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Plaintiff Alleges Hip Implant Caused Heightened Levels of Metals in Bloodstream in Suit Against DePuy

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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. ....

United States , Depuy Orthopaedics Inc , Drug Administration , Salsbury Sullivan , Northern District , Device Amendments , Pinnacle Device , Virginia Consumer Protection Act , ஒன்றுபட்டது மாநிலங்களில் , டேபுய் எலும்பியல் இன்க் , சால்ஸ்பரி சல்லிவன் , வடக்கு மாவட்டம் , சாதனம் திருத்தங்கள் , உச்சம் சாதனம் , வர்ஜீனியா நுகர்வோர் ப்ரொடெக்ஶந் நாடகம் ,

Defending Our Right to Test: How the FDA Restricts Direct-to-Consumer At-Home Testing

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When in November 2020 the Food and Drug Administration (FDA) proudly announced that it had approved the first at‐home self‐administered test for COVID-19, there was one catch: patients must get a prescription from a licensed health care practitioner (who is instructed to prescribe it only to symptomatic patients) to purchase and self‐administer the test. This not only defeats the purpose of an at‐home test but runs counter to the goal of restraining contagion. ....

Drug Administration , Device Amendments , Cosmetic Act , சாதனம் திருத்தங்கள் , ஒப்பனை நாடகம் ,