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

Present Issues in Pharmacy Litigation

Robert P. Esgro, R.Ph., Esq.Attorney & PharmacistVillanova, Pennsylvania

1

EDUCATIONAL OBJECTIVESAt the conclusion of this program, participants will be

able to:1. Describe the requirements to bring a negligence

case2. 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.


2

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


3

Terms in Civil Cases

1. Civil Liability – Legally enforceable debt

2. Tort – wrongs committed by a breach of legal duty

3. Negligence – Lack of diligence or careFailure to use reasonable care


4


4. Implied Warranty or Warranty of Merchantability - unwritten or

assumed that the product will do what is supposed to.

5. Warranty of Fitness for a Particular Purpose – Exists when a buyer is

relying on seller’s expertise

5

6. 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."


6

7. Learned Intermediary RuleA legal term used to describe the physician’s 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.


7

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 there’s 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.


8

NEGLIGENCE Plaintiff must prove these 4 elements to succeed or no recovery

1. Duty 2. Breach of Duty 3. Causation 4. Damages


9

Pharmacist Duty1. Maintaining professional competence2. 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.*

3. Pharmacy Owners have additional duty to employ only qualified persons.

*Pharmacy Law Digest 36th Edition 2002


10

Standard of CareReally 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.


11

Duty to WarnState 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


12

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."


13

Happel v. Wal-Mart Stores, Inc., (Illinois, 2000 - 2004)

Facts: Patient known allergy to NSAIDs and was dispensed Toradol.

Damages: Long term medical problemClaim Asserted: breach of “Duty to Warn”Defense Asserted: Learned intermediaryHolding: Pharmacy had specific knowledge of

potential allergic reaction and should have warned.


14

Causation

It may seem clear at first that the pharmacist’s breach of duty “caused” a recoverable loss.

However, the pharmacist’s breach of duty may not have been the actual cause of harm.


15

Two Types of Damages

1. Actual DamagesMoney paid from the actual lossCalculated

2. Punitive DamagesMoney paid as a form of punishmentJury determines amount


16

Damages • May seem obvious there were or were not

damages, but this can be deceiving.• There must be an injury or loss of

property1. Patient2. Family member(s)


17

Attempt by States to Reduce Malpractice1. Requiring a Certificate of Merit2. Expert Witness Report may be required

to validate the cause of action and breach.3. Expert Witness Testimony which

increases costsDepositionTrial

4. Cap to non-economic damage awards


18

5. 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)


19

Pharmacist Malpractice Cases

Pharmacy has had relatively few malpractice claims as compared to other professions.

However, this will likely change.


20

Progression of a Civil Trial1. Plaintiff files a claim and defendant

answers.

2. Discovery – parties collect evidence

3. Deposition – statements are taken

4. Trial or Settle


21

Case 1 – Misfill Prescription1. Prescription was mistyped

- wrong strength, directions, or drug

2. Refilled with wrong drug

Prevention – Go back to original on 1st refill and review what was typed


22

Case 1 – Plaintiff Claims 1. Pharmacist

Negligent filling practice2. Employer

Negligent Hiring PracticeNegligent Employee

RetentionNegligent Training and PolicyNegligent Work Conditions


23

Case 1 – Damages and OutcomeActual Damages would need to be calculatedAre there enough damages to bring an action or enough to cause you grief

Settlement or trial


24

Case 2 – Patient DiesNo apparent pharmacy errorPrescriptions for

Oxycodone SR Oxycodone/APAPCyclobenzaprine Zolpidem

Patient on meds for years and tolerant

Patient dies

Pharmacy sued even though no apparent mistake by pharmacy


25

Case 2 – Plaintiff ClaimsNegligence on behalf of the Pharmacy/Pharmacist

Negligence on behalf of the Physician

Negligence on behalf of the State


26

Case 2 – Why the PharmacistPhysician 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


27

Case 3 – Failure to MonitorLawyers 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.


28

How can you reduce you liability risk?

1. Fill prescriptions (retail/hospital) at your own pace.

2. Get to know your patients



29

3. Follow your company’s/hospital’s filling policy

4. Follow your company’s error reporting procedure



30

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”



31

6. Never put anything in writing on your own!!!

It will likely be used against you or at least embarrass you.



32

7. 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.

Patient’s 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.



33

Malpractice InsuranceYour 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.



34

Contact Information

Robert P. Esgro, R.Ph., Esq.Pharmacist-Lawyer80 Ithan Avenue

Villanova, PA 19085Phone: (610) 308-6666

[email protected]

35

mailto:[email protected]

Documents

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