Insights

Washington – June 6, 2024: Crowell & Moring earned 78 rankings for 67 lawyers, as well as 41 national and statewide practice area rankings, in the Chambers USA 2024 guide. The rankings are driven by independent interviews of clients and lawyers at peer firms.

On July 31, 2025, the Department of Justice (DOJ) announced that Illumina, Inc. will pay $9.8 million to resolve allegations that it violated the False Claims Act (FCA) by selling genomic sequencing systems with software containing cybersecurity vulnerabilities to federal agencies. This is the first FCA settlement involving claims that a medical manufacturer failed to incorporate adequate product cybersecurity into its software design and development.The allegations were first made in United States ex rel. Lenore v. Illumina Inc., No. 1:23-cv-00372 (D.R.I.), a qui tam action filed by Illumina’s former Director for Platform Management, On-Market Portfolio in September 2023. The relator alleged that, between February 2016 and September 2023, Illumina knowingly sold genomic sequencing systems to government agencies without adequate security programs or quality systems to identify and address software vulnerabilities. The complaint further alleged that Illumina failed to properly resource personnel and processes responsible for product security, did not remediate design features introducing cybersecurity risks, and misrepresented the software’s adherence to required cybersecurity standards.According to the government, Illumina’s actions included:

On July 25, 2025, the Eleventh Circuit Court of Appeals issued its decision in United States ex. rel. Sedona Partners LLC v. Able Moving & Storage Inc. et al., holding that a district court cannot ignore new factual allegations included in an amended complaint filed by a False Claims Act qui tam relator based on the fact that those additional facts were learned in discovery, even while a motion to dismiss for failure to comply with the heightened pleading standard under Federal Rule of Civil Procedure 9(b) is pending.  Under Rule 9(b), allegations of fraud typically must include factual support showing the who, what, where, why, and how of the fraud to survive a defendant’s motion to dismiss.  And while that standard has not changed, Sedona gives room for a relator to file first and seek out discovery in order to amend an otherwise deficient complaint and survive a motion to dismiss, at least in the Eleventh Circuit.  Importantly, however, the Eleventh Circuit clarified that a district court retains the discretion to dismiss a relator’s complaint before or after discovery has begun, meaning that district courts are not required to permit discovery at the pleading stage.  Nevertheless, the Sedona decision is an about-face from precedent in the Eleventh Circuit, and many other circuits, where, historically, facts learned during discovery could not be used to circumvent Rule 9(b) by bolstering a relator’s factual allegations while a motion to dismiss was pending.  While the long-term effects of the decision remain to be seen, in the short term the decision may encourage relators to engage in early discovery in hopes of learning facts that they can use to survive otherwise meritorious motions to dismiss.

On June 23, 2025, the Ninth Circuit issued a long-awaited decision in Island Industries Inc. v. Sigma Corp. affirming a $26M False Claims Act (“FCA”) judgment against the defendant importer.  Sigma had appealed the judgment after a jury found the company violated the FCA by failing to pay customs duties owed to U.S. Customs and Border Protection (“CBP”).  The Ninth Circuit’s decision addresses an important jurisdictional issue and illustrates the significant financial exposure importers can face under the FCA at a time of increased tariffs and enforcement by the government.  

Crowell & Moring is pleased to announce the launch of our Government Contracts Breakfast Series. All of the sessions will be held in Northern Virginia and focus on issues most important to government contractors. Our January session is described below. When performing government contracts, contractors frequently experience performance challenges such as delays; increased performance costs attributable to government action; costs resulting from government-initiated contract termination; and costs of remediating certain environmental pollution and toxic tort litigation. Each of these add time or additional expense for which the government may have a legal obligation to pay. Join us as we discuss the process of filings claims and REAs, including a discussion of formal and informal dispute resolution under government contracts. We will provide a CLE certificate of attendance and other materials to use in seeking continuing education credits. Registration begins at 8:00 am.

Crowell & Moring is pleased to announce the launch of our Government Contracts Breakfast Series. All of the sessions will be held in Northern Virginia and focus on issues most important to government contractors. Our second session is described below.

Government spending cuts will mean cuts to your bottom line.  In this time of budget sequestration and programmatic uncertainties, it is more important than ever for contractors to quickly recognize and effectively respond to potentially costly contract changes. Join us for a practical discussion as we guide participants through several types of constructive changes, addressing the critical role for front-line personnel in recognizing changes, methods to ensure notice requirements are met, maintenance of proper documentation, and the use of cross-disciplinary teams to ensure impacts are evaluated correctly.  We will examine the preparation of contract claims and requests for equitable adjustment, as well as techniques to preserve agency relationships while still protecting the company from unjust losses.

Small business regulations and requirements can be perilous for small businesses and large companies alike. From certifications related to small business subcontracting goals to eligibility for set-aside procurements, and much more, civil and even criminal liability looms for those who intentionally break the rules, with the False Claims Act providing treble damages that in some cases can be measured as the entire value of a contract. In this webinar we will discuss enforcement trends and pitfalls for both small and large businesses to guard against.

In this episode, Jason Crawford, Brian Tully McLaughlin, and Agustin Orozco explore the issues before the Supreme Court in two consolidated cases involving the False Claims Act. The hosts discuss the April 18 oral argument in Schutte/Proctor where the question before the Justices is whether a defendant’s subjective knowledge about whether its conduct was legal is relevant to whether it “knowingly” submitted false claims.

In this episode, hosts Michael Shaheen and Tully McLaughlin cover part one of a discussion about the Department of Justice’s authority to dismiss qui tam complaints brought by relators.  The podcast: (1) outlines the government’s authority under the statute and the caselaw; (2) discusses how the Department of Justice wields that authority; and (3) describes the false controversy between the Department and Senator Grassley on the scope of that authority. "Let's Talk FCA" is Crowell & Moring’s podcast covering the latest developments with the False Claims Act.

In this episode, host Mana Lombardo and partner Tully McLaughlin discuss the top FCA decisions and developments of 2020 and look ahead to what’s in store in 2021 and beyond. "Let's Talk FCA" is Crowell & Moring’s podcast covering the latest developments with the False Claims Act.