In recent years, there have been several examples of harmful drugs entering the market and being withdrawn from sale within 12 months of their release. Worse yet, a few drugs continued to be marketed to consumers despite noted evidence of serious side effects or death. Drug manufacturers are legally strictly liable for injuries caused by the products they sell in several ways.
- As a result of an error in the manufacturing process, the product may be defective
- The possible negative side effects of using the product have not been properly communicated to consumers
- A design flaw may cause the product to be dangerous
In all of these cases, the manufacturer is liable and can be sued for damages whether they were aware of the danger of their product or not. The level or care in development, testing, production, or labeling is not relevant.
In the case of an extremely popular and widely used dangerous drug, litigation takes the form of class action suits or mass torts. Many individual cases and injuries are all addressed simultaneously, therefore enhancing the influence and power of any single case. Such drugs as Baycol, Phen-Fen, Rezulin, Propulsid, and PPA have been named in class-action suits.
Additionally, dietary supplements are rising in popularity. Although not regulated in the same way, the FDA mandates that manufacturers assure the safety of these products before they are sold. However, there are no testing or approval requirements.
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