PharmacyChecker.com LLC v. National Association of Boards of Pharmacy
S.D.N.Y.4/17/2023
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UNITED STATES DISTRICT COURT SOUTHERN DISTRICT OF NEW YORK PHARMACYCHECKER.COM, Plaintiff, No. 19-CV-7577 (KMK) v. OPINION & ORDER NATIONAL ASSOCIATION OF BOARDS OF PHARMACY, et al., Defendants. Appearances: Aaron R. Gott, Esq. James F. Lerner, Esq. Matthew R. Riley, Esq. Bona Law PC Minneapolis, MN, New York, NY, and La Jolla, CA Counsel for Plaintiff/Counter-Defendant Erik T. Koons, Esq. Jana I. Seidl, Esq. Baker Botts LLP Washington, DC Counsel for Defendant/Counter-Plaintiff National Association of Boards of Pharmacy Brian E. Casey, Esq. Barnes & Thornburg LLP Washington, DC Counsel for Defendant/Counter-Plaintiff National Association of Boards of Pharmacy Leslie E. John, Esq. Justin W. Lamson, Esq. Elizabeth P. Weissert, Esq. James A. Mitchell, Esq. Ballard Spahr LLP Philadelphia, PA, and New York, NY Counsel for Defendant Partnership for Safe Medicines, Inc. Rachel J. Adcox, Esq. Melanie Kiser, Esq. Denise Plunkett, Esq. Jeny Maier, Esq. Axinn Veltrop & Harkrider LLP Washington, DC and New York, NY Counsel for Defendant Alliance for Safe Online Pharmacies Barry Werdin, Esq. Nicholas G. O. Veliky, Esq. Joshua M. Herman, Esq. Herrick, Feinstein LLP New York, NY Counsel for Defendant Center for Safe Internet Pharmacies Ltd. KENNETH M. KARAS, United States District Judge: PharmacyChecker.com (âPCCâ or âPlaintiffâ) brings this Action against the National Association of Boards of Pharmacy (âNABPâ), Alliance for Safe Online Pharmacies (âASOPâ), Center for Safe Internet Pharmacies Ltd. (âCSIPâ), and Partnership for Safe Medicines (âPSMâ; collectively, âDefendantsâ) alleging that Defendants unlawfully conspired to restrain trade in violation of § 1 of the Sherman Act, 15 U.S.C. § 1, and that NABP falsely advertised or promoted in violation of § 43(a) of the Lanham Act, 15 U.S.C. § 1125. (See generally Am. Compl. (Dkt. No. 82).)1 Before the Court are four motions: (1) Defendantsâ Joint Motion for Summary Judgment on Plaintiffâs Sherman Act § 1 claim, (see Not. of Mot. (âSJ Not. of Mot.â) (Dkt. No. 263)); (2) Plaintiffâs Motion to Strike Portions of Defendantsâ Submissions in Support of Defendantsâ Motion for Summary Judgment, (see Pl.âs Mot. to Strike Portions of Def.âs Submissions (âMot. to Strikeâ) (Dkt. No. 273)); (3) Defendantsâ Joint Motion to Strike Portions of the Declaration of Gabriel Levitt (see Defs.â Pre-Motion Letter to Strike (âLevitt Decl. PMLâ) (Dkt. No. 280)); and (4) Defendantsâ Joint Motion to Exclude the Expert Testimony of Benjamin 1 PCC also originally brought claims against LegitScript LLC. (See Am. Compl.) However, PCCâs claims against LegitScript LLC were severed and transferred to the U.S. District Court for the District of Oregon. (See Dkt. No. 219.) England, Esq., (see Not. of Mot. (âDaubert Not. of Mot.â) (Dkt. No. 260)). For the following reasons, Defendantsâ Joint Motion for Summary Judgment on Plaintiffâs Sherman Act § 1 claim is granted, Plaintiffâs Motion to Strike is denied, Defendantsâ Motion to Strike is denied, and Defendantsâ Joint Motion to Exclude Expert Testimony is granted in part and denied in part. I. Background A. The Partiesâ Motions to Strike To start, the Court must address the Partiesâ motions to strike, which ask this Court to strike portions of both Plaintiffâs and Defendantsâ submissions related to Defendantsâ motion for summary judgment. (See generally Mot. to Strike; Levitt Decl. PML; Defs Mem. of Law in Supp. of Mot. (âDefs.â Mot. to Strikeâ) (Dkt. No. 288).) âBecause âa decision on the motion to strike may affect [the movantâs] ability to prevail on summary judgment,â it is appropriate to consider a motion to strike prior to a motion for summary judgment.â Pugliese v. Verizon N.Y. Inc., No. 05-CV-4005, 2008 WL 2882092, at *5 (S.D.N.Y. July 9, 2008) (alterations in original) (quoting Gucci Am., Inc. v. Ashley Reed Trading, Inc., No. 00-CV-6041, 2003 WL 22327162, at *2 (S.D.N.Y. Oct.10, 2003)); see also Pearlstein v. BlackBerry Ltd., No. 13-CV-7060, 2022 WL 19792, at *7 (S.D.N.Y. Jan. 3, 2022) (â[I]f [the] defendantsâ motion to strike is denied, there are numerous genuine issues of material fact that would preclude summary judgment in their favor.â). Specifically, â[b]ecause the purpose of summary judgment is to weed out cases in which there is no genuine issue as to any material fact and . . . the moving party is entitled to judgment as a matter of law, it is appropriate for district courts to decide questions regarding the admissibility of evidence on summary judgment,â where the Court must exercise this âgatekeeperâ role.â Congregation Rabbinical Coll. of Tartikov, Inc. v. Vill. of Pomona, 138 F. Supp. 3d 352, 398 (S.D.N.Y. 2015) (quoting Raskin v. Wyatt Co., 125 F.3d 55, 66 (2d Cir. 1997)). In its Memorandum of Law, Plaintiff argues that certain exhibits and statements âshould be stricken and/or disregarded because they violate the Federal Rules of Evidence, are false, and/or blatantly misrepresent the evidence.â (Mot. to Strike 1.) Specifically, Plaintiff argues that several of Defendantsâ statements pursuant to Local Rule 56.1 ârely[] on quoted deposition questions masquerading as testimony.â (Id.) Plaintiff also argues that several exhibits are not properly authenticated, contain inadmissible hearsay, and lack foundation. (Id. at 8.) In their Memorandum of Law, Defendants argue that Plaintiff offered ârebuttal-type expert witness testimonyâ in a declaration by PCCâs President Gabriel Levitt accompanying Plaintiffâs 56.1 reply. (Defs.â Mot. to Strike 2.) Specifically, Defendants request that the Court strike nine statements from the Levitt declaration for lack of foundation based on Mr. Levittâs expertise, as well as for âconclusory opinionsâ that âcontradict the findings of Defendantsâ SEO expert without evidentiary support.â (Id. at 2â5.) For the reasons stated below, Plaintiffâs Motion to Strike and Defendantsâ Motion to Strike are both denied. 1. Applicable Law Under Local Rule 56.1, motions for summary judgment must be supported by âa separate, short[,] and concise statement, in numbered paragraphs, of the material facts as to which the moving party contends there is no genuine issue to be triedâ and, for each paragraph, a âcitation to evidence which would be admissible.â Local Rules of the United States District Courts for the Southern and Eastern District of New York, Rule 56.1(a) & (d) (âLocal Rule 56.1â). âThe purpose of Local Rule 56.1 is to streamline the consideration of summary judgment motions by freeing district courts from the need to hunt through voluminous records without guidance from the parties.â Mayaguez S.A. v. Citibank, N.A., No. 16-CV-6788, 2022 WL 901627, at *8 (S.D.N.Y. Mar. 25, 2022) (quoting Holtz v. Rockefeller & Co., 258 F.3d 62, 74 (2d Cir. 2001). Accordingly, a Rule 56.1 statement âis not itself a vehicle for making factual assertions that are otherwise unsupported in the record.â Holtz, 258 F.3d at 74. However, â[m]otions to strike are generally disfavored and will not be granted unless the matter asserted clearly has no bearing on the issue in dispute.â Pearlstein, 2022 WL 19792, at *7 (quoting Kehr ex rel. Kehr v. Yamaha Motor Corp., U.S.A., 596 F. Supp. 2d 821, 829 (S.D.N.Y. 2008)). âA party seeking to strike a Rule 56.1 statement bears a heavy burden . . . .â Christians of Cal., Inc. v. Clive Christian N.Y., LLP, No. 13-CV-275, 2014 WL 3407108, at *2 (S.D.N.Y. July 7, 2014) (quotation marks and citation omitted). Accordingly, âcourts in this Circuit frequently deny motions to strike paragraphs in Rule 56.1 statements, and [instead] simply disregard any improper assertions.â Ross Univ. Sch. Of Med., Ltd. v. Brooklyn-Queens Health Care, Inc., No. 09-CV-1410, 2012 WL 6091570, at *6 (E.D.N.Y. Dec. 7, 2012) (collecting cases), report and recommendation adopted in relevant part, 2013 WL 1334271 (E.D.N.Y. Mar. 28, 2013); see also In re Namenda Direct Purchaser Antitrust Litig., No. 15-CV- 7488, 2017 WL 6606629, at *1 (S.D.N.Y. Dec. 20, 2017) (disregarding improper legal argument in 56.1 statement). For that reason, â[w]here . . . the record does not support the assertions in a Local 56.1 statement, those assertions [are] disregarded and the record reviewed independently.â Holtz, 358 F.3d at 74; see also Baity v. Kralik, 51 F. Supp. 3d 414, 419 (S.D.N.Y. 2014) (finding statements âlack[ing] citations to admissible evidenceâ to violate Local Rule 56.1 and Federal Rule of Civil Procedure 56). Similarly, the Court can also disregard legal conclusions or unsubstantiated opinions in a Local Rule 56.1 statement. See Am Gen. Life Ins. Co. v. Diana Spira 2005 Irrevocable Life Ins. Trust, No. 08-CV-6843, 2014 WL 6694502, at *1 (S.D.N.Y. Nov. 25, 2014) (âThe Court grants [the plaintiffâs] motion [to strike] as to argumentative statements in the [56.1 statement] and as to purported factual statements which are unsupported by any citation to record evidence.â); Epstein v. Kemper Ins. Cos., 210 F. Supp. 2d 308, 314 (S.D.N.Y. 2002) (âStatements in an affidavit or Rule 56.1 statement are inappropriate if they are not based on personal knowledge, contain inadmissible hearsay, are conclusory or argumentative, or do not cite to supporting evidence.â); Simmons v. Woodycrest Ctr. for Human Dev., Inc., No. 10-CV- 5193, 2011 WL 855942, at *1 n.1 (S.D.N.Y. Mar. 9, 2011) (disregarding portions of the defendantsâ Rule 56.1 statement consisting of legal conclusions or âgross distortions of the summary judgment recordâ). Importantly, Courts have âbroad discretion to determine whether to overlook a partyâs failure to comply with local court rules.â Holtz, 258 F.3d at 73. 2. Plaintiffâs Motion to Strike In contravention of this Courtâs Individual Rules, Plaintiff filed an unauthorized motion asking the Court to strike, in whole or in part, over a quarter of Defendantsâ statements pursuant to Rule 56.1 and related exhibits: 37 statements and 24 exhibits to be exact. (See generally Mot. to Strike.) Plaintiff proffers several overlapping reasons for striking each statement and exhibit, including alleging that Defendants improperly insert legal argument, disputing the factual accuracy of several of Defendantsâ statements based on quoted material in associated exhibits, as well as questioning the admissibility of exhibits for lack of foundation, authentication, and hearsay concerns. (Id.) In opposition, Defendants categorize Plaintiffâs objections as â(i) arguments about how to interpret the evidence provided by Defendants, and (ii) arguments regarding the admissibility of the evidence.â (Defs.â Joint Opp. to Mot. to Strike (âDefs Mot. to Strike Opp.â) 4 (Dkt. No. 292).) As to the interpretation arguments, Defendants argue that the Court may âdraw its conclusions from the documents and depositions submitted, not [a partyâs] characterization [sic] of [them],â and should deny the formal motion to strike. (Id. (quoting Pharm., Inc. v. Am. Pharm. Partners, Inc., No. 05-CV-776, 2007 WL 2728898, at *1 (E.D.N.Y. Sept. 14, 2007)).) As to the admissibility arguments, Defendants broadly disagree, and state that they have satisfied their responsibility at this stage of litigation. (Id. at 4â5.) Regarding Plaintiffâs argument that Defendantsâ statements are replete with legal conclusions and contain factual errors, the Court is well equipped to âdisregardâ these assertions and review the record independently. Holtz, 358 F.3d at 74; see also Baity, 51 F.Supp.3d at 419 (finding statements âlack[ing] citations to admissible evidenceâ to violate Local Rule 56.1 and Federal Rule of Civil Procedure 56); Simmons, 2011 WL 855942, at *1 n.1 (disregarding portions of the defendantsâ Rule 56.1 statement consisting of legal conclusions or âgross distortions of the summary judgment recordâ). The Court therefore declines to make piecemeal rulings on the relevance of each statement, although it will, as a matter of course, decline to rely upon disputed or otherwise inaccurate assertions. As to the statements that Plaintiff alleges rely on inadmissible evidence, this Court will exercise its broad discretion and âsimply ignore . . . those paragraphs lacking factual support or citing to inadmissible evidence.â Mayaguez S.A., 2022 WL 901627, at *8 (alterations and quotation marks omitted) (citing Emanuel v. Griffin, No. 13-CV-1806, 2015 WL 1379007, at *2 (S.D.N.Y. Mar. 25, 2015)); see also Sauerhaft v. Bd. of Educ. of Hastings-on-Hudson Union Free Sch. Dist., No. 05-CV-9087, 2009 WL 1576467, at *8 (S.D.N.Y. June 2, 2009) (â[N]othing in the rules or the case law requires a court to strike any portion of a Rule 56(e) affidavit that is not properly supported.â (alteration, quotation marks, and citation omitted)). The Court âdeclines Defendant[sâ] invitation to analyze [exhibits] line-by-line to determine which parts comport with the local rules and Fed. R. Civ. P. 56(e) and which do not. The better course of action is to admitâ the exhibits and consider only the portions that are admissible. Miller v. Batesville Casket Co., No. 02-CV-5612, 2007 WL 2120371, at *5 (E.D.N.Y. July 23, 2007), vacated on other grounds, 312 Fed. Appâx 404 (2d Cir. 2009) (summary order); see also Mayaguez S.A., 2022 WL 901627, at *8; Sauerhaft, 2009 WL 1576467 at *8 (âA court may decline to conduct a line-by-line analysis and instead simply disregard the allegations that are not properly supported.â). Plaintiff also lodges a blanket objection at scores of exhibits, stating that the exhibits lack authentication and foundation. (See, e.g., Mot. To Strike 8 (listing objections to âother exhibitsâ).) Evidence is authenticated if its proponent provides sufficient evidence to demonstrate that it âis what the proponent claims it is.â Fed. R. Evid. 901(a). âA district court âhas broad discretion in determining whether an item of evidence has been properly authenticated.ââ Hallett v. Stuart Dean Co., 517 F. Supp. 3d 260, 268 (S.D.N.Y. 2021) (quoting United States v. Dhinsa, 243 F.3d 635, 658 (2d Cir. 2001)). As Defendants point out, (See Defs. Mot. to Strike Opp. 5), the majority of these exhibits âwere produced [by Plaintiff to Defendants] in this litigation, and [Plaintiff] offers no specific reason to doubt any documentâs authenticity.â Hallett, 517 F. Supp. 3d at 268; see also John Paul Mitchell Sys. v. Quality King Distribs., Inc., 106 F. Supp. 2d 462, 472 (S.D.N.Y. 2000) (â[T]he act of production implicitly authenticate[s] [a] document[].â). To the extent that Plaintiffâs authentication and foundation objections rest upon documents Plaintiff itself produced, the Court will overrule this objection for the purposes of summary judgment. Comm. Data Servers Inc. v. IBM, 262 F. Supp. 2d 50, 58 n.3, 60 (S.D.N.Y. 2003) (âThere is sufficient evidence of their authenticity for the court to consider these documents on this motion for summary judgment.â). For other objections related to authentication or foundation, the Court will address the objections as needed throughout the Courtâs analysis. As such, the Court will not âexpend judicial resources addressing each of the [exhibits and associated statements] that [Plaintiff] identifies in its motion to determine whether it should be stricken.â Mayaguez S.A., 2022 WL 901627, at *8 (alteration omitted). Instead, this Court will, as it is required to do, carefully review and disregard inadmissible or unsupported material. Id. To the extent that Defendantsâ Rule 56.1 Statement cites inadmissible material, or does not provide supporting citations to the record, this Court will disregard it in resolving Defendantsâ motion for summary judgment. 3. Defendantsâ Motion to Strike Defendants argue that â[i]nstead of retaining one or more expertsâ to rebut Defendantsâ proffered experts, âPlaintiff has instead attempted a run-around by including what is clearly on its face rebuttal-type expert witness testimony from a lay witness,â namely Gabriel Levitt. (Levitt Decl. PML 1.) Specifically, Defendants allege that the relevant statements in the Levitt Declaration âeither reference selected portions from the opinions and detailed computations of Defendantsâ experts, and attempt to refute or twist them to favor Plaintiff, or offer conclusory opinions . . . without evidentiary support.â (Id. at 2 (citations omitted).) In opposition, Plaintiff argues that the testimony represents âan objective recitation of factual information rather than opinion[,]â and that the statements were otherwise admissible as lay opinion under Federal Rules of Evidence 701. (Pl.âs Opp. to Mot. (âPl.âs Strike Opp.â) 1 (Dkt. No. 299).) For reasons similar to Plaintiffâs motion to strike, this Court denies Defendantsâ motion to strike as well. This Court will exercise its broad discretion and âsimply ignore . . . those paragraphs lacking factual support or citing to inadmissible evidence.â Mayaguez S.A., 2022 WL 901627, at *8 (citing Emanuel, 2015 WL 1379007, at *2); see also Sauerhaft, 2009 WL 1576467, at *8 (explaining that ânothing in the rules or the case law requires a court to strike any portion of a Rule 56(e) affidavit that is not properly supportedâ and that â[a] court may decline to conduct a line-by-line analysis and instead simply disregard the allegations that are not properly supported.