Hope Medical Enterprises, Inc. v. Fagron Compounding Services, LLC et al, No. 2:2019cv07748 - Document 476 (C.D. Cal. 2022)

Court Description: AMENDED FINAL JUDGMENT by Judge Christina A. Snyder: The Court hereby ORDERS, ADJUDGES, and DECREES that judgment be, and hereby is, entered as follows:Judgment. Judgment is entered in favor of plaintiff Hope Medical Enterprises Inc. d/b/a Hope Pharm aceuticals (Hope). Declaratory Relief. Defendants Fagron Compounding Services, LLC, JCB Laboratories, LLC, AnazaoHealth Corporation, and Coast Quality Pharmacy LLC (collectively defendants) have violated (1) Californias Unfair Competition Law, (2) F loridas Deceptive and Unfair Trade Practices Act, (3) Tennessees Consumer Protection Act, (4) South Carolinas Unfair Trade Practices Act, and (5) Connecticuts Unfair Trade Practices Act. Permanent Injunction: Defendants and their officers, agents, se rvants, employees, attorneys, and all those acting in concert with any of them, shall be permanently enjoined from directly or indirectly distributing in or to California, Connecticut, Florida, South Carolina, or Tennessee any unapproved drug compoun ded from bulk sodium thiosulfate, unless: bulk sodium thiosulfate appears on the Food and Drug Administrations Clinical Need List of bulk drug substances for which FDA has found a clinical need for use by Section 503Boutsourcing facilities; IT IS SO ORDERED, ADJUDGED, AND DECREED. See order for more information. (MD JS-6, Case Terminated). (shb)

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Hope Medical Enterprises, Inc. v. Fagron Compounding Services, LLC et al Doc. 476 JS-6 1 2 3 4 5 6 7 8 UNITED STATES DISTRICT COURT 9 CENTRAL DISTRICT OF CALIFORNIA 10 11 12 13 14 15 16 17 18 HOPE MEDICAL ENTERPRISES, INC. Case No. 2:19-cv-07748-CAS-PLAx D/B/A HOPE PHARMACEUTICALS, The Honorable Christina A. Snyder Plaintiff, AMENDED FINAL JUDGMENT v. FAGRON COMPOUNDING SERVICES, LLC; JCB LABORATORIES, LLC; ANAZAOHEALTH CORPORATION; COAST QUALITY PHARMACY, LLC, Defendants. 19 20 21 22 23 24 25 26 27 28 AMENDED FINAL JUDGMENT Dockets.Justia.com 1 2 3 4 5 The Court hereby ORDERS, ADJUDGES, and DECREES that judgment be, and hereby is, entered as follows: 1. Judgment. Judgment is entered in favor of plaintiff Hope Medical Enterprises Inc. d/b/a Hope Pharmaceuticals (“Hope”). 2. Declaratory Relief. Defendants Fagron Compounding Services, LLC, 6 JCB Laboratories, LLC, AnazaoHealth Corporation, and Coast Quality Pharmacy LLC 7 (collectively “defendants”) have violated (1) California’s Unfair Competition Law, (2) 8 Florida’s Deceptive and Unfair Trade Practices Act, (3) Tennessee’s Consumer 9 Protection Act, (4) South Carolina’s Unfair Trade Practices Act, and (5) Connecticut’s 10 Unfair Trade Practices Act. 11 3. Permanent Injunction. 12 a. Defendants and their officers, agents, servants, employees, attorneys, and 13 all those acting in concert with any of them, shall be permanently enjoined from directly 14 or indirectly distributing in or to California, Connecticut, Florida, South Carolina, or 15 Tennessee any unapproved drug compounded from bulk sodium thiosulfate, unless: 16 i. bulk sodium thiosulfate appears on the Food and Drug 17 Administration’s “Clinical Need List” of bulk drug substances for 18 which FDA has found a clinical need for use by Section 503B 19 outsourcing facilities; 20 ii. the drug compounded by defendants from bulk sodium thiosulfate 21 appears on FDA’s “drug shortage” list at the time of compounding, 22 distribution, and dispensing; or 23 iii. if FDA’s January 2017 “Interim Policy on Compounding Using 24 Bulk Drug Substances Under Section 503B” remains in effect, bulk 25 sodium thiosulfate appears on FDA’s “Category 1” list. 26 b. In addition to the injunction set forth in paragraph 3.a, Defendants and their 27 officers, agents, servants, employees, attorneys, and all those acting in concert with any 28 of them, shall also be permanently enjoined from directly or indirectly dispensing or 1 AMENDED FINAL JUDGMENT 1 distributing any unapproved sodium thiosulfate product from a Section 503B 2 outsourcing facility into California, Connecticut, Florida, South Carolina, or Tennessee, 3 unless: 4 i. 5 defendants are provided with an individual clinic order form for the product; and 6 ii. the order form includes an attestation specifically indicating that 7 defendants’ compounded product, which does not contain 8 potassium, will produce a clinical difference; and 9 iii. the attestation specifies why defendants’ compounded product, 10 rather than the comparable commercially available drug product, is 11 “medically necessary” for the specified patients to whom 12 defendants’ drug will be distributed or dispensed; and 13 iv. 14 the attestation indicates that it is made or approved by the prescribing practitioners of such specified patients. 15 An order that only identifies the product formulation, without more information, is 16 insufficient to comply with this injunction. 17 18 19 4. Attorney’s Fees and Costs. +RSH LV DZDUGHG DWWRUQH\V IHHV LQ WKH DPRXQW RI DQG OLWLJDWLRQ FRVWV LQ WKH DPRXQW RI . 5. Service of this Judgment. This Judgment shall be deemed to have been 20 served upon defendants when distributed through the ECF system of the United States 21 District Court. 22 6. Notice Provision. Defendants shall be required to notify purchasers of 23 their unapproved drug that the drug is compounded under Section 503B and as such 24 each order must be made or approved by the prescribing practitioner of specified 25 patients and must contain a statement of clinical difference as defined in Section 503B 26 Some examples of clinical difference statements from the FDA Guidance on Section 27 503B include: 28 2 AMENDED FINAL JUDGMENT 1 2 a. “Liquid form, compounded drug will be prescribed to patients who can’t swallow tablet (if the comparable drug is a tablet)”; 3 b. “Dilution for infusion solution to be administered to patients who need this 4 formulation during surgery (if the comparable drug is not available at that 5 concentration, pre-mixed with the particular diluent in an infusion bag)”; 6 c. “1 mg, pediatric patients need lower dose (if the comparable drug is only 7 8 available in 25 mg dose)”. IT IS SO ORDERED, ADJUDGED, AND DECREED. 9 10 DATED: March 31, 2022 11 12 13 THE HONORABLE CHRISTINA A. SNYDER UNITED STATES DISTRICT JUDGE 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 3 AMENDED FINAL JUDGMENT

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