SIMPSON v. BAYER PHARMACEUTICAL CORP. et al

Filing 147

OPINION. Signed by Judge Jose L. Linares on 4/11/14. (jr)

NOT FOR PUBLICATION

UNITED STATES DISTRICT COURT
DISTRICT OF NEW JERSEY

UNITED STATES of AMERICA, et al.,
Lx rel. Laurie Simpson,

Civil Action No. 05-3 895 (JLL) (JAD)

Plaintiff! Relator,
OPiNION
V.

BAYER CORP., et a!.,
Defendants.
LINARES, District Judge.
This matter comes before the Court by way of Bayer Corporation, Bayer Healthcare
Pharmaceuticals, Inc., and Bayer Healthcare LLC (collectively “Bayer”)’s motion to dismis
s
Relator Laurie Simpson (“Simpson”)’s Eighth Amended Complaint pursuant to Federa
l Rule of
Civil Procedure 12(b)(6). (ECF No. 144). The Court has considered the parties’ submis
sions in
support of and in opposition to the instant motion and decides this matter without oral
argument
pursuant to Federal Rule of Civil Procedure 78. For the reasons set forth below, the Court
GRANTS Bayer’s motion.
I.

BACKGROUND
Simpson brings this qui tam action against Defendant Bayer, her former employ
er, under

the False Claims Act (“FCA”), 31 U.S.C.
(Compi.

¶J 4-8,

§

3729 et seq., and similar state and local statutes.

ECF No. 135). Bayer employed Simpson from April 27, 1998 until January 1,

2005. (Id. at ¶ 91). As an employee of Bayer, Simpson helped market one of Bayer’
s
prescription drugs, Trasylol. (See Id. at ¶J 9 1-96). Simpson alleges, in short, that Bayer
illegally

promoted Trasylol by “engag[ing] in a campaign of concealment and disinformation concerning
Trasylol’s safety and efficacy that continued at least until May 2008, when Bayer recalled
Trasylol from the market.” (Id. at ¶ 9). These promotional activities, according to Simpson,
violated the Food Drug and Cosmetic Act (the “FDCA”)’s prohibition against “misbranding.”
(Id. at 13).

A.

The FDCA’s Prohibition Against Misbranding

“The FDCA regulates the manufacturing, marketing and sale of prescription drugs,” and
explicitly prohibits “misbranded” drugs from entering interstate commerce. In re Schering
Plough Corp. Intron/Temodar Consumer Class Action, 678 F.3d 235, 239-40 (3d Cir. 2012)

(citations omitted). A drug is misbranded if its labeling is “false or misleading in any particular.”
21 U.S.C.

§

352(a). Likewise, a drug is misbranded if its “labeling, which under the statute

includes all drug manufacturer promotional and advertising material, describes any intended uses
for the drug not approved by the [Food and Drug Administration (“FDA”)j.” Ironworkers Local
Union 68 v. AstraZeneca Pharm., LP, 634 F.3d 1352, 1357 n.5 (11th Cir. 2011) (citations
omitted). Thus, the FDCA “generally restricts pharmaceutical manufacturers—and all those
within their chain of distribution—from promoting a drug’s potential off-label uses to...
physicians.” Id. (citations omitted); see also in re Schering Plough Corp., 678 F.3d at 240
(“[T]he FDCA’s regulatory regime prohibits manufacturers from directly advertising off-label
uses, such as through labeling claims or explicit statements made by sales representatives.”).
B.

Bayer’s Alleged Misbranding of Trasylol

Simpson generally alleges that Bayer misbranded Trasylol by promoting off-label uses
of
the drug. (Compl.

¶J 134,

136-37, 143, 145, 148, 151-52, 157, 164, 166-69). The FDA

approved Trasylol for administration to patients undergoing coronary artery bypass
graft surgery
2

using a cardiopulmonary bypass pump (hereinafter “on-pump CABG surgery”) to prevent excess
bleeding. (See id. at ¶J 99-100, 102-03). Simpson alleges that Bayer disregarded the limited
scope of the FDA’s approval by promoting the use of Trasylol in: (1) valve replacement
surgeries; (2) off-pump CABG surgeries; (3) surgeries involving pediatric patients; (4) surgeries
involving patients on the antiplatelet drug Plavix; (5) orthopedic surgeries; and (6) liver
transplant surgeries. (Id. at ¶J 146-52, 157, 164-65). She further alleges that Bayer failed to
update Trasylol’s label to provide relevant safety and efficacy information concerning such offlabel uses. (Id.). These allegations are at the heart of the thirty causes of action that Bayer now
moves to dismiss.’
C.

Simpson’s Causes of Action Against Bayer

The causes of action that Bayer now moves to dismiss in their entirety fall into three
categories. Counts I through VI fall within the first category: FCA causes of action that allege
that Bayer’s misbranding of Trasylol resulted in the submission of false claims to the
2
Government. (Id. at ¶J 31 8-53(I1)). Counts VII and VIII fall within the second category: FCA
causes of action that allege that Bayer’s misbranding of Trasylol caused healthcare providers to
submit false claims for Medicare reimbursement. (Id. at 354(II)-65(II)). Counts XIII throug
h
¶J

‘Bayer had also moved to dismiss Simpson’s New York City False Claims Act cause of action
(Count XXXV).
(Def’s Br. 23, ECF No. 141-1). On March 28, 2014, the parties stipulated to the dismissal
of that cause of action
pursuant to Federal Rule of Civil Procedure 4l(a)(l), and, as a result, the Court dismissed
it on March 31, 2014.
(Stipulation & Order of Dismissal, ECF No. 146).
2

Simpson alleges that Bayer submitted, or caused to be submitted, false claims for Trasylol
to the following
Government entities: (1) the Civilian Health and Medical Program of the Department
of Veterans Affairs
(CHAMPVA”); (2) the Federal Employees Health Benefits (“FEHB”) Program; (3) Medicaid;
(4) Medicare; (5)
TRICARE; (6) the United States Department of Defense (the “DOD”); and (7) the United
States Department of
Veterans Affairs (the “VA”). (Compl.
3 18-353(11)).
The numbering of Simpson’s Complaint is incorrect. The Complaint uses the numbers
346 through 365 twice
when numbering paragraphs. When this Court cites to the first instance in which a number
is used for a paragraph,
the Court follows that number with a (I), e.g., 346(I). When this Court cites to the second
instance in which a
number is used for a paragraph, the Court follows that number with a (II), e.g., 346(11).

