Dutchess Bus. Servs. v. State, Bd. of Pharm.

184 P.3d 397, 2008 WL 2219817
CourtNevada Supreme Court
DecidedMay 29, 2008
Docket46345
StatusPublished
Cited by3 cases

This text of 184 P.3d 397 (Dutchess Bus. Servs. v. State, Bd. of Pharm.) 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 Bus. Servs. v. State, Bd. of Pharm., 184 P.3d 397, 2008 WL 2219817 (Neb. 2008).

Opinion

184 P.3d 397 (2008)

DUTCHESS BUSINESS SERVICES, INC.; and Legend Pharmaceuticals, Inc., Appellants,
v.
NEVADA STATE BOARD OF PHARMACY, Respondent.

No. 46345.

Supreme Court of Nevada.

May 29, 2008.

*399 Chesnoff & Schonfeld and Richard A. Schonfeld and David Z. Chesnoff, Las Vegas, for Appellants.

Louis A. Ling, General Counsel, Nevada State Board of Pharmacy, Reno, for Respondent.

BEFORE THE COURT EN BANC.

OPINION

By the Court, HARDESTY, J.:

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 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, three 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 (1) an administrative agency's discretion concerning joinder in an administrative proceeding; (2) an administrative agency's discretion with respect to discovery in an administrative proceeding; and (3) 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." 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. After addressing those issues, we *400 resolve Dutchess's 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.

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.

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 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 *401 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. The Board found that these facts should have caused Dutchess to discover the questionable character of Crystal Coast's distributor status.

Dutchess's purchases of Lupron and Zoladex from Genendo, Xenigen, and Rekcus

Genendo and Xenigen both falsely represented that they were authorized distributors of Lupron and Zoladex, and Rekcus falsely represented that it was an authorized distributor of Lupron. Both Dutchess and Legend purchased Lupron at prices below WAC, and Dutchess purchased Zoladex at prices below WAC.

Dutchess's recordkeeping

The record is unclear whether Dutchess conducted business with Cactus RX, another pharmaceutical wholesaler. However, for certain pharmaceutical purchases, Dutchess maintained two sets of pedigrees. One set of pedigrees listed Cactus RX as the original seller and authorized distributor. The other set identified a chain of wholesalers who handled the drug in question before it reached Dutchess, but the Board found that the information identifying that chain had been "crudely redacted." Additionally, Dutchess's records indicate that Dutchess made several purchases of Serostim from Crystal Coast where no corresponding record of sale of the Serostim was provided. Additionally, while the records demonstrated that Dutchess purchased its Lupron from Crystal Coast, Genendo, Xenigen, and Rekcus, Dutchess represented itself as an authorized distributor to its Lupron customers without indicating that it had purchased Lupron from Crystal Coast, Genendo, Xenigen, or Rekcus.

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Bluebook (online)
184 P.3d 397, 2008 WL 2219817, Counsel Stack Legal Research, https://law.counselstack.com/opinion/dutchess-bus-servs-v-state-bd-of-pharm-nev-2008.