UNITED STATES OF AMERICA, - against - SAM GLOVER,
24-CR-370 (VSB)
UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK
June 3, 2025
VERNON S. BRODERICK, United States District Judge
VERNON S. BRODERICK, United States District Judge:
Trial in this matter is scheduled to begin on June 16, 2025. Pending before me are the parties’ motions in limine. For the reasons that follow:
- The Government‘s motion in limine is GRANTED IN PART and DENIED IN PART:
- The motion to admit evidence of Glover‘s prior uncharged conduct is GRANTED as to (1) the Ponazuril and the Pain Medication, and (2) the 2015 FDA Investigation. With regard to the state board of pharmacy violations and the sales to the California customer, the motion is DENIED at this time, but will be considered at the final pretrial conference.
- The motion to preclude evidence of Glover‘s prior lawful conduct is GRANTED with regard to conduct outside the scope of the charged conspiracy.
- The motion to preclude evidence or argument regarding the Government‘s exercise of its prosecutorial discretion, including its motives for this prosecution, is DENIED as moot.
The motion to preclude evidence of Glover‘s personal circumstances and his potential punishment is DENIED as to Glover‘s family ties to U.S. Compounding, Inc. (“USC“) and is GRANTED in all other respects. - The motion to admit Glover‘s co-conspirators’ statements in furtherance of the conspiracy is DENIED without prejudice to eliciting such statements at trial upon establishing a foundation.
- The motion to admit the drug purchase orders is GRANTED as to Exhibit A and is DENIED without prejudice to introducing other such orders at trial subject to any specific objections.
- Glover‘s motion in limine is GRANTED IN PART and DENIED IN PART:
- The motion to preclude evidence of Glover‘s prior uncharged conduct is DENIED as to the Ponazuril and the Pain Medication and is GRANTED as to the 2015 FDA Investigation. With regard to the state board of pharmacy violations and the sales to the California customer, the motion is GRANTED at this time, but this category of evidence will be considered at the final pretrial conference. The motion is DENIED as to Glover‘s purported agreements with other veterinarians.
- The motion to preclude the use of the words “illegal,” “scheme,” “sham,” or “kickbacks” is DENIED.
- The motion to preclude evidence of USC‘s bankruptcy is DENIED as moot.
- The motion to preclude introduction of USC‘s corporate compliance policy is DENIED.
- The motion to preclude the expert witness testimony of Dr. Mongeluzzi (the “Expert“) is DENIED.
The motion to preclude the use of summary charts and witnesses is DENIED as moot.
I. Background1
Defendant Sam Glover (“Glover” or “Defendant“) worked at USC, a drug compounding company, from approximately 2010 to 2021, serving as the company‘s Vice President of Sales from “at least” 2015 until mid-2021. (Doc. 2 (“Indictment“) ¶ 3; see also Doc. 32 (“Def. Mot.“) 1-2.) “Drug compounding is the process of combining, mixing, or altering ingredients to create a medication tailored to the needs of an individual, animal or a small group of animals.” (Def. Mot. 1.) Glover “oversaw the development of sales for [USC]‘s veterinary and animal medications.” (Id. 2.) USC, located in Arkansas, was owned by Glover‘s father, and employed both Glover and his sister. (See Doc. 29 (“Gov‘t Mot.“) 3; Def. Mot. 1–2.) When Glover joined USC in 2010, it was privately held. (See Def. Mot. 1.) In 2016, USC was acquired by Adamis Pharmaceuticals Corporation (“Adamis“), a publicly traded company.2 (Indictment ¶ 3.)
On July 9, 2024, an Indictment was unsealed charging Glover—in connection with his role at USC—with participating in a conspiracy to distribute an adulterated or misbranded3 equine drug (the “Drug“) with intent to defraud and mislead in violation of
Glover was arraigned on July 19, 2024, and was released on a $75,000 personal recognizance bond the same day. (See Docs. 11–14.) Trial is scheduled to begin on June 16, 2025. (See Doc. 18.)
