Source: https://www.scribd.com/document/321207576/US-ex-rel-Noah-Nathan-v-Takeda-Pharmaceuticals-4th-Cir-2013
Timestamp: 2019-04-25 01:58:44+00:00

Document:
Anthony J. Trenga, District Judge.
Affirmed by published opinion. Judge Keenan wrote the opinion, in which Judge Motz and Judge Bredar joined.
OF SUSAN R. PODOLSKY, Alexandria, Virginia; Daniel S.
employer under the False Claims Act (the Act), 31 U.S.C.
Relator does not appeal the district courts dismissal of Relators separate claim brought under 31 U.S.C. 3729(a)(1)(B).
file a fourth amended complaint.
false claims for payment or approval. 31 U.S.C.
only if it constitutes a "false or fraudulent claim." Harrison v.
Pharm., Inc., 588 F.3d 1318, 1325-26 (11th Cir. 2009).
Wash. Legal Found. v. Henney, 202 F.3d 331, 332-33 (D.C. Cir. 2000).
only a lower dose has been approved by the FDA.
Food and Drug Administration rejected this request.
has been approved to treat 13 conditions, including GERD.
Kapidex to "fill the Prevacid void."
government for payment or approval under 31 U.S.C.
required causation element for a claim asserted under the Act.
We review de novo the district courts dismissal of a complaint for failure to state a claim under Fed. R. Civ. P.
do not address those claims here.
relief that is plausible on its face." Ashcroft v. Iqbal, 556 U.S.
(4th Cir. 2012) (citation and internal quotation marks omitted).
mistake. Malice, intent, knowledge, and other conditions of a persons mind may be alleged generally.
relaxed pleading standard is appropriate in this case.
underlying fraudulent scheme. Id. (citing United States v.
conclusory fashion."); cf. United States ex rel. Joshi v. St.
inference that false claims were presented to the government.
claims were submitted as part of that scheme." United States ex rel. Lemmon v. Envirocare of Utah, Inc., 614 F.3d 1163, 1172 (10th Cir. 2010).
and the allegedly false certification language.
a more relaxed construction of Rule 9(b) in such circumstances, we disagree with that approach.
facts that support all the elements of a claim. See Dickson v.
such factual allegations in a given case meet the required standard must be evaluated on a case-specific basis.
Employing the above pleading standard, we turn to consider the sufficiency of the amended complaint in this case.
even though Kapidex was not approved for 10 of the 13 indications for which Prevacid was approved, including the gastric conditions commonly suffered by rheumatology patients.
often experienced by rheumatology patients.
in a case brought under the Act.8 See United States ex rel.
ingestion of anti-inflammatory drugs such as Advil. However, as discussed above, Kapidex is not approved for gastric protection.
State for Defence v. Trimble Navigation Ltd., 484 F.3d 700, 705 (4th Cir.
drug"), overruled on other grounds by Allison Engine Co. v.
actually were presented to the government for payment.
not plausibly allege that the prescriptions were written for offlabel uses.
the overall sales of Kapidex are for dosages of 60 mg.
to the 98 prescriptions for Kapidex. Cf. United States ex rel.
by the relator did not "directly implicate defendants").
Takeda caused presentment of a false claim to the government.
later in the litigation, in this case, in opposition to Takedas motion to dismiss.
to the government for payment.
insufficient because they are inherently speculative in nature.
leave" to amend a complaint "when justice so requires."
F.3d 404, 426 (4th Cir. 2006) (en banc) (quoting Johnson v.
Oroweat Foods Co., 785 F.2d 503, 509 (4th Cir. 1986)).
leave to file a fourth amended complaint.
amended complaint could not be considered in an attempt to avoid dismissal under Rule 12(b)(6).
denying Relator leave to file a fourth amended complaint.
Jack Levine v. New Jersey State Police et al.

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