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Morcellation Media Monitoring 10/22/2015
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Uterine Surgical Device Suits Consolidated in MDL
Oct 19, 2015 | National Law Journal
By Amanda Bronstad
A federal judicial panel has coordinated more than two dozen lawsuits alleging that power morcellators—medical devices used in laparoscopic surgeries—have caused women to develop an aggressive form of cancer. -
JPML Grants Plaintiffs’ Request to Consolidate Power Morcellator Actions in Kansas
Oct 20, 2015 | Harris Martin Publishing
The Judicial Panel on Multidistrict Litigation have granted plaintiffs’ request for creation of a federal docket in the District of Kansas for lawsuits alleging a link between the use of power morcellators and the spread of cancerous cells. -
Lawsuits Over Hysterectomy Device Centralized In NE Kansas
Oct 20, 2015 | Heartland Health Monitor
By Dan Margolies
More than two dozen lawsuits alleging that a laparoscopic device used to break up fibroid tissue caused cancerous cells to spread in women’s bodies have been consolidated in federal court in Kansas City, Kansas. -
Government Finally Investigating Power Morcellators
Oct 21, 2015 | Press Release
By Akin Law Office LLC
Patients undergoing medical treatments expect that their physicians will utilize tools that will assist in the treatment without causing undue harm or damage to their bodies. One of these tools, a power morcellator which is used for removing fibroids or assisting in hysterecomy surgery is being scrutizined by the US Government Accountability Office. -
Morcellator Lawsuit Plaintiffs Learn Pathologist Warned Ethicon Of Risks In 2006
Oct 21, 2015 | Press Release
By Tracey & Fox
Tracey & Fox have reported that Ethicon may have been aware of the risks associated with the use of a power morcellator as early as 2006. Dr. Robert Lamparter, who has worked as a pathologist at Evangelical Community Hospital for almost 30 years, wrote several letters and emails to Ethicon in 2006, asking them to “reconsider the risk to the patient” associated with the use of a power morcellator during gynecological surgeries.
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Uterine Surgical Device Suits Consolidated in MDL
Oct 19, 2015 | National Law Journal
By Amanda Bronstad
A federal judicial panel has coordinated more than two dozen lawsuits alleging that power morcellators—medical devices used in laparoscopic surgeries—have caused women to develop an aggressive form of cancer.
Litigation over power morcellators has been a hot topic among the plaintiffs bar for the past year, although the number of cases brought so far is relatively small. About 45 lawsuits have been filed in federal and state court on behalf of women or their family members claiming a power morcellator used to remove uterine fibroids or the uterus during a hysterectomy led to cancer, “recurrent parasitic fibroids” or other injuries. In court papers, plaintiffs lawyers have estimated there could be more than 300 cases filed over power morcellators.
In its Oct. 15 decision, the U.S. Judicial Panel on Multidistrict Litigation appeared persuaded that there could be more cases, noting that 650,000 women per year have surgeries or hysterectomies due to uterine fibroids and, until last year, were likely to have them done laparoscopically with power morcellators.
The panel ordered most of the federal lawsuits consolidated in Kansas. About 15 power-morcellator lawsuits also have been filed in state courts.
Paul Pennock, managing attorney at New York’s Weitz & Luxenberg, who argued to coordinate all the cases to Kansas, said an MDL would benefit many of the women and their families who have faced challenges so far in bringing a case—most prominently identifying the power morcellator used in a surgery.
“There is absolutely not a shred of doubt in my mind they will actually not only achieve justice faster but be actually able to achieve it through an MDL where, separately, we’ll be crushed,” he said.
Although four power-morcellator manufacturers opposed the creation of an MDL, the panel limited its order to cases filed against Johnson & Johnson’s Ethicon Inc. unit. Matthew Johnson, a spokesman for Johnson & Johnson, which faces the most lawsuits of any defendant, wrote in an email: “Because Ethicon acted appropriately and responsibly at all times in relation to our morcellation devices, we will defend ourselves in the lawsuits that have been filed against us.”
As of Oct. 15, plaintiffs had filed 22 lawsuits against Ethicon in federal court.
On April 17, 2014, the U.S. Food and Drug Administration issued a safety advisory discouraging doctors from using the devices, which shred tissue into smaller pieces to be extracted through a small incision in a woman’s body. The FDA cited data that one in 350 women could be at risk for developing cancer from their use. On July 30, 2014, Ethicon pulled its power morcellators from shelves across the globe.
On Nov. 24, the FDA stopped short of banning power morcellators but found that the devices should not be used for the majority of women.
The FBI is investigating the devices, according to the suits, and the U.S. Government Accountability Office has “accepted a congressional request to examine the issue,” according to spokesman Charles Young.
The other defendants include Germany’s Richard Wolf GmbH and its Vernon Hills, Illinois-based subsidiary, Richard Wolf Medical Instruments Corp.; Karl Storz Endoscopy-America Inc. in El Segundo, California, and its German parent company, Karl Storz GmbH & Co. K.G.; and Gyrus ACMI L.P., now part of Olympus Corp. in Japan.
