Pharmacy Unaware of Pregnancy—Is There a Duty to Warn?
Issue of the Case
In this month's case, the SupremeCourt of Mississippi was askedwhether a pharmacy had a duty towarn about the contraindication of adrug when it was unaware that thepatient was pregnant.
Facts of the Case
The plaintiff in this case had a historyof hypertension and anemia. Duringher pregnancy, she was hospitalizedand was prescribed methyldopa(Aldomet), vitamins, and iron. Uponher discharge from the hospital, theplaintiff had her Aldomet prescriptionfilled by the defendant pharmacy. Thephysician later increased the Aldometdosage to 500 mg every 8 hours andfurther prescribed Diovan 80 mg oncea day.
The plaintiff had a normal delivery,but 4 days later the infant had anepisode of apnea. The child was hospitalizedwith respiratory distress, wentinto cardiopulmonary arrest, and wasdiagnosed with acute renal failure. Thedischarge diagnosis was end-stagerenal disease, secondary to maternaltreatment with an angiotensin IIreceptor blocker for hypertension duringthe third trimester of pregnancy.
The child has developed hypertensionand is not growing at a normalrate. She cannot eat any solids becauseshe has a hyperactive gag reflex. Witha diagnosis of end-stage kidney failure,she requires a kidney transplant.
The plaintiff and her husband fileda lawsuit on behalf of their infantdaughter, alleging that Diovan causedthe child's kidney failure. They suedthe physicians for prescribing a drugthat is known to cause renal failure infetuses, and the pharmacy for negligencein dispensing a drug that is contraindicatedfor pregnant women.
The pharmacy countered by assertingthat it accurately filled the prescriptionas written by the physician.Thus, pursuant to the learned intermediarydoctrine, it claimed that itwas under no duty to advise the plaintiffof possible side effects of the medicationor to second-guess the appropriatenessof the prescription, becausethe prescriber had the duty to warnthe patient.
The Court's Ruling
The trial court agreed with the pharmacyand granted summary judgment.On appeal, the Supreme Courtof Mississippi noted several instancesin which a pharmacy would have aduty to warn, but it found that thoseexceptions did not exist in this case.The court affirmed the trial court'sholding.
The Court's Reasoning
The plaintiffs argued that the trialcourt erred because its characterizationof a pharmacist's duty was toonarrow, and that a pharmacist mustdo more than provide the right drugin the right dosage. They claimed thatthe pharmacy knew or should haveknown that the plaintiff was pregnant,and that Diovan should not have beendispensed to her.
The learned intermediary doctrineholds that pharmaceutical companiesare required to warn only the prescribingphysician of dangers associatedwith a drug, because the prescriberacts as the intermediary between themanufacturer and the patient. Thecornerstone of the doctrine is the abilityof the physician to intervenebetween the manufacturer and thepatient to make an informed decisionas to the course of treatment, based onthe physician's knowledge of the drug,as well as the particular needs of thepatient.
Following this legal theory, it is thephysician, not the pharmacist, who isbest situated to know the properties ofthe drug being prescribed and theneeds of the patient. It is the physicianwho bears the duty to warn.
An exception to the learned intermediarydoctrine exists when it isundisputed that a plaintiff has informedthe pharmacy of health problemsthat contraindicate the use of thedrug in question. In this case, therewas absolutely no evidence that thepharmacist dispensing the drug knewthat the plaintiff was pregnant.
A second exception arises whenpharmacists are presented with prescriptionsfor dosages that are excessiveor inconsistent with prescribingguidelines. Here, however, it was clearthat the Diovan dosage was not excessiveand that the pharmacy properlyfilled the prescription as written.
Because the 2 exceptions to the generalrule were not applicable to thiscase, it was appropriate that the lawsuitproceed against the physicians butbe dismissed against the pharmacy.
Larry M. Simonsmeier isEmeritus Professor ofPharmacy Law atWashington State UniversityCollege of Pharmacy.