David Franklin is an American

microbiologist A microbiologist (from Greek ) is a scientist who studies microscopic life forms and processes. This includes study of the growth, interactions and characteristics of microscopic organisms such as bacteria, algae, fungi, and some types of par ...

and former fellow of

Harvard Medical School Harvard Medical School (HMS) is the medical school of Harvard University and is located in the Longwood Medical and Academic Area, Longwood Medical Area in Boston, Massachusetts. Founded in 1782, HMS is the third oldest medical school in the Un ...

who while employed by

Parke-Davis Parke-Davis is a subsidiary of the pharmaceutical company Pfizer. Although Parke, Davis & Co. is no longer an independent corporation, it was once America's oldest and largest drug maker, and played an important role in medical history. In 1970 ...

filed the 1996 whistleblower lawsuit exposing their illegal promotion of Neurontin (

gabapentin Gabapentin, sold under the brand name Neurontin among others, is an anticonvulsant medication primarily used to treat neuropathic pain and also for partial seizures of epilepsy. It is a commonly used medication for the treatment of neuropath ...

) for off-label uses. Franklin's suit, filed on behalf of the citizens of the United States under the

qui tam In common law, a writ of ''qui tam'' is a writ through which private citizen, private individuals who assist a prosecution can receive for themselves all or part of the damages or financial penalties recovered by the government as a result of the p ...

provisions of US federal and state law, uncovered illegal pharmaceutical industry practices and created new legal precedent that resulted in a cascade of criminal convictions and civil and criminal penalties against Pfizer and several other pharmaceutical companies totalling more than $7 billion.David Evans for Bloomberg News. November 9, 2009
Pfizer Broke the Law by Promoting Drugs for Unapproved Uses
/ref> Civil cases also followed '' Franklin v. Parke-Davis''. Insurance companies, led by

Kaiser Permanente Kaiser Permanente (; KP) is an American integrated delivery system, integrated managed care consortium headquartered in Oakland, California. Founded in 1945 by industrialist Henry J. Kaiser and physician Sidney Garfield, Sidney R. Garfield, the ...

, sued Pfizer for fraud and violation of the federal

Racketeer Influenced and Corrupt Organizations Act The Racketeer Influenced and Corrupt Organizations (RICO) Act is a United States federal law that provides for extended criminal penalties and a civil cause of action for acts performed as part of an ongoing criminal organization. RICO was e ...

; the Kaiser case settled in April 2014 after Pfizer's appeal at the US Supreme Court was rejected. ''Franklin v. Pfizer'' also spawned more than a thousand wrongful death (suicide) suits associated with use of Neurontin. Numerous books have addressed the social, economic and healthcare implications of Dr. Franklin's stance and actions. The settlement was the first off-label promotion settlement under the False Claims Act.Joseph JN, et al
Enforcement Related to Off-Label Marketing and Use of Drugs and Devices: Where Have We Been and Where Are We Going?
Journal of Health & Life Sciences Law 2(2):73-108. January 2009David S. Torbor
The Dark Side of the Boom: The Peculiar Dilemma of Modern False Claims Act Litigation
26 J.L. & Health 181 (2013

''Franklin v. Parke-Davis'' case

Franklin's suit, filed under the

False Claims Act False or falsehood may refer to: * False (logic), the negation of truth in classical logic * Lie or falsehood, a type of deception in the form of an untruthful statement * False statement, aka a falsehood, falsity, misstatement or untruth, is a st ...

, claimed that Parke-Davis (since acquired by

Pfizer Pfizer Inc. ( ) is an American Multinational corporation, multinational Pharmaceutical industry, pharmaceutical and biotechnology corporation headquartered at The Spiral (New York City), The Spiral in Manhattan, New York City. Founded in 184 ...

) had used fraudulent scientific evidence supported by "tens of thousands of payments" to doctors for "consultations" and "studies" to encourage them to prescribe the drug

Neurontin Gabapentin, sold under the brand name Neurontin among others, is an anticonvulsant medication primarily used to treat neuropathic pain and also for partial seizures of epilepsy. It is a commonly used medication for the treatment of neuropath ...

for conditions including

migraine Migraine (, ) is a complex neurological disorder characterized by episodes of moderate-to-severe headache, most often unilateral and generally associated with nausea, and light and sound sensitivity. Other characterizing symptoms may includ ...

bipolar disorder Bipolar disorder (BD), previously known as manic depression, is a mental disorder characterized by periods of Depression (mood), depression and periods of abnormally elevated Mood (psychology), mood that each last from days to weeks, and in ...

and

attention deficit disorder Attention deficit hyperactivity disorder (ADHD) is a neurodevelopmental disorder characterised by symptoms of inattention, hyperactivity, impulsivity, and emotional dysregulation that are excessive and pervasive, impairing in multiple con ...

, even though it was approved for use only as adjunctive treatment in patients with partial

seizure A seizure is a sudden, brief disruption of brain activity caused by abnormal, excessive, or synchronous neuronal firing. Depending on the regions of the brain involved, seizures can lead to changes in movement, sensation, behavior, awareness, o ...

s and postherpetic neuralgia. Prescribing a drug for such

off-label use Off-label use is the use of pharmaceutical drugs for an unapproved indication or in an unapproved age group, dosage, or route of administration. Both prescription drugs and over-the-counter drugs (OTCs) can be used in off-label ways, although mo ...

was not itself illegal, but promoting such use was prohibited by the

U.S. Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a federal agency of the Department of Health and Human Services. The FDA is responsible for protecting and promoting public health through the control and supervision of food ...

and federal law. The case revealed that the company marketed the drug for these illnesses while withholding evidence that the drug was not effective for these illnesses. After initially denying wrongdoing, Pfizer pleaded guilty on 13 May 2004 to criminal violation of the

Federal Food, Drug, and Cosmetic Act The United States Federal Food, Drug, and Cosmetic Act (abbreviated as FFDCA, FDCA, or FD&C) is a set of laws passed by the United States Congress in 1938 giving authority to the U.S. Food and Drug Administration (FDA) to oversee the food safety ...

and paid a criminal fine of $240 million and $152m to state and federal healthcare programmes. Under the False Claims Act, Dr Franklin received $24.6m as part of the settlement agreement. ''Franklin v. Parke-Davis'' opened a unique window into pharmaceutical industry practices through UCSF's archiving and studyNarrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents -- Steinman et al. 145 (4): 284 -- Annals of Internal Medicine
/ref> of documents obtained by Franklin's attorney Thomas Greene. The case was unique in a number of ways: it was the largest settlement obtained for U.S. taxpayers in a case not joined by the Department of Justice, it established a new standard of accountability for pharmaceutical industry marketing practices, it broadened the use of the False Claims Act to include fraudulent marketing claims (not just financial fraud) as criminal violations of federal and state law, it revealed the involvement, complicity and active participation in fraud by many renowned physicians, and it demonstrated that the medical literature which is the foundation for medical practice (particularly off-label prescribing by physicians) has been deeply adulterated by the pharmaceutical industry and its paid clinical consultants.

References

{{DEFAULTSORT:Franklin, David Living people American whistleblowers American microbiologists 1961 births Scientists from Rhode Island Harvard Medical School people