3

XXXIV and XXXVII fall within the third and final category: state and District of Columbia
false claims act causes of action. (Id. at ¶J 395-53 7, 545-46). Notably, this Court previously
4
dismissed these causes of action without prejudice last August. US. ex rel. Simpson v. Bayer
Corp., No. 05-3895, 2013 WL 4710587, *17 (D.N.J. Aug.30, 2013) (Linares, J.). Bayer also
moves to dismiss Simpson’s remaining causes of action to the extent that they are premis
ed on
conduct predating the applicable statute of limitations. (Def.’s Br. 27-29).
D.

Jurisdiction

The Court has jurisdiction over Simpson’s federal FCA causes of action pursuant to 28
U.S.C.

§ 1331, and jurisdiction over her state false claims act cause of action pursuant to both 28

U.S.C.

§ 1367 and 31 U.S.C. § 3732(b).

1!.

LEGAL STANDARD

For a complaint to survive dismissal, it “must contain sufficient factual matter, accept
ed
as true, to ‘state a claim to relief that is plausible on its face.” Ashcroft v. Iqbal, 556
U.S. 662,
678 (2009) (citing Bell Ati. Corp. v. Twombly, 550 U.S. 544, 570 (2007)). “Threa
dbare recitals
of the elements of a cause of action, supported by mere conclusory statements, do
not suffice.”
Id.
In determining the sufficiency of a complaint, the Court must accept all well-p
leaded
factual allegations in the complaint as true and draw all reasonable inferences
in favor of the
non-moving party. See Phillips v. County ofAllegheny, 515 F.3d 224, 234
(3d Cir. 2008). But,
“the tenet that a court must accept as true all of the allegations contained in
a complaint is
Simpson alleges that Bayer violated the false claims acts of twenty-two differe
nt jurisdictions: (1) California
(Count XIII); (2) Delaware (Count XIV); (3) Florida (Count XV); (4) Georgi
a (Count XVI); (5) Hawaii (Count
XVII): (6) Illinois (Count XVIII); (7) Indiana (Count XIX); (8) Louisiana (Count
XX); (9) Massachusetts (Count
XXI): (10) Michigan (Count XXII); (11) Montana (Count XXIII); (12) Nevad
a (Count XXIV); (13) New Hampshire
(Count XXV): (14) New Mexico (Count XXVI); (15) New York (Count
s XXVII and XXXVII); (16) Oklahoma
(Count XXVIII); (17) Rhode Island (Count XXIX); (18) Tennessee
(Count XXX); (19) Texas (Count XXXI); (20)
Virginia (Count XXXII); (21) Wisconsin (Count XXXIII); and (22) the Distric
t of Columbia (Count XXXIV).
(Compl. ¶j 395-537, 545-46).
‘

4

inapplicable to legal conclusions.” Iqbal, 556 U.S. at 678. Thus, legal conclusions draped in the
guise of factual allegations may not benefit from the presumption of truthfulness. Id.; In re Nice
Svs., Ltd. Sec. Litig., 135 F. Supp. 2d 551, 565 (D.N.J. 2001).
Additionally, in evaluating a plaintiffs claims, generally “a court looks only to the facts
alleged in the complaint and its attachments without reference to other parts of the record.”
Jordan v. Fox, Rothschild, O’Brien & Frankel, 20 F.3d 1250, 1261 (3d Cir. 1994). However, “a

document integral to or explicitly relied on in the complaint may be considered without
converting the motion [to dismiss) into one for summary judgment.” In re Burlington Coat
Factory Sec. Litig., 114 F.3d 1410, 1426 (3d Cir. 1997) (internal quotation marks omitted and
alteration in the original). With this framework in mind, the Court now addresses Bayer’s
motion to dismiss Simpson’s Eighth Amended Complaint.
5
III.

DISCUSSION

As explained above, the causes of action that Bayer now moves to dismiss fall into three
categories: (1) FCA causes of action premised on Bayer’s misbranding of Trasylol and the
resultant submission of false claims to the Government; (2) FCA causes of action premised on
Bayer’s misbranding of Trasylol and the resultant submission of false claims for Medicare
reimbursement by healthcare providers; and (3) state and District of Columbia false claims act
causes of action. The Court will now consider, in turn, whether each category survives
dismissal, and will then consider the extent to which Simpson’s remaining causes of action
are
cabined by the applicable statute of limitations.

All further references to Simpson’s Complaint refer to the Eighth Amended Complaint unless
otherwise specified.

5

A.

Whether Simpson’s FCA Causes of Action Premised on Bayer’s Misbranding of
Trasylol and the Resultant Submission of False Claims to the Government
Survive Dismissal

The first six counts of Simpson’s Eighth Amended Complaint allege that Bayer violated
sections 3729(a)(l) and (2) of the FCA. (Compi.
6

¶J 3 18-53(11)). Simpson alleges in those

counts that “Bayer misbranded Trasylol by marketing and selling the drug for off-label uses,”
and “by misrepresenting the drug’s safety and efficacy.” (Id. at 321-22, 330-31, 339-40,
¶J
348(I)-49(1), 357(1)-58(1), 347(II)-48(1I)). She also alleges that since Bayer misbranded
Trasylol, it “was prohibited from interstate commerce,” and that, as a result, each claim for
payment for Trasylol “was false or fraudulent in implying that the drug was not misbranded and
was permitted in interstate commerce.” (Id. at ¶J 323-24, 333-34, 341-42, 351(I)-52(1), 359(1)60(I), 350(11)-51(lI)). Bayer now moves to dismiss the first six counts of Simpson’s Complaint
for failure to state a claim. (Def.’s Br. 6-12).
Sections 3729(a)(1) and (2) of the FCA impose liability on any person who:
(1) knowingly presents, or causes to be presented, [to the United
States Government] a false or fraudulent claim for payment or
approval; [or]
(2) knowingly makes, uses, or causes to be made or used, a false
record or statement to get a false or fraudulent claim paid or
approved by the Government.
31 U.S.C.

§ 3729(a)(1)-(2) (pre-FERA). Based on this language, the Third Circuit has concluded

that a plaintiff must plead three elements to state a claim under section 3729(a)(1) of the FCA:
“(1) the defendant presented or caused to be presented to an agent of the United States a claim

6

In May 2009, Congress enacted the Fraud Enforcement and Recovery Act of 2009 (“FERA”),
thereby amending
the FCA and redesignating section 3729(a)(1) as section 3729(a)(1)(A) and section 3729(a)(2)
as section
3729(a)(l)(B). Pub. L. No. 111-21, 123 Stat. 1617 (2009). Simpson’s Complaint cites to
the pre-FERA version of
the FCA, which she asserts applied during the time period relevant to this action. (Compi.
31). Bayer explicitly
agrees with that assertion, and cites to the pre-FERA version of the FCA in its briefs. (Def.¶
‘s Br. 1 n. 1).

