A lawsuit was filed on behalf of investors in Medtronic plc (NYSE: MDT) shares over alleged securities laws violations.
San Diego, CA -- (SBWIRE) -- 09/19/2022 -- An investor, who purchased shares of Medtronic plc (NYSE: MDT), filed a lawsuit over alleged Securities Laws violations by Medtronic plc.
Investors who purchased shares of Medtronic plc (NYSE: MDT) have certain options and for certain investors are short and strict deadlines running. Deadline: November 7, 2022. NYSE: MDT investors should contact the Shareholders Foundation at email@example.com or call +1(858) 779 - 1554.
Ireland based Medtronic plc develops, manufactures, and sells device-based medical therapies to healthcare systems, physicians, clinicians, and patients worldwide. Among its products is the MiniMed insulin pump system for the treatment of diabetes. The systems include the MiniMed 600 series models and the MiniMed 780G model. Medtronic plc is currently seeking regulatory approval for the MiniMed 780G model, which uses an advanced hybrid closed loop system. Between June 8, 2019 and May 25, 2022, Medtronic plc repeatedly assured investors that the MiniMed 780G model was "on track" for approval by the U.S. Food and Drug Administration ("FDA") and would provide Medtronic with the edge it needed to close a growing gap with its competitors in the diabetes market.
In November 2019, Medtronic plc issued a warning that certain MiniMed 600 series insulin pumps might have damaged pump retainer rings, which could cause the system to release too much insulin, and instructed customers with damaged rings to contact the company for replacements.
On February 7, 2020, the FDA classified Medtronic's November 2019 notification as a Class I recall—the most serious type of recall.
Problems with the MiniMed 600 series mushroomed in October 2021, when the company expanded its recall to all MiniMed model 630G and 670G insulin pump systems—whether or not any retainer ring damage was actually visible. Despite these serious issues with the 600 series, Medtronic assured investors that they expected the MiniMed 780G "to drive growth." Consistent with these optimistic statements, Medtronic plc again assured investors that FDA approval of the MiniMed 780G was imminent.
Then on December 15, 2021, Medtronic plc revealed that it had received a warning letter from the FDA regarding its Northridge, California facility (the "Warning Letter"). The Warning Letter followed an FDA inspection relating to the company's MiniMed 600 series recall, and focused on "the inadequacy of specific medical device quality system requirements . . . in the areas of risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events."
As a result of the Warning Letter—including the resulting uncertainty about FDA approval of the MiniMed 780G and other products in Medtronic's diabetes operating unit, the Diabetes Group, Medtronic lowered its guidance for its Diabetes Group, now projecting that Diabetes Group product revenues would decline in the mid-single digit range for fiscal year 2022.
On May 26, 2022, Medtronic plc reported its financial results for the fourth quarter and full fiscal year 2022, and provided guidance for fiscal year 2023. Notably, Medtronic disclosed that as a result of the company's need to improve its quality control system and its expectation that the MiniMed 780G model—which Defendants had repeatedly identified as crucial to future growth—would not be approved in 2023, the company expected revenues from its Diabetes Group to decline between 6% and 7% in fiscal year 2023.
The plaintiff claims that between June 8, 2019, and May 25, 2022, he Defendants made materially false and/or misleading statements, as well as failed to disclose material adverse facts, about the company's business and operations by failing to disclose that Medtronic plc's product quality control systems were inadequate, that Medtronic had failed to comply with numerous regulations regarding risk assessment, corrective and preventive action, complaint handling, device recalls, and reporting of adverse events, that these failures increased the risk of regulatory investigation and action, that as a result of the company's misconduct, the FDA would delay the approval of additional Medtronic MiniMed devices, including the MiniMed 780G, that these delays in product approvals, as well as the company's need to improve its quality control systems, would negatively affect Medtronic's financial performance and cause it to fall further behind its competitors, and that as a result of the foregoing, Defendants' statements about the company's business, operations, and prospects lacked a reasonable basis.
Those who purchased shares of Medtronic plc (NYSE: MDT) have certain options and should contact the Shareholders Foundation.
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