We’ve blogged repeatedly about preemption in PMA medical device cases. We’ve also had a lot to say about using TwIqbal (that is Ashcroft v. Iqbal, 129 S.Ct. 1937 (2009), and Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007)) to police plaintiffs’ persistently poor pleading habits.
Today we’re synergizing the two, and looking at what defendants can do when they mix TwIqbal and PMA preemption together. We’ll tell you this up front – the result is quite to our liking – more like peppermint and egg nog, rather than, say, chocolate and ketchup.
What makes PMA preemption cases so amenable to TwIqbal treatment is that, after Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), PMA cases basically boil down to “parallel” violation claims. This limitation means that, to plead an unpreempted claim, a plaintiff has to allege something that’s: (1) a violation of the Food, Drug and Cosmetic Act (“FDCA”), and (2) also a violation of independent state law. This is also something we’ve discussed at length, for instance here, here, and here. But we’re not doing doctrine today, we’re doing pleading, so simply accept that legal framework for now.
There are a lot of plaintiffs out there who don’t do their homework. If they’re aware of the Riegel problem at all, they’ll try to fudge things by throwing in a warning letter if they’ve got one. But a lot of the time, we’ll get a standard, fill-in-the-blanks, form product liability complaint with a PMA device filled in. That’s not because plaintiffs’ lawyers are any lazier than the rest of us (we don’t think), but more a reflection on how contingent fees affect incentives to do legal spadework. When time isn’t money, time consuming (not to mention money consuming) things don’t get done.
The standard complaints don’t require very much TwIqbal. See Lemelle v. Stryker Orthopaedics, 698 F. Supp.2d 668, 678 (W.D. La. 2010) (TwIqballing claim that didn’t mention a violation at all); Yost v. Stryker Corp., 2010 WL 1141586, at *4-5 (M.D. Fla. Mar. 23, 2010) (complaint “only asserts a state law, without reference to a federal violation, [and] is preempted”); McQuiston v. Boston Scientific Corp., 2009 WL 4016120, at *7 (W.D. La. Nov. 19, 2009) (“[a] claim asserting that [defendant] did not comply with FDA specifications simply does not exist in the petition”). They’re pretty much sitting ducks for Riegel preemption motions because all they allege is garden variety negligence, strict liability, and warranty claims.
One place where TwIqbal can help with a boilerplate complaint is getting rid of express warranty – a theory that some courts (but not most, see our preemption scorecard for express warranty cases) have allowed to escape PMA preemption. But a boilerplate complaint never pleads the language of the purported express warranty. That’s why it’s called boilerplate. There’s plenty of PMA device authority (and probably even more general product liability precedent elsewhere) holding that express warranty claims aren’t viable under TwIqbal when they don’t state the warranty’s language (and often reliance/basis of the bargain as well):
The complaint contains only generalized statements alleging that [defendant] breached an express warranty. . . . Taken at face value, these bare statements fail to establish the creation of an express warranty that [defendant’s] product met safety standards exceeding the requirements of the PMA process or the FDA’s regulations. Because [plaintiff] has not explained how these statements created an express warranty, she fails to state a plausible claim for breach of express warranties.
Bishoff v. Medtronic, Inc., 2010 WL 4852650, at *3 (N.D.W. Va. Nov. 22, 2010).
As for Plaintiffs’ breach of express warranty claim, the Complaint is also severely lacking. . . . Plaintiffs have failed to allege any affirmative statement made by Defendants regarding the safety or effectiveness of the product on which Plaintiffs actually relied. They never state how Defendants’ product did not “live up to the promises contained on its FDA-approved label” or how such a breach caused their injuries. . . . Therefore, the Court finds that the failure to meet the Twombly pleading standard is another equally firm ground on which to dismiss Plaintiffs’ claims.
