Babette Davis from Wisconsin filed a morcellator product liability lawsuit in the U.S. District Court for the Eastern District of Wisconsin against Johnson & Johnson’s Ethicon unit after being diagnosed with leiomyosarcoma, a deadly aggressive form of uterine cancer. According to Davis, the Johnson & Johnson’s Ethicon Gynecare power morcellator that was used during the laparoscopic hysterectomy caused the undiagnosed uterine cancer to be spread throughout her abdomen and pelvis.
Davis has to take expensive oral chemotherapy drugs to keep the leiomyosarcoma cancer from spreading further and she knows that beating the uterine cancer is going to be a tough battle that she may not win.
Increased Risk of Cancer Spread After Morcellator Use
Davis alleges that Johnson & Johnson failed to disclose the increased risk of cancer after laparoscopic hysterectomy morcellation use.
The morcellation also known as a power morcellator device, is used to grind up the bulky uterus filled with fibroids which may contain undiagnosed sarcomas within the uterus. This morcellation process allows for the easy removal of the ground up uterus segments via the laparoscopic technique, but can also cause rapid spread of the aggressive uterine cancer during the grinding process.
According to Davis, her doctors used a Gynecare morcellator to grind up the uterus through a laparoscopic procedure. Unfortunately, a biopsy of the removed uterine tissue was noted to contain highly malignant leiomyosarcoma cancer cells. Her doctors did not diagnose the uterine leiomyosarcoma cancer before the laparoscopic procedure. Davis received multiple cycles of chemotherapy after the hysterectomy, but three large masses were detected in her abdomen and pelvis, confirming metastatic cancer spread.
Why are Morcellators used?
Power morcellators, which is a fancy term for a tissue grinder, has been use during minimally invasive laparoscopic hysterectomy and uterine fibroid removal procedures over the past several years. These minimally invasive procedures speed up recovery time but this benefit comes at a high cost. Power morcellator use has decreased significantly since it was discovered that they cause an unreasonable risk of spreading aggressive uterine cancer cells during the procedure.
J&J Ethicon Morcellator Recall
All Ethicon power morcellators were recalled in 2014. J&J, acknowledged that the devices pose an unreasonable risk of spreading uterine cancer. Ethicon, requested that hospitals voluntarily return all laparoscopic surgery morcellators. The J&J company announced that it will no longer sell the devices since there is no way to make them safe.
FDA Morcellator Black Box Warning
The FDA announced November 24, 2014 that it is adding a black box warning to uterine morcellator devices that remain on the market. A BLACK BOX WARNING, is the strongest warning that can be placed on any medical device.
Patients, doctors and hospitals are now on notice of the potential danger of increased uterine cancer spread risk associated with the use of these devices. Furthermore, the FDA announced that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision.
This contraindication prohibits the use of the devices in the vast majority of women who undergo laparoscopic or vaginal uterine morcellation procedures.
Federal Multidistrict Litigation
Since October 2015, all federal Ethicon morcellator lawsuits have been consolidated and and centralized as part of a federal MDL, or multidistrict litigation, before U.S. District Judge Kathryn H. Vratil in the District of Kansas. As of February 16, 2016 there are 35 filed Ethicon product liability lawsuits on file at the Kansas courthouse.