January 28, 2008
IN THE MATTER OF THE SUSPENSION OR REVOCATION OF THE LICENSE OF RONALD SORR, LICENSE NO. RI 14509, TO PRACTICE PHARMACY IN THE STATE OF NEW JERSEY.
On appeal from a Final Decision of the New Jersey State Board of Pharmacy.
NOT FOR PUBLICATION WITHOUT THE APPROVAL OF THE APPELLATE DIVISION
Argued December 18, 2007
Before Judges Winkelstein, Yannotti and LeWinn.
Ronald C. Sorr (Sorr) appeals from a final determination of the State Board of Pharmacy (Board) dated June 18, 2007, which found that Sorr violated certain statutes and regulations applicable to his practice as a pharmacist. The Board suspended Sorr's license to practice pharmacy in this State for five years, imposed a civil penalty in the amount of $10,000, and required him to pay attorneys' fees and investigative costs of $99,639.75. For the reasons that follow, we affirm.
On August 29, 2005, the Attorney General filed a four-count complaint charging Sorr with various statutory and regulatory violations arising from his participation in a voucher program in which individuals could obtain free samples of drugs manufactured by Novartis Pharmaceutical Company (Novartis). The complaint sought the suspension or revocation of Sorr's license to practice pharmacy and operate his pharmacy; imposition of penalties and costs, including attorneys' fees and investigative costs; and such other relief as the Board considered just and appropriate. Sorr filed an answer in which he contested all of the allegations and asserted that he should not be subject to any discipline.
The matter was referred to the Office of Administrative Law for a hearing before an Administrative Law Judge (ALJ). On October 2, 2006, the Attorney General filed a motion for summary decision, and on October 12, 2006, Sorr filed a cross motion for partial summary decision. The parties stipulated to certain facts pertinent to the charges. They also filed certifications in support of their respective motions.
The record before the ALJ revealed the following. Sorr is a registered pharmacist who is licensed to practice pharmacy in New Jersey. He holds a permit to operate and is the registered pharmacist for the Trenton Avenue Pharmacy (TAP) in Atlantic City. In 2000, McKesson HBOC Pharmaceutical Partners Group (McKesson) developed a voucher system that allowed patients to obtain certain drug samples free of charge. Novartis utilized the McKesson voucher system.
The voucher program required that a physician diagnose a patient and prescribe medication on a form called the New Jersey Prescription Blank (NJPB). A voucher for payment was attached to the back of the NJPB for each drug that was prescribed. After the pharmacist filled and dispensed the medication, the pharmacist would submit the voucher to the company for reimbursement and dispensing fees.
In the period from June 2002 to September 2002, Novartis sales representative Gbubemi "Thomas" Nanna (Nanna) "serviced" the Atlantic City area, including the TAP. Nanna delivered to Sorr bundles of NJPBs bearing Novartis vouchers. Between June 2002 and September 2002, Sorr filled 965 prescriptions for the voucher program, including the 104 NJPBs that formed the basis for the Attorney General's complaint. The 104 NJPBs were for certain prescription drugs including: Diovan HTC, which is prescribed for hypertension; Elidel, which is used to treat eczema; Exelon, which is prescribed for patients suffering from Alzheimer's disease; Famvir, an anti-viral medication; Lamisil, a cream for infections; and Starlix, which is prescribed for high blood sugar levels in patients with Type-2 diabetes.
The parties stipulated that the patients identified in the 104 NJPBs did not deliver their prescriptions to Sorr, nor did they pick up the drug samples at the TAP. Instead, Sorr either provided the drugs to Nanna or mailed them to Dr. Pravin B. Vasoya. Dr. Vasoya's name did not appear as the prescribing licensee on the 104 NJPBs that Sorr processed. The Attorney General submitted affidavits from the doctors whose names appeared on the 104 NJPBs. In those affidavits, the doctors stated that they did not sign the prescriptions.
