Most of us pay our bills on time. If we break a neighbor’s rake, we promptly purchase a replacement. If our child dumps fruit punch on a friend’s carpet, we pay to have it cleaned. In fact, we don’t really think about these unwritten rules often; it’s just the right…
Articles Posted in medical devices
HBO’s John Oliver Reports on Dangerous Medical Devices and the FDA
I’ve been writing about dangerous medical devices on this site for four years. Over that time I’ve reached thousands and thousands of people injured by these harmful implanted medical products. John Oliver, host of Last Week Tonight, picked up the subject this week, and I am grateful to him and…
Beware Big Business Spin: A Defense of “Ambulance Chasers”
Let me see if I have this straight: There is a huge medical device manufacturer that earns over $75 billion dollars each year. This corporation decides to market and sell a new medical device. The corporation refuses to do extensive testing on the device because that would take too long…
FDA to Manufacturers: Don’t Base 510(k) Medical Device Approval on Old Technology
At some point in your life, a medical device will likely become a necessary part of your medical care. You may need external items such as hearing aids, blood glucose meters, insulin pumps, or feeding tubes. You may also need the help of surgically implanted medical devices like artificial hips,…
New York Times Notes Dangers of 510(k) and Untested Artificial Hips
It’s nice to see that I may be out in front of a national publication like The New York Times. For two and a half years I have been writing on the dangers of metal-on-metal artificial hips and the deeply-flawed 510(k) medical device approval process. On Saturday Jeanne Lenzer published a…
21st Century Cures Act: Faster Approval of Devices and Drugs a Public Health Threat?
If you’ve kept up with politics even a little bit, you know how much gridlock exists in Congress. It’s amazing that anything can get done in Washington. However, a new law called the 21st Century Cures Act just passed with tremendous bipartisan support; this law must be really good, right?…
Failed Medical Devices Deprive People of Vitally Important Exercise
I was reading an article about the latest study touting the benefits of exercise. It was stunning. The study involved analyzing the brains of two groups of mice: one group in a cage with an exercise wheel; the other in a cage without the wheel. Researchers watched the mice for…
My Challenge to Medical Device and Drug Companies: Put Me Out of Business!
I don’t drink the Kool-Aid. I distrust simple answers, group-think, zealotry. I can’t stand when people make sweeping generalizations about the absolute evil of one side and the unconditional good of the other side. I don’t usually spend much time with plaintiffs’ attorneys who think every corporate decision is an…