- Condition Centers
A drug manufacturer is sued over an adverse effect, and pharmacy dispensing records are entered as evidence.
Issue of the Case
In a lawsuit against a manufacturer alleging development of a severe drug-induced adverse reaction, is the patient’s introduction into evidence of records from the pharmacy listing “manufacturer” sufficient to indicate that the defendant firm’s product was in fact dispensed?
Facts of the Case
A patient in a southern state received a prescription for metoclopramide to treat reflux disorder, nausea, and vomiting. She consumed the medication on a long-term basis and began to experience abnormal body movements, subsequently diagnosed as tardive dyskinesia. Development of this disorder was linked to her consumption of the medication.
As part of the preliminary activities prior to trying the case in court, the plaintiff- patient produced 20 pages of pharmacy records from 1 pharmacy chain and 42 pages of similar information from another chain. In both instances, the records were described as coming from the “custodian/ person in charge of records” at the respective pharmacies. In the affidavits accompanying the records, the staff members stated that these were records “maintained in the regular course of business” and “were made at or near the time or reasonably soon after the time that the service was provided.” Finally, the affidavit indicated that the data had been “transmitted to the plaintiff-patient by a representative of the pharmacy who had personal knowledge of the information.”
At 1 pharmacy chain, the column on the records labeled “Drug Mfr.” bore the name of the manufacturer of the generic version of the medication, which was 1 of the defendants in the suit. The manufacturer of the brand name version had also been identified as a defendant in the suit. At the other pharmacy chain, the patient records indicated neither manufacturer name nor National Drug Code (NDC) number.
The generic manufacturer asked the court to enter summary judgment in its favor. A summary judgment is a determination made by the court without conducting a full trial. The relevant standard to decide such a request is that the motion should be granted only if “there is no genuine issue as to any material fact.” The party seeking the summary judgment bears the burden of convincing the judge that such a disposition of the matter is appropriate.
The core issue here was whether the pharmacy records submitted by the plaintiffpatient were sufficient to support the claim and send the matter to trial for a jury to decide.
The Court’s Ruling
The motion for summary judgment made by the defendantmanufacturer of the generic version of the product was denied. The pharmacy records were deemed to be sufficient.
The Court’s Reasoning
Citing a prior case, the court noted that in order to support the claim against the generic manufacturer the product identification evidence must “afford…more than mere speculation, conjecture or guess” in order to deny the motion for summary judgment and hold the issue over for a jury to decide.
The manufacturer had argued that the “records produced fail to adequately and sufficiently identify their firm as the manufacturer of the metoclopramide the patient-plaintiff ingested.” They based this argument on the fact that at 1 pharmacy chain the records disclosed neither manufacturer’s name nor NDC number. The records from the other chain “provided a manufacturer name with no supporting information as to how, when or who entered that information.” The manufacturer also argued that the records “included the prescription number for some entries but not for all, there were seemingly duplicate entries on some dates, and there was at least one questionable entry for a refill dispensed on a date weeks before it was due.”
The judge pointed out that while there were a number of unanswered questions at this stage of the proceedings, at this preliminary phase “the evidence of the non-movant (the plaintiff-patient here) is to be believed, and all justifiable inferences are to be drawn in his favor.” Any shortcomings in the evidence relate to the “credibility and weight” of the evidence, matters best left to the jury to determine at trial. To grant the summary judgment motion at this stage would short-circuit the process and deny the jury this important role.
The manufacturer also argued that the NDC number should have been included in the pharmacy’s dispensing records. The court reviewed the statutory and regulatory authority of the FDA in this field and concluded that there was no requirement that the NDC number be included in records at the pharmacy to identify the product that had been dispensed.
Dr. Fink is professor of pharmacy law and policy at the University of Kentucky College of Pharmacy, Lexington.