Month: May 2026
DOJ Targets Failure to Report Adverse Events: Lessons From the ExThera Enforcement Action
In March 2026, the US Department of Justice (DOJ) announced criminal charges against medical device company ExThera Medical Corporation and its former chief regulatory officer for allegedly concealing patient deaths associated with the company’s experimental blood filtration device. The case highlights a familiar, but often underappreciated, risk area for life […]
Featured in Law360: Key Tronic Case Shows SEC Isn’t Ignoring Controls Violations
Law360 recently published an article authored by Cooley attorneys Tejal Shah and Bingxin Wu analyzing a recent Securities and Exchange Commission (SEC) enforcement action against a public company for books and records and internal controls violations – the first nonfraud enforcement action brought against a public company during Chairman Paul […]