October 15, 2015 — Federal judges have centralized lawsuits involving morcellator-induced cancer into a Multi-District Litigation (MDL No. 2652) in the District of Kansas under Judge Kathryn H. Vratil.
The U.S. Judicial Panel on Multi-district Litigation (JPML) issued an order (PDF) centralizing 20 lawsuits against Johnson & Johnson’s Ethicon subsidiary.
The panel rejected an industry-wide MDL and did not centralize lawsuits against Karl Storz, Richard Wolf Medical Instruments, and Gyrus ACMI.
All of the lawsuits claim that power morcellators are defective because they can disseminate and upstage uterine cancer. Ethicon is accused of failing to warn about these risks or provide a surgical bag to contain tissue.
Most lawsuits ask “what Ethicon knew about that risk and when,” according to the JPML.
Doctors have long known that morcellators can spread cancer, essentially “seeding” malignant cells throughout a woman’s abdomen. In general, the risk is low — only 1 in 10,000 women has un-diagnosed uterine cancer.
However, women who undergo hysterectomies or fibroid surgeries are not the general population. These women often suffer from pain or bleeding, which are also symptoms of cancer. Last year, the FDA warned that 1 in 350 women who has a hysterectomy also has un-diagnosed uterine cancer.
Unfortunately, diagnosis can only be made after the surgery, which is why surgical containment bags are so important. The bags were commonly used with hand-operated morcellators, but too cumbersome to use with electric power morcellators introduced by Ethicon during the 1990s.
Ethicon suspended sales of morcellators in April 2014, following an FDA warning discouraging doctors from using the devices due to the risk of spreading cancer. Until then, Ethicon had been the leading manufacturer of morcellators, commanding 72% of the market in 2011, according to the Wall Street Journal.
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