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Reporting Product Liability

Written by Kathleen Gagne
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Reporting product liability issues is a serious responsibility to which manufacturers must strictly adhere. Any event associated with a possible malfunction of a medical device, for example, must be reported by the manufacturer to The Manufacturer User Facility Device Experience Database (MAUDE). The FDA allows interested parties such as claimants or plaintiffs and even attorneys to access the database containing information about medical devices which may have caused death or serious injury through malfunction.

Manufacturers Reporting Product Liability

In addition to warnings that advise medical personnel and end users about the potential risks of using any medical device, manufacturers are also now required to report those issues and concerns to their liability insurance companies. This is especially true if an incident or occurrence relating to those issues has been reported to MAUDE. If the manufacturer does not follow through in reporting product liability in all of these cases and a claim is later made, the insurance company may then have grounds to refuse payment leaving the manufacturer to deal with a potential award to a claimant in the millions of dollars.

Not only medical devices fall into this category. Product liability policies today may include detailed reporting requirements, and coverage may exclude those product failures in which a known occurrence was not appropriately reported. One result of the increase in reporting product liability and litigation is that product recalls are now commonplace. A product recall advises of a defect or safety issue related to just about any type of product. The manufacturer takes back the product and absorbs the cost of replacing it with a similar, safe product. In some cases, the manufacturer supplies a part that will correct the safety issue, or, as in automobiles, provides both the part and the labor to install it.

Product Liability Reporting and Other Agencies

According to Federal law, government agencies can order a recall. If the manufacturer refuses to comply, these agencies can seek a court-ordered recall of the product. While most manufacturers recall products in which a defect has been observed voluntarily, the Federal laws provide an additional measure of safety for consumers. One amazing problem with product liability reporting is that, in spite of the publicity and notifications that surround recalls, many consumers continue to use the defective products, resulting in serious injury or death. No product recall should be ignored, especially if the recall indicates the risk of injury or death.


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