Legal Duty When Advising on the Use of OTC Products

ISSUE OF THE CASE

When a patient consults a pharmacist by telephone about a medication for her spouse, and the spouse uses it, which allegedly results in adverse health consequences, can the pharmacist and pharmacy be held liable for monetary damages?

FACTS OF THE CASE

This case arose in a western state where a woman allegedly received advice for her husband, by telephone, from a pharmacist at a national pharmacy chain. The facts, alleged by the plaintiff, were that the pharmacist discussed the husband’s health history with the wife and said, during the telephone consultation, that it was acceptable for the husband to use a pseudoephedrine product. The pharmacist did not ask the wife about matters that would have revealed that the husband had a history of “a little bit of prostate trouble.”

In response to the filing of the lawsuit, the pharmacist denied that the telephone conversation had ever occurred. The pharmacist also argued that if the verbal exchange had occurred, she would not have recommended use of the pseudoephedrine product. The pharmacy added the argument that there was no notation of a history of prostate problems in the husband’s health record on file at the pharmacy.

The allegation in the lawsuit was that consumption of a single dosage unit of the pseudoephedrine product worsened the husband’s prostate issues. The alleged injury was that he “suffered from difficulty urinating, bladder distension, and burst blood vessels in his bladder.” All of this allegedly led to his hospitalization for surgery, and subsequent use of catheters. An additional part of the declared damages was that the husband suffered nerve injury that led to constant pain, with disability, for 2 years until he died 2 years later due to an unrelated illness.

The pharmacy chain made a motion with the US District Court seeking partial summary judgment. This is a request in which the court concludes no material issues of fact are to be decided and, hence, no trial is necessary. Such a motion can be made with regard to the entire case or can be limited to specific issues within the case, as a whole. The chain’s motion asked the judge to declare that it had no liability for the husband’s injuries for 2 reasons: first, it argued that the legal duty of care, extended by a pharmacist, did not require giving adequate advice about nonprescription medications, and second, a legal principle, known as the “learned intermediary doctrine,” insulates the pharmacist from liability for failure to warn. This doctrine places responsibility on the physician to decide what information and cautions associated with the use of a medication to pass along to a patient. The attorneys for the chain cited a prior decision from the supreme court of that state that addressed the duty of a pharmacist to alert a patient to potential problems with the use of a pharmaceutical classified as a federal legend medication.

THE COURT’S RULING

The motion for partial summary judgment was denied by the court.

THE COURT’S REASONING

The federal court dealing with this matter was bound by legal doctrines dictating that it apply the law of the state where the matter arose. This federal trial court differentiated the prior decision by the state’s highest court, cited by the pharmacy chain, because it was limited to the legal doctrine of “strict liability” (ie, liability irrespective of fault). For this present matter, the trial court concluded that the law of the state is that “a 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.”

The federal trial court handling this matter stated, “It appears that (the chain) argues that a pharmacist is exempt from any and all liability when giving advice to customers about nonprescription drugs, even when the pharmacist dispenses bad advice.” A provision in the state pharmacy act refuted that argument by the chain. The practice of pharmacy was defined there to include “providing information on drugs and devices, which may include advice relating to therapeutic values, potential hazards, and uses…”

Regarding the learned intermediary doctrine, the court stated that “…the pharmacy cannot reap the benefits of offering advice and then hide behind the learned intermediary doctrine to avoid the consequences if their advice is incorrect. This is especially so when pharmacies hold themselves out to the public and the pharmacy’s customers as experts on drugs, both prescription and nonprescription alike.”

The court also pointed out that protecting the learned intermediary doctrine applies solely when prescription-only medications are involved: “It has no application to the factually different context of nonprescription drugs.”

Dr. Fink is a professor of pharmacy law and policy and the Kentucky Pharmacists Association Endowed Professor of Leadership at the University of Kentucky College of Pharmacy, Lexington.