United States, ex rel., Witkin, et al. v. Medtronic, Inc., et al.

UNITED STATES DISTRICT COURT
DISTRICT OF MASSACHUSETTS
UNITED STATES OF AMERICA, et al., ex
rel. ADAM WITKIN,
Plaintiffs and Relator,
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v. 	*
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Civil Action No. 1:11-cv-10790-IT
MEDTRONIC, INC., & MEDTRONIC
MINIMED, INC.,
Defendants.
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MEMORANDUM & ORDER
November 14, 2025
TALWANI, D.J.
Pending before the court is Defendants Medtronic, Inc., and Medtronic MiniMed, Inc.’s
(collectively, “Medtronic”) Motion for Reconsideration [Doc. No. 309] of the court’s order
denying Medtronic’s Motion for Summary Judgment [Doc. No. 175], see Mem. & Order [Doc.
No. 271], in light of the First Circuit’s ruling in United States v. Regeneron Pharmaceuticals,
Inc., 128 F.4th 324 (1st Cir. 2025). In short, the court’s summary judgment order rejected
Medtronic’s argument that the phrase “resulting from” in a 2010 amendment to the Anti-
Kickback Statute (“AKS”), see 42 U.S.C. 1320a-7b(g), requires but-for causation. The First
Circuit subsequently held that the statutory language does require but-for causation. See
Regeneron, 128 F.4th at 336.
For the reasons explained below, the court reconsiders its prior order in part and again
denies summary judgment.
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I. 	Procedural Background
A. 	Denial of Summary Judgment
As relevant to the pending Motion for Reconsideration, in March 2024, the court denied
summary judgment on the False Claims Act (“FCA”) claims against Medtronic because Relator
Adam Witkin (“Relator” or “Witkin”) had presented sufficient evidence that Medtronic provided
remunerative activities to healthcare providers related to Medtronic’s continuous glucose
monitoring device, the iPro2/iPro CGM (“iPro”). Mem. & Order 6, 37–46 [Doc. No. 271]. The
evidence tended to show that Medtronic’s conduct in running gratuitous iPro clinics “crossed the
line from mere product support to effectively running the iPro clinics on behalf of the
physicians[,]” and further provided “substantial, independent value to physician’s offices in the
form of additional in-office staff, repeated iPro clinics, data interpretation, and patient
scheduling.” Id. at 38, 40. As to scienter, the court held there was
sufficient evidence for a reasonable jury to find that Medtronic knowingly and
willfully violated the AKS by having its sales representatives and Medtronic
Managers continuously involved in iPro clinics, and by consistently staffing
Medtronic personnel in physician’s offices as a means of ‘adding value’ to those
physicians’ practices, in order to induce physicians to prescribe Medtronic’s insulin
pumps in lieu of competitors’ products.
Id. at 45.
As to the link between an AKS violation and an FCA violation, the parties disputed the
standard of causation required by the phrase “resulting from” in the 2010 amendment to the
AKS: “a claim that includes items or services resulting from a violation of [the AKS] constitutes
a false or fraudulent claim for purposes of [the FCA].” 42 U.S.C. § 1320a-7b(g). The court
rejected Medtronic’s argument that the statute requires but-for causation and instead applied a
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“sufficiency standard of causation[.]” Mem. & Order 40–41 [Doc. No. 271].1 The court found
Witkin had presented triable evidence under the sufficiency standard because he “proffer[ed]
evidence that could support a reasonable jury’s conclusion that the physician’s billing practices
were related to Medtronic’s improper conduct vis-à-vis the iPro clinics.” Id. at 43. Thus, the
court denied summary judgment as to the FCA claims, holding:
Relator’s allegations that false claims were being submitted to federal health care
programs survives summary judgment where he has presented sufficient evidence
that: 	(1) 	Medtronic 	sales 	representatives 	and 	Medtronic 	Managers 	were
consistently involved in running iPro clinics long after those iPro clinics should
have been conducted independently by physicians and their staff, and that
physicians were therefore improperly billing for services not provided by their own
offices, and (2) that Medtronic knowingly offered other benefits to physicians,
particularly in the form of free office staff/support (e.g., “DCM in the Office” days),
to induce physicians to prescribe Medtronic insulin pumps.
Id. at 46.
