US Pharm. 2014;39(12):61-63.
Imagine you are the pharmacist on duty when the phone rings. A woman identifies herself as the spouse of one of your pharmacy’s patients. She asks you whether it would be safe for her husband to take an OTC pseudoephedrine product (Sudafed) to treat cold symptoms. (At the time of this phone call, pseudoephedrine was available OTC without the current restrictions.) You talk to the caller for a while and advise that it is okay for her husband to use the medication. Later, the patient develops complications related to the drug. Can you be held liable for the damages suffered by the patient? According to the opinion issued by a judge in a federal court sitting in Utah, the answer is yes.1
Facts of the Case
The wife claims that she had talked to the pharmacist and inquired whether her husband should take Sudafed. The pharmacist answered affirmatively. The husband had been a regular patient of the pharmacy for some time. During the phone conversation, the wife did not mention that her husband had previously suffered from “a little bit of prostate trouble.”1 Although the pharmacist did not check the patient’s records during the phone conversation, there was also no indication in those records that the patient had any prostate problems.
The wife alleged that as a result of taking one Sudafed tablet her husband developed difficulty urinating, bladder distention, and then burst blood vessels in the bladder. These problems necessitated the use of catheters, which required frequent hospital visits for multiple weeks as well as two operations to close the blood vessels. Permanent nerve injury resulting from the bladder distention caused the man to suffer pain and disability for 2 years until he died from an unrelated illness.
The pharmacist denied that she had ever had a telephone conversation with the patient’s wife about whether or not it was safe for the patient to take Sudafed. The pharmacist also claimed that she would never recommend Sudafed to a patient over the telephone regardless of his condition.
Lawsuit
The plaintiff sued the pharmacist and the pharmacy for medical malpractice and lack of informed consent, claiming the pharmacist was negligent in giving bad advice.1 The pharmacy asked the court to dismiss the complaint against it and the pharmacist, claiming that they could not be held liable for the patient’s injuries because the pharmacist’s duty of care does not require giving adequate directions for OTC nonprescription drugs. A motion for summary judgment is usually inappropriate when material facts of the case are in dispute. Here, the parties disagreed as to whether the phone call ever took place as alleged. The pharmacy claimed that even if the phone call did occur and the pharmacist did advise the plaintiff’s husband to take the drug, neither the pharmacy nor the pharmacist could be held liable.
The pharmacy contends that under Utah law, the pharmacist’s duty of care extends to the filling of prescription drug orders correctly and that because pseudoephedrine was an OTC product, the pharmacist had no duty to warn the plaintiff’s husband of adverse effects from taking the drug. The pharmacy also argued that imposing liability under the circumstances of this case would force customers to choose between consulting with their physician about every medication or attempting to make an educated decision on their own. According to the court, it appeared that the pharmacy was contending that the pharmacist is exempt from any and all liability in giving advice to customers about nonprescription drugs even when the pharmacist “dispenses bad advice.”1
Decision
Because this federal case arises under state law, the trial court judge was required to apply Utah law in deciding whether or not to grant the pharmacy’s motion to dismiss the case. However, because the Utah Supreme Court has not determined the extent of a pharmacist’s liability under the circumstances alleged in this case, the judge was forced to “predict” what the Utah Supreme Court would decide if it were confronted with this situation. Citing an earlier court case, the judge stated that although pharmacists are exempt from strict product liability in Utah, they may still be held liable to claims of professional malpractice or negligence.2 The judge noted that the pharmacist has a generally recognized duty to possess and exercise the reasonable degree of skill, care, and knowledge that would be exercised by a reasonably prudent pharmacist in the same situation. He also recognized that while this duty is most commonly breached within the pharmacy profession by negligent packaging or dispensing of prescription drugs, the scope of that duty has not been particularly defined, and that this duty is not specifically limited to the filling of prescription drugs.
The judge interpreted Utah law as recognizing that pharmacists and pharmacies may give advice and recommendations to customers about nonprescription drugs. He quoted the Utah statute defining patient counseling as “the written and oral communication by the pharmacist or pharmacy intern of information to the patient or caregiver in order to ensure proper use of drugs”3 and concluded that this includes counseling on nonprescription medications.
The judge went on to state that pharmacists in Utah clearly have duties regarding nonprescription drugs. “If a pharmacist answers a customer’s question and offers advice about nonprescription drugs, the pharmacist must advise and act in a nonnegligent manner consistent with a reasonably prudent pharmacist’s response to the customer’s question about the safety of a nonprescription drug. And this question is inextricably tied to the facts and needs expert testimony to establish the standard of care of a reasonably prudent pharmacist in the situation.”1
The judge went on to comment that imposition of a duty regarding nonprescription drugs is consistent with public policy. He concluded that policy judgments applied to the relationship between a pharmacist and a customer mandate that pharmacists have a duty to their customers. He also stated that pharmacists can avoid liability for failure to warn in the prescription drug context when they are viewed only as service providers because the law restricts what they can “sell.” A pharmacist can only sell what the customer’s doctor has prescribed to the customer. In the prescription drug setting, according to this judge, pharmacists are not sellers because they do not market or sell prescription drugs to customers and customers do not choose which prescription drugs they will purchase based upon the recommendations or advice of the pharmacist.
