Dutchess Business Services, Inc. v. Nevada State Board of Pharmacy

191 P.3d 1159, 124 Nev. 701, 124 Nev. Adv. Rep. 63, 2008 Nev. LEXIS 78
CourtNevada Supreme Court
DecidedSeptember 11, 2008
Docket46345
StatusPublished
Cited by28 cases

This text of 191 P.3d 1159 (Dutchess Business Services, Inc. v. Nevada State Board of Pharmacy) is published on Counsel Stack Legal Research, covering Nevada Supreme Court primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
Dutchess Business Services, Inc. v. Nevada State Board of Pharmacy, 191 P.3d 1159, 124 Nev. 701, 124 Nev. Adv. Rep. 63, 2008 Nev. LEXIS 78 (Neb. 2008).

Opinion

*704 OPINION

By the Court,

Hardesty, J.:

On May 29, 2008, this court issued an opinion in this matter affirming in part and reversing in part the district court’s order and remanding with instructions. Subsequently, appellants filed a petition for rehearing of that decision. On July 17, 2008, this court withdrew the prior opinion pending resolution of the petition for rehearing. After reviewing the rehearing petition, as well as the briefs and appendix, we conclude that rehearing is warranted under NRAP 40(c)(2), and we grant the petition for rehearing. We now issue this opinion in place of our prior opinion.

In this case, two pharmaceutical wholesalers appeal from the district court’s denial of a petition for judicial review of an order by respondent Nevada State Board of Pharmacy revoking the wholesalers’ licenses for violations of Nevada’s statutes and regulations governing the secondary prescription drug market. After a *705 disciplinary hearing, the Board found that appellants Dutchess Business Services, Inc., and its successor company, Legend Pharmaceuticals, Inc., violated numerous sections of the Nevada Revised Statutes and the Nevada Administrative Code; therefore, the Board revoked Dutchess’s and Legend’s wholesaler’s licenses and imposed fines on the entities. Dutchess and Legend appeal on multiple grounds, four of which raise issues of first impression.

Specifically, after addressing the Board’s jurisdiction to discipline Dutchess and Legend for conduct that occurred outside of Nevada, we consider the following issues in the context of resolving Dutchess and Legend’s appellate contentions: an administrative agency’s discretion concerning joinder in an administrative proceeding; an administrative agency’s discretion with respect to discovery in an administrative proceeding; whether intent must be proven to render an entity liable for violating NRS 585.520(1), which prohibits “[t]he manufacture, sale or delivery, holding or offering for sale of any food, drug, device or cosmetic that is adulterated or misbranded”; and whether a wholesaler that has established an ongoing relationship with a pharmaceutical manufacturer must nonetheless provide a pedigree when reselling the prescription drugs under NAC 639.603(1). Concerning an administrative agency’s discretion to decide joinder and discovery issues during an administrative proceeding, we conclude that in the absence of a rule, statute, or regulation governing the type of proceeding before the agency, issues such as joinder and discovery are generally left to the agency’s discretion. With regard to determining liability under NRS 585.520(1), because the plain language of that statute does not require intent for its violation, we conclude that the Board may find that a licensee violated NRS 585.520(1) without proving a licensee’s intent to cause harm or violate the statute. And with respect to NAC 639.603(l)’s pedigree requirement, that regulation plainly requires authorized distributors to provide pedigrees on subsequent sales of prescription drugs if they purchased the drug from another wholesaler, even if the wholesaler has established an ongoing relationship with the pharmaceutical manufacturer. After addressing those issues, we resolve Dutchess and Legend’s remaining contentions.

FACTS

The Board regulates the practice of pharmacy in Nevada. Among its myriad responsibilities, the Board licenses and oversees entities engaged in the buying and selling of pharmaceutical drugs. The Board licensed Dutchess and Legend as pharmaceutical wholesalers in 1998 and 2002, respectively. As pharmaceutical wholesalers, Dutchess and Legend purchased pharmaceuticals from manufacturers, wholesalers, and pharmacies and resold the pharmaceuticals to other wholesalers and pharmacies.

*706 Over a three-year period, Dutchess, and then Legend as Dutchess’s successor company, conducted business with a number of questionable entities. Dutchess’s and Legend’s dealings with these companies formed the basis of an investigation by the Board. As a result of the Board’s investigation, in August 2003, the Board filed a Notice of Intended Action and Accusation 1 against Dutchess and Legend. In the accusation, the Board alleged that from 2001 to 2003, Dutchess and Legend bought and sold adulterated and misbranded prescription drugs; failed to make, maintain, and provide accurate pedigrees detailing the sources of the drugs; 2 failed to make, keep, and provide accurate records of their purchases; and purchased drugs from unlicensed distributors. The following facts are taken from evidence presented to the Board during the five-day hearing it conducted on the charges listed in the accusation.

Dutchess and Legend bought and resold three drugs in particular that form the subject of this action: (1) Lupron, which is used to treat advanced prostate cancer and is manufactured by TAP Pharmaceutical Products, Inc.; (2) Zoladex, which is also used to treat prostate cancer and is manufactured by AstraZeneca; and (3) Serostim, which is used to treat cachexia 3 and is manufactured by EMD Serono, Inc. Dutchess bought and sold multiple shipments of these drugs from three Florida-based wholesalers — Crystal Coast, Inc.; Genendo Purchasing Organization; and Xenigen, Inc. — and one South Carolina-based wholesaler — Rekcus, Inc.

Dutchess bought Lupron, Zoladex, and Serostim from all four wholesalers. Legend bought Lupron from Rekcus. Dutchess’s and Legend’s purchases from these wholesalers totaled approximately $8.5 million.

Dutchess’s purchases of Serostim from Crystal Coast

Although Crystal Coast represented itself as an authorized distributor of Serostim on the invoices that it sent to Dutchess, it was not an authorized distributor. 4 Dutchess purchased at least 927 *707 boxes of Serostim from Crystal Coast at prices below the Wholesale Acquisition Cost (WAC), 5 and 399 of the boxes contained counterfeit Serostim. In late 2000, Serono became aware that counterfeit Serostim was circulating in the drug market and sent notification to pharmacists and its customers, including Dutchess. Even though Dutchess received formal notification from Serono and informal notification from its own customers about counterfeit Serostim, Dutchess never asked Crystal Coast to provide invoices to demonstrate Crystal Coast’s source of the Serostim. The evidence presented to the Board demonstrated that the person who supplied the counterfeit Serostim to Crystal Coast, before going to federal prison, had apparently conducted a pharmaceutical wholesale business in Florida without a permit, in violation of Florida law.

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Cite This Page — Counsel Stack

Bluebook (online)
191 P.3d 1159, 124 Nev. 701, 124 Nev. Adv. Rep. 63, 2008 Nev. LEXIS 78, Counsel Stack Legal Research, https://law.counselstack.com/opinion/dutchess-business-services-inc-v-nevada-state-board-of-pharmacy-nev-2008.