June 2007

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OK class, for today’s lesson, assume you are a major, sophisticated drug company. That means you have to have at least one (actually, a bunch) FDA-approved drug that’s safe and effective for its indicated use. So assume that, too – let’s say your drug alleviates muscular inflammation from over-exercise.

There being at least some reality

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Under the Vioxx rule, stated previously here here, the blame – or credit – for this post goes entirely to Bexis, as Herrmann this time takes a pass due to client representation.
We’ve learned that Judge Garruto, who’s apparently clearing his docket before a bellwether HRT (hormone replacement therapy) trial and his September 1

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The United States Supreme Court today granted certiorari in Riegel v. Medtronic.

We’ll know next Term (certainly before the end of June 2008, and probably long before then) whether the Federal Food, Drug, and Cosmetic Act preempts state law claims involving medical devices that came on the market through the premarket approval process.

As

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On this issue, Beck can’t speak. (Stop cheering, “Thank God for small favors.”) His firm, Dechert, is in the thick of the Vioxx litigation.
So this post is pure, unadulterated Herrmann. (Stop shouting, “We’d rather have Beck.”)
We’re thinking today about Judge Higbee’s recent decision awarding plaintiffs $3.7 million in attorneys’ fees (and costs) for

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We’re pleased to report that the ATLA anti-preemption language was stripped out of the FDARA legislation before that legislation was voted on favorably by the House Energy and Commerce Health Subcommittee. Our post and the vote apparently occurred on the same day.

That’s good news, but it doesn’t mean it’s over. We’ll keep watching.

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The day after we ran our post alerting readers to the threat suddenly being posed by House language concerning preemption, “The Hill” blog ran a much more detailed piece on the same subject.
The Hills’ report provides the exact text of the anti-preemption language that’s been circulating in the draft House of Representatives bills:

“Nothing

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It’s hard to find a political constituency for the preemption defense. Liberals want to permit plaintiffs to sue; conservatives believe in federalism, and so don’t think the federal government should lightly override state law. What’s a defense lawyer to do?
Be smart, and be careful. We’ve recently posted on the need for defendants to pick