Merck, the Fda, and the Vioxx Recall Essay

1120 Words Nov 28th, 2012 5 Pages
Do you believe that Merck acted in a socially responsible and ethical manner with regard to Vioxx? Why or why not? In your answer, please address the company’s drug development and testing, marketing and advertising, relationships with government regulators and policymakers, and handling of the recall.
No, Merck didn’t act in a corporate social responsibility in regards to Vioxx. Corporate social responsibility means that a corporation should act in a way that enhances society and its inhabitants and be held accountable for any of its actions that affect people, their communities, and their environment.
Over a five year period from 1999 to 2004 over 139,000 people in the United States has had a heart attack or stroke as a result of
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Protection of the public from these risks typically takes two forms. Before such products can be sold, manufacturers must satisfy the Food and Drug Administration (FDA) that they are safe and effective. Tort law private lawsuits brought by injured patients’ serves as a second method of influencing manufacturers' behavior. The threat of lawsuits alleging that a drug or device was defectively designed, defectively manufactured, or accompanied by inadequate warnings which arise under state rather than federal law gives manufacturers an incentive to take all reasonable precautions to ensure that their products are as safe as possible and that all knowable risks are adequately disclosed. Actual lawsuits can provide compensation to the injured and result in a product's removal from the market.
The weight that the Supreme Court gives to this FDA opinion could signal its inclination in resolving an even more important preemption question. In publishing new labeling rules for prescription drugs, the FDA asserted that its approval of label language preempts private lawsuits alleging that a manufacturer failed to provide an adequate warning of a drug's risks. Whereas medical devices are governed by the MDA, no federal law expressly provides that FDA requirements for pharmaceuticals should preempt any form of state law. This means that the survival of the FDA's claim of preemption

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