Elliott-Lewis et al v. Abbott Laboratories, Inc.
Judge Indira Talwani: ORDER entered. MEMORANDUM AND ORDER re: 61 MOTION to Amend Complaint and file First Amended Complaint. See Attached Order.(DaSilva, Carolina)
UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
EBONIA ELLIOTT-LEWIS, et al.,
ABBOTT LABORATORIES, INC.,
Civil Action No. 14-cv-13155-IT
MEMORANDUM & ORDER
May 5, 2017
Currently pending before the court is Relator Ebonia Elliott-Lewis’s Motion to Amend &
File Her First Amended Complaint (“Motion for Leave to Amend”) [#61]. For the reasons set
forth below, that motion is GRANTED with respect to Counts 3 and 4, and DENIED with
respect to Counts 1 and 2.
On March 28, 2016, the court granted Defendant Abbott Laboratories, Inc.’s (“Abbott”)
Motion to Dismiss [#14], finding that Relator’s Complaint [#1] failed to adequately allege that
Abbott violated the False Claims Act (“FCA”), 31 U.S.C. § 3729, the Anti-Kickback Statute, 42
U.S.C. § 1320a-7b, or the retaliation provisions of the False Claims Act, 42 U.S.C. § 3730(h).
Mem. & Order [#44]. Seventeen days later, the court issued an Order of Dismissal [#49] closing
On April 26, 2016, Relator filed a Notice of Appeal [#50], and the next day, filed a
Motion for Relief from Judgment Pursuant to Federal R. Civ. Proc. Rule 60(b)(6) (“Motion for
Relief from Judgment”) [#53].
On May 23, 2016, after this court stated that it was inclined to allow the motion for relief
from judgment if the case was remanded, Mem. [#56], the First Circuit returned the case to allow
this court to adjudicate Relator’s motions, Order of Court [#59].
This court subsequently allowed the Motion for Relief from Judgment [#53], but denied
the Motion to Amend Complaint [#54] without prejudice. Mem. & Order [#60]. The court noted
that the Motion to Amend Complaint [#54] was not presented to Abbott prior to filing as
required by the local rules, and that the proposed amended complaint was not a short and plain
statement as required under Rule 8 of the Federal Rules of Civil Procedure. Mem. & Order
[#60]. Relator thereafter filed the currently pending Motion to Amend [#61] which attached a
revised proposed First Amended Complaint [#61-1].
A. Relator’s Motion May Be Considered Under Fed. R. Civ. P. Rule 15(a)
Abbott argues that Relator’s Motion for Leave to Amend [#61] falls outside of the scope
of Fed. Rule Civ. P. 15(a)’s permissive amendment policy because Relator originally requested
leave to amend only in a footnote in her opposition to the motion to dismiss, and because a ruling
on the motion to dismiss has already issued. Def.’s Opp’n Relator’s Mot. Leave Am. (“Def.’s
Opp’n”) 4, 5 n.1 [#65]. Citing Fisher v. Kadant, Inc., 589 F.3d 505, 510 (1st Cir. 2009), Abbott
argues that Relator is not entitled to “test the mettle of successive complaints,” and may not file a
motion to amend after dismissal was granted. Def.’s Opp’n 4 [#65].
As the Fisher court noted, however, the context within which the court addresses a
request for leave to amend is important. While the district court in Fisher had no authority to
consider a motion to amend under Rule 15(a) filed after judgment had entered, the court only
lacked such authority “until the judgment is set aside.” Fisher, 589 F.3d at 508; AcevedoVillalobos v. Hernandez, 22 F.3d 384, 389 (1st Cir. 1994) (“Unless postjudgment relief is
granted, the district court lacks power to grant a motion to amend the complaint under Rule
15(a).”). Here, the court has set aside the judgment.
