Attorney General Jack Conway announced that Kentucky will participate in a $75.3 million settlement with Ortho-McNeil-Janssen Pharmaceuticals, Inc., a subsidiary of global pharmaceutical manufacturer Johnson & Johnson over allegations that the company illegally and improperly marketed the anti-seizure drug Topomax.
According to Conway’s Office, the settlement resolves claims brought by the federal government and participating states’ attorneys general that the company knowingly engaged in a scheme to market Topomax for uses that had not been approved by the federal Food and Drug Administration (FDA). The FDA only approved Topomax for use in treating epileptic seizures and to prevent migraine headaches. Despite the limited approvals, the company marketed Topomax to physicians for use in the treatment of a variety of other unapproved psychiatric conditions, including bipolar disorder and drug and alcohol dependency.
Ortho-McNeil-Janssen pleaded guilty to the criminal charge of distribution of a misbranded product and entered into an agreement to ensure that there are no future violations in the marketing of Topomax by the company.
Kentucky’s state and federal portion is $1.9 million.