Jerry Woodell, from North Carolina man has filed a product liability and wrongful death personal injury lawsuit against the makers of power morcellator medical device that he says caused cancer spread and killed his wife.
Her surgeon used a laparoscopic power morcellator, an electric-powered medical tool “with spinning blades that shred, grind, and core tissue into smaller pieces or fragments so the tissue can be removed through small incisions in the abdomen.”
According to the lawsuit, “During tissue morcellation, fragments can be left in the abdomino-pelvic cavity, or attach to surrounding organs, and cancerous cells can travel to remote areas of the body.”
Within six months of that surgery, Bethann was in a hospital emergency room complaining of fatigue and migraines. Woodell said that Bethann was diagnosed with large masses in her pelvis. Doctors originally thought the masses were benign but surgical pathology soon revealed high-grade leiomyosarcoma, a highly malignant tumor.
Bethann underwent extensive chemotherapy and numerous surgeries over the next year and the half, but the masses only spread and increased in size. She died on Sept. 9.
The lawsuit alleges that, “Long before [Bethann] underwent surgery in 2012, defendants knew or should have known that their laparoscopic power morcellators could cause occult malignant tissue fragments to be disseminated and implanted in the body, which, in turn, upstages any cancer present and significantly worsens a woman’s chance of survival.”
Laparoscopic Hysterectomy Over Utilized in U.S.
According to the Centers for Disease Control and Prevention (CDC), from 2006-2010, 11.7 percent of women or 1 in 8, between the ages of 40-44 had a hysterectomy.
Approximately 650,000 hysterectomies are performed annually in the United States, and approximately 20 million American women have had a hysterectomy.
By the age of 60, more than one third of all women have had a hysterectomy. According to the National Women’s Health Network (NWHN) unnecessary hysterectomies have put women at risk, and that doctors should search for hysterectomy alternatives before performing life-changing operations.
What is Laparoscopic Hysterectomy?
Minimally invasive or laparoscopic removal of the uterus, is know as hysterectomy and typically performed for the treatment of fibroids or benign tumors of the uterus. During the surgery, many doctors remove the uterus in pieces using a mechanical grinding or chopping device known as a power morcellator.
Recently, many product liability and personal injury lawsuits being filed against the manufacturers of power morcellators. The injured women claim that patients and doctors should have been warned about the risks associated with use of the medical devices during minimally invasive, laparoscopic hysterectomies.
What Are Power Morcellators?
Power morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy (fibroid removal) procedures. The device allows the surgeon to grind up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The medical device is used during minimally invasive surgery, and reduces recovery time, scarring and speeds up recovery time.
How Morcellator Causes Uterine Cancer Spread
According to medical experts and the FDA, about one out of every 350 women undergoing a laparoscopic hysterectomy with morcellation may have undiagnosed sarcoma, which doctors are unable to detect before the surgery. Undiagnosed uterine sarcoma is highly malignant and is a lethal form of cancer, with poor life expectancy and treatment options. Most women die shortly after diagnosis and there are no curative treatments.
There is no bullet proof way for doctors to diagnose the uterine cancer before using the morcellator devices. Because of this, the FDA strongly urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures in April 2014.
Power morcellators spread this undiagnosed leiomyosarcoma, endometrial stromal sarcoma or other cancer throughout the pelvis and abdomen during the grinding process, leading to rapid upstaging of the cancer and reducing the risk of long-term survival. As this risk becomes known, many doctors and hospitals have stopped the use of power morcellators over the past year.
Morcellators Approved Under the 510(k) Program
The controversial 510(k) program allows medical devices to be approved without pre-market testing requirements. Under the program, the manufacturer just needs to show that the devices are “substantially equivalent” to devices already on the market. Power morcellators were approved under the 510(k) process without any safety testing.
J&J Ethicon Morcellator Recall
All Ethicon power morcellators were recalled by the manufacturer in 2014. J&J, acknowledged that the devices pose an unreasonable risk of spreading uterine cancer. Ethicon, a J&J subsidiary requested that hospitals voluntarily return all laparoscopic surgery morcellators. The company, noted that it will no longer sell the devices since there is no way to make them safe.
FDA Morcellator Black Box Warning
The FDA announced November 24, 2014 that it is adding a black box warning to uterine morcellator devices that remain on the market. A BLACK BOX WARNING, is the strongest warning that can be placed on any medical device.
Patients, doctors and hospitals are now on notice of the potential danger of increased uterine cancer spread risk associated with the use of these devices. Furthermore, the FDA announced that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision.
This contraindication prohibits the use of the devices in the vast majority of women who undergo laparoscopic or vaginal uterine morcellation procedures.
Power Morcellator Litigation Centralized
In October, the Judicial Panel on Multidistrict Litigation agreed and transferred at least 28 morcellator lawsuits to the U.S. District Court for the District of Kansas, for centralization in the multidistrict litigation (MDL) court. This is centralized only against Johnson and Johnson’s subsidiary, Ethicon.
This means that all federal morcellator lawsuits will be consolidated for pre-trial discovery and early bellwether trials in the U.S. District Court for the District of Kansas. Federal courts consolidate lawsuits to MDLs when a large number of plaintiffs claim the same facts against the same defendant. The process allows the courts to operate more efficiently and decreases the costs for all parties involved.
All of the lawsuits filed against manufacturers of these devices claim that hysterectomy morcellators are unreasonably dangerous and that information about the risk of uterine cancer being spread was withheld from the patients and doctors.
Shezad Malik is an Internal Medicine and Cardiology specialist, a licensed Texas Medical Doctor and Defective Medical Device and Dangerous Drug Attorney. Dr Shezad Malik Law Firm has offices based in Fort Worth and Dallas and represents people who have suffered catastrophic and serious personal injuries including wrongful death, caused by the negligence or recklessness of others.