Guidant Pacemakers
Guidant Corp., one of the largest pacemaker manufacturers in the world, has recalled over 150,000 potentially defective pacemakers amid speculation that Guidant was aware of problems long before they warned doctors and patients. Pacemakers are potentially life-saving medical devices that are surgically implanted to correct abnormal heart rhythms or slow heart beats. If a pacemaker malfunctions, there can be serious health consequences such as shortness of breath, loss of consciousness, weakness, dizziness, excess fatigue, heart failure and even death. Anyone experiencing these symptoms should seek medical attention immediately.
If you or a loved one has or had a Guidant pacemaker, you may be able to obtain compensation for any harm suffered through a settlement or product liability lawsuit. However, there are strict time limits on filing defective medical device lawsuits, so it is important to speak to a personal injury lawyer as soon as possible. If the statute of limitations expires, you may be unable to pursue a legal claim.
Defects in Guidant Pacemakers
If a pacemaker detects an abnormal heart rhythm or slow heart rate, it delivers electrical energy to the heart to restore normal function. If the pacemaker is defective, it may not be able to provide this life-saving stimulation. Defects have been discovered in both the hermetic seal and the capacitor of Guidant's devices.
Hermetic seal. In 2005, Guidant recalled 78,000 pacemakers manufactured between October 27, 1997 and October 26, 2000. The recall was issued because of a potentially faulty hermetic seal that could allow moisture to seep into the device and disrupt the power supply. This could cause a loss of pacing therapy and/or a rapid heart rate. Guidant acknowledged that at least 69 devices had already malfunctioned because of this defect. Though the company stressed these were older models that had not been implanted or sold in over four years, more than 28,000 patients were using these models at the time of the recall. A few months later the company identified a second group of approximately 54,000 devices at risk for this same defect, 19,200 of which were in use by patients at the time.
Capacitor. In 2006, Guidant recalled 27,200 defibrillators and pacemakers after reports of five device failures that were associated with faulty capacitors. Devices manufactured with this potentially faulty capacitor can experience intermittent or permanent loss of function, premature battery depletion or other malfunctions.
Several injuries and at least one death are already associated with faulty Guidant pacemakers. If you believe your pacemaker is defective or may be among the group of devices that could be defective, contact a personal injury attorney to discuss your legal rights, examples of settlements, and possible compensation. If one of your loved ones has died as a result of a defective pacemaker, contact a wrongful death attorney to begin filing your wrongful death lawsuit.
Defective Pacemaker Liability
If you have a Guidant pacemaker, you may be able to file a product liability lawsuit based on a claim that the design was inherently flawed, an error occurred in the manufacturing process (for example, the use of the faulty hermetic seal) and/or the company failed to warn of dangers associated with the device. You may be entitled to sue the manufacturer and/or other suppliers for negligence, breach of implied and express warranty, and strict liability (meaning you do not need to show negligence), as permitted by the laws in your state. Many defective product lawsuits end in settlement.
Sometimes medical devices receiving pre-market approval by the FDA are exempt from product liability lawsuits. Even if this is the case, you may still be able to sue the manufacturer. For example, if the manufacturer did not make or handle the product according to the safety processes laid out in the FDA approved documents and/or if manufacturers deceived the FDA by providing false data or withholding data on safety and effectiveness in order to get their pre-market approval, you may have a good claim against the manufacturer.
The laws relating to product liability for medical devices are complicated. If you or your loved one has had a Guidant pacemaker, a product liability attorney who has experience with medical device litigation is in the best position to analyze the laws as they relate to your case. 
[Last revision: July 12, 2010]
Guidant's initial projected rate of failure from faulty hermetic seals was between 0.17 percent and 0.51 percent but this range was later revised upward and set at 0.31 percent to 0.88 percent.