If ever there were a case that reads like a checklist for how not to plead around preemption, it’s Dunham v. Boston Scientific Corp., — F.Supp.3d–, 2026 WL 539533 (W.D. Mich. Feb. 24, 2026). Plaintiff alleged that his spinal cord stimulator—a Class III, premarket approved device—implanted to treat his chronic back pain caused him complications and injuries. He filed suit against the manufacturer alleging manufacturing defect, breach of implied warranty, failure to warn, negligence, breach of express warranty, and fraud. Id. at *1-2. Defendant moved to dismiss all counts primarily on preemption grounds. The court went claim by claim. The result? A clean sweep. Every count dismissed with prejudice.
When you are dealing with a PMA device, you are operating in the land of narrow pathways and narrower pleadings. Plaintiff here tried to navigate that terrain with broad references to federal regulations and a hope that “parallel claim” magic words would do the trick. They did not.
Plaintiff’s first move was familiar–allege violations of Current Good Manufacturing Practices (CGMPs), such as failure to implement adequate design controls, and call it a manufacturing defect. Because he invoked federal requirements, plaintiff argued his claim was not expressly preempted—it was “parallel.” But that only solves half the problem.
The complaint never identified a state-law duty that mirrored those federal obligations. At most, plaintiff generally referenced the Michigan Product Liability Act, but it does not create the type of “regulatory obligations embodied in the manufacturing practices upon which Plaintiff relies.” Id. at *6. Without that state-law hook, the claim depended entirely on federal requirements. And that is where implied preemption—courtesy of Buckman—steps in and shuts the door.
Even better (from a defense perspective), plaintiff did not address implied preemption in his brief. The court treated that silence as forfeiture. Id. Count I: dismissed.
Next up: breach of implied warranty, again premised on the same alleged CGMP violations. Under Michigan law, implied warranty turns on “fitness” of the product. But if a jury found the device unfit, it would necessarily be saying the device was not as safe and effective as the FDA-approved model. That is a textbook example of express preemption—state law imposing requirements “different from or in addition to” federal approval. Id. at *6-7.
And even if preemption somehow failed, Michigan permits conspicuous disclaimers of implied warranties. Defendant had one. It was clear. Plaintiff did not respond to that argument either. Preempted. Disclaimed. Forfeited. Count II: dismissed.
On to warnings. First and foremost, in the PMA approval, the FDA proscribes the “precise labeling” for the device and the manufacturer cannot deviate from it. Id. 7. So, any claim that the label should have said something different is expressly preempted. But here, plaintiff also alleged that defendant should have warned the general public and the medical community, via means beyond the label, about “emerging adverse event trends” and “known failure modes.” Id. The problem? The FDA does not require that. So, just as with any purported label change, plaintiff’s theory would impose warning obligations beyond federal law. Again, that’s express preemption. Count III: dismissed.
Plaintiff’s negligence claim recycled the alleged CGMP violations. It was, in essence, the manufacturing defect claim wearing a different label. It failed for the same reasons—no viable parallel state-law duty and implied preemption under Buckman. Id. at *8-9. Same song, second verse. Count IV: dismissed.
Plaintiff’s express warranty claims fell into two categories. Those focused on safety, effectiveness, durability, and fitness were expressly preempted because, again, any finding that those warranties were breached would require a finding that the device was not safe and effective—contrary to the FDA’s PMA approval. Id. at *9. On the other hand, an express warranty claim premised on allegedly voluntary and false warranties that go beyond the federally-approved label can sometimes escape preemption. But here, those claims ran into a different wall: privity. Michigan requires it, plaintiff did not plead it. No alleged contractual relationship between plaintiff and manufacturer. And once again, plaintiff did not address the issue in his briefing. Id. at *10. Preempted in part. Barred for lack of privity in the rest. And forfeited besides. Count V: dismissed.
Finally, plaintiff claimed fraud based on allegedly false misrepresentations or omissions concerning the “safety, efficacy, and regulatory compliance” of the device. Id.at *10. In response to defendant’s express preemption challenge, plaintiff argued that his claim was based on allegations that the device was unsafe “despite the PMA approval.” Id. at *11. That theory sounds suspiciously like the FDA was wrong, and a state jury should say so. That is precisely the type of claim the Supreme Court rejected in Buckman. Fraud-on-the-FDA claims are impliedly preempted because they exist solely by virtue of the FDCA’s regulatory scheme. The court was unpersuaded by plaintiff’s attempt to recast the claim as independent of federal law. If your theory depends on the FDA having erred in granting approval, you are squarely in preemption territory. Count VI: dismissed.
Plaintiff did not seek leave to amend, so the court dismissed the entire case with prejudice. Id.
For many of our posts we try to come up with a clever take, a play on words, a theme. Sometimes there is no grand theme. Sometimes the theme is just this: preemption still works. And when plaintiffs ignore half the doctrine—or half the briefing—the results can be swift and decisive. Defense checklist complete. Case closed.
