United States Ex Rel. Keeler v. Eisai, Inc. ( 2014 )

Case: 13-10973 Date Filed: 06/11/2014 Page: 1 of 44
[DO NOT PUBLISH]
IN THE UNITED STATES COURT OF APPEALS
FOR THE ELEVENTH CIRCUIT
________________________
Nos. 13-10973; 13-11949
________________________
D.C. Docket No. 1:09-cv-22302-KMW
UNITED STATES OF AMERICA,
Ex rel., et al.,
Plaintiff,
MICHAEL KEELER,
Relator,
Plaintiff-Appellant,
versus
EISAI, INC.,
Defendant-Appellee,
100 TICE BLVD, et al.,
Defendants.
_______________________
Appeals from the United States District Court
for the Southern District of Florida
_______________________
(June 11, 2014)
Case: 13-10973 Date Filed: 06/11/2014 Page: 2 of 44
Before MARTIN, FAY, and SENTELLE, * Circuit Judges.
PER CURIAM:
We affirm the dismissal of this case for the reasons set forth in the district
court’s scholarly and thorough January 31, 2013, Order and its April 1, 2013,
clarification Order.
AFFIRMED.
*
Honorable David Bryan Sentelle, United States Circuit Judge for the District of
Columbia, sitting by designation.
2
Case: 13-10973 Date Filed: 06/11/2014 Page: 3 of 44
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF FLORIDA
Case No. 09-22302-CV-WILLIAMS
UNITED STATES OF AMERICA, et al.,
ex rel. Michael Keeler,
Plaintiffs,
vs.
EISAI, INC.,
Defendant.
ORDER
THIS MATTER is before the Court on Defendant Eisai Inc.’s (“Eisai”) Motion to
Dismiss (DE 95). Eisai is a Japanese manufacturer of pharmaceutical drugs. Michael
Keeler (“Relator”) was one of twenty-four sales representatives for Eisai’s United States
subsidiary, a position he held during a three-year period from sometime in 2006 through
April 2009. He initiated this qui tam action on August 4, 2009 under the False Claims
Act (“FCA”), which allows individuals to bring private actions in the name of the
Government against individuals who defraud the Government. 31 U.S.C. § 3730(b).1
1
More specifically, the Act imposes liability on anyone who knowingly presents “or
causes to be presented” a false claim for payment to be approved by the
government. 31 U.S.C. § 3729(a)(1) (2006). It also prohibits knowingly making,
using, or causing to be used “a false record or statement to get a false or
fraudulent claim paid or approved by the government.” Id. § 31 U.S.C.
3729(a)(2). The Fraud Enforcement of Recovery Act (“FERA”), Pub. L. No. 111-
21, § 4, 123 Stat. 1617 renumbered portions of the FCA and revised Section
(a)(2) - now Section (a)(1)(8) - so that it imposes liability on any person who
“knowingly makes, uses, or causes to be made or used, a false record or
statement material to a false or fraudulent claim.” Although this case was
commenced after the FERA’s June 7, 2008 effective date, the false claims
Case: 13-10973 Date Filed: 06/11/2014 Page: 4 of 44
After reviewing the pleadings and the parties’ arguments, the Court concludes that
although the Complaint - at 189 pages - recites numerous factual allegations and legal
conclusions,2 it fails to plead key elements of fraud in accordance with Federal Rule of
Civil Procedure 9(b). Because Relator has had ample opportunities to correct the
deficiencies, the Court will now dismiss his claims with prejudice.
I. BACKGROUND
Principally, Relator claims that Eisai promoted its drugs for non-approved uses
and paid medical providers to use its drugs in non-approved ways, which he personally
observed or became aware of while working at the company. According to Relator,
service providers allegedly submitted claims for reimbursement through government-
administered health care programs that were not reimbursable and with respect to
which they falsely certified that they had not received a kickback in connection with the
claim. Further, Relator contends that Eisai falsified drug payment information and
submitted it to the Government, thereby failing to give the Government preferred rates
as it was contractually obligated to do. The Complaint describes this conduct as
beginning in 2006 and continuing to this date.
alleged bridge that timeframe and implicate both versions of the law. See United
States ex rel. Hopper v. Solvay Pharmaceuticals, Inc., 588 F.3d 1318, 1327 n.3
(11th Cir. 2009). Nevertheless, the distinction between the old and new statutory
language is immaterial for purposes of the motion and for ease of convenience,
the Court refers to the superseded numbering. See United States ex Rel. Nowak
v. Medtronic, Inc., 806 F. Supp. 2d 310, 342 nn.19-20 (D. Mass. 2011).
2
In arguing against dismissal, Relator notes “the Complaint now contains 86 more
pages” than the previous complaint. As is made clear from this order, volume
does not necessarily equate to specificity.
Case: 13-10973 Date Filed: 06/11/2014 Page: 5 of 44
A. Off-Label Promotion
Relator contends that the Defendant marketed and promoted two cancer-treating
drugs, Ontak and Dacogen, for off-label uses, i.e., uses that go beyond what has been
approved after an exacting review process by the Food and Drug Administration. Ontak
was approved to treat cutaneous T-Cell lymphoma “for patients whose malignant cells
express the CD-25 component of the IL-2 receptor.” (Compl. ¶ 92.) Despite this, Eisai
allegedly promoted the drug for treatment of follicular non-Hodgkin’s lymphoma, chronic
lymphatic lymphoma, relapsed/refractory B-cell non-Hodgkin’s lymphoma, adult T-cell
leukemia lymphoma, peripheral T-cell lymphoma, graft versus host disease and
melanoma. (Id. ¶ 83).3 Dacogen is indicated solely for the treatment of myleodysplastic
syndromes, a condition in which bone marrow does not produce enough healthy blood
cells, but Eisai allegedly promoted it for treatment of acute myelogenous leukemia,
which is a cancer affecting blood cells. (Id. ¶¶ 165-66.)
As a sales representative for Eisai, who also attended company meetings and
interacted with other employees, Relator claims to have direct and personal knowledge
of the message Eisai sought to communicate to physicians. (Compl. ¶ 12-14, 54.)
While Eisai’s official policy was that off-label studies should not be distributed during
sales, he was “supplied with numerous articles of dubious scientific nature, touting
various off-label uses of Ontak which were to be distributed to physicians and referred
to during visits to physicians.” (Id. ¶¶ 87, 96, 125.) Apart from educating physicians
about the suitability of its drugs for other indications, Eisai “marketed the spread”: that
3
Additionally, Relator suggests that Eisai might have promoted Ontak for
cutaneous T-Cell lymphoma, a treatment outside the approved parameters.
(Compl. ¶¶ 92-93.)
Case: 13-10973 Date Filed: 06/11/2014 Page: 6 of 44
is, Eisai alerted certain providers of the profit to be earned based on the difference
between the discounted price of Ontak they received and the reimbursements they
would recoup. (Id. ¶ 129.) The “spread” was approximately $700 per dose
administered and motivated doctors to prescribe the drug as much as possible. (Id. ¶
133.)4 He alleges that sales representatives were trained to use similar tactics to
market Dacogen. (Id. ¶ 172.)
Eisai incentivized its representatives to act by providing “lucrative commissions to
its marketing force” and counting off-label sales toward representatives’ sales quotas.
(Compl. ¶ 36.) The pressure was such that Relator complained to his supervisor, David
Trexler, about having “to achieve the company’s required sales quotas which were
inflated because they included a high percentage of off-label sales.” (Id. ¶ 109.) In
October 2008, Eisai’s oncology sales representatives compiled sales information
showing that between 50 and 70 percent of Ontak’s total sales were derived from off-
label sales. (Id. ¶ 111.)
In the Complaint, Relator refers to just a few instances in which Eisai engaged in
this promotional conduct. For example, in November 2006, Relator was a trainee in an
Ontak sales class in which he received off-label studies to use in making presentations
to physicians and other similar materials. (Compl. ¶¶ 81-82, 88-90.) At an unspecified
time and with no details of its contents, an Eisai District Manager distributed a paper
advocating off-label use of Ontak to sales representatives. (Id. ¶ 90.) In June 2007,
4
Because of this, at least one medical institution, the University of Louisville
Cancer Center, was ultimately persuaded to purchase Ontak for off-label
treatment. (Compl. ¶ 131 (“The University of Louisville Cancer Center was an
institution persuaded to purchase Ontak for the off-label treatment of melanoma
due to the “spread.’”).)
Case: 13-10973 Date Filed: 06/11/2014 Page: 7 of 44
Eisai’s director of research wrote an e-mail to Eisai’s sales managers suggesting that an
unapproved off-label marketing update (which is not further described) should be shown
to providers but not left with them. (Id. ¶ 99.) 5 At an unspecified time and without
elaboration, Eisai’s Vice President of Sales, Leslie Mirani, instructed unknown sales
representatives to promote Dacogen for off-label use, to promote longer administration
at more frequent intervals, and to use larger dosages. (Id. ¶ 174.) Finally, without
describing who was involved, where it occurred, or when it was said, Relator claims he
“was directed to tell physicians . . . that there were studies showing that CD-25
positive/negative made no difference in the treatment of patients, which was known to
be untrue.” (Id. ¶ 93.)
Beyond employing its sales force to deliver such sales messages, Relator
alleges that Eisai engaged physicians to promote off-label uses. “Dr. Peter Heald was
compensated by Eisai to speak and write articles on off-label uses of Ontak.” (Compl.
