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Sekyi v. Delaware Board of Pharmacy

Superior Court of Delaware

August 29, 2018

KODWO BEDU SEKYI, Appellant-Defendant Below,
v.
DELAWARE BOARD OF PHARMACY, Appellee-Plaintiff Below.

          Submitted: June 7, 2018

         Upon an Appeal from the Decision of the Delaware Board of Pharmacy.

          Gregory A. Morris, Esquire of Liguori & Morris, Dover, Delaware; attorney for Appellant/Defendant-Below.

          Eileen Kelly, Esquire of the Delaware Department of Justice, Dover, Delaware; attorney for appellee/Plaintiff-Below.

          OPINION AND ORDER

          William L. Witham. Jr. Resident Judge.

         Before the Court is Kodwo Bedu Sekyi's (hereinafter, the "Appellant") appeal from the Delaware Board of Pharmacy's (hereinafter, the "Pharmacy Board") decision to impose sanctions, including a two-year suspension of the Appellant's pharmacist license, against the Appellant based upon a hearing officer's (hereinafter, the "Hearing Officer") determination that the Appellant violated certain provisions of the Pharmacy Board's Practice Act, Chapter 25 of Title 24 (hereinafter, the "Practice Act") of the Delaware Code, and certain Pharmacy Board regulations. After an extensive review of the record, it is clear to the Court that the Pharmacy Board improperly considered additional evidence, that was not included in the written record, when the Pharmacy Board imposed the sanctions against the Appellant. Accordingly, the Pharmacy Board's decision is hereby REVERSED and REMANDED.

         FACTUAL AND PROCEDURAL BACKGROUND[1]

         The facts leading to the Pharmacy Board's sanctions against the Appellant are undisputed. The Appellant was, prior to the Pharmacy Board's proceedings, a permit holder and pharmacist-in-charge (hereinafter, "PIC") of the Pill Box Pharmacy in Milford, Delaware.

         In July and August of 2015, the Drug Enforcement Administration (hereinafter, the "DEA") and Delaware's Division of Professional Regulation inspected the Pill Box Pharmacy. The investigation uncovered a number of violations of federal and State laws and regulations pertaining to the operation of pharmacies. Many of those violations formed the basis of the allegations against the Appellant before the Hearing Officer and the Pharmacy Board.

         On May 23, 2017, the Hearing Officer held a hearing pursuant to the authority granted by 29 Del. C. § 8735(v)(1). The Hearing Officer recommended, based on his factual findings, the following conclusions of law:

         The Appellant violated 24 Del. C. § 2515(a)(6) and Pharmacy Board Regulation 2.1.1 in that he violated sections of both the Practice Act and Board regulations.

         The Appellant violated Pharmacy Board Regulation 3.1.2.2 in his failure to maintain records required by the Uniform Controlled Substance Act and other relevant State and federal regulations.

         The Appellant violated Pharmacy Board Regulation 3.1.2.3 in that he failed to maintain proper security at the Pill Box Pharmacy. In particular, a substantial number of filled prescriptions were left in the pharmacy in cardboard boxes available to employees. And, the Appellant did not maintain inventory of stock at the Pill Box Pharmacy.

         The Appellant violated Pharmacy Board Regulation 3.1.2.7 in that, as the PIC, he failed to conduct an annual pharmacy inspection and prepare a PIC report.

         The Appellant violated Pharmacy Board Regulation 3.4.4 with respect to the required parameters for refrigeration of drugs. Testimony at the hearing established that there was no evidence of a temperature monitor in the refrigerator nor were any records routinely kept logging refrigerator temperatures.

         The Appellant violated Pharmacy Board Regulation 2.1.11 which, in part, precludes the dispensing of "legend" drugs without a valid order from a prescriber. During the inspection, the investigators found a prescription for a controlled substance which was not signed by the prescriber but which was dispensed by the Appellant.

