Hope Med. Enters. v. Fagron Compounding Servs.

Full title: HOPE MEDICAL ENTERPRISES, INC. v. FAGRON COMPOUNDING SERVICES, LLC ET AL.

Court: United States District Court, Central District of California

Date published: Jan 25, 2021

2:19-CV-07748-CAS-PLAx (C.D. Cal. Jan. 25, 2021)

Opinion

2:19-CV-07748-CAS-PLAx

01-25-2021

HOPE MEDICAL ENTERPRISES, INC. v. FAGRON COMPOUNDING SERVICES, LLC ET AL.

PRESENT: THE HONORABLE CHRISTINA A. SNYDER, JUDGE

REDACTED CIVIL MINUTES - GENERAL

Proceedings: [REDACTED] - (IN CHAMBERS) - PLAINTIFF HOPE MEDICAL ENTERPRISES, INC.'S NOTICE OF MOTION AND MOTION FOR SUMMARY JUDGMENT OR IN THE ALTERNATIVE PARTIAL SUMMARY JUDGMENT (Dkt. 151, filed on November 2, 2020)

PLAINTIFF HOPE MEDICAL ENTERPRISES, INC.'S NOTICE OF MOTION AND MOTION FOR FINDING OF CIVIL CONTEMPT AND SANCTIONS (Dkt. 153, filed on November 2, 2020)

DEFENDANTS' [UNDER SEAL] NOTICE OF MOTION AND MOTION FOR RECONSIDERATION OF ORDER GRANTING PRELIMINARY INJUNCTION (Dkt. 176, filed on November 24, 2020)

DEFENDANTS' NOTICE OF MOTION AND CROSS MOTION FOR SUMMARY JUDGMENT (Dkt. 178, filed on November 24, 2020)

I. INTRODUCTION

On September 6, 2019, plaintiff Hope Medical Enterprises, Inc., d/b/a Hope Pharmaceuticals ("Hope Medical") filed suit in this Court against defendants Fagron Compounding Services, LLC, JCB Laboratories, LLC, AnazaoHealth Corporation, and Coast Quality Pharmacy, LLC (collectively, "defendants"). Dkt. 1 ("Compl."). The gravamen of Hope's claims is that defendants' drug compounding practices constitute unfair competition in violation of several states' consumer protection laws.

Hope filed the operative first amended complaint on November 12, 2019. Dkt. 47 ("FAC"). The FAC asserts claims for: (1) violation of California's Unfair Competition Law, Cal. Bus. & Prof. Code § 17200, et seq. ("UCL"); (2) violation of Florida's Deceptive and Unfair Trade Practices Act, Fla. Stat. Ann. § 501.201, et seq. ("FDUTPA"); (3) violation of Tennessee's Consumer Protection Act, Tenn. Code Ann. § 47-18-104(b)(44)(C) ("TCPA"); (4) violation of South Carolina's Unfair Trade Practices Act, SC Code Ann. § 39-5-20 ("SCUTPA"); and (5) violation of Connecticut's Unfair Trade Practices Act, Conn. Gen. St. § 42-110b ("CUTPA"). See generally FAC. Defendants filed their operative amended answer on January 27, 2020.¹ Dkt. 67.

1 On January 13, 2020, the Court granted in part and denied in part Hope's motion to strike and for judgment on the pleadings as to affirmative defenses in defendants' prior answer to the FAC. Dkt. 66. Defendants thereafter filed their operative amended answer.

Hope filed a motion for a preliminary injunction on June 1, 2020, dkt. 105 ("PI Mot."), which the Court granted in part on July 7, 2020, dkt. 141 ("PI Ord.").

On November 2, 2020, Hope filed the instant motion for summary judgment, dkt. 151 (redacted); dkt. 154-1 ("MSJ"), along with a request for judicial notice, dkt. 152. Hope contends there is no genuine dispute over any material fact regarding (1) defendants' 503A pharmacy's violating Section 503A by (a) compounding a sodium thiosulfate drug that is "essentially a copy" of plaintiffs Sodium Thiosulfate Injection, and (b) engaging in anticipatory compounding; and (2) defendants' 503B outsourcing facilities' violating Section 503B by (a) compounding a sodium thiosulfate drug that is "essentially a copy" of plaintiffs, and (b) impermissibly using bulk sodium thiosulfate before it was on an approved FDA list.

On November 23, 2020, defendants opposed the motion and filed a cross-motion for summary judgment. Dkt. 178 (redacted); Dkt. 180-2 ("Opp. to MSJ"); see dkt. 174 ("Def RJN"). Hope replied on November 30, 2020. Dkt. 192; see dkt. 193 (supplemental request for judicial notice, evidence in support of plaintiff s reply).

Also on November 2, 2020, Hope filed a motion for contempt, which alleges defendants are in violation of the Court's preliminary injunction, dkt. 153 (redacted); dkt. 154-2 ("Mot. for Contempt"), along with a request for judicial notice, dkt. 174. On November 24, 2020, defendants filed a combined opposition and a motion for reconsideration of the preliminary injunction. Dkt. 183 (redacted); dkt. 176-1 ("Opp. to Contempt"). Hope replied on November 30, 2020. Dkt. 194.

On November 9, 2020, the Court granted defendants' ex parte application to extend the hearing date for the motion for summary judgment and the motion for contempt to December 14, 2020. Dkt. 168. Defendants' cross motion for summary judgment and motion for reconsideration were calendared for December 28, 2020.

Having carefully considered the parties' arguments and submissions, the Court finds and concludes as follows.

II. BACKGROUND

At issue in this case are defendants' drug compounding practices.² "Drug compounding is a process by which a pharmacist or doctor combines, mixes, or alters ingredients to create a medication tailored to the needs of an individual patient." Thompson v. W. States Med. Or., 535 U.S. 357, 360-61 (2002). "Compounding is typically used to prepare medications that are not commercially available, such as medication for a patient who is allergic to an ingredient in a mass-produced product." Id. "Many States specifically regulate compounding practices as part of their regulation of pharmacies." Id.

2 In its preliminary injunction order, the Court provided a detailed history of the regulatory framework surrounding drug compounding. See Hope Med. Enterprises, Inc. v. Fagron Compounding Servs., LLC, No. 2:19-CV-07748-CAS-PLAx. 2020 WL 3803029 (CD. Cal. July 7, 2020). The Court incorporates that order by reference and lays out the factual and legal background relevant to the motions at issue here.

A. Regulatory Framework

In 2013, "Congress passed new legislation that ... created federal regulatory power over compounding pharmacies." Cruz v. Preferred Homecare, No. 2:14-cv-00173-MMD, 2014 WL 4699531, at *3 (D. Nev. Sept. 22, 2014). This legislation-the Drug Quality and Security Act ("DQSA")-"amend[ed] FDCA Section 503A and add[ed] Section 503B." Allergan USA Inc. v. Imprimis Pharm.. Inc., No. 8:17-cv-01551-DOC-JDE, 2017 WL 10526121, at *2 (CD. Cal. Nov. 14, 2017).

1. Section 503A of the FDCA

Section 503A regulates "pharmacy compounding." See 21 U.S.C. § 353a. "Drug products compounded 'for an identified individual patient that are necessary for the identified patient' are exempted from normal drug-approval requirements under Section 503A when certain conditions are met." Allergan v. Imprimis, 2017 WL 10526121, at *2 (alterations omitted) (citing 21 U.S.C. § 353a(a)). Accordingly, "Section 503A allows pharmacy compounding in two scenarios: (1) drug compounding after the receipt of a prescription; and (2) drug compounding before the receipt of a prescription when the compounding is 'based on a history of receiving valid prescription orders for the compounding of the drug product, which orders have been generated solely within an established relationship between' the compounding pharmacy and the patient or prescribing physician." Allergan v. Imprimis, 2017 WL 10526121, at *2 (alterations omitted) (citing 21 U.S.C. § 353a(a)).

"In both scenarios. Section 503A also requires that the compounded drug is (1) compounded using approved drug products; (2) compounded using ingredients that comply with national standards; (3) not compounded 'regularly or in inordinate amounts (as defined by the Secretary)' if the compounded drug is 'essentially a copy of a commercially available product'; (4) not a drug product whose safety or effectiveness may be adversely effected by compounding; and (5) compounded in a state that has entered into a 'Memorandum of Understanding' ('MOU') with the FDA or, if no such MOU exists for that state, compounded by a pharmacy or individual that distributes less than '5 percent of its total prescription orders' to out-of-state patients." Allergan v. Imprimis, 2017 WL 10526121, at *2 (alterations omitted) (citing 21 U.S.C. § 353a(b)).

2. Section 503B of the FDCA

"Section 503B created a new category of drug maker called an 'outsourcing facility.'" Athenex, 397 F.Supp.3d at 59 (citing 21 U.S.C. § 353b). "An outsourcing facility may compound drug products in large quantities without obtaining a prescription for 'an identified individual patient.'" Id. (alteration omitted) (citing 21 U.S.C. § 353b). Accordingly, outsourcing facilities "are permitted to sell bulk compounded drug products to health care practitioners and hospitals as 'office stock,' for providers to have available and to use on an as-needed basis." Id.

