Several models of a surgical device designed for the treatment of uterine fibroids have been linked to the spread of cancer in patients. Starting this month, many federal product liability lawsuits against one of the makers of these devices will be transferred to a single federal trial court where they will undergo coordinated pretrial proceedings.
The device is called the laparoscopic power morcellator. Johnson & Johnson’s Ethicon division is the defendant named in those lawsuits that the U.S. Judicial Panel on Multidistrict Litigation centralized on Oct. 15 at the federal District of Kansas. Anyone who has undergone a power morcellator procedure and who since has been diagnosed with certain cancers may call 1-866-LAW-2400 to get a free consultation as to what her legal options are.
The morcellator is used in the removal of the uterus (hysterectomy) and in the removal of uterine fibroids (myomectomy). The morcellation process, according to the U.S. Food and Drug Administration, “refers to the division of tissue into smaller pieces or fragments and is often used during laparoscopic surgeries to facilitate the removal of tissue through small incision sites.”
The FDA warned against the use of laparoscopic power morcellators “in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.” The reason is the risk of the spread of hitherto undetected cancer, to include:
- Uterine cancer
- Uterine sarcoma
- Endometrial stromal sarcoma
- Metastatic leiomyosarcoma
The FDA, based on its own analysis, estimated in 2014 that “approximately 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 that includes leiomyosarcoma. At this time, there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.”
The agency got to the point in the nearly year-old safety alert, writing, “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival. While the specific estimate of this risk may not be known with certainty, the FDA believes that the risk is higher than previously understood. Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.”
There are several morcellator lawsuit defendants. At this point, the federal Ethicon litigation has been grouped together, ideally to foster a more efficient and less duplicative pretrial process.
When the panel of judges ordered the Ethicon power morcellator lawsuits centralized, it wrote, “These actions all involve common factual questions arising from allegations that (1) defects in the design of Ethicon’s power morcellators made laparoscopic hysterectomy or myomectomy procedures more likely to result in the dissemination and upstaging of occult cancer or other conditions, and (2) Ethicon failed to warn patients adequately of these risks given the FDA’s recent communication discouraging the use of power morcellation for treatment of uterine fibroids and revising the risk that uterine fibroids were actually sarcoma to 1 in 350.”
Ethicon is the firm that led the pack of manufacturers in voluntarily withdrawing its morcellators from the market. The corporation made that announcement in July 2014, which fell between the dates on which the FDA issued a pair of morcellator missives last year. Not long after Ethicon pulled its morcellators, members of Congress began writing to the FDA and requesting that the agency take a proactive stance to addressing the health risks that the power morcellators apparently posed.
Every medical device, one might say, comes with some sort of risk. One of the issues in power morcellator lawsuits is whether that risk was unreasonable. Another is whether the manufacturer knew what it should have known about that risk and whether it took appropriate steps to minimize it.
Every case has its own nuance, although power morcellator lawsuits do inherently involve some common legal questions. One thing is certain. A woman diagnosed with previously undetected cancer following a power morcellation procedure for hysterectomy or myomectomy may not even know whether she has a case at all until she talks to an attorney. The same applies to the surviving family of cancer decedents.