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Neurontin was FDA approved only as a powerful epilepsy drug for adjunctive or supplemental use. Under FDA provisions a company must specify the intended uses of a drug in new drug application to the federal agency. Only if the FDA approves it can a company then market or promote it. Pfizer pleaded guilty to criminal charges that its Warner-Lambert subsidiary, which Pfizer bought in 2000, promoted Neurontin for off-label uses that lacked any type of scientific support.
Pfizer has been sentenced to pay $240 million, which is the second largest criminal fine ever imposed in a health care fraud prosecution according to the Justice Department. Hundreds of thousands of dollars went into Pfizer's efforts to promote such off-label uses like bipolar mental disorder, pain disorders, Amyotrophic Lateral Sclerosis, attention deficit disorder, migraines, drug and alcohol withdrawal seizures, restless leg syndrome, and as a first line monotherapy treatment for epilepsy. Scientific studies had already shown Neurontin was not an effective treatment as a monotherapy for epileptic seizures, and the FDA already rejected its solo use.
Patients are angered by the realization that their Neurontin prescriptions may have been based on false and misleading information that was part of a financial scheme. Legal action is expected to occur in response to the sentencing of criminal health care fraud and whether or not a Neurontin class action emerges can only be told with time. While a Neurontin class action lawsuit may not develop because of the wide range of conditions Neurontin was prescribed to treat, lawyers will investigate individual cases to see if a strong claim exists.
Pfizer used many different approaches to reach the marketing goals it had set for off-label promotions. Part of a widespread effort, Pfizer also chose not to bother seeking FDA approval for any of the new uses because of the company's concern that it could allow for generic competitors to emerge as competition just as the patient was expected to soon end.
For more information on a Neurontin class action lawsuit, please contact us.
More Neurontin Resources
Neurontin Side Effects - Legal rights and information for patients suffering from the side effects of neurontin.
Neurontin - Prescribing and product information on Neurontin, including side effects, uses and other commonly asked questions.
Neurology.org - Articles and information on partial seizures.