San Diego, CA – [Date] — Biotechnology company Illumina Inc. has agreed to pay $9.8 million to settle a landmark cybersecurity qui tam lawsuit brought under the False Claims Act, the U.S. Department of Justice announced. The resolution addresses allegations that Illumina violated federal cybersecurity requirements related to medical devices used in research and clinical settings.
The lawsuit was originally filed in September 2023 by whistleblower Erica A. Lenore, a former employee of Illumina. Lenore alleged that the company failed to incorporate sufficient cybersecurity measures into its software and systems, misrepresenting compliance with FDA standards from February 2016 to September 2023. The government intervened in the case earlier this month.
According to the complaint, Illumina’s software design, development, and marketing practices left critical vulnerabilities unaddressed and lacked adequate security protocols. While no confirmed breaches were reported, the DOJ alleged that the vulnerabilities themselves, along with systemic failures to identify and remediate them, were grounds for False Claims Act liability.
As part of the settlement, Lenore will receive $1.9 million of the total amount. The agreement also includes $4.3 million in restitution, with interest accruing at 4.33% beginning March 6, 2025, until full payment is made.
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