For decades, Johnson & Johnson manufactured power morcellators for use in hysterectomies and uterine fibroid removal procedures. While use of the morcellator promoted faster healing times, for women with undiagnosed uterine cancer, morcellation was usually fatal. This was because morcellators grind body tissue into small fragments, which are then removed from the body. Tragically, the morcellator would also grind up cancerous tissue, and tiny pieces of the cancerous tissue would spread across the abdominal cavity, taking a treatable Stage 1 cancer and turning it into Stage 4 cancer in a short period of time.
In recent months, approximately 100 women and surviving family members brought claims against Johnson & Johnson, a major manufacturer of the power morcellator. For decades, surgeons used the power morcellator used in hysterectomies and myomectomies, which remove uterine fibroids. The morcellator works by grinding body tissue into tiny pieces. For women with undetected uterine cancer, or leiomyosarcoma, the morcellator would grind cancerous tissue and spread this cancer throughout the body. As a result, cancer that could have been treated was upstaged to Stage 4 cancer within a brief period of time.
For decades, surgeons used power morcellators in hysterectomies and in myomectomies, a procedure to remove uterine fibroids. Unfortunately, for women with undiagnosed uterine cancer, power morcellation causes cancer to spread throughout the abdominal cavity. This can take a relatively treatable Stage 1 cancer and transform it into Stage 4 cancer within weeks.
In late 2015, litigation began against various manufacturers of power morcellators in federal court in Kansas. Most of these claims are brought by individuals and surviving family members against Ethicon, Inc., a subsidiary of Johnson & Johnson. Three other companies, Karl Storz, Richard Wolf Medical Instruments Corp. and Gyrus ACMI are named in some of these claims. Each of these companies manufactured power morcellators. Each company faces allegations that they created a defective product, and failed to warn patients of the risks associated with their product.
While A Welcome Development, This Is Too Late For Victims of Morcellation
In a memorandum titled "Public Notification of Emerging Postmarket Medical Device Signals" the Food and Drug Administration (FDA) announced that it intends to take a more proactive approach to warning the public about potentially dangerous medical devices. Currently, the FDA relies on reports of patient deaths, complications and other adverse outcomes before deciding whether to warn the public about drugs and devices.
For nearly two decades, physicians across the United States used power morcellators in hysterectomies and to remove uterine fibroids. This device promoted faster recovery times and allowed for hysterectomies and fibroid removal to be conducted on an outpatient basis. For women with undiscovered uterine cancer, however, undergoing morcellation was often fatal.
Hospitals are required under federal law to report patient deaths suspected to have been caused by defective medical devices to the Food and Drug Administration (FDA). Medical device manufacturers are under a similar obligation. Michael Fitzpatrick, a Congressman for Pennsylvania's 8th District, asked the FDA's Office of Criminal Investigations to look into why three hospitals and one medical device manufacturer failed to report deaths caused by a power morcellator.
In 2014, the Food and Drug Administration (FDA) warned physicians on the use of power morcellators in hysterectomies and other procedures. For years, physicians used power morcellators to grind up and remove fibroids within the uterus. While minimally invasive, morcellation can also grind up cancer cells within the uterus and spread them through the body.
On November 17, 2015, the House Committee on Energy and Commerce held a hearing entitled "Examining the Regulation of Diagnostic Tests and Laboratory Operations." In this hearing, various members of Congress questioned Dr. Jeffrey Shuren, the Director of the Center for Devices and Radiological Health (CDRH), which is part of the Food and Drug Administration (FDA).
Dozens of families across the United States have taken a crucial step in their pursuit of justice against the makers of a medical device that has led to upstaged cancer and for many women, death. The United States District Panel on Multidistrict Litigation (MDL) transferred all claims against Ethicon, one of the leading makers of the power morcellator to the U.S. District Court for the District of Kansas before U.S. District Judge Kathryn H. Vratil. These claims, which will be heard in Kansas City, Kansas, allege that the makers of the power morcellator failed to adequately warn users of the risks involved with their device.