The Food and Drug Administration (FDA) has publicly announced that defibrillators manufactured by St. Jude Medical (which was recently acquired by Abbott Laboratories) contained defective batteries which could be prematurely drained and were also vulnerable to hacking. Making matters worse, the company falsely claimed to not have been aware of the source of the drainage problems. The FDA also announced in a publicly-available warning letter to the company that, even though the FDA had previously called for the defibrillators to be recalled, the company nevertheless continued to send out the defective devices for implantation in patients.
The Company Falsely Claimed No Deaths Occurred Due to Premature Drainage
The FDA stated in the April 14 warning letter that the products that failed to conform with federal guidelines included the Fortify, Unify, Assura (including Quadra) implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators. The letter accuses the company of having been made aware that premature draining of batteries had been caused by “lithium cluster bridging” and yet the company falsely concluded that the cause of the drainage of the batteries “could not be determined.”
Because the company failed to properly address defects within its defibrillators and ignored evidence of problems in its internal reviews of the issues, the company caused there to be, “significant underestimations of the probability of occurrence of the hazardous situation.” The FDA pointed out that, as part of this ongoing underestimation of danger and improper response to risk, the company said there had been no serious injuries or death even though at least one death had already occurred in 2014 due to the defective batteries.
The Defibrillators Could Be Hacked
The FDA also pointed out that, in addition to the premature drainage hazard posed by the devices, the devices were also at risk of being hacked due to an exploitable “universal unlock code,” and yet the company failed to properly evaluate this cybersecurity risk or address it.
St. Jude Continued to Ship Defective Defibrillators After Recall
Even after St. Jude was made aware of serious issues concerning its defibrillators, it continued to distribute the defective devices. Specifically, the company initiated a recall of the affected devices on October 11, 2016, and yet ten devices were nevertheless shipped from company headquarters following the recall with seven devices being implanted into patients.
Contact a Mississippi Defective Device Attorney Today
If you have been injured by a defective defibrillator or any other defective medical device, contact an experienced defective device attorney today to begin the process of winning financial recovery for your injuries. Herrington Law in Jackson, Mississippi has become a class action leader because of its constant focus on what matters most: obtaining justice for individual plaintiffs who have been wronged by defendants. Contact us to set up a free consultation today regarding filing or joining a defective medical device class action lawsuit.