Philip S. Goldberg, Christopher P. Gramling, and Sarah B. O’Rourke

Determining liability over prescription drugs is a balancing act.  For some people, medicine can save their lives or enhance their well-being.  But, as medicines can also come with side effects, some people will have unavoidable and perhaps serious adverse reactions.  The United States Food and Drug Administration (FDA) works with manufacturers of prescription drugs to manage known public risks.  The FDA assesses the benefit-risk analysis for each drug and must approve the design and warnings before the drug can be made, marketed and sold.  Once on the market, the FDA continues to work with the manufacturers to identify risks and assure the warnings that accompany the drugs continue to provide adequate information about these risks.  Physicians then manage a patient’s personal risk by deciding, often through informed consent by the patient or responsible person, whether a drug’s benefit-risk profile is appropriate for that patient.

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