Authorities criticize FDA regulation of medical devices

The U.S. Supreme Court last year held that individual victims cannot sue if they are injured by defective medical devices, if the product was approved for safety by the FDA.  This week, the Government Accountability Office reported that the FDA has failed, in some cases for decades, according to the New York Times, to rigorously review the safety of medical devices.

Under a 1976 law, the Food and Drug Administration was to separate medical devices into three categories and assess their safety more rigorously based upon the danger a failed device would represent to patients.  Class I devices are not particularly dangerous and require much less regulation.  Class III devices, such as pacemakers and heart valves, for example, require very stringent regulation by the FDA.  It was this regulatory scheme which the Supreme Court relied upon, thirty years later, to hold that Congress intended to eliminate private lawsuits in deference to regulation by the FDA.

Unfortunately, the legislation allowed already approved devices, or their "substantial equivalent", to be marketed without the stringent review otherwise required of Class III devices.  Since that time, various administrations of the FDA have completely failed to define these "grandfathered" devices, leaving many very dangerous new "equivalent" devices uncategorized and not regulated to Class III standards. 

It turns out that FDA scientists have been objecting to this failure to regulate through much of the Bush Administration, but to no avail, as good science has fallen victim to political pressure from Congress and an administration that rejected, on philosophical grounds, the concept of government regulation.  We need look no further than the 2008 collapse of the American financial community to see where that attitude is likely to take us.  It is reassuring, though, to know that the U.S. Supreme Court considers us to be in such safe hands with FDA regulation that we can eliminate the right to seek private compensation for injury caused by defective devices.