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Health
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January 26, 2021
On Monday in the Northern District of Texas, two individuals filed a complaint against DePuy Orthopaedics Inc., Johnson & Johnson, and affiliated entities that claimed that the defendants knowingly continue to manufacture, market, and sell a hip implant device that allegedly caused harm, in the form of “debilitating pain” and increased blood levels of certain metals.
The medical device in question, called the pinnacle device, is a Class III hip implant, which means it “operates to sustain human life, (is) of substantial importance in preventing impairment of human health, or pose(s) potentially unreasonable risks to patients,” according to the complaint. Class III devices generally have to undergo a rigorous premarket approval process by the Food and Drug Administration (FDA) to thoroughly vet a product for safety and efficacy, pursuant to the 1976 Medical Device Amendments (MDA) to the Food, Drug, and Cosmetics Act. ....

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