Politics makes strange bedfellows. So does the law. Weird cases also make weird law. The Supreme Court decision in National Pork Producers Council v. Ross, No. 21–468, — S. Ct. — , 2023 WL 3356528 (U.S. May 11, 2023) (“NPP”), evidences each of those old saws. Deciphering just what the Supreme Court held entails interpreting a 3-D Rorschach image by touch. Charting which justices joined which opinions on which issues looks like a psilocybin-induced Venn diagram. We are not looking do either of those, but we will weigh in on what NPP means for non-product liability cases involving FDA-regulated medical products. The most prominent litigation in this space these days relates to reproductive rights. Are we down to talk about NPP and its impact on reproductive rights litigation? You know us.
The core issue in NPP is the dormant commerce clause (“DCC”), which we have described as follows:
The dormant commerce clause perks up every once in a while to announce that a state’s effort to regulate commerce has gone too far. James Madison originally harbored doubts that states could impose shipping tonnage duties, given that the commerce clause invested such powers in a unitary, federal authority. In the judicial context, Chief Justice Marshall first alluded to the dormant commerce clause in Gibbons v. Ogden, 22 U.S. 1 (1824). The notion is that implicit in the power of Congress to regulate commerce is a corollary constraint on the power of states to enact legislation that interferes with or burdens interstate commerce. A state cannot regulate commerce occurring wholly outside its borders. A state law violates the dormant commerce clause’s extraterritoriality principle if it either expressly applies to out-of-state commerce or if it has that practical effect, regardless of the legislature’s intent.
See here. In that case, the Fourth Circuit knocked out a Maryland law designed to prevent price gouging on drugs because of its extraterritorial reach. We (and one of our guest bloggers) have touted the DCC as something of an adjunct to preemption in placing limits on state actions that affect medical products and their manufacturers. See, e.g., here, here, and here. We do not often see them applied in the same case in our space, though, with preemption typically used to knock out specific state tort claims and the DCC mostly used to challenge state laws. There is no particular reason why they cannot work hand in hand, as seen in some of the suits seeking to knock out state laws and threatened state actions related to medication abortion.
The oldest Supreme Court decisions we know about relating to products regulated by the FDCA or its predecessor, the Pure Food Act, are McDermott v. Wisconsin, 228 U.S. 115 (1913), and Savage v. Jones, 225 U.S. 501 (1912). They look a lot like they are analyzing preemption, the DCC, or the plain old CC. Yet, neither mentions preemption, the Supremacy Clause, the DCC, or the CC. Both talk a fair amount about “commerce” and the respective roles of the states and federal government. And both invalidated state laws that conflicted with federal laws and had extraterritorial effects. A hundred years later, we detailed three rounds of litigation over Massachusetts’ serial efforts to ban, or at least substantially limit, the use of FDA-approved pain medications. While preemption ruled the day for the first two rounds, the third round saw the manufacturer relying on the DCC in trying to knock out more permissive regulations.
Since Bartlett (and in some cases before it), stop selling claims as to NDA and ANDA drugs have been widely preempted. However, we cannot recall any of them looking to the DCC or CC to buttress the preemption arguments. As one district court put it, it was “aware of no state law duty that would compel generic manufacturers to stop production of a drug that under federal law they have the authority to produce.” See Gross v. Pfizer, Inc., 825 F. Supp.2d 654, 659 (D. Md. 2011), aff’d, 741 F.3d 470 (4th Cir. 2014). The word “generic” in that sentence was not limiting, as the logic applied more broadly: “Nor could such a state law duty exist, as it would directly conflict with the federal statutory scheme in which Congress vested sole authority with the FDA to determine whether a drug may be marketed in interstate commerce.” Id. Of course, in the context of medication abortion, the marketed version of mifepristone is a generic, proceeding under an ANDA approval, so no extension is needed. Nonetheless, given the history of courts shucking and jiving to find ways not to preempt tort claims—often expanding state law to do so—it is more than an academic exercise to evaluate whether the CC or DCC provide some oomph to keep states’ hands off of whether and how FDA-approved drugs can be prescribed, dispensed, and used.