â (alterations, quotation marks, and citations omitted)). To the extent that the Levitt Declaration cites inadmissible material, or does not provide supporting citations to the record, this Court will disregard it in resolving the instant motion for summary judgment.2 B. Factual Background The following facts are taken from the Partiesâ statements pursuant to Local Civil Rule 56.1, specifically Defendantsâ 56.1 Statement, (Defs.â Mem. in Supp. of Joint Mot. for Summ. J. Ex. 1 (âDefs.â 56.1â) (Dkt. No. 264-1)), Plaintiffâs Response to Defendantsâ 56.1 Statement, (Pls.â Resp. to Defs.â 56.1 Statement (âPl.âs Resp. 56.1â) (Dkt. No. 269-1)), Defendantsâ Reply to Plaintiffâs 56.1 Statement, (Defs.â Reply to Pl.âs 56.1 (âDefs.â56.1 Replyâ) (Dkt. No. 281-1)), and the admissible evidence submitted by the Parties.3 The facts are recounted âin the light most 2 Defendants also lodge several objections to Levittâs âanalysis and computations based on numbers derived from the expert report[s]â of Defendantsâ experts, specifically arguing that this practice is improper expert testimony. (Defs.â Mot. to Strike 2â3 (quotation marks omitted).) It is true that an affidavit may not contain expert testimony unless the affiant has first been designated an expert under Fed. R. Civ. P. 26(a)(2). In this case, no such designation was made. However, Levittâs testimony is more properly understood as testimony by a lay witness âresult[ing] from a process of reasoning familiar in everyday life,âânamely, basic arithmeticâ instead of expert testimony which âresults from a process of reasoning which can be mastered only by specialists in the field.â Fed. R. Evid. 701, advisory committeeâs notes to 2000 amends.; see also United States v. Rigas, 490 F.3d 208, 224 (2d Cir. 2007) (ruling that a witness provided permissible lay testimony under Rule 701 âbecause he merely did the mathâ (quotation marks omitted)); Bryant v. Farmers Ins. Exch., 432 F.3d 1114, 1124 (10th Cir. 2005) (finding that âthe mere calculation of an average of 103 numbers is not the sort of statistical determination which requiresâ special knowledge). Accordingly, the Court will consider the mathematical calculations contained in Mr. Levittâs declaration. 3 While âLocal Civil Rule 56.1 does not provide for a âreplyâ in further support of a Rule 56.1 statement of undisputed facts,â it also âdoes not prohibit such replies.â Cap. Rec., LLC v. Vimeo, LLC, No. 09-CV-10101, 2018 WL 4659475, at *1 (S.D.N.Y. Sept. 7, 2018). The Court will consider Defendantsâ reply to the extent that it responds to new facts raised by Plaintiffs in their response, including Plaintiffâs additional statements of undisputed facts and any new evidence introduced in Plaintiffâs response. See Roth v. Cheesecake Factory Rests., Inc., No. 19- CV-6570, 2021 WL 1103505, at *2 (S.D.N.Y. Feb. 5, 2021) (considering only facts asserted in response to new facts raised in the non-movantâs response), report and recommendation favorable toâ Plaintiff, the non-movant. Wandering Dago, Inc. v. Destito, 879 F.3d 20, 30 (2d Cir. 2018) (quotation marks omitted). 1. Overview of Plaintiff PCCâs Website The Parties agree that PCC itself âis not a pharmacy and does not sell, dispense, or distribute drugs.â (Pl.âs Resp. 56.1 ¶ 96; Defs.â 56.1 Reply ¶ 96.)4 However, the Parties dispute the ultimate mission of PCC, specifically whether PCC is targeting its marketing toward U.S. consumers. (See Defs.â 56.1 ¶¶ 38â50; Pl.âs Resp. 56.1 ¶¶ 38â50.) Defendants assert that âPCCâs mission is to help U.S. consumers find and purchase lower-cost medicine from pharmacies outside the U.S.â (Defs.â 56.1 ¶ 38.) Plaintiff asserts that PCCâs mission is to âensure that consumers are properly informed about purchasing safe and affordable medication online to meet their individual health needsâ and âto help consumers afford medication they need.â (Pl.âs Resp. 56.1 ¶ 38.) Defendants argue that âPCC solicits American consumers to use PharmacyChecker.com to find and import drugs from international pharmacies to save money.â adopted, No. 19-CV-6570, 2021 WL 912416 (S.D.N.Y. Mar. 10, 2021); Cunningham v. Cornell Univ., No. 16-CV-6525, 2019 WL 4735876, at *1 n.3 (S.D.N.Y. Sept. 27, 2019) (âThe Court will not consider . . . [the] [d]efendantsâ [r]eply except to the extent it responds to new facts in [the] [p]laintiffsâ [c]ounterstatement.â); Pape v. Dircksen & Talleyrand Inc., No. 16-CV-5377, 2019 WL 1435882, at *3 (E.D.N.Y. Feb. 1, 2019) ( declining âto consider the Reply Rule 56.1 Statement, except to the extent it responded to [] new factsâ), report and recommendation adopted, No. 16-CV-5377, 2019 WL 1441125 (E.D.N.Y. Mar. 31, 2019). 4 Defendants dispute this clause only insofar as it âimplies that [PCC] does not assist in or enable the sale and distribution of drugs to consumers.â (Defs.â 56.1 Reply ¶ 96.) This dispute does not substantively undermine the factual allegation, and accordingly, the Court deems this fact admitted. See Arch Specialty Ins. Co. v. TDL Restoration, Inc., No. 18-CV-6712, 2021 WL 1225447, at *1 n.1 (S.D.N.Y. Mar. 31, 2021) (collecting cases) (âWhere the Parties identify disputed facts but with semantic objections only or by asserting irrelevant facts, [the Court will not consider] these purported disputes, which do not actually challenge the factual substance described in the relevant paragraphs, . . . as creating disputes of fact.â). (Defs.â 56.1 ¶ 39.) 5 Plaintiff argues that PCC âencourages visitors worldwide to use information on its website.â (Pl.âs Resp. 56.1 ¶ 39.) Finally, Defendants claim that PCC âtargets U.S. consumers with the âtitle tagsâ of its web pagesâaround 70% of the siteâs pages have âUSâ or âU.S.â in their title tags.â (Defs.â 56.1 ¶ 41.) Plaintiff counters that the HTML meta tags âreflect information [P]laintiff tracks so that [PCC] users have an accurate idea of what to expect on [P]laintiffâs website.â (Pl.âs Resp. 56.1 ¶ 41.) Regardless, the Parties agree that âPCCâs âforteâ is âinternational online pharmaciesâ prices[,]ââ (Defs.â 56.1 ¶ 44; Pl.âs Resp. 56.1 ¶ 44), and that âPCC has described itself as a âmaverickâ for recommending foreign pharmacy websites and providing âinformation to consumers about safe international pharmacies that sell to consumers in the United States[,]ââ (Defs.â 56.1 ¶ 50; Pl.âs Resp. 56.1 ¶ 50). When a user navigates to PCCâs website, the homepage allows users to search for a prescription drug name in search of âprescription savings you can trust.â (Defs.â 56.1 ¶ 45; Pl.âs Resp. 56.1 ¶ 45.) The page states that there are âVerified International and Canadian online 5 Plaintiff lodges evidentiary objections to Defendants Exhibits 40 and 41 which are used to support statement 39. (See Pl.âs Resp. 56.1 ¶ 39; Mot. To Strike 8.) As to Exhibit 41, Plaintiff appears to mistakenly believe that this is a draft email rather than a blog post. (See Pl.âs Resp. 56.1 ¶ 39.) As to both exhibits, Plaintiff argues that these exhibits are not authenticated, lack foundation, and are inadmissible hearsay. (Pl.âs Resp. 56.1 ¶ 39; Mot. To Strike 8.) First, as the documents were produced by Plaintiff during discovery, the Court overrules the authentication and foundation objection. See Hallett, 517 F. Supp. 3d at 268 (overruling authentication objections because the exhibits âwere produced [by Plaintiff to Defendants] in this litigation, and [Plaintiff] offers no specific reason to doubt any documentâs authenticityâ). In addition, while both statements are hearsay being offered for the truth of the matter asserted (i.e. that âPCC solicits American consumers to use [PCC] to find and import drugs from international pharmacies to save moneyâ), both statements fall firmly within the hearsay exception as admissions by a party-opponent. See Fed. R. Evid. 801(d)(2). Exhibit 40 is a pamphlet created by PCC, presumably to provide to consumers to âempower[] patients to afford medication.â (Defs.â Mem. of Law in Supp. of Mot. Ex. 40 (Dkt. No. 264-41).) Exhibit 41 is a blog post from PCCâs own website, quoting PCCâs CEO Tod Cooperman. (Defs.â Mem. of Law in Supp. of Mot. Ex. 41 (Dkt. No. 264-42).) As such, the Court will consider these exhibits at summary judgment. pharmacy optionsâ as well as â[f]ree U.S. pharmacy coupons.â (Defs.â 56.1 ¶ 45; Pl.âs Resp. 56.1 ¶ 45.) PCC also states that users can â[c]ompare drug prices and save up to 90%.â (Defs.â 56.1 ¶ 45; Pl.âs Resp. 56.1 ¶ 45.) In addition, at the top of PCCâs homepage, a user can click on two relevant links, one taking the user to a page about âAccredited Online Pharmacies,â and another about âPrescription Savings.â (See Defs.â 56.1 ¶ 45; Pl.âs Resp. 56.1 ¶ 45.) On the âAccredited Online Pharmaciesâ page, the âweb page listing . . . is titled âAccredited Canadian and International Online Pharmacies.ââ (Defs.â 56.1 ¶ 46; Pl.âs Resp. 56.1 ¶ 46.) Here, PCC describes the companyâs purpose as âhelping patients across the world find the lowest prescription medication costs from licensed pharmacies in Canada and other countries.â (See Defs.â 56.1 ¶ 46; Pl.âs Resp. 56.1 ¶ 46.)6 PCC also lists several countries with pharmacies that are accredited through âthe PharmacyChecker Verification Program[,]â including âCanada, Australia, India, Mauritius, New Zealand, Turkey, the UK, and the United States.â (Defs.â 56.1 ¶ 46; Pl.âs Resp. 56.1 ¶ 46; Defs.â Mem. of Law in Supp. of Mot. Ex. 48 at 1.) On the starting page for âPrescription Savings,â PCC âcompares U.S. prices to Canadian and International prices and shows the percentage savings availableâ to users interested in purchasing certain drugs from âtrusted international mail order online pharmacies, including licensed Canadian pharmacies and local U.S. pharmacies.â (Defs.â 56.1 ¶ 47; Pl.âs Resp. 56.1 ¶ 47.)7 The page includes a comparison chart that lists a drug name, followed by the price of the 6 The Court notes that the excerpted portion of PCCâs website included in the body of Defendantsâ 56.1 statement differs from the attached Exhibit 48. (Compare Defs.â 56.1 ¶ 46 with Defs.â Mem. of Law in Supp. of Mot. Ex. 48 (Dkt. No. 264-49).) Specifically, Exhibit 48 excludes the first paragraph quoted in the excerpt in Defendantsâ 56.1. However, Plaintiff does not dispute the excerpt in ¶ 46, and the Court deems this fact admitted. 7 Plaintiff disputes Defendantsâ assertion that these prices are specifically targeted to âAmericans who import drugs from foreign pharmacies rather than buying those drugs locally in the U.S.,â because there is âno admissible evidence that the prices are âfor Americans who drug in the United States, Canada, and internationally. (Defs.â 56.1 ¶ 47; Pl.âs Resp. 56.1 ¶ 47.) All prices are listed on the website in U.S. dollars. (Defs.â 56.1 ¶ 42; Pl.âs Resp. 56.1 ¶ 42.)8 When a user searches for a specific drug price comparison, PCC will first state the lowest price found for the drug at the top of the page. (Defs.â 56.1 ¶ 16 (screenshot stating â[t]he lowest price on PharmacyChecker.com for Januvia . . . is $0.60 per tablet for 84 tablets at PharmacyChecker-accredited online pharmaciesâ); Pl.âs Resp. 56.1 ¶ 16 (same); see also Defs.â 56.1 ¶ 52.)9 PCC then shows a chart of âPharmacy Savings Option[s]â with international price comparisons, âincluding direct links to the online pharmacy pages where the consumer can order the drug.â (Defs.â 56.1 ¶¶ 16, 52; Pl.âs Resp. 56.1 ¶¶ 16, 52.) Each listing also states which country the drug will ship from. (Defs.â 56.1 ¶ 16 (stating that Sunshine Pharmacy will â[s]hip[] [w]orldwide from Canadaâ); Pl.âs Resp. 56.1 ¶ 16 (same).) Though the Parties dispute the timing, this chart is at least in part sorted by a âbidding system,â where PCC âdisplays accredited pharmacies on its website in order of the highest import drugs.ââ (See Pl.âs Resp. 56.1 ¶ 47.) However, as Plaintiff does not appear to dispute the actual text of the webpage and excerpted exhibit, the Court deems the relevant undisputed facts admitted. 8 Plaintiff appears to have mistakenly stated that the relevant portion of this statement is disputed. As excerpted by the Court, Defendants stated that PCC âlists prices for prescription drugs in U.S. dollars and no other currency.â (Defs.â 56.1 ¶ 42.) Plaintiff asserts that this statement is disputed, but then notes that âPlaintiff does list prices for prescription drugs in U.S. dollars,â citing the same evidence as Defendants. (See Pl.âs Resp. 56.1 ¶ 42.) Plaintiff continues, seemingly explaining why PCC lists prices in U.S. dollars, but not disputing the fact that prices are indeed listed in a single currency. (Id.) As such, the Court deems this relevant fact admitted. 9 Plaintiffâs objection to Defendantsâ statement 52 is purely semantic: the screenshot as provided would be seen by a U.S. consumer, as stated by Defendant. Accordingly, the Court deems this fact admitted. See Arch Specialty Ins. Co., 2021 WL 1225447, at *1 n.1. bidder.â (Defs.â 56.1 ¶¶ 16â17; Pl.âs Resp. 56.1 ¶¶ 16â17.)10 âOn instruction from an accredited pharmacy customer, PCC increases or decreases bids, and adds, removes, and adjusts daily budgets for total click through fees that a pharmacy is to be charged before being removed from the site for the remainder of the day once the daily budget is hit.â (Defs.â 56.1 ¶ 20; Pl.âs Resp. 56.1 ¶ 20.) âAt times, PCC advises its accredited pharmacies on how to test bid amounts to get to the top of the list displayed on PCCâs website.â (Defs.â 56.1 ¶ 21; Pl.âs Resp. 56.1 ¶ 21.) This bidding system âis not disclosed to consumers using its website.â (Defs.â 56.1 ¶ 19; Pl.âs Resp. 56.1 ¶ 19.) Finally, âPCCâs website has been published in English since 2003.â (Defs.â 56.1 ¶ 43; Pl.âs Resp. 56.1 ¶ 43.) âWhen PCC launched a Spanish version of the website in 2016, PCC focused on the value of this for Spanish speakers in the U.S., noting that â38% of Hispanics living in the U.S. speak mainly Spanish.â The press release announcing the Spanish version quoted PCC CEO Tod Cooperman as saying âNo one living in the U.S. should have to forgo filling a prescription because of high drug prices, especially when lower prices on the same drugs are available to informed consumers. We are pleased to extend our information to the Spanish- speaking community.ââ (Defs.â 56.1 ¶ 43; Pl.âs Resp. 56.1 ¶ 43.) 2. PCCâs Pricing Model From January 2015 through August 2021, the majority of PCCâs revenue came from three sources: approximately came from cost-per-click fees âthat PCC charges its accredited pharmacies for sending consumers to those accredited pharmaciesâ websitesâ; came from fees pharmacies pay to participate in PCCâs Verification Program; and came from fees 10 Again, Plaintiffâs objection to Defendantsâ characterization of a âbidding systemâ is purely semantic and immaterial to this Court. The Court acknowledges Plaintiffâs evidentiary objection to Exhibit 11, but admits this statement of fact based on the other supporting Exhibits not in dispute by the Parties. verified pharmacies pay to be listed on PCCâs website. (Defs.â 56.1 ¶¶ 8â9; Pl.âs Resp. 56.1 ¶¶ 8â9.)11 As to the verification program, approximately of the fees paid to PCC were paid by foreign pharmacies. (Defs.â 56.1 ¶¶ 8, 22; Pl.âs Resp. 56.1 ¶¶ 8, 22.) As to the listing program, the Parties dispute nearly every aspect of the programâs makeup, including how many U.S. pharmacies have participated in the listing program both currently and historically. (Defs.â 56.1 ¶¶ 24â25; Pl.âs Resp. 56.1 ¶¶ 24â25.) However, the Parties agree that âPCCâs other revenue streams, including application fees received from online pharmacies, revenue from discount cards, Medicare drug plans, advertising, and e-book, provide less than of its total revenues.â (Defs.â 56.1 ¶ 10; Pl.âs Resp. 56.1 ¶ 10.) At all times relevant to this litigation, the majority of PCCâs accredited pharmacies were based outside of the United States. (Defs.â 56.1 ¶ 27; Pl.âs Resp. 56.1 ¶ 27.) In fact, during this period, between and of PCCâs total revenue and âover of its click-through revenue . . . came from PCC-accredited foreign pharmacies.â (Defs.â 56.1 ¶ 22; Pl.âs Resp. 56.1 ¶ 22.) U.S. consumers in particular âgenerat[ed] of click-through fees paid to the companyâ during this period. (Defs.â 56.1 ¶ 40; Pl.âs Resp. 56.1 ¶ 40.)12 In addition, different pharmacy websites received paid clicks from PCC. (See Defs.â 56.1 ¶¶ 29â30, 35 (comparing clicks for pharmacy websites during the relevant period); Pl.âs Resp. 56.1 ¶¶ 29â30, 11 Plaintiff disputes the characterization of this evidence, but does not dispute its factual basis. As such, the Court deems this fact admitted. See Arch Specialty Ins. Co., 2021 WL 1225447, at *1 n.1. 12 Again, Plaintiff disputes the characterization of this evidence, but does not dispute its factual basis. Instead, Plaintiff introduces yet another metric it argues the Court should use to understand how cost-per-click fees factor into PCCâs revenue, based on calculations by PCC CEO Gabriel Levitt. (See Pl.âs Resp. 56.1 ¶ 40.) The Court will address this characterization as needed while applying the law to the facts. As such, the Court deems this fact admitted. See Arch Specialty Ins. Co., 2021 WL 1225447, at *1 n.1. 35 (same).) âThe â â of users who visit [PCC] click-through to pharmacies â (Defs.â 56.1 ¶ 31; Pl.âs Resp. 56.1 ¶ 31.) However, the Parties dispute the relevance of this data as it pertains to U.S. consumers, disagreeing primarily about how much of the click- through fees from U.S. consumers were billed to these foreign websites. (See Defs.â 56.1 ¶¶ 32â 34; Pl.