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A product liability lawsuit has been filed against Karl Storz Endoscopy, alleging that one of the company’s power mocellators used during a laparoscopic hysterectomy caused a New York woman’s leiomyosarcoma cancer to be upstaged, spreading cancerous cells throughout her body.
The complaint (PDF) was filed by Linda Bobletz in the U.S. District Court for the Northern District of New York on August 18, alleging that the Storz Rotocut G1 uterine morcellator is defectively designed and unreasonably dangerous for women with unsuspected leiomyosarcoma contained within their uterus.
Bobletz underwent a laparoscopic supracervical hysterectomy for uterine fibroids in August 2011, at which time surgeons used the Storz morcellator to cut up the uterus through a small incision in her abdomen, allowing them to remove the tissue through a minimally invasive procedure designed to reduce recovery time and the risk of complications.
Prior to the hysterectomy, Bobletz indicates that she had no signs or diagnosis of any form of cancer. However, only months after undergoing the hysterectomy with morcellation, she was diagnosed with leiomyosarcoma, an aggressive and deadly form of uterine cancer.
The lawsuit comes in the wake of an April warning by the FDA, which urged doctors not to use power morcellators during laparascopic hysterectomies or myomectomies for uterine fibroid removal, warning that the devices carry an risk of spreading unsuspected cancer cells contained within the uterus.
The FDA estimated that about one in 350 women undergoing uterine fibroid surgery may have undiagnosed cancer, which doctors are unable to detect prior to the surgery. For these women, power morcellators may cause the cancerous tissue to be spread throughout the abdomen, quickly upstaging the cancer and reducing the chances for long-term survival.
Since the warning, Johnson & Johnson’s Ethicon subsidiary, which was the largest manufacturer of power morcellators at the time, announced that it was recalling it’s morcellators from the market, acknowledging that there is currently no way to make the devices safe.
Despite calls for other morcellator recalls to be issued, Karl Storz and manufacturers of similar devices have not yet followed suit.
Bobletz’s leiomyosarcoma lawsuit alleges that Karl Storz knew or should have known that the Rotocut G1 morcellator carried a risk of spreading undiagnosed cancer, but failed to adequately warn her or her doctor.
The lawsuit charges Storz with negligence, strict product liability, breach of warranty, and fraudulent misrepresentation and omission. The lawsuit seeks compensatory and punitive damages for pain, suffering, emotional distress, loss of enjoyment of life, medical expenses, and other economic and non-economic damages.
Laparoscopic Morcellator Cancer Lawsuits
As women and families learn that cases of leiomyosarcoma diagnosed following a hysterectomy or uterine fibroid removal may have been caused by morcellation, questions are being raised about why adequate warnings were not provided and whether manufacturers failed to make the devices as safe as they could have been.
A number of hysterectomy morcellation lawsuits are now being pursued on behalf of individuals diagnosed with leiomyosarcoma, endometrial stromal sarcoma or other cancers spread following a hysterectomy or myomectomy performed laparoscopically or through robotic surgery.
Plaintiffs allege that as they were originally designed and sold, power morcellators are unreasonably dangerous. In addition, women claim that they may have avoided spreading cancer throughout their body if information about the risk had been provided to the medical community, since a number of alternative treatment options are available for women with symptomatic uterine fibroids, including traditional surgical hyesterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.