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

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

2. 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. 2

3. 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 3

4. 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 4

5. 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 seller’s expertise 5

6. 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." 6

7. Present Issues in Pharmacy Litigation • Learned Intermediary Rule A 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

8. 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 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

9. 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 9

10. 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 10

11. 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. 11

12. 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 12

13. 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." 13

14. 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. 14

15. Present Issues in Pharmacy Litigation 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

16. 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 16

17. 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) 17

18. 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 18

19. 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) 19

20. 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. 20

21. 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 21

22. 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 22

23. 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 23

24. 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 24

25. 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 25

26. 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 26

27. 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 27

28. 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. 28

29. 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 29

30. Present Issues in Pharmacy Litigation Present Issues in Pharmacy Litigation • Follow your company’s/hospital’s filling policy • Follow your company’s error reporting procedure 30

31. 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” 31

32. 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. 32

33. 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. 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

34. 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. 34

35. Contact Information Robert P. Esgro, R.Ph., Esq. Pharmacist-Lawyer 80 Ithan Avenue Villanova, PA 19085 Phone: (610) 308-6666 Bob@PharmacyLawyer.com 35