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The law guarantees that the device will be safe when used in a predictable and reasonable way, regardless of product liability disclaimers. That may differ in case of written contracts that contain a disclaimer clause signed by the customer. Contact an attorney for a customized assessment. The black box warning is known as the strictest warning printed on the label of drug products and prescription drugs by the FDA (The Food and Drug Administration). These warnings are generally found on the drugs' label when the aforementioned drug has been associated with certain health hazards repeatedly and it presents the risks or adverse effects associated with use, as revealed by medical studies.
A product liability disclaimer does not usually work as a shield for the manufacturer in cases when the customer purchased the defective product from a store. For clients, the law guarantees that the device will be safe when used in a predictable and reasonable way. It is true that manufacturers often try to avoid taking responsibility for their devices by inserting a written product liability disclaimer. Even so, they are usually not being taken into consideration by the judge because, as a customer, you have not lost your warranty rights.
The only situation where such disclaimers are sometimes considered being available is the ones where written contracts that contain a disclaimer clause have been signed by the customer.
Also, if the disclaimer warns customers about the risks that the misuse of the product implies, your product liability claim will not be considered a valid one as the judge might agree that you were aware of the fact that particular use of the device would lead to injury. This kind of written contract is not common but they exist, especially for handmade products or other customs, high-priced devices.
However, if you find yourself in one of the situations mentioned above, the best option for you would be to consult a product liability attorney to evaluate your case and advise about what to do next.
The black box warning, or boxed warning, is FDA's strictest warning added to the labeling of any prescription drug. The warning is designed to call attention to significant risks or even life-threatening adverse effects.
A boxed warning is a warning with a black box around it, hence the name. In the absence of clinical data, the black box warning is based on clinical data or serious animal toxicity data. Prescription drugs with a black box warning have either shown or are expected to have a serious adverse event or death. The FDA requires the warning to be placed in the package insert so that practitioners can heed the warnings and monitor on a regular basis the patients who are on these medications.
A boxed warning is implemented in collaboration with the pharmaceutical company that produced the drug only after the FDA confirms the serious risk, and depending on the severity of adverse events. The warning does not mean the drug should not be used, it is just a means of communication from the FDA to prescribers to highlight the risk. If you have concerns regarding your prescription, discuss it with your physician.
If you have been hurt by the use of dangerous prescription drugs, you will need an experienced and resourceful personal injury lawyer who can understand the problems with your medicinal regimen, determine the strength of your case, and define potentially liable parties. Our Miami-based law firm, The Law Offices of Sean M. Cleary has represented clients who have suffered medication-related injuries throughout the state of Florida. Call us today to protect your right to recovery before legal deadlines expire.