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Morcellation Media Monitoring 11/30/2015
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Couple sues Ethicon over cancer treatment device, alleging negligence
Nov 27, 2015 | Pennsylvania Record
By Carrie Bradon
A Richmond couple is suing a surgical corporation over claims that a defective surgical device caused the wife's cancer to spread. Anna and Marvin Fultz filed a complaint on Nov. 6 in the U.S. District Court for the Middle District of Pennsylvania against Ethicon Inc., as well as a number of affiliated divisions of the corporation, citing negligence; strict products liability for design defect and marketing defect; breach of express and implied warranty; fraud, misrepresentation and suppression and other counts. -
Ethicon Morcellator MDL Proceeds With November 18th Status Conference
Nov 27, 2015 | Top Class Actions
By Ashley Vanover
The newly consolidated litigation over power morcellator injuries is moving forward, with an initial scheduling conference held on November 18 -
Johnson And Johnson’s Knowledge Of Power Morcellator Risks Questioned
Nov 25, 2015 | Righting Injustice
By Jennifer Walker-Journey
Rep. Tim Murphy, chairman of the Subcommittee on Oversight and Investigations questioned whether Johnson & Johnson and Brigham & Young Hospital violated federal law by not reporting reports of cancer spread in patients who had undergone hysterectomies and uterine fibroid removals using power morecellator tools. -
Power Morcellator Lawsuits Spur House Congressional Panel Questions
Nov 23, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on another update in the trials against power morcellator devices and various manufacturers. The House Committee on Energy and Commerce has now stepped up, asking new questions regarding whether Johnson & Johnson and Brigham Hospital fulfilled their requirement of reporting adverse events associated with laparoscopic power morcellator devices to the U.S. Food and Drug Administration.
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Couple sues Ethicon over cancer treatment device, alleging negligence
Nov 27, 2015 | Pennsylvania Record
By Carrie Bradon
A Richmond couple is suing a surgical corporation over claims that a defective surgical device caused the wife's cancer to spread.
Anna and Marvin Fultz filed a complaint on Nov. 6 in the U.S. District Court for the Middle District of Pennsylvania against Ethicon Inc., as well as a number of affiliated divisions of the corporation, citing negligence; strict products liability for design defect and marketing defect; breach of express and implied warranty; fraud, misrepresentation and suppression and other counts.
The plaintiffs claim that following a laparoscopic power morcellator (LPM) procedure that was carried out on March 28, 2007, Fultz, a uterine cancer patient, suffered a complication of her condition caused by the surgical procedure. The complaint states that the device caused "occult malignant tissue fragments to be disseminated and implanted in the body" and this caused the cancer to spread.The plaintiffs claim that the defendant failed to inform the plaintiff of the risk that the using a LPM device posed, and in November 2014, the FDA updated a warning regarding use of such devices. As a result of the negligence of the defendant, Fultz now has been affected by leiomyosarcoma, a fast-acting and aggressive cancer, from which it is unlikely that she will fully recover, the complaint states.
Fultz is seeking monetary compensation of an unspecified amount for all damages, fees and anguish suffered. She is represented by Laura A. Feldman and Rosemary Pinto of Feldman and Pinto, P.C. in Philadelphia and Sean P. Tracey, Rebecca B. King and Andrew Rubenstein of Tracey and Fox in Houston. -
Ethicon Morcellator MDL Proceeds With November 18th Status Conference
Nov 27, 2015 | Top Class Actions
By Ashley Vanover
The newly consolidated litigation over power morcellator injuries is moving forward, with an initial scheduling conference held on November 18.
The multidistrict litigation pulls together power morcellator lawsuits filed on behalf of women who have allegedly developed aggressive uterine cancers after undergoing procedures using a power morcellator manufactured by Ethicon Inc.
Ethicon, a division of Johnson & Johnson, is facing more than two dozenpower morcellator lawsuits alleging the surgical tool can spread and upstage undetected uterine cancer cells when used to perform minimally-invasive hysterectomies and uterine fibroid removal surgery.
Consolidation of the federal docket in the U.S. District Court, District of Kansas, is intended to promote judicial efficiency by allowing all pending and future lawsuits involving similar allegations to undergo coordinated pretrial proceedings, including discovery and motions practice.
According to the Court’s October 16 Order, this month’s Status Conference addressed all matters relating to pretrial and discovery proceedings. The parties were directed to submit any proposed case management orders or agenda items to the Court by November 10.
The Court has also requested that the parties submit a brief written statement on or before that date indicating their preliminary understanding of the facts involved in the Ethicon morcellator litigation, as well as the critical factual and legal issues.
FDA Issues Safety Alerts Regarding Power Morcellators
Laparascopic power morcellators are employed in non-invasive surgery to remove masses in the uterus. The device is inserted through a small incision in the abdomen and used to cut up tissue for easy extraction. Many women have chosen to have a power morcellator procedure because of the minimal scarring it causes.
However, recent findings by the U.S. Food and Drug Administration (FDA) and other organizations show that power morcellators pose a risk of spreading unsuspected cancer throughout the body. Since April 2014, the FDA has issued two public health alerts regarding the potential for power morcellators to disseminate undetected uterine cancer cells into the peritoneal cavity.
