• 22
  • September
    2010

In the United States, drug manufacturers are only allowed to market their products for purposes which have been approved by the Federal Drug Administration (FDA). Botox-maker Allergan Inc. learned this the hard way earlier this year when the pharmaceutical company agreed to pay out $600 million in both fines and civil settlements following a lawsuit by the U.S. Department of Justice.

A whistleblower within the company had come forward to inform authorities of efforts by Allergan Inc. to market Botox to physicians as a pain reliever, though it had never been evaluated in that respect. While it is completely legal for doctors to prescribe the drug for that purpose, the company is not allowed to promote it for that use.

More recently, Allergan Inc. settled a second lawsuit stemming from a wrongful death claim by a Texas family. In the suit, the children of a woman who died after being treated with Botox accused the company of deceptive marketing and non-disclosure of important safety concerns posed by the drug.

The woman, a 70-year-old nurse, passed away in 2008 after receiving 100 units of Botox to alleviate persistent shoulder pain. The amount of Botox she was treated with far eclipsed the normal amount given to even plastic surgery patients and her children claimed that she would never have accepted the treatment had she been aware of the risk.

Botox has also come under fire for negative side effects experienced by children with cerebral palsy, who are often treated with the drug to alleviate the spastic movements associated with the disease. Negative reactions to the drug have included paralysis, problems breathing and trouble swallowing.

These are all symptoms of botulism poisoning.

The specific details related to the Texas wrongful death settlement were not released.

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