Vol 22, 2013 Annals of Health Law 414
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
label marketing regulations.41
A. False Claims Act
In recent years, the DOJ dramatically expanded its prosecutions for off-
label marketing using the False Claims Act (“FCA”).42 Although claims for
violations of the FDCA may be included in these prosecutions, the FCA has
become the “primary vehicle for government health care fraud
enforcement,” which carries the potential for both criminal and civil
Under the FCA, a company is liable to the government if it “knowingly
presents, or causes to be presented . . . [to the government] a false or
fraudulent claim for payment or approval.”44 Qui tam suits are common
under the FCA. These involve a private citizen (referred to as the relator or
sometimes as a “whistleblower”) bringing suit against the drug company on
behalf of the government. The matters are filed under seal and the
government is given an opportunity to investigate the allegations and
determine whether to intervene in the suit. If there is a recovery, the private
individual can collect between fifteen to thirty percent of the government’s
recovery plus attorneys’ fees and costs.45 Thus, private individuals have a
powerful incentive to blow the whistle.
A typical FCA suit against a drug company will allege that the company
systematically promoted the drug for an off-label use, and that this
promotion caused physicians to prescribe the medicine for that use, in turn
leading to payments by the government—usually under Medicare or
Medicaid—for such off-label prescription. These suits are usually civil in
nature, although there is a criminal FCA counterpart.46 It has been
postulated that the government believes the “false claims” theory is too
attenuated for use in a criminal prosecution, and thus uses the FDCA
criminal provisions, which were described in Section I above.47
Because the FCA is a fraud statute, claims under it must be pled with
particularity, consistent with Federal Rule of Civil Procedure 9(b).48 Some
FCA cases have been dismissed when the relator did not plead with
41. Girard, supra note 10, at 126.
42. 18 U.S. C. § 287 (2011).
43. D. Douglas, et al., Presentation at DRI Annual Meeting: Trends in Criminal and
Civil Sanctions for Health Care Fraud Under the False Claims Act (October 2011).
44. 31 U.S. C. § 3729(a)(1) (2011).
45. 31 U.S. C. § 3730 (2012).
46. 18 U.S. C. § 287.
47. Burroughs, supra note 29, at 557.