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Morcellation Media Monitoring 02/01/2016
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Gynecare Power Morcellator Lawsuit Filed By Woman Battling Leiomyosarcoma
Jan 29, 2016 | AboutLawsuits.com
By Irvin Jackson
Johnson & Johnson’s Ethicon unit faces a product liability lawsuit filed by a woman diagnosed with leimoyosarcoma following a laparoscopic hysterectomy, which alleges that one of the company’s Gynecare power morcellators caused the hidden uterine cancer to be spread throughout her body. -
Study Shows Power Morcellator Use Is Declining
Jan 29, 2016 | Top Class Actions
By Paul Tassin
A recent study shows that laparoscopic hysterectomies are on the decline following a warning from the Food and Drug Administration (FDA) about the cancer risk associated with power morcellation.
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Gynecare Power Morcellator Lawsuit Filed By Woman Battling Leiomyosarcoma
Jan 29, 2016 | AboutLawsuits.com
By Irvin Jackson
Johnson & Johnson’s Ethicon unit faces a product liability lawsuit filed by a woman diagnosed with leimoyosarcoma following a laparoscopic hysterectomy, which alleges that one of the company’s Gynecare power morcellators caused the hidden uterine cancer to be spread throughout her body.
The complaint (PDF) was filed by Babette Davis in the U.S. District Court for the Eastern District of Wisconsin on January 27, indicating that she now must take oral chemotherapy to keep the leiomyosarcoma cancer spread by the hysterectomy surgical tool from killing her.
The lawsuit alleges that the manufacturer failed to adequately disclose the risk of cancer following laparoscopic hysterectomy morcellation, as the device may take hidden sarcomas contained within the uterus and chop up the tissue, causing a rapid dissemination of the aggressive cancer.
During her hysterectomy in November 2008, Davis indicates that doctors used a Gynecare morcellator to cut up the uterus through a small incision in the abdomen. However, a biopsy of the removed tissue taken during the surgery was found to contain leiomyosarcoma cancer cells, which doctors were unable to discover or diagnose before the procedure.
As a result of the leiomyosarcoma diagnosis, Davis underwent multiple cycles of chemotherapy, but by April 11, three large masses were detected in her abdomen and pelvis, confirming that the cancer had spread. She underwent additional chemotherapy and now continues to take harsh oral chemotherapy drugs.
“Plaintiff continues to suffer from abdominal pain, weakness, fatigue and takes oral chemotherapy to treat the life-threatening cancer that use of Defendant’s Gynecare Laparoscopic Power Morcellator caused to disseminate in her body,” the lawsuit states. “Had the Laparoscopic Power Morcellator used on Plaintiff not disseminated her leiomyosarcoma, Plaintiff would not have suffered and continued to suffer these symptoms.”
In recent years, power morcellators have become increasingly popular for use during minimimally invasive hysterectomy and uterine fibroid removal procedures, allowing the doctors to cut up the uterus or fibroids and remove the tissue through a small incision in the abdomen.
While these procedures are designed to reduce recovery time and the risk of infections or other complications, morcellators have largely been abandoned by the medical community since it was discovered that they pose an unreasonable risk of spreading aggressive cancer cells that may be hidden within the uterus of some women, which doctors are unable to detect or diagnose before the surgery.
Davis’s complaint is one of a growing number of laparoscopic morcellator cancer lawsuits filed against Ethicon and other manufacturers of devices sold in recent years. Each of the cases raise similar allegations, indicating that manufacturers sold a defective and unreasonably dangerous medical device, failing to warn about the link between uterine fibroid surgery and cancer.
Since October 2015, all Ethicon morcellator lawsuits filed throughout the federal court system have been consolidated as part of a federal MDL, or multidistrict litigation, which is centralized before U.S. District Judge Kathryn H. Vratil in the District of Kansas. Davis’s complaint will be transferred into the MDL for coordinated discovery and other pretrial proceedings.
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Study Shows Power Morcellator Use Is Declining
Jan 29, 2016 | Top Class Actions
By Paul Tassin
A recent study shows that laparoscopic hysterectomies are on the decline following a warning from the Food and Drug Administration (FDA) about the cancer risk associated with power morcellation.
The power morcellator study was published in August 2015 in the American Journal of Obstetrics & Gynecology. Researchers were interested in tracking trends in gynecological surgery following a warning issued by the FDA in April 2014.
In that warning, the FDA noted that use of a power morcellator on women with unsuspected cancer in the uterus created the risk of spreading and upstaging that cancer, significantly lowering the patient’s chances of long-term survival. By the FDA’s estimate, one in every 350 women who undergo hysterectomy or myomectomy has unsuspected uterus cancer.
Since the FDA issued that warning, the researchers found that surgeons began to avoid laparascopic techniques like power morcellation. In the eight months following the warning, laparoscopic hysterectomies decreased by 4.1 percent. At the same time, the researchers found increases in abdominal and vaginal hysterectomies by 1.7 percent and 2.4 percent, respectively.
Power Morcellators and the Risk of Uterus Cancer
A power morcellator is a device used during laparoscopic surgery to slice up and remove masses of tissue. By cutting up the tissue inside the body, a morcellator allows removal of larger masses of tissue through the smaller incisions used in laparoscopic surgery.
That feature in turn allows female patients to undergo hysterectomy or uterine fibroid surgery with the advantages that laparoscopic surgery offers over open surgery: the procedure is less invasive, and the patient enjoys a shorter recovery time.
But the same action has the potential to accidentally cut up cancer in the uterus and spread it throughout the abdomen. The FDA noted in its warning that there is no reliable way to predict whether a patient with uterine fibroids also has uterus cancer. Therefore even a negative pre-surgery screening for cancer may not be completely reliable.
Power Morcellator Lawsuits
Since the risk of morcellation cancer became more widely known, several women have also taken legal action against the manufacturers of power morcellators. In October 2015, 15 power morcellator lawsuits filed against Ethicon Inc. were consolidated into a single multidistrict litigation, or MDL, in a federal court in Kansas.
Ethicon, a subsidiary of Johnson & Johnson, has been one of the largest sources of power morcellators. The company accounted for 72 percent of the power morcellator market in 2011, according to a report by The Wall Street Journal. Ethicon pulled its morcellators off the market soon after the FDA issued its April 2014 warning.
This MDL will not include claims against other manufacturers such as Richard Wolf, Carl Storz, or Gyrus. Existing power morcellator lawsuits against those companies will continue separate from the MDL.
Generally, the plaintiffs in these actions say that the manufacturers failed to adequately warn the public about the risk that these devices could spread cancer in the uterus. They also say the devices are inherently defective and that alternative designs or techniques exist that would reduce the risk of morcellator cancer.
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