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Morcellation Media Monitoring 11/23/2015
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Women outnumber men in power morcellator MDL leadership
Nov 20, 2015 | Reuters
By Jessica Dye
Note: APCO is in the process of getting the full text from the reporter. Attorneys from Andrus Wagstaff and Weitz & Luxenberg will lead a majority-female plaintiffs' steering committee in federal multidistrict litigation alleging that power morcellator devices made by Johnson & Johnson subsidiary Ethicon are defective. -
In a First, Women Compose Majority of MDL Committee
Nov 19, 2015 | National Law Journal
By Amanda Bronstad
A federal judge has appointed the first plaintiffs steering committee in multidistrict litigation made up of a majority of women members, according to the lawyers in the case. The appointments, which U.S. District Judge Kathryn Vratil of Kansas approved on Wednesday, come in lawsuits alleging that Ethicon Inc.’s power morcellators—medical devices used in laparoscopic uterine surgeries—have caused women to develop an aggressive form of cancer. -
It’s about time – First Women Majority MDL – Ethicon Power Morcellator
Nov 20, 2015 | The Legal Examiner
By John Bair
It’s about time! Congratulations to the well deserved women in the Ethicon Inc’s (a unit of Johnson & Johnson)Power Morcellator MDL. Our firm just represented one of these clients in the medical malpractice suit in NY, in which the client died. Bravo to U.S. District Judge Kathy Vratil of Kansas for speaking loudly about “best practices” in MDL’s. -
North Carolina Hysterectomy Morcellator Uterine Cancer Lawsuit
Nov 20, 2015 | The Legal Examiner
By Shezad Malik MD JD
Jerry Woodell, from North Carolina man has filed a product liability and wrongful death personal injury lawsuit against the makers of power morcellator medical device that he says caused cancer spread and killed his wife. -
Power Morcellator Lawsuits Obtain MDL Consolidation
Nov 22, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on the consolidation of personal injury and wrongful death power morcellator lawsuits, issued by the Judicial Panel on Multidistrict Litigation on October 15th, 2015. The consolidation is designed to help the litigation process run more smoothly and efficiently. It ensures that those involved can avoid duplicate discovery and different rulings from multiple judges, and also conserves resources. The cases in the MDL, (MDL number 2652), are being overseen by the Honorable Judge Kathryn H. Vratil in the U.S. District Court for the District of Kansas. -
Morcellator Lawsuit Update: Attorney Rebecca King Appointed To Plaintiff Steering Committee
Nov 20, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on the latest update to the power morcellator litigation. United States District Judge Kathy Vratil has now approved members of the MDL’s plaintiff steering committee. The appointments, approved Wednesday, November 18th, come via lawsuits which allege that power morcellators, manufactured by Ethicon Inc., (a division of Johnson & Johnson), have resulted in the spread of an aggressive form of cancer when used during laparoscopic gynecological surgeries.
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Women outnumber men in power morcellator MDL leadership
Nov 20, 2015 | Reuters
By Jessica Dye
Attorneys from Andrus Wagstaff and Weitz & Luxenberg will lead a majority-female plaintiffs' steering committee in federal multidistrict litigation alleging that power morcellator devices made by Johnson & Johnson subsidiary Ethicon are defective.
In an order Thursday, U.S. District Judge Kathryn Vratil in Kansas appointed Paul Pennock of Weitz & Luxenberg and Andrus Wagstaff's Aimee Wagstaff to serve as co-lead counsel for power morcellator plaintiffs, who allege that the devices - used during surgery to remove women's uteruses or uterine fibroids - are defective and can spread cancerous cells throughout the body.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/1OWHd4f
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In a First, Women Compose Majority of MDL Committee
Nov 19, 2015 | National Law Journal
By Amanda Bronstad
A federal judge has appointed the first plaintiffs steering committee in multidistrict litigation made up of a majority of women members, according to the lawyers in the case.
