Risk for Cancer Development
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.
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Lawsuits filed by plaintiffs outline several causes of action against device makers, including:
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.
Failure to warn
Device makers did not warn the public that these devices may cause the spread of cancer.
Failure to properly test
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.
Failure to recall
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.
People Who Filed Power Morcellator Lawsuits
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 claim 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 complaint states that Ethicon failed to warn her about the risks, complications and adverse events associated with the Morcelex morcellator.
Finding an Experienced Morcellator Lawyer
If you or a loved one was diagnosed with uterine cancer after having a surgery that included the use of a power morcellator, you could contact a product liability attorney. He or she can help you understand your legal rights related to this controversial device.
Fighting cancer is emotional and draining, and your entire family is affected by it. You are likely to be impacted financially by doctor, hospital and care-giving costs. 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.
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.
- Paduda v. Karl Storz Endoscopy-America, Inc. et al
- Leuzzi v. Ethicon Endo Surgery et al
- FDA. (2014, April 17). Laparoscopic uterine power morcellation in hysterectomy and myomectomy: FDA safety communication. Retrieved from http://www.fda.gov/medicaldevices/safety/alertsandnotices/ucm393576.htm
- Lowes, R. (2014, April 30). J&J; suspends power morcellator sales over cancer risk. Retrieved from http://www.medscape.com/viewarticle/824371