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Articles Posted in FDA

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FDA Issues Warning About the Synovo Total Hip System

Artificial hips offer many patients the opportunity to live active and full lives, but sometimes they don’t always work as intended. Thankfully, these are relatively rare situations. Unfortunately, if it’s your artificial hip that fails, there’s not much comfort in knowing the artificial hips in most other patients work as…

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FDA Criticized for Flawed and Delayed CPAP and BiPAP Recall

I’ve written extensively about problems with some Philips CPAP and BiPAP machines, including alleged injuries, affected machines, recalls, and potential litigation. That litigation is ramping up, but a new concern has arisen over the FDA’s inadequate and delayed recall process. Specifically, governmental safeguards designed to protect the public from faulty…

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Zantac Master Complaint, Part 2: Invention of Ranitidine, Discovery of NDMA

In Part 1 I discussed the concept of the Master Complaint in product liability multi-district litigation, and we also set the table with the plaintiffs and the many defendant-companies involved in the Zantac litigation. Now let’s keep grinding through the Zantac Master Complaint. The story of Zantac, the presence of…

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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…

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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…

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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,…

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Carcinogens Found in Valsartan Drugs Lead to Massive Recall

On November 27, 2018, Teva Pharmaceuticals announced a huge recall of all products containing the medication valsartan. The prescription medications containing valsartan may contain chemicals that are considered possible carcinogens. So What is Valsartan? Valsartan is a drug used to treat hypertension, high blood pressure, congestive heart failure, and other conditions.…

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The Bleeding Edge: Film Examines Dangers of Medical Device Industry

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…

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Opioids: Lawsuits Filed by Individual Victims Taking Shape

Most of you have heard reports about the devastating effects of opioids. Millions of people have become addicted, and many of those people have overdosed and died while taking the addictive pain medication. Even in cases when death does not occur, addiction has caused job losses, ravaged families, and cost…

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Federal Preemption Strips State Law Claims From Smith & Nephew Artificial Hip Victims

Have you ever had a problem with a medical device? If you want to bring state law claims against the manufacturer or a doctor, there’s an important legal concept you should know about: federal preemption. In a recent case, the court dismissed several of the plaintiff’s claims against Smith &…

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