Power Morcellator Lawsuits
Women are filing lawsuits against Johnson & Johnson and other manufacturers, claiming that power morcellators spread their undetected cancer.
Johnson & Johnson and other manufacturers of power morcellators are facing lawsuits claiming that the devices spread undetected cancer and harmed women.
Lawsuits claim that women and their doctors were never warned of the potential of morcellators to spread cancer, even though it’s been understood since the 1990s that the devices present such a risk.
Women with noncancerous growths called uterine fibroids may undergo a hysterectomy (removal of the uterus) or myomectomy (removal of the growths) to treat fibroids. Power morcellators allow these procedures to be performed in a minimally invasive manner that reduces complications, but in women who have undetected uterine cancer, the devices can spread and worsen the cancer.
J&J, which suspended sales of its morcellators in 2014 over cancer spreading risks, is the leading defendant in morcellator lawsuits.
The Problem With Power Morcellators
Traditional hysterectomies/myomectomies involve removing the uterus/uterine fibroids intact through a large incision in the abdomen. Performing these procedures with a power morcellator—which uses a rotating cylindrical blade within a long tube that grinds up and vacuums out tissue—allows for minimally invasive surgery through a much smaller incision that is associated with better outcomes, such as shorter hospital stays and fewer infections.
Although removal of tissue with a power morcellator can make the surgery less stressful on the patient, morcellation can have the unintended consequence of dispersing uterine sarcoma, a type of cancer, beyond the uterus.
1 in 350 Women Have Undetected Uterine Cancer
According to the FDA, approximately 1 in 350 women undergoing hysterectomy or myomectomy for treatment of fibroids has undetected uterine sarcoma. That is, their uterine fibroids are cancerous, not benign. Unfortunately, there is no reliable way to detect before surgery whether a woman’s fibroids are cancerous. When a woman does have sarcoma, morcellating tissue can spread it inside of her body, making it much more likely that she will die from the cancer.
Previously, it was thought that the number of women with undetected uterine sarcoma was closer to 1 in 10,000.
No Warning, No Testing
While the risk of spreading cancer through tissue morcellation is a danger in and of itself, what’s worse, according to lawsuits, is that power morcellator manufacturers never warned doctors and patients of this risk. That could be because the risk was never assessed in clinical testing.
Perhaps the single biggest problem with power morcellators is that many of the devices used today have never undergone clinical testing for safety and efficacy
By 1991—the year that a power morcellator was first approved by the FDA—it was well understood that cutting cancer in the body could spread it. In 1995, during the application process for a new morcellator, an FDA medical offer told a manufacturer that he had concerns about the device spreading dangerous cells, according to a report in The Wall Street Journal.
Some morcellators specify that the devices should be used with a tissue extraction bag to avoid spreading malignant tissue, although the adequacy of extraction bags for reducing the spread of cancerous tissue is not well studied.
Perhaps the single biggest problem with power morcellators is that many of the devices used today have never undergone clinical testing for safety and efficacy. As the WSJ shows, some of the most popular morcellators currently used on patients were approved through an FDA fast track approval program that allows devices to forego testing if they are “substantially equivalent” to a device already on the market. Many health experts believe that this so-called “510(k)” approval process cannot adequately protect public health and should be done away with.
Studies Linking Morcellators to Cancer Metastasis
Spreading cancer from its primary site to secondary sites is known as “metastasis,” while a patient’s cancer changing from a less extensive level (e.g., Stage 1) to a more extensive level (e.g., Stage 4) is known as “upstaging” the disease.
Evidence suggests that power morcellators can both metastasize and upstage cancer:
- “Approximately 1 in 350 women who are undergoing hysterectomy or myomectomy for fibroids is found to have an unsuspected uterine sarcoma. If laparoscopic power morcellation is performed in these women, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.” –FDA safety guidance
- “Women with apparent uterine-confined neoplasms at the time of morcellation have been found to have intraperitoneal tumor dissemination at the time of reexploration.” –Journal of the American Medical Association
- “Tumor morcellation and spillage during surgery may adversely affect treatment outcomes in patients with these highly malignant tumors.” –Oncology Times
- “If an occult malignancy is present, the use of power morcellation will increase the likelihood of intraperitoneal dissemination. It may also worsen the patient’s prognosis, make a definitive diagnosis and accurate staging of the underlying malignancy more difficult, and result in the need for additional surgery, medical management, or both.” –The American College of Obstetricians and Gynecologists
- “Women with sarcoma who are morcellated are about 4 times more likely to die from sarcoma than if they had not been morcellated.” – Hooman Noorchashm
Hundreds of Morcellator Lawsuits Filed
Johnson & Johnson (through its Ethicon division) has since been hit with about 100 morcellator lawsuits that are centralized in Kansas federal court. J&J morcellator cases have also been filed in state courts.
In addition to J&J, morcellator manufacturers include Karl Storz, LiNA Medical, Cook Medical, Olympus America Inc., Blue Endo, FemRx, Lumenis, Ltd., and Richard Wolf GmbH.
Power morcellator lawsuits allege, among other things, that manufacturers:
- Introduced inherently dangerous medical devices to the market.
- Did not sufficiently test morcellators.
- Provided inadequate warnings about the risks of spreading and worsening undetected cancer.
Plaintiffs claim that, had they been properly informed about the cancer risks of morcellators, they would have chosen a different surgical procedure. According to lawsuits, manufacturers’ negligence led to women suffering injuries, harm, and economic losses.
J&J is reportedly paying $100,000 to $1 million per case to settle power morcellator lawsuits behind the scenes, and it’s expected that the manufacturer will pay many millions to settle the claims when all is said and done.
A morcellator lawsuit against LiNA Medical settled in 2015 for an undisclosed amount.
Companies often settle lawsuits confidentially to prevent damaging information from coming to light.
How a Lawsuit Can Help
If you experienced medical device complications, a lawsuit may be able to recover damages for medical bills (including future medical bills), as well as for lost wages or reduced earning power. Lawsuit compensation may also cover things like physical pain, mental anguish, and reduced quality of life.
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