Vol 22, 2013 Annals of Health Law 431
PROSECUTIONS OF PHARMACEUTICAL COMPANIES
effective. Indeed, we expect more from our physicians—we expect them to
stay current on the scientific literature, and remain skeptical of potential
scientific advances until proven with high probability. In prosecutions for
off-label promotion, the government typically relies on more general
evidence rather than specific proof of the basis for a specific prescription.
For example, if the overall sales revenue for the drug is high for off-label
uses, that may be evidence that the company was marketing it for that
purpose. This was the case in the context of Neurontin sales by Warner-
Lambert, which ultimately paid $430 million to resolve criminal and civil
claims.165 Isolated and inflammatory testimony by a sales manager, to the
effect that the company needed to sell the drug for the off-label use of pain
management, weighed heavily against the company in the context of the
dramatic off-label sales revenue.166 Despite the plea of Warner-Lambert to
misdemeanors, the matter was automatically converted to a felony because
of previous and separate convictions for FDCA violations.167 Other
evidence such as business plans that depend upon growth in the off-label
area, or visits by sales representatives to physicians who practice outside
the area where they would be expected to prescribe the drug for the labeled
purpose, are also used as proof that the company engaged in illegal
Despite the many prosecutions pursued, some courts have called into
question whether the off-label promotion violations of the FDCA can form
the basis of FCA liability.169 One court rejected the concept that
pharmaceutical companies cause false claims by promoting off-label uses,
stating that “the mere fact that Pfizer may have been violating FDA
regulations does not translate into liability for causing a false claim to be
filed . . . Pfizer did not file any claims for reimbursement and made no
implied certifications to obtain payment.”170
V. THE DOJ’S PURSUIT OF OFF-LABEL MARKETING SETTLEMENTS
CREATES A DOMINO EFFECT, TRIGGERING FURTHER
LIABILITIES FOR ACCUSED COMPANIES
Even if a company settles with the DOJ, the risk to the company is not
over. It is not uncommon for other types of actions to follow in the wake of
an off-label marketing settlement. First, state attorneys general may try to
165. Burroughs, supra note 29, at 573.
166. Id. at 574.
167. Id.; see 21 U.S. C. § 333(a)(2).
168. Burroughs, supra note 29, at 577-80.
169. See United States ex rel Polansky v. Pfizer, No. 04-cv-0704, 2009 WL 1456582 at
*7 (E.D.N. Y. May 22, 2009).