Pursuant to Section 503B, "[a]n outsourcing facility remains exempt from the FDCA's premarket approval requirements and certain labeling and supply-chain requirements, but only if it satisfies eleven statutory criteria." Id. (citations omitted). Relevant here, these criteria include, inter alia, requirements that: "(1) the drug is not 'essentially a copy of one or more approved drugs;' (2) the drug is not sold wholesale; and (3) the 'drug is compounded in an outsourcing facility in which the compounding of drugs occurs only in accordance with Section 503B."' Allergan v. Imprimis, 2017 WL 10526121, at *2 (alterations omitted) (citing 21 U.S.C. § 353b(a)). In addition, Section 503B "specifically limits the types of drugs that can be compounded at outsourcing facilities" to those "compound bulk drug substances that appear on (1) a list established by the FDA identifying bulk drug substances for which there is a clinical need ('503b bulks list'); or (2) a drug shortage list established by the FDA." Id. (alterations omitted) (citing 21 U.S.C. § 353b(a)(2)(A)).

B. Hope's Sodium Thiosulfate Drugs

Hope is a pharmaceutical manufacturer that sells pharmaceutical products including a Sodium Thiosulfate Injection. SUF No. 3; FAC ¶ 26. The active pharmaceutical ingredient ("API") in the Sodium Thiosulfate Injection is sodium thiosulfate at a concentration of 12.5g/50mL. SUF No. 3; FAC ¶¶ 28, 38. Notably, Hope's Sodium Thiosulfate Injection includes potassium. The Sodium Thiosulfate Injection is the only FDA-approved drug with an API of sodium thiosulphate, SUF No. 4; FAC *[ 43, and since 2012, Hope has had FDA approval to sell its Sodium Thiosulfate Injection as a treatment for acute cyanide poisoning, SUF No. 2; FAC ¶¶ 28, 38. But Hope also sells its Sodium Thiosulfate Injection to dialysis providers (including to dialysis providers in California, Connecticut, Florida, South Carolina and Tennessee), SUF No. 5, for treatment of calciphylaxis, which is "a painful condition suffered by some end stage renal disease patients," MSJ at 2 n.4. Hope alleges that during the time period for which it is seeking damages, namely, September 2014 through July 7, 2020, ³ the only companies that sold sodium thiosulfate drugs to dialysis companies were Hope and defendants. SUF No. 1: FAC ¶ 26. Defendants contend another company, XXXXX. SUF No.1

3 Defendants contend XXXXX (Image Omitted).

C. Defendants' Alleged Compounding Practices

Hope alleges that defendants "are owned either directly or indirectly by Fagron BV, a company registered in Belgium, and/or its affiliate, Fagron NV, a company registered and headquartered in the Netherlands." FAC ¶ 13. According to Hope, defendants "are under common ownership and control and work closely together" in "creating, marketing, and selling unapproved new drugs for unapproved uses ... under the false guise of 'compounding." Id. ¶¶ 11, 13. Defendants operate one 503A pharmacy, in Tampa, Florida, SUF No. 42, and two 503B outsourcing facilities, both in Wichita, Kansas, Id. Nos. 15, 16. As noted, defendants also sell their compounded sodium thiosulfate to treat calciphylaxis. Id. No. 1. Like Hope's Sodium Thiosulfate Injection, defendants' compounded sodium thiosulfate drug relies on sodium thiosulfate at a concentration of 12.5g/50mL. Id. Nos. 12, 18. It is also injected intravenously. Id. No. 13. Notably, though, it does not contain potassium, id No. 7, and is not FDA-approved, id No. 9.

By way of background, XXXXX. SUF ¶ 14; MSJ at 4. During these seven months, customers were forced to source sodium thiosulfate from either defendants' 503A pharmacy, where the sodium thiosulfate was potassium-free, or from Hope. SUF No. 8.

1. 503A Pharmacy

Coast, under the tradename AnazaoHealth ("Anazao"), owns and operates a compounding pharmacy in Tampa, Florida, that purports to operate pursuant to Section 503A. SUF No. 42; FAC ¶ 14. Hope alleges that, from November 2017, to at least November 2019, Anazao regularly sold its compounded sodium thiosulfate drug from its 503A compounding pharmacy to dialysis providers, including in the five states at issue here. SUF Nos. 6, 31-32; FAC ¶14. (Defendants dispute this fact and respond that Anazao only sold the compounded sodium thiosulfate drug from December 2017, to October 2019, thus for two months less than Hope alleges. SUF Nos. 6, 42.)

a. Facts Relevant to "Essentially a Copy" Claims

Hope makes several allegations in support of its claim that Anazao's compounded drug was "essentially a copy" of Hope's Sodium Thiosulfate Injection. (This allegation and the evidence that purportedly supports it are relevant to both the 503A pharmacy and the 503B outsourcing facilities.) First, Hope argues that dialysis clinics purchase defendants' compounded sodium thiosulfate because it is cheaper than Hope's Sodium Thiosulfate Injection, and that the lack of potassium is pretense. MSJat4, 15. As evidence, Hope cites to an FDA publication entitled List of Bulk Drug Substances for Which There is a Clinical Need Under Section 503B of the Federal Food, Drug, and Cosmetic Act, dated July 31, 2020. Seedkt. 152-1, Exh. F ("503B Bulks List Notice"). In this notice, the FDA identifies several bulk drug substances that it considered for, but proposes not to include on, the 503B Bulks List. Id. at 46, 126. Among those is sodium thiosulfate. Id. Specifically, the FDA considered sodium thiosulfate for inclusion on the 503B Bulks List "for treatment of calciphylaxis." Id. at 46, 139. The nomination of sodium thiosulfate was based on the proposal "to remove potassium chloride from the proposed injectable compounded product used in the treatment of calciphylaxis" based on the premise that "the safety of the approved product is of concern because the potassium level of the product is too high for patients with renal disease or impairment." Id. at 46, 139. However, the FDA concluded:

This assertion is inaccurate because the amount of potassium in the approved 12.5 g/50 mL (250 mg/mL) solution for intravenous administration is small ..., and when it is used off-label for the treatment of calciphylaxis, to the best of our knowledge, the product is generally administered during hemodialysis, which allows for removal of the excess potassium.

Id. at 46, 139. The FDA found "no basis to conclude that an attribute of the FDA-approved product [Hope's Sodium Thiosulfate Injection] makes it medically unsuitable to treat patients with calciphylaxis and that the sodium thiosulfate drug products proposed to be compounded are intended to address." Id. In short, the FDA directly considered and rejected defendants' asserted reason for compounding sodium thiosulfate, namely, that the potassium posed a threat to dialysis patients.

Hope presents circumstantial evidence, too, that customers purchased defendants' compounded drug for economic as opposed to clinical reasons. Hope alleges that, over the seven months during which defendants' 503B facilities were not compounding sodium thiosulfate drugs, dialysis clinics that typically sourced sodium thiosulfate from the 503B defendants turned to Hope (and to the 503 A pharmacy) for sodium thiosulfate, suggesting the customers' preference for sodium thiosulfate from the 503B defendants was not for clinical reasons: If the clinics' patients really required potassium-free sodium thiosulfate drugs, they could not have used Hope's Sodium Thiosulfate Injection, which contains potassium. SUF ¶ 46; MSJ at 4. Furthennore, several XXXXX Dkt 154-11. Craig Decl. Exh. D. Declaration of Joseph N. Akrotirianakis ("Akro. Dec!."), Exh. N ("Trull Email Oct. 12, 2018 at 1; MSJ at 5. Finally, Hope alleges that, XXXXX MSJ at 5; see dkt. 154-14, Akro Decl., Exh. Q XXXXX but also Hopp;s sodium thiosulfate was adequate for Fresenius' patients' needs. MSJ at 5.

Defendants dispute that clinics purchase defendants' compounded sodium thiosulfate for economic reasons. Defendants contend their customers purchase their compounded drug instead of Hope's Sodium Thiosulfate Injection because the compounded drug lacks potassium. Opp. to MSJ at 14. Dr. Jeffrey Hymes, Chief Medical Officer at Fresenius, gave deposition testimony on the significance of the lack of potassium in a sodium thiosulfate drug. Dkt. 180, Francis Decl. ¶ 10; see dkt. 180-9, Fracis Decl., Exh. I ("Hymes Depo."). Dr. Hymes testified that "[a]n accumulation of potassium can be harmful to a dialysis patient" for several reasons, including causing "disturbances in the heart rhythm" and "muscle weakness." Hymes Depo. at 36:9-21. For these reasons. Dr. Hymes testified, "potassium is not something I would want to give to a patient on dialysis if I didn't have to." Hymes Depo. at 27:23-24. Dr. George Aronoff, Vice President of Clinical Affairs for DaVita, also stated that:

Our preference from a clinical perspective is to use the STS compounded by JCB/Fagron because the commercially available 25 gram dose of STS provided by Hope Pharmaceuticals contains 880 mg of potassium. This large amount of potassium represents a significant percentage of the recommended intake of potassium for a dialysis patient and could lead to cardiac arrhythmias and death.

SUF No. 35 (citing Francis Decl., Exh. J ("Aronoff Letter")).⁴

4 No. Exhibit J was attached to the Francis Declaration.

In addition to evidence that defendants' customers purchase defendants' compounded drug for financial reasons, Hope presents evidence that Anazao inappropriately compounded the sodium thiosulfate drug for use by dialysis patients without obtaining a clinical difference determination made by a prescribing practitioner. SUF Nos. 35, 38; MSJ at 9. (This evidence applies only to the 503A pharmacy, although Hope presents similar evidence with regard to the 503B defendants, discussed below.) Hope argues this is important because, pursuant to FDA guidance on Section 503A's "essentially a copy" requirement, "[i]f a compounder intends to rely on such a determination to establish that a compounded drug is not essentially a copy of a commercially available drug product, the compounder should ensure that the determination is documented on the prescription." Dkt. 152-1, Exh. D, Food and Drug Administration, Compounded Drug Products That Are Essentially Copies of a Commercially Available Drug Product Under Section 503A of the Federal Food, Drug, and Cosmetic Act: Guidance for Industry (Jan. 2018) ("FDA Guidance on 503A 'Essentially a Copy' Requirement") at 8.

