Several states, including Washington, Wisconsin and Ohio, are set to receive a portion of a settlement totaling more than $81 million paid by two pharmaceutical subsidiaries of Johnson & Johnson to resolve allegations surrounding its illegal promotion of its epilepsy drug Topamax, according to a DOJ news release.
Johnson & Johnson's subsidiary Ortho-McNeil Pharmaceutical has agreed to pay $6.14 million for misbranding Topamax in violation of the Food, Drug and Cosmetic Act. The FDA had approved Topamax as an anti-epileptic drug but not as a treatment for psychiatric use. Despite this, Ortho-McNeil promoted Topamax as a treatment for unapproved psychiatric uses, or "off-label" uses, through its "Doctor-for-a-Day" program. For this program, Ortho-McNeil hired physicians to join their sales representatives in promoting Topamax for unapproved uses and doses to other healthcare providers, according to the news release.
Ortho-McNeil-Janssen Pharmaceuticals, Johnson & Johnson's other pharmaceutical subsidiary, has agreed to pay $75.37 million to resolve allegations under the False Claims Act that it illegally promoted Topamax, causing false claims to be billed to government healthcare programs for unapproved psychiatric uses. The government will receive $50.69 million of the share, while state Medicaid programs will receive $24.68 million, according to the news release.
The investigation against the pharmaceutical companies stem from two lawsuits filed by three whistleblowers under the qui tam, or whistleblower, provisions of the False Claims Act, which allows private citizens with knowledge of fraud to bring actions on behalf of the United States and share in any recovery. The whistleblowers will receive payments totaling more than $9 million from the settlement, according to the news release.
Read the DOJ news release about Ortho-McNeil and Ortho-McNeil-Janssen Pharmaceuticals' settlement.
Read other coverage about pharmaceutical company settlements:
- New Jersey Pharmaceutical Company Settle Medicaid Fraud Allegations for $2M
- Forest Pharmaceuticals to Pay $313M to Settle Criminal and Civil Charges, Including Paying Kickbacks to Physicians
- Pharmaceutical Company to Pay $27M for Medicaid Fraud
Johnson & Johnson's subsidiary Ortho-McNeil Pharmaceutical has agreed to pay $6.14 million for misbranding Topamax in violation of the Food, Drug and Cosmetic Act. The FDA had approved Topamax as an anti-epileptic drug but not as a treatment for psychiatric use. Despite this, Ortho-McNeil promoted Topamax as a treatment for unapproved psychiatric uses, or "off-label" uses, through its "Doctor-for-a-Day" program. For this program, Ortho-McNeil hired physicians to join their sales representatives in promoting Topamax for unapproved uses and doses to other healthcare providers, according to the news release.
Ortho-McNeil-Janssen Pharmaceuticals, Johnson & Johnson's other pharmaceutical subsidiary, has agreed to pay $75.37 million to resolve allegations under the False Claims Act that it illegally promoted Topamax, causing false claims to be billed to government healthcare programs for unapproved psychiatric uses. The government will receive $50.69 million of the share, while state Medicaid programs will receive $24.68 million, according to the news release.
The investigation against the pharmaceutical companies stem from two lawsuits filed by three whistleblowers under the qui tam, or whistleblower, provisions of the False Claims Act, which allows private citizens with knowledge of fraud to bring actions on behalf of the United States and share in any recovery. The whistleblowers will receive payments totaling more than $9 million from the settlement, according to the news release.
Read the DOJ news release about Ortho-McNeil and Ortho-McNeil-Janssen Pharmaceuticals' settlement.
Read other coverage about pharmaceutical company settlements:
- New Jersey Pharmaceutical Company Settle Medicaid Fraud Allegations for $2M
- Forest Pharmaceuticals to Pay $313M to Settle Criminal and Civil Charges, Including Paying Kickbacks to Physicians
- Pharmaceutical Company to Pay $27M for Medicaid Fraud