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							                                      Dalkon Shield


             +   Lateral Spikes
                                  =
Incon Ring
A.H. Robins
                    A.H. Robins
   4,000,000
possible lawsuits
                                  306,931 pending lawsuits
                     A.H. Robins
             Lawsuit Actions     Total Possible Lawsuits




306,931 pending lawsuits
                                 7%




                           93%
The Dalkon Shield Case
               by

       Anthony Chan
       Ramdy Chau
      Dawn Escobedo
         Clair Hsieh
        Wendy Tsui
        Sophia Yung



      SFU Business 303, Ethics
            Spring 2011
                                  [ˈsteɪkˌhəʊldə] (n.): a person, group, organization, or
                                  system
                                  who affects or can be affected by an organization's actions

Factors and changes which caused the ethical issues to           Our choice of solution and
occur                                                            justification


    Stakeholder
                           Issues            Changes           Alternatives            Decision
         s

        Ethical issues identified in the               Possible solutions to rectify
        case                                           situation
Owners/Shareholders                Financial return
  Government
                                   Obedience to laws and regulations
     (FDA)
                                    Fair competition
                                        High quality goods and
Women                                          services
                                    Value
  Management of A.H.               Efficiency
         Robins                    Effectiveness
Physicians                            Ensure health and safety of
                                                patients
                                      Provide care & sound medical
                                                 advice




  Stakeholder
                Issues   Changes        Alternatives   Decision
Too many people and not enough resources


                                                 Needs birth control which requires less effort

                     Population Control in Developing
                                Countries

                  Reliance on women for contraceptives




   Stakeholder
                       Issues          Changes           Alternatives         Decision
Increases risks of infection




                     Issues of the Intrauterine Devices (IUD)


                                                  Poor regulation by the FDA




     Stakeholder
                               Issues   Changes      Alternatives        Decision
                          Incomplete and inaccurate studies



                               Corporate Bias

                                                          False marketing

       Mass exportation




Stakeholder
                   Issues             Changes          Alternatives         Decision
         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.



                          Incomplete and inaccurate studies




                              Conflict of Interest

                                                             False marketing


                  Dr. Hugh Davis has a financial interest in the Dalkon Shield




Stakeholder
                     Issues            Changes            Alternatives           Decision
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).
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.
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. 44-46).
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. 114-115).

                                                                    Environmenta
     Societal                    Technological                                                     Governance
                                                                          l




 Stakeholder
                            Issues                Changes               Alternatives              Decision
                                Chances
                  June
              December
                  1970
                1970 1972
                 Mid

Stakeholder
                 Issues     Changes   Alternatives   Decision
      June
      1970contemplating the purchase of the Dalkon Shield
A. H. Robins


      Delay the purchase of the Dalkon Shield
                More time for conclusive reports, divert funds to other operations
                Risk losing the opportunity to purchase Dalkon Shield


    Purchase Dalkon Shield, wait for accurate results and implement changes
                 Results in a good product - improve brand recognition
                 Time consumption, increased costs


     Purchase the Dalkon Shield and immediately sell it
                   Reduce costs
                   Potential risk for consumers


     Stakeholder
                           Issues           Changes           Alternatives           Decision
     December
         1970 his conflict of interest with A. H. Robins
Dr. Hugh Davis and


       Hire another investigator other than Davis
                    No conflict of interest
                   Increased cost, Davis will not contribute



      Remove Davis’ share within the company
                    No conflict of interest
                   Davis will not be motivated for development of the product


        Let Davis contribute
                   The most knowledgable person will be contributing
                    Conflict of interest


     Stakeholder
                            Issues            Changes          Alternatives     Decision
 Mid 1972
Sales decline of the Dalkon Shield within the US


       Reevaluate their product
                   Maintain brand image
                   Increased time consumption and costs



     Ignore the issues in the Dalkon Shield, sell internationally
                   Increase short-term sales
                   Spreads the problem internationally




     Stakeholder
                           Issues              Changes    Alternatives   Decision
           Long-term profits and increase brand image

Dalkon Shield had problems itself
Complete current studies and implement changes before placing it onto the
                                 market
                   Deontology: that judges the morality of an
                   an approach to ethics
                   action based on the action's adherence to a rule or
                                                                              Plausible
                   rules.




   Stakeholder
                      Issues           Changes            Alternatives   Decision
                           Or maybe
                           comments
Do you have
questions
                   Thank
                     You
              How about
              concerns

						
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