Power Morcellator General Information
A power morcellator is a helpful surgical tool that is used during gynecological surgeries including hysterectomies and myomectomies. While this tool is not new (having been approved by the FDA since 1991), there have been recent developments that suggest the device’s use could severely shorten a woman’s long-term life expectancy by spreading cancerous cells throughout their abdomen and pelvis.
Power morcellators work by using blades to rapidly cut tissue for removal during laparoscopic surgeries. Unfortunately, if there are cancer cells in the tissue (which is almost impossible to know prior to surgery), then the cancerous cells will be spread by the morcellator throughout the abdomen and pelvic areas.
Power morcellators are often used during surgeries to treat uterine fibroids—noncancerous growths of the uterus. Although many times women are not even aware they have uterine fibroids because they have no side effects, if they do have side effects, they can be very serious and can include heavy menstrual bleeding, pelvic pain, or back or leg pains. In a safety communication issued by the FDA in November 2014, the FDA warned however, that about 1 in 350 women will have unsuspected uterine sarcoma—a type of uterine cancer.
Unfortunately, what this means is that with every laparoscopic surgery that uses a power morcellator to treat uterine fibroids, the doctor runs the risk that they might spread unknown cancer throughout their patient’s body. In their safety communication, the FDA advised that there is no reliable method for testing or predicting whether a woman with uterine fibroids will have a uterine sarcoma. Further, the FDA suggested most women not use a power morcellator in myomectomy or hysterectomies for the treatment of uterine fibroids.
After the FDA issued this safety communication, some manufacturers of power morcellators like Johnson and Johnson pulled theirs off the market. Even though they pulled their morcellators off the market, it was later discovered that Dr. Robert Lamparter notified Johnson and Johnson as early as 2006 of the risk of potentially spreading cancer when using a power morcellator. Johnson and Johnson’s only response, unfortunately, was to put a warning in the instructions on how to use the tool.
Power morcellators got FDA approval through their controversial 510(k) process, which allows devices to be approved without testing as long as the device is as safe and effective (substantially equivalent) to a device already on the market. Once again, the 510(k) process is under serious scrutiny from consumers and doctors alike.
Currently, 12 members of Congress are asking the Government Accountability Office to investigate as to why the morcellator has been on the market for over 20 years before the FDA ever issued a warning about the device’s potential to spread cancer. It is unclear at this point what stage the FBI investigation is in, but they are thoroughly investigating Johnson and Johnson and are taking note of Dr. Lamparter’s warnings to the company.
Current State of Litigation
More than 20 lawsuits have been filed against manufacturers of power morcellators, and in October of 2015, the Judicial Panel on Multidistrict Litigation consolidated the pending lawsuits in the U.S. District Court for the District of Kansas under Judge Kathryn H. Vratil.
The majority of the lawsuits have been filed against Johnson and Johnson’s Ethicon division, which is the subsidiary that manufactured power morcellators. The pending suits are all alleging that the power morcellators used caused serious complications, including the spread of cancerous tissue.
Because power morcellators are used in about 60,000 procedures each year, the number of lawsuits against manufacturers of the devices will almost certainly increase over time. The first trials to be heard in the MDL will be the bellwether trials, which will allow the parties to test their arguments with the goal of resolving the entire litigation. The bellwether trials are scheduled to be heard in 2017.
There is speculation the Ethicon might have settled some of the pending cases, because at least 2 attorneys in the MDL have requested to resign because all of their clients and Ethicon have reached a settlement. Unfortunately for the rest of the pending cases, however, there is no large group settlement meaning that unless there is a larger settlement in the future, the rest will have to go to trial in 2017.