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About a year ago we blogged about a strong preemption decision from the Eastern District of New York, Gallego v. Tandem Diabetes Care, Inc., 2025 WL 948282 (E.D.N.Y. March 28, 2025). Gallego involved a Class III insulin injection pump that sent a warning alarm to its user that insulin was no longer being delivered. The diabetic using the pump then spoke with a representative of the manufacturer who confirmed that the pump was not delivering insulin and that the user should replace the insulin cartridge. The user of the pump died later the same day, and his estate filed a lawsuit. As discussed in our prior post, the court dismissed with prejudice most of the estate’s claims, but it granted plaintiff leave to file a second amended complaint (SAC) that included a claim for negligent defective design and wrongful death. Today’s decision, Gallego v. Tandem Diabetes Care, Inc., 2026 WL 1130316 (E.D.N.Y. Apr. 27, 2026), applies another robust preemption analysis and dismisses the plaintiff’s remaining claims with prejudice.

Continue Reading Preemption Round Two in the Eastern District of New York
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The latest medical device express preemption decision, Wieder v. Advanced Bionics LLC, 2026 U.S. Dist. LEXIS 70645, 2026 WL 880370 (S.D.N.Y. Mar. 31, 2026), comes out of the Southern District of New York and involves a Class III, PMA‑approved cochlear implant. 

Fluid allegedly worked its way into the device and caused a short‑circuit and device

Photo of Stephen McConnell

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

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Council for Responsible Nutrition v. James, 2025 WL 3165673 (2d Cir. Nov. 13, 2925), is a Second Circuit decision about a New York state restriction on the sale of certain dietary supplements to minors. This blog covers the case because the court’s decision includes a disturbing preemption holding.  This particular blogger covers the case

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Not too long ago, we tried to extrapolate from a doctoral thesis on quantum dots to lessons for litigation.  That “[q]uantum dots are between one-billionth of a meter and one-hundred-millionth of a meter in size” emphasized that “appreciating the scope and scale of what is being discussed can be critical.”  In the spate of litigation

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Today’s decision, Croci v. Zoll Medical Corp., 2025 WL 2307728 (S.D.N.Y. Aug. 11, 2025), is a straightforward, preemption-based 12(b)(6) dismissal of a complaint involving a Class III medical device.  The case involves claims about a Life Vest, which is worn externally and monitors the wearer’s heart rate. The device is able to detect ventricular tachycardia and ventricular fibrillation, and it can deliver a therapeutic shock to restore the wearer’s heart rate to a normal rhythm.  The complaint alleged that the decedent experienced problems with the Life Vest, and that a representative of the Life Vest’s manufacturer visited the decedent’s home to “desensitize the device.”  Id. at *1.  Shortly after the alleged visit from the representative, the decedent experienced a cardiac arrest and died.

Continue Reading PMA Preemption in the Southern District of New York
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Medical device preemption should be straightforward.  The statute could not be clearer.  Federal regulation supplants state laws that would impose requirements that are different from or in addition to the federal requirements.  But the law has evolved into a bit of a mess, with misreadings of certain approval/clearance pathways and inventions of exceptions, such as

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We often say here that we try not to do the other side’s homework for them or give them ideas about new ways to sue our clients.  When the Supreme Court takes a well-known statute and says, essentially, that it can now be applied in personal injury cases that also have economic damages, we do