Gelber v. Stryker Corp., ___ F. Supp.2d ___, 2010 WL 4740432, at *6 (S.D.N.Y. Sept. 14, 2010) (assuming, without deciding, that express warranty claim escaped PMA preemption). Accord: Yost, 2010 WL 1141586, at *4 (complaint “does not plead sufficient facts to state a claim on which relief may be granted” because it “fails to identify the specific language on which his breach of express warranty claim is based”); Williams v. Cyberonics, Inc., 654 F. Supp. 2d 301, 308 (E.D. Pa. 2009) (no express warranty claim where plaintiffs “fail to set forth any facts demonstrating that [defendant] made an express guarantee”), aff’d, 2010 WL 2982839 (3d Cir. July 30, 2010) (unpublished); Delaney v. Stryker Orthopaedics, 2009 WL 564243, at *5 (D.N.J. Mar. 5, 2009) (“the plaintiff must demonstrate that there was some form of promise or affirmative statement made”; the “Complaint does not sufficiently allege that any promise, either verbal or written was made”).
The only “violation” language that we usually see in any of these boilerplate complaints that warrants TwIqbal treatment for preemption-related reasons is a broad allegation (usually in negligence subparagraph “p” or so) that the defendant “violated applicable statutes, regulations, and/or ordinances.” TwIqbal works like a charm against that kind of thing – requiring dismissal where “Plaintiffs failed to identify any specific federal requirement . . . that forms the basis for an unpreempted parallel claim.” In re Medtronic, Inc., Sprint Fidelis Leads Products Liability Litigation, 623 F.3d 1200, 1206 (8th Cir. 2010). Thus, a “blunderbuss assertion (i.e., that unspecified ‘statutes, codes, laws ordinances, rules and regulations’ were somehow ‘violated’) is insufficient.” Burgos v. Satiety, Inc., 2010 WL 4907764, at *4 (E.D.N.Y. Nov. 30, 2010).
The complaint does allege generally that the [device] was unreasonably dangerous and defective because [it] did not satisfy the Food and Drug Administration’s Pre-Market Approval standards . . .” and that the device was sold “in direct violation of the Code of Federal Regulations”. . . . However, such conclusory allegations standing alone are not sufficient to sustain plaintiff’s burden of pleading under Twombly.
Parker v. Stryker Corp., 584 F. Supp.2d 1298, 1301 (D. Colo. 2008). “[F]ailure to plead a relevant statute alone gives this Court sufficient grounds to dismiss all related claims.” Heisner v. Genzyme Corp., 2010 WL 894054, at *3 (N.D. Ill. Mar. 8, 2010). Accord: Bass v. Stryker Corp., 2010 WL 3431637, at *4 (N.D. Tex. Aug. 31, 2010) (TwIqballing “complaint [that] does not allege a failure to comply with any particular regulation”); Franklin v. Medtronic, Inc., 2010 WL 2543579, at *9 (Mag. D. Colo. May 12, 2010) (“Plaintiff makes only conclusory allegations as to how Defendant actually failed to comply with the FDA regulations”), adopted, 2010 WL 2543570 (D. Colo. June 22, 2010); Funk v. Stryker Corp., 673 F. Supp.2d 522, 532 (S.D. Tex. 2009) (no viable parallel claim where plaintiff “does not cite a single FDA requirement violated by [defendant]”); Covert v. Stryker Corp., 2009 WL 2424559, at *16 n.10 (M.D.N.C. Aug. 5, 2009) (“plaintiff must point to a specific federal requirement”).
Where TwIqbal really gets interesting is when plaintiffs go beyond pure boilerplate and, without a lot of study, throw in a negligence per se claim or something similar alleging a “violation” of something or other. At this point we on the defense side start appreciating the real difference between TwIqbal and the old Conley anything goes pleading. Under TwIqbal, just pleading a violation doesn’t cut it. Plaintiffs must plead sufficient facts and circumstances to make a violation claim “plausible.” That means they actually have to do some work before bringing suit – and many of them don’t or won’t.
