The action concerned alleged breaches of fiduciary duty by certain current and former officers and directors of Vanda Pharmaceuticals Inc. (“Vanda”) relating to the purported off-label promotion of Vanda’s two commercially-available drugs: Fanapt®, which is FDA-approved to treat schizophrenia in adults, and Hetlioz®, which is FDA-approved to treat Non-24-Hour Sleep-Wake Disorder (“Non-24”), a circadian rhythm disorder, as well as (2) the FDA’s imposition of a partial clinical hold on clinical trials for tradipitant, a drug in Vanda’s development pipeline.
Hynes & Hernandez, LLC was part of the litigation team that negotiated a settlement conferring substantial benefits on Vanda. The terms of the settlement included the creation of a management-level Disclosure Committee and the adoption of a charter outlining the Committee’s membership, the responsibilities and duties of its members, and its annual training. In addition, Vanda’s General Counsel and Head of Compliance were required to undertake together a comprehensive review of Vanda’s policies to ensure that such policies are consistent with current laws and regulations, and appropriate in scope with respect to Vanda’s operations and risks. The Company’s decision to implement and maintain the reforms led to improved policies and procedures relating to all of Vanda’s most important processes and improved transparency.