A U.S. Congressman from Pennsylvania is calling for a criminal investigation into what he says are several uterine cancer deaths related to power morcellators.
In a December 18th letter to the U.S. Food & Drug Administration’s (FDA) Office of Criminal Investigations, Rep. Mike Fitzpatrick (R-Pa) points out that power morcellators were first introduced some two decades ago. However, the FDA did not receive any reports of a death or serious injury associated with the morcellator-related dissemination of undiagnosed uterine cancer until late 2013. The letter also cites FDA regulations requiring hospitals and medical device companies to report any incidents that “reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility.”
“In fact, the 1st time the FDA received a report of death or serious injury was neither from a user facility nor a device manufacturer. It was ‘from a physician citing the case of a family member who has a disseminated cancer that was suspected to have resulted from a procedure in which a power morcellator was used.’ It should not have taken a family devastated by this device to raise the issue to the FDA. Had the regulations works as intended, it is likely many women’s lives could have been spared from the horrific consequences of morcellation,” the letter states.
Rep. Fitzpatrick specifically asks that the FDA Office of Criminal Investigations look into three cancer deaths at Boston’s Brigham & Women’s Hospital, Rochester General Hospital and the University of Rochester Medical Center. All involved morcellators made by Johnson & Johnson’s Ethicon, Inc. unit. That company recalled several power morcellators in July 2014, after suspending sales of the devices the previous April.
Power morcellators are used during minimally-invasive gynecological surgeries to cut tissue into small pieces so that it can be removed via a small abdominal incision. The surgical tools have been under scrutiny for several years now, after it became apparent that they can spread and upstage undetected uterine cancer cells when used in hysterectomies and fibroid removal procedures. In November 2014, the FDA cautioned against the use of power morcellators in the majority of women who need these surgeries, and ordered device manufacturers to add a black box warning to their labels regarding their potential to disseminate undiagnosed cancers.
Ethicon is currently faces dozens of morcellator lawsuits that were filed on behalf of women who were diagnosed with advanced uterine cancer following surgery with one of these devices. In October, all such federal claims involving the company’s morcellator products were centralized in the U.S. District Court, District of Kansas, for the purposes of coordinated pretrial proceedings. A Scheduling Order issued by the Court in December stipulated that written discovery was to begin this month, and indicated that most non-expert discovery will be completed within one year. This could pave the way for bellwether trials to begin at some point in 2017.