This post is from the non-Reed Smith side of the blog only.

It is a bit chilly and dreary in the Mid-Atlantic region today.  So, we went looking for something to warm and brighten up our day.  And we found a tropical twofer (do radio stations still do Twofer Tuesdays?) from one of our recent favorite litigations.  Two new Infuse decisions from Hawaii — Beavers-Gabriel v. Medtronic, Inc., 2014 U.S. Dist. LEXIS 50030 (D. Haw. Apr. 10, 2014) and Florida – Brady v. Medtronic, Inc., 2014 U.S. Dist. LEXIS 52151 (S.D. Fla. Apr. 8, 2014).  If you’re someplace where Spring hasn’t quite sprung yet or Summer seems very far away, grab your shades, flowered shirt, and a fancy umbrella drink and picture yourself litigating in one of these jurisdictions.

If you’ve missed our other Infuse posts, we’ve gathered them all here.   In a nutshell, the plaintiffs allege injury as a result of spinal surgery in which their surgeons chose to use the Infuse device in an off-label manner.  Plaintiffs have attempted to argue, without much success, that the off-label use and promotion of the device somehow gets them around express and implied preemption.  And, if we wanted to sum up these most recent cases just as succinctly, we’d say they follow the majority to have considered the issue and hold that off-label promotion doesn’t change a thing.

The language of § 360k(a) is extremely broad. There is nothing in the provision that suggests that the applicability of the preemption analysis turns on either how the device was used or marketed, or on the conduct of the manufacturer.

Brady, 2014 U.S. Dist. LEXIS 52151 at *13-14; see Beavers-Gabriel, 2014 U.S. Dist. LEXIS 50030 at *23-24 (“[E]ven though off-label use of only a component of the Infuse Device is at issue, the FDA approval applies “with respect to” the Infuse Device generally and therefore such approval includes its components. Plaintiff’s claims meet the first step of Riegel.”).

Having decided that the cases are subject to the preemption analysis, both courts move on to examine the individual causes of action alleged.  Here again, these cases are strikingly similar to those that have gone before – most causes of action are preempted and those that aren’t are not pleaded sufficiently to survive a motion to dismiss.

There are two significant differences between these cases based on their respective jurisdictions.  Florida does not recognize strict liability claims for unavoidably unsafe products, such as medical devices.  So, plaintiff’s strict liability claims in Brady were dismissed off the top.  Hawaii is in the Ninth Circuit and therefore, the plaintiff in Beavers-Gabriel may have a claim for failure to report adverse events to the FDA that survives preemption.  We say may because plaintiff didn’t plead it in her complaint, only arguing it in response to the motion to dismiss.  Id. at *44.

Now for the similarities.  Both courts quickly dismissed traditional failure to warn claims.  Brady, at *20 (“To the extent that this claim is based upon alleged misrepresentations and omissions contained in the FDA approved warning, the claim is expressly preempted. In order to prevail, Brady would need to show that Medtronic was required to include warnings beyond those in the FDA-approved label. This would impose a requirement ‘different from or in addition to’ the federal requirements.”); Beavers-Gabriel, at *42 (“Plaintiff’s [failure to warn] claim seeks to impose on Defendants a duty to provide warnings beyond those already outlined by the FDA, which Riegel prohibits.).  They also both dismissed design defect claims (whether sounding in negligence or strict liability).   Brady, at *22; Beavers-Gabriel, at *45-46 (to prevail on this claim, Plaintiffs would need to establish that the Infuse Device should have been designed in a manner different  than that approved by the FDA.”); *47.

Neither court was persuaded by vague allegations of violations of federal law.

This [negligence] claim also fails to the extent it vaguely asserts that Defendants violated federal law — Plaintiff does not specify what federal laws were violated such that the court cannot determine whether Plaintiff is asserting a parallel state law claim. Plaintiff cannot simply incant the magic words [Defendant] violated FDA regulations in order to avoid preemption.

Beavers-Gabriel, at *47; Brady, at *22.

And both courts found that negligence claims based solely on the fact that defendant promoted the device off-label – without an allegation that such promotion was misleading or inaccurate – were impliedly preempted under Buckman:

Defendants’ duty (as an element of the negligence claim) to abstain from off-label promotion exists solely by virtue of the federal prohibition of off-label promotion and finds no independent source from traditional state law.  . . . In other words, absent the FDCA’s prohibition of off-label promotion, Defendants have no duty based on state law to abstain from promoting the Infuse Device for off-label purposes.

Beavers-Gabriel, at *48-49 (citations omitted); Brady, at *22 (“allowing this claim to proceed would essentially allow Brady, a private litigant, to attempt to enforce the FDCA.  Buckman prohibits this.”).

That leaves breach of express warranty and fraud/misrepresentation.  Here, both courts found it plausible that plaintiffs’ claims could survive preemption.  On fraud/misrepresentation, the courts draw a distinction between claims for misrepresentations and omissions in the labeling – which are preempted (like failure to warn) — and misrepresentations and omissions in off-label promotion:

To the extent, however, that this claim is based upon alleged misrepresentations and omissions made in promoting off-label use of Infuse, it survives preemption. Brady’s claim that Medtronic made affirmative misrepresentations to promote off-label uses of Infuse parallels federal requirements, which prohibit false or misleading advertisements. So, Brady’s fraud claim is “genuinely equivalent” to federal law because there is no likelihood that Medtronic could be liable under Florida law without having violated federal law. This claim is also not impliedly preempted because it sounds in traditional state common law that exists independently from the FDCA and not solely by virtue of the FDCA.

Brady, at *20-21 (citations omitted); Beavers-Gabriel, at *38.  But, like so many of the other Infuse complaints, these too failed to meet federal pleadings requirements.  “Missing from the Complaint, however, is the connection between Defendants’ alleged misdeeds and Plaintiff and Plaintiff’s physicians — i.e., that Plaintiff and Plaintiff’s physicians relied on these misrepresentations.”  Beavers-Gabriel, at *39; Brady, at *21.

Plaintiff’s breach of express warranty claims suffered a similar fate.  The courts found that they were not preempted because the state law claim paralleled the federal duty “to ensure that any warranty statements [defendant] voluntarily makes are truthful, accurate, not misleading and consistent with applicable federal and state law.”  Brady, at *23; Beavers-Gabriel, at *51.  Both counts were dismissed, however, for failure to plead facts sufficient to show that any alleged representations became the “basis for the bargain.”  Beavers-Gabriel, at *52.  Neither complaint alleged the specific express warranties made to plaintiff or his/her surgeon.  Brady, at *23.

That’s two more wins for Infuse.  Two more cases adding to the growing body of case law that off-label promotion doesn’t give plaintiff a pass to avoid preemption.  And, two lovely, sunny vacation destinations.  We’re feeling warmer already.