New California Morcellator Lawsuit FiledTwo women in California are alleging that a Karl Storz morcellator spread their uterine cancer. Two women have filed a lawsuit against power morcellator manufacturer Karl Storz Endoscopy. In both cases, the plaintiffs underwent a laparoscopic supracervical hysterectomy and their surgeons used a 12-mm power morcellator.
The first plaintiff underwent her hysterectomy on December 18th, 2010. Prior to her procedure, her pre-anesthetic workup did not give doctors any indication that she was harboring uterine cancer. After her surgery, her doctor informed her that one of the uterine fibroids he had cut with the morcellator contained a form of uterine cancer called endometrial stromal sarcoma (ESS).
The second plaintiff has an almost identical story. On March 6th, 2012 she also underwent a laparoscopic hysterectomy to treat uterine fibroids. Pathologists found ESS in her shredded fibroids as well.
Power Morcellator LawsuitsThese women joined a growing group of plaintiffs whose lawsuits all allege the same thing: that the use of a power morcellator during their gynecological surgery spread undetected uterine cancer to other areas of the body.
These new complaints state that “The Defendants had actual knowledge and constructive notice of and knew, or in the exercise of reasonable care should have known, of the risk of disseminating and seeding undiagnosed uterine cancers with the normal and customary use of the Storz Morcellator and failed to properly communicate those risks to physicians and/or patients.”
The U.S. Food and Drug Administration approved power morcellators several decades ago, under what is called a 501(k). 501(k)’s need to show that a tool is substantially equivalent to a previously approved device. This process allows companies to bypass the usual safety testing and immediately place their product on the market. On April 17th, 2014, the FDA released a safety warning that urged doctors to reconsider the use of the morcellator during hysterectomies and myomectomies due to recent finding which suggested that the morcellator may spread uterine cancer cells throughout the body as it cut.
Following this warning, one company, Ethicon, announced on July 30th, 2014, a voluntary withdrawal of all morcellator devices. A letter, which was sent to millions of doctors around the country, stated, “We believe Ethicon Morcellation Devices perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators, 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 until further medical guidelines are established and/or new technologies are developed to mitigate the risk.”
Other companies have taken a different approach, and have maintained that their products are not defective, even going so far as to threaten legal action against doctors who speak out against the use of power morcellators.