316:. In 1999, the government declined, and the case moved forward. The defendants sought to have the complaint dismissed, arguing that the causal link between any representations made by Parke-Davis sales representatives and reimbursements for off-label Neurontin prescriptions was too remote. Furthermore, Warner-Lambert argued that Franklin could only prove the pharmaceutical company's liability by showing that Parke-Davis sales liaisons made fraudulent misrepresentations about the drug, as opposed to merely engaging in truthful off-label promotion.
348:, resulting in a $ 240 million criminal fine. Civil damages under the False Claims Act were paid out to the federal government in the amount of $ 83.6 million, and damages paid out to the states totaled $ 106.4 million. Relator David Franklin was awarded one of the highest shares ever under the False Claims Act, 29.5% of the settlement, in recognition of his important role in exposing the illicit marketing scheme. Pfizer agreed to institute a corporate compliance program as part of the settlement. Also as part of the settlement the
28:
238:, to be used only when the first medication had not brought the epileptic seizures entirely under control. Warner-Lambert executives found the potential revenue in that indication was 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
327:
motion to dismiss the lawsuit. Judge Saris found that, if it could be proven that the off-label marketing of
Neurontin caused doctors to prescribe the drug and submit prescriptions to Medicaid, then the company would indeed be liable under the False Claims Act. In addition, Judge Saris found that the
276:
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. 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
264:
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
300:
Franklin's suit proposed a novel theory, that Warner-Lambert had perpetrated a fraud against the federal government by causing doctors and patients to submit claims for reimbursement to
Medicaid that Medicaid should not pay for, since by law, Medicaid only pays for treatments that are either
328:
submission of false
Medicaid claims was a foreseeable result of Warner-Lambert's marketing scheme. The case established for the first time that drug companies could be held liable under the False Claims Act for off-label promotion of pharmaceutical products.
200:
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
922:
711:
365:
208:
290:
38:
340:
announced that it had reached an agreement with Warner-Lambert and Pfizer. Warner-Lambert agreed to pay $ 430 million to resolve criminal and civil liability related to the off-label promotion of
196:
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
223:
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
370:
Since the settlement in 2004, whistleblowers and the federal government have prosecuted numerous off-label promotion cases under the False Claims Act using this case as a precedent.
361:
212:
297:, a federal statute which permits private citizen-whistleblowers (also known as "relators") to sue on behalf of the federal government for fraud involving federal money.
312:
The suit remained sealed for three years while the
Department of Justice decided if it would intervene and take over the case, which it had the right to do under the
708:
778:
188:, a pharmaceutical subsidiary of Warner-Lambert (Warner-Lambert was subsequently acquired by Pfizer in 2000). In denying the defendants' motion for
882:
932:
445:
Our Daily Meds: How the
Pharmaceutical Companies Transformed Themselves into Slick Marketing Machines and Hooked the Nation on Prescription Drugs
349:
254:
like
Franklin, were hired to conduct this marketing. Franklin also alleged that physicians and other health care providers were paid illegal
894:
428:
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)
345:
553:
465:"Press Release: Warner-Lambert to Pay $ 430 Million to Resolve Criminal & Civil Health Care Liability Relating to Off-Label Promotion"
429:
947:
337:
698:
Hogan & Hartson LLP. June 2003. FDA Update: Government Files "Statement Of
Interest" in Neurontin Off-Label Promotion Case
522:
539:
374:
231:
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to recommend the use to institutions, and paying people to write about the drug in any positive context including in
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Enforcement
Related to Off-Label Marketing and Use of Drugs and Devices: Where Have We Been and Where Are We Going?
273:
247:
177:
937:
301:
approved by the FDA, or are otherwise "medically accepted" (as evidenced, for instance, by being included in an
251:
779:"The Potential for State Attorneys General to Promote the Public's Health: Theory, Evidence, and Practice"
386:
373:
Subsequent research reported that the wrongful promotion of the drug was planned by integrating it into
352:
was established to fund public programs to raise awareness of problems with pharmaceutical advertising.
110:
Off-label promotion of pharmaceutical products which causes false claims for payment under the federal
66:
302:
584:
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382:
49:
United States of America ex rel. David Franklin v. Parke-Davis, Division of Warner-Lambert Company
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306:
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835:"Narrative Review: The Promotion of Gabapentin: An Analysis of Internal Industry Documents"
793:
927:
715:
683:
614:
526:
378:
97:
464:
794:"False Claims Act prosecution did not deter off-label drug use in the case of neurontin"
655:
630:
320:
181:
159:
131:
27:
792:
Kesselheim, AS; Darby, D; Studdert, DM; Glynn, R; Levin, R; Avorn, J (December 2011).
344:, and also agreed to plead guilty to two felony counts of misbranding drugs under the
916:
540:
The Dark Side of the Boom: The Peculiar Dilemma of Modern False Claims Act Litigation
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193:
260:
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complaint. At the time of the settlement in May 2004, it represented one of the
185:
155:
94:
781:. Robert Wood Johnson Foundation Public Health Law Research Program, via FOLIO.
572:
519:
810:
341:
224:
860:
729:
False Claims Act Liability for Off-Label Promotion of Pharmaceutical Products
646:
239:
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finally prompted him to quit and hire a Boston attorney, Thomas M. Greene.
100:(D. Mass. 2001); protective order modified, 210 F.R.D. 257 (D. Mass. 2002).
