Implanted defibrillators can be a miraculous device for heart patients. Implanted under the skin, the defibrillator automatically detects abnormal heart rhythms and shocks the heart to regulate the heartbeat. When functioning properly, implanted defibrillators can prevent sudden death and provide security and comfort to patients and their families. However, it may be a false security. Reports of defects resulting in injury, and sometimes death, are rapidly increasing and recalls of the devices are on the rise.
Problems with defibrillators.
- Internal short circuit
- Programming errors
- Defective magnetic switch
- Internal memory problems
- Delayed shock
These defects can cause injury or death. Short circuits can cause the device to fail entirely. Programming errors can cause the unit to administer a shock when it is not needed. Patients who rely on the device to restart or regulate heartbeat can die if the unit fails. An unnecessary shock can cause serious injuries, for example one patient with the device has suffered a fractured jaw and nose from falling due to an unneeded shock.
Who has a claim?
- Patients who have experienced a malfunction may have a claim for any health problems or injury that the device has caused.
- Families of those who have died as a result of a malfunction may have a wrongful death claim.
- Anyone who has a model known to have a defect may have a claim for removal and replacement of the device, whether or not the device has malfunctioned.
- Those who need a replacement but are not healthy enough to undergo the replacement surgery may have a claim as well.
Who is liable for a defective or recalled defibrillator? Several companies have recalled defective defibrillators including Guidant, Medtronic, and St. Jude. Out of all of the companies issuing recalls, Guidant’s handling of the situation is the most disturbing. Guidant became aware of the problem and made changes to the device in 2002. However, for three years Guidant chose not to disclose information about the defect to doctors and patients. Guidant claims that the danger of replacement surgery may outweigh the likelihood of a malfunction. Clearly, the information should have been disclosed so that patients could confer with their doctors on their individual cases to determine whether they should have the device replaced. Guidant revealed the defect to doctors on May 23, 2005, the night before the New York Times ran a story uncovering the problem and the death of a 21-year-old man whose defibrillator short circuited. More shocking than the fact that Guidant withheld the information about the malfunctioning devices is the fact that, after discovering the problem and creating an improved model, it continued to sell the defective models it had in stock rather than destroying or remanufacturing preexisting units. The cover up may have been intended to raise stock prices. Johnson & Johnson had planned to buy Guidant, but reduced their offer after problems came to light. Now Boston Scientific has beat Johnson & Johnson’s offer.
At one time there appeared to be 50,000 patients with recalled implanted defibrillators. The numbers are increasing as models are added to the list and between Guidant and other companies now issuing recalls the number is thought to be upwards of 150,000. Malfunctions have been reported in at least 45 implanted devices, 2 resulting in death. If you or someone you know has an implanted defibrillator speak to your doctor and an experiencedpersonal injury attorney such as Harvey L. Walner & Associates in Chicago, Illinois to determine whether your model is subject to recall and whether you should seek replacement and/or are entitled to compensation.