Ortho-McNeil Pharmaceutical
| Company type | Subsidiary |
|---|---|
| Industry | Pharmaceutical |
| Founded | 1993 |
| Headquarters | Raritan , United States |
| Products | Ortho Tri-cyclen, Ortho-Evra, Doribax, Elmiron, Levaquin, Ultram ER, Aciphex, Concerta, Topamax |
| Parent | Johnson & Johnson |
Ortho-McNeil Pharmaceutical was a pharmaceutical firm headquartered in Raritan, New Jersey, created through the 1993 merger of Ortho Pharmaceutical and McNeil Pharmaceutical. These entities were prominent in the fields of pain relief, treatment of acid reflux, and managing infectious diseases. Ortho-McNeil later became part of Janssen Pharmaceuticals.
Together with Janssen Pharmaceuticals, Ortho-McNeil formed the Ortho-McNeil-Janssen division within Johnson & Johnson. This structure remained until 2011, when all operations were unified under the Janssen brand.
Products
The company's portfolio featured several important prescription medications, including:
Federal false claims case
In 2010, Ortho-McNeil admitted guilt to a misdemeanor offense under the Food, Drug & Cosmetic Act due to improper promotion of its epilepsy medication Topamax for psychiatric uses not approved by the FDA. The company implemented a "Doctor for a Day" initiative aimed at psychiatrists without regulatory authorization for these purposes and incurred a penalty of $6.14 million.
Parent corporation Johnson & Johnson settled civil False Claims Act allegations concerning unapproved psychiatric marketing of Topamax by paying $75.37 million.
Civil litigation
In two separate civil trials in 2013, Ortho-McNeil was held responsible for birth defects associated with prenatal exposure to Topamax. The juries determined that the company failed to adequately inform patients and healthcare providers about these dangers, resulting in damage awards of $11 million and $4 million.
Subsequent to these verdicts and further adverse event reports, the FDA required an update to Topamax’s prescribing information to include warnings about birth defect risks such as cleft lip and palate.