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Morcellation Media Monitoring 11/16/2015
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Status Conference Scheduled in Ethicon Power Morcellator MDL
Nov 12, 2015 | Injury Lawyer News
By Sarah May
Following the recent establishment of multidistrict litigation for Ethicon morcellator lawsuits in the U.S. District Court for the District of Kansas, Judge Kathryn Vratil has set an initial status and scheduling conference for November 18. -
Power Morcellator Lawsuit Filed In Missouri Claims Device Caused Spread Of Cancer
Nov 13, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a lawsuit filed by the family of a deceased woman claiming wrongful death after she underwent a hysterectomy and uterine fibroid removal with the use of a laparoscopic power morcellator. The morcellator in this particular case was manufactured by Ethicon, a subsidiary of pharmaceutical conglomerate Johnson & Johnson. -
Power Morcellator Lawsuit Plaintiffs Note Recent University Of Michigan Study
Nov 14, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a study conducted by the University of Michigan which was designed to evaluate the overall impact of the U.S. Food and Drug Administration’s 2014 warning regarding power morcellation use on the general public. The warning indicated that the devices should no longer be used in gynecological surgeries to remove uterine fibroids due to cancer-spreading risks connected to the devices.
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Status Conference Scheduled in Ethicon Power Morcellator MDL
Nov 12, 2015 | Injury Lawyer News
By Sarah May
Following the recent establishment of multidistrict litigation for Ethicon morcellator lawsuits in the U.S. District Court for the District of Kansas, Judge Kathryn Vratil has set an initial status and scheduling conference for November 18.
The proceeding will offer the parties an opportunity to discuss pretrial procedures designed to achieve economical resolution of cases with common allegations and preserve judicial resources. Discovery plans and other organizational matters are also likely to be addressed at the status conference.
According to the October 16 order setting the initial conference date, Judge Vratil revealed that the parties to this litigation should be prepared to operate within a time frame tailored to facilitatecompletion of discovery in 12-18 months. If significant settlement progress is not made between the parties in that time, individual matters may be remanded to the courts from which they originated for further proceedings.
Ethicon morcellator claims share common allegations
The matters now consolidated before Judge Vratil in the Ethicon MDL are the culmination of growing suspicions that the manufacturers of power morcellators were or should have been aware of the risk that power morcellation could disperse cancer cells and result in rapid escalation of existing, undetected disease.
Litigants in these cases commonly argue that the device makers did not sufficiently warn patients and physicians of known risks, depriving them of the option of seeking alternative, perhaps safer treatment methods including traditional hysterectomies. Some plaintiffs assert that morcellator manufacturers had knowledge of the dangers of these devices dating back to the early 1990s, yet their silence caused thousands of women to expose themselves to unnecessary harm.
Background of morcellator controversy
Laparoscopic power morcellators are bladed tools designed to facilitate the shredding of fibroids and other tissues as well as their removal through small incisions in the abdomen of patients. The use of devices of this type has grown in the recent past, as they can often prevent the need for more invasive surgical procedures. In response to numerous adverse event reports, in 2014, the U.S. Food and Drug Administration issued a safety communication recommending that physicians cease using these devices in fibroid removal due to concerns regarding the possible spread of endometrialstromal sarcoma and leiomyosarcoma, particularly deadly forms of cancer.
Johnson & Johnson/Ethicon soon made a voluntary suspension of morcellator marketing and sales, stating that further study of their safety was required. Shortly thereafter, the company declared its intention to completely exit the power morcellator sales market and asked physicians to return all such devices in their possession.
Scope of morcellator litigation
Despite continued requests from watchdog groups, the FDA has refused to recall power morcellatorsfrom the U.S. market, and multiple manufacturers continue selling them without any indication that recalls may be imminent.
The creation of the Ethicon MDL and the widespread use of morcellators in recent years provides a hint into the potentially large scope of litigation that may ultimately materialize.
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Power Morcellator Lawsuit Filed In Missouri Claims Device Caused Spread Of Cancer
Nov 13, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a lawsuit filed by the family of a deceased woman claiming wrongful death after she underwent a hysterectomy and uterine fibroid removal with the use of a laparoscopic power morcellator. The morcellator in this particular case was manufactured by Ethicon, a subsidiary of pharmaceutical conglomerate Johnson & Johnson.
The suit details that the Missouri woman underwent laparoscopic power morcellation surgery to remove painful uterine fibroids and uterine tissue in December of 2012. The device was inserted through a small incision in her abdomen, where it worked much like a drill, spinning small blades and tearing apart uterine and fibroid tissue so that it can be removed through the incision. In doing so, however, the family alleges that the device also exposed previously encapsulated cancer cells, and spread them throughout the woman’s body.