The judge also observed that nonprescription drug sales are not determined or limited by a physician’s prescription and customers may shop for a nonprescription drug, while a pharmacist may market and sell nonprescription drugs to customers without any input or advice from
a medical doctor. If a pharmacist offers advice and recommendations to customers about nonprescription drugs, pharmacists are less like service providers and more like the sellers of any other product. They may market and sell nonprescription drugs and offer advice about those nonprescription drugs, including whether they will interact with other drugs.
The judge wrote: “This advice has an independently powerful effect on the purchaser.” Most tellingly, the judge stated: “In a modern day pharmacy, where pharmacists serve as both sellers and service providers, if a pharmacy offers advice and recommendations about nonprescription drugs, and that advice turns out to be contrary to what a reasonably prudent pharmacist would give in a similar situation, the pharmacy cannot reap the benefits of offering advice but then hide behind [a limited duty to warn] doctrine to avoid the consequences if their advice is incorrect. This is especially so when pharmacies often hold themselves out to the public and [their] customers as experts on drugs—both prescription and nonprescription alike.”1
Accordingly, the judge refused to dismiss the case and noted that testimony would be required during trial to determine the facts and the extent of the pharmacist liability if it turns out the pharmacist did give “bad advice.”1
Discussion
If allowed to stand, this case could have far-reaching results regarding the liability of pharmacies and pharmacists when giving advice on the use of OTC products. In the dispensing of prescription drugs, pharmacists often have limited liabilities to warn of adverse consequences associated with the use of medications; under the holding of this case, a pharmacist could be held liable any time he or she advised a patient on whether or not it was safe to use an OTC medication and the patient suffered damages as a result.
This case could have a chilling effect on the motivation of pharmacists to give advice about using OTC products. Pharmacists could be held liable for giving advice practically anytime a patient had a bad outcome from using the medication. In order to avoid liability in this situation, the pharmacist would have to check the patient’s medication records, make inquiries into the patient’s medical conditions, and be reasonably assured that the drug being considered is appropriate for that patient. Otherwise, the pharmacist might reasonably refuse to give any advice on the use of any OTC product. Given the education, training, and experience that pharmacists have with regard to the use of drugs, such an outcome would be extreme. It is logical to assume that patients come to pharmacies to shop for OTC products knowing that a pharmacist is available to help them make wise decisions. If the patient can sue the pharmacist anytime something goes wrong, more pharmacists are going to be reluctant to provide any information about OTC drugs.
In this case, it would not have made any difference if the pharmacist had checked the patient’s medical records before advising his spouse on the safety of taking pseudoephedrine. The patient’s records did not reflect that he had any prostate problems. The spouse admittedly never told the pharmacist that the patient had prostate issues. Did the judge in this case assume the pharmacist should have specifically inquired if the patient had any prostate problems before advising the patient to take pseudoephedrine? Put another way, is there a specific duty on the part of a pharmacist to ask male patients if they suffer from a prostate problem before telling them it’s okay to take a pseudoephedrine product? The product literature implies that the drug could cause problems urinating but says nothing specific about contraindications with prostate issues. Should reasonable pharmacists expect to know more about OTC drug products than the labeled warnings indicate? Probably yes, but how much more?
Before getting too worried about this case, remember that the opinion only indicates that the pharmacy and pharmacist may be held liable if the actual facts of the case indicate that the pharmacist knew or should have known that the patient had a prostate problem and that pseudoephedrine would be contraindicated. The judge specifically said that an expert witness would be necessary to testify as to what a reasonable pharmacist would have said or done under the circumstances. The facts must also establish that the phone call even occurred and that the pharmacist did say it was okay for the patient to use the OTC drug.
This case serves as a warning to pharmacists not to take the responsibility for advising patients on the use of OTC products lightly. While nonprescription medications can be purchased in a variety of venues such as grocery stores or gas stations, where no one likely to hold expert knowledge about drugs is available, a special duty arises when the purchase is made after talking to a pharmacist. Patients have much different expectations while shopping for OTC products in a pharmacy. Relying on a knowledgeable pharmacist, patients expect and deserve expert advice.
REFERENCES
1. Whiting v. Rite Aid, (Slip Op 2:12-cv-288 DN, June 24, 2014), 2014 USDC Lexis 87354; 2014 WL 2871441.
2. Schaerrer v. Stewart’s Plaza Pharmacy, 2003 UT 43, 79 P3d 922.
3. Utah Code Ann §58-17b-102(41).
