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 made laparoscopic hysterectomy or myomectomy procedures more likely to result in the dissemination and upstaging of occult cancer or other conditions, and (2) Ethicon, Inc. failed to warn patients adequately of these risks given the FDA’s recent communication discouraging the use of power morcellation for treatment of uterine fibroids and revising the risk that uterine fibroids were actually sarcoma.”
Laparascopic power morcellators are tools used during a hysterectomy or myomectomy that shred uterine fibroids and other tissue so that it can be easily removed. In April 2014, the FDA issued a safety communication discouraging the use of laparascopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids. Several months later, the agency issued a November, 2014 advisory indicating as follows:
Based on an FDA analysis of currently available data, we estimate that approximately 1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer that includes leiomyosarcoma. At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.
If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood.
Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.
Limiting the patients for whom laparoscopic morcellators are indicated, the strong warning on the risk of spreading unsuspected cancer, and the recommendation that doctors share this information directly with their patients, are part of FDA guidance to manufacturers of morcellators. The guidance strongly urges these manufacturers to include this new information in their product labels.
(Emphasis in original.)
The plaintiffs in the morcellator lawsuits allege that the manufacturers of power morcellators knew as far back as the early 1990s about this issue, but failed to warn women and their physicians.
After multiple lawsuits were filed, in October, 20015, the Judicial Panel on Multidistrict Litigation granted plaintiffs’ request for creation of a federal MDL in the District of Kansas for lawsuits alleging a link between the use of power morcellators and the spread of cancerous cells. Specifically, in the Oct. 15 order, the panel appointed Senior Judge Kathryn H. Vratil to oversee the coordinated or consolidated pretrial proceedings. Judge Kathryn H. Vratil is the twenty third judge and the first woman named to the U.S. District Court for the District of Kansas.
The order stated as follows: “These actions all involve common factual questions arising from allegations that (1) defects in the design of Ethicon’s power morcellators made laparoscopic hysterectomy or myomectomy procedures more likely to result in the dissemination and upstaging of occult cancer or other conditions, and (2) Ethicon failed to warn patients adequately of these risks given the FDA’s recent communication discouraging the use of power morcellation for treatment of uterine fibroids and revising the risk that uterine fibroids were actually sarcoma to 1 in 350. Centralization will eliminate duplicative discovery, avoid inconsistent pretrial rulings (including with respect to discovery, privilege, and Daubert motion practice), and conserve the resources of the parties, their counsel and the judiciary.”
Status conferences are scheduled in the Ethicon Morcellator MDL on the following dates: January 6, 2016 at 9:00 am; February 10, 2016 at 9:00 am; March 4, 2016 at 8:00 am, March 30, 2016 at 9:00 am, May 4, 2016 at 9:00 am, and June 1, 2016 at 9:00 am.
For more information about the morcellator cancer lawsuits, feel free to contact Pharmaceutical/Medical Device Litigation Attorney Pamela A. Borgess of Borgess Law, LLC at (567) 455-5955 or toll-free at (844) LAW-9144. You can also contact Borgess Law, LLC by submitting an online inquiry or emailing Attorney Borgess directly at [email protected]. Borgess Law, LLC never charges a fee for an initial consultation.