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Present Issues in Pharmacy Litigation Robert P. Esgro, R.Ph., Esq. Attorney & Pharmacist Villanova, Pennsylvania 1 EDUCATIONAL OBJECTIVES At the conclusion of this ... – PowerPoint PPT presentation

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Title: Present Issues in


1
  • Present Issues in
  • Pharmacy Litigation
  • Robert P. Esgro, R.Ph., Esq.
  • Attorney Pharmacist
  • Villanova, Pennsylvania

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Present Issues in Pharmacy Litigation
  • EDUCATIONAL OBJECTIVES
  • At the conclusion of this program, participants
    will be able to
  • 1. Describe the requirements to bring a
    negligence case
  • 2. Apply the principles of negligence to
    pharmacy practice.
  • 3. Identify problem areas in pharmacy practice
    that can effect the rise of professional
    liability.
  • 4. Recognize how to reduce problem areas.
  • 5. Discuss the current topics in pharmacy
    litigation.

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Present Issues in Pharmacy Litigation
  • Specific Topics that will be covered
  • 1. Negligence - generally defined then
    specifically applied to pharmacy.
  • 2. Standard of Care - Define what is meant by
    pharmacy
  • 3. Duty to Warn - Address what is meant by the
    duty to warn

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Present Issues in Pharmacy Litigation
  • Terms in Civil Cases
  • Civil Liability Legally enforceable debt
  • Tort wrongs committed by a breach of legal duty
  • Negligence Lack of diligence or care
  • Failure to use reasonable care

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Present Issues in Pharmacy Litigation
  • Implied Warranty or Warranty of
    Merchantability - unwritten or assumed that the
    product will do what is supposed to.
  • Warranty of Fitness for a Particular Purpose
    Exists when a buyer is relying on sellers
    expertise

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Present Issues in Pharmacy Litigation
  • Respondeat Superior(rehs-pond-dee-at superior)
    Latin for "let the master answer"
  • This doctrine which makes the principal
    (employer) responsible for the actions of his/her
    agent (employee) in the "course of employment."

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Present Issues in Pharmacy Litigation
  • Learned Intermediary Rule
  • A legal term used to describe the physicians
    relationship with the patient.
  • Some state courts have held that the physician
    is in the best position to warn patients.
    Therefore, removing claims against the
    manufacturer and the pharmacists.

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Present Issues in Pharmacy Litigation
  • Types of Negligence
  • Ordinary Negligence It is a level of care or
    skill, which is acceptable and appropriate by
    reasonably prudent pharmacist under similar
    circumstances.
  • Gross Negligence - Reckless disregard or acting
    so reckless that theres a lack of concern
    whether an injury will occur. Wanton or reckless
    conduct is more than ordinary negligence and is a
    higher degree of carelessness. This includes
    willful misconduct or intent to harm.

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Present Issues in Pharmacy Litigation
  • NEGLIGENCE
  • Plaintiff must prove these 4 elements to succeed
    or no recovery
  • 1. Duty
  • 2. Breach of Duty
  • 3. Causation
  • 4. Damages

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Present Issues in Pharmacy Litigation
  • Pharmacist Duty
  • Maintaining professional competence
  • Using such skill and precaution in preparation,
    compounding, dispensing, labeling, and sale of
    drugs so as to prevent injury or death to all
    who are exposed to his professional services.
  • Pharmacy Owners have additional duty to employ
    only qualified persons.
  • Pharmacy Law Digest 36th Edition 2002

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Present Issues in Pharmacy Litigation
  • Standard of Care
  • Really a test of what the Ordinary Reasonable
    Pharmacist would do in that particular situation.
  • State Regulations and Law may help define.
  • Probably going to be the most basic or minimal
    standard of ORP.

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Present Issues in Pharmacy Litigation
  • Duty to Warn
  • State and federal laws required pharmacist to
    counsel. The duty to warn has really stemmed
    from those laws.
  • State Courts still seem to take the approach that
    the physician should provide drug warnings
    Learned Intermediary.
  • However, when a pharmacist warns, they must
    provide accurate information. The pharmacist
    does not have to provide every risk.
  • Kasin v. Osco Drugs, Slip Op No 2-99-0356 (April
    12, 2000), 2000 Ill App Lexis 242

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Present Issues in Pharmacy Litigation
  • Morgan v. Wal-Mart Stores, Inc., (Tex.App. Dist.3
    08/10/2000)
  • Texas appeals court held that there was a law
    requiring pharmacists to counsel, but it was not
    specific. The court held pharmacists have no
    generalized duty to warn patients of potential
    adverse reactions to prescription drugs absent
    some special circumstances not present here."

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Present Issues in Pharmacy Litigation
  • Happel v. Wal-Mart Stores, Inc., (Illinois, 2000
    - 2004)
  • Facts Patient known allergy to NSAIDs and was
    dispensed Toradol.
  • Damages Long term medical problem
  • Claim Asserted breach of Duty to Warn
  • Defense Asserted Learned intermediary
  • Holding Pharmacy had specific knowledge of
    potential allergic reaction and should have
    warned.

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Present Issues in Pharmacy Litigation
  • Causation
  • It may seem clear at first that the pharmacists
    breach of duty caused a recoverable loss.
  • However, the pharmacists breach of duty may not
    have been the actual cause of harm.

