A state appellate court has found that Osco pharmacists were not responsible for warning a patient that the drug his doctor prescribed for six years is only intended to be taken for 12 weeks.
Stephan and Susan Urbaniak filed a lawsuit in 2016 against his doctor, his doctor’s professional group, and American Drug Stores LLC, the parent company for Osco Drug, after developing two severe neurological disorders that cause uncontrollable muscle movements and contractions. The disorders are a known side effect of prolonged exposure to metoclopramide, sold commercially as Reglan.
Urbaniak was first prescribed Reglan while under the care of a gastroenterologist, but his primary care physician eventually took over management of his gastroenterological condition and continued the prescription. The doctor – who, along with his professional group, settled with Urbaniak – admitted he was unaware the Food and Drug Administration has placed a black-box warning on the drug recommending against its use for more than 12 weeks.
Urbaniak continued to take the drug for six years, always filling it at his local Osco pharmacy. In his lawsuit, he claims the pharmacy staff should have spoken with him or with his doctor about his long-term treatment with this drug.
On March 25, a three-justice panel of the Illinois First District Appellate Court in Chicago determined the case falls squarely within Illinois’ learned intermediary doctrine, which dictates that it is not the place of pharmacists to question or second-guess a doctor’s prescribed treatment. The doctrine places the responsibility of warning the patient about potential side effects on the doctor, who is presumed to know not only about the drug but about the patient’s medical condition and history.
Osco said it did, in fact, warn Urbaniak about the drug’s side effects. It included a medication information sheet with his prescriptions that details the black-box warning. Urbaniak admitted he never read the sheet and maintained the staff should have warned him orally, not just in writing.
“To be clear, in defining the issue in this case, it is not whether Osco had a generalized duty to warn plaintiff about the dangers of Reglan, because it did so in writing,” Justice John Griffin wrote in the court’s opinion. “The issue is whether Osco had a specific duty to verbally advise [Urbaniak] about the risks … or to advise the prescribing physician about the risks.”
The circuit court granted Osco summary judgment in the case, and the appellate court agreed. Ruling in Urbaniak’s favor would expand the duty Illinois courts have recognized for pharmacists. Urbaniak’s suit asks that Osco be required to be aware of the black-box time limit, to make sure refills do not exceed the limit, and to discuss the issue with the doctor or patient.
On the contrary, the court wrote, it is the duty of the drug manufacturer to warn the doctor about the potential for adverse side effects, and it is the duty of the doctor to take that information into consideration when prescribing the drug. To ask the pharmacy to do more than follow the doctor’s orders would violate the learned intermediary doctrine, the court said, which dictates pharmacists should “stay out of the physician-patient relationship.”
“It is the doctor’s duty to know what he is prescribing and it is the pharmacy’s duty to give the patient what the doctor orders,” the court wrote. “Plaintiff is asking us to require the pharmacy to skeptically question the doctor’s judgment and to delve into whether the doctor’s judgment is being exercised prudently. … Our courts have already made clear that pharmacies do not have a duty to determine whether a prescription is ‘excessive.’”
Justices Mary Mikva and Carl Anthony Walker concurred in the judgment and opinion.
According to Cook County court records, Urbaniak has been represented by attorney Bruce R. Pfaff, of Chicago.
Osco has been represented by attorneys with the firm of Kopon Airdo LLC, of Chicago.