The Attorney General also submitted an expert report dated April 15, 2006, from Donna M. Horn, R.Ph., D.Ph. (Dr. Horn). In her report, Dr. Horn stated that the prescriptions at issue were fictitious. She concluded that Sorr failed to question the "bundled" prescriptions and the fact that many of the patients would be simultaneously suffering from the conditions to be addressed by the medications prescribed. Dr. Horn stated that Sorr's "repeated failure to suspect bundled prescriptions and [his] failure to recognize and question the prescription of [the] combinations of drugs [were] a gross deviation from the standard of care."
Dr. Horn also stated that Sorr's "repeated failure to complete drug utilization reviews and [his] failure to utilize pharmaceutical care in his practice setting [were] gross deviations from the standard of practice." The doctor noted that the TAP's patient records contained only the 104 prescriptions. She wrote that there was no evidence that Sorr tried to obtain other current medical information about the patients and there were no "pharmacist's notes" in any of the TAP files.
Dr. Horn added, "[t]he standard of practice in any pharmacy is to ask the patient for any known allergies and any other medication that they may be taking." The doctor stated that, "[i]f the patient is not available, a prudent pharmacist would call the prescriber or send a demographic sheet home to the patient to have them fill in the information . . . or speak directly with the caregiver about the patient's condition, allergies and other medication." Concerning the 104 NJPBs at issue, Dr. Horn observed, "[n]o pharmacist would consider the sales representative to be the 'caregiver' of all those patients."
In addition, Dr. Horn opined that Sorr's failure to attempt to counsel each patient was a gross deviation of professional pharmacy practice. She stated that patient counseling "is the expected and accepted standard of practice for all pharmacists in [New Jersey] and nationwide. Counseling is beneficial to both patients and pharmacists." Dr. Horn wrote that Sorr's lack of counseling, the lack of documentation of counseling, and his failure to perform adequate drug utilization reviews, were a gross violation of pharmacy practice and violations of the Board's regulations. Dr. Horn also opined that Sorr's failure to dispense filled prescriptions to the ultimate users constituted a gross violation of the standard of care for the practice of pharmacy.
In support of his cross motion for partial summary decision, Sorr submitted two certifications. In the certification dated October 10, 2006, Sorr stated that he never made a fraudulent submission for payment to any entity, including Novartis and McKesson. He asserted that he never falsified a NJPB or any record kept in connection with the operation of the TAP. Sorr also stated that he never engaged in any act of dishonesty during the course of his pharmaceutical practice, or attempted to defraud, deceive or make misrepresentations to any person or entity in the course of his practice.
Sorr said that he met Nanna in the late spring of 2002, when Nanna came to the TAP with other Novartis representatives. According to Sorr, Nanna presented himself as a "courier" for doctors and asserted that the doctors "would be glad if the [TAP] could provide a starter supply of medications because [Nanna] was not able to give samples of the mediations covered by the coupons." Sorr stated that the dispensing fee was only $4 to $5 for each prescription.
Sorr admitted that Nanna personally presented him with "a number of prescriptions." He said that he believed the prescriptions were "valid prescription orders by valid prescribers written on valid [NJPBs]." Sorr stated that Nanna personally picked up the prescriptions and would sign for them in the prescription log. Sorr also stated that he mailed certain filled prescriptions to Dr. Vasoya. Sorr asserted:
The medications that I dispensed were in very small amounts designed to be starter samples. None of the medications were controlled substances. I believed that Nanna was simply trying to encourage the various doctors to utilize the medications as part of his job as a sales representative for Novartis. I knew Novartis to be a highly reputable pharmaceutical company and I trusted that [its] representatives were not engaged in any improper behavior.
In his supplemental certification dated October 12, 2006, Sorr stated that he entered the prescriptions at issue in the TAP computer system and he never was given a warning "regarding any dangerous interaction or any interaction whatsoever" concerning the medications. Sorr said that the computer routinely provides such warnings and "none were given in this case." Sorr stated that he "reasonably concluded that the doctors at issue intended to issue prescriptions for the medications."
Sorr added that all of the prescriptions had signatures that were different for each doctor. He said that many times, an individual in a doctor's office "other than the doctor" will complete the identifying information for the patient "and the doctor will simply sign." Sorr asserted that, in his opinion, "there was nothing out of the ordinary in the prescriptions[.]"
