Vol 22, 2013 Annals of Health Law 415
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
particularity the details of any false claim for government reimbursement.49
Because the drug companies themselves do not submit claims for
reimbursement to the government, the FCA theory is that the company’s
unlawful marketing for an off-label use is the reason a physician prescribed
According to some courts, even a truthful statement made by the drug
company can be the foundation of a false claim based on “misbranding” if
the use is off-label.51 The court in Parke-Davis found that a violation of the
FDCA for off-label promotion may be sufficient in itself to establish
liability under the FCA, whether or not the underlying promotional
statements were false.52 Thus, the FCA does not require both a false
statement and a false claim under the court’s ruling. Parke-Davis had
argued that forty-two state Medicaid programs permitted off-label
prescriptions and, thus, there were no “false claims” made in those states.53
The court disagreed, noting that the relator had treatment histories of many
patients that reflected the drug was prescribed off-label, which was illegal
in at least some states.54 Parke-Davis also argued that because it did not
directly submit claims to the government, it therefore did not “cause” a
false claim to be submitted.55 The court disagreed on this point too, holding
that company acts could be a “substantial factor” in the physicians’
prescriptions leading to the claims for reimbursement that were ultimately
Importantly, the Fraud Enforcement and Recovery Act (“FERA”) was
enacted in 2009, revising aspects of the FCA.57 Under the statute, there can
be liability even when the false claim was not submitted to the government,
but to a private contractor or agent, thus removing one protection that
certain cases had applied previously.58 The definition of “claim” was
broadened and the statute of limitations expanded.59
49. U.S. ex rel. Roop v. Hypoguard USA, Inc., 559 F.3d 818, 825-26 (8th Cir. 2009);
see also Burroughs, supra note 29, at 558.
50. See U.S ex rel. Kennedy v. Aventis Pharm., Inc., 512 F. Supp. 2d 1158, 1163 (N.D.
51. See U.S. ex rel. Franklin v. Parke-Davis, No. Civ. A. 96–11651PBS, 2003 WL
22048255 at *2 (D. Mass. Aug. 22, 2003).
53. Id. at *3.
55. Id. at *4-5; U.S. ex rel. Franklin v. Parke-Davis, 147 F. Supp. 2d 39, 52-53 (D.
56. Franklin, 2003 WL 22048255 at *6; Franklin, 147 F. Supp. 2d at 52-53.
57. See generally Fraud Enforcement and Recovery Act of 2009, Pub. L. 111-21, 123
Stat. 1617 (2009).
58. See Id. at 1621-25.