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''Franklin v. Parke-Davis'' is a lawsuit filed in 1996 against Parke-Davis, a division of Warner-Lambert Company, and eventually against Pfizer (which bought Warner-Lambert in 2000) under the ''qui tam'' provisions of the False Claims Act.〔U.S. ex rel. Franklin v. Parke-Davis, Div. of Warner-Lambert Co., No. CIV.A.96–11651PBS, 2003 WL 22048255, at *1 (D. Mass. Aug. 22, 2003) (2003 Decision )〕 The suit was commenced by Dr. David Franklin, a microbiologist hired in the spring of 1996 in a sales capacity at Parke-Davis, a pharmaceutical subsidiary of Warner-Lambert (Warner-Lambert was subsequently acquired by Pfizer in 2000).〔Melody Petersen, ''Our Daily Meds: How the Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs'', New York: Sarah Crichton Books (2008).〕 In denying the defendants' motion for summary judgment, the court for the first time recognized off-label promotion of drugs could cause Medicaid to pay for prescriptions that were not reimbursable, triggering False Claims Act liability. The case was also significant in exposing the degree to which publication bias impacts the randomized controlled studies conducted by pharmaceutical companies to test the efficacy of their products.〔 Ultimately, the parties reached a settlement agreement of $430 million to resolve all civil claims and criminal charges stemming from the ''qui tam'' complaint.〔http://www.justice.gov/opa/pr/2004/May/04_civ_322.htm〕 At the time of the settlement in May 2004, it represented one of the largest False Claims Act recoveries against a pharmaceutical company in U.S. history, and 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 2009〕〔David S. Torborg (The Dark Side of the Boom: The Peculiar Dilemma of Modern False Claims Act Litigation ) 26 J.L. & Health 181 (2013〕 ==Factual Background== After four months of employment at Parke-Davis, Franklin became disillusioned by what he believed to be the company's illegal marketing practices in connection with sales of the drug Neurontin. In December 1993, the Food and Drug Administration (FDA) had approved Neurontin as a secondary course of treatment for epilepsy, to be used only when the first medication had not brought the epileptic seizures entirely under control.〔Mack A. (Examination of the evidence for off-label use of gabapentin ). J Manag Care Pharm. 2003 Nov-Dec;9(6):559-68. PMID 14664664〕 Warner-Lambert executives found the potential revenue in that indication to be too low, and decided to promote Neurontin for additional indications, for which the drug was not approved by the FDA and for which there was little to no evidence, including migraines, bipolar disorder and attention-deficit disorder.〔 Members of the Parke-Davis sales team, including medical liaisons like Franklin, were hired to conduct this marketing. Franklin also alleged that physicians and other health care providers were paid illegal kickbacks as a ''quid pro quo'' for prescribing Neurontin, including expensive meals, stays at luxury resorts, and cash payments and that Parke-Davis hired ad agencies and marketing firms to produce articles about gabapentin describing the drug's emerging uses and recruited physicians and paid them to sign their names to the ghost written articles as authors.〔 According to Dr. Franklin, a case report stating that Neurontin had made a child's attention deficit disorder worse, and his supervisor's dismissal of the report, was a key factor in his decision to leave Parke-Davis in July 1996 after only four months of employment.〔Melody Petersen for the New York Times. March 12, 2003 (Doctor Explains Why He Blew the Whistle at Pfizer )〕 He also reported being told by a supervisor that his career would be threatened or ended if he continued to raise objections, and this is what finally prompted him to quit and hire a Boston attorney, Thomas M. Greene.〔 抄文引用元・出典: フリー百科事典『 ウィキペディア（Wikipedia）』 ■ウィキペディアで「Franklin v. Parke-Davis」の詳細全文を読む スポンサード リンク
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