The test for determining whether a state law claim is impliedly preempted is whether or not the claim would exist in the absence of the FDCA.
Rarely do we drug and device law bloggers read such a pleasing sentence. It’s lyrical. It reads like romance language. Well, at least to us it does. The opening contains wondrous words like “test” and “determining.” The closing tantalizes us with phrases such as “whether or not the claim would exist.” We like it so much that we don’t even mind the grammatically unnecessary “or not.” The sentence is pure. It comes with no deception, no early seduction that fades to disappointment. You read it, you know what’s coming, you like what’s coming, and then it comes.
The court used that beautiful sentence in Evans v. Rich, 2014 U.S. Dist. LEXIS 76721 (E.D.N. Car. June 5, 2014). It used it as the foundation for dismissing plaintiff’s claim against the manufacturer of a suture device that was used in plaintiff’s back surgery. Plaintiff claimed that the manufacturer had encouraged his doctor to use the suture device “off-label.” That term is unique to FDA regulation, yet plaintiff claimed that he was asserting a claim under North Carolina’s unfair trade practices laws. Id. at *4-5.
But the FDA creates all things on- or off-label, not North Carolina’s unfair trade practices laws. The court recognized this:
At bottom, plaintiff seeks to hold [the manufacturer] liable for off-label promotion of its X-close suture device, but such claim is impliedly preempted as it exists solely by virtue of the requirements of the FDCA. Buckman Company v. Plaintiff’s Legal Committee, 531 U.S. 341, 353 (2001); see also In re Epogen & Aranesp Off-Label Mktg. & Sales Practices Litig., 590 F. Supp.2d 1282, 190-91 (C.D. Cal. 2008) (off-label promotion violates the FDCA but the FDCA provides for no private right of action; nor can plaintiffs use “state unfair competition laws as a vehicle to bring a private cause of action that is based on violations of the FDCA.”).
Id. at *5-6.
And, since “[t]ere is no private right of action under” the FDCA, id. at *4, plaintiff can’t sue for product promotion that supposedly violates FDA regulations. Only the government can. With these truths in hand, this court didn’t struggle to invent a construct under which plaintiff could claim that he was actually asserting a state-law claim. It saw plaintiff’s claim for what it was: an effort to privately enforce the FDCA. And so it dismissed the claim. Music to our ears.