Monday, April 14, 2008

Pre-emption, part I

The New York Times has an editorial today in support of an article from last week on the topic of FDA preemption. Not surprisingly, the Times gets the facts wrong, wrong, wrong. I fully expect this issue of preemption to become more of a major news story, as the Supreme Court has already ruled on a case involving medical devices and may soon rule on a case involving pharmaceuticals, so it's a shame the reporting on the most basic aspects of law involved has been so piss poor.

Rather than get into all the technical aspects of FDA regulation and judicial review of regulatory authority, we can just stick with the basics. Basically, the idea of preemption is that when a product's sale is conditional on some form of government approval, that approval should preempt the right of parties to sue a company for a defective product, when the company manufactured the product while relying on the government's approval. The way the New York Times has been reporting, you get the impression that preemption means Company X would have blanket immunity for any product that causes injury. That's not the case. To understand the actual impact of preemption, you need to understand some of the basics of product liability law.

Product liability law is a subset of tort law that allows injured individuals to sue and recover for damages without having to show fault on the part of the manufacturer. Two means of bringing a product liability lawsuit is to prove that the product in question was defective because of either 1- a design defect, or 2- a manufacturing defect. The notion of preemption applies only to design defects, the idea being that if the government approves a specific design in the first place, manufacturers should be protected from being sued for that design.

It should be fairly obvious, but preemption does not apply to manufacturing defects. A manufacturing defect means that the product in question was not manufactured according to specs. Therefore, it would make little sense if government approval of a specific design would preempt a lawsuit filed on the grounds that a product was not manufactured in accordance with the approved methods.

The Times discusses the case of Johnson & Johnson's Ortho Evra birth control pill as an example of horrors preemption means for consumers, but they seem to be missing the boat. I don't know much at all about the case, but the facts the New York Times seems to be concerned with seem to be a question of fraud more than anything else.

I'm amazed that basic legal issues can get so twisted that they become unrecognizable to the lay public, but that's exactly what the Times has done. The question of preemption is certainly relevant, just not in the way it's been reported. The truth is that I don't see an easy answer whether you're coming from a liberal, conservative, or libertarian point of view. More later ...


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