Key Takeaways
What Happened: The U.S. Department of Justice (DOJ) issued its first department-wide Corporate Enforcement and Voluntary Self-Disclosure Policy for corporate criminal matters. Within days, DOJ applied it to decline prosecution of the French medical device company Balt SAS and its U.S. subsidiary Balt USA in an FCPA bribery matter, while simultaneously indicting two individuals. The declination letter gives companies their first concrete look at what the new framework requires in practice.
Who’s Impacted: Companies confronting potential criminal exposure, especially those managing internal investigations, whistleblower reports, parallel regulatory inquiries, or possible disclosures to more than one DOJ component.
What Should They Consider Doing in Response: Update disclosure and investigation playbooks now. Companies should identify who decides whether to self-disclose, how quickly that decision reaches management, which DOJ component should receive a disclosure, how the company will preserve and produce any overseas evidence, and how it will gather facts about individual conduct while remediation is underway.
By When Should They Act: The policy rewards early disclosure, but not every allegation warrants such disclosure. Companies should evaluate whether disclosure is required or would be beneficial. However, especially where the risk of independent discovery is real, the policy’s timing incentives are worth taking seriously. Companies can still seek a declination if they report within 120 days after receiving an internal whistleblower report, even if the whistleblower has already gone to DOJ. These new directives eliminate the prior “Race to DOJ” dynamic for self-disclosures, which mandated that a company would only get full credit if they were the first to alert DOJ.
But Even a Declination Still Has Consequences: Even though Balt obtained a declination, the government still ordered the entity to disgorge $1.2 million in profits. Importantly, Balt avoided penalties and monitorships that are often required even in non-prosecution agreements or deferred prosecution agreements.
In March 2026, DOJ released its first department-wide Corporate Enforcement and Voluntary Self-Disclosure Policy for corporate criminal matters, superseding nearly all preexisting component-specific (excluding antitrust) and USAO-specific corporate enforcement policies. Shortly thereafter, DOJ published the first public example—here involving French medical device company Balt SAS and its U.S. subsidiary, Balt USA LLC—of what corporate conduct and disclosures the Department believes to be sufficient to support a declination to prosecute.
Between roughly 2017 and 2023, Balt allegedly paid about $602,000 in bribes—disguised as consulting fees and bonuses routed through a third-party consultant—to a senior physician at a French state-owned hospital to steer purchases of Balt’s endovascular embolization coils and related products. Balt self-disclosed the scheme to DOJ while its internal investigation was still underway, cooperated with the federal investigation, and took remedial action, including disciplining employees and terminating the business relationships that gave rise to the misconduct. DOJ then issued a declination letter under the new policy. Balt was still required to disgorge roughly $1.2 million, two individuals—a former Balt USA executive and the consultant—were indicted, and Balt entered into a coordinated resolution in France that includes a three-year compliance program supervised by the Agence Française Anticorruption.
The Balt outcome—a “Part I” declination, the most favorable resolution available under the new policy—turned on the company’s early disclosure, detailed cooperation, credible remediation, and the absence of aggravating circumstances. Even so, Balt faced disgorgement, ongoing cooperation obligations, individual prosecutions of associated personnel, and parallel enforcement abroad. A declination is not an acquittal, and it is not free.
Five Practical Lessons from the Balt Resolution
- DOJ Expects Companies to Report Before the Internal Investigation is Finished
The declination letter states that Balt disclosed misconduct discovered during an internal investigation that was still ongoing when the company self-reported. Companies that wait for a polished final report may wait too long to preserve the strongest available credit. This is especially true in whistleblower situations: the policy allows companies to seek a declination if they report to DOJ within 120 days after receiving an internal whistleblower report, even if the whistleblower has already contacted DOJ independently.
- Cooperation Means More Than Answering Questions
Balt reportedly received declination credit not only for self-disclosure, but also for full and proactive cooperation, including providing known relevant facts about the misconduct and the individuals involved, and agreeing to continue cooperating in ongoing investigations and prosecutions. Companies should expect DOJ to assess whether cooperation was fast, specific, and genuinely useful.
- Remediation Must Be Concrete and Credible
DOJ pointed to Balt’s disciplinary actions, termination of business relationships tied to the misconduct, tailored compliance training for senior management, and improvements to compliance controls as support for the declination. DOJ did not impose an independent compliance monitor, crediting the compliance oversight that would be imposed under the parallel French resolution. The takeaway: revised policies on paper are not enough. DOJ will look for action against the people involved, structural fixes, and evidence that the company addressed the root cause, and companies with credible compliance infrastructure may avoid a monitor.
- A Corporate Declination Still Comes with Real Cost
Balt agreed to disgorge over $1.2 million in profits and to continue cooperating with DOJ as the Department pursued indictments against individuals associated with the alleged conduct. Balt also entered into a coordinated resolution with France’s Parquet National Financier (National Financial Prosecutor), which included an additional fine and a three-year compliance program supervised by the Agence Française Anticorruption (French Anticorruption Agency). The French fine was calibrated to credit the U.S. disgorgement and avoid duplicative punishment, but the combined financial and operational cost was still substantial. Companies operating across borders should expect that a declination in the U.S. will not insulate them from enforcement abroad.
- Declination for the Company Does Not End Individual Exposure
DOJ announced the Balt declination alongside the indictments of a former Balt USA executive and a consultant for their alleged roles in the bribery scheme. The declination letter expressly states that it protects no individuals from prosecution. Companies should expect DOJ to continue treating individual accountability as a central part of the bargain. That makes early fact development about relevant employees, officers, agents, and third parties critical to any disclosure strategy.
What Companies Should Do Now
DOJ’s new corporate enforcement policy rewards preparation. Companies that have not yet stress-tested their disclosure and investigation protocols should assume that the next credible allegation will force a decision faster than they expect. Uncertainty about the facts, venue, or process will not excuse delay if DOJ later concludes the company could have come forward sooner.
- Refresh whistleblower intake and escalation protocols so legal, compliance, and executive-level decision-makers receive credible allegations quickly.
- Decide in advance who will analyze disclosure routing when criminal and regulatory issues overlap.
- Build a response plan that can run an internal investigation and a self-disclosure analysis at the same time.
- Preserve and map sources of evidence early, including personal-device communications and records held by third parties.
- Prepare to identify relevant individuals, disciplinary decisions, and remedial actions in a form DOJ can evaluate quickly.
- Document why the company acted when it did, especially if it chooses to disclose before the facts are fully developed.
The Balt resolution is the first public data point for DOJ’s application of the new department-wide policy. Until DOJ publishes more declinations or, just as informatively, declines to grant one, this is the best available benchmark for what the Department expects from companies that want to avoid prosecution.
Christopher M. Bolte contributed to this article
