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Morcellation Media Monitoring 2/12/2015
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MI Woman Files Lawsuit Over Cancer from Morcellator
Feb 9, 2015 | Injury Lawyer News
By Dawn Snyder
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. -
Hysterectomy Leiomyosarcoma Lawsuits Filed Over Use of Ethicon Morcellators
Feb 11, 2015 | About Lawsuits
By Irvin Jackson
Over the first week of this month, at least two new wrongful death lawsuits have been filed against Johnson & Johnson’s Ethicon subsidiary, alleging that two women died from the spread of leiomyosarcoma following a laparoscopic hysterectomy where the company’s power morcellators were used. -
Ethicon Hit With Gynecare Morcellex Cancer Lawsuit
Feb 11, 2015 | The Schmidt Law Firm
Ethicon, Inc., a subsidiary of Johnson & Johnson, has been hit with a lawsuit on behalf of a woman who died of cancer after she was treated with a Gynecare Morcellexmorcellator. -
Pre-Operative Morcellator Evaluations Recommended To Lower Hidden Uterine Cancer Risk
Feb 10, 2015 | Mass Tort Report
Researchers from the Irvine Medical Center at the University of California indicated in a report published on February 5, 2015 by the American Journal of Obstetrics & Gynecology that more specific guidelines are needed before determining whether power morcellators should be used in laparoscopic hysterectomies.
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MI Woman Files Lawsuit Over Cancer from Morcellator
Feb 9, 2015 | Injury Lawyer News
By Dawn Snyder
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 ahysterectomy 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 hadStage 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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Hysterectomy Leiomyosarcoma Lawsuits Filed Over Use of Ethicon Morcellators
Feb 11, 2015 | About Lawsuits
By Irvin Jackson
Over the first week of this month, at least two new wrongful death lawsuits have been filed against Johnson & Johnson’s Ethicon subsidiary, alleging that two women died from the spread of leiomyosarcoma following a laparoscopic hysterectomy where the company’s power morcellators were used.
The cases join a growing number of similar leimyosarcoma lawsuits filed against Ethicon and other manufacturers of morcelltors, which have been used in recent years to allow doctors to perform a hysterectomy or uterine fibroid removal through a minimally invasive, laparoscopic procedure.
The devices are used to cut up and remove tissue through a small incision in the abdomen. However, over the past year concerns have emerged about the safety of the devices, since some women may have unsuspected cancer hidden within their uterus, which doctors are unable to detect before the procedure.
For these women, the hyesterectomy morcellation may cause the dissemination of leiomyosarcoma or other aggressive uterine cancers, greatly reducing the changes for long-term survival and their overall quality of life.Power Morcellator Wrongful Death Lawsuits
One complaint (PDF) filed last week was brought by the widower of Cynthia Ostrander, a South Carolina woman who died in September 2014, less than two years after undergoing a total laparoscopic robotic hysterectomy and cystocopy for uterine fibroids, where an Ethicon Gynecare Morcellex was used.
According to allegations raised in the wrongful death lawsuit filed by her husband, John, Ostrander underwent all reasonable and standard procedures to diagnose cancer before surgery, but none was detected.
“The leiomyosarcoma cancer tissue in Ms. Ostrander would have remained encapsulated but for the tissue shredding and tissue dissemination of the GYNECARE MORCELLEX,” the lawsuit states. “The device, in cutting and shredding the uterine fibroid, ruptured the capsule containing the cancerous tissue and spread the shredded tissue in Ms. Ostrander’s abdominal cavity. That action changed the course and prognosis of the leiomyosarcoma cancer which had been encapsulated; upstaging it and profoundly injuring the patient, leading to her death.”
Ostrander died of leiomyosarcoma cancer only two months after Johnson & Johnson announced an Ethicon power morcellator recall, indicating that it would no longer manufacturer the devices since there was not way to make them safe and reduce the risk of spreading undiagnosed cancer.
On February 5, a similar lawsuit was filed by Arthur Johnson on behalf of himself and his late wife, Jonel Rollins-Davis-Johnson. According to the complaint (PDF) filed in the U.S. District Court for the Eastern District of Pennsylvania, Davis-Johnson underwent robotic total laparoscopic hysterectomy in June 2012, involving an Ethicon Morcellex Sigma Tissue Morcellator.
Davis-Johnson’s surgery even involved the use of an endoscopic bag, which some defenders of power morcellators have indicated will catch tissue debris and prevent the spread of cancer cells. However, the surgical bag appears to have failed to prevent Davis-Johnson’s leiomyosarcoma cancer from spreading following the surgery.