In May 2024, Medtronic moved to certify the summary judgment order for interlocutory
appeal, and to stay proceedings while the First Circuit decided the issue of causation required by
42 U.S.C. § 1320a-7b(g) in Regeneron. See Mot. for Cert. of Appealability [Doc. No. 277];
Mem. ISO Mot. 1 [Doc. No. 278]. The court declined. See Mem. & Order 2 [Doc. No. 292]. The
court entered a scheduling order proposed by the parties that provided: “In the event the First
Circuit resolves [Regeneron] . . . during the pendency of this case, any party may request a status
conference, . . . or seek other relief as needed.” Scheduling Order 2 [Doc. No. 297].
B. 	Regeneron
In February 2025, the First Circuit decided Regeneron. As relevant here, the First Circuit
was careful to distinguish between two theories of FCA liability predicated on an AKS violation.
1 In so deciding, the court recognized the existence of alternate theories of liability that do not
require but-for causation, including “express and implied certification theories of falsity.” Id. at
42 (citing United States ex rel. Hutcheson v. Blackstone Med., Inc., 647 F.3d 377, 392–94 (1st
Cir. 2011); Gov’t Statement of Interest 9–10 [Doc. No. 250]).
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The first theory pertains to the 2010 amendment to the AKS, which “turn[s] an AKS kickback
into a per se FCA violation.” Regeneron, 128 F.4th at 327. The First Circuit considered the
statutory language from the 2010 amendment, see 42 U.S.C. § 1320a-7b(g), and held that the
statutory phrase “resulting from” requires but-for causation. Id. at 327–30; see also id. at 330
(rejecting government’s contrary theory and noting that this court had accepted that theory in its
summary judgment order).
The second theory precedes the 2010 amendment. “Under this [false-certification] theory,
a defendant violates the FCA when presenting (or causing to be presented) a claim that
misrepresents compliance with a ‘statutory, regulatory, or contractual requirement’ that ‘the
defendant knows is material to the [g]overnment’s payment decision.” Id. at 332 (citation
omitted). Thus, “a defendant who falsely represented AKS compliance when seeking a payment
from Medicare could be liable under the FCA.” Id. The First Circuit highlighted that “claims
under the 2010 amendment run on a separate track than do claims under a false-certification
theory[,]” and that these tracks treat causation differently. Id. at 334. “[F]alse-certification claims
require no proof of causation[.]” Id.
II. 	Standard of Review
A. 	Reconsideration
To succeed on a motion for reconsideration, the moving party generally must show (1) an
intervening change in the controlling law; (2) the need to correct a clear error of law; or (3)
newly discovered evidence not available to the court when the order was issued. See In re
Genzyme Corp. Sec. Litig., 754 F.3d 31, 46 (1st Cir. 2014). “Unless the court has
misapprehended some material fact or point of law, such a motion is normally not a promising
vehicle for revisiting a party’s case and rearguing theories previously advanced and rejected.”
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Palmer v. Champion Mortg., 465 F.3d 24, 30 (1st Cir. 2006) (citation omitted). A party is
generally not entitled to present new arguments on a motion for reconsideration. Global Naps,
Inc. v. Verizon New England, Inc., 489 F.3d 13, 26 (1st Cir. 2007).
B. 	Summary Judgment
Under Rule 56 of the Federal Rules of Civil Procedure, summary judgment is appropriate
when “the movant shows that there is no genuine dispute as to any material fact and the movant
is entitled to judgment as a matter of law.” Fed. R. Civ. P. 56(a). A fact is material when, under
the governing substantive law, it could affect the outcome of the case. Anderson v. Liberty
Lobby, Inc., 477 U.S. 242, 248 (1986); Baker v. St. Paul Travelers, Inc., 670 F.3d 119, 125 (1st
Cir. 2012). A dispute is genuine if a reasonable jury could return a verdict for the non-moving
party. Anderson, 477 U.S. at 248.
The moving party bears the initial burden of establishing the absence of a genuine dispute
of material fact. Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986). This burden can be satisfied
in two ways: (1) by submitting affirmative evidence that negates an essential element of the non-
moving party’s claim or (2) by demonstrating that the non-moving party failed to establish an
essential element of its claim. Id. at 323-324.
Once the moving party establishes the absence of a genuine dispute of material fact, the
burden shifts to the non-moving party to set forth facts demonstrating that a genuine dispute of
material fact remains. Id. at 324. The non-moving party cannot oppose a properly supported
summary judgment motion by “rest[ing] on mere allegations or denials of [the] pleadings.”
