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Evan Jensen [email protected]

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Safa Jalal

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Miki Huang

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Christine Kang Nguyen

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Carmen Kee [email protected] Mi Hung

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(Group 9)

BUSINESS ETHICS ASSIGNMENT ‘Bad to the Bone’ Part 2 – Answer the Biz Ethics 4 Questions (in-class with group) Write up your answers to the four questions below and submit your .doc where indicated on Titanium. You will use these answers to complete Part 3 of the Business Ethics assignment. Four Questions As a way of developing your own ethical values and learning about professional codes of ethics, specifically, the American Marketing Association (AMA) Statement of Ethics, briefly reflects on which of the parties you thought were guilty of wrongdoing in the Synthes Norian XR case, what you think should have been done differently, and what might be done to prevent such incidents in the future by answering the four questions below.

1 Describe briefly (time frame, persons involved) the ethical and legal marketing issues in the Bad to the Bones situation. Your thinking is more important than being accurate to the facts or complete. The issue that revolves around this case is the CEO of Synthes, Hansjorg Wyss, marketing and selling off-label marketing. The Synthes was a company that specialized in broken bones that could be fixed internally with implants. The company bought Norian, a cement that not only fills cracks but transforms itself into human bone, in 1999 for 50 million. FDA did not approve Norian for the spine but it was only approved for the arm and skull. Synthes, in order to market for the spine, had to undergo expensive and crucial experimental treatments and clinical trials. They chose to ignore FDA’s instructions and launched into market research. They were advised to test on animals prior to humans, however, the trial would take three years and cost one million dollars. In 2001 Synthes got the FDA to approve Norian for the spine but claimed it could not be mixed with another

substance before injecting it into the spine. In 2002 it was approved as Norian XR for general use in the spine but ordered Synthes to add a warning label that it should not be used to treat vertebral compression fractures. The company was blinded by the twenty million revenue they were generating and ignored the ethical responsibility to report deaths to the FDA as instructed. The company had multiple people come forward and state that the product they were selling and marketing was harmful rather than beneficial but Wyss being a businessman ignored the health precautions and warnings. The product had multiple people lose their lives on the operating table. Wyss and top management involved in the scandal were charged and imprisoned.

2 In the Bad to the Bone situation which one or more of the AMA’s ethical norms and values were violated? Synthes violated the AMA’s ethical norms and values: -Ethical norms violated: Do no harm, foster trust in the marketing system, and embrace ethical values -Ethical values: Honesty, Responsibility, Fairness, and Transparency.

3

Three-part Question:

(a) What do you think should have been done within Synthes to stop the marketing of the product? I believe the company should’ve had an audit within itself where an audit company comes and clears the company of any mistakes that could be occurring in the company. The employees who came forward with a warning to top management should have informed the FDA of the rule breaks that were occurring and the fatal results. (b) What company(ies) internally or externally associated the Synthes? What product(s)? Norian (Norian SRS), SRS-R, Norian XR, FDA, University of Washington (animal testing), J&J which purchased the parent company Synthes. (c) out of all the entities which one(s) are to blame for the deaths of the surgical patients? I believe the doctors who agreed to work with Norian and Synthes, the company Synthes is the major blame for the deaths of the surgical patients for falsely advertising and promoting a product that wasn’t 100% safe. The Employees, surgeons, and executives.

4 Specifically, using the AMA Statement of ethics and your own understanding of marketing, what could each of the parties do to address this “crime” and to avoid future injuries and deaths?

The parties should come out with a statement first apologizing for the harm they have caused and make it clear that their intentions moving forward is to help and benefit people not harm them. They should state how they will be following the AMA’s Ethical norms which are: do no harm, foster trust in the marketing system, and embrace ethical values. Following the Ethical values as well which are: honesty, Responsibility, Fairness, Respect, Transparency, and citizenship. The parties should focus on the products they are using and selling in order not to harm individuals. Showing good faith can regain trust in the community such as giving generous donations and being transparent about every step they take....