If At First You Don't Succeed....

by Dechert LLP

Sometimes good ideas don’t prevail the first time – or even the first few times – they make their appearance.  With that in mind we bring to your attention Windle v. Synthes USA Products, Inc., 2012 U.S. Dist. Lexis 52397 (N.D. Tex. April 13, 2012).  Windle was a removal attempt – an unsuccessful one – in a PMA device case.  Premarket approval means, of course, that preemption bars virtually every claim, except the so-called “parallel violation” claim, that is, a state-law claim that parallels some sort of FDCA violation.

Such claims are relatively hard to come by, as our post-Riegel preemption scorecard indicates.

And as some of the cases on our post-Riegel preemption scorecard also hold, under TwIqbal (at least a lot of courts’ interpretations of it), the plaintiff must plead what was violated, the nature of the violation, how the violation caused injury – things like that.  Some states, the so-called “fact-pleading” states (like Pennsylvania) have traditionally required even more intensive pleading than the federal courts.  Some other states have adopted TwIqbal.

Windle highlights an interesting possible consequenceof TwIqbal-compliant “parallel violation” claims.  That is, it’s possible, at least in some cases, that the very same factual pleading necessary to push a parallel violation claim over the TwIqbal pleading threshold might also plead a sufficient embedded federal issue to justify removal of the case to federal court under the oft-cited but rarely met federal question test enunciated in Grable & Sons Metal Products, Inc. v. Darue Engineering & Manufacturing, 545 U.S. 308 (2005).  Usually, plaintiffs get to hide behind the “well-pleaded complaint rule” and frame their claims as state-law causes of action in order to keep them out of federal court.  However, to the extent that a combination of Riegel preemption and TwIqbal pleading flush plaintiffs out from under the well-pleaded complaint rule and require the pleading of FDCA violations with considerable exactitude, then the complaint starts looking more and more like the kind of action that could be removed to federal court under Grable.

Now, the defendant in Wimble didn’t get to the promised land of the federal courts, but consider how it stated the Grable test:

"[F]ederal question jurisdiction exists where (1) resolving a federal issue is necessary to resolution of the state-law claim; (2) the federal issue is actually disputed; (3) the federal issue is substantial; and (4) federal jurisdiction will not disturb the balance of federal and state judicial responsibilities."

2012 U.S. Dist. Lexis 52397, at *16 (citation and quotation marks omitted).

The court in Wimble didn’t dispute that item one (an FDCA violation being “necessary”) and item two (the violation being “actually disputed”) are met in post-Riegel PMA preemption cases.  2012 U.S. Dist. Lexis 52397, at *18-19.  Rather the defendant came up short because the violation was not necessarily “substantial.”  Id. at *19-20.  Instead, the violation “could be as straightforward as deciding whether the responsible party did or did not furnish the information required by FDA regulation.”  Id. at *20.

For the purposes of this post, we’ll take the Wimble court’s statement as gospel.  Some, perhaps even most, claimed “parallel violation” claims might well be simple and straightforward enough to flunk the “substantial” federal question prong of Grable.

But we invite our readers to ponder whether the converse is also true.  There may well be other PMA preemption cases where the plaintiff’s FDCA violation claims are complex and involved.  The violation allegations could well run on for several pages in the complaint – especially if the plaintiff copied some complicated MDL or similar pleading verbatim (it does happen).

Further, to the extent that these instances of complicated and pervasive FDCA violation allegations are, indeed, relatively few, then pushing them into federal court would be less likely to “disturb the balance” between the state and federal courts.  Many, perhaps most, Grable arguments that we’ve seen fail because they prove too much – their adoption would open the door to removal of large number of state tort cases because some federal matter (say, preemption) is merely at issue.  It’s something of a tautology, but the fewer and farther between the Grable-worthy cases are, the more likely they are to be held Grable-worthy in the first place.

In light of all that, we’re not recommending any particular action in any particular case – only alerting our colleagues to the possibility of the argument that:  (1) the more that post-Riegel PMA preemption cases rise or fall on allegations of violations of the federal FDCA, and (2) the more that plaintiffs are forced plead these purported federal violations in gory detail, then (3) the chances increase that the prerequisites to Grable federal question jurisdiction are met, as long as (4) the defendant’s arguments are sufficiently tied to a particularly involved claim of FDCA violation so that the plaintiff can’t make a plausible floodgates argument.

We’ll be looking for cases that fit this syllogism, and we invite our readers to do the same.

DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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