Guidant

Guidant Litigation

The Brandi Law Firm is actively investigating cases involving the failure of GUIDANT cardiac defibrillators.

On June 17, 2005, Guidant Corporation recalled nearly 50,000 of its cardiac defibrillators implanted in patients worldwide because of malfunctions with the device which could lead to serious injury or death. The recall includes several defibrillator models, including the Prizm 2 DR, the Contak Renewal and Contak Renewal 2, the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT ICDs.

According to Guidant, the devices have reportedly failed at least 45 times and have caused at least two deaths as of May 30, 2005.

On May 23, 2005, Guidant issued a safety advisory to physicians concerning its heart defibrillator, reportedly after the company learned an article by the New York Times was being prepared. The New York Times reported that Guidant did not tell doctors or patients for three years that the device contains a flaw that has caused a small number of defibrillators to short-circuit and stop working.

Guidant Issues Further Warning on its Pacemakers and Defibrillators on June 24, 2005

Guidant advised physicians to halt use of five models of cardiac defibrillators. Guidant said it is advising doctors about safety problems with its Contak Renewal 3 and 4, Renewal 3 and 4 AVT, and Renewal RF implantable cardioverter defibrillators, or ICDs. The Renewal 3 and 4 AVT models were also included in Guidant's June 17, 2005 recall. Guidant said “As a precautionary measure, physicians should discontinue implants of these devices pending further notice.”

FDA URGES GUIDANT DEFIBRILATOR USERS TO SEE PHYSICIANS

On July 1, 2005 the FDA urged users of GUIDANT defibrillators to consult with their doctors.

“Malfunctions in these devices can lead to serious consequences and it’s important for patients to call their doctor for additional information and personalized advice,” said Daniel Schultz, MD, Director of FDA’s Center for Devices and Radiological Health.
The affected devices are:

• PRIZM 2 DR, Model 1861, manufactured on or before April 16, 2002
   
  
• CONTAK RENEWAL, Model H135, manufactured on or before August 26, 2004
   
  
• CONTAK RENEWAL 2, Model H155, manufactured on or before August 26, 2004

For these devices the FDA said “The firm’s investigation determined these devices can develop an internal short circuit when attempting to deliver an electrical shock to the heart, preventing the treatment of abnormal heart rhythms. The problem is caused by deterioration of electrical insulation in the device and can only be detected after the device has already malfunctioned. The device does not give any sign of impending failure and there is no test that predicts whether the device will fail.”

• VENTAK PRIZM AVT
• VITALITY AVT
• RENEWAL AVT Devices

The FDA said “These Guidant devices are subject to a memory error”.

• CONTAK RENEWAL 3 and 4,
• RENEWAL 3 and 4 AVT,
• RENEWAL RF Devices- Class II

The FDA said “These devices are subject to a component failure that in rare cases may limit available therapy. A magnetic switch in these devices may become stuck in the closed position, which in some cases inhibits the device’s ability to treat ventricular or atrial tachyarrhythmias (abnormally fast heart rhythms) and also accelerates battery depletion. Four occurrences have been confirmed out of approximately 46,000 devices; a fifth occurrence is suspected but cannot be confirmed. In the four confirmed cases, patients and/or physicians were alerted to the condition by audible device tones signaling that the magnetic switch was closed. Based on this information, it is important that patients who hear tones from their device immediately contact their physician or go to the hospital emergency room.”

The Brandi Law Firm has extensive experience in medical device litigation. Thomas Brandi has over 30 years of trial experience successfully taking on defective drug companies on behalf of injured people. He has successfully represented clients injured from numerous drugs and devices including Vioxx, Rezulin, Phen-fen, L Tryptophan, Felbatol, breast implants, artificial hips and the Dalkon Shield IUD. Mr. Brandi serves on the Plaintiff's Management Committee in the California Vioxx Litigation, and he also serves on the MDL Science and Discovery Committee in the national Vioxx litigation. The Brandi Law Firm has a team of attorneys, investigators, doctors and nurses investigating these cases.

If we represent you, Mr. Brandi will be your trial attorney. On November 13, 2004 Mr. Brandi was named Trial Lawyer of the Year for the State of California by the Consumers Attorneys of California. He has been a finalist for Trial Lawyer of the Year for the Trial Lawyers of Public Justice (2004), Consumer Attorneys of California (2002) and San Francisco Trial Lawyers Association (1999, 2001, and 2004). If you consult with any counsel, you should ask who will be working on your case, and if the case goes to trial, the identity of the trial attorneys and their courtroom trial experience.

If you wish any further information, please contact the Brandi Law Firm at mlr@brandilaw.com or

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