FDA's Essure Order Affirms Role Of Learned Intermediary

By Robert Friedman and Mark Sentenac (April 23, 2018, 1:11 PM EDT) -- The historic, paternalistic doctor-patient paradigm, where the "doctor knows best" and patients are given only so much of their own medical information as the doctor deems proper, is steadily being eroded. Advancements in technology are democratizing medical information in a way that is increasingly shifting the balance of power to patients to make their own informed medical decisions. Today, patients have access to extensive amounts of medical research and information online, the ability to collaborate directly with other patients in similar situations and raise money through peer-to-peer funding for causes the medical and scientific community might otherwise ignore, and have greater access to their own medical information, test results and medical histories via online patient portals. Indeed, patients are now creating more and more of their own medical data through the use of the smart, connected devices that we carry around with us (or now wear) every day. Fear also plays a role, as media coverage and ubiquitous advertisements for drug and device injury litigation have heightened patient sensitivities to risks....

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