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March 04, 2009


I hate to say it, being a great champion of Justice Thomas, but while I believe that his analysis is quite correct as to the current state of jurisprudence, Justice Breyer actually hit the nail on the head: state tort liability in this particular matter did not interfere with any FDA regulations. I have a feeling that, if in Breyer's opinion it did, for once we'd have had a dissent where Breyer actually joined the Federalist side of the Court.


I hate to say it, but I have to agree with Justice Breyer (and the majority) on this one. That's saying quite a bit as I despise Breyer's opinions and views in the IP area, as well as joining the majority of SCOTUS in the eminent domain case (Kelo v. City of New London) which is one of the worst decisions that SCOTUS has ever opined.

What we have here is an issue of tort liability which has traditionally been governed by state law. Nothing in the FDA labeling requirements changes that. In fact, under traditional "strict liability" theories, it doesn't even matter whether the label was correct (or not).

The dissent's comment about having potentially "50 voices" here is simply the fact of our federalism structure, unless Congress clearly preempts the area, which they haven't in the area of drug labeling. Sorry, as one who generally sides with the so-called "conservative" block of SCOTUS, I can't go along with them on this one

Dear Patrick:

I agree with your assessment of Justice Breyer's opinion.

Actually, Justice Thomas had a much more extreme view of the matter. He thinks that the Court's penchant for looking for Congressional intent is misplaced, and that if Congress has an intent they should put it in the statute. I think in a perfect world that would be right, but it ignores the political realities (not even reaching the issue of Presidential signing statements).

Thanks for the comment.

Dear EG:

I think Justice Alito has a point, however - if the FDA were properly set up, it makes more economically efficient sense for the experts to make these safety determinations.

What his analysis ignores is that the FDA would have to have the resources not only to approve drugs but then to monitor them after approval. As it is, this responsibility is put on the drug manufacturers, but in view of the various instances of post-approval problems (the COX-2 inhibitors, Phenfen, and some of the antidepressants with obesity and diabetes complications), it is pretty evident that it won't happen. UNLESS, there is the threat of plaintiffs out there who will expose the drugs that have problems and "force" companies to be sure the consumer and their physicians have been warned.

This is a case where there was a chance that the decision could have gone the other way. There was clearly pretty gross malpractice here if you look at Justice Alito's reference to the facts, and the plaintiff clearly wanted the warning to be a "thou shalt not" use IV push for this drug. I could see a way clear for the Justices to have decided that something this stringent was not for a lay jury to decide.

But I think the majority got it right, especially in view of Justice Breyer's reminder that the Court wasn't giving plaintiff's lawyers a blank check on these lawsuits. There was also, I think, a recognition that the Bush administration had tried by rule (and an unvetted preamble to a rule at that) to change the litigation landscape (hence the lack of deference by the majority).

Overall, a very sage decision, right or wrong - this wasn't something that was either overly partisan or overly ideological.

Thanks for the comment.

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