XXXXX (Image Omitted)

Furthermore, defendants provide several examples of order forms from their 503A pharmacy. SUF No. 35; see dkt. 180-10, Francis Decl., Exh. K (Sample 503A Pharmacy Prescriptions). These include the following statements regarding the clinical difference between sodium thiosulfate drugs with and without potassium: XXXXX At the December 14, 2020 hearing, Hope argued that these XXXXX See Akro. Decl. ¶ 23. Defendant responded that these examples were indicative of others. The Court is aware of no other prescriptions filled by the 503 A pharmacy, with or without clinical difference statements.

Finally, defendants contend XXXXX SUF No. 35. In support of this defendants cite to Dr. Hymes deposition testimony. Id. (citing Hymes Depo. At 105-106). XXXXX Hymes Depo. at 106:12-15.

b. Facts Relevant to Anticipatory Compounding Claims

Hope also presents evidence it argues supports its allegation that defendants' 503A facility engaged in impermissible anticipatory compounding, which falls outside the exception provided by Section 503A. See 21 U.S.C. 353a(a). Hope alleges that, prior to 2018, Anazao compounded its sodium thiosulfate drug "only in response to individual patient prescriptions that [it] received." SUF No. 43; MSJ at 10. However, when Fagron and JCB stopped production due to quality concerns, Anazao began compounding its sodium thiosulfate drug "based on Fagron and JCB's historical volumes of sodium thiosulfate sales." SUF No. 44; MSJ at 10-11. Specifically, Hope cites to the deposition testimony of Anazao's Rule 30(b)(6) designee. MSJ at 18-19. In that testimony, the designee was asked:

Q: So your batching up of sodium thiosulfate at the time that Fagron and JCB in Wichita were taking down their sodium thiosulfate production line, was based on Fagron and JCB's historical volumes of sodium thiosulfate sales; is that fair?

A: Yes. ... As a 503A, we couldn't get close to it [the quantities produced by Fagron and JCB in Wichita], so we ramped up whatever we could to satisfy their patient needs.

Dkt. 154-8, Craig Deck, Exh. I ("Anazao Depo.") at 59:12-25. Hope argues that this testimony establishes that Anazao engaged in anticipatory compounding that was beyond any established patient-pharmacist relationship and therefore was impermissible under Section 503A. (Image Omitted) XXXXX.

But defendants argue that Anazao compounded in advance of orders it knew would come from former Fagron and JCB customers based on those patients' established relationships with those outsourcing facilities. To that point, defendants assert that Dennis Davis, the pharmacist in charge of the defendants' 503A pharmacy, provided deposition testimony that:

XXXXX

Dkt. 180-13, Francis Decl., Exh. O ("Davis Depo.") at 75:20-24, 76:13-22; SUF No. 44. Finally, at the December 14, 2020 hearing, defendants added that, although 503B outsourcing facilities typically do not receive prescriptions, but rather orders, defendants' 503B facilities did receive prescriptions until sometime in 2017. As such, they argue, the 503A pharmacy was compounding based on prior prescriptions when it began compounding based on historical order volumes at the 503B facilities.

2. 503B Outsourcing Facilities

Fagron and JCB operate 503B outsourcing facilities in Wichita, Kansas ("503B defendants"). SUF Nos. 15, 16; FAC ¶ 14. Hope alleges that, since at least May 2011, through July 7, 2020, 503B defendants sold a compounded sodium thiosulfate drug to dialysis providers in the five states at issue. SUF No. 7.

a. Facts Relevant to "Essentially a Copy" Claims

Hope challenges the attestations that accompanied orders from 503B defendants. See dkt. 180-6, Francis Decl., Exh. F ("Sample Attestation Forms"). According to Hope, these attestations, or clinical difference statements, are important because without a clinical difference statement, a compounded drug is "essentially a copy" of an approved drug if the two share a bulk drug substance, in this case, sodium thiosulfate. Dkt. 152-1, Exh. C, Food and Drug Administration, Compounded Drug Products That Are Essentially Copies of a Approved Drug Products Under Section 503B of the Federal Food. Drug, and Cosmetic Act: Guidance for Industry (Jan. 2018) ("FDA Guidance on 503B 'Essentially a Copy' Requirement") at 6; see 21 U.S.C. § 353b(d)(2)(B).

Hope's argument is that the attestation forms (1) were insufficient in their own right, (2) that they did not accompany each order, but rather were provided ex ante, and (3) that they were not signed by authorized prescribers. MSJ at 14. The Court presents the evidence adduced to support each claim in turn.

First is evidence that the clinical difference statements are inherently insufficient as written. To substantiate this argument, Hope points to one form, entitled XXXXX SUF No. 24; Sample Attestation Forms at 4. Another attestation, on a form entitled,

XXXXX

SUF No. 24; Sample Attestation Forms at 22. Others, though, are more brief, such as one that only states XXXXX Dkt. 154-16, Akro. Decl., Exh. S.

Second is evidence that, XXXXX No. 25; MSJ at 7. As evidence of this allegation, Hope points to the deposition testimony of Fagron's Rule 30(b)(6) designee:

XXXXX

Fagron Depo. at 210:13-23; SUF No. 25.

Furthermore, Hope identifies evidence that XXXXX For instance, Hope points to XXXXX Dkt. 154-20. Akro. Decl. Exh. W at 591; MSJ at 8. Furthermore, the Fagron Rule 30(b)(6) designee testified:

XXXXX

Fagron Depo. at 239:4-17; see SUF No. 30. Hope also establishes that at least XXXXX (Image Omitted) The Court is aware of no order forms sent from DaVita to defendants' 503B outsourcing facilities that contain a clinical difference statement, and defendants point to none.

Hope also argues that certain Fresenius orders of compounded sodium thiosulfate were unaccompanied by a clinical difference statement. For instance, Hope argues XXXXX MSJ at 15. Hope points to an XXXXX Dkt. 154-26, Akro. Decl., Exh. GG ("Fresenius Sodium Thiosulfate Policy") at 641. Furthermore, this XXXXX Id. at 642. Although the order form XXXXX See Id. Hope argues XXXXX as Hope required by the FDA and Section 503B. See FDA Guidance on 503B "Essentially a Copy" Requirement at 6; 21 U.S.C. § 353b(d)(2)(B). The Court is aware of no order forms sent from Fresenius to defendants' 503B outsourcing facilities that contain a clinical difference statement, and defendants point to none .

Third is evidence that the clinical difference statements that did accompany orders were XXXXX Hope argues because the FDA guidance requires that there be a "prescriber determination" of clinical difference. FDA Guidance on 503B "Essentially a Copy" Requirement at 8. Specifically Hope alleges that although the 503B attestation forms XXXXX SUF No. 26; Sample Attestation Forms at 22, XXXXX (Image Omitted).

(Image Omitted)

b. Facts Relevant to Bulk Drug List Claims

Aside from the alleged lack of attestations, Hope also alleges defendants violated Section 503B by using bulk sodium thiosulfate before the FDA included it on the Bulk Drug List or the Category 1 List. MS J at 10. Specifically, Fagron and JCB have compounded sodium thiosulfate in their 503B facilities since at least 2012. SUF No. 39. Furthermore, Hope alleges that Fagron and JCB have always used bulk sodium thiosulfate rather than compounding it from a finished drug product. Id. No. 40. Finally, Sodium thiosulfate did not appear on the Category 1 list until October 31, 2019. Id. No. 41. Before then, sodium thiosulfate was on the Category 3 list. Id.

Defendants respond that the XXXXX Opp. to MSJ at 18. Defendants add that "The FDA inspected Defendants' 503B facilities ... and made no inspectional observations against Defendants for compounding potassium-free sodium thiosulfate." Id.

At oral argument, Hope, in turn, argued that a lack of enforcement by the FDA does not mean the FDA condoned the compounding. Hope points to the FDA's 2018 Compounding Policy Priorities Plan, in which the FDA "caution[ed] ] that the exercise of enforcement discretion during this time period for a certain nominated substance consistent with the 503A or 503B interim policies does not reflect a determination that the substance belongs on the 503A or 503B bulks lists or that there is a clinical need under section 503B to compound with the bulk drug substance." Dkt. 152-1, Exh. H ("2018 Compounding Policy Priorities Plan"), at 94. Hope further points to the FDA's Interim Policy on Compounding Using Bulk Drug Substances Under Section 503B of the Federal Food, Drug, and Cosmetic Act Guidance for Industry, published January 2017. See dkt. 152-1, Exh. E ("FDA 503B Interim Policy"). This document states that a bulk drug substance on the FDA's Category 3 list "is not on the 503B bulks list, and cannot be used for compounding consistent with section 503B(a)(2) unless the bulk drug substance is used to compound a drug that appears on FDA's drug shortage list." Id. at 10.

3. Consumer Confusion

In briefing the preliminary injunction, Hope produced evidence that certain consumers were confused about the source of the compounded sodium thiosulfate they purchased from defendants. Specifically, Hope presented the declaration of Dr. Craig Sherman, Hope's president, in which he stated that Hope had received several inquiries into what appeared to be orders actually placed with defendants. Dkt. 105-4, Declaration of Craig Sherman ("Sherman Decl.") ¶¶ 10-12. Attached to the declaration is a copy of a prescription form that matches those used by defendants' 503B outsourcing facilities, and which requests 25 vials of "compounded preparation" of sodium thiosulfate, which Hope does not produce. Dkt. 105-4, Sherman Deck, Exh. C (redacted order form). Nevertheless, Dr. Sherman averred that this order form was sent to Hope. Sherman Decl. ¶ 10. Dr. Sherman added that he received emails requesting updates on several ostensibly late orders which Hope had no record of receiving, and which Dr. Sherman alleges were likely actually placed by defendants. Sherman Decl. ¶ 11; see dkt. 105-4, Sherman Deck, Exh. D (emails regarding order numbers 2-JCB.91039.3572, 2-JCB-91039-9595).

