Guidant Defibrillator Recall and Lawsuit

Introduction

On June 1, 2005, Lieff Cabraser filed a lawsuit against Guidant Corporation in federal court in Indianapolis, Indiana, on behalf of a proposed nationwide class of patients implanted with the Guidant Ventak Prizm defibrillator. This was the first lawsuit filed against Guidant based on its faulty defibrillator. The complaint alleges that Guidant misrepresented the safety of its defibrillator, which is subject to short circuiting and malfunctioning.

GUIDANT DEFIBRILLATORS: POSSIBLE DANGER

Class I (most serious) recall: Ventak Prizm 2 DR (model 1861), Contak Renewal (model H135) and Contak Renewal 2 (model H155.)

Class II (any injury caused by a malfunction should be temporary or reversible) recall: Guidant models Ventak Prizm AVT, Vitality AVT, Renewal AVT, Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal RF.

Guidant Defibrillators Recalled

On June 17, 2005, Guidant recalled more than 50,000 of its cardiac defibrillators implanted in patients because of potential malfunctions in the devices. The recall includes the Ventak Prizm 2 DR (model 1861), Contak Renewal (model H135) and Contak Renewal 2 (model H155), Ventak Prizm AVT, Vitality AVT, Renewal AVT, Contak Renewal 3 and 4, Renewal 3 and 4 AVT and Renewal RF. Guidant said it has determined that a magnetic switch in these devices may get stuck in the closed position, which in some cases inhibits their ability to treat ventricular or atrial tachyarrhythmias and can accelerate battery depletion.

Boston Scientific, which bought Guidant in 2006, announced in June 2006 the recall of more defibrillators and pacemakers. The recalled devices include Ventak Prizm 2, Vitality, and Vitality 2 cardioverter defibrillators. On June 23, 2006 Guidant issued a warning letter to physicians, informing them of the recall expansion and urging patient exams and possible removal of the defective devices.

The suspension affects 46,000 of these devices, Guidant said, without specifying how many have been surgically implanted in people's chests and how many may be on supply shelves.

Patient Injuries and Deaths

As of June 2005, Guidant admitted that it was aware of 43 reports of device failures, and two patient deaths. Guidant has acknowledged that the actual rate of failure may be higher than the reported rate and that the number of associated deaths may be underreported, since implantable cardio-defibrillators are not routinely evaluated after death. The FDA and Guidant have advised physicians and patients to make individual decisions about whether to remove and replace the affected defibrillators on the basis of the specific medical situation of the patient.

Lieff Cabraser represents persons across America injured by defective Guidant and Ancure heart devices. Our firm was one of the first law firms in the U.S. to file a Guidant defibrillator recall lawsuit.

Guidant's Delay in Announcing the Recall

The recall came shortly after 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 that since 2002 it knew that a small number of its defibrillators contained a flaw that caused them to short-circuit and stop working.

On July 1, 2005, the FDA classified the recall of certain Guidant defibrillator models as a Class 1 recall, the most serious level of product recall.

In June of 2006, a U.S. Food and Drug Administration analysis dated a year earlier on June 16, 2005 was released, revealing that Guidant’s implantable heart devices may fail 10 times more frequently than the company projected. The FDA found that “most” of the 16,000 Contak Renewal defibrillators had damaged insulation within five years of use and that 40% of those devices would fail to produce an adequate shock in an emergency.

To read copies of "Urgent Medical Device Safety Information" letters sent to physicians and Guidant patients regarding Guidant defibrillators and pacemakers, click here.

The Guidant Heart Device Flaw Explained

Battery-powered defibrillators are used to shock an erratically beating heart back into normal rhythm. The devices typically are replaced about every five years.

A short circuit in the defibrillator can occur when the device builds a charge to deliver the type of high-energy shock needed in emergency situations. In three cases, when doctors intentionally induced abnormal heart rhythms during routine checkups, the Guidant device failed to work, forcing doctors to rescue those patients by jolting them with the type of external defibrillator used in emergency rooms.

Nationwide Class Action Lawsuit Against Guidant

Lieff Cabraser, with co-counsel, filed a lawsuit in early June against Guidant Corporation on behalf of a proposed nationwide class of patients implanted with the Guidant Ventak Prizm defibrillator. This was the first lawsuit filed against Guidant based on its faulty defibrillator.

The complaint alleges that Guidant misrepresented the safety of its defibrillator, which is subject to short circuiting and malfunctioning. Plaintiff and the class are seeking a declaratory judgment that Guidant is liable for all medical care and corrective surgery caused by Guidant's alleged misconduct, along with other damages.

Current Warnings on Guidant Pacemakers

Guidant has also issued an advisory warning physicians that replacements might be needed for nine pacemaker models made between 1997 and 2000, of which some 28,000 remain implanted in patients worldwide. To learn more about this warning, click here.

	Our Guidant defect lawyers have years of experience successfully representing patients with faulty or defective medical implants.
	There is no charge or obligation for our review of your case.
	We are pleased to visit Guidant patients, or families of loved ones who died, at or near where you live and at no cost, to discuss your legal rights and answer your questions.
	To assist our clients with their claims, we have on staff nurses with cardiac training and have retained physicians to provide expert advice.

Legal Rights of the Injured

The law in most states provides individuals with legal claims and the right to compensation for injuries they suffer as a result of a defective product or the negligence of another. The injured person may file a lawsuit seeking compensation for his or her pain and suffering, medical expenses, lost past and future wages and punitive damages.

Damages sought against manufacturers of an allegedly defective medical device typically include damages for:

Physical pain and suffering, mental anguish and physical impairment;
Medical expenses associated with the allegedly defective product; and
Loss of earnings and/or earning capacity.

About Lieff Cabraser

Founded in 1972, Lieff Cabraser Heimann & Bernstein, LLP is a 50-plus attorney law firm with offices in San Francisco, New York and Nashville. For each of the last six years, the National Law Journal has recognized Lieff Cabraser as one of the top plaintiffs’ law firms in America.

For our personal injury cases, we bring a team of experienced lawyers. Each client is assigned an individual lawyer. In addition, we have on staff multiple nurses, legal assistants, scientific analysts and case clerks to assist the attorneys. To learn more about our firm, click here.

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