This can be seen by the request of the court in one of the active medication abortion cases against a state (discussed here) for the parties to brief how NPP affected the DCC issues in that case. Rather than summarizing or critiquing those briefs, which largely focused on whether the balancing test from Pike v. Bruce Church, Inc., 397 U.S. 137 (1970), survived NPP, we have our own spin on things.
First, NPP did limit using the DCC to invalidate state laws based on their extraterritorial effects to state actions that discriminate against out-of-state economic interests, consistent with Healy v. Beer Institute, 491 U.S. 324 (1989). Extraterritorial effects, even without discriminatory intent, are still part of the analysis, though. In that Fourth Circuit case we mentioned above, the court looked to Healy (which knocked out a Connecticut wholesale beer pricing law) and Pharmaceutical Research & Manufacturers of America v. Walsh, 538 U.S. 644 (2003), but not to Pike. We find it unlikely, but not impossible, that some state law about medication abortion might still violate Healy and Walsh. For instance, Sorsaia primarily involves a challenge to a state trying to prevent in-state use of an FDA-approved drug for its FDA-approved use. Other state laws affecting FDA-approved drugs are more likely to have the required protectionist bent.
Second, the discussion in the various part of NPP about whether states can ban “ordinary consumer goods” despite the DCC is somewhat irrelevant to medication abortion or any FDA-approved drug. Pork, like horsemeat, foie gras, shark fins, fireworks, and plastic bags—products discussed in the cited cases—is an ordinary consumer good. Prescription drugs are not. You never need an authorization from a licensed professional to buy pork or fireworks. And no federal agency specifies an intended use for these products. Consider “street drugs” and other drug that have at times been widely illegal to manufacture, import, sell or possess. Without diving into the intricacies and inconsistencies of the federal Controlled Substances Act, states cannot without federal acquiescence declare a schedule I drug to be legal within its territorial boundaries. Likewise, states cannot ban a drug that FDA has approved, including ones that once were considered street drugs. They can regulate doctors, pharmacies, and grocery stores, but cannot ban an FDA-approved drug like they can pork that comes from pigs not raised in a specific way, the gist of the California law at issue in NPP.
Third, in addition to not being ordinary consumer goods, prescription drugs are clearly products where “national uniformity” is important. Across multiple opinions, NPP recognized that the DCC applies with added effect where there is such an interest in national uniformity. There was no such interest in the record for how pigs are raised, but we know there is such an interest for prescription drugs because Congress said so in connection with enacting the FDCA in 1938 and in a number of related laws since then. One of those laws, FDAAA in 2007, established the REMS system, which reflects the importance of national uniformity in the delivery of healthcare. After NPP, prescription drugs, like mifepristone, that are subject to REMS continue to have an even stronger basis to argue that state restrictions that fall short of facial bans still run afoul of the DCC. That brings us full circle, because FDA approvals and REMS—particular for generic drugs subject to the duty of sameness—should have very strong preemption arguments. Generic mifepristone sure does.
Interestingly, NPP was not the first time a California law related to pork was decided by the Supreme Court. In National Meat Ass’n v. Harris, 565 U.S. 452 (2012), which we discussed here but which no NPP opinion mentioned, preemption ruled the day and the DCC never came up. That was because the California law relating to practices in swine slaughterhouses was inconsistent with a federal law, the Federal Meat Inspection Act. The unanimous Court opinion in Harris, which reversed the Ninth Circuit, was written by Justice Kagan. In NPP, she sided with majority position to affirm the Ninth Circuit, although not with much of its reasoning. It should be obvious that state actions against FDA-approved drugs with REMS plans are much closer to what was decided in Harris than what was decided (if you can call it that) in NPP, where there was no federal law on point with the California law. So, while the DCC has certainly been reduced by NPP, it still has some teeth, while preemption has not been affected. If anything, the contrast between Harris and NPP underscores how the Supremacy Clause (on which preemption is based) operates. Boiled down to suit our needs, it provides “the Laws of the United States [made pursuant to the Constitution] . . . shall be the supreme Law of the Land; and the Judges in every State shall be bound thereby, any thing in the Constitution or Laws of any State to the Contrary notwithstanding.” That means that the existence of a federal law that can compared against some potentially contrary state law makes it much easier for judges to evaluate preemption than the somewhat amorphous and changeable DCC.