Sorr additionally stated that the TAP is a community pharmacy and many of its patrons are low income persons. He said that it is his "standard practice" to have the patient's name, address, and date of birth in his records. Sorr asserted that he commonly deals with individuals who do not have phones or phone numbers. He stated that, in his opinion, it is not a breach of the standard of care to fill prescriptions for individuals without a phone or phone number so long as the pharmacist has the patron's address and a date of birth.
Sorr also said that it is not unusual to see more than one patient who is suffering from numerous conditions for which multiple medications are required. He reiterated that none of the prescription combinations at issue in this matter had been "flagged" by his computer system. Sorr additionally stated that, in his view, it is not necessary to offer to counsel each and every patient who presents a prescription for filling. He asserted:
Given that the computer system in this case allowed each [prescription] to be filled with multiple medications and did not give a warning, I did not feel it to be necessary to counsel the patients at issue. The prescription blanks were valid and gave the proper identifying information for each doctor. Given what I knew about these medications through the computer system and my experience, it was not unreasonable for me to rely upon the doctors who issued the prescriptions.
Sorr submitted an expert report, dated July 7, 2006, from Donald F. McKenna (McKenna). McKenna is a retail pharmacist. In his report, McKenna stated that Sorr filled the prescriptions and submitted claims for reimbursement "in the standard manner used by the prescription filling industry." McKenna wrote that the process for sample distribution is different from that used in the "everyday prescription filling process." McKenna stated that the medications being distributed were not controlled substances and were distributed in very small amounts. He asserted:
[Sorr] was dealing with a large reputable drug company. He was dispensing small amounts of sample medication through Novartis who presented him with the coupons and then accepted the samples from him. This was a prescription filling situation that was different from the day in and day out prescription filling process and must be analyzed as such. Where the actual company presents and collects the prescription and samples to and from the pharmacist, it is not unreasonable for the pharmacist to conclude that the samples are being properly distributed and that the health and safety of the public is not being jeopardized. It is not unreasonable for the pharmacist to conclude that the company that put the samples into the stream of commerce is properly carrying through with its plan to put the samples into the hands of doctors and patients -- as it does with any samples that it distributes -- to which it hopes to sell the drugs in the future.
The ALJ found that there was no genuine issue of material fact and granted the Attorney General's motion for summary decision in part. The ALJ found that Sorr had engaged in dishonestly, fraud, deception, or misrepresentation as charged in count one "by accepting bundled prescriptions delivered by a sales representative, filling those prescriptions without question, dispensing medications in bulk to an unknown end user, and then collecting $90,000 in reimbursement." The ALJ additionally found that Sorr's actions in respect of the 104 NJPBs constituted gross negligence, negligence, and evidenced a lack of professional judgment, as charged in count two.
In addition, the ALJ granted summary decision on certain charges in counts three and four. The ALJ found that Sorr failed to record patient information in the patient profile system and failed to counsel the patients for whom the medication was prescribed. The ALJ determined, however, that there were genuine issues of material fact as to whether Sorr failed to conduct the required drug utilization review, and whether he failed to place his initials on the prescriptions.
The ALJ determined that, because the charges in counts one and two were the most serious, and the remaining issues would not have a material impact on the penalties, the matter should be submitted to the Board for its immediate review pursuant to N.J.A.C. 1:1-12.5(e). The Board considered the matter at its meeting on April 25, 2007, and afforded the parties an opportunity to be heard on Sorr's exceptions to the ALJ's initial decision. Sorr also was permitted to present evidence in mitigation of the penalty. Sorr presented testimony from Nanna.
On June 18, 2007, the Board issued a final decision in which it adopted the ALJ's initial decision, including the ALJ's findings of fact. The Board ordered a five-year suspension of Sorr's license to practice pharmacy, with the first two years as an "active" suspension. The remainder of the suspension was stayed and would be served as probation. The Board additionally ordered Sorr to pay the State's counsel fees and investigative costs in the amount of $99,639.75, and a civil penalty of $10,000. Sorr appealed. We entered an order on September 17, 2007, staying the Board's order pending disposition of this appeal.
