OPUS III-VII Corp. v. Ohio State Board of Pharmacy

671 N.E.2d 1087, 109 Ohio App. 3d 102, 1996 Ohio App. LEXIS 304
CourtOhio Court of Appeals
DecidedFebruary 1, 1996
DocketNo. 95APE05-595.
StatusPublished
Cited by10 cases

This text of 671 N.E.2d 1087 (OPUS III-VII Corp. v. Ohio State Board of Pharmacy) is published on Counsel Stack Legal Research, covering Ohio Court of Appeals primary law. Counsel Stack provides free access to over 12 million legal documents including statutes, case law, regulations, and constitutions.

Bluebook
OPUS III-VII Corp. v. Ohio State Board of Pharmacy, 671 N.E.2d 1087, 109 Ohio App. 3d 102, 1996 Ohio App. LEXIS 304 (Ohio Ct. App. 1996).

Opinion

*106 Petree, Judge.

This matter is before this court upon the appeal of plaintiff, OPUS III-VII Corporation (“OPUS”), from a judgment of the Franklin County Court of Common Pleas denying OPUS’s request for injunctive and declaratory relief.

Upon appeal, OPUS sets forth four assignments of error:

“I. The common pleas court erred by deferring to the Pharmacy Board’s power to interpret the meaning of ‘unopened’ in its own rule where the alleged ‘interpretation’ is plainly inconsistent with the express language of the rule, O.A.C. § 4729-9-04.

“II. The common pleas court erred by affirming a ‘determination’ by the Pharmacy Board where no procedures or substantive criteria for such ‘determination’ had ever been properly rule-filed and adopted pursuant to R.C. § 119.03.

“III. The common pleas court erred by affirming the Board’s ad hoc ‘determination’ regarding OPUS’ unit dose system where no statute or administrative rule provides for such ‘determination’ as part of the board’s power to regulate the practice of'pharmacy.

“IV. The common pleas court erred by finding that the Pharmacy Board’s pronouncement concerning OPUS products complies with equal protection requirements where OPUS’ products were discriminatorily singled out for such treatment, where no prior or subsequent ‘determinations’ addressed the status of products marketed by OPUS’ competitors, and where no official standards furnished any rational basis for so treating OPUS’ products.”

The essential facts of this case are not in dispute, having been stipulated by the parties. In December 1993, defendant, Ohio State Board of Pharmacy (“board”), received a facsimile inquiry from one of its licensed terminal distributors, Malcolm Meyer, Manager of HSI-LTC, regarding whether unused medications dispensed in OPUS’s unit dose system could be returned for credit and subsequently redispensed to other patients, under the terms of Ohio Adm.Code 4729-9-04. 1

Ohio Adm.Code 4729-9-04 governs the return and redispensing of medications by a pharmacy after (1) those medications have been sent out by the pharmacy for dispensing to patients in an institutional setting; and (2) have been returned unused to the pharmacy. The rule provides that in order for drugs that have been returned to the pharmacy to be reused the system must be (a) both *107 “unopened” and “single dose”; or (b) “unopened” and “hermetic,” and the medication must not have been in the possession of the ultimate user (the patient).

The board has no established official procedures for responding to requests from licensed terminal distributors, but generally furnishes whatever official resolutions or determinations the board has made regarding the subject matter of the inquiry. In instances where the board has made no official determination or resolution, the subject matter of a request may be submitted to the board for the purpose of having the board make an official determination or resolution.

Because the board was unfamiliar with the OPUS system, in order to respond to the inquiry, Nancy Little, the board’s licensing administrator, contacted OPUS and arranged for OPUS’s representatives to make a presentation to the board regarding their unit dose system at the board’s headquarters on January 11, 1994. Although members of the board itself were not present and made no official determination or resolution regarding the system, the board’s staff, after review of Ohio Adm.Code 4729-9-04, felt that drugs used in the OPUS system could not be returned for credit and subsequently redispensed to other patients after return to the pharmacy from an institutional setting.

As a result, on January 27, 1994, Little advised the licensee, Meyer, that there were problems with the OPUS system and that it did not meet the requirements of Ohio Adm.Code 4729-9-04.

On February 14, 1994, counsel for OPUS drafted a letter to the board indicating that OPUS had been advised that the board had informed competitors of OPUS that the OPUS system did not meet the requirements for use in Ohio, and that such information was being used by these competitors to gain a competitive advantage over OPUS in Ohio’s unit dose system market. The letter specifically demanded that the board immediately confirm in writing that it had not “disapproved” the OPUS unit dose system, and to affirmatively state that the OPUS system may “legally” be used in Ohio. The letter threatened litigation if the board did not immediately comply with this demand.

In an effort to clarify its position regarding the OPUS system, the board, through its Assistant Executive Director, William T. Winsley, R.Ph., M.S., responded to counsel by letter dated February 18, 1994. According to Winsley’s letter, after the presentation on January 11, 1994, the OPUS representatives were requested by the board staff to forward samples of their product to the board before January 24, 1994, so that the board members could actually see OPUS’s product and give an opinion as to its compliance with Ohio Adm.Code 4729-9-04. Furthermore, the representatives were informed that the board would not specifically approve or disapprove the OPUS product for use in Ohio, but would give only an opinion as to the product’s compliance with Ohio *108 Adm.Code 4729-9-04 and that OPUS was to refrain from representing to customers that the OPUS product has been “board-approved.” The letter also indicated that the board had learned that an OPUS representative had represented to potential customers that the OPUS system had been approved by the board.

The letter further indicated that the board, had not considered the OPUS system since OPUS had never submitted its product for review by the board. Winsley further explained that the board’s staff had never stated that the OPUS system could not be marketed or used in Ohio and that the response to the board’s licensed terminal distributor was only “part and parcel of a continuing conversation, between the parties privileged to the facsimile, which involved the limited question of re-use after return of the drugs.” The letter reiterated that the board staff felt that the system did not comply with Ohio Adm.Code 4729-9-04 and concluded by suggesting that OPUS submit samples of its product for review by the full board.

On March 10, 1994, Mark G. Keffeler, Vice President of OPUS, and David Grauer, counsel for OPUS, met with the board to review the OPUS unit dose system. At this meeting, Winsley conducted a test of the OPUS product to determine if the system met the requirements of Ohio Adm.Code 4729-9-04. The test consisted of placing an Advil tablet in a sample OPUS unit dose container and resealing the container. After the container had been resealed, Winsley and various board members present at the meeting could not physically tell that the lid had been opened. Some of the board members were unable to detect the tampering even after being told what to look for. As a result, the board concluded that it was impossible for persons working with the OPUS system to verify whether the container remained unopened as required by the rule.

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Bluebook (online)
671 N.E.2d 1087, 109 Ohio App. 3d 102, 1996 Ohio App. LEXIS 304, Counsel Stack Legal Research, https://law.counselstack.com/opinion/opus-iii-vii-corp-v-ohio-state-board-of-pharmacy-ohioctapp-1996.