¶¶ 90, 154.) Additionally, Lauren Pinter-Brown, M.D. was paid $20,000 as another
Ontak consultant and spoke to a group of South Florida physicians in 2008 about off-
label uses of Ontak and “presenting claims to Medicare and Medicaid.” (Id. ¶¶ 154,
164, 249.) And in October 2008, Dr. Francine Foss spoke at a dinner in South Florida
“on the use of Ontak for treating peripheral T cell lymphoma.” (Id. ¶ 153.)6
5
Eisai’s director of research “routinely provided Eisai sales representatives
updates and information on studies, events, and use of Ontak for various off­
label uses for the sales representatives to use in their marketing and promotion
of Ontak.” (Compl. ¶ 98.)
6
Through “Advisory Board” meetings starting in 2008, Eisai hired doctors to speak
about off-label uses for Ontak and Dacogen and hosted conferences at high-end
resorts. (Compl. ¶¶ 152-54.) Attendees were “frequently paid thousands of
dollars for their attendance.” (Compl. ¶ 158.) Two speakers - Drs. Dang and
Case: 13-10973 Date Filed: 06/11/2014 Page: 8 of 44
According to the allegations, doctors were also paid to conduct off-label studies.
Relator provides a single example of this: a doctor named Nam Dang, M.D. was paid
$50,000 in consulting fees, and authored “clinical studies related to the off-label use of
Ontak for unapproved conditions, including B-cell lymphoma and [peripheral T-cell
lymphoma].” (Compl. ¶ 248.) Dr. Dang was also identified as an Eisai contact to
physicians, who were told to “call [him] directly with questions about the suitability of
Ontak for off-label uses.” (Id. ¶¶ 148, 154, 248.) 7
Additionally, Eisai funded hospitals for their role in facilitating Eisai’s promotion of
off-label uses of its products to doctors. In March 2007, the University of Miami
Sylvester Cancer Center was given an “educational grant” to allow a doctor to make a
presentation on Ontak’s approved uses, but which ultimately addressed the off-label
use of Ontak. (Compl. ¶¶ 148-49.) Likewise, in July 2007, the University of Arizona and
a doctor received a “preceptorship” grant, which was followed by that doctor presenting
on Ontak’s use for treatment of 8-cell lymphoma. (Id. ¶ 150.) Relator believes that
similar educational grants were given to two other facilities – the Dana Farber Cancer
Center and the Lurie Cancer Center at Northwestern University. (Id. ¶ 151.)
Finally, although it is not tied to any payment, prescription, or claim submission,
Relator makes much of Eisai’s Oncology Reimbursement Assistance (“OAR”) Program,
Foss - received $50,000 and $25,000, respectively, on an annual basis in
speaking and consulting fees. (Compl.164.)
7
The complaint also briefly mentions that Dr. Foss was paid “to conduct supposed
clinical trials which were not submitted to the FDA . . . primarily to encourage and
reward Dr. Foss and [her institution] for prescribing Ontak off-label and making
false and fraudulent claims to Medicare and Medicaid.” (Compl. ¶ 256(a).) It is
unclear whether the results of this study were included in marketing materials
sent to physicians. (See Compl. ¶ 88 (referring to a “Foss paper”).)
Case: 13-10973 Date Filed: 06/11/2014 Page: 9 of 44
which guaranteed that prescribers would be paid at Medicare rates. As purportedly
reflected in an e-mail that Relator sent to an Eisai employee in March 2007, Eisai
promised to cover the price of Ontak if it was not covered in whole or in part by
Medicare when a claim was submitted, regardless of whether it was ultimately approved
or rejected by the Government. (Compl. ¶¶ 139, 146.) 8 Relator alleges that this
practice “greatly increase[ed] the number of drug prescriptions and, indirectly, the
amount of money spent by the federal government for reimbursement of prescriptions
covered by the Government Health Care Programs.” (Id. ¶¶ 139-141.) More to the
point, he alleges that this practice was a recognition by Eisai that off-label uses might
not be reimbursed by the government. (Id. ¶¶ 142-43.) Relator claims that unnamed
Eisai sales representatives were trained at unspecified times to deliver messages that
Relator loosely describes in his Complaint as “essentially” comprised of the following:
Medicare could reject these claims because you’re prescribing Ontak for
an offlabel use. But don’t worry: We’ll coach you on the claims
submission process to optimize reimbursement. With our tips on coding,
these claims submissions will fly below the radar. Trust us. Besides,
we’ve got your back—If Medicare or Medicaid doesn’t pay you, we will
ensure that you are not out of pocket!
(Id. ¶ 142.)
8
The e-mail states in relevant part: “FCS financial coordinator called me they are
having problems getting the [Ontak] credit from the wholesaler even though we
have officially taken care of everything on our end. I asked her to send me an
email with what’s going on with wholesaler names & emails. That’s the 1st
problem that occurred today.” Although not entirely straightforward, Relator
contends that “[t]his e-mail reflects the existence of the OAR Program, and
Eisai’s efforts to assure providers that they would not be out-of-pocket when a
claim for reimbursement of Ontak was not approved.” (Compl. ¶ 146.)
Case: 13-10973 Date Filed: 06/11/2014 Page: 10 of 44
B. Kickbacks
Next, Relator alleges that Eisai engaged in a “nationwide system” of kickbacks as
part of its marketing strategy. (Compl. ¶ 33.) In addition to the payments to physicians
for conducting off-label studies and advocating off-label use and payments to hospitals
for hosting related lectures, 9 Relator cites several other instances of what he takes to
constitute illegal kickbacks: “any money, fee, commission, credit, gift, gratuity, thing of
value, or compensation of any kind which is provided, directly or indirectly, to any prime
contractor, prime contractor employee, subcontractor or subcontractor employee, for the
purpose of improperly obtaining or rewarding favorable treatment in connection with a
prime contract or in connection with a subcontract relating to a prime contract.” (Id. ¶¶
20-21 (quoting 41 U.S.C. §§ 52-53).)
However, there few details regarding the payments these health care providers
received from Eisai. For example, Relator contends that at an unidentified Tampa
resort at some point in 2007, one unnamed physician received $3,000 in
accommodations relating to his attendance at a lecture “focus[ing] on Ontak’s use for T-
cell lymphoma and other cancers.” (Compl. ¶ 157.) In July 2007, unspecified “[m]onies”
were paid to a “Dr. Miller” for making a “presentation regarding use of Ontak for B cell
lymphoma.” (Id. ¶ 150.) And without elaboration, Relator claims that “[o]ther
physicians promoting off-label use of Ontak who received very substantial
compensation from Eisai were Dr. Nam Dang, Nevada Cancer Center, Dr. Pinter-
Brown, UCLA, Dr. Timothy Kuzel with Northwestern, and Dr. Peter Heald, a
9
The kickback allegations overlap significantly with details of Eisai’s scheme to
promote off-label uses, particularly aspects that involved payments to physicians
and hospitals for their assistance in promoting Eisai’s drugs.
Case: 13-10973 Date Filed: 06/11/2014 Page: 11 of 44
dermatology professor.” (Id. ¶ 154.) “[S]imilar educational grants were paid in return
for off-label presentation access to such well-known cancer treatment centers as:
the Dana Farber Cancer Center in Boston, Lurie Cancer Center at Northwestern
University in Chicago, and the M.D. Anderson Cancer Center in Houston, Texas.”
(Id. ¶ 151.)
C. Submission of False Claims for Reimbursement
Relator alleges that any claim for reimbursement resulting from Eisai’s off-label
promotion or payment of kickbacks is fraudulent, unreimbursable, and constitutes a
“false claim” within the meaning of the FCA. (Compl. ¶¶ 135, 219, 229.) Providers can
receive payment by submitting claims through three government-funded programs:
Medicare, which provides health services for individuals 65 and older (Compl. ¶ 2);
Medicaid, which provides health services to low-income individuals, and is paid for by
states that are reimbursed to some degree by the federal government (Id. ¶ 3); and
TRICARE, which provides health services to military personnel and their dependents.
(Id. ¶ 4.)
With respect to kickbacks, providers seeking Medicare coverage agree that their
claims are “conditioned upon the claim and the underlying transaction complying with
[Medicare] laws, regulations, and program instructions (including, but not limited to, the
Federal anti-kickback statute and Stark law, and on the [provider’s] compliance with all
applicable conditions of participation in Medicare.” (Id. ¶ 224.) Similar language is
contained in certifications accompanying cost reports they must submit. (Id. ¶¶ 225-
226.)10 Individual state statutes control Medicaid reimbursements, but they generally
10
In greater detail, the complaint alleges that:
Case: 13-10973 Date Filed: 06/11/2014 Page: 12 of 44
provide that payment may be withheld for fraud or misrepresentation, concealment of a
material fact, or receipt of a kickback in connection with furnishing treatment. (ld. ¶¶
230-237.) According to Relator, kickbacks run afoul of the FCA because Medicare
participants must certify compliance with the Anti-Kickback Act to receive payments for
prescriptions given to their Medicare patients. (ld. ¶ 23.) Alternatively, because the
Government would not have paid the claims had it known of the violation of a law, they
are false under an “implied certification” theory. (ld. ¶ 31.)
However, there are few details to support a conclusion that any hospital or doctor
that received payments from Eisai as described above - assuming they constitute
224. In order to be eligible for Medicare reimbursement, both hospitals
and doctors are required to sign a Provider Agreement which states:
“I agree to abide by the Medicare laws, regulations and program
instructions that apply to [me]....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 Stark law), and on the [provider’s] compliance with all
applicable conditions of participation in Medicare.
