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 and his counsel. 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. On March 31, 2022, the court granted the motion to dismiss the action without prejudice which allows the plaintiff 60 days to refile the complaint. On May 27, 2022, the plaintiff filed an amended complaint and on July 11, 2022, the Company filed a motion to dismiss the action for failure to state a claim. That motion was referred to a magistrate judge. On March 3, 2023, the magistrate judge agreed with Senseonics and recommended that the amended complaint be dismissed. That recommendation to dismiss is now pending before the district court. The parties have until March 31, 2023, to respond to any objections to the magistrate judge's report and recommendation.
66
In February 2021, in compliance with the security incident notification obligations laid out in the GDPR, the Company notified the Italian Data Protection Authority (“Garante”), of an unintended disclosure of certain user e-mail addresses to other users in Italy. Subsequent to this notification, the Company was able to settle the matter with the Garante. It is possible under the applicable process that the Garante may, in the future, follow up further regarding the Company’s corrective measures and overall GDPR compliance.
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.
PART II
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.