Relator had requested leave to amend in the opposition to the motion to dismiss and had
reiterated that request during oral argument, and the court had indicated that such a motion could
be filed after the court issued its order on the motion to dismiss. While Relator failed to file a
motion for leave to amend before the case was closed, there was no date set by the court for
Relator to file such a motion. Relator’s counsel has explained that he failed to file a motion to
amend the complaint in a timely fashion because he had not had the opportunity to speak with
defense counsel and present a proposed amended complaint to defense counsel prior to final
judgment being entered. Thus, given the totality of circumstances, the court reviews Relator’s
request for leave to amend pursuant to the standards governed by Rule 15(a). See United States
ex rel. D’Agostino v. EV3, Inc., 802 F.3d 188, 195 (1st Cir. 2015) (leave can be granted even
where party requested such leave after a motion to dismiss has been fully briefed); United States
ex rel. Rost v. Pfizer, Inc., 507 F.3d 720, 734 (1st Cir. 2007), abrogated on other grounds by
Allison Engine Co., Inc. v. United States ex rel. Sanders, 553 U.S. 662 (2008).
B. Compliance with Rule 8
Abbott argues that the Motion for Leave to Amend [#61] should be denied because
Relator has failed to comply with Rule 8’s “short and plain” pleading standards. Def.’s Opp’n 69 [#65]. Although Relator’s First Amended Complaint is ninety-one pages, wordiness alone
would not warrant dismissal. “Dismissal [for noncompliance with Rule 8] is usually reserved for
those cases in which the complaint is so confused, ambiguous, vague, or otherwise unintelligible
that its true substance, if any, is well disguised.” Sayied v. White, 89 F. App’x 284 (1st Cir. Mar.
12, 2004) (unpublished) (per curiam) (quoting Salahuddin v. Cuomo, 861 F.2d 40, 42 (2d Cir.
1988)). The complaint, while unwieldy, is not so unintelligible as to warrant dismissal based on
C. The Requirements of Rule 15(a)
Generally, Rule 15(a) provides that leave to amend shall be “freely given when justice so
requires,” and reflects a “liberal amendment policy.” O’Connell v. Hyatt Hotels of P.R., 357
F.3d 152, 154 (1st Cir. 2004) (citing Fed. R. Civ. P. 15(a)) (internal quotation marks omitted).
Grounds for denial include undue delay, bad faith, dilatory motive, repeated failure to cure
deficiencies, futility of amendment, and undue prejudice to the opposing party. Foman v. Davis,
371 U.S. 178, 182 (1962). Relator has not filed multiple amendments, there has been no
discovery, no scheduling order has issued, and while Relator failed to file the motion for leave to
amend within seventeen days of the order of dismissal, the court does not find that delay to be
Abbott argues that amendment of the complaint would be futile. A determination of
futility is based on whether “the complaint, as amended, would fail to state a claim upon which
relief could be granted.” Glassman v. Computervision Corp., 90 F.3d 617, 623 (1st Cir. 1996);
Giuffre v. Deutsche Bank Nat. Trust Co., 759 F.3d 134, 139 (1st Cir. 2014). The standard
applied is the same as in a Rule 12(b)(6) motion to dismiss. Glassman, 90 F.3d at 623.
1. Count 1: Violations of 31 U.S.C. § 3729, False Claims Act
Relator posits two theories to support Count 1: fraud in the inducement, and off-label
That said, the court will not require Abbott to answer the proposed First Amended Complaint’s
Fraud in the Inducement
To plead her fraud in the inducement theory, Relator asserts that Abbott engaged in preapproval promotion of ABSORB Bioresorbable Vascular Scaffold System (“ABSORB”)2 for use
in treating coronary and peripheral vascular disease (i.e. for use in the heart and the leg). First
Am. Compl. ¶¶ 38, 62-63. Relator contends that pre-approval promotion of ABSORB for use in
the leg was tantamount to initiating an unapproved clinical trial, and the implantation of
ABSORB in the leg would be tantamount to medical battery. Id. ¶¶ 11, 29, 31, 62, 65. She
asserts that because the alleged unapproved clinical trial would involve medical battery, no
patient could give valid informed consent to participation in that trial. Id. ¶¶ 28.2, 31, 90. And
where patients could not give valid informed consent, the supposed trials would be in violation
of human subject protection regulations requiring informed consent. Id. ¶¶ 29, 31, 63, 90.
Moreover, according to Relator, pre-approval promotion of ABSORB for use both in the heart
and the leg violated 21 CFR § 812 (specifically, 21 CFR § 812.5 and 21 CFR § 812.7), an
additional human subject protection regulation. Id. ¶¶ 11, 31, 107-08. These violations of human
subject protection regulations, stemming from pre-approval promotion of ABSORB, affected all
supposed clinical trials for ABSORB. Id. ¶¶ 36, 65, 72, 108. Compliance with human subject
protection regulations is a precondition for Medicare’s payment of routine clinical trial costs. Id.