D. Preliminary Injunction

On July 7, 2020, the Court granted in part Hope's motion for a preliminary injunction. Dkt. 141 ("PI Ord."). Specifically, the Court enjoined defendants, at both their 503A pharmacy and 503B outsourcing facilities, from distributing compounded sodium thiosulfate unless:

(i) defendants are provided a valid prescription or order form for the product; (ii) the prescription or order form includes an attestation specifically indicating that defendants' compounded product, which does not contain potassium, will produce a significant difference for the intended patient; (iii) the attestation specifies that defendants' compounded product, rather than the comparable commercially available drug product, is "medically necessary" for the intended patient; and (iv) the attestation indicates that the attestation is made or approved by the intended patient's prescribing practitioner.

PI Ord. at 38-39.

E. Alleged Conduct Since the Preliminary Injunction

(Image Omitted) ⁵

5 (Image Omitted)

However, the record is unclear as to what new procedure defendants have implemented at their 503A pharmacy and 503B outsourcing facilities to comply with the Court's preliminary injunction order.

F. Claims at Issue

Hope now argues that defendants' compounding practices do not comply with sections 503A or 503B, and that they have violated the Court's preliminary injunction order. Because of this non-compliance, Hope argues, defendants have violated state-law parallels to the FPCA, namely (1) California's Sherman Food, Prug, and Cosmetic Law, Cal. Health & Safety Code § 111550 ("Sherman Law"), (2) Florida's Prug and Cosmetic Act, Fla. Stat. Ann. § 499.001, et seq., (3) Tennessee's Food, Prug and Cosmetic Act, Term. Code Ann. § 53-1-101, et seq., and (4) South Carolina's Prug Act, SC Code Ann. § 39-23-70.⁶ FAC ¶¶ 101, 116, 120, 126. Pefendants dispute Hope's allegations and argue that all Hope's state law claims are impliedly preempted by the FPCA. Opp. to MSJ at 13.

6 Hope's FAC does not identify a Connecticut state law parallel to the FPCA, but rather relies solely on the state's unfair competition law.

III. LEGAL STANDARD

Summary judgment is appropriate where "there is no genuine dispute as to any material fact and the movant is entitled to judgment as a matter of law." Fed.R.Civ.P. 56(a). The moving party bears the initial burden of identifying relevant portions of the record that demonstrate the absence of a fact or facts necessary for one or more essential elements of each claim upon which the moving party seeks judgment. See Celotex Corp. v. Catrett, 477 U.S. 317, 323 (1986).

If the moving party meets its initial burden, the opposing party must then set out specific facts showing a genuine issue for trial in order to defeat the motion. Anderson v. Liberty Lobby. Inc., 477 U.S. 242, 250 (1986); see also Fed.R.Civ.P. 56(c), (e). The nonmoving party must not simply rely on the pleadings and must do more than make "conclusory allegations [in] an affidavit." Luian v. Nat'l Wildlife Fed'n, 497 U.S. 871, 888 (1990); see also Celotex, 477 U.S. at 324. Summary judgment must be granted for the moving party if the nonmoving party "fails to make a showing sufficient to establish the existence of an element essential to that party's case, and on which that party will bear the burden of proof at trial." Celotex, 477 U.S. at 322; see also Abromson v. Am. Pac. Corp., 114 F.3d 898, 902 (9th Cir. 1997).

In light of the evidence presented by the nonmoving party, along with any undisputed facts, the Court must decide whether the moving party is entitled to judgment as a matter of law. See T.W. Elec. Serv.. Inc. v. Pac. Elec. Contractors Ass'n, 809 F.2d 626, 631 & n.3 (9th Cir. 1987). When deciding a motion for summary judgment, "the inferences to be drawn from the underlying facts ... must be viewed in the light most favorable to the party opposing the motion." Matsushita Elec. Indus. Co. v. Zenith Radio Corp., 475 U.S. 574, 587 (1986) (citation omitted); Valley Nat'l Bank of Ariz, v. A.E. Rouse & Co., 121 F.3d 1332, 1335 (9th Cir. 1997). Summary judgment for the moving party is proper when a rational trier of fact would not be able to find for the nonmoving party on the claims at issue. See Matsushita, 475 U.S. at 587.

IV. DISCUSSION

A. Requests for Judicial Notice

The parties have filed several requests for judicial notice, some of which have been opposed. See dkt. 152 ("Hope RJN"); dkt. 174 ("Def RJN"); dkt. 203 ("Opp. to Def. RJN"); dkt. 193 ("Hope Supp. RJN"); dkt. 200 ("Opp. to Hope Supp. RJN"); dkt. 221 ("Def. Supp. RJN"). "A matter may be judicially noticed if it is either 'generally known within the territorial jurisdiction of the trial court' or 'can be accurately and readily determined from sources whose accuracy cannot reasonably be questioned."' Gustavson v. Wrigley Sales Co., 961 F.Supp.2d 1100, 1113 n.1 (N.D. Cal. 2013) (quoting Fed.R.Evid. 201(b)).

Hope requests the Court take judicial notice of 10 FDA publications or lists posted to the FDA's website or the Federal Register. See Hope RJN, Exhs. A-H; Hope Supp. RJN, Exhs. I-J. The Court previously took judicial notice of the existence of five of these 10 documents. PI Ord. at 7-8; see Hope RJN, Exhs. A-D, H. Defendants oppose the request as to Exhibit J, which is an FDA inspection report of the Fagron 503B outsourcing facility, dated June 21, 2019, and which is available on the FDA website. Opp. to Hope Supp. RJN at 2-A. Defendants object that Exhibit J is irrelevant, and its contents are hearsay. Id. The Court finds it may take judicial notice of the existence of Exhibits A through H attached to the Hope RJN, and Exhibits I and J attached to the Hope Supp. RJN. See Gustavson, 961 F.Supp.2d at 1113 n.1 ("The Court may take judicial notice of materials available on government agency websites." (citation omitted)). The Court overrules defendants' evidentiary objections as moot because the Court does not rely on Exhibit J in its ruling.

Defendants request the Court take judicial notice of three orders issued in Nexus Pharm.. Inc. v. Cent. Admixture Pharmacy Servs.. Inc., No. SACV 20-01505-CJC(JDEx), dkts. 47, 59, 70 (CD. Cal. Oct. 29, 2020), see Def. RJN, Exhs. A-C, and the declaration of Maria Edisa Gozun, the FDA's Acting Director of the Division of Compounded Drugs at the Center for Drug Evaluation and Research, which was entered into the record in Nexus, see Def. RJN, Exh. D ("Gozun Decl."). Defendants only request notice be taken of the declaration as it was filed in Nexus, and do not file it in this case. Hope opposes this request as to Exhibit D, the Gozun declaration, on the grounds that the declaration lacks foundation, is irrelevant pursuant to Fed.R.Evid. 401, is hearsay pursuant to Fed.R.Evid. 801-802, and further that, pursuant to Fed.R.Evid. 201, the contents of the declaration and the exhibits attached thereto should not be judicially noticed. Opp. to Def. RJN at 1-2. The Court takes judicial notice of the existence of these documents because "[t]he Court may take judicial notice ... of proceedings in other courts." Gustavson, 961 F.Supp.2d at 1113 n.1 (citation omitted); see Rev's Pasta Bella, LLC v. Visa USA, Inc., 442 F.3d 741, 746 (9th Cir. 2006) (taking judicial notice of "other pleadings, memoranda, expert reports, etc." from other litigation). The Court overrules Hope's evidentiary objections as moot because the Court does not rely on the Gozun declaration in its ruling.

B. Preemption

In its order granting a preliminary injunction, the Court found that, consistent with Allergan. Inc. v. Athena Cosmetics, Inc., 738 F.3d 1350 (Fed. Cir. 2013), and Allergan USA. Inc. v. Imprimis Pharm. Inc., No. 8:17-cv-01551-DOC-JDE, 2019 WL 4545960 (CD. Cal. Mar. 27, 2019), "it appears that the FDCA does not preempt state-law, consumer protection claims based on alleged violations of the FDCA where there is a parallel state law that renders the same noncompliant conduct independently unlawful." PI Ord. at 23 (citing Farm Raised Salmon Cases, 42 Cal.4th 1077. 1091 n. 13, 1094(2008)). In Allergan v. Athena, the Federal Circuit concluded "that the FDCA [did] not impliedly pre-empt [Allergan's] UCL claim," which was premised on the Sherman Law, ⁷ because the Sherman Law "incorporates various provisions of the FDCA, which does not itself allow a private right of action." Id. at 1354. The Federal Circuit explained that' '[t]he purpose of Congress is the ultimate touchstone in every pre-emption case.'" Id. at 1355 (citing Wyeth v. Levine, 555 U.S. 555, 565 (2009)). With this principle in mind, the Federal Circuit "d[id] not find a clear purpose by Congress to preempt" the Sherman Law. Allergan v. Athena, 738 F.3d at 1355. The Federal Circuit determined that the Sherman Law "is not an obstacle to realizing federal objectives. To the contrary, it contains provisions that parallel the FDCA, such that the statutes have consistent goals." Id. at 1356; see Allergan v. Imprimis, 2019 WL 4545960, at *8 ("[t]he Sherman Law remains a valid mechanism for private enforcement of FDCA violations" through the UCL's unlawful prong).