On May 14, 2025, the Government and Defendant each filed motions in limine (see Doc. 29 (Government‘s motion); Doc. 30 (Defendant‘s motion)), along with supporting memoranda and exhibits under seal. On May 21, 2025, the Government, (Doc. 33 (“Gov‘t Opp‘n“)), and Defendant, (Doc. 34 (“Def. Opp‘n“)), filed opposition briefs to the respective motions.4
II. Applicable Law
A. Motion in Limine
“The purpose of an in limine motion is to aid the trial process by enabling the Court to rule in advance of trial on the relevance of certain forecasted evidence, as to issues that are definitely set for trial, without lengthy argument at, or interruption of, the trial.” Doe v. Lima,
B. Federal Rules of Evidence
Pursuant to
“Hearsay is any out-of-court statement offered to prove the truth of the matter asserted in the statement.” Porter v. Quarantillo, 722 F.3d 94, 97 (2d Cir. 2013) (citing
I discuss other of the applicable Federal Rules of Evidence as relevant infra.
III. Discussion
A. Prior Uncharged Conduct
The Government seeks to introduce evidence at trial that on several instances, Glover “was made aware that distributing USC‘s compounded medications in a particular manner was illegal.” (Gov‘t Mot. 6.) The Government argues that this evidence is admissible either (A) “as direct proof that [Glover] was on notice of regulations governing the distribution of USC‘s compounded pharmaceutical products” and therefore “explains [Glover‘s] affirmative steps to engage in, conceal, and adapt the scheme charged in the Indictment,” or (B) “under Rule 404(b) to show [Glover‘s] knowledge, intent, absence of mistake, motive, and lack of accident.” (Id. 6–7.) Defendant opposes the Government‘s request to deem this evidence admissible, (Def. Opp‘n 2-5), and the Defense‘s motion in limine seeks the exclusion of this evidence during trial, (Def. Mot. 19-34).
As an initial matter, Defendant argues that the Government‘s notice of its intent to use this evidence at trial was insufficient. (Def. Mot. 18–19.) This contention is without merit.
There is no dispute that the Government provided notice of the categories of
I next address each category of uncharged conduct in turn.
1. State Board of Pharmacy Violations
USC faced various state board-of-pharmacy disciplinary actions over the course of Glover‘s employment at USC. The Government seeks to introduce evidence of the following state board-of-pharmacy enforcement proceedings: (1) in 2014, Colorado “disciplined USC for distributing drugs without patient-specific prescriptions,” and Michigan “instituted reciprocal proceedings“; (2) in 2015, Minnesota “disciplined USC for compounding and distributing prescription drugs without patient-specific prescriptions“; and (3) in 2019, Maryland “instituted disciplinary proceedings against USC for dispensing drugs wholesale without a wholesale drug distributor permit and without a valid prescription, and for distributing drugs into [Maryland] during periods of time when USC‘s pharmacy license had lapsed.” (Gov‘t Mot. 7.) The Government states that “[a]s an executive at his family company, [Glover] participated in leadership meetings with USC‘s pharmacists, where these types of topics“—the state regulatory issues—“were raised and discussed.” (Id. 13.)
The Government proffers that “several of the state disciplinary actions related to the unlawful distribution of prescription drugs without valid prescriptions.” (Gov‘t Mot. 13.)
The state pharmacy board infractions are too attenuated from the charged conspiracy to be “direct proof” of it, so this evidence must be analyzed as “other crimes” evidence under
2. 2015 FDA Investigation
USC‘s sterile pharmacy facility (known as the “503B Facility“) shared a building with its non-sterile pharmacy facility (the “503A Facility“). USC compounded and shipped the Drug that was the subject of the purported conspiracy in the non-sterile facility. (See Gov‘t Mot. 7.) In 2015, following a recall of certain USC drugs, FDA investigators inspected the 503B Facility and met with various USC executives, including Glover. (Id.) The FDA “identified multiple compliance failures creating contamination risks” within the 503B Facility. (Id.) As a result, USC closed the 503B Facility for nearly a year and recalled or destroyed millions of dollars’ worth of sterile drugs. (Id.) The closure of the 503B Facility “forc[ed] USC to terminate numerous employees and default on vendor payments.” (Id.)