The appointments, which U.S. District Judge Kathryn Vratil of Kansas approved on Wednesday, come in lawsuits alleging that Ethicon Inc.’s power morcellators—medical devices used in laparoscopic uterine surgeries—have caused women to develop an aggressive form of cancer.
Vratil approved a proposed committee recommended by Paul Pennock, managing attorney at New York’s Weitz & Luxenberg and Aimee Wagstaff, founding partner of Andrus Wagstaff in Lakewood, Colorado. Pennock, now co-lead counsel with Wagstaff on the official committee, said he was inspired to create a leadership team of mostly women after hearing Vratil, a former member of the U.S. Judicial Panel on Multidistrict Litigation, talk at a conference on “best practices” in MDLs held by Duke Law School’s Center for Judicial Studies in September 2014.
“She spoke very pointedly about the lack of women in leadership on all of these MDLs historically,” said Pennock, who is chairman of the newly created power morcellator litigation section at the American Association of Justice. He said he reached out to Wagstaff to coordinate “a [plaintiffs steering committee] with a majority of women, which has never happened.”
In a Thursday order, Vratil approved a committee of 20 members, 11 of whom are women. Rebecca King, an attorney at Houston’s Tracey & Fox, who was one of them, said it’s the first time she’s been appointed to a plaintiffs steering committee in an MDL.
“I think we’re seeing a lot of women’s health issues in these various mass torts over the past few years,” she said. “It’s necessary to involve women because we bring a woman’s perspective to the case. We can identify with these clients in a way that’s unique.”
Wagstaff, who founded a networking group of women attorneys in mass torts, said she and Pennock didn’t handpick the litigation for a female slate of leaders; they just happened to both be working on power morcellator cases. The entire process took 10 months.
“We’ve been working on this for a while and inviting women we knew were involved to join us,” she said. “The leadership team was created before we even applied for an MDL.”
Power morcellators are used to remove uterine fibroids or the entire uterus during a hysterectomy. Ethicon pulled its devices from shelves worldwide last year after the U.S. Food and Drug Administration, citing potential cancer risks, issued a safety advisory discouraging the use of power morcellators, which shred tissue into smaller pieces to be extracted through a small incision in a woman’s body.
About 50 lawsuits have been filed against power morcellator manufacturers in federal and state courts, most against Ethicon, a unit of Johnson & Johnson. But the MDL panel on Oct. 15 coordinated only those cases against Ethicon.
Pennock acknowledged that Vratil had concerns about the size of the committee for such a relatively small MDL. But he noted that each case has required extensive investigation and that lawyers have had trouble identifying the specific power morcellator used in a surgery, he said. And he predicted there could be as many as 300 lawsuits against Ethicon.
In the end, Vratil approved all 20 applicants. They had one advantage: Unlike most MDLs, there was little competition for the leadership of the power morcellator litigation. According to Thursday’s order, one attorney withdrew an alternative proposal while another agreed to join the committee instead of compete.
Pennock said the lack of competition was the result of bringing together a top group from the start.
“Part of our effort over the last year was to get the team together, a real working organized team, that was so tight and organized that we wouldn’t have to worry about competition,” Pennock said. “It worked.”
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It’s about time – First Women Majority MDL – Ethicon Power Morcellator
Nov 20, 2015 | The Legal Examiner
By John Bair
It’s about time! Congratulations to the well deserved women in the Ethicon Inc’s (a unit of Johnson & Johnson)Power Morcellator MDL. Our firm just represented one of these clients in the medical malpractice suit in NY, in which the client died. Bravo to U.S. District Judge Kathy Vratil of Kansas for speaking loudly about “best practices” in MDL’s.
The leadership of Paul Pennock and Aimee Wagstaff should be commended. The women members of the PSC are Anne Andrews of Andrews Thornton, Sindhu Daniel of Baron & Budd, Yvonne Flaherty of Lockridge Grindal Nauen, Elizabeth Graham of Grant Eisenhofer, Andrea Hirsch of Herman Gerel, Rebecca King of Tracy & Fox, Megan Mckenzie of Robins Kaplan, Stephanie O’connor of Douglas and London, Meghan Quinlivan of Burg Simpson, and Carmen Scott of Motley Rice.
