A Michigan woman who developed cancer after undergoing hysterectomy and fibroid removal surgery with a power morcellator has filed a product liability lawsuit against the device’s manufacturer, Karl Storz Endoscopy-America, Inc. The complaint alleges the company knew about the cancer risk associated with its morcellator, but failed to adequately warn the public and medical communities about it.
Free Morcellator Cancer Lawsuit Evaluation: If you or a loved one was diagnosed with cancer after undergoing surgery with a laparoscopic power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a suit against the manufacturer of the morcellator and we can help.
What’s the Problem?
In June 2011, plaintiff Denise Whitfield underwent hysterectomy and fibroid removal surgeries in which the surgeon used a Rotocut G1 laparoscopic power morcellator, according to the lawsuit. In 2013, Whitfield had a mammogram which showed no signs of cancer; however, when she was admitted to the hospital for spine surgery a year later, it was discovered that she had stage 4 bone and breast cancer.
The complaint alleges that Karl Storz Endoscopy-America, Inc. and related entities were negligent for manufacturing and releasing a defective medical device, and for failing to warn of its dangers. Whitfield is seeking both compensatory and punitive damages for her injuries, breach of warranty, and negligent misrepresentation that the Rotocut G1 power morcellator was safe. The lawsuit was filed in U.S. District Court for the Eastern District of Michigan.
FDA Warning on Power Morcellators
In April 2014, the FDA issued a warning advising surgeons to avoid using morcellators during hysterectomy and myomectomy procedures due to the risk they may spread undetected cancerous tissue beyond the uterus. According to the agency, about 1 in 350 women who require these procedures have previously undiagnosed uterine sarcoma. If power morcellators are used on these patients, the devices spread cancerous tissue to other parts of the body.
Then in Nov. 2014, FDA updated its previous warning, stating that morcellators should not be used for the vast majority of women undergoing hysterectomy and myomectomy surgeries. The agency advised manufacturers to update their products’ labeling to include a “boxed warning,” and to detail specific cases where morcellators should not be used.
“The FDA’s primary concern is the safety and well-being of patients and taking these steps will help the agency’s safety recommendations to be implemented as quickly as possible,” said William Maisel, M.D., M.P.H., deputy director for science and chief scientist at the FDA’s Center for Devices and Radiological Health. “Updating the device label with a boxed warning and contraindications will provide clinicians and patients with critical information about the risk of spreading cancerous tissue when these procedures are performed.”
Do I Have a Morcellator Cancer Lawsuit?
The Medical Device Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in laparoscopic power morcellator lawsuits. We are handling individual litigation nationwide and currently accepting new morcellation cancer cases in all 50 states.
Free Morcellator Cancer Lawsuit Evaluation: Again, if you or a loved one was diagnosed with cancer after undergoing surgery with a laparoscopic power morcellator, you should contact our law firm immediately. You may be entitled to compensation by filing a Morcellation Cancer Suit and we can help.