225. Hospitals, but not physicians, are also required to submit a Hospital
Cost Report with their submissions of requests for claims
reimbursement. It states: punishable by criminal, civil and
administrative action, fine and/or imprisonment under federal law.
Furthermore, if services identified in this report [were] provided or
procured through the payment directly or indirectly of a kickback or
where otherwise illegal, criminal, civil and administrative action,
fines and/or imprisonment may result.
226. The person signing the Hospital Cost Report must certify: “To the
best of my knowledge and belief, [the Hospital Cost Report] is a
true, correct and complete statement prepared from the books and
records of the provider in accordance with applicable instructions,
except as noted. I further certify that I am familiar with the laws and
regulations regarding the provision of health care services, and that
the services identified in this cost report were provided in
compliance with such laws and regulations.
Case: 13-10973 Date Filed: 06/11/2014 Page: 13 of 44
kickbacks - submitted a claim for reimbursement. As best the Court can tell, Dr. Foss,
whose role is otherwise described as a speaker and director of off-label studies,
“prescribe[ed] Ontak off-label and ma[de] false and fraudulent claims to Medicare and
Medicaid.” (Compl. ¶ 256(a).) The Dana Farber Cancer Center and the M.D. Anderson
Cancer Center appear on a company report as having purchased Ontak, a purchase for
which Relator believes they sought reimbursement. (Id. ¶ 240.) Dr. Pinter-Brown was
paid for serving as a consultant; at one point in the Complaint, Relator refers to the fact
that she “made off-label Ontak claims to Medicare and Medicaid.” (Id. ¶ 249.) Finally,
the Complaint suggests that the most frequent lecturers were also the top off-label
prescribers. (Compl. ¶¶ 156, 163). As discussed below, without more, these
conclusory allegations are insufficient to assert that claims were actually submitted to
the Government for reimbursement.
Similarly, with regard to off-label promotion - assuming this activity can render a
claim false - there are few allegations to support Relator’s assertion that doctors who
were persuaded by Eisai to prescribe medication off-label submitted claims to the
Government. With respect to the three doctors who were paid for speeches regarding
Ontak as described above - Drs. Heald, Pinter-Brown, and Foss - the Complaint is
conspicuously silent as to whether any prescribing doctor was in attendance or whether
any speaker caused any particular off-label claim to be submitted. The same is true of
Dr. Dang, who was allegedly hired as Eisai’s consultant and to conduct off-label studies,
and the hospitals that were paid to host off-label presentations. In sum, it is unclear
whether any doctor who attended any of those lectures, read any of those articles or
Case: 13-10973 Date Filed: 06/11/2014 Page: 14 of 44
studies, or spoke to Eisai’s consultants were persuaded to make off-label prescriptions
and to seek reimbursement for them.
Nevertheless, the Complaint does provide limited discussion of submissions that
resulted from Eisai other promotional activities. Over a nine month period, Eisai sales
representatives made in-person sales calls to three doctors at Baptist Hospital, stating
that clinical data demonstrated that Dacogen was effective for an off-label indication and
leaving behind Eisai-sponsored studies and marketing materials. (Compl. ¶ 177.)
According to the Complaint, Baptist Hospital then used Dacogen for non-approved
uses. (Id. ¶ 177.) Relator alleges that Eisai “intended that [its] above-described
marketing practices would result in the submission of off-label claims to Medicare and
Medicaid” and that they “caused [the hospital] to submit false or fraudulent claims . . .
which were approved and paid by Medicare and Medicaid respectively.” (Id. ¶ 178.)
Relator makes verbatim allegations with respect to in-person sales calls by unspecified
“Eisai sales representatives” to two doctors at Memorial Regional Hospital, two doctors
at Sylvester Cancer Center, and two doctors at Boca Raton Community Hospital. (Id.
¶¶ 179-184.) Relator asserts that the promotions and other activities resulted in false
claims by roughly two dozen hospitals during the two-and-a-half year timeframe of the
Complaint and Relator provides approximate dollar figures based on his estimation. (Id.
¶¶ 57, 59, 256.)
Relator also alleges that Eisai was directly involved in falsifying submissions.
Without specifying exactly who, where, when, or what statements were made, the
Complaint states that Eisai hired reimbursement specialists to coach physicians,
hospitals, and other medical providers on how to present off-label Ontak claims for
Case: 13-10973 Date Filed: 06/11/2014 Page: 15 of 44
reimbursement, including through telephone support. (Compl. ¶¶ 241-42.) For
instance, Eisai recommended that they provide an “off-label secondary diagnosis
code[]” on a Medicare claim form, such as diabetes. (Id. ¶¶ 241-246.)11 Through this,
Eisai intended and caused false claims for payment to be submitted to Medicare and
Medicaid. (Id. ¶¶ 243-45.)
The most significant document Relator points to regarding false submissions is a
GOERS report, which was provided to Eisai’s sales representatives. This report shows
the number of units of Ontak that Eisai sold to 188 named providers, and lists their
addresses and reporting dates. (Compl. ¶¶ 59, 238, 240; Compl. Ex. G.) Although the
report provides little more than the provider’s name and the quantity of drugs each had
bought by a certain date (notably, it includes no billing information, such as dollar value
of the sales and how much was reimbursed by the Government}, he alleges that he
“was informed by managers that the providers listed in the GOERS report routinely bill
Medicare and Medicaid.” (Id. ¶ 240.) Based on his own experience, Relator estimates
that of his $5.5 million in sales of Ontak, twenty-five percent was later falsely or
fraudulently submitted to Medicare for reimbursement and two percent was submitted to
Medicaid. (Id. ¶ 255.) He further estimates that 2,000 hospitals, oncology offices,
11
Like other allegations, this claim fails to identify who was involved, what precisely
was said at what time and in which location, or whether there were any specific
instances where a prescriber followed Eisai’s guidance. Moreover, the Court is
unsure how the statement furthers the scheme alleged. There is no allegation
that using such codes reflected false diagnoses - that is, that the patient did not
suffer from diabetes- and there is no explanation of how listing them rendered
the claims more likely to be reimbursed.
Case: 13-10973 Date Filed: 06/11/2014 Page: 16 of 44
oncologists, and pharmacies submitted claims that involved off-label promotion or
kickbacks. (Id. ¶ 59.)
D. Best Price Violations
While all other allegations assert that Eisai engaged in conduct that caused false
claims to be filed, Relator asserts one way in which Eisai made a false claim to the
Government directly - falsely reporting pricing information. Medicare and Medicaid
rebate programs ensure that pharmaceutical companies offer state governments
reimbursement rates for drugs that are no greater than the rate charged to other entities
(i.e., manufacturers must provide the Government with the “Best Price”). (Compl. ¶¶
187-88.) As part of the agreement to provide such rebates, manufacturers must make
quarterly reports that disclose pricing information for covered drugs, including the best
price offered to any purchaser. (Id. ¶¶ 188-89, 191.) Relator contends that Eisai
falsified information about its drug pricing to the Government with respect to Ontak,
Dacogen, and two other drugs: Aloxi, which is used to treat nausea caused by
chemotherapy, and Fragmin, which is used to treat blood clots caused by cancer or
heart conditions. (Id. ¶¶ 185-86.) Relator alleges that this conduct is actionable under
the FCA. (Compl. ¶ 192.)
These drugs were highly profitable to Eisai, but also faced stiff competition from
rival manufacturers making versions under their own name. (Id. ¶¶ 194-96.)
Accordingly, Eisai gave prospective buyers aggressive discounts, which were approved
at the sales representative and management level, but not tracked centrally by Eisai.
(Id. ¶¶ 194, 196.) Eisai’s discounts were based on volume and bundling with other
drug sales. Relator was told by unnamed supervisors that Eisai’s best customers were
Case: 13-10973 Date Filed: 06/11/2014 Page: 17 of 44
allowed volume discounts that were not included on company price lists or information
sent to the Government. (Id. ¶ 201.) At a conference in 2008, Relator and other sales
representatives learned that Eisai planned to falsely report an increase in the cost of
Aloxi - which would increase its average sales price - and obtain a higher
reimbursement rate from Medicare and Medicaid. (Id. ¶¶ 204-05.) In reality, because
of discounts offered to physicians, the sales price was decreasing. (Id. ¶ 205.) At a
sales meeting in 2008, an Eisai sales representative named “Frank” told Relator that
“[n]obody else” but Jackson Memorial Hospital in Miami, Florida was getting a low price
on Fragmin. (Id. ¶¶ 207-08.) While he did not specify a price that Jackson paid or the
price Eisai reported to the Government, he mentioned that “[w]e are almost giving it
away.” (Id. ¶ 207.) And finally, two upper level Eisai managers launched a plan to
bundle Aloxi and Dacogen in order to “gain a formulary position at each institution
purchasing them.” (Id. ¶¶ 214-15.)
E. Procedural History
This case has a procedural history commensurate with the breadth and
complexity of the allegations. After his initial complaint, Relator filed an amended
complaint on July 8, 2010 (DE 19). 12 On February 24, 2011, the Government filed a
notice declining to intervene in this action, leaving Relator to prosecute this action on its
12
Additionally, while it does not involvethe issues currently before the Court, Keeler
brought an action for retaliation under Florida’s Whistleblower’s Protection Act in
state court sometime after filing his initial complaint under seal in this case. That
action was removed to federal court and re-captioned Keeler v. Eisai Inc., No.