¶¶ 11, 32, 58, 76. Relator concludes that where all supposed clinical trials for ABSORB were in
violation of human subject protection regulations, all claims for reimbursement of routine costs
of those trials, certifying such compliance, were false. Id. ¶¶ 37, 66, 91, 108.
ABSORB is an absorbable drug-eluting stent. Pl.’s Reply Br. Relating Futility Issues Raised by
Def.’s Opp’n Pl.’s Mot. Amend Compl. & File First Am. Compl. 2 n.1 [#72].
Although the First Amended Complaint thus alleges a violation of a human subject
protection regulation (i.e. the requirement of informed consent), based on implantation of
ABSORB into the leg, which would in turn have rendered false the claims for reimbursement of
routine costs that certify such compliance, a claim based on a fraud in the inducement theory is
futile for two reasons. First, the First Amended Complaint does not allege that any physician
who received such pre-approval promotion actually implanted ABSORB into a leg. Second,
Relator does not allege any claim submitted for reimbursement to Medicare or Medicaid based
on that hypothetical ABSORB implantation into a leg. Although the First Amended Complaint
lists numerous claims submitted to Medicare for ABSORB implantation procedures, all of those
claims were based on coronary catheterization, not implantation into a leg. See id. ¶¶ 111-13.
Thus, the First Amended Complaint does not connect pre-approval promotion of ABSORB for
use in the leg, and any false claims submitted.
With respect to pre-approval promotion of ABSORB for use in the heart, the First
Amended Complaint is futile for different reasons. Relator’s theory only succeeds if the
regulatory violations she asserts are in fact human subject protection regulations.3 But although
the First Amended Complaint alleges that by conducting pre-approval promotion of ABSORB
for use in the heart, Abbott violated 21 CFR § 812, specifically 21 CFR § 812.5 and 21 CFR
§ 812.7, and that these regulations are human subject protection regulations, 21 CFR § 812.5 and
21 CFR § 812.7 are not listed as one of the human subject protection regulations set forth in 45
CFR § 46 or 21 CFR § 50. Nor are they identified as an additional human subject protection
regulation by their own language. Rather, 21 CFR § 812.5 relates to labeling of investigational
The First Amended Complaint does not allege that the clinical trials studying implantation of
ABSORB in the heart violated any informed consent requirements.
devices, and 21 CFR § 812.7 relates to prohibiting promotion and other practices. Neither of
those provisions plausibly relates to human subject protection. Thus, while relator may have
alleged regulatory compliance violations, those regulations were not human subject protection
regulations, and therefore compliance with those regulations was not a precondition of payment
by Medicare. Where there is no precondition that Abbott is alleged to have violated, the relator
cannot show a causal link between the claim for reimbursement and the violation.
The First Amended Complaint also appears to assert that certification of compliance with
21 CFR § 812 is a requirement for a Premarket Approval Application, which is submitted to the
FDA, and that because Abbott violated 21 CFR § 812, its Premarket Approval Application,
which certified compliance with 21 CFR § 812, was a false statement to the FDA. First Am.
Compl. ¶¶ 10, 91-93. Leaving aside the fact that the First Amended Complaint does not close the
loop and allege a causal link between the Premarket Approval Application and any later claims
for reimbursement, FCA liability would not attach even if it had. The First Circuit rejected such a
theory in D’Agostino v. ev3, Inc., 845 F.3d 1 (1st Cir. 2016). In D’Agostino, the relator alleged
that false statements made to the FDA to obtain FDA approval tainted all future claims made to
Medicare and Medicaid, where FDA approval was a precondition to those payments. Id. at 7.
The First Circuit rejected this theory both on materiality and causation grounds. First, it stated
that “[t]he fact that CMS has not denied reimbursement for [the device] in the wake of [relator’s]
allegations casts serious doubt on the materiality of the fraudulent representations that [relator]
alleges.” Id. Second, it stated that “alleging that the fraudulent representations ‘could have’
influenced the FDA to approve [the device] falls short of pleading a causal link between the
representations made to the FDA and the payments made by CMS.” Id. The court reasoned that
“[i]f the representations did not actually cause the FDA to grant approval it otherwise would not
have granted, CMS would still have paid the claims.” Id. Moreover, “[t]he FDA’s failure actually
to withdraw its approval of [the device] in the face of [relator’s] allegations precludes [relator]
from resting his claims on a contention that the FDA’s approval was fraudulently obtained.” Id.
at 8. Relator’s substantially similar argument here is thus precluded by First Circuit precedent.
