Individual alleges that an equivalent product from another manufacturer precipitated series of seizures.
Issue of the Case
A patient who presented a prescription for dispensing received an equivalent product from a different manufacturer and alleged that a series of seizures resulted from the change. Will she prevail in her negligence lawsuit against the pharmacy?
Facts of the Case
The patient had been taking the antiseizure medication levetiracetam for 10 years, always receiving it in a form described as yellowish white. She presented a new prescription at a chain pharmacy and received a pink version of the medication. She asked the pharmacist whether this new version would be safe to use; he told her it would.
After starting to use the new version, the patient experienced 3 seizures, which led to her being admitted to the hospital. This was cause for concern, because she had been using the yellowish-white version for 10 years and had not had a seizure for 7 years.
She filed a lawsuit against the pharmacy, the pharmacist, and the pharmacy technician involved in dispensing the medication. The patient subsequently added the manufacturer of the pink dosage form as a defendant.
The patient’s attorney advanced several legal theories as the basis for liability and made submissions to the state trial court that had jurisdiction. A total of 4 amended complaints were submitted on behalf of the patient as the matter progressed. As is sometimes appropriate, a complaint would be submitted and rejected by the court but with authorization to revise it and resubmit. Through this process, the pharmacist and technician were deleted as defendants, but the matter was decided as amended against the pharmacy chain and the manufacturer.
The trial court judge received a motion from the attorneys for the defendants to dismiss the lawsuit and reviewed the legal arguments and theories advanced by the attorneys for the patient. All arguments were rejected and the lawsuit was dismissed. The plaintiff appealed to the state’s appellate court.
The appellate court reviewed the various arguments of the plaintiff and the lower court judge’s decisions. All decisions were affirmed on appeal. The matter was dismissed.
The Court's Reasoning
The negligence claim advanced by the plaintiff argued that the pharmacy had a legal duty to dispense the medication without a change in source, as well as to warn of potential dangers associated with the version dispensed. The pharmacy chain responded that the prescription was issued using generic product identification and that the various expectations found in the state’s drug product selection statute, which were the basis for the plaintiff’s arguments, did not apply. Moreover, the chain argued that any duty to warn of danger associated with the medication rested with the prescriber under the learned intermediary doctrine. The appellate court agreed with the pharmacy chain.
Next, the patient’s allegation that the pharmacist’s response that use of the different version of medication would be OK did not give rise to any legal duty on the part of the pharmacist or pharmacy in the view of the appellate court judges.
The plaintiff’s attorneys also argued that the pharmacy had a legal duty to dispense the medication without changing the source. The court agreed with the pharmacy chain that because the prescriber had not marked the portion of the prescription form that read “DAW [dispense as written]: No product selection indicated,” that interchange of product source had not been prohibited by the prescriber.
In another revision, the plaintiff argued that the subpotency of the dispensed product resulted in it being considered adulterated. That led to the argument that the pharmacy had been negligent because of obtaining tablets in an adulterated state that were initially made in a form less than 500 mg. The pharmacy chain responded that it was not the manufacturer of the dosage forms and thus the plaintiff should not prevail with this argument. The court agreed.
The manufacturer of the tablets that had been dispensed argued that the FDA had found its version to be therapeutically equivalent to the product the patient had originally received. If there were a difference in therapeutic effect, the sole enforcement authority for that rested with the FDA under a specific provision in the relevant federal statute. The trial court judge dismissed that argument by the plaintiff, and the court of appeals affirmed it.
Finally, the plaintiff had argued that the pharmacy knew about the purported defect in the medication dispensed and had ignored that, resulting in her injury. In response, the defendants pointed out that plaintiff had been in possession of the allegedly subpotent dosage forms for more than 2 years with an opportunity to examine the chemical composition of the tablets. The plaintiff had never allegedly pursued such testing and had made no direct allegation of a defect existing in the dosage forms.
In conclusion, the court of appeals rejected all arguments advanced by the plaintiff in the various amended complaints, affirmed the decisions of the trial court, and, overall, affirmed dismissal of the lawsuit.
About the Author
Joseph L. Fink III, JD, DSS (Hon), BSPharm, FAPHA, is professor emeritus of pharmacy law and policy at the University of Kentucky College of Pharmacy in Lexington.