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Spotlight on Pfizer, Inc.Defenses to Product Liability. Prescription drugs in the United States must be approved by the Food and Drug Administration (FDA) before they

Spotlight on Pfizer, Inc.Defenses to Product Liability. Prescription drugs in the United States must be approved by the Food and Drug Administration (FDA) before they can be sold. A drug maker whose product is approved through the FDA's "abbreviated new drug application" (ANDA) process cannot later change the label without FDA approval. Pfizer, Inc., makes and sells Depo-T, a testosterone replacement drug classified as an ANDA-approved drug. Rodney Guilbeau filed a claim in a federal district court against Pfizer, alleging that he had suffered a "cardiovascular event" after taking Depo-T. He sought recovery based on a state-law product liability theory, arguing that Pfizer had failed to warn patients adequately about the risks. He claimed that after the drug's approval, its maker had become aware of a higher incidence of heart attacks, strokes, and other cardiovascular events among those who took it but had not added a warning to its label. What is Pfizer's best defense to this claim? Explain.

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