The Judicial Panel on Multidistrict Litigation consolidated lawsuits against Johnson & Johnson’s Ethicon unit involving its power morcellators in its order dated October 15, 2015. Judicial Panel on Multidistrict Litigation (referred to as the “JPML” or “MDL Panel”) consists of seven sitting federal judges who were appointed to serve on the MDL Panel by the Chief Judge of the United States Supreme Court. The MDL Panel found that the lawsuits against Ethicon involving its power morcellators involve common issues and centralized them to the United States District Court of the District of Kansas on October 15.
A power morcellator is an electrically powered medical device used in laparoscopic gynecological surgeries. The device has a grasper and a rapidly spinning blade to break tissue into fragments for removal through an incision. Power morcellators are used in hysterectomies (removal of uterus) and myomectomies (removal of fibroids).
The lawsuits against Ethicon allege the company failed to warn patients about the true dangers of the power morcellator and that the defective design of its morcellator can spread undetected cancerous tissue in a woman’s body during a gynecological surgery.
As many as 650,000 women undergo surgery for symptomatic uterine fibroids in the U.S. each year, the MDL Panel noted.
On April 17, 2014, the U.S. Food and Drug Administration (FDA) issued a Safety Communication discouraging the use of power morcellators during hysterectomies and myomectomies for uterine fibroids because of a risk the procedure will spread unsuspected cancer. Following the warning, Ethicon first suspended sales of the device and then took the drastic step of pulling the product from the market in July 2014. In November 2014, the FDA issued a “black box warning” for power morcellators, which is the most serious warning that can be placed in a label. The first power morcellator lawsuit against Ethicon was filed in May 2014 in New York federal court.
Before the FDA’s serious warning and the company’s withdrawal of the product, laparoscopic procedures using power morcellation had been increasingly preferred over traditional techniques. Approximately one in 350 women undergoing a hysterectomy or fibroid removal have an unsuspected uterine sarcoma, according to the FDA.
The case is titled In Re: Power Morcellator Products Liability Litigation, MDL number 2652.