Clark, Perdue & List's Blog

Last year, the Guidant Corporation (Indianapolis, Indiana) recalled or issued warnings on more than 80,000 of its implantable cardioverter defibrillators ("ICD") - many of which are in use in the United States. The defibrillators can short-circuit, causing them to fail and not work as intended. The company has received reports of the device malfunctioning at least 45 times, resulting in at least one death.

Guidant came under fire following reports that it had failed to alert physicians about potential problems with one of the defibrillator models, the Ventak Prizm 2 DR Model 1861. One of these devices was implanted in Joshua Oukrop, a 21-year-old Minnesota college student who died when his defibrillator short-circuited while he was mountain biking.

Joshua's doctors were stunned by his death because the autopsy indicated no clinically significant pathology other than hypertrophic cardiomyopathy - a thickening of the heart muscle - the condition for which the ICD was implanted. Until his death, it was widely believed that ICD's were invariably successful in preventing sudden cardiac death in young patients with Joshua's condition, as long as they did not have end-stage heart failure (which he did not).
These recalls have caused anxiety among thousands of people who have the ICD devices embedded in their chests. In some situations, physicians are having difficult conversations with their patients about ICD replacement - a procedure that carries serious risks, including the risk of infection.

What is an ICD?

An ICD is an electronic device implanted in the body and intended to prevent cardiac arrest from severe ventricular tachycardia (an abnormally rapid beating of the heart). An electrode is connected between the heart and a tiny computer in the ICD. The computer monitors the heartbeat and, if it detects an arrhythmia, it activates a built-in pacemaker to restabilize the heart's rhythm. If that fails, the ICD delivers a small defibrillating electrical jolt to the heart. In an extreme case, it resorts to a far stronger jolt to reset the heart rate.

Who is Guidant?

Guidant is a major manufacturer of implantable medical devices, including defibrillators. Following the recall of many devices, Guidant was purchased by Boston Scientific Corp.

Although the ICD litigation is ongoing, Guidant has had past legal troubles. In 2003, one of its subsidiaries, Endovascular Technologies, pled guilty to multiple felony charges and paid more than $90 million in fines for failing to notify the FDA about device malfunctions and patient deaths related to its Ancure Endograft system, a stent-graft device used for the treatment of aortic aneurysms. As part of the settlement, Guidant and Endovascular agreed to notify the FDA about future product-related problems. The issue of whether Guidant complied with that agreement will be hotly contested in the ICD litigation.

What models have been called into question?

ICD models that have been called into question include the following: Contak Renewal (Model H135), manufactured on or before August 26, 2004; Contak Renewal (Model H155), CRT-D, manufactured on or before August 26, 2004; Contak Renewal AVT, Contak Renewal 3; Contak Renewal 4; Ventak Prizm 2 DR (Model 1861), manufactured on or before April 16, 2002; Ventak Prizm AVT; Vitality AVT; Renewal 3 AVT; Renewal 4 AVT; and Renewal RF.

Unfortunately, these devices do not give any sign of imminent failure, and there is no reliable test to determine whether the ICD is defective prior to failure. This creates a substantial dilemma for physicians - whether to advise patients to remove ICD's without knowing whether a particular device is in fact defective.