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JPML Grants Plaintiffs’ Request to Consolidate Power Morcellator Actions in Kansas
Oct 20, 2015 | Harris Martin Publishing
The Judicial Panel on Multidistrict Litigation have granted plaintiffs’ request for creation of a federal docket in the District of Kansas for lawsuits alleging a link between the use of power morcellators and the spread of cancerous cells.
In an Oct. 15 order, the panel appointed Senior Judge Kathryn H. Vratil, a former JPML chairman, to oversee the coordinated or consolidated pretrial proceedings. Pursuant to the order, 20 lawsuits pending against Ethicon Inc., Ethicon Endo-Surgery Inc., Johnson & Johnson, Richard Wolf Medical Instruments Corp., and Karl Stortz Endoscopy-America Inc. will be transferred to Kansas City.
The panel found the actions involve common questions of fact, and that centralization “will serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.” Moreover, “centralization will eliminate duplicative discovery, avoid inconsistent pretrial rulings, and conserve the resources of the parties, their counsel and the judiciary,” the panel added.
“These actions all involve common factual questions arising from allegations that (1) defects in the design of Ethicon’s power morcellators made laparoscopic hysterectomy or myomectomy procedures more likely to result in the dissemination and upstaging of occult cancer or other conditions, and (2) Ethicon failed to warn patients adequately of these risks given the FDA’s recent communication discouraging the use of power morcellation for treatment of uterine fibroids and revising the risk that uterine fibroids were actually sarcoma to 1 in 350,” the order says.
Laparascopic power morcellators are electronically powered tools that use a bladed feature to shred uterine fibroids and other tissue so that they can be easily removed through small incisions in the abdomen. The process has been used in recent years as an alternative to traditional, open abdominal surgical hysterectomies, myomectomies and laparotomies.
According to the plaintiffs, however, manufacturers of power morcellators knew as far back as the early 1990s that tissue fragments created by the morcellation process are frequently left in the abdomino-pelvic cavity and can become implanted in surrounding tissue or organs.
“When tissue fragments escape into the abdomino-pelvic cavity and seed in other tissue or organs, complications can arise months or years after the surgery,” plaintiffs’ June 18 petition for consolidation stated. “As a result, the use of laparoscopic power morcellators can spread, upstage or worsen a women’s occult cancer, changing the state of the cancer from an early stage cancer into a much higher stage cancer and significantly worsening a woman’s prognosis.”
Plaintiffs allege that the manufacturers of power morcellators failed to disclose evidence linking use of the device to the dissemination and upstaging of occult cancer and other injuries, and instead aggressively marketed the devices without adequate warnings.
In April 2014, the FDA issued a safety communication discouraging the use of laparascopic power morcellation during hysterectomy or myomectomy for the treatment of women with uterine fibroids. Several months later, the agency issued an advisory indicating that use of the device in patients with unsuspected uterine sarcoma may worsen the long-term survival.
The plaintiffs contend that in addition to the power morcellator lawsuits currently pending in federal courts around the country, numerous additional claims are expected or have already been filed in several state court venues.
All of the defendants opposed centralization. Ethicon argued that unique factual questions regarding plaintiffs will overshadow any common questions of fact. The panel disagreed, explaining that while the actions may present individual factual issues, “these actions involve common factual questions surrounding the design, testing, manufacture, and marketing of Ethicon’s power morcellators, including the warnings accompanying those devices and whether they should have included a bag to contain tissue.”
“Most actions also involve common factual questions regarding the risk that women undergoing hysterectomies and myomectomies had occult cancer, and what Ethicon knew about that risk and when,” Discovery, including expert discovery, will overlap with respect to these common issues.”
The motion to transfer was filed by Paul J. Pennock of Weitz & Luxenberg in New York.
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Lawsuits Over Hysterectomy Device Centralized In NE Kansas
Oct 20, 2015 | Heartland Health Monitor
By Dan Margolies
More than two dozen lawsuits alleging that a laparoscopic device used to break up fibroid tissue caused cancerous cells to spread in women’s bodies have been consolidated in federal court in Kansas City, Kansas.
The device, known as a power morcellator, was the subject of a U.S. Food and Drug Administration warning last November. The agency said it posed a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus and shouldn’t be used on most women.
Lawsuits alleging manufacturers of the device failed to provide patients with adequate warning of the risks have been filed in more than a dozen states. The Wall Street Journal reported in July that a lawsuit filed against device maker Lina Medical ApS and expected to be the first to go to trial was settled on undisclosed terms.
Power morcellators are drill-like devices that surgeons can use to make small incisions and break up uterine fibroids. Most women develop such fibroids but they usually don’t cause symptoms.
In some cases, however, the fibroids can lead to prolonged menstrual bleeding, pelvic pain and other conditions.
The FDA estimated that about 1 in 350 women undergoing a hysterectomy or myomectomy – a surgical procedure to remove fibroids – for the treatment of fibroids is found to have an unsuspected uterine sarcoma, including a very rare and aggressive cancer called leiomyosarcoma.