The FDA‘s investigation is not related enough to the charged conspiracy to constitute “direct proof” of it. Kaiser, 609 F.3d at 570. The Drug that was the subject of the conspiracy was not manufactured in the 503B Facility, and the Government does not proffer that Glover would have discussed regulations pertinent to the subject Drug during the meetings with the FDA regarding its inspection of the 503B Facility. Nor is this information “necessary to complete the story of the crime on trial.” United States v. Robinson, 702 F.3d 22, 37 (2d Cir. 2012) (internal quotation marks omitted).
However, evidence of the pressures—both financial and operational—that the FDA inspection placed on USC is relevant to Glover‘s motive to engage in the charged conspiracy. See
Defendant argues that evidence of the target of the investigation—“contamination risks” in USC‘s sterile pharmacy facility—would be unfairly prejudicial. (Def. Opp‘n 4.) However, based upon the description of this evidence and the purpose for which it is being offered, it is unnecessary for the Government to discuss the details of the subject of the investigation in order to explain its operational and financial impact on USC. Accordingly, the Government‘s motion is GRANTED concerning the financial impact of the 2015 FDA investigation and relevant background. The Government‘s motion is DENIED and the Defense‘s motion is GRANTED with regard to the details of the investigation. Ahead of the final pretrial conference, the parties should meet and confer regarding proposed limiting principles and curative instructions for this testimony.
3. Disagreements with USC Pharmacists Regarding Ponazuril and a Pain Medication
In two instances, Glover disagreed with USC pharmacists regarding the propriety of shipping particular orders. Specifically, in 2019, Glover agreed to sell Ponazuril, a USC-compounded drug, to a farm (the “Farm“) that raised food-producing hogs. (Gov‘t Mot. 8.) Even though USC pharmacists warned Glover that “it was illegal to distribute the drug knowing it would be used on food-producing animals,” Glover “insisted on fulfilling the order, and repeatedly misrepresented to the pharmacists that the medications would be used on horses or non-food-producing hogs.” (Id.) Over USC pharmacists’ objections, Glover directed USC‘s shipping department to send the Ponazuril to the Farm. (Id.) After learning the Ponazuril
Additionally, “[b]etween in or about 2019 and 2020,” USC pharmacists learned that Glover sought to ship a human pain medication (the “Pain Medication“) overseas. (Id.) One pharmacist told Glover “that USC lacked a permit to sell the Pain Medication overseas, [that USC] could not verify prescriptions for this international shipment, . . . that shipping the pain Medication overseas was not legal[,] and that other USC pharmacists did not agree with the practice and would not put their names on any such shipments.” (Id.) During a visit to the USC compounding facility, Glover “demand[ed]” that USC ship the Pain Medication overseas “that day[,] . . . stating that he would pack the order himself if necessary.” (Id.) Despite the pharmacists’ admonishments, when they returned to work the next day, they were told that Glover had brought the Pain Medication to the USC shipping department himself and that it had been dispatched. (Id. 9.) The Government contends that “[t]he USC pharmacists” involved in warning Glover about the Ponazuril and the Pain Medication “are the very same individuals who told [Glover] that the charged scheme involving the Veterinarian was illegal.” (Id. 14.)
This evidence is admissible under
Accordingly, the Government‘s motion in limine is GRANTED as to this evidence, and Defendant‘s motion is DENIED.