         The Appellant violated Pharmacy Board Regulation 2.1.21 in that he engaged in activities that would "discredit the profession of pharmacy." In support of this recommended conclusion, the Hearing Officer pointed to the Appellant's failure to maintain required inventories at the Pill Box Pharmacy for years since he opened it and became PIC in 2006; the Appellant failed to report suspected theft; the Appellant left substantial quantities of filled prescriptions for both controlled and non-controlled substances unattended in cardboard boxes; and, on at least one occasion, the Appellant dispensed a Schedule II controlled substance with an unsigned prescription.

         The Appellant practiced pharmacy negligently. In support of this recommendation, the Hearing Officer noted that the Appellant's neglect of record-keeping was a persistent failure over a number of years. The Hearing Officer further noted that the Appellant's testimony about certain personal issues that occupied his time away from the Pill Box Pharmacy did not excuse his substantial regulatory violations.

         In light of the foregoing violations, the Hearing Officer determined that a one-year period of suspension of the Appellant's pharmacist license, along with other sanctions, was appropriate.

         On August 16, 2017, the Pharmacy Board provided the Appellant an opportunity to present oral exceptions to the Hearing Officer's recommendations (hereinafter, the "Pharmacy Board Hearing"). The Appellant did not dispute the Hearing Officer's findings of fact but asked the Pharmacy Board to consider the personal hardships that he faced in determining appropriate sanctions. Ultimately, the Pharmacy Board accepted the Hearing Officer's recommended conclusions of law. However, the Pharmacy Board rejected the sanctions proposed by the Hearing Officer. Instead, the Pharmacy Board, in addition to numerous other sanctions not listed here, extended the suspension period of the Appellant's pharmacist license from one-year to two-years and imposed a five-year probationary period to follow the suspension.

         On September 20, 2017, the Pharmacy Board issued a final order (hereinafter, the "Pharmacy Board's Final Order"). The order memorialized, in writing, the Pharmacy Board's decision to accept the Hearing Officer's recommended conclusions of law and set forth the newly agreed upon sanctions that were discussed during the Pharmacy Board Hearing. The order specified that it declined to accept the Hearing Officer's recommended discipline because it was insufficient to address the "significant risk to the public" presented by the Appellant.

         The Appellant appealed the Pharmacy Board's final decision to this Court.

         THE PARTIES CONTENTIONS

         The Appellant's only contention is, essentially, that the Pharmacy Board's decision was based upon facts or allegations not previously made against the Appellant or considered by the Hearing Officer.

         In response, the Pharmacy Board contends that the Court is not permitted to consider the Pharmacy Board's comments at the Pharmacy Board Hearing. The Court's review, apparently, is confined to the Pharmacy Board's Final Order. And, upon such a review, the Pharmacy Board's decision should be affirmed because the modified sanctions have a substantial and rational basis, are supported by substantial evidence, and are free from legal error.

         STANDARD OF REVIEW

         Upon appeal from a decision of the Pharmacy Board, the Court's function "is confined to ensuring that the [Pharmacy] Board made no errors of law and determining whether there is 'substantial evidence' to support the [Pharmacy] Board's factual findings."[2] Substantial evidence means "such relevant evidence as a reasonable mind might accept as adequate to support a conclusion."[3] The "substantial evidence" standard requires "more than a scintilla but less than a preponderance of the evidence."[4]

         The Court "does not weigh the evidence, determine questions of credibility, or make its own factual findings."[5] These functions are reserved exclusively for the Pharmacy Board.[6] The Court must afford "a significant degree of deference to the [Pharmacy] Board's factual conclusions and its application of those conclusions to the appropriate legal standards."[7] In reviewing the evidence, the Court must consider the record "in the light most favorable to the prevailing party below."[8] The Court reviews questions of law de novo "to determine whether the [Pharmacy] Board erred in formulating or applying legal precepts."[9]

         In applying the standard of review, the Court must search the entire record to determine whether, on the basis of all the testimony and exhibits, the Pharmacy Board could fairly and reasonably reach its conclusions.[10] Where the evidence is sufficient to support the Pharmacy Board's conclusions, its decision will not be disturbed absent an error of law.[11]

