In 1996, microbiologist David Franklin filed a whistleblower lawsuit under the False Claims Act alleging that Parke-Davis, later acquired by Pfizer, illegally promoted Neurontin for conditions including migraine, bipolar disorder, and attention deficit disorder. The drug was approved only as adjunctive treatment for partial seizures and postherpetic neuralgia. The suit alleged that Parke-Davis used tens of thousands of payments to physicians for purported consultations and studies, promoted favorable scientific claims, and withheld evidence that Neurontin was ineffective for several marketed uses. Prescribing off-label was legal; promoting those uses was not.
On May 13, 2004, Pfizer pleaded guilty to a criminal violation of the Federal Food, Drug, and Cosmetic Act. The company paid a $240 million criminal fine and $152 million to federal and state health-care programs; Franklin received $24.6 million under the settlement. The case was the first off-label-promotion settlement under the False Claims Act and helped establish that fraudulent marketing claims could support such actions. Subsequent litigation included insurer fraud and RICO claims led by Kaiser Permanente, settled in April 2014 after the Supreme Court rejected Pfizer’s appeal, and more than 1,000 wrongful-death suits associated with Neurontin use. The broader proceedings exposed the alleged corruption of medical literature through industry-paid consultants and contributed to pharmaceutical penalties exceeding $7 billion.
