A Republican Congressman out of the 8th District of Pennsylvania, Michael Fitzpatrick, is calling on the U.S. Food and Drug Administration (FDA) to investigate a number of deaths linked to the use of a popular surgical device for gynecological procedures including hysterectomies and uterine fibroid removals. The congressman is also calling for a criminal investigation into the device’s manufacturer, Johnson & Johnson subsidiary, Ethicon.
FDA Issues Black box Warning on Power Morcellators
Power Morcellators are drill like devices used by surgeons to, very literally, cut-up the uterus and uterine fibroids before removing them.
In November 2014, the FDA added a serious warning to the packages of Ethicon power morcellators, stating that the devices could potentially spread or upstage (or advance) undiagnosed uterine cancer. According the FDA’s calculations, as many as 1 of every 350 women could suffer the spread of uterine cancer after use of the device. Shortly after the issuance of that warning, Ethicon pulled the morcellators off the market.
Just over a year later, Congressman Fitzpatrick sent a letter to George Karavetsos, a Director in the FDA’s Office of Criminal Investigations, questioning whether there was factual evidence that hospitals had properly reported adverse events regarding the dangerous devices.
In addition to Ethicon, the congressman’s letter also called for investigation into Brigham and Women’s Hospital, Rochester General Hospital, and University of Rochester Medical Center, for possible failure to report deaths associated with the use of the morecellators in surgeries performed at the hospitals.
Lawsuits Filed on Behalf of Women with Upstaged Uterine Cancer After Morcellator Procedures
In a multi-district litigation, the families of thirty women diagnosed with upstaged cancer after morcellator procedures have filed lawsuits. The cases are currently consolidated before Senior Judge Kathryn H. Vratil in Federal Court in Kansas. Many additional cases are pending in state courts.
The FDA has not yet responded to the Congressman Fitzpatrick’s call for investigation.
Philadelphia and New Jersey Personal Injury Attorneys
The Philadelphia personal injury attorneys at Messa & Associates are experienced at handling products liability cases involving laparoscopic power morcellators that have caused injuries to women. Our extremely skilled team of personal injury attorneys and medical experts is dedicated to ensuring you receive proper compensation for your personal injuries. If you have suffered an injury as a result of the use of a laparoscopic power morcellator, another defective medical device, or any other type of personal injury, contact the personal injury attorneys of Messa & Associates for a free consultation. Call toll free at 1-877-MessaLaw, or submit a free online inquiry.