Perhaps the Sprint Fidelis district court said it best, that the old ways of claim everything and hope to find something in discovery have ended, and plaintiffs now actually have to do their own pre-complaint investigation:
Plaintiffs’ failure to allege in detail the federal requirement(s) purportedly violated by [defendant] also raises the specter of Twombly. Plaintiffs cannot simply incant the magic words “[defendant] violated FDA regulations” in order to avoid preemption. Hence, their assertion that the [product] did not comply with [good manufacturing practices/quality system regulation] is insufficient, without more, to save their claims. Under Twombly, Plaintiffs were required to provide enough factual detail in the Complaint to alert [defendant] of the “grounds” upon which their manufacturing-defect claim rests. Merely alleging that [it] failed to comply with the CGMPs/QSR by using spot welding is insufficient without some factual detail about why that violates federal standards. Instead, Plaintiffs were required to point to something in the CGMPs/QSR precluding the use of spot welding in order to state a manufacturing-defect claim that is “plausible on its face.”
In re Medtronic, Inc. Sprint Fidelis Leads Products Liability Litigation, 592 F. Supp.2d 1147, 1158 (D. Minn. 2009), aff’d, 623 F.3d 1200 (8th Cir. 2010). Yessssss, indeed. We also like:
[Plaintiff’s] allegations hardly cross the line from conclusory to factual (if at all), let alone the line from factually neutral to factually suggestive of a right to relief. Indeed, it would seem that Plaintiff has offered the Court little more than a formulaic recitation of the elements of a “parallel” claim, coupled with vague citations to generic allegations of wrongdoing by [defendant]. . . . The mere allegation that [defendant] may have violated some federal “requirement” in one or more instances is not enough to “plausibly suggest” that it has violated any such federal “requirement” in this particular instance.
Covert, 2009 WL 2424559, at *15.
That’s just the tip of the iceberg. For more “facts and circumstances” TwIqbal/PMA preemption precedent, see: Bishoff, 2010 WL 4852650, at *2 (requiring “specific factual support in [the] complaint identifying how or why [defendant] failed to comply with the PMA process”); Gelber, 2010 WL 4740432, at *5 (plaintiffs “have not pointed to evidence of device-specific violations of federal law”); Bass, 2010 WL 3431637, at *4-5 (“unelaborated allegations do not provide enough facts to support a cause of action”; plaintiff’s “complaint makes no attempt to relate the alleged deficiencies and deviations to the premarket-approval process or Defendants’ implementation of the approval”); Steen v. Medtronic, Inc., 2010 WL 2573455, at *2-3 (N.D. Tex. June 25, 2010) (rejecting res ipsa loquitur argument); Heisner, 2010 WL 894054, at *4 (“verbosity cannot substitute for factual allegations”; the violation “allegations are nothing more than the sort of formulaic recitation of elements rejected by [TwIqbal]”); Ilarraza v. Medtronic, Inc., 677 F. Supp.2d 582, 588 (E.D.N.Y. 2009) (TwIqbal mandates dismissal where “the plaintiff has done nothing more that recite unsupported violations of general regulations”); Riley v. Cordis Corp., 625 F. Supp.2d 769, 784 (D. Minn. 2009) (“general” alleg[ations] that [defendant] marketed the [device] for off-label or unapproved uses” not enough; because “there are many such potential uses, [the] allegations are too vague to make his claim more than speculative”); Horowitz v. Stryker Corp., 613 F. Supp.2d 271, 280 (E.D.N.Y. 2009) (plaintiff cannot avoid dismissal by claiming “it is anticipated that there will be additional violations alleged regarding the Defendants’ breaches of federal regulations”); Williams v. Allergan USA, Inc., 2009 WL 3294873, at *4 (D. Ariz. Oct. 14, 2009) (“Plaintiffs alleged no facts regarding FDA requirements, the premarket approval process, the study, or [the patient]”; held “insufficient to assert a justiciable claim based on Defendants’ noncompliance”); Parker, 584 F. Supp.2d 1302 (“nowhere does plaintiff’s complaint provide any factual detail to substantiate that crucial allegation”); Bausch v. Stryker Corp., 2008 WL 5157940, at *3 (N.D. Ill. Dec. 9, 2008) (“inclusion of separate allegations . . . that Defendants violated regulations of the FDA does not make her strict liability claim premised in any way on those violations”); Heisner v. Genzyme Corp., 2008 WL 2940811, at *5 (N.D. Ill. July 25, 2008) (“Plaintiff’s vague suggestion that Defendant violated these [regulations] does not help Plaintiff avoid dismissal of his claims; Plaintiff has not alleged anything in his Complaint that would put Defendant on notice”).
