Medical device and pharmaceutical giant Johnson & Johnson (J&J) has settled nearly 70 of the roughly 100 claims that have been filed against its morcellator hysterectomy device. The Wall Street Journal reports that individual settlements range from $100,000 to $1 million. On the whole, J&J will end up paying many millions to claimants.
Morcellators Could Metastasize Undiagnosed Cancer Cells
Power morcellators were intended to grind up and vacuum out nonmalignant uterine fibroid tumors in a surgical procedure called a laparoscopic hysterectomy.
However, in some cases where cancer cells were hidden and undetected within the fibroids, the shredding action of the morcellators sprayed those cells throughout a woman’s body, metastasizing the cancer.
The FDA estimated that women who undergo morcellation procedures have a 1 in 350 chance of experiencing cancer repercussions.
Voluntary Morcellator Recall
After an April 2014 letter from the FDA, Ethicon, the device manufacturer and a subsidiary of J&J, pulled its morcellators from the market and recommended that physicians stop using the devices and return them. The morcellators in question were the Gynecare Morcellex, the Morcellex Sigma, and the Gynecare X-Tract. Ethicon’s press release on July 30, 2014, said:
“We believe Ethicon Morcellation Devices perform as intended…but the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain. Because of this uncertainty, Ethicon believes that a market withdrawal of Ethicon Morcellation Devices is the appropriate course of action at this time…”
FDA’s Puzzling Actions Under Investigation
The FDA approved use of at least 10 morcellators since 1991 and some US lawmakers are questioning why the agency didn’t act sooner. As a response to the congressional request, in September 2015 the US Government Accountability Office said it would launch an investigation into the delayed reaction.
The morcellators were approved as part of a “fast track” system used by the FDA for products that are “substantially equivalent” to products that are already approved. However, as far back as 2011, the Institute of Medicine had criticized the system and called for scrapping it.
In the FDA’s defense, its chief medical device scientist, Dr. William Maisel, said that “the agency and the clinical community didn’t have an appreciation of the risks of cutting presumably benign fibroids.”
If you or a loved one has faced cancer repercussions after a morcellator procedure, talk to our personal injury lawyers. You could be entitled to reimbursement of medical costs, lost wages, and more.