The U.S. Food and Drug Administration (FDA) provides leadership and guidance on natural resources, food, agriculture, nutrition, and biological products. Many Maine product liability lawsuits follow consumer complaints to the FDA. While the agency is responsible for protecting the public, many products slip through until consumers suffer an adverse side effect. Some dangerous products even remain available but receive a “black box” warning.
The FDA issues black box warnings to alert the public about prescriptions or medical devices that pose serious and life-threatening side effects. The warnings often include specific warnings to vulnerable populations, such as infants, pregnant women, and older adults. The FDA works in conjunction with pharmaceutical companies to study the products before issuing a warning. These warnings generally follow post-market studies; in other words, the warnings come after significant numbers of consumers have already used the product. Even though the product may pose serious dangers, the benefits may outweigh the risks in some cases. Individuals who consume products with a black box warning should consult with their physician to determine the appropriate amount of monitoring.
While black-box warnings have many implications for prescribing physicians and pharmacies, they may also impact a Maine product liability lawsuit. Drug companies often resist these warnings to preserve sales; however, the warnings may also protect them from certain lawsuits. Many common medicines have black box warnings, such as antidepressants, anticoagulants, diabetes medications, and antibiotics.