Thursday, July 3, 2008

Doctors Say Preemption Is A Bad Idea

In an astonishingly frank and well-written article published this week in the New England Journal of Medicine, three doctors make the case that preemption of state law tort claims against drug and medical device manufacturers is a bad idea, and that physicians should be concerned about it. The physicians, Gregory D. Curfman, M.D., Stephen Morrissey, Ph.D., and Jeffrey M. Drazen, M.D., say:

Why should doctors be concerned about preemption? In stripping patients of their right to seek redress through due process of law, preemption of common-law tort actions is not only unjust but will also result in the reduced safety of drugs and medical devices for the American people. Preemption will undermine the confidence that doctors and patients have in the safety of drugs and devices. If injured patients are unable to seek legal redress from manufacturers of defective products, they may instead turn elsewhere.

We Are The Federal Government And We're Here to Help
The preemption issue is a hot topic in Was hington as a result of the landmark U.S. Supreme Court decision in Riegel v. Medtronic, 128 S. Ct. 999 (2008). Although limited in its application, Riegel has bolstered efforts by the FDA and drug/device manufacturers to limit lawsuits involving defective drugs and medical devices. Essentially, what preemption means to consumers is that the United States Government would be placed in the position of determining whether or not a drug or device is safe, and if it says that it is, the manufacturer of that drug or device cannot be sued if the product is later found to be dangerous or defective, even if the manufacturer knows that it is defective and distributes it anyway.

The problem, of course, is that the FDA is notoriously terrible at providing an oversight role in the design and manufacturing of drugs and medical devices. Even its own scientists have left in disgust after the FDA failed or refused to properly regulate the pharmaceutical industry. The same can be said of other federal agencies that simply do not have the staff, the funding, and most importantly, the passion, to ensure that the health and safety of American citizens are protected.

The truth is that we should all be concerned about preemption. While the concept may have superficial appeal because it would no doubt wipe out what we all know to be meritless lawsuits, it would be a classic case of "throwing the baby out with the bath water." If preemption proponents prevail, the meritorious claims of injured citizens against companies that knowingly manufacture and distribute defective products would be denied merely because such products bear the imprimatur of a federal agency. The doctors are right, preemption is a bad idea.