Anderson, 477 U.S. at 256. Rather, the non-moving party must “go beyond the pleadings and by
[his or] her own affidavits, or by ‘the depositions, answers to interrogatories, and admissions on
file,’ designate ‘specific facts showing that there is a genuine issue for trial.’” Celotex, 477 U.S.
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at 324 (quoting Fed. R. Civ. P. 56(e)). Disputes over facts “that are irrelevant or unnecessary”
will not preclude summary judgment. Anderson, 477 U.S. at 248.
When reviewing a motion for summary judgment, the court must take all properly
supported evidence in the light most favorable to the non-movant and draw all reasonable
inferences in the non-movant’s favor. Griggs-Ryan v. Smith, 904 F.2d 112, 115 (1st Cir. 1990).
“Credibility determinations, the weighing of evidence, and the drawing of legitimate inferences
from the facts are jury functions, not those of a judge . . . ruling on a motion for summary
judgment.” Anderson, 477 U.S. at 255.
III. 	Discussion
A. 	Per Se Theory of FCA Liability
As to the per se theory of FCA liability based on the 2010 amendment to the AKS, the
court finds the standard of reconsideration has been met because Regeneron’s requirement of
but-for causation is an intervening change in controlling law. See In re Genzyme Corp. Sec.
Litig., 754 F.3d at 46. Accordingly, the Motion for Reconsideration is GRANTED as to that
theory of liability, and the court reconsiders its order on summary judgment as follows.2
Although the First Circuit did not elaborate on what but-for causation entails, the district
court opinion it affirmed is instructive. When applying the but-for causation standard, the district
court noted that the standard does not require “prov[ing] that the AKS violation was the only
cause of the resulting false claim[,]” but rather that “it was more likely than not that the AKS
violation was the cause of the false claim[,]” which may be proven “through circumstantial
evidence and reasonable inferences.” United States v. Regeneron Pharms., Inc., 2023 WL
2 In its summary judgment order, the court detailed at length the relevant facts viewed in the light
most favorable to Witkin, see Mem. & Order 5–29 [Doc. No. 271], which the court does not
repeat here.
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6296393, at *12 (D. Mass. Sept. 27, 2023). The court added that it “sees no reason why [a
plaintiff’s] evidence may not, in the right circumstances, include proof of temporal proximity[,]”
although temporal proximity alone “may not be sufficient, and the reasonableness of the
inference may be attenuated as the time period grows longer.” Id. (citations omitted).
There, the alleged AKS violations were based on the defendant’s “efforts to funnel
money into [a third-party charity] specifically to reimburse the copays of” patients prescribed the
defendant’s drug. Id. at *2. Before 2011, another manufacturer was the only manufacturer-donor
to the fund and remained its leading donor until the end of 2013; in 2014, the defendant became
the fund’s only manufacturer-donor. Id. The evidence the court found sufficient to survive
summary judgment on the but-for causation standard was an expert report that filtered
disbursement data from the third-party charity in 2013 and 2014 “in conjunction with Medicare
claims data and performed a ‘matching’ analysis identifying Medicare claims for which [the
charity] paid some or all of the beneficiary’s copay.” Id. at *12. The court also considered
evidence that the price of an alternative therapy that was not covered by the charity’s fund “was
dramatically lower than the price of [defendant’s drug], and it is surely true that physicians and
patients alike would take the out-of-pocket cost of a drug into account when making medical
decisions.” Id.
Here, the court similarly considered evidence matching the presence of Medtronic
personnel with an uptick in specific claims submitted by healthcare providers:
Witkin submitted evidence of CMS claims data from physicians who had
Medtronic 	sales 	representatives 	and 	Managers 	extensively 	and 	repeatedly
participate in iPro clinics, and has provided temporal links between certain
physicians’ claims data to certain patients known to have attended iPro clinics. Rel.
Post-Hrg. Mem. 15-19 [Doc. No. 221] (listing specific claims from Adventist
Medical Center, Portland Diabetes and Endocrinology Center, Dr. Berelowitz, Dr.
Krishnamurthy, Dr. Ravuri, and Dr. Stephens) (citing Exs. 328-330 [Doc. No. 224
*SEALED*] (Excel files showing insurance claims for patients); see also Rel.
