This post is not from the Reed Smith side of the Blog.

Welcome to the Garden State—where you can get cursed out in traffic, eat a pork roll (not a Taylor ham) sandwich that changes your life, and see a beautiful beach… all before 10 a.m. Where driving is both a sport and a trust fall exercise with strangers going 90 mph while drinking Dunkin’ or chowing down on a Wawa hoagie. North Jersey thinks it’s basically NYC (with better pizza and worse parking), while South Jersey swears it’s practically part of Philly (honestly, maybe?). Then there’s Central Jersey, which may or may not exist depending on who you ask and what time of day it is (it doesn’t). It’s got nature too.  The Pine Barrens are real, and they may or may not be haunted by a demonic flying goat. And you can’t beat the gorgeous shorelines, though if you call it “the beach” instead of “the shore,” someone will correct you with passive-aggressive enthusiasm. Diners on every corner, but you have to use jughandles to reach them. New Jersey is like that one weird uncle at Thanksgiving—loud, chaotic, unapologetically themselves, and full of stories you’re not sure are legal. But deep down–a total gem.

And if that’s a little confusing and contradictory—that was the point. Because so is today’s case: Hollenstein v. St. Jude Medical, Inc., 2025 U.S. Dist. LEXIS 121547 (D.N.J. Jun. 26, 2025). Plaintiff brought standard products claims against the manufacturer of his automatic implantable cardioverter-defibrillator alleging a “lead failure” caused the device to administer inappropriate shocks. The device was pre-market approved by the FDA, so you know we are going to be talking about preemption.  But before we get there, there is a personal jurisdiction ruling worth mentioning.

Plaintiff sued both the company that manufactured his particular device and that company’s successor.  The successor moved to dismiss on the grounds that the court had neither general nor specific personal jurisdiction. General jurisdiction didn’t exist because the company was incorporated in Delaware and its principal place of business is Illinois.  Id. at *17-18. Plaintiff argued in response to the motion to dismiss that the predecessor’s jurisdictional contacts, which are sufficient for specific jurisdiction, should be imputed to the successor. The court acknowledged that the question of “whether product line successor liability could support specific jurisdiction over a successor lacking minimum contacts” was a matter of first impression. Id. at *21. But it was also a question the court did not have to decide because nowhere did the complaint allege one defendant was the successor to the other. The successor was dismissed without prejudice.

Now we come to preemption.  All of plaintiff’s claims other than breach of express warranty are subsumed by the New Jersey Products Liability Act (NJPLA) and boil down to claims for design defect, manufacturing defect, and failure to warn.  The opinion starts off strong finding plaintiff’s design claim both preempted and insufficiently pleaded. Id. at *33-35.  Any state law challenge to the safety or efficacy of the device would be different from or in addition to the FDA’s approval and therefore the claim is preempted. Plaintiff also failed to plead that either the device’s risks outweighed its harm or that there was a “practical and feasible alternative design.” Id.

On manufacturing defect, the court went in the opposite direction.  It found the claim was not preempted because plaintiff alleged that defendants did not manufacture the device in accordance with enumerated PMA requirements. The court would not consider, at the pleadings stage, rulings by other courts on summary judgment that found no evidence of the purported PMA requirements. Id. at *35-36. For similar reasons, the court found the claim sufficiently pleaded, including pleading a causative connection between the alleged PMA violations and plaintiff’s injuries.  Id. at *37-38. 

Now we get to the confusing part—failure to warn.  Plaintiff’s warning claim is premised on allegations that defendant did not report adverse events to the FDA. We direct you to either our failure-to-report preemption round up or our 50-state survey on whether state law recognizes a failure-to-report. Both will show you that New Jersey courts have consistently held failure-to-report claims are either preempted or not recognized. Indeed, Hollenstein cites and relies on the New Jersey cases that “declin[e] to recognize a separate state law duty to the warn the FDA.” Id. at *44-45.

Here comes the twist. The court drew an inexplicable and unprecedented distinction between plaintiff’s claim based on (a) “[d]efendants fail[ure] to report newly acquired information to the FDA about the defects in the [device] after the initial PMA approval by the FDA,” id. at *44; and (b) [d]efendants’ alleged failure to disclose newly acquired information to the general public through the FDA’s Manufacturer and User Facility Device Experience (“MAUDE”) public, searchable database.” Id. at *45.

The court found the former was impliedly preempted, like the other New Jersey courts to have considered the issue. As to the latter, however, the court concluded it survived preemption as a parallel claim on the theory that it is a failure to warn the public claim. But that incorrectly assumes that manufacturers have any say in or control over what is reported in the MAUDE database. They don’t. The court blindly accepts the allegation “that had Defendants disclosed [event reports], it would have been published on the MAUDE database used by physicians.” Id. at *47.  MAUDE is an FDA database. No device manufacturer adds information to any FDA database–only the FDA does. And the FDA does not place all adverse events on the MAUDE database. So, this is just another way of alleging some sort of duty to report to the FDA. The court drew a distinction without merit that keeps failure to warn alive, for now. And has us wondering how plaintiffs are going to try to use this sideways ruling.

Plaintiff also brought a breach of express warranty claim that the court ruled might not be preempted if based on “voluntary” statements not regulated by FDA. But since plaintiff failed to plead the specifics of any actual statements made, the claim was dismissed without prejudice under TwIqbal.  On the facts, the claim seems weak, as the device functioned for 16 years, and thus met or exceeded the product’s expected useful life.

Just remember, Jerseyans don’t pump their own gas, will defend their favorite mall like it’s a football team, and say things like wudder, cawfee, and heum.  And we’ll complain endlessly about the state—but if you do, you’re an outsider. Only we get to make fun of our jughandles and toxic air.