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Illegal Topamax Promotions Lead to Guilty Plea by Ortho-McNeil

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Ortho-McNeil Pharmaceutical LLC, a division of Johnson & Johnson, has plead guilty to charges that it illegally promoted off-label uses for the epilepsy drug, Topamax, and agreed to pay a $6.1 million fine. 

On Monday, in U.S. District Court in Boston, the drug maker admitted that it used its “Doctor for a Day” program, paying doctors thousands of dollars to travel with salespersons to psychiatrist offices, to promote Topamax for uses that were not approved by the FDA as safe and effective. In addition to the fine, the company agreed to sign a corporate responsibility agreement which is supposed to restrict them from future wrongdoing.

The criminal fine was part of a Topamax settlement agreement reached by the drug maker and an affiliate, Ortho-McNeil-Janssen Pharmaceuticals, Inc., with the Department of Justice earlier this month. Janssen has reached a civil settlement that will require it to pay $75.37 million to resolve whistleblower lawsuits that brought the “Doctor for a Day” program to light.

The allegations were brought to the federal government’s attention after two individuals filed qui tam 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.

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.

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.

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3 comments

  1. Eric Reply

    If the company has already been found guilty and admitted liability, why aren’t there any class action lawsuits for patients that suffered terrible side effects from the improper prescribing of this drug due to fraudulent actions by the manufacturer? The only class actions that I can find are for birth defects and blindness. What about patients that now suffer from aphasia due to topamax? If there are any class actions lawsuits that are being filed, or are in process, please put them online so that other victims can join them.

  2. rebecca Reply

    I recently began Topamax for migraine prophylaxis. After i week of 25mg daily, i increased to 50mg. The next day I had severe blurred vision. I went to opthamalogist and was diagnosed with glaucoma due to Topamax. I was given several eye drops and strong steroids and diuretics to save my vision without surgery. I have suffered horrible headaches, nausea and vomitting as well as severe visual disturbances. I have been unable to work because I can’t read, write or function in any capacity at the doctor’s office where I work. I am extremely light sensitive. It has made me very anxious and depressed to the point im having panic attacks. I have fallen several times due to imbalance. My vision has improved but I am unable to focus my eyes to rrad or write. Would this qualify for a lawsuit?

  3. Kelly Reply

    Are you currently working on any who’s teeth have been effected? Failing out?

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