6

for payment;[’] (2) the claim was false or fraudulent; and (3) the defendant knew the claim was
false or fraudulent.” US. ex rel. Schmidt v. Zimmer, Inc., 386 F.3d 235, 242 (3d Cir. 2004)
(quotation marks and citation omitted). A plaintiff must plead the same three elements to state a
claim under section 3729(a)(2) of the FCA along with a fourth element, i.e., “that the defendant
made or used (or caused someone else to make or use) a false record in order to cause the false
claim to be actually paid or approved.” Id. (citation omitted).
In this case, the parties dispute whether the first six counts of Simpson’s Complaint
adequately plead the second element—a false or fraudulent claim for payment. (See Def.’s Br.
7-12; Pl.’s Opp’n Br. 4-15, ECF No. 144-17; DeE’s Reply Br. 3-5, ECF No. 144-23). In
resolving their dispute, the Court is guided by the Third Circuit’s pronouncement that there are
two categories of false or fraudulent claims under the FCA: factually false claims and legally
false claims. US. ex rd. Wilkins v. United Health Grp., Inc., 659 F.3d 295, 305 (3d Cir. 2011)
(citing US. cx rd. Conner v. Sauna Reg’l Health Ctr., Inc., 543 F.3d 1211, 1217 (10th Cir.
2008)). “A claim is factually false when the claimant misrepresents what goods or services that
it provided to the Government.

.

.

.“

Id. Alternatively, “a claim is legally false when the

claimant knowingly falsely certifies that it has complied with a statute or regulation the
compliance with which is a condition for Government payment.” Id. “A legally false FCA
claim is based on a ‘false certification’ theory of liability.” Id. (citation omitted).
There are two “false certifications” theories of liability: the express false certification
theory and the implied false certification theory. Id. (citation omitted). “Under the ‘express false
certification’ theory, an entity is liable under the FCA for falsely certifying that it is in
compliance with regulations which are prerequisites to Government payment in connection with
‘

The FCA defines a claim in pertinent part as a “request or demand.
to an officer, employee, or agent of the United States....” 31 U.S.C.

.

7

.

for money or property that.

§ 3729(c) (pre-FERA).

.

is presented

the claim for payment of federal funds.” Id. (citation omitted). On the other hand, under the
implied false certification theory, an entity is liable if it “seeks arid makes a claim for payment
from the Government without disclosing that it violated regulations that affected its eligibility for
payment.” Id. (citation omitted).
Here, Simpson contends that the first six counts of her Complaint “are viable without
reliance on a false certification theory.” (Pl.’s Opp’n Br. 11). Specifically, she maintains that
her “primary theory of liability.

.

.

is based on the evident materiality of misbranding to the

government, and not solely on false certification.” (Id. at 3). However, Simpson cites to no
binding Third Circuit authority explicitly recognizing the viability of such a theory of liability
under the FCA, and this Court is aware of none. See Wilkins, 539 F.3d at 305 (“There are two
8
categories of false claims under the FCA: a factually false claim and a legally false claim.”). At
bottom, the first six counts of Simpson’s Complaint rely on an implied false certification theory
since they are predicated on Bayer’s alleged violation of the FDCA. Indeed, those counts
explicitly allege that each claim for payment for Trasylol was “false or fraudulent in implying
that the drug was not misbranded and was permitted in interstate commerce.” (Compl.

¶J 324,

334, 342, 352(1), 360(I), 351(11)).
To plead an implied false certification theory, “a plaintiff must show that compliance
with the regulation which the defendant allegedly violated was a condition ofpavment from the
Government.” Id. at 309 (emphasis added and citations omitted); see also Mikes v. Straus, 274
F.3d 687, 697 (2d Cir. 2001) (“[A] claim for reimbursement made to the government is not

s Simpson
cites to US. ex rd. Dunleavy v. county ofDelaware, 123 F.3d 734 (3d Cir. 1997) abrogated
by Graham
County Soil & Water Consen’ztion District v. U.S. cx rd. Wilson, 559 U.S. 280 (2010), for
the proposition that
“Bayer’s concealment of the fact that Trasylol was misbranded and illegal in interstate commerce
rendered those
claims false.” (Pl.’s Opp’n Br. 6). Simpson’s reliance on Dunleavy is misplaced since
that case dealt with the
public disclosure bar, and does not suggest that Simpson’s theory of FCA liability is viable.
See Dunleavy, 123 F.3d
734.

8

legally false simply because the particular service furnished failed to comply with the manda
tes
of a statute, regulation or contractual term that is only tangential to the service for which
reimbursement is sought.”). Whether a defendant’s compliance with a statute or regulation
is a
“condition of payment” from the Government is distinct from whether such compliance is
“material” to the Government. See Mikes, 274 F.3d at 697 (explaining that a condition
of
payment requirement is distinct from a materiality requirement); see also Harrison v.
Westinghouse Savannah River Co., 176 F.3d 776, 793 (4th Cir. 1999) (“The prerequisite
standard in the false certification cases is essentially a heightened materiality requirement:
the
government must have conditioned payment of the claim upon certification of compl
iance with
the provision of the statute, regulation, or contract at issue.”). A defendant’s compliance
with a
statute or regulation is a condition of payment when knowledge of the defendant’s failure
to
comply “‘might cause [the Government] to actually refuse payment.” Wilkins, 659
F.3d at 309
(quoting Conner, 543 F.3d at 1220). In contrast, a defendant’s compliance with a statute
or
regulation is material to the Government when the defendant’s failure to comply “has
a natural
tendency to influence agency action or is capable of influencing agency action.” Harriso
n, 176
F.3d at 785 (quotation marks and citation omitted).
Simpson argues at length that this Court should not dismiss the first six counts
of her
Complaint because they sufficiently allege that Bayer’s compliance with the misbra
nding
provisions of the FDCA was material to the Government. (P1.’s Opp’n Br. 4-10).
While the
Court is mindful that there is some overlap between the “materiality” and “condi
tion of
payment” concepts, they are in fact distinct. Indeed, a defendant’s failure to
comply with a
statute or regulation when submitting a claim for payment to the Govern
ment may induce the
Government to act in a manner other than refusing to pay the claim. See Wilkins,
659 F.3d at
9

309 (noting that the defendant’s noncompliance with Medicare marketing regulations could
induce the Government to eventually bar the defendant from participating in the Medicare
program, but that it did not necessarily provide the Government with a reason to refuse the
defendant’s requests for payment). Even if the Court were to consider Simpson’s allegations
pertaining to the materiality of misbranding to the government, as explained below, those
allegations do not adequately plead that Bayer’s compliance with the FDCA’s misbranding
provisions was a condition of payment from the Government. See Id., 659 F.3d at 307 (“[A]
plaintiff must show that if the Government had been aware of the defendant’s violations of the..
laws and regulations that are the bases of [her] FCA claims, it would not have paid the
defendant’s claims.”).
Simpson’s Complaint alleges that the United States Department of Justice (“DOJ”)’s
“pursuit of [a number of misbranding] cases, and the resulting settlements, are evidence that the
federal government deems misbranding to be a material ground for recovering federal funds
expended on pharmaceuticals.” (Compi.