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Resp. Def. SMF, Ex. 325 (Excel file of Relator Witkin’s territory claims data) [Doc.
No. 195-75 *SEALED*]. Medtronic does not dispute the validity of Relator’s CMS
data or the dates on which the relevant events occurred. Def. Resp. Post-Hrg. Mem.
15-17 [Doc. No. 226].
Mem. & Order 43–44 [Doc. No. 271]; see also id. at 24–27 (summarizing evidence supporting
Witkin’s assertion that “physicians were . . . submitting improper claims . . . in offices where
Medtronic [personnel] were frequently present, either during prescheduled ‘DCM in the Office’
or ‘TM in the Office’ days, or during iPro clinics purportedly run by the physician’s office
alone”). The court found “there is evidence in the record to support Witkin’s claim that
designated Medtronic field personnel . . . were instructed to ‘work with [the] office to identify
and schedule 4-6 patients for the clinic,’ ‘come[] into the office on [the] scheduled day with
Medtronic owned equipment,’ place and train the patient on the iPro, and follow-up to review the
interpretation[,]” with documents indicating that “demonstration clinics[] should lead to . . .
selling Medtronic products.” Id. at 13 (citations omitted). The court also found that Witkin had
“presented evidence showing that to address a ‘stagnant’ account in one physician’s office,
[Medtronic personnel] reported ‘implement[ing] weekly iPro clinics coupled with a ‘TM in the
clinic day[,]’ . . . resulting in an 850% growth in Medtronic pump prescriptions in that previously
stagnant physician’s office.” Id. at 14 (citations omitted); see also id. at 20 (Medtronic’s services
to this office “removed competitors from the office and resulted in [the physician] being ‘100%
Medtronic[]’”). Finally, the court found sufficient Witkin’s reliance on “indirect evidence that
Medtronic’s presence resulted in physician billing, where a reasonable jury could infer that more
likely than not the defendant presented a false bill to the government[.]” Id. (internal quotation
marks and citation omitted).
In sum, although the court previously rejected (and thus did not consider) the application
of a but-for causation standard, the court now finds Witkin proffered evidence sufficient to
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survive summary judgment under such a standard. The extensive activities of Medtronic
personnel, which the court determined to constitute remuneration under the AKS, see Mem. &
Order 6, 37–46 [Doc. No. 271], provide more concrete evidence of causation than the “temporal
proximity” questioned by the district court in Regeneron or the cases it cited. See Regeneron,
2023 WL 6296393, at *12; United States ex rel. Greenfield v. Medco Health Sols., Inc., 880 F.3d
89, 99–100 (3d Cir. 2018) (rejecting application of but-for causation but finding temporal
proximity insufficient based solely on evidence of donations to charities during broad time
period of submitted claims); United States ex rel. Martin v. Hathaway, 63 F.4th 1043, 1053 (6th
Cir. 2023) (evidence of but-for causation insufficient where alleged hiring scheme fell through,
submitted claims “would [] have occurred anyway, no matter whether the underlying business
dispute occurred[,]” and one identified claim was “over seven months after” the alleged quid pro
quo, which was too long to create an inference of cause and effect).
Accordingly, because the court finds that Witkin’s evidence is sufficient to survive
summary judgment as to the causation issue on his FCA claims even under the standard now set
forth in Regeneron, Medtronic’s Motion for Summary Judgment [Doc. No. 175] is DENIED.
B. 	False Certification Theory of FCA Liability
The parties dispute the false certification theory’s role here.3 Medtronic’s Motion for
Reconsideration argues that but-for causation as required by Regeneron is dispositive. Mem. ISO
Mot. for Reconsideration 1, 7 [Doc. No. 309-1]. Witkin’s opposition argues that reconsideration
3 Although the phrase “false certification” does not appear in the statute, the First Circuit
followed the parties’ lead in using the phrase “to describe the body of case law linking the FCA
and AKS without reference to the 2010 amendment . . . [p]urely for the sake of simplicity[.]”
Regeneron, 128 F.4th at 332 n.2. Here, Medtronic refers to that theory of liability as “false
certification” and Witkin refers to it as “material falsity.” For simplicity, this court follows the
First Circuit’s lead in using the term “false certification.”