Accordingly, the First Amended Complaint is futile with respect to any FCA allegations
supported by a fraud in the inducement theory.
Off-Label Promotion Theory
The First Amended Complaint also posits an off-label promotion theory of false claims,
as follows: Abbott promoted off-label use of XIENCE stents for use in patients with diabetes
mellitus, without FDA approval for that indication. First Am. Compl. ¶¶ 10, 14. According to
Relator, statistical analysis shows that approximately 40,000 claims for reimbursement of
XIENCE stents implanted in diabetic patients were submitted to the government for
reimbursement. Id. ¶¶ 10, 17-20. A condition of payment by Medicare and Medicaid is that
devices and related services be authorized for marketing by the FDA, and that the procedures be
reasonable and necessary. Id. ¶ 20. Relator asserts that claims for XIENCE stents in patients with
diabetes mellitus were not reasonable and necessary. Id. ¶ 20. Nor were XIENCE stents
authorized for marketing by the FDA for use in patients with diabetes mellitus. Id. ¶¶ 10, 14, 25.
Therefore, she concludes, submission of claims to Medicare and Medicaid for implantation of
XIENCE stents in patients with diabetes mellitus were false (i.e. not reimbursable). Id. ¶¶ 20,
Count 1 is also futile on this theory. Relator alleges that Abbott targeted 2500 physicians4
with promotional materials touting the use of XIENCE in patients with diabetes mellitus, and
those 2500 physicians accounted for 80% of implantation procedures during the relevant period.
First Am. Compl. ¶¶ 15, 21. Relator then identifies claims submitted to the government in two
ways. First, she engages in statistical calculation to arrive at an approximation of 40,000 claims
submitted.5 Second, she provides a list of XIENCE stent-related claims submitted to the
government for reimbursement during the relevant period. Id. ¶ 109. Missing from all of relator’s
allegations is any causal link between the promotional materials sent to the 2500 physicians and
any decisions by those or any other physicians to use an XIENCE stent to treat a diabetic patient.
Without these links, she has not properly alleged a false claim.
Additionally, even assuming the 2500 targeted physicians submitted claims to Medicare
for implantation of XIENCE stents in diabetic patients, Medicare claims for off-label uses are
not categorically false under the FCA. See U.S. ex rel. Nowak v. Medtronic, Inc., 806 F. Supp.
2d 310, 345, 347-48 (D. Mass. 2011). Medicare does reimburse for an off-label use of a medical
device, where the procedure is reasonable and necessary. Id. at 347-48. Relator provides only a
bare allegation that the XIENCE stent implantation procedures were not reasonable or necessary,
Relator states that these physicians can be identified by their National Provider Identifiers, a list
of which is attached at Appendix A to the First Amended Complaint. First Am. Compl. ¶ 21.
Relator states that 990,000 stents were implanted during the relevant period. From this, she
calculates that because XIENCE stents make up 35% of the market for stents, and because 80%
of those XIENCE stents were implanted by the 2500 targeted physicians, and 30% of the patients
who received those stents were diabetic, and 45% of those patients had Medicare, the physicians
submitted approximately 37,500 claims to Medicare. She also calculates that because XIENCE
stents make up 35% of the market for stents, and because 80% of those XIENCE stents were
implanted by the 2500 targeted physicians, and 30% of the patients who received those stents
were diabetic, and 3.7% of those patients had Medicaid, the physicians submitted approximately
3,000 claims to Medicaid. This calculation is flawed, as Relator does not state that the 30% of
patients who were diabetic received their treatment from the 2500 targeted physicians. First Am.
Compl. ¶ 19.
First Am. Compl. ¶ 20, and this barebones conclusion is insufficient to attach FCA liability
under Fed. R. Civ. P. 9.
Accordingly, the First Amended Complaint is futile with respect to FCA allegations
supported by an off-label promotion theory, and the Motion for Leave to Amend [#61] is
DENIED as to Count 1.
