by Maria Markou
Our firm specializes in representing people with serious injuries as a result of harmful medical devices and drugs. Recent FDA recall statistics sadly confirm what we already know: more dangerous medical devices are flooding the market, some even killing patients. The FDA tried to justify the 97% increase in medical device recalls from 2003 to 2012, by alleging that the medical industry faces these problems both effectively and efficiently. Despite this meaningful and imminent concern, the FDA recorded nearly 1,200 recalls in 2012, 57 of which were Class I recalls (those that can provoke serious injury or even death).
The increase in Class I recalls has occurred because of the speedy trial and testing procedures of the FDA’s Center for Devices. Janet Trunzo, AdvaMed Senior Executive Vice President for technology and regulatory affairs tried to explain the FDA’s position. She explains that the FDA reports results by noting the rise of more complex medical devices now than a decade ago. Nevertheless, the complexity of the devices is not a significant factor for the increase of devices’ recalls.
Furthermore, Dr. Robert Hauser, a prominent cardiologist casts doubt on the FDA report’s conclusion, and crucified this by underlying the ineffectiveness of the FDA’s regulatory system to prevent the defective devices’ presentation on the market. He also emphasized the statistics’ absence from the report regarding the torts to patients and the ensuing cost to our health system. According to FDA report, most of the medical devices are recalled due to problems associated with device design, software, and non-conforming material or component issues. Despite the facts that medical device industry and FDA try to implement and release on the market the most harmless medical devices for improvement of our lives, the recent data show that every year we face a huge increase of defective and unsafe medical devices, and as a consequence a great number of patients can be in darkness of these issues and mainly in great peril.