All’s Well That Ends Well? Eh, Fine, If You Say So.

The preemption case du jour is Gregory v. Boston Sci. Corp., 2025 U.S. Dist. LEXIS 164801, 2025 WL 2452382 (E.D.N.Y. Aug. 25, 2025), in which the Eastern District of New York granted summary judgment on federal preemption grounds.

Every time we see a case that does that—upholds preemption on summary judgment—we wonder why the court didn’t uphold preemption at the pleading stage, on a motion to dismiss.

As the Supreme Court recognized in Riegel v. Medtronic, Inc., 552 U.S. 312, 330  (2008), when Congress enacted 21 U.S.C. § 360k(a) as part of the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, it did not just intend to protect manufacturers of Class III, premarket approved (“PMA”) devices from litigation judgments–it hoped to protect manufacturers against the costs of discovery as well.  In other words, federal preemption is most effective in carrying out congressional intent when it is enforced at the outset of the case, not after years of expensive litigation.

So we checked the Gregory docket. 

Three years ago, in 2022, the defendant filed a preemption motion to dismiss, and (sensibly) asked the court to stay discovery until that pleading-stage motion was decided.  The Court denied the stay and ordered discovery to proceed. And then, basically, the Court just sat on the motion to dismiss until case events and the passage of time rendered it moot: 

• After more than a year had passed without a decision on the motion to dismiss, discovery closed. 
• Then two years passed, and defendant filed its summary judgment motion. 
• Then three years passed. 
• Finally, the Court granted the motion for summary judgment, which brings us to the opinion that is the subject of our present post.  After it does so, the clerk administratively closes the motion to dismiss in the process of closing the case, meaning that first motion to dismiss was never heard and never decided. 

So much for the prohibition against plaintiffs “unlocking the doors” to discovery with an inadequately-pled or legally-barred claim. 

We are frustrated just recounting these facts, because we do not think this is anyone’s idea of the swift and efficient administration of justice.  Sadly, we have been in this situation ourselves, with preemption motions pending unheard as the months and years click by.

This situation also reminded us of the pair of preemption motion to dismiss denial/preemption summary judgment grant opinions we wrote about in this post. 

Setting our frustrations aside, we now turn to the opinion at hand, which would have been a perfectly acceptable preemption decision had it been issued three years earlier on motion to dismiss.

The plaintiff in Gregory had been implanted with a urinary control device, a Class III medical device approved by the FDA through the PMA process.  This is a product liability case, so of course alleged device failures and a revision surgery were involved.  The plaintiff asserted the usual assortment of claims—strict liability, negligence, breach of express and implied warranties—and he threw in a few extras, like a New York General Business Law claim alleging deceptive representations related to the device.

As you would expect, the court’s analysis centered on the express preemption provision, 21 U.S.C. § 360k(a), which prohibits states from imposing requirements “different from, or in addition to” federal requirements applicable to medical devices, and Riegel.  The court reiterated that state law claims are preempted unless they are “parallel” to federal requirements—i.e., premised on a state law claim that involves a parallel federal duty, rather than a state law claim that would impose additional or different obligations beyond the federal requirements in effect for the device.

Strict Liability, Negligence, Strict and Negligent Infliction of Emotional Distress

Plaintiff’s claims for strict products liability and negligence were found to be preempted, as were the related claims for negligent or intentional infliction of emotional distress.

Although “Plaintiff [did] assert, albeit in conclusory fashion, that Defendant’s manufacturing process violated federal requirements…. Plaintiff does not explain how Defendant’s manufacturing process violated federal law.”  Moreover, “to survive MDA preemption, a plaintiff cannot simply demonstrate a defect or a malfunction and rely ‘on res ipsa loquitor’.”

Given that plaintiff never identified any particular manufacturing-related PMA violation on summary judgment, you can bet his complaint never articulated what that alleged violation was either.  So, good on the court for recognizing that conclusory assertions of noncompliance are insufficient, but that was a light bulb that should have gone off three years earlier. 

Implied Warranty

The court likewise dismissed the implied warranty claim, because the FDA had granted premarket approval and plaintiffs cannot used implied warranty to demand a different, allegedly safer design.  As the court acknowledged,

“[t]o do so would impose different and additional requirements to federal law. And again, Plaintiff’s allegations in support of this claim are scant. Plaintiff has not identified a particular defect in the device or a particular FDA requirement Defendant allegedly violated.” 

Really?  Bet that was true at the pleading stage as well. 

Express Warranty

The express warranty claim was preempted to the extent it was based on FDA-approved representations and, in any event, there was no evidence the defendant made any express warranty to plaintiff, either directly or through his physician, anyway.  (And also, promises the plaintiff’s doctor allegedly made about the device’s longevity were not attributable to the defendant manufacturer, as the doctor was not the manufacturer’s agent.)

Deceptive Business Practices

Plaintiffs’ New York deceptive business practices claim was also preempted to the extent it challenged FDA-approved promotional materials. The court further found that, even if the claim were not preempted, plaintiff failed to provide evidence of any materially misleading statement by the defendant regarding the device’s expected lifespan.

So, there you have it.  The decision in Gregory reaffirms the formidable barrier that federal preemption poses to state law claims involving PMA-approved Class III medical devices. Plaintiffs must plead and prove specific violations of federal law to avoid preemption; generalized allegations of defect or malfunction are insufficient. 

Eventually.