Power Morcellators are a medical device used to remove fibroids or the entire uterus during a hysterectomy. Ethicon and J&J had these devices removed from stock after the US Food and Drug Administration issued a safety advisory due to the potential increase in cancer risks.
Although creating change in the practice of law can sometimes seem like a sea of unchanging currents, the effects of grass root collaboration and networking inspired by and captured in theWEM(womenenmass.com), conference cannot be understated.
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North Carolina Hysterectomy Morcellator Uterine Cancer Lawsuit
Nov 20, 2015 | The Legal Examiner
By Shezad Malik MD JD
Jerry Woodell, from North Carolina man has filed a product liability and wrongful death personal injury lawsuit against the makers of power morcellator medical device that he says caused cancer spread and killed his wife.
According to Woodell, his wife Bethann underwent a total laparoscopic hysterectomy to remove her uterine fibroids in March 2012.
Her surgeon used a laparoscopic power morcellator, an electric-powered medical tool “with spinning blades that shred, grind, and core tissue into smaller pieces or fragments so the tissue can be removed through small incisions in the abdomen.”
According to the lawsuit, “During tissue morcellation, fragments can be left in the abdomino-pelvic cavity, or attach to surrounding organs, and cancerous cells can travel to remote areas of the body.”
Within six months of that surgery, Bethann was in a hospital emergency room complaining of fatigue and migraines. Woodell said that Bethann was diagnosed with large masses in her pelvis. Doctors originally thought the masses were benign but surgical pathology soon revealed high-grade leiomyosarcoma, a highly malignant tumor.
Bethann underwent extensive chemotherapy and numerous surgeries over the next year and the half, but the masses only spread and increased in size. She died on Sept. 9.
The lawsuit alleges that, “Long before [Bethann] 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 the body, which, in turn, upstages any cancer present and significantly worsens a woman’s chance of survival.”
Laparoscopic Hysterectomy Over Utilized in U.S.
According to the Centers for Disease Control and Prevention (CDC), from 2006-2010, 11.7 percent of women or 1 in 8, between the ages of 40-44 had a hysterectomy.
Approximately 650,000 hysterectomies are performed annually in the United States, and approximately 20 million American women have had a hysterectomy.
By the age of 60, more than one third of all women have had a hysterectomy. According to the National Women’s Health Network (NWHN) unnecessary hysterectomies have put women at risk, and that doctors should search for hysterectomy alternatives before performing life-changing operations.
What is Laparoscopic Hysterectomy?
Minimally invasive or laparoscopic removal of the uterus, is know as hysterectomy and typically performed for the treatment of fibroids or benign tumors of the uterus. During the surgery, many doctors remove the uterus in pieces using a mechanical grinding or chopping device known as a power morcellator.
Recently, many product liability and personal injury lawsuits being filed against the manufacturers of power morcellators. The injured women claim that patients and doctors should have been warned about the risks associated with use of the medical devices during minimally invasive, laparoscopic hysterectomies.
What Are Power Morcellators?
Power morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy (fibroid removal) procedures. The device allows the surgeon to grind up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The medical device is used during minimally invasive surgery, and reduces recovery time, scarring and speeds up recovery time.
How Morcellator Causes Uterine Cancer Spread
According to medical experts and the FDA, about one out of every 350 women undergoing a laparoscopic hysterectomy with morcellation may have undiagnosed sarcoma, which doctors are unable to detect before the surgery. Undiagnosed uterine sarcoma is highly malignant and is a lethal form of cancer, with poor life expectancy and treatment options. Most women die shortly after diagnosis and there are no curative treatments.
There is no bullet proof way for doctors to diagnose the uterine cancer before using the morcellator devices. Because of this, the FDA strongly urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures in April 2014.
