Franklin v. Parke-Davis
Franklin v. Parke-Davis is a Massachusetts federal case decided on August 22, 2003. David Franklin, who worked for Parke-Davis (a Warner-Lambert company, later bought by Pfizer), filed a qui tam lawsuit under the False Claims Act. He alleged that Parke-Davis illegally promoted Neurontin (gabapentin) for uses not approved by the FDA, and that doctors were paid kickbacks and that ghostwritten articles promoted these off-label uses.
The big issue was whether off-label promotion could cause Medicaid to pay for uses the FDA had not approved, thereby creating false claims under the False Claims Act. Judge Patti B. Saris refused to dismiss the case, saying that if off-label marketing caused doctors to prescribe Neurontin and Medicaid to reimburse those prescriptions, the company could be liable. The ruling also found that such false claims were a foreseeable result of the marketing scheme.
This case marked a major shift: drug companies could be held liable under the False Claims Act for promoting drugs for off-label uses.
In May 2004, the Department of Justice reached a settlement with Warner-Lambert and Pfizer. Warner-Lambert/Pfizer agreed to pay $430 million to resolve criminal and civil liability. Of that, $240 million was a criminal fine, civil damages to the federal government were about $83.6 million, and damages to the states were about $106.4 million. The whistleblower, David Franklin, received about 29.5% of the settlement. Pfizer also agreed to implement a corporate compliance program, and a Consumer & Prescriber Grant Program was created to fund public education about pharmaceutical advertising.
Franklin started the case in 1996 after roughly four months with Parke-Davis, when he raised concerns about marketing practices related to Neurontin and decided to quit. The case helped expose how publication bias can influence drug studies and set a precedent for pursuing off-label promotion under the False Claims Act.
This page was last edited on 2 February 2026, at 13:42 (CET).