MCQ Quiz: Product Liability

Product liability is a critical area of law that holds manufacturers and sellers responsible for harm caused by their products, including pharmaceuticals. For pharmacists, understanding these legal principles, a core topic in the Principles of Pharmacy Law and Ethics course “, is essential for navigating the complexities of the medication-use system. This quiz will test your knowledge on the legal theories of negligence and strict liability, the different types of product defects, and the evolving duties of both manufacturers and pharmacists.

1. Product liability law holds which parties responsible for injuries caused by defective products?

• a. Only the manufacturer.
• b. Only the retailer.
• c. All parties in the chain of distribution, including manufacturers, distributors, and retailers.
• d. Only the consumer.

Answer: c. All parties in the chain of distribution, including manufacturers, distributors, and retailers.

2. Which legal theory for product liability focuses on the product itself being unreasonably dangerous, regardless of the defendant’s level of care?

• a. Negligence
• b. Breach of express warranty
• c. Strict liability
• d. Breach of implied warranty

Answer: c. Strict liability

3. A batch of blood pressure medication is accidentally manufactured with double the active ingredient. This is an example of a(n):

• a. Design defect
• b. Manufacturing defect
• c. Warning defect
• d. Acceptable deviation

Answer: b. Manufacturing defect

4. A medication is known to cause a rare but serious side effect, but this information is not included in the package insert or Medication Guide. This is an example of a(n):

• a. Design defect
• b. Manufacturing defect
• c. Warning defect (failure to warn)
• d. An unfortunate but not actionable issue

Answer: c. Warning defect (failure to warn)

5. The legal theory of “negligence” in a product liability case requires the plaintiff to prove duty, breach, damages, and:

• a. Intent
• b. Malice
• c. Causation
• d. Profit

Answer: c. Causation

6. The “Principles of Pharmacy Law and Ethics” is a core course in the curriculum.

• a. True
• b. False

Answer: a. True

7. The “learned intermediary” doctrine is a legal principle that traditionally holds that a drug manufacturer’s duty to warn extends to:

• a. The patient directly.
• b. The general public via television ads.
• c. The prescribing physician.
• d. The pharmacy benefits manager (PBM).

Answer: c. The prescribing physician.

8. A pharmacist who compounds a sterile product that is contaminated and causes a patient to develop an infection can be held liable under:

• a. Negligence theory
• b. Strict liability theory
• c. Breach of warranty theory
• d. All of the above

Answer: d. All of the above

9. In a strict liability lawsuit, the plaintiff must prove that the defendant pharmacist:

• a. Intended to cause harm.
• b. Was negligent in their actions.
• c. Did not exercise reasonable care.
• d. They do not need to prove negligence, only that the product was defective and caused harm.

Answer: d. They do not need to prove negligence, only that the product was defective and caused harm.

10. A pharmacist dispenses the correct drug from an intact, sealed manufacturer’s bottle. The patient is harmed due to an unknown contaminant from the manufacturing process. Who is most likely to be the primary defendant in a product liability suit?

• a. The pharmacist
• b. The prescriber
• c. The manufacturer
• d. The patient’s insurance company

Answer: c. The manufacturer

11. The curriculum covers the principles of sterile and non-sterile compounding.

• a. True
• b. False

Answer: a. True

12. An “express warranty” is created when:

• a. A seller makes a specific factual claim or promise about a product that becomes part of the basis of the bargain.
• b. The law implies that a product is fit for its ordinary purpose.
• c. A patient uses a product for an off-label indication.
• d. A product is sold “as is.”

Answer: a. A seller makes a specific factual claim or promise about a product that becomes part of the basis of the bargain.

13. The FDA’s rigorous new drug approval process is designed to ensure that drugs are:

• a. Safe and effective, which helps to minimize the manufacturer’s liability risk.
• b. Inexpensive.
• c. Easy to manufacture.
• d. Marketed effectively.

Answer: a. Safe and effective, which helps to minimize the manufacturer’s liability risk.

14. A key defense a manufacturer might use in a product liability case involving a known side effect is that:

• a. They were unaware of the risk.
• b. They provided an adequate warning of the risk in the product’s labeling.
• c. The patient assumed the risk.
• d. Both b and c.

Answer: d. Both b and c.

15. A pharmacist’s professional liability insurance (malpractice insurance) typically covers:

• a. Claims arising from negligence in the practice of pharmacy.
• b. Fines from the Board of Pharmacy.
• c. The cost of stolen inventory.
• d. Lawsuits related to billing disputes.

