A company manufacturing artificial hip devices approved by the FDA has been informed that a number of

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A company manufacturing artificial hip devices approved by the FDA has been informed that a number of patients (about 35 percent) using their artificial hips are experiencing a high level of lead in their blood. The high lead levels are due to a leaching process caused by the hip articulating on the metal of the artificial hip as the patient walks. The manufacturer has decided this is a risk that accompanies a hip transplant, and it continues to manufacture and sell the device. The manufacturer has informed physicians that leaching of lead can occur, and it has encouraged them to explain the risk to their patients as part of the “informed consent” process. The manufacturer feels this is an ethical decision because the FDA has approved the company’s artificial hips, and the majority of patients do not experience the blood disorder. Do you agree?

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The Legal And Ethical Environment Of Business

ISBN: 9781454893028

2nd Edition

Authors: Gerald R. Ferrera, Mystica M. Alexander, William P. Wiggins, Cheryl Kirschner, Jonathan J. Darrow

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