Actions initiated by the U.S. Department of Justice and other regulatory agencies often involve parallel state and federal cases, third-party litigation and highly publicized speculation. To meet these challenges, Shook employs a comprehensive approach, combining defense expertise with effective compliance counseling, a robust discovery strategy, and an advanced public relations strategy. Our team also advises on preventive measures, which can circumvent expensive and potentially damaging litigation.

Government Investigations and Enforcement Litigation

  • Represented numerous companies responding to DOJ Antitrust or FTC investigations of alleged price-fixing, monopolization, or mergers.
  • Represented financial services provider in a Federal Trade Commission lawsuit that alleged violations of Section 5 of the FTC Act and the Restore Online Shoppers' Confidence Act arising out of the sale of online discount clubs.
  • Retained a by pharmaceutical manufacturer to assume responsibility for response to an ongoing criminal and civil investigation by the Department of Justice concerning alleged underpayments of Medicaid rebates. Shook's responsibilities included negotiating the scope of several subpoenas with the DOJ, producing documents and information in response to those negotiated subpoenas, preparing and producing current and former employees for both DOJ interviews and grand jury testimony, presenting internal investigation findings to the DOJ, and securing successful pre-complaint resolution of the matter.
  • Represented a pharmaceutical company in a DOJ Civil Division investigation that was the outgrowth of a civil case filed in the U.S. District Court for the District of New Jersey, which alleged that the company caused false claims for provider reimbursement to be submitted to state and federal health care programs. The DOJ investigation sought information regarding company practices regarding the payment of speaker's honoraria to individuals for speaking engagements, when such individuals may also be prescribing physicians. Shook's responsibilities again included negotiating scope of the subpoena with the DOJ, producing documents and information in response to the negotiated subpoena, and responding to follow-up inquiries from the DOJ. The DOJ ultimately took no action.
  • Retained by a pharmaceutical manufacturer to respond to an investigative subpoena served by the California Department of Insurance seeking the production of records dating back decades regarding a specific drug. The subpoena appeared to emanate from a whistleblower's assertion of violations of the California False Claims Act, with the subpoena then being a function of the state conducting an investigation to determine whether to intervene in the FCA action. Shook represented the client in negotiating a reduced scope of the subpoena, collecting and producing documents, and ultimately preparing and presenting to counsel representing the California Department of Insurance. The state took no further action following the presentation.
  • Represented a health information, technology and clinical research organization in criminal and civil investigations by DOJ. After negotiation and presentation to the government of written and document discovery responses, the matter resulted in a “no action” resolution with the government.
  • Represented a pharmaceutical company in connection with an investigation by DOJ regarding alleged improper drug promotions and physician remuneration.
  • Represented a pharmaceutical company in FTC suit for allegedly abusing the FDA citizen petition process through sham petitioning.
  • Represented a food import company in DOJ/NOAA investigation regarding potential violations of Endangered Species Act; Illegal, Unreported, and Unregulated Fishing Enforcement Act; and Food and Drug Act involving importation and labeling of products.
  • Produced and defended company witnesses for pharmaceutical manufacturers when questioned by AUSA on the issue of alleged off-label promotion. 
  • Represented a construction contractor in multiple DOT Office of Inspector General (OIG)  enforcement actions, including taking an exclusive role in responding to investigative subpoenas, whether issued by DOT OIG itself, or on behalf of DOT OIG by federal enforcement agencies.