7 California's Sherman law provides that '"no person shall sell, deliver, or give away any new drug' that has not been approved by the California Department of Human Services or the FDA." Allergan USA Inc. v. Imprimis Pharm., Inc., No. 8:17-cv-01551-DOC-JDE, 2019 WL 3029114, at *6 (CD. Cal. July 11, 2019) (citing Cal. Health & Safety Code § 111550(a)-(b)). And, "[i]t follows that failure to comply with the FDCA . . . affronts" the Sherman Law. Id. at *6.

This conclusion is in keeping with the principle that "claims seeking to enforce the FDCA must thread a 'narrow gap' to escape preemption." Somers v. Beiersdorf, Inc., 467 F.Supp.3d 934, 937 (S.D. Cal. 2020). "The plaintiff must be suing for conduct that violates the FDCA (or else [the] claim is expressly preempted by § 360k(a)), but the plaintiff must not be suing because the conduct violates the FDCA (such a claim would be impliedly preempted under Buckman Co. v. Plaintiffs' Legal Committee, 531 U.S. 341 (2001))." Perez v. Nidek Co. Ltd., 711 F.3d 1109, 1120 (9th Cir. 2013) (quotation omitted).

Nevertheless, defendants urge the Court to reconsider its previous conclusion. Defendants argue that Hope's "state law claims are based entirely on Defendants' alleged violations of provisions of the FDCA," and are therefore impliedly preempted. Opp. at 4. Hope, in turn, argues that "the FDCA does not preempt state laws that '"parallel," rather than add to, federal requirements.'" Reply at 4 (citing Riegel v. Medtronic, Inc., 552 U.S. 312, 330 (2008)).

Defendants cite to several cases they argue should compel this Court to reconsider its finding that Hope's claims are not preempted. First is Nexus Pharm., Inc. v. Cent-Admixture Pharmacy Servs. Inc., No. SACV 20-01505-CJC(JDEx), 2020 WL 6555052 (CD. Cal. Oct. 29, 2020), which was issued after the Court's preliminary injunction order. In Nexus, the plaintiff alleged claims under several states' unfair competition laws, including the UCL, FDUTPA and CUPTA, on the grounds that the defendants' conduct violated the "essentially a copy" requirement of Section 503B. 2020 WL 6555052, at *1. The plaintiff there sought a court order enjoining production of a compound that was allegedly "essentially a copy" of plaintiff s drug. Id. at *1. The Nexus court found that plaintiffs claims were impliedly preempted because "Defendants' actions [were] unfair only because they purportedly violate the FDCA." Id. at *3. The court emphasized that, "like in Buckman, Nexus' claims exist only because of the FDCA's requirements. Consequently, Nexus' unfair competition claims are impliedly preempted under Perez." But here, by contrast, Hope alleges a violation of the state unfair competition laws premised not solely on violations of the FDCA, but also on violations of state parallels to the FDCA. Because those parallels are viable means by which to privately sue, the alleged misconduct is not unfair "only because" it violates the FDCA. Allergan, 738 F.3d at 1356.

The Court is aware that other courts have reached a contrary conclusion. In Somers v. Beiersdorf. Inc., 467 F.Supp.3d 934 (S.D. Cal. 2020), for instance, the court rejected the argument that the plaintiff was not "suing because [the defendant] ha[d] violated the FDCA, but rather because [it] ha[d] violated the Sherman Act." Id. at 938. The Somers court reasoned there were two problems with the 'parallel obligation' argument in [that] context." Id. at 939. First, the court reasoned that "new drug approval[ is] a process that is uniquely federal." Id. Second, the court concluded that the plaintiff really was "seeking to 'enforce the FDCA."' Id. (quoting Farm Raised Salmon Cases, 42 Cal.4th 1077, 1093 (2008)). But, as the Alergan v. Athena court noted, "[t]he Supreme Court acknowledged 'the historic primacy of state regulation of matters of health and safety.'" 738 F.3d at 1355. And the Court here, contrary to the court in Somers. concludes that Hope is seeking to enforce state law parallels to the FDCA, not only the FDCA itself.

Finally, defendants argue that, even if the Court concludes the Sherman Law and other state law parallels to the FDCA are viable avenues through which Hope can sue, the Court should find that the "essentially a copy" claims are preempted because they, more than others, implicate FDA rulemaking authority. Defendants point out that even the Allergan v. Imprimis court found that the defendants' "alleged violation of Section 503A and 503B's 'essentially a copy' rule are precluded because the rule implicates various exceptions that 'directly implicate the FDA's rulemaking authority." Allergan v. Imprimis, 2017 WL 10526121, at *8 (citing JHP Pharmaceuticals. LLC v. Hospira. Inc., 52 F.Supp.3d 992, 1004 (CD. Cal. 2014)). Defendants add that, before the Nexus court was testimony from the FDA's Acting Director of the Division of Compounded Drugs at the Center for Drug Evaluation and Research that the "FDA has not taken any complaint or enforcement action ... in which FDA relied on the 'essentially a copy' provisions set forth in Section 503B of the FDCA with respect to outsourcing facilities that compound drug products using FDA-approved drug products ... as a starting point."⁸ Id. at * 3 (alteration in original). The Nexus court relied on this testimony to the extent that it "highlight[ed] the fact that determination of whether Defendants' product is 'essentially a copy' of Nexus's, in violation of the FDCA, must be left to the FDA." Id. at *3.

8 The Court notes that, in this case, defendants do not "use[] FDA-approved drug products ... as a starting point," but rather use bulk sodium thiosulfate. See dkt. 200 ("Opp. To Def. RJN") at1.

The Court respectfully disagrees, though, and finds that the Federal Circuit's reasoning in Allergan v. Athena remains persuasive. Although determining whether a compounded drug is essentially a copy of an approved drug may involve application of facts to FDA rules and guidance, the question of documentation of such differences, at issue in the claims here, is not a question of rulemaking authority. See Allergan v. Imprimis, 2017 WL 10526121, at *7 ("In short, the preclusion question turns on the specific nature of the claim in question-only claims where the law is unclear and the FDA's particular expertise or rulemaking authority is required are precluded by the FDCA").

C. Standing

Defendants argue that "summary judgment on behalf of Defendants would [] be appropriate because Plaintiff provides no evidence that Defendants' sales of their potassium-free sodium thiosulfate caused any consumer deception or injury, which is an essential element of Hope's claims brought under the consumer protection statutes at issue." Opp. to MSJ at 19. "Similarly, California's UCL does not allow the disgorgement of profits to a competitor (as opposed to a consumer) in a UCL claim." Opp. to MSJ at 19. Plaintiffs respond that, pursuant to each of the state laws at issue, "consumer deception or injury is not required in competitor cases." Reply at 22. Furthermore, Hope argues that even if "the laws of the Five States required a showing of consumer deception or injury, Hope has provided the Court with such evidence." Reply at 24-25. In its preliminary injunction order, the Court found that Hope had adduced evidence of consumer confusion, and, further, that sale of an illegal product itself gave rise to claims under each state statute at issue. PI Ord. at 29-30.

Defendants cite to no authority contrary to the Court's previous conclusion, and accordingly the Court sees no reason to depart from its prior ruling. Each of the consumer protection statutes that form the bases for Hope's claims appear to recognize consumer confusion as a form of consumer harm. See Xerox Corp. v. Apple Computer, Inc., 734 F.Supp. 1542, 1550 (N.D. Cal. 1990) (noting that competitor could state UCL claim where "there is a likelihood of consumer confusion as to source or sponsorship"); Wyndham Vacation Resorts. Inc. v. Timeshares Direct. Inc., 123 So.3d 1149, 1152 (Fla. Dist. Ct. App. 2012) (determining that "conduct [that] could create consumer confusion and damage [competitor's] goodwill ... is actionable under FDUTPA"); Suisman, Shapiro, Wool, Brennan. Gray. & Greenberg. P.C. v. Suisman., No. 3:04-cv-745-JCH, 2006 WL 387289, at *13 (D. Conn. Feb. 15, 2006) ("evidence of actual consumer confusion supports the inference that the plaintiff ... has suffered an ascertainable loss entitling it to relief under CUTPA."); Sinclair & Assocs. of Greenville. LLC v. Crescom Bank, No. 2:16-cv-00465- DCN, 2016 WL 6804326, at *3 (D.S.C. Nov. 17, 2016) (noting that SCUTPA allows a plaintiff "to show that an unfair or deceptive act or practice adversely affects the public interest by demonstrating a potential for repetition" such as repeated "public confusion"); Kaldyv.Urshow.tvJnc, No. 2:16-cv-00054, 2017 WL 104148, at *4 (E.D. Tenn. Jan. 10, 2017) (finding that "likelihood of confusion among consumers" can give rise to "claims under the TCPA").

Here, as discussed in the Court's preliminary injunction order, Hope has produced evidence of consumer confusion. PI Ord. at 29. For instance, Hope submits evidence that consumers are confused about the source of defendants' sodium thiosulfate drug, blaming Hope for defendants' allegedly deficient shipping practices and causing Hope to suffer a loss in Hope's reputation and goodwill. See Sherman Decl. ¶¶ 10-12; Dkt. 105-4, Exhs. C-D. Defendants, for their part, have introduced evidence they argue establishes that there was no consumer confusion, namely, the testimony of Dr. Hymes and Dr. Aronoff, who both stated that Fresenius and DaVita, respectively, were not deceived into purchasing defendants' compounded sodium thiosulfate. Hymes Depo. at 30:4-21; SUF No. 35 (citing Francis Decl., Exh. J ("Aronoff Letter")). But defendants' evidence only establishes that certain consumers prefer their compounded drug, not that there are no other consumers who are confused about the source of defendants' compounded drug.

