By Chris Shakib and Wayne Hogan
According to a report issued by the U.S. Food and Drug Administration (FDA) in March of this year, the number of medical device recalls nearly doubled between 2003 and 2012. Even more alarming was the increase in the number of Class I recalls, recalls in which the defective products carried a reasonable probability of causing death or serious adverse health consequences; the number of Class I recalls was eight times higher in 2012 than 2003! Medical devices include a broad range of products that affect our daily lives, from tongue depressors and disposable gloves, to artificial hip replacements, CAT scan machines, and infusion pumps.
The FDA’s report was prepared in response to criticism in 2011 by the Government Accountability Office (GAO), which found that companies were issuing recalls for defective medical devices when it was already too late to help the people affected by them. The GAO complained that the FDA was not being proactive in its approach to oversight, was not using its own vast quantities of data to analyze trends, and needed to take tighter control over manufacturers.
According to the FDA’s report, more than 60% of medical device recalls were due to design or material/component failures. The types of devices requiring the greatest number of recalls were heart devices, such as pacemakers and implantable defibrillators.
Given the sharp rise in medical device recalls, most surprising of all are the conclusions the FDA has drawn; rather than seeing the higher number of recalls as evidence of the need for greater regulation of medical devices before they are approved for the public, the FDA concludes in its report that the greater number of recalls is evidence of the agency’s more effective incident monitoring and reporting. Not surprisingly, AdvaMed, the medical device manufacturers’ trade association, has also interpreted the rise in recalls as evidence that manufacturers are “taking a more cautious, pro-active, patient-centric approach to quality, safety and reporting…”
In the absence of tighter regulation by the FDA, on countless occasions in the past, it has been personal injury and wrongful death lawsuits filed on behalf of injured consumers that have caused companies to improve or completely remove unsafe medical devices.
Terrell • Hogan attorneys Wayne Hogan and Chris Shakib handle cases involving dangerous and defective medical devices. If you or a loved one has suffered a personal injury due to a defective medical device, you may be entitled to compen¬sation. At Terrell • Hogan, we represent the injured as they seek justice. We want to help make sure that if you or your loved ones have been injured, your rights are protected.
Medical Device Recalls Nearly Doubled in a Decade