Washington Supreme Court Establishes No Duty for Pharmacists to Warn of Long-Term Drug Side Effects

Washington Supreme Court Establishes No Duty for Pharmacists to Warn of Long-Term Drug Side Effects

Introduction

In the landmark case of Elaine McKee v. American Home Products Corporation, et al. (113 Wn. 2d 701), decided on November 30, 1989, the Supreme Court of Washington addressed the extent of pharmacists' responsibilities concerning the dispensing of prescription drugs. Elaine McKee, the appellant, sought damages after becoming addicted to a prescription drug, Plegine, which she had been taking for a decade. McKee alleged negligence against the pharmacists for failing to warn her about the potential adverse effects of prolonged use of Plegine. The court's decision affirmed a summary judgment in favor of the pharmacists, establishing critical precedents regarding the scope of pharmacists' duties.

Summary of the Judgment

The Supreme Court of Washington reviewed the case where McKee claimed that the pharmacists were negligent in dispensing Plegine without adequately warning her of its addictive properties and long-term side effects. The trial court had granted summary judgment in favor of the pharmacists, a decision which McKee appealed. The Supreme Court affirmed the lower court's ruling, holding that McKee had not sufficiently established the pharmacists' duty of care as required by Washington law. The court emphasized that the standard of care must be established by experts in the same field and found that McKee's affidavit did not meet this requirement.

Analysis

Precedents Cited

The judgment extensively references prior cases to delineate the boundaries of pharmacists' duties. Key precedents include:

  • WILSON v. STEINBACH: Outlined the criteria for granting summary judgment.
  • YOUNG v. KEY PHARMACEUTICALS, Inc.: Established that pharmacists are not licensed to prescribe medication and lack the rigorous training of physicians, limiting their duty to warn.
  • TERHUNE v. A.H. ROBINS CO.: Affirmed the "learned intermediary" doctrine, placing the duty to warn on physicians rather than pharmacists.
  • HAND v. KRAKOWSKI and RIFF v. MORGAN PHARMACY: Presented scenarios where pharmacists had knowledge of prescription errors, contrasting the current case where no such errors were present.
  • HARRIS v. GROTH: Highlighted that determining due care is a question of fact for the jury, not a matter of law.

Legal Reasoning

The court's legal reasoning centered on the statutory definitions and the applicability of existing laws. Under RCW 7.70.040, McKee had to prove that the pharmacists failed to exercise the degree of care expected of a reasonably prudent pharmacist in Washington. The court held that:

  • The standard of care for pharmacists must be established by experts within the same field, which McKee failed to do.
  • The "learned intermediary" doctrine shifts the duty to warn from pharmacists to prescribing physicians.
  • Pharmacists are obligated to accurately fill prescriptions and be vigilant for obvious prescription errors but are not required to question the prescribing physician's judgment or warn about potential side effects not mandated by law.
  • Mandating pharmacists to warn about all potential side effects would disrupt the physician-patient relationship and impose undue burdens on pharmacists.

Furthermore, the court examined the statutory and regulatory framework, noting that RCW 18.64.011(11) defines the practice of pharmacy but does not mandate pharmacists to provide warnings about drug side effects. The court also discussed the practical implications of imposing such duties, including economic burdens and the potential for overwhelming patients with technical information.

Impact

This judgment has significant implications for the scope of pharmacists' duties in Washington:

  • Clarification of Duties: Pharmacists are affirmed to have no legal obligation to warn patients about the long-term side effects of prescription drugs unless there are clear, glaring errors in the prescription.
  • Reinforcement of the Learned Intermediary Doctrine: The responsibility to inform patients about drug risks predominantly lies with the prescribing physician.
  • Liability Limitations: Pharmacists are protected from liability in cases where they dispense drugs according to prescribed orders without additional warnings, provided there are no identifiable prescription errors.
  • Guidance for Future Cases: Sets a precedent that pharmacists must adhere strictly to their role in dispensing and verifying prescriptions but are not required to engage in medical judgment or patient counseling beyond regulatory mandates.

Complex Concepts Simplified

Summary Judgment: A legal procedure where the court decides a case without a full trial when there is no dispute over the key facts.

Standard of Care: The level of care and skill that a typical professional in the same field would provide under similar circumstances.

Learned Intermediary Doctrine: A legal principle that places the responsibility of informing patients about drug risks on the prescribing physician rather than the drug manufacturer or pharmacist.

Affidavit: A written statement confirmed by oath or affirmation, used as evidence in court.

RCW: Revised Code of Washington, the statutory law of the state.

WAC: Washington Administrative Code, the set of rules and regulations developed by state agencies.

Conclusion

The Washington Supreme Court's decision in McKee v. American Home Products Corporation establishes a clear limitation on the duties of pharmacists concerning the warning of long-term drug side effects. By affirming that pharmacists are not required to warn patients about potential adverse effects beyond their regulatory obligations, the court reinforces the delineation of responsibilities between healthcare providers. This judgment underscores the primacy of the physician-patient relationship in managing drug therapy and limits the scope of pharmacists' liability to the accurate dispensing of prescribed medications and the correction of obvious prescription errors. The ruling provides essential clarity for both pharmacists and patients, ensuring that each party understands their respective roles in the healthcare ecosystem.

Moving forward, pharmacists must focus on adhering to prescriptions accurately and vigilantly checking for any apparent errors without overstepping into medical counseling unless explicitly required by law. This decision balances the need for professional accountability with the practical limitations of the pharmacists' role in patient care, ultimately promoting a more efficient and legally sound healthcare system.

Case Details

Year: 1989
Court: The Supreme Court of Washington. En Banc.

Judge(s)

CALLOW, C.J. DORE, J. (dissenting)

Attorney(S)

Stephen J. Dwyer and Richard F. McDermott, Jr. (of McDermott Jones, P.S.) and Robert J. Conklin, for appellant. Carney, Stephenson, Badley, Smith, Mueller Spellman, P.S., Palmer Robinson, and James E. Horne, for respondent Sidran. John Patrick Cook, Timothy A. Reid, David L. Martin, and Lee, Smart, Cook, Martin Patterson, P.S., for respondent Mezistrano. Gary N. Bloom and Bryan P. Harnetiaux on behalf of Washington State Trial Lawyers Association, amici curiae for appellant. Ronald S. Dinning and Bruce G. Lamb on behalf of Washington Defense Trial Lawyers; Joseph D. Puckett, Stephan J. Francks, and Paul R. Cressman on behalf of Washington State Pharmacists' Association, amici curiae for respondents.

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