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Bexis went gallivanting off to California last week to (among other things) speak to the Product Liability Advisory Council, Inc. (“PLAC”) about the joys of pleading in the post-Twombly/Iqbal era. That meant that he had to update the Twombly/Iqbal research that previously appeared here. Being the lazy pedants that we are, we’re going to piggy back on that today. But at least this time, we’re sticking to drug/device cases.
The first case Bexis found was Gilmore v. DJO Inc., ___ F. Supp.2d ___, 2009 WL 3352859 (D. Ariz. Oct. 15, 2009). It’s a pain pump case, but the beneficiary of the Twombly/Iqbal ruling wasn’t the pain pump manufacturer. Rather the motion was brought by defendants alleged to have supplied the analgesic drug used in the pump. The plaintiffs had simply substituted the word “products” for “pain pump” in one paragraph of the complaint and then alleged, in rote fashion, the identical allegations against the drug companies who supplied a at most a component as against the pump manufacturer itself. Id. at *4.
Sorry plaintiffs, you can’t get away with that kind of tripe after Twombly/Iqbal. The same boilerplate allegations can’t be repeated against differently situated defendants.

[L]ike so many of plaintiffs’ allegations, these are conclusory allegations that lack the requisite factual information to suggest that plaintiffs’ claims are facially plausible. Plaintiffs’ amended complaint is little more than blanket recitations of legal conclusions, which is not sufficient under the Twombly/Iqbal standard.

2009 WL 3352859, at *4 Plaintiffs in Gilmore made the lame argument, “defendants have not complained about similar complaints in other pain pump suits.” Id. That got nowhere, because each case is a separate suit. Id. They also claimed, unsuccessfully, that because they gave the defendant a courtesy copy of some medical records, that somehow excused them from pleading their claims. Id.

Another very interesting case is Williams v. Allergan USA, Inc., 2009 WL 3294873 (D. Ariz. Oct. 14, 2009). It’s a device preemption case (see the entry in our device preemption scorecard for details of the preemption ruling), and the plaintiff tried to go the “parallel” violation claim route. Trouble was, there were no facts in the complaint supporting a violation. Under Twombly/Iqbal, just saying “the defendant broke the law” doesn’t hack it:

Even construing the Complaint broadly, however, Plaintiffs alleged no facts regarding FDA requirements, the premarket approval process, the study, or [plaintiff’s] consent. The Complaint also did not assert any of these arguments in either the count for strict liability or for negligence. This is insufficient to assert a justiciable claim based on Defendants’ noncompliance with the MDA and FDA.

2009 WL 3294873, at *5 (citing Twombly). Williams is one more nail in the coffin of the unsupported violation claim. Here’s another. ADT Security Services, Inc. v. Swenson, ___ F. Supp.2d ___, 2009 WL 3069733, at *7 (D. Minn. Sep. 28, 2009) (Twombly/Iqbal require negligence per se claims to “specifically state-with reference to specific, numbered provisions, which regulation or statute they are relying on”) (not a drug/device case).
We’ve already discussed Central Regional Employees Benefit Fund v. Cephalon, Inc., 2009 WL 3245485 (D.N.J. Oct. 7, 2009), and its use of Twombly/Iqbal to hold that boilerplate class action allegations were insufficiently pleaded:

To the extent that the plaintiffs state in the “Class Action Allegations” section of the Complaint that one of the issues to be determined in the case is whether the defendants misrepresented the efficacy and/or cost effectiveness and/or economic efficiency of the drugs, that statement contains no factual allegations, which are required under Twombly and Iqbal.

2009 WL 3245485, a *4. We won’t go any further than to re-emphasize the point that the Twombly/Iqbal requirements apply to every allegation governed by Rule 8(a) – which includes class action allegations, but presumably not affirmative defenses governed by Rule 8(c), which doesn’t contain the same “short and plain statement” language. See, e.g., Davis v. Indiana State Police, 541 F.3d 760, 763 (7th Cir. 2008) (Twombly inapplicable to affirmative defenses).
In Dittman v. DJO, LLC, 2009 WL 3246128 (D. Colo. Oct. 5, 2009), another pain pump case, the plaintiffs couldn’t be bothered with determining which of several possible analgesic drugs (both branded and generic) might have been given to the plaintiff. So plaintiffs sued them all, stating simply that the defendant’s drug “may” have been involved. Id. at *1. Well, the attitude “sue ‘em all and let discovery sort ‘em out” (apologies to the Albigensian Crusaders) doesn’t cut it after Twombly/Iqbal:

