We just read with interest the recent DC Court of Appeals decision in Ivy Sports Medicine, LLC v. Burwell, ___ F.3d ___, 2014 WL 4801283 (D.C. Cir. Sept. 26, 2014). In Ivy Sports, the FDA drew back a nub when it argued that it had “inherent authority,” beyond that granted by statute (specifically 21 U.S.C. §360c(e)) to change the classification of a medical device. The court of appeals held that, where the statute mandated procedures that the FDA had to follow in revisiting a previously-adopted device classification, the FDA couldn’t ignore those procedures by asserting unbounded “inherent” power to do what the statute governed. In the words of the court:
FDA’s statutory reclassification authority covers the same concerns, and achieves the same result, as revocation of a substantial equivalence determination. Therefore . . . Congress has provided a mechanism capable of rectifying mistaken actions, and it would be unreasonable under this statutory scheme to infer that FDA retains inherent authority to short-circuit or end-run the carefully prescribed statutory reclassification process in order to correct the same mistake. . . . [B]ecause FDA concededly could have used Section 360c(e) to reclassify the [device], it could not rely on a claimed inherent reconsideration authority to short-circuit that statutory process and revoke its prior substantial equivalence determination to achieve that same result.
Ivy Sports, 2014 WL 4801283, at *6.
The facts that brought about this decision are messy, as they involve the politicization of the FDA’s processes. In late 2008 (in the waning days of the Bush Administration) the medical device in question obtained 510k clearance. “Soon” – meaning after the change in administrations – that clearance “came under fire in the press and from some Members of Congress amid allegations that the process had been tainted by improper political pressure from other Members of Congress.” Id. at *1 (emphasis original). The FDA, under new management, “concluded that some procedural irregularities had occurred.” Id. For more gory details about the ebb and flow of external political influence at the FDA, see id. at *3-4.
Rather than follow the proper procedures, the FDA, now goaded by political influence from the opposite direction, “short-circuited the statutory reclassification process by relying on what it called its inherent reconsideration authority.” Id. at *1. Against this background, the court of appeals gave the Agency’s “inherent authority” argument little deference. The court seemed particularly miffed that, although the FDA justified its actions due to prior alleged misconduct within the Agency, it was “unable” or “unwilling” to identify and punish the “wrongdoers.” Id. at *8. We find that particularly instructive, given that political influence has also reared its head during the FDA’s currently pending statutory-language-be-damned proposal to get rid of generic preemption by administrative fiat, something we’ve discussed here. The court of appeals' adverse reaction in Ivy Sports to the FDA acting politically and ignoring its organic statute gives us still moer reason to believe that this proposal is ultimately going nowhere.
But that’s not our preemption idea. This is:
Our preemption idea harks back to PLIVA v. Mensing, 131 S. Ct. 2567 (2011), but isn’t about generic drugs. Instead it applies the explicit “holding” in Mensing:
[I]t is enough to hold that when a party cannot satisfy its state duties without the Federal Government's special permission and assistance, which is dependent on the exercise of judgment by a federal agency, that party cannot independently satisfy those state duties for pre-emption purposes.
Id. at 2580-81.
First of all, let’s bring things up to the present. Ivy Sports points out that, “[d]uring the time period relevant to this litigation,” §360(c)(e) required the FDA to effectuate device reclassifications by notice and comment rulemaking. 2014 WL 4801283, at *2. That’s no longer true. Congress has since made it a little easier for the FDA. Now that section of the FDCA requires fewer – but still significant – hoops:
[FDA] may . . . change the classification of such device . . .by administrative order published in the Federal Register following publication of a proposed reclassification order in the Federal Register, a meeting of a device classification panel described in subsection (b), and consideration of comments to a public docket.
21 U.S.C. §360(c)(e) (1)(A)(i).
What this section (new or old), combined with the Mensing principle quoted previously, means is that plaintiffs can no longer argue that a defendant’s device is wrongly classified. Typically, this argument arises in cases involving Class II devices – often involving off-label use – where the plaintiff argues that the device isn’t really “substantially equivalent”/doesn’t really have a predicate device, and therefore should be considered Class III. This happened all the time in Bone Screw litigation, and we’ve seen similar, updated versions in hip and knee implant cases.
However, since the FDA doesn’t have any “inherent authority” to reclassify a device, then it is impossible for even the Agency to “independently satisfy those state duties for preemption purposes,” as Mensing requires. Thus any claim that a device, for whatever reason, should be reclassified is preempted.
There may be more, and here’s where you want to consult with FDA regulatory counsel (such as the FDA Law Blog folks who have their own post about Ivy Sports), because the FDA has lots of other types of classifications − pregnancy classifications of drugs come to mind. We’d say that the mere fact that the FDA must act to change such classifications is enough for preemption under Mensing, but to the extent that even the FDA doesn’t have unilateral power to act further underscores the preempted nature of such claims.