According to the agency, this occurrence greatly reduced a woman’s chances of long-term survival. The FDA now warns against the use of uterine morcellation in the majority of women who require hysterectomies or myomectomies, stating that, “1 in 350 women undergoing hysterectomy or myomectomy for the treatment of fibroids . . . have an unsuspected uterine sarcoma.” As a result, doctors may be spreading cancer in hundreds of female patients every year.
Ethicon Power Morcellator Multidistrict Litigation
Ethicon, a subsidiary of Johnson & Johnson and the leading manufacturer of power morcellators, is facing increasing scrutiny for its device. Ethicon has decided it will no longer manufacture the devices, but is still facing a number of lawsuits.
Power morcellator lawsuits filed in federal courts across the U.S. have been centralized in the U.S. District Court for the District of Kanas. The number of power morcellator lawsuits included in the MDL is expected to increase over the coming months
If you or woman you care about were diagnosed with advanced uterine cancer following a power morcellation surgery, contact an attorney to determine whether you may be eligible to file a morcellator lawsuit.
The Ethicon Power Morcellation MDL is In Re: Ethicon, Inc., Power Morcellator Products Liability Litigation, MDL No. 2652, in the U.S. District Court, District of Kansas.
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Johnson And Johnson’s Knowledge Of Power Morcellator Risks Questioned
Nov 25, 2015 | Righting Injustice
By Jennifer Walker-Journey
Rep. Tim Murphy, chairman of the Subcommittee on Oversight and Investigations questioned whether Johnson & Johnson and Brigham & Young Hospital violated federal law by not reporting reports of cancer spread in patients who had undergone hysterectomies and uterine fibroid removals using power morecellator tools.
During a hearing by the Subcommittee on Health, Murry asked Jeffrey Shuren, director of the FDA Center for Devices and Radiological Health, “Are you aware of this problem?” meaning whether manufacturers of power morcellators, includingJohnson & Johnson, or the hospitals that used them had failed to notify the agency of any adverse events, according to The Cancer Letter.
Power morcellators are surgical tools fitted with a tube-like blade that shreds entire uteruses or uterine fibroids inside the body and removes them through a small incision in the abdomen. The tools have been linked to the spread of undiagnosed uterine cancer, called uterine sarcoma, which makes the disease more difficult to treat.
After months of petitioning by women who claim they were injured by the devices and their family members, the FDA conduced a safety review which resulted in a black box warning and a recommendation by the agency that power morcellation not be used on most women due to the risk of cancer spread.
The agency said that about 1 in 350 women have uterine sarcoma, which is difficult to detect without first removing the tissue. Power morcellation in women with uterine sarcoma can sling cancerous tissue throughout the abdomen, which can seed new cancer growth and worsen the odds of the patient’s survival.
In his questioning of Shuren, Murry argued that Johnson & Johnson “was apparently aware of the dangers of this device as early as 2006, based upon a report from Dr. (Robert) Lamparter, a pathologist from central Pennsylvania, who cited about one out of 300 samples of morcellated tissue from his hospital had evidence of a hidden cancer, which is morcellated.”
The congressional hearings are part of an investigation into power morcellator risks. The FBI is conducting a separate investigation into when Johnson & Johnson knew of the risk of cancer spread with its power morcellator. Last summer,Johnson & Johnson pulled its device from the market.
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Power Morcellator Lawsuits Spur House Congressional Panel Questions
Nov 23, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on another update in the trials against power morcellator devices and various manufacturers. The House Committee on Energy and Commerce has now stepped up, asking new questions regarding whether Johnson & Johnson and Brigham Hospital fulfilled their requirement of reporting adverse events associated with laparoscopic power morcellator devices to the U.S. Food and Drug Administration.
New reports show that during a hearing the week of November 16th, the chairman of the Subcommittee on Oversight and Investigations began to question the manufacturer's practices, and to investigate whether or not they had violated a federal law by failing to report all adverse outcomes regarding their power morcellator tools. The Chairman, Representative Tim Murphy (R-Pa.), directly addressed Johnson & Johnson (parent company of morcellator manufacturer Ethicon), and Brigham & Women’s Hospital.
Shortly after these questions were brought to light, the director of the U.S. Food and Drug Administration’s Center for Devices and Radiological Health sought out to investigate this further, and determine if the manufacturer or hospital had neglected to keep them informed of patients who were reportedly harmed during the process.
Officials from the FDA stated that their agency received no reports of adverse outcomes relating to power morcellation procedures before December of 2013. The lawsuits contained in the surrounding litigation, however, seem to note many adverse events prior to this date. The device has become one surrounded by much controversy.
Laparoscopic power morcellators are used during gynecological surgeries such as hysterectomies and myomectomies. They are inserted into a woman’s abdomen through a small incision, where they work to break apart troublesome uterine fibroids or uterine tissue. The problem, however, is that as the tool shreds the tissue much like a drill, it can also allegedly uncover previously undetected cancer cells, and spread them throughout the body. After undergoing this procedure, many patients have suddenly been diagnosed with high-grade, widespread cancer. This type of diagnosis can have a significant impact on the patient’s life expectancy. In fact, several power morcellator lawsuit plaintiffs have passed away from cancer since filing.
The attorneys at Tracey & Fox are working to ensure that anyone who has undergone laparoscopic power morcellation and who has subsequently been diagnosed with cancer is able to explore their full legal rights. These individuals may be entitled to compensation, and Tracey & Fox is offering them free legal consultations.
For additional information on power morcellation lawsuits, or to ask questions, please contact Tracey & Fox directly by calling (713) 322-5375.
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