Legal Briefs: The Vinci Code

April 30, 2010 1:02 PM

By Dale J. Atkinson, JD
The procedural and evidentiary rules followed by the judiciary in civil and criminal proceedings provide formality to a process that involves trained and experienced judges and lawyers advocating on behalf of their respective clients. Of course, criminal proceedings, where the right to freedom may be at stake, necessitate the application of all substantive and procedural rights of the accused, including constitutional principles of due process as the “state” prosecutes persons for the protection of society as a whole.

Administrative proceedings, whereby the board of pharmacy prosecutes persons accused of violating the practice act and/or rules or regulations, involve, by design, certain “lay” persons who provide expertise in their particular field of practice. Under these administrative proceedings, which still involve lawyers for each respective party, the strict rules of evidence and procedures are relaxed to provide flexibility to the process and allow volunteer appointees to assist in the adjudication of licensure matters. Consider the following.

An owner/pharmacist and employee/pharmacist (collectively referred to as licensees) were eventually issued a Notice of Opportunity for Hearing by the Ohio State Board of Pharmacy. In a voluminous complaint, the notice alleged the licensees did knowingly sell, conspire to sell, and/ or aid and abet the sale of controlled substances when the conduct was not in accordance with applicable Ohio law; specifically, such licensees sold controlled substances to patients “when not for a legitimate medical purpose issued by a prescriber acting in the usual course of professional practice and in compliance with the administrative code rules addressing pain management…”

The charges against the licensees were subsequent to an Ohio State Board of Pharmacy investigation which originally targeted a particular pain management clinic. The clinic closed its doors in December 2003 after the execution of a search warrant and was not the subject of the administrative action against the licensees. However, during the scrutiny of the clinic, investigators discovered that customers of the clinic were having their scripts filled by the licensees’ pharmacy, which was located approximately three to five miles from the clinic. Initial visits to the pharmacy and interviews of the licensees were undertaken by investigators examining the activities of the clinic. During such times, the pharmacy and licensees were not the focus of the investigation.

Investigators reviewed the records of the pharmacy and discovered that in less than four months, the pharmacy had dispensed in excess of 500,000 doses of hydrocodone 10 and carisoprodol 350 milligrams and that 78% of licensees’ pharmacy scripts came from the clinic under investigation. Evidence also revealed that multiple other pharmacies during this time period contacted the Board of Pharmacy questioning the prescribing activities of the clinic based upon red flags noted by the pharmacists. These red flags included customers who came from long distances, paid cash, asked for certain pills by color, and arrived in groups, sometimes in the same car.

In spite of these red flags, including Drug Enforcement Administration evidence that such pharmacy was the second largest retail purchaser of hydrocodone 10 tablets in the state of Ohio, the licensees filled these prescriptions in significant volumes. The licensees also received and filled scripts that were faxed to the pharmacy and included multiple scripts on the same fax sheet. Indeed, the licensees actually cut the sheets of faxed prescriptions to separate the multiple orders. Based upon these discoveries, the investigators turned their attention to the licensees resulting in the referenced charges issued in July 2005.

An administrative hearing was held in January 2007 before the Board of Pharmacy with the president of the Board presiding. Significant evidence and testimony was presented during the hearing resulting in an order by the Board suspending the licensees of each respondent for five and three years respectively. The suspensions were based in part on the fact that under the Ohio Administrative Code and the Code of Federal Regulations, pharmacists “have a responsibility with the prescriber to ensure that a prescription is issued for a legitimate medical purpose by a licensed prescriber in the usual course of medical practice.” In short, pharmacists must review every prescription for legitimacy and must make a professional judgment on whether or not to fill the prescription. This accountability to the Board and the public served is based upon professional training, experience, licensure, and continuing pharmacy education in applicable laws. The Board found that the licensees shirked such responsibilities under these circumstances.

