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What makes a drug defective?

A pharmaceutical drug may be considered defective if its effects, manufacturing, labeling or inadequate warning has caused harm to a consumer. In Louisiana, a product liability case involving drugs may proceed under one of these theories or a combination of all of them. A drug may have harmful side effects that were  previously unknown or concealed. There may also have been issues with a drug’s manufacturing, which cause it to either be corrupted in its composition or otherwise contaminated or improperly packaged. If a drug’s labeling provides insufficient information or an inadequate warning, then use of the drug on that basis could cause harm. Instructions also may be deficient or incomplete and recommendations on the use of the drug could be incorrect.

Under the Louisiana Product Liability Act, a drug may be “unreasonably dangerous” if a manufacturer fails to provide an adequate warning that the product may cause damage to the consumer. However, a manufacturer is not required to provide such a warning if the product is not abnormally dangerous or the consumer should know that the product is dangerous.

However, if a manufacturer later learns that a drug may cause damage, it has a duty to  provide an adequate warning, or it may be liable for harm to the user or handler of the product. A manufacturer must act as a “reasonably prudent manufacturer.” In all these things, the consumer who has been harmed has the burden to prove that the drug’s manufacturing, design or warning was defective or inadequate.

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