Photo of Eric Alexander

Last week, we were reminded that Eliot wrote that April was the “cruellest month.”  This week, the Elliott case reminds us of the wasteland that can result when vague complaints meet device preemption.  Elliott v. Smith & Nephew, Inc., No. 1:12-CV-0070-EJL-MHW, 2013 WL 1290812 (D. Idaho Mar. 28, 2013), involves fairly standard allegations about a Class II shoulder implant device that was recalled about a year after it was implanted in the plaintiff—we are using the singular here, despite the consortium plaintiff.  The recall apparently was for the same issue that led to plaintiff’s own device being explanted about a year after recall.  So, it sounds like a tough case on the merits and little hints from the court like—skipping ahead—“victims of defective products, like Mr. Elliott, may not be able to determine without discovery” what they are suing over suggest that the motion to dismiss was going to be in for a bumpy ride.  *8.  We think it was bumpier than it needed to be because the court put the cart before the horse by deciding preemption before Twiqbal.  That may have been from the ordering of arguments in the motion, but the more important point is that we now understand the relationship between the expressions in the prior sentence.  While there may be an olfactory advantage to being in a cart pushed by a horse, the ride in a cart pulled by a horse is clearly better.

Ignoring the adage above, the Elliott decision took the opposite approach and evaluated the preemption defense before determining if plaintiff had properly pleaded any claims in a “rather threadbare” complaint.  The opinion started out fairly systematically, walking through basic 12(b)(6) law and Twiqbal, before heading into its analysis of preemption, starting with express preemption.  Of course, since this was a Class II device, not a Class III/PMA device, there was no express preemption under Riegel and Lohr, although the court took a while to get there.  2013 WL 1290812, *4.  The real fun started with the analysis of implied preemption.  As we have said before, when a court starts off its discussion of implied preemption with a call to the “presumption against federal preemption of state laws that operate in traditional state law domains,” id., *4 (citing Stengel v. Medtronic Inc.,704 F.3d 1224, 1227 (9th Cir. 2013) (sometimes referred to as “Stengel” in Elliott), you tend to have a good idea where things are going.  Of course, when Stengel was reversed after rehearing en banc, you also might have considered whether to push implied preemption.

Elliott read the second Stengel as “limiting” the implied preemption based on fraud-on-the-FDA articulated in Buckman to allegations of premarket conduct.  Id., **5-6.  We do not normally think of Circuit decisions limiting the scope of Supreme Court decisions, but maybe we are being too technical.  The Elliott court still properly framed the issue of implied preemption as whether the claims asserted seek to impose requirements that are parallel to federal requirements—over which FDA has the exclusive power and duty of enforcement—or requirements that are in addition to federal requirements.  The issue is a familiar one to regular readers and preemption nerds. Where things went awry was in the reliance on the lousy Hughes and Bausch decision relied on in the second Stengel.  Specifically, Elliott denied the motion to dismiss on implied preemption with “to the extent [plaintiff] can establish Defendant violated Idaho state-law requirements which parallel federal-law requirements, their claims are not impliedly preempted under the MDA,” which in turn hinged on a footnote that brushed aside the relationship between pleading and preemption we think needed to be addressed.  Id. at *6.  So that we do not mischaracterize it, here is the court’s entire analysis:

Although Defendant argues it is impossible to analyze whether [plaintiff’s] claims are based on state-law requirements that are parallel to federal-law requirements given the generality of the Complaint, the Court need not determine at this stage whether [plaintiff’s] claim that Defendant failed to comply “with applicable design, manufacturing and/or testing standards,” refers to state standards that are different from or in addition to the federal regulatory standards (and which would thus be preempted under § 360k(a)).  Complaints “that combine legally valid and invalid claims are common. When a complaint asserts claims that are legally valid and those that are not, the correct judicial response is not to dismiss the complaint … The case may proceed … with the understanding … as to the proper scope of claims that can survive the legal challenge.”  Bausch, 630 F.3d 546, 559.

Id. at *6 n.3.

We have seen this sort of “logic” before.  We recall the didactic exchange in “Monty Python and the Holy Grail” on the important subject of how to determine if someone is a witch—with our apologies on borrowed “transcript” below:

Sir Bedevere:    Tell me, what do you do with witches?

Villager:          Burn!

Crowd:            Burn, burn them up!

Sir Bedevere:    And what do you burn apart from witches?

Villager:          More witches!

Villager:          Wood!

Sir Bedevere:    So, why do witches burn?


Villager:          Because they’re made of wood?

Sir Bedevere:    Good!

Crowd:            Oh yeah, yeah…

Sir Bedevere:    So, how do we tell whether she is made of wood?

Villager:          Build a bridge out of her.

