Yes, you can sue if the facts of your case support a claim against the manufacturer of the laproscopic power morcellator used for uterine fibroid removal (myomectomy) or hysterectomy. To have a claim, you need to have evidence to prove that the morcellator used in your surgery shred tissue containing previously undetected cancer cells, spreading them to surrounding tissue.
Laparoscopic power morcellation shreds the uterus and uterine fibroids before removal. If this tissue is cancerous, it can spread throughout the abdomen and pelvic area, significantly worsening the woman’s chance of survival. Women who have been diagnosed with a uterine sarcoma, including leiomyosarcoma, after a myomectomy or hysterectomy can call 1-888-377-8900 (toll free) to contact me for a free consultation. Even if you do not hire me to represent you, I want to help you understand your rights and what action you should take to hold the morcellator manufacturer and others accountable.
Morcellator manufacturers include LiNA Medical, Ethicon Inc. (a Johnson & Johnson (J&J) company) and others. Ethicon recently suspended worldwide sales of its laparoscopic power morcellators:
- Gynecare Morcellex Tissue Morcellator;
- Morcellex Sigma Tissue Morcellator System; and
- Gynecare X-Tract Tissue Morcellator.
This was not a recall, and at this time no other manufacturer has issued a recall of laparoscopic power morcellation products.
FDA Issues Warning and Hospitals Discontinue Use of Power Morcellator for Hysterectomy
The U.S. Food and Drug Administration (FDA) issued a safety communication warning surgeons and other health professionals that, “when used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.” Several hospitals reacted to this by suspending the use of power morcellators in these cases. According to the FDA, “1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids is found to have an unsuspected uterine sarcoma, a type of uterine cancer.” With over 75,000 of these surgeries happening each year, this means that each year over 200 women may have had the cancer spread because a power morcellator was used. According to the Wall Street Journal, manufactures may have know about this risk long before the FDA issued this warning.
Hundreds of women may have been harmed by these products. Under product liability law, evidence that a manufacturer knew of a health risk and failed to act can be used to file claims for punitive damages, amounts of money meant to punish a company for wrongdoing.
Thursday of this week (July 10, 2014), the FDA’s Obstetrics and Gynecological Medical Devices Panel is holding meetings to discuss laparoscopic power morcellation. The FDA is seeking a boxed warning related to the risk of cancer spread, not a recall of these products.