Power morcellators spread this undiagnosed leiomyosarcoma, endometrial stromal sarcoma or other cancer throughout the pelvis and abdomen during the grinding process, leading to rapid upstaging of the cancer and reducing the risk of long-term survival. As this risk becomes known, many doctors and hospitals have stopped the use of power morcellators over the past year.
Morcellators Approved Under the 510(k) Program
The controversial 510(k) program allows medical devices to be approved without pre-market testing requirements. Under the program, the manufacturer just needs to show that the devices are “substantially equivalent” to devices already on the market. Power morcellators were approved under the 510(k) process without any safety testing.
J&J Ethicon Morcellator Recall
All Ethicon power morcellators were recalled by the manufacturer in 2014. J&J, acknowledged that the devices pose an unreasonable risk of spreading uterine cancer. Ethicon, a J&J subsidiary requested that hospitals voluntarily return all laparoscopic surgery morcellators. The company, noted that it will no longer sell the devices since there is no way to make them safe.
FDA Morcellator Black Box Warning
The FDA announced November 24, 2014 that it is adding a black box warning to uterine morcellator devices that remain on the market. A BLACK BOX WARNING, is the strongest warning that can be placed on any medical device.
Patients, doctors and hospitals are now on notice of the potential danger of increased uterine cancer spread risk associated with the use of these devices. Furthermore, the FDA announced that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision.
This contraindication prohibits the use of the devices in the vast majority of women who undergo laparoscopic or vaginal uterine morcellation procedures.
Power Morcellator Litigation Centralized
In October, the Judicial Panel on Multidistrict Litigation agreed and transferred at least 28 morcellator lawsuits to the U.S. District Court for the District of Kansas, for centralization in the multidistrict litigation (MDL) court. This is centralized only against Johnson and Johnson’s subsidiary, Ethicon.
This means that all federal morcellator lawsuits will be consolidated for pre-trial discovery and early bellwether trials in the U.S. District Court for the District of Kansas. Federal courts consolidate lawsuits to MDLs when a large number of plaintiffs claim the same facts against the same defendant. The process allows the courts to operate more efficiently and decreases the costs for all parties involved.
All of the lawsuits filed against manufacturers of these devices claim that hysterectomy morcellators are unreasonably dangerous and that information about the risk of uterine cancer being spread was withheld from the patients and doctors.
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Power Morcellator Lawsuits Obtain MDL Consolidation
Nov 22, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on the consolidation of personal injury and wrongful death power morcellator lawsuits, issued by the Judicial Panel on Multidistrict Litigation on October 15th, 2015. The consolidation is designed to help the litigation process run more smoothly and efficiently. It ensures that those involved can avoid duplicate discovery and different rulings from multiple judges, and also conserves resources. The cases in the MDL, (MDL number 2652), are being overseen by the Honorable Judge Kathryn H. Vratil in the U.S. District Court for the District of Kansas.
On November 16th, Judge Vratil scheduled the first status conference date for the management of these cases. The number of cases included in the current MDL is expected to rise as additional women develop cancer after undergoing laparoscopic power morcellation during gynecological surgeries such as hysterectomies or myomectomies. Several of the suits currently filed had to be done so by familial representatives of the victims, due to the fact that some victims have passed away from cancer.
Plaintiffs are happy with the MDL consolidation. They had been requesting it for some time, and it enables them to maintain their individual lawsuits while speeding up pretrial and discovery processes, and minimizing legal costs. Defendants in the suit were, however, opposed to motions requesting an MDL transfer.
Many lawsuits involved similarly make note of the United States Food and Drug Administration's’ April 2014 safety warning, which discouraged the use of laparoscopic power morcellation during gynecological surgeries involving uterine fibroids due to the risk of exposing and spreading previously undetected uterine sarcomas. The FDA additionally noted that an estimated 1 in every 350 women who undergo laparoscopic power morcellation for gynecological surgeries have hidden cancer cells they may be unaware of prior to surgery. As power morcellator devices spread these cells, a patient’s likelihood of long term survival substantially diminishes. According to allegations, the tool can create a widespread, high-grade cancer which is difficult to treat and often fatal.
