In 1996, Dr. David Franklin, an employee of the drug company Parke-Davis, filed the lawsuit under federal whistleblower statutes alleging that the company was illegally promoting an epilepsy drug called Neurontin (gabapentin) for so called “off-label” uses.
Under federal law, once the FDA approves a drug, a doctor can prescribe it for anything. But the law specifically prohibits the drug company from promoting the drug for any unapproved uses.
Parke-Davis were then bought by Pfizer.
In 2004 it cost Pfizer $430 million to settle both criminal and civil liability related to the promotion of the drug for off-label use.
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