âs Resp. 56.1 ¶¶ 32â34.) The Parties agree, however, that â[a]t least websites that received clicks between January 2015 and August 2021 were foreign. Those foreign websites accounted for of the click fees ( ) and of clicks ( ).â (Defs.â 56.1 ¶ 29; Pl.âs Resp. 56.1 ¶ 29.) âOnly [websites] are U.S. sites, accounting for of the click fees ( ) and of total clicks ( ).â (Defs.â 56.1 ¶ 30; Pl.âs Resp. 56.1 ¶ 30.) 3. PCC Consumer Support Materials and Services PCC maintains a âConsumer Support pageâ which lists several frequently asked questions and associated answers. (See Defs.â 56.1 ¶ 48; Pl.âs Resp. 56.1 ¶ 48.)13 First, the page states that âPharmacyChecker is the only free, independent company that verifies the safety of Canadian and other international online pharmacies. We then compare their drug prices to U.S. discounts so you get the best deal.â (Defs.â 56.1 ¶ 48; Pl.âs Resp. 56.1 ¶ 48.) Next, the page asks several questions, excerpted as relevant below: How much can Americans save by purchasing their prescription drugs online? U.S. consumers could pay up to 90% less than what they pay at a local pharmacyâ savings like this has meant thousands of dollars a year for users of PharmacyChecker price comparisons. Cost is the difference between patients adhering to their prescribed medication and having to go without it. Americans are 13 Plaintiff disputes this statement because it is âoverly broadâ and ânot supported by admissible evidenceâ that the page is âfocused on Americans buying drugs from abroad.â (Pl.âs Resp. 56.1 ¶ 48.) However, Plaintiff does not dispute the actual statements listed on the consumer support page, including the accuracy of the answers excerpted in Defendantsâ 56.1 or related Exhibit 6. (Id.) As such, the Court deems the relevant facts as excerpted by the Court admitted. forced to make tough decisions: Do I pay my bills? Or should I skip my meds this week? This is unacceptable. Everyone deserves the opportunity and choice to purchase more affordable medication from licensed pharmacies, whether domestic or international. How fast is international prescription delivery? Be advised that medication ordered from outside the U.S. can normally take 2-3 weeks to arrive. If ordering medication from India, it can take even longer. If you need your medication quickly, then you should consult your local pharmacy for immediate supply, and then you may want to purchase more internationally for future use. We publish a pharmacy profile for each accredited pharmacy in the PharmacyChecker Verification Program to provide consumers with specific details, such as particular shipping locations, shipping costs, and payment methods accepted by the pharmacy. Is it safe to order medication online from a pharmacy outside the U.S.? Yes, as long as you buy from the safest international online pharmacies. With a valid prescription for the medication ordered, dispensed from a licensed pharmacy that is verified in the PharmacyChecker Verification Program, it is exceedingly safe. Peer-reviewed studies based on testing of prescription medication and online pharmacy practices, strongly demonstrate the safety of ordering medications from an international online pharmacy approved in the PharmacyChecker Verification Program. It is important to note, risks do exist when ordering medication from an unverified international online pharmacy, particularly one that does not require a prescription. [. . . ] [Unknown Question]? [ . . . ] Online pharmacies based outside the U.S. are not ârogueâ by definition. Licensed and legitimate pharmacies in Canada and other countries sell safe and effective medications internationally, including to consumers in the U.S. Some regulatory bodies, including the Food and Drug Administration (FDA), refer to such pharmacies as âillegalâ or âfakeâ but such distinctions can mislead consumers and impede their access to affordable, safe and effective medication that they cannot obtain locally due to high U.S. drug prices. Pharmacies in some countries are equally as safe if not safer than those in the U.S. [ . . . ]14 14 Plaintiff argues that Defendantsâ Rule 56.1 statement, which excerpts this question and answer, should be stricken in its entirety because âit is not supported by admissible evidence and is legal conclusion couched as fact.â (Pl.âs Resp. 56.1 ¶ 3.) As discussed, this Court will only rely on admissible evidence and disregard improper statements or legal conclusions. Here, Plaintiff offers no substantive evidentiary objection to Defendantsâ Exhibit 6, which is relevant to the quoted statement. Instead, Plaintiff argues that the Exhibit does not support Defendantsâ statement that âbuying medications internationally is federally prohibitedâ Is it legal to order prescription drugs online? There is no law against ordering medication online. As a resident of the U.S., itâs entirely legal to order medication online that is mailed directly from a state-licensed pharmacy. International drug importation is another story: Technically, in the U.S., under most circumstances, it is prohibited to import medication that you order internationally online. However, it is important to know that people in the U.S. are not prosecuted for doing so, as long as the medication imported is for your own use and not for resale. [ . . . ] What if my medication gets stuck at Customs? While the law allows the FDA and U.S. Customs and Border Patrol to detain and refuse international prescription orders arriving through the mail, less than one percent of medication orders are actually stopped, at least for orders where a prescription is required. If that happens, you will receive a letter from the FDA that your drug order was detained or refused. You are allowed to challenge the FDAâs decision and try and have it released. [ . . . ] (See Defs.â 56.1 ¶ 48; Pl.âs Resp. 56.1 ¶ 48; Defs.â Mem. Ex. 6 (Dkt. No. 264-7).) On the Consumer Support page, PCC maintains a customer complaint form. (Defs.â 56.1 ¶ 61; Pl.âs Resp. 56.1 ¶ 61.) The complaint form states: Weâre sorry if a PharmacyChecker accredited online pharmacy has let you down. Below, you have the opportunity to file a complaint with us about the pharmacy. For us to process your complaint, you must authorize us to contact the company on your behalf. Please describe the problem you had with the pharmacy, and we will do our best to resolve the issue. (Defs.â 56.1 ¶ 61; Pl.âs Resp. 56.1 ¶ 61.) âUnder âDesired Action,â the form allows the consumer to choose between the options of a full refund, a partial refund, send replacement product, or other.â (Defs.â 56.1 ¶ 61; Pl.âs Resp. 56.1 ¶ 61.) While the Parties do not dispute that PCC has assisted U.S. consumers with issues that arose from their purchases from foreign pharmacies, the because the cited excerpt concerns pharmacies operating internationally, rather than the legality of importation. (Pl.âs Resp. 56.1 ¶ 3.) While the provided Exhibit appears to be cut off, Plaintiff again does not appear to dispute the statement that is actually quoted. (Id.) As such, the Court deems the relevant fact as excerpted by the Court admitted. Parties do dispute the extent to which PCC intervened and the frequency of these types of requests. (Defs.â 56.1 ¶¶ 57, 59â60, 62â64; Pl.âs Resp. 56.1 ¶¶ 57, 59â60, 62â64.) For example, the Parties agree that PCC has assisted at least one consumer with obtaining a refund from an accredited pharmacy for unfulfilled purchases. (Defs.â 56.1 ¶ 62; Pl.âs Resp. 56.1 ¶ 62.) The Parties also agree that PCC has responded and assisted some consumers who receive incorrect or unmarked medication and has followed up and worked with accredited pharmacies on consumersâ behalf regarding issues with orders. (Defs.â 56.1 ¶¶ 63â64; Pl.âs Resp. 56.1 ¶¶ 63â 64.) C. Procedural History15 PCC filed its initial Complaint on August 13, 2019. (See Compl. (Dkt. No. 1).) After the Courtâs denial of PCCâs Motion for a Preliminary Injunction, (see Dkt. No. 73), PCC filed its Amended Complaint on October 21, 2019, (see Am. Compl.). On November 6, 2019, NABP, PSM, and LegitScript filed pre-motion letters in anticipation of moving to dismiss PCCâs Amended Complaint. (See Dkt. Nos. 85, 86, 87.) After receiving responses from PCC, (see Dkt. Nos. 89, 90, 91), the Court held a pre-motion conference and set a briefing schedule, (see Dkt. (minute entry for Feb. 6, 2020); Dkt. No. 94). On March 13, 2020, Defendants filed a Joint Motion To Dismiss PCCâs Amended Complaint. (See Not. of Joint Mot. (Dkt. No. 97); Defs.â Mem. of Law in Supp. of Joint Mot. (Dkt. No. 100); Decl. of Erik T. Koons in Supp. of Joint Mot. (Dkt. No. 102); Decl. of Marjorie Clifton in Supp. of Joint Mot. (Dkt. No. 103).) On the same day, PSM, ASOP, and LegitScript filed individual Motions To Dismiss PCCâs Amended Complaint. (See PSMâs Not. of Mot. 15 The procedural history of this case is lengthy and complex, involving a higher-than- average number of motions, which have often been briefed simultaneously. (See generally Dkt.) The Court herein recounts only the procedural history relevant to the instant Motion. (Dkt. No. 97); PSMâs Mem. of Law in Supp. of Mot. (Dkt. No. 98); Decl. of Leslie E. John in Supp. of PSMâs Mot. (Dkt. No. 99); ASOPâs Not. of Mot. (Dkt. No. 104); ASOPâs Mem. of Law in Supp. of Mot. (Dkt. No. 105); LegitScriptâs Not. of Mot. (Dkt. No. 106); Decl. of Rachel J. Adcox in Supp. of LegitScriptâs Mot. (Dkt. No. 107); Decl. of John Horton in Supp. of LegitScriptâs Mot. (Dkt. No. 108); LegitScriptâs Mem. of Law in Supp. of Mot. (Dkt. No. 109).) On April 17, 2020, PCC filed responses to all four motions to dismiss. (See PCCâs Mem. of Law in Oppân to Joint Mot. (Dkt. No. 113); PCCâs Mem. of Law in Oppân to PSMâs Mot. (Dkt. No. 111); PCCâs Mem. of Law in Oppân to ASOPâs Mot. (Dkt. No. 110); PCCâs Mem. of Law in Oppân to LegitScriptâs Mot. (Dkt. No. 109).) On May 15, 2020, Defendants jointly filed their Reply and PSM, ASOP, and LegitScript each filed individual Replies. (See Defs.â Reply Mem. of Law in Supp. of Joint Mot. (Dkt. No. 116); PSMâs Reply Mem. of Law in Supp. of Mot. (Dkt. No. 115); ASOPâs Reply Mem. of Law in Supp. of Mot. (Dkt. No. 118); LegitScriptâs Reply Mem. of Law in Supp. of Mot. (Dkt. No. 117).) The Court held oral argument on all four motions on November 10, 2020, (see Dkt. (minute entry for Nov. 10, 2020)), and on March 30, 2021, the Court granted LegitScriptâs Motion To Dismiss, denied Defendantsâ Joint Motion To Dismiss, denied ASOPâs Motion To Dismiss, and granted in part and denied in part PSMâs Motion To Dismiss, (see Dkt. No. 129).16 On May 11, 2021, ASOP and PSM each filed Answers to PCCâs Amended Complaint, (see ASOPâs Answer (Dkt. No. 147); PSMâs Answer (Dkt. No. 150)), and NABP filed both an 16 By virtue of the Courtâs granting of LegitScriptâs Motion To Dismiss, PCCâs claims against LegitScript were later severed and transferred to the U.S. District Court for the District of Oregon. See supra Note 1. Answer and Counterclaims, (see NABPâs Answer & Counterclaims (Dkt. No. 148).). CSIP filed its Answer on May 25, 2021. (See CSIPâs Answer (Dkt. No. 157).) On April 14, 2022, Defendants filed a pre-motion letter in anticipation of moving to exclude Plaintiffâs expert testimony of Benjamin England, Esq. (See Dkt. No. 235.) On the same day, Defendants also filed a pre-motion letter in anticipation of a joint motion for summary judgment. (See Dkt. No. 233.) After receiving a response on both letters from PCC, (see Dkt. Nos. 238â39), the Court held a pre-motion conference and set a briefing schedule, (see Dkt. (minute entry for May 9, 2022); Dkt. No. 251). On June 22, 2022, Defendants filed a joint motion to exclude the expert testimony. (See Daubert Not. of Mot.; Defs.â Mem. of Law in Supp. of Mot. (âDefs.â Daubert Mem.â) (Dkt. No. 261).) PCC filed its Opposition on July 20, 2022. (See PCCâs Mem. of Law in Oppân to Mot. (âPCCâs Daubert Mem.â) (Dkt. No. 268); Decl. of James Lerner in Supp. of Pl.âs Opp. to Mot. (âLerner Decl.â) (Dkt. No. 268-1).) Defendants filed their Reply on August 5, 2022. (See Defs.â Reply Mem. of Law in Supp. of Mot. (âDefs.â Daubert Replyâ) (Dkt. No. 278).) On June 22, 2022, Defendants also filed a joint motion for summary judgment. (See SJ Not. of Mot.; Defs.â Mem. of Law in Supp. of Mot. (âDefs.â SJ Mem.â) (Dkt. No. 264); Defs.â 56.1.) PCC filed its Opposition on July 20, 2022. (See PCCâs Mem. of Law in Oppân to Mot. (âPCCâs SJ Mem.â) (Dkt. No. 269); Decl. of Gabriel Levitt in Opp. of Mot. (âLevitt Decl.â) (Dkt. No. 271).) Defendants filed their Reply on August 5, 2022. (See Defs.â Reply Mem. of Law in Supp. of Mot. (âDef.âs SJ Replyâ) (Dkt. No. 281).) On July 20, 2022, PCC filed a motion to strike portions of Defendantsâ submissions in support of Defendantsâ Motion for Summary Judgment. (See Mot. to Strike.) Defendants filed their Opposition on August 17, 2022. (See Defs Mot. to Strike Opp; Decl. of Melanie M. Kiser in Supp. of Defs.â Opp. to Mot. to Strike (Dkt. No. 292-1).) PCC filed its Reply on August 24, 2022. (See Pl.âs Reply Mem. of Law in Supp. of Mot. (Dkt. No. 302).) On August 5, 2022, Defendants filed a pre-motion letter requesting leave to file a motion to strike certain paragraphs of the Declaration of Gabriel Levitt. (See Levitt Decl. PML.) In lieu of a pre-motion conference, the Court set a briefing schedule. (Dkt. No. 284.) On August 15, 2022, Defendants filed a memorandum of law in support of their Motion. (See Defs.â Mot. to Strike.) Plaintiff filed its Opposition on August 22, 2022. (Pl.âs Strike Opp.) Finally, on February 16, 2023, Defendants filed a notice of supplemental authority in support of Defendants joint motions for summary judgment and motion to exclude testimony. (See Dkt. No. 337.) Plaintiff filed a response on February 24, 2023. (See Dkt. No. 342.) II. Discussion A. Standard of Review Summary judgment is appropriate where the movant shows that âthere is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law.â Fed. R. Civ. P. 56(a); see also Psihoyos v. John Wiley & Sons, Inc., 748 F.3d 120, 123â24 (2d Cir. 2014) (same). âIn deciding whether to award summary judgment, the [C]ourt must construe the record evidence in the light most favorable to the non-moving party and draw all reasonable inferences in its favor.â Torcivia, 17 F.4th at 354; see also Horror Inc. v. Miller, 15 F.4th 232, 240 (2d Cir. 2021) (same). âIt is the movantâs burden to show that no genuine factual dispute exists.â Vt. Teddy Bear Co. v. 1-800 Beargram Co., 373 F.3d 241, 244 (2d Cir. 2004); see also Red Pocket, Inc. v. Interactive Commcâns Intâl, Inc., No. 17-CV-5670, 2020 WL 838279, at *4 (S.D.N.Y. Feb. 20, 2020) (same). âHowever, when the burden of proof at trial would fall on the non[-]moving party, it ordinarily is sufficient for the movant to point to a lack of evidence to go to the trier of fact on an essential element of the non[-]movantâs claim,â in which case âthe non[-]moving party must come forward with admissible evidence sufficient to raise a genuine issue of fact for trial in order to avoid summary judgment.â CILP Assocs., L.P. v. Pricewaterhouse Coopers LLP, 735 F.3d 114, 123 (2d Cir. 2013) (alteration and quotation marks omitted). Further, â[t]o survive a [summary judgment] motion . . . , [a non-movant] need[s] to create more than a âmetaphysicalâ possibility that his allegations were correct; he need[s] to âcome forward with specific facts showing that there is a genuine issue for trial,ââ Wrobel v. Cnty. of Erie, 692 F.3d 22, 30 (2d Cir. 2012) (emphasis omitted) (quoting Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 586â87 (1986)), âand cannot rely on the mere allegations or denials contained in the pleadings,â Guardian Life Ins. Co. v. Gilmore, 45 F. Supp. 3d 310, 322 (S.D.N.Y. 2014) (quotation marks omitted); see also Wright v. Goord, 554 F.3d 255, 266 (2d Cir. 2009) (âWhen a motion for summary judgment is properly supported by documents or other evidentiary materials, the party opposing summary judgment may not merely rest on the allegations or denials of his pleading.â). And, â[w]hen opposing parties tell two different stories, one of which is blatantly contradicted by the record, so that no reasonable jury could believe it, a court should not adopt that version of the facts for purposes of ruling on a motion for summary judgment.â Scott v. Harris, 550 U.S. 372, 380 (2007). âOn a motion for summary judgment, a fact is material if it might affect the outcome of the suit under the governing law.â Royal Crown Day Care LLC v. Depât of Health & Mental Hygiene, 746 F.3d 538, 544 (2d Cir. 2014) (quotation marks omitted). At this stage, â[t]he role of the court is not to resolve disputed issues of fact but to assess whether there are any factual issues to be tried.â Brod v. Omya, 653 F.3d 156, 164 (2d Cir. 2011) (quotation marks omitted). Thus, a courtâs goal should be âto isolate and dispose of factually unsupported claims.â Geneva Pharms. Tech. Corp. v. Barr Labs. Inc., 386 F.3d 485, 495 (2d Cir. 2004) (quoting Celotex Corp. v. Catrett, 477 U.S. 317, 323â24 (1986)). When ruling on a motion for summary judgment, a district court should consider only evidence that would be admissible at trial. See Nora Beverages, Inc. v. Perrier Grp. Of Am., Inc., 164 F.3d 736, 746 (2d Cir. 1998). â[W]here a party relies on affidavits . . . to establish facts, the statements âmust be made on personal knowledge, set out facts that would be admissible in evidence, and show that the affiant . . . is competent to testify on the matters stated.