Since June 2005, Indianapolis-based Guidant Corporation has recalled thousands of its medical devices. According to a new study conducted by Harvard Medical School researchers and funded by the Food and Drug Administration, the recalls signal a larger, more troubling trend: A steady increase in malfunctions that has gone largely unnoticed by government regulators.

The lawyers of AttorneysTrialGroup.com have a strong, 15-year trial record in defective product cases. If you have been injured or lost someone because of a dangerous medical device, you have the right to file a claim against the supplier or manufacturer. Our statewide litigation firm has been committed to protecting the safety of Florida families since 1988.

The Harvard study notes that in the mid-1990s, doctors replaced 7.9 of 1,000 implanted defibrillators because of malfunctions. By 2001, the rate rose to 38.6 per 1,000 implants. It fell slightly to 20.7 of every 1,000 by 2002. More than half of the malfunctions occurred in the study's last three years.

On June 17, 2005, Guidant announced a recall of the following implantable cardiac defibrillators:

• 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

The company estimated that more than 500,000 patients in the United States had one of the recalled defibrillators. Guidant Corp. has said that the devices have malfunctioned at least 45 times, causing two deaths. The malfunction that is the subject of the recall causes damage to the device’s circuitry, potentially resulting in the inability to deliver the required shock during episodes of arrhythmia. This malfunction could lead to a serious, life-threatening event. Importantly, the device does not give any sign of impending failure, and there is no test that predicts whether any particular device will fail. Guidant recently conceded that it waited three years before telling doctors and patients about the electrical defect.

On July 1, 2005, two weeks after the defibrillator recall, Guidant told the FDA it was recalling another set of defibrillators called the Ventak Prizm AVT, Vitality AVT, Renewal 3 AVT and Renewal 4 AVT. The company has said the devices are subject to a memory error, which may affect device performance.  The FDA advised patients with any of the recalled defibrillators to keep their regular doctor appointments, and to contact their doctors if they felt an electrical shock from the device, or if there is an audible “beeping” from their Contak Renewal or Renewal 2 device. Beeping may mean the defibrillator is damaged.

On July 18, 2005, Guidant issued a warning about nine older models of its pacemakers because a hermetic sealing component used in the devices could leak, allowing moisture to affect the electronic circuits. This defect can cause the pacemakers to fail to provide pacing or can cause a rapid heart rate. The problems may occur without warning and can lead to loss of consciousness, and possibly heart failure and death. The warning covers 28,000 pacemakers made between November 1997 and October 2000 and still implanted in patients. The following models are affected by this recall. All were manufactured between November 25, 1997 and October 26, 2000:

• Pulsar® Max Models 1170, 1171, 1270
• Pulsar Models 0470, 0870, 0970, 0972, 1172, 1272
• Discovery® Models 1174, 1175, 1273, 1274, 1275
• Meridian® Models 0476, 0976, 1176, 1276
• Pulsar Max II Models 1180, 1181, 1280
• Discovery II Models 0481, 0981, 1184, 1186, 1187, 1283, 1284, 1285, 1286
• Contak TR® Model 1241
• Virtus Plus® II Models 1380, 1480
• Intelis II Models 1483, 1484, 1485, 1384, 1385, 1349, 1499

Of the 78,000 pacemakers sold, 69 exhibited a problem, with five patients suffering dizziness or temporary loss of consciousness. The projected rate of failure for the implanted devices appears to be between 0.17 percent and 0.51 percent for the remaining life of the pacemaker.

Guidant has stated that it will cover the cost of a new pacemaker, plus $2,500 in any additional costs for replacement surgery beyond what Medicare or other health insurance would pay.

AttorneysTrialGroup.com is representing patients and families who have been harmed by a malfunction of Guidant defibrillators and pacemakers. Our attorneys know the law, the legal system and victim’s rights. We are on your side, and we can help you make informed decisions about your personal injury claim. Our cases are handled by a team of professionals, including nurses, doctors, engineers and other experts. We offer free consultations in your home, at the hospital or in our offices. There are no fees or costs unless we win. Contact us today in Orlando at (407) 381-4123, or in Kissimmee, (407) 846-2240, or via our online contact form.