DOJ Settlement With Medical Technology Company Signals Expanding Cybersecurity FCA Risk for Life Sciences Companies

Lexology August 7, 2025
Skadden Arps Slate Meagher & Flom LLP

Executive Summary

• What is new: DOJ announced a $9.8 million FCA settlement with Illumina Inc. to resolve claims arising out of alleged cybersecurity deficiencies in DNA sequencing systems Illumina sold to government agencies.
• Why it matters: The case underscores that in addition to traditional FDA enforcement risk, cybersecurity failures may expose medical device manufacturers to increasing FCA risk.
• What to do next: Companies should proactively assess and address cybersecurity vulnerabilities, ensure the accuracy of their cybersecurity compliance representations, and stay abreast of evolving regulatory expectations to mitigate potential liability.

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On July 31, 2025, the Department of Justice (DOJ) announced a $9.8 million settlement with Illumina Inc., a leading manufacturer of DNA sequencing systems, to resolve potential False...

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