10-cv-60959 (S.D. Fla.). Keeler and Eisai then reached a settlement of their
claims that resulted in the dismissal of that action with prejudice. As part of the
settlement, Keeler executed a release of claims against Eisai, but failed to
disclose the existence of this qui tam action, which was still under seal. The
Court previously ruled that Keeler’s qui tam claims can proceed because they
were already pending at the time of the release and could only be dismissed with
the consent of the Court and the Attorney General. (See DE 61.)
Case: 13-10973 Date Filed: 06/11/2014 Page: 18 of 44
behalf. 13 The Court subsequently ordered that the complaint be unsealed and served
upon the Defendant (DE 25). The First Amended Complaint was dismissed by order
dated June 21, 2011 (DE 61). Relator filed a Second Amended Complaint on July 1,
2011 (DE 62) and a Third Amended Complaint on July 29, 2011. The Court had
warned Relator that he “will not be afforded any more opportunities to amend his
complaint.” (DE 85.)
Based on the allegations described above, Relator essentially brings three
distinct claims. Count I alleges that Defendant’s promotion of off-label uses caused
doctors to prescribe drugs for off-label purposes and submit false claims for
reimbursement, violating the False Claims Act. Second, in that same Count, Relator
alleges that Eisai failed to provide the Government with “best prices” for Ontak,
Dacogen and two other drugs, Aloxi and Fragmin. Finally, Count II alleges that Eisai
paid prescribers to induce them to prescribe Eisai’s drugs and to submit claims for
reimbursement to Medicare and Medicaid, and also paid for physicians’ speeches and
for physicians to conduct off-label clinical trials. In so doing, Relator asserts that Eisai
violated the Anti Kickback Act, 41 U.S.C. §§ 52 et seq., and by extension, the FCA.14
13
Although the United States declined to intervene in this suit, it filed a statement of
interest in connection with the instant motion. The United States takes no
position on “whether the relator has adequately plead[ed] facts that would state a
cognizable claim under the FCA as properly interpreted” and “whether the relator
has sufficiently plead[ed] elements of falsity, causation, or materiality.” (DE 110,
at 2.)
14
Counts I and II seek relief under § 3729(a)(1) and (a)(2) of the False Claims Act,
as amended by FERA. Count II alleges that Eisai violated the Anti-Kickback Act,
rendering false the claims of health care providers for purposes of the FCA.
(Compl. ¶¶ 30.)
Case: 13-10973 Date Filed: 06/11/2014 Page: 19 of 44
Because of this conduct, Relator also brings claims under various state anti-fraud
statutes (Counts III-XXXII). Eisai has moved to dismiss primarily on the ground that
Relator has failed to sufficiently state a claim.
II. LEGAL STANDARD
To survive a Rule 12(b)(6) motion to dismiss, a plaintiff must plead sufficient facts
to state a claim that is “plausible on its face.” Ashcroft v. Iqbal, 556 U.S. 663, 678
(2009) (quoting Bell Atlantic Corp. v. Twombly, 550 U.S. 544, 570 (2007)). The Court’s
consideration is limited to the allegations presented. See GSW, Inc. v. Long Cnty., 999
F.2d 1508, 1510 (11th Cir. 1993). All factual allegations are accepted as true and all
reasonable inferences are drawn in the plaintiff’s favor. See Speaker v. U.S. Dep’t of
Health & Human Servs. Ctrs. for Disease Control & Prevention, 623 F.3d 1371, 1379
(11th Cir. 2010); see also Roberts v. Fla. Power & Light Co., 146 F.3d 1305, 1307 (11th
Cir. 1998). Nevertheless, while a plaintiff need not provide “detailed factual allegations,”
the allegations must consist of more than “a formulaic recitation of the elements of a
cause of action.” Twombly, 550 U.S. at 555 (internal citations and quotations omitted).
Additionally, “conclusory allegations, unwarranted factual deductions or legal
conclusions masquerading as facts will not prevent dismissal.” Davila v. Delta Air Lines,
Inc., 326 F.3d 1183, 1185 (11th Cir.2003). The “[f]actual allegations must be enough to
raise a right of relief above the speculative level.” Watts v. Fla. lnt’l Univ., 495 F.3d
1289 (11th Cir. 2007) (quoting Twombly, 550 U.S. at 545).
In addition to the requirements of Twombly, Iqbal, and Federal Rules of Civil
Procedure 8(a) and 12(b)(6), claims asserted under the False Claims Act (as well as
other fraud claims) are subject to the pleading standards of Federal Rule of Civil
Case: 13-10973 Date Filed: 06/11/2014 Page: 20 of 44
Procedure 9(b). See United States ex. rel. Clausen v. Laboratory Corp. of Am., Inc. ,
290 F.3d 1301, 1309-10 (11th Cir. 2002). 15 That rule provides that “[i]n allegations of
fraud or mistake, a party must state with particularity the circumstances constituting
fraud or mistake” but that “[m]alice, intent, knowledge, and other condition of mind of a
person shall be averred generally.” FED. R. CIV. P. 9(b). Rule 9(b) is satisfied if the
plaintiff pleads “(1) precisely what statements were made in what documents or oral
representations or what omissions were made, and (2) the time and place of each such
statement and the person responsible for making (or, in the case of omissions, not
making) same, and (3) the content of such statements and the manner in which they
misled the plaintiff, and (4) what the defendants obtained as a consequence of the
fraud.” Ziemba v. Cascade lnt’l, Inc., 256 F.3d 1194, 1202 (11th Cir. 2001) (quoting
Brooks v. Blue Cross & Blue Shield of Fla., Inc., 116 F.3d 1364, 1371 (11th Cir. 1997)).
In the context of the False Claims Act, the complaint must set forth “facts as to
time, place, and substance of the defendant’s alleged fraud” and “the details of the
[defendant’s] allegedly fraudulent acts, when they occurred, and who engaged in them.”
Clausen, 290 F.3d at 1309-10 (quotation omitted); accord United States ex rel. Sanchez
v. Lymphatx, Inc., 596 F.3d 1300, 1302 (11th Cir. 2010). “Underlying schemes and
other wrongful activities that result in the submission of fraudulent claims are included in
the ‘circumstances constituting fraud or mistake’ that must be pled with particularity
pursuant to Rule 9(b).” United States ex. rel. Karvelas v. Melrose-Wakefield Hosp., 360
15
Based on the Eleventh Circuit’s FCA precedent, the Court rejects Relator’s
suggestion that because he is pursuing a false claim and not a fraudulent claim,
the pleading requirements applicable to fraud claims are not controlling. (See
Opp’n at 9.) Accordingly, Relator is incorrect that he need not provide the “who,
what, where, when” of fraud under that rule. (Opp’n at 9.)
Case: 13-10973 Date Filed: 06/11/2014 Page: 21 of 44
F.3d 220, 232 (1st Cir. 2004). As discussed herein, the Eleventh Circuit has recognized
that while these requirements of Rule 9(b) may, in practice, make it difficult for a qui tam
plaintiff to bring an action, they are necessary to prevent “[s]peculative suits against
innocent actors for fraud” and charges of guilt by association. Clausen, 290 F.3d at
1308 (quoting United States ex rel. Cooper v. Blue Cross & Blue Shield of Fla., 19 F.3d
562, 566-67 (11th Cir. 1994) (per curiam)).
III. DISCUSSION
The Court previously found that Relator stated a claim under Rule 12(b)(6), but
that his claims were not pleaded with the degree of particularity required by Rule 9(b).
Significantly, Relator failed to describe specifically what Eisai did to cause false claims
to be submitted, omitted critical details of claim presentation, and did not describe how
the alleged kickbacks “crossed the line from legal conduct in compliance with federal
statutes to illegal kickbacks.” (DE 61.) 16 Now, despite having greatly expanded his
pleading and having crafted additional arguments to support his FCA claims, Relator’s
complaint - however prolix - fails to provide the requisite particularity to survive
dismissal. The Court addresses each of Relator’s claims in turn.
16
In particular, Judge Ungaro, who presided over this action until it was transferred
to the undersigned on September 8, 2011 (DE 99), held that “Plaintiff fails to
identify with particularity a false claim that was presented to the government as a
result of Defendant’s conduct. Plaintiff fails to identify who presented the claim,
what it was for, when it was presented, and what specific conduct on the part of
the Defendant caused the presentment of the claim.” (DE 61). For purposes of
this order, the Court presumes that Relator’s claims are not subject to dismissal
under Rule 12(b)(6).
Case: 13-10973 Date Filed: 06/11/2014 Page: 22 of 44
A. Scheme to Promote Off-Label Uses
The bulk of Relator’s complaint is focused on imposing liability under the FCA
due to Eisai’s scheme to promote off-label use of its pharmaceutical products. 17 Section
(a)(1) requires that the Defendant make or cause a claim to be made; that the claim was
false; that the falsity was known to the Defendant; and that payment was actually
sought from the Government. Under the FCA’s “cause to be submitted” language, a
defendant may be liable notwithstanding the fact that it was not the submitter of a claim
or that it was not in contractual privity with the government. United States v. Tauber
Extrusions, LP, 341 F.3d 843, 835 (8th Cir. 2003) (quoting, inter alia, United States ex
rel. Marcus v. Hess, 317 U.S. 537, 544-45 (1943)). According to the Complaint, Eisai
allegedly did this in four ways: (1) Eisai trained sales representatives to promote off-
label uses (providing incentives to do so), gave prescribers materials showing off-label
effectiveness, and marketed the spread; (2) Eisai paid consulting doctors to promote
such uses and to conduct off-label clinical studies; (3) Eisai gave medical facilities
grants and other payments for supporting Eisai’s promotion; and (4) Eisai ran
reimbursement programs to guarantee payment for off-label prescriptions to doctors.