         These general standards are guidelines regularly administered by Delaware appellate courts in reviewing various board's decisions, e.g. Industrial Accident Board proceedings. The application of these guidelines, however, is not limited. They have been expanded in application to the decisions and proceedings of other boards and administrative agencies, e.g. Board of Adjustment proceedings;[12] Board of Accountancy proceedings;[13] Delaware Alcoholic Beverage Control Commission proceedings;[14] and Delaware State Board of Examiners in Optometry proceedings.[15]It is with these guidelines in mind that the Court conducts its review of the appeal of the Pharmacy Board's sanctions against the Appellant.

         DISCUSSION

         Despite the Appellant and the Pharmacy Board's failure to address 29 Del. C. § 8735(v)(1), the Court finds that the claims on appeal require interpretation of it. The General assembly enacted 29 Del. C. § 8735(v)(1) to give the Division of Public Regulation "the power to retain hearing officers to handle evidentiary hearings and other matters."[16] By its terms, § 8735(v)(1) creates the full-time position of Hearing Officer' "[w]ith respect to case decisions arising under Title 29, Chapter 101, subchapter III."[17] The provision confers upon 'Hearing Officers' "[a]ll the powers and duties conferred or imposed upon such officers by law or by the Rules of Procedure for any board or commission under Titles 23, 24 and 28."[18] Title 24 creates regulatory boards for a number of professions, including pharmacists; accordingly, § 8735(v)(1) applies to the Pharmacy Board.[19]

         The Hearing Officer's powers under § 8735(v)(1) include the "power to conduct hearings, including any evidentiary hearings."[20] Specifically, § 8735(v)(1)d states:

The testimony or evidence so taken [by the Hearing Officer] shall have the same force or effect as if taken or received by the board or commission. Upon completion of such hearings or the taking of such testimony and evidence, the hearing officer shall submit to the board or commission findings and recommendations thereon. The findings of fact made by a hearing officer on a complaint are binding upon the board or commission. The board or commission may not consider additional evidence. When the proposed order is submitted to the board or commission, a copy shall be delivered to each of the other parties, who shall have 20 days to submit written exceptions, comments and arguments concerning the conclusions of law and recommended penalty. The board or commission shall make its final decision to affirm or modify the hearing officer's recommended conclusions of law and proposed sanctions based upon the written record[21]

         The Court has emphasized the preceding language because, as contended by the Appellant, it is readily apparent from the transcript of the Pharmacy Board Hearing that the Pharmacy Board considered additional evidence, not included in the written record, when the board modified the Hearing Officer's recommended sanctions against the Appellant. The Court relies upon the following excerpts from the transcript in making this finding:

[Susan] Esposito:[22] Um, that if I had to produce them - but I would -and the other concern I have is that I did not see anywhere, where he tried to contact the [Pharmacy] Board to ask for assistance in what was needed of recordkeeping or -1 mean, if he came here as the PIC, we are pretty good about reviewing what the - what your responsibilities are.
I'm just a little concerned that it took - um, an inspection, to - you know, whatever your personal life was, this is a business, and there's a lot of laws. And they are readily available.
So, I mean - um, as [Pharmacy] Board Members, we get calls from people all the time, asking questions. And we're here to help people, from getting into these types of situations.
So, you know, I'm - I'm a little concerned that - that you didn't reach out for that kind of assistance.
[Eileen] Kelly:[23] Well, I don't know whether he did or not. That's just not on the record[24]
[Kimberly] Robbins:[25] One of my biggest concerns, in all this, is the 280 prescriptions -
[Hooshang] Shanehsaz:[26] Yes.
Ms. Robbins: - that had not been reversed.
Mr. Shanehsaz: For five years.
Ms. Robbins: That, to me, it's probably any pharmacist, who is working any type of retail claims, should know that ...

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