The licensees appealed the matter to the trial court, which reversed the ruling of the Board. The trial court held that the Board findings were not supported by reliable, probative, and substantial evidence, that the licensees’ due process rights were infringed during the investigative stages, and that evidentiary rulings of the Board president during the hearing, specifically the admission of hearsay evidence, were prejudicial to the licensees, meriting reversal. The Board of Pharmacy appealed the trial court reversal to the appellate court.

The Board first argued that the trial court erred in holding that the Board findings were not supported by reliable, probative, and substantial evidence. The appellate court defined each respective term and reviewed that the appellate court review of a trial court determination is limited determining whether the trial court abused its discretion. Abuse of discretion is more than an error of law or judgment, but rather implies that the trial court’s ruling was arbitrary or unconscionable. An abuse of discretion shows “perversity of will, passion, prejudice, or partiality or moral delinquency.”

The Board argued that none of the prescriptions in question were validly issued, but the licensees argued that there was no direct evidence of such invalidity. The court referred to the lack of specific Ohio cases addressing the scope of a pharmacist’s responsibilities to properly dispense medications. However, it cited other recent federal cases and federal regulations that require pharmacists to “use common sense judgment,” which includes “paying attention to the number of prescriptions issued, the number of dosage units prescribed, the duration and pattern of the alleged treatment, the number of doctors writing the prescriptions and whether the drugs prescribed have a high rate of abuse.” The court also noted that hydrocodone and carisoprodol have high abuse potential and a high illegal street market value.

The court noted that at issue was whether the licensees knew or should have known that the prescriptions were not issued for a legitimate medical purpose or in the usual course of medical practice. Based upon the facts and in spite of the lack of direct admissible evidence, the court held that there was sufficient circumstantial evidence supporting the allegations of the sale of controlled substances when not for a legitimate medical purpose. It therefore found that the decision of the trial court on this issue was arbitrary, unconscionable, and unreasonable in view of the evidence.

Addressing the due process argument, the trial court held that the licensees were denied due process when they were not advised of a right to counsel during the investigative stage of the case as required under Ohio law. Noting that a certain level of formality must exist to apply the statutory right to counsel, the appellate court noted that an informal interview does not trigger such a right. In the current matter, the Board investigator visited and collected information as part of his investigation of the clinic and the licensees were not compelled to answer questions, nor were they not free to leave the interviews that were conducted at the pharmacy. In addition, the court held that the due process rights to notice and an opportunity to be heard were met. Thus, the court sustained the Board’s second assignment of error.

Next the court addressed the argument of the Board that the trial court failed to recognize the scope and duties of the Board president. In its ruling, the trial court emphasized that the Board president was not a lawyer and had “no formal legal or judicial training” and that in the course of the proceedings “allowed nonadmissible hearsay evidence to be presented and failed to ensure that [the licensees’] due process rights were protected.” The appellate court reviewed the make-up of the Board and the fact that the statutory scheme does not require the Board president to be a lawyer or have some type of legal training. The appellate court rejected these findings of the trial court and sustained the arguments of the Board.

Finally, the court addressed the Board argument that the trial court failed to use the applicable standards of administrative proceedings regarding the use of hearsay evidence. It held that many of the alleged hearsay admissions were not objected to by the licensees during the proceedings and that these arguments may be waived absent plain error. Further, the court held that administrative proceedings follow a relaxed evidentiary standard and that hearsay statements are permitted where they are not inherently unreliable and may constitute reliable, probative, and substantial evidence. The court noted that there was no evidence that the admitted hearsay statements were inherently unreliable. In addition, the court held that even if the Board erred in admitting certain hearsay evidence, there was overwhelming evidence supporting that the licensees engaged in unprofessional conduct.

Based upon its findings, the appellate court reversed the trial court and upheld the findings and sanctions of the Board of Pharmacy.

This opinion presents an excellent example of how administrative proceedings operate under relaxed standards. Board members who preside over such hearings may not necessarily be versed in or required to abide by stringent legal procedural principles. Of course, all parties are entitled to legal representation and possess the right to appeal matters to the judiciary for review.

Vinci v Ohio State Board of Pharmacy, 2010 WL 529468 (App. Ct. OH 2010)