¶ 49).

It can be reasonably inferred from this allegation

that the Government may eventually sue a drug manufacturer for failing to comply with the
FDCA’s misbranding provisions. It does not follow, however, that the Government conditions
its payments for pharmaceuticals on a drug manufacturer’s compliance with the FDCA’s
misbranding provisions. Thus, Simpson’s allegation concerning the DOJ’s pursuit of a number
of misbranding cases does not adequately plead the existence of a condition of payment.
Simpson’s allegation that the DOJ’s filing of statements of interest (“SOIs”) in two
separate cases—(l) US. ex rel. Krahling v. Merck & C’o., No. 10-4374 (E. D. Pa.); and (2) Us.
ex rel. Provuncher v. Angioscore, Inc., No. 09-12176 (D. Mass.)—evidences “[t]hat the federal
government considers misbranding to be material to its decisions to pay or seek reimbursement
10

of payments for pharmaceuticals,” (Id. at ¶J 50-51), also fails to plead the existence of a
condition of payment. In Krahling, as Bayer notes, the DOJ challenged the defendant’s legal
argument that a private relator—as opposed to the Government—could not state a claim under
the FCA premised on allegations of fraud or a violation of FDA regulations. No. 10-4734, ECF
No. 54 (E. D. Pa. March 20, 2013). In doing so, the DOJ did not explicitly argue or suggest that
the Government generally conditions its payments for drugs on a drug manufacturer’s
compliance with the FDCA provisions at issue here. See Id. In Provuncher, the DOJ addressed
a theory of fraud on the FDA that Simpson has not alleged here, and which the District Court of
Massachusetts eventually dismissed. No. 09-12176, 2012 WL 3144885 (D. Mass. Aug. 3, 2012).
Therefore, Simpson’s allegations concerning the materiality of the FDCA’s misbranding
provisions to the Government do not allege the existence of a condition of payment. The Court
now considers whether Simpson otherwise alleges the existence of a condition of payment in her
causes of action involving payments from: (1) CHAMPVA, the FEHB Program, the DOD,
TRICARE, and the VA (Counts I and II); (2) Medicaid (Counts III and IV); and (3) Medicare
(Counts V and VI).
1.

Whether Simpson’s Complaint Alleges that CHAMP VA, the FEHB
Program, the DOD. TRICARE, and the VA Conditioned Their Payments
for Trasylol on Bayer’s Compliance with the Misbranding Provisions of
the FDCA

Counts I and II of Simpson’s Complaint allege that Bayer violated the FCA by
submitting, or causing others to submit, false or fraudulent claims for payment for Trasylol to
CHAMPVA, the FEHB Program, the DOD, TRICARE, and the VA. (Compl.

¶ 318-35).

Those Counts allege that such claims for payment were false or fraudulent since they implied
that Bayer had complied with the misbranding provisions of the FDCA. (See Id. at 324, 334).
¶J
Those Counts, however, do not allege that Bayer’s compliance with the misbranding provisions
11

was a condition of payment from any of the aforementioned federal entities. (See id. at
¶J 31835). They provide only the conclusory statement that

“[i]f the United States had known that

Trasylol was misbranded and prohibited from interstate commerce, it would not have
paid for it.”
(Id. at ¶11 325, 335). This bare legal conclusion does not adequately plead the existence
of a
condition of payment. çf Fowler v. UPMC Shadyside, 578 F.3d 203, 210 (3d Cir. 2009)
(noting
that conclusory or bare-bones allegations do not survive a motion to dismiss). As a result,
this
Court dismisses Counts I and II of Simpson’s Complaint without prejudice. See Wilkin
s, 659
F.3d at 311 (affirming district court’s dismissal of the plaintiff’s FCA cause of action becaus
e the
defendant’s compliance with a marketing regulation was not a condition of payment).
2.

Whether Simpson’s Complaint Alleges that the United States Conditioned
its Medicaid Reimbursements for Trasylol on Bayer’s Compliance with
the Misbranding Provisions of the FDCA

Counts III and IV of Simpson’s Complaint allege that Bayer violated the FCA by causin
g
healthcare providers to submit false or fraudulent claims for Medicaid reimbursemen
t for
Trasylol to the Government. (Compi.

¶ 336-53(I)). Those Counts further allege that those

reimbursement claims were false or fraudulent since they implied that Bayer had compl
ied with
the misbranding provisions of the FDCA. (Id. at ¶J 342, 3 52(1)). Simpson’s Compl
aint
elsewhere alleges that “[mjany state Medicaid Programs require health care provid
ers to certify
compliance with federal and state law,” and to also acknowledge that they could
be prosecuted
for submitting a false claim. (Id. atJ 72; Pl.’s Opp’n Br. 12).
Based on that allegation, the Court can plausibly infer that a healthcare provid
er’s
outright refusal to provide such a certification would be met with a refusal by the
Government to
pay Medicaid reimbursements. But the Court cannot plausibly infer from that
allegation that the
Government would refuse to pay Medicaid reimbursements for Trasylol based
on Bayer’s
12

noncompliance with the misbranding provisions of the FDCA. Such an inference would be
speculative at best. Cf Zavala v. WalMart Stores Inc., 691 F.3d 527, (3d Cir. 2012) (“Even on a
motion to dismiss, we are not required to credit mere speculation.”). Moreover, that the
Government may prosecute a false claim has no bearing on whether one’s compliance with the
misbranding provisions of the FDCA is a condition of payment from the Government for
Medicaid reimbursements. Accordingly, the Court dismisses counts III and IV of Simpson’s
Complaint without prejudice. In holding so, the Court observes that “the [FCA] was not
designed for use as a blunt instrument to enforce compliance with all medical regulations—but
rather only those regulations that are a precondition to payment.” Mikes, 274 F.3d at 699.
3.

