This post is from the Dechert half of the blog as the Reed Smith team is involved in this litigation.
We’ve seen courts struggle applying preemption in device cases when the plaintiff’s claim is based on off-label promotion. Plaintiffs have argued that the PMA process addresses only the approved use of the product and that the FDA’s regulation therefore doesn’t extend to off-label use or promotion. And, so the argument goes, state-law claims based on off-label promotion are not preempted.
This is hogwash. The FDA regulates the device, not just a particular use. In fact, as we all know, the FDA has regulations that specifically address off-label promotion, something that would strike us as highly unusual for a body that supposedly doesn’t regulate off-label promotion of products.
In any event, while some courts get caught up in this argument, others – like the court in Caplinger v. Medtronic, Inc., No. CIV-12-630-M (W.D. Ok. Feb. 6, 2013) – don’t. The plaintiff in Caplinger had posterior lumbar interbody fusion surgery on his back, a surgery that involved the defendants’ Infuse Bone Graft device (“Infuse Device”). Id. at 1. This was an off-label use of the Infuse Device, as the FDA had approved it for anterior (through the stomach), not posterior (through the back), surgery. Id. at 1-2. It had nevertheless been approved under the FDA’s PMA process, which brought into play FDCA §360k, which preempts any state-law claim that is “different from or in addition to” the FDA’s regulation. Id. at 2.
The plaintiff had significant problems after the surgery and filed claims against the manufacturers of the Infuse Device for fraud, failure to warn, design defect, breach of implied and express warranties, negligence and negligent misrepresentation. Id. at 1-2. Defendants moved to dismiss. The court easily found the majority of plaintiff’s claims to be preempted. We highlight here, however, two important areas of the court’s decision that focus on plaintiff’s off-label allegations. Because this is a court that got it right.
First, plaintiffs argued, as described above, that preemption under §360k didn’t apply because his claims were based on off-label promotion. This court saw through this. The FDA regulates the device, not the particular approved use. Section 360k says that it preempts state laws “with respect to a device.” It does not mention, or restrict itself to, the particular approved use:
[A]llegations of promotion of off-label use of a device in violation of federal law does not automatically immunize a plaintiff’s claims from being subject to a preemption analysis under §360k(a). As the court is Riley aptly stated:
under § 360k(a)(1), the question is not whether there are federal requirements applicable to a particular use of a device; the question is whether there are federal requirements applicable “to the device.” If there are – and, as Riegel makes clear, the PMA process unquestionably imposes such requirements – then any state requirements that are different from, or in addition to, those federal requirements are preempted. Nothing in the statute suggests that the preemption analysis somehow depends on how the device is used.
Riley, 625 F. Supp. 2d. at 779 (emphasis in original). For the same reasons, the Court finds that nothing in § 360k(a) suggests that the preemption analysis somehow depends on how the device is being promoted to be used.
Id. at 16-17. In other words, off-label promotion doesn’t take plaintiff’s claims outside §360k’s preemptive reach. Section 360k’s language is broad, as is the FDA’s regulatory authority. As a side note, we mention that the court emphasized, as we have on this blog many times, that there’s nothing at all wrong with the off-label use of medical devices.
The Court would note that the Supreme Court recognized in Buckman that off-label use is not illegal or even disfavored under federal law but is an accepted and valuable part of the practice of medicine. “‘[O]ff-label’ usage of medical devices . . . is an accepted and necessary corollary of the FDA’s mission to regulate in this area without directly interfering with the practice of medicine.” Buckman, 531 U.S. at 350.
Id. at 16 n.3.
Second, plaintiff argued that his off-label claims were proper “parallel violation” claims that merely enforced the FDA’s prohibition of off-label promotion. This is an argument that, in our view, other courts have improperly accepted (see here). The Caplinger court, however, saw one of the primary problems with such claims. There is no state law to run parallel to anything:
The Court also finds that plaintiff’s off-label promotion allegations do not somehow turn plaintiff’s claims into “parallel” claims that are not preempted. Specifically, the Court finds that the federal requirement that manufacturers not promote devices for off-label uses is not genuinely equivalent to the state law requirements that a manufacturer provide adequate warnings to physicians about the risks of its medical device and that a manufacturer not produce a product with a defective design. It is possible to violate the state law requirement while complying with the federal requirement and vice versa.
Id. at 17 n.4.
Plaintiff made this argument in connection with his fraud and negligence claims, charging that defendants made misrepresentations as part of their alleged off-label promotion, and the FDA prohibits off-label promotion. But what state law claims? “[T]he concept of “off-label use” is a creature of the FDCA, is defined by the FDCA, and is not a part of Oklahoma substantive law.” Slip op. at 19. In other words, plaintiff really wasn’t bringing state law claims. He was trying to enforce the provisions of the FDCA. But he’s not allowed to do that. The FDCA leaves that to only the United States. 21 U.S.C. §337.
Plaintiff similarly tried to save his warranty claims as “parallel violation” claims by arguing that defendant had improperly warranted that the device was safe and effective for off-label use when it wasn’t. This claim, however, is premised on the argument that the device wasn’t safe and effective. But the FDA had already approved it as safe and effective, and the court said that it didn’t matter that the claim dealt with an off-label use: “To succeed on [this] claim . . . plaintiff must persuade a jury that the Infuse Device was not safe and effective, a finding that would be contrary to the FDA’s approval. Id. at 23-24. Accordingly, the warranty claims were preempted. Additionally, the court found that the warranty claims interfered with the FDA’s regulation of the device. Again, this was so even though the claims dealt with off-label use. For this separate reason, the claims were preempted.
So there you have it. A terrific win, and one chock full of smart and helpful quotes about preemption, off-label use, and the application of sections 360k, 337, Buckman and Riegel. We recommend you read and cite it.