The Court need not delve into the myriad arguments made by the parties in their
extensive briefing since there are immediately apparent defects regarding the
circumstances of the fraud. 18 As to the fraud’s “who” and “where,” although Relator
17
Keeler asserts that this is a “cause to be submitted’ case in which Eisai has
caused providers to present claims for improper Medicare and Medicaid
reimbursement, stemming from Eisai’s schemes.” (Opp’n at 12.)
18
The parties’ prolific briefing does not focus on the central, threshold question for
the Court - whether the claims properly plead the circumstances of the fraud.
Rather than addressing the actual allegations of the Complaint, Plaintiff
Case: 13-10973 Date Filed: 06/11/2014 Page: 23 of 44
concentrates on the standard of review, arguing that this Court need not adhere
to the Eleventh Circuit’s precedent applying Federal Rule of Civil Procedure 9(b)
to qui tam actions like this one. As noted above, the Court rejects that argument.
And for the reasons explained below, the Court declines to relax the pleading
requirements under the circumstances here.
For its part, Defendant seeks a ruling that no false claim is implicated as a matter
of law because even if Eisai promoted its drugs for off-label uses and they were
prescribed for an off-label use, the claims were still reimbursable. Cases
recognize that while off-label promotion is an illegal act under federal law, a
relator may not have standing to bring suit for it; a defendant is not subject to
FCA liability unless it seeks government compensation (or causes someone else
to seek compensation) for which it is not entitled. See United States ex rel.
Bennett v. Boston Scientific Corp., No. H-07-2467, 2011 WL 1231577, at *12
(S.D. Tex. Mar. 31, 2011) (collecting authority). Looking at the reimbursement
requirements of the government programs at issue, Defendant asserts that off­
label prescriptions are reimbursable if a physician determines that the use is
medically reasonable and necessary. See, e.g., 42 U.S.C. § 1395y(a)(1)(A).
Because of that statutory language and because the Court is not bound to accept
a plaintiffs assertions regarding legal conclusions, Defendant suggests that the
Court should find that the off-label allegations could never implicate a false claim.
However, other courts, including the Eleventh Circuit, have declined to address
this issue where, as here, Plaintiff fails to sufficiently articulate the details of the
fraud. See Solvay, 588 F.3d at 1326 (assuming “arguendo that when a physician
writes an off-label prescription with knowledge or intent that the cost of filling that
prescription will be borne by the federal government, and when a claim is
ultimately submitted to the federal government to pay for that prescription, 31
U.S.C. § 3729(a)(1) may have been violated,” but dismissing the complaint for
failure to link promotion to submission of false claims); see also United States ex
rel. Carpenter v. Abbott Labs., Inc., 723 F. Supp. 2d 395, 410 (D. Mass. 2010).
While the Court ultimately does not reach the issue of whether Defendant’s
theory is correct as a matter of law, it notes that it would have difficulty accepting
that Relator’s allegations, as pleaded, satisfy the FCA’s falsity requirement.
Relator has not developed, in pleading or in argument, how the mere act of
promoting the subject drugs resulted in the submission of a claim containing a
false representation. See United States ex rel. Hess v. Sanofi-Synthelabo, Inc.,
No. 4:05CV570MLM, 2006 WL 1064127, at *10 (E.D. Mo. Apr. 21, 2006)
(requiring a relator basing a claim on a promotion scheme to allege “conduct
which was designed to present false information”); see also Nowak, 806 F. Supp.
2d at 345-46. For instance, he does not contend that a prescribing physician
falsely represented that the treatment was for an indicated condition when
seeking reimbursement from the Government. Similarly, he has not alleged that
a claim for reimbursement is the equivalent of a representation that the
requested service is covered, that submission of off-label claims runs afoul of any
Case: 13-10973 Date Filed: 06/11/2014 Page: 24 of 44
specified receiving training and marketing materials advocating off-label use, he has
failed to properly demonstrate Eisai’s act of promotion. Relator has not alleged which
individuals at Eisai instructed him (or other sales representatives) to fraudulently
promote off-label uses, what those instructions were, which doctors sales
representatives contacted and induced to prescribe Eisai’s drugs, and what was said to
them to cause them to do so. There are no allegations that Eisai’s inducing statements
themselves were expressly false with the exception of one conclusory allegation that he
“was directed to tell physicians . . . that there were studies showing that CD-25
positive/negative made no difference in the treatment of patients, which was known to
be untrue.” (Compl. ¶ 93.) He has not alleged, for instance, that off-label studies Eisai
provided to physicians contained false data, that its representatives gave the impression
that the drugs were reimbursable when they were in fact not, or that Eisai
misrepresented the indications for which the drugs were approved. See Bennett, 2011
WL 1231577, at *26 (“Importantly, there is no allegation that the defendants concealed
or misstated the limits of the FDA’s approval on the use of the FlexView system.”).
That same key information is lacking with respect to the speakers and lecturers
who allegedly were engaged to promote Eisai’s products. Notably, the Complaint is
completely silent as to the substance of their remarks and whether any plan participants
of the certifications that prescribers make, or that the Government would not
have reimbursed the claim had it known of the off-label nature of the use or the
fact of the promotion. See United States ex rel. Polansky v. Pfizer, No. 04-cv-
0704, 2009 WL 1456582, at *7-8 (E.D.N.Y. May 22, 2009) (citing authorities
explaining the FDA’s position and concluding that “the entities to which
reimbursement claims are made could hardly be understood to have operated on
the assumption that the physician writing the prescription was certifying implicitly
that he was prescribing [the subject drug] in a manner consistent with the
Guidelines”).
Case: 13-10973 Date Filed: 06/11/2014 Page: 25 of 44
were present. One example states in its entirety that “[i]n June 2007, Dr. Dang gave a
presentation at the University of Miami’s Sylvester Cancer Center. Dr. Dang’s
presentation was advertised as being on Ontak’s use in treating CTCL. Instead, Dr.
Dang lectured on his off-label use of Ontak.” (Compl. ¶ 149.) Or, “in October, 2008, Dr.
Franine Foss, a longstanding paid speaker of Eisai, spoke in south Florida at a dinner
program for physicians on the use of Ontak for treating peripheral T cell lymphoma.”
(Id. ¶ 153.) The Complaint makes other passing references to unnamed physicians
speaking about Eisai’s products at unspecified dates and locations. These allegations
fail to comply with the basic elements of pleading any fraudulent scheme. See, e.g.,
Sanofi-Synthelabo, Inc., 2006 WL 1064127, at *7 (“Plaintiff fails to allege the who, what,
when, where, and how regarding Defendant’s sales representatives allegedly promoting
the off-label uses of Elitek to doctors nor does he makes such allegations regarding
Defendant[ ] allegedly training its sales representatives in off-label uses of Elitek.”
(citation omitted)); Franklin v. Parke-Davis, 147 F. Supp. 2d 39, 50 (D. Mass. 2001)
(discussing promotion claim under Rule 9(b) where relator failed to specify who
“engaged in [the scheme to cause false submissions], where such conduct took place,
which [of defendant’s] personnel were involved, or any specific fraudulent statements
made to personnel”); see also United States ex rel. Butler v. Magellan Health Servs,
Inc., 74 F. Supp. 2d 1201, 1216-17 (M.D. Fla. 1999) (noting that the “complaint fails to
refer to specific employees who may have been involved in submitting false claims”).
Moreover, even if there were sufficient allegations of statements made by and to
physicians, Relator has failed to explain how the representations resulted in
prescriptions and requests for reimbursement. For instance, the Complaint does not tie
Case: 13-10973 Date Filed: 06/11/2014 Page: 26 of 44
the efforts of Drs. Heald, Brown, Foss, and Dang - all of whom allegedly received
payment for lecturing on off-label uses or conducting off-label studies - to any claim
submitted by them or others. There is no allegation that a prescribing doctor who later
sought reimbursement attended those lectures or considered the studies. At no point
does Relator allege that any particular prescriber that is alleged to have submitted off­
label claims was actually aware of any of Eisai’s representations as communicated by
these doctors. The same is true of the named hospitals and institutions that received
money in exchange for research and lectures regarding Eisai’s drugs. For instance, the
University of Arizona is alleged to have received a grant in July 2007 (presumably for
allowing a presentation on off-label use of Ontak) (Compl. ¶ 150), but it is not one of the
institutions that is alleged to have submitted claims. Indeed, it is not mentioned again
anywhere else in the Complaint.
Similarly, Relator has failed to plead with particularity that any claims for off-label
use were in fact submitted to the Government and reimbursed as a result of the
scheme, which is a requirement for an action based on off-label promotion under
Section (a)(1) and which deficiency scuttled the previous iteration of his Complaint. See
Solvay, 588 F.3d at 1325 (requiring a plaintiff to link the fraudulent scheme to the
submission of false claims); United States ex rel. Atkins v. Mclnteer, 470 F.3d 1350,
1359 (11th Cir. 2006) (holding that a plaintiff must “provide the next link in the FCA
liability chain: showing that the defendants actually submitted reimbursement claims for
the services he describes”); Corsello v. Lincare, Inc., 428 F.3d 1008, 1013-14 (11th Cir.
2005) (affirming dismissal where complaint “did not allege that a specific fraudulent
claim was in fact submitted to the government”); Clausen, 290 F.3d at 1311 (calling the
Case: 13-10973 Date Filed: 06/11/2014 Page: 27 of 44
submission or presentment of a claim to the government the “sine qua non” of a False
Claims Act violation).
