Legal Implications of Medical Errors

Introduction

• The Institute of Medicine has quantified that medication errors contribute to 1 out of 131 outpatient deaths and 1 out of 854 inpatient deaths. These errors can arise from a combination of factors:¹
  • Medication factors: similar-sounding drug names and drugs with a low therapeutic index
  • Patient factors: poor renal or hepatic function, impaired cognition, and polypharmacy
  • Healthcare professional factors: using abbreviations in prescriptions and other communications and cognitive biases
• The repercussions for physicians following medication errors are multifaceted.
  • Loss of patient trust
  • Civil litigation
  • Criminal charges
  • Disciplinary actions by medical boards
• Various strategies have been employed to mitigate such errors.
  • Information technology utilization
  • Improved drug labeling
  • Medication reconciliation
• When an error is identified, patients rightfully expect timely disclosure, preferably delivered in person, along with a sincere apology and a clear communication of preventive measures. Enhancing awareness about medication errors can empower healthcare professionals to safeguard patient well-being effectively.¹

Legal Process for Claims and Malpractice

• In the realm of healthcare, medical malpractice litigation serves three essential purposes:²
  • Deterrence: By holding physicians accountable, it discourages unsafe practices. The fear of legal consequences encourages adherence to professional standards.
  • Compensation: When patients suffer due to negligence, these lawsuits provide compensation. It addresses the physical, emotional, and financial impact on those harmed.
  • Corrective justice: It rectifies the harm caused by negligence and upholds accountability within the healthcare system.
• For a civil medical malpractice suit to succeed against a healthcare professional, several elements must be established:¹
  • Negligence: The physician’s actions must demonstrate negligence.
  • Injury: The negligence must result in harm to the patient.
  • Standard of care: The injured party must prove that a recognized standard of care exists.
  • Breach: The physician involved must have breached that standard.
  • Causality: The breach must directly cause the patient’s injury.
• The civil litigation process in medical malpractice cases includes several steps.³
  • Filing the summons and complaint:
    • The plaintiff initiates the process by filing a summons and complaint with the court, naming both the plaintiff and the defendant.
    • The complaint outlines the specific allegations of negligence, detailing the facts of the case and the resulting damages.
  • Expert affidavit (in some jurisdictions):
    • In certain jurisdictions, the complaint must be accompanied by an affidavit from a plaintiff expert witness.
    • This expert reviews the records and determines whether the care provided by the defendant’s psychiatrist was likely negligent.
  • Defendant’s answer:
    • The defendant responds by filing an answer, addressing each allegation in the summons and complaint.
    • This point-by-point response outlines the defendant’s position.
  • Discovery Process:
    • Both parties engage in the discovery process to gather facts and information about the case.
    • Methods include:
      • Document production: Sharing relevant documents
      • Interrogatories: Written questions posed by one party to another, requiring answers
      • Depositions: Formal question-and-answer sessions under oath

Closed Claims Database

• The Closed Claims Project was established by the American Society of Anesthesiologists (ASA) in 1984. Its primary purpose is to:
  • Systematically evaluate adverse anesthetic outcomes
  • Reviewing and analyzing closed claims files from professional liability insurance companies
  • Contributing to ongoing efforts to improve anesthesia safety and enhance patient outcomes⁴
• Medication-related issues accounted for approximately 7% of anesthesia claims between 1990 and 2007. These claims were fairly evenly distributed between adverse drug reactions and medication errors. Notably, medication management for chronic pain emerged as a significant patient safety concern in more recent claims. Here are some key points regarding medication errors in surgical and obstetric anesthesia care:⁴
• Common Errors:
  • Incorrect dosage: One of the most prevalent medication errors during anesthesia care was administering the wrong dosage.
  • Drug substitution errors: These errors included both syringe swaps and infusion swaps, where the incorrect medication was used.
  • Commonly implicated medications: Vasopressors and muscle relaxants were frequently involved in medication error claims.
• Preventability:
  • Most medication errors were considered preventable.
  • Unfortunately, these errors often resulted in a high proportion of brain injuries to patients.

Criminalization

• The criminalization of medical errors has garnered significant attention recently, particularly following the conviction of a Tennessee nurse. In this case, the nurse faced charges of gross neglect of an impaired adult and criminally negligent homicide after a patient died due to a medication error and lack of proper monitoring. The court granted judicial diversion, and the nurse received a three-year supervised probation sentence.
• It is essential to recognize that there are situations where criminal prosecution may be warranted, such as:
  • When a healthcare provider engages in reckless behavior
  • Commits errors while under the influence of impairing substances
  • Intentionally causes harm (which, by definition, is not an “error”)
• Balancing accountability with a supportive environment for learning and improvement remains a critical challenge in healthcare. Statutes and courts impose varying levels of responsibility when prosecuting healthcare professionals for negligent conduct under criminal law compared to civil penalties. The distinctions are as follows:^3,5
  • Definition: Criminal negligence, as defined by Oregon law, involves a person failing to be aware of a substantial and unjustifiable risk. This risk must constitute a gross deviation from the standard of care that a reasonable person would observe.
  • Standard: The accused must have failed to perceive a significant risk, demonstrating a more serious level of negligence.
  • Severity: Criminal negligence can escalate to a felony, especially if it leads to homicide or manslaughter; for example, a nurse knowingly administers the wrong medication, resulting in a patient’s death.
• In summary, while civil negligence focuses on compensation, criminal negligence involves a higher degree of risk awareness and potential legal consequences. The balance between these standards remains crucial in ensuring accountability within the healthcare system.
• Both criminal and civil negligence standards face limitations when applied to medical professionals. Most medication errors are often considered accidents, making it difficult to establish culpable fault. However, evolving public sentiments may lead to increased use of criminal standards in the future.