4. USC Sales to California Customer
In June 2020, a new USC sales representative emailed a California-based customer of USC offering to sell USC-compounded drugs to the customer if it could receive the drugs at an address outside of California. (Gov‘t Mot. 9.) Surprised, the customer forwarded the email to a USC sales director, expressing concern that the new sales representative was “willing to basically illegally sell drugs to us if we were able to receive them in another state and then bring them across the border.” (Id.) The sales director then forwarded the email to others at USC, stating that he had notified Glover of the new representative‘s message and expressing concern
Unlike with the Ponazuril and the Pain Medication, the Government‘s proffer here is limited to Glover‘s possible knowledge of the actions of a different person, namely, the new sales representative. The Government does not assert that Glover took any action in connection with the new sales representative‘s offer to the California customer of USC. As with the state board-of-pharmacy violations, see supra § III.A.1., I will hold a ruling on the parties’ motions in abeyance pending further discussion at the pretrial conference. The parties should be prepared to discuss Glover‘s involvement with this incident, if any, during the conference.
5. Agreements with Other Veterinarians
“[A]t the end of 2013 or early 2014,” Glover and a co-conspirator at USC “had a ‘handshake’ deal with two other licensed veterinarians . . . to sign off on prescription veterinary medications without having an established vet-client-patient relationship (‘VCPR‘).” (Def. Mem. 32.) The deal included Glover‘s agreement “to pay” the two veterinarians, (id. 33), to whom I will refer to as “Veterinarian-1” and “Veterinarian-2.” The Government explains that “the kickback scheme began with Veterinarian-1, eventually include[ed] Veterinarian-2, and, ultimately, the Veterinarian” that is the subject of the charged conspiracy. (Gov‘t Opp‘n 24.) Eventually, Veterinarian-2 ended his participation in the agreement, “citing a state law restricting payments from pharmaceutical companies to veterinarians.” (Id.) Defendant argues, over the Government‘s opposition, that this evidence should be excluded during trial. (See Def. Mem. 32-34; Gov‘t Opp‘n 24-28.)5
The Defense argues that the fact that these agreements predated the 2015 FDA inspection and resulting financial pressure undermines the Government‘s argument, see supra § III.A.2., that these pressures were motive for Glover‘s involvement in the charged conspiracy. (Def. Mot. 33-34.) I find that this argument goes to the weight of this evidence, not its admissibility.
The Defense also argues that admitting this evidence “would result in a mini-trial that would cause jury confusion and undue delay,” citing United States v. Jadusingh, No. 18-CR-257, 2020 WL 207950, *4 (E.D.N.Y. Jan. 14, 2020) in support. (Def. Mot. 34.) There, the defendant was alleged to have picked up her co-defendant from JFK airport knowing the co-defendant possessed drugs. Jadusingh, 2020 WL 207950, at *4. The Court denied the Government‘s motion in limine to introduce evidence that nineteen years prior to the charged offense, the defendant—under duress of violence and threats—agreed to ingest drugs to smuggle them into the United Kingdom. Id. The Court reasoned that the conduct and circumstances of the prior drug smuggling “differ[ed] starkly” from the charged offense and would therefore confuse the jury. Id. The facts in Jadusingh are clearly distinguishable from the facts here. The handshake deal with Veterinarian-1 and Veterinarian-2 flowed directly in time into the written agreement with the Veterinarian, and both agreements involved the same conduct on the part of Glover—paying a veterinarian to write fake prescriptions. Therefore, rather than this evidence being a “mini-trial,” (Def. Mot. 34), it is directly relevant to the charged conspiracy and helps explain how the conspiracy developed.
Accordingly, Defendant‘s motion in limine is DENIED as to this category of evidence.
