Around 100,000 women have filed transvaginal mesh (TVM) lawsuits against Johnson & Johnson, Bard, Boston Scientific and others as a result of severe and debilitating injuries they’ve suffered after being implanted with TVM. In January, the U.S. Food and Drug Administration announced a new warning about vaginal mesh, now classifying the device as “high risk.” Transvaginal mesh is...
A discovery schedule has been proposed in the roughly 100 IVC Filter lawsuits pending in a federal MDL in Arizona before U.S. District Judge David G. Campbell. The medical device lawsuits include claims based on injuries caused by the Bard Recovery, G2, and G2 Express retrievable filters. The discovery schedule would apply to the earliest cases filed in the MDL. Those cases might see a trial...
Metal-on-metal hip replacement manufacturers must now submit a premarket approval application (PMA) to the U.S. Food and Drug Administration for two types of hip systems, one having a cemented acetabular component and the other having an uncemented acetabular component. The FDA’s final order released this past February reportedly gives medical device makers until May 18 to submit their new...
What did medical device maker C.R. Bard do after it learned problems existed with its blood clot filter? The medical device in question was developed to replace a different filter implicated in the deaths of 27 people? Bard continued selling the filters — more than 160,000 of them in a five-year period.
Bard is a New Jersey-based corporation that manufacturers medical devices,...
Orthopedic surgeons in Europe will often mix-and-match components when performing hip replacement surgery. This is happening in spite of warnings against the practice from manufacturers of metal-on-metal and other hip systems. This was the finding of Dr. Keith Tucker, an orthopedic surgeon in Norwich, United Kingdom, and his colleagues, who conducted a recent study to learn how many total hip...
January 21, 2016 – Patients are now being enrolled in a new study to assess the effectiveness and safety of inferior vena cava (IVC) filters — small medical devices implanted in the body to stop blood clots from reaching the heart or lungs. The five-year-long study will involve 2,100 patients at 60 medical sites around the country. PRESERVE (Predicting the Safety and Effectiveness of...
January 14, 2016 – The U.S. Food and Drug Administration is receiving push-back on its 2014 warning about the threat to women from the use of power morcellators during gynecological procedures. A group of gynecologists from respected universities has asked the FDA to alter its position concerning the potentially dangerous medical devices.
Surgeons Ask FDA to Alter its Stance Concerning...
Five years ago, Mercy Hospital in Springfield, Missouri began a Unique Device Identifier (UDI) pilot project — a program to track implanted medical devices. The project has financial backing from the U.S. Food and Drug Administration (FDA). With a new grant from the FDA, Mercy Hospital reportedly is set to receive up to $5.2 million in the next three years. The additional funding will allow...
Coloplast, the Danish medical device manufacturer, has set aside $445 million to pay U.S. women injured by the company’s transvaginal surgical mesh products. After making the announcement, Coloplast’s financial results for the year reportedly fell 62 percent.
Danish Transvaginal Mesh Manufacturer Predicts that Some Lawsuits Against it are Likely to Go to TrialVaginal mesh is a...
The U.S. Food and Drug Administration (FDA) has issued a partial response to an inquiry from a Pennsylvania congressman concerning hazards surrounding the use of power morcellators in gynecological surgeries. A power morcellator uses small rotating blades to cut up fibroid tumors, allowing the growths to be removed laparoscopically through small incisions in the abdomen. Unfortunately, many...
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