Hardly a day goes by in which Americans are not hearing about a defective product that has been recalled because it poses a danger to consumers. There is, of course, a hierarchy of danger ranging from a kitchen gadget that could overheat to an automotive defect that could cause a fatal car accident. The current General Motors recall scandal is a good example of how dangerous and deadly a seemingly small defect can be.
Near the top of the hazard hierarchy, however, are recalls of medical devices; particularly those which are given Class 1 status. The Food and Drug Administration has explained that recalled medical devices are given a Class 1 designation if there is “a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.” According to an FDA report issued last month, Class 1 recalls for defective medical devices have gone up by 900 percent since 2003.
The nightmare scenario for many patients would involve the recall of an implantable medical device, such as a pacemaker. But even when a defective product is housed outside the body, it can still be highly dangerous if the device is meant to regulate critical bodily functions like breathing or the monitoring/delivery of insulin.
Why has the number of Class 1 recalls skyrocketed over the past decade? The FDA says that it is due, in part, to the fact that more recalls are being considered serious. In other words, recalls have not necessarily increased, but more recalls than in the past are being designated as Class 1. The FDA also notes that medical device manufacturers are being more conscientious about self monitoring, which has led to more recalls.
Nonetheless, the high rate of Class 1 recalls should not be taken lightly. Patients have a right to expect that the medical device they are using (or having implanted) is safe and effective.
If you or a loved one has been seriously injured or killed by a defective medical device, you may not know where to turn for help. Please contact an experienced personal injury attorney who can help you understand your rights and options.
Source: Boston Business Journal, "Life-threatening medical device recalls up eightfold since 2003," Don Seiffert, March 21, 2014