The Dalkon Shield Case Study Report

Abstract
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 accurate results. The point Dalkon Shield’s life where unethical practices first become apparent was during the acquisition of A.H. Robins Company of the product from Dalkon Company. The first contributing factor was the financial motivations when Dalkon Company realized that their product needed corporate distribution especially since they lacked the sale team in the organization. A.H Robins Company just did not acquire the product, but put the two inventors became consultants for the company as well. This makes a biased unilateral perspective for pushing financial opportunity gains over appropriate procedural practices when offering this particular new product. The second contributory factor is utilization of a legal loophole that the IUD did not require filing a New Drug Application (NDA) with the Food and Drug Administration (FDA) because it was classified under medical device instead of a drug, thus there was not any current jurisdiction available at that time. The company intentionally took advantage of this loophole and lack of legal precedence. Instead of using their due diligence to independently test the relative safety