Omnipod Class Action Lawsuit Filed Over Recalled Insulin Delivery System

Investor alleges Insulet concealed manufacturing control problems that led to two Omnipod recalls involving millions of insulin delivery pods, which caused the company’s stock price to decline.

An Omnipod class action lawsuit has been filed on behalf of investors who allege Insulet Corporation made false and misleading statements before issuing recalls involving insulin delivery pods that could fail to provide users with enough insulin.

The complaint (PDF) was brought by Zhenjun Hu in the U.S. District Court for the District of Massachusetts on July 2, seeking class action status on behalf of investors who acquired Insulet securities between February 21, 2025, and May 26, 2026. The lawsuit names Insulet Corporation and several current and former executives as defendants, including CEO Ashley A. McEvoy and former CEO James R. Hollingshead.

Unlike product liability claims filed by patients who suffered injuries from defective insulin delivery devices, the lawsuit seeks compensation for investors who allegedly suffered financial losses after Insulet’s prior statements about its manufacturing controls and product quality were called into question by later corrective actions involving millions of Omnipod products.

Omnipod Insulin Delivery Problems

Insulet manufactures several wearable insulin delivery systems for individuals with diabetes, including Omnipod 5 and Omnipod DASH. The company also previously sold the original Omnipod Insulin Management System, commonly referred to as Omnipod Eros.

The devices use small wearable pods to deliver insulin without the need for traditional exterior tubing techniques. However, manufacturing defects can potentially interfere with insulin delivery, placing users at risk of dangerously high blood sugar levels and diabetic ketoacidosis.

In March 2026, Insulet announced a medical device correction involving certain lots of Omnipod 5 pods after discovering small tears could develop in internal tubing used to deliver insulin. The defect could allow insulin to leak inside the pod instead of entering the user’s body, potentially resulting in insulin under-delivery.

Hu indicates Insulet’s stock price fell $16.23 per share, or 6.88%, following the announcement, closing at $219.84 on March 13.

However, the complaint alleges Insulet continued to downplay the scope of the manufacturing problems, assuring customers and investors that other Omnipod products remained safe to use and indicating the defect affected only a small percentage of pods.

Omnipod Class Action Lawsuit Allegations

According to the Omnipod class action lawsuit, Insulet executives repeatedly assured investors before and after the March corrective action that the company maintained strong manufacturing processes, quality controls and product safety standards.

The complaint points to public statements made during earnings calls, regulatory filings and investor conferences that highlighted Insulet’s investments in automated manufacturing, product inspections and quality assurance systems.

However, Hu alleges those statements were false or misleading because Insulet failed to disclose deficiencies in its manufacturing controls that increased the risk of product defects, safety problems and regulatory actions.

The lawsuit claims Insulet continued making misleading statements following the March corrective action, including assurances that the manufacturing problem was limited in scope and that corrective measures had addressed the defect.

The complaint alleges the extent of the manufacturing problems became clearer on May 26, when Insulet announced another medical device correction involving specific lots of Omnipod 5, Omnipod DASH and Omnipod Eros pods.

Like the earlier action, the second Omnipod recall involved small tears in tubing that could allow insulin to leak instead of being delivered into the body.

However, the May corrective action involved about 7 million pods distributed in the United States and international markets, representing approximately 8.5% of Insulet’s global pod production during 2025.

Hu indicates Insulet subsequently acknowledged the March and May corrective actions both involved cannula tears associated with manufacturing processes at the company’s Acton, Massachusetts facility.

Following the second announcement, Insulet’s stock price declined another $7.79 per share, or 5.07%, closing at $146.01 on May 27.

The lawsuit alleges Insulet and its executives knew or recklessly disregarded information about the company’s manufacturing problems while making statements that artificially inflated the value of its securities. Hu also claims several company executives sold more than 21,000 shares of Insulet stock during the proposed class period, receiving more than $5.9 million in proceeds.

“Throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operations, and compliance policies.”

— Zhenjun Hu v. Insulet Corporation et al.

The Omnipod class action lawsuit seeks to represent investors who acquired Insulet securities during the proposed class period and suffered financial losses after information about the manufacturing problems became public.

The complaint raises claims under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5. It seeks damages for affected investors, as well as interest, attorneys’ fees and other costs.

Omnipod Recall Lawsuits

Following the expanded Omnipod recall, attorneys across the country are investigating potential Omnipod 5 lawsuits on behalf of diabetes patients who experienced serious injuries allegedly linked to insulin under-delivery.

Individuals who suffered complications after using an Omnipod 5 or other kind of Insulet pod may be eligible to seek compensation for medical costs, pain and suffering and other losses. Potential claims may involve injuries such as:

• Diabetic ketoacidosis (DKA)
• Hyperosmolar hyperglycemic state (HHS)
• Hospitalization
• Diabetic coma
• Other severe health problems

Consumers who believe they may qualify for an Omnipod 5 lawsuit can request a free case evaluation to have an attorney review their injury, explain available legal options and determine whether they may be eligible to pursue a claim.

Lawyers handling Omnipod cases work on a contingency fee basis, meaning there are no upfront legal costs and attorney fees are paid only if compensation is recovered.

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