Legal Duty to Notify Patient of Product Recall?

Pharmacy Times, March 2012- Central Nervous System, Volume 78, Issue 3

When a recalled medication causes the death of a patient, a grieving family files suit against the pharmacy.

When a recalled medication causes the death of a patient, a grieving family files suit against the pharmacy.

Issue of The Case

When a pharmacy has provided a prescription medication to a patient which is subsequently subject to a product recall, does a legal duty exist requiring that the patient be notified that the medication being used has been withdrawn from the market?

Facts of The Case

A female patient in an elder care facility was prescribed a medication for a cardiac condition. This medication was the subject of a product recall and allegedly caused her demise. Her surviving relatives filed suit against 14 defendants, 4 of which were pharmacies. The other defendants were the manufacturers of the product and the retirement living facility where she resided.

The legal action was filed in a state court in the southern state where the patient lived and 7 of the defendants sought to transfer the case to federal court. As part of reaching a decision on that motion for removal to a federal forum, the judge needed to ascertain whether the claims being asserted against the pharmacies were, in fact, legitimate. The defendant manufacturers entered the fray, arguing that “the defendant pharmacies have no post-sale duty to warn” under the law of the state that would govern the situation.

The plaintiffs, the surviving relatives of the deceased patient, advanced the allegation that “the defendant pharmacies’ negligent actions, or omissions to act in order to prevent (the patient) from consuming the defective product and failure to exercise reasonable prudent care under the notification process which cause the pain and suffering and the ultimate death of the (patient).”

This framed the pharmacy-related issue for the federal judge deciding whether the case properly belonged in federal court or should remain in state court, focusing on whether the pharmacies were properly named as defendants in the case—is there a legal duty on the part of the pharmacies to retain information that could be used to contact a patient in the event of a recall or a legal duty to, in fact, notify the patient should a recall occur?

The Court’s Ruling

The court concluded that it saw “no possibility that the plaintiffs can recover against the pharmacy defendants on either of the theories asserted in the complaint.” Accordingly, the court ruled that the pharmacy defendants had been improperly included in the lawsuit.

The Court’s Reasoning

Two possible bases for liability on the part of the pharmacies were advanced by the patient’s survivors who had initiated the lawsuit. The first was based on the state statutes governing the practice of pharmacy, whereas the second was based on a common law argument. The common law as used in this context is the law derived from the decisions of judges as contrasted with law derived from the actions of legislatures (statutes) or agencies in the executive branch of government (regulations).

Looking first at the state statutes, the court noted that although the law requires that a prescription include certain information such as the patient’s name and contact information, this mandate relates to accepting and honoring the prescription. It does not impose on the pharmacy a duty “to retain that information for purposes of contacting patients or health care providers in the event of a drug recall, or to provide notice of any such recalls.”

Finding no legal obligation in statutes, the court turned to the judicial or case law of the state to ascertain whether such a legal duty had been established by judges’ decisions.

A review of past cases decided in the state revealed 1 decision that specified that “a product seller has a duty to warn only of dangers actually or constructively known at the time of the sale.”

The judge in a different case stated this rule of law: “The seller is required to warn if he has knowledge, or by the application of reasonable, developed human skill and foresight should have knowledge of the danger.” The judge in this present case noted that “As a logical extension of that rule, product sellers are not required to issue recalls for defective products, but if a seller chooses to do so voluntarily, it must act reasonably.”

The judge concluded that the plaintiffs had failed to allege that the pharmacies had actual or constructive knowledge of the allegedly defective medication at the time of dispensing. Further, they presented no evidence that the pharmacies had voluntarily instituted a product recall at their level, thereby creating a duty to inform the patient of any defects. As a result, the court saw no possibility that the plaintiffs could recover against the pharmacy defendants on either of the theories asserted in the complaint.

As a concluding note, it should be emphasized that the focus of this decision is on the legal duty to notify of defects, not the ethical or professional duty, which is an entirely separate matter. PT

Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy in Lexington, Kentucky.