ââ DiStiso v. Cook, 691 F.3d 226, 230 (2d Cir. 2012) (quoting Fed. R. Civ. P. 56(c)(4)); see also Sellers v. M.C. Floor Crafters, Inc., 842 F.2d 639, 643 (2d Cir. 1988) (âRule 56 requires a motion for summary judgment to be supported with affidavits based on personal knowledge . . . .â); Baity, 51 F. Supp. 3d at 419 (disregarding âstatements not based on [the] [p]laintiffâs personal knowledgeâ); Flaherty v. Filardi, No. 03-CV-2167, 2007 WL 163112, at *5 (S.D.N.Y. Jan. 24, 2007) (âThe test for admissibility is whether a reasonable trier of fact could believe the witness had personal knowledge.â (quotation marks omitted)). B. Analysis On March 30, 2021, this Court denied Defendantsâ Motion To Dismiss, holding that Plaintiffâs Amended Complaint â[did] not establish that Plaintiffâs enterprise is completely illegal or geared toward illegality.â PharmacyChecker.com LLC v. Natâl Assân of Bd. of Pharm., 530 F. Supp. 3d 301, 330 (S.D.N.Y. 2021). However, the Court noted that â[a]t summary judgment, Plaintiff will no longer be sheltered by the vagueness of itsâ complaint, stating that â[i]f discovery supports Defendantsâ claim that the primary purpose of Plaintiffâs business is to facilitate unlawful importation, [Defendants] may advance the same argument at that juncture.â Id. at 330â31 (citation, alterations, and quotation marks omitted). In the instant Motion, Defendants do just that: moving for summary judgment on the very limited issue of illegality. (See generally Defs.â SJ Mem.) In support of their motion for summary judgment, Defendants argue that (1) personal importation of prescription drugs from foreign online pharmacies is unambiguously illegal, (see id. at 11â15), (2) almost all of PCCâs revenue is derived from accredited international online pharmacies that sell to U.S. consumers, (see id. at 15â19), and (3) that PCCâs âprimary missionâ is to facilitate U.S. consumersâ unlawful importation of foreign pharmaceuticals, (see id. at 19â 27). The Court will address each argument in turn. 1. Applicable Law Section 4 of the Clayton Act provides for a private right of action and treble damages to â[a]ny person who shall be injured in his business or property by reason of anything forbidden in the antitrust laws.â 15 U.S.C. § 15(a). However, the Supreme Court has recognized that âCongress did not intend the antitrust laws to provide a remedy in damages for all injuries that might conceivably be traced to an antitrust violation.â Associated Gen. Contractors of Cal., Inc. v. Cal. State Council of Carpenters, 459 U.S. 519, 534 (1983) (quotation marks omitted). As such, the right to seek treble damages for federal antitrust violations has âdeveloped limiting contours . . . embodied in the concept of âantitrust standingâ.â Gatt Commcâns v. PMC Assocs., L.L.C., 711 F.3d 68, 75 (2d Cir. 2013) (quoting Daniel v. Am. Bd. of Emergency Med., 428 F.3d 408, 436â38 (2d Cir. 2005)). The Second Circuit has explained that â[t]o establish antitrust standing, âa plaintiff must show (1) antitrust injury, which is injury of the type the antitrust laws were intended to prevent and that flows from that which makes [the] defendantsâ acts unlawful, and (2) that he is a proper plaintiff in light of the four efficient enforcer factors.ââ Schwab Short-Term Bond Mkt. Fund v. Lloyds Banking Grp. PLC, 22 F.4th 103, 115 (2d Cir. 2021) (quoting In re DDAVP Direct Purchaser Antitrust Litig., 585 F.3d 677, 688 (2d Cir. 2009) (quotation marks omitted)). Importantly, â[t]he fact that private plaintiffs have been injured by acts that violate the antitrust laws is not enough to confer standing to sue.â Daniel v. Am. Bd. of Emergency Med., 428 F.3d 408, 438 (2d Cir. 2005). â[R]ather, the issue is whether that harm is an âinjury of the type the antitrust laws were intended to prevent.ââ In re Aluminum Warehousing Antitrust Litig., 95 F. Supp. 3d 419, 440 (S.D.N.Y. 2015) (quoting Brunswick Corp. v. Pueblo Bowl-O-Mat, Inc., 429 U.S. 477, 489 (1977)). While legality is not formally an element of the antitrust inquiry, several courts around the country have found that a plaintiff cannot suffer an antitrust injury if its asserted harm is based in illegal conduct. This principle was established in Maltz v. Sax, 134 F.2d 2 (2d Cir. 1943), where the court held that the plaintiff could not recover because âthe damages claimed were for an injury to something which the laws did not recognize as a legal rightâ; namely, gambling. Id. at 5. The Maltz court explained: â[The] [p]laintiff has no legal right in a business, the conduct of which was gambling, for which he may obtain protection either in an action at law, or by a suit in equity. He had no legal rights to protect. Therefore [the] defendants could not invade them.â Id. In ruling on Defendantsâ Motion To Dismiss, this Court surveyed opinions of courts across the country that issued similar opinions at various stages of litigation, finding that each case supports the principle of assessing the legality of an enterprise during an antirust standing inquiry. PharmacyChecker.com LLC, 530 F. Supp. 3d at 328â31. From these cases, the Court adopted the following principle: âwhere the plaintiffâs enterprise is completely or almost completely illegal, or completely or almost completely geared toward facilitating illegality, that plaintiff cannot plead an antitrust injury.â Id. at 329â30.17 2. Application a. Expert Testimony As an initial matter, the Court will address Defendantsâ putative motion to disqualify Plaintiffâs proffered expert witness. (See generally Daubert Not. of Mot.; Defs.â Daubert Mem.) 17 PCC argues that this Court applied the wrong antitrust standing standard by introducing illegality, stating that âa federal court may not decline to enforce [§] 1 of the Sherman Act on the purported basis that a plaintiffâs business is completely or almost completely geared toward facilitating unlawful conduct by others.â (PCCâs SJ Mem. 8â16 (quotation marks omitted).) Defendants in reply reiterate the âample law supporting [the Courtâ] holdingâ and argue that PCC waived any alternative standing argument at this time. (Defs.â SJ Reply 3â6.) The Court agrees with Defendants for the reasons stated below. Contrary to PCCâs assertion that âthis marks [P]laintiffâs first opportunity to litigate the appropriate standard for determining standing,â (see PCCâs SJ Mem. 11), PCC has had ample opportunity to argue the âproperâ standard. Of course, the Court did not create this standard out of thin air, despite PCCâs assertion that the Court adopted this standard âwithout briefing.â (Id. at 12.) In fact, the Parties briefed antitrust standing extensively at the motion to dismiss stage, and PCC raises very similar arguments here as it did at the motion to dismiss. (Compare id. at 8â15 with Pl.âs Opp. to Defs.â Joint Mot. to Dismiss 8â16 (Dkt. No. 114).) Moreover, as Defendants point out, this Court again revisited this issue in relation to Defendantsâ motion for Phase One discovery as well as Defendantsâ objection to the Magistrate Judgeâs order on expert disclosure sequencing. (See Dkt. Nos. 163, 194, 195.) At each stage of the litigation, this Court has reiterated the law of the case as it relates to antitrust standing. âThe law-of-the-case doctrine generally provides that when a court decides upon a rule of law, that decision should continue to govern the same issues in subsequent stages in the same case.â Musacchio v. United States, 577 U.S. 237, 244â45 (2016) (citations and quotation marks omitted); see also Bergerson v. N.Y. State Off. of Mental Health, Cent. N.Y. Psychiatric Ctr., 652 F.3d 277, 288 (2d Cir. 2011) (noting that âthere is a strong presumption against amendment of prior ordersâ (citation omitted)); Bellezza v. Holland, No. 09-CV-8434, 2011 WL 2848141, at *3 (S.D.N.Y. July 12, 2011) (explaining that reconsideration is appropriate only where there are âcogent or compelling reasons not to [follow the earlier decision], such as an intervening change of controlling law, the availability of new evidence, or the need to correct a clear error or prevent manifest injusticeâ (citation and quotation marks omitted)). PCC fails to introduce any âcogent or compelling reasonsâ counselling this Court to reconsider the rule of law for this case, instead choosing to relitigate old arguments under the guise of PCCâs âfirst opportunity to litigateâ antitrust standing. As such, this Court will continue to adjudicate the issue of antitrust standing under the same standard delineated in deciding the motions to dismiss. In opposing Defendantsâ Motion for Summary Judgment, Plaintiff relies on the expert testimony of Benjamin England, Esq. (âEnglandâ). (See generally PCCâs SJ Mem.) England is the founding member and CEO of a â[f]ood [and] [d]rug [c]onsulting [p]ractice and FDA/USDA/Customs and Trade focused law firm . . . providing regulatory consulting and representation of clientsâ before various federal and state regulatory agencies. (Defs.â Daubert Mem. Ex. 1 (âEngland CVâ) (Dkt. No. 261-1).) Plaintiff retained England to âreview case files, deposition testimony[,] and marketing materials for [PCC] to opine upon the operation and the interpretation and implementation of the Personal Importation Policy (PIP)â of the FDA. (Defs.â Daubert Mem. Ex. 3 (âEngland Reportâ) at 6 (Dkt. No. 261-3).) Defendants argue that Englandâs testimony âprovides impermissible and incorrect legal conclusionsâ as well as âspeculationâ that is not helpful to the Court to assess the legality of Plaintiffâs business. (Defs.â Dabuert Mem. 1.) The Court will address each argument to the extent necessary to decide the instant Motion. At the summary judgment stage, a court can âdecide questions regarding the admissibility of evidence, including expert opinion evidence[.]â Gjini v. U.S., No. 16-CV-3707, 2019 WL 498350, at *13 (S.D.N.Y. Feb. 8, 2019) (alteration in original) (quoting Bah v. Nordson Corp., No. 00-CV-9060, 2005 WL 1813023, at *6 (S.D.N.Y. Aug. 1, 2005)). âIf a proffer of expert testimony is excluded as inadmissible pursuant to [Federal Rule of Evidence] 702, the court must make the summary judgment determination on a record that does not include that evidence.â Colon ex rel. Molina v. BIC USA, Inc., 199 F. Supp. 2d 53, 68 (S.D.N.Y. 2001). Rule 702 of the Federal Rules of Evidence provides: A witness who is qualified as an expert by knowledge, skill, experience, training, or education may testify in the form of an opinion or otherwise if: (a) the expertâs scientific, technical, or other specialized knowledge will help the trier of fact to understand the evidence or to determine a fact in issue; (b) the testimony is based on sufficient facts or data; (c) the testimony is the product of reliable principles and methods; and (d) the expert has reliably applied the principles and methods to the facts of the case. Fed. R. Evid. 702. Although it is the role of the jury to determine the credibility of an expert witness, it is the role of the trial court to serve as a âgatekeep[er]â to ensure that the expert testimony is reliable and relevant before it is presented to the jury. See Kumho Tire Co. v. Carmichael, 526 U.S. 137, 147 (1999) (finding that the trial judgeâs gatekeeping obligation applies to all expert testimony); Daubert v. Merrell Dow Pharm., Inc., 509 U.S. 579, 597 (1993) (holding that the district court must ensure that a witness is qualified as an expert and âthat an expertâs testimony both rests on a reliable foundation and is relevant to the task at handâ). â[T]he proponent of expert testimony has the burden of establishing by a preponderance of the evidence that the admissibility requirements of Rule 702 are satisfied.â I.M. v. United States, 362 F. Supp. 3d 161, 191 (S.D.N.Y. 2019) (alteration in original) (quoting United States v. Williams, 506 F.3d 151, 160 (2d Cir. 2007)); see also LVL XII Brands, Inc. v. Louis Vuitton Malletier S.A., 209 F. Supp. 3d 612, 635 (S.D.N.Y. 2016) (same). â[T]he trial judge has broad discretion in the matter of the admission or exclusion of expert evidence[.]â Salem v. United States Lines Co., 370 U.S. 31, 35 (1962); see also Zerega Ave. Realty Corp. v. Hornbeck Offshore Transp., LLC, 571 F.3d 206, 213 (2d Cir. 2009) (âThe decision to admit expert testimony is left to the broad discretion of the trial judge and will be overturned only when manifestly erroneous.â). The Court must first address âthe threshold question of whether a wItness is qualified as an expert by knowledge, skill, experience, training, or education to render his or her opinions.â Nimely v. City of N.Y., 414 F.3d 381, 396 n.11 (2d Cir. 2005) (quotation marks and citation omitted). In doing this, the Court asks âwhether the proffered expert has the educational background or training in a relevant field . . . by looking at the totality of the witnessâs background.â Arista Recs. LLC v. Lime Grp. LLC, No. 06-CV-5936, 2011 WL 1674796, at *2 (S.D.N.Y. May 2, 2011) (citations and quotation marks omitted). Then, the Court must âcompare the area in which the witness has superior knowledge, education, experience, or skill with the subject matter of the proffered testimonyâ to âensure that the expert will actually be testifying on issues or subject matters within his or her area of expertise.â Id. (alteration, citations, and quotation marks omitted). Courts in the Second Circuit liberally construe the expert qualifications requirement, and generally will not exclude expert testimony provided âthe expert has educational and experiential qualifications in a general field closely related to the subject matter in question[.]â In re Zyprexa Prods. Liab. Litig., 489 F. Supp. 2d 230, 282 (E.D.N.Y. 2007); see also In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531, 559 (S.D.N.Y. 2004) (âThe Second Circuit has taken a liberal view of the qualification requirements of Rule 702, at least to the extent that a lack of formal training does not necessarily disqualify an expert from testifying if he or she has equivalent relevant practical experience.â). Here, England has a Bachelorâs degree in Biological Sciences from the University of Maryland and a law degree from the University of Miami School of Law. (See England CV 3â 4.) Of significance, England spent approximately 14 years working for the FDA in several different capacities, including as: (1) a senior special agent charged with â[e]nforc[ing] [f]ood, [d]rug[,] and [c]osmetic [l]awsâ; (2) as a âconsumer safety officer/compliance officerâ who â[a]pplied [f]ederal [f]ood, [d]rug[,] and [c]osmetic [l]aws . . . and directed civil and regulatory investigations related to the fraudulent importation of FDA regulated commoditiesâ; and (3) as regulatory counsel to the Associate Commissioner for Regulatory Affairs âadvising on matters related to FDA enforcement, imports, bioterrorism, and product safety; law, regulation, and policy development, [as well as] agency-wide implementation of international trade issues for FDA-regulated products and jurisdiction.â (Id. at 3.) Since leaving the FDA, England has spent almost 20 years in private practice counseling clients on similar regulatory issues, including the requirements of FDA, USDA, and US Customs law. (Id. at 2â3.) Given Englandâs almost 35 years of experience directly related to the issues at hand in this case, the Court concludes that he has the educational credentials, experience, and training to qualify as an expert in FDA policy and practice. However, this does not end the Courtâs inquiry into the permissibility of Englandâs expert testimony. Defendants argue that â[t]he Court should exclude Englandâs first three opinions about the federal laws and accompanying regulatory framework governing prescription drug importation because they state legal conclusions.â (Defs.â Daubert Mem. 1.) Specifically, Defendants argue that England impermissibly âopines as to the federal laws and regulationsâ in his first three opinions, and the Court should exclude this testimony because âthey state ultimate legal conclusions at the heart of Defendantsâ . . . motion for summary judgment and thus usurp the Courtâs role as arbiter of law.â (Id. at 4â5.) In the alternative, Defendants argue that the Court âshould exclude these opinions because they are simply incorrect.â (Id. at 5.) An expertâs role, under Federal Rule of Evidence 702(a), is to assist the trier of fact in âunderstand[ing] the evidenceâ or âdetermin[ing] a fact in issue,â not to dictate either the facts or the law to the jury. Fed. R. Evid. 702(a); see also Scentsational Technologies, LLC v. Pepsi, Inc., No. 13-CV-8645, 2018 WL 1889763, at *3 (S.D.N.Y. Apr. 18, 2018) (â[E]xpert testimony may not usurp the province of the judge to instruct on the law, or of the jury to make factual determinations.â). âThus, while âan opinion is not objectionable just because it embraces an ultimate issue,â the Second Circuit âis in accord with other circuits in requiring exclusion of expert testimony that expresses a legal conclusion.ââ Joint Stock Co. Channel One Russ. Worldwide v. Infomir LLC, No. 16-CV-1318, 2021 WL 4810266, at *14 (S.D.N.Y. Sept. 30, 2021) (memorandum and order) (citations omitted) (quoting Fed. R. Evid. 704(a); then quoting Hygh v. Jacobs, 961 F.2d 359, 363 (2d Cir. 1992) (collecting cases)); see also United States v. Bilzerian, 926 F.2d 1285, 1294 (2d Cir. 1991) (â[A]lthough an expert may opine on an issue of fact within the juryâs province, he may not give testimony stating ultimate legal conclusions based on those facts.