Lawsuits Mount over Cancer Risks Associated with Power Morcellators

New lawsuits continue to be filed against the manufacturers of the power morcellator, a surgical tool used in fibroid surgeries and hysterectomies that is alleged to spread undetected cancers.

In October 2015, the U.S. Judicial Panel on Multidistrict Litigation transferred more than 20 power morcellator lawsuits into a federal multidistrict litigation (MDL). More than 30 cases were centralized for pretrial proceedings. The lawsuits have been filed primarily against Johnson & Johnson’s Ethicon division. Plaintiffs in these cases allege that the morcellator caused serious complications, including the spread of cancerous tissue.

In one of the cases, the plaintiff alleges that the morcellator used in her surgery exposed and spread previously undetected cancer cells beyond her uterine walls. She needed the surgery to treat painful uterine fibroids. The morcellator procedure was chosen as a less invasive technique than open surgery. After the surgery, the woman was unexpectedly diagnosed with widespread and aggressive cancer.

The laparoscopic power morcellator is inserted through the lower abdomen via a small incision. Rapidly spinning blades cut uterine or fibroid tissue into tiny pieces that can be removed from the body through the incision. But if the uterine tissue contains cancerous cells—which are virtually impossible to detect prior to surgery—the procedure can spread the cancer throughout the abdomen, where it rapidly becomes more aggressive and sharply reduces the woman’s long-term survival chances.

In 2015, twelve members of Congress asked the U.S. Government Accountability Office (GAO) to investigate why the power morcellator was on the market for two decades before the Food and Drug Administration (FDA) issued a warning about the device’s potential to spread uterine cancer. The GAO investigation increases scrutiny into how the FDA has handled issues with power morcellators, some of which date back to 1991, when the device first received clearance for use in the U.S. The FDA now says evidence indicates a far higher risk of hidden uterine sarcomas than many gynecologists previously believed.

While defending the regulatory process used to approve the power morcellator, the FDA has said it is strengthening its surveillance of devices on the market. Johnson and Johnson, the largest manufacturer of morcellators, voluntarily pulled its morcellators from the market, according to the Wall Street Journal.

In November 2014, the FDA amended an earlier morcellator advisory by ordering a black box warning for the device. The black box is the agency’s strongest warning. Despite calls for a complete ban, the power morcellator remains on the market, although many hospitals have restricted its use to carefully screened patients at low risk for uterine sarcomas. A number of health insurers have decided they will no longer cover routine use of the morcellator in fibroid surgery and hysterectomies.

from Parker Waichman http://www.yourlawyer.com/blog/lawsuits-mount-over-cancer-risks-associated-with-power-morcellators/