Photo of Bexis

Our post the other day on Wolicki-Gables v. Arrow International, Inc., 2011 WL 780684, slip op. (11th Cir. March 8, 2011) (“W-G”), generated a fair amount of attention from some of the more sophisticated reporters who cover our field, because we discussed how the decision contributed to a growing circuit split concerning the pleading of “parallel” FDCA violation claims in cases involving PMA device preemption under Riegel v. Medtronic, Inc., 552 U.S. 312 (2008).
Even though we’re all lawyers here, we try to stay away from legal jargon and “inside baseball” stuff as much as possible.  We’re not sure our first W-G post did that very well, so we’ll try again today.
The first two questions to answer are pretty basic:  (1) What is a “circuit split” anyway? and (2) Why are they important?  A “circuit” refers to one of the twelve federal courts of appeals (putting aside a number of specialized courts), which are the federal courts just below the United States Supreme Court. “Circuit” is basically an anachronism from back during Jacksonian times when federal appellate judges did indeed ride from place to place in their designated territory on horseback (the “circuit”) to hear cases.  Unless and until the Supreme Court has decided a particular legal issue, these twelve appellate courts aren’t obligated to agree with each other on how that issue should be resolved – and frequently they don’t.  When that happens, we lawyers call it a “circuit split.”
Note that the same is often true of federal appellate courts and the supreme courts (sometimes named differently, but we’re being generic here) of the fifty states.  They also aren’t obligated in any way to agree with each other as to the outcome of any particular question – except determinations of state law, where the “Erie doctrine” (a subject for another time) requires federal courts to follow the highest state court.  Where a state supreme court and a federal appellate court disagree, we sometimes call that a “circuit split” too, even though technically it’s not, because it’s effect on further appellate review is the same.
Which brings us to question number two.  Why should anyone care about circuit splits?  Answer:  Because of the effect on “further appellate review” – which means the United States Supreme Court.  The only way to resolve a circuit split, short of one court saying “oops, we were wrong” (which doesn’t happen often, as appellate judges have even healthier egos than the average judge, lawyer, or legal blogger), is for the Supreme Court to step in and decide the question.  And indeed, the Supreme Court’s own rules recognize circuit splits as the number one reason for accepting an appeal:

Review on a writ of certiorari is not a matter of right, but of judicial discretion. . . .  The following . . . indicate the character of the reasons the Court considers:
(a) a United States court of appeals has entered a decision in conflict with the decision of another United States court of appeals on the same important matter; has decided an important federal question in a way that conflicts with a decision by a state court of last resort. . . .

U.S. Supreme Court Rule 10(a)
The Supreme Court accepts only a small fraction of the cases appealed to it.  It certainly doesn’t accept every circuit split, or always require one (it took the generic drug preemption issue without a split).  But when a circuit split is combined with a sexy issue like preemption, that ups the chances of Supreme Court review enormously.  All three of the “FDA Cubed” preemption trilogy that the Court took in 2007-08 involved circuit splits.  The recent Bruesewitz vaccine preemption case involved a split between a federal appeals court (the Third Circuit) and a state supreme court (Georgia).
So while, short of a U.S. v. Nixon situation, there’s no such thing as a “sure” Supreme grant, when a circuit split is combined with an “important” (see Rule 10(a)) issue like preemption, a grant of review is often the result.  Since one thing legal reporters love to do is speculate about/handicap the likelihood of Supreme Court appeals, our pointing out the split prompted their phone calls.
So what is this circuit split, anyway?  Well, as any frequent reader of our blog has to know, in the wake of the favorable Riegel preemption decision concerning PMA medical devices, just about the only thing left for a plaintiff to allege is a “parallel” violation claim.  That’s what they all try to do these days, as our Device Preemption Scorecard details.
The problem most plaintiffs face in post-Riegel PMA cases is that the device they are targeting didn’t violate anything.  So they try to make something up.  Plaintiffs try to gin things up in various ways, but the two most popular are:
(1) find something – anything – in the device’s regulatory history that has been the subject of some sort of FDA action (even if it’s just a preliminary Form 483 or a warning letter) and claim a violation based on that, even if the purported “violation” had nothing to do with the plaintiff’s own device, and
(2) try to infer from a purported “failure” that something in the FDA’s very broad, and often quite vague Good Manufacturing Practices was violated, even if the plaintiff has little or no idea what that might be.
Not too long ago that might have worked.  But the year after the Supreme Court decided Riegel, it decided Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009), which formally applied to all cases (something we had always assumed would happen) its stricter interpretation of pleading requirements originally recognized in Bell Atlantic Corp. v. Twombly, 550 U.S. 544 (2007).  The Court specifically rejected the old saw of “wait until after discovery”:

Rule 8 marks a notable and generous departure from the hyper-technical, code-pleading regime of a prior era, but it does not unlock the doors of discovery for a plaintiff armed with nothing more than conclusions.

