may result in regulatory action being initiated by the FDA without further notice."
A spokesman for Abbott Laboratories said in an e-mailed statement that patient safety comes first, and that Abbott has a strong history of product safety and quality. "We take these matters seriously, continue to make progress on our corrective actions, will closely review FDA's warning letter, and are committed to fully addressing FDA's concerns," spokesman Jonathon Hamilton wrote.
The statement didn't specifically address the allegations in the warning letter.
In the past, St. Jude has staunchly defended the safety of its products and even filed a defamation lawsuit against its cybersecurity critics.
St. Jude Medical was a Little Canada-based company when most of the alleged failures to correct the problems took place. The company was acquired in January by Chicago-based Abbott Laboratories in a $25 billion deal. Wednesday's warning letter is addressed to Michael Rousseau, president of Abbott's cardiovascular device division and former CEO of St. Jude.
The letter ties together two controversies that, until Wednesday, had been separate headaches for St. Jude.