David B. Brushwood, BSPharm, JD
Many opioid-related legal cases are currently being pursued against pharmacies, alleging that a patient’s brief period of opioid use years ago caused the patient to become addicted to opioids and that the dispensing pharmacy should be held legally liable for causing the patient’s overdose death years later. An Ohio appellate court recently explained why this theory of liability could be legally maintainable.
Background
A high school football player injured his shoulder during a game, and he required surgery. His physician prescribed opioid medication once prior to the surgery and 4 times following the surgery, all within a period of less than 2 months in late 2009. The court indicated that the pharmacy dispensed “260 opioids” to the patient during this timeframe. The patient allegedly “became addicted to drugs based on the initial opioid pills.” The patient “entered rehabilitation five times to treat his drug addiction.” However, despite periods of sobriety, he overdosed on fentanyl and oxycodone and died in the fall of 2017.
The patient’s estate sued the pharmacy, contending that the “over dispensing of medication to the decedent caused him to become addicted to opioids and ultimately overdose.”
A physician expert witness, who was qualified as a pain and addiction specialist, testified that “there was a causal connection between the prescribed opioids in 2009, the decedent’s diagnosis of opioid use disorder, and untimely death in 2017.”
The trial court concluded that the estate “could not demonstrate that [the pharmacy’s] actions were the proximate cause of the decedent’s death.” The trial court ruled that the expert’s opinion was “speculative, and based on assumptions, not facts in the record.”
The case against the pharmacy was dismissed, and the patient’s estate appealed.
Rationale
The appellate court reviewed evidence presented by the pharmacy concerning the pharmacy’s 2009 policy for pharmacist review of duplicate controlled substance prescriptions. The policy indicated that over-prescribing of opioids would be flagged by the pharmacy computer, bringing the problem to the attention of the dispensing pharmacist. However, the court noted that there was “no testimony provided that demonstrated [the pharmacy’s] policy of flagging a duplicate prescription occurred even if it was designed to do so.” The pharmacy’s electronic recordkeeping system had been purged of any records from 2009.
The appellate court also noted that the patient’s opioid prescriptions maintained on file did not show that any telephone calls were made by a pharmacist to the prescriber.
The court acknowledged that “the period between the dispensing of the drugs and the decedent’s overdose is significant.” However, the court concluded that “addiction is a ‘long-term, chronic, and relapsing disease’ that is complex to evaluate in this context.”
The dismissal of the case against the pharmacy was reversed. The case was remanded back to the trial court for further proceedings. The outcome of the case is yet to be determined. The plausibility of the estate’s legal argument has been judicially recognized.
Takeaways
This judicial ruling is significant for several reasons:
- An allegation that five opioid prescriptions dispensed over a 2-month period may be the legal cause of a patient’s death eight years later can be legally feasible.
- Simply because a pharmacy’s policy from years ago required that a particular action be taken by a pharmacist does not support a legal conclusion that the action was taken at that time.
- If there is no written notation on an opioid prescription, then an expert witness may be allowed to speculate that the prescriber was not contacted by a pharmacist.
- Although concerns for the effects of opioid use disorder have expanded over time, judicial rulings may reflect perspectives of today rather than perspectives from the time care was provided.
These observations suggest that effective pharmacy risk management programs must anticipate judgments that will be made years in the future. Pharmacies must create enduring records that will support future judicial evaluations of decisions made today. ■