The False Claims Act (also known as the qui tam whistleblower statute) is another mechanism used more and more often in recent years by private plaintiffs and federal and state governments to seek civil recoveries and extensive penalties from companies who receive compensation of any kind from either the federal or state government.  Shook attorneys are well-versed in the very extensive body of jurisprudence that accompanies these statutes, and counsel their clients in the very best means of defense.

Representative Matters

  • Served as co-counsel for a Fortune 500 company, with shared responsibilities for all litigation matters, in an FCA case filed in the Eastern District of Pennsylvania, alleging that our client (and its predecessor) engaged in improper sales and marketing practices related to a pharmaceutical product. The federal government (through a qui tam relator) alleged that our client improperly induced purchases of the drug through the payment of improper remuneration (grants, speaker's fees, entertainment) for eight years, resulting in increased Medicare payments.
  • Represented a manufacturer in a case where the government alleged that our client delivered out-of-specification product to fill U.S. military orders, and that such deliveries were fraudulent. Government investigated case on both criminal and civil bases.
  • Defended a client in a matter involving allegations that the distributor conspired with the manufacturer of a drug to market the “overfill” vials of a drug. The essential claim was that the distributor and manufacturer directed medical providers to bill for use of overfill product in drug vials, and thereby caused the provider to falsely certify compliance with government reimbursement programs and to violate the anti-kickback act. The case raised complex issues relating to government reimbursement programs, pricing of pharmaceuticals, regulatory approval and manufacture of drugs, and sales and marketing compliance. In a related action to the False Claims Act case, a consumer filed a class action alleging deceptive marketing of the pharmaceuticals relating to the use of overfill. After Shook filed a motion to dismiss, the plaintiff’s lawyer voluntarily dismissed the lawsuit.
  • Represented medical device manufacturer in a case where the federal government (through qui tam relator) alleged that medical device manufacturer improperly induced purchases of certain of its products through improper sales and marketing practices for ten years, resulting in increased payments by VA Healthcare, Tricare, and Medicare. Shook served as local counsel, with extensive pretrial discovery and pleading responsibilities, including the taking of current and former VA employee depositions and other healthcare professional depositions, as well as having significant involvement in developing and drafting motions to dismiss.