When we think about litigation involving the FDA, our first thought is about preemption of claims brought by product liability plaintiffs. Our second is probably the relatively recent line of cases where these plaintiffs would like no mention of FDA’s existence, let alone its requirements and actions, during the trial on their claims. However, there is an even more obvious kind of case involving FDA: one where FDA is a party. Of course, there have been many such case we have discussed in the past. The Amarin case on the interplay of the First Amendment and FDA limits on off-label promotion comes to mind. There are cases where the U.S. brings a civil or criminal proceeding over an alleged violation of FDA requirements. Sometimes, like Amarin, FDA is sued by an applicant over some decision it has made.
Genus Med. Techs. LLC v. U.S. FDA, No. 20-5026, __ F.3d __, 2021 U.S. App. LEXIS 10928 (D.C. Cir. Apr. 16, 2021), is such a case. A manufacturer of a diagnostic contrast agent sued FDA under the Administrative Procedures Act over FDA’s decision to regulate the product as a drug instead of a device. This brings us to a detour and a disclaimer. The detour is that, from our perspective, we do not think FDA is infallible, but that it is an active regulator with qualified people working hard to advance its public health mission. It is not a “rubber stamp” or a “pawn of Big Pharma” or any of the other slights we have heard in arguments by the other side in front of judges and juries. While our clients may not like all the things FDA does to make their life more difficult with strict regulatory requirements, vigorous inspections, etc., when it comes to litigating claims about the safety of marketed products, we see the benefits of an active and sometimes oppositional FDA. The disclaimer is that we are not APA lawyers, so we are going to pass on some aspects of the opinion and the entire concurrence.
The facts of Genus, such as they are set out in the opinion, are fairly straightforward. The contrast agent had been marketed as a device in the U.S. since 2015 based on a 510(k) application. (The opinion never describes the clearance, just that it was sought, and no clearance is listed on FDA’s database.) During a 2016 inspection, the company was cited for and ultimately received a warning letter about failing to obtain New Drug Application approval for the contrast agent. Id. at *9. In the back-and-forth on the warning letter, FDA acknowledged that it appeared the contrast agent met the definition for a device but it determined that the product should be regulated as a drug because its practice “for many years” had been to “regulate these products as drugs in order to regulate them consistently under the same authority.” Id. at *10. The manufacturer filed a formal Request for Determination, something typically done before submitting a marketing application, to have FDA determine that the contrast agent was a device. FDA’s response was that the contrast agent met the definitions for both a drug and device, but FDA chose to regulate it as a drug for consistency. Id. at *11. The lawsuit followed and, because FDA agreed that the contrast agent met the regulatory definition for a device, the issue was narrow:
[W]hether the FDCA grants the FDA discretion to classify as a “drug” a product that satisfies the statutory definitions of both a “drug” and a “device.”
Id. at **12-13.
The district court granted summary for the manufacturer, finding that FDA had abused its discretion in applying a meaning of the applicable regulations that was inconsistent with the unambiguous meaning of the applicable statutes. An appeal and de novo review of a pure legal question followed. To us, knowing the history of the FDCA and MDA, this was not a terribly hard question. Aside from combination products, where FDA regulates based on the primary mode of action, a product is going to be a drug, a device, or neither. Drugs are “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals . . . .” Devices are
. . . articles . . . intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or other animals, . . . and which does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.
The first part of the definitions is basically the same, but devices are carved out based on not achieving their “primary intended purposes through chemical action within or on the body” or not being “dependent upon being metabolized for the achievement of its primary intended purposes.” The efficacy of drugs depends on such chemical action within the body and/or being metabolized in the body. Once FDA decides, as it did here, that the particular contrast agent did not depend on a chemical action in the body or being metabolized—barium sulfate does not really get absorbed and absorbs x-rays well because it contains a heavy metal, making it a good contrast agent—then it has no discretion to regulate it as drug for the sake of consistency or anything else. (We will skip discussion of whether x-ray absorption is a chemical action and the place of heavy metal among musical genres. Feel free to discuss separately.)
The Genus court reached the same conclusion, albeit with a much longer and more detailed discussion, delving into principles of statutory interpretation and rejecting a number of arguments raised by FDA in favor of giving it discretion. Along the way, there are a number of useful statements about FDA’s regulatory scheme. For instance, the middle part of this is pretty good:
It would make little sense, then, for the Congress to have constructed such elaborate regulatory regimes—carefully calibrated to products’ relative risk levels—only for the FDA to possess the authority to upend the statutory scheme by reclassifying any device as a drug, no matter its relative risk level.
Id. at **23-24. Same with this:
Rather, the Congress has elaborated separate regulatory tracks for drugs and devices and, to the extent that the FDA possesses the discretion to choose one track or the other, such discretion must be exercised in a manner consistent with the statutory “drug” and “device” definitions.
Id. at 28. You may find more nuggets.
So, what does this decision mean in our area of interest? In terms of preemption and FDA evidence, probably not much. Like we said, some of the statements about the FDA’s regulatory scheme and approach may be useful for briefing on these issues, but the core decision on FDA’s lack of discretion in this narrow area seems unlikely to move the needle. For some of our clients, the ability to have certain contrast agents regulated as devices may be beneficial. The knock against FDA’s claim of discretion to decide how to regulate certain products may also matter in other areas, perhaps making it easier or cheaper to market some of their products. Maybe that will get the attention of plaintiff lawyers about the type of products to target for lawsuits down the road. We are not suggesting they should, but it would certainly be within their discretion.