Once A Medical Device Passes FDA’s Most Rigorous Testing, The Company Is Safe From Lawsuits. Here’s Why.
The Washington Post examines the Supreme Court's decision which protects companies from potentially huge product liability lawsuits in state courts. In other medical device news: hospitals may start booting sales reps from the operating room and spinal-cord stimulators are far more dangerous than perhaps doctors realized.
The Washington Post:
Supreme Court Sets High Bar For Medical Device Lawsuits
The tiny balloon was supposed to stretch open a blocked artery on Charles Riegel’s diseased heart. Instead, when the doctor inflated the balloon, it burst. The patient went on life support but survived. His lawsuit against the manufacturer of that arterial balloon did not. The U.S. Supreme Court ruled in favor of Medtronic, among the world’s largest makers of medical devices, setting a precedent that has killed lawsuits involving some of the most sophisticated devices on the market. (Pritchard, 11/25)
Hospitals Rethink Role Of Medical Device Sales Reps During Surgery
In the operating room, surgical masks and matching scrubs can make it hard to tell who's whom — at least for outsiders. Patients getting wheeled in might not realize that salespeople working on commission are frequently present and sometimes even advise the clinical team during surgery. Who are these salespeople, and why are they there? (Farmer, 11/23)
The Associated Press:
Spinal-Cord Stimulators Help Some Patients, Injure Others
For years, medical device companies and doctors have touted spinal-cord stimulators as a panacea for millions of patients suffering from a wide range of pain disorders, making them one of the fastest-growing products in the $400 billion medical device industry. Companies and doctors aggressively push them as a safe antidote to the deadly opioid crisis in the U.S. and as a treatment for an aging population in need of chronic pain relief. But the stimulators — devices that use electrical currents to block pain signals before they reach the brain — are more dangerous than many patients know, an Associated Press investigation found. They account for the third-highest number of medical device injury reports to the U.S. Food and Drug Administration, with more than 80,000 incidents flagged since 2008. (Weiss and Mohr, 11/25)