IV Solutions v. Cal. Board of Pharmacy CA2/4

CourtCalifornia Court of Appeal
DecidedSeptember 1, 2020
DocketB281845
StatusUnpublished

This text of IV Solutions v. Cal. Board of Pharmacy CA2/4 (IV Solutions v. Cal. Board of Pharmacy CA2/4) is published on Counsel Stack Legal Research, covering California Court of Appeal primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
IV Solutions v. Cal. Board of Pharmacy CA2/4, (Cal. Ct. App. 2020).

Opinion

Filed 9/1/20 IV Solutions v. Cal. Board of Pharmacy CA2/4 NOT TO BE PUBLISHED IN THE OFFICIAL REPORTS

California Rules of Court, rule 8.1115(a), prohibits courts and parties from citing or relying on opinions not certified for publication or ordered published, except as specified by rule 8.1115(b). This opinion has not been certified for publication or ordered published for purposes of rule 8.1115.

IN THE COURT OF APPEAL OF THE STATE OF CALIFORNIA

SECOND APPELLATE DISTRICT

DIVISION FOUR

IV SOLUTIONS, INC., et al., B281845

Plaintiffs and Appellants, (Los Angeles County Super. Ct. No. BS160527) v.

CALIFORNIA BOARD OF PHARMACY,

Defendant and Respondent.

APPEAL from a judgment of the Superior Court for Los Angeles County, Amy D. Hogue, Judge. Affirmed. Wolf, Rifkin, Shapiro, Schulman & Rabkin, Jason M. Flom and Marc E. Rohatiner for Plaintiffs and Appellants. Xavier Becerra, Attorney General, Carl W. Sonne, Assistant Attorney General, Shawn Paul Cook and Matthew A. King, Deputy Attorneys General, for Defendant and Respondent. Following a lengthy administrative hearing, respondent California Board of Pharmacy (the Board) revoked the pharmacy license issued to appellant IV Solutions, Inc. (IVS), and ordered that IVS and its president, Alireza Varastehpour, also known as Alex Vara (we will refer to him as Vara; we refer to IVS and Vara together as IVS/Vara), are prohibited from serving as a manager, administrator, owner, member, officer, director, associate, or partner of a licensee of the Board. IVS/Vara filed in the superior court a petition for writ of administrative mandamus. Finding the weight of the evidence supported the Board’s findings and that the Board did not abuse its discretion in imposing the penalty, the superior court denied the petition. IVS/Vara appeal, arguing that (1) the Board applied an incorrect standard of proof; (2) certain findings of the Board were not supported by the weight of the evidence; and (3) the Board abused its discretion by imposing the most severe penalty. None of these arguments have merit. Accordingly, we affirm the judgment.

BACKGROUND IVS is a closed-door clinical pharmacy that provides home infusion therapy to patients.1 Vara, who has a background in marketing and business development for healthcare-related companies, created IVS and is its president and sole owner. The Board issued a pharmacy permit to IVS, with Vara as president, in 2002.

1 A closed-door pharmacy is a pharmacy that provides products and services only to its select clients, and is not open to the general public.

2 As part of its business, IVS compounds sterile injectable products. At the time of the events at issue here, a pharmacy that did sterile compounding was required to either have a sterile compounding permit issued by the Board or be accredited by a Board-approved accrediting agency. IVS performed sterile compounding under an accreditation from the Joint Commission on Accreditation of Healthcare Organizations (now known as the Joint Commission), a Board-approved agency. During the relevant time, IVS employed 15 to 20 people. Vara, who is not a pharmacist, was in charge of business development, and Marlene Casillas, the chief operating officer, was in charge of human resources, billing, and business operations (although the evidence showed that Vara often made decisions regarding IVS’s business operations). The “Pharmacist In Charge” (PIC) was in charge of prescriptions and the clinical aspects of the pharmacy. At least 12 different people served as PIC between 2002 and 2014. From February 2009 until March 2012, the PIC was Renee Sadow, who was a party to the administrative proceeding at issue here but is not a party to this appeal.

