The Food and Drug Administration (FDA) repeatedly issued warnings to the diagnostic division of Abbott Laboratories (Abbott Labs) (defendant). Abbott Labs had filed an annual Securities and Exchange Commission (SEC) 10-K report on March 9, 1999, detailing the corporation’s financial status. On March 17, 1999, the FDA sent Abbott Labs a letter that threatened severe consequences if Abbott Labs did not comply with regulatory requirements. Subsequently, on September 29, 1999, Abbott Labs issued a public statement explaining the FDA’s arguments and indicating that Abbott Labs and the FDA were engaging in settlement discussions. Abbott Labs and the FDA reached an agreement on November 2, 1999, that required Abbott Labs to remove numerous products from the market and pay a large civil fine. Lena Gallagher (plaintiff), representing a class of investors, sued Abbott Labs, arguing that Abbott Labs had committed fraud by deferring the public revelation of information. The district court dismissed the complaint, and Gallagher appealed.