The FDA does not inspect and regulate vitamins, nutritional products and medicinal remedies designed to shed weight or build bulk, in the same controlled manner that it approves and monitors prescription drugs and some over-the-counter medicines. If a so-called nutritional compound is found to be a defective product that causes harm to consumers in West Virginia or elsewhere, the FDA will step in with appropriate measures to assure public safety. When necessary, it will make sure that defective products are recalled.
Recently, over two dozen people in another state came down with severe liver inflammation and in some cases, sudden liver shutdown, after ingesting a product with the brand name of “OxyElite Pro.” The brand is marketed by a national chain of retail stores selling nutritional supplements. The compound is billed as a weight reduction and body-firming aid, such as would be used in training and workout regimens.
The illnesses were all so far reported in Hawaii. At least one injured victim sued the manufacturer of the apparently defective product and the product’s national retailer. With so many consumers becoming seriously ill in a short space of time, and all of them having ingested the same product, it should be relatively easy for plaintiffs to establish that this was a defective product that was unreasonably dangerous to consumer users.
Once a defect is established in a product liability case, the manufacturer is held to be strictly liable for damages caused by the defect to consumers, unless adequate warnings were given. While the crisis emerged, the FDA investigated and the agency eventually announced that the manufacturer had earlier this month issued a product recall across the country. This included all products containing an ingredient called “aegeline,” according to the FDA.
That substance is reportedly the manufacturer’s attempt at creating a chemical equivalent of a natural extract from a sacred tree that grows wild in India. It’s revered there for its healing properties. In West Virginia and elsewhere, the manufacturer has a duty to refrain from putting a defective product on the market. When it puts an unreasonably dangerous product in retail circulation, without issuing warnings, it will be held strictly liable to consumers for the damages suffered.
Source: Courthouse News Service, Hepatitis Outbreak Traced to OxyElite Diet Supplements, Purna Nemani, Nov. 21, 2013