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Oct. 10, 2013Chapter 8

Pharmacist Malpractice Liability & Risk

Management Strategies

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Introduction

• Malpractice is negligence and a type of tort• Negligence is an unintentional act that

causes harm as contrasted from intentional torts

• Purposes of negligence or malpractice law is to compensate the victim and to deter careless and irresponsible acts

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Legal Procedure

• Settlements common in negligence actions• Settlements do not establish precedent• Preliminary motions such as summary

judgments which are appealed do establish precedent, even if the case is ultimately settled

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Elements of Negligence• Elements

– Duty– Breach of duty– Causation– Damages

• The plaintiff must prove all 4 elements with a preponderance of evidence

• The defendant will try to establish an affirmative defense

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Duty• Duty for pharmacists is an objective reasonable standard

requiring that degree of care that a reasonable prudent pharmacist would use under similar circumstances

• Pharmacists held to an error-free standard for mechanical type acts (those not requiring professional judgment)

• In contrast, decisions requiring professional judgment will be judged on the basis of reasonableness

• One important determinant of duty is relationship• Another important factor of duty is foreseeability• Courts are reluctant to find existence of a duty to a person

other than patient (c.f., loss of consortium)

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Breach of Duty• A nonjudgmental error in filling (misfilling) a Rx is a

breach of duty as a matter of law• With judgmental acts, proof of the standard of care

and whether it was breached will likely be established by expert witnesses

• Expert witnesses not generally required for misfiling• Doctrine of negligence per se means that if a

pharmacist violates a statute or regulation, the violation in itself could establish negligence– Plaintiff must be within the class the statute or

regulation seeks to protect; and, the harm must be of the type it seeks to protect

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Causation• Actual cause

– Plaintiff must prove defendant’s negligent conduct was a substantial factor in the harm caused

– Often difficult to prove in drug cases and requires expert witnesses

• Proximate cause

– A determination of the extent to which the defendant should be held liable for the conduct

– Usually based upon a determination of foreseeability– Unforeseeable superceding causes will sever the

defendant’s responsibility

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Damages

• Actual damages– Loss of income– Medical expenses– Pain & suffering• Many states have established ceilings on awards

– Eggshell rule- must accept patient as he/she is• Punitive damages– Awarded for willful or reckless negligence– Considered as punishment

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Defenses to Negligence• Contributory negligence

– Common law rule completely barring recovery• Comparative negligence

– Statutory, requiring court to base judgment award on relative negligence of each party

• Modified Comparative Negligence– Can recover if plaintiff’s fault less than that of all defendants

• Statute of limitations [Against RPh – 6 years!]

– Plaintiff must bring claim within a specified period of time (Personal Injury from Negligence: 6 years ME, 3 years MA) (Medical Malpractice 3 years ME, but pharmacists are NOT health care practitioners afforded the 3 year statute of limitations)

– Discovery rule defers the time until plaintiff actually discovers what caused the injury

– Statute of repose limits the discovery period time

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Vicarious LiabilityRespondeat Superior

• Employer responsible for the negligent act of employees

• Purpose of rule to cause employers to hire and train competent employees

• Plaintiff has right to sue employer and/or employee

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Liability for Failure to Perform Expanded Responsibilities

• Pharmacy practice has evolved from where pharmacists were only responsible for processing Rxs accurately to today where pharmacists now have expanded responsibility to improve patient outcomes

• The Riff decision held that the pharmacist is a member of the health care team and as such must play a brother’s role with regard to others on the team

• The pharmaceutical care model is patient oriented, not physician oriented

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Traditional Rule of Law

Historically courts have taken the position that a pharmacist has no legal duty to warn a patient of the adverse effects of a drug. The pharmacist’s duty is to accurately dispense the Rx as written.

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Reasons for Traditional Rule of Law

• Relationship• Physician primacy

– Patient relies on physician, not pharmacist– Interfere with physician-patient relationship– No independent pharmacist-patient relationship

• Foreseeability

– Only physician has requisite patient information• Social Policy

– Unfair burden on pharmacists• Requires them to question every Rx• Creates antagonism with prescribers

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Emerging Judicial Trend

Duty of a pharmacist to provide expanded patient services based upon 3 factors (Hooks SuperX decision)– Relationship– Foreseeability– Public policy

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Reasons for Emerging Judicial Trend(Hooks Super X Case)

• Relationship

– Pharmacist-patient relationship is independent– Patient relies on pharmacist because of knowledge &

expertise• Foreseeability

– Pharmacist only expected to warn of foreseeable risks, not all risks

• Social policy

– Prevent drug abuse– Reinforces physician-patient relationship– Health care costs will decrease

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Continuance of Trend

Courts across the country have adopted some version of the Hooks SuperX rationale for recognizing expanded responsibilities for pharmacists.

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Modifications of General Duty Approach(Discussed with Happel Case Study 8-1)

• Rather than adopt a general duty approach, some courts have adopted a more limited approach as exemplified by the Morgan & Pettus v. Wal-Mart decision

• Court found pharmacists have no general duty to warn absent “special circumstances” which include:

– Special instructions by manufacturer to warn– Contraindications– Special knowledge by pharmacist of patient’s

condition

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ASSUMPTION OF DUTYBaker Decision

A pharmacy will be held liable when it voluntarily assumes a function that it was under no legal obligation to assume and a patient relies on that function to his/her detriment.

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Risk Management Strategies

• Failures of quality cause error and human harm and may lead to board disciplinary action

• The goal of risk management is to reduce the incidence of errors thus protecting patients

• Over zealous risk management can result in such a restrictive approach to practice as to compromise good patient care

• Effective risk management requires the development of quality systems

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Institutional Controls

• Courts recognize the responsibility of companies to develop and maintain appropriate systems for order processing and to detect errors before a patient is harmed

• Failure of a business to develop such systems in spite of numerous errors could result in punitive damages for reckless or conscious disregard for the safety of patients

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Corporate Negligence

• Corporate negligence differs from professional negligence and respondeat superior. It establishes that a corporation is responsible and liable for its own acts, apart from the acts of its employees

• Corporate negligence focuses on the company’s system as a cause of errors, rather than the individual

• Punitive damages may be awarded to force companies to develop a higher quality system

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Quality Assurance Programs

The risk of corporate negligence requires companies to develop continuous quality improvement programs and use them. This requires companies to:

• Maintain policies and procedures related to error situations• Implement an incident reporting system where errors are

reported and documented, investigated, and acted upon• Periodically evaluate employees• Continually assess and improve the quality of their system

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Pharmacist as Risk Manager• Pharmacists have a responsibility to the patient after an

error is made known• Pharmacists should understand the importance of verbal

communication with patients when discussing an error and the importance of adequate documentation

• Pharmacists should be able to apply some general risk management rules to error situations

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Malpractice Insurance

• Important to have individual insurance even if covered by employer

• Most policies exclude coverage for intentional violations• Pharmacists should make certain the policy covers all

activities in which they might be engaged including compounding, blood testing, immunizations, and initiating or adjusting drug therapies pursuant to a collaborative practice agreement.

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Duty to Warn Under Learned Intermediary Doctrine

• Assuming the risk is known, the manufacturer owes the duty to warn to the prescriber

• This is known as the learned intermediary doctrine

• DTC advertising may erode this doctrine(Perez v. Wyeth case)