materials

1. a case study analysis
Identify a biomedical-related case study which you find interesting (Case studies generally
cross an ethical line, resulting in something going terribly wrong (usually). An ethical issue
must be present in your case study selection, and it must be a topic other than the ones we
discussed in class and the exemplar previous student work provided below).
Provide a brief summary of the article (make sure you properly cite other's work!).
Discuss the ethical and/or motivating factors of both sides of the issue.
Analyze the outcome of the case and its effects (think broad effects: such as any legislature
that may have come from it, FDA changes, etc.).
Discuss how things would be different if something was not done in response to the case or
if the opposite outcome had occurred.
Discuss how the case influences YOUR thinking as a biomedical engineer professional and
how YOU will identify and handle ethical issues
(most important part of the assignment).
Formatting: Font: Times New Roman, size: 12, 1" margins, include a header with your name
and title for your case study. Provide a properly cited reference to your case. Word count:
500-700 words. Word count must be included at the bottom of your paper.
Article chosen: https://www.newyorkhipknee.com/case-studies/infect...
I have attached an example document for reference, please look at
Requirements: 500-700
Student Name BMEN 153-901 Date The Elixir Sulfanilamide Tragedy Case Study In 1937,
the first sulfa antimicrobial drug, Elixir Sulfanilamide, caused the death of 105 patients due
to the use of diethylene glycol as a dilutant in the creation of this medicine [1]. Originally
designed by S.E. Massengill Company to treat streptococcal infections, this medicine was
released to the public and tragically caused the death of 71 adults and 34 children due to
acute kidney failure [1]. Although the results of this incident proved the lack of proper
regulation in the development of medicine, it paved the way for revisions in the process in
which a medicine becomes available to the public and brought up ethical questions worth
mentioning. The failure of Elixir Sulfanilamide to serve its intended purpose caused the U.S.
Government and the public to re-examine the ethics and safety behind the development and
release of a new medicine. From the company’s viewpoint, the process for manufacturing
and sale of the medicine was lawfully followed. However, even though the medicine was
reviewed and approved by the government, there was no law requiring the toxicity of the
ingredients in the medicine to be tested [1]. Thus, many blame the government’s lack of

2. regulation as a leading cause of this tragedy. On the other hand, S.E Massengill Company
was perceived as accountable for the defectiveness of the medicine. Despite the fact that the
company followed the laws and regulations set by the government, they still did not provide
sufficient evidence and testing to prove the safety of the medicine. Simultaneously, the
inclusion of a toxic ingredient in the production of the medicine led to concern regarding
public knowledge of what each medicine is comprised of. Many believed they deserved the
right to know exactly what ingredients enter their body. While there is controversy about
whether the government or the company is at fault, it is important to mention that this was
at a time period when drug safety was at a developmental stage and various laws and
regulations had yet to be established. As a result of the Elixir Sulfanilamide tragedy,
President Roosevelt signed the passing of the 1938 Food, Drug, and Cosmetic Act [1]. This
act constructed the first laws requiring the testing of the toxicity of the ingredients of a
medicine as well as “banned dangerous drugs and false and misleading labeling, required
formula disclosures of all active ingredients, and, unless the drug was sold by prescription,
required directions for use and warnings about possible misuse” [1]. Consequently, this act
expanded the power of the FDA, increased regulation in the manufacture of a medicine, and
required the components of a medicine to be made public. Had the new laws and
regulations not been formulated in response to the tragedy, the issues of drug safety and
publicity of ingredients of a medicine would continue to be concerns today. The testing of
the toxicity of ingredients used in medicines assists in the prevention of the production of
dangerous drugs, and countless lives could be harmed or lost if there is no testing being
done.
This case has allowed me to realize that the law does not always ensure purely ethical
processes, and engineering and medicine are evolving fields where there can be exceptions
and unprecedented scenarios that cause the rules to change. As a biomedical engineering
professional, I must consider all sides of a scenario and the ethical questions they may bring
up. I will proceed in a manner that follows all laws and regulations as well as professional
morals to the best of my knowledge. While doing so, I must use my own judgment and the
opinion of my peers to evaluate factors that can maximize the safety and effectiveness of a
product. Word count: 663 References [1] P. M. Wax, "ELIXIRS, DILUENTS, AND THE
PASSAGE OF THE 1938 FEDERAL FOOD, DRUG AND COSMETIC ACT," Ann. Intern. Med.,
Article vol. 122, no. 6, pp. 456-461, Mar 1995, doi: 10.7326/0003-4819-122-6-199503150-
00009.