The U.S. Food and Drug Administration (FDA) has ordered Bayer, the company that manufactures Essure, to conduct a new postmarket surveillance study for the permanent birth control device. The purpose of the study is “to provide important information about the risks of the device in a real-world environment.” Essure is a permanent birth control method...
Laparoscopic power morcellators are medical devices used during different types of laparoscopic (minimally invasive) surgeries. These surgeries can include procedures to treat uterine fibroids, hysterectomies or myomectomies. Morcellators cut up tissue into smaller pieces which is intended to facilitate the removal of the tissue through small incision sites. Unfortunately, as reported by the FDA, when...
The U.S. Food and Drug Administration (FDA) just announced actions to provide important information about the risks of using Essure, an implantable permanent contraceptive device. According to the FDA, the purpose of these actions is “to help women and their doctors be better informed of the potential complications associated with implantable forms of sterilization.” As...
The Judicial Panel on Multidistrict Litigation (JPML) has issued an order transferring federal cases alleging injuries caused by Bair Hugger Forced Air Warming units or blankets to the District of Minnesota for coordinated or consolidated pretrial proceedings before the Honorable Joan N. Ericksen. The JPML is a group of seven federal judges designated by the...
On January 15, 2016, the U.S. Food and Drug Administration (FDA) cleared the Olympus TJF-Q180V duodenoscope with modifications to the device’s design and labeling intended to help reduce the risk of bacterial infections. (1/15/16 FDA News Release) Olympus will voluntarily recall its original model currently being used in health care facilities and make the needed...
Filings of morcellator cancer lawsuits are continuing to be filed since consolidation of the Ethicon cases by a federal judicial panel in October, 2015. As described on the District of Kansas’ website, “The cases in this MDL involve common factual questions arising from allegations that (1) defects in the design of Ethicon, Inc.’s power morcellators...
In December, 2015, a California jury awarded Florence Kuhlmann and her husband $79,813,000 in a defective Ethicon PPH 03 surgical stapler lawsuit. The verdict included $4 million for past pain and suffering, $4 million for future pain and suffering, and $513,000 for past and future medical expenses, $1.3 million for past and future loss of...
