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Morcellation Media Monitoring 11/02/2015

    Client Attorney Privileged/Attorney Work Product/At Request of Counsel

    Morcellation

  1. Ethicon Morcellator MDL Judge Schedules Initial Status Conference for November 18

    Oct 30, 2015 | AboutLawsuits.com

    By Austin Kirk

    Shortly after the U.S. Judicial Panel on Multidistrict Litigation established consolidated pretrial proceedings for all Ethicon morcellator lawsuits filed on behalf of women who had aggressive uterine cancers spread by the medical device, the U.S. District Judge assigned to preside over the cases has scheduled an initial status conference.
  2. Power Morcellator Lawsuits Coordinated in Kansas Federal Court

    Oct 29, 2015 | Injury Lawyer News

    By Ava Lawson

    Harris Martin reports that the JPML has granted plaintiff’s requests to centralize some 20 power morcellator lawsuits for more efficient pretrial proceedings. The complaints center on allegations that that the devices, which are commonly used in laparoscopic fibroid removal and hysterectomy procedures, can inadvertently spread occult cancer cells throughout surrounding tissue, and that manufacturers knew of these inherent risks yet failed to warn the public or medical community.
  3. Legal-Bay Lawsuit Settlement Funding Reports Consolidation of Morcellator Lawsuits in Multidistrict Litigation Court in Kansas

    Nov 2, 2015 | Press Release

    By Legal Bay LLC

    Legal-Bay LLC, the Lawsuit Settlement Funding Company, announced today that the Judicial Panel on Multidistrict Litigation recently made a decision to transfer morcellator cases against Johnson & Johnson's subsidiary, Ethicon, to a single multidistrict litigation court in Kansas. According to Drug Watch, at least 28 morcellator lawsuits against J&J's Ethicon have been transferred to the U.S. District Court for the District of Kansas, and the lawsuits accuse Ethicon "of designing a defective product and failing to warn patients of risks." The morcellator product has sparked controversy, with risks of unintentionally spreading uterine cancer. In April of 2014, the FDA put out a warning stating that the risk was 1 in 350. That same month, J&J recalled their morcellators from the market, however, lawsuits have been growing against the company.
  4. Press Release Power Morcellator Lawsuit Claims Moved To Kansas

    Oct 30, 2015 | Press Release

    By Tracey & Fox

    Tracey & Fox reports on a transfer order which was recently issued by the Judicial Panel on Multidistrict Litigation. The order would move all morcellator lawsuits filed against manufacturer Ethicon Inc. (a subsidiary of Johnson & Johnson) to the United States District of Kansas. Lawsuits involved similarly allege that Ethicon neglected to warn both physicians and patients about the cancer spreading risks associated when their power morcellators are used for hysterectomies and similar gynecological surgeries.
  5. Press Release Power Morcellator Lawsuit Spurs FBI Investigations

    Oct 29, 2015 | Press Release

    By Tracey & Fox

    Tracey & Fox reports on FBI investigations of pharmaceutical conglomerate Johnson & Johnson, in regard to their power morcellator devices. As new studies and lawsuits indicate that the tool may put women's lives at risk, the FBI has stepped in to further evaluate matters. One of the latest studies concerning power morcellation was recently accepted by the American Journal of Obstetrics and Gynecology for publication. In the study, researchers look more closely at many of the risks that have come to light in recent allegations against power morcellation, and compare these risks with the overall benefits associated with laparoscopic surgery vs. open surgery in patients.
  6. Full Text of Stories Below

    Client Attorney Privileged/Attorney Work Product/At Request of Counsel

    Morcellation

  1. Ethicon Morcellator MDL Judge Schedules Initial Status Conference for November 18

    Oct 30, 2015 | AboutLawsuits.com

    By Austin Kirk

    Shortly after the U.S. Judicial Panel on Multidistrict Litigation established consolidated pretrial proceedings for all Ethicon morcellator lawsuits filed on behalf of women who had aggressive uterine cancers spread by the medical device, the U.S. District Judge assigned to preside over the cases has scheduled an initial status conference.