â). â[T]he general rule is that an expert may not testify as to what the law is, because such testimony would impinge on the trial courtâs function.â In re Air Disaster at Lockerbie Scot. on Dec. 21, 1988, 37 F.3d 804, 826â27 (2d Cir. 1994), overruled on unrelated grounds by Zicherman v. Korean Air Lines Co. Ltd., 516 U.S. 217 (1996). âWhereas an expert may be uniquely qualified by experience to assist the trier of fact, he is not qualified to compete with the judge in the function of instructing the jury [on the law].â Hygh, 961 F.2d at 364. England offered four opinions in his expert report, three of which are relevant to this portion of the inquiry. (England Report 6.) Specifically, England stated the following opinions: 1. Drugs that comply with FDAâs labeling and approval requirements can be and are legally imported whether commercially or by individuals for their own personal use and FDA lacks the power to prevent such importations. 2. Drugs that comply with FDAâs approval requirements except for labeling or packaging differences may be imported under FDAâs drug labeling exemptions, whether they are imported commercially or by individuals for their own personal use. 3. FDA was mandated by Congress to establish clear guidance to consumers explaining when FDA would permit the importation of drugs that might otherwise be refused admission if imported commercially and FDAâs Personal Importation Policy is that guidance. (Id.; see also Defs.â Daubert Mem. 3.) While Plaintiff argues that âMr. England is not being proffered to testify whether plaintiffâs enterprise is completely or almost completely geared toward facilitating illegality,â (PCCâs Daubert Mem. 5 (quotation marks omitted)), it is clear to the Court that, at least with respect to these three opinions, England is doing exactly that. To decide whether PCC is âfacilitating illegality,â this Court must determine the purely legal question of whether personal importation is permissible under U.S. law. Each of the opinions England has proffered is an attempt to âtestify as to what the law is,â by offering Englandâs view of the meaning of these statutes based on his experience as a lawyer under the guise of expert advice. In re Air Disaster at Lockerbie Scot. on Dec. 21, 1988, 37 F.3d at 826â87 (stating that this type of testimony would âimpinge on the trial courtâs functionâ by âimplicitly provid[ing] a legal standard to the juryâ). In response, Plaintiff asserts that âin cases involving a specialized industry or complex regulatory scheme . . . courts routinely allow experts to interpret regulatory requirements and procedures because âa lay jury cannot be expected to understand the complex regulatory framework that informsâ the legality of the actorâs conduct.â (PCCâs Daubert Mem. 8â13 (citing In re Fosamax Prods. Liab. Litig. (âFosamaxâ), 645 F. Supp. 2d 164 (S.D.N.Y. 2009).) However, Fosamax as cited by Plaintiff is distinguishable for several reasons. In Fosamax, the court permitted an expert witness to testify âabout general FDA regulatory requirements and proceduresâ and âoffering an opinion as to [the companyâs] compliance therewith.â Fosamax, 645 F. Supp. 2d at 191. However, in deciding to allow this expertâs testimony, the court cited the expertâs âvoluminous report of 143 pagesâ which was divided into four sections applying the duties and obligations of the FDA to the drug at issue. Id. at 189. Specifically, the court noted that the sections âthen extensively summarize or quote the record evidence that provides the bases for her opinions.â Id. In comparison, Englandâs report totals a mere 14 pages, including five pages describing his qualifications. (See England Report 2â6.) Moreover, England spends an additional four pages describing his interpretation of federal statutes and implementing regulations, followed by three pages of his view of the personal importation program without any citations to support his assertions. (See id. at 11â13.) For example, England states that the personal importation program was â[i]nitially established as travel policy[] in the 1970sâ and the âFDA began permitting individuals who traveled abroad for medical treatment to return with personal use quantities of drugs even though the drugs were unapproved new drugs and misbranded.â (Id. at 11.) England does not appear to base this fact and others throughout the report on his time at the FDA, as he was not employed at the FDA in the 1970s. (See generally England CV.) And despite Plaintiffâs assertions that Englandâs report is grounded on publicly available materials, (see PCCâs Daubert Mem. 4), England offers several conclusory statements without any support. (See, e.g., England Report 14 (âClearly there are drugs that can be imported legally, ipso facto, under the PIP or relevant law and regulations.â); id. (âTherefore, any [PCC] accredited (and licensed) pharmacy that ships to the U.S. a drug that is from an approved source, the fact that the labeling does not conform to the FDCA requirements for adequate directions for use does not make the drug misbranded if it is dispensed by the pharmacy pursuant to a valid prescription. The valid prescription (and other factors described in the FDA regulation) bring the drug within a drug labeling exemption and so the personal importation of the drug by the patient is legal.â).) To borrow from language in Fosamax, â[s]ome opinions in [Englandâs] report are too conclusory . . . to be admitted.â Fosamax, 645 F. Supp. 2d at 191. The other cases Plaintiff cites in support of this principle are similarly unavailing. For example, the court in In re Namenda Direct Purchaser Antitrust Litig., 331 F. Supp. 3d 152 (S.D.N.Y. 2018) specifically admitted expert testimony about a complex statutory scheme because the expert did not provide âlegal conclusionsâ or âopine on whether [the defendants] violated the Act, but simply explain[ed] the mechanics of drug approval.â Id. at 184 (quotation marks and citation omitted). Englandâs testimony in contrast attempts to directly state what the law is as it relates to personal pharmaceutical importation. (See, e.g., England Report 6 (âDrugs that comply with FDAâs labeling and approval requirements can be and are legally imported whether commercially or by individuals for their own personal use . . . .â (emphasis added)).) Plaintiffâs other cases fare no better as they acknowledge the limits of an expertâs opinions about the law. See, e.g., In re Suboxone Antitrust Litig., No. 16-CV-5073, 2020 WL 6887885, at *40 (E.D. Pa. Nov. 24, 2020) (excluding an expertâs testimony on regulations related to citizen petitions because âher opinion is, at its core, a pure legal conclusion as to whether the [petition at issue] had merit,â thus âusurp[ing] the juryâs role in applying the law to the factsâ); Am. Home Assur. Co. v. Merck & Co., 462 F. Supp. 2d. 435, 448 (S.D.N.Y. 2006) (allowing expert testimony on FDA regulations but excluding other expert testimony that âclearly impinges upon the province of the [c]ourt, in so far as he essentially proffers his own version of contractual interpretationâ). At bottom, England is not providing the Court with an extensive interpretation of a complex regulatory scheme, as was the case in Fosamax and similar cases. Instead, England is using his first three opinions to dictate what the law is for personal importation of prescription drugs. For these reasons, the Court grants Defendantsâ Motion to exclude Englandâs testimony as to the first three opinions listed in the expert report.18, 19 Defendants also challenge Englandâs fourth opinion, arguing that the opinion should be excluded because it is (1) âirrelevant to the critical issue of whether Plaintiff facilitatesâ personal importation, (2) âconstitutes unreliable speculation about the intent or motivation of a party,â and (3) lacks foundation. (Defs.â Daubert Mem. 16 (emphasis omitted).) For the reasons stated below, the Court disagrees. âIn determining whether an expertâs opinion should be excluded as unreliable, âthe district court should undertake a rigorous examination of the facts on which the expert relies, the method by which the expert draws an opinion from those facts, and how the expert applies the 18 In the alternative, Defendants also argue that the Court âshould exclude these opinions because they are simply incorrect.â (Defs.â Daubert Mem. at 5.) However, the Second Circuit has held multiple times that the focus of the Daubert inquiry is the relevance of an expertâs testimony, not its âcorrectness.â See In re Pfizer Inc. Secs. Litig., 819 F.3d 642, 661 (2d Cir. 2016) (declining to weigh in as to whether â[p]laintiffsâ [expertâs] theory is either legally or factually sustainableâ because âDaubert and Rule 702 merely authorize the court to ensure that the expertâs testimony both rests on a reliable foundation and is relevant to the task at handâ (quotation marks and citation omitted)); Amorgianos v. Nat'l R.R. Passenger Corp., 303 F.3d 256, 266â67 (2d Cir. 2002) (âIn undertaking this flexible inquiry, the district court must focus on the principles and methodology employed by the expert, without regard to the conclusions the expert has reached or the district court's belief as to the correctness of those conclusions.â). 19 To be clear, however, Englandâs testimony would not have created a genuine issue of material fact sufficient to withstand summary judgment. Though the Court has determined Englandâs opinions here to be impermissible legal opinions, taken most charitably, this testimony would represent âspecialized knowledgeâ that could âhelp the trier of fact to understand the evidence or to determine a fact in issue.â Fed. R. Evid. 702(a). In other words, Englandâs opinions here are not âfactsâ themselves, but are instead additional context for the Courtâs ultimate legal conclusion on the statutory scheme for personal importation of pharmaceutical drugs. As such, Englandâs opinions on the statutory scheme would not be dispositive or dictate what the law must be in this inquiry, as this is strictly the province of the Court. See, e.g., In re Suboxone Antitrust Litig., 2020 WL 6887885, at *40 (excluding an expertâs testimony because âher opinion is, at its core, a pure legal conclusion as to whether the [petition at issue] had merit,â thus âusurp[ing] the juryâs role in applying the law to the factsâ). facts and methods to the case at hand.ââ Houser v. Norfolk S. Ry. Co., 264 F. Supp. 3d 470, 475 (W.D.N.Y. 2017) (quoting Amorgianos, 303 F.3d at 267). Neither âDaubert [n]or the Federal Rules of Evidence require[ ] a district court to admit opinion evidence which is connected to existing data only by the ipse dixit of the expert. A court may conclude that there is simply too great an analytical gap between the data and the opinion proffered.â Nimely, 414 F.3d at 396 (italics omitted) (quoting Gen. Elec. Co. v. Joiner, 522 U.S. 136, 146 (1997)). âThus, when an expert opinion is based on data, a methodology, or studies that are simply inadequate to support the conclusions reached, Daubert and Rule 702 mandate the exclusion of that unreliable opinion testimony.â Amorgianos, 303 F.3d at 266. As relevant to the instant inquiry, Englandâs fourth opinion reads as follows: PharmacyChecker.com does not buy, sell, distribute, dispense or process orders for drugs and its requirements for pharmacy participation in the accreditation program are clearly consistent with FDAâs Personal Importation Policy and designed to ensure participating pharmacies conform to the FDA policy as mandated by Congress. (England Report 6.) Defendants argue that Englandâs opinion is âirrelevant to the key issue of antitrust injury,â counseling the Court to exclude the evidence on this ground. (Defs.â Daubert Mem. 16â17.)20 However, while this Court has an essential gate-keeper role in determining the admissibility of expert testimony, the standards for inclusion of expert testimony are quite permissive for qualified expertsâand rightfully so. Englandâs testimony here has a âvalid . . . connection to the pertinent inquiry,â which is the relevant âprecondition to admissibility.â Kumho Tire Co., 526 U.S. at 149 (quotation marks and citation omitted). Moreover, it is the role 20 Defendants also argue that âwhether Plaintiff itself buys, sells[,] or dispenses orders is a question of fact which is not an appropriate subject for expert testimony.â (Defs.â Daubert Mem. 16 n.5.) However, and as Plaintiff points out in opposition, Defendants have lodged no dispute to this fact and thus the Court deems it admitted for the purpose of summary judgment. (See PCCâs Daubert Mem. 19â20; Pl.âs Resp. 56.1 ¶ 96; Defs.â 56.1 Reply ¶ 96.) of the Court at summary judgment to assess admissible evidence to determine whether it is âsufficient to raise a genuine issue of fact for trial in order to avoid summary judgment.â CILP Assocs., L.P., 735 F.3d at 123 (quotation marks and citation omitted). While the Court declines to determine whether Englandâs fourth opinion is material at this time, the Court willâas it mustârigorously review the record and expert evidence provided in determining whether to grant summary judgment. To put it simply: whether the Defendants find this evidence âirrelevantâ is irrelevant to the Court at this time. The Court will determine the weight to give this expert testimony in deciding summary judgment. Defendants also argue that Englandâs opinion that PCCâs verification program is âpurportedly designed to ensure compliance with FDA policyâ is âunfounded speculation about the intent of Plaintiff. (Defs.â Daubert Mem. 17â18.) Plaintiff argues that England âis not being proffered to testify as to the institutional intent or motive of [P]laintiff when it created its accreditation program,â but instead represents Englandâs âinterpretation of the written language of the program.â (PCCâs Daubert Mem. 20â21.) While this is a much closer question, the Court agrees with Plaintiff. The Parties argue about the import of Town of Halfmoon v. Gen. Electric Co., No. 09- CV-228, 2016 WL 866343 (N.D.N.Y. Mar. 3, 2016). (See PCCâs Daubert Mem. 20â21; Defs.â Daubert Reply 9.) In Halfmoon, the defendant gave notice that it would call an expert to address whether certain âresponse costs were necessary and consistentâ with federal regulations that were a prerequisite to recovery under the relevant statute. 2016 WL 866343, at *15 (quotation marks omitted). The plaintiff challenged the expertâs testimony on several grounds, including that the opinions âimpermissibly rest[ed] on conclusions about the motivations and intent of [the plaintiffâs] decision-makers.â Id. at *16 (quotation marks omitted). The Halfmoon court disagreed, noting that the expertâs report did not ârest on any effort to read [the plaintiffâs] institutional mind,â but was instead âbased on a review of the paper trailâ created by a town official and âan examination of whether or not any documentary evidence produced in discovery substantiates [the plaintiffâs] claim.â Id. Here, while Defendants are correct that England did not review a âpaper trail or documentary evidenceâ as the expert did in Halfmoon, this does not mean that Englandâs expert opinion rests on motivations and intent. Instead, England relies on a thorough review of PCCâs website, a 30(b)(6) deposition and its associated exhibits discussing PCCâs verification program, and his expertise as a compliance officer to provide his view of compliance with laws and regulations. (See PCCâs Daubert Mem. Ex. 2 (Dkt. No. 268-3).) Moreover, the Halfmoon court acknowledged that âthe distinction between fact and legal conclusions is extremely fine,â and âthe mere fact that an expertâs opinion is based on criteria delineated by the applicable law does not transmogrify it into a legal conclusion.â Halfmoon, 2016 WL 866343, at *16 (alteration, quotation marks, and citation omitted). Defendants also cite to In re Rezulin Prods. Liab. Litig., 309 F. Supp. 2d 531 (S.D.N.Y. 2004), for the same principle. However, the proposed testimony in Rezulin differed in ways that supported its exclusion. In Rezulin, the expertâs proposed testimony âmerely repeated facts or other opinions stated by other potential witnesses or in documents produced in discovery,â including speculating about âwhat the FDA might have done with different information.â 309 F. Supp. 2d at 546. In addition, the expert drew several inferences from documents produced in discovery, making comments such as the expert âknows for sureâ that a pharmaceutical company took the drug off the market âfor safety reasons because the chairman of the company allegedly wrote this in a letter.â Id. at 546â47 (quotation marks omitted). The expert repeatedly made such claims and speculative inferences about intent, with the plaintiffs conceding that the expert was describing âthe facts and conditions from which the jury could infer [the] defendantâs motivation in stifling research.â Id. at 547 & n.45. Here, Englandâs testimony does not come close to the improprieties at issue in Rezulin. And to the extent that the Court believes that the testimony does begin to veer that way, âthe Court will exercise its supervisory authority . . . to ensure that neither [the expertâs] testimony nor the testimony of any other expert for that matter, usurps the role of the trial judge . . . as to the applicable law or . . . applying that law to the facts before it.