Uterine Cancer Spread By LiNA XCise Morcellator, Lawsuit Claims

LiNA Medical faces a product liability lawsuit that alleges one of its power morcellators spread uterine cancer cells throughout a woman’s body during a laparoscopic-assisted supracervical hysterectomy. 

The complaint (PDF) was filed by Dawn Pythress, and her husband, Gary, in the U.S. District Court for the Eastern District of Tennessee on April 27. LiNA Medical and Kebomed, AG are named as defendants in the case.

Poythress underweint the minimally invasive hysterectomy in April 2015, during which a LiNA Xcise Laparoscopic Morcellator was used to allow the surgeon to remove the uterus through a small incision in the abdomen. However, the lawsuit indicates that the morcellator’s whiling blade spread undiagnosed cancer that was contained within the uterus.

“The velocity with which these blades spin causes dispersal of microscopic tumor fragments, thus seeding the peritoneum with small pieces of cancerous tissue,” the lawsuit states. “What is created is a forced metastasis.”

Power morcellators have been used during an increasing number of laparoscopic hysterectomy and myomectomy procedures over the past decade, for women with symptomatic uterine fibroids. While the device allows the surgeon to perform a minimally invasive procedure, which reduces recovery time, complication risks and scarring, morcellators have been largely abandoned by the medical community over the past few years, since it was discovered that they pose an unreasonable risk of spreading hidden or unsuspected sarcoma, which doctors are unable to diagnose or detect before the procedure.

Following the hysterectomy, Poythress was diagnosed with endometrioid adenocarcinoma with squamous differentation. Just 11 days after her procedure, the FDA issued a morcellator cancer warning warning doctors about use of the device and the risk that they may cause the spread of uterine cancers.

According to allegations raised in the Lina XCise morcellator lawsuit, the manufacturer of the device knew or should have known about the risk of problems for years, yet failed to provide adequate warnings for women or the medical community about the risk of upstage undiagnosed cancer during the minimally invasive procedure.

“Long before Plaintiff, Dawn Poythress, underwent surgery on April 6, 2015, Defendants knew or should have known that the LiNA Laparoscopic Power Morcellator would cause occult malignant tissue fragments to be disseminated and implanted in the body, which in turn would upstage any cancer present and significantly worsen a woman’s chance of survival,” according to the complaint filed earlier this week. “Although evidence was available to Defendants for decades prior to [Poythress’] surgery, Defendants failed to respond to multiple published studies and reports describing the risk of disseminating and upstaging occuult cancer with [LiNA Morcellator] use, and failed to design, promote and otherwise make their [morcellator] in a manner to reduce this life-threatening risk.”

The month after her hysterectomy, Poythress underwent a robotic assisted trachelectomy with pelvic lymphadenectomy in an attempt to arrest the spread of the cancer after her doctors learned about the between hysterectomy morcellation and uterine cancer. However, her physicians now have detected suspicious spots they suspect to be cancerous in her pelvic region and she is awaiting further diagnosis.

The case is one of a growing number of morcellator cancer lawsuits filed against medical device manufacturers, with other similar claims brought against Johnson & Johnson’s Ethicon unit, Karl Storz and other companies.

Since October 2015, all Ethicon morcellator lawsuits filed throughout the federal court system have been consolidated as part of a federal MDL, or multidistrict litigation, which is centralized before U.S. District Judge Kathryn H. Vratil in the District of Kansas.

Cases filed against LiNA and other morcellator manufacturers are proceeding as individual lawsuits in federal and state courts nationwide.