Illinois Appellate Court Finds That Physician and Pharmacy Have No Duty to Warn of Medical Risks Associated With Long-Term Use of Reglan

The plaintiff, Stephan Urbaniak,was prescribed and took a drug called Reglan for six years. He developed severe movement disorders. The prescribing physician, Dr. John Ross, admits that he was unaware of the risk of developing these movement disorders from long-term use of this prescription drug.

By operation of the “learned intermediary doctrine,” the pharmacy cannot be held liable for choosing not to verbally warn the plaintiff or his physician about the medical risks associated with long-term use of Reglan.

There is no specific reason that the pharmacy could have known about that, which would have made plaintiff specifically someone who could not be treated with Reglan longer than 12 weeks.
Accordingly, the Illinois Appellate Court affirmed the dismissal of the lawsuit against the pharmacy and physician.

In 2008, Urbaniak was under the care of a gastroenterologist who prescribed him a prescription drug called Reglan to treat gastroparesis. Beginning in 2010, Urbaniak’s primary care physician, Dr. John Ross, took over writing Urbaniak’s prescription for the drug. Urbaniak took Reglan continuously from May 2008 to August 2014.

In August 2014, Urbaniak was diagnosed with tardive dyskinesia and dystonia. Tardive dyskinesia and dystonia are well-known side effects from the prolonged use of Reglan.

Tardive dyskinesia is a serious movement disorder that causes involuntary movements of parts of the body. Dystonia is a similar movement disorder that causes involuntary and uncontrollable muscle contractions. There is no known cure for either disorder. Urbaniak is now unable to work and suffers from extensive disabilities.

In 2009, after plaintiff was prescribed and was using Reglan, the Food and Drug Administration (FDA) approved a black box warning for the drug. A black box warning is the strongest form of warning that the FDA requires for prescriptions, and it indicates that there is reasonable evidence that there are serious or life-threatening risks associated with taking the drug. The black box warning for Reglan, speaking in terms of its generic name, metoclopramide, addresses tardive dyskinesia directly.

The warning on the prescription medication is definitive.

For six years, Urbaniak took Reglan. All his prescriptions were filled at Osco Drug, a local Illinois retailer of the defendant American Drug Stores, LLC.

Urbaniak filed this lawsuit against Dr. Ross, Dr. Ross’s professional corporation and the pharmacy. The doctor and his professional corporation settled the case for their insurance policy limits.

American Drug Stores moved for summary judgment on the claims against it, arguing that it had no duty to warn plaintiff or his doctor about the plaintiff being at risk of developing tardive dyskinesia and dystonia as a result of taking Reglan for longer than 12 weeks.

Depositions and other discovery were completed; the trial court entered summary judgment on Osco’s motion finding that it did not owe Urbaniak the duty of care it was alleged to have breached. That dismissal order led to this appeal, which was affirmed.

Frequently at issue in pharmaceutical cases, the “learned intermediary doctrine” has a role in a case like this. The learned intermediary doctrine helps courts decide which participant in the chain of administering prescription drugs to consumers should be charged with the duty to warn patients about the potential adverse effects. Hernandez v. Schering Corp., 2011 IL App (1st) 093306, ¶ 30.

In its most basic form, 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. Martin v. Ortho Pharmaceutical Corp., 169 Ill.2d 234, 238-39 (1996).

The doctor acts as an intermediary of the information for the benefit of and on behalf of the patient. The learned intermediary doctrine applies to pharmacists in the same way that it does drug manufacturers – the duty to warn of side effects is not placed on the pharmacist, it is placed on the prescribing physician. Leesley v. West, 165 Ill.App.3d 135, 143 (1988) (quoting Kirk v. Michael Reese Hospital & Medical Center, 117 Ill..2d 507, 524 (1987)).

Urbaniak v. American Drug Stores, LLC d/b/a Osco Drug, 2019 IL App (1st) 180248 (March 25, 2019).

Kreisman Law Offices has been handling product defect cases, pharmaceutical defect cases, brain injury cases and medical negligence lawsuits for individuals, families and loved ones who have been harmed, injured or died as a result of the carelessness or negligence of another for more than 40 years in and around Chicago, Cook County and its surrounding areas, including River Grove, Geneva, Chicago, Gurnee, Crystal Lake, Morton Grove, Melrose Park, Crete, Frankfort and Cary, Ill.