Whether Simpson’s Complaint Alleges that the Government Conditioned
its Medicare Reimbursements for Trasylol on Bayer’s Compliance with
the Misbranding Provisions of the FDCA

Counts V and VI of Simpson’s Complaint allege that Bayer violated the FCA by
submitting, or causing others to submit, false or fraudulent claims for Medicare reimbursement
for Trasylol to the Government. (Compl.

¶J 354(I)-53(1I)). Those Counts allege that such

reimbursement claims were false or fraudulent because they implied that Bayer had complied
with the misbranding provisions of the FDCA. (Id. at ¶J 360(I), 35 1(11)). Simpson points the
Court to two allegations in her Complaint, which she suggests establish that Bayer’s compliance
with the misbranding provisions was a condition of payment from the Government. (Pl.’s Opp’n
Br. 12-13).
First, Simpson points to her allegation that “[tb enroll in Medicare, healthcare providers
and suppliers must fill out and sign an application form. Institutional providers, such as
hospitals, use the CMS-855A form, physicians and non-physician practitioners use the CMS

13

8551 form, and all other healthcare providers use the CMS-855B form.” (Compi.

¶ 53).

All

CMS-855 forms, according to Simpson’s Complaint, require healthcare providers to certify:
I understand that payment of a claim by Medicare is conditioned
upon the claim and the underlying transaction complying with such
laws, regulations, and program instructions (including, but not
limited to, the Federal anti-kickback statute and the Stark law), and
on the provider’s compliance with all applicable conditions of
participation in Medicare.
(Id. (emphasis added)). Simpson suggests that this language establishes that Bayer’s compliance
with the misbranding provisions of the FDCA was a condition of payment from the Government.
(See

Pl.’s Opp’n Br. 12). Bayer counters that this allegation is “insufficient because Simpson

does

not

identify any authority for the proposition that the FDA marketing rules at issue here are

among the requirements on which Medicare.. payment is conditioned.” (Def.’s Reply Br. 4.

5). The Court agrees. The Court is incapable of reasonably inferring that “such laws [and]
regulations” in the above quoted language refers to the FDCA misbranding provisions because
Simpson has not provided the Court with the broader context of that language nor has she alleged
other facts that would allow the Court to infer which laws and regulations “such laws [and]
regulations” includes.
9
Second, Simpson points to her allegation that hospitals are required to file a cost report to
participate

in the Medicare Program. (Pl.’s Opp’n Br. 12). Hospitals allegedly certify therein

that they are “familiar with the laws and regulations regarding the provision of health care
‘

When deciding a motion to dismiss, generally, “a court looks only to the facts alleged in the complaint
and its
attachments
Jordan, 20 F.3d at 1261. However, a court may also look to “a document integral to or explicitly
relied on in the complaint” without converting the motion into one for summary judgment.
In re Burlington Coat
Factory Sec. Litig., 114 F.3d at 1426 (quotation marks and citation omitted). This exception
to the general rule
exists “so that [a] plaintiff cannot maintain a claim ‘by extracting an isolated statement from
a document and placing
it in the complaint, even though if the statement were examined in the full context of the
document, it would be clear
that the statement [did not support the claim].” Mele v. Fed. Reserve Bank ofN. Y., 359
F.3d 251, 256 n.5 (3d Cir.
2004) (quoting In re Burlington Coat Factory Sec. Litig., 114 F.3d at 1426). Here,
Simpson did not attach a copy of
a CMS-855 form to her Complaint, and neither party has supplied a copy in its moving papers.
Since the Court does
not have a copy of a CMS-855 form, the Court is unable to examine the full context of the
language from the form
that Simpson quotes in her Complaint.
“

14

services and that the services.. were provided in compliance with such laws and regulations.”
.

(Compi.

¶ 64). Based on this certification, the Court cannot reasonably infer that the

Government would refuse to pay Medicare reimbursements for Trasylol due to Bayer’s
noncompliance with the misbranding provisions of the FDCA. Cf Wilkins, 659 F.3d at 309-10
(“[T]he fundamental flaw in appellants’ allegations is that the amended complaint does not cite
to any regulation demonstrating that a participant’s compliance with Medicare marketing
regulations is a condition for its receipt of payment from the Government.”). Thus, the Court
dismisses Counts V and VI of Simpson’s Complaint without prejudice.
B.

Whether Simpson’s FCA Causes of Action Premised on Bayer’s Misbranding of
Trasylol and the Resultant Submission of False Claims for Medicare
Reimbursement Survive Dismissal

Counts VII and VIII of Simpson’s Complaint allege, in essence, that because Bayer
falsely certified compliance with the Medicare statute, Bayer is liable under the FCA. (Comp
l.

¶J 354(ll)-65(II)). A defendant falsely certifies compliance with the Medicare statute if it
submits, or causes to be submitted, a claim for Medicare reimbursement of a drug when the use
of that drug was not “reasonable and necessar for the diagnosis or treatment of illness or
injury
,“

42 U.S.C.

§

1395y(a)(1)(A) (emphasis added); Mikes, 274 F.3d at 700. Thus, whether

Counts Vii and VIII may proceed hinges on whether the Complaint alleges that the off-lab
el uses
of Trasylol that Bayer promoted were not “reasonable and necessary.” Mikes, 274 F.3d
at 700.
The Medicare statute explicitly empowers the Secretary of Health and Human Servic
es to
decide one’s entitlement to Medicare benefits. 42 U.S.C.

