This is an old page on power morcellator lawsuit that was updated in 2024.
History of Power Morcellator Lawsuits
In the United States, an estimated 650,000 women per year undergo surgical hysterectomies or myomectomies to manage symptomatic uterine fibroids. Traditionally, these procedures involved removing the uterus or fibroids intact.
Power morcellators were introduced in the 1990s as tools to facilitate minimally invasive surgeries, such as hysterectomies and myomectomies, by cutting large tissues into smaller fragments that could be easily removed through small incisions. It sounded good. These devices promised quicker recovery times, less postoperative pain, and reduced surgical trauma, quickly becoming popular in gynecological procedures.
Early Concerns and FDA Warnings
Despite their advantages, concerns about the safety of power morcellators began to surface in the early 2000s. The primary issue was the potential for spreading undetected cancerous tissues, particularly uterine sarcomas, during morcellation.
In April 2014, the FDA issued a safety communication discouraging the use of power morcellators for hysterectomy or myomectomy due to the risk of spreading undetected uterine sarcoma. The FDA’s analysis indicated that approximately 1 in 350 women undergoing these procedures for fibroids might have an unsuspected uterine sarcoma.
Following the FDA’s warning, Johnson & Johnson withdrew its power morcellators from the market. The FDA also convened an Advisory Committee meeting in July 2014 to discuss the risks associated with these devices, ultimately recommending that power morcellators should not be used in patients with known or suspected malignancy and suggesting that a black box warning be included on these devices.
Power Morcellator Lawsuits
The history here is stunning. In December of last year, the FDA and, let’s be honest, most of the world has been sleeping on the issue of whether these morcellators can spread cancer that otherwise might have laid dormant. Five months later, in April 2014, the FDA issued a statement urging doctors to stop using power morcellators for uterine fibroid removal and hysterectomies.
This was a complete screw up on many levels. Numerous medical studies dating back to the 1990s have identified the risks of using power morcellators. For instance, a 1991 patent for a Surgical Tissue Bag highlighted the potential for morcellation to spread malignant tissue fragments. Further studies published in prominent medical journals throughout the years continued to report on the risks and complications associated with morcellation, including the possibility of rapid cancer progression and poorer long-term outcomes for patients who underwent morcellation compared to those who had traditional surgeries.
As someone who follows the history of how the science unfolds in mass tort medical device cases, the speed of this discovery of what has always been there to be seen was breakneck. Yet it was in front of the FDA and morcellator manufacturers’ faces all along: these morcellators are cancer spreaders.
How so? Doctors have no way to know whether the fibroids they are breaking up with a morcellator have cancerous cells. It is estimated that one in 350 women who undergo uterine fibroid surgery have unsuspected sarcoma contained within the uterus, while another one in 400 has the even deadlier, leiomyosarcoma (LMS). These cancer cells can be hidden inside the uterine fibroids. If a fibroid contains cancer cells, the cutting of the uterus with the power morcellator will cause cancer cells to spread throughout the peritoneal cavity, posing an extremely serious risk to a woman’s health. The spreading of these cells can quickly ignite the spread of cancer.
While a recall was not issued in April, the FDA indicated that it would convene an advisory panel to determine what additional regulatory steps should be taken. Despite the lack of a recall, many hospitals and doctors announced that they would no longer use the device until further guidance was provided. Johnson & Johnson’s Ethicon unit, the largest manufacturer of the morcellator, did something that surprised me: it stopped sales as well as the production of the device, pending further FDA recommendations.
Surge of Lawsuits
Following the FDA warning, numerous lawsuits were filed against manufacturers of power morcellators, including major companies like Johnson & Johnson (through its subsidiary Ethicon). Plaintiffs alleged that the manufacturers failed to warn patients and doctors about the risks associated with the devices, leading to the spread of undiagnosed cancer. Many of these lawsuits were filed by women who developed advanced stages of cancer after undergoing morcellation procedures.
Legal Developments and Settlements
In response to the growing number of lawsuits, Ethicon voluntarily withdrew its power morcellators from the market in July 2014. By 2015, the Judicial Panel on Multidistrict Litigation (JPML) centralized many of the federal lawsuits involving power morcellators into multidistrict litigation (MDL) to streamline pretrial proceedings and manage the growing caseload efficiently.
Several significant settlements followed. For example, in 2015, Johnson & Johnson settled a number of cases for undisclosed amounts, reflecting the company’s acknowledgment of the potential risks and the severity of the plaintiffs’ claims. These settlements often involved confidentiality agreements, making specific details sparse.
Continued Impact and Regulatory Changes
The controversy surrounding power morcellators had a significant impact on the medical community and regulatory practices. The FDA updated its guidelines, recommending that morcellators should not be used in the majority of women undergoing fibroid removal. They also mandated the addition of boxed warnings on the devices to inform users of the potential risks. Moreover, the medical community saw an increased emphasis on alternative surgical techniques and heightened vigilance in preoperative cancer screenings.
Ongoing Litigation and Awareness
As of the late 2010s and early 2020s, litigation related to power morcellators continues, though at a reduced pace compared to the peak years. The legacy of these lawsuits has led to greater awareness about the risks associated with medical devices and the importance of informed consent. Patients and healthcare providers are now more cautious, ensuring thorough discussions about potential risks and benefits before proceeding with surgical procedures involving morcellation.
J&J settled these cases. Although there may well still be viable claims, you do not see new power morcellator lawsuits in 2024.
- Morcellator | Lawsuit Update
- Does this spell the end for Morcellators?
- 2024 Update: Morcellator lawsuit settlements: J&J paid between $100,000 and $1 million to settle these lawsuits in 2016. J&J received some credit for owning its mistake and offering settlement amounts to victims.