It’s opening day here in NYC. The Nationals are in town to play the Mets. And the sun is supposed to emerge just before game time. A perfect day. In fact, as all ragged and abused Mets fans know, opening day is the highlight of the year. And it’s generally downhill from there. But on opening day, the Mets are the best team in baseball. It’s a fact: 34-18 (.654) on opening days. And that’s after having been so bad in the 1960s that they lost their first 8 opening day contests. Since then, they’re 34-10 (.772). So it’s imperative to see the first game. It’s not likely to get any better. So this post will be quick.
Zeltiq Aesthetics, Inc. v. BTL Indus., 2014 U.S. Dist. LEXIS 40402 (N.D. Cal Mar. 25, 2014), is another business-on-business decision with favorable implications for product liability litigation, particularly cases involving off-label claims and medical devices. The plaintiff markets a medical device named CoolSculpting, which lowers the temperature of fat cells and then somehow eliminates them. Id. at *4-5. That’s a nice deal if it works. The FDA cleared it under §510(k). The defendant firm markets a device called Vanquish, which the FDA cleared under §510(k) for treating muscle aches and pain. Id. at *5-7. That’s nice too.
The plaintiff alleged that the defendant firm didn’t market Vanquish for treating muscle aches and pains. Instead, it marketed Vanquish for fat reduction. Id. at *6-7. That’s not the use for which the FDA cleared it. But it is the use for which the FDA cleared CoolSculpting, the plaintiff’s device. So now you see the dispute.
Plaintiff filed for a preliminary injunction, asserting claims for false advertising under the Lanham Act and, more important, for misleading and deceptive advertising under California’s ubiquitous Unfair Competition Law (“UCL”). Id. at *21. After hearing evidence, the court denied the preliminary injunction. It ruled that the plaintiff was not likely to succeed on its Lanham Act claim because it couldn’t show that the defendant’s advertising was either literally false or false by implication. Id. at *24-34. Since much of the plaintiff firm’s allegation concerned FDA clearance issues, we wonder whether the court might have simply barred application of the Lanham Act in favor of the FDCA, which is to be enforced solely by the United States, not private plaintiffs. But we won’t dwell on that.
More important is the court’s treatment of the plaintiff’s two UCL claims for off-label promotion.
First, plaintiff claimed that the defendant sold Vanquish without 510(k) clearance, violating California Health and Safety Code § 111550: “No person shall sell, deliver, or give away any … new device unless … [i]t is … [a] device that is reported under Section 510(k) of the federal act (21 U.S.C. Sec. 360(k)) . . . .” The problem is that the FDA did clear Vanquish under §510(k). Plaintiff hoped that it could side step that clearance because Vanquish was cleared for treating aches and pains, not fat reduction. Maybe, but that doesn’t matter. Off-label use doesn’t turn a 510(k) device into a device that wasn’t cleared. Even if California law tried to do that, it would almost certainly be preempted. In fact, there are a number of ways that this law, if applied as plaintiff requested, would conflict with federal regulation. Firms don’t have the authority to create instructions for off-label uses without FDA clearance. And the FDA recognizes that cleared devices will be used off-label as part of the every-day practice of medicine. And so disallowing off-label use or requiring distributors to use unapproved instructions would run head on into preemption.
Second, plaintiff claimed that Vanquish was unlawfully “misbranded” under California law, which requires devices to have “adequate instructions for use.” Cal. Health & Safety Code §111375. The plaintiff got to this claim by arguing that Vanquish was misbranded because its labeling failed to include “adequate directions for” its off-label use, fat reduction. But Vanquish was sold with instructions on the FDA cleared uses of the device. Id. at *37. So plaintiff’s argument would require the defendant to add unapproved instructions on its own. That’s preempted. Plaintiff also argued that once the defendant sold the device for an off-label use those actions rendered it misbranded because it didn’t have the required instructions for such use. This is just a different way to make the same argument. The labeling of the device is regulated by the FDA. California law can’t change that. It can’t be different. The court rejected plaintiff’s argument:
[Plaintiff] has not cited any authority to suggest that a device may be “misbranded” by virtue of its overall promotional practices as opposed to the more obvious source of “labeling”: the Instructions for Use in the Operator’s Manual.
Id. at *38.
So we now have in the bucket a California federal court holding that the UCL cannot be used to create a misbranding claim from off-label allegations. We’re certainly happy with that.
OK, done. Now it’s off to the ballpark.