Furthermore, and also as discussed in the Court's preliminary injunction order, PI Ord. at 30, the consumer protection statutes upon which Hope's claims are based each recognize that, in particular circumstances, the sale of an illegal product can itself give rise to a claim, see Gitson v. Trader Joe's Co., No. 13-CV-01333-WHO, 2013 WL 5513711, at *10 (N.D. Cal. Oct. 4, 2013) (finding that plaintiffs could state a UCL claim predicated on violation of the Sherman Law based on defendant's alleged failure to comply with FDA's regulations); Morris v. Viking Pools Ne., Inc., 492 F.Supp.2d 90, 94 (D. Conn. 2007) (determining that plaintiff could state CUTPA claim against pool installer where installer unlawfully installed pool without a license and recognizing that unlawful installation would cause redressable "financial injury" in form of higher price); In re StarLink Corn Prod. Liab. Lhig., 212 F.Supp.2d 828, 835, 852 (N.D. 111. 2002) (determining that manufacturers' sale of genetically modified corn that failed to comply with Environmental Protection Agency's requirements gave rise to TCPA claim); Debernardis v. IO Formulations. LLC, 942 F.3d 1076, 1085 (11th Cir. 2019) (determining that plaintiffs could state FDUTPA claim based on purchase of dietary supplements unlawfully adulterated in violation of the FDCA because "a dietary supplement that is deemed adulterated and cannot lawfully be sold has no value."); Jones v. Ram Med.. Inc., 807 F.Supp.2d 501, 510 (D.S.C. 2011) (determining that pharmaceutical device manufacturers' sale of surgical mesh gave rise to SCUTPA claim based on allegations that manufacturers' product was a counterfeit that violated FDA regulations and reasoning that plaintiffs "have alleged that [defendants have acted in a manner which is clearly not permitted under FDA regulations."). Here, then, if the Court finds defendants' sale of compounded sodium thiosulfate was illegal, it would provide an independent means by which Hope could show consumer injury.

Having addressed the threshold issues of pre-emption and standing, the Court turns to the merits of Hope's claims.⁹

9 Defendants cross-move for summary judgment on "the preemption issues ..., as well as on Hope's failure to establish causation of damages under any of the state statutes." Opp. to MSJ at 23. Because the Court finds that the FDCA does not preempt Hope's various state law claims, and because the Court finds Hope has standing under these laws, both discussed above, see Sections IV.B and C, supra, the Court DENIES defendants' cross-motion for summary judgment.

D. 503A

Hope argues defendants violated two separate provisions of Section 503A: (1) the "essentially a copy" prohibition, and (2) the prohibition against anticipatory compounding. MSJ at 17. Hope alleges defendants violated the "essentially a copy" provision because the fact that their compounded sodium thiosulfate lacks potassium does not provide any clinical difference for patients, and, even if it did, defendants have failed to document clinical difference statements attached to each prescription, as Hope argues is required by 21 U.S.C. § 353a(a), and the FDA Guidance on 503A "Essentially a Copy" Requirement. Id. at 17-18. Hope further alleges defendants have violated the prohibition against anticipatory compounding because, when defendants' 503B facilities stopped compounding sodium thiosulfate, the 503A pharmacy began compounding sodium thiosulfate based on the 503B facilities' order histories, not based on established patient relationships, thus in violation of 21 U.S.C. § 353a(a)(2)(B). Id. at 18-19.

1. Essentially a Copy

Pursuant to Section 503A, "[a] drug product may be compounded if the licensed pharmacist or licensed physician ... does not compound regularly or in inordinate amounts (as defined by the Secretary) any drug products that are essentially copies of a commercially available product." 21 U.S.C. § 353a(b)(1)(D). "This means that a compounded drug product is not eligible for the exemptions in Section 503A if it is (1) essentially a copy of a commercially available drug product, and (2) compounded regularly or in inordinate amounts."¹⁰ FDA Guidance on 503A "Essentially a Copy" Requirement at 4. "The term 'essentially a copy of a commercially available drug product' does not include a drug product in which there is a change, made for an identified individual patient, which produces for that patient a significant difference, as determined by the prescribing practitioner, between the compounded drug and the comparable commercially available drug product." 21 U.S.C. § 353a(b)(2) (emphasis added). The non-binding FDA guidance suggests, "If a compounder intends to rely on such a determination to establish that a compounded drug is not essentially a copy of a commercially available drug product, the compounder should ensure that the determination is documented on the prescription." FDA Guidance on 503A "Essentially a Copy" Requirement at 8. The FDA guidance continues, stating that, "FDA does not believe that a particular format is needed to document the determination, provided that the prescription makes clear that the prescriber identified the relevant change and the significant difference that the change will produce for the patient." Id. However, "if a prescription identifies only a patient name and drug product formulation, this would not be sufficient to establish that the prescriber made the determination described by section 503A(b)(2)." Id. The FDA guidance gives three examples of satisfactory clinical difference statements:

10 A drug is compounded "regularly" if is "compounded at regular times or intervals, usually or very often." FDA Guidance on 503A "Essentially a Copy" Requirement at 10. A drug is compounded in "inordinate amounts" if "it is compounded more frequently than needed to address unanticipated, emergency circumstances, or in more than the small quantities needed to address unanticipated, emergency circumstances." Id.

• "No Dye X, patient allergy" (if the comparable drug contains the dye);

• "Liquid form, patient can't swallow tablet" (if the comparable drug is a tablet);

• "6 mg, patient needs higher dose" (if the comparable drug is only available in 5 mg dose).

Id.

Hope first argues that "Defendants' compounded ST [sodium thiosulfate] drug is essentially a copy of Hope's FDA-approved ST Injection, because it has the same API as Hope's ST Injection, the identical dosage strength, and the same route of administration (intravenous injection)." SUF ¶¶ 12-13; MSJ at 18. Hope also points to the FDA's determination that there is no basis to conclude that the presence of potassium in Hope's Sodium Thiosulfate Injection makes it unsuitable or unsafe for use with patients on dialysis. 503B Bulks List Notice at 46, 139. Hope further argues circumstantial evidence corroborates its argument, namely, that dialysis clinics did purchase Hope's Sodium Thiosulfate Injection when the defendants' compounded product was unavailable, XXXXX.

Defendants respond that providers purchase their compounded sodium thiosulfate drug because it is potassium-free. SUF No. 25; Opp. to MSJ at 16. To support this claim, defendants elicited deposition testimony from Dr. Hymes, of Fresenius, and Dr. Aronoff, of DaVita, to the effect that they purchase defendants' compounded sodium thiosulfate because it lacks potassium.

In the preliminary injunction order, the Court concluded that "[t]he disputed record before the Court precludes the Court from determining, at this juncture, whether defendants' compounded sodium thiosulfate drug is 'essentially a copy' of Hope's product, given that Hope's product contains potassium, while defendants' compounded product does not." Ord. at 11.

The Court finds that there remains a disputed issue of material fact as to whether the absence of potassium in defendants' compounded sodium thiosulfate could be medically significant for some dialysis patients. Although Hope is correct that the FDA appears to have concluded that the presence of potassium in Hope's Sodium Thiosulfate Injection does not pose a risk for dialysis patients, the fact remains that Fresenius and Da Vita attest that they order defendants' compounded drug because it is potassium-free, and that the absence of potassium is significant for their patients. Furthermore, Hope's evidence that clinics sometimes purchase its Sodium Thiosulfate Injection does not establish that clinics do not prefer to use a potassium-free compounded drug when possible. Therefore, a jury question remains as to whether a reasonable clinician could conclude that his or her dialysis patient would benefit from a potassium-free sodium thiosulfate. In any event, to the extent clinicians have made clinical difference statements to the effect that there is a significant difference for their patient, see Sample 503A Pharmacy Prescriptions, Hope's argument is beside the point because these attestations are sufficient pursuant to 21 U.S.C. § 353a(b)(2).

Hope further argues that "[t]he prescription orders filled by Defendants' 503A pharmacy lack any language that would take them outside the essentially a copy prohibition." SUF No. 37; MS J at 18. Hope argues that the form statement attached to at least some 503A pharmacy orders XXXXX (Image Omitted).

Defendants respond that the form statement is adequate, that the three examples previously noted are also adequate, and that, contrary to Hope's allegation, many other prescriptions contain similar statements. SUF No. 32; Opp. at 15. The Court is aware of no additional 503A prescriptions in the record, with or without clinical difference statements.

In the preliminary injunction order, the Court concluded that "the pre-formulated, generic statements on defendants' website and standard prescription forms that defendants accept from prescribers appear to be inadequate in that these statements do not require the prescribers to "make clear that the prescriber made the determination required by section 503A(b)(2)." Ord. at 13. The Court continued, "[t]o the extent that Hope claims that defendants violate Section 503A's 'essentially a copy' requirement because defendants fulfill orders for their compounded sodium thiosulfate products without sufficient, affirmative determinations by prescribers that defendants' compounded products-as opposed to Hope's FDA-approved products-are necessary, Hope raises a likelihood of success on the merits." Ord. at 14.

The Court finds that there remains a disputed issue of material fact as to whether the form statement, either alone or in conjunction with any additional notations of clinical difference, satisfies the FDA's requirements. Furthermore, the question as to how many of the 503 A prescriptions contain a clinical difference statement that is sufficient is a matter better decided after trial. However, the Court may revisit this issue on a Federal Rules of Civil Procedure, Rule 50 motion at the end of trial.