Sorr argues that the Board erred by adopting the ALJ's decision and granting summary decision on counts one and two. Sorr maintains that there were genuine issues of material fact that required an evidentiary hearing regarding the charges in those counts. We disagree.
The actions of administrative agencies are entitled to a "strong presumption of reasonableness." Newark v. Natural Res. Council, 82 N.J. 530, 539 (1980). We will not substitute our judgment "for the expertise of an agency 'so long as [its] action is statutorily authorized and not otherwise . . . arbitrary or unreasonable.'" Williams v. Dep't of Human Servs., 116 N.J. 102, 107 (1989) (quoting Dougherty v. Dep't of Human Servs., 91 N.J. 1, 12 (1982)). Our role in reviewing a final decision of an administrative agency is limited to three inquiries: 1) whether the agency's action is consistent with the governing statues and implied legislative policies; 2) whether there is substantial evidence in the record to support the agency's findings of fact; and 3) whether in applying the legislative policies to the facts, the agency reached a conclusion "that could not reasonably have been made after weighing the relevant factors." Id. at 108.
We are convinced that the agency's decision in this case is entirely consistent with the applicable statutes and regulations, and there is substantial credible evidence in the record to support the agency's final determination. We are satisfied that there was no genuine issue of material fact warranting an evidentiary hearing in this matter and the parties' stipulation, along with other undisputed material facts, provided an ample basis for the Board's decision. We therefore affirm the Board's final determination substantially for the reasons stated by the ALJ in his initial decision dated November 20, 2006, and by the Board in its final decision dated June 18, 2007. We add the following comments.
Sorr contends the Board erred in granting summary decision in this matter because there were numerous genuine issues of material fact. Sorr maintains that one such material fact was the amount of money that he made as a result of filling the 104 NJPBs. Here, the ALJ found that Sorr collected $90,000 in reimbursement when he filled the prescriptions. That finding was supported by the record. In support of the motion for summary decision, the Attorney General submitted a certification from Mark Hennion, an investigator for Novartis, in which Hennion stated that Sorr received more than $90,000 "in prescription voucher redemption." Hennion stated that this was the highest voucher redemption amount in New Jersey, and the second highest nationwide. Sorr never disputed the facts in Hennion's certification.
In his exceptions to the ALJ's decision, Sorr took issue with what he perceived to be the ALJ's assumption that he had acted dishonestly because he collected $90,000 for the prescriptions. Sorr asserted that the ALJ "jump[ed] to the conclusion" that he was dishonest when, according to Sorr, he "made very little money." Sorr therefore argued that the entire foundation for the ALJ's decision respecting the charges in count one was wrong and unsupported by the record.
In its final decision, the Board addressed this contention, stating that the stipulation of facts indicated that Sorr received reimbursement for the cost of the drugs already incurred by Sorr, and a dispensing fee. The Board noted that the ALJ never mentioned profit in its decision and this was not the basis of the ALJ's findings regarding the charges in count one. As the Board pointed out, the ALJ's decision was based on the facts that Sorr turned a "blind eye" when filling the prescriptions; ignored the applicable statutes, regulations, and standard of care; and placed the public at risk by dispensing drugs to unknown end-users, without considering the potential harm to the public. Therefore, contrary to Sorr's assertions, the amount of profit that Sorr may have earned by filling the 104 prescriptions at issue was not a fact material to the Board's decision and an evidentiary hearing on that issue was not required.
Sorr also argues that summary decision was inappropriate because there was a genuine issue of material fact as to whether he should have reasonably concluded that the public was put "in harm's way" by his actions in filling the 104 prescriptions. Sorr disputes the ALJ's finding that the prescriptions were going to unknown end-users. Sorr points out that he provided the medications to Nanna, a representative of a reputable pharmaceutical company, based on what he says were valid prescriptions forms. Sorr says that in these circumstances, he could have reasonably concluded that "everything was proper and that the public was not put in danger." Sorr contends that the ALJ and the Board should not have questioned the reasonableness of his actions without giving him the benefit of a hearing. Again, we disagree.