Iqbal, 129 S. Ct. at 1950 (citation to Twombly omitted) (emphasis added).

[T]he question presented by a motion to dismiss a complaint for insufficient pleadings does not turn on the controls placed upon the discovery process. . . . We decline respondent’s invitation to relax the pleading requirements on the ground that the Court of Appeals promises petitioners minimally intrusive discovery. That promise provides especially cold comfort. . . . Because respondent’s complaint is deficient under Rule 8, he is not entitled to discovery, cabined or otherwise.

Id. at 1953-54 (citation to Twombly omitted) (emphasis added).

It is no answer to say that a claim . . . can, if groundless, be weeded out early in the discovery process through careful case management given the common lament that the success of judicial supervision in checking discovery abuse has been on the modest side.

Twombly, 550 U.S. at 559 (citation and quotation marks omitted) (emphasis added).
So not only do PMA preemption cases involve preemption, they also involve TwIqbal – another hot topic these days – especially among those law professors who view their job description as ensuring that litigation forever expands, so all their law students (and by extension, they themselves) can find jobs.
Thus the circuit split exemplified most recently in W-G involves not one, but two, sexy issues – preemption and TwIqbal.
Now, here’s the split we’re talking about.
First up was the Eighth Circuit in Bryant v. Medtronic, Inc., 623 F.3d 1200 (8th Cir. 2010) (our longer post on Bryant is here).  In Bryant, the court itself split.  The majority affirmed the trial court’s strict application of TwIqbal to the plaintiffs’ purported violation claims – that a GMP violation could not be pleaded in the abstract:

The district court concluded that Plaintiffs’ general allegations of failure to comply with [GMPs] do not save these claims from preemption under §360k because Plaintiffs failed to identify any specific federal requirement in the PMA approval . . . that forms the basis for an unpreempted parallel claim.  Plaintiffs failed to allege a parallel manufacturing defect claim with the detail required by [TwIqbal].
On appeal, Plaintiffs primarily argue that the district court’s application of [TwIqbal] in this case held them to an impossible pleading standard. . . .  This argument . . . would have considerable force in a case where a specific defective Class III device injured a consumer, and the plaintiff did not have access to the specific federal requirements in the PMA prior to commencing the lawsuit.
But that is not the case Plaintiffs presented to the district court.  Plaintiffs alleged that state law entitles every person who has an implanted [device] to damages (for emotional distress) and to equitable relief (monitoring or implanting of a replacement device) because all [units] have an unreasonably high risk of fracture failure.  In the district court, Plaintiffs conceded that the PMA Supplement doubtless authorized the use of spot welding. . . .  Thus, as pleaded and argued, the manufacturing defect claims are not parallel, they are a frontal assault on the FDA’s decision to approve a PMA Supplement after weighing the product’s benefits against its inherent risks.  On this record, the district court properly concluded these claims are preempted.

Bryant, 623 F.3d at 1206-07 (various citations omitted).
One judge on the Bryant panel dissented on this point, wanting to relax TwIqbal’s requirements and give plaintiffs precisely what the Supreme Court said they weren’t entitled to – “cabined” discovery (limited to the PMA) to let them rummage through the defendant’s voluminous PMA to see if they could find anything that they could claim as a violation:

I would hold the specificity requirements of Twombly must be applied in a practical manner that recognizes the parties’ relative access to information necessary to articulate claims with specificity.  Here, as described by the majority and determined by the district court, the parallel state claim that may escape preclusion under §360k requires the plaintiffs to prove [defendant] failed to manufacture the [device] in compliance with the requirements set forth in the confidential PMA and supplemental PMAs.  To apply Twombly rigidly without permitting discovery as to these documents effectively creates an impossible-to-achieve specificity requirement.  I do not believe the Court intended Twombly to create this type of insurmountable hurdle.  Rather, I believe the application of Twombly must be pragmatic.  Here, that means requiring only a degree of specificity that may be achieved without use of the confidential documents.  After discovery . . . a court reasonably and consistently with Twombly may demand more from plaintiffs in the articulation of their claims.