I agree with [defendants] that Plaintiff has not sufficiently alleged that any of their products were actually used in Plaintiff’s pain pump and therefore could have caused his injury. This deficiency is fatal to the claim. Plaintiff has no facts, only speculation, on which to base his claim that defendants’ products caused or contributed to his injury. This mere possibility, i.e., that the medicine used could have been made by
these defendants, rather than by any number of other manufacturers of anesthesia drugs, is not adequate to state a claim under the prevailing standards as set forth by Twombly and Iqbal.

2009 WL 3246128, at *3. Failure to identify the manufacturer led to failure of all product claims.
Southern Illinois Laborers’ & Employers Health & Welfare Fund v. Pfizer, Inc., 2009 WL 3151807 (S.D.N.Y. Sep. 30, 2009), is yet another third-party payer case. Twombly/Iqbal came into play with the court holding that the complaint failed to plead any prescriber reliance upon any false statement, or any use of formularies influenced by misrepresentations. Id. at *5-6. These criticisms will probably be fatal to this type of claim, because the TPPs aren’t likely to bother investigating the prescribing habits of any doctors or the development of particular formularies.
Remember how we flagged the Twombly/Iqbal issue in our recent post on removal? We recommended that defendants consider seeking Twombly/Iqbal dismissal of inadequately pleaded claims against non-diverse sham defendants as an alternative to attacking such allegations under the relatively tough legal standard for fraudulent joinder. Well, Braden v. Tornier, Inc., 2009 WL 3188075 (W.D. Wash. Sep. 30, 2009), directly addressed which court system’s pleading standard applies to a removed complaint, and came down squarely on the side of the Federal Rules:

Contrary to Plaintiffs’ assertions, it is well-settled that the Federal Rules of Civil Procedure apply in federal court, irrespective of the source of the subject matter jurisdiction, and irrespective of whether the substantive law at issue is state or federal. Accordingly, the Federal Rules of Civil Procedure and the U.S. Supreme Court’s holding regarding pleading requirements announced in [Twombly/Iqbal] apply. The Court understands Plaintiffs’ plight – being held to one pleading standard in state court, where they chose to file their case, and being held to another after the case is removed. However, the law is clear, Fed. R. Civ. P. 81(c)(1) states that the Federal Rules of Civil Procedure “apply to a civil action after it is removed from a state court.” This action has now been removed and the federal rules apply.

2009 WL 3188075, at *2 (citations and quotation marks omitted). There it is – that’s probably our side’s best argument (and it’s a good one) that looser state pleading requirements can’t save a complaint from Twombly/Iqbal in federal court.
As to the merits of the defendants’ Twombly/Iqbal arguments, Braden was a mixed bag. The court found that the products claims against the implant manufacturer defendant were adequately pleaded, but that the consumer fraud claims weren’t. Id. at *3-4. The consumer fraud claims failed, however, because Washington state did not allow personal injury damages to be recovered. Id. at *4. Dismissal was without prejudice to plaintiffs amending to allege proper damages. Id.

Finally, Ivory v. Pfizer Inc., 2009 WL 3230611 (W.D. La. Sep. 30, 2009), allowed most of the plaintiff’s claims to survive Twombly/Iqbal, except where the complaint omitted essential elements of the causes of action. See Id. at *3 (design claim dismissed because complaint was “completely devoid of any reference to an alternative design”); at *6-7 (emotional distress claim dismissed for failure to allege contemporaneous perception).
Thus, we’re pleased to see that Twombly/Iqbal continues to be employed by the courts to remedy a host of long-standing pleading sins – from vague class action allegations, to glomming defendants together, to our personal bête noire, the fact-free FDCA violation claim. Still, there are fifty years of unwarrantedly loose interpretation of Rule 8 that needs cleaning up.
But to paraphrase President Obama, it’s high time for defendants to grab the Twombly/Iqbal mop and get to work.