Whether submission of the claim is sufficiently established is a different question
than whether the scheme has been sufficiently pleaded. See Corsello, 428 F.3d at
1014 (“In short, Corsello provided the ‘who,’ ‘what,’ ‘where,’ ‘when,’ and ‘how’ of
improper practices, but he failed to allege the ‘who,’ ‘what,’ ‘where,’ ‘when,’ and ‘how’ of
fraudulent submissions to the government.”). The presentment requirement calls on
relators not only to describe details about how the schemes operated (however well that
might be pleaded), but to cite specific occurrences of actual fraud. Clausen, 290 F.3d at
1305, 1311-1312 & n.21. Thus, for at least some of the claims, a relator must provide
the following: “details concerning the dates of the claims, the content of the forms or
bills submitted, their identification numbers, the amount of money charged to the
government, the particular goods or services for which the government was billed, the
individuals involved in the billing, and the length of time between the alleged fraudulent
practices and the submission of claims based on those practices.” United States ex rel.
Karvelas v. Melrose-Wakefield Hosp., 360 F.3d 220, 232-33 (1st Cir. 2004) (quoting
Clausen, 290 F.3d at 1312 n.21).
Illustrating this principle is the decision in Clausen (relied on for various points by
both sides), which involved allegations that a medical testing company submitted claims
for unnecessary tests to government programs, thereby violating the FCA. Clausen,
290 F.3d at 1303-04, 1306. Additionally, there were allegations of illegal kickback and
self-referral schemes that resulted in improper billing. Id. at 1304. The Eleventh Circuit
affirmed the district court’s dismissal of the complaint because the relator provided
Case: 13-10973 Date Filed: 06/11/2014 Page: 28 of 44
details about the preparatory scheme, but failed to submit any bill, claim, or payment;
amounts charged by the defendant on what dates; or details of how the billing was
fraudulent. Id. at 1306, 1311-12. It concluded that “nowhere in the blur of facts . . . can
one find any allegation, stated with particularity, of a false claim actually being submitted
to the Government . . . as to the plot’s execution, Clausen merely offers conclusory
statements, and does not adequately allege when - or even if - the schemes were
brought to fruition.” Id. at 1312. As the Fifth Circuit noted, “[t]he Clausen court made
plain its position that to plead a presentment claim, the minimum indicia of reliability
required to satisfy the particularity standard are the specific contents of actually
submitted claims, such as billing numbers, dates, and amounts.” United States ex rel.
Grubbs v. Kannenganti, 565 F.3d 180, 186, 190 & n.32 (5th Cir. 2009) (commenting that
“[t]o require these details at pleading is one small step shy of requiring production of
actual documentation with the complaint” (citing United States ex rel. Pogue v. Diabetes
Treatment Ctrs. of Am., Inc., 238 F. Supp. 2d 258, 269 (D.D.C. 2002)). 19
19
Although the Fifth Circuit in Grubbs criticized the stringent requirements of
Clausen, subsequent cases decided by the Eleventh Circuit emphatically
reaffirms the holding as binding precedent. Indeed, in Solvay- a promotion case
- the relators were able to provide “a highly-compelling statistical analysis [that]
renders inescapable the conclusion that a huge number of claims for ineffective
off-label uses of [the subject drug] resulted from [the defendant’s illegal
marketing] campaign.” 588 F.3d at 1326. However, even that evidence was
deficient in that it did “not allege the existence of a single actual false claim.” Id.(“In fact, we are unable to discern from the complaint a specific person or entity
that is alleged to have presented a claim of any kind, let alone a false or
fraudulent claim.”). To tie the promotion to false claims, relators must “identify
specific persons or entities that participated in any step of this process” as well
as “dates, times, or amounts of individual false claims.” Id. And in Atkins, the
relator could point to dates of services, name the patients that received the
Case: 13-10973 Date Filed: 06/11/2014 Page: 29 of 44
As applied to this case, Relator broadly alleges that Eisai engaged in “endemic,”
“nationwide,” and “systemati[c]” fraud by causing physicians and hospitals to submit
false claims for reimbursement under Medicare Part D. and Medicaid. (Compl. ¶¶ 53-
55, 255.) He also approximates the dollar amounts that hospitals purportedly received
in false claims during a time period covering three years, without any basis for his guess
or reference to any actual financial data of those hospitals. ( Id. ¶¶ 177-84, 256). But
Relator never discusses or proffers a single false claim that was made to the
Government in the detail required by Clausen, nor has he submitted a copy of such a
bill or payment. Instead, he proffers only conclusory assertions based on his own
speculation that claims were submitted. For these reasons, Relator’s claims based on a
promotional scheme are fatally deficient.
B. Kickback Allegations
Relator’s kickback allegations present an independent ground for an FCA
violation, but also fail to meet the applicable heightened pleading standards. The
Complaint alleges that as part of the promotion of its drugs, Eisai paid doctors to speak
and write articles regarding off-label uses; paid doctors to conduct off-label studies; paid
hospitals, through grants and other mechanisms, to use Eisai’s drugs; and paid
providers guaranteed revenue through Eisai’s Oncology Reimbursement Program.
Those payments, the Complaint contends, constitute illegal kickbacks. Relator’s claim
implicates the FCA because he asserts that physicians receiving those payments
certified compliance with the anti-kickback laws on reimbursement forms. (Compl. ¶¶
services, and identify the records that would prove his claim, but could not show
that any claims were actually submitted to the Government. 470 F.3d at 1354.
Case: 13-10973 Date Filed: 06/11/2014 Page: 30 of 44
224-226, 230-37.) For instance, Medicare requires providers to sign a provider
agreement acknowledging that reimbursement is “conditioned upon the claim and the
underlying transaction complying with [Medicare] laws, regulations, and program
instructions (including, but not limited to, the Federal anti-kickback statute and Stark
law),” as well as other certifications. (Id. ¶¶ 224-226.) With respect to Medicaid, which
is a state-run program funded by the federal government, the Complaint asserts that
Eisai ultimately caused states to submit claims to the federal government for
reimbursement that falsely certified that the claims were in compliance with federal law.
(Id. ¶¶ 264.)20
Courts have recognized that under an express certification theory, “[f]alsely
certifying compliance with the . . . Anti-Kickback Act[ ] in connection with a claim
submitted to a federally funded insurance program is actionable under the FCA.” United
States ex rel. Wilkins v. United Health Gp., Inc., 659 F.3d 295, 312 (3d Cir. 2011)
20
The anti-kickback regulations applicable to the Medicaid program state that:
Whoever knowingly and willfully offers or pays any remuneration
(including any kickback, bribe, or rebate) directly or indirectly,
overtly or covertly, in cash or in kind to any person to induce such
person -- (A) to refer an individual to a person for the furnishing or
arranging for the furnishing of any item or service for which
payment may be made in whole or in part under a Federal health
care program, or (B) to purchase, lease, order, or arrange for or
recommend purchasing, leasing, or ordering any good, facility,
service, or item for which payment may be made in whole or in part
under a Federal health care program, shall be guilty of a felony and
upon conviction thereof, shall be fined not more than $25,000 or
imprisoned for not more than five years, or both.
42. U.S.C. § 1320a-7b(b)(2).
Case: 13-10973 Date Filed: 06/11/2014 Page: 31 of 44
(quotation and citation omitted); see also Parke-Davis, 147 F. Supp. 2d at 54 (stating
that “a violation of the federal antikickback provision is not a per se violation of the FCA”
and that “[i]n order for the antikickback violation to be transformed into an actionable
FCA claim, the government must have conditioned payment of a claim upon the
claimant’s certification of compliance with the antikickback provision” (citations
omitted)).
Alternatively, an implied certification theory, which is also alleged, recognizes
that the FCA is violated where compliance with a law, rule, or regulation is a
prerequisite to payment but a claim is made when a participant has engaged in a
knowing violation. Wilkins, 659 F.3d. at 313. So, for example, in McNutt v. Haleyville
Medical Supplies, Inc., 423 F.3d 1256 (11th Cir. 2005), the Eleventh Circuit affirmed the
denial of a motion to dismiss finding that allegations of kickbacks can create FCA
liability where compliance with the Anti-Kickback Statute is a prerequisite for payment.
Id. at 1259-60. In particular, the alleged kickbacks in McNutt – which the Government
identified with “detailed facts” as well as “specific claims” that were submitted for
reimbursement – disqualified the defendants’ medical services from reimbursement
under the Medicare program, but the defendants nevertheless submitted claims for
reimbursement. Id. at 1257-1259. The court concluded that “[w]hen a violator of
government regulations is ineligible to participate in a government program and that
violator persists in presenting claims for payment that the violator knows the
government does not owe, that violator is liable, under the [FCA], for its submission of
those false claims.” Id. at 1259.
Case: 13-10973 Date Filed: 06/11/2014 Page: 32 of 44
It is important to note, however, that as with any basis for FCA liability, such
claims are subject to Rule 9(b)’s pleading requirements. Cf. Wilkins, 659 F.3d. at 313
n.20 (finding that relator stated a claim but declining to address whether it was pleaded
with particularity). Thus, the Court in Parke-Davis held that even if kickbacks are illegal,
dismissal was proper since the relator “failed to allege that physicians either expressly
certified or, through their participation in a federally funded program, impliedly certified
their compliance with the federal antikickback statute as a prerequisite to participating in
the federal program.” 147 F. Supp. 2d at 55. In particular, the complaint did not assert
that the defendant “caused or induced a doctor and/or pharmacist to file a false or
fraudulent certification regarding compliance with the anti-kickback statute.” Id.Herein lies the problem with Relator’s claims. Even assuming that the payments
alleged constitute illegal kickbacks, 21 the allegations that participants actually received
payments and falsely certified compliance - like the complaint in Parke-Davis and in
contrast to McNutt- are not sufficiently pleaded. As noted above, there are scarcely any
allegations that any doctor or facility that received such payments filed a claim for
reimbursement - and none that are pleaded with any degree of particularity. With
respect to those few who did submit claims for reimbursement, there are no submission
allegations that can satisfy Clausen. Thus, Relator fails to connect the scheme to
particular instances of fraud or misrepresentation. His allegations are insufficient to
support claims under Rule 9(b).