Bryant, 623 F.3d at 1209 (Melloy, J. dissenting in part).
Second up was the Seventh Circuit in Bausch v. Stryker Corp., 630 F.3d 546 (7th Cir. 2010) (our longer post on Bausch is here).  Bausch created the circuit split by following the Melloy dissent in Bryant, holding that vague allegations of violating GMPs would suffice, and ignoring altogether the TwIqbal holdings (quoted above) that vague pleadings do not entitle plaintiffs to discovery – limited or otherwise:

[W]e essentially agree with Judge Melloy’s dissent in Medtronic Leads.  Judge Melloy argued that the plaintiffs could not be expected to plead their claims with greater specificity without discovery to obtain access to confidential government and company documents.

* * * *

In applying [the TwIqbal] standard to claims for defective manufacture of a medical device in violation of federal law . . . district courts must keep in mind that much of the product-specific information about manufacturing needed to investigate such a claim fully is kept confidential by federal law.  Formal discovery is necessary before a plaintiff can fairly be expected to provide a detailed statement of the specific bases for her claim.  Accordingly, the district court erred in this case by dismissing plaintiff’s original complaint and by denying her leave to amend her complaint. . . .
Defendants object that the original complaint does not specify the precise defect or the specific federal regulatory requirements that were allegedly violated.  Although the complaint would be stronger with such detail, we do not believe the absence of those details shows a failure to comply with Rule 8 of the Federal Rules of Civil Procedure or can support a dismissal under Rule 12(b)(6). . . .
Here, there has not yet been an opportunity for discovery. . . .  For [plaintiff] to plead with any more detail . . . she would need access to the confidential materials in the premarket approval application setting forth the medical device’s specifications.  This is simply not possible without discovery.

Bausch, 630 F.3d at 554, 558-61
Third up was the Fifth Circuit in Funk v. Stryker Corp., 631 F.3d 777 (5th Cir. 2011) (our longer post on Funk is here).  Funk aligned itself with the Bryant majority in requiring pleading of a specific, causal FDCA violation in PMA preemption cases:

This complaint is impermissibly conclusory and vague; it does not specify the manufacturing defect; nor does it specify a causal connection between the failure of the specific manufacturing process and the specific defect in the process that caused the personal injury.  Nor does the complaint tell us how the manufacturing process failed, or how it deviated from the FDA approved manufacturing process.  It instead relies on res ipsa loquitur to suggest only that the “that the thing speaks for itself.”

631 F.3d at ___, 2011 WL 207961, *4.  Note: we had thought, wrongly, going into this post that Hughes v. Boston Scientific Corp., 631 F.3d 762 (5th Cir. 2011), also dealt with the TwIqbal/PMA preemption issue, and had aligned itself with Bausch.  We were incorrect, as Hughes was a summary judgment case, to which TwIqbal does not apply (different federal rules), and the court did not see fit to comment.  Hughes followed Bausch and messed up the law in other ways, but not with respect to TwIqbal.
That set the stage for W-G to become the fourth appellate court to weigh in on TwIqbal in the PMA preemption context.  As we reported the other day, W-G sharpened the circuit split by also coming down hard on the side of specificity in pleading “parallel” violation claims.  W-G held:

Plaintiffs cannot simply incant the magic words “[Appellees] violated FDA regulations” in order to avoid preemption.  Parallel claims must be specifically stated in the initial pleadings.  A plaintiff must allege that the defendant violated a particular federal specification referring to the device at issue.  To properly allege parallel claims, the complaint must set forth facts pointing to specific PMA requirements that have been violated. . . .  [A]n allegation that “the manufacturing processes for the device and certain of their . . . components did not satisfy [FDA’s] Pre-Market Approval standards for the devices” is insufficient to satisfy the requisite elements of a parallel claim as set forth in Riegel if the complaint fails to provide any factual detail to substantiate that crucial allegation.

2011 WL 780684, at *5 (citations and quotation marks omitted).
So that’s the current anatomy of the circuit split that now exists concerning the intersection of PMA device preemption, “parallel” violation claims, and TwIqbal pleading.  Given that both PMA preemption/”parallel” violations and TwIqbal are hot topics these days, we wouldn’t be surprised if one of these cases (but not Bryant, which settled, ironically, the day before the Eighth Circuit ruled), or another presenting the same issues, made its way to the Supreme Court in the reasonably near future.