Question

You are a leader at a pharmaceutical firm that supplies both prescription drugs (e.g., for depression, diabetes, and migraine headaches) and over-the-counter drugs (e.g., for acid reflux, allergies, and antibacterial ointments). Seven months ago a routine FDA inspection of a company drug manufacturing plant found a series of quality control problems. FDA advised your company to investigate and fix the problems promptly. The plant employs 900 people making 20 different types of drugs for the US market.

Two days ago an express package arrived at your office from a woman named Cheryl Smith, a Manager of Quality Assurance at your company. You are meeting with other corporate leaders to discuss Smith's report. In her letter and accompanying documents, Smith reports the following: At the instruction of the Vice-President of Quality she led a team of investigators to the plant. She states that the problems were much more serious and widespread than the FDA investigators had discovered.
Among the problems she identifies are the following:
(a) antibacterial ointment routinely contaminated with bacteria;
(b) water used to make tablets routinely contaminated by bacteria;
(c) erroneous drug dosing mix-ups (e.g., 20 mg doses put into 10 mg pills and vice versa);
(d) nine different examples of regular, erroneous drug packaging mix-ups (e.g., prescription drugs packaged with over-the-counter drugs, two different drugs mixed together in the same bottles, 25 mg doses with 10 mg labels). Production line errors make these mistakes repeatedly and they are still being shipped to customers.
Smith reports that Chris Brown, the Vice-President of Quality, is aware of these findings and has declined to stop production to address the problems and has not informed the FDA of the nature and extent of her findings. Smith strongly recommends that her findings be reported to the FDA, the plant shut down, and products recalled.
The meeting is called to order and Brown is asked to explain what is going on. He reports the following: (1) The company is aware of issues at the plant and has been working to resolve them quietly and with little or no disruption to production. (2) The fact that Smith went over Brown's head and contacted the others is insubordination. (3) According to Brown, Smith is overwrought and emotional and an ideal candidate for being laid off given the reduction in workforce resulting from a recent acquisition. Brown recommends letting Smith go and assures everyone that the problems at the plant are being brought under control. You have met Smith before, and while you agree that she is a sensitive and caring person, you disagree that she is overwrought. You also believe that she is good at her job.
Discussion Questions
Is Smith a disloyal employee for going over Brown's head? Should she be criticized or praised, or something else, for going over Brown's head? Explain.

Answer 1

Cheryl Smith acted with integrity and prioritized public safety by reporting serious quality control issues, despite her superior's instructions to continue production. Her actions align with ethical responsibilities and historical precedents teach that disregarding safety can lead to severe consequences. Smith should be praised for her commitment to safety and compliance.

Step-by-step explanation:

In the scenario presented, Cheryl Smith, a Manager of Quality Assurance, reported serious quality control issues at a pharmaceutical plant that could endanger public safety. Despite the actions of Chris Brown, the Vice-President of Quality, to continue production, Smith's concerns are substantial and integrity-driven. She is not disloyal for going over Brown's head; rather, her actions arise from a commitment to safety and compliance with regulatory standards, which align with the ethical responsibilities of her role. In this context, loyalty to public safety and adherence to regulations must override internal company politics.

Recent historical events in the pharmaceutical industry underscore the significance of proper quality control and the risks associated with suppressing information about product safety. The case involving FDA officials accepting bribes and the repercussions that followed provide a cautionary tale about the consequences of disregarding quality and safety for financial or political gains.

In the interest of public safety, adherence to regulatory standards, and long-term company credibility, Smith should be praised for her actions. It's crucial that rigorous quality control measures are upheld and that any issues are reported to the appropriate regulatory bodies. Smith's recommendation to shut down production and recall products reflects an appropriate level of caution given the gravity of the situation.