When we discuss the learned intermediary rule, it is typically in the context of protecting our drug and device manufacturer clients. If a manufacturer warned the doctor, it discharged its duties, and a plaintiff should not be able to claim that he or she was not directly warned. We do not often represent pharmacies, but we'd usually just as soon see them escape liability as well, if only to keep them out of the case and keep them from wrecking federal diversity. Thus, we have often written about cases that shut down failure to warn claims against pharmacies – see here and here, for example.
Illinois was already on the correct side of the ledger, refusing to put pharmacies on the hook for failure to warn. That same legal position was applied, and perhaps even slightly extended, in Urbaniak v. American Drug Stores, LLC, 2019 IL App. (1st) 180248 (Ill. App. March 25, 2019). In Urbaniak, the plaintiff had taken Reglan for six years to treat gastroparesis. Unfortunately, the plaintiff developed tardive dyskinesia and dystonia. The prescribing physician admitted that he was unaware of the risk that a patient might develop these movement disorders from long-term ingestion of Reglan. The plaintiff sued that doctor for medical malpractice and separately settled. One might think that is where the tale ends.
It did not end that way here. The plaintiff also sued the pharmacy, and the central issue in that case was whether the pharmacy could be liable for failing to issue an oral warning to the plaintiff about the medical risks associated with the long-term ingestion of Reglan. Why an oral warning? We'll get to that point. It is a major weakness in the plaintiff's case. Another weakness was that the plaintiff wanted to prove that the pharmacy should have known the risks about which the doctor was clueless, should have deduced that the doctor was clueless, and should have stepped into the breech and warned the patient.
That seems a trifle ambitious. It also seems more than a trifle wrong.
(Why did the plaintiff not sue the manufacturer? Dunno. Perhaps the plaintiff used a generic version. Or perhaps the plaintiff saw the learned intermediary rule as an insurmountable barrier against manufacturer liability. If the latter, then what happened in Urbaniak becomes even a little more interesting.)
In February 2009, after the plaintiff began taking Reglan, the Food and Drug Administration approved a black box warning for the drug. The black box warning addressed tardive dyskinesia directly. For the six years he took Reglan, the plaintiff had all of his prescriptions filled at the same pharmacy. When dispensing Reglan, the pharmacy distributed a medication guide to consumers. The medication guide for Reglan provided warnings and other information about the drug, including the warning about tardive dyskinesia. But the pharmacy never orally warned the plaintiff about the risks associated with taking Reglan longer than 12 weeks. Do you see where this is going?
Why would the pharmacy butt in and nag the plaintiff? That must be what the pharmacy thought when it moved for summary judgment on the claims against it. The pharmacy argued that it had no duty to warn the plaintiff or his doctor about the risk of developing tardive dyskinesia and dystonia as a result of taking Reglan for longer than 12 weeks. The trial court agreed and entered summary judgment in the pharmacy's favor. The plaintiff appealed.
The Illinois appellate court reasoned that 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 duty to warn of side effects is not placed on the pharmacist, it is placed on the prescribing physician. A pharmacist owes just a duty of ordinary care in practicing his or her profession.
The issue in Urbaniak was not whether the pharmacy had a generalized duty to warn the plaintiff about the dangers of Reglan, because it did so in writing. (Remember the medication guide?). Rather, the issue is whether the pharmacy had a specific duty to advise the plaintiff orally about the risks of the prolonged ingestion of Reglan or to advise the prescribing physician about the risks of taking Reglan long term. That makes the Urbaniak case slightly different from prior Illinois cases. It makes Urbaniak weirder. We think it also makes Urbaniak easier.
The plaintiff argued that it is "highly unusual" for a black box prescription warning to have a time limitation – 12 weeks in this case – and that the pharmacy should have told both the prescribing doctor and the patient "about the 12 week warning so they could have evaluated whether to continue the drug." The plaintiff argued that the pharmacy owed a duty "to be aware of the black box time limitation, to make sure that the refill does not exceed the limitation, and if it does, discuss that issue with the doctor or patient."
The appellate court sensibly concluded that such a rule would require pharmacies to inquire into the doctor's judgment about, at a minimum, the duration of prescriptions when side effects could develop from long-term use. Such a rule would run afoul of Illinois court decisions that have "consistently declined to impose upon a pharmacy, any duty to monitor patients, make medical decisions, or to warn a physician or a patient of 'excessive' prescribed doses." Illinois law imposes "no duty on a pharmacist to warn the customer or notify the physician that drugs are being prescribed in dangerous amounts, that the customer is being overmedicated or that various drugs in the prescribed quantities could have an adverse effect."
Again, the pharmacy did warn the plaintiff about the dangers of taking Reglan for longer than 12 weeks. It just did so in writing. The plaintiff argued that the pharmacy should have been done orally, as well. That is not a theory of liability the appellate court would accept. The plaintiff admitted that he never read the medication guide given to him with his prescription. The plaintiff seemed to want a nanny at every turn. He demanded that the pharmacy should have waded further into the situation. But, according to the appellate court, "the learned intermediary doctrine dictates that pharmacists stay out of the physician-patient relationship."
(Some of you might be thinking that Urbaniak smells like assumption of the risk, contributory negligence, or a break in the failure to warn claim inasmuch as the plaintiff either 1) read the warning and accepted the tardive dyskinesia risk without any questions, 2) read the warning, discussed it with the doctor he later sued, and accepted the risk, or 3) never read the medication guide at all. All of that points to personal responsibility, which this plaintiff threw away with the medication guide.)
Moreover, the pharmacy had no reason to know that the doctor was ignorant of the effects of the drug for which he wrote a prescription. It is not as if the pharmacy was saddled with an "independent duty to inquire into the doctor's pharmaceutical competence." 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.
There is another way to style the plaintiff's claim in Urbaniak. To fit within Illinois precedents, the plaintiff tried to make the case that Reglan should be considered contraindicated for anyone after 12 weeks of use. Consequently, per this line of reasoning, the pharmacy was required to speak up about such contraindication. But contraindications "speak in terms of specific patients and specific treatments. Reglan was not specifically contraindicated for the plaintiff for any articulable reason. The plaintiff presented with no allergy and there was no concern about the interaction of multiple drugs in this case."
The pharmacy simply had no duty to speak.
This article is presented for informational purposes only and is not intended to constitute legal advice.