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St. Jude Medical Defibrillators

The pacemaker and defibrillator injury attorneys at the Drug Law Center are now investigating cases involving injuries caused by implantable cardioverter defibrillators.

What is a Medical Defibrillator?

St. Jude Medical Defibrillators RecallsThe St. Jude medical defibrillator is a cardioverter device that surgeons implant in the abdomen or chest to treat arrhythmias (irregular heartbeats). Then wires connect the heart muscle to the defibrillator that can deliver electrical shocks to restore an irregular heartbeat to normal. The implantable cardioverter device is implanted in individuals suffering from tachycardia (rapid heartbeat), bradycardia (slow heartbeat), or other heart rhythm disorder. The sent electrical current remedies the rhythmic disturbance to allow the heart to be normally.

The American Heart Association supports the recommendations of implantable cardioverter devices because they are known to prevent sudden death in individuals experiencing fibrillation, ventricular tachycardia, and other heart conditions. While effective, the device has been involved in a Class I recall by the Food and Drug Administration due to a faulty battery design that is known to cause short-circuiting and unexpected battery failure. This defect has the potential of causing harm to more than 400,000 individuals who have received the St. Jude Medical defibrillator prior to May 2015. The company has since been acquired by Abbott Laboratories (January 2017).

Who Would Use an Implantable Medical Defibrillator?

Drs. often recommend that patients use implantable cardioverter devices if they suffer life-threatening ventricular arrhythmias caused by numerous factors. Some of these include:

  • Previous heart attacks or ventricular arrhythmias
  • Heart rhythm disorders including Long QT Syndrome that produce a chaotic, rapid heart rate
  • Sudden cardiac arrest survivors
  • Genetic diseases including Brugada syndrome that produces abnormal electrocardiogram results and sudden cardiac death
  • Other congenital heart diseases relating to sudden cardiac arrest

Cardiac resynchronization therapy defibrillators (CRT-Ds) are somewhat similar to implantable cardioverter devices but have added concomitant therapies for additional treatment in individuals who suffer from or have the potential for serious heart failure. Medical professionals typically recommend CRT-Ds instead of an implantable cardioverter device if the patient has other qualifications including:

  • Heart failure
  • Increased potential risk of experiencing ventricular fibrillation or ventricular tachycardia when the heart muscle beats too fast
  • Heart attacks that cause damage to the heart muscle pumping action

Implantable Medical Defibrillator Risks

There are many risks associated with an implanted medical defibrillator that includes:

  • Implementation site infection
  • Collapsed lung
  • Life-threatening bleeding around the heart muscle
  • Bruising, bleeding or swelling at the device implementation site
  • Allergic reaction to drugs used during the implantation
  • Heart valve blood leakage where the device’s lead connects to the heart muscle
  • Brain damage at the location where the leads attached to the device

Individuals with an implanted CRT-D device also experience dislodging leads and infections.

FDA and Manufacturer Warnings

In an effort to protect the public, the Food and Drug Administration (FDA) continues to update safety announcements and warnings to consumers, the public, and the medical health industry. Recently, the FDA recalled numerous St. Jude implantable medical defibrillators and issued a stern warning to the device manufacturer to start correctly categorizing problems with their defective batteries to better understand the seriousness of its unsafe prematurely depleting implanted battery cells.

  • FDA Recalls Many Defibrillators from the Medical Marketplace
    October 2016 – A press release issued by St. Jude Medical, Inc. notified doctors of the potential risk of prematurely depleted energy from the batteries used to operate their defibrillators. The company asserted that prematurely depleting batteries is a rare occurrence but was making the problem known to doctors whose patients might be affected by the defective battery.On October 11, 2016, Reuters article said that the company would be recalling approximately 400,000 units because of the defective rapidly depleting battery failure. Some cases involve a complete depletion of the battery within a day or up to a few weeks after the patient was alerted to the problem. Two patients have died from unexpected premature battery energy loss. The short-circuiting batteries are known to cause serious health risks that involve:

    • Shortness of breath
    • Chest pain
    • Dizziness and lightheadedness
    • Loss of consciousness

    In October 2016, the FDA recalled numerous St. Jude Medical defibrillators that had been manufactured prior to May 2015. Some of these recalls involved Fortify, Unify, and Quandra Assura devices. As a result of the recall, over 840 St. Jude Medical defibrillators were returned to the medical device manufacturer for analysis because the units had experienced premature depreciation of the battery energy.

    St. Jude Medical Officer Mark Carlson said during an interview that “because of the risks associated with replacing the devices outweighs the low risk of patient problem occurring” that the St. Jude Advisory Board of physicians strongly recommended that the majority of their patients not seek prophylactic replacements.

  • FDA Warns St. Jude Medical of Miscategorizing Serious Battery Depleting Defect
    April 2017 – The Food and Drug Administration issued a new warning letter to St. Jude Medical concerning their cardiac resynchronization therapy defibrillators and implantable cardioverter defibrillators involving their battery defects. The federal agency was making the device manufacturer aware that they had been missed categorizing battery failures in devices that had been returned to the company.The FDA says that the device manufacturer was recording “unconfirmed” as the cause of the batteries depletion instead of confirming premature depreciation had occurred in the batteries providing energy to the devices. The FDA claims that St. Jude was minimizing the battery depletion process.

