February 3, 2015 — A woman who was diagnosed with stage-4 bone and breast cancer has filed a lawsuit against Karl Storz, Inc., the manufacturer of a morcellator that spread cancer during her hysterectomy.
The lawsuit was filed on January 26 in the U.S. District Court for the Eastern District of Michigan. The woman, Denise Whitfield, was treated with a Storz Rotocut G1 power morcellator in June 2011, when she had a hysterectomy to treat fibroids.
The morcellator was used to slice up tissues in her uterus, making them easier to remove through small incisions in her abdomen. In July 2014, while she was hospitalized for spinal surgery, doctors found late-stage cancer had metastasized in her body.
Whitfield blames the spread of cancer on the morcellator. Last year, the FDA added a “Black Box” warning that morcellators can spread undiagnosed cancer, greatly worsening a patient’s prognosis. Whitfield must now endure extensive medical treatments, including radiation therapy.
The lawsuit accuses Karl Storz of negligence for failing to warn about the risk of disseminating cancer. Furthermore, the product was approved with a 510(k) application, which means it was allowed on the market without because it was “equivalent” to another device.
One major issue raised in the lawsuit is the lack of a surgical tissue bag, which might have contained malignant cells and prevented the spread of cancer. Long before Karl Storz marketed the Rotocut G1, surgical bags were routinely used with non-power morcellators. However, they fell out of favor as power morcellators replaced hand-held morcellators.
According to the lawsuit:
“Defendants knew or should have known that use of the tissue bag could prevent the spread of malignant cells to healthy tissue in the body cavity, yet failed to require concomitant use of the bag, or warn that failure to use the tissue bag can lead to subsequent development of cancer outside the uterus.”
Do I have a Morcellator Lawsuit?
The Schmidt Firm, PLLC is currently accepting Karl Storz morcellator induced injury cases in all 50 states. If you or somebody you know has been diagnosed with cancer after a hysterectomy or fibroid surgery, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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