February 2013

Photo of Eric Alexander
            We are not
sure why we have heard so much cheesy music from the 1970s recently.  (It is a musical mystery, like why Genius
determined that Billy Joel’s “Lullabye” belongs in its Nü-Metal Mix.)  We
do not think that Foreigner was talking about writing a blog post in “Feels Like
The First Time,” but

Photo of Michelle Yeary
            The legal community is still buzzing about the Second Circuit’s decision in United States v. Caronia, ___ F.3d ___, 2012 WL 5992141 (2d Cir. Dec. 3, 2012) and what it bodes for the future.  Whatever its eventual implications, today, it is important to remember that the FDA bans off-label promotion and that there

Photo of John Sullivan
In our business, it’s good to have intermediaries, particularly learned ones.  They add a dose of reality to cases that are otherwise conjecture.  They shift the focus from dramatic accusations about profits and hidden risks to tangible realities such as science and medicine and the professionals who know a thing or two about both.  Hidden

Photo of Bexis

Schadenfreude – That probably best describes how we felt when we read Secrest v. Merck, Sharp & Dohme Corp., No. 11-4358, slip op. (2d Cir. Jan. 30, 2013).  We’ve seen time and time again how plaintiffs attempt to manipulate treating physician testimony, usually but not always cloaked by biased judicial rulings that prevent one

Photo of Bexis

Every now and then we run into a decision that we think is wrong in so many different ways that we call it an example of “spherical error” – that is, error no matter how one looks at it.  We only do that rarely.  Back in May, 2010 we first applied that description to In re Gadolinium-Based Contrast Agents Products Liability Litigation, 2010 WL 1796334 (N.D. Ohio May 4, 2010).  Then in September of that year we likewise identified spherical error in Sheet Metal Workers Local 441 Health & Welfare Plan v. GlaxoSmithKline, PLC, 737 F. Supp.2d 380 (E.D. Pa. 2010) – or at least the Pennsylvania part of it, which dealt with the law we knew best.

That’s it – two cases earned that sobriquet in the blog’s six-plus years of existence.

Make that three.

The recent decision in Arters v. Sandoz Inc., 2013 WL 308768 (S.D. Ohio Jan. 25 2013), likewise bollixed up the law in so many different ways that we think it rises (falls?) to the level of spherical error.

Arters involved a question that a lot of courts have considered lately with almost (but not quite) uniformly good results – preemption in the context of generic drugs following PLIVA v. Mensing, 131 S. Ct. 2567 (2011).  As in many generic preemption cases, the defendant sought to have the case dismissed under Rule 12.

That – Rule 12 – is the first error in Arters.  The decision states:

A motion for judgment on the pleadings pursuant to Rule 12(c) should not be granted “unless it appears beyond doubt that the plaintiff can prove no set of facts in support of his claim which would entitle him to relief.”  Conley v. Gibson, 355 U.S. 41, 45–46, 78 S.Ct. 99, 2 L.Ed.2d 80 (1957).

Arters, 2013 WL 308768, at *1.

Umm….  No.

Someone must have been the second coming of Rip Van Winkle and slept through the last five years.  In a rather well-publicized decision, back in 2007, the Supreme Court expressly overruled Conley on specifically this “no set of facts” point.  See Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 561-63 (2007).
Twombly?  Maybe you’ve heard of it.  If so, you’re already one up on Arters.  Anyway, the Supreme Court in Twombly explicitly “retired” the Conley standard relied upon in Arters:

On such a focused and literal reading of Conley’s “no set of facts,” a wholly conclusory statement of claim would survive a motion to dismiss whenever the pleadings left open the possibility that a plaintiff might later establish some set of undisclosed facts to support recovery. . . .  It seems fair to say that this approach to pleading would dispense with any showing of a reasonably founded hope that a plaintiff would be able to make a case; Mr. Micawber’s optimism would be enough.

Seeing this, a good many judges and commentators have balked at taking the literal terms of the Conley passage as a pleading standard.  [many citations omitted]  We could go on, but there is no need to pile up further citations to show that Conley’s “no set of facts” language has been questioned, criticized, and explained away long enough. . . .  [A]fter puzzling the profession for 50 years, this famous observation
has earned its retirement.  The phrase is best forgotten as an incomplete, negative gloss on an accepted pleading standard.

Twombly, 550 U.S. at 561-63 (emphasis added).  Then, a couple of years later, the Court made clear that Twombly’s interment of the Conley language cited in Arters applies across the board to all types of cases.  See Ashcroft v. Iqbal, 556 U.S. 662, 684 (2009).Continue Reading Spherical Error Revisited