2019 IL App (1st) 180248
Ill. App. Ct.2019Background
- Stephan Urbaniak took the prescription drug Reglan (metoclopramide) continuously from May 2008 to August 2014 and was diagnosed in August 2014 with tardive dyskinesia and dystonia, irreversible movement disorders associated with prolonged Reglan use.
- In February 2009 the FDA added a black-box warning advising that metoclopramide use beyond 12 weeks increases the risk of tardive dyskinesia and that treatment beyond 12 weeks should be avoided except in rare cases.
- Osco (American Drug Stores, LLC) dispensed Urbaniak’s Reglan prescriptions for six years, provided the FDA medication guide (which contained the black-box warning) in writing, but did not give any verbal warnings to Urbaniak or his prescribing physician, Dr. Ross.
- Dr. Ross testified he was unaware of the tardive dyskinesia risk; he and his corporation settled with Urbaniak. Urbaniak sued the pharmacy alleging failure to verbally warn patient or physician about long-term risks.
- The trial court granted summary judgment for Osco on the basis that no legal duty to provide a verbal warning existed; Urbaniak appealed.
Issues
| Issue | Plaintiff's Argument | Defendant's Argument | Held |
|---|---|---|---|
| Whether the dispensing pharmacy owed a duty to verbally warn the patient or notify the prescribing physician about the cumulative/time-based risk of Reglan (beyond the written medication guide) | Osco should have known Urbaniak had been on Reglan for years and thus had a duty to warn patient/doctor about the 12‑week risk and to question continuing refills | Pharmacy’s duty is limited by the learned intermediary doctrine; it satisfied any warning duty by providing the FDA medication guide and may not be required to second‑guess physician prescribing or monitor duration | Affirmed: no duty to give verbal warning or to investigate/notify physician; learned intermediary doctrine places warning obligation on physician/manufacturer |
| Whether the facts here take the case outside the learned intermediary rule (analogous to a known contraindication) | Argued that prolonged use effectively made Reglan relatively contraindicated for Urbaniak and thus pharmacy should be liable (Happel-like exception) | Pharmacy lacked any knowledge that Reglan was contraindicated for Urbaniak (no allergy, no drug interactions); prolonged use requires medical judgment, not pharmacist intervention | Held: Not like Happel; no specific contraindication known to pharmacy and Reglan can be appropriately used >12 weeks in some cases, so learned intermediary applies |
Key Cases Cited
- Martin v. Ortho Pharmaceutical Corp., 169 Ill. 2d 234 (Illinois Supreme Court) (describes learned intermediary doctrine allocating warning duty to physicians)
- Frye v. Medicare-Glaser Corp., 153 Ill. 2d 26 (Illinois Supreme Court) (physicians are primary source of warnings to patients)
- Happel v. Wal-Mart Stores, Inc., 199 Ill. 2d 179 (Illinois Supreme Court) (pharmacy liability where pharmacy knows of a patient‑specific contraindication)
- Kirk v. Michael Reese Hospital & Medical Center, 117 Ill. 2d 507 (Illinois Supreme Court) (learned intermediary doctrine applied in pharmaceutical context)
- Eldridge v. Eli Lilly & Co., 138 Ill. App. 3d 124 (Ill. App. Ct.) (pharmacist owes ordinary care but not broad duty to warn patients)
- Fakhouri v. Taylor, 248 Ill. App. 3d 328 (Ill. App. Ct.) (pharmacies not required to determine whether prescribed dosage or duration is excessive)
- Leesley v. West, 165 Ill. App. 3d 135 (Ill. App. Ct.) (learned intermediary doctrine applies to pharmacists)