For some, receiving a new medical device leads to a vastly improved quality of life. For those who receive defective medical devices, the results can be painful or even fatal. The problems involved with faulty medical devices have long been complicated by the difficulty in identifying which patients received devices that ended up failing. The U.S. Food and Drug Administration has released new rules that are intended to make it easier to track defective devices and get in touch with patients who have received potentially dangerous implants.
More information is coming to light concerning the hip implants recalled by Johnson & Johnson's DePuy Orthopaedics division. According to Johnson & Johnson's internal documentation, the metal hip implants known as Articular Surface Replacement, or A.S.R., fail at a rate of almost 40 percent within the first five years after they are implanted. The company conducted that analysis shortly after it recalled the devices, but it never released the projection publicly. The spate of lawsuits concerning the defective medical product led to the release of this information.
A series of high profile recalls led the Food and Drug Administration (FDA) to seek recommendations for how the medical device approval system could be improved. Recently, defective product recalls involving Medtronic defibrillators and DuPuy artificial hips have drawn significant attention to how the FDA grants approval for medical devices. These and many other medical devices were approved under a fast-track process known as 510(k). According to at least one group, the process is inherently flawed.
In recent years medical device manufacturers have increasingly been using what is known in the industry as "federal preemption" defenses to defeat personal injury lawsuits soon after they are filed. In many of these cases dismissal comes so fast the manufacturer is not even required to produce a single document addressing whether the medical device was made as it should have been.