In Otis-Wisher v. Medtronic, Inc., 2015 U.S. App. LEXIS 9565 (2d Cir. June 9, 2015), an Infuse device decision, the Second Circuit offered its thoughts on the viability of parallel violation claims based on allegedly misleading off-label promotion.  In short, they are not viable.  The court saw no state law that could be capable of paralleling any federal off-label regulation and, regardless, no federal regulation that actually prohibits off-label promotion.  In other words, neither side of the parallel exists:

The weight of authority both in this Circuit and elsewhere casts doubts on the viability of [claims for misleading off-label promotion]. See, e.g., Caplinger v. Medtronic, Inc., 784 F.3d 1335, 1341-45 (10th Cir. 2015) (finding no federal regulation that paralleled state common law claims and further concluding that state law off-label promotion claim was preempted by § 360k); United States v. Caronia, 703 F.3d 149, 162 (2d Cir. 2012) ("[T]he FDCA itself does not expressly prohibit or criminalize off-label promotion.");In re Zyprexa Prods. Liab. Litig., Nos. 04-MD-1596, 07-CV-1933 (JBW), 2008 U.S. Dist. LEXIS 10355, 2008 WL 398378, at *5 (E.D.N.Y. Feb. 12, 2008) ("[T]here is no state-law equivalent of 'off-label.'").

See id. at *3-4 & n. 2 (emphasis added).  

Now, it’s dictum.  The court based its actual ruling on plaintiff’s failure to meet Twiqbal pleading requirements.  But it’s strong dictum that goes to the very root of the problem with parallel violation claims based on off-label promotion.  There can be no state-law off-label claim enforcing requirements similar to FDA regulations because the entire notion of off-label is a creature of federal law.  And, even if there could be such a state-law claim, federal law does not prohibit off-label promotion.  In short, there’s no there there from which plaintiffs could construct a claim.  

So, while it’s dictum, it is good insight into how the court that gave us Coronia (blogged about here) thinks about off-label claims in device cases.

In the non-dictum portions of the opinion, it was all good too. The court upheld preemption of plaintiff’s failure to warn and design defect claims under Riegel.  Id. at *3.  It upheld dismissal of plaintiff’s manufacturing claims for pleading deficiencies.  Id. And it upheld dismissal of plaintiff’s Vermont Consumer Fraud Act claim, rejecting her attempt to turn a product liability claim into a consumer protection claim: “Plaintiff did not constitute a ‘consumer’ under the statute because she did not, for her personal use, purchase Infuse, which in any event is not available for consumer purchase, but rather was prescribed the medical device by her doctor.”  Id. at *4-5.  

The Second Circuit is one of the circuits that seems to “get it” when it comes to off-label promotion.