    The Food and Drug Administration announced that St. Jude Medical Inc. failed to take sufficient action to remedy the problem and was slow to recall the faulty products when the defect was first detected. The federal agency stated that faulty implanted devices including defibrillators can be extremely problematic because their removal typically requires surgical procedures that expose the patient to a higher level of infection and risks.

The Food and Drug Administration stated that the malfunction defect was likely not widespread but warned that “patients could be at greater risk of complications from the surgical procedure required to replace the device.” Speaking on behalf of the FDA, Angela Stark, stated in April 2017 that approximately 200,000 individuals in the U.S. have an implanted defibrillator that has been recalled by her agency.

The FDA also revealed that St. Jude Medical was well aware of patient deaths in 2014 that were associated with the defective design but failed to disclose the information to the company’s management, the medical advisory board, the medical health industry, and consumers.

St. Jude Medical Defibrillator Class Action Lawsuit

In August 2016, a class-action lawsuit was filed by plaintiffs against St. Jude Medical Inc. who alleged that their implantable cardioverter devices and pacemakers do not provide a level of security against hacking. The complaint, filed in the U.S. District Court for the Central District of California, alleges that cardiac resynchronization therapy defibrillators and implantable cardioverter devices manufactured by St. Jude Medical threatens the device’s basic performance because of missing essential security measures.

Attorneys working on behalf of the plaintiffs have built the case around facts that St. Jude Medical in 2008 began advertising new features of its ICDs and pacemaker devices to include “remote monitoring.” This telemetry system used a network to allow doctors to receive transmitted data from their patient’s implant device.

While the unit was convenient to the patient who no longer needed to see the doctor in person for routine checkups to provide data testing results, and doctors who could perform treatment without seeing the patient in the office, the cardiac device manufacturer failed to provide basic security defenses to protect the device. The device did not have anti-debugging tools, encrypted code, and software, strong authentication, or anti-tampering mechanisms to ward off hackers.

Lawsuit documents reveal that researchers could demonstrate how hackers obtained root access to the devices to take over control. The lawsuit makes claims that doctors and patients were told by St. Jude that the remote monitoring device was safe. The argument supporting the complaint reveals that St. Jude Medical breached its express warranty to patients and fraudulently concealed the defects in its medical device network.

$300 Million in Fines

Other implantable cardioverter device manufacturers have also been accused of taking too long to warn consumers about defective defibrillators. Guidant, a competitive device manufacturer, pleaded guilty to federal criminal charges in 2011 and was ordered to pay approximately $300 million in fines because the company still allowed its defective defibrillators to be implanted in individuals even though they were well aware of the short-circuit problems.

It was that same year that St. Jude Medical was scrutinized for taking too much time to recall devices with faulty wiring that connected the heart to the defibrillator.

What to Do

Many of the devices manufactured by St. Jude Medical, Inc. have proven to be defective because they fail to deliver life-saving electrical impulses to ensure the erratic behavior (heart arrhythmia) the patient is experiencing can return to normal.

If you believe someone you know has experienced the painful reality suffered from the experience of unnecessary electrical shocks of the heart caused by a defective implanted heart defibrillator, they likely have the legal right to sue the medical device manufacturer, including Abbott Laboratories and St. Jude Medical Inc.

However, these cases tend to be highly complex and require the skills of an attorney who understands tort law and medical malpractice/product liability lawsuits. A lawyer can handle every aspect of the case to allow the victim time to recover from their injuries including undergoing corrective surgeries or other treatments.

Filing a Defective Defibrillator Lawsuit

The defective implantable defibrillator injury case attorneys at the Drug Law Center are currently evaluating and accepting cases involving serious harm and wrongful death caused by defective medical devices including the St. Jude Medical defibrillator. We understand that even though St. Jude Medical found the fix to repair its prematurely depleting batteries, many of the defective batteries were still available for use three years after the company learned of the defect.

Our attorneys fight aggressively on behalf of our clients to ensure they receive the financial compensation their family deserves. If you have suffered serious injuries or loss of a loved one due to a defect in a recall St. Jude medical defibrillator, we are here to help. Are reputable attorneys have recovered millions of dollars for our clients and are standing by to investigate your claim for compensation.

Contact us today to schedule a free, no-obligation, complimentary case evaluation with one of our reputable lawyers. We accept all wrongful death cases, medical malpractice claims, and product liability lawsuits through contingency fee arrangements. This means you and your family will receive immediate legal representation while we postpone payment of our fees until your case has been successfully resolved through adequate financial compensation. We offer a 100 percent hassle-free guarantee in handling your case, meaning if we are unable to obtain compensation, you owe us nothing.

Sources:

http://www.heart.org/HEARTORG/Conditions/HeartAttack/TreatmentofaHeartAttack/Implantable-Medical-Devices_UCM_303940_Article.jsp#.WR9LHyryv4Y

https://www.fda.gov/iceci/enforcementactions/warningletters/2017/ucm552687.htm

http://www.heart.org/HEARTORG/Conditions/Arrhythmia/PreventionTreatmentofArrhythmia/Implantable-Cardioverter-Defibrillator-ICD_UCM_448478_Article.jsp#.WR9LHyryv4Y

https://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm535843.htm