Off Label Use of Topamax
The FDA first approved Topamax to treat epilepsy in 1996, and it is used either by itself or with other medications to treat a variety of forms of epilepsy, including:
- Simple partial seizures
- Complex partial seizures
- Generalized tonic-clonic seizures
- Lennox-Gastaut syndrome
However, there were many doctors prescribing Topamax off-label to treat the following:
- Bipolar disorder
- Cluster headaches
- Weight loss
Johnson & Johnson agreed to pay $6.14 million in criminal fines and $75.37 million in civil penalties to settle off-label promotion claims brought by the Department of Justice in April of 2010. The Department of Justice alleged that J&J promoted the sale of Topamax for off-label psychiatric uses through a practice known as the ‘Doctor-for-a-Day” program.
What is the “Doctor-for-a-Day” Program?
J&J hired outside physicians to join the sales representatives in his/her office visits to health care providers to speak at meetings and other functions about prescribing Topamax for unapproved uses and unapproved doses. This practice was known as the “Doctor-for-a-Day” program.
Ortho-McNeil-Janssen Pharmaceuticals (a division of Johnson & Johnson), has since agreed to enter into a corporate integrity agreement with the Department of Health & Human Services’ Office of Inspector General. This agreement will enable procedures and reviews to be enacted to avoid and promptly detect similar future conduct.
The criminal case was handled by the Justice Department’s Civil Division and the U.S. Attorney’s Office for the District of Massachusetts. The civil lawsuit was handled in conjunction with the National Association of Medicaid Fraud Control Units and various offices of state Attorney Generals. The Corporate Integrity Agreement was negotiated by the Office of Inspector General of the Department of Health and Human Services.
If you were prescribed Topamax for one its off-label, unapproved uses and/or doses, call one of our Topamax lawyers to discuss your potential case.