Amid device recalls and FDA warnings, medical device manufacturer Ethicon is facing a wave of legal claims over power morcellation cancer risks.

Power morcellators are devices used to cut up and remove large masses of tissue through the smaller incisions used in laparoscopic surgery.

They have seen application in gynecological procedures like hysterectomy and uterine fibroid surgery, allowing patients to enjoy the benefits that come with laparoscopic surgery like shorter recovery time and reduced chance of infection.

Unfortunately, gynecological surgery that uses these devices can create power morcellation cancer risks.

FDA Warns About Morcellation and Cancer

The FDA described the issue in a safety communication originally issued in April 2014.

The agency says about 1 in 350 women who undergo hysterectomy or surgical removal of fibroids have a uterine sarcoma that goes undetected before the surgery.

Power morcellation creates a risk that the morcellator will shred cancerous tissue and spread it throughout the abdomen.

This can cause the cancer to upstage and greatly reduce the patient’s chances of survival.

The FDA followed up on its warning in November by advising doctors not to use power morcellation in the majority of women undergoing surgery for uterine fibroids.

The agency also strongly urged manufacturers of power morcellators to include information about the risk of morcellation cancer in their product labels.

Plaintiffs Sue over Power Morcellation Cancer Risks

The federal court system has already begun preparing for the large number of personal injury lawsuits it expects will be filed over cases of cancer that were allegedly aggravated by power morcellation.

The federal Judicial Panel on Multidistrict Litigation has created a multidistrict litigation, or MDL, charged with coordinated pretrial processing for all morcellator lawsuits filed against manufacturer Ethicon.

The morcellator MDL will be hosted in the U.S. District Court for the District of Kansas.

The Panel establishes MDLs in cases like this where a large number of claims are expected.

MDLs coordinate pretrial procedures like discovery and motion practice, making the overall process more efficient.

Since they are overseen by a single judge, they avoid the risk of inconsistent judicial decisions on pretrial issues.

The Ethicon MDL begins with the transfer of 28 morcellator lawsuits to the federal court for the District of Kansas.

Generally, plaintiffs in these claims are patients who say their previously undetected cancer was spread and aggravated by the use of a power morcellator.

The MDL will likely also contain claims brought by close family members of patients who have died from their cancer.

The plaintiffs allege that Ethicon and its parent company Johnson & Johnson failed to adequately address power morcellation cancer risks.

Doctors and patients were never provided with adequate warnings about those risks, the plaintiffs say, leaving them unable to make fully informed decisions about whether or not to use power morcellation.

Evidence suggests Ethicon and J&J knew about power morcellation cancer risks for years. An FBI investigation revealed a report from a pathologist who says he warned J&J about the risks as far back as 2006.