Answer: a. Claims arising from negligence in the practice of pharmacy.

16. The concept of medication safety is a core topic in the Patient Care curriculum.

• a. True
• b. False

Answer: a. True

17. The “duty to warn” for a pharmacist has historically been limited, but is expanding in some states to include:

• a. Warning about obvious risks only.
• b. Warning about foreseeable risks based on the pharmacist’s knowledge of the patient and the drug.
• c. Only warning the physician.
• d. No duty to warn exists.

Answer: b. Warning about foreseeable risks based on the pharmacist’s knowledge of the patient and the drug.

18. A product’s FDA-approved package insert is a key piece of evidence in what type of product liability case?

• a. Manufacturing defect
• b. Design defect
• c. Warning defect
• d. It is never used as evidence.

Answer: c. Warning defect

19. A pharmacist who fails to counsel a patient on a serious, well-known side effect could be found liable under what theory?

• a. Strict liability
• b. Professional negligence
• c. Breach of express warranty
• d. Antitrust law

Answer: b. Professional negligence

20. A pharmacist who correctly dispenses a prescription for a “perfectly safe” drug to the wrong patient, who is then harmed, has committed what type of error?

• a. A product liability error.
• a. A professional negligence error (dispensing error).
• c. No error has been committed.
• d. A manufacturing defect.

Answer: b. A professional negligence error (dispensing error).

21. A “design defect” means that:

• a. Only one batch of the product was made incorrectly.
• b. The product was designed in such a way that its foreseeable risks outweigh its benefits; the entire product line is unreasonably dangerous.
• c. The instructions for the product were unclear.
• d. The product was not advertised correctly.

Answer: b. The product was designed in such a way that its foreseeable risks outweigh its benefits; the entire product line is unreasonably dangerous.

22. A pharmacist who adds a flavoring to a medication is engaging in compounding and assumes some liability for the quality of the final product.

• a. True
• b. False

Answer: a. True

23. The law course PHA5703 is foundational to understanding pharmacist liability.

• a. True
• b. False

Answer: a. True

24. An active learning session on pharmacy law is a key part of which course?

• a. PHA5703 Principles of Pharmacy Law and Ethics
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5782C Patient Care 2

Answer: a. PHA5703 Principles of Pharmacy Law and Ethics

25. In most states, pharmacists have been traditionally shielded from strict product liability for manufacturers’ products as long as they:

• a. Acted as a healthcare provider, not just a seller of a product.
• b. Did not alter the product.
• c. Dispensed the medication in the original sealed container.
• d. All of the above have been used as arguments.

Answer: d. All of the above have been used as arguments.

26. The “learned intermediary” doctrine is being challenged in the modern era due to:

• a. The rise of direct-to-consumer (DTC) advertising by manufacturers.
• b. The expanding clinical role of the pharmacist.
• c. Increased patient access to health information.
• d. All of the above.

Answer: d. All of the above.

27. A key risk management strategy for a pharmacy to reduce liability is to:

• a. Have robust quality assurance procedures for the dispensing process.
• b. Ensure pharmacists have adequate time to perform professional duties like DUR and counseling.
• c. Maintain clear and accurate documentation.
• d. All of the above.

Answer: d. All of the above.

28. An active learning session on medication safety is part of the Patient Care 5 curriculum.

• a. True
• b. False

Answer: a. True

29. Punitive damages may be awarded in a product liability case to:

• a. Compensate the plaintiff for their medical bills.
• b. Punish the defendant for egregious or reckless conduct and deter future wrongdoing.
• c. Pay the plaintiff’s attorney’s fees.
• d. Pay for the cost of the defective product.

Answer: b. Punish the defendant for egregious or reckless conduct and deter future wrongdoing.

30. The drug approval process is a topic in the Medicinal Chemistry and Pharmacology I course.

• a. True
• b. False

Answer: a. True

31. A pharmacist recommends an OTC product for an off-label use. If the patient is harmed, the pharmacist’s liability exposure:

• a. Decreases
• b. Increases
• c. Stays the same
• d. Is eliminated

Answer: b. Increases

32. The concept of “causation” requires the plaintiff to prove that the defendant’s action was:

• a. The only cause of the harm.
• b. A substantial factor in causing the harm.
• c. A possible cause of the harm.
• d. Unrelated to the harm.

Answer: b. A substantial factor in causing the harm.

33. Adherence to FDA regulations and providing FDA-approved labeling is a strong defense for a manufacturer against which type of claim?

