By now, most of you have probably heard about the tragic death of a two-year-old child due to a rare bacterial infection apparently caused by tainted Triad alcohol prep wipes. It is alarming that such a dangerous defect could escape the detection of a medical supply manufacturer. Even more troublesome are recent revelations that the U.S. Food and Drug Administration (FDA) may have known about the potential hazard but failed to take any action. Triad has recalled millions of pads and swabs, but its slow response and failure to ensure the safety of its products is likely to come under heavy fire in the coming months.
The FDA appears to have known about sterilization problems at Triad as early as July 2009, about a year and a half before the infant died. The stated goal of the FDA is “Protecting and Promoting Your Health,” but too often it falls short of its mandate. When that happens, the civil justice system should be available to hold negligent medical supply manufacturers accountable for their wrongdoing. Unfortunately, Michigan law offers added protection to medical product manufacturers, giving them a legal presumption of no negligence if the product has been approved by the FDA. Drug manufacturers are even granted full immunity in Michigan if the drug has been FDA approved. As a result, Michigan residents are disproportionately deprived of their right to seek justice when the FDA fails to do its job.