GAO: FDA Oversight of Medical Devices Inadequate

A Government Accountability Office (GAO) review of FDA’s oversight of medical devices has found a number of deficiencies that could expose the public to potentially dangerous and defective medical devices. The report was submitted as testimony today at a congressional hearing regarding legislation that would restore patients’ ability to file product liability lawsuits against the manufacturers of medical devices.

The House Energy and Commerce Committee’s health subcommittee is holding hearings today about the Medical Device Safety Act of 2009, which seeks to overturn a 2008 Supreme Court decision in Riegel vs. Medtronic. In that case, the Supreme Court held that medical device lawsuits against manufacturers for injuries caused by defective products may be barred if the device was approved by the FDA.

The GAO report identifies gaps in the FDA reviewing process, deficiencies in the agency’s postmarket surveillance, and also found that FDA has not kept up with regular inspections of medical device manufacturing facilities. Proponents of the new legislation point to the report as evidence that the FDA is not capable of ensuring medical device safety, and that manufacturers need to bear ultimate responsibility for the safety and effectiveness of their products.

Health subcommittee chairman Frank Pallone, Jr. said that there is already evidence that the medical device approval system is “broken” and cannot be the only defense between the public and defective medical devices.

The GAO report found that the FDA does not put all of the high risk category Class III medical devices, such as pacemakers, through its premarket approval process (PMA), which is its most stringent form of premarket review. Some Class III devices are approved through the less strict premarket notification process instead, which only looks to see if a new device is substantially equivalent to an already legally approved device out on the market.

The GAO report points out that Congress intended all Class III devices to be PMA approved since 1976, but that has yet to occur. Between 2003 to 2007, the FDA cleared 228 submissions, covering 24 types of Class III devices, for approval through the less stringent premarket notification process.

According to Dr. William Maisel, director of the Medical Device Safety Institute at Harvard Medical School, one type of device still cleared by FDA through the less stringent notification process is the automated external defibrillator (AED). More than 20% of AEDs have been recalled by FDA, and 370 fatalities have been attributed to defective AEDs between 1996 to 2005.

The report also found fault with FDA’s postmarket surveillance of medical devices, a problem area the FDA has itself noted. According to the GAO report, in 2006 the FDA noted that it was overwhelmed by the volume of submitted reports on medical device-related risks and does not review those reports in a timely or routine manner. FDA indicated that it has so far been unsuccessful in alleviating the backlog.

The GAO also noted that FDA has not kept up on inspections of manufacturing establishments, including a statutory requirement that the agency inspect certain domestic facilities every two years. FDA officials estimate that they inspect Class III facilities every three years and Class II facilities every five years. Foreign manufacturing facilities of Class III devices have only been inspected every six years.

“Taken together, these shortcomings in both premarket and postmarket activities raise serious concerns about FDA’s regulation of medical devices,” Crosse said in her testimony. “In January 2009, we added FDA’s oversight of medical products, including devices, to GAO’s list of high-risk areas warranting attention by Congress and the executive branch.”

The FDA’s own reviews have blamed both a lack of resources and increasing technical complexity of medical devices as causes for the agency’s inability to keep up with medical device safety standards.

Recent lawsuits over the Medtronic Sprint Fidelis defibrillator lead, which was recalled in October 2007, have been used as an example of the need for legislation to restore individuals ability to pursue lawsuits against medical device manufacturers. The Medtronic defibrillator lead recall was issued after they were implanted in more than 250,000 patients, when they were found to be defective and prone to fracture or break.

Although evidence suggests that Medtronic was aware of the reported lead problems for months before the recall was issued, an order was issued in January by a federal judge dismissing all of the Medtronic lead lawsuits based on the Supreme Court ruling in Riegel.

While those cases are on appeal and other medical device product liability lawsuits are in limbo, consumer advocates are pushing for the Medical Device Safety Act of 2009 to be enacted, which could be retroactive to any case still pending in the court system at the time the bill is signed into law.