â Halfmoon, 2016 WL 866343, at *17 (citation and quotation marks omitted). Finally, as to Defendantsâ claim that the England opinion lacks âreasonable foundation,â (see Defs.â Daubert Mem. 18), the Court disagrees for the same reasons stated above. To the extent that Defendants argue that Englandâs lack of foundation is amplified by discrepancies between exhibits from discovery, testimony, and Englandâs opinions, âfactors which make evidence less than conclusive affect only weight, not admissibility.â United States v. Schultz, 333 F.3d 393, 416 (2d Cir. 2003) (citation and quotation marks omitted); see also United States v. Mustafa, 753 F. Appâx 22, 36 (2d Cir. 2018) (summary order) (citing Schultz). Accordingly, the Court grants Defendantsâ Motion to Exclude Englandâs testimony as to Englandâs first three opinions, and denies Defendantsâ Motion to Exclude as to the final opinion. b. Federal Standards for Illegality Defendants first argue that they are entitled to summary judgment on the legal question as to whether the personal importation of prescription drugs from foreign online pharmacies is illegal. Specifically, Defendants argue that federal law âunambiguouslyâ makes the personal importation of prescription drugs illegal, citing to the comprehensive scheme of federal laws and to decisions from courts outside of this District and Circuit who have found as such. (See Defs.â SJ Mem. 11â15.) The importation of prescription drugs is governed by the Federal Food, Drug, and Cosmetic Act (âFFDCAâ). In relevant part, the FFDCA prohibits the âintroduction or delivery for introduction into interstate commerce of any food, drug, device, or cosmetic that is adulterated or misbranded[,]â as well any introduction into interstate commerce of any new drug that is not manufactured pursuant to FDA approval. 21 U.S.C. § 331(a), (d); see also 21 U.S.C. § 355(a). The Eighth Circuit has noted that: [t]he United States Food and Drug Administration (âFDAâ) repeatedly has expressed the view that virtually all importation of drugs into the United States by individual consumers violates the FFDCA, because the drugs are not approved in accordance with 21 U.S.C. § 355, are not labeled as required by 21 U.S.C. § 352, or are dispensed without a valid prescription in contravention of 21 U.S.C. § 353(b)(1). In re Canadian Import Antitrust Litg. (âCanadian Importâ), 470 F.3d 785, 788â89 (8th Cir. 2006); see also Pharm. Rsch. & Mfrs. of Am. v. Depât of Health & Human Servs., No. 10-CV- 3402, 2023 WL 1795644, at *1â2 (D.D.C. Feb. 6, 2023) (analyzing Canadian Import). These laws overlap by design, âwork[ing] in conjunction with the other statutory standards and FDA regulations to create a system that excludes noncompliant and potentially unsafe pharmaceuticals. Canadian Import, 470 F.3d at 790. For example, the FFDCA describes in various sections what drugs are âadulteratedâ or âmisbranded.â Drugs are considered misbranded in a variety of circumstances, including lacking information required by statute, see 21 U.S.C. § 352, if they are labeled in a language other than English, see 21 C.F.R. § 201.15(c), or are dispensed without a valid prescription, see 21 U.S.C. § 353(b)(1). In addition, the FFDCA expressly prohibits knowingly importing or reimporting drugs, subject to limited exceptions. 21 U.S.C. § 333(b)(1)(A). Importantly, foreign pharmaceuticalsâmanufactured and distributed abroad and later imported into the United Statesâare âunapprovedâ drugs within the meaning of 21 U.S.C. § 355. See Pharm. Rsch. & Mfrs. of Am., 2023 WL 1795644, at *1 (stating that âthe domestic drug supply chain is strictly monitoredâ); Canadian Import, 470 F.3d at 789; Vermont v. Leavitt, 405 F. Supp. 2d 466, 473 (D. Vt. 2005) (âAny drug, even a foreign version of an FDA approved drug, will be an unapproved drug unless it meets all United States packaging, labeling and dosage requirements.â); Personal Importation, Food & Drug Admin. (last updated January 10, 2023), https://www.fda.gov/industry/import-basics/personal-importation (âIf a drug is approved for use in another country but is an unapproved new drug in the U.S. it is illegal to import.â); United States v. Rx Depot Inc., 290 F. Supp. 2d 1238, 1245 (N.D. Okla. 2003) (finding that the defendants violated the FFDCA âeach timeâ they introduce an unapproved Canadian drug in violation of 21 U.S.C. § 355). As the Eighth Circuit has summarized: [d]rugs that are manufactured and distributed [outside of the United States] are not approved pursuant to [the FDAâs approval process]. Because foreign labeling differs from domestic labeling, approval granted to a particular product to be distributed in the United States does not constitute approval of another drugâeven one with the same chemical compositionâto be distributed [internationally] with different labeling, and then imported into the United States. Canadian Import, 470 3d. at 780â90. While Plaintiff is correct that there are various exceptions to and exemptions from these laws, (see, e.g., PCCâs SJ Mem. 22 (citing labeling exemptions listed under 21 C.F.R. § 201.100)), these exemptions do not negate the bright-line rule of illegality. The FDA defines personal importation as âa product not for further sale or distribution into U.S. commerce . . . carried in baggage or shipped by a courier or international mail.â Personal Importation, Food & Drug Admin. (last updated January 10, 2023), https://www.fda.gov/industry/import- basics/personal-importation. The FDA further notes that â[i]n most circumstances, it is illegal for individuals to import drugs . . . into the U.S. for personal use because these products purchased from other countries have not been approved by the FDA for use and sale in the U.S. Id. The FDA emphasizes the importance of this scheme, stating that it âcannot ensure the safety and effectiveness of the medicine purchased over the Internet from foreign sources. . . . For these reasons, the FDA recommends only obtaining medicines from legal sources in the U.S.â Id. The FDA continues to provide information regarding situations for which personal importation of a prescription drug âmight be allowedâ: (1) the drug âis for a serious condition for which effective treatment may not be available domestically either through commercial or clinical meansâ; (2) â[t]here is no known commercialization or promotion of the product to persons residing in the U.S.â; (3) the product âdoes not represent an unreasonable riskâ; (4) the consumer âaffirms in writing that the product is for personal useâ; and (5) the quantity is âgenerally not more than a three month supplyâ and the consumer must â[p]rovide the name and address of the doctor licensed in the U.S. responsible for . . . treatment with the product, or [p]rovide evidence that the product is for the continuation of a treatment begun in a foreign country.â Id. Notably, however, the FDA does not specifically state whether personal importation would indeed be allowed under these circumstances, just that it âmightâ be allowed. Id. However, there are two clear statutory exceptions to this bright-line rule. First, the Secretary of Health and Human Services (âHHSâ or âthe Secretaryâ) may authorize importation for emergency use. 21 U.S.C. § 381(d)(2). Second, importation may be permitted under section 1121 of the Medicare Prescription Drug, Improvement, and Modernization Act, Pub. L. No. 108â173, 117 Stat. 2066 (2003) (the âMMAâ). See 21 U.S.C. § 384. In 2003, Congress passed the MMA which provided the Secretary with various authorities to relax enforcement of prescription drug importation penalties. See id. For example, the Secretary is given the authority to âpromulgate regulations permitting pharmacists and wholesalers to import prescription drugs from Canada into the United States.â Id. at §384(b). In addition, â[t]he Secretary may grant to individuals, by regulation or on a case-by-case basis, a waiver of the prohibition of importation of a prescription drug . . . under such conditions as the Secretary determines to be appropriate.â Id. § 384 (j)(2)(A). Specifically, the Secretary may grant a waiver to permit personal importation of a prescription drug under with the following conditions: the drug is (1) âimported from a licensed pharmacy for personal use by an individual, not for resale, in quantities that do not exceed a 90-day supplyâ; (2) âaccompanied by a copy of a valid prescriptionâ; (3) âis imported from Canada, from a seller registered with the Secretaryâ; (4) âis a prescription drug approved by the Secretaryâ; (5) âis in the form of a final finished dosage that was manufactured in an establishment registered under [the FFDCA]â; and (6) âis imported under such other conditions as the Secretary determines to be necessary to ensure public safety.â Id. § 384(j)(3). The Parties strongly disagree about whether this exception and related guidance (the âPersonal Importation Policyâ) is indeed operative and relevant to PCCâs business, and whether it governs the personal importation of prescription drugs from foreign pharmacies. (See generally Defs.â SJ Mem.; PCCâs SJ Mem.) Specifically, the Parties disagree as to (1) whether the Secretary must certify any use of the personal importation plan under § 384(j); and, if so, (2) whether the Secretary has in fact ever invoked the Personal Importation Policy for importation from foreign pharmacies. To both questions, Defendants argue that the Secretary has ânever implemented this section to allow for personal importation,â citing another section of the statute that notes that â[t]his section shall become effective only if the Secretary certifies to the Congress that the implementation of this section will pose no additional risk to the publicâs health and safety; and result in a significant reduction in the cost of covered products to the American consumer.â (Defs.â SJ Mem. 13). See also 21 U.S.C. § 384(l)(1). Plaintiff disagrees with Defendantsâ assertion that the Secretary must make this certification prior to invoking § 384(j), arguing that the âprogramâ referenced in the relevant clause refers to the âwholesale importation program under subsection (b), not (j).â (PCCâs SJ Mem. 25â26.) However, based on basic principles of statutory interpretation, it is clear that where the certification provision states that âthis section shall become effectiveâ only if preconditions occur, the statute intends for the entire section (i.e., § 384) to be affected, rather than just particular subsections (i.e., § 384(b)). Moreover, Plaintiffâs interpretation of the statute has been roundly rejected by other courts, and this Court finds no compelling reason to disagree. For example, in Vermont v. Leavitt, 405 F. Supp. 2d 466 (D. Vt. 2005), the court called Plaintiffâs proposed reading of the statute âhighly implausible,â finding that the âonly sensible way to read the statute is to assume that Congress intended the certification provision to apply to the whole of [§] 384.â Id. at 474â75 (âThe certification provision clearly states that âthis section shall become effectiveâ only if the Secretary certifies. Thus, the Court begins with a very strong presumption that Congress meant âsectionâ when it wrote âsection.ââ (citations omitted)). Other courts have agreed, citing the courtâs reasoning in Leavitt. See Canadian Import, 470 F. 3d at 790 (âIn 2000 and 2003, Congress enacted amendments to the FFDCA that would permit limited importation of certain prescription drugs from Canada by pharmacists, wholesalers, or individuals, 21 U.S.C. § 384(b), (j), but only if the Secretary of Health and Human Services first certifies[.]â); Montgomery Cnty. v. Leavitt, 445 F. Supp. 2d 505, 510â11 (D. Md. 2006) (citing Leavitt to support the proposition that âit is clear that Congress intended the certification provision to apply to both subsection (b) and to the individual waiver provision of subsection (j)â); cf. Pharm. Rsch. & Mfrs. of Am., 2023 WL 1795644, at *2 (describing the Secretaryâs certification as a âpreconditionâ to promulgating regulations to import prescription drugs from Canada). Given this authority, this Court concludes that the Secretary has never invoked § 384(j) to put the Personal Importation Policy into effect. In July 2019, HHS and the FDA announced the âSafe Importation Action Plan,â which proposed two pathways âto allow the safe importation of certain drugs originally intended for foreign marketsâ to provide âsafe, lower cost drugs to consumers.â Dept. of Health & Human Servs. & U.S. Food & Drug Admin., Safe Importation Action Plan (2019), https://www.hhs.gov/sites/default/files/safe-importation-action-plan.pdf. In December 2019, the FDA issued a Notice of Proposed Rulemaking pursuant to the Safe Importation Action Plan, outlining the steps that the federal government intended to take for the importation of drugs. See Importation of Prescription Drugs, 84 Fed. Reg. 70796 (proposed Dec. 23, 2019). In the proposed rule, the FDA was careful to underscore that it was ânot proposing to implement the personal importation provisions [in § 384(j)] through this rulemaking.â Id. at 70800. The FDA went on to explain: The internet provides consumers with instant access to information and services, including prescription medications. Medications that are purchased online and imported through international mail, express couriers, and other means pose significant challenges for FDA and its ability to adequately safeguard the quality and safety of drugs taken by U.S. consumers. While there are pharmacy websites that operate legally and offer convenience, privacy, and safeguards for purchasing medicines, there are many rogue online pharmacies that sell medicines at deeply discounted prices, often without requiring a prescription or adhering to other safeguards followed by pharmacies licensed by a State in the United States. These rogue online pharmacies are often run by sophisticated criminal networks that knowingly and unlawfully cause the importation of adulterated, counterfeit, misbranded and unapproved drugs into the United States. [ . . . ] Consumers go to these websites believing they are buying safe and effective medications, but often they are being deceived and put at risk by individuals who put financial gain above patient safety. [ . . . ] Given these risks, and other concerns . . ., the proposed rule, if finalized, would not implement personal importation provisions under [§ 384(j)]. Id. In the final rule promulgated in October 2020, the FDA addressed several comments that âask[ed] FDA to expand the proposed rule to . . . allow personal importation of certain prescription drugs.â Importation of Prescription Drugs, 85 Fed. Reg. 62094, 62097 (Oct. 1. 2020) (to be codified at 21 C.F.R. pts. 1, 251). Here, the FDA again reiterated that it was ânot implementing the personal importation provisions . . . through this rulemaking.â Id. Despite this, Plaintiff continues to argue that there is significant daylight between federal lawâs prohibition on personal importation and the practical reality of importation, claiming that âthere is no prohibition on introducing FDA-approved drugs, provided other requirements are met.â (PCCâs SJ Mem. 21.) In making this argument, Plaintiff appears to conflate the FDA website guidance on personal importation with the requirements of § 384, arguing that the existence of the Personal Importation Policy is, by design, evidence that there are some exceptions to the prohibition on personal importation that would make the conduct not per se illegal. (Id. at 21â28.)21 Defendants largely rely on Canadian Import to argue that âpersonal 21 In particular, Plaintiff cites Cook v. Food & Drug Admin., 733 F.3d 1 (D.C. Cir. 2013) for several propositions, including that the FDA has discretion as to how it implements personal importation. (PCCâs SJ Mem. 22â23.) Specifically, Plaintiff states that the FDA has pointed to § 384(j) â[a]s evidence that the Congress is aware of and agreesâ that âit can âallow the importation of drugs that are clearly for personal use.ââ (Id. (citing Cook, 733 F.3d at 10 (quotation marks omitted)).) However, the D.C. Circuit plainly disagreed with Plaintiff in the same paragraph, agreeing instead with the statutory interpretation outlined by this Court. Cook, 733 F.3d at 10. The D.C. Circuit stated that â[t]he FDA . . . conveniently overlooks the very next subsection, which effectuates the statute by authorizing the Secretary to grant individual waivers to import prescription drugs. [ ] Congress would have no reason to grant the FDA explicit waiver importation of prescription drugs from foreign on[]line pharmacies is unambiguously illegal.â (Defs.â SJ Mem. 11.) As explained above, the Eighth Circuit in Canadian Import noted that the FDA ârepeatedly has expressed the view that virtually all importation of drugs into the United States by individual consumers violates the FFDCA.â 470 F.3d at 788â79; see also Pharm. Rsch. & Mfrs. of Am., 2023 WL 1795644, at *2 (âThe statutory drug-importation scheme has thus lain dormant for most of its history, and importing drugs from Canada or elsewhere has remained effectively illegal.â). The Canadian Import court also found that this was a âcongressional plan to create a closed system designed to guarantee safe and effective drugs for consumers in the United States.