+ + Lateral Spikes = = Dalkon Shield Incon Ring

60%

A.H. Robins

306,931 pending lawsuits 4,000,000 possible lawsuits

306,931 pending lawsuits A.H. Robins

The Dalkon Shield Case by Ramdy Chau Anthony Chan Sophia Yung Wendy Tsui Clair Hsieh Dawn Escobedo SFU Business 303, Ethics Spring 2011

AlternativesDecisionChangesIssues Stakeholder s [ ˈ ste ɪ k ˌ hə ʊ ldə] (n.): a person, group, organization, or system who affects or can be affected by an organization's actions Ethical issues identified in the case Factors and changes which caused the ethical issues to occur Possible solutions to rectify situation Our choice of solution and justification

Decision Stakeholder s IssuesChangesAlternatives Owners/Shareholders Women Government (FDA) Management of A.H. Robins Physicians Financial return Obedience to laws and regulations Fair competition High quality goods and services Value Efficiency Effectiveness Ensure health and safety of patients Provide care & sound medical advice

Decision Stakeholder s IssuesChangesAlternatives Population Control in Developing Countries Too many people and not enough resources Needs birth control which requires less effort Reliance on women for contraceptives

Decision Stakeholder s IssuesChangesAlternatives Issues of the Intrauterine Devices (IUD) Increases risks of infection Poor regulation by the FDA

Decision Stakeholder s IssuesChangesAlternatives Corporate Bias False marketing Incomplete and inaccurate studies Mass exportation

Decision Stakeholder s IssuesChangesAlternatives False marketing Incomplete and inaccurate studies Conflict of Interest Dr. Hugh Davis has a financial interest in the Dalkon Shield A.H. Robins Company knew it was harming people with the sale of their products but still did it because it gave them profit. At the same time, the government also knew it was wrong, but did not prevent it from happening.

Decision Stakeholder s IssuesChangesAlternatives GovernanceSocietal Environmenta l Technological Late nineteenth century America was marked by a rising professional class. Many roles that had been filled by craftsmen or women trained in traditional methods for providing goods and services were increasingly filled by members of these new experts. In particular, women came to rely, not on traditional methods for contraception, but on the new technologies and methods made available by the medical profession (Grant, 9-10). Societal There were negative side effects from oral contraceptives back then. (birth-control pills) Women had the desire to seek out better contraceptives that seemed to have no side effects and be effective as well. Technological Environmenta l At this time, there were over 70 IUDs on the market. Davis wrote a book and several articles promoting his device over the others. IUDs were increasingly popular among physicians, because they were not associated with the demonstrated adverse effects of the Pill and had a high "use-effectiveness" ratio (Grant, pp ). Governance The study was performed with 640 women subjects and, on average, these women participated in the study for 5.5 months. There was a 60 percent discontinuation rate, and these data were not included in Davis' final assessment. Davis instructed participants to use sperimcidal foam for added protection against pregnancy; however, this was not disclosed in his published documents (Perry and Dawson, 33). In 1976, a new Medical Devices amendment to the Food and Drugs Act required that companies demonstrate the safety of IUDs before they could be put on the market (Mintz, pp ).

Decision Stakeholder s IssuesChangesAlternatives June 1970 December 1970 Mid Chances

Decision Stakeholder s IssuesChangesAlternatives June 1970 A. H. Robins contemplating the purchase of the Dalkon Shield Delay the purchase of the Dalkon Shield Purchase Dalkon Shield, wait for accurate results and implement changes Purchase the Dalkon Shield and immediately sell it More time for conclusive reports, divert funds to other operations Risk losing the opportunity to purchase Dalkon Shield Results in a good product - improve brand recognition Time consumption, increased costs Reduce costs Potential risk for consumers

Decision Stakeholder s IssuesChangesAlternatives December 1970 Dr. Hugh Davis and his conflict of interest with A. H. Robins Hire another investigator other than Davis Remove Davis’ share within the company Let Davis contribute No conflict of interest Increased cost, Davis will not contribute No conflict of interest Davis will not be motivated for development of the product The most knowledgable person will be contributing Conflict of interest

Decision Stakeholder s IssuesChangesAlternatives Mid 1972 Sales decline of the Dalkon Shield within the US Reevaluate their product Ignore the issues in the Dalkon Shield, sell internationally Maintain brand image Increased time consumption and costs Increase short-term sales Spreads the problem internationally

Decision Stakeholder s IssuesChangesAlternatives Deontology: Dalkon Shield had problems itself Complete current studies and implement changes before placing it onto the market Long-term profits and increase brand image Plausible an approach to ethics that judges the morality of an action based on the action's adherence to a rule or rules.

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