Most of the suits consolidated in federal court Kansas City, Kansas, were brought against Ethicon, a subsidiary of Johnson & Johnson. Johnson & Johnson voluntarily withdrew the device from the market last year. The cases have been assigned to U.S. District Judge Kathryn H. Vratil.
“There are other manufacturers of these devices, but it’s only the cases against (Ethicon) that were consolidated,” said Thomas J. Preuss, a Kansas City attorney representing a plaintiff in one of the actions.
He said Vratil has a lot of experience handling what is known as multi-district litigation, one reason the cases may have been consolidated here.
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Government Finally Investigating Power Morcellators
Oct 21, 2015 | Press Release
By Akin Law Office LLC
Patients undergoing medical treatments expect that their physicians will utilize tools that will assist in the treatment without causing undue harm or damage to their bodies. One of these tools, a power morcellator which is used for removing fibroids or assisting in hysterecomy surgery is being scrutizined by the US Government Accountability Office.
Research has shown that the risk of spreading uterine cancer by using a power morcellator is not the 1 in 1000 risk it was believed; it is closer to 1 in 350. This is a significant difference that has lawmakers and Chicago personal injury attorneys justifiably concerned. As such, lawmakers have asked the GAO to investigate the reasoning behind the FDA’s 20 year delay in issuing a warning to physicians and patients about the use of power morcellators in surgery.
These devices were first approved by the FDA in 1993, however, concern for their use did not begin to grow until 2006. After investigation, the FDA concluded that morcellators were more dangerous than initially believed, but did nothing until 2014 when they finally issued a warning letter advising physicians to better inform their patients of the risk. At that time, only Ethicon, a division of Johnson and Johnson, issued a voluntary recall.
The danger of spreading uterine cancer and other cancers is considerable. The power morcellator has been shown to spread it to such an extent that patients being treated for Stage 1 cancer quickly found themselves facing Stage 4 terminal cancer. The failure of this device to function safely has led to approximately 20 lawsuits this year alone. It is estimated that there could be several hundred more in the not to distant future.
In addition to the spread of uterine cancer, Chicago personal injury attorneys have seen numerous cases where power morcellators have been implicated in the spread of endometrial stromal sarcoma, carcinoma, leiomyosarcoma, and endometrial adenocarcinoma.
There are more than a dozen manufacturers of power morcellators that are used in the United States. To date, only three, Ethicon, LiNA, and Blue Endo have been named as defendants in these suits.
Of the suits that have been filed, it appears LiNA may opt to settle rather future suits rather than undergo trial. This summer they settled with Scott Burkhart whose wife, Donna, died at age 53; less than one year after receiving treatment with a power morcellator. The case had been scheduled to go to trial in December.
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Morcellator Lawsuit Plaintiffs Learn Pathologist Warned Ethicon Of Risks In 2006
Oct 21, 2015 | Press Release
By Tracey & Fox
Tracey & Fox have reported that Ethicon may have been aware of the risks associated with the use of a power morcellator as early as 2006.
Dr. Robert Lamparter, who has worked as a pathologist at Evangelical Community Hospital for almost 30 years, wrote several letters and emails to Ethicon in 2006, asking them to “reconsider the risk to the patient” associated with the use of a power morcellator during gynecological surgeries.
Ethicon, which is a subdivision of Johnson & Johnson, first began to market and sell power morcellators in 1993. The morcellator is a surgical tool which is placed into the body cavity through tiny incisions, where it is used to cut and shred tissue. The risk that Dr. Lamparter was referring to comes when the device is used to cut uterine fibroids.
Uterine fibroids are typically assumed to be benign, but recently the U.S. Food and Drug Administration announced that research had led them to postulate that 1 in 350 women who were undergoing a hysterectomy or myomectomy to remove fibroids also had undiagnosed uterine cancer. Due to the encapsulating nature of fibroids, cancer contained within is virtually undetectable.
Eight years after Dr. Lamparter voiced his concerns, the U.S. Food and Drug Administration issued a safety warning, indicating that they believed surgeons should stop using morcellators on women with uterine fibroids because the device could potentially spread cancer cells throughout the body cavity, resulting in new, rapidly growing tumors. The FDA suspected that this could “significantly worsen the patient’s likelihood of long-term survival.”
Following this publication, Ethicon voluntarily withdrew all of their morcellators from the market and sent letters globally to surgeons urging them to stop using the device. At this time, they are the only morcellator manufacturer who has decided to stop the development, production, marketing, and selling of their product.
It wasn’t long before women across the country began to file lawsuits against several morcellator manufacturing companies. Each case alleges that the use of a morcellator spread previously undetected cancer. Each plaintiff has had to undergo aggressive chemotherapy and radiation treatments as a result, and sadly, at least nine have died despite being treated.
In mid-October, the Judicial Panel on Multidistrict Litigation announced that they had decided to consolidate all morcellator lawsuits in the U.S. District Court for the District of Kansas. This will hopefully save the plaintiffs time and money by expediting the process and preventing duplicate discovery.
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