The lawsuit indicates that Davis-Johnson also underwent testing and evaluation prior to the procedure, and there was no evidence of cancer. Her husband also indicates that she was not warned of the high-risk that use of a laparoscopic morcellator could disseminate and upstage hidden cancer.
“Long before [Davis-Johnson] underwent surgery in 2012, Defendants knew or should have known that their Laparoscopic Power Morcellators could cause occult malignant tissue fragments to be disseminated and implanted in teh body, which, in turn, upstages any cancer present and significantly worsens a woman’s chance of survival,” according to the wrongful death lawsuit.
After the tissue removed during Davis-Johnson’s hysterectomy was diagnosed as containing leiomyosarcoma cancer cells, she underwent another operation in August 2012, which found that the cancer had already spread to her right fallopian tube. She died on February 6, 2013.Power Morcellator Cancer Concerns
Amid aggressive marketing by Ethicon and other manufacturers, morcellators were rapidly adopted throughout the medical community over the past decade, providing a less invasive procedure that results in reduced recovery times, less scaring and less change of infections or other complications. However, most doctors remained unaware that some women may face a risk of having undiagnosed cancer spread by the devices.
Estimates now suggest that about one out of every 350 women undergoing a laparoscopic supracervical hysterectomy with morcellation may have unsuspected sarcoma, which doctors are unable to detect before the surgery.
Over the summer, an FDA advisory panel was convened to evaluate the available data on the controversial devices, and determined that there is no way to make power morcellators safer. However, the panel was split on whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.
In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.
The two latest complaints join about a dozen other hysterectomy leiomyosarcoma lawsuits filed by women and families throughout the U.S., raising nearly identical allegations that the manufacturers sold unreasonably dangerous devices without providing adequate warnings.
Plaintiffs maintain that the spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have been avoided if any number of different alternative treatment options available for women with symptomatic uterine fibroids had been used, including traditional surgical hysterectomy 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.
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Ethicon Hit With Gynecare Morcellex Cancer Lawsuit
Feb 11, 2015 | The Schmidt Law Firm
Ethicon, Inc., a subsidiary of Johnson & Johnson, has been hit with a lawsuit on behalf of a woman who died of cancer after she was treated with a Gynecare Morcellexmorcellator.
The lawsuits was filed in federal court in South Carolina by the husband of Cynthia Ostrander, a woman who died in September 2014 ofleiomyosarcoma, a highly-aggressive form of uterine cancer.
The Gynecare Morcellex was used during her hysterectomy in October 2012. The surgical tool was used to cut up and remove three large fibroids. Before this surgery, she had no idea that her fibroids contained cancerous cells.
According to the lawsuit (PDF):
“The device, in cutting and shredding the uterine fibroid, ruptured the capsule containing the cancerous tissue and spread the shredded tissue in Ms. Ostrander’s abdominal cavity.”
Had the Morcellex not been used in her hysterectomy, the cancerous cells would have remained encapsulated inside the fibroid. Instead, the morcellator upstaged her cancer and it spread throughout her body. Despite aggressive chemotherapy, she died in less than two years.
Ethicon is accused of failing to warn doctors about the risk of disseminating cancer, or provide a closed system that would prevent cancerous cells from spreading.
Soon after Ostrander died, the FDA added a “Black Box” warning against the use of power morcellators for the treatment of fibroids in menopausal or post-menopausal woman. Ethicon allegedly knew about the risk as early as 2006, but was negligent in failing to take appropriate action.Do I have a Morcellator Cancer Lawsuit?
The Schmidt Firm, LLP is currently accepting morcellator induced injury cases in all 50 states. If you or somebody you know has been diagnosed with leiomyosarcoma, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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Pre-Operative Morcellator Evaluations Recommended To Lower Hidden Uterine Cancer Risk
Feb 10, 2015 | Mass Tort Report
Researchers from the Irvine Medical Center at the University of California indicated in a report published on February 5, 2015 by the American Journal of Obstetrics & Gynecology that more specific guidelines are needed before determining whether power morcellators should be used in laparoscopic hysterectomies. Morcellators are surgical tools that doctors use to less invasively break up uterine fibroids during hysterectomy and myomectomy procedures. The device has been found to spread unknown cancer cells hidden in the tissue—sparking a number of lawsuits in recent months.
This new research concluded that more pre-operative screening should be required before patients undergo morcellation. Previous research studies yielded poor-quality data, giving no reliable conclusions about whether a patient’s uterine fibroids were cancerous before they were to be removed. The study concluded that surgeons should consider alternatives to morcellation, and that: “Specific guidelines for the use of power morcellation may be of benefit while awaiting advances in preoperative diagnosis of sarcomas. If preoperative evaluation raises suspicion for malignancy, morcellation clearly should be avoided.”
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