Guidant Ventak Prizm heart defibrillator device

Guidant Ventak Prizm heart defibrillator device

CONFIDENTIAL FDA ANALYSIS SAYS GUIDANT DEFIBRILLATORS MAY MALFUNCTION

A U.S. Food and Drug Administration (FDA) analysis of Guidant implantable defibrillators written on June 16, 2005 said the devices may malfunction, leading to failures at a rate 10 times higher than that stated by Guidant within the next five years. The analysis was a confidential document unsealed in a June 2006 product liability lawsuit involving Guidant’s products in Texas.

Guidant Corporation recalled over 100,000 implantable devices in 2005 after it was revealed an electrical malfunction could lead to the failure of the device. The devices were supposed to deliver an electrical shock in the event of abnormal heart rhythm to prevent atrial fibrillation, or pooling and clotting of the blood in the chambers of the heart. Atrial fibrillation leads to heart attacks, strokes and cardiac deaths.

After Guidant began its series of recalls, the company stated no more than 292 of its units were likely to break down. The unsealed FDA document could damage the position of Boston Scientific, Guidant Corporation’s new parent company, which bought the company for $27.5 billion in April 2006. Boston Scientific said in a May 2006 regulatory filing that more than 3,000 patients may pursue personal injury lawsuits against Guidant, with 340 cases already in court.

How many Guidant defibrillator lawsuits will there be? Will the FDA demand a Guidant defibrillator recall?

Source: “Boston Scientific device woes grow,” Bloomberg News, June 23, 2006.

Canadians filed a Guidant class action lawsuit in June 2005

Weeks after the FDA analysis, a class action lawsuit was filed in Canada on behalf of patients who received defective Guidant defibrillators. The suit alleged that, despite knowing its defibrillators were defective, Guidant continued to market the defibrillators without disclosing the problem to medical professionals or patients. Guidant’s defibrillators have been linked to at least four incidents of short-circuiting, including one that resulted in the death of a U.S. patient.

Guidant manufactures the defibrillators, which are devices used to control irregular heartbeats by delivering electrical shocks to the heart when irregular rhythm is detected. With the short-circuit defect, the defibrillator is no longer able to detect irregular rhythm. In May 2007, Guidant communicated the failure to physicians despite having received complaints about their products going back to 1994.

Source: “Guidant national class action commenced,” Yahoo! Finance, June 29, 2005. (http://www.advfn.com/news_Guidant-national-class-action-commenced_11736319.html)

Guidant recalled even more defibrillators-50,000 in total-in January 2007

In January 2007, Guidant attempted to silence intense criticism of its previous failure to notify doctors of problems with its implantable devices by announcing a recall of nearly 50,000 defibrillators implanted in patients worldwide. It announced once again that units it manufactured could develop a short circuit, which could lead to cardiac arrest and death in patients with the implants. Guidant agreed to replace over 28,000 of the implants that could not be reprogrammed, and to reprogram the remainder of the units. An estimated 24,000 of the devices are in use in the United States.

A Pennsylvania man filed suit against Guidant on June 1, saying the company should have notified all patients that its devices might short-circuit. Lawyers for 74-year old patient John Brennan hope to turn their complaint into a Guidant class action lawsuit. Twenty-one-year-old college student Joshua Oukrop also died of cardiac arrest after his defibrillator implant short-circuited.

Sources: Ashley M. Heher, “Devices for heart recalled,” Associated Press, June 18, 2005; Lisa Girion, “Implanted Defibrillators Recalled by Manufacturer,” Los Angeles Times, June 18, 2005.

Do you need a Guidant Contak Renewal 2 Lawyer? Free Call, No Obligation

If you or someone you love has been using a Guidant Contak Renewal 2 to treat recurrent or sustained ventricular tachycardia or fibrillation and have experienced a heart attack, blood clot or other adverse heart problems, it may be essential that you contact your doctor immediately. Contact our personal injury law firm today.

A consultation with a product liability lawyer may also be in your best interest. If Guidant or Boston Scientific knew that the risks of using a Guidant Contak Renewal 2 were more dangerous than they claimed, you may be entitled to compensation for the injuries you may have suffered as a result. Our lawyers are investigating the circumstances of this case. Your information will be reviewed by a Guidant Contak Renewal 2 lawyer who may be able to help you gain compensation from a Guidant Contak Renewal 2 lawsuit.

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