21
Eisai contends that the payments at issue were not reciprocity for physicians’
prescriptions of its drugs and that its rebate program falls under a statutory safe
harbor exception that allows discount arrangements.
Case: 13-10973 Date Filed: 06/11/2014 Page: 33 of 44
C. Best Price Violations
Finally, the Court is compelled to reach the same conclusion with respect to
Relator’s FCA claims based on allegations of false best price submissions. As with
other claims, the linchpin of these allegations is not that Eisai violated any law requiring
it to provide the Government with the best price of its drugs or provided less in program
rebates than what was owed, but that it falsified information provided to the Government
and profited from it (although Relator confuses the two in the Complaint and in
argument). Section 3729(a)(1)(B) imposes liability on “any person who . . . knowingly
makes, uses, or causes to be made or used, a false record or statement material to a
false or fraudulent claim. Before the May 2009 amendment, the statute exposed a
person to damages if he or she “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)(2) (2006).
In this regard, the Complaint alleges that Eisai provided participants with
discounts that presumably did not factor into best price reports?22 It also alleges that
Eisai affirmatively and knowingly falsified information provided to the Government by
altering its reported prices. Because of this, Eisai presumably was able to charge the
Government more than it otherwise would have. Again, as with Relator’s other
allegations, these claims are subject to Rule 9(b). See United States ex. rel. Foster v.
Bristol-Myers Squibb Co., 587 F. Supp. 2d 805, 825 (E.D. Tex. 2008).
22
The Complaint also alleges that Eisai failed to instruct sales representatives that
they could not provide prices to prescribers that were less than the best price
offered to the Government. However, Relator does not tie this practice to a false
price that was reported to the Government.
Case: 13-10973 Date Filed: 06/11/2014 Page: 34 of 44
Very briefly, the Complaint fails to allege with specificity what data was submitted
by Eisai to the Government that was false or fraudulent. The time periods alleged are
broad and often run from when Eisai acquired the rights to produce the drugs at issue
until Relator ended his employment. Nevertheless, there is not one description of a
single discount that was offered to a single provider. There is no discussion of any
particular pricing report and any assertions that discounts were not reported are
conclusory and unsupported by specific facts. None of the allegations set forth
precisely what statements were made, when such statements were made, where such
statements were made, and who made them. See Ziemba, 256 F.3d at 1202 (citations
omitted). Relator’s best price violations thus fail to meet the 9(b) standard.
D. Relaxation of the 9(b) Standard
Despite the infirmities of his complaint, Relator devotes the majority of his brief to
arguing against a heightened pleading standard. In particular, to the extent that his
Complaint is deficient, he asks the Court to apply a relaxed standard that would allow
him to proceed to discovery based upon his information and belief. He contends that as
an insider, he is able to proffer sufficient indicia of reliability that can excuse a lack of
particularity; that because he has alleged a far-reaching scheme, general discussions of
unlawful conduct are sufficient to establish his claim; and that the information needed to
properly plead his claim is exclusively in the hands of the Defendant, depriving him of
the ability to plead with particularity. Nevertheless, the Court concludes that relaxation
is not warranted here.
First, it is true that some courts have recognized that information based on first­
hand knowledge can lend credibility to the relator’s claims and propel it over pleading
Case: 13-10973 Date Filed: 06/11/2014 Page: 35 of 44
hurdles. For instance, in Hill v. Morehouse Medical Associates, Inc., No. 02-14429,
2003 WL 22019936 (11th Cir. Aug. 15, 2003)- a case upon which Relator heavily relies
(see Opp’n at 10-11) – the Eleventh Circuit allowed an FCA claim against a medical
services provider to proceed where the relator was a billing coder in the department
where the fraud occurred and possessed first-hand knowledge of the fraudulent conduct
(i.e., altering diagnosis codes to qualify for payment) based on her experience there.
Among other things, she was able to name some of the participants in the scheme,
describe the defendant’s practices in detail, recount the frequency of submission of
each type of claim, and identify the documents in the defendant’s possession that would
prove the fraud. Hill, 2003 WL 22019936, at *4-5. However, she could not recite the
names of patients or the dates that the claims were submitted, at least in part because
copying private records would violate laws regarding patient confidentiality. Id. at *2, 4-
5 & n.8. The Eleventh Circuit concluded that these were appropriate circumstances in
which 9(b)’s heightened pleading requirements could be relaxed. Therefore, the district
court’s dismissal was reversed notwithstanding the fact that Hill could not point to a
specific false claim.
However, it is important to understand that the Court in Atkins later emphasized
that Hill was not binding precedent and stated that “Clausen supercedes Hill to the
extent that Hill is inconsistent with Clausen.” United States ex rel. Atkins v. Mclnteer,
470 F.3d 1350, 1358 n.15 (11th Cir. 2006). Thus, while the relator in Atkins
“cite[d] particular patients, dates and corresponding medical records for services that
he contend[ed] were not eligible for government reimbursement,” he was in the same
position as the relator in Clausen insofar as he “fail[ed] to provide the next link in the
Case: 13-10973 Date Filed: 06/11/2014 Page: 36 of 44
FCA liability chain: showing that the defendants actually submitted reimbursement
claims for the services he describe[d].” Id. at 1359. As this Court has concluded
previously, Relator has failed to proffer “facts as to time, place, and substance of the
defendant’s alleged fraud, specifically, the details of the defendants’ allegedly fraudulent
acts, when they occurred, and who engaged in them.” Clausen, 290 F.3d at 1310(citations and internal quotation omitted). 23 Accordingly, Relator’s claims must fail.
23
A line of decisions from the Eleventh Circuit - Clausen, Corsello, Atkins, and
Solvay - make clear that this court has an important gatekeeping function where
FCA claims are involved. Significantly, in Clausen, the Eleventh Circuit held that
“[w]e cannot make assumptions about a False Claim Act defendant’s submission
of actual claims to the Government without stripping all meaning from 9(b)’s
requirement of specificity or ignoring that the ‘true essence of the fraud’ of a
False Claims Act action involves an actual claim for payment and not just a
preparatory scheme.” 290 F.3d at 1312-13 & n.21. It reasoned that Rule 9(b)
serves not only to give defendants notice of the fraud charges, but also protects
them from frivolous suits. The danger in FCA cases in particular - which gives
the relator a share of any recovery obtained on behalf of the government - is that
lowering the pleading requirements would allow plaintiffs without knowledge of
the fraud to bring baseless actions, “learn the complaint’s bare essentials through
discovery,” and extract settlements, all while damaging the defendant’s goodwill
and reputation. Id. at 1313-14 & nn. 24-25 (citations omitted). In this case,
Relator has made numerous attempts to bypass the pleading requirements, even
making an unusual request to defer ruling on Eisai’s motion to dismiss until after
discovery and summary judgment because of supposed discovery violations.
Yet, “[i]f Rule 9(b) is to carry any water, it must mean that an essential allegation
and circumstance of fraudulent conduct cannot be alleged in such conclusory
fashion.” Clausen, 290 F.3d at 1312-13 & n.21.
Indeed, the Clausen court was keenly aware of the hardship the decision might
work upon relators given the circumstances in which such actions are brought.
See id. at 1314. It noted that the relator - a corporate outsider - might have
needed to “work hard to learn the details of the alleged schemes” if that was
even possible, but that “neither the Federal Rules nor the Act offer any special
leniency under these particular circumstances to justify Clausen failing to allege
with the required specificity the circumstances of the fraudulent conduct he
asserts in his action.” Id. The Eleventh Circuit spoke more to Rule 9(b)’s “policy
Case: 13-10973 Date Filed: 06/11/2014 Page: 37 of 44
Moreover, apart from the controlling decisions of Clausen and its progeny, the
Court is not persuaded that Relator’s complaint bears sufficient indicia of reliability that
would warrant relaxation. Unlike the relator in Hill, Relator summarily states that he has
“both personal and inside knowledge of Eisai’s corporate endorsement of its national
off-label marketing scheme of Ontak and Dacogen and other illegal conduct regarding
the Subject Drugs.” (Compl. ¶ 14.) But the basis for his knowledge underpinning his
claims is often absent. For example, there is no indication of how he knows that doctors
were paid to endorse off-label uses or the amount of money paid to them. Similarly, his
belief that false claims were actually submitted apparently rests on his knowledge that
doctors were sold drugs (as demonstrated through the GOERS report) and that
unknown people at Eisai told him that those providers participate in Government
programs. He concludes from this, but provides nothing to support, that they naturally
must have sought reimbursement for some or all of those prescriptions. (Id. ¶ 240.)
This gap illustrates Relator’s difficulty; he was only a salesman and had no personal
knowledge of what providers did after they were incentivized to prescribe Eisai’s drugs,
if that is true. The knowledge of that fact, however, is the crux of any FCA claim.
Most concerning, however, is that many of the details that were required to have
been pleaded and should have been known to Relator are absent from the Complaint.