Accordingly, the Court cannot grant summary judgment to the effect that defendants have violated the "essentially a copy" provision of Section 503A.

2. Anticipatory Compounding

Section 503A permits compounding in advance of the receipt of a prescription, but only "in limited quantities" and only "based on a history of the licensed pharmacist or licensed physician receiving valid prescription orders for the compounding of the drug product." 21 U.S.C. § 353a(a)(2). Furthermore, the prescriptions must "have been generated solely within an established relationship between the licensed pharmacist or licensed physician[] and such individual patient for whom the prescription order will be provided[, ] or the physician or other licensed practitioner who will write such prescription order." 21 U.S.C. § 353a(a)(2).

In Allergan v. Imprimis, the court concluded, at the summary judgment stage, that '[u]nder the plain language of the statute, anticipatory mass compounding of standardized drugs in a 503A facility without identified individual patients based on valid prescription orders is clearly violative of the FDCA." 2019 WL 4545960, at *11. There, Allergan challenged, inter alia. Imprimis' alleged practice of preparing compounded product "in advance" of actually having received a particular prescription tied to a specific patient. Id. The court noted that "[t]he parties dispute whether the formulations at the 503A facilities are generated pursuant to valid prescriptions from a practicing doctor for an identified individual patient," but concluded that "this dispute is not genuine." Allergan v. Imprimis, 2019 WL 4545960, at * 11. That is because Allergan adduced evidence that "Imprimis has not matched orders with specific patients and customized prescriptions." Id. For example, rather than disburse compounded product to a customer to fill a particular patient's needs, Imprimis appeared to '"pick 3 names' in order to ship[.]" Id. Similarly, instead of fulfilling orders based on a valid prescription, "Imprimis has allowed customers to provide a surgery schedule or list of patients to obtain drug orders from the 503 A facility." Id.

Hope argues that "Anazao failed to comply with this requirement of Section 503A by engaging in anticipatory compounding well beyond any established history between any pharmacist and a patient or prescribing physician." MS J at 18-19. Specifically, Hope alleges "Anazao began compounding based on the 503B Defendants' historical volumes" when the 503B defendants temporarily stopped compounding sodium thiosulfate between September 2018, and March 2019-"not based on its own history of Anazao's pharmacists 'receiving valid prescription orders ... generated solely within an established relationship between' Anazao's pharmacists and the 'individual patient for whom the prescription order will be provided' or 'the physician or other licensed practitioner who will write such prescription order." MSJ at 19 (quoting 21 U.S.C. § 353a(a)(2)(B)). To support this allegation, Hope points to the deposition testimony of Anazao's Rule 30(b)(6) designee in which the designee answered "Yes" when asked whether Anazao began compounding "based on Fagron and JCB's historical volumes of sodium thiosulfate sales" when those 503B facilities temporarily stopped compounding sodium thiosulfate drugs. Anazao Depo. at 59:12-25. Anazao's designee admitted that Anazao "ramped up whatever we could to satisfy their [the 503B facilities ] patient needs." Id. Hope also points to circumstantial evidence, namely that XXXXX SUF No. 45.

Defendants argue that Hope "has produced no evidence to dispute Defendants' sworn testimony and record evidence that its 503A pharmacy compounds in advance for the amount of prescriptions it expects to receive." Opp. to MSJ at 18. They also argue that "the FDA has inspected the facility on multiple occasions and has never observed or taken enforcement action related to Defendants' anticipatory compounding." Opp. to MSJ at 19. Furthermore, at the hearing, defendants averred that their 503B facilities had historically, at least until 2017, collected prescriptions pertaining to individual patients and that, therefore, when the 503A pharmacy began compounding based on the 503B facilities' histories, it was in effect engaging in permissible anticipatory compounding based on prescriptions "generated solely within an established relationship between the licensed pharmacist or licensed physician[] and such individual patient." 21 U.S.C. § 353a(a)(2). However, the record contains no such prescriptions. Finally, defendants point to the deposition testimony of their pharmacist XXXXX (Image Omitted).

In its preliminary injunction order, the Court found that, "[b]ecause of the disputed record presently before the Court, the Court [could not] determine, at this juncture, whether Hope is likely to succeed on the merits of its claim that defendants have violated Section 503[A]'s 'individual prescription' requirement." Ord. at 15.

The Court finds a disputed issue of material fact remains as to whether defendants' 503A pharmacy engaged in impermissible anticipatory compounding. First, although some evidence suggests the 503A pharmacy engaged in anticipatory compounding based solely on the 503B facilities' order volumes, other evidence suggests that the 503A pharmacy's compounding was based on specific patient orders, including the sample prescription forms m the record. See Sample 503A Pharmacy Prescriptions at 5 XXXXX Furthermore, the Court finds a question remains whether there was a sufficiently documented set of historical relationships with patients at defendants' 503B facilities. And, if so, there is a question as to whether the compounding by defendants' 503A pharmacy was based on that historical relationship. These questions are more properly considered at a trial on the merits. However, the Court cautions defendants that it may reconsider this finding on a renewed Federal Rules of Civil Procedure, Rule 50 motion at the conclusion of trial.

Accordingly, the Court cannot grant summary judgment to the effect that defendants have engaged in anticipatory compounding prohibited by Section 503A.

"Section 503B regulates drug products compounded by an 'outsourcing facility.'" Athenex Pharma Sols.. LLC v. Par Pharm. Inc., No. 1:18-cv-896, 2019 WL 4511914, at * 1 (W.D.N.Y. July 9, 2019). "Under certain conditions, drugs compounded by a registered outsourcing facility are exempt from certain FDA drug approval requirements[.]" Id. "One condition is that the outsourcing facility may only compound products using bulk drug substances included on either (1) a list established by the FDA identifying bulk drug substances for which there is a clinical need"; or "(2) the FDA's drug shortage list." Id. at *1 (citing 21 U.S.C. § 353b(a)(2)) (alterations omitted). "Another condition is that the compounded drug cannot be 'essentially a copy' of a drug approved by the FDA." Id. at *1 (citing 21 U.S.C. § 353b(a)(5)). Hope alleges that defendants have violated each of these provisions. MS J at 13.

1. Essentially a Copy

Section 503B defines "essentially a copy of an approved drug" as "a drug, a component of which is a bulk drug substance that is a component of an approved drug ... unless there is a change that produces for an individual patient a clinical difference, as determined by the prescribing practitioner, between the compounded drug and the comparable drug." 21 U.S.C. § 353b(d)(2)(B).

The FDA has issued an advisory document which "explain[s] how [the FDA] intend[s] to apply the definition of essentially a copy of an approved drug in section 503B(d)(2) when the compounded drug is compared to an approved drug[.]' FDA Guidance on 503B "Essentially a Copy" Requirement at 6 (emphasis in original). The FDA's guidance indicates that "[i]f a component of the compounded drug is a bulk drug substance that is also a component of an approved drug, the compounded drug product is essentially a copy of an approved drug, and cannot be compounded under Section 503B, unless there is a prescriber determination of clinical difference[.]" Id. at 8. The FDA's guidance further indicates that '[i]f an outsourcing facility intends to rely on" a determination that there is a clinical difference "to establish that a compounded drug is not essentially a copy of an approved drug, the outsourcing facility should ensure that the determination is noted on the prescription or order (which may be a patient-specific prescription or a non-patient specific order) for the compounded drug." Id. The FDA's guidance document acknowledges that the FDA "is aware that a health care practitioner who orders a compounded drug from an outsourcing facility for office stock will not know the identity of individual patients who will receive the compounded drug at the time of the order." Id. at 9. The FDA's document advises, however, that "[i]n that case, the outsourcing facility should obtain a statement from the practitioner that specifies the change between the compounded drug and the comparable approved drug and indicates that the compounded drug will be administered or dispensed only to a patient for whom the change produces a clinical difference, as determined by the prescribing practitioner for that patient." Id. The FDA further indicates that "[s]uch assurances should be provided by the health care practitioner or a person able to make the representation for the health care practitioner." Id. The FDA sets forth the following examples of notations on a non-patient-specific order form that "would be sufficient" to satisfy Section 503B's "clinical difference" requirement:

• 'Liquid form, compounded drug will be prescribed to patients who can't swallow tablet' (if the comparable drug is a tablet);

• 'Dilution for infusion solution to be administered to patients who need this formulation during surgery' (if the comparable drug is not available at that concentration, pre-mixed with the particular diluent in an infusion bag);

• '1 mg, pediatric patients need lower dose' (if the comparable drug is only available in 25 mg doses).

Id. at 10.

Hope first argues that the attestation forms were insufficient in their own right. MSJ at 14-15. To support this contention, Hope points to the language of the form attestations provided by defendants' 503B outsourcing facilities to the facilities' customers. One form attestation stated that XXXXX (Image Omitted) The record does not indicate how many of the contested 503B orders contained any of the three form attestations referenced above. Defendants do not directly address this argument, instead arguing simply that "[e]ach and every sale by Defendants' 503A and 503B facilities of sodium thiosulfate is made to treat a dialysis patient with chronic renal disease." Opp. to MSJ at 15.

Second, Hope argues that clinical difference statements did not accompany each order, but rather were provided ex ante, if at all. MS J at 14. To support this assertion, Hope points to the deposition testimony of Fagron's Rule 30(b)(6) designee, who answered XXXXX (Image Omitted).

Finally, Hope argues the form clinical difference statements in the record are deficient because XXXXX (Image Omitted).