• a. A manufacturing defect claim.
• b. A failure-to-warn claim.
• c. A design defect claim.
• d. All types of claims.

Answer: b. A failure-to-warn claim.

34. The pharmacist’s role in medication safety includes identifying potential product-related problems.

• a. True
• b. False

Answer: a. True

35. A key difference between strict liability and negligence is that strict liability focuses on the _____, while negligence focuses on the _____.

• a. defendant’s conduct, product’s condition
• b. product’s condition, defendant’s conduct
• c. patient’s harm, defendant’s duty
• d. defendant’s duty, patient’s harm

Answer: b. product’s condition, defendant’s conduct

36. A pharmacist who accurately dispenses a properly manufactured drug based on a prescription that is lethal on its face, without questioning the prescriber, has likely:

• a. Fulfilled their professional duty.
• b. Breached their professional duty of care.
• c. Acted as a prudent pharmacist.
• d. No liability in this situation.

Answer: b. Breached their professional duty of care.

37. The standard of care for pharmacists is defined by:

• a. Federal law only.
• b. State law only.
• c. The pharmacy’s policies and procedures.
• d. A combination of laws, regulations, and professional standards.

Answer: d. A combination of laws, regulations, and professional standards.

38. The law and ethics course PHA5703 is foundational to understanding these concepts.

• a. True
• b. False

Answer: a. True

39. In a product liability case, a key role for a pharmacist may be to serve as a(n):

• a. Judge
• b. Jury member
• c. Expert witness
• d. Plaintiff’s attorney

Answer: c. Expert witness

40. An active learning session covering pharmacy law is part of which course?

• a. PHA5703 Principles of Pharmacy Law and Ethics
• b. PHA5163L Professional Skills Lab 3
• c. PHA5781 Patient Care I
• d. PHA5782C Patient Care 2

Answer: a. PHA5703 Principles of Pharmacy Law and Ethics

41. The legal concept that a product comes with an unwritten guarantee that it is fit for its ordinary purpose is:

• a. An express warranty.
• b. An implied warranty of merchantability.
• c. Strict liability.
• d. Negligence per se.

Answer: b. An implied warranty of merchantability.

42. Which of the following is NOT a defense in a product liability case?

• a. The patient’s contributory negligence.
• b. The patient’s assumption of the risk.
• c. The statute of limitations has passed.
• d. The product was very profitable for the manufacturer.

Answer: d. The product was very profitable for the manufacturer.

43. The expanding role of the pharmacist in MTM and other clinical services has likely _____ their potential professional liability.

• a. decreased
• b. increased
• c. had no effect on
• d. eliminated

Answer: b. increased

44. A pharmacist who makes an error but immediately discloses it to the patient and takes steps to mitigate harm is:

• a. Admitting legal guilt.
• b. Acting in accordance with ethical and professional standards, which may help reduce liability.
• c. Making the situation worse.
• d. Violating HIPAA.

Answer: b. Acting in accordance with ethical and professional standards, which may help reduce liability.

45. A key way to manage liability risk is to:

• a. Carry professional liability insurance.
• b. Practice according to the highest professional standards.
• c. Maintain excellent documentation.
• d. All of the above.

Answer: d. All of the above.

46. “Negligence per se” can occur if a pharmacist’s actions violate a:

• a. Pharmacy policy.
• b. Suggestion from a colleague.
• c. Statute or regulation that was designed to protect the public.
• d. Patient’s preference.

Answer: c. Statute or regulation that was designed to protect the public.

47. Understanding product liability is essential for pharmacists in which role?

• a. Community pharmacist
• b. Hospital pharmacist
• c. Pharmacy manager
• d. All of the above

Answer: d. All of the above

48. The “Medication Safety” module in the curriculum is directly tied to preventing situations that lead to liability.

• a. True
• b. False

Answer: a. True

49. The overall trend in pharmacy law has been to:

• a. Decrease the pharmacist’s responsibility.
• b. Increase the pharmacist’s responsibility for ensuring positive patient outcomes.
• c. Focus only on dispensing accuracy.
• d. Eliminate the role of the pharmacist.

Answer: b. Increase the pharmacist’s responsibility for ensuring positive patient outcomes.

50. The ultimate reason for a pharmacist to understand product liability is to:

• a. Be able to practice in a way that minimizes risk to patients and to their own professional license.
• b. Win a lawsuit.
• c. Be able to blame the manufacturer for everything.
• d. Pass the pharmacy law exam.

Answer: a. Be able to practice in a way that minimizes risk to patients and to their own professional license.