At the very least, as a salesman, Relator should be familiar with Eisai’s drug sales and
marketing program. But he is unable to plead with particularity what was told to him by
underpinnings” again in Atkins (a case where the government declined to
intervene). 470 F.3d at 1360. It reiterated that 9(b) prevents spurious lawsuits
and counseled that courts must be principled in not giving a plaintiff a “ticket” to
discovery absent a suitable basis. Id. at 1359-60 (quotation omitted).
Case: 13-10973 Date Filed: 06/11/2014 Page: 38 of 44
Eisai employees and what he told doctors when he met with them. He states, for
example, that he “was directed” to make false statements about Ontak’s effectiveness,
but he cannot say who instructed him, when, or where. (Compl. ¶ 93.) And despite the
fact that the information was not protected, in contrast to Hill, Relator has no
documentation to illustrate the false nature of the claims. As Defendant observes, “[i]f
Keeler were a genuine whistleblower with information about actual fraud, it would not
have been difficult for him as a disgruntled former employee to satisfy these
requirements.” (Reply at 7.) Consequently, in light of the paucity of details, the Court
has no basis to find that Relator’s claims are more likely to be reliable rather than purely
speculative or as the court in Clausen warned, spurious. 290 F.3d at 1313 n.24.
With that in mind, the remaining bases for relaxation are inapplicable. While the
broad nature of a scheme may make pleading each instance impractical, Relator has
not proffered representative samples of conduct and the Court must not lose sight of the
purpose underlying Rule 9(b). See United States ex rel Sanchez v. Lymphatx, Inc., 596
F.3d 1300, 1302-03 (11th Cir. 2010); United States ex rel. Bledsoe v. Cmty Health Sys.,
Inc., 501 F.3d 493, 509-10 (6th Cir. 2007) (“We conclude that the concept of a false or
fraudulent scheme should be construed as narrowly as is necessary to protect the
policies promoted by Rule 9(b).”). In other words, a relator cannot segue into discovery
simply by filing prolix but unsubstantiated claims. Moreover, to rely on the assertion that
the information is exclusively in the hands of the defendant requires a relator to set forth
a detailed factual basis for that belief, details which are missing here. See Clausen, 290
F.3d at 1314 n.25 (citations omitted).
Case: 13-10973 Date Filed: 06/11/2014 Page: 39 of 44
IV. REMAINING STATE CLAIMS
Relator’s remaining claims are brought pursuant to various states’ false claims
laws. Those claims are subject to the heightened pleading standard of Rule 9(b) and
based on the foregoing, are subject to dismissal. See United States ex rel. Rost v.
Pfizer, Inc., 507 F.3d 720, 723, 731 (1st Cir. 2007) (affirming district court’s dismissal of
entire complaint, including counts brought under state statutes analogous to the FCA,
since “[t]he heightened pleading standard of Rule 9(b) generally applies to state law
fraud claims brought in federal court” (citations omitted)); Hopper v. Solvay Pharms.,
Inc., 590 F. Supp. 2d 1352, 1363 (M.D. Fla. 2008), aff’d 588 F.3d 1318 (11th Cir. 2009).
V. CONCLUSION
In sum, Relator has failed to set forth a claim under even the minimal pleading
requirements recognized by long-standing and well-established FCA precedent. While
the repeated failure to cure deficiencies requires that this matter be brought to an end,
the Court nevertheless emphasizes how limited its review of the alleged conduct has
been and how many questions remain outstanding. Clausen and subsequent authority
speak to a critical policy consideration of filtering out frivolous or harassing claims that
are burdensome to defend against, balanced against the rights of litigants to access
courts and to pursue their claims without having to prove them at the outset of litigation.
Thus, we do not know if Mr. Keeler’s allegations are actually true – indeed, for purposes
of this motion, the Court has presumed them to be so to the extent they are properly
supported.
It is similarly unknown whether another insider (with more knowledge of Eisai’s
activities) or the Government (with the benefit of claim submission records) could have
pursued this case. See Atkins, 470 F.3d at 1360 n.17 (“We note, however, that the
Case: 13-10973 Date Filed: 06/11/2014 Page: 40 of 44
government already possesses the claims - false or otherwise - a potential defendant
has submitted for payment. The government can, therefore, access those claims on its
own and evaluate any FCA liability that it believes should attach before determining
whether to bring suit or intervene . . . when the government brings an FCA action or
intervenes in a qui tam action, we may assume that it does not do so solely to use the
discovery process as a fishing expedition for false claims.”). And finally, there still may
be other allegations that fall outside the FCA ambit altogether; that is not to say that
Eisai may not be immune from action under other statutes by other parties. See
Clausen, 290 F.3d at 1311 (“The False Claims Act does not create liability merely for a
health care provider’s disregard of Government regulations or improper internal policies
unless, as a result of such acts, the provider knowingly asks the Government to pay
amounts it does not owe.” (citation omitted)). What can be said is that Mr. Keeler has
had the chance to litigate his assertions of fraud but has been unable to posit a
sufficient link between Eisai, doctors, and Government programs to sustain a claim.
In light of the foregoing, it is hereby ORDERED AND ADJUDGED as follows:
(1) Defendant’s Motion to Dismiss (DE 95) is GRANTED. The above-styled
case is DISMISSED WITH PREJUDICE.
(2) Defendant’s Motion to Unseal (DE 197) is DENIED. Any and all other
pending motions are DENIED AS MOOT.
(3) The Clerk is directed to CLOSE this case for administrative purposes.
Case: 13-10973 Date Filed: 06/11/2014 Page: 41 of 44
DONE AND ORDERED in chambers in Miami, Florida, this day January,
2013.
Case: 13-10973 Date Filed: 06/11/2014 Page: 42 of 44
UNITED STATES DISTRICT COURT
SOUTHERN DISTRICT OF FLORIDA
Case No. 09-22302-CV-WILLIAMS
UNITED STATES OF AMERICA, et al.,
ex rel. Michael Keeler,
Plaintiffs,
vs.
EISAI, INC.,
Defendant.
ORDER
THIS MATTER is before the Court on Relator’s Motion to Amend Order of
Dismissal under Rules 60(a) and (b) and Rule 59(e) (DE 236). The motion seeks three
things: (1) to clarify the Court’s January 31, 2013 Order of Dismissal to state that the
case is not dismissed with prejudice as to other parties in interest that might be able to
make out a claim; (2) to revise that Order to state that the dismissal is without prejudice
as to Mr. Keeler (since he may be able to join with others or the Government to provide
missing information necessary to form a claim); and (3) to allow Relator leave to file a
fourth amended complaint based on “rich,” newly-discovered of fraud that he obtained in
discovery and which “adds an extremely high indicia of reliability to Relator’s
allegations.” Essentially, the motion is one for reconsideration and to amend the
Complaint.
Case: 13-10973 Date Filed: 06/11/2014 Page: 43 of 44
The Court has reviewed the motion and the record and concludes that under any
standard, Relator’s requests must be denied. As to the first, Relator has not shown how
he has been affected by the Court’s order to the extent it may affect other potential
plaintiffs or relators. See Mot. at 5 (stating that the United States “should not be
prejudiced if a relator’s allegations are challenged under Rule 9(b)”). As to the
remaining grounds - which raise similar issues - Relator has not shown that dismissal
with prejudice was not warranted. See Corsello v. Lincare, Inc., 428 F.3d 1008, 1014-
15 (11th Cir. 2005) (holding that trial court did not err in denying relator’s request to file
an amended complaint where there was a repeated failure to cure deficiencies in three
prior complaints).
Finally, as Mr. Keeler acknowledges in his reply, he has neither attached a
proposed complaint for the Court to review in accordance with Local Rule 15.1 nor has
explained how his allegations would withstand the scrutiny required by Federal Rule of
Civil Procedure 9(b). In any event (and aside from the fact that, as Defendant sets
forth, this motion is a totally inappropriate vehicle for the relief requested), allowing Mr.
Keeler to use documents obtained in discovery to overcome pleading hurdles would
circumvent the purpose of Rule 9(b). See, e.g., United States ex rel. Karvelas v.
Melrose-Wakefield Hosp., 360 F.3d 220, 229, 231 (1st Cir.2004) (“[A] qui tam relator
may not present general allegations in lieu of the details of actual false claims in the
hope that such details will emerge through subsequent discovery.”). Indeed, in United
States ex. rel. Clausen v. Laboratory Corp. of Am., Inc., 290 F.3d 1301 (11th Cir. 2002),
the Eleventh Circuit warned of a situation where “a plaintiff does not specifically plead
Case: 13-10973 Date Filed: 06/11/2014 Page: 44 of 44
the minimum elements of their allegation, [and is able] to learn the complaint’s bare
essentials through discovery and may needlessly harm a defendants’ goodwill and
reputation by bringing a suit that is, at best, missing some of its core underpinnings,
and, at worst, are baseless allegations used to extract settlements.” Id. at 1313 n.24
(citation omitted).
Accordingly, it is hereby ORDERED AND ADJUDGED that Relator’s Motion (DE
236) is DENIED. Although Relator suggests that he may seek to re-file the motion, he
is warned that having dismissed this action and denied reconsideration, the proper
avenue for challenging the Court’s rulings is an appeal. (See DE 256, at 1 (“[T]he Court
will need to see and evaluate Relator’s additional allegations and/or evidence in order to
determine if it is proper to vacate or modify its Order.”) Any further filings in this action
may result in the imposition of sanctions.
DONE AND ORDERED in chambers in Miami, Florida, this day of April, 2013.