Because we hail from San Francisco, we sometimes feel a certain hometown pride in the Ninth Circuit, whose San Francisco home is one of the most beautiful public buildings in the United States. Opened in 1905, the James R. Browning United States Courthouse underwent a spectacular renovation in the late 1990s and has survived two catastrophic earthquakes — the big one in 1906 and the one in 1989 that knocked down elevated highways and famously disrupted the World Series at now-decrepit Candlestick Park. We also frequently praise the Ninth Circuit here on the DDL blog for its sense of justice and learned contributions to drug and device law. But not today. The Ninth Circuit swung mightily and missed with McClellan v. I-Flow Corp., No. 11–35109, 2015 WL 294292 (9th Cir. Jan. 23, 2015), where the court allowed the plaintiff to proceed on a negligence per se theory based on alleged violations of the FDCA. We have another name for claims like that—private enforcement of the FDCA, and the Supreme Court ruled that federal law impliedly preempts such claims more than ten years ago in Buckman. In fact, this negligence per se scenario is where it seems most transparent that the plaintiff is purporting to enforce the FDCA and where Buckman should apply most strongly. Yet the Ninth Circuit somehow gave the plaintiff a green light.
the FDA” case where federal statutes were “a critical element” of the plaintiff’s case. Id. at *4. The same, however, can be said for a negligence per se claim that is predicated on the FDCA, so that distinction really doesn’t work. After all, what in negligence per se?
It’s the substitution of a governmental standard, here that of the FDA, for the “reasonable man” standard of negligence. The federal standard in McClellan and any other FDCA-related negligence per se claim is beyond “critical” – it’s essential. Without it, there is no such thing as “negligence per se.”
In this case, we perceive nothing about McClellan’s requested instructions that conflicts with the congressional intent behind the MDA. McClellan’s claims were not fraud-on-the-FDA claims. The failure-to-warn claims McClellan alleged did not arise solely by virtue of the MDA. Further, there is no suggestion that Congress intended to displace traditional tort law by making all policing of medical labels and warnings the exclusive province of the FDA.
McClellan, at *4. Let’s unpack that statement, because there are so many things wrong with it. For one thing, the requested instructions do conflict with the congressional intent behind the FDCA (which the Ninth Circuit refers to as the MDA, although section 337 was enacted long before the MDA came about in 1976) because Congress prohibited private enforcement, which is what the instructions would have asked the jury to do. Moreover, it does not make a meaningful difference in our minds that the plaintiff’s clams were not “fraud on the FDA” claims because they sought to enforce the FDCA regardless. If anything, that is more offensive to the statute.