Hope Medical Enterprises, Inc. v. Fagron Compounding Services, LLC

CourtDistrict Court, C.D. California
DecidedJanuary 13, 2020
Docket2:19-cv-07748
StatusUnknown

This text of Hope Medical Enterprises, Inc. v. Fagron Compounding Services, LLC (Hope Medical Enterprises, Inc. v. Fagron Compounding Services, LLC) is published on Counsel Stack Legal Research, covering District Court, C.D. California primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Hope Medical Enterprises, Inc. v. Fagron Compounding Services, LLC, (C.D. Cal. 2020).

Opinion

UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA CIVIL MINUTES —- GENERAL ‘O’ No. 2:19-cv-07748-CAS(PLAx) Date January 13, 2020 Title HOPE MEDICAL ENTERPRISES, INC. v. FAGRON COMPOUNDING SERVICES, LLC ET AL.

Present: The Honorable CHRISTINAA.SNYDER Catherine Jeang Laura Elias N/A Deputy Clerk Court Reporter / Recorder Tape No. Attorneys Present for Plaintiffs: Attorneys Present for Defendants: Aaron Craig Lawrence Silverman Joseph Akrotirianakis

Proceedings: PLAINTIFF’S MOTION TO STRIKE CERTAIN AFFIRMATIVE DEFENSES OR IN THE ALTERNATIVE FOR JUDGMENT ON THE PLEADINGS AS TO CERTAIN AFFIRMATIVE DEFENSES (Dkt. [ 57 ], filed December 17, 2019) PLAINTIFF’S REQUEST FOR JUDICIAL NOTICE (Dkt. [ 58 |, filed December 17, 2019) DEFENDANTS’ REQUEST FOR JUDICIAL NOTICE (Dkt. [ 61 |, filed December 23, 2019) I. INTRODUCTION AND BACKGROUND Plaintiff Hope Medical Enterprises, Inc., d/b/a/ Hope Pharmaceuticals (“Hope”) filed this action against defendants Fagron Compounding Services, LLC (“Fagron’’), JCB Laboratories, LLC (“JCB”), AnazaoHealth Corporation (“AnazaoHealth”), and Coast Quality Pharmacy, LLC (“Coast”) (collectively, “defendants’’) on September 6, 2019. Dkt. 1. Hope filed its operative first amended complaint on November 12, 2019. Dkt. 47 (“FAC”). The FAC asserts claims for: (1) violation of California’s Unfair Competition Law (“UCL”): (2) violation of Florida’s Deceptive and Unfair Trade Practices Act (“FDUTPA”):; (3) violation of the Tennessee’s Consumer Protection Act (““TCPA”): (4) violation of South Carolina’s Unfair Trade Practices Act (“SCUTPA”); and (5) violation of Connecticut’s Unfair Trade Practices Act (“CUTPA”). Id. Hope is a pharmaceutical company which markets and sells Sodium Thiosfulfate Injection and Sodium Nitrite Injection. FAC § 26. Hope sells its Sodium Thiosulfate Injection to medical facilities and other customers located in states including California,

UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA CIVIL MINUTES — GENERAL ‘Oo’ No. 2:19-cv-07748-CAS(PLAx) Date January 13, 2020 Title HOPE MEDICAL ENTERPRISES, INC. v. FAGRON COMPOUNDING SERVICES, LLC ET AL. Florida, South Carolina, Tennessee, and Connecticut. Id. { 27. Hope’s Sodium Thiosulfate Injection and Sodium Nitrite Injection are used to treat acute cyanide poisoning that is judged to be serious or life-threatening. FAC { 38. Hope is the exclusive supplier of Sodium Thiosulfate Injection in the United States that has approval from the Food and Drug Administration (“the FDA”). Id. {| 26. The active ingredient in Hope’s Sodium Thiosulfate Injection is bulk sodium thiosulfate pentahydrate (“bulk sodium thiosulfate’). Id. 28. According to Hope, Hope “is the only supplier of bulk sodium thiosulfate that has been approved by the FDA for use as an active ingredient in medications that are intended for administration to humans.” Id. { 43. Hope alleges that Fagron and JCB own “outsourcing facilities” located in Wichita, Kansas, that AnazaoHealth owns an “outsourcing facility” in Las Vegas, Nevada, and that Coast owns and operates a “compounding pharmacy” located in Tampa, Florida. FAC § 14. According to Hope, “[d]efendants are under common ownership and control and work closely together. All [d]efendants 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.” Id. § 13. At issue in this case are defendants’ alleged “compounding” practices. “Compounding” refers to the “practice in which a licensed pharmacist, a licensed physician, or, in the case of an outsourcing facility, a person under the supervision of a licensed pharmacist, combines, mixes, or alters ingredients of a drug to create a medication tailored to the needs of an individual patient.” FAC § 12. Hope contends that “{c]ompounding is typically appropriate when the medical needs of an individual patient cannot be met by a commercially available, approved medication.” Id. § 18. Thus, “[ilfa patient has an allergy and needs a medication to be made without a certain dye, .. . compounding may be appropriate.” Id, Similarly, compounding may be warranted “if an elderly patient or a child cannot swallow a pill and needs a medicine in liquid form that is commercially available only in tablet form|.|” Id. “To preserve traditional compounding as a way to treat patients whose needs cannot be met by commercially available, approved drugs, state and federal law permit compounded drugs, in limited circumstances, to forgo approval by state health departments or [the] FDA.” FAC § 18. However, according to Hope, “[u|nlike Hope and other law- abiding pharmaceutical manufacturers, [d]efendants falsely claim to be engaged in compounding and thus to be exempt from state and federal approval requirements.” Id. § 21. Hope alleges that defendants’ “[i|gnoring drug-approval requirements provides . . . an

UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA CIVIL MINUTES —- GENERAL ‘O’ No. 2:19-cv-07748-CAS(PLAx) Date January 13, 2020 Title HOPE MEDICAL ENTERPRISES, INC. v. FAGRON COMPOUNDING SERVICES, LLC ET AL. unfair competitive advantage” in that defendants have been able to bypass the “time- consuming and very costly” processes of “|t]esting new drugs and obtaining the legally required regulatory approval|[.|” FAC 416. Thus, defendants’ conduct has allowed them to “profit[] at the expense of public health” and has “deprived [Hope] of money or property .. . In the forum of the sales and market share that have been diverted from Hope to [djefendants.” Id. 9] 21,96. That is because, according to Hope, “the demand for sodium thiosulfate is inelastic and there are no substitutes,” such that “each purchase of a vial of unlawfully compounded sodium thiosulfate from [d]efendants would have been a purchase of a vial of Hope’s FDA-approved Sodium Thiosulfate Injection for [d]efendants’ unlawful and unfair competition.” Id. 4 96. Defendants filed an answer on October 15, 2019, dkt. 35, and the operative first amended answer on November 26, 2019, dkt. 51 (“Answ.”). According to defendants, the FDA “added Sodium Thiosulfate to its Category 1 List on October 30, 2019,” meaning that defendants “can produce Sodium Thiosulfate as an outsourcing facility . . . pursuant to the FDA’s interim policy, under which the FDA has advised it will take no action against outsourcing facilities compounding drugs on the FDA’s Category | List.” Id. § 1. Defendants further “deny that it is unlawful to compound and sell Sodium Thiosulfate without potassium, in order to provide essential care to dialysis patients, who would otherwise be exposed to the unnecessary risk of adverse consequences from potassium accumulation from Hope’s product.” Id. (emphasis added). Defendants assert the following defenses: (1) waiver, acquiescence, and estoppel; (2) laches; (3) failure to mitigate; (4) unclean hands; (5) acts of plaintiff; (6) actions of others; (7) lack of standing; and (8) FDA Authority. See generally id. On December 17, 2019, Hope filed a motion to strike a number of the affirmative defenses in defendants’ answer or, in the alternative, for judgment on the pleadings as to several of those defenses. Dkt. 57 (“Mot.”). Defendants filed an opposition on December 23,2019. Dkt. 60 (“Opp.”). Hope filed a reply on December 30, 2019. Dkt. 64 (“Reply”). The Court held a hearing on January 13, 2020. Having carefully considered the parties’ arguments, the Court finds and concludes as follows.

UNITED STATES DISTRICT COURT CENTRAL DISTRICT OF CALIFORNIA CIVIL MINUTES — GENERAL ‘Oo’ No. 2:19-cv-07748-CAS(PLAx) Date January 13, 2020 Title HOPE MEDICAL ENTERPRISES, INC. v. FAGRON COMPOUNDING SERVICES, LLC ET AL. Il. LEGAL STANDARDS A.

Free access — add to your briefcase to read the full text and ask questions with AI

Related

Whittlestone, Inc. v. Handi-Craft Co.
618 F.3d 970 (Ninth Circuit, 2010)
Jose Chavez v. James Ziglar
683 F.3d 1102 (Ninth Circuit, 2012)
In Re Dynamic Random Access Memory (DRAM) Antitrust Litigation
516 F. Supp. 2d 1072 (N.D. California, 2007)
RDF Media Ltd. v. Fox Broadcasting Co.
372 F. Supp. 2d 556 (C.D. California, 2005)
Rosen v. Masterpiece Marketing Group, LLC
222 F. Supp. 3d 793 (C.D. California, 2016)
Qwest Communications Corp. v. City of Berkeley
208 F.R.D. 288 (N.D. California, 2002)
Kohler v. Islands Restaurants, LP
280 F.R.D. 560 (S.D. California, 2012)
Wyshak v. City National Bank
607 F.2d 824 (Ninth Circuit, 1979)
Sidney-Vinstein v. A.H. Robins Co.
697 F.2d 880 (Ninth Circuit, 1983)

Cite This Page — Counsel Stack

Bluebook (online)
Hope Medical Enterprises, Inc. v. Fagron Compounding Services, LLC, Counsel Stack Legal Research, https://law.counselstack.com/opinion/hope-medical-enterprises-inc-v-fagron-compounding-services-llc-cacd-2020.