Sue Has an Ethical and Legal Dilemma

This article will discuss Sue’s obligations as an agent of the drug company, provide a legal and ethical analysis, and give Sue recommended courses of action. In order to do this, this article uses the FILOP guideline as presented in the Browne, Giampetro-Meyer, and Williamson text (2004, pp. 163 – 170).

The facts are that Sue, a single mother with two children, was told by her boss to change the numbers on a report going to a federal agency for approval of a new drug. Some missing facts that may help in the analysis are; who are the intended recipients of the drug and what is the purpose of the drug.

Should Sue change the numbers on the report as her boss asked to help the company gain approval of the new drug? That is the main issue in this case.

Is it legal for Sue’s boss to ask her to change the numbers and if Sue does change the numbers who is legally at risk? Sue is in an employer-employee relationship with her boss. As stated in the Kubasek, Brennan, and Browne text, Sue is an agent to the principal and has several duties that pertain in this case, including loyalty, obedience, and performance. However, when the principal asked Sue to change the facts the important question becomes, are these “reasonable and lawful instructions” (in Hartigan, ed., 2004, p. 212)? In addition, is Sue by complying with the wishes of her boss acting in the best interest of the company? The final question, is Sue living “up to the standards of performance expected of people in [her] their occupation” (in Hartigan, ed., 2004, p. 212)?

The answer to all three of the last questions is no! If the facts came out in a tort case later, Sue would be liable for misrepresenting the facts that led to the FDA’s decision to approve the drug. In that case, Sue would not be acting in the best interest of the company because of the fallout that could come from a legal case. The FDA makes its decisions based on factual reports, therefore others in Sue’s occupation would be required to present the facts as they are known and not change them to help their respective companies gain FDA approval. It is the company’s responsibility to develop a drug that meets the FDA’s standards, not change the numbers that are reported to the FDA.

Since the principal in this case knows about the wrongful activity, both the agent and the principal would be liable. Kubasek, et al. (2004) presented a case where Jones uses the defense that he was following orders and that did not hold any weight in a criminal case (in Hartigan, ed., p. 217). Therefore, it is unlikely that Sue could use that as an excuse should this activity go to court as a tort case.

What are Sue’s options? At first appearance it would seem she only has two options; to either change the data or not change the data. However, upon closer examination other options present themselves; she could report to her boss’s senior what her boss has asked her to do. She could also see if she could get her boss to change his mind based on the possible repercussions if the facts were to come out in the future. She could tell her boss that if he can change the results; however, she would not endorse the document or the results that are presented. She could try to convince her boss that the company should do additional testing to try to obtain better results. The last option would be to quit her job.

For the principle, this paper will use the Public Disclosure Test as described by Browne, et al. (2004, p. 170). How would Sue feel if her two children found out about the decision she made and the consequences of that decision if it causes patients who are using the drug to die? Could Sue live with herself if her decision to comply with her boss caused people to die?

In conclusion, this article recommends that Sue try several approaches starting from the least conflicting and ending up in the extreme. First, Sue should try to get her boss to see the dangers involved in performing this task and what the possible negative outcomes would be to the company and her boss. Second, she should go to her boss’s senior and see if she condones this practice within the company. Third, if there is an anonymous company hotline for this type of activity, she could try to report it through the hotline. Fourth, submit the report without changes the facts and maintain a copy for her records and start looking for work elsewhere. Finally, if the principal makes it an either do it or else decision then she seek legal counsel and quit her job.

References

Browne, M.N., Giampetro-Meyer, A., & Williamson, C. (2004). Practical business ethics for the busy manager. Upper Saddle River, NJ: Pearson Prentice Hall.

Kubasek, N., K., Brennan, B.A., & Browne, M.N. (2003). The legal environment of business: A critical thinking approach (3rd ed.). In R. Hartigan (Ed.). Ethics and legal concepts for business (pp. 202-217). Upper Saddle River, NJ: Pearson Prentice Hall.