B. Prior Lawful Activity
The Government moves to preclude Glover “from introducing evidence that the Drug, or any other USC product, was lawfully dispensed with valid prescriptions on particular occasion.” (Gov‘t Mot. 17.) In opposing the motion, Defendant indicates that he intends to introduce: (1) evidence of “[i]nstances in which the Veterinarian had a proper [VCPR] and the Drug was lawfully dispensed pursuant to a valid prescription“; (2) evidence of Glover‘s “duties, responsibilities, work and observations at [USC] . . . including his knowledge of lawful prescriptions“; and (3) evidence that will show Glover “was aware that []USC retained lawyers, finance professionals and other subject matter specialists in connection with its business.” (Def. Opp‘n 8-9, 10 n.2.) Glover states that he intends to introduce this evidence “not as evidence of good character but rather as evidence of his state of mind and good faith beliefs, negating an intent to defraud.” (Id. 9.)
Evidence of a defendant‘s participation “in other, non-fraudulent activity is generally irrelevant,” except where “‘a defendant is alleged to have always or continually committed bad acts or where the evidence of good acts would undermine the underlying theory of a criminal prosecution.‘” United States v. Balboa, No. 12-CR-196, 2013 WL 6196606, at *3 (S.D.N.Y. Nov. 27, 2013) (quoting United States v. Damti, 109 F. App‘x 454, 455–56 (2d Cir. 2004) (summary order)) (cleaned up); accord United States v. Scarpa, 913 F.2d 993, 1011 (2d Cir. 1990) (“A defendant may not seek to establish his innocence . . . through proof of the absence of criminal acts on specific occasions.“).
The parties proffer conflicting interpretations of the Indictment. The Government states that “the indictment does not allege ‘ceaseless criminal conduct.‘” (Gov‘t Mot. 18 (quoting Scarpa, 913 F.2d at 1010).) Defendant, on the other hand, characterizes the Indictment as
Thus, the Government‘s motion is GRANTED to the extent that Glover may not introduce evidence regarding “other, non-fraudulent activity” outside the scope of the charged conspiracy; such information is “irrelevant” to Defendant‘s guilt or innocence of the charged conspiracy. Balboa, 2013 WL 6196606, at *3 (internal quotation marks omitted). He may, however, introduce evidence of his mental state as to the prescriptions alleged to be part of the charged conspiracy in order to negate the mental-state element of the offenses for which he is charged. The parties should meet and confer concerning whether a curative instruction should be given with regard to this evidence, and, if so, propose language for such an instruction.
C. Selective Prosecution
The Government moves to “preclude evidence and argument concerning the Government‘s motives [for prosecuting Glover], any claim that the defendant is being selectively prosecuted, and any suggestion that the defendant‘s conduct should be dealt with solely as a regulatory matter.” (Gov‘t Mot. 20.) Defendant disclaims any intent to introduce such evidence or argument at trial. (See Def. Opp‘n 5.) The Government‘s motion is therefore DENIED as moot.
D. Glover‘s Personal Circumstances and Potential Punishment
The Government seeks to preclude “evidence and argument” regarding Glover‘s “family background, health, age, [] any similar factors,” or “the punishment or consequences he faces if convicted,” including in Glover‘s opening statement. (Gov‘t Mot. 22–23.)
“District courts generally have ‘wide discretion concerning the admissibility of background evidence,’ including evidence of a defendant‘s personal characteristics.” United States v. Konstantinovskiy, No. 19-CR-408, 2024 WL 3360379, at *11 (E.D.N.Y. July 10, 2024) (quoting United States v. Blackwell, 853 F.2d 86, 88 (2d Cir. 1988)). Although “[b]asic background information, such as education and employment, are routinely admitted, a defendant‘s personal characteristics and circumstances are . . . usually irrelevant to the issue of guilt or innocence under FRE 401, or any relevance of such evidence is outweighed by the risk of prejudice under FRE 403, and such evidence is therefore generally excluded.” Id. (citations omitted).
