It’s the most wonderful time of year, or at least Sirius channel 79 keeps telling us that.  Too much food, too much drink, too much family, and not quite enough presents.  Or, at least, not enough of the right presents.  Or, maybe, lots of those veritable mixed bags.  You know – a six pack of Samuel Smith’s oatmeal stout (for the moment, we will forget about that ‘too much drink’ remark above), and a six pack of white tube socks.  You smile ruefully at the socks. Then you reach for the bottle opener.

Today’s case, Weider v. Advanced Bionics LLC, 2025 WL 3237257 (S.D.N.Y. Nov. 20, 2025), is a mixed bag.  To be sure, it is mostly good. It contains a splendid class III, premarket approval (PMA) preemption decision by a magistrate judge.  At the same time, it is slightly spoiled by a case-specific negligent undertaking claim about post-implant testing surviving non-preemption challenges.  We’ve been talking in terms of holiday gifts, but tomorrow’s holiday is Thanksgiving, so let’s consider Weider in a different way. The application of preemption is like the delightful, satisfying turkey, spuds, stuffing, and cranberries.  But at the end, squatting in squalid loneliness on the plate is the lump of turnips.  Do we really have to eat that? We look over at Aunt Marie, who made the turnips, just like she has for 60 years.  Yes, we have to.

Let’s set the table. The product was a cochlear implant.  The plaintiffs were suing on behalf of their child, who had received the cochlear implant. They alleged that an inadequate seal permitted moisture ingress, which caused a short circuit in the medical device, which caused a malfunction, which caused permanent problems in terms of hearing and the patient’s ability to speak and learn. The plaintiffs’ first amended complaint (FAC) contained claims of manufacturing defect, design defect, breach of an implied warranty of merchantability, violations of New York General Business Law sections 349-50, negligent failure to warn, negligence, and loss of services. The defendant moved to dismiss the FAC on the grounds that it was preempted by federal law and/or otherwise failed to state a claim for relief. That motion succeeded — mostly. 

First, the plaintiffs failed to allege any manufacturing defect with sufficient specificity.  New York law, like most places, provides that a strict liability manufacturing defect claim be supported by a showing that the product did not perform as intended because of “some mishap in the manufacturing process itself, improper workmanship, or because defective materials were used in construction.” To get past the Riegel/Medical Device Amendments section 360k(g) express preemption of any requirement that is “different from, or in addition to, any requirement applicable to a medical device under the Food, Drug, and Cosmetic Act (FDCA) the plaintiff must hang a manufacturing defect on a violation of a state rule that is parallel to the federal rule.  The plaintiff in Weider failed that test. The FAC included a conclusory laundry list of purported Current Good Manufacturing Practice (CGMP) violations, including an alleged inconsistency, but that was not enough. It alleged that the silicone seal was “applied manually by manufacturing workers,” but that was not enough. The FAC also cited to a voluntary recall, but that bare fact was not enough. It certainly did not establish an unpreempted design defect.    

Second, the design defect claims facially challenged what the Food and Drug Administration (FDA) approved and were, therefore, preempted. Under New York law, “[t]o establish a prima facie case for design defect, the plaintiff must show that the defendant breached its duty to market safe products when it marketed a product designed so that it was not reasonably safe and that the defective design was a substantial factor in causing plaintiff[‘]s injury.”  The design defects alleged in the FAC were either too vague or actually sounded like manufacturing defects, but either way, the FAC’s allegations “directly challenge[] the FDA’s judgment in approving the allegedly defective” design “and thereby seek to “impose different or additional standards” on the product line “in violation of the MDA.”

Ditto for implied warranty.  The parties agreed that the warranty claim “rises or falls with the[] manufacturing defect and design defect claims.” So they fell.

Similarly, the negligent warning, consumer fraud, and fraud claims challenged FDA-approved warnings and were, again, preempted. The guts of these claims was that the defendant allegedly did not disclose the true failure rate of the cochlear implants. According to the plaintiffs, the disclosure of the true failure rates should have been included in various “consumer-oriented” statements. But the plaintiffs offered no allegations that the defendant made statements contrary to what the FDA approved. Moreover, even if New York law can be construed to mandate non-physician warnings, the FDCA does not. Consequently, the plaintiffs’ theory would impose a state requirement that is “different from, or in addition to” the FDA’s requirements.  Hello, FDCA preemption, goodbye claims.  

The negligent warning claim based on failure to report allegations was also preempted. Under New York law, device warnings go to learned intermediaries, not regulatory agencies.  The FDA is not a learned intermediary. After all, the FDA does not treat patients. Further, there is no basis to believe that a warning to the FDA “necessarily or even likely results in a warning to treatment providers.” A failure to warn claim under New York law would be “different from, or in addition to” a manufacturer’s duty to supply adverse event reports to the FDA. In any event, factually, the plaintiffs’ warning claims were conclusory and contradictory.  

So far, so good. Now we get to the turnips or, if you prefer, the not so good present. (Think of the Jelly of the Month club certificate that Clark Griswold gets in National Lampoon’s Christmas Vacation). The negligent undertaking claim rested on Restatement of Torts (Second) section 323, which provides that one “who undertakes, gratuitously or for consideration, to render services to another which he should recognize as necessary for the protection of the other’s person or things, is subject to liability to the other for physical harm resulting from his failure to exercise reasonable care to perform his undertaking if (a) his failure to exercise such care increases the risk of such harm, or (b)the harm is suffered because of the other’s reliance upon the undertaking.” Call it the no-good-deed-goes-unpunished proposition. The plaintiffs contended that a sales representative of the manufacturer conducted “integrity testing” of the subject device and incorrectly concluded that it was working properly. The defendant did not contend that a negligent undertaking claim based on a representative’s testing of the device while implanted was preempted. Rather, the debate was whether there was any duty in this case. The defendant pointed to New York cases holding that a manufacturer is not generally responsible for how a physician uses a device and renders medical care, and that New York law does not recognize a duty to test.  But the Weider court concluded that the plaintiffs’ factual allegations about known problems with the testing were sufficient to state a negligent undertaking under New York law.  Thus, the negligent undertaking claims, as well as the claim for loss of services, were the only causes of action that escaped preemption in Weider.

In the spirit of the season, we will not grouse unduly about the survival of what we see as frail causes of action,  Instead, we’ll give thanks for the excellent preemption rulings. And you’ll be thankful that we are abstaining from any turkey or other fowl puns.