The number of safety recalls of medical devices nearly doubled from 2003 to 2012, according to a report released in March by the U.S. Food and Drug Administration (FDA). According to the Star Tribune, out of the nearly 1,200 recalls recorded by the FDA in 2012, 57 were Class 1 recalls – or those recalls deemed to involve problems most likely to cause injury or death – compared with just seven Class I recalls in 2003.
“The annual number of Class I recalls increased in part due to CDRH [the FDA’s Center for Devices and Radiological Health] and industry efforts to improve performance of devices historically associated with high numbers of device problems, such as ventilators, infusion pumps, and external defibrillators,” the FDA report said.
Although the FDA attributes the increase in medical device recalls, in part, to greater vigilance on the part of the industry and FDA swift response to medical device problems, many question this proposition. For instance, Dr. Robert Hauser, a cardiologist and medical device industry watchdog, has criticized the FDA’s review process and device tracking procedures. Dr. Hauser said in an email to the Star Tribune: “The FDA suggests that the rise in the number of recalls reflects favorably on the regulatory process. I disagree. A truly effective regulatory system would have prevented most recalled devices from being approved for use in the United States. The report also fails to measure the harm to patients and the cost to the health system.”
Liability for Unsafe Medical Devices
As we recently discussed, medical device manufacturers – as well as doctors and hospitals, in some cases – can be held liable for defective medical devices. Medical device engineers and manufacturers have an obligation to provide safe medical devices to the public, and if a medical device is found to be dangerous or defective, the manufacturer has an obligation to remove the unsafe product from the market and correct any safety issues. The failure to do so promptly could result in liability assessed against the manufacturer. Additionally, if a doctor or hospital continues to use an unsafe medical device, liability could be assessed in a medical malpractice lawsuit.
Contact a Medical Malpractice Lawyer
The medical malpractice lawyers at Cogan & Power, P.C. have significant experience representing clients in and around Chicago who are injured as a result of unsafe medical devices. In fact, we recently obtained an $11.4 million verdict in a lawsuit against both a hospital and medical device manufacturer filed on behalf of the family of a patient who died as a result of injuries sustained by a defective head holder used in surgery.
If you or a family member has been injured, or a loved one has died, as a result of an unsafe medical device, please contact our office at (312) 436-0731 to schedule a free consultation with one of our Chicago medical malpractice lawyers.