Sir Bedevere:    Aah, but can you not also build bridges out  of stone?

Villager:          Oh, yeah.

Sir Bedevere:    Does wood sink in water?

Villager:          No, no.

Villager:          It floats!  It floats!

Villager:          Throw her into the pond!

Crowd:            The pond!

Sir Bedevere:    What also floats in water?

Villager:          Bread!

Villager:          Apples!

Villager:          Very small rocks!

. . .

Villager:          Lead — lead!

King Arthur:   A duck.

Crowd:            Oooh.

Sir Bedevere:    Exactly!

So, logically…,

Villager:          If… she.. weighs the same as a duck, she’s made of wood.

Sir Bedevere:    And therefore–?

Villager:          A witch!

So, there is no implied preemption if a claim seeks to impose parallel state law requirements.  And there is no requirement that pleading of state law claims, other than fraud, be specific.  And a vaguely pleaded claim that may or may not try to assert parallel state law requirements counts as if it were actually written to impose only parallel state law requirements.  And you decide whether there is implied preemption before you decide if the Complaint properly pleads cognizable state law claims at all.  Then it is a witch—or, rather, a denial of a motion to dismiss.  The court will not be finding implied preemption or requiring meaningful pleading following this logic.

We jumped ahead a bit, but the actual analysis of the pleading part of this—whether actual claims were asserted consistent with Fed. R. Civ. P. 8 and Twiqbal after determining whatever may have been asserted was not preempted—was anticlimactic.  Again relying on Bausch, the decision accepted the propositions that “there are no special pleading requirements for product liability claims in general, nor for claims involving preemption under the MDA in particular” and plaintiff “need not ‘specify the precise defect or the specific federal regulatory requirements  that were allegedly violated.”   Id. at **7 & 8.  From there, it was easy to conclude claims had been asserted under the Idaho Products Liability Act.  In looking at what was asserted, however, the court did not analyze whether the claims being asserted were parallel to federal requirements, even though the court noted that the complaint apparently predicated the IPLA claims on the defendant’s recall notice to FDA and FDA’s classification of the recall.  We have two basic problems with this.

First, even under the basic notice pleading requirements of the Federal Rules of Civil Procedure, a complaint must “allow[] the court to draw the reasonable inference that the defendant is liable for the misconduct alleged” (Iqbal, 129 S.Ct. at 1949) and make enough factual allegations to put the Defendant on notice of what is being alleged and what its defense might be (see generally Phillips v. County of Allegheny, 515 F.3d 224, 231–32 (3d Cir. 2008)) .  Similarly, on a 12(b)(6) motion, the court must consider only the facts that are alleged in the pleading, and not any un-alleged facts that a plaintiff might later prove.  Associated Gen. Contractors of California, Inc. v. Cal. State Counsel of Carpenters, 459 U.S. 519, 526  (1983).  So, the court should not be punting on “whether [plaintiff’s] claim that Defendant failed to comply “with applicable design, manufacturing and/or testing standards,” refers to state standards that are different from or in addition to the federal regulatory standards (and which would thus be preempted under § 360k(a)).”  2013 WL 1290812, *6 n.3.

Second, whether an asserted claim is merely parallel to federal requirements probably does require some analysis.  We learned in middle school that it is pretty easy to see if lines are parallel even without a graph.  y = ax + b and y = ax + c (where b ≠ c) are parallel lines.  y = ax + b and y = cx + d (where a ≠ c and it does not matter if b = d) are intersecting lines.  It is not so algebraic, but it is possible to determine if a complaint properly asserts a claim that is both recognized under state law and not expressly or impliedly preempted.  When presented with a motion to dismiss based on failure to state a claim and federal preemption, it would seem incumbent on the court to do some analysis of whether the asserted claim is parallel to or intersects with federal requirements.  A starting point might be asking whether the only standards identified in the complaint are federal, as they seem to be here.

The rest of the decision, while good, was basically limited to Idaho law and/or sloppy pleading.  The court dismissed with prejudice a negligent misrepresentation claim because Idaho only has that for accountants, dismissed without prejudice express and implied warranty claims without prejudice because Idaho does not allow those for product liability cases without an allegation of a contractual relationship with the manufacturer, and struck punitive damages because Idaho’s statutory scheme requires leave be sought to plead it.  Id. at **8-10.  Also, a fraud count was dismissed without prejudice where it did “nothing more than recite the elements of fraud, punctuated with conclusory, non-specific allegations.”  Id. at **9-10.  This was different than the vague allegations that satisfied the IPLA because of 9(b)’s requirement that fraud allegations “state with particularity the circumstances constituting fraud or mistake.”  It should not have been a different result if the court had really considered the adequacy of the complaint in the context of the preemption defense.  But now we are beating a dead horse.  Or duck.