§ 1395ff(a)(l)(A). In doing so, the

Medicare statute authorizes the Secretary “to determine whether the numerous medica
l services
and items covered by Medicare are ‘reasonable and necessary’ in particular circum
stances.”
Willowood of Great Barrington, Inc. v. Sebelius, 638 F. Supp. 2d 98, 105 (D. Mass.
2009) (citing

15

Goodman v. Sullivan, 891 F.2d 449, 450 (2d Cir. 1989)). The Secretary sets forth such
determinations in “both formal regulations and informal policy manuals.” Id. In her Oppos
ition
Brief, Simpson cites to two such manuals, the Medicare Benefit Policy Manual (the “MBPM)
and Medicare Program Integrity Manual (the “MPIM”). (Pl.’s Opp’n Br. 18).
Specifically, Simpson cites to section 50.4.2 of chapter 15 of the MBPM, which states:
FDA approved drugs used for indications other than what is
indicated on the official label may be covered under Medicare if
the carrier determines the use to be medically accepted, taking into
consideration the major drug compendia,[’°] authoritative medical
literature and/or accepted standards of medical practice.
(Normand Dccl. Ex. A, ECF No. 144-19; Pl.’s Opp’n Br. 18). She also cites to section 13.7.1
of
chapter 13 of the MPIM, which states that “[a]cceptance by individual health care provid
ers.
and limited case studies distributed by sponsors with a financial interest in the outcom are
e,
not
sufficient evidence of general acceptance by the medical community.” (Normand Decl.
Ex. B,
ECF No. 144-20; Pl.’s Opp’n Br. 18). Based on these statements, Simpson concludes
that an
off-label drug use is “reasonable and necessary” only if the major drug compendia “taken
together” support that use. (Id. at 19-21). Bayer counters that the compendia need
not be
unanimous—a supportive listing in one major compendium is sufficient for an off-lab
el use to
qualify as reasonable and necessary. (Def.’s Br. 15; Def.’s Reply Br. 6-7).
The Court agrees with Bayer. Indeed, the above quoted MBPM language states
only that
a carrier should consider the major drug compendia, and Simpson cites to no bindin
g authority
supporting her restrictive reading of that language. Moreover, an off-label drug
use is considered

A “drug compendium” is a database of information concerning drugs, which
includes, among other things,
approved and unapproved uses. (Compi. 56 n.6). The Medicaid statute provid
es that “one or more citations”
supporting an off-label drug use in any of the following major drug compe
ndia may establish the medical acceptance
of that use: (1) American Hospital Formulary Service Drug Information; (2)
United States Pharmacopeia-Drug
Information (or its successor publications); and (3) the DRUGDEX Inform
ation System. See 42 U.S.C. § 1396r8(k)(6) (referring to subsection (g)(l)(B)(i) of that section).

16

medically accepted under the Medicaid statute if that use is supported by “one or more citations”
in the major drug compendia. 42 U.S.C.

§ 1396r-8(k)(6) (emphasis added); US. ex rel. Worsfold

v. Pfizer, Inc., No. 09-11522, 2013 WL 6195790, *3 (D. Mass. Nov. 22, 2013) (noting that
medical acceptance of an off-label use depends on whether that particular use is included in one
of the compendia). It would be anomalous to read the Medicaid and Medicare statutes
divergently, finding that an off-label drug use is medically acceptable, and thus compensable,
when supported by one compendium under Medicaid but not under Medicare. Accordingly, the
Court now assesses whether the Complaint adequately alleges that not a single drug compendium
supported the off-label uses of Trasylol that Bayer promoted.
The Complaint generally alleges that each of the major drug compendia does not support
the off label uses of Trasylol that Bayer promoted. (See Compl.

¶J 170-75). With regard to the

American Hospital Formulary Service Drug Information compendium, the Complaint alleges
that “[njone of the entries for Trasylol

.

.

.

from 1997 through 2007 describe well-supported uses

for Trasylol other than the FDA approved indication, on-pump CABG surgery,” and that “[o]ther
uses of Trasylol are only mentioned as either unproven or with reference to potential adverse
effects.” (Id. at ¶J 171-72). With regard to the United States Pharmacopeia-Drug Information
compendium, the Complaint alleges that the 1999 and 2000 entries for Trasylol “list[] only
repeat CABG surgery and initial CABG surgery in cases of high risk of bleeding as
‘Accepted[,]” and that “[t]he 2001 and 2002 entries list only CABG surgery as ‘Accepted.”
(Id. at ¶ 173). The Complaint further alleges that, according to that compendium, “[ajil other
uses, including liver transplants, heart transplants, orthopedic surgery, and pediatric surgery,
are
listed as ‘Acceptance not established.” (Id. at ¶ 173). Both aforementioned compendia,
according to the Complaint, explicitly state that the “safety and efficacy” of Trasylol for
17

pediatric use has not been established. (Id. at ¶J 172, 174). With regard to the DRUGDEX
Information System compendium (hereinafter “DRUGDEX”), the Complaint alleges:
The DRUODEX entry for Aprotinin [Trasylol] was reviewed and
approved by Bayer in 2000. Although this entry lists numerous
off-label uses for Trasylol, none of these off-label uses are
described as having ‘good’ documentation that they are both safe
and effective, and some, such as orthopedic surgery, are described
as ‘ineffective.’
(Id. atJ 175).

Bayer argues that Simpson’s allegation concerning the 2000 DRUGDEX entry for
Trasylol amounts to an admission that at least some off-label uses of the drug were supported by
a major drug compendium. (See Def.’s Br. 16). Relatedly, Bayer suggests that that allegation
misconstrues the 2000 DRUGDEX entry, and cites to parts of that entry that it considers
supportive of the medical acceptance of various off-label uses. (See id. at 14-15). For instance,
with regard to the off-label use of Trasylol for orthopedic surgery, Bayer points out that although
the 2000 DRUGDEX entry describes the efficacy of Trasylol for orthopedic surgery as
“ineffective” for adults, that entry simultaneously provides in its summary that Trasylol “[mjay
decrease blood loss and transfusion requirements during and after major orthopedic surgery.”
(Def’s Br. 18 n.11; Def.’s Ex. B

§ 4.5(G)(2), ECF No. 144-6). In response, Simpson cites to

various parts of the 2000 DRUGDEX entry that she considers unsupportive of off-label use, and
contends that “Bayer’s skewed reading of [the 2000 DRUGDEX entryj does not warrant
dismissal.” (See Pl.’s Opp’n Br. 2 1-22).
Ultimately, for the purpose of resolving this motion, the Court need not determine which
off-label uses of Trasylol the 2000 DRUGDEX actually supports. As it stands, Simpson’s
Complaint does not plausibly allege that the off-label uses of Trasylol that Bayer promoted
lacked medical acceptance. This conclusion stems from the Court’s inability to reasonably infer
18

from the Complaint which particular off-label uses of Trasylol the 2000 DRUGDEX entry
considers unsupported.
The Complaint specifically alleges that Bayer promoted the off-label use of Trasylol in:
(I) valve replacement surgeries; (2) off-pump CABG surgeries; (3) surgeries involving pediatric
patients; (4) surgeries involving patients on the antiplatelet drug Plavix; (5) orthopedic surgeries;
and (6) liver transplant surgeries. (Compi.

