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Home > Medical Devices > Guidant Defibrillators

Defective Guidant Defibrillators Attorneys

in Denver,Colorado and Nationwide

In June 2005, Guidant Corp. recalled many of its implantable cardiac defibrillators (ICDs) due to short-circuiting and other malfunctions that could cause the devices to fail to deliver the required shock during episodes of arrhythmia. ICDs are used to shock the heart into normal rhythm after a patient suffers ventricular tachycardia or fibrillation--rapid, life-threatening arrhythmias originating in the lower chambers of the heart.

Models affected by the Class 1 (most serious) recall include: Ventak Prizm 2 DR (model 1861), Contak Renewal (model H135), Contak Renewal 2 (model H155). Models affected by the Class 2 recall (any injury caused by a malfunction should be temporary or reversible) include: Ventak Prizm AVT, Vitality AVT, Renewal AVT, Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal RF.

The New York Times reported that, although Guidant knew of the defects in a small number of its defibrillators as early as 2002, it continued to sell the old models, even though it had corrected the defect and was manufacturing newer models; and that it didn't inform doctors and patients of the defect until it knew that the New York Times article would be published.

Presently, Guidant is responding to Department of Justice administrative subpoenas requesting information related to faulty manufacturing, as well as FDA observations regarding manufacturing and quality control processes. Additionally, Guidant filed suit this month against Johnson & Johnson in an attempt to enforce an agreed-upon merger; J&J maintains that the Guidant recalls and regulatory probes justify its pulling out of the planned acquisition.

New York Attorney General Eliot Spitzer filed suit against Guidant on November 3, 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 into four categories: death, injury, medical monitoring, and replacement. On November 7, 2005, all Federal Guidant cases were consolidated and transferred to Judge Donovan Frank in the District of Minnesota for further pre-trial proceedings. Additionally, several state-court medical monitoring class actions have been filed.

Click here to read the pretrial order.

Burg Simpson has filed several cases against Guidant and we represent dozens of clients who have a recalled device and have suffered an injury as a result of the defective medical device, such as death, heart attack, shock, or explanation.

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