Defective Pacemakers and Implantable Cardioverter-Defibrillators
Defective pacemakers and implantable cardioverter-defibrillators (ICDs) pose a serious health risk to people suffering from heart conditions. Pacemakers and ICDs are implanted into the body to help monitor the hearts of people who have experienced heart trauma of some kind (typically a heart attack). Such medical devices have been proven effective in treating people suffering from a variety of heart conditions.
It is the responsibility of medical device manufacturers to ensure that each and every product they put on the market is functioning properly in order to safeguard consumers from any detrimental effects that might be incurred as a result of defects.
Heart disease is one of the leading causes of death in the United States. Sudden cardiac arrest, also known as heart failure, is the cause of approximately 300,000 deaths each year. Pacemakers and defibrillator products are designed to save as many of these lives as possible by monitoring the heart and accounting for any rhythmic or heart rate issues; however, if any of the products are defective, it provides users with a life-threatening sense of false security.
Defective Pacemakers and ICDs – Legal Ramifications
Manufacturers are liable for injuries caused as a result of using their products, especially if the defects are proven to be widespread and serious. A pacemaker recall is required if manufacturer defects have been proven responsible for causing injuries. Similarly, a defibrillator recall (ICD recall) is required if manufacturer defects have been proven responsible for causing injuries.
After a medical device is found to be defective, it must be recalled by the manufacturer in an effort to minimize the harm associated with use of the product. Patients injured by defective medical devices have a right to personal injury compensation from the manufacturer of the device. The defective medical device lawyers of Aylstock, Witkin, Kreis & Overholtz can evaluate the situation and help obtain restitution for the patient, or the patient’s family members.
Pacemakers and ICDs
Pacemakers are a group of cells that create electric impulses responsible for controlling the rhythmic beating of the heart. Pacemaker cells can be rendered ineffective if the heart undergoes some type of severe trauma like a heart attack; synthetic or artificial pacemakers were developed to aid those who have experienced such trauma.
Artificial pacemakers are medical devices that are surgically implanted to stimulate the heart when pacemaker cells are unable. First implanted into a human in 1958, artificial pacemakers were a breakthrough of mammoth proportions for people suffering from heart troubles.
On occasion, another type of artificial device called an implantable cardioverter-defibrillator is surgically implanted. Somewhat resembling pacemakers, ICDs are implanted under the skin of patients who are at risk of sudden stopping of the heart (ventricular fibrillation). ICDs constantly monitor heart rate, applying appropriate therapies when it exceeds a certain limit. Defective ICDs put patients at risk of sudden death resulting from ventricular fibrillation.
Guidant Corporation and Medtronic Inc.
Guidant and Medtronic are two large manufacturers of implantable medical devices like pacemakers and ICDs. Medtronic is credited as the first company to design and manufacturer wearable pacemakers. Guidant manufactures a number of medical devices, some of which include:
- Cardiac pacemakers
- Cardiac resynchronization therapy (CRT)
Guidant and Medtronic have recently been under fire because of defective defibrillators and defective pacemakers manufactured by both. The defective devices have led to the deaths of a number of patients, making both Guidant and Medtronic liable for personal injuries suffered by anyone using one of their respective medical devices.
In March of 2007, a safety advisory update was issued by the UK Medicines and Healthcare Products Regulatory Agency with regards to a defect affecting some implantable heart devices’ ability to function properly. The exact nature of the defect relates to the devices’ failure to administer necessary shocks in a timely manner. Though there have been no injuries reported as a result of this most recent safety advisory, it certainly stokes the fears of consumers still wary of the threats posed by certain pacemakers and ICDs.