How about some special situations? Sometimes the regulations relied upon are every bit as vague as the allegations. Plaintiffs can’t get away with vaguely citing to equally vague regulations – because where:
[n]one of the  regulations cited by plaintiffs impose any specific requirements related to [the device] at issue . . . tort liability based on those regulations would necessarily impose requirements that are “different from or in addition to” federal requirements and are preempted by federal law.
Cenac v. Hubble, 2010 WL 4174573, at *5 (E.D. La. Oct. 21, 2010).
Simply alleging that the device was recalled isn’t enough either:
Plaintiff makes only conclusory allegations as to how Defendant actually failed to comply with the FDA regulations. Rather, it seems that Plaintiff hopes to point out that Defendant learned of a potential defect in its [device], and then point to Defendant’s alleged recall . . ., and thereafter asks the court to assume (1) that there must have been adverse events and product failures involving the [device] in the interim, and (2) that Defendant failed to comply with federal regulations regarding these events and product failures. These allegations amount to a mere “suspicion [of] a legally cognizable right of action,” and do not state a “plausible” parallel claim for relief as required to overcome Section 360k(a) preemption.
Franklin, 2010 WL 2543579, at *9 (quoting Twombly).
Finally, the plaintiffs side’s most popular evasive maneuver when faced with TwIqbal in a PMA preemption case is the pleading equivalent of throwing mud against the wall and hoping something sticks. Plaintiffs indiscriminately plead any recall, FDA warning letter, inspection violation, etc. that ever happened concerning the device in question – regardless of its relevance to any particular case. Here, TwIqbal has been indispensable, since courts hold that plaintiffs must also plead causation, which puts a stop to the mudfest rather neatly.
In the present action plaintiff lacks such a tie to the device in question. Although plaintiff cites to recalls instituted by defendants, such recalls did not include the [this device] or any of its components. Plaintiff introduces FDA warning letters mentioning defendants’ violations of federal regulations, but she never alleges that her particular product was included in the devices which were the subject of those letters nor does she provide a necessary link between the federal violations and her specific injury. Finally, plaintiff never alleges that any enforcement action was brought against defendants concerning the allegedly defective [device].
Horowitz, 613 F. Supp.2d at 282.
[T]o state a plausible parallel claim, the plaintiff was required to show a link between a specific federal violation, and plaintiff’s injury. . . . Here, Plaintiff fails to set forth any specific problem, or failure to comply with any FDA regulation that can be linked to the injury alleged. Indeed, in view of the long period of time during which the device at issue functioned without incident, the allegation that general manufacturing violation caused the particular problem here seems all the more remote. Under these circumstances, and for the reasons set forth above, the court holds that Plaintiff’s claim is preempted, and fails to allege a plausible claim as required by Twombly.
Ilarraza, 677 F. Supp.2d at 589.
Plaintiff is correct in stating that his complaint is rife with allegations of wrongdoing by [defendant] in both the PMA process and in the subsequent manufacturing of their products; however, he has not alleged any particular non-conclusory link between that alleged wrongdoing and his particular injuries, let alone a causal one, as he would ultimately be required to do before he is entitled to recover anything. . . . Thus, at this point, the Court is left with nothing more than a mere “suspicion” that Plaintiff may have a legally cognizable claim, which, as stated above is insufficient to survive a motion to dismiss.
Covert, 2009 WL 2424559, at *15; see id. at *12 (“Plaintiff does not allege that . . . there is an independent reason to believe that his particular system violated a federal regulation in any way”), at *13 (“a reviewing court should require factual amplification as to how a defendant’s alleged federal violations relate to the putative plaintiff’s claims”), at *14 (“to ultimately show an entitlement to relief under any of his ‘tort’ theories of recovery, [plaintiff] must also show that said violation caused his injury”). Covert has this point covered.
