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

A linchpin of the preemption analysis in Wyeth v. Levine, 2009 WL 529172 (U.S. March 4, 2009), was the Court’s discussion of the “changes being effected” regulation, id. at *7-8, which in turn depended on the existence of either “newly acquired information” or “new analyses of previously submitted data.” Id. at *7. Factually, there

The Seventh Circuit just released its published opinion affirming the judgment entered on a defense verdict in an SSRI-suicide case. Giles v. Wyeth, No. 07-3149, slip op. (7th Cir. Feb. 12, 2009) (link here). Since Herrmann both tried the case and argued the appeal, we’ll be circumspect with what we say here.

Jeff

As most of our regular readers no doubt already know, not quite two weeks ago, we had to flip one of the cases in our Drug Preemption Scorecard. Specifically, the pro-preemption decision Tucker v. SmithKline Beecham Corp., 2007 WL 2726259 (S.D. Ind. Sept. 19, 2007) (“Tucker I”), became the anti-preemption decision,