Defibrillator (ICD) Lawyer

St. Jude Defibrillator Lawsuit in Syracuse, New York

Implantable Cardioverter-Defibrillators (ICDs) manufactured by St. Jude Medical (now part of Abbott) are designed to save lives by delivering electrical therapy to correct dangerous heart rhythms. However, defective St. Jude defibrillators have experienced premature battery failures, leaving patients vulnerable to sudden cardiac death. If you or a loved one was harmed by a failed St. Jude ICD, the experienced St. Jude defibrillator lawyers at Gillette & Izzo can help you recover compensation.

Call 315-421-1000 today for a free consultation with a Syracuse defibrillator failure attorney who will fight for your rights.

The St. Jude Defibrillator Lawsuit – Battery Crisis

In October 2016, St. Jude Medical issued a massive recall of nearly 400,000 implantable defibrillators worldwide due to premature battery depletion. The recall affected 13 models in the Fortify, Unify, and Assura product lines manufactured between 2010 and 2015.

According to the FDA’s recall announcement, the battery failures were caused by lithium clusters forming within the battery, creating a short circuit that caused rapid battery depletion. The FDA classified this as a Class I recall—the most serious type—because the device failures could cause serious injury or death.

Scope of the Problem

• 398,740 devices sold worldwide were affected by the recall

• 841 devices returned for analysis showed evidence of premature battery depletion

• 46 confirmed cases of lithium clusters causing battery shorts

• 2 deaths reported as of January 2017

• Hundreds of adverse events have been reported to the FDA

As reported by The New York Times and confirmed by FDA documents, St. Jude knew about the battery defects as early as 2011 but continued selling the devices for nearly five years before issuing a recall.

How St. Jude Defibrillators Fail

Implantable defibrillators contain lithium batteries designed to last 5-6 years under normal conditions. However, the defective St. Jude defibrillators experienced catastrophic battery failures with little warning.

The Lithium Cluster Defect

According to technical analysis, lithium deposits form “clusters” within the battery that bridge the cathode and anode, causing a short circuit. When this occurs:

• Battery depletion accelerates dramatically

• Elective Replacement Indicator (ERI) alarms provide inadequate warning

• Full battery drainage can occur within 24 hours to a few weeks after the ERI alert

• The device becomes unable to deliver life-saving therapy

Normally, patients have three months after an ERI alert to schedule device replacement. With these defective St. Jude defibrillators, some batteries died within 24 hours of the alert.

Affected St. Jude Defibrillator Models

The recall includes these models:

• Fortify™ ICDs

• Fortify Assura™ ICDs

• Unify™ ICDs and CRT-Ds

• Unify Assura™ ICDs and CRT-Ds

• Unify Quadra™ CRT-Ds

• Quadra Assura™ CRT-Ds

• Quadra Assura MP™ CRT-Ds

All models manufactured before May 23, 2015 are affected.

Injuries Caused by St. Jude Defibrillator Failures

When a defective St. Jude defibrillator battery dies unexpectedly, the device cannot deliver therapy. According to the Heart Rhythm Society, this can result in:

Sudden Cardiac Death

Patients with ventricular tachycardia or ventricular fibrillation depend on their ICD to deliver life-saving shocks. Battery failure means no shock is delivered, resulting in cardiac arrest.

Pacemaker-Dependent Patient Risks

Some ICD patients are “pacemaker-dependent,” meaning their hearts cannot maintain an adequate rhythm without pacing. Battery failure in these patients is immediately life-threatening.

Inappropriate Shocks

Some defective St. Jude defibrillators malfunction before complete battery failure, delivering painful, inappropriate shocks or failing to pace correctly.

Revision Surgery Complications

Patients must undergo device replacement surgery, which carries risks including:

• Infection at the device pocket site

• Lead displacement or damage

• Bleeding and hematoma

• Pneumothorax (collapsed lung)

• Anesthesia complications

• Death

Many patients required emergency device replacement with minimal preparation time.

St. Jude’s Concealment of Safety Data

The FDA issued a harsh warning letter to Abbott (which acquired St. Jude in January 2017) documenting the company’s mishandling of the battery defect issue. According to FDA documents and news reports:

• St. Jude downplayed the significance of battery failures for years

• The company failed to notify its own management about patient deaths linked to the defect

• St. Jude continued shipping recalled devices to hospitals even after the recall was announced

• The company failed to adequately investigate known battery problems

• St. Jude waited nearly five years after discovering the defect before issuing a recall

A class action lawsuit filed on behalf of insurance payors alleges that St. Jude knew about the battery depletion defect as early as 2011 but failed to disclose the risk to the FDA, physicians, or patients.

What Compensation Can a St. Jude Defibrillator Lawsuit Recover?

Our Syracuse St. Jude defibrillator attorneys pursue full compensation for all injuries:

• Emergency device replacement surgery and hospitalization

• Diagnostic testing (chest X-rays, device interrogation, blood tests)

• Increased cardiac monitoring and follow-up care

• Treatment for complications (infections, lead problems)

• Future medical costs for ongoing cardiac care

Lost Wages and Income

• Time off work for emergency surgery and recovery

• Lost income during hospitalization

• Reduced earning capacity if complications prevent returning to work

• Disability benefits

Pain and Suffering

• Physical pain from emergency surgery

• Emotional distress knowing your life-saving device could fail at any moment

• Anxiety and fear of living with a defective device

• Loss of enjoyment of life due to cardiac limitations

• Depression from chronic health concerns

Wrongful Death Damages

If a defective St. Jude defibrillator caused your loved one’s death:

• Funeral and burial expenses

• Loss of financial support

• Loss of companionship, guidance, and consortium

• Estate claims for the deceased’s pain and suffering before death

Contact Us About How A Dangerous Or Defective Medical Product Harmed You

We provide a free consultation with an experienced defective medical products attorney in Syracuse, New York. To schedule an appointment with Gillette & Izzo Law Office, complete our intake form or call 315-421-1000. We represent all clients injured by a dangerous or defective medical product on a contingency basis. You do not owe any legal fees unless we recover compensation for you.