Articles Posted in FDA

I’ve been representing people injured by defective medical devices and harm drugs for many years. Because I study these types of products on a daily basis, I have become leery about putting anything inside my body, whether it is an artificial joint like a hip or knee, or a prescription medication. As I often tell…

For more than three years I have been writing about the dangers of certain implanted medical devices. These devices include artificial hips, hernia mesh, IUDs, IVC filters, and others. And some have caused massive human suffering: neurological problems, sexual dysfunction, immobility, infertility, headaches, pain, even death. If you are reading this sentence then you discovered…

Bayer’s Essure birth control device is coming off the market, thanks to a public campaign aimed at raising awareness about its dangers. After years of silence, in which women were told that their pain wasn’t real, and years of incident reports that went unheeded, the U.S. Food and Drug Administration (FDA) finally agreed that Bayer…

Invokana is a drug prescribed to treat people with Type 2 diabetes. The medication lowers blood sugar levels by preventing the kidneys from reabsorbing blood glucose. I’ve written often about Invokana and the studies that have identified problems with the drug, which you can read about here. I thought it may be useful to give…

Two recent clinical trials studying Invokana (canagliflozin) shed light on the diabetes drug’s alarming side effects. Canagliflozin is a type 2 sodium-glucose transport inhibitor (SGLT2 inhibitor) marketed by Janssen Pharmaceuticals, a subsidiary of Johnson & Johnson. The medication works to lower blood sugar levels in the body by stopping the kidneys from reabsorbing blood glucose.…

Over the past few years, an opioid epidemic has caused horrific problems for many regions of the country. In 2015 alone, the US Department of Health and Human Services estimated that 12.5 million people misused prescription opioids, causing over 33,000 overdose deaths. In 2013, the opioid epidemic resulted in $78.5 billion in economic losses. In…

According to the American Society of Plastic Surgeons almost 280,000 breast augmentation procedures took place in the United States in 2015. Given the popularity of breast implants, a wide range of breast implant products have been released in the United States and the rest of the world. One such product is the textured breast implant.…

Let me state the obvious: companies sell you stuff with one purpose in mind, to make money. McDonald’s doesn’t sell you quarter pounders because the company believes what you need to live a better life is to eat more quarter pounders. The NRA doesn’t advocate gun ownership because it believes you need to own five…

Dr. Robert Califf is a cardiologist and the departing Commissioner of the Food and Drug Administration. He resigned his post last Friday, on Inauguration Day. Recently he gave a speech regarding his thoughts on the future of prescription drug testing, and he urged lawmakers to respect the value of science in approving and marketing prescription…

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? 21st Century Cures Act: The…