Late last year, when we were putting together our massive post that collected and categorized every case that had ever judicially noticed an FDA document, we ran across the intriguing proposition that in deciding Rule 12 pleading-based motions, “allegations in a complaint are not credited where contradicted by judicially noticeable documents.” We cited several appellate
Pleading
An Ultra Processed Complaint Fails
This post comes from the non-RS and non-Dechert side of the Blog.
The great post-modern existentialist philosopher John Madden once said, “If you have two quarterbacks, you actually have no quarterback.” This was not the result of a fanciful math equation where you (impermissibly) divide by zero. In American football, except on rare trick plays…
Non-Patent Implications of Supreme Court’s “Skinny Label” Hikma Decision
We don’t normally discuss patent/intellectual property issues on the Blog, even though they arise all the time in prescription medical product litigation. The reason is simple − our clients (and target audience) can be found on either side of the “v.” So, it’s best that we leave the offering of opinions on patent/IP issues to…
Pleading Around Obvious Defenses
The now well-known requirement from the TwIqbal cases that a complaint contains factual allegations that establish that relief is plausible derives from Rule 8(a)(2) requirement that each pleading contain “a short and plain statement of the claim showing that the pleader is entitled to relief.” One recurring point of contention in drug and device litigation…
S.D. Ohio Dismisses Device Case for Lack of Personal Jurisdiction
Whenever defense hacks get together, the conversation inevitably turns to horror stories about hostile jurisdictions. There is another word for those jurisdictions, and you know it well. We’ll mangle a phrase from the poet William Blake and call those jurisdictions satanic litigation mills. There’s a chance we’re headed for such a place soon, a place…
Hardly a Shock – PMA Preemption Prevails in New Mexico
Our PMA Preemption Scorecard now collects 729 opinions, the vast majority of which find preemption (which is why it’s a “scorecard”). Only three of them are from the Land of Enchantment, New Mexico – with two of them being in the same case. The third is Yusnukis v. Nevro Corp., 2026 WL 509227 (D.N.M.
More Than A Feeling Required In Psych Drug Case
This post comes from the non-RS side of the Blog.
Prescription medications for psychiatric conditions fill an important role in modern healthcare. They tend to have labels with lots of information about the risks of various emotional, psychological, and neuroreceptor-mediated conditions, including worsening of the underlying conditions being treated, interactions with other medications or substances…
EDPA Dismisses Acthar RICO/Antitrust/Fraud Case
At the DDL blog we unashamedly confess our biases. Foremost among those biases is that we walk the defense side of the street. Another inescapable bias, at least for this particular scribbler, is that we know and like many of the Philly judges. In the City of Brotherly Love, familiarity breeds respect.
Over the past…
Shady Grove Gets Shadier
We’ve only discussed Shady Grove Orthopedic Associates, P.A. v. Allstate Insurance Co., 559 U.S. 393 (2010), a couple of times. Shady Grove, displaced – in federal court – a variety of state-law limitations on class actions because those restrictions were at odds with Fed. R. Civ. P. 23, and in federal…
Preemption, Plausibility, and Parallel Claims
We’ve bashed the horrible decision in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010), more times than we care to count. This time we’re taking a look precedent contrary to Bausch’s statement that “[t]here are no special pleading requirements for product liability claims.” Id. at 558. While that is true as a platitude, the fact of the matter is that TwIqbal does not recognize legal conclusions such as “X violated the FDCA” unless they are supported by facts that plausibly establish the purported violation. Plaintiffs “cannot simply incant the magic words [defendant] violated FDA regulations in order to avoid preemption.” Caplinger v. Medtronic, Inc., 921 F. Supp.2d 1206, 1224 (W.D. Okla. 2013), aff’d, 784 F.3d 1335 (10th Cir. 2015)
Thus, in the specific context of allegations of “parallel” claims that seek to evade preemption, most courts have recognized that “[p]arallel claims must be specifically stated in the initial pleadings.” Wolicki-Gables v. Arrow International, Inc., 634 F.3d 1296, 1301 (11th Cir. 2011).
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