Undiagnosed Uterine Cancer Spread During Laparoscopic Hysterectomy, Lawsuit Alleges

The medical device manufacturer Karl Storz and Brigham and Women’s Hospital face a wrongful death lawsuit brought by the husband of a woman who died of uterine cancer that was spread during a laparoscopic hysterectomy involving the use of a power morcellator. 

The complaint was filed by Rick Kaitz in Suffolk County Superior Court in Boston, Massachusetts on June 18, naming the hospital, surgeon and manufacturer of the power morcellator as defendants.

Power morcellators are medical devices that have been used in recent years during many laparoscopic hysterectomy and uterine fibroid removal surgical procedures, allowing the surgeon to cut up the uterus or fibrois and remove the tissue through a minimally invasive incision in the abdomen. However, concerns have emerged about the safety of the devices, as many women may have undiagnosed uterine cancers contained within the uterus.

For these women, morcellation during a hysterectomy may spread aggressive cancers, causing the contained tissue to be disseminated throughout the body.

Kaitz indicates in the complaint that his wife, Erica Kaitz, died of uterine cancer in December 2013, which was allegedly upstaged and spread by a Karl Storz morcellator used by Brigham and Woman’s Hospital during a laparoscopic hysterectomy performed to remove uterine fibroids about a year and a half earlier.

The case joins about two dozen other morcellator cancer lawsuits currently pending in courts throughout the U.S., each involving similar allegations that medical device manufacturers failed to adequately warn women or the medical community that morcellation may spread undiagnozed leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers.

In the federal court system, a motion was filed earlier this month with the U.S. Judicial Panel on Multidistrict Litigation calling for all lawsuits over undiagnosed cancer spread by morcellators to be centralized before one judge for coordinated pretrial proceedings.

As additional families learn about the potential link between morcellators and uterine cancers diagnosed after a hysterectomy or fibroid removal, it is ultimately expected that more than 100 complaints could be filed in courts throughout the country. Plaintiffs seek that the federal cases be consolidated as part of an MDL, or multidistrict litigation, to reduce duplicative discovery into common issues in the cases, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

Since the FDA issued uterine cancer warnings about morcellators in April 2014, use of the devices has been largely abandoned by many facilities and much stronger warnings are now being provided to women considering a laparoscopic hysterectomy or myomectomy.

An FDA advisory panel was convened over the summer to evaluate the available data on the controversial devices, which resulted in a determination that there is no way to make power morcellators safer. However, the panel was split on whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.

In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.

Despite the decision not to require a morcellator recall, many hospitals have announced that they will no longer perform a hysterectomy with morcellation, and many experts agree that the vast number of prior procedures performed involving the device are no longer appropriate.