In this case, as the Defense points out, (see Def. Opp‘n 6), Glover‘s family circumstances are relevant insofar as USC was his father‘s company and because his sister also worked at the company. As discussed supra § III.A.2., Glover‘s family ties to USC may be relevant to his motives, and more details about his background as to these relationships may be relevant depending on the evidence and argument introduced at trial. Other matters related to Glover‘s “circumstances” and “personal characteristics,” however, are not relevant to his guilt or innocence. Konstantinovskiy, 2024 WL 3360379, at *11. The Government‘s motion is therefore DENIED as to Glover‘s family circumstances in relation to his family‘s ownership of USC and his sister‘s employment by USC, and is GRANTED as to other of Glover‘s circumstances and characteristics. The parties are directed to provide notice to me of the substance of the evidence
Additionally, the Defense states that it “expects” that the Government, “through the cooperating witnesses and their plea agreements,” will be the party to “introduce the concept of punishment.” (Def. Opp‘n 6.) It is well-established that a defendant cannot make argument or offer evidence concerning the consequences he would face if convicted. See Shannon v. United States, 512 U.S. 573, 579 (1994) (“[P]roviding jurors sentencing information invites them to ponder matters that are not within their province, distracts them from their factfinding responsibilities, and creates a strong possibility of confusion.“). Permitting such a sympathy pitch “creates a substantial danger that the jury will consciously or subconsciously allow knowledge of such punishment to impact on their deliberations on the question of the defendant‘s guilt or innocence,” United States v. Graziano, 558 F. Supp. 2d 304, 327 (E.D.N.Y. 2008), and thus reach a verdict contrary to the law. The Government‘s motion in limine is GRANTED to preclude introduction of such evidence during trial.
E. Co-Conspirator Statements
The Government next seeks a ruling that statements6 from “two cooperating witnesses (‘CW-1’ and ‘CW-2‘)” are admissible under
CW-1 and CW-2 are expected to testify that, following Adamis‘s acquisition of USC, the kickback payments to the Veterinarian were concealed by entering into a consulting agreement with the Veterinarian, which provided ‘cover’ for the payments to the Veterinarian . . . instead of the true reason for the payments, namely, the commission payments for sales of the Drug. . . .
CW-1 is expected to testify that he worked with others, including the Vice President
(Id. 23–24, 26.)
To admit an out-of-court statement offered for its truth under
I agree with Defendant that the Government‘s motion is not ripe for a ruling at this time. (See Def. Opp‘n 10.) The bases on which to admit testimony under
The Government‘s motion is therefore DENIED without prejudice to offering this evidence at trial after offering some evidence of the existence of the conspiracy. See Bankman-Fried, 2023 WL 6283509, at *3; United States v. Ilori, No. 21-CR-746, 2022 WL 2452258, at *3 (S.D.N.Y. July 5, 2022) (“These statements may well be admissible as statements of co-conspirators. But Defendant is free to object that any particular statement does not meet the tests [for admission under Rule 801], and the Court cannot rule until it has the information necessary to do so.”).
F. Drug Purchase Orders
Next, the Government seeks a ruling in limine to admit emails from USC sales representatives to USC pharmacists containing orders for the Drug with instructions to process the order as a prescription from the Veterinarian. (Gov‘t Mot. 27–30; see also id., Ex. A.)7 The Government states that these orders are admissible: (1) as “non-hearsay because they communicate a directive or an action” rather than being offered for truth; (2) as business records under
The Government‘s motion is therefore GRANTED as to Exhibit A as a non-hearsay imperative statement. I decline to rule at this time on the other proffered grounds for the admission of Exhibit A, and on any grounds for the drug purchase orders not before me. See Bankman-Fried, 2023 WL 6283509, at *3 (denying as premature motion based on, inter alia,
G. Use of the Words “Illegal,” “Scheme,” “Sham,” or “Kickback”
Glover seeks an in limine ruling precluding the Government—except for during its opening statement and summation—from using the words “illegal,” “scheme,” “sham,” or “kickback” to describe Glover‘s conduct or the arrangement with the Veterinarian. (Def. Mot. 7–8 (use of “illegal,” “scheme,” or “sham”); Def. Opp‘n 11–12 (use of “kickback”).) The Defense argues that the use of these words is “prejudicial” and “would amount to assuming facts not in
1. References to “Illegal” Conduct
In opposing Glover‘s request to preclude references to “illegal” conduct, the Government points out that the Indictment charges Defendant with violating
This evidence is relevant to Glover‘s intent, i.e., whether he knew or had reason to know that the Veterinarian‘s prescriptions of the Drug and/or the consulting agreement with the Veterinarian violated the law. Cf. United States v. Skelos, 988 F.3d 645, 663 (2d Cir. 2021) (affirming decision to admit evidence of a “nasty” and “rude[]” phone call because the evidence “tended to prove [the defendant‘s] awareness that his conduct was unlawful,” and therefore its “considerable probative value regarding [the defendant‘s] intent” outweighed any unfair prejudice). To the extent that the jury may confuse references to “illegal” conduct as testimony that Glover‘s conduct at issue in this case violated
Glover‘s motion to preclude references to “illegal” conduct is DENIED.
