Topamax Settlement Will Cost $81 Million
Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals, subsidiaries of Johnson & Johnson, will pay $81 million in federal settlement charges regarding the illegal marketing of Topamax.
Made by Ortho-McNeil Neurologics, a division of Johnson & Johnson, the drug was originally approved for epilepsy in adults and children, but in 2004, the approved uses for Topamax expanded to include migraine headache prevention.
The U.S. Justice Department settlement resolved lawsuits filed in 2003 and 2004 under the False Claims Act, which allows citizens aware of fraud to sue on behalf of the government and share in the recovery. The companies were accused of marketing Topamax for unapproved psychiatric uses. The government said that Ortho-McNeil Pharmaceutical hired physicians through its “Doctor-for-a-Day” program to assist sales representatives when visiting doctors and speaking to colleagues about unapproved uses and doses.
According to Ortho-McNeil-Janssen’s statement, Ortho-McNeil Pharmaceutical will admit that from 2001 to 2003 it promoted Topamax “for certain uses not approved” by the FDA. The declaration said the “Doctor-for-a-Day” program was voluntarily stopped before the company received the government’s initial subpoena in the investigation.
Under the agreement terms, Ortho-McNeil Pharmaceutical LLC agreed to plead guilty to a misdemeanor and pay a $6.14 million criminal fine for misbranding the drug. Ortho-McNeil-Janssen Pharmaceuticals will also pay $75.37 million to settle civil allegations that it illegally marketed Topamax and submitted false claims to government health programs. Additionally, Ortho-McNeil-Janssen will sign a five-year corporate integrity agreement with the U.S. Health and Human Services Department.
Under the civil settlement, the federal government will receive $50.69 million, state Medicaid programs will share $24.68 million and three whistleblowers will pocket more than $9 million.
Posted on Friday, April 30th, 2010 at 5:41 pm under 