Dalkon Shield Case Study Paper

2538 Words 11 Pages
The Dalkon Shield Case Study Report

The case study involving A.H. Robins Company will discuss blatant lack of due diligence of the product Dalkon Shield. Ignoring appropriate measures to ensure safety or the product along with misleading aggressive promotional strategies and literature show the malicious intent of the company for short-term profits, despite the fatal and devastating impacts on the public.

The Dalkon Shield Case Study Report
Unethical Practices As inventors, Davis and Lerner, at first were following protocol by developing, testing, distributing, and refining their product to a small controlled portion of the public with good faith and due diligence along with documenting their studies and recording
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These are the first clear unethical practices in the Dalkon Shield’s life.
In the public arena unethical practices in the Dalkon’s Shield life might not have become apparent until later on between 1972 and 1973 when complaints started mounting against the device. Even though these were more from the difficulty of insertion this was the beginning of the more seriously natured complaints. Some might argue that Robins Company took corrective action by bringing out a new, smaller version Shield out, but the same unethical practices continue with lack of any safety or effectiveness testing again. So essentially the product might be a improved product, but there is still no independent testing evidence. Secondly, despite the mounting complaints and all the objections, Robins Company, by 1973, continued to produce over five million pieces of promotional literature stating, “No general effects on the body, blood, or brain…safe and trouble-free…the safest and most satisfactory method of contraception…truly superior.” This was false advertising to general public, not to mention unethical, when the company was at least minimally aware of mounting issues as well as full knowledge of no testing to confirm this marketing.
Ethically Correct Actions
Since A.H. Robins Company was already established in prescription and nonprescription drugs, they are fully aware of the proper and ethical protocols and procedures through the FDA.

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