In its preliminary injunction order, the Court concluded that "Hope appears likely to succeed on the merits of its claim that defendants' outsourcing facilities violate Section 503B's 'essentially a copy' requirement" because, "[u]nlike these examples [provided in the FDA guidance], which specify the change as between the FDA-approved product and the desired compounded product, defendants' forms do not appear to specify that Hope's product contains potassium, while defendants' do not. Nor do defendants' forms appear to make clear that this change is 'clinically' significant for patients suffering from calciphylaxis, to whom the presence of potassium would pose a health risk." PI Ord. at 19.

The Court finds that there remain disputed issues of material fact as to whether defendants' 503B facilities violated Section 503B's "essentially a copy" provision. For instance, there remains a question as to whether the form attestations are sufficient under Section 503B or the FDA's guidance. Furthermore, there remains a question as to how many of the orders contained a clinical difference statement, or whether the FDA's guidance requires that repeat orders from the same customer contain a new clinical difference statement. However, the Court may revisit this issue on a Federal Rules of Civil Procedure, Rule 50 motion at the end of trial.

Accordingly, the Court cannot grant summary judgment to the effect that defendants have violated the "essentially a copy" provision of Section 503B.

2. Bulk Drug Substance

Bulk sodium thiosulfate appears on neither the FDA's bulks list nor the FDA's drug shortage list. Nevertheless, "[t]he FDA is currently developing the bulks list" and has, '[i]n the meantime, ... issued an industry guidance document that describes interim regulatory policies[.]" Par, 2019 WL 4511914, at *2. The FDA's interim policy explains "that the FDA 'does not intend to take action against an outsourcing facility for compounding a drug using a bulk drug substance ... if, among other conditions, the substance appears on a list of 'Category 1' substances that are currently under evaluation." Id; Opp. to MSJ at 12. And, "on October 30, 2019," the FDA "moved bulk sodium thiosulfate," the bulk ingredient in defendants' compounded products, onto the FDA's Category 1 list. SUF No. 41.

Nevertheless, Hope argues that all the 503B defendants' sales of sodium thiosulfate prior to the date on which sodium thiosulfate was included on the FDA Category 1 list are not exempted by 21 U.S.C. 353b(a)(2). MSJ at 17. Hope further argues that the FDA's "exercise of enforcement discretion ... does not reflect a determination that the substance belongs on the 503A or 503B bulks lists or that there is a clinical need under section 503B to compound with the bulk drug substance." 2018 Compounding Policy Priorities Plan at 94. Finally, Hope points to Allergan USA, Inc. v. Prescribers Choice, Inc., 364 F.Supp.3d 1089 (CD. Cal. 2019), where another court in this District found "Defendants violated the Sherman Law and the UCL's unlawful prong by making and selling unapproved drugs without complying with Section 503B or the FDA's Interim Policy" where "the undisputed facts show[ed] that [defendant] began compounding and distributing drugs before they appeared on the FDA's Category 1 list." Id. at 1107.

Defendants respond that, "though FDA had actual notice that Defendants were compounding potassium-free sodium thiosulfate before that substance was placed on List 1, FDA used its enforcement discretion and took no enforcement action against Defendants for that practice." Opp. to MSJ at 13; dkt. 180-3, Francis Deck, Exh. C ("McGuire Deck"), ¶¶ 7-16.

The record is not sufficiently developed to determine what effect the FDA's eventual inclusion of bulk sodium thiosulfate on the Category 1 list had on prior violations. The Court has considered Allergan v. Prescribers Choice, and recognizes that summary judgment was entered in favor of the moving party in that case in similar circumstances. While this may be the Court's ultimate conclusion, at this juncture, because the record is not sufficiently developed, the Court denies summary judgment on this issue. However, the Court will consider this issue after trial when the facts have been developed further.

Accordingly, the Court cannot grant summary judgment to the effect that defendants have violated Section 503B by compounding sodium thiosulfate using bulk sodium thiosulfate before it was included on the Category 1 List.

Because the Court denies Hope's motion for summary judgment, the Court does not reach the question of damages.

F. Motion for Contempt

'[C]ourts have inherent power to enforce compliance with their lawful orders through civil contempt." California Dep't of Soc. Servs. v. Leavitt, 523 F.3d 1025, 1033 (9th Cir 2008) (quoting Shilhtam v. United States, 384 U.S. 364, 370 (1966)). A party requesting an adjudication of civil contempt must establish "by clear and convincing evidence that the contemnors violated a specific and definite order of the court." Stone v. City and County of San Francisco, 968 F.2d 850, 856 n.9 (9th Cir. 1992). "The burden then shifts to the contemnors to demonstrate why they were unable to comply." hi The respondent's conduct "need not be willful" to violate a court order, and there is "no good faith exception to the requirement of obedience." In re Dual-Deck Video Cassette Recorder Antitrust Litigation, 10 F.3d 693, 695 (9th Cir. 1993). However, a respondent may avoid being found in contempt by demonstrating that their failure to comply with a court order was "based on a good faith and reasonable interpretation of the order." Id. Additionally, "contempt is appropriate only when a party fails to comply with a court order that is both specific and definite." Balla v. Idaho State Bd. of Corr., 869 F.2d 461, 465 (9th Cir. 1989).

In its preliminary injunction order, the Court enjoined defendants from "dispensing or distributing any compounded sodium thiosulfate product" from a 503A pharmacy or a 503B outsourcing facility into California, Connecticut, Florida, South Carolina, or Tennessee unless:

(i) defendants are provided a valid prescription or order form for the product; (ii) the prescription or order form includes an attestation specifically indicating that defendants' compounded product, which does not contain potassium, will produce a significant difference for the intended patient; (iii) the attestation specifies that defendants' compounded product, rather than the comparable commercially available drug product, is "medically necessary" for the intended patient; and (iv) the attestation indicates that the attestation is made or approved by the intended patient's prescribing practitioner.

PI Ord. at 38-39.

Hope argues that defendants have violated this order because, XXXXX (Image Omitted).

(Image Omitted)

The Court finds that, while some prescriptions or orders were not accompanied by a significant difference statement, others were. The record is unclear on how many were or were not. The Court therefore reserves judgment until the time of trial on whether defendants' non-compliance is contemptuous.

G. Defendants' Motion for Reconsideration

Defendant requests this Court reconsider its preliminary injunction order, issued on July 7, 2020. See Section II.D, supra. A court may reconsider its own order. See CD. Cal. L.R. 7-18. Reconsideration of a court's order is an '"extraordinary remedy, to be used sparingly in the interests of finality and conservation of judicial resources." Kona Enterprises. Inc. v. Estate of Bishop, 229 F.3d 877, 890 (9th Cir. 2000). "In this district, motions for reconsideration are governed by Local Rule 7-18," Milton H. Greene Archives, Inc. v. CMG Worldwide, Inc., 568 F. Supp.2d 1152, 1162 (CD. Cal. 2008), which states: "[a] motion for reconsideration of the decision on any motion may be made only on the grounds of (a) a material difference in fact or law from that presented to the Court before such decision that in the exercise of reasonable diligence could not have been known to the party moving for reconsideration at the time of such decision, or (b) the emergence of new material facts or a change of law occurring after the time of such decision, or (c) a manifest showing of a failure to consider material facts presented to the Court before such decision," CD. Cal. L.R. 7-18; see Fed.R.Civ.P. 54(b). Furthermore, '[n]o motion for reconsideration shall in any manner repeat any oral or written argument made in support of or in opposition to the original motion," CD. Cal. L.R. 7-18, and "a motion for reconsideration may not be made on the grounds that a party disagrees with the Court's application of legal precedent," Pegasus Satellite Television, Inc. v. DirecTV. Inc., 318 F.Supp.2d 968, 981 (CD. Cal. 2004). Finally, "[w]hether to grant a motion for reconsideration under Local Rule 7-18 is a matter within the court's discretion." Milton H. Greene, 568 F.Supp.2d at 1162.

Here, defendant argues that reconsideration is proper in light of the Gozun declaration entered in Nexus, see Section IV.A, supra; and in light of that and three other rulings from this District which were issued after the Court's preliminary injunction order, Opp. to Mot. for Contempt at 23; dkt. 220, Not. of Supp. Authority. In those four cases, the Nexus court found the FDCA impliedly preempted plaintiffs' state unfair competition claims based on alleged violations of Section 503B. Opp. to Mot. for Contempt at 23; see Nexus, dkt. 59 (order denying motion for preliminary injunction); Nexus Phannaceuticals. Inc. v. Ouva Pharma. Inc., et. al., No. CV 20-07518-CJC (JDEx) (CD. Cal. Oct. 29, 2020), dkt. 47 (order granting motion to dismiss); Nexus Pharmaceuticals. Inc. v. Leiters. Inc., et. al., No. CV 20-07328-CJC (JDEx) (CD. Cal. Oct. 29, 2020), dkt. 70 (same); Nexus Pharmaceuticals. Inc. v. U.S. Compounding. Inc., No. CV 20-07331-CJC (JDEx) (CD. Cal. Jan. 7, 2021), dkt. 33 (same). Defendants urge this Court to reconsider its preliminary injunction ruling and find the same in this case. However, as discussed above, the rulings in the Nexus cases are not binding on this Court, and this Court declines to adopt their reasoning. Instead, the Court maintains that the reasoning in Allergan v. Athena is more persuasive, notwithstanding the Gozun declaration and the Nexus court's orders. Accordingly, the Court DENIES defendants' motion to reconsider its preliminary injunction order, which remains in effect.

V. CONCLUSION

According with the foregoing, the Court DENIES plaintiffs motion for summary judgment and DENIES plaintiffs motion for a finding of civil contempt and sanctions. The Court further DENIES defendants' cross-motion for summary judgment and DENIES defendants' motion for reconsideration.

IT IS SO ORDERED.