    Following oral arguments presented earlier this month, an Ethicon power morcellator MDL (multidistrict litigation) was established in the U.S. District Court for the District of Kansas, where cases filed throughout the federal court system will be centralized before Judge Kathyryn H. Vratil for coordinated handling during discovery and other pretrial proceedings.

    Each of the claims involves similar allegations that women were diagnosed with the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers following the use of an Ethicon Gynecare morcellator during a laparoscopic hyesterectomy or myomectomy for symptomatic uterine fibroids.

    Ethicon’s Gynecare division was the leading manufacturer of laparoscopic morcellators in recent years, which are medical devices used during minimally invasive surgery to allow the doctors to cut up and remove uterine fibroids or the uterus through a small incision in the abdomen. However, for women who may have undiagnosed and unsuspected sarcoma hidden within their uterus, the devices may pose a deadly risk, rapidly spreading the cancer cells throughout the abdomen.

    In a practice and procedure order (PDF) issued on October 16, Judge Vratil indicated that an initial scheduling conference will be held on Wednesday, November 18 at 1:00 p.m., at the Robert J. Dole U.S. Courthouse in Kansas City.

    The parties involved in the lawsuits have been directed to be prepared to discuss procedures that will facilitate the “expeditious, economical and just resolution of this litigation,” including the organizational structure of the litigation and discovery plans.

    Judge Vratil indicates that the parties should anticipate a time line where common fact discovery in the litigation will be completed in less than 12 to 18 months. Thereafter, cases may be promptly remanded back to their original courts if Ethicon morcelletion settlements are not reached to resolve the claims.Power Morcellator Cancer Concerns

    Centralizing the Ethicon morcellator cases before Judge Vratil is designed to reduce duplicative discovery efforts into common issues in the cases, avoid conflicting rulings from different judges and to serve the convenience of the parties, witnesses and the courts.

    Each of the lawsuits against Ethicon involve similar allegations that the medical device manufacturer knew or should have known about the risk that laparoscopic morcellation may disseminate uterine cancer, yet failed to adequately warn the medical community or women deciding to undergo a minimally invasive procedure instead of a traditional hysterectomy or myomectomy.

    Similar lawsuits have been filed against other manufacturers of power morcellators used in operating rooms throughout the U.S., including Karl Storz, Richard Wolf Medical Instruments, and Gyrus ACMI. While plaintiffs originally proposed that all cases, regardless of manufacturer, be centralized as part of one MDL, the U.S. JPML determined that there will be sufficient differences among each manufacturer’s power mocellator with respect to product design, development, testing, warnings and marketing to justify keeping them separate.

    The litigation has emerged since early last year, when the FDA first warned about the uterine cancer risks with morcellation.

    In April 2014, the FDA estimated that one out of every 350 women undergoing surgery for symptomatic uterine fibroids may actually have undiagnosed and unsuspected sarcoma contained within the uterus. For these women, morcellators may rapidly spread cancerous cells throughout the body, rapidly upstaging leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers to an advanced stage that is difficult to treat and often fatal. This may greatly reduce the likelihood of long-term survival and the woman’s overall quality of life.

    Two FDA advisory panels were convened by the agency, which determined that there was no safe way to use power morcellators for uterine fibroid removal. However, they could not agree on whether to recommend that the agency demand a power morcellator recall or simply add a black box warning.

    Shortly afterwards, Ethicon, who previously dominated the power morcellator market, decided that it will no longer manufacturer the devices, essentially issuing an Ethicon power morcellator recall after acknowledging that there is no way to make the devices safer.

    While the FDA has allowed laparoscopic morcellators to remain on the market, with much stronger warnings about the potential cancer risks, many hospitals and doctors have announced that they will no longer perform hysterectomy or myomectomy procedures with morcellation, indicating that there is no way to justify the risk.