¶J 146-52, 157,

164-65). Yet, with regard to the 2000

DRUGDEX entry, the Complaint vaguely alleges that “[a]lthough [that] entry lists numerous offlabel uses for Trasylol, none of these off-label uses are described as having ‘good’
documentation that they are both safe and effective, and some, such as orthopedic surgery, are
described as ‘ineffective.” (Id, at ¶ 175). It is unclear from this allegation which of the six offlabel uses mentioned above are unsupported by the 2000 DRUGDEX entry for Trasylol,” and
the Court cannot now look to Simpson’s Opposition Brief for clarity. See Commonwealth ofPa
cx rd. Zimmerman v. PepsiCo, Inc., 836 F.2d 173, 181 (3d Cir. 1988) (noting that it is
“axiomatic” that a plaintiff may not amend her complaint via her opposition brief). Instead,
Simpson must point to specific statements in the 2000 DRUGDEX entry to demonstrate that it
does not support each individual off-label use. Without pleading which particular off-label uses
are unsupported with specificity, the Court cannot reasonably infer which uses are not
“reasonable and necessary” under Medicare.
Alternatively, Simpson suggests that this Court need not consider the DRUGDEX
compendium, or any compendia at all, since “doing so.

.

.

ignores the fact (easily inferred from

[her] allegations) that the compendia listings themselves are the product of Bayer’s misbranding
With regard to the off-label use of Trasylol for orthopedic surgery, the Court finds insufficient support
for
Simpson’s position that DRUGDEX does not support that off-label use. Indeed, Bayer directs this Court’s
attention
to the 2000 DRUGDEX entry’s statement that the off-label use of Trasylol for orthopedic surgery “[m]ay
decrease
blood loss and transfusion requirements during and after major orthopedic surgery.” (Def.’s Br. 18 n.1
1; DeE’s Ex.
B § 4.5(G)(2)).

19

of Trasylol through consistent false and misleading statements, articles, and reports about the
drug’s safety and efficacy, including off-label uses.” (Pl.’s Opp’n Br. 20 (citation omitted)).
This suggestion is unavailing, since, as Bayer notes, the Complaint does “not allege[] a single
fact regarding what Bayer submitted to the compendia or how the compendia evaluated
Trasylol.” (Def.’s Reply Br. 8). Instead, Simpson alleges only that “[t]he DRUGDEX entry for
Aprotinin [Trasylolj was reviewed and approved by Bayer in 2000.” (Compl.

¶ 175). The Court

cannot plausibly infer from this statement that DRUGDEX and the other compendia are
unreliable because Bayer exerted undue influence, and that, as a result, the Court should ignore
them. In any event, it bears mentioning that section 50.4.2 of chapter 15 of the MBPM requires
the “consideration of the major drug compendia,” and Simpson has not pointed to any
qualifications to this language. Accordingly, the Court dismisses Counts VII and VIII of
Simpson’s Complaint without prejudice.
12
C.

Whether Simpson’s State and District of Columbia False Claims Act Causes of
Action Survive Dismissal

As discussed above, Simpson brings causes of action under the false claims acts of
twenty-one states and the District of Columbia. (Id. at
¶J 395-537, 545-46). Bayer contends
that this Court must dismiss these causes of action as premature because those jurisdictions
have
not validly declined to intervene. (Def.’s Br. 23-24). On October 16, 2013, John J. Hoffman,
the
Acting Attorney General for the State of New Jersey, filed a “Joint Notice of Election Decline
to
Intervention” with this Court. (ECF No. 137). He noted therein that the District of Columbia
and every state but Texas had specifically requested that New Jersey notify the Court
of their
decision to decline intervention. (See id.).

12

Since the Court dismisses Simpson’s misbranding causes of action (Counts I through VIII)
without prejudice, the
Court need not consider Bayer’s alternative grounds for dismissal of these causes of action.

20

Bayer argues that New Jersey’s filing did not validly decline intervention on behalf of the
states and the District of Columbia for two reasons. (Def.’s Br. 24). First, because that filing
does not comply with the specific non-intervention procedures set forth in each jurisdiction’s
false claims act. (Id.). Second, because New Jersey is not a party to this action. (Id.). Simpson
counters that New Jersey’s filing is sufficient since “Bayer does not explain how the filing fails
to provide notice.” (PL’s Opp’n Br. 30). In support, she cites to an unpublished opinion from
the District Court for the Southern District of West Virginia that implicitly deemed a similar
notice declining intervention acceptable. (Id. (citing US. ex rd. May v. Purdue Pharma L.P.,
No. 10-1423, 2012 WL 4056720, *4(S. D. W. Va. Sept. 14, 2012) rev’d on other grounds 737
F.3d 908 (4th Cir. 2013) (implicitly permitting the United States to decline intervention on behalf
of California, Georgia, Illinois, New York, and Tennessee))). Simpson further argues that there
is no conceivable reason to think that New Jersey misrepresented the requests of the states and
the District of Columbia. (Id. at 31).
“When interpreting a statute, ‘the literal meaning of the statute is the most important, and
[courts] are always to read the statute in its ordinary and natural sense.” In re Harvard Indus.,
Inc., 568 F.3d 444, 451 (3d Cir. 2009) (quoting Galloway v. United States, 492 F.3d 219, 233
(3d
Cir. 2007)). 1-lere, each jurisdiction’s false claims act requires either the jurisdiction or an
official thereof to notify the Court of that jurisdiction’s decision to decline intervention. Since
13

Specifically, the California statute requires the state “Attorney General” to “notify the court
that it declines to
proceed with the action....” Cal. Gov’t Code § 1 2652(b)(3)(B). The Delaware statute requires
the state
“Department of Justice” to “[njotify the court that it declines to take over the action....”
6 Del. C. § 1203(b)(4)(b).
The Florida statute requires the state “Department of Financial Services” to “[njotify
the court that it declines to take
over the action
Fla. Stat. Ann. 68.083(6)(b). The Georgia statute requires the state “Attorney General”
to
“[njotify the court that it declines to take over the civil action
Ga. Code Ann. § 49-4-168.2(c)(4)(B). The
Hawaii statute requires the “State” to “[njotify the court that it declines to take over the
action
Haw. Rev. Stat.
§ 66 1-25(d). The Illinois statute requires the “State” to “notify the court that it declines to take over the action..
740 Ill. Comp. Stat. 175/4(b)(4)(B). The Indiana statute provides that “[i]f the attorney
general or the inspector
general elects not to intervene in the action, the person who initially filed the complaint has
the right to prosecute the
action.” md. Code § 5-11-5.5-5(f). The Louisiana statute provides that
“[ilf the secretary [of the Department of
.

