To get the latest experience from our website, please upgrade your browser.
A growing number of legal actions stem from the use of power morcellators in hysterectomies and other gynecological surgeries. The FDA warns that the surgical instrument can spread cancer cells in the abdominal cavities of women. Several models of the device were recalled and legal action is ongoing.
Some women whose surgeons used power morcellators discovered later that they had cancer. In many cases, the cancer was aggressive and diagnosed at a late stage. These women sought justice by filling lawsuits against manufacturers.
Power morcellators remove noncancerous growths, typically uterine fibroids, from the uterus and that surgeons use when performing hysterectomies and certain kidney and spleen surgeries. Doctors insert these devices through small incisions and remove tissue after cutting and shredding it.
Unfortunately, the morcellators also have a risk factor. The devices can put women at increased risk for a number of deadly uterine cancers, including a rare and aggressive type called leiomyosarcoma.
The FDA issued serious warnings, saying these devices are not safe for the majority of women undergoing fibroid removals or hysterectomies because of fibroids. A number of insurance companies also weighed in, saying they will not pay for morcellation surgery without prior approval and added that there are safer options available for women. Hospitals also came down hard on these devices, and many large chains banned them.
Democratic Sens. Chuck Schumer and Kirsten Gillibrand, both from New York, urged the FDA in a letter to stop the use of the device in women to reduce the risk of uterine cancer. In the letter, the senators cited a recent study at Brigham and Women’s Hospital in Boston, which showed the risk of spreading cancer is “nine times greater than is currently communicated to patients.” They urged the FDA to follow the lead of Johnson & Johnson’s Ethicon division and request all manufacturers pull their devices from the market. Other lawmakers also spoke out against the device.
In October 2015, the Judicial Panel on Multidistrict Litigation consolidated several morcellator cases against Johnson & Johnson's Ethicon unit in U.S. District Court for the District of Kansas before Senior District Judge Kathryn H. Vratil. For the first time in history, the plaintiff's steering committee responsible for spearheading the litigation is made up of a majority of female attorneys.
The U.S. Food and Drug Administration (FDA) issued a safety communication in April 2014 discouraging doctors from using these devices to remove uterine fibroids because of the risk of spreading undiagnosed cancer throughout the abdominal cavity. Shortly after, Johnson & Johnson pulled its laparoscopic power morcellators, sold by its Ethicon division, from the market. In November of the same year, the FDA strengthened its warning saying, "The FDA is warning against using laparoscopic power morcellators in the majority of women undergoing hysterectomy or myomectomy for uterine fibroids."
According to the FDA, doctors use these devices in thousands of hysterectomies a year, and 1 in 350 women may be at risk for cancer development because they have undiagnosed cancer that may spread after the surgery. In some cases, men can be affected. Their procedures usually involve the kidney or spleen, but the disease-spreading complication is the same. Morcellators can spread previously undetected cancers into the abdomen.
The devices also spread benign tissues throughout the abdominal cavity, where they can grow on other organs, causing pain, bowel obstruction and infection.
Device manufacturers have a duty to develop, produce, label and market a product to avoid harm to the public. Complaints state that these companies are “guilty of carelessness, recklessness, negligence and willful, wanton, outrageous and reckless disregard for human life.”
Defendant companies presented their products are safe and effective, when they were not.
Device makers did not warn the public that these devices may cause the spread of cancer.
Complaints state that device makers did not properly test these devices before selling them.
Plaintiffs also state that device makers were aware of the dangers of morcellators but continued to profit from their sales.
Manufacturers of these devices should have stopped selling them because of the potential harm they can cause, but they failed to recall or remove the products from the market.
On November 25, 2014, the FDA issued an “Immediately in Effect Guidance Document” recommending that manufacturers of these surgical tools add a black box warning to the product’s packaging.
The black box warning is the FDA’s strongest warning. According to the agency, the proposed warning should read:
“WARNING: Uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
The agency also recommended that laparoscopic power morcellators not be used in the following cases:
Immediately following the FDA’s April 2014 safety announcement warning about the possibility of spreading cancer through power morcellation, Johnson & Johnson’s Ethicon unit pulled three of its devices in a “worldwide voluntary market withdrawal.”
The company admitted in a letter to medical providers that the “risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain.”
The company listed the names of the three devices included in the recall: Gynecare Morcellex, the Morcellex Sigma and the Gynecare X-Tract.
Meanwhile, in September 2014 Karl Storz threatened Dr. Hooman Noorchashm, an outspoken advocate for the removal of morcellators from the market, with legal action. Noorchashm’s wife, Dr. Amy Reed had a hysterectomy with a Storz power morcellator in a hospital in Boston. The German company threatened Noorchashm with “appropriate legal actions to protect our good name and our rights” if he did not stop with his “unfounded and unproven allegations.”
A number of women and their husbands already filed lawsuits against several morcellator manufacturers after being diagnosed with aggressive uterine cancers such as leiomyosarcoma. Their claims allege that device makers did not warn patients properly about the risks and dangers of morcellators and that they manufactured defective products.
Floridian Peggy Paduda filed a lawsuit against Karl Storz Endoscopy America, the manufacturer of the Karl Storz Rotocut Morcellator. Paduda underwent a hysterectomy in 2013 to remove fibroids from her uterus. Doctors used the device to shred and cut the tissue to remove it. Prior to surgery, there was no evidence that she had endometrial stromal sarcoma, a rare and deadly cancer. After the procedure, however, doctors found that the morcellator spread the cancer throughout her abdominal cavity, shortening her life expectancy and reducing her quality of life.
Paduda’s complaint states: “The Defendants failed to adequately warn about the true risk of dissemination and fulmination of cancer from the use of the Storz Morcellator. Despite their knowledge of that true risk and of their own failure to adequately warn of it, they failed to make the instrument safe for its intended use, making it unsafe for that use.”
New York’s Brenda Leuzzi had a hysterectomy, during which her surgeon used an Ethicon Morcellex morcellator. Shortly after the procedure, Leuzzi was diagnosed with acute uterine leiomyosarcoma. Her legal filing states that Ethicon failed to warn her about the risks, complications and adverse events associated with the Morcelex morcellator.
Fighting cancer is emotional and draining, and your entire family is affected by it. You are likely to be impacted financially by a number of expenses. Sometimes filing a lawsuit is the only way to gain any compensation for medical bills that pile up – not to mention compensation for pain and suffering.
Some costs that may be covered include:
Companies that manufacturer morcellators have a duty to ensure any patients touched by their products are aware of the risks. Unfortunately, sometimes they neglect to inform patients until it is too late. Experienced product liability lawyers have a familiarity with Big Pharma and device manufacturers and with the history of medical devices. They can also help you through a complicated legal process. If you wonder if you have a legal claim, Drugwatch can connect you with an attorney that can provide a free case review.