The material facts concerning the circumstances under which Sorr filled the 104 prescriptions were not disputed. The undisputed facts provided ample support for the ALJ's and the Board's finding that Sorr filled the prescriptions under circumstances that should have alerted him to the fact that the prescriptions were not valid. Drawing upon its expertise, the Board properly found that Sorr: should have taken note of the remarkable similarity of the handwriting on the face of the prescriptions supposedly written by different prescribers; the unusual distance between the practitioners' offices and the patients' homes from the [TAP]; the bundled presentation of prescriptions; the oddity that so many patients were concurrently suffering from identical conditions, all covered by the specific Novartis products.
Moreover, as the ALJ noted in his decision, Sorr gave the medications to Nanna or mailed them to Dr. Vasoya. Sorr never counseled any of the purported patients. He had no idea who was receiving the medications.
The ALJ stated that the public was potentially at great risk because the "unaccounted [for] medication" could fall "into the wrong hands, or [could be] sold on the streets for recreational use." The Board concurred, stating that Sorr placed "drugs into the stream of commerce that he knew or should have known were not going to a valid patient and that [were] unaccounted for, may be used by unauthorized individuals for consumption or sold through unlawful channels to an unsuspecting member of the public." In our view, there are sufficient undisputed facts in the record to support these findings.
Sorr additionally contends that a hearing was required to consider other so-called material facts, specifically: whether his response to Nanna's actions was reasonable; whether it was proper to characterize him as "deliberately ignorant" when he filled the prescriptions; and the absence of any evidence on "the whereabouts of the medications." These contentions also are without merit. The stipulated and undisputed material facts provided the ALJ and the Board with a sufficient basis to determine whether Sorr acted reasonably, whether he turned a "blind eye" on the obvious deficiencies in the NJPBs, and whether he should have been aware that the public would be at risk if he dispensed the medication in the circumstances presented.
Sorr further argues that the Board's finding that Nanna was not credible is another reason why a hearing should have been held in this matter. As we stated previously, Sorr presented testimony from Nanna at the hearing before the Board on the penalty. In its final decision, the Board observed that Sorr had argued that he relied upon Nanna's veracity in filling the NJPBs at issue. The Board found that Nanna's testimony was "replete with misrepresentations." The Board additionally observed that it was "hard-pressed to understand why [Sorr], given the questionable circumstances surrounding the presentation of the prescriptions, as well as the suspect nature of the prescriptions, would rely on Nanna . . . [who] was not credible."
Nevertheless, we are convinced that an evidentiary hearing was not required so that Sorr could further explore Nanna's veracity in an effort to establish that he reasonably relied upon Nanna when he filled the questionable prescriptions. Although the Board may have commented on Nanna's testimony, its decision makes clear that the findings that Sorr violated the applicable statutes, regulations and standard of care did not turn on Nanna's credibility but rather on the undisputed material facts concerning the prescriptions and the manner in which they were filled.
Sorr also maintains that the penalty imposed here is excessive. Again, we disagree. A sanction imposed by an administrative agency is entitled to substantial deference. In re License Issued to Zahl, 186 N.J. 341, 353 (2006) (citing Matturri v. Bd. of Trs. of the Judicial Ret. Sys., 173 N.J. 368, 381 (2002)). A reviewing court will modify a sanction only when necessary to bring the agency's action into conformity with its delegated authority. The Court has no power to act independently as an administrative tribunal or to substitute its judgment for that of the agency. It can interpose its views only where it is satisfied that the agency has mistakenly exercised its discretion or misperceived its own statutory authority. [In re Polk, 90 N.J. 550, 578 (1982).]
To warrant reversal, the sanction must be "'so disproportionate to the offense, in light of all the circumstances, as to be shocking to one's sense of fairness.'" Ibid. (quoting Pell v. Bd. of Educ., 313 N.E.2d 321, 327 (N.Y. 1974)). We are satisfied from our review of the record that the Board acted within the scope of its statutory authority and discretion in imposing the sanctions at issue here and there is no basis for our intervention.
Accordingly, we affirm the Board's decision and order of June 18, 2006, and vacate our order of September 17, 2006 staying the sanctions imposed by the Board.
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