Guidant pacemaker and Defibrillators

An implantable cardioverter defibrillator (ICD) refers to a device implanted in the patients’ chest to regulate and monitor, if necessary to rectify the episodes of abnormal heart beat (arrhythmia). ICDS can generate the following:

• Series of low intensity electrical pulses to retune the abnormal heart beat to normal heart beat when the heart rhythm becomes faster than normal (ventricular tachycardia)

• Electric shocks that feels like a kick in the chest to stop life-threatening quivering of the heart.

Moreover, doctors program the ICD to work as a pacemaker and send electrical signals whenever it founds an abnormal low heart beat (bradycardia).

Surgeons implant these electronic medical devices in the patients’ body to prevent cardiac arrest from serious ventricular tachycardia. The Guidant defibrillator functions by connecting a small electrode between a computer and a heart. This medical device monitors and regulates the heartbeat and if in case, it detects an abnormal heartbeat, it successfully activates a built – in pacemaker to stabilize the pulse rate. On its failure, pacemakers send a jerk to the heart.

Of all the cluster of medical devices or products, ICDs are one of the fastest growing devices. In 2005, approximately 200,000 underwent an ICD implant. Generally, an ICD costs about $ 25,000 for the device and an uncomplicated doctor or hospital costs can run anything from $20,000 to $25,000.

If the device fails to work properly, them the patient can even lost his life. Initially, Guidant knew about the defects in the defibrillators manufactured by them. However, they continued to sell them for implantation in the thousands of patients. Now, Guidant recalled 100,000 faulty defibrillators from the market. Common faults of Guidant Defibrillators include early depletion of battery causing failure of the device or short-circuiting on the occurrence of an arrhythmic event.

Guidant Failed to Notify Patients and Doctors about its Defective Device

Guidant came under fire in 2005 after the report published in The New York Times revealed that the company failed to warn the heart patients and doctors about the potential risk associated with the VENTAK PRIZM DR model defibrillator. According to the report published in The New York Times, Guidant knew of the faults as early as 2003 but it continued to sell the old models of defibrillators, even though it corrected the faults and manufactured new models. Additionally, Guidant failed to inform the patients and doctors about this defect until the article published in the New York Times. Since then Guidant admitted that it continued to sell the faulty ICDs for the past three years knowing that the patients were at an increased risk of serious failures that could lead to serious health complications including death.

FDA Recalls 50,000 Guidant ICDs

The United States federal Food and Drug Administration (FDA) looks after the safety of medical products and devices. On June 17, 2005, FDA announced a nationwide recall of 50,000 ICDs manufactured by Guidant. There is high possibility that these devices may lead to “internal short circuit without warning,” which may result into failure to deliver a shock when required and may lead to memory errors. Therefore, in June 2005, Guidant recalled its implantable cardiac defibrillators (ICDs) due to malfunctioning and short-circuiting that could fail the devices to deliver the needed shocks during the arrhythmia episodes.

The FDA classified this recall in two different classes – Class I recall and Class II recall. Class I recall is the most urgent kind of recall as the defects may lead to serious health injury and even death. The Class I recall affects the following models of medical devices:

• Ventak Prizm 2 DR (model 1861)
• Contak Renewal (model H135), and
• Contak Renewal 2 (model H155)

The Class II recall includes those models that may cause temporary or irreversible injury. Models affected by this recall include the following:

• Renewal RF
• Renewal AVT,
• Renewal 3 and 4 AVT
• Vitality AVT
• Contak Renewal 3 and 4
• Ventak Prizm AVT

The Food and Drug Administration advised the patients to take the following measures:

• Contact your health care professional immediately if you have an affected ICD
• Contact your doctor if you experience any electrical shock from your implanted medical device.
• Consult your doctor or visit any nearest emergency clinic if you hear a beeping sound from your implanted ICD.

In July 2005, Guidant warned the doctors and surgeons that nine of its pace maker models manufactured between 1997 and 2007 might need a replacement. Pacemakers send electrical signals to the heart to speed up a slow heartbeat and generally, they can remain implanted for about eight to ten years before second replacement. In September 2005, Guidant recalled its Nexus and Insignia pacemakers due to their failures including ten cases of hospitalization.

Guidant and Lawsuits:

Currently, Guidant is reacting to the Department of Justice administrative subpoenas asking for the information related with the defective manufacturing and FDAs observations regarding the quality control processes and manufacturing. In addition, Guidant filed a lawsuit against Johnson & Johnson this month in effort to enforce an agreed-upon amalgamation. However, Johnson & Johnson continue to maintain that Guidant regulatory probes and recalls justify its pulling out of the intended acquisition.

New York Attorney General Eliot Spitzer filed a lawsuit against Guidant in November 2005, stating, “We wouldn’t permit this type of conduct in connection with the sale of cars or washing machines. It is simply unconscionable that it occurred with a critical medical device.”

Individual Guidant cases fall under four categories:

• Replacement
• Medical monitoring
• Injury
• Death

On November 7, all federal cases associated with Guidant were consolidated into one class action and transferred to Judge Donovan Frank in the Minnesota district for further proceedings. In addition, various state court medical class action lawsuits have been filed.

If you or someone you know have a Guidant pacemaker or defibrillator then immediately get it removed, or if you have suffered any injury because of it then you may have a legal claim. Contact an experienced medical device attorney who will help you in evaluating your claim and help you file a lawsuit so that you may receive some monetary compensation for the damages, pain and sufferings, medical bills and other related costs.