â Canadian Import, 470 F.3d at 790 (quotation marks and citation omitted). While foreign drugs may be âsimilar in substanceâ to those manufactured in the United States, foreign drugs may also have âchemical compositions that are not yet approved by the FDAâ and may not be âmanufactured in accordance with FDA rules[ ] or . . . transported or stored in a manner that is deemed safe by the FDA.â Id. Specifically, this âclosed system ensures that approved prescription drugs are subject to FDA oversight and are continuously under the custody of a U.S. manufacturer or authorized distributorâ which makes the drugs safe, consistent, and predictable for the American consumer. Id. (quotation marks and citation omitted). Plaintiff attempts to limit Canadian Import by arguing that the case âconsidered only a class of U.S. plaintiffs who, as alleged, purchased certain drugs in the United States also sold in Canada with different labeling,â but ââthe Canadian prescription drugs at issue [were] not labeled in conformity with federal lawâ and were therefore illegal to import under the provisions the authority if, as the FDA argues, the agency was already authorized not to enforce [the personal importation of drugs].â Id. (citations omitted). class invoked.â (PCCâs SJ Mem. 23 (citing Canadian Import, 470 F.3d at 788â89).) In the alternative, Plaintiff argues that âmany drugs sold in Canada ae FDA-approved drugsâ and Canadian Import only applies to the small, mislabeled class of drugs at issue in the opinion. (Id.) However, and as noted in Canadian Import, the âfundamental[]â issue regarding the mislabeled drugs in the case âillustrates why . . . Canadian drugs are âunapprovedâ drugsââ under federal lawâforeign manufactured and distributed drugs are not approved according to the existing statutory framework. Canadian Import, 470 F.3d at 789â790. This Court finds the Eighth Circuitâs reasoning is particularly persuasive given its discussion of the MMA. Specifically, the Eighth Circuit reasoned that it was under this âclosed systemâ backdrop that Congress created a âspecial procedure for authorizing importation of prescription drugs from Canada,â ultimately supported the conclusion that federal law does not permit personal importation. See id. at 790â91. âWhile it is true that no federal statute by its express terms bans importation of prescriptions drugs from Canada, such an explicit country-by- country prohibition is unnecessary to accomplish the task. By creating the comprehensive regulatory system . . ., Congress has effectively precluded importation of these drugs absent the sort of special authorization contemplated by 21 U.S.C. § 384.â Id. As such, and as relevant to the instant Motion, the Court finds that personal importation of prescription drugs is illegal under current federal law. Plaintiff argues in the alternative that its verification and accreditation system âfilters out unlawful importations with requirements consistent with lawful importation.â (See PCCâs SJ Mem. 26â28.) Plaintiff cites provisions in its âVerification Program Accreditation Standards and Guide,â which largely correlate with the FDAâs personal importation guidance on its website. (See id. at 27 (listing the requirements); Pl.âs Mem. in Opp. Ex. 27 (Dkt. No. 270-28).) See also Personal Importation, Food & Drug Admin. (last updated January 10, 2023), https://www.fda.gov/industry/import-basics/personal- importation. However, PCC does not establish that its accreditation program even follows all of the listed guidance. Compare Personal Importation, Food & Drug Admin. (last updated January 10, 2023), https://www.fda.gov/industry/import-basics/personal-importation (requiring that the product âis for a serious condition for which effective treatment may not be available domestically either through commercial or clinical meansâ and does not represent an âunreasonable riskâ) with (PCCâs SJ Mem. 27). Moreover, the Court emphasizes the fragility of this argument, as evidenced by the language the FDA itself uses to describe personal importation. See Personal Importation, Food & Drug Admin. (last updated January 10, 2023), https://www.fda.gov/industry/import-basics/personal-importation (providing âinformation regarding situations for which [personal importation of unapproved drugs] might be allowedâ (emphasis added)). In addition, to the extent Plaintiff argues that its accreditation guidelines comport with the MMA, Plaintiff has quite the mountain to climb. Section 384(j) not only has not been invoked by the Secretary, but even if it had been invoked, the potential provisions only apply to Canada, not all international personal importation. Id. As such, Plaintiffâs arguments are unpersuasive. c. PCCâs Revenue Share from International Pharmacies Defendants next argue that âPCCâs financial records firmly establish that its enterprise is almost completely geared toward facilitating illegal importation of drugs,â because the âoverwhelming majority of PCCâs revenue comes from consumers clicking on the links that allow them to directly connect to, and unlawfully purchase drugs from, foreign pharmacies.â (Defs.â SJ Mem. 15 (quotation marks omitted).) Specifically, Defendants argue that â of PCCâs total revenue comes from PCCâs foreign online pharmacies for aspects of its business . . . that enable [those pharmacies] to make illegal prescription drug sales to consumers.â (Id.) The Court agrees that revenue is highly probative in determining whether summary judgment should be granted to Defendants because it is indicative of how much of Plaintiffâs business is derived from illegality or facilitating illegality. In denying Defendantsâ Motion To Dismiss, this Court provided a non-exhaustive list of examples as to factors that may indicate âillegalityâ at summary judgment. See PharmacyChecker.com, 530 F. Supp. 3d at 330â331. For example, the Court found that Plaintiffâs Amended Complaint âalleges that its business consists of presumably legal activities, including accrediting U.S. online pharmacies, and providing price comparisons for U.S. online pharmacies.â Id. at 330 (citations omitted). The Court also noted that the Amended Complaint âdoes not allege that all or almost all of Plaintiffâs business relates to these foreign pharmacies,â nor did admissions at oral argument âconcern the presumably legal aspects of Plaintiffâs business.â Id. In a later discovery order, this Court stated that the Amended Complaint âmade no claims regarding the share of [PCCâs] business related to the sales of prescription drugs from foreign pharmacies to U.S. consumers[.]â (Order 3 (Dkt. No. 167).) However, as Plaintiff is no longer âsheltered by the vagueness of its [amended complaint],â Plaintiff now faces the tall task of showing that the âprimary purposeâ of its business is not âto facilitate unlawful importation.â PharmacyChecker.com, 530 F. Supp. 3d at 330â331. Based on this background and the Courtâs finding here that personal importation of prescription drugs is illegal under current federal law, it follows that the overall breakdown of PCCâs revenue is crucial: PCCâs enterprise is necessarily âcompletely or almost completely illegal, or completely or almost completely geared toward facilitating illegalityâ if the majority of its revenue stems from facilitating the purchase of foreign drugs by U.S. consumers. The Parties do not dispute that between of PCCâs total revenue from January 2015 to August 2021 is attributable to online pharmacies located outside of the United States. (Defs.â 56.1 ¶ 22; Pl.âs Resp. 56.1 ¶ 22; see also Defs.â Mem. Ex. 16 (âFarrar Reportâ), at ¶¶ 16, 38, 41 (Dkt. 264â17).) This Court underscores that it is not illegal for a U.S. business to receive some or even almost all of its revenue share from foreign entities. It is, however, illegal if this revenue stems from illegal activity (i.e., facilitating the purchase of foreign drugs the importation of which is prohibited by federal law). To make this determination, the Court must assess the sources of this revenue, and whether each of these sources facilitate illegal importation. During the relevant period, the vast majority of PCCâs revenue came from three sources: approximately came from cost-per-click fees âthat PCC charges its accredited pharmacies for sending consumers to those accredited pharmaciesâ websitesâ; came from fees pharmacies pay to participate in PCCâs Verification Program; and came from fees verified pharmacies pay to be listed on PCCâs website. (Defs.â 56.1 ¶¶ 8â9; Pl.âs Resp. 56.1 ¶¶ 8â9; see also Farrar Report at ¶ 14.) âPCCâs other revenue streams, including application fees received from online pharmacies, revenue from discount cards, Medicare drug plans, advertising, and e- book, provide less than of its total revenues.â (Defs.â 56.1 ¶ 10; Pl.âs Resp. 56.1 ¶ 10; see also Farrar Report at ¶ 14.) Most relevant to this inquiry is an analysis of PCCâs âcost-per-clickâ fees, otherwise described as âclick-fees.â Defendantsâ expert described this type of monetization for PCC, stating that â[a]ccredited [w]eb [s]ite[s] . . . pay[] a fee each time a consumer clicks on a link in [PCC] pointing to the[ir] website.â (Defs.â Mem. Ex. 19 (âKent Am. Reportâ) at ¶ 24 (Dkt. No. 264-20).) These click-fees are âa very common form of payment for traffic on the Internet,â according to Defendantsâ expert. (Id.) Click-fees are also the key metric in analyzing PCCâs revenue because they show (1) whether U.S. consumers are clicking on predominantly foreign pharmacies; and (2) whether these clicks represent the majority of Plaintiffâs revenue. Importantly, the Parties agree that â[a]t least websites that received clicks between January 2015 and August 2021 were foreign[,]â which accounted for â of the click fees ( ) and of clicks ( )[.]â (Defs.â 56.1 ¶ 29; Pl.âs Resp. 56.1 ¶ 29; see also Kent Am. Report ¶¶ 39â 40.) âOnly [websites that received clicks] are U.S. sites, accounting for of the click fees ( ) and of total clicks ( ).â (Defs.â 56.1 ¶ 30; Pl.âs Resp. 56.1 ¶ 30; see also Kent Am. Report ¶ 40.) As such, the vast majority of users who visit PCC end up clicking through to pharmacies outside of the U.S. (See Defs.â 56.1 ¶ 31; Pl.âs Resp. 56.1 ¶ 31.) As it relates to U.S. consumers, the Parties agree that U.S. consumers âgenerat[ed] of click-through fees paid to the companyâ during this period. (Defs.â 56.1 ¶ 40; Pl.âs Resp. 56.1 ¶ 40; see also Kent Am. Report ¶¶ 56â58 (âI found that clicks by US visitors on the [PCC] site were responsible for most of [PCCâs] revenues.â).) Put another way, within the almost share of PCCâs total revenue represented by U.S. consumers, those consumers were searching for prescription drugs from online pharmacies by clicking on links to accredited websites of the time. This percentage is particularly stark when looking at the click percentages for users in other countries: the next largest share comes from users who generate of PCCâs click fees, followed by users from the who generate of click fees. (Kent Am. Report ¶ 57.) At bottom, the only material dispute between the Parties is how the Court should interpret the of click-through fees. Defendants contend that the Court should rely on calculations from their expert, Mr. Peter Kent (âKentâ), who found that â[a]bout of the click fees for clicks from U.S. consumers were billed to foreign PCC-accredited websites.â (Defs.â 56.1 ¶ 32; see also Kent Am. Report ¶¶ 16, 62 (âAbout of the click fees for clicks from US consumers were paid by non-US Accredited Web Sites.â).) In other words, Defendants calculate that of the of PCCâs total revenue derived from U.S. consumers results from fees for U.S. consumers clicks to foreign websites. On the other hand, Plaintiff asks the Court to rely on a different figure, calculated based upon Defendantsâ expert testimony, which found that of PCCâs total revenue is from fees generated by U.S. consumers clicking to foreign online pharmacies. (See Pl.âs Resp. 56.1 ¶¶ 32â33; Levitt Decl. ¶ 45.) It is clear to the Court, however, that no matter how one slices this pie, click fees from U.S. consumers to foreign pharmacies represents the largest share of PCCâs revenue. Indeed, as outlined above, there is no source of revenue that could come even close to the costs per clicks generated by U.S. consumers. âThe almost total magnitude of this illegal conduct by [Plaintiff] makes their miniscule conduct that may be legal, insignificant . . . .â Pearl Music Co., Inc. v. Recording Indus. Assân of Am., Inc., 460 F. Supp. 1060, 1068 (C.D. Cal. 1978); see also id. (comparing the facts of the case to Memorex Corp. v. IBM Corp., 555 F.2d 1379 (9th Cir. 1977) where the business was âengaged in wrongful or illegal conduct only in part of its sizeable enterpriseâ). And, most importantly for purposes of deciding Defendantsâ summary judgment motion, there is no genuine dispute of material fact as to the data that underlie these two calculations because, if PCC were to lose the click fees from U.S. consumer clicks to foreign websites under either calculation, PCCâs business would likely cease to exist. While not dispositive on its own, this finding is bolstered by PCCâs statements on its website as well as PCCâs actions toward U.S. consumers who request PCCâs support for issues with their transactions. As Defendants explain: âPCCâs primary mission is to facilitate U.S. consumersâ unlawful importation of foreign pharmaceuticals,â because (1) the company âexists to facilitate the purchase of foreign drugs by American consumersâ; (2) âPCC actively âintervenesâ in U.S. consumersâ purchase transactions with PCC accredited foreign pharmaciesâ; and (3) âPCC is well aware of the illegality of the personal importation it facilitates and from which it profits.â (Defs.â SJ Mem. 19â27.) While the Court recognizes the dispute between the Parties about the true âmissionâ of PCC, (see Defs.â 56.1 ¶¶ 38â50; Pl.âs Resp. 56.1 ¶¶ 38â50), there are several uncontroverted and undisputed facts bolstering Defendantsâ remaining assertions. To start, when a user navigates to the âPrescription Savingsâ page on PCCâs website, PCC states that it âcompares U.S. prices to Canadian and International prices and shows the percentage savings availableâ to users interested in purchasing certain drugs from âtrusted international mail order online pharmacies, including licensed Canadian pharmacies and local U.S. pharmacies.â (Defs.â 56.1 ¶ 47; Pl.âs Resp. 56.1 ¶ 47.)22 As users search for prescription drugs, all prices are listed in U.S. dollars, without regard to the location of the pharmacy or the location of the potential consumer. (See Defs.â 56.1 ¶ 42; Pl.âs Resp. 56.1 ¶ 42.) In addition, PCC and its executives have made several statementsâmany of which are still available on PCCâs websiteâindicating that the company is, at a minimum, aware of an effort to contravene the American pharmaceutical statutory scheme, and at most, aware of the illegality of personal importation that PCC offers to facilitate. For example, when announcing 22 The Court notes that Plaintiff disputes that these prices are specifically targeted to âAmericans who import drugs from foreign pharmacies rather than buying those drugs locally in the U.S.,â because there is âno admissible evidence that the prices are âfor Americans who import drugs.ââ (See Pl.âs Resp. 56.1 ¶ 47.) However, as discussed in the factual background, Plaintiff does not dispute the text of the page itself. (See Defs.â 56.1 ¶ 47; Pl.âs Resp. 56.1 ¶ 47.) the Spanish version of its website, CEO Tod Cooperman was quoted in the press release stating âNo one living in the U.S. should have to forgo filling a prescription because of high drug prices, especially when lower prices on the same drugs are available to informed consumers.â (Defs.â 56.1 ¶ 43; Pl.âs Resp. 56.1 ¶ 43.) In its press release, PCC also focused on the value of a Spanish language website for U.S. consumers, ânoting that 38% of Hispanics living in the U.S. speak mainly Spanish.â (Defs.â 56.1 ¶ 43; Pl.âs Resp. 56.1 ¶ 43 (quotation marks omitted).) In addition, PCC openly touts its work helping all consumers âget the best dealâ on its Consumer Support page, while simultaneously providing advice specifically to U.S. consumers. (See Defs.â Mem. Ex. 6; Defs.â 56.1 ¶ 48; Pl.âs Resp. 56.1 ¶ 48.) PCC lists at least seven âfrequently asked questionsâ on its Consumer Support page, providing consumers with information on a variety of topics, including â[h]ow much can Americans save by purchasing their prescription drugs onlineâ and how âfastâ international prescription delivery can be for consumers. (See Defs.â Mem. Ex. 6; Defs.â 56.1 ¶ 48; Pl.âs Resp. 56.1 ¶ 48.) In response, PCC states that âU.S. consumers could pay up to 90% less than what they pay at a local pharmacyâ and that â[e]veryone deserves the opportunity and choice to purchase more affordable medication from licensed pharmacies, whether domestic or international.â (See Defs.â Mem. Ex. 6 (emphasis added).) PCC âadvise[s] [consumers] that medication ordered from outside the U.S. can normally take 2-3 weeks to arrive[,]â and tells consumers to purchase from a local pharmacy âfor immediate supplyâ and later âpurchase more internationally for future use.â (Id.) Even more probative, however, are PCCâs statements regarding its interpretation of federal law on personal importation, as well as various statements about the safety of prescription drugs from foreign pharmacies. In response to a question about the legality of ordering prescription drugs online, PCC describes the prohibition of â[i]nternational drug importationâ as a technicality, stating: âTechnically, in the U.S., under most circumstances, it is prohibited to import medication that you order internationally online.