A. Initial Complaint, Investigation, and Accusation In February 2008, the Board received a complaint from IVS’s former PIC, who had left his employment with IVS after a disagreement with Vara regarding the acquisition of the prescription medication Lovenox. Two Board investigators investigated the complaint. During the course of that investigation they discovered, among other things,

3 that (1) Vara had a key to the pharmacy (as opposed to the business office) in his possession;2 (2) IVS staff had been using the name “Stat Clinical Pharmacy” on documentation relating to several patients;3 (3) Vara had obtained Lovenox from a company in Canada that was not licensed to sell wholesale prescription medications in California; and (4) some vials of Lovenox, which Vara had obtained from a different unlicensed wholesaler, had been shipped to Vara’s father’s home, i.e., an unlicensed facility. The Board filed an accusation against IVS, with Vara as its president, alleging eight causes for discipline related to the above discoveries and other issues discovered during the inspection of IVS’s records.

B. Patient Complaints and Amended Accusations While the former PIC’s complaint was being investigated, and after the initial accusation was filed, the Board received additional complaints related to several of IVS’s patients.

1. Patient D.K. In April 2010, patient D.K. was prescribed a six-week regimen of an antibiotic to be administered intravenously 24 hours a day, with a

2 As a non-pharmacist, Vara was not permitted to have a key to the pharmacy. The key was required to be kept in a sealed envelope signed by the pharmacist who last used it, and the pharmacy could not be opened without a pharmacist present.

3 No permit had been issued to operate a pharmacy under that name.

4 specific dosage delivered every six hours by a prism infusion pump. Sadow, IVS’s PIC, filled the prescription and programmed a Curlin 4000 CMS pump—an ambulatory infusion pump that may be obtained only by prescription from a licensed practitioner—to provide the required doses. IVS delivered the pump, medication, and supplies to D.K. IVS contracted with another company to provide a nurse to set up the pump, start the intravenous line, and show D.K. and his family how to change the IV bags of medication. The first nurse visited D.K. every day for the first few days, and then was replaced by a different nurse. On the eighth day of D.K.’s therapy, which was a Friday, that replacement nurse started a new IV bag early in the afternoon. That evening, after the nurse had left, the alarm on the pump went off and would not stop, so members of D.K.’s family called the nursing company. The supervisor of the nursing company, who was unable to reach the nurse assigned to D.K., spoke with D.K.’s family members that night, but was unable to resolve the issue. When D.K.’s son-in-law, Kevin G., checked in on D.K. at around 11:00 p.m. that night, the IV bag appeared to be full. When Kevin checked on D.K. early the next morning, the IV bag was empty. Because he believed the IV bag had been changed less than 12 hours before, Kevin was afraid that D.K. had received the full 24-hour cycle of the medication in much less than 24 hours. Kevin tried to call the nurse assigned to D.K., but was not able to reach her, so he called his mother, Donna G. (who is a registered nurse), who came and checked on D.K.

5 In the meantime, the nursing company contacted IVS at 4:49 a.m. that morning. At 4:50 a.m., PIC Sadow received a call from IVS’s answering service, telling her that a member of D.K.’s family had called requesting a nurse. Sadow was on vacation, and had received permission from Vara and Casillas to have Jeannie Kim be the on-call pharmacist while she was away. Therefore, Sadow told the answering service to contact the pharmacist on call, i.e., Kim. At 8:57 a.m., Sadow called Vara to tell him about the call she had received; she confirmed that she was away for the weekend and that Jeanie Kim was the pharmacist on call. She told Vara that either Kim or the nurse assigned to D.K. should be involved in the situation.

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IV Solutions v. Cal. Board of Pharmacy CA2/4, Counsel Stack Legal Research, https://law.counselstack.com/opinion/iv-solutions-v-cal-board-of-pharmacy-ca24-calctapp-2020.