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is unwarranted because Regeneron preserved the false certification theory. Opp. to Mot. for
Reconsideration 4–11 [Doc. No. 312]. On reply, Medtronic argues that Witkin failed to raise the
false certification theory in summary judgment and only raised it for the first time in a “sur-reply
brief, to which Medtronic had no opportunity to respond[,]” Reply ISO Mot. for Reconsideration
4 [Doc. No. 317], and suggests further briefing is warranted under that theory if the court “has
any doubt[,]” id. at 5.
To the extent that Medtronic seeks reconsideration based on the false certification theory,
the court finds the standard for reconsideration has not been met.
First and most importantly, Regeneron did not disturb the false certification theory of
liability, which “require[s] no proof of causation” and remains an alternate “pathway to FCA
liability for an AKS violation when someone falsely represents compliance with a material
requirement that there be no AKS violation in connection with the claim.” Regeneron, 128 F.4th
at 333, 334. Medtronic thus cannot show an intervening change in controlling law, a need to
correct a clear error of law, or newly discovered evidence. See In re Genzyme Corp. Sec. Litig.,
754 F.3d at 46.
Second, Medtronic did not move for summary judgment on this theory. In its moving
papers, Medtronic only argued that Witkin had failed to proffer evidence of “any element of a
substantive FCA violation” or that “any specific false claims [were] directly induced by
Medtronic’s conduct[.]” Mem. ISO Mot. for Summ. J. 32, 34 [Doc. No. 176]. To the extent
Medtronic suggests this broad argument encompassed any theory of liability and Medtronic was
prejudiced because it “had no opportunity to respond” to rebuttals based on the false certification
theory, see Reconsideration Reply 4 [Doc. No. 317], this is incorrect. The theory was present in
the summary judgment briefing prior to Witkin’s surreply. In Medtronic’s summary judgment
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reply, Medtronic argued that “in any False Claims Act case, regardless of the theory of liability,
the government or relator must prove that the defendant knowingly ‘present[ed], or cause[d] to
be presented’ to the government a claim for payment that is materially false.” Reply ISO Mot.
for Summ. J. 10 (emphasis added) [Doc. No. 249]. The government’s Statement of Interest cited
this Reply and noted that “Defendants correctly observe that there is another theory of liability
available to Relator—implied certification.” Gov’t Statement of Interest 9 [Doc. No. 250].
Medtronic also discussed cases involving implied and express false certification theories in its
responses to Witkin’s notices of supplemental authority and an earlier Statement of Interest filed
by the government.4 See, e.g., Defs.’ Response 2–4 [Doc. No. 238] (citing Hutcheson, 647 F.3d
at 391–92; Universal Health Servs., Inc. v. United States ex rel. Escobar, 579 U.S. 176, 185–87
(2016)).5 Medtronic thus failed to argue for summary judgment on the false certification theory,
and even if this was the result of “nothing more than [Medtronic] having second thoughts about
its best arguments, [Medtronic is] bound by the choices [it] make[s].” Glob. Naps, 489 F.3d at
26.
Accordingly, to the extent Medtronic’s motion seeks reconsideration of the court’s order
on summary judgment based on arguments under a false certification theory, the Motion is
DENIED.
4 These were filed prior to the supplemental reply and sur-reply this court directed the parties to
file after the case was reassigned. See Elec. Clerk’s Notes [Doc. No. 248]; Tr. of 7/21/2023
Status Conference at 13:13–14:9 [Doc. No. 252].
5 Medtronic’s position is also belied by its acknowledgment that the false certification theory was
present in the pleadings. See Reply ISO Mot. for Reconsideration at 3 [Doc. No. 317]; see also,
e.g., Second Am. Compl. ¶¶ 107–08 [Doc. No. 74] (quoting Provider/Supplier Agreement, Form
CMS-855, which certifies “understanding that payment of claims are conditioned upon the
‘underlying transaction complying with . . . the Federal Anti-Kickback Statute . . .’” and thus,
“claims submitted in violation of the AKS . . . violate material conditions of payment of
government healthcare programs, and are false claims under the FCA”).
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IV. 	Conclusion
For the foregoing reasons, Medtronic’s Motion for Reconsideration [Doc. No. 309] is
GRANTED as to the per se theory of FCA liability and DENIED as to the false certification
theory. On reconsideration, Medtronic’s Motion for Summary Judgment [Doc. No. 175] is
DENIED.
IT IS SO ORDERED.
November 14, 2025 	/s/ Indira Talwani
United States District Judge
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