According to details found within the suit, the family alleges that this caused the woman an accelerated upstaging of cancer, and a deadly cancer diagnosis post-surgery. The woman died due to metastatic uterine cancer in August of 2014, less than two years after her surgical procedure. The family notes that if the cancer cells had not been disseminated by the power morcellator, the cancer would have remained encapsulated in that area, and may have been treatable before spreading.
The United States Food and Drug Administration has also recently noted this problem, making a statement warning women against using the tool for gynecological surgeries due to its risk of spreading previously undetected cancer. The organization also noted that an estimated 1 in every 350 women who are undergoing hysterectomies or myomectomies for uterine fibroids may have unsuspected, hidden uterine cancer called uterine sarcoma. Using a power morcellation tool on these cancer cells, the FDA states, may significantly worsen a patient’s likelihood of long-term survival.
Laparoscopic power morcellation is also the subject of over 1,700 federal lawsuits today, all similarly alleging that the device spreads cancer. Since the FDA warnings were released, Johnson & Johnson has ceased all production of the devices, and has recalled those which were already sold to the medical community.
Power morcellator lawsuits have been consolidated to form multidistrict litigation number 2652. It is anticipated that as these cases await trial, additional ones will join them. Because of this, the attorneys at Tracey & Fox are working to ensure that anyone who may have been diagnosed with widespread cancer due to a gynecological surgery involving a power morcellator has the opportunity to explore their legal rights. These women may be entitled to compensation. Currently, the attorneys at Tracey & Fox are offering free consultations to those involved.
To obtain additional information on power morcellator lawsuits or to ask questions, please contact the attorneys at Tracey & Fox by calling 713-322-5375.
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Power Morcellator Lawsuit Plaintiffs Note Recent University Of Michigan Study
Nov 14, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a study conducted by the University of Michigan which was designed to evaluate the overall impact of the U.S. Food and Drug Administration’s 2014 warning regarding power morcellation use on the general public. The warning indicated that the devices should no longer be used in gynecological surgeries to remove uterine fibroids due to cancer-spreading risks connected to the devices.
These warnings are additionally supported by decades of research, and they have led to change in many prominent medical facilities. Additionally, one large power morcellator manufacturer (Johnson & Johnson) has completely ceased production of the devices, and has recalled those currently on the market.
Researchers from the University of Michigan decided to find out how surgeons had chosen to react to these FDA alerts, and to see how these findings were affecting the outcomes of patients. Their study covered women who had undergone hysterectomy procedures at hospitals located in the statewide Michigan Surgical Quality Collaborative. Data analyzed was from 9,597 hysterectomies which were performed over a 16-month period of time following the initial FDA warning as well as 5,775 hysterectomies which were performed up to 8 months following the warning.
As predicted, findings indicated that laparoscopic hysterectomies with the use of power morcellator tools decreased by 4.1%. Accordingly, this meant that there was an increase in abdominal and vaginal hysterectomies, which did not use a power morcellator. Instances of abdominal hysteretomies increased by 1.7% and vagnial hysterectomies increased by 2.4%. Although this highlighted the decrease they assumed, authors stated that the amount of the decrease seemed small. They mentioned a recent survey which indicated that half of surgeons had considered changing their surgical approach from power morcellation after observing the safety warnings.
Further studies, however, which looked only at supracervical laparoscopic hysterectomies (which are specifically associated with power morcellator use), noted a decline of 59% in use, which seemed much more in line with the results of the surgeon survey noted.
Power morcellators are the subject of more than just FDA warnings and studies. They have become addressed in a growing number of lawsuits which have now been consolidated to form multidistrict litigation. Allegations surrounding the devices allege that they can spread cancer in patients, causing the patients to be diagnosed with aggressive, widespread cancers post-surgery.
When used, the tool is inserted through patient’s abdomen, where it spins small blades to tear apart uterine tissue and uterine fibroids. In doing so, however, plaintiffs allege that it also exposes previously hidden cancer cells and spreads them throughout the body.
The attorneys at Tracey & Fox are working to ensure that anyone who has undergone a laparoscopic power morcellation procedure and who has subsequently been diagnosed with cancer is able to explore their legal rights. These individuals may be entitled to compensation, and Tracey & Fox is currently offering them free consultations.
To receive additional information concerning power morcellators or surrounding lawsuits, or to ask questions, please contact Tracey & Fox by calling 713-322-5375.
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