By Jeff Stier, Esq.
Posted: Friday, February 27, 2009

EDITORIAL
Publication Date: February 27, 2009

This article first appeared on February 27, 2009 on Forbes.com:

You would think liberal politicians are the only ones who stand up for us, the consumers. But consider the current effort to allow consumers in all fifty states to sue over injuries sustained from FDA-approved medical devices.

The Supreme Court properly ruled last February that manufacturers of medical devices approved by the Food and Drug Administration (FDA) cannot be sued in state courts on the grounds that they were defective products.

The doctrine of federal pre-emption, which the court held applied to drug devices in this case, says that FDA approval means the devices are safe enough to sell as regulated, without threat of litigation, except in the case of fraud.

There's a rationale behind the pre-emption doctrine--and it applies precisely to cases like this one. The potential for different standards in each state would create chaos and inhibit innovation. The court's decision was great news--not only for defendant Medtronics and other device makers but for all of us who'll benefit from newer devices like improved coronary artery stents, pacemakers and joint replacements.

But poised to offer a "legislative fix" to the decision are Reps. Henry Waxman, D-Calif., and Frank Pallone, D-N.J., who have joined Sens. Ted Kennedy, D-Mass., and Patrick Leahy, D-Vt., in an effort to undermine the Supreme Court decision. It is Congress' prerogative to change the law. However, this change would hurt not only industry but consumers as well.

If manufacturers (read: innovators) cannot rely on FDA approval to defend them against lawsuits, they will have less of an incentive to invest in new devices. The specter of litigation, with different standards in each state, would sometimes stall development of lifesaving devices; it shifts the profit-risk balance so much that it'll be financially prudent to not sell a device. It will also increase the cost to consumers of all new medical devices.

The Waxman-Kennedy position is, by and large, endorsed by the public health community. Yet public health experts fail to recognize that increased litigation--while it would help certain injured and innocent patients--will harm a much broader and equally innocent group of (probably less litigious) patients who may not live to benefit from devices that will never make it to market if this law passes.

This point rarely makes it beyond the conservative echo chamber. After all, those injured by medical devices make for great news stories. But patients who don't get the devices that never made it to market because of the risk of litigation won't get the same attention. They will just die, prematurely, of "natural causes." But in truth, their deaths should be blamed on the sponsors of this legislation and their allies in "public health."


Jeff Stier is an associate director of the American Council on Science and Health.