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Legal duty of drug manufacturers

Drug companies have a legal obligation to properly test each product before seeking FDA approval. In addition, drug labels must fully disclose all relevant and material information about the drug and adequately warn of its side effects. Drug companies also have a legal duty to discourage misuse.

Under the law of strict liability, drug manufacturers can be held strictly liable for injuries or deaths caused by their products regardless of the care they took to prevent such harm. A key legal issue is whether the product is unreasonably dangerous for its intended use.