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By: AboutLawsuits | Published: May 3rd, 2010
Following whistleblower lawsuits filed against Johnson & Johnson subsidiaries over illegal marketing and promotion for the epilepsy drug Topamax, the Justice Department has reached a settlement of $81 million with the drug makers.
Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals have admitted that they promoted Topamax between 2001 and 2003 for uses that were not approved by the FDA. Under the terms of the Topamax settlement, Ortho-McNeil Pharmaceutical will plead guilty to a criminal misdemeanor violation and pay a $6.1 million fine. Ortho-McNeil-Janssen Pharmaceuticals has agreed to pay more than $75 million.
Although Topamax was only approved for treatment of epilepsy and preventing headaches, the medication was promoted for unapproved psychiatric uses. The drug makers had outside physicians join sales representatives when they visited health care providers and spoke at meetings and dinners about prescribing Topamax for psychiatric uses that were not approved by the FDA as safe and effective.
The allegations were brought to the federal government’s attention after two individuals filed whistleblower lawsuits under the False Claims Act. As a result of the settlement, whistleblower compensation of more than $9 million will be paid to the individuals who brought the suits.
Topamax (topiramate) generated more than $2 billion in annual sales for Johnson & Johnson before a generic version became available last year. Side effects of Topamax have been linked to an increased risk of suicide and suicidal thoughts, which has been added to a black box warning for the medication and other epilepsy drugs. Research has also linked the use of the drug during pregnancy to a risk of Topamax birth defects, such as cleft lips, cleft palates, genital defects and other birth malformations.