2. Count 2: Violations of 42 U.S.C. § 1320a-7b, Anti-Kickback Statute
The First Amended Complaint also contains a claim under the Anti-Kickback Statute, 42
U.S.C. § 1320a-7b. Relator alleges that Abbott paid conference speakers and sent funding to
hospitals or other research foundations who ran continuing medical education events. First Am.
Compl. ¶¶ 39, 95, 98. She alleges further that these payments, totaling more than $1 million, id.
¶ 97, were kickbacks because they were payments made to induce the recipients to recommend
purchasing ABSORB and XIENCE products, and to allow Abbott employees the opportunity to
deliver promotional presentations at Continuing Medical Education events which items may be
paid for under a Federal health care program, id. ¶¶ 13, 27, 60, 96-98, 100-01.
Relator’s Anti-Kickback claim fails for the same reasons it was initially dismissed. First,
although the First Amended Complaint now identifies a series of alleged kickback payments, it
does not identify any false claims submitted for payment as a result of those payments.
Moreover, the transactions alleged as the kickback payments from Abbott to the providers are
represented by “CMS Open Payments transaction identification numbers.” Id. ¶¶ 97, 109. The
First Amended Complaint does not allege why or how Medicare payment transaction numbers
are evidence of a kickback payment from Abbott to the treatment providers.
The remaining allegations regarding kickbacks state that Abbott hosted presentations or
gave educational grants to Continuing Medical Education conferences. As discussed in this
court’s prior Memorandum & Order [#44] dismissing the complaint, these allegations are
insufficient to state a claim for a False Claims Act claim based on a violation of the AntiKickback statute. Id. at 8; see New York v. Amgen, Inc., 652 F.3d 103, 110 (1st Cir. 2011)
(relators “must show that the defendants knowingly caused the submission of the false or
fraudulent claims, the submission of false records or statements to get the false or fraudulent
claims paid, or otherwise conspired to defraud the state by getting the false or fraudulent claims
paid”). The First Amended Complaint fails to allege any form of remuneration upon which FCA
liability could attach, and also fails to allege false claims that were submitted as a result of that
remuneration. Accordingly, the Motion for Leave to Amend [#61] is DENIED as to Count 2.
3. Count 3: Retaliation in Violation of 31 U.S.C. § 3730(h)
In Count 3 of the First Amended Complaint, retaliation in violation of 31 U.S.C.
§ 3730(h), Relator alleges that she submitted complaints about, and refused to engage in, illegal
activity, and that that refusal and those complaints constituted protected conduct under the FCA.
First Am. Compl. ¶¶ 42, 100, 116-17, 120. She alleges that her employment was terminated as a
result of this protected conduct, and that her termination therefore was an act of retaliation in
violation of 31 U.S.C. § 3730(h). Id. ¶¶ 118, 120-23.
To adequately state a claim for retaliation, a relator “must show that 1) the employee’s
conduct was protected under the FCA; 2) the employer knew that the employee was engaged in
such conduct; and 3) the employer discharged or discriminated against the employee because of
his or her protected conduct.”6 United States ex rel. Karvelas v. Melrose-Wakefield Hosp., 360
F.3d 220, 235 (1st Cir. 2004), abrogated on other grounds by Allison Engine, 553 U.S. 662.
Protected conduct is that which “reasonably could lead to a viable FCA action,” id. at 236
(stating further that “this standard is most consistent with the broad interpretation for protected
Abbott does not argue that Relator has failed to adequately allege prong 3, the causation
element. Accordingly, the court does not address it.
activity under § 3730(h) urged by the legislative history”), including “investigations, inquiries,
testimonies or other activities that concern the employer’s knowing submission of false or
fraudulent claims for payment to the government,” id. at 237. A relator claiming retaliation for
her protected activity need not prove an actual FCA violation, and an employer, even if innocent
of the FCA violation, may not retaliate against an employee for engaging in protected conduct.
Graham Cty Soil & Water Conservation Dist. v. United States ex rel. Wilson, 545 U.S. 409, 416
& n.1 (2005) (noting that Karvelas and other decisions “properly recognized that proving a
violation of [31 U.S.C.] § 3729 is not an element of a § 3730(h) cause of action”). Accordingly,
the question before the court is whether Relator can establish an objectively reasonable basis for
her belief that Abbott violated the FCA.
