November 24, 2020
South Dakota Family Sues Walgreens Over Amiodarone Death
The family of a Pierre, South Dakota man is suing Walgreens’ Pharmacy, claiming the pharmacy mishandled his prescription, leading to his death. The man, 71-year-old John Stengle, a longtime advocate for the disabled, had been prescribed Amiodarone by a cardiologist. The drug was prescribed correctly a 90-day regimen, starting with two weeks at 800 mg per day, then down 200 mg every two weeks in order to taper off of the drug. A refill was included part-way through the 90-day period. Stengle’s family alleges that the patient suffered from Amiodarone toxicity due to improper handling of the prescription. The family’s lawyer claims numerous errors on the part of the pharmacy, including: dispensing far too many pills, refilling the prescription long before the pills ran out, mistakenly restarting the heavy-tiered dosing again in the middle of the regimen, and failing to give the patient the final two weeks of the 200 mg dose. The patient suffered from toxicity, and his organs began to shut down until he finally succumbed to multi-organ failure and died. His family did not sue the cardiologist who prescribed the medication, only Walgreens, claiming that the pharmacist failed to properly instruct the patient about the medication and effectively overdosed him. Walgreens has not responded to the details in the complaint, but the chain did make a motion to change the venue from state to federal court.
Professional Negligence vs. Ordinary Negligence at a Drive Through Pharmacy Window
An appellate court was asked to decide whether dispensing medications in error was simple or professional negligence, and whether punitive damages were required against the pharmacy. The problem began when the wife of a patient with Alzheimer’s disease, diabetes, and high blood pressure went to her drive-through pharmacy to pick up a prescription for her husband. The pharmacy clerk mistakenly gave the wife two prescriptions for a patient with the same last name. The prescriptions were for alprazolam and sertraline. The patient’s wife gave him the medications at 11 pm, and at 4 am she was awoken by the sound of him shouting her name. She found him on the floor near the front door to the house. Nothing near him was a tripping hazard or accounted for his fall. Yet, the patient could not get up. His wife called an ambulance, and he was taken to the hospital. In the emergency department he was found to have a broken hip, requiring immediate surgery. The couple filed a lawsuit alleging professional negligence, simple negligence, and punitive damages. The pharmacy’s attorney made a motion to dismiss. The court granted the motion as far as the professional negligence and punitive damages and dismissed those claims. The plaintiffs appealed. On appeal, the appellate court looked first at the professional negligence claim. The court noted that professional negligence requires the testimony of expert witnesses to establish the professional standards applicable to the case. The court went on to note that prior cases in the state had held that sometimes actuals performed under the supervision of a professional are no professional acts constitution professional negligence, but rather acts of simple negligence that do not require an expert to decipher. Applying that precedent to this case the court held that the clerk’s act of handing the wife the wrong medication, with or without properly confirming identity, was simple negligence and not professional malpractice. As for the issue of punitive damages, the appellate court agreed with the lower court that they were not appropriate, and should only be used in cases where there is willful misconduct, fraud, malice, or other outrageous acts showing indifference to consequences. The appellate court agreed with the lower court that only a claim of simple negligence could be pursued in this case.
Walmart Sues DOJ and DEA Seeking Clarity for Pharmacists
Walmart has sued the US Drug Enforcement Agency (DEA) and Department of Justice (DOJ) seeing clarification of the roles and responsibilities of pharmacists and pharmacies under the Controlled Substances Act. The company claims that the DOJ has threatened a lawsuit against Walmart claiming that in hindsight pharmacists should have refused to fill otherwise valid prescriptions for opioids written by licensed physicians.
“We are bringing this lawsuit because there is no federal law requiring pharmacists to interfere in the doctor-patient relationship to the degree DOJ is demanding…” said the company in a statement. “At the same time that DOJ is threatening to sue Walmart for not going even further in second-guessing doctors, state health regulators are threatening Walmart and our pharmacists for going too far and interfering in the doctor-patient relationship. Doctors and patients also bring lawsuits when their opioid prescriptions are not filled.”
Walmart is one of several pharmacy chains and drug distributors that have drawn official criticism for allegedly ignoring suspicious prescribing patterns of doctors or not going far enough in reporting or blocking doctors who are inappropriately prescribing opioids.
“Walmart and our pharmacists are torn between demands from DEA on one side and health agencies and regulators on the other, and patients are caught in the middle,” the company said in a statement. “We need a court to clarify the roles and legal responsibilities of pharmacists and pharmacies in filling opioid prescriptions.”
Ann W. Latner, JD, is a freelance writer and attorney based in New York. She was formerly Director of Periodicals at the American Pharmacists Association.