By Terry Baynes
Jan 11 (Reuters) - A whistle-blower accusing Takeda
Pharmaceutical North America Inc of off-label drug marketing in
violation of the False Claims Act cannot rely on statistical
evidence to make the claim, a federal appeals court ruled on
The 4th U.S. Circuit Court of Appeals in Richmond, Virginia,
rejected the suit, finding that the whistle-blower failed to
point to specific reimbursement claims submitted to Medicare or
other government programs as a result of the alleged off-label
Noah Nathan, a sales manager for Takeda Pharmaceuticals,
filed the suit against his employer in 2009. He accused the
company of engaging in a scheme to market its heartburn drug
Kapidex to physicians for off-label uses, or uses not approved
by the Food and Drug Administration.
He pointed to evidence that the company was promoting the
drug to rheumatologists, who don't typically treat conditions
for which Kapidex is approved.
Another Takeda drug, Prevacid, is approved to treat
rheumatology patients for stomach problems from medications, but
the patent was set to expire in 2009. Nathan argued that Takeda
was promoting Kapidex, the heartburn drug, to "fill the Prevacid
Nathan inferred that the Kapidex prescriptions written by
rheumatologists were for off-label uses. He also argued that
some of these prescriptions must have been reimbursed by the
government, given statistical data showing that a significant
percentage of prescriptions from the geographic area was
submitted for reimbursement to government healthcare programs.
After allowing Nathan to amend his complaint three times,
the district court in 2011 dismissed the suit, finding no
plausible claim that Takeda caused the submission of any
off-label claims to the government.
A three judge panel of the 4th Circuit agreed.
"General allegations such as those made here, that
unidentified Medicare patients received prescriptions for
off-label uses, do not identify with particularity any claims
that would trigger liability under the Act," Judge Barbara
Keenan wrote for the unanimous panel.
Nathan's lawyer, Jeffrey Lamken, was not immediately
available for comment.
Takeda's lawyer, William Cavanaugh, did not immediately
respond to requests for comment. Takeda said it was pleased with
The case is U.S. v. Takeda Pharmaceuticals, 4th U.S. Circuit
Court of Appeals, No. 11-2077.
For the United States ex rel. Noah Nathan: Jeffrey Lamken of
For Takeda: William Cavanaugh of Patterson Belknap Webb &
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