Overruled


FDA Rolls The Dice on Untested Medical Device
March 6, 2009, 2:25 pm
Filed under: Ian | Tags: ,

The Wall Street Journal has lengthy and well-researched piece today about how lobbyists for a company called ReGen Biologics Inc. convinced the FDA to ignore its own procedures and approve a device which is surgically implanted into the knee.  The short version is that federal law normally requires that a new device undergo clinical trials, and that the result of those trials be reviewed by the FDA to ensure the devices’ safety, before the device is allowed on the market.  When ReGen’s product, a device called “Menaflex,” wasn’t faring very well in these trials, however, the company decided to bypass the law.

As the WSJ tells the story, ReGen lobbyists convinced several Members of Congress to apply pressure to the FDA, and the FDA eventually agreed to form a committee to decide if Menaflex should be approved through a “fast track” approval process that does not require clinical trials—and then allowed ReGen’s lobbyists to play a significant role in choosing the members of that committee.  Unsurprisingly, the device was subsequently approved last December.

Menaflex may, in fact, be perfectly safe.  It may be a miracle cure for thousands of people with knee injuries.  Or it could be a time bomb like the Dalkon Shield.  Because the FDA didn’t bother to screen the device, however, we won’t know if Menaflex is dangerous until after it starts injuring people—and potentially after it has already been implanted into thousands of unsuspecting patients.

I’ll also add that this incident shows why it is absolutely essential that Congress enact the Medical Device Safety Act, which would overturn an absurd Supreme Court decision holding that the makers of dangerous medical devices are immune from lawsuits when their defective devices injury or kill a patient.  The reasoning of that decision, Riegel v. Medtronic, was that consumers don’t need something as silly as state tort law so long as the FDA is there to screen devices and keep the defective ones off the market.  As the Menaflex incident teaches, however, the FDA doesn’t always do its job; and even when it does do its job, the FDA can’t catch everything.

As Justice Stevens just reminded us, “[s]tate tort suits uncover unknown drug hazards and provide incentives for drug manufacturers to disclose safety risks promptly.”  They offer the same benefits when they are applied to medical device manufactureres.  It’s time for Congress to get on the ball and fix the Supreme Court’s mistake in Riegel.

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