Does it Matter if the Product had a Disclaimer, Warning or Other Instructions?

If products are so complex that customers cannot be expected to understand and appreciate latent dangers, then manufactures, distributors, and other sales agents must provide warnings and instructions so that customers can act on an informed basis. However, they are not let off the hook that easily. The instructions must be sufficiently informative so that customers have a real sense of the danger and what they need to do. This issue often comes up with prescriptions. Patients can hardily be expected to understand why a particular medication is being given to them or if there is a superior alternative. What makes this area even trickier is that manufacturers can shed responsibility under the "learned-intermediary rule" if they inform doctors of the risks involved. Therefore, while it is incredibly important if there are disclaimers/warnings/instructions on products-especially complicated products-that is not the whole story. They need to be sufficient and sometimes manufacturers fulfill their duty merely by telling the doctor what to do.

The Food and Drug Administration (FDA) as well as the Federal Trade Commission (FTC) govern the rules and practice related to product labels, warnings, instructions, and related markings. Their jurisdiction is set forth under the Fair Packaging and Labeling Act (FPLA). According to the government's explanation, they mandate that "All consumer commodities be labeled to disclose net contents, identity of the product, and the name and place of business of the product's manufacturer, packer or distributor." See https://www.sba.gov/managing-business/running-business/marketing/product-labeling. This authority extends to toys, food, medications, tools, equipment, and most-if not all-consumer goods sold in the United States.

If the defendant can show that it put proper labels, warnings, or instructions on its product, then they can use that fact to imply that you assumed the risk of whatever injury you sustained. Products are becoming more and more complicated in modern times, especially with medications. Therefore, to balance the interests of commerce and safety, the law requires companies to completely and sufficiently disclose all risks their products pose. Then, it is on the patient's shoulder to carry them or not by buying the good. If they do, then they have assumed the risk and cannot seek recourse in court. However, this doesn't mean that defendants always prevail at trial. How can you get around a good label or warning? Well, you can say that the injury you suffered had nothing to do with the label; you can say the label was not prominently posted on the product; or you can say a variety of other things that undercut the presumption of assumption.