Present Issues in

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• 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 [phone]
• Bob_at_PharmacyLawyer.com

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