When a possible defect is found in the design or manufacture of a product, a company may either voluntarily recall the affected units or be forced to by a government agency. The severity of the defect is measured by the possible injuries that could result when a consumer uses the product. Class 1 recalls are considered to be the most serious recalls.
Class 1 medical device recalls are defined as those products that have “a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death,” according to the U.S. Food and Drug Administration’s recent Medical Device Recall Report. According to this report, the number of Class 1 medical device recalls has exponentially increased over the past decade.
In 2003, there was only one Class 1 medical device recall. By 2012, there were a total of 57 Class 1 medical device recalls. Although the number in 2003 was unusually low, there has still been a significantly measurable increase between the following four years and the 2012 data.
These numbers beg the question “Are medical devices becoming more dangerous?” According to the FDA, much of the increase is attributable to a better recall classification structure affecting commonly recalled products. The Boston Business Journal detailed the agency’s report, commenting that the most common products are “defibrillators, infusion pumps, ventilators and vascular catheters.”
If the agency is right, this means that the fatal risk has always been there, it is simply now more defined. When a Minnesota resident suffers adverse health consequences related to a medical device, there may be a viable personal injury or wrongful death claim for compensation under product liability law. A Minneapolis personal injury attorney can help victims or their families with their individual case.
Source: Boston Business Journal, “Life-threatening medical device recalls up eightfold since 2003,” Don Seiffert, March 21, 2014