IADC Past President Andrew Kopon Jr., a founding partner of Kopon Airdo, obtains win in the Illinois First District Appellate Court affirming the Circuit Court’s summary judgment in favor of American Drug Stores, LLC d/b/a Osco Drug #3086 based on the learned intermediary doctrine and holding of no duty.
On March 25, 2019, the Illinois Appellate Court affirmed the lower court’s entry of summary judgment in deciding that defendant pharmacy did not owe a customer a duty of care to verbally warn the customer or the doctor that use of the medication, Reglan (metoclopramide), for a period exceeding twelve weeks, as stated by the FDA in its “black box” warning, may cause certain serious side effects, such as tardive dyskinesia. The Court held that this case falls squarely within the purview of the learned intermediary doctrine. The doctrine generally absolves pharmacies and pharmaceutical companies from liability for failing to warn a customer about the potential side effects of prescription drugs. (Urbaniak v. American Drug Stores, LLC, #3086, No 1-18-0248, March 25, 2019.) The Court noted that the purpose of the learned intermediary doctrine, “obligates drug manufacturers to warn only physicians about the potential risks of a drug, and then physicians are required to use medical judgment to determine which warnings to provide to patients to whom the drug is prescribed.”
The Appellate Court refused to place the pharmacy in the middle of the relationship between doctor and patient and refused to impose upon the pharmacy a duty to monitor patients, make medical decisions, or to warn the physician or the patient regarding the wisdom of administering the drug for a certain duration. In this case, a patient was prescribed a drug, Reglan, to treat a serious condition called gastroparesis. Discovery established that Reglan is the only medication available to treat gastroparesis, but the FDA issued a “black box” warning in 2009 stating that, “treatment with metoclopramide can cause tardive dyskinesia, a serious movement disorder that is often irreversible…treatment with metoclopramide for longer than 12 weeks should be avoided in all but rare cases where therapeutic benefit is thought to outweigh the risk of developing tardive dyskinesia.”
This written warning was included with each filled prescription from the pharmacy; however, no verbal warning was given to the patient and no warning was provided by the pharmacy to the prescribing physician. Despite the FDA duration warnings for Reglan, the treating physician continued to prescribe the drug for a period of six years. The doctor claimed that he was unaware of the duration warning for Reglan. The patient developed the movement disorder tardive dyskinesia and filed suit against the prescribing physician and the pharmacy that filled the prescriptions, alleging that the pharmacy had a duty to warn the doctor and verbally warn the patient that using this drug for more than 12 weeks could cause tardive dyskinesia.
The question before the Appellate Court was whether the lower court erred in granting summary judgment in favor of the pharmacy on the basis that the pharmacy did not owe plaintiff the duty of care to verbally warn him or warn his doctor of the possible serious side effects of the medication that was being prescribed. The Court held that there was no such duty on the part of the pharmacy because it was the doctor, the learned intermediary, who had the duty and the responsibility to decide what treatment was best for the patient. The doctor is a trained medical professional and he was in the best position to determine the best course of treatment. The Court reasoned that the pharmacy had no independent duty to inquire into the doctor’s pharmaceutical competence. The doctor and patient relationship is a special relationship and the decision to prescribe Reglan and to continue to prescribe Reglan were medical decisions. The Court stated that the pharmacist is fully “entitled to presume that Dr. Ross knew the potential consequences of Reglan and prescribed it to plaintiff in spite of those warnings.”
The Court provided a comprehensive analysis of the purpose of the learned intermediary doctrine and noted that the doctor is intimately familiar with the patient’s health history and current condition. The doctor knows what other drugs the patient is taking. He knows the seriousness of the patient’s disease and the best treatments available to treat the disease. The doctor is in the best position to exercise his medical judgment regarding the best options for this particular patient. This duty of care that is owed by the doctor to the patient cannot be shifted to the pharmacist, who does not have familiarity with the patient’s condition or treatment history and cannot exercise medical judgment. The pharmacist has a duty of care to dispense medications in accordance with the medical prescriptions. To impose an additional duty on the pharmacist to know and understand all the other factors about the patient that are necessary to evaluate whether a prescription is appropriate would be imposing a duty on the pharmacist that he is not qualified to undertake. It would also place the pharmacist squarely in the middle of the doctor patient relationship, which is not in anyone’s best interest.
The Court stated that the learned intermediary doctrine imposes a duty on drug manufacturers to warn only physicians about the potential risks of a drug and the physicians are required to use medical judgment to determine which warnings to provide to patients when the drug is prescribed. The doctor is the learned intermediary of the information for the benefit of the patient. The Court also noted that the pharmacy did warn plaintiff about the dangers of the drug he was prescribed, in writing. The question was whether the pharmacy had a specific duty to warn his doctor or verbally advise the patient about the risks of the prolonged ingestion of the drug. The Court held that it did not. Imposing such a duty on a pharmacist would require the pharmacist to question the doctor’s medical judgment, which is not the law in Illinois. Urbaniak v. American Drug Stores, LLC, No 1-18-0248, March 25, 2019 (Ill. App. 1st District). Colette L. Kopon and Andrew Kopon Jr. for American Drug Stores, LLC d/b/a Osco Drug #3086. Opinion by Justice John Griffin, Presiding Justice Mikva and Justice Walker concurred in the judgment and the opinion.