A trio of medical device makers are looking to slip patent infringement and product liability lawsuits based on recent U.S. Supreme Court rulings governing out-of-state lawsuits. In TC Heartland v. Kraft Foods Group Brands, the Supremes limited the ability of patent holders to sue in other states. Kraft sued TC Heartland in its incorporated state of Delaware […]
FDA regulators put their highest-risk Class I label on the recall of DePuy Synthes’ Craniomaxillofacial Distraction System after the company reported 15 injuries associated with the jaw implant.
Long-embattled Dow Corning is still on the hook for complaints about 3 of its implantable tissue expanders after a 6th Circuit Court ruled that the devices count as breast implants for the purposes of a liability settlement worth more than $2 billion.
FDA regulators refused this week to ban U.S. sales of pelvic mesh implants, rejecting in large part a petition filed by consumer advocacy group Public Citizen, but offered some consolation in a potential reclassification of the devices to a higher-risk category.
Scores of speakers expressed outrage before a panel of FDA experts gathered at a public meeting yesterday and today to discuss the future of laparoscopic power morcellators (LPMs), devices used to break up and extract tissue during minimally invasive gynecologic surgeries.