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Topamax Drugmaker Agrees To Settle Case For Over $75 Million

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Ortho-McNeil-Janssen Pharmaceuticals, Inc., has agreed to settle a lawsuit filed in 2003 by a Michigan law firm in conjunction with the United States Department of Justice for over $75 Million. The lawsuit concerned OMJP’s drug Topamax, and was filed under the qui tam provisions of the federal False Claims Act on behalf of Angela Majer and Anastasia Savka-Klovski.

The lawsuit alleged that the Raritan, NJ based pharmaceutical firm acted improperly concerning the marketing, promotion and sale of the anticonvulsant drug Topamax. Michigan attorneys David Haron and Monica Navarro, in conjunction with the Department of Justice helped navigate the 7 year long litigation, which will not only affect the parties involved, but will also have a ripple effect on our nation’s annual healthcare expenses.

"The government’s annual healthcare expenses total nearly $1 trillion. It is estimated that nearly $100 billion of that money is lost each year to fraud, waste and abuse," continued Haron. "Only when those aware of fraud bring it to the attention of lawyers who have the resources to investigate and verify the allegations can that money be retrieved. This case is an example of how the system is supposed to work and how it will work given the increased resources and enhanced anti-fraud provisions in the health reform legislation recently signed by President Obama."

While OMJP neither admitted nor denied any liability, it did agree to enter into a plea agreement with the government in a criminal action filed in federal district court in Massachusetts. Among some of the government’s claims were that OMJP promoted the sale and use of Topamax for reasons other than those specifically approved by the FDA. Some of the uses were not medically-accepted indications for which State Medicaid programs provide coverage, thus resulting in OMJP’s knowingly causing false or fraudulent claims for Topamax to be submitted to, or caused purchase by, Medicaid and other government health programs.

The potentially dangerous use of Topamax and the substantial amount of fraud and governmental waste would have potentially gone unnoticed, if not for the efforts of citizens like Angela and Anastasia. However, their efforts were given force by the little-known qui tam provisions of the False Claims Act.

The False Claims Act and similar state acts, such as the Michigan Medicaid False Claims Act, provides incentives to private citizens, called Relators, who discover fraud against the federal or state governments and who bring their information to the government and help pursue the defrauding entities. The qui tam provisions allow Relators to represent the interests of the government to seek damages and civil penalties for a violation of law and, if the action is successful, to receive a portion of the awarded damages.

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    I was on Topamax for migraines and it was an awful experience. The side effects were horrible.