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Present Issues in Pharmacy Litigation
  • Two Types of Damages
  • Actual Damages
  • Money paid from the actual loss
  • Calculated
  • 2. Punitive Damages
  • Money paid as a form of punishment
  • Jury determines amount

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Present Issues in Pharmacy Litigation
  • Damages
  • May seem obvious there were or were not damages,
    but this can be deceiving.
  • There must be an injury or loss of property
  • Patient
  • Family member(s)

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Present Issues in Pharmacy Litigation
  • Attempt by States to Reduce Malpractice
  • Requiring a Certificate of Merit
  • Expert Witness Report may be required
  • to validate the cause of action and breach.
  • 3. Expert Witness Testimony which
  • increases costs
  • Deposition
  • Trial
  • 4. Cap to non-economic damage awards

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Present Issues in Pharmacy Litigation
  • Prior bad acts
  • Some states have laws that prohibit prior
    reports prescription errors reports, certain
    Board of Pharmacy complaints, and evidence of
    other lawsuits filed against the pharmacy.
  • A national chain in one state had 2,900
    misfilled prescription in one year. This was
    allowed to be introduced to a jury. This lead
    to an enormous jury verdict against the pharmacy.
  • An attempt to reduce punitive damages.
  • Hundley v. Rite Aid of South Carolina, Inc.,
    339 S.C. 285, 529 S.E.2d 45 (S.C. App. Ct. 2000)

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Present Issues in Pharmacy Litigation
  • Pharmacist Malpractice Cases
  • Pharmacy has had relatively few malpractice
    claims as compared to other professions.
  • However, this will likely change.

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Present Issues in Pharmacy Litigation
  • Progression of a Civil Trial
  • Plaintiff files a claim and defendant answers.
  • Discovery parties collect evidence
  • Deposition statements are taken
  • Trial or Settle

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Present Issues in Pharmacy Litigation
  • Case 1 Misfill Prescription
  • Prescription was mistyped
  • - wrong strength, directions, or drug
  • Refilled with wrong drug
  • Prevention Go back to original on 1st refill
    and review what was typed

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Present Issues in Pharmacy Litigation
  • Case 1 Plaintiff Claims
  • 1. Pharmacist
  • Negligent filling practice
  • 2. Employer
  • Negligent Hiring Practice
  • Negligent Employee Retention
  • Negligent Training and Policy
  • Negligent Work Conditions

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Present Issues in Pharmacy Litigation
  • Case 1 Damages and Outcome
  • Actual Damages would need to be calculated
  • Are there enough damages to bring an action or
    enough to cause you grief
  • Settlement or trial

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Present Issues in Pharmacy Litigation
  • Case 2 Patient Dies
  • No apparent pharmacy error
  • Prescriptions for
  • Oxycodone SR Oxycodone/APAP
  • Cyclobenzaprine Zolpidem
  • Patient on meds for years and tolerant
  • Patient dies
  • Pharmacy sued even though no apparent mistake by
    pharmacy

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Present Issues in Pharmacy Litigation
  • Case 2 Plaintiff Claims
  • Negligence on behalf of the Pharmacy/Pharmacist
  • Negligence on behalf of the Physician
  • Negligence on behalf of the State

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Present Issues in Pharmacy Litigation
  • Case 2 Why the Pharmacist
  • Physician has insufficient insurance and can not
    be found
  • Pharmacist is the next in line
  • Lack of documentation for drug interactions
  • Pharmacist will likely pay some amount

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Present Issues in Pharmacy Litigation
  • Case 3 Failure to Monitor
  • Lawyers have little or no knowledge of what you
    do.
  • Lawyer wanted to bring an action against a
    retail pharmacist for not monitoring, suggest to
    monitor, or knowing lab values before dispensing.

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Present Issues in Pharmacy Litigation
Present Issues in Pharmacy Litigation
  • How can you reduce you liability risk?
  • Fill prescriptions (retail/hospital) at your own
    pace.
  • Get to know your patients

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Present Issues in Pharmacy Litigation
Present Issues in Pharmacy Litigation
  • Follow your companys/hospitals filling policy
  • Follow your companys error reporting procedure

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Present Issues in Pharmacy Litigation
Present Issues in Pharmacy Litigation
  • 5. Document anything unusual on the
    prescription.
  • Why did you do what you did
  • Staple a cut out of the package insert to back of
    the prescription write what you did discussed
    with pt or gave copy to pt

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Present Issues in Pharmacy Litigation
Present Issues in Pharmacy Litigation
  • Never put anything in writing on your own!!!
  • It will likely be used against you or at least
    embarrass you.

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Present Issues in Pharmacy Litigation
Present Issues in Pharmacy Litigation
  • When an error is made
  • The pharmacist must promptly rectify it.
  • You should inform the patient and physician.
  • i.e. Alprazolam was misfilled for another
    drug.
  • Patients physician was not notified by the
    pharmacist. Therefore, the patient was abruptly
    discontinued instead of being tapered as was
    later done. The situation became even worse due
    to lack of action the part of the pharmacist.

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Present Issues in Pharmacy Litigation
Present Issues in Pharmacy Litigation
  • Malpractice Insurance
  • Your employer will likely have coverage that
    insures you as well as the pharmacy
  • Because pharmacy coverage is relatively
    inexpensive it is wise to have your additional
    coverage.

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  • Contact Information
  • Robert P. Esgro, R.Ph., Esq.
  • Pharmacist-Lawyer
  • 80 Ithan Avenue
  • Villanova, PA 19085
  • Phone (610) 308-6666
  • Bob_at_PharmacyLawyer.com

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