Relator alleges that she complained about regulatory violations of 21 CFR § 801 and 21
CFR § 812, which she “genuinely believed” to be criminal violations. First Am. Compl. ¶ 116.
Without more, such allegations would be insufficient. Relator goes on to allege, however, that
she identified her complaints as implicating possible violations of the FCA. Id. ¶¶ 120-23.
Moreover, these allegations are supported by additional facts indicating that Relator had firsthand experience regarding the alleged activities that she asserts constituted regulatory violations.
Id. ¶ 100. Thus, the First Amended Complaint contains sufficient support for the allegation that
Relator had an objectively reasonable basis for her belief that Abbott’s activities induced the
submission of false claims, and thus amounted to a violation of the FCA.
Relator further alleges that Abbott knew that she was engaged in protected conduct. For
example, she alleges that in the months leading up to her employment termination, she notified
the company of her belief that those regulatory violations “implicate[d] the False Claims Act.”
Id. ¶¶ 120-23. She also alleges that she initiated several internal complaints, seeking an
investigation into the potentially problematic activities, and met with individuals in the company
regarding those complaints. Id. ¶ 100, 116-23. These allegations, concerning Relator’s
complaints to Abbott about Abbott’s “knowing submission of false or fraudulent claims for
payment to the government,” satisfy the requirement for Abbott to have knowledge of her
protected conduct. See Nowak, 806 F. Supp. 2d at 340-41; see also Karvelas, 360 F.3d at 238
(stating that a defendant’s requisite awareness “mirrors the kind of activity in which the plaintiff
must be engaged”).
Accordingly, Relator’s Motion for Leave to Amend [#61] is GRANTED as to Count 3.
4. Count 4: Violation of Public Policy
The First Amended Complaint contains one new, state-based claim—wrongful discharge
in violation of public policy. First Am. Compl. ¶¶ 135-38. Generally, under Massachusetts law,
an at-will employee “can be fired for any reason or for no reason at all.” Smith v. Mitre Corp.,
949 F. Supp. 943, 948 (D. Mass. 1997). The exception to this rule, construed narrowly by the
Massachusetts Supreme Judicial Court, operates “where the discharge is for reasons that violate
public policy.” Id. at 948-49. For example, “[r]edress is available for employees who are
terminated for asserting a legally guaranteed right . . . for doing what the law requires . . . or for
refusing to do that which the law forbids . . . .” Id. at 949. Similarly, the public policy exception
“protects an at-will employee who, in good faith, reports criminal conduct in her place of
employment” either to public authorities or her superiors. Shea v. Emmanuel College, 682
N.E.2d 1348, 1350 (Mass. 1997); Smith, 949 F. Supp. at 950-51 (concluding that whistleblowers
“can qualify for the public policy exception”).
Relator alleges that she voiced concerns about regulatory violations, which she believed
in good faith to be criminal violations. First Am. Compl. ¶ 116. She also alleges that she reported
to her superiors that these regulatory violations implicated the FCA, and that she initiated an
internal investigation into those alleged violations. Id. ¶¶ 100, 116-23. These complaints are
“sufficiently important to command the invocation of the exception.” Smith, 949 F. Supp. at 95152 (citing Tighe v. Career Sys. Dev. Corp., 915 F. Supp. 476, 485 (D. Mass. 1996) (concluding
that 31 U.S.C. § 3730(h) “clearly express[es] a legislative policy encouraging persons . . . to
inform the [government] of possible contractual or statutory violations by their employers”)).
Accordingly, Relator has stated a claim for termination in violation of public policy, and the
Motion for Leave to Amend [#61] is GRANTED as to Count 4.
For the foregoing reasons, Relator’s Motion for Leave to Amend [#61] is GRANTED
with respect to Counts 3 and 4 and DENIED with respect to Counts 1 and 2. Relator is hereby
ordered to docket her First Amended Complaint [#61-1], and must include—Leave to file
granted on (date of order)—in the caption of the document. Abbott must file a responsive
pleading, except as to Counts 1 and 2 and the footnotes, to the First Amended Complaint [#61-1]
within twenty-one days of the date of this order.
IT IS SO ORDERED.
Date: May 5, 2017
/s/ Indira Talwani
United States District Judge
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