Negligence in Selecting Which Generic to Use?
Author: Joseph L. Fink, III, BSPharm, JD
Does liability attach when pharmacy staff selects a particular brand of medication delivery system and that patient passes away with the medication allegedly contributing to that death?
Issue of the Case
Does liability attach when pharmacy staff, acting pursuant to the state’s drug product selection law, selects a particular brand of medication delivery system for use by a patient and then that patient subsequently passes away, with the medication allegedly contributing to that death?
Facts of the Case
A woman in an Eastern state received a prescription for a brand-name transdermal patch to deliver the medication fentanyl to relieve pain. The statemandated prescription request form bore a box to be checked by the prescriber if the brandname version of the medication was being requested. The prescriber did not check that box, so use of a generic equivalent was permitted under state law. The pharmacist selected a transdermal patch containing fentanyl produced by a different brand-name pharmaceutical manufacturer.
It was alleged in the lawsuit that the version of the patch actually dispensed was defective due to a design flaw, resulting in release of a level of medication above that intended, which contributed to the demise of the patient. The lawsuit was filed by the surviving husband, both as representative of the estate of his deceased wife and in his own right to recover for the loss of his spouse. The defendants were 2 pharmaceutical firms, 1 of which manufactured the patches and the other being the distributor of them. The pharmacy where the medication was obtained was also named as a defendant.
The case was originally filed in state court because the plaintiff was a resident of that state and the pharmacy was located there. The 2 pharmaceutical firms were located out of state and incorporated in other jurisdictions. A pivotal issue in this litigation was whether the pharmacy should really be a party to the suit. That was important because if the in-state pharmacy was not involved then the out-of-state manufacturers could remove the case to federal court.
In fact, the manufacturers did remove the case to federal court and then sought to have the pharmacy deleted from the case. Their argument was that the pharmacy had been fraudulently named in the suit solely to justify having the matter handled in state court. The issue of interest to us in this case is whether there really is a possibility of liability based on the actions of the pharmacy staff.
The Court’s Ruling
The court concluded that the plaintiff/ husband had established no possible basis for a claim of negligence against the pharmacy under state law, and the pharmacy was dismissed as a defendant in the case.
The Court’s Reasoning
The court began by noting that the plaintiff had conceded that the medication dispensed conformed to the prescription issued by the prescriber. Additionally, there was no allegation that the pharmacy staff in some way dispensed the medication in a fashion at variance with the manufacturer’s information. With regard to the manufacturers, while it was alleged that they had failed to submit information to the US Food and Drug Administration (FDA) that would have “exposed defects and risks” associated with the version of patch actually dispensed, it was conceded that the product was FDA approved at the time of dispensing.
The central argument advanced by the plaintiff with regard to the pharmacy was that state law imposed “a duty on a pharmacist to fill a prescription with the safer of two competing products.”
That argument continued that this duty applied even despite both versions of the transdermal patch being FDA approved. The plaintiff’s argument continued that the legal duty of the pharmacy or pharmacist was violated when it “knowingly” sold the actual patch dispensed rather than the one originally prescribed which he viewed as “another, safer patch on the market at the time.”
Unfortunately for the plaintiff and fortunately for the pharmacy, the court pointed out that the plaintiff had “failed to point to a single case in which any court has used his theory to find a pharmacy liable for negligence.” Indeed, this state had a provision in its drug product selection law requiring that the pharmacist dispense a less expensive alternative, unless the prescriber requested otherwise.
The court concluded that it could see “no valid reason for finding that the company could be negligent for inadequately second-guessing the FDA.” Accordingly, the pharmacy was dismissed as a defendant and the case remained in the federal court. PT
Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.