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Consumer protection is an area in which states have had long-standing authority to govern in a way that protects their citizens. Relatedly, state tort actions are a tool consumers can use to uncover unknown drug hazards and seek compensation if they have suffered injuries.??

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In the case, the U.S. Food and Drug Administration (?FDA?) rejected a drug manufacturer?s proposal to use a label that identified a specific risk of using the drug. State-law claims of failure to warn of a different risk were brought against the manufacturer, but the district court erroneously determined that it would have been impossible for the company to comply with both state and federal law. The ruling was made despite the fact that the FDA?s actions and the claims currently brought are related to?different risks.??

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The district court?s decision could have implications beyond the case by imperiling the right of individuals to hold accountable companies that do not properly disclose the potential harms of their drugs.?

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The Virginia-led amicus brief states: ?The district court?s judgment . . . would upset Congress? careful balance between federal and state regulatory authority in this important area of traditional state concern. The ruling risks undermining core principles of federalism and could prevent States from allowing their citizens to hold pharmaceutical companies to account for their actions. It also could promote gamesmanship, including incentivizing companies to file broad and inadequate label requests to the FDA in an effort to immunize themselves from future tort claims. This Court should reverse.??