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  2. Power Morcellator Lawsuits Coordinated in Kansas Federal Court

    Oct 29, 2015 | Injury Lawyer News

    By Ava Lawson

    Harris Martin reports that the JPML has granted plaintiff’s requests to centralize some 20 power morcellator lawsuits for more efficient pretrial proceedings. The complaints center on allegations that that the devices, which are commonly used in laparoscopic fibroid removal and hysterectomy procedures, can inadvertently spread occult cancer cells throughout surrounding tissue, and that manufacturers knew of these inherent risks yet failed to warn the public or medical community.

    In an order dated October 15, 2015 the panel appointed Senior Judge Kathryn H. Vratil to preside over the product liability multidistrict litigation in the District of Kansas.

    The motion will transfer at least 20 actions pending against defendants including Ethicon Inc., Johnson & Johnson, Karl Stortz Endoscopy-America Inc. and Richard Wolf Medical Instruments Corp. Plaintiffs say they believe additional federal actions will be filed in the coming months, which may then be transferred to Kansas City for shared pretrial proceedings.

    Multidistrict litigation established for morcellation claims

    The complaints filed by plaintiffs who had morcellation-assisted gynecological surgeries all contained common questions of fact concerning the safety and overt dangers of the medical devices when used for their intended purpose. The JPML decided to consolidate all actions before one judge to “… serve the convenience of the parties and witnesses and promote the just and efficient conduct of the litigation.” Additionally, consolidated litigation helps prevent inconsistent pretrial rulings while conserving resources of the parties, their counsel and the courts.

    The defendants stand accused of strict products liability-failure to warn, design defect and other causes of action relating to the uterine cancer risks posed to women who had myomectomy or hysterectomyprocedures with morcellation.

    Ethicon, along with the other defendants, opposed the formation of an MDL, arguing that specific factual questions regarding claimants will eclipse common issues of fact. The JPML disagreed on the basis that all of the 20 morcellation cases revolved around the testing, design, manufacture and marketing of the defendant’s morcellators, as well as the accompanying warnings.

    Power morcellators and cancer risk

    According to allegations raised by plaintiffs thus far, Ethicon and other manufacturers of morcellators have known for more than two decades that uterine and fibroid tissue broken up by the devices is frequently left behind, and can embed into surrounding organs and tissues. Considering that some women have undiagnosed cancer before these operations, this poses a grave risk of disseminating cancerous tissue around the body, thus reducing the patient’s chance of long-term survival.

    In 2014, the FDA warned against the use of morcellators in the majority of patients having surgery for fibroid removal, given the increased risk of spreading uterine sarcoma.

    Despite their safety communication regarding cancer risks, health regulators have not banned the use power morcellators in the U.S., though J &J has voluntarily recalled its devices.  Given the increased publicity about sarcoma risks and FDA warning, a large number of hospitals have stopped using power morcellators in laparoscopic myomectomies and hysterectomies, and several insurance chains will not cover the procedure, stating the risks do not outweigh the benefits.

    Each of the lawsuits joined under MDL 2652 will share in pretrial processes that are helpful for streamlining early proceedings among similar cases. However, if settlements do not materialize, the claims will be remanded back to their original court of filing for resolution.

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  3. Legal-Bay Lawsuit Settlement Funding Reports Consolidation of Morcellator Lawsuits in Multidistrict Litigation Court in Kansas

    Nov 2, 2015 | Press Release

    By Legal Bay LLC

    Legal-Bay LLC, the Lawsuit Settlement Funding Company, announced today that the Judicial Panel on Multidistrict Litigation recently made a decision to transfer morcellator cases against Johnson & Johnson's subsidiary, Ethicon, to a single multidistrict litigation court in Kansas. According to Drug Watch, at least 28 morcellator lawsuits against J&J's Ethicon have been transferred to the U.S. District Court for the District of Kansas, and the lawsuits accuse Ethicon "of designing a defective product and failing to warn patients of risks." The morcellator product has sparked controversy, with risks of unintentionally spreading uterine cancer. In April of 2014, the FDA put out a warning stating that the risk was 1 in 350. That same month, J&J recalled their morcellators from the market, however, lawsuits have been growing against the company.

