We knew as soon as we read the Supreme Court’s opinion in Mutual Pharma v. Bartlett that its reasoning should extend beyond generic drugs and would support implied preemption in generic and innovator products alike. We were generally correct. Bartlett held that federal law preempted state law design defect claims involving a generic drug because the manufacturer could not have changed the design without the FDA’s pre-approval. That made it impossible to comply with state and federal requirements at the same time—thus preemption. Cases like Yates v. Ortho-McNeil extended that to innovator products, making Yates our number one best decision of 2015.

Plaintiffs have been trying to get around Bartlett ever since, including by dividing a drug manufacturer’s alleged duties into “pre-approval” and “post-approval” buckets. Surely “post-approval” design defect claims are preempted, since a manufacturer cannot unilaterally deviate from a product design to meet purported state-law duties after the FDA has approved the drug. Some courts, however, have accepted “pre-approval” design defect claims, on the theory that federal law would not have prevented a drug manufacturer from designing a safer product before the FDA gave its stamp of approval and federal requirements kicked in.

As we explained in detail here, “pre-approval” design defect claims are a fiction, and Bossetti v. Allergan Sales, LLC, No. 1:22-cv-523, 2023 WL 4030681 (S.D. Ohio June 15, 2023), is a good example of exactly why that is. In Bossetti, the plaintiffs alleged a design defect in the defendant’s brand-name antidepressant, but the district court ruled that federal law preempted those claims. If fuzzy discussion of preemption is a bad sign—and it usually is—then this court’s crystal clear approach was a welcome antidote:

First, the court opens with an assumption the state retains its “historic police power . . . unless [a different result] was the clear and manifest purpose of Congress.” Second, the court identifies the actions state law would compel the defendant to take. And third, the court asks whether the defendant cannot take those actions because federal law expressly forbids it.

Id. at *3 (citing Yates and Wyeth v. Levine). That’s how it is done. Once you have identified the state duty and determined that federal law would not permit fulfilling that duty, a finding of implied impossibility preemption should follow very closely behind. That is what happened in Bossetti. The district court held (and the parties agreed) that federal law preempted any state duty that would require changes to a drug’s composition following FDA approval. Id. at *4. In other words, “post-approval” design defect claims were preempted.

So were the plaintiffs’ “pre-approval” claims. According to the plaintiffs, the defendant designed the drug defectively from the start and therefore violated state duties before the FDA ever got involved. That is to say, the defendant could have and should have designed a “safer” product before the FDA evaluated and approved the drug, i.e., before the design became a federal requirement.

That argument failed because the plaintiffs were saying essentially that the defendant should never have marketed the drug or should have sold a different drug altogether. That does not work. The Sixth Circuit in Yates and the Supreme Court in Bartlett expressly rejected the idea that a defendant should have to cease acting altogether to avoid liability. This “stop selling” rationale extends to “never start selling” claims, like the plaintiffs’ design claims here:

In contending that defendants’ pre-approval duty would have resulted in a [drug] with a different formulation, [plaintiff] essentially argues that defendants should never have sold the FDA-approved formulation of [the drug] in the first place. We reject this never-start-selling rationale for the same reasons the Supreme Court in Bartlett rejected the stop-selling rationale.

Id. at *5 (quoting Yates, emphasis added). Another way to look at it is that the plaintiffs were flat-out second guessing the FDA by arguing that the FDA approved a “defective” design. But that design is ultimately what the FDA approved, and that is the product that federal requirements allowed the defendant to sell. When federal law says “yes,” state law cannot say “no.”

As an added benefit, the district court ruled not only that the design claims were preempted, but also rejected the plaintiff’s request for discovery. According to the court, “[A] state-law duty that would require a drug manufacturer to stop selling—or indeed never start selling—a drug that ultimately received FDA approval collides with the FDCA as a matter of law.” Id. at *5. As a result, discovery into whether the defendant could have designed a “better” drug as a factual matter would provide “no help.” Id. The correct result all around, for the correct reasons.