Leiomyosarcoma Wrongful Death Lawsuit Filed Against Laparoscopic Morcellator Manufacturers

A New York man has filed a wrongful death lawsuit against Ethicon, Karl Storz and other power morcellator manufacturers, alleging that his wife died after undiagnosed leiomyosarcoma was spread throughout her body by a medical device used during a laparoscopic hysterectomy for removal of uterine fibroids. 

The complaint (PDF) was filed earlier this month in the U.S. District Court for the District of Minnesota by Israel Arama, husband and executor of the estate of Ester Arama, who died in December 2014.

According to allegations raised in the lawsuit, Ester Arama died from cardiac arrest caused by side effects of leiomyosarcoma, which was disseminated throughout her body by a laparoscopic morcellator used during the hysterectomy.

In recent years, power morcellators have become increasingly popular for use during minimimally invasive uterine fibroid removal procedures, allowing the doctors to cut up the uterus or fibroids and remove the tissue through a small incision in the abdomen.

While these procedures are designed to reduce recovery time and the risk of infections or other complications, morcellators have largely been abandoned by the medical community since it was discovered that they pose an unreasonable risk of spreading aggressive cancer cells that may be hidden within the uterus of some women, which doctors are unable to detect or diagnose before the surgery.

The complaint, which does not identify the specific type of power morcellator used during Arama’s surgery, is one of a growing number of leiomyosarcoma cancer lawsuits filed against manufacturers devices sold by a number of different companies. Ethicon and Karl Storz were two of the leading manufacturers of the devices.

Each of the lawsuits raise similar allegations, indicating that manufacturers sold a defective and unreasonably dangerous medical device, failing to warn about the link between laparoscopic morcellation and cancer.

This latest claim indicates that Arama underwent a supracervical hysterectomy on June 6, 2011, during which a power morcellator was used for uterine fibroid removal. The complaint indicates that there was no evidence of cancer at that time, but an examination of the tissue removed during the procedure determined that the fibroids were benign leiomyoma.

In 2014, Arama began to complain of abdominal pain, which was linked to tumors in her abdomen and ovarian cysts. The tumors were removed and determined to be advanced metatstatic leiomyosarcoma. Pathologists at the Memorial Sloan Kettering Cancer Center evaluated her condition in April 2014, and determined that the laparascopic morcellation procedure had spread and upstaged leiomyosarcoma which had been in the fibroids.

She underwent numerous treatments, harsh drugs, chemotherapy, pain and suffering before dying of cardiac arrest, the lawsuit indicates.

“Had the Laparoscopic Power Morcellator used on Plaintiff-Decedent not disseminated and fulminated cancerous cells and tissue, she would not have needed to undergo the invasive, debilitating and damaging chemotherapy treatment nor would she have succumbed to the spread of her cancer to her lungs which ultimately caused her death,” the lawsuit states. “The Laparoscopic Power Morcellator used on Plaintiff-Decedent during her 2011 surgery caused this specific cancerous condition, profoundly and gravely injuring Plaintiff-Decedent, and caused her death.”

Power Morcellator Litigation

The litigation over power morcellators has emerged over the past eighteen months, following FDA warnings in April 2014, which warned about the uterine cancer risks with morcellation.

FDA estimates suggest that one out of every 350 women undergoing surgery for symptomatic uterine fibroids may actually have undiagnosed and unsuspected sarcoma contained within the uterus.

For these women, morcellators may rapidly spread cancerous cells throughout the body, rapidly upstaging leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers to an advanced stage that is difficult to treat and often fatal. This may greatly reduce the likelihood of long-term survival and the woman’s overall quality of life.

While the FDA has allowed laparoscopic morcellators to remain on the market, with much stronger warnings about the potential cancer risks, many hospitals have announced that they will no longer perform hysterectomy or myomectomy procedures with morcellation, indicating that there is no way to justify the risk.

As more families learn about the link between the devices and uterine cancers diagnosed in recent years, a growing number of laparoscopic morcellation lawsuits are expected to be filed against the manufacturers in the coming months.

In October, the U.S. Judicial Panel on Multidistrict Litigation ordered that all product liability lawsuits filed against Johnson & Johnson’s Ethicon subsidiary over the spread of cancer from uterine morcellation will be centralized before U.S. District Judge Kathryn H. Vratil in the District of Kansas as part of a federal MDL, or multidistrict litigation. No other manufacturers were included in the MDL.