False Claims Act - Examples

Examples

In 2010, a subsidiary of Johnson & Johnson agreed to pay over $81 million in civil and criminal penalties to resolve allegations in a FCA suit filed by two whistleblowers. The suit alleged that Ortho-McNeil-Janssen Pharmaceuticals, Inc. (OMJPI) acted improperly concerning the marketing, promotion and sale of the anti-convulsant drug Topamax. Specifically, the suit alleged that OMJPI "illegally marketed Topamax by, among other things, promoting the sale and use of Topamax for a variety of psychiatric conditions other than those for which its use was approved by the Food and Drug Administration, (i.e., "off-label" uses)." It also states that "certain of these uses were not medically-accepted indications for which State Medicaid programs provided coverage" and that as a result "OMJPI knowingly caused false or fraudulent claims for Topamax® to be submitted to, or caused purchase by, certain federally-funded healthcare programs.

Two qui tam lawsuits brought by whistleblowers (“Relators”) under the provisions of the Federal False Claims Act (FCA) has resulted in a significant recovery for taxpayers. The $22 Million state and federal recovery resolves the Relators allegations that Schwarz Pharma Inc. and its subsidiary Kremers Urban, LLC sold drugs to Medicaid that had never been approved by the Food and Drug Administration for safety and effectiveness as required by law. Pursuant to the settlement, the two whistleblowers will receive a total of $1,836,575 from the federal share and additional amounts from the states. The settlement resolves allegations against Schwarz in two separate multi-defendant whistleblower actions captioned United States ex rel. Constance Conrad v. Schwarz Pharma, et al., No. 02-11738-NG (D. Mass.), and United States ex rel. James Conrad v. Kremers Urban, et al., Civil No. 08-cv-428 (S.D. Tex.).