As current morcellator lawsuits await litigation, the attorneys at Tracey & Fox are working to ensure that everyone affected has had the opportunity to join. Women who have undergone laparoscopic power morcellation during gynecological surgeries, and who have subsequently received cancer diagnoses are encouraged to explore their full legal rights. Tracey & Fox offers free legal consultations for these individuals.
To ask questions, or request additional information on power morcellation lawsuits, please contact the attorneys at Tracey & Fox by calling (713) 322-5375.
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Morcellator Lawsuit Update: Attorney Rebecca King Appointed To Plaintiff Steering Committee
Nov 20, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on the latest update to the power morcellator litigation. United States District Judge Kathy Vratil has now approved members of the MDL’s plaintiff steering committee. The appointments, approved Wednesday, November 18th, come via lawsuits which allege that power morcellators, manufactured by Ethicon Inc., (a division of Johnson & Johnson), have resulted in the spread of an aggressive form of cancer when used during laparoscopic gynecological surgeries.
The leadership team comprises mostly female attorneys. This comes following a talk Judge Vratil gave at Duke Law School’s Center for Judicial Studies conference, discussing multidistrict litigation “best practices” and noting a historical lack of female leadership. As a former member of the United States Judicial Panel on Multidistrict Litigation, Judge Vratil recognizes that there has never before been a plaintiffs steering committee with a majority of female members.
The approved committee is made up of 20 members, 11 of whom are female, including Tracey & Fox’s own Rebecca King. Attorney King commented on the responsibility, a first for her in an MDL, stating: “I am honored to have been appointed to the Ethicon Power Morcellator Plaintiffs’ Steering Committee by the Honorable Kathryn H. Vratil and the Honorable James P. O’Hara. We are passionate about these cases and intend to do all in our power to swiftly seek justice for these women and their families.”
The honor is perhaps a small victory for the many female plaintiffs within the MDL. The cases surround a serious women’s health issue, and bringing a woman’s perspective to the situation seems very appropriate. The allegations within these women’s cases all similarly allege that during gynecological surgeries such as hysterectomies and myomectomies, the laparoscopic power morcellator spread previously undetected cancer cells within their respective bodies. Allegations state that this aggressively accelerates the natural process of the cancer, making it more difficult to treat and significantly impairing the life expectancy of the patients.
Power morcellator devices are made by several manufacturers, and lawsuits have been filed nationally against many different brands. The lawsuits in the current MDL, however, are focused on Ethicon brand morcellators.
During gynecological surgeries, morcellators are inserted through a small incision in the abdomen of the patient. Once inside, the tool works much like a drill, rapidly spinning tiny blades that shred apart troublesome uterine tissue and uterine fibroids. According to plaintiffs, the tool exposes previously undiscovered cancer cells, and spreads those cells throughout the abdominal cavity, which can result in a more aggressive and high-grade cancer.
The United States Food and Drug Administration has also stepped forward to release a public safety warning concerning the power morcellator. This warning informed women that most should refrain from undergoing a power morcellation for gynecological surgeries involving uterine fibroids, due to the risk of spreading hidden cancer cells. They noted that approximately 1 in every 350 women who undergo laparoscopic power morcellation to treat uterine fibroids may have uterine sarcomas, and that using a power morcellator in these cases could significantly impact a patient’s chances of survival.
It is fully anticipated that as the cases in the current power morcellator MDL progress through the legal system, others will continue to be filed. The attorneys at Tracey & Fox, including newly appointed plaintiff steering committee member, Rebecca King, Esq., are dedicated to helping those women affected. Women who have undergone laparoscopic power morcellation and who have subsequently been diagnosed with cancer deserve the opportunity to explore their legal rights. They may be eligible for financial compensation. Tracey & Fox offers free legal consultations for women and families concerned that they were affected by this surgical device.
For additional information on the pending power morcellator litigation, or questions about this news release, please contact Tracey & Fox by calling (713) 322-5375.
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