21

this procedure was not complied with here—only the Acting Attorney General of New Jersey
notified the Court—the Court grants Bayer’s motion to dismiss Counts XIII through XXX,
XXXII through XXXIV, and XXXVII. The Court also grants Bayer’s motion to dismiss
Count
XXXI of Simpson’s Complaint, her Texas false claims act cause of action, because Texas
has

not yet declined to intervene in this action. See V.T.C.A. Hum. Res. Code

§ 36.104(a)(2)

(requiring the “state” to “notify the court that [itj declines to take over the action” before it may
proceed). Since these causes of action are premature, the Court dismisses them without
4
prejudice.’
D.

Whether Simpson’s Remaining Causes of Action are Cabined by Any Applicable
Statutes of Limitations

Bayer moves to dismiss Simpson’s remaining causes of action, Counts IX through XII
and XXXVI, to the extent that they are premised on conduct predating the applicable statute of
limitations, (Def.’s Br. 27-29). Counts IX through XII allege, in essence, that because Bayer
Health and Hospitals, or his authorized designee,] or the attorney general does not intervene,
the qui tam plaintiff
may proceed with the qui tam action....” La. Rev. Stat. Ann. 46:439.2(B)(4)(a). The
Massachusetts statute
§
requires the state “attorney general” to “notify the court that he declines to take over the action
Mass. Gen.
Laws Ann. ch. 12 § 5C(4). The Michigan statute requires the state “attorney general” to
“notify the court and the
person initiating the action
[t]hat [he] declines to take over the action.
Mich. Comp. Laws Ann. §
400.61 Oa(3)(b). The Montana statute requires the “government attorney. to notify
the court that [he] declines to
take over the action.” Mont. Code Ann. § 17-8-406(3). The Nevada statute provides that
the state “Attorney
General or a designee of the Attorney General pursuant to NRS 357.070” must elect
“whether to intervene.” Nev.
Rev. Stat. Ann. § 3 57.080(4). The New Hampshire statute requires the “state” to “[n]otify
the court that it declines
to take over the action
N. H. Rev. Stat. Ann. § 167:61-c(II)(e)(2). The New Mexico statute requires the state
“attorney general” to “notify the court that the state. declines to take over the action
NMSA § 44-95(D)(2). The New York statute provides that “[i]f the state declines to participate in the
action or to authorize
participation by a local government, the qui tam action may proceed
N. Y. State Fin. Law § 190(2)(f. The
Oklahoma statute requires the “state” to “notify the court that it declines to take over
the action
Okia. Stat.
Ann. tit. 63 § 5053.2(B)(4)(b). The Rhode Island statute requires the “state” to “[n]otify
the court that it declines to
take over the action
R. 1. Gen. Laws Ann. § 9-1.1-4(b)(4)(ii). The Tennessee statute requires the “attorney
general and reporter” to “[n]otify the court that it declines to proceed with the action
Tenn. Code Ann. § 4-18104(b)(3)(B). The Virginia statute requires the “Commonwealth” to “notify the court
that it declines to take over the
action
Va. Code Ann. § 8.01-216.5(D). The Wisconsin statute requires the “attorney
general” to “[n]otify the
court that he or she declines to proceed with the action
Wis. Stat. Ann. § 20.93 1(5)(d)(2). Lastly, the District
of Columbia statute requires the “Attorney General for the District of Columbia”
to “[n]otify the court that he or she
declines to take over the action
D.C. Code § 2-381.03(b)(4)(B).
.

.

.

.

.

.

.

.“

.

.

14

Because the Court dismisses Simpson’s state and District of Columbia false claims
act causes of action on this
basis, the Court need not consider Bayer’s alternative grounds of dismissal for some
of these causes of action.

22

violated the Anti-Kickback Statute, 42 U.S.C.

§ 1 320a-7b(b), it in turn violated sections

3729(a)(1), (2), and (7) of the FCA by submitting false claims for Medicaid and Medic
are
reimbursement. (Compi.

¶ 366-94). Those Counts allege that Bayer submitted such false

reimbursement claims for Trasylol and another one of Bayer’s prescription drugs, Avelox
. (Id.).
Count XXXVI alleges that Bayer retaliated against Simpson, in violation of 31 U.S.C.

§ 3730(h).

In its motion to dismiss these remaining counts, Bayer argues that Simpson “cannot
sustain a cause of action under the FCA for Trasylol claims submitted more than six years
prior
to filing the complaint, on August 5, 2005.” (Id. at 27). Bayer further argues that Simps
on “may
not recover for alleged Avelox-related violations that occurred more than six years before
she
added these allegations—i.e., before July 24, 2006.” (Id. at 28). Simpson does not refute
these
arguments. (See Pl.’s Opp’n Br. 3 5-36).
The FCA generally bars relators from bringing “[a] civil action.. more than 6 years
.

after the date on which the violation of [the FCA] is committed.

15

31 U.S.C.

§ 3731 (b)( 1).

Thus, to the extent that Simpson’s remaining causes of action are based on Trasyl
ol-related
violations, they may proceed only insofar as they are predicated on violations of
the FCA
occurring on or after August 5, 1999. In addition, to the extent that Simpson’s remain
ing FCA
causes of action are based on Avelox-related violations, they may proceed only
insofar as they
are predicated on violations of the FCA occurring on or after July 24, 2000. If Simps
on chooses
to amend her Complaint, the Court instructs her to remove any time-barred allegat
ions.

15

The three-year tolling period set forth in 31 U.S.C. 3731(b)(2) applies only
when the Government elects to
§
intervene in a qui tam action. See US. ex rel. Bauchwitz v. Holloman, 671 F.
Supp. 674, 692-95 (offering a
thorough and well-reasoned explanation as to why such is the case). When
the Government declines to intervene,
the six-year statute of limitations set forth in 31 U.S.C. 373 1(b)(1) applies. Id.
§

23

IV.

CONCLUSION
For the reasons set forth above, the Court GRANTS Bayer’s motion to dismiss Counts I

through VIII, XIII through XXXIV, and XXXVII. In doing so, the Court dismisses those causes
of action without prejudice. The Court also instructs Simpson to remove any time barred
allegations from Counts IX through XII and XXXVI. Simpson may amend her Complaint
within thirty days if she chooses, but may do so only to: (1) allege the existence of a condition
of payment from the Government; (2) add allegations concerning the 2000 DRUGDEX entry for
Trasylol; and (3) remove time barred allegations from Counts IX through XII and XXXVI.
An appropriate Order accompanies this Opinion.

DATED: ofApril, 2014.

J9SEL. LINARES
DISTRICT JUDGE
.

24