Preview Newsletter
Morcellation Media Monitoring 09/3/2015
-
Power Morcellator Lawsuits May Be Centralized
Sep 1, 2015 | Injury Lawyer News
By Jacky Gale
This past June, some of the plaintiffs who filed power morcellator lawsuits filed a motion to centralize the cases into multidistrict litigation (MDL). The U.S. Judicial Panel on Multidistrict Litigation (JPML) is expected to hear oral arguments pertaining to this issue on October 1, 2015. Currently, at least 21 lawsuits in 16 different U.S. District Courts are pending against the manufacturers of power morcellators. They claim that the devices are unreasonably dangerous because there is the potential to spread cancerous cells well beyond their point of origin, causing a rapid acceleration in cancer staging. -
Power Morcellator Lawsuit Update: Number of Lawsuits Grow
Sep 2, 2015 | Press Release
By Tracey & Fox
Tracey & Fox have reported continuous updates on where current power morcellator litigation stands. The number of lawsuits filed alleging that the use of a power morcellator spread undetected uterine cancer is growing at a steady pace. Power morcellators have been used in gynecological laparoscopic surgeries for several decades, but it wasn’t until recently that the dangers associated with this surgical tool have been made known to the public. The tool was first approved by the U.S. Food and Drug Administration under a 501(k), which allows approval of a surgical instrument if it can be shown that the device is “substantially equivalent” to a previously approved device. Under the 501(k), the device seeking approval does not need to undergo safety testing.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
-
Power Morcellator Lawsuits May Be Centralized
Sep 1, 2015 | Injury Lawyer News
By Jacky Gale
This past June, some of the plaintiffs who filed power morcellator lawsuits filed a motion to centralize the cases into multidistrict litigation (MDL). The U.S. Judicial Panel on Multidistrict Litigation (JPML) is expected to hear oral arguments pertaining to this issue on October 1, 2015. Currently, at least 21 lawsuits in 16 different U.S. District Courts are pending against the manufacturers of power morcellators. They claim that the devices are unreasonably dangerous because there is the potential to spread cancerous cells well beyond their point of origin, causing a rapid acceleration in cancer staging.
The plaintiffs demand compensation for the alleged failure of the defendants to provide adequate warning with regard to the life-threatening risks of power morcellation.
Manufacturers oppose centralization of morcellator lawsuits
The purpose of creating an MDL is to consolidate similar litigation filed against particular defendants. This streamlines the litigation process and ensures uniform application of pre-trial matters such as discovery and rulings. It also conserves financial resources for all involved parties.
The manufacturers named as defendants in the power morcellator lawsuits have opposed the motion to centralize the complaints. The defendants argue that the number of power morcellator lawsuits is too low to justify the creation of an MDL and that the lawsuits involve varied products by different manufacturers. Most of the power morcellators sold in the U.S. were designed and manufactured by Ethicon, a division of Johnson & Johnson.
Johnson & Johnson also opposes the establishment of a single MDL and the possibility of a separate MDL for each manufacturer.
It is possible that more lawsuits will be filed against power morcellator manufacturers in the coming months and years. If the JPML does decide to centralize and consolidate morcellator cancer lawsuits, the newly filed complaints might be directly entered into the MDL. The parties would proceed with pre-trial matters such as depositions and evidentiary exchange.
Following discovery, a handful of cases would be selected to serve as bellwether cases. These cases would be the first in the MDL to go to trial. They allow the parties to assess the responses of jurors to certain evidence and witness testimony. At any time during the discovery process or bellwether trials, the parties may agree to settlement deals. Otherwise, any remaining cases would be remanded back to their home districts for trial.
Latest study to evaluate morcellation and cancer risks
During the trials, it is expected that the counsel for the plaintiffs would call expert witnesses to testify. These experts may discuss various clinical studies that evaluated the safety profile of power morcellation. One of the latest studies was published in the American Journal of Obstetrics and Gynecology in August 2015. The researchers compared the rates of women undergoing laparoscopichysterectomies and myomectomies involving morcellation before and after the FDA issued a safety communication regarding the potential risks of power morcellation. That notice was issued in April 2014.
The researchers determined that there was a 4.1 percent decline in the rate of surgeries performed with power morcellation during the eight months following the release of the safety communication. The researchers also determined that any increase in the rate of complications due to the increase of open surgeries was not statistically significant.
-
Power Morcellator Lawsuit Update: Number of Lawsuits Grow
Sep 2, 2015 | Press Release
By Tracey & Fox
Tracey & Fox have reported continuous updates on where current power morcellator litigation stands. The number of lawsuits filed alleging that the use of a power morcellator spread undetected uterine cancer is growing at a steady pace.
Power morcellators have been used in gynecological laparoscopic surgeries for several decades, but it wasn’t until recently that the dangers associated with this surgical tool have been made known to the public. The tool was first approved by the U.S. Food and Drug Administration under a 501(k), which allows approval of a surgical instrument if it can be shown that the device is “substantially equivalent” to a previously approved device. Under the 501(k), the device seeking approval does not need to undergo safety testing.
Many women who undergo gynecological surgeries do so because of the presence of uterine fibroids. Most uterine fibroids are found to be benign, however, recent studies have found that around 1 in 350 women undergoing a hysterectomy or myomectomy have undetected uterine cancer. The form most commonly diagnosed is leiomyosarcoma, a form of cancer which is difficult to treat with chemotherapy and radiation. If a morcellator is used in women harboring undetected uterine cancer, the tool might disseminate the cancer cells to other areas of the abdomen, resulting in metastasis.
Following the first morcellator lawsuit which was filed on March 14th, 2014, the FDA released a safety warning on April 17th, 2014. The warning stated that “the FDA discourages the use of laparoscopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids.” It further recommended that surgeons discuss the risks of using the morcellator with their patients prior to surgery.
The FDA then updated its warning on November 24th, 2014, stating that “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival.”
The FDA has yet to issue a power morcellator recall, however, one of the largest manufacturers, Ethicon, issued its own worldwide voluntary market withdrawal on July 30th, 2014. Ethicon urged surgeons to return three of the morcellators, the Gynecare Morcellex, Morcellex Sigma, and Gynecare X-Tract immediately. To date, Ethicon is the only company which has voluntarily removed their surgical instruments from the market.
For more information regarding this press release, call Tracey & Fox at (713) 322-5375.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
Add recipients
Suggested