Bischoff v. Albertsons Co., 2023 U.S. Dist. LEXIS109367 (SDNY June 26, 2023), is another favorable preemption ruling in the current spate of class action strike suits attacking “rapid release” over-the-counter (OTC) products, here acetaminophen, that were marketed in conformity with FDA regulations.
The plaintiff claimed that she purchased a generic form of “rapid release” OTC acetaminophen. She commissioned an “independent study” proving that the allegedly “rapid release” products aren’t any faster than “lower-priced” competing products that are not so labeled. (Wow. That is one fully engaged consumer – kind of like the Seinfeld characters who ran a test on not-so low fat yogurt) In fact, the tests purported to show that the “rapid release” medicine was slightly less rapid. The plaintiff then filed a lawsuit bringing claims for (1) violation of New York General Business Law section 349, (2) violation of New York GBL section 350, (3) breach of express warranty, (4) breach of the implied warranty of merchantability, (5) unjust enrichment, (6) negligent misrepresentation, and (7) fraud. The plaintiff sought to represent both nationwide and New York-specific classes of purchasers.
The defendant filed a motion to dismiss the complaint on several grounds, but express preemption was the main ground. (Or maybe we could call preemption the “hero” of the motion to dismiss, in the same way that cooking competition shows call the key ingredient of a dish the “hero.”) The plaintiff amended her complaint, but the preemption defense still applied, and then the court got down to business.
As you’ve heard from us before, OTC medicines enjoy express preemption under 21 U.S.C. section 379r(a). State law, including via jury verdicts, cannot impose any requirement that “is not identical to the requirements of the FDCA and FDA regulations.” The Bischoff court observed an “important caveat” that such preemption does not apply “if the state requirement is outside the scope of the relevant federal requirements.” (There is also a carve-out for product liability actions, but that is not what we have here.)
The labeling for the rapid release OTC acetaminophen conforms to legally binding FDA OTC drug monographs. Consequently, the plaintiff’s claims for purported economic loss were expressly preempted. The court took judicial notice of relevant FDA documents, including two FDA guidances regarding immediate release drugs. These guidances state absolute dissolving rates required to call a medicine immediate release (as opposed to a comparison with a medicine not labeled as such), and guess what? The OTC acetaminophen at issue in the case met the test for immediate release. Thus, the plaintiff’s allegations are certainly in tension with, and certainly not “identical” to, the FDA’s requirements. A product meeting the criteria for immediate or rapid release does not have to be identified as such, but the manufacturer may do so, after conducting the relevant tests.
The plaintiff argued that the FDA guidances lacked the force of law and, in any event, they discussed “immediate,” not “rapid” release, and they applied only to tablets not gelcaps. But the court refused to stand on ceremony. Minor differences in terminology would not permit the plaintiff to evade preemption. If a medicine qualifies as “immediate” release, it seems that, a fortiori, it also qualifies as “rapid” release. (Our autocorrect wanted us to write “Abe Fortas.” What’s weirder: AI or us?). Further, gelcaps are a type of tablet and are covered by the FDA’s requirement. The plaintiff’s effort to elevate form over substance failed.
It should come as no surprise that other courts had already addressed similar claims. One court in N.D. Cal. rejected preemption, another court in N.D. Cal. applied it, and a court in Massachusetts applied it. Two out of three ain’t bad. Now, with Bischoff, it’s three out of four on the side of preemption.
For several reasons, the Bischoff court denied the plaintiff’s request for another amendment to the complaint. The plaintiff had amended the complaint once, and there was simply no way it could fix the preemption problem. The Bischoff court believed it need not be subjected to a “presentation of theories seriatim,” and was not in the business of providing plaintiffs with an “advisory opinion from the Court informing them of the deficiencies in the complaint and then an opportunity to cure those deficiencies.” The court dismissed the Bischoff case with prejudice. You might say that the plaintiff’s effort to cobble together a class action was rapidly released from the court system.