Item 3. Legal Proceedings
Item 3. Legal Proceedings
From time to time, we are subject to litigation and claims arising in the ordinary course of business.
In February 2021, we received notice and accepted service of a civil complaint that had been filed in the Western District of Texas and styled Carew ex rel. United States v. Senseonics, Inc., No. SA20CA0657DAE. The complaint was filed by a relator under seal in May 2020 pursuant to the qui tam provisions in the federal False Claims Act. Prior to the unsealing of the complaint, the government declined to intervene in the case. The case, therefore, is being pursued only by the relator. The complaint alleges the Company’s marketing practices with physicians for its product, Eversense CGM system, violated the False Claims Act, 31 U.S.C. § 3729 and the Texas Medicaid Fraud Prevention Law, Tex. Hum Res. Code § 36.002. Outside counsel, on behalf of the Company, has filed a motion to dismiss the action for failure to state a claim. The motion is currently pending before the court.
In February 2021, in compliance with the data breach notification obligations laid out in the GDPR, the Company notified the Italian Data Protection Authority, or the Garante, of an unintended disclosure of certain user e-mail addresses to other users in Italy. Subsequent to this notification, the Company engaged in communications with the Garante concerning additional details about the data breach and other GDPR-related obligations of the Company. In January 2022, the Garante informed the Company of its determination that certain violations of the GDPR had occurred,
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and invited the Company to submit defensive arguments. In February 2022, the Company filed a brief with the Garante setting forth its defensive arguments to the alleged violations. The Company’s brief is pending before the Garante and the Company expects a decision from the Garante in the second quarter of 2022.
Except as described above, we are not currently a party to any material legal proceedings, and we are not aware of any pending or threatened legal proceeding against us that we believe could have a material adverse effect on our business, operating results or financial condition.
Item 4. Mine Safety Disclosures
Not applicable.
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.