August 2015

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Here’s a copy of today’s 71-page decision in Amarin Pharma, Inc v. FDA, No. 15 Civ. 3588 (PAE), slip op. (S.D.N.Y. Aug.7, 2015), in which the court granted a First Amendment-related injunction against the FDA’s prohibition against all off-label promotion, regardless of truth.  First, the court found standing to sue, because the FDA had threatened the company with enforcement action.  “Here, 10 days before Amarin filed suit, the FDA had expressly threatened . . . to bring a misbranding action against it for promoting [the drug] off-label.”  Id. at 40.  That was sufficient “chilling effect” to support litigation.  Id.  Significantly, the court had earlier recognized another possible adverse consequence – that of privately prosecuted False Claims Act litigation also asserting illegal off-label promotion.  Id. at 13.

On the merits, applying U.S. v. Caronia, 703 F.3d 149 (2d Cir. 2012), the court held that a pharmaceutical company has a First Amendment-protected right to engage in off-label promotion that is “truthful.”

The Court’s considered and firm view is that, under Caronia, the FDA may not bring such an action based on truthful promotional speech alone, consistent with the First Amendment.  A fair reading of that decision refutes the FDA’s view that the Second Circuit’s ruling was limited to the facts of Caronia’s particular case.

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The Second Circuit’s thoroughgoing First Amendment analysis in Caronia, which led it to construe the FDCA’s misbranding provisions so as not to reach truthful speech promoting off-label use, further defeats the FDA’s attempt to marginalize the holding in that case as fact-bound.  The Circuit cast the issue as whether a misbranding prosecution that “identified [a defendant’s] speech alone as the proscribed conduct” is constitutionally permissible.  And the Circuit’s ensuing analysis underscored the categorical, rather than case-specific, nature of its holding that it is not.Continue Reading Breaking News − Amarin Hits First Amendment Home Run Off FDA

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Yes, we’re well aware of the latest development in the Pelvic Mesh MDL.  See Mullins v. Ethicon, Inc., C.A. No. 2:12-cv-02952, slip op. (S.D.W. Va. Aug. 4, 2015).  However, due to Reed Smith’s Pelvic Mesh representations, we’re constrained in what we can say.  We’ll just have to let prior, non-Mesh posts speak for us…

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A recent pelvic mesh case in the District of Maryland, Sullivan v. Calvert Memorial Hospital, No. PJM 14-118, Memorandum Opinion (D. Md. July 30, 2015), offers an interesting and useful take on federal jurisdiction when plaintiffs name local doctors as co-defendants.  You know the drill.  In order to manipulate the forum and avoid removal jurisdiction in a case against an out-of-state product manufacturer, plaintiffs will sometimes join a local doctor as a co-defendant.  One response could be to remove the case to federal court on the basis that the local doctor was fraudulently joined, a strategy that is legally sound and often successful when dealing with intermediaries in the chain of distribution, such as distributors and pharmacies.  Those kinds of defendants do not owe independent duties to plaintiffs and have zero involvement in the design, manufacturing, and labeling of drugs and medical devices (setting aside the potentially vexing issues presented by 3D-printed medical devices, but that is a topic for another day.)  Their citizenship therefore should be disregarded.

Fraudulent joinder with doctors is more complicated because doctors obviously do owe duties of care to their patients, so we tend to approach cases involving doctors also from the point of view of fraudulent misjoinder.  Under fraudulent misjoinder, the defendant argues that the federal court should disregard the citizenship of the local or non-diverse co-defendant because the claims against that defendant are distinct from the product liability claims against product manufacturer.  The case most often cited as the landmark for fraudulent misjoinder is Tapscott v. MS Dealer Serv. Corp., 77 F.3d 1353, 1360 (11th Cir. 1996)), and as the argument goes, product liability claims on the one hand are based on facts and law different from medical malpractice claims on the other hand.  It is as though two different lawsuits were improperly joined under one caption, which gives the district court discretion to disregard the citizenship of the non-diverse or local doctors and retain federal diversity jurisdiction.  (We discussed severance of malpractice claims from product liability claims here, although not in the context of federal jurisdiction.)

Some courts have been slow to adopt fraudulent misjoinder, sometimes citing Tapscott as a minority rule and often ignoring Tapscott altogether.  And that is where Sullivan v. Calvert comes in.  In Sullivan, the plaintiff’s surgical team allegedly left a piece of a catheter in the plaintiff’s bladder during a procedure to insert a transvaginal sling.  Op. at 2.  The Maryland plaintiff therefore sued multiple Maryland healthcare providers alleging medical malpractice for leaving the catheter behind, but she also separately pleaded product liability claims against the transvaginal sling manufacturer.  Id. at 3.Continue Reading Using Severance Under Rule 21 To Preserve Removal Jurisdiction

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To keep the DDL blog up and running even through the dog days of Summer, your trusted correspondents try to stagger their vacations.  Bexis recently got back from his typically Hemingway-esque adventure, and now it’s our turn.  Unlike Bexis, if we go hiking anywhere, it is more likely in pursuit of beer or chocolate, not…

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When we read the opinion in Kline v. Zimmer Holdings, 2015 WL 4077495 (W.D. Pa. July 6, 2015), it felt like driving back from the mountains (or the Jersey Shore) after a holiday weekend, listening to classic rock radio playing last half-hour or so of some “countdown” of the top 500 (1000, whatever) songs of all time.  Kline granted summary judgment to the defendant, ending a lot of bobbing and weaving by the plaintiff, who claimed injury from a hip implant that broke.  It’s a two-part opinion, with the judge adopting and supplementing an earlier magistrate’s recommendation.

The design claims were dismissed because plaintiff ultimately couldn’t coax the necessary design defect opinions out of his experts – and non-experts.  The most interesting witness was the plaintiff’s treater, who was also alleged to have “involvement with the design team of the device at issue.”  Kline, 2015 WL 4077495, at *2.  However, that “unique” status fell rather hard by the wayside because plaintiff played fast and loose with the rules, sandbagging the defendant by failing to file any expert report.  Id. at *3.  Yes, he was a treater, so that’s allowed – but only to the extent that the physician “give[s] opinion testimony based upon the physician’s examination, diagnosis, and treatment of a patient.”  Id.  The opinions that the treater offered about his interactions with the defendant’s design team could not be considered:

[The witness] was not identified as an expert witness to testify about the design of the device at issue. While [he] may have been a consultant to [defendant] about the device at issue, there is no record that he is an expert in the design of or warning about the product or that his consulting services enabled him to give an opinion as a design or warnings expert. . . .  There was no identification of his qualifications to be a design or warnings expert, he was not designated as such, and he did not submit an expert report about design defects or warnings.

Id. at *3.  Oops.  That’s what happens when a plaintiff tries to be too cute.Continue Reading Medical Device Decision Plays PA’s Greatest Hits

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FDA-regulated products now account for an estimated one-fifth of overall economic activity in the U.S. They have also been the focus of a litigation explosion. This timely guide covers all aspects of litigation involving drugs, medical devices, vaccines and other FDA-regulated prescription products.
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