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Posted by Andy Sperbeck on Oct 21, 2016

Product Designers and Manufacturers Whose Products Cause Harm to Users Face the Possibility of a Product Liability Lawsuit

In June of 2016, the U.S. Food and Drug Administration (FDA) issued a safety alert that warned about serious heart problems with high doses, abuse and misuse, of the anti-diarrheal medicine loperamide (Imodium). The Safety Announcement’s exact message said, “The U.S. Food and Drug Administration (FDA) is warning that taking higher than recommended doses of the common over-the-counter (OTC) and prescription diarrhea medicine loperamide (Imodium), including through abuse or misuse of the product, can cause serious heart problems that can lead to death. The risk of these serious heart problems, including abnormal heart rhythms, may also be increased when high doses of loperamide are taken with several kinds of medicines that interact with loperamide.” (

It was in 1976 when loperamide was first approved. From then up until 2015, the FDA has received reports of 48 cases of serious heart problems associated with its use. Of these 48 cases, 31 patients were hospitalized, while 10 died. Most of these cases involved patients who took doses that were much higher than recommended.

Making sure that every medicinal that they produce are safe and effective is a legal duty of pharmaceutical companies. At least these are parts of the requirements for FDA approval. Drugs will have to be tested and all test results showing a drug’s safety, effectiveness and, especially, negative effects, will have to be reported to the FDA.

Pharmaceutical companies also have the obligation to include in their drug’s prescription label the risk/s associated with using their drug. It could be an act of negligence (which can be unintentional or intentional) if a company fails in its duty to inform consumers about the risks associated with using its medicinal product.

It is stated in the website of the law firm Habush Habush & Rottier S.C. ® that product designers and manufacturers whose products cause harm to users face the possibility of a product liability lawsuit for purposes of answering before the law due to their failure to uphold their essential responsibility (of ensuring product safety) and to answer for all the damages suffered by those they harm through the use of their product.

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