Pharmaceutical

Medical device company settles power morcellator lawsuit

morcellator Medical device company settles power morcellator lawsuitDonna Burkhart believed that a minimally invasive hysterectomy would be the answer to the heavy bleeding she was experiencing, presumably caused by uterine fibroids. But the surgery left her in even worse health.

Donna’s hysterectomy was performed in March 2012 using a power morcellator, a laprascopic surgical tool fitted with a tube-like blade that minces uterine fibroids or entire uteruses within the body and removes the tissue through a small incision in the abdomen. The procedure was recommended over open surgery because it was less invasive, left less scarring and offered shorter recovery.

What doctors didn’t realize is that Donna had an aggressive type of uterine cancer, called leiomyosarcoma, that is very difficult to detect before the tissue is removed. The process of power morcellation flung bits of cancerous tissue throughout Donna’s abdomen, seeding new cancer growth and making her disease more difficult to treat.

Eleven months after her hysterectomy, Donna passed away. Her husband, Scott, filed a lawsuit against Lina Medical ApS, maker of the power morcellator, alleging the company knew that the device could cause cancer spread in women with hidden cancer but failed to warn doctors or patients.

The Food and Drug Administration (FDA) conducted a safety review of power morcellators, and ultimately placed a black box warning on the surgical tools and urged doctors not to use them in most women.

Burkhart’s lawsuit was expected to be the first of dozens of similar lawsuits expected to reach trial. But the case was settled last summer for an undisclosed amount. The Burkhart family says they are grateful the case didn’t have to go to trial, but it doesn’t take away their suffering.

“The pain of saying goodbye and the pain of watching her in the pain that she was in,” said Donna’s daughter, Jen, “it’s really hard to move past.”

Sources:
WSJ
CBS Philadelphia