2. References to “Scheme,” “Sham,” or “Kickbacks”
Glover argues that references to the terms “scheme,” “sham,” or “kickbacks” would be unfairly prejudicial under
Glover‘s motion to preclude the use of these words is DENIED.
H. USC‘s 2024 Bankruptcy
Glover‘s motion to preclude the Government from offering evidence regarding USC‘s 2024 bankruptcy is DENIED as moot, since the Government does not intend to introduce such evidence at trial. (See Gov‘t Opp‘n 1 n.1.)
I. USC‘s Promotional and Marketing Compliance Policies
Glover next seeks a ruling precluding the Government from introducing a USC-produced document titled Promotional and Marketing Compliance Policies for Veterinary Services (the “Policies”). (Def. Mot. 11–14; Id., Ex. 2.)9 The “Introduction” section of this document includes a section excerpting various state laws “relating to the sale and marketing of prescription drug products,” and the document makes general reference throughout that some federal laws are relevant to USC‘s business. (Ex. 2 at 2, id. 2–10.) The document also states that it is a USC policy that “[n]o grant may be made for the purpose of influencing any veterinarian‘s purchasing, prescribing, or treatment decisions in favor of USC products.” (Id. 12.) The Defense argues that the document should be precluded because the federal and state laws it references “have no bearing on [Glover‘s] alleged violation of federal misbranding and adulteration statutes.” (Def. Mot. 12.) Further, Glover asserts that if the Policies “were introduced into evidence, the jury might falsely assume that [USC]‘s alleged payments to the Veterinarian based on the volume of medications he prescribed violates federal anti-kickback laws.” (Id. 13–14.) I disagree.
As discussed supra § III.A.3. and III.G., Glover‘s state of mind as to whether his conduct was illegal will be at issue during trial. Glover‘s knowledge of USC‘s Policies is relevant to
Glover‘s motion is therefore DENIED.
J. Expert Witness
During trial, the Government intends to call Dr. Stephanie Mongeluzzi (“Dr. Mongeluzzi” or the “Expert”) as an expert witness. (See Def. Mem., Exs. 8–10 (expert witness notification and disclosures)).10 Dr. Mongeluzzi graduated from Cornell University in 2013 with a B.S., magna cum laude, in Animal Science and Biological Sciences, received a Doctor of Veterinary Medicine from Cornell in 2017, and received a M.S. in Veterinary Epidemiology from the Royal Veterinary College in London in 2021. (Ex. 9 (“CV”).) Between January 2010 and July 2020, Dr. Mongeluzzi held various positions as a veterinarian in clinical practice. (Id.) From October 2021 to May 2022, she was a fellow in the FDA Center for Veterinary Medicine, Office of Research. (Id.) Since September 2022, Dr. Mongeluzzi has served as a Veterinary Medical Officer at the FDA Center for Veterinary Medicine, Office of Surveillance and Compliance. Her work at the FDA “involves numerous aspects of unapproved new animal drug matters, . . . reviewing compounded veterinary drugs distributed in the United States to determine
Dr. Mongeluzzi is expected to testify—based on her education, experience, and review of the relevant laws and regulations—that “one of the ways in which a drug can be misbranded is if it is a prescription drug that is not accompanied by a lawful prescription.” (Id. 1.) She is also expected “to opine that a veterinarian who is not acquainted with an animal cannot issue a lawful prescription,” and that “[p]ursuant to a bona fide VCPR relationship, a veterinarian is expected to be acquainted with the animal and establish its current health conditions.” (Id. 2.) According to the Expert, “[b]efore issuing a prescription, typically a veterinarian needs to establish a diagnosis following an examination of the animal, discuss the diagnosis with the owner, conduct any necessary tests, create a treatment plan and be available for after-care.” (Id.) Additionally, the Expert is expected to “opine that the practice at USC of listing [the Veterinarian]‘s name when submitting orders to USC pharmacists for the Drug does not alone reflect the issuance of a lawful prescription.” (Id.)
