St. Jude Pacemaker Battery Failure Drug Lawsuit SourceSt. Jude Pacemaker Lawsuits: Complication Lawsuits

Commonly asked questions about St. Jude pacemakers:

What are Pacemakers?

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.

Pacemakers are implanted in the chest via minor surgery and can be implanted temporarily or permanently. Patients may require pacemakers for a variety of reasons, but generally it is due to arrhythmia, a group of conditions in which the heart’s rhythm is abnormal.

The heart’s rhythm can become abnormal due to natural aging, or as a result of heart muscle damage from a heart attack or heart failure. Other causes of heart rate disruption are medications or genetic conditions.

The devices work by monitoring your heartbeat, and if it is too slow, the pacemaker will send electrical signals to your heart to speed it up.

Pacemakers are manufactured by a variety of medical device companies, but most notably, the pacemakers manufactured by St. Jude Medical, Inc. have recently become the subject of litigation for putting patients in serious danger.

St. Jude ICDs manufactured before May 2015 feature a faulty battery design that makes them prone to short circuiting, which can cause total battery failure in as little as 24 hours. This gives patients very little warning to have the batteries replaced, and puts them in danger of heart attack or death due to device failure.

What are Complications of St. Jude Pacemakers?

Pacemakers are designed to provide ample warning, usually three months in advance, of impending battery depletion. St. Jude Pacemaker devices have been found to feature a defective battery design that can short circuit and cause total battery failure in as little as 24 hours.

The sudden battery failure in these devices occurs because of lithium clusters that form inside the battery. If these clusters form in such a way that connects the two internal terminals of the battery, it will short circuit and rapidly lose power.

As a result, patients do not have enough time to seek treatment for the failing battery, and once it dies, the pacemaker is unable to deliver life-saving pacing or shocks. This can lead to a heart attack or even death.

The batteries in these St. Jude pacemaker devices are Q High Rate batteries, and it is this QHR technology that is suspected to cause the lithium cluster formation. Interestingly, the QHR batteries were not featured in the devices when they were initially approved by the FDA. St. Jude later updated the pacemakers to include the QHR batteries, which they claimed to be novel technology that would increase battery life.

What are Symptoms of a Failed St. Jude Pacemaker 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 the battery has short-circuited. These symptoms include:

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

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

FDA Warnings About St. Jude Pacemakers

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

St. Jude also received a warning letter from the FDA in April 2017, which accused the company of violating good manufacturing practice requirements. The FDA used the letter to reprimand St. Jude for improperly categorizing battery failures and waiting too long to recall the devices.

There is evidence that St. Jude knew of the faulty battery design well before the recall and thus could have initiated it much sooner. The lithium cluster battery failure was identified by physicians at Duke University in a 2014 publication, and there is evidence that St. Jude knew of the issues even before then. However, the company waited until October 2016 to recall the pacemakers.

In some cases, lithium clusters can dissipate back into the electrolyte fluid and leave no trace. This can make it difficult to definitively determine the reason for failure from a retroactive inspection of the dead battery. This also provided St. Jude the opportunity to classify battery failures as “unconfirmed,” in cases where there were no traces of lithium clusters.

This allowed the company to under report the number of battery failures and justify not recalling the device because of a “low incidence of failures.” St. Jude 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 Lawsuit?

St. Jude has a responsibility to ensure that its products are safe and perform as intended. There is evidence that the company knew of the batteries’ defect 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 lawsuit against St. Jude include the following:

  • Must have received 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 pacemaker was included in the recall, you can enter the model number and serial number into this website.

Can I File a Defective St. Jude Pacemaker Battery Lawsuit?

Our dangerous device attorneys can help if you or someone you care about was harmed by a pacemaker device.

Lawsuits have been filed against St. Jude by both patients and their families seeking compensation for injuries caused by the dangerous pacemakers. You may be entitled to a settlement.

We do not charge any legal fees unless you receive a settlement and we pay all of the case costs. If your claim is not successful for any reason, you do not owe us anything. We put it all in writing for you.

Our defective pacemaker lawyers will help you file your lawsuit.

Our No-Fee Promise on St. Jude Pacemaker 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 are always free

How Do I Start a St. Jude Pacemaker Failed Battery Claim?

Our St. Jude ICD lawyers will help you file your lawsuit. To get started, you can:

  1. Submit the Free Case Review Box on this page, or
  2. Call (866) 280-3417 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 pacemaker lawsuit claims.

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