On The Docket
David B. Brushwood, BSPharm, JD
When a manufacturer initiates a recall, a health care institution will need to conduct a thorough search to remove all recalled drugs from patient care settings. A recent case from Florida reviewed the adequacy of a hospital’s efforts to retrieve and return all medication that was the subject of a manufacturer’s recall.
Background
A heparin manufacturer informed the defendant hospital of a recall for certain lots of their heparin product due to possible contamination. The hospital’s pharmacy buyer was responsible for executing recalls. She testified that, per hospital procedure, once heparin entered the hospital’s pharmacy, “lot numbers were not tracked; and the vials were subsequently distributed to multiple locations throughout the hospital, including automated dispensing units, satellite pharmacies, the operating room pharmacy, and heart boxes.”
The buyer instructed pharmacy technicians to conduct 3 searches of the hospital to remove recalled product from areas where it might be used in patient care. The buyer “noted that no documentation was created or maintained reflecting which areas were searched or which vials had been removed.”
A patient was admitted for heart bypass surgery. An anesthesiologist administered heparin to the patient but did not record the lot numbers of the vials he used. The anesthesiologist testified that he had not been notified of the recall of heparin and that he used heparin located in a blue box in his anesthesia cart. The buyer testified that she was not aware of the blue boxes used by anesthesiologists for medication storage.
Following his surgery, the patient suffered heparin-induced thrombocytopenia with thrombosis (HITT). As a result, his left leg and right foot were amputated. There was testimony that HITT is a usual and expected result of heparin use. There was also testimony that the way HITT manifested in this patient was atypical and consistent with contaminated heparin use.
The buyer testified that 10 days after the surgery, the heparin manufacturer notified the hospital that some hospitals had “failed to retrieve heparin from ancillary locations such as anesthesia carts.” As a result, those areas at the defendant hospital were searched. The buyer was shown a receipt “documenting hospital return of heparin” one month after the surgery, and she testified that it “reflected delayed credit for vials returned several months prior.”
The patient’s estate sued the hospital alleging that “as a result of inadequate pharmaceutical tracking and recall procedures, contaminated heparin remained at the hospital and was administered by [the anesthesiologist] who had not been informed of the contaminated heparin or its recall.”
The trial court ruled in favor of the hospital and dismissed the case, concluding that there was insufficient evidence for a jury to find the hospital liable. The plaintiffs appealed.
Rationale
The appellate court reversed dismissal of the case. The court said that “doubt exists” as to whether contaminated heparin was “still circulating” and whether it was administered to the patient.
The hospital had not conclusively stated that it had removed all contaminated heparin prior to the patient’s surgery “when it failed to track lot numbers or obtain a certificate of compliance with the recall.”
The court concluded that “the evidence in this case, while conflicting and susceptible to different reasonable inferences, should have been submitted as a question of fact to be determined by the jury.”
The case will be presented to a jury unless it is settled out of court.
Takeaways
An expert witness in this case outlined appropriate strategies for addressing a recall.
- Either record lot numbers and track them throughout distribution, or retrieve all product after a recall regardless of lot number.
- Identify all end users and all locations where the drug is stored, then notify end users and search all storage areas.
- Document the implementation of a recall from the time of notice to the time of full removal.
- Sign the standard certificate indicating that all recalled product has been removed. ■■■