Pharmaceutical

Widower sues hospital, surgeon, power morcellator maker

morcellator Widower sues hospital, surgeon, power morcellator maker The widower of a woman who died after undergoing a hysterectomy involving a controversial power morcellator surgical tool has filed a lawsuit against the medical device manufacturer, the prominent medical center where the operation took place, and the surgeon who performed the procedure.

Rick Kaitz is suing Brigham and Women’s Hospital, medical device maker Karl Storz GmBH & Co. KG, and surgeon Jon Einarsson for wrongful death. He claims the parties were aware that power morcellation surgery could spread undiagnosed cancer, worsening the odds of survival. Yet, his wife Erica Kaitz was never warned of these dangers. She died December 2013 at the age of 52.

Power morcellators are surgical tools fitted with a tube-like blade that minces uterine fibroids or entire uteruses inside the uterine cavity and removes them through a small incision in the abdomen. The procedures have been favored over open surgeries because they are less invasive, leave less scar tissue, and offer shorter recovery periods. As many as 50,000 power morcellation procedures have been performed annually.

Last year, the Food and Drug Administration (FDA) warned that 1 in 350 women could have a form of uterine cancer, called uterine sarcoma, for which there are no reliable ways of diagnosing the disease without removing and testing uterine tissue. Women with this type of cancer who have uterine fibroids or uteruses removed by power morcellation are at risk of bits of cancerous tissue spreading throughout the abdomen during the procedure and seeding new cancer growths and making the disease more difficult to treat.

The FDA has since placed a black box warning on power morcellators recommending that the devices not be used on most women due to the risk of cancer spread.

In November, the Wall Street Journal reported that doctors at Brigham and Women’s continued to use power morcellators for two years after pulling together information in 2011 that raised red flags about the safety of power morcellation. In 2013, the hospital began cutting back on its use of the devices, and acknowledged that two patients who had undergone power morcellation procedures had been diagnosed with uterine cancer – Kaitz, and Amy Reed, an anesthesiologist who now has advanced uterine sarcoma.

The medical center has since discontinued using the devices.

Source: WSJ