    Morcellators have been used in different laparoscopic surgeries, including hysterectomy and myomectomy procedures, as well as laparoscopic spleen and renal surgeries. While the morcellator device provides a less-invasive surgery and quicker recovery time, the following have been listed as potential side effects: spread of malignant tissue, advanced-stage cancerous growths, and metastatic leiomyosarcoma, an aggressive uterine cancer. If you, or a loved one, have been injured by a morcellation device, please contact Legal-Bay so you can speak to a law firm immediately.

    Patty Kirby, COO and Head of Client Relations, commented on the recent news in the morcellator lawsuits against Ethicon, "We are starting to see a lot more activity on the morcellator cases of late. These cases allege the most serious injuries of advanced stage cancer, leading some to wrongful death lawsuits. Our firm has been very active in helping patients or family members get the lawsuit cash advance they need, or helping them get a free consultation with a qualified morcellator lawyer. Unfortunately, cases of this nature with potential for high award values or amounts, if won at trial, typically take years to resolve."

    Legal-Bay urges users of morcellator products, or family members who have had a loved one injured or deceased as a result of a cancer diagnosis, to contact a law firm immediately. Legal-Bay works with nationally recognized morcellator law firms and attorneys who can assist you with obtaining a free legal consultation on your potential lawsuit claim if you have not retained a lawyer yet. To request to speak with a qualified morcellator lawyer, contact Legal-Bay at:http://lawsuitssettlementfunding.com/morcellator-lawsuit-loans.php

    Legal-Bay's programs are non-recourse lawsuit cash advances, also known as case funding. None of the programs should be considered to be a settlement loan, settlement loans, lawsuit loan, lawsuit loans, pre-settlement loans, or a pre-settlement loan. To learn more about Legal-Bay's funding process, visit: http://www.lawsuitssettlementfunding.com/funding-process.php

    To apply right now for pre-settlement lawsuit funding, which can be approved within 24 hours, feel free to contact Legal-Bay on the company's 24-hour hotline at: 877.571.0405.

    You may also fill out an online application to receive a free evaluation on your case at: http://lawsuitssettlementfunding.com

    Legal-Bay LLC (as well as their related companies) is not a law firm and cannot provide legal advice on your case; however, Legal-Bay works with lawyers involved in mass tort litigations who can provide you with a free legal consultation at the consumer's direction.

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  4. Press Release Power Morcellator Lawsuit Claims Moved To Kansas

    Oct 30, 2015 | Press Release

    By Tracey & Fox

    Tracey & Fox reports on a transfer order  which was recently issued by the Judicial Panel on Multidistrict Litigation. The order would move all morcellator lawsuits filed against manufacturer Ethicon Inc. (a subsidiary of Johnson & Johnson) to the United States District of Kansas. Lawsuits involved similarly allege that Ethicon neglected to warn both physicians and patients about the cancer spreading risks associated when their power morcellators are used for hysterectomies and similar gynecological surgeries.

    The order noted that morcellator lawsuit claims contained many common, factual questions. Other manufacturers involved include Karl Storz, Richard Wolf, and Gyrus ACMI, although the court has decided that these manufacturers will not be included in any type of industry-wide MDL, because of “differences among each defendant’s product design, development, testing, warnings, and marketing…”

    An MDL was created for the Ethicon cases, and plaintiffs’ lawyers appear pleased with this decision. Generally, the consolidation of cases to form MDL allows things to move more quickly and efficiently, saving time and money for everyone involved. Additionally, it helps to avoid presentations of duplicate discovery.