As relevant here,11 Glover objects to the Expert‘s testimony because: (1) the notice does not explain how “Dr. Mongeluzzi‘s role at the FDA . . . contribut[es] to the basis for her opinions”; and (2) “her proposed ‘expert’ testimony simply regurgitates the regulations selected by the [G]overnment to fit its theory of the case.” (Def. Mot. 36–37.)
As to Glover‘s second objection, it is true that an expert may not testify as to “legal conclusions,” that is, that certain conduct violated the law. Tang Cap. Partners, LP v. BRC Inc., 757 F. Supp. 3d 363, 391 (S.D.N.Y. 2024) (internal quotation marks omitted); accord id. (collecting cases). This rule prohibits testimony that “invade[s] the province of the court to determine the applicable law and to instruct the jury as to that law,” or testimony that “determine[s] the outcome of the case.” Id. at 392 (internal quotation marks omitted). Experts may, however, “testify about regulatory frameworks, rules, purposes, and background,” including “‘background concerning the meaning of terms, the procedures which are followed[, and]
Here, by stating that the Expert would opine that USC‘s practice of filling prescriptions for the Drug listing the Veterinarian‘s name “does not alone reflect the issuance of a lawful prescription,” the Government‘s expert disclosure could be read to anticipate expert testimony that is impermissible because it states a legal conclusion that the Veterinarian‘s prescriptions were in fact illegal. (Expert Disclosure 2.) However, the Government states in its opposition brief that “Dr. Mongeluzzi would not testify that anyone violated the law,” and instead would “help explain the circumstances under which veterinary prescriptions are considered valid, i.e., issued ‘in the course of the veterinarian‘s professional practice.’” (Gov‘t Opp‘n 34.) In other words, Dr. Mongeluzzi‘s testimony will explain—based on her clinical and FDA experience—the types of conduct that is within a veterinarian‘s professional practice, including developing a VCPR. Given this context, the Expert‘s anticipated testimony that certain practices would “not alone” be consistent with a valid prescription/VCPR reflects the Expert‘s experiences as a clinician, not a legal conclusion that any participation Glover may have had with the Veterinarian‘s or USC‘s practices violated the law.
Accordingly, Glover‘s motion to preclude the expert testimony is DENIED.
K. Summary Charts and Witnesses
Finally, noting that the Government frequently calls agents or U.S. Attorney‘s Office paralegals as witnesses to read summary charts of electronically stored information admitted under
IV. Conclusion
For the foregoing reasons, and consistent with this Opinion & Order, the Government‘s motion in limine is GRANTED IN PART and DENIED IN PART, and Defendant‘s motion in limine is GRANTED IN PART and DENIED IN PART. I will address any remaining disputes at the pretrial conference.
The Clerk of Court is respectfully directed to terminate the pending motions at Docs. 29 and 30.
SO ORDERED.
Dated: June 3, 2025
New York, New York
Vernon S. Broderick
United States District Judge
