We see it on the web today that the FDA has just approved Allergan’s Botox for several forms of spasticity. Hooray! It’s about time. This has been an effective and widely used off-label use for quite a while now.
Having been interested observers a decade or so ago during the long-running Washington Legal Foundation litigation
The other day we learned that the U.S. Supreme Court will decide Vaccine Act preemption in Bruesewitz v. Wyeth. We’ll have plenty of time to obsess about the Bruesewitz case itself in the coming months, so today we’ll just use it as a convenient excuse to get a couple of things out of the way.
Remember Colacicco v. Apotex? At one point it was all the rage – indeed the surge in interest about the original 2006 district court opinion, Colacicco v. Apotex, Inc., 432 F. Supp.2d 514 (E.D. Pa. 2006), in which Bexis was involved as local counsel, was one factor that motivated creation of this blog. For a while we thought that Colacicco would be the case the Supreme Court would take to decide prescription drug preemption. But for a bunch of reasons, not the least of which was consolidation with another case, the wheels of appellate practice ground exceedingly slowly in Colacicco, and it got overtaken by Wyeth v. Levine. The rest, as they say, was history.
We still thought that we might at least get another crack at preemption post-Levine back in the district court in Colacicco. The plaintiff in the case did too, and didn’t like that prospect one bit. So really late in the game, he tried to be slick, sever some claims, and get out of Dodge (or at least Judge Baylson’s courtroom). No such luck. See Colacicco v. Apotex, Inc., 2009 WL 4729883 (E.D. Pa. Dec. 10, 2009) (denying transfer).Continue Reading First Random Thoughts About The Vaccine Act
We’ve ranted recently about plaintiff expert witnesses who believe they are the world’s foremost authority on everything. We’re on that subject again today because we just love it when those windbags get deflated. And because these folks like to pontificate – they have been anointed as experts, after all – their own words often can
We can’t comment very much because our firm is involved in the case (and we can’t avoid that by shipping it off to Herrmann any more), but we wanted to direct your attention to an interesting opinion in the Baycol litigation. Flesner v. Bayer AG, 2010 WL 711972 (8th Cir. Mar. 3, 2010). The
Today the Supreme Court granted certiorari in Bruesewitz v. Wyeth., No. 09-152. That means that the Supreme Court will resolve a split between the pro-preemption Third Circuit, and the anti-preemption Georgia Supreme Court regarding whether the Vaccine Act expressly preempts design defect claims in vaccine cases.
In what could be an important development,
Less than a month ago we posted about a good no-remand decision out of the Southern District of New York, where the court found that a fraudulent joinder could not defeat diversity jurisdiction. We went out of our way to contrast that SDNY decision with the usual doings in the Southern District of Illinois, where
Our recent post concerning the adverse (and we thought rather obtuse) SSRI preemption decision in Mason v. SmithKline Beecham drew a response from blog subscriber Mal Wheeler. He was good enough to pass along the letter he recently wrote to the court in the pending Dobbs v. Wyeth SSRI preemption appeal concerning the Mason
We see so many cases alleging “illegal” promotion of off-label use that when we find one where the plaintiffs don’t make that sort of allegation, it makes us sit up and take notice. That’s the case with Meharg v. I-Flow Corp., No. 1:08-cv-184-WTL-TAB, slip op. (S.D. Ind. March 1, 2010). It’s a pain pump case – the allegations being that these pumps, which are used after shoulder surgery, continuously “infused” various types of anesthetics intended to (evidently successfully) reduce post surgical pain, but that the continuous exposure (or anything else a creative expert might come up with to blame on defendants) caused long-term deterioration (“chondrolysis”) of shoulder cartilage.
The pumps (which are FDA approved) are machines, and of course machines don’t care what you put in them – they’ll infuse it. Thus, the most interesting aspect of pain pump cases we’d seen prior to Meharg had to do with product identification. That is, plaintiffs have been trying to sue various drug companies without even being able to allege the the defendant’s drug was actually used. That’s a no-no, and it’s produced some favorable decisions reaffirming the rule that a plaintiff can only sue the manufacturer of a product s/he actually used. Timmons v. Linvatec Corp., ___ F.R.D. ___, 2010 WL 476661, at *3-4 (C.D. Cal. Feb. 9, 2010); Haskins v. Zimmer Holdings Inc., 2010 WL 342552, at *2 (D. Vt. Jan. 29, 2010); Gilmore v. DJO Inc., 663 F. Supp.2d 856, 860-61 (D. Ariz. 2009); Combs v. Stryker Corp., 2009 WL 4929110, at *2-3 (E.D. Cal. Dec. 14, 2009); Dittman v. DJO, LLC, 2009 WL 3246128, at *3 (D. Colo. Oct. 5, 2009); Sherman v. Stryker Corp., 2009 WL 2241664 at *5 (C.D. Cal. March 30, 2009). These pain pump cases are yet another reason why we like Twombly/Iqbal.
We expect that the pain pump litigation will continue producing decisions on weird points, because the plaintiffs will be suing the wrong defendants, the manufacturers of the drugs used in the pumps, over injuries that were caused, not so much by the drugs, but by how the drugs were continuously infused by the pumps – if there’s any causation at all, that is. In fact, we can almost guarantee it.Continue Reading On State Of The Art And Preemption
Last week we threw up a quickie post about the preemption – or more properly no-preemption decision in Mason v. SmithKline Beecham Corp., 2010 WL 605922, slip op. (7th Cir. Feb. 23, 2010). We promised you our thoughts when we’d had a chance to read it thoroughly. We’ve had that chance, but there’s still not a lot to say. That’s because the Mason opinion is almost totally bereft of legal analysis of the preemption issue. It’s too bad – particularly since Mason is the first post-Levine SSRI preemption case – that a circuit with such legal heavyweights as Posner and Esterbrook would release such lightweight opinion.
Here’s what we mean. For one thing, the court spends a page and a half criticizing the lawyers on both sides for being too argumentative in their statements of facts, 2010 WL 605922, at *1-2, which is about a page more than it spends on the law of preemption.
Mason involved a 23-year-old who committed suicide in 2003. That means that at the time, it was the FDA’s position that there was insufficient scientific data to support a warning of increased risk of suicide. The FDA had said so several times, rejecting various proposals to require such warnings over the years.
Eventually, after new SSRI studies were completed, the FDA authorized a warning for minors and young adults (that would have covered plaintiff) in 2007. Largely because of these warnings, SSRI prescriptions in this age group have declined and – since SSRI’s treat depression, which is far more suicide-provoking than the drugs – suicide rates have increased. We commented on this perverse (but predictable) effect here.Continue Reading Mason Jarring, But Very Little There There
A friend recently sent us a helpful decision squelching a plaintiff’s proposal to share defendants’ confidential information with anyone who asks. Doriand v. Centocor Inc., 2010 WL 325742 (N.D. Fla. Jan 26, 2010). We noted before the relevant dearth of citable authority on this subject, and we’re glad to see another judicial vote for