June 5th, 2008
Time to overhaul grandfather's FDA approval process?
In February the U.S. Supreme Court ruled, in Riegel vs. Medtronic, that the FDA’s authority to approve medical devices means states, and their courts, have no recourse when something goes wrong.
At a stroke this pre-emption ruling eliminated medical device product liability. Once the FDA approves a device, it’s safe and no one can argue different — not even someone harmed by it.
While Congress debates the merits of this there’s another point to make, namely that most devices don’t go through rigorous pre-market screens at all.
AdvaMed, which represents device makers, calls the FDA’s pre-market approval process “the most stringent in the world.” But how stringent is it really?
As Richard Deyo noted in a recent Seattle Times editorial, most device approvals are grandfathered. If it does what something did in 1976, we assume it still does and approval is quick.
The result is that, if your pacemaker fails, the pacemaker company may offer you a new one. But you’ll have to pay to put it in. And you have no recourse to the courts, even though it was approved for use with no human studies, only lab work.
Want to get a little angrier? AdvaMed constantly pushes for more FDA money to study imported products. In testimony the head of the group, Stephen J. Ubl, is frank in noting that the U.S. still retains a positive balance of trade on medical devices.
What we’re moving toward is a closed market, with no meaningful pre-market regulation, and no recourse to the courts for those who are harmed.
Pretty slick.
But is it right? If we’re to pre-empt states and courts from looking at patient safety, shouldn’t pre-market FDA approvals include human testing, as it does for drugs? If we’re to study imported devices closely, what about domestic products?
And if courts are to be closed to those whose medical devices fail, shouldn’t they be closed to all those hurt by faulty products? After all, we have consumer product regulators.
Dana Blankenhorn has been a business journalist since 1978, and has covered technology since 1982. He launched the Interactive Age Daily, the first daily coverage of the Internet to launch with a magazine, in September 1994. See his full profile and disclosure of his industry affiliations.
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