Court Addresses Liability in Dispensing Controlled Substances

Issue of the Case

When a lawsuit is filed alleging negligence and negligence per se by a pharmacist dispensing controlled substances, is summary judgment for the pharmacy appropriate based on an expert witness’s affidavit?

Facts of the Case

A lawsuit was filed in a southwestern state by the legal representative of a deceased 19-year-old female patient who had received a number of controlled substances from a pharmacy that were used in a fatal overdose. The medications were alprazolam, oxycodone, and oxymorphone. The defendants were the prescribing physician and the pharmacy.

The basic argument in the negligence portion of the lawsuit against the pharmacy was that the dispensing pattern “departed from the standard of care, knowledge, and skill of a reasonably trained pharmacist” and was thus a breach of duty to “properly and reasonably dispense medications.”

Evidence presented at trial showed that the pharmacy had repeatedly honored early requests for refills (7 times, ranging from 2-23 days early), including “at least 1 instance in which the young woman paid a substantial amount of cash [more than $1100] to purchase Oxycontin, although her prescription expenses were covered by insurance on other occasions.”

The negligence per se allegations were tied to deviation from a statutory standard rather than from a standard of performance based on the actions of one’s professional peers.

The allegation here was that the pharmacy, when dispensing “excessive quantities of medications” to the young woman, “departed from the standard of care, knowledge, and skill of a reasonably trained pharmacist” and “breached regulatory duties to ‘properly and reasonably dispense controlled medications’ mandated by state law.”

Both parties presented expert witness opinions that differed widely regarding “the conduct required of a pharmacist in these circumstances, pursuant to statutes, regulations, and public policy.”

The attorney representing the pharmacy filed a motion with the state trial court to dismiss all legal claims in the lawsuit based on the argument that “a pharmacist who accurately fills prescription medication as prescribed by the doctor has no liability exposure to one who is injured by the drugs or claims the amounts were excessive, unless the pharmacist has some reason to know the specific customer will be harmed.”

The state trial court granted the motion, and the claims against the pharmacy were dismissed. The plaintiff filed an appeal with the state’s intermediate appellate court requesting review of the trial court’s decision.

The Ruling

The state court of appeals ruled that dismissal of the pharmacy as a defendant was improper, and the matter was sent back to the trial court for further proceedings. Several months later, the state supreme court declined a request to review this decision by the court of appeals.

The Court's Reasoning

The court of appeals’ opinion, written by the chief judge, began with the observation that this case presented a “matter of first impression,” meaning the legal issue had never before been presented for the state’s appellate courts to address.

The court characterized the issue this way: “The conduct required of retail pharmacists in filling prescriptions for controlled substances with a significant potential for abuse and addiction.”

Moreover, the court identified early on that the case had been inadequately developed during proceedings before the trial court, pointing to “the parties’ case development and the trial judge’s opinion” being deficient in that “the factual record and the law potentially relevant to this determination were not adequately developed.”

The court’s 3-judge panel offered insights into the law relevant to the case, noting the attorney for the pharmacy “appeared to advocate that a retail pharmacist owes ‘only a clerical accuracy’ standard to a customer,” ie, “requiring only that a retail pharmacist fill a prescription accurately, unless the prescription is facially invalid, or the pharmacist has personal knowledge that filling the prescription would harm a specific customer.”

In the judges’ opinion, “the pharmacy failed to establish this as the standard under [the law of the state], given federal and state laws and regulations governing pharmacy practice and the prescribing/ dispensing of opioids as well as cases in other jurisdictions rejecting that standard for a higher one.”

The court also noted that “a standard of care that requires nothing more than clerical accuracy where the facts involve ‘repeated requests for high dosages of Schedule II opioids taken with Schedule IV benzodiazepines...raises other policy concerns related to the potential harm to patients and the public at large.’”

To grant a motion for summary judgment, the trial court judge must conclude there remains no dispute regarding a material fact in the case. The differing opinions of expert witnesses presented by the 2 sides established there was indeed a dispute regarding a material fact to be resolved at trial. Therefore, dismissal was incorrect.

About The Author

Joseph L. Fink III, JD, DSC (Hon), BSPharm, FAPhA, is a professor emeritus of pharmacy law and policy and former Kentucky Pharmacists Association Professor of Leadership at the University of Kentucky College of Pharmacy in Lexington.