A heart defibrillator is a device that sends an electric current through the body to restore a person’s heartbeat after they have gone into cardiac arrest or their heart has stopped beating regularly. Doctors have just begun implanting these devices in individuals at high risk of cardiac arrest.
The Guidant Corporation is the leading manufacturer of internal heart defibrillators.
Guidant recently announced that their Ventak Prizm 2 Mode 1861 defibrillator has an electrical system defect that might cause the device to short-circuit and malfunction, putting the patient at risk of cardiac collapse. Guidant maintains that the odds of the defibrillator failing are extremely low (about 0.0720) and that it exceeds design expectations and requirements.
The potential legal issue is that Guidant did not disclose the possible electrical failure of the defibrillator to clinicians or their patients until the New York Times identified the problem three years after they were widely used.
In June 2005, the United States Food and Drug Administration (FDA) issued a worldwide recall notice for some Guidant implantable defibrillators and cardiac resynchronization therapy defibrillators. The following devices were affected by the June 2005 notification:
The PRIZM 2 and RENEWAL devices are susceptible to various faults, resulting in the devices’ inability to deliver an electrical shock during arrhythmia episodes. This can result in a serious, life-threatening occurrence for a patient with these devices implanted. The FDA received reports of two deaths that are thought to be related to this problem.
Boston Scientific issued another recall on some defibrillators in June 2006. Boston Scientific sent this notice because it purchased Guidant Corporation in April 2006. Boston Scientific issued a recall for:
Boston Scientific/Guidant confirmed five device malfunction reports from the approximately 27,200 patients who had these devices implanted worldwide.
One problem occurred during implantation, while four patients required device replacement.
When the patients’ equipment malfunctioned in two situations, they lost consciousness. There have been no reported deaths.
The FDA suggests the following procedures in the June 2005 notification if you believe you have been affected by a malfunctioning defibrillator:
Boston Scientific addressed letters to doctors and patients in the most recent recall, alerting and advising individuals to contact their doctors as soon as possible.
Product liability lawsuits generally originate from a branch of tort law that deals with injuries and damages caused by defective or faulty products.
This area of law can help decide whether a manufacturer may be held accountable for allowing defective medical items and devices to enter the marketplace, which can then be sold to consumers, hospitals, and other medical facilities.
For example, if you are injured due to a faulty medical device or product, you may be entitled to bring a claim for medical product liability.
It is crucial to highlight that most medical product liability cases involve genuine medical devices or items rather than medicinal or pharmaceutical-related claims such as prescription medicines. However, specific medications may be filed as this type of claim in some situations.
Medical products or devices can give rise to a medical product liability lawsuit for a variety of reasons.
Defects in medical products, like other product liability claims, fall into three broad categories:
Although a single claim may encompass more than one of these three types of defects, each requires a unique set of standards to establish that the precise fault being claimed exists. If you want to pursue a medical product liability claim, you should consult with a local products and services lawyer.
Product responsibility laws may prescribe harsh legal repercussions and broad remedies for injuries resulting from a medical product liability claim, depending on the facts of an individual case and which set of laws applies to a case.
In most cases, medical product liability lawsuits contain monetary damages awards that can be utilized to recompense the injured person for any losses generated by the defective product and consequent harm.
Medical expenses, lost wages, hospital bills, loss of future earnings, pharmacy-related costs, and numerous other charges required to treat a person’s injuries may be covered by monetary damages awards.
Plaintiffs may also be awarded monetary damages for non-tangible injuries like pain and suffering, mental distress, loss of reputation, deformity, and other factors. Noneconomic or broad monetary damages are what they are.
Furthermore, the court may award punitive damages if a case is bad enough. However, punitive damages are often reserved for exceptional circumstances.
If a medical product injures enough people, the afflicted can band together and bring a class action medical product liability lawsuit against the manufacturer of the dangerous medical product. If the plaintiffs prevail in the class action complaint, the Food and Drug Administration can recall the faulty medical product.
Similarly, plaintiffs who win a class action medical product liability lawsuit typically get very high settlement payments. However, given the number of complicated standards that the plaintiffs must comply with and the particularities linked with how these lawsuits must be filed, such cases should be launched with the assistance of an expert products and services lawyer.
Internal heart defibrillators are a relatively new technology, and determining if the defibrillator used on you or a loved one worked properly may be tricky.
An experienced defective products lawyer in your area can advise you on whether you should file a claim against Guidant. Such cases can be complex, but your attorney can guide you through the process from start to finish to ensure your rights are protected.
16 people have successfully posted their cases
