Product Liability Law, FDA Pre-Emption, and Public Opinion

On December 3, the U.S. Supreme Court began to hear Wyeth v. Levine, which will determine whether the FDA’s regulations governing the labels of prescription drugs “pre-empt” state tort laws. I’ve already discussed the details of the case, wherein Wyeth (the manufacturer) claims that the Vermont state court had no right to award damages to the injured patient (Levine), for harm suffered through the wrongful use of Phenergan.

Subsequently, I expressed dissatisfaction with the doctrine of federal pre-emption, while recognizing that state tort laws are often out of control, and impose costs far greater than their benefits.

Well, things have really heated up. John E. Calfee of the American Enterprise Institute has written a compelling defense of FDA pre-emption. Among other things, he points out that the FDA is already overly cautious. It undoubtedly slows down the introduction of new drugs to a pace much more sluggish than that which would be optimal. Laying on another costly layer of government intervention – reckless state product liability laws – reduces competition and innovation.

Nevertheless, I remain unconvinced. The heart of the pre-emption doctrine is acceptance that the federal government has monopolistic power over the information that a drugmaker can communicate via a product-label – and that’s a good thing. On the contrary, government monopoly over anything is bad – especially medical information.

Another AEI scholar, Michael Krauss, has another proposal: Allow state tort law to prevail – but only the law of the state where the product was sold. So, even if you fill a prescription in Maryland and drive back home to West Virginia where you consume the medicine, you’d only have the right to sue in WV.

In any case, I suspect that FDA pre-emption will soon be a matter for scholarly debate alone. Three large-circulation daily newspapers recently published editorials opposing it. Mr. Calfee anticipates that the Democratic majority will quickly overturn this doctrine, which dates only from the Bush administration.

If that is to be the case, we might as well pose a rhetorical libertopian question: What product liability laws would we like to see govern prescription drugs if there were no FDA?

Nothing contained in this blog is to be construed as necessarily reflecting the views of the Pacific Research Institute or as an attempt to thwart or aid the passage of any legislation.

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