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. […]
Category: Defective 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 […]
Even if you eventually win, being involved in transvaginal mesh litigation is an expensive proposition, so Endo Health Solutions has put aside at least $520 million to prepare for any outcome. Endo purchased American Medical Systems (AMS) in 2011 for $2.9 billion and in doing so acquired the AMS product […]
The evidence seemed overwhelming. The transvaginal tape (TVT made by Ethicon, a division of Johnson & Johnson) had caused a foreign body reaction inside Carolyn Lewis of Texas, the woman suing the healthcare giant. Her trial began February 10 and was the first federal case to be heard against Johnson […]
Two years ago, the Food and Drug Association (FDA) was still uncertain about how to address growing concerns over the effects of metal-on-metal (MoM) hip implants. So, on June 27, 2012, the FDA’s Orthopaedic and Rehabilitation Devices Panel convened an Advisory Committee in order to hear experts and the public […]
