A major move toward public safety may be one step closer with the U.S. Food and Drug Administration announcing this week that it will put a proposal out for public comment that would reclassify pelvic organ prolapse (POP) mesh from moderate to high risk. If approved, that move would require […]
Category: Defective Medical Devices
Please read our most recent blog at our sister site, StrykerImplantRecall.com. We’ve filed 71 cases in one week, and we’re making some serious headway on the Stryker Rejuvenate litigation.
For the first time, a Texas jury has decided the pelvic mesh made by healthcare giant Johnson & Johnson was defectively designed. The jury awarded the 64-year-old Dallas woman $1.2 million following a two-and-a half week trial. The case has implications for all pelvic mesh which is overwhelmingly made of […]
This news is not surprising to anyone who pays attention to medical device recalls. There has been a substantial jump in medical device recalls – up 97 percent over the last decade! This news comes from the division within the U.S. Food and Drug Administration (FDA) that regulates medical devices. […]
Based on new documents uncovered within the bowels of the Food and Drug Administration (FDA), researchers at Harvard University have joined voices with many FDA watchers to conclude the way most medical devices make it to market does nothing to assure patient safety. Specifically, the researchers were looking at how […]
Shareholders have sued the maker of a surgical robot claiming the company has “grossly underreported” injuries and deaths attributed to the da Vinci. The 67-page shareholder derivative complaint was filed by the city of Birmingham and Alabama’s Relief and Retirement System naming Intuitive Surgical of Sunnyvale, California, the maker of […]
The U.S. Attorney General’s office says it is reviewing an open letter submitted by a consumer group encouraging a criminal probe into the destruction by Johnson & Johnson (J&J) of pelvic mesh litigation documents. That announcement comes after Corporate Action Network (CAN) asked Eric Holder Jr. to explore how and […]
The Wall Street Journal reports on conflict of interest disclosures that have evolved as a result of transvaginal mesh (TVM) lawsuits filed against healthcare giant, Ethicon, a division of Johnson & Johnson. Amid the hundreds of thousands of pages of documents provided in the 17,000 cases filed in federal court […]
While it is not official, Bloomberg is reporting that Coloplast A/S, one of the smaller manufacturers of transvaginal meshes, is said to be willing to settle a number of lawsuits for $16 million. Three different individuals tipped the news outlet, but none were reportedly authorized to speak. The Danish company […]
In 2011 Endo Health Solutions bought American Medical Systems for $2.9 billion. That may have been a mistake because since then, the number of product liability lawsuits naming AMS over its transvaginal mesh has grown to 22,000 cases. Now the company is looking ahead to the impact on its bottom […]
