MI Woman Files Lawsuit Over Cancer from Morcellator

 Each year, more than 200,000 women undergo surgeries performed with power morcellators and an alarming number have gone on to develop advanced cancer. One of these women, Denise Whitfield, recently filed a morcellator-related cancer lawsuit in the United States District Court for the Eastern District of Michigan.

According to the lawsuit, the plaintiff underwent a hysterectomy and fibroid removal procedure in June 2011 – the surgeon used the Rotocut G1 morcellator to shred and remove her fibroids and uterus. The plaintiff’s 2013 mammogram did not show any signs of cancer but in July 2014, she was admitted to the hospital for spine surgery. During that hospital stay, it was discovered that she had Stage 4 (metastasized) bone and breast cancer.

The Rotocut G1 power morcellator used during Whitfield’s laparoscopic treatment was designed, manufactured, advertised, and distributed by Karl Storz Endoscopy-America, Inc. and its related entities. The lawsuit alleges that the Karl Storz companies were negligent; released a defective design; manufactured the morcellator device defectively; failed to warn of its dangers; is strictly liable for the plaintiff’s injuries; breached warranties; and negligently misrepresented that the device was safe. She has requested both compensatory and punitive damages.

Power morcellator hysterectomy and cancer risk

Power morcellator procedures have become increasingly more common as many patients have been drawn to minimally invasive surgeries. Morcellator surgeries are performed through a small keyhole, aka laparascopic, opening; surgeons use the morecellator to break tissue down into particles that are then removed through the tiny opening.

Morecellator procedures have been especially common in uterine surgeries such as hysterectomies and fibroid removal. Unfortunately, studies have shown that the procedure can increase a risk for highly aggressive cancer.

The FDA warned last year that one out of every 350 women undergoing a uterine procedure has an undetectable form of cancer. As the morcellator blasts the uterine tissues, it can spread these undiagnosed cancer cells throughout the abdomen. The result is prematurely-spread cancer that is difficult to treat. In the case of metastic leiomyosarcoma, a severe form of cancer, for example, this dispersal accelerates the cancer’s growth and makes the patient’s survival much less likely.

The Whitfield complaint alleges that the defendants knew the risks of spreading cancer cells through morcellation procedures but failed to warn about it.

FDA warned of morcellator cancer connection

In July 2006, the FDA approved Karl Storz’s Rotocut G1 device under its 510(k) clearance. To obtain the approval, the manufacturer’s application described the Rotocut as “substantially equivalent” to earlier devices with minor differences in design and dimensions that offer no improvements in performance, function, or intended use.

Last year, after growing reports of advanced cancer in women who had undergone power morcellator procedures, the FDA mandated a boxed warning – the FDA’s strictest type of warning – about the cancer risk.

In response, Johnson & Johnson, whose Ethicon division produced more than 75% of the morcellators on the market, announced a voluntary morcellator recall. Despite the risks, other manufacturers, including Karl Storz, Richard Wolf Medical Instruments Corp., LiNA Medical and Blue Endo, and Gyrus ACMI, refused to follow suit.

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