There’s tons more. See Lemelle, 698 F. Supp.2d at 678 (“nor do the allegations put [defendant] on notice of how violations of a federal requirement relate to the plaintiff’s alleged injuries”); Gelber, 2010 WL 4740432, at *6 (“there must be a cognizable link between the violations and the injury suffered by the plaintiff”); Bass, 2010 WL 3431637, at *4 (complaint “does not allege a failure to comply . . . nor how that failure caused [plaintiff’s] injuries”); Poole v. Hologic, Inc., 2010 WL 3021528, at *5 n.9 (W.D. La. July 29, 2010) (finding preemption “[a]bsent any allegations that the specific [device] used in [plaintiff’s] surgery failed to conform to the FDA-approved standards”); Franklin, 2010 WL 2543579, at *10 (“merely alleging some violation of FDA regulation will not suffice to establish a ‘parallel’ claim, unless Plaintiff can factually demonstrate that the violation actually caused her injuries”); Anthony v. Stryker Corp., 2010 WL 1387790, at *4 (N.D. Ohio Mar. 31, 2010) (plaintiff pleaded warning letters but “did not plead any facts that would lead this court to plausibly infer that [defendant’s] noncompliance with FDA regulations led to his injury”); Riley, 625 F. Supp.2d at 784-85 (plaintiff “must sufficiently allege causation – both that implanting the [device] in a particular off-label way caused his [injury], and that, had [defendant] adequately warned or instructed about this particular off-label use, [his] physician would not have implanted [it] (or would have implanted it in a different way)”); Hayes v. Howmedica Osteonics Corp., 2009 WL 6841859, at *7 (D.N.J. Dec. 15, 2009) (because the “complaint does not connect the device implanted in the plaintiff with any of the allegations about noncompliance with FDA requirements . . ., I must reject the effort to ‘plead around’” preemption).
At this point some of our plaintiff-side readers might be scratching their heads wondering what they have to do in order just to plead an arguably unpreempted claim in a PMA medical device case. We don’t usually do the other side’s research for them, but there are a couple of cases that repeatedly pop up in the cases that we’ve just cited – so we’re hardly giving anything away. These cases are examples of allegations that courts found sufficient to state claims in this sort of litigation. In Rollins v. St. Jude Medical, 583 F. Supp.2d 790 (W.D. La. 2008), the plaintiffs pleaded: (1) that a device was required by the FDA to be packaged in a particular fashion, (2) that packaging issues prompted an FDA recall; (3) that mis-packaging typically caused the device to malfunction in a particular manner; (4) that the plaintiff’s device malfunctioned in this manner, inferring that it should have been included in the recall; and (5) that the malfunction caused injury. Id. at 800. While we might quibble with the plaintiff’s failure to plead outright that she was implanted with a recalled device, this complaint passed TwIqbal. Id. at 801.
The other frequently cited case is Purcel v. Advanced Bionics Corp., 2008 WL 3874713 (N.D. Tex. Aug. 13, 2008). Purcel involved a device that had been recalled and before that subject to adverse FDA inspection reports and warning letters due to certain moisture problems. The plaintiff’s device, while not one of the recalled devices, was tested after explanation and found to suffer from the same moisture issue. Id. at *1. The FDA commenced an enforcement action against the defendant over these moisture problems. Id. at *2. The court held that plaintiff’s violation claim, based “solely” on the same grounds as the FDA enforcement activity, was plausible, and that causation was also plausible given the results of the test run on the plaintiff’s device. Id. at *3-4. The plaintiff in Purcel did his homework and thus was able to satisfy TwIqbal’s pleading requirements. If our plaintiff-side readers do the same, their PMA device cases might meet with the same outcome.
But if “past is prologue,” and we think it is, then the Tempest of TwIqbal/preemption dismissals in PMA medical device cases will continue for quite some time to come. We offer the “excellent dumb discourse” of this post in hopes of girding our side for that battle.