It’s twenty-four years post-Buckman and here we are still talking about the dismissal of cases premised on allegations that a manufacturer made misrepresentations to the FDA. Which means plaintiffs are still filing them.  We thought Buckman was the legal equivalent of a big red “STOP” sign. But it seems not everyone got the message.  So here it is again.  The federal Food, Drug & Cosmetic Act (“FDCA”) doesn’t have a private right of action, which means you can’t sue someone just because they violated FDA regulations. It’s the FDA’s job to enforce the FDCA. It has investigators, auditors, warning letters, and lots of fun acronyms. If a manufacturer actually misrepresented something, the FDA can handle it. It doesn’t need a tort suit from New York or California or any parts in between to tell it how to do its job. If that wasn’t clear enough, try this. If your claim is that the manufacturer misled the FDA, that claim exists solely by virtue of the FDA’s regulatory scheme. In other words, if the FDA didn’t exist, your lawsuit wouldn’t either. That makes it 100% federal territory and 100% impliedly preempted.

So, what if –hypothetically speaking– plaintiffs brought a putative class action against the manufacturer of a cochlear implant system alleging that the device fails to perform as expected and that they were misled into purchasing the devices. And let’s assume that the sole foundation for their claims is an allegation that the defendant provided fraudulent test results to the FDA during the pre-market approval process. One would assume that between PMA-preemption and Buckman preemption such a lawsuit should not exist. Unfortunately, Gibson v. Advanced Bionics, LLC, 2025 U.S. Dist. LEXIS 170605 (C.D. Cal. Sep. 2, 2025), isn’t hypothetical, those were the allegations, and defendant did have to spend the money to get it dismissed. But dismissed it is.  

Before we get to the preemption analysis, we should note that plaintiffs are residents of Arizona and defendant is a California company, but the complaint alleged a nationwide class. The court found plaintiffs only had standing to pursue claims under the laws of Arizona and California, all claims under any other state’s law were dismissed. Id. at *9-10.  

That didn’t really matter here because the entire case was dismissed as preempted. Plaintiffs’ fraud claims were both expressly and impliedly preempted. To the extent plaintiffs tried to argue defendant had a continuing duty to disclose, that is asking the court to impose a requirement that is “in addition to” what the FDCA requires and therefore the claim is expressly preempted. Id. at *14-15. So too are challenges to FDA-approved statements. As part of the PMA process, the FDA reviews the manufacturer’s promotional materials. Plaintiffs did not allege that defendant went beyond those approved statements, so any finding that those statements are fraudulent would impose a requirement “different from” those imposed by federal law. Id. at *15-16.

Such claims also are impliedly preempted. Any duty to provide test results or communicate with the FDA exists solely because of the FDCA. Furthermore, the FDA was aware of plaintiffs’ allegations and took no action against the manufacturer.  It’s up to the FDA to investigate potential violations of the FDCA, not private plaintiffs. Id. at *16-17.

Plaintiffs’ express warranty claim was likewise based on statements made in the device’s FDA-approved labeling and therefore was likewise expressly preempted.  Id. at *18-19.  So too was plaintiffs’ implied warranty claim since it challenged statements made in promotional materials that were reviewed and approved by the FDA. Id.at *19-20. And while plaintiff also tried to bring a breach of contract claim, it suffered from the same problems as it was based on the same FDA-approved statements. Id. at *20-21.

Since leave to amend would be futile, the dismissal was granted with prejudice.

If Buckman was a STOP sign, plaintiffs should read the twenty-four years of further legal precedent as steel bars bearing a federal seal and a very clear sign that says: “Private Enforcement Not Allowed. Go Home.”