Medical Device Safety: FDA Can't Do It Alone

Matt Shudtz

June 22, 2009

While his colleagues (and former colleagues) jockey for the healthcare reform limelight, Rep. Frank Pallone is quietly busy making sure that, regardless of who pays for healthcare, the sick and injured will have safe and effective solutions to their problems. Last Thursday, Rep. Pallone held a hearing to assess FDA’s ability to properly oversee the medical device industry. The testimony outlined a troubling picture.

GAO has been closely monitoring FDA’s medical device program for years. On Thursday, Marcia Crosse, the head of the government watchdog’s health care division, testified about three serious shortcomings in FDA’s work. To begin, FDA isn’t necessarily reviewing high-risk devices according to the most stringent premarket review processes, meaning the devices might reach the market without adequate review of their inherent dangers, putting patients at increased risk. That problem leads to the second flaw GAO identified – FDA is overwhelmed by the adverse event reports submitted to the agency. Manufacturers, doctors, patients, and hospitals all inform the agency when medical devices are linked to patient injuries, but the sheer volume of these reports is too great for FDA to review. Finally, Crosse testified about FDA’s poor record of inspections on medical device manufacturing facilities. (Check out the recent ProPublica/Chicago Tribune article that highlights the tragic consequences of insufficient inspections.)

Crosse’s testimony was based in large part on a January report from GAO that provided thoughtful suggestions for how FDA might improve its work. I hate to sound like a broken record, but there’s one more thing Congress could do to promote medical device safety – restore the traditional role of state common law as a complement to FDA’s work. Since the Supreme Court decided in Riegel v. Medtronic last year that the Medical Devices Safety Act preempts state common law, patients injured by dangerous medical devices have lost an avenue for seeking compensation for their injuries. Preemption is a dangerous policy, particularly when FDA doesn’t have the capacity to do the job it needs to.

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