Power Morcellator Lawsuit
The OBGyn medical community is questioning the inherent dangers of power morcellation in hysterectomies and other gynecological procedures as growing evidence suggests significant cancer risks. Open power morcellation is a technique commonly used to break down fibroid tumors or abnormal tissue growth into pieces, which is then removed laparoscopically. Now, the FDA warns that power morcellation during hysterectomy or myomectomy (fibroid removal) procedures pose a risk of spreading cancerous tissue, such as uterine sarcomas, into the pelvic cavity.
In one recent power morcellator lawsuit, a Philadelphia widower argues that his wife had no evidence of metastatic cancer before she underwent a hysterectomy aided by power morcellation in 2012. Donna Burkhart died at the young age of 53 of a rare type of cancer known as metastatic leiomyosarcoma less than one year after a routine, minimally-invasive hysterectomy to address her uterine bleeding. The American Congress of Obstetricians and Gynecologists says that electric or power morcellation is used in about 11 percent of all hysterectomies, as was the case for Burkhart.
The product liability claim is the first federal morcellation cancer lawsuit involving a manufacturer of uterine morcellators and names Ethicon, Blue Endo, and Lina Medical as defendants. Many experts believe this litigation is just the tip of the iceberg, as FDA officials are discouraging laparoscopic power morcellation in gynecological surgeries due to cancer threats.
FDA warns of power morcellation and cancer risk
On April 17, 2014, health regulators at the FDA issued a public safety communication regarding power morcellation dangers. Based on available data, the agency found that roughly one out of every 350 women who undergo myomectomy or hysterectomy have uterine sarcoma, which can spread outside of the uterus when using electric morcellation. The agency cautions of the risk that the device will inadvertently spread cancer cells within the pelvis, “significantly worsening the patient’s likelihood of long-term survival.”
“There is no reliable way to determine if a uterine fibroid is cancerous prior to removal. Patients should know that the FDA is discouraging the use of laparoscopic power morcellation for hysterectomy or myomectomy, and they should discuss the risks and benefits of the available treatment options with their health care professionals,” explains the deputy director for the agency’s Center for Devices and Radiological Health.
In their safety announcement, the FDA encourages women to adhere to the following guidelines:
- Thoroughly discuss the risk to benefit ratio of various gynecological procedures with your doctor
- If your health care provider recommends power morcellation during your fibroid removal or hysterectomy, ask why this method is suitable
- Those who have already had a myomectomy or hysterectomy with power morcellation and had no cancerous tissue during follow-up tissue sample tests, continue with routine checkups to help detect early symptoms of uterine leiomyosarcoma or sarcoma
According to Robert L. Barbieri, MD, the majority of medical experts suggest a preoperative evaluation of uterine fibroid tumors in cases where power morcellation will be used. Cervical cytology, biopsy of endometrial tissue and imaging with sonography or MRI may all be indicated to help detect cancer prior to the procedure.
Men who undergo power morcellator-assisted surgeries in the spleen or kidney can also suffer adverse outcomes as well, as the device can spread unsuspected or undiagnosed cancerous tissue into the abdomen.
Manufacturers of power morcellators face litigation
A number of manufacturers produce open power morcellators and may be open to legal liability. In the wake of the FDA warning on cancer risk associated with power morcellation, Johnson & Johnson and its Ethicon unit have stopped selling the following models:
- Gynecare Morcellex
- Gynecare X-Tract
- Morcellex Sigma
Other morcellator manufacturers include:
- Hologic – MyoSure
- FemRx – Diva Morcellator
- Lumenis Inc. – VersaCut Morcellator
- Smith & Nephew – Trueclear Hysteroscopic Morcellator
- Richard Wolf – Morce-Power 2306 Electronic Morcellator
- Olympus – Gyrus PKS PlasmaSORD
- Nouvag – Morcellator TCM3000BL
- Interlace Medical – Hysteroscopic Morcellator
- LiNA Medical – Xcise Laparoscopic Morcellator
- Karl Storz –Steiner, Sawalhell Supercut Morcellator and Rotocut G1, G2
Allegations raised in morcellator lawsuits
Plaintiffs are filing morcellation lawsuits under a number of legal theories, and demanding just compensation for related hospital and medical expenses, lost income, emotional trauma, pain and suffering, loss of spousal consortium and other economic damages linked to patients who have since been diagnosed with cancer.
Causes of action levied against defendants include:
- Strict liability – failure to warn
- Negligent misrepresentation
- Breach of implied warranty
- Breach of express warranty
- Loss of services
Power morcellator manufacturers are now faced with litigation filed by women who contend that they were not properly warned that devices may spread cancer to other parts of the body when used during routine gynecological procedures. Court dockets indicate that less than a dozen claims have been filed to date, but as further research on morcellation risks comes to light, more women may come forward in an attempt to secure legal compensation.
Even while critics argue for power morcellator recalls, the devices continue to be used in hundreds of hysterectomies and fibroid tumor removals every year, leaving innocent women at increased risk for various types of cancer including leiomyosarcoma, uterine sarcoma and endometrial stromal sarcoma.
If enough women were to file a uterine fibroid surgery cancer lawsuit alleging similar injuries, cases may be coordinated on a state or federal level for more efficient sharing of pretrial processes. Since morcellator litigation is still in its early stages, it is too soon to know if a mass tort or multidistrict litigation will be established. This type of consolidated litigation is often useful in product liability complaints where large numbers of plaintiffs can share in discovery proceedings and possibly reach settlements should early trials prove costly for the defendants.
Power morcellator lawyers across the country are currently reviewing cases of injured women to determine if they are eligible to pursue compensation through product liability and/or personal injury litigation.
- FDA, FDA discourages use of laparoscopic power morcellation for removal of uterus or uterine fibroid http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm393689.htm
- FDA, Laparoscopic Uterine Power Morcellation in Hysterectomy and Myomectomy: FDA Safety Communication http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm393576.htm
- OBG Management, Benefits and pitfalls of open power morcellation of uterine fibroids http://www.obgmanagement.com/browse-by-article-type/latest-articles/article/benefits-and-pitfalls-of-open-power-morcellation-of-uterine-fibroids/b5f1ba058eec68919b6cdce61720db77.html
- ABC News, Couple That Fought to Ban Medical Procedure After Wife's Cancer Looks Back at Year of Changes http://abcnews.go.com/Health/couple-fought-ban-medical-procedure-wifes-cancer-back/story?id=24797149
- Philly.com, Widower sues medical-device maker over hysterectomy http://articles.philly.com/2014-03-19/news/48334892_1_uterine-cancer-hysterectomy-leiomyosarcoma
- Bloomberg, FDA Discourages Uterine Procedure for Cancer Threat http://www.bloomberg.com/news/2014-04-17/fda-discourages-common-fibroid-removal-approach-on-cancer-threat.html