â (Id. (emphasis in original).) PCC continues by opining on FDAâs enforcement discretion, telling its U.S. consumers that âit is important to know that people in the U.S. are not prosecuted for [importing medication], as long as the medication imported is for your own use and not for resale.â (Id.) In response to another question about international shipping, PCC states that âthe law allows the FDA and U.S. Customs and Border Patrol to detain and refuse international prescription orders[,]â but counsels that âless than one percent of medication orders are actually stopped, at least for orders where a prescription is required.â (Id.) With these statements, PCC is attempting to downplay the potential illegality by citing unsubstantiated statistics about the FDAâs interception of imported foreign prescription drugs. Of course, several cases cited within this Opinion agree with this Courtâs analysis: to the extent that there is statutorily authorized enforcement discretion for the FDA, HHS, or the FDA, these agencies have not officially invoked that discretion to allow personal importation. See, e.g., Cook, 733 F.3d at 9â10 (disagreeing with FDAâs various arguments for discretion in drug importation); Canadian Import, 470 F.3d at 789â91 (describing a âcomprehensive regulatory systemâ where âCongress has effectively precluded importation of these drugs absent . . . special authorizationâ). Moreover, PCC answers at least two frequently asked questions by directly contradicting FDA guidance about the safety of prescription medications from foreign pharmacies, enticing U.S. consumers to purchase from foreign pharmacies despite the carefully controlled congressional scheme designed to keep consumers safe. In response to a question describing possible dangerous pharmacies, PCC states that â[o]nline pharmacies based outside the U.S. are not ârogueâ by definition.â (See Defs.â Mem. Ex. 6.) However, PCC does not stop there, explaining that: [s]ome regulatory bodies, including the [FDA], refer to such pharmacies as âillegalâ or âfakeâ but such distinctions can mislead consumers and impede their access to affordable, safe and effective medication that they cannot obtain locally due to high U.S. drug prices. Pharmacies in some countries are equally as safe if not safer than those in the U.S. [ . . . ] (Id.) This is in direct contravention of FDA guidance that PCC cites throughout its briefing arguing that personal importation is not always illegal. See Personal Importation, Food & Drug Admin. (last updated January 10, 2023), https://www.fda.gov/industry/import-basics/personal- importation (recommending that consumers âonly obtain[] medicines from legal sources in the U.S.â because the FDA âcannot ensure the safety and effectiveness of the medicine purchased over the Internet from foreign sourcesâ); Importation of Prescription Drugs, 84 Fed. Reg. 70796 (proposed Dec. 23, 2019) (describingârouge online pharmacies . . . run by sophisticated criminal networks,â but also stating that â[g]iven these risks, and other concerns[,]â the proposed rule would not implement personal importation provisions (emphasis added)). Of course, in offering this assessment, PCC also holds itself out as a source for âexceedingly safeâ medication âfrom a pharmacy outside the U.S.â to U.S. consumers, despite apparently knowingâand attempting to discountâthe exact risks that the FDA and federal laws are designed to prevent. (Defs.â Mem. Ex. 6; see also id. (reminding consumers that ârisks do exist when ordering medication from an unverified international online pharmacy,â unlike the pharmacies accredited by PCCâs verification program).) Finally, it is important to note that PCC does not stop by providing this information on its website. In fact, when consumers reach out to PCC with complaints of all varieties, it is undisputed that members of PCCâs support team endeavor to assist. (See Defs.â 56.1 ¶¶ 57, 59â 60, 62â64; Pl.âs Resp. 56.1 ¶¶ 57, 59â60, 62â64.) These complaints vary, including issues with âaddress delivery details, obtain[ing] refunds for orders of prescription drugs, and follow[ing] up on order errors.â (See Defs.â 56.1 ¶ 60.)23 In addition, PCC advertises its ability to âcontact the companyâ or âinterveneâ on a consumerâs behalf. (See Defs.â 56.1 ¶ 61 (âFor us to process your complaint, you must authorize us to contact the company on your behalf.â); Pl.âs Resp. 56.1 ¶ 61 (same); Defs.â SJ Mem. Ex. 64 (Dkt. No. 264-65) (âIf you would like us to assist you with a customer complaint we can intervene on your behalf.â).) Specifically, exhibits offered by Defendants establish that PCC has intervened on behalf of U.S. consumers with foreign pharmacies with issues related to their order. For example, PCC helped at least two U.S. consumers with relatively mundane requests: (1) ascertaining an order confirmation for a customer without a working email address for a prescription drug purchased from a Canadian pharmacy, (see Defs.â SJ Mem. Ex. 71 (Dkt. No. 264-72) (mailing the prescription drug to Los Angeles); Kent Am. Report ¶ 39 (listing QualityPrescriptionDrugs.com 23 Plaintiff lodges a slew of objections to statement 60 and its supporting exhibits, almost all of which are unavailing to this Court. (See Pl.âs Resp. 56.1 ¶ 60.) Plaintiff argues that statement 60 should be stricken because it is âirrelevantâ and âunsupported by admissible evidence.â (Id.) The Court disagrees with Plaintiffâs assessment of relevance for reasons discussed below. See infra (â[W]hile not dispositive, these emails are relevant in that they are consistent with the other evidence that reveals the mission and purpose of Plaintiffâs business.â). The other objections are equally unpersuasive. First, the Court disagrees with Plaintiffâs objection as it relates to Exhibits 75, 76, 77, and 78 as unauthenticated, as these exhibits were produced by Plaintiff to Defendants and Plaintiff âoffers no specific reason to doubt any documentâs authenticity.â Hallett, 517 F. Supp. 3d at 268; John Paul Mitchell Sys, 106 F. Supp. 2d at 472 (â[T]he act of production implicitly authenticate[s] [a] document[].â). Second, the Court will disregard Exhibits 28, 74, and 79 for the purposes of this analysis, given Plaintiffâs evidentiary objections, but this does not change the analysis. (See Pl.âs Resp. 56.1 ¶ 60.) There are several other Exhibits that Defendants rely upon to substantiate this statement, to which Plaintiff has not lodged objections. (See id. (citing no objections to Exhibits 5, 10, 64, 73, and 80).) as based in Canada)); and (2) assisting a customer with credit card processing issues (see Defs.â SJ Mem. Ex. 73 (Dkt. No. 264-74) (identifying a customer with an American phone number)). More poignantly, PCC intervened on behalf of two U.S. customers who received incorrect or unmarked medication, potentially dangerous issues which are exactly the type of issues federal law is designed to prevent. (See Defs.â 56.1 ¶ 64; Pl.âs Resp. 56.1 ¶ 64.) In one email, a customer received a prescription order from pharmacies in Delhi, India that contained âno imprint to identify or verify their validity as a genericâ drug. (Defs.â SJ Mem. Ex. 81 (Dkt. No. 264-82).) The customer expressed particular frustration with PCC because that customer âplaced great reliance on [PCCâs] association to oversee standards and compliance[,]â underscoring federal law that â[p]rescription pills without imprints are considered invalid in the US.â (Id.) In this email chain, PCCâs President Gabriel Levitt personally forwarded this email to two employees, recognizing that the pills could âbe non-compliantâ and urging the employees to âdraft a response and plan of actionâ for his review. (Id.) Presumably after receiving a question through PCCâs customer complaint form, (see Defs.â 56.1 ¶ 61; Pl.âs Resp. 56.1 ¶ 61), PCC sent a U.S. consumer an email advising the customer that â[m]edications approved for sale in other countries often have different packaging, labeling[,] and can also have different inactive ingredients and appearances than those approved for sale in the U.S.[,]â (Defs.â SJ Mem. Ex. 82 (Dkt. No. 264-83)). The customer responded to PCC with further information about their purchase from a Canadian pharmacy, where the customer received an order of prescription drugs âwithout any markings on the capsulesâ and were ânot the same sizeâ as the expected drug. (Id.) Plaintiff argues that these exhibits are largely âirrelevant and overly broad based on the cited evidence showing a total of [two] consumer complaints.â (Pl.âs Resp. 56.1 ¶ 64.) However, while not dispositive, these emails are relevant in that they are consistent with the other evidence that reveals the mission and purpose of Plaintiffâs business. Simply put, PCC cannot have it both ways. PCC cannot both lodge repeated objections to its mission and purpose throughout its briefing, arguing that its business is âencourag[ing] visitors worldwide,â (see Defs.â 56.1 ¶¶ 38â50; Pl.âs Resp. 56.1 ¶¶ 38â50), while also instructing U.S. consumers specifically about ways to get around the âtechnicalitiesâ of federal law. And as discussed, PCCâs actions are not surprising, as U.S. consumersâ clicks through to foreign pharmacies are what sustain PCCâs business. PCCâs only remining argument attacks the sufficiency of Defendantsâ submissions, arguing that Defendants ârel[ied] on impermissible inferencesâ because they failed to âconnect[] a click to a transaction and a transaction to an unlawful importation.â (PCCâs SJ Mem. 19â20.)24 24 Plaintiff also argues that Defendants cannot prove as a matter of law that PCC is âalmost completely geared toward facilitating illegalityâ because Defendantsâ âstatistics do not account for their anticompetitive conductâs effect on [P]laintiffâs enterprise.â (PCCâs SJ Mem. 28â30.) To support this argument, Plaintiff cites one email produced in discovery between PCC and a Kentucky-based pharmacy, alleging that the pharmacy withdrew its accreditation with PCC because of this pharmacyâs potential concerns with their Verified Internet Pharmacy Practice (âVIPPSâ) certification, which was provided by NABP. (See Pl.âs Resp. 56.1 ¶¶ 9, 11, 24â25; Pl.âs Resp. 56.1 Ex. 22 (Dkt. No. 269-14).) Defendants argue that âPCCâs claim rests on hearsay and speculation,â noting that PCC âpoints to two employee declarations (both of whom Defendants deposed and PCC could have cross-noticed) and an unauthenticated email, all containing, at least double hearsay.â (Defs.â SJ Reply 13â15.) For the reasons stated below, the Court agrees with Defendants. As to the hearsay allegations, while the Court does not agree that this testimony and associated exhibit is unauthenticated, the email and associated testimony does include inadmissible hearsay. Exhibit 22 is an email that was produced in discovery by PCC and attested to by Mr. Levitt in a declaration, which is sufficient for authentication purposes at summary judgment. John Paul Mitchell Sys, 106 F. Supp. 2d at 472 (â[T]he act of production implicitly authenticate[s] [a] document[].â). However, PCC attempts to use this email to prove the truth of the matter asserted (i.e. that NABP âthreatened to stripâ a U.S. pharmacyâs VIPPS accreditation) through an out-of-court statement from a non-party to the litigation, who learned from another unidentified source that working with PCC âis considered a violation.â (See PCCâs SJ Mem. 29; Pl.âs Resp. 56.1 Ex. 22.) There is no evidence or testimony indicating that this U.S. pharmacy representative was unavailable to testify to this email, nor do any other hearsay exceptions apply. PCC describes this as a ânecessary assumption[]â in the Courtâs analysis as to whether Plaintiffâs enterprise is completely or almost completely geared toward facilitating illegality. (Id. at 20.) However, and as Defendants rightfully point out, this is not the standard. On its face, to âfacilitateâ illegal action does not require actual proof of purchases. âFacilitatingâ an offense means that a party âmake[s] [the offense] easierâ or âhelp[s] [to] bring [it] about.â Facilitate, Merriam-Webster, https://www.merriam-webster.com/dictionary/facilitate#legalDictionary (last visited Dec. 2, 2022). This is not just a dictionary definition: courts within and outside the Second Circuit have also used this definition of facilitation in other areas of the law. See, e.g., United States v. Wyly, 193 F.3d 289, 302 (5th Cir. 1999) (finding property used to facilitate money laundering was âforfeitable[] because of its substantial nexus to the crimeâ as it was Fed. R. Evid. 803, 804. And this Court finds no compelling reason to admit this statement under the residual hearsay exception, given that Plaintiff failed to provide any evidence to âcorroborat[e] the statement.â Fed. R. Evid. 807. Plaintiff attempts to excuse this conduct by stating that PCC âdoes not know the full extent of [D]efendantsâ conduct . . . [because] [i]t has not been permitted to take that discovery.â (PCCâs SJ Mem. 29.) Presumably, PCC is arguing (without stating) that this Court precluded it from taking this discovery. However, PCC is incorrect. The Court adopted a phased discovery schedule, starting discovery with a focus on âwhether Plaintiffâs enterprise is completely or almost completely geared toward facilitating illegality.â (See Dkt. No. 167.) As this Court has stated repeatedly, â[i]t is a threshold requirement that Plaintiffâs enterprise not be completely or almost completely geared toward facilitating illegalityâ because it is essential to the antitrust injury. (Order at 2 (Dkt. No. 167); see also Order at 6 (Dkt. No. 220) (finding that âillegality is not an affirmative defense, but rather negates an element of Plaintiffâs prima facie caseâ).) In Phase One, Plaintiff bore âthe burden of proving that its business is legal.â (Order at 6 (Dkt. No. 220).) And as the nonmovant here at summary judgment, if Plaintiff âfail[s] to make a sufficient showing on an essential element of [its] case with respect to which [it] has the burden of proof[,â the movant is âentitled to a judgment as a matter of law.â Celotex, 477 U.S. at 323. Plaintiff was well within its rights to seek affirmative discovery on this issue. Instead, PCC chose not to and rested on an inconsistent statement. Without this inadmissible evidence, Plaintiff is asking this Court to ârely on mere speculation or conjecture as to the true nature of the facts to overcome a motion for summary judgment,â which it is well-established is improper in the Second Circuit. Hicks v. Baines, 593 F.3d 159, 166 (2d Cir. 2010) (quoting Fletcher v. Atex, Inc., 68 F.3d 1451, 1456 (2d Cir. 1995)). This Court declines Plaintiffâs invitation. âindispensableâ to the conspiracy at issue); United States v. Sabhnani, 566 F. Supp. 2d 148, 152 (E.D.N.Y. 2008) (âFacilitation occurs when the property makes the prohibited conduct less difficult or more or less free from obstruction or hinderance.â (citing Wyly, 193 F.3d at 302)); United States v. Schlesinger, 396 F. Supp. 2d 267, 272 (E.D.N.Y. 2005) (establishing that the property at issue was âintegral to the fraud perpetrated by the Defendantsâ and âfacilitatedâ the offense). Here, it is clear that PCC âmakes easierâ the illegal conduct at issue: PCC directs U.S. consumers to foreign pharmacies where they can purchase prescription medication in violation of federal law. In fact, PCC has described this facilitation as its mission âto help consumers afford medication they need.â (Pl.âs Resp. 56.1 ¶ 38.) As such, Defendants have met their burden to prove that PCCâs enterprise is âcompletely or almost completely geared towards facilitating illegality.â PharmacyChecker.com, 530 F. Supp. 3d at 329â30. Plaintiff accordingly does not have standing to maintain its claim pursuant to § 1 of the Sherman Act. Id. (describing the principle and finding that, if true, â[P]laintiff cannot plead an antitrust injuryâ); Pearl Music Co., 460 F. Supp. at 1068 (finding that plaintiffs lacked âthe standing or capacity to maintain [an] anti-trust actionâ because the plaintiffs âengaged in a business which is, by its very nature, entirely illegalâ). Therefore, the Court grants Defendantsâ Motion for Summary Judgment on Plaintiffâs Sherman Act § 1 claim, and Defendants ASOP, CSIP, and PSM are dismissed from this case. III. Conclusion For the foregoing reasons, Defendantsâ Joint Motion for Summary Judgment on Plaintiffâs Sherman Act § 1 claim is granted, Plaintiffâs Motion to Strike is denied, Defendantsâ Motion to Strike is denied, and Defendantsâ Joint Motion to Exclude Expert testimony is granted in part and denied in part. The Clerk of Court is respectfully requested to file this Opinion under seal, restricted to the Parties and the Court, and to terminate the pending motions at Dkt. Nos. 260, 263, and 273. The Court will hold a status conference on May 1, 2023 at 2:00 PM.25 SO ORDERED. Dated: March 28, 2023 White Plains, New York KENNETH M. KARAS United States District Judge 25 Because unredacted versions of these Motions and accompanying Memorandum were filed under seal, the Parties may have two weeks from the date of this Opinion & Order (the âOpinionâ) to propose redactions to the Opinion before it is issued publicly.
Case Information
- Court
- S.D.N.Y.
- Decision Date
- April 17, 2023
- Status
- Precedential