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Pacemaker Battery Failure Lawyers - St. Jude ICD Lawsuits

Pacemakers, also known as implantable cardioverter defibrillators (ICDs) or cardiac resynchronization therapy defibrillators, are small cardiac devices placed in the chest or abdomen that use electrical impulses to regulate the beating of the heart.

The FDA has recalled nearly 400,000 pacemakers manufactured by St. Jude Medical, Inc. because the devices' batteries have been found to short circuit or fail at an alarmingly high rate. 

ICDs are designed to provide ample warning, usually three months in advance, of potential battery failure. The recalled defibrillator devices produced by St. Jude feature a defective battery design that can short circuit and cause total battery failure in as little as 24 hours.

This does not give patients enough time to seek treatment for the failing battery, and once it dies, the pacemaker is unable to deliver life-saving pacing or shocks, which can lead to patient death.

What Causes a Pacemaker Battery to Fail?

The sudden and rapid depletion of the batteries in St. Jude ICDs occurs because of lithium clusters that form inside the battery. If these clusters form in a way that connects the two internal terminals of the battery, the battery will short circuit and quickly lose its power.

Interestingly, the batteries in the recalled units are not the same as the original batteries that powered the devices when they were approved by the FDA. The recalled batteries were updated later to include what St. Jude called novel technology that would increase battery life.

The updated batteries were Q High Rate (QHR) batteries, and it is this QHR technology that is suspected to cause the lithium cluster formation.

What are Signs of a Short-Circuited Defibrillator Battery?

Although a St. Jude ICD battery can deplete rapidly and die with very little warning, there are some physical symptoms that may appear if your pacemaker battery has short-circuited. Symptoms may include:

  • Lightheaded
  • Dizziness
  • Loss of consciousness
  • Chest pain
  • Shortness of breath

If you rely on a St. Jude defibrillator and you experience any of the above symptoms, you should seek immediate medical attention.

Which Pacemaker Devices Have Been Recalled?

The FDA has recalled the following St. Jude cardiac devices manufactured before May 2015:

  • Fortify VR
  • Fortify ST VR
  • Fortify Assura VR
  • Fortify Assura ST VR
  • Fortify DR
  • Fortify ST DR
  • Fortify Assura DR
  • Fortify Assura ST DR
  • Unify
  • Unify Quadra
  • Unify Assura
  • Quadra Assura
  • Quadra Assura MP

Nearly 400,000 St. Jude pacemakers have been recalled by the FDA. More than 800 have been returned for analysis due to premature battery depletion.

FDA Warnings About St. Jude ICDs

In April 2017, St. Jude received a warning letter from the FDA, stating that St. Jude had violated good manufacturing practice requirements. The FDA reprimanded St. Jude for improperly categorized battery failures and waiting so long to recall the devices.

The lithium cluster battery failure in St. Jude devices was identified by physicians at Duke University in a 2014 publication, and there is evidence that St. Jude knew of the battery problems even before then. However, the company waited until October 2016 to recall the defective devices.

When lithium clusters form in a manner to short circuit a battery, in some cases, the clusters can dissipate back into the electrolyte fluid and leave no trace. This means that the reason for failure is difficult to definitively determine just by a retroactive inspection of the dead battery. This also means that when St. Jude received batteries that had been removed from patients due to premature depletion, in cases where there were no traces of lithium clusters, they categorized the failure as "unconfirmed."

This allowed the company to underreport the number of failures and justify not recalling the device because of a "low incidence of failures." They continued to sell the defective devices for more than three years after learning of the problem.

What are the Criteria for Filing a St. Jude Pacemaker Battery Failure Lawsuit?

St. Jude has a responsiblity to ensure that its products are safe and perform as intended. There is evidence that the company knew of the battery issues and still continued to sell the devices, putting the lives of patients in danger. 

If you or a loved one were dependent on a St. Jude ICD and were harmed by its defective battery, you could be entitled to compensation. The criteria for filing a St. Jude ICD battery failure lawsuit include the following:

  • Must have had one of the recalled St. Jude devices manufactured before May 2015:
    • Fortify VR
    • Fortify ST VR
    • Fortify Assura VR
    • Fortify Assura ST VR
    • Fortify DR
    • Fortify ST DR
    • Fortify Assura DR
    • Fortify Assura ST DR
    • Unify
    • Unify Quadra
    • Unify Assura
    • Quadra Assura
    • Quadra Assura MP
  • Underwent premature replacement surgery
  • Suffered heart attack or death due to device failure and/or emergency replacement of device due to premature battery depletion

In order to confirm that your device was included in the recall, you can enter the model number and serial number into this website. Our award-winning medical device lawyers will help you file your lawsuit. We will work hard to get you the compensation you deserve for your injuries.

Who are the Best Rated Pacemaker Battery Failure Lawyers?

Best Michigan Car Accident LawyersOur legal team includes the most successful medical device attorneys in Michigan. Buckfire & Buckfire, P.C. and our lawyers have won the top awards in the legal profession, including:

  • U.S. News & World Report Best Law Firms
  • "Best Michigan Personal Injury Attorney" by American Lawyer Academy
  • Named Top 100 Trial Lawyers in Michigan
  • Honored as "Super Lawyers"
  • Top Martindale-Hubbell Rating (AV) for Skill & Integrity
  • Member of Million Dollar Advocates Forum

Our No-Fee Promise on St. Jude ICD Battery Failure Cases

You can afford to have our great team of lawyers on your side. When you choose us, it literally costs nothing to get started. We promise you in writing:
  • No money to get started
  • We pay all case costs and expenses
  • No legal fees whatsoever unless you receive a settlement
  • Phone calls to our office are always free

Contact our Defibrillator Battery Failure Lawyers & Start Your Claim

Our medical device lawyers will help you file your lawsuit. There are three ways to get started on your case:
  1. Submit the Free Case Review Box on this page and we will contact you shortly.
  2. Chat with our online intake specialist and we will call you for more information.
  3. Call (800) 606-1717 any time of day to tell us about your case.

We will listen to your story and answer your questions. If you have claim, we will start immediately.

WARNING: There are strict time deadlines for filing St. Jude defibrillator lawsuit claims. Contact our medical device attorneys and find out if you are entitled to a settlement.

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