We never know what will happen when we post something. Earlier this week we tossed up a short post about a case involving FDA warning letters – at least that’s what we thought.
What we got back was a rip-roaring comment from the attorney for the plaintiff in the case, Regenerative Sciences, Inc. v. FDA
FDA Evidence
A warning about FDA warning letters
Lawyers for tort plaintiffs just love it every time the FDA issues a warning letter. To them, FDA warnings = liability (just don’t use the dirty word “preemption”). You can book it that our opponents will use, overuse, and abuse those warnings letters at every opportunity. They will base entire parallel violation claims on FDA…
“A Causal Relationship Need Not Have Been Proved”
Here’s a dirty little secret – plaintiffs’ lawyers really love preemption. They love it, but they won’t ever admit it. To them, it’s a doctrine that dares not speak its name. In contrast to defendants’ open resort to preemption to bar claims that conflict with the FDCA, plaintiffs use it in a stealth fashion. They…
Good Ideas From Our Readership
We love it when our readers share good ideas with us. For one thing, it saves us the trouble of having to think up ideas ourselves. Today we’re sharing a couple of those with you.
Ted Heise, who’s at Cook Medical, was reading our post on methods of proving up FDA-related evidence. He took…
This And That
Seroquel Expert Non-Causation Order
We can’t say much about this, as Herrmann is on vacation and Bexis is involved in the Seroquel litigation. The MDL judge today ruled on the defendant’s motion to exclude various “non-causation” opinions/testimony by the plaintiff’s experts. Here is a brief summary of what Judge Conway excluded:
- “[N]arrative history” of the defendant’s “marketing and
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Some Thoughts On Pleading And Proving FDA Actions
This post is largely about drug and medical device litigation “inside baseball.” Some of it’s going to be really technical. So if you’re looking for philosophical musings, or just a chuckle or two over the latest bizarre goings on in our neck of the woods, come back later.
But if you’ve ever had to worry…
Seroquel MDL: Motions In Limine Granted
We reported last week that Judge Anne Conway, who’s overseeing the Seroquel MDL, had granted summary judgment in favor of AstraZeneca in the bellwether cases involving the first two plaintiffs. She had not yet issued her written decision at that time.
She still hasn’t entered that written decision. (We just couldn’t leave you hanging there.)…
Colacicco and Judicial Notice
We’ve previously offered our collective four cents worth about tactical considerations that pharmaceutical defendants need to think about in deciding whether or not to bring preemption motions in particular cases. Given the importance of the issue, and (until 2008) the relative equipoise in the opposing positions, we strongly recommended the Hippocratic Oath – “First, do…
Preemption In Philadelphia
As regular watchers of our Drug Preemption Scorecard know, the good guys had been on a bit of a roll with preemption in prescription drug cases in 2008. We’d gone 5 for five, with courts in Dobbs v. Wyeth Pharmaceuticals, 530 F. Supp.2d 1275 (W.D. Okla. 2008); O’Neal v. SmithKline Beecham Corp., 551…