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[Guidelines and jurisprudence: advice, guidance or regulation?]
1Dipartimento di Medicina Generale, St Mary's Hospital Medical School, Londra.
Epidemiologia E Prevenzione
|October 28, 1998
Summary
Clinical guidelines are increasingly used in legal cases, but adherence doesn't guarantee protection from liability. Courts critically evaluate guidelines, considering their authority and flexibility in determining medical negligence. Developers may face liability for faulty guidance.
Area of Science:
- Legal Medicine
- Medical Malpractice
- Clinical Practice Guidelines
Background:
- The proliferation of clinical guidelines raises questions about their advisory versus mandatory nature and regulatory functions.
- Concerns exist regarding the extent to which guidelines permit clinical discretion.
- The interplay between legislation and clinical guidelines, and judicial determination of their legal status, are areas of ongoing discussion.
Purpose of the Study:
- To analyze the legal status and implications of clinical guidelines within the context of negligence law.
- To determine if deviating from guidelines increases a doctor's risk of liability.
- To assess whether guideline compliance protects healthcare professionals from liability and examine the legal responsibility of guideline developers.
Main Methods:
- Identification and analysis of common law cases involving clinical guidelines or protocols from UK, Commonwealth, and US jurisdictions using the Lexis database.
- Consultation of secondary literature, including bibliographies of clinical guidelines, to supplement case law analysis.
- Examination of statutory backing, acceptance by medical professionals, and sanctions for non-compliance to gauge the mandatory effects of guidelines.
Main Results:
- The legal status of a guideline depends on its development, application, statutory backing, and acceptance by a responsible body of doctors.
- US courts have established that guideline developers can be liable for faulty guidelines, and adherence does not absolve physicians of liability.
- While guidelines offer examples of clinical standards, courts critically evaluate their authority, flexibility, and scope before equating adherence with reasonable practice.
Conclusions:
- Clinical guidelines are increasingly influential in legal settings, serving as benchmarks for clinical standards.
- Adherence to guidelines is not automatically considered reasonable practice; courts maintain a critical stance on their application.
- The legal landscape suggests a nuanced approach where guidelines inform, but do not solely dictate, standards of care in negligence cases.
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