Challenging Medical Ghostwriting in US Courts

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25. Randi W. v. Muroc Joint Unified School Dist., 14 Cal.4th 1066, 1077 (1997)

26. Glanzer v. Shepard, 233 N.Y. 236, 239 (1922)

27. Randi W., 14 Cal.4th at 1077; Garcia v. Superior Court, 50 Cal.3d 728, 734 (Cal.1990); Clark v. St. Dominic-Jackson Mem'l Hosp., 660 So. 2d 970, 974 (Miss. 1995); Brown v. Neff, 603 N.Y.S.2d 707, 709 (N.Y. Sup. Ct. 1993)

28. Restatement (second) of Torts §§ 310 and 311 (1977)

29. Rest. 2d Torts § 311, com. b (Garcia, supra, 50 Cal.3d at pp. 728, 735, 268 Cal. Rptr. 779, 789 P.2d 960, quoting Rest.2d Torts, § 311, com. b, at p. 106)

30. Knipe v. SmithKline Beecham, 583 F.Supp.2d 602, 621 (E.D.Pa. 2008)

31. Risperdal Litigation (Philadelphia Court of Comm. Pleas, March Term 2010). Available: http://www.courts.phila.gov/pdf/clc/100300296-05262010.pdf. Accessed 14 December 2011

32. 31 U.S.C. § 3729–3733. Available: http://www.taf.org/federalfca.htm. Accessed 14 December 2011

33. KesselheimASMelloMMStuddertDM 2011 Strategies and practices in off-label marketing of pharmaceuticals: a retrospective analysis of whistleblower complaints. PLoS Med 8 e1000431 doi:10.1371/journal.pmed.1000431

34. 31 U.S.C. § 3730. Section 3730: Civil actions for false claims

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36. LoucksMK 2006 Pros and cons of off-label promotion investigations and prosecutions. Food Drug Law J 61 577 583

37. MelloMMStuddertDMBrennanTA 2009 Shifting terrain in the regulation of off-label promotion of pharmaceuticals. N Engl J Med 360 1557 1566

38. 21 U.S.C. §§ 301–97

39. Department of Justice 13 May 2004 Warner-Lambert to pay $430 million to resolve criminal & civil health care liability relating to off-label promotion. Department of Justice [press release]. Available: http://www.justice.gov/opa/pr/2004/May/04_civ_322.htm. Accessed 14 December 2011

40. Associated Press 5 December 2007 Drug whistleblower collects $24M. Available: http://www.cbsnews.com/stories/2004/05/13/health/main617223.shtml. Accessed 14 December 2011

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43. US Food and Drug Administration. FD&C Act Chapter III: Prohibited Acts and Penalties. Available: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChapterIIIProhibitedActsandPenalties/default.htm. Accessed 4 December 2011

44. 42 U.S.C. 1320a-7b; see also United States ex rel. Hutcheson v. Blackstone Med., Inc., __ F.3d __, 2011 WL 2150191 (1st Cir. June 1, 2011)

45. StuddertDMMelloMMBrennanTA 2004 Financial conflicts of interest in physicians' relationships with the pharmaceutical industry–self-regulation in the shadow of Federal prosecution. N Engl J Med 351 1891 1900

46. 18 U.S.C. § 3571

47. 42 U.S.C. § 1320a-7

48. McIntyre v. Ohio Elections Comm'n, 514 U.S. 334 (1995)

49. Illinois, ex rel. Madigan v. Telemarketing Associates, Inc., 538 U.S. 600, 612 (2003)

50. United States v. Caronia, 576 F.Supp.2d 385 (E.D.N.Y. 2008)