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Ortho-McNeil Pharmaceutical (now operating under Janssen Pharmaceuticals) was a pharmaceutical company based in Raritan, New Jersey, that was formed from the merger of Ortho Pharmaceutical and McNeil Pharmaceutical in 1993. These pharmaceutical companies were pioneers and leaders in areas such as pain management, acid reflux disease, and infectious diseases.

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.

Products

Amongst its many prescription drugs are:

• Ortho Tri-cyclen
• Ortho-Evra
• Doribax
• Elmiron
• Levaquin
• Ultram ER
• Aciphex
• Concerta

Lawsuits

Topamax

False claims federal case

In 2010, Ortho-McNeil pled guilty in U.S. District Court to one count of misdemeanor violation of the Food, Drug & Cosmetic Act for illegally promoting its epilepsy drug Topamax for uses that were not approved by the FDA. 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. The company was sentenced to pay a fine of $6.14 million.

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.

Civil lawsuits

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. The jury found that they negligently failed to warn the patients and their doctors of the risks associated with Topamax when used by patients during pregnancy. They awarded $11 million in damages to one family and $4 million to the other.

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.

See also

• Biotech and pharmaceutical companies in the New York metropolitan area
• Cilag
• Janssen Pharmaceutica

References

1. "Ortho-McNeil Pharmaceutical LLC". Synapse. 11 July 2024. Retrieved 3 September 2024.
2. "Our Company". ortho-mcneil.com. Archived from the original on 5 June 2011. Retrieved 3 September 2024.
3. "PriCara, Ortho-McNeil now named Janssen Pharmaceuticals". Managed Healthcare Executive. 5 August 2011. Retrieved 3 September 2024.
4. ^ "Ortho-McNeil Pharmaceutical, LLC Pleads Guilty to Illegal Promotion of Topamax and is Sentenced to Criminal Fine of $6.14 Million". justice.gov. 21 May 2010. Retrieved 3 September 2024.
5. ^ Miller, Emily (16 May 2024). "Topamax Lawsuits". drugwatch.com. Retrieved 3 September 2024.
6. Pearson, Sophia (18 November 2013). "J&J's Janssen Loses $11 Million Jury Verdict Over Topamax". Bloomberg. Retrieved 3 September 2024.

External links

• Official website

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