Immunity that’s just wrong

Monday, Feb. 25, 2008 | 2:08 a.m.

In the past two years, numerous reports have assailed the Food and Drug Administration’s ability to make sure the food, drugs and medical devices sold to Americans are safe.

So it is disturbing that the U.S. Supreme Court last week ruled manufacturers of medical devices, including those implanted in the body, are immune from personal injury lawsuits if those devices fail — as long as the FDA approved the devices.

The 8-1 ruling, issued Wednesday, applies to devices approved through the FDA’s premarket process, in which they had to meet certain standards before being sold. Devices that have been the subject of personal injury cases include heart defibrillators, an artificial heart valve and artificial hips and knees.

Justices based their ruling on a 1976 law that placed medical devices under the premarket scrutiny of the FDA. Before then, medical devices were regulated by only a few states.

Justice Ruth Bader Ginsberg, the lone dissenter, said the 1976 law was designed to protect consumers rather than strip them of their right to hold medical device manufacturers accountable.

The New York Times reports that Sen. Edward Kennedy, D-Mass., who sponsored the 1976 legislation, agreed, saying Congress “never intended that FDA approval would give blanket immunity to manufacturers from liability for injuries caused by faulty devices.” Congress, Kennedy added, “obviously needs to correct the court’s decision.”

Even more troubling is that the Bush administration, which sought the ruling that favors medical device manufacturers, hopes the decision will help obtain similar immunity for drug manufacturers whose products gain FDA approval before going to market. Basically, that is every drug on the market.

Reports by the Institute of Medicine, the Government Accountability Office and the FDA’s own science board have asserted the FDA is failing to do its job because of faulty scientific work, poor management and a lack of adequate funding.

And yet the public is to have no legal recourse when devices — and possibly drugs — approved by the agency cause injury or death? It is preposterous.