    Since additional lawsuits began to arise, Ethicon has pulled their power morcellation tools from production, and has asked that all those previously sold be returned. The FDA has issued several warnings about the morcellator, and even the FBI has stepped in to investigate whether Ethicon was aware of the cancer risks associated with their product before they removed it from the market.

    Women who have undergone power morcellation and have subsequently suffered from widespread, aggressive cancer may be entitled to compensation. During hysterectomies and myomectomies, the morcellator breaks up uterine tissue and uterine fibroid. In doing so, however, it can allegedly spread previously undiscovered cancer cells throughout the body.

    Tracey & Fox is currently offering free consultations to individuals who have suffered additional cancer diagnosis after undergoing power morcellator procedures. For more information on this topic, or to ask questions, please contact the attorneys at Tracey & Fox by calling 713-322-5375.

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  5. Press Release Power Morcellator Lawsuit Spurs FBI Investigations

    Oct 29, 2015 | Press Release

    By Tracey & Fox

    Tracey & Fox reports on FBI investigations of pharmaceutical conglomerate Johnson & Johnson, in regard to their power morcellator devices. As new studies and lawsuits indicate that the tool may put women's lives at risk, the FBI has stepped in to further evaluate matters. One of the latest studies concerning power morcellation was recently accepted by the American Journal of Obstetrics and Gynecology for publication. In the study, researchers look more closely at many of the risks that have come to light in recent allegations against power morcellation, and compare these risks with the overall benefits associated with laparoscopic surgery vs. open surgery in patients.

    Power morcellators are generally used to perform minimally invasive women’s gynecological surgeries, rather than open, more invasive surgeries. These surgeries generally include hysterectomies and myomectomies to treat and remove uterine fibroids. Initially, power morcellator devices were very popular in the medical world, because they were able to tear tissue apart into smaller pieces for fast and simple surgical removal. Unfortunately, it has since been discovered that these surgical devices potentially pose significant health risks to women who are undergoing laparoscopic surgical procedures.

    After the morcellator is inserted, it tears apart bad tissue, including tissue within the uterus, or uterine fibroids. The problem is, however, that as this tissue is ripped up, it has been found to uncover previously undetected cancer cells. The morcellator tool has been alleged to spread these cells, causing a rapid expansion of the previously contained cancer, and significantly worsening a patient’s prognosis.

    According to the U.S. Food and Drug Administration, a new study conducted by Italian researchers highlighted that in 1 out of each 498 myomectomy procedures women underwent, the chance of spreading leiomyosarcoma existed. They noted that, “When used for hysterectomy or myomectomy in women with uterine fibroids, laparoscopic power morcellation poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”

    One suggested option to provide safer morcellation is morcellation in a bag. Research done on this procedure has noted that “Myoma morcellation in a bag could theoretically limit intraperitoneal dissemination of malignant cells, but the efficacy of such containment devices has yet to be proven.” In this instance, surgeons would use the power morcellator in an enclosed environment, trapping and removing any cancerous cells that may be torn up. The idea sounds more promising, but is certainly surrounded by concern and potential limitations.

    Across the U.S., more than 30 women have filed lawsuits which similarly allege that having a power morcellation procedure subsequently spread their cancer cells. Already, one manufacturer of the product, Ethicon, has fully pulled it from their inventory, and has asked for those morcellators in use at hospitals to be returned. The FBI investigations are said to be focused on uncovering exactly what Johnson & Johnson knew about the risks of the morcellator, and how long they have known this information. Currently, anyone who has undergone power morcellation and now has aggressive or widespread cancer may be entitled to legal compensation.

    The attorneys at Tracey & Fox are working to help ensure that anyone who has suffered health problems after a power morcellator procedure is able to look into their legal rights. They offer free and confidential consultations.

    To obtain additional information on this topic or ask questions, contact the attorneys at Tracey & Fox by calling 713-322-5375 today.

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