Williams Hart files lawsuit against Olympus over power morcellator
Posted on Monday, September 21st, 2015 at 3:16 pm
Williams Hart is representing a Pennsylvania woman who is now the third person to file suit against the Olympus manufacturing company responsible for the PKS PlasmaSORD Bipolar Morcellator after the machine was found to have caused the spread of uterine cancer. The complaint, along with the two existing complaints, claims that Olympus either knew or should have known that the power morcellator could potentially cause the spread of undetected cancer cells during gynecological surgery.
The device was approved under a 501(k) by the U.S. Food and Drug Administration several decades ago, as it was “substantially equivalent” to previously approved technology and therefore allowed to bypass testing. The morcellator uses cutting jaws to remove tissue laparoscopically, and has caused damage by cutting through uterine fibroids that contained cancerous cells, allowing them to propagate throughout the abdomen and pelvis. The consequences are an increased rate of cancerous growth and a worsened prognosis.
The FDA eventually recognized the risks associated with these devices and published a safety warning regarding the potential danger of power morcellator use during hysterectomies and myomectomies. In response to numerous lawsuits, Johnson and Johnson voluntarily recalled all of their power morcellators in 2014. Other makers, however, have threatened to pursue legal action against individuals or parties who denounce their product.