Score One-Half For IDE Preemption

It’s a little stale, by our standards at least, but we thought we ought to say something about Burgos v. Satiety, Inc., 2011 WL 1327684 (E.D.N.Y. April 5, 2011).  It’s got some good things about it – especially that it’s another case recognizing broad preemption in the context of investigational (“IDE”) medical devices.  Id. at *2 (“negligent manufacture is one of the many state law tort claims that is preempted by the federal regulatory scheme that governs the testing and approval process for experimental medical devices”).  Since there are still some plaintiffs who argue that Riegel v. Medtronic, Inc., 552 U.S. 312 (2008), doesn’t apply to IDE devices, Burgos is OK to that extent.


The decision also kicks out a somewhat bizarre claim based on purported improper record-keeping that, while invoking 21 C.F.R. §§812.110, 812.140, sounds like a disguised claim for spoliation.  The court holds that the allegations don’t parallel anything at state law because of remoteness.  Burgos, 2011 WL 1327684, at *3 (plaintiff “cannot establish that her injury was ‘substantially caused’ by [defendant’s] alleged breach of its record-keeping duties”).

But then the Court goes all flabby.  Plaintiff alleges “adulteration” because the defendant somehow violated the terms of its IDE.  How?  The court admits that, from the complaint, it has no idea.  Plaintiff “does not allege how the . . . device's manufacture violated the IDE, nor does she specify the terms, conditions, standards, or specifications that she claims were violated.”  Burgos, 2011 WL 1327684, at *3.  The court cuts the plaintiff a break, saying that because the IDE documents are non-public, plaintiff can’t be expected to plead anything specific:

[A]t this stage of the proceedings she cannot reasonably be expected to do so [plead what violation happened], because the information she requires to provide the requisite degree of specificity – the IDE documentation submitted by [the defendant] to the FDA – is confidential and not available to the public.

Id. at *4 (relying on dissent in Sprint Fidelis).  Instead, plaintiff gets “cabined” discovery in order to engage in a pure fishing expedition to “explore” whether there’s anything she can gin into a regulatory violation:

[Plaintiff] is entitled to a brief and strictly-cabined period of discovery in order to determine the terms of [defendant’s] IDE, and to explore whether or not the specific device used in her procedure was manufactured in accordance with the IDE.

Id. at *5.

Feh.

“Cabined discovery”…. Let’s see, where have we heard that phrase before?

Oh, right.  That’s what the plaintiffs claimed they should get in Ashcroft v. Iqbal, 129 S. Ct. 1937 (2009), because – surprise, surprise – the government defendants were also engaged in secret conspiracy to violate the law.  The Supreme Court said “no,” no discovery before actually pleading a claim:

We decline respondent’s invitation to relax the pleading requirements on the ground that the Court of Appeals promises petitioners minimally intrusive discovery. . . .  Because respondent’s complaint is deficient under Rule 8, he is not entitled to discovery, cabined or otherwise.

Id. at 1953-54 (emphasis added).

So there you have it – the spectacle of a plaintiff being allowed in Burgos to get exactly what the Supreme Court held in Iqbal she was “not entitled” to.

Sure, courts thumb their noses at Supreme Court precedent they don’t like all the time, but rarely do they do so in such a blatant fashion.