Florida Karl Storz Morcellator Cancer Lawsuit
A Florida woman has filed a product liability lawsuit against manufacturers of power morcellators used during laparoscopic hysterectomies and uterine fibroid surgeries, alleging that the devices caused cancer contained within the uterus to be spread throughout the abdomen.
Peggy Paduda filed her claim on May 7, in the U.S. District Court for the Southern District of Florida, naming Karl Storz Endoscopy-America as a defendant.
According to Paduda, she underwent a laparoscopic hysterectomy, a minimally invasive procedure designed to allow surgeons to remove the uterus through a small incision in the abdomen.
During the operation a Storz Rotocut Morcellator was used to cut, shred and remove one or more uterine fibroids from her uterus.
Paduda indicates that there was no evidence she suffered endometrial stromal sarcoma, which is a rare type of uterine cancer. Paduda discovered that use of the morcellator, spread the cancer throughout her abdominal cavity and shortening her life-expectancy.
Several women, have filed complaints alleging that manufacturers sold a defective and unreasonably dangerous medical device without providing adequate warnings for the medical community about the risk of endometrial stromal sarcoma, leiomyosarcoma or other uterine cancers being spread during a minimally invasive hysterectomy or myomectomy.Morcellator Cancer Concerns
Power morcellators are medical devices used during uterine fibroid surgical procedures, such as a laparoscopic hysterectomy, robotic hysterectomy and laparoscopic myomectomy. Morcellation cuts the tissue or uterine fibroid into small pieces that can be removed through a port incision, reducing recovery time.FDA Morcellator Warning
The FDA issued a warning that urged doctors to avoid morcellation during uterine fibroid surgery or laparoscopic hysterectomy procedures, indicating that about 1 in 350 women undergoing the procedures may have unsuspected sarcoma that could be spread by the devices.
Since there is no reliable way to detect the cancer prior to the surgery, the FDA indicates that surgeons should consider alternative surgical techniques.
According to Paduda, Karl Storz Endoscopy-America had a duty to sell uterine morcellators to avoid harm to patients, and to warn about the risk of spreading leiomyosarcoma, endometrial stromal sarcoma and other uterine cancers during a laparoscopic hysterectomy or fibroid removal.
Following the FDA warnings issued on April 17, many hospitals have indicated that they will no longer be performing laparoscopic hysterectomy or uterine fibroid removal surgery with morcellators.
Johnson & Johnson’s Ethicon subsidiary, which was the leading manufacturer of power morcellators, announced in April that it was halting sales, distribution and promotion of all power morcellators.
The FDA has indicated that it will convene a public meeting of the Obstetrics and Gynecological Medical Device Advisory Committee to discuss the clinical role of laparoscopic morcellators in treatment of uterine fibroids and whether surgical techniques or the use of accessories like tissue collection bags may make the devices safer.
The FDA advisory committee will also review whether a “boxed warning” should be placed on all laparoscopic power morcellators regarding the risk of spreading cancer.
Paduda’s lawsuit charges Storz with negligence, strict product liability, breach of warranty, and fraudulent misrepresentation and omission. The lawsuit seeks both compensatory and punitive damages.