Products Liability Law Daily Wrap Up, JURISDICTION—MEDICAL DEVICES—E.D.N.C.: Deceased patient’s suit against insulin pump and glucose monitor suppliers remanded to state court, (Dec 11, 2025)

By Pankhuri Bhatnagar, B.A. LL.B.

The suppliers failed to show that an in-state clinic was fraudulently joined.

In an action brought against the suppliers of an automated insulin delivery system used with a continuous glucose monitor by the estate of a woman who died due to the system’s alleged defects, a federal district court in North Carolina granted the estate’s motion to remand. The court found that the non-diverse endocrinology clinic’s citizenship could not be disregarded because the estate sufficiently pleaded an express warranty claim based on the clinic’s sale, promotion, and alleged representations about the devices, the clinic owner’s affidavit created a factual dispute rather than proving impossibility, and severing the clinic would be improper because the alleged warranty and product liability theories asserted against the other suppliers arose from the same transaction (Sciandra v. Insulet Corp. et al., No. 5:25-CV-519-FL (E.D.N.C. Dec. 2, 2025)).

Background. A woman was a Type 1, insulin-dependent diabetic from the age of three years old until her death at the age of 75 on August 27, 2023. A year before her death, Cary Endocrine & Diabetes Center, P.A. (clinic) sold her the Omnipod 5—a wearable insulin delivery system designed to deliver insulin subcutaneously, used in conjunction with the Dexcom G6 continuous glucose monitoring system (CGMS). The devices were designed to automatically adjust insulin delivery based on her blood glucose levels. On the day of the incident, the patient noticed elevated glucose levels, directed the Omnipod to administer insulin doses, and went to sleep. She later collapsed due to elevated glucose levels and was admitted for severe diabetic ketoacidosis, acute kidney injury, and hypotension, which ultimately led to her death. The doctors discovered that the Omnipod unit used by the decedent had a bent infusion needle and did not deliver the insulin or alert the user to the issue.

The decedent’s estate/claimant sued Dexcom, Inc., Insulet Corporation, and US Med, LLC (collectively, suppliers or companies) and the clinic for allegedly designing, manufacturing, assembling, inspecting, selling, marketing, and/or distributing the insulin pump and monitoring system in question. The estate asserted 17 claims including negligence, breach of express and implied warranties, consumer-protection, misrepresentation, and punitive damage. Insulet removed the case to federal court on grounds of diversity, asserting that the North Carolina-based clinic had been fraudulently joined or alternatively, that claims against the clinic could be severed. The estate moved to remand while the suppliers sought permission to file their proposed sur-reply.

Sur-reply. The suppliers sought leave to file a sur-reply to address certain legal and factual issues raised for the first time in the estate’s response, in which the latter purportedly raised a new argument regarding the “no possibility” standard for fraudulent joinder and attached an affidavit containing new factual allegations. The court exercised its discretion to grant the motion and deemed the proposed sur-reply as lodged.

Legal standard. Invocation of the fraudulent joinder doctrine is appropriate only where “there is no possibility that the plaintiff would be able to establish a cause of action against the in-state defendant in state court; or... there has been outright fraud in the plaintiff’s pleading of jurisdictional facts” as per Marshall v. Manville Sales Corp., 6 F.3d 229, 232 (4th Cir. 1993). A “complaint is legally sufficient so long as it states enough to give the substantive elements of at least some legally recognized claim” as per Howell v. Cooper, 388 N.C. 71, 77 (2025).

Express warranty. The court took into consideration North Carolina’s liberal notice-pleading standard and the statutory definition of express warranty under N.C. Gen. Stat. § 25-2-313. The estate administrator alleged that the clinic sold the Omnipod and Dexcom units to the decedent, advertised their availability and safety, and made express representations that users could use the devices safely and without fear of sudden malfunction to induce customers to purchase them, and the decedent relied upon these representations when purchasing and using the devices. The court held these allegations sufficiently pleaded the elements of an express warranty claim under state law: an affirmation of fact or description of goods, which became part of the basis of the bargain, upon which the decedent relied. N.C. Gen. Stat. § 25-2-313(1). Thus, there was at least a “slight possibility” or “glimmer of hope” that a state-law claim against the clinic could be established—enough to stop a finding of fraudulent joinder. The suppliers pointed out that N.C. Gen. Stat. § 90-21.13(d) does not allow express warranty claims against healthcare providers “in the absence of a writing signed by a physician” but that defense applies only to an action involving “assurance as to the result of any medical, surgical or diagnostic procedure or treatment” and not to products marketed or sold by a healthcare provider.

Contrary to the companies’ assertion, the claimant did allege a specific representation made by Cary Endocrine—that the public could use the Omnipod 5 and Dexcom G6 CGMS devices “safely and without fear of sudden malfunction in ordinary uses.” The companies next claimed that an affidavit submitted by the clinic’s owner defeated the warranty count because it showed that “Cary Endocrine never designed, manufactured, inspected, marketed, sold or supplied the Omnipod 5 or Dexcom G6,” and it was decedent’s “health care provider, nothing more.” The court held that the affidavit only created a factual dispute as to one element of the claim, and it was not the role of this court to determine the “ultimate success” of a plaintiff’s claim upon the instant limited record.

Finally, the companies relied upon Boss v. Nissan N. Am., Inc., 228 F. App'x 331, 336 (4th Cir. 2007) for the proposition that “[w]hen the Defendants’ affidavits are undisputed by the Plaintiffs, the court cannot resolve the facts in the Plaintiffs’ favor based solely on the unsupported allegations in the Plaintiffs’ complaint.” However, the plaintiffs in Boss made no attempt to rebut the defendants’ affidavits while the estate here had made a specific and detailed attempt to rebut the supplier’s affidavit. Accordingly, all the challenges failed, the companies could not establish fraudulent joinder to defeat diversity jurisdiction, and remand was warranted.

Severance. The court considered whether dropping the clinic or severing its claims could salvage federal jurisdiction and noted that all claims arose from the decedent’s death and were brought against the suppliers and the clinic together because they were involved in the design, manufacture, marketing, or supply of the devices at issue. The companies attempted to distinguish the claims brought against Cary Endocrine from the product liability claims asserted against them, but express warranty claims were brought against each defendant and arose out of the use of the same products alleged to have caused the patient’s death. As such, maintaining the claims against all parties in one suit was warranted, and the court declined to sever the clinic. Although diversity jurisdiction was ultimately foreclosed, the suppliers presented objectively reasonable arguments in favor of maintaining jurisdiction as per Martin v. Franklin Capital Corp., 546 U.S. 132, 141 (2005). Accordingly, no award of remand costs under 28 U.S.C. § 1447(c) was made and each side was directed to bear its own costs and fees.

The case is No. 5:25-CV-519-FL.

Judge: Flanagan, L.

Attorneys: Genevieve Mary Zimmerman (Meshbesher & Spence Ltd.) for Kimberly Ann Sciandra. Kirk G. Warner (Smith, Anderson, Blount, Dorsett, Mitchell & Jernigan, LLP) for Insulet Corp. and US Med, LLC. Claude Rob Wilson (Hedrick Gardner Kincheloe & Garofalo, LLP) for Dexcom, Inc. Elizabeth Pharr McCullough (Hall Booth Smith, P.C.) for Cary Endocrine & Diabetes Center, P.A.

Companies: Insulet Corp.; Dexcom, Inc.

Cases: CourtDecisions JurisdictionNews MedicalDevicesNews NorthCarolinaNews