Laparoscopic Supracervical Hysterectomy Lawsuit Filed Over Cancer Spread by Morcellator

Karl Storz, Inc. faces a new product liability lawsuit filed by a Michigan woman, who alleges that a power morcellator used during a laparoscopic supracervical hysterectomy (LSCH) caused cancer cells to be spread throughout her body, leaving her with stage 4 bone and breast cancer.

The complaint (PDF) was filed by Denise Whitfield in the U.S. District Court for the Easter District of Michigan on January 26, alleging that the manufacturer failed warn about the cancer risk associated with use of Storz Rotocut G1 morcellator during the LSCH procedure.

Whitfield underwent laparoscopic supracervical hysterectomy and bilateral salpingectomy for uterine fibroids on June 14, 2011, according to the lawsuit. During the minimally invasive surgery, a Storz Rotocut G1 morcellator was used to cut up and shred her uterus, allowing doctors to remove the tissue through a small incision in the abdomen. However, she indicates that the device also caused the spread of undiagnosed cancerous cells, rapidly spreading the cancer.

The upstaged cancer was not discovered until July 2014, when she had to undergo spinal surgery. They then found metastasized bone and breast cancer at its most virulent stages.

“As a result of the use of the Rotocut G1 power morcellator, Plaintiff developed Stage 4 bone and breast cancer, and has had to undergo extensive and intensive therapies for the treatment and management of her advanced-stage cancer. This treatment includes daily hormone medications, regular injections of medications by her physicians and multiple ten-week rounds of radiation therapy,” the lawsuit states. “Fibroid removal surgery without the use of a morcellator generally poses almost no danger of dissemination of cancerous cells, subsequent development of cancer outside the uterus and/or upstaging of cancer.”

Whitfield joins a growing number of women and families throughout the U.S. now pursuing laparoscopic supracervical hysterectomy cancer lawsuits over the use of power morcellators in recent years, alleging that Karl Storz and other manufacturers failed to provide adequate warnings about the cancer risks for consumers and the medical community.

Power Morcellator Cancer Concerns

Power morcellators are medical devices that have been increasingly used in recent years during laparoscopic hysterectomy procedures for removal of the uterus and myomectomy procedures for removal of uterine fibroids, providing for reduced recovery times, less scarring and reduced risks of infections or other complications associated with traditional surgery.

Although morcellators were rapidly adopted throughout the medical community, concerns have emerged over the past year about the risk that the devices may spread undiagnosed cancer, which many women have hidden and contained within the uterus.

Estimates suggest that about one out of every 350 women undergoing a laparoscopic supracervical hysterectomy with morcellation may have unsuspected sarcoma, which doctors are unable to detect before the surgery.

Since power morcellators may spread this cancerous tissue throughout the abdomen, rapidly upstaging the cancer and reducing the risk of long-term survival, the medical community has largely abandoned the use of power morcellators over the past year.

Over the summer, an FDA advisory panel was convened to evaluate the available data on the controversial devices, and determined 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.

All of the product liability lawsuits filed in recent months against manufacturers of these devices outline similar factual patterns and raise nearly identical allegations those being pursued by Whitfield, claiming that laparoscopic supracervical hysterectomy morcellation poses an unnecessary risk and that manufacturers should have provided stronger warnings years ago.

Whitfield’s complaint pursues claims against Karl Storz Inc. for negligence, designing and manufacturing a defective medical device, failure to warn, strict liability, breach of warranty, negligent and fraudulent misrepresentation. The lawsuit seeks both compensatory and punitive damages.