Morcellator Lawsuit Filed Over Spread of Endometrial Stromal Sarcoma

A product liability lawsuit filed by a Florida woman is the latest in a growing number of complaints filed against manufacturers of power morcellators used during laparoscopic hysterectomies and uterine fibroid surgeries, alleging that the devices caused cancer contained within the uterus to be spread throughout the abdomen.

The complaint (PDF) was filed by Peggy Paduda on May 7, in the U.S. District Court for the Southern District of Florida, naming Karl Storz Endoscopy-America as a defendant.

According to allegations raised in the morcellator lawsuit, Paduda underwent a laparoscopic supra-cervical hysterectomy on April 8, 2013 at the Cleveland Clinic, which is a minimally invasive procedure designed to allow surgeons to remove the uterus through a small incision in the abdomen. During the operation a Storz Rotocut Morcellator was used to cut, shred and remove one or more uterine fibroids from her uterus.

Prior to the hysterectomy, Paduda indicates that there was no evidence she suffered endometrial stromal sarcoma, which is a rare type of uterine cancer. However, it was later discovered that use of the morcellator upstaged an endometrial stroma sarcoma that was within her uterus, spreading the cancer throughout her abdominal cavity, shortening her life-expectancy and reducing her quality of life.

The complaint is one of about a half-dozen morcellation cancer lawsuits filed in recent weeks by women, raising similar allegations that manufacturers sold a defective and unreasonably dangerous medical device without providing adequate warnings for the medical community about the risk of endometrial stromal sarcoma, leiomyosarcoma or other uterine cancers being spread during a minimally invasive hysterectomy or myomectomy.

Morcellator Cancer Concerns

Power morcellators are medical devices used in recent years during a number of different uterine fibroid surgical procedures, such as a laparoscopic supracervical hysterectomy, robotic hysterectomty or laparoscopic myomectomy. Morcellation cuts the tissue or uterine fibroid into small pieces that can be removed through a port incision, reducing recovery time and providing a minimally invasive surgery.

Paduda’s lawsuit was filed only a few weeks after the FDA issued a warning that urged doctors to avoid morcellation during uterine fibroid surgery or laparoscopic hysterectomy procedures, indicating that about 1 in 350 women undergoing the procedures may have unsuspected sarcoma that could be spread by the devices. Since there is no reliable way to detect the cancer prior to the surgery, the FDA indicates that surgeons should consider alternative surgical techniques.

According to the allegations raised by Paduda, Karl Storz Endoscopy-America had a duty to sell uterine morcellators in such a way as to avoid harm to patients, and to warn about the risk of spreading leiomyosarcoma, endometrial stromal sarcoma and other uterine cancers during a laparoscopic hysterectomy or fibroid removal.

“The Defendants failed to adequately warn about the true risk of dissemination and fulmination of cancer from the use of the Storz Morcellator,” according to the complaint filed by Paduda. “Despite their knowledge of that true risk and of their own failure to adequately warn of it, they failed to make the instrument safe for its intended use, making it unsafe for that use.”

Following the FDA warnings issued on April 17, many hospitals have indicated that they will no longer be performing laparoscopic hysterectomy or uterine fibroid removal surgery with morcellators.

Johnson & Johnson’s Ethicon subsidiary, which was the leading manufacturer of power morcellators, announced late last month that it was halting sales, distribution and promotion of all power morcellators until the FDA and medical communities can determine the correct course of action regarding the devices.

The FDA has indicated that it will convene a public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee to discuss the clinical role of laparoscopic morcellators in treatment of uterine fibroids and whether surgical techniques or the use of accessories like tissue collection bags may make the devices safer. The FDA advisory committee will also review whether a “boxed warning” should be placed on all laparoscopic power morcellators regarding the risk of spreading cancer.

Paduda’s lawsuit charges Storz with negligence, strict product liability, breach of warranty, and fraudulent misrepresentation and omission. The lawsuit seeks both compensatory and punitive damages.