235:
111:
203:
168:
77:
163:
923:
United States District Court for the District of Massachusetts cases
728:
709:
Franklin v. Parke-Davis: First Off-Label Case Under False Claims Act
529:
Journal of Health & Life Sciences Law 2(2):73-108. January 2009
209:
largest False Claims Act recoveries against a pharmaceutical company
408:
led to a 2015 court decision that changed the FDA's approach to
305:). The suit also alleged that Warner-Lambert had broken federal
366:
List of largest pharmaceutical settlements in the United States
291:
United States District Court for the District of Massachusetts
234:
had approved Neurontin as a secondary course of treatment for
39:
United States District Court for the District of Massachusetts
883:
Court Forbids F.D.A. From Blocking Truthful Promotion of Drug
631:"Whistleblower charges drug company with deceptive practices"
554:"Examination of the evidence for off-label use of gabapentin"
319:
In an opinion handed down on August 22, 2003, District Judge
285:
In August 1996, Franklin and attorney Thomas Greene filed a
895:
F.D.A. Deal Allows Amarin to Promote Drug for Off-Label Use
613:
Melody Petersen for the New York Times. March 12, 2003
93:
Motion to dismiss granted in part, denied in part, 147
362:
List of off-label promotion pharmaceutical settlements
881:
Andrew Pollack for the New York Times. 7 August 2015
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agreed with David Franklin, denying Warner Lambert's
250:. Members of the Parke-Davis sales team, including
184:hired in the spring of 1996 in a sales capacity at
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127:
122:
104:
89:
84:
72:
62:
54:
44:
34:
20:
893:Katie Thomas for the New York Times. 8 March 2016
731:. Penn State Law Review, Vol. 110, pp. 41-68, 2005
615:Doctor Explains Why He Blew the Whistle at Pfizer
166:(which bought Warner-Lambert in 2000) under the
377:, supporting consultants and members of medical
114:program is a valid theory of recovery under the
777:Rutkow, Lainie; Teret, Stephen (October 2010).
624:
622:
8:
609:
607:
605:
478:Krautkramer, Christian J. (June 1, 2006).
439:
437:
272:stating that Neurontin had made a child's
192:, the court for the first time recognized
26:
17:
850:
809:
694:
692:
654:
497:10.1001/virtualmentor.2006.8.6.hlaw1-0606
495:
467:. US Department of Justice. May 13, 2004.
459:
457:
455:
453:
447:, New York: Sarah Crichton Books (2008).
852:10.7326/0003-4819-145-4-200608150-00008
421:
350:Consumer & Prescriber Grant Program
303:approved list of drugs and their uses
7:
346:Federal Food, Drug, and Cosmetic Act
480:"Neurontin and Off-Label Marketing"
400:Litigation around the marketing of
211:in U.S. history, and was the first
154:is a lawsuit filed in 1996 against
232:Food and Drug Administration (FDA)
14:
162:Company, and eventually against
542:26 J.L. & Health 181 (2013)
933:2003 in United States case law
213:off-label promotion settlement
1:
833:Steinman, Michael A. (2006).
265:written articles as authors.
718:Page accessed August 8, 2014
375:Continuing medical education
215:under the False Claims Act.
176:. The suit was commenced by
839:Annals of Internal Medicine
629:Lenzer J (March 22, 2003).
402:ethyl eicosapentaenoic acid
964:
948:Fraud in the United States
684:147 F. Supp. 2d 39
573:10.18553/jmcp.2003.9.6.559
404:(branded as "Vascepa") by
359:
274:attention deficit disorder
248:attention-deficit disorder
811:10.1377/hlthaff.2011.0370
686: (D. Mass. 2001).
268:According to Franklin, a
142:
109:
25:
714:August 10, 2014, at the
647:10.1136/bmj.326.7390.620
679:Franklin v. Parke-Davis
151:Franklin v. Parke-Davis
21:Franklin v. Parke-Davis
230:In December 1993, the
727:Stephanie M. Greene
590:on September 17, 2010
387:letters to the editor
338:Department of Justice
336:On May 13, 2004, the
293:in Boston under the
410:off-label marketing
389:, and managing the
383:academic literature
943:Off-label drug use
561:J Manag Care Pharm
525:2016-03-04 at the
518:Joseph JN, et al.
484:The Virtual Mentor
406:Amarin Corporation
219:Factual background
172:provisions of the
538:David S. Torborg
443:Melody Petersen,
289:complaint in the
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146:
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938:Drug advertising
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314:False Claims Act
295:False Claims Act
252:medical liaisons
244:bipolar disorder
198:publication bias
190:summary judgment
174:False Claims Act
158:, a division of
143:False Claims Act
123:Court membership
116:False Claims Act
30:
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804:(12): 2318–27.
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716:Wayback Machine
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58:August 22, 2003
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490:(6): 397–402.
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333:
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321:Patti B. Saris
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182:microbiologist
178:David Franklin
160:Warner-Lambert
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45:Full case name
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567:(6): 559–68.
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85:Case history
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707:Greene LLP
391:STEPS trial
270:case report
186:Parke-Davis
156:Parke-Davis
95:F. Supp. 2d
63:Docket nos.
917:Categories
594:August 10,
416:References
332:Settlement
861:0003-4819
342:Neurontin
256:kickbacks
240:migraines
225:Neurontin
194:off-label
869:16908919
820:22147859
767:at *4-*5
765:Franklin
753:Franklin
741:Franklin
712:Archived
665:12649230
581:14664664
523:Archived
506:23234671
307:kickback
236:epilepsy
138:Keywords
112:Medicaid
80:22048255
73:Citation
656:1125531
287:qui tam
281:Lawsuit
204:qui tam
169:qui tam
105:Holding
55:Decided
928:Pfizer
867:
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682:,
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356:Impact
309:laws.
164:Pfizer
755:at *1
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588:(PDF)
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865:PMID
857:ISSN
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