[2] Ortho-McNeil and Janssen Pharmaceuticals together composed the Ortho-McNeil-Janssen group within Johnson & Johnson before a decision to operate under the Janssen Pharmaceuticals name in 2011.

The company was charged with using a program called "Doctor for a Day" to promote Topamax to psychiatrists for treatment of mental health conditions, despite never applying for FDA approval of Topimax for any psychiatric indication.

[4] Ortho-McNeil's parent company, Johnson and Johnson, also paid $75.37 million to resolve civil allegations under the False Claims Act that it caused false claims to be submitted to government health care programs for a variety of psychiatric uses that were not FDA approved.

[4] Ortho-McNeil was found liable in two 2013 civil suits by women who gave birth to children with birth defects after taking Topamax while pregnant.

[5] As a result of these and other patient reports, the FDA ordered that a warning be added to the prescribing information for Topamax detailing the risk of birth defects such as cleft lip and cleft palate.