Walls v. Alpharma USPD, Inc.

Citations: 887 So. 2d 881; 2004 WL 406759Docket: 1010645

Court: Supreme Court of Alabama; March 4, 2004; Alabama; State Supreme Court

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In the case of Judith D. Walls v. Alpharma USPD, Inc., the Supreme Court of Alabama addressed certified questions regarding the duty of pharmacists to warn about potential injuries from prescription drugs. The court considered whether a pharmacist has a duty to provide warnings under the Alabama Extended Manufacturer's Liability Doctrine (AEMLD) or common-law negligence and whether that duty extends to third parties, such as the fetus of a customer’s spouse, when dispensing medication.

The background involves Judith Walls, who used Lindane lotion, prescribed to her husband for scabies, during her pregnancy, leading to the birth of a child with medical conditions allegedly caused by the medication. Claims against pharmacies were previously dismissed due to the absence of a patient-healthcare provider relationship. The current claims allege that the pharmacies acted negligently by placing a dangerous product into commerce without adequate warnings.

Defendants argue that their duty is limited to filling prescriptions accurately as directed by physicians, who act as learned intermediaries responsible for communicating risks to patients. The court recognized that this case involves the learned-intermediary doctrine, which limits a manufacturer’s duty to warn to the prescribing physician, and noted that it had not previously ruled on the specific issue of a pharmacist's duty to warn foreseeable consumers about medication risks.

The learned intermediary doctrine serves as an exception to the general rule requiring manufacturers to warn end users about product dangers. Instead, the emphasis is placed on the warning's effectiveness for prescribing physicians, who are deemed capable of understanding complex medical information. In *Stone v. Smith, Kline, French Laboratories*, the court affirmed that if a warning adequately informs a physician about a drug's risks, it suffices legally, even if the ultimate consumer is not warned. The case involved a risk of cholestatic jaundice associated with Thorazine, which was known to the prescribing physician; thus, the court rejected the plaintiffs' claim that the physician's inability to predict which patients would suffer adverse effects negated the adequacy of the warning. The court highlighted that the physician’s role is to make an informed decision based on the drug’s risks and the patient's condition, reflecting a personalized medical judgment. Consequently, pharmaceutical companies are required to inform only the prescribing physician about potential medication dangers, rather than the consumers themselves, aligning with the doctrine's rationale.

The appellate courts in Alabama have not yet ruled on whether pharmacists have a duty to warn customers about the risks or side effects of prescribed medications. However, other states have addressed this, providing persuasive authority on whether to apply the learned-intermediary doctrine to pharmacists. The Kansas Court of Appeals, in Nichols v. Central Merchandise, Inc., extended this doctrine to pharmacists, holding that manufacturers of prescription medications have a duty to warn of dangers, which is satisfied when the prescribing doctor is informed of a drug’s risks. The doctor, as the learned intermediary, is responsible for informing the patient, thereby relieving the pharmacist of any legal duty to warn patients about potential drug consequences in this case.

Various cases support this view, emphasizing that imposing a warning duty on pharmacists would intrude on the doctor-patient relationship and effectively require pharmacists to practice medicine without a license. Additionally, it would be unreasonable to impose a greater duty on pharmacists than on drug manufacturers. The Washington Supreme Court's conclusion reinforces that while pharmacists must accurately fill prescriptions and be vigilant for errors, they are not obligated to question a physician's judgment or provide warnings about side effects.

In McKee v. American Home Products, the court found that the pharmacist correctly filled a prescription for Gantanol without any evident errors, and the prescribing physician acted within his professional judgment. Consequently, Super D Drugs and its pharmacist did not have a duty to warn the patient or her doctor about the medication. The court upheld summary judgment, aligning with various precedents that support the learned-intermediary doctrine. This doctrine holds that the duty to inform patients about medication risks lies primarily with the prescribing physician, as they have the necessary medical knowledge and understanding of the patient’s history. Pharmacists, lacking such training, are not expected to evaluate dosages or risks beyond what is explicitly required by law or the prescription's labeling. Thus, pharmacists are shielded from liability regarding warnings about prescribed medications, as any duty to assess the safety of the prescription falls to the physician. The court concluded by affirming that no additional duty exists for pharmacists under these circumstances.