After multiple whistleblower lawsuits were filed against Johnson & Johnson subsidiaries over the epilepsy drug Topamax alleging that the drug makers illegally marketed and promoted the pills’ off-label uses, the DOJ had agreed to a settlement worth $81 million.
The lawsuits were filed against Ortho-McNeil Pharmaceutical LLC and Ortho-McNeil-Janssen Pharmaceuticals. The companies have decidedly admitted to promoting off-label uses for the anti-seizure medication Topamax between 2001 and 2003. Under the terms of the settlement, Ortho-McNeil is going to plead guilty to a criminal misdemeanor violation and cough up $6.1 million in fines. But the big story is that Ortho-McNeil-Janssen Pharmaceuticals has agreed to pay more than $75 million.
Topamax was originally approved as an anti-seizure medication for epileptics, but some of the off-label uses that were not approved by the FDA included treatment for migraines and psychiatric conditions. As part of the drug makers’ promotion efforts, the company had outside physicians accompany sales representatives during health care provider visits where the reps discussed prescribing Topamax for psychiatric conditions. They also did so during meetings and dinners with doctors. Eventually, the illegal off-label promotions were brought to the attention of the federal government after two whistleblower lawsuits were filed under the False Claims Act. The resulting settlement compensated the whistleblowers for more than $9 million.
Topamax has been linked to an increased risk of suicide and suicidal thoughts, as well as birth defects in women whose babies are exposed to the drug in-utero. Some of those birth defects linked to Topamax use during pregnancy include cleft lips, cleft palates, genital defects and other birth malformations.
If your baby was born with birth defects after in-utero exposure to Topamax, contact attorney Greg Jones today for a free consultation. I am experienced at fighting Topamax lawsuits and may be able to help you recover money for your child’s injuries.
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