In 1996, microbiologist David Franklin, then a Parke-Davis employee and Harvard Medical School fellow, filed a qui tam lawsuit under the False Claims Act alleging that the company promoted Neurontin for migraine, bipolar disorder, attention deficit disorder, and other unapproved uses. The drug was approved only as adjunctive treatment for partial seizures and postherpetic neuralgia. Prescribing medicines off-label was not itself illegal, but prosecutors alleged that Parke-Davis used tens of thousands of payments to physicians for purported consultations and studies, while suppressing or withholding evidence that the drug was ineffective for several promoted conditions.
After initially denying wrongdoing, Pfizer—whose acquisition of Warner-Lambert included Parke-Davis—pleaded guilty on May 13, 2004, to a criminal violation of the Federal Food, Drug, and Cosmetic Act. It paid a $240 million criminal fine and $152 million to federal and state healthcare programs; Franklin received $24.6 million under the settlement. The case was described as the first False Claims Act settlement based on off-label promotion and helped spur later civil litigation, including insurer fraud and RICO claims and more than 1,000 wrongful-death lawsuits associated with Neurontin use. Its archived documents also fueled scrutiny of industry-funded medical literature and physician marketing practices.
