/publications/issue/2005/2005-10/2005-10-4908

Pharmacy Unaware of Pregnancy—Is There a Duty to Warn?

Author: Larry M. Simonsmeier, JD, RPh

Issue of the Case

In this month's case, the Supreme Court of Mississippi was asked whether a pharmacy had a duty to warn about the contraindication of a drug when it was unaware that the patient was pregnant.

Facts of the Case

The plaintiff in this case had a history of hypertension and anemia. During her pregnancy, she was hospitalized and was prescribed methyldopa (Aldomet), vitamins, and iron. Upon her discharge from the hospital, the plaintiff had her Aldomet prescription filled by the defendant pharmacy. The physician later increased the Aldomet dosage to 500 mg every 8 hours and further prescribed Diovan 80 mg once a day.

The plaintiff had a normal delivery, but 4 days later the infant had an episode of apnea. The child was hospitalized with respiratory distress, went into cardiopulmonary arrest, and was diagnosed with acute renal failure. The discharge diagnosis was end-stage renal disease, secondary to maternal treatment with an angiotensin II receptor blocker for hypertension during the third trimester of pregnancy.

The child has developed hypertension and is not growing at a normal rate. She cannot eat any solids because she has a hyperactive gag reflex. With a diagnosis of end-stage kidney failure, she requires a kidney transplant.

The plaintiff and her husband filed a lawsuit on behalf of their infant daughter, alleging that Diovan caused the child's kidney failure. They sued the physicians for prescribing a drug that is known to cause renal failure in fetuses, and the pharmacy for negligence in dispensing a drug that is contraindicated for pregnant women.

The pharmacy countered by asserting that it accurately filled the prescription as written by the physician. Thus, pursuant to the learned intermediary doctrine, it claimed that it was under no duty to advise the plaintiff of possible side effects of the medication or to second-guess the appropriateness of the prescription, because the prescriber had the duty to warn the patient.

The Court's Ruling

The trial court agreed with the pharmacy and granted summary judgment. On appeal, the Supreme Court of Mississippi noted several instances in which a pharmacy would have a duty to warn, but it found that those exceptions did not exist in this case. The court affirmed the trial court's holding.

The Court's Reasoning

The plaintiffs argued that the trial court erred because its characterization of a pharmacist's duty was too narrow, and that a pharmacist must do more than provide the right drug in the right dosage. They claimed that the pharmacy knew or should have known that the plaintiff was pregnant, and that Diovan should not have been dispensed to her.

The learned intermediary doctrine holds that pharmaceutical companies are required to warn only the prescribing physician of dangers associated with a drug, because the prescriber acts as the intermediary between the manufacturer and the patient. The cornerstone of the doctrine is the ability of the physician to intervene between the manufacturer and the patient to make an informed decision as to the course of treatment, based on the physician's knowledge of the drug, as well as the particular needs of the patient.

Following this legal theory, it is the physician, not the pharmacist, who is best situated to know the properties of the drug being prescribed and the needs of the patient. It is the physician who bears the duty to warn.

An exception to the learned intermediary doctrine exists when it is undisputed that a plaintiff has informed the pharmacy of health problems that contraindicate the use of the drug in question. In this case, there was absolutely no evidence that the pharmacist dispensing the drug knew that the plaintiff was pregnant.

A second exception arises when pharmacists are presented with prescriptions for dosages that are excessive or inconsistent with prescribing guidelines. Here, however, it was clear that the Diovan dosage was not excessive and that the pharmacy properly filled the prescription as written.

Because the 2 exceptions to the general rule were not applicable to this case, it was appropriate that the lawsuit proceed against the physicians but be dismissed against the pharmacy.

Larry M. Simonsmeier is Emeritus Professor of Pharmacy Law at Washington State University College of Pharmacy.