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Morcellation Media Monitoring 10/1/2015
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MDL Watch: Panel to consider Zofran, power morcellator, Cymbalta cases
Sep 30, 2015 | Reuters
By Jessica Dye
The U.S. Judicial Panel on Multidistrict Litigation is set to consider products liability claims over power morcellators, anti-nausea drug Zofran, Honda CR-V cars and Eli Lilly's antidepressant Cymbalta. The following cases are scheduled for oral argument during an Oct. 1 hearing in Manhattan. -
The Three Hurdles of Proving Damages in a Power Morcellation Case
Sep 30, 2015 | US Recall News
The number of hysterectomy operations in the United States each year exceeds 500,000. Of that number, approximately 55,000 involved the use of power morcellation devices between 1995 (when they were licensed for use in gynecological surgery) and 2014 (when the FDA started to issue warnings against their use in certain circumstances). -
Power Morcellator Lawsuit Update: FDA’s 501(k) Approval Process Questioned
Sep 30, 2015 | The Legal Herald
By Laurence Banville
As the number of power morcellator lawsuits climb, the GAO has agreed to investigate the FDA's 501(k) approval process. As power morcellator lawsuit numbers grow, the public has been made aware of the U.S. Food and Drug Administrations 501(k) approval process. -
Power Morcellator Lawsuit Numbers Climb
Sep 29, 2015 | The Legal Herald
By Laurence Banville
Several power morcellator manufacturers are facing a growing number of lawsuits after the FDA published a safety warning. As word spreads of the U.S. Food and Drug Administration safety warning regarding the use of power morcellators during gynecological procedures, numerous women and their families have come forward and filed lawsuits against several morcellator manufacturing companies. -
Colorado Woman Files Power Morcellator Lawsuit Against Ethicon
Sep 28, 2015 | The Legal Herald
By Laurence Banville
Ethicon, a company facing numerous power morcellator lawsuits, is named as the defendant in the newest power morcellator lawsuit. Ethicon has once again been sued by a woman who alleges that a power morcellator they manufactured spread her undetected uterine cancer. -
Deadly Uterine Sarcomas Potentially Spread by Morcellation
Sep 29, 2015 | The Legal Examiner
By Steven Davis
Power morcellators have been used in laparoscopic surgical procedures for several decades. In women, two of the most common laparoscopic procedures performed are hysterectomies and myomectomies, as suggested by a surgeon for the treatment of uterine fibroids.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
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MDL Watch: Panel to consider Zofran, power morcellator, Cymbalta cases
Sep 30, 2015 | Reuters
By Jessica Dye
The U.S. Judicial Panel on Multidistrict Litigation is set to consider products liability claims over power morcellators, anti-nausea drug Zofran, Honda CR-V cars and Eli Lilly's antidepressant Cymbalta.
The following cases are scheduled for oral argument during an Oct. 1 hearing in Manhattan.
To read the full story on WestlawNext Practitioner Insights, click here: bit.ly/1FIPg0W
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The Three Hurdles of Proving Damages in a Power Morcellation Case
Sep 30, 2015 | US Recall News
The number of hysterectomy operations in the United States each year exceeds 500,000. Of that number, approximately 55,000 involved the use of power morcellation devices between 1995 (when they were licensed for use in gynecological surgery) and 2014 (when the FDA started to issue warnings against their use in certain circumstances).
Based on these numbers, well over a million hysterectomy surgeries have been performed with the aid of power morcellators. Of that number the FDA estimated that 1 in 350 that used power morcellators may have caused cancer to spread beyond its initial primary site and been the cause of unnecessary suffering and death in hysterectomy patients. This means that just counting hysterectomy procedures alone over that 19 year period, approximately 3,000 patients may have suffered as a direct result of their use. These victims and their families may be entitled to recover damages through product liability litigation.
There are three main hurdles in the way of proving damages in a power morcellation case:
What was the state of the pre-existing cancer?
This may be difficult to prove as power morcellators are typically used only where the treated tissue is diagnosed as being benign. One of the key diagnosis weaknesses that the FDA warnings in April and November 2014 revealed was that in a small, but significant number of hysterectomies involving uterine fibroid tumors (approximately 1 in 350), the supposedly “benign” fibroid tissue could hide cancerous tissue. In these cases, a power morcellator might have spread the cancer in the patient.
There may be significant challenges in establishing a baseline of health. It should be noted however that there is the potential to extrapolate this, to some extent at least, from the rate of development of the cancer. One of the key issues with power morcellators is that they facilitate the spread of cancer to new sites, the spread rate and its deviation from the norm is critical to establishing a causal link.
What is the likely survival rate?
The second big hurdle is that cancer is present in all cases and so any damages need to be argued in the context of how much difference the use of the power morcellator made to the patient’s suffering and life-expectancy.
According to one July 2002 study for example, only 10% of women who have advanced stage leiomyosarcoma can expect to live beyond 5 years.
Any damages may therefore need to be set in context of how much difference any spread of cancer (assuming it is proven) has made to the patients final life-expectancy.
How has the patients quality of life been affected?
This third question is predicated on an analysis of what a patient’s quality of life would have been like both with and without her cancer spreading.
In order to argue this effectively, it is necessary to draw on similar patient profiles both with and without the cancer spreading.
In this way it is possible to draw meaningful conclusions as to how the spread of cancer that was caused by the use of a power morcellator has impacted an individual patient, and what damages she or her family may be entitled to recover.
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Power Morcellator Lawsuit Update: FDA’s 501(k) Approval Process Questioned
Sep 30, 2015 | The Legal Herald
By Laurence Banville
The 501(k): Is it a safe process?
As the number of power morcellator lawsuits climb, the GAO has agreed to investigate the FDA's 501(k) approval process. As power morcellator lawsuit numbers grow, the public has been made aware of the U.S. Food and Drug Administrations 501(k) approval process.The 501(k)
This process allows the manufacturers of surgical tools to expedite the approval process by showing that the instrument is essentially equivalent as a previously approved device. If the FDA agrees with that determination, the new device is not required to undergo the normal safety testing and clinical trial procedures.
Today, many women are wondering if the FDA missed a potentially deadly risk associated with the use of a power morcellator by allowing the tool to be approved this way. The power morcellator has been used by surgeons for several decades, but it wasn’t until recently that the FDA announced to the medical community and the public that if the device is used during a gynecological surgery, there was a chance that undetected uterine cancer could be spread through the body cavity.The GAO Investigation
On August 7th, 2015, twelve members of Congress sent a letter to Mr. Gene Dodaro, the Comptroller General and the head of the U.S. Government Accountability Office, requesting that the GAO investigate FDA’s approval of the device. Additionally, the question was raised as to why it took so long for the FDA to issue the safety warning. The morcellator was cleared for use in 1991, but the safety warning wasn’t issued until April 2014.
Uterine Cancer and the Power Morcellator
The safety warning published by the FDA reads, “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. Because of this risk and the availability of alternative surgical options for most women, the FDA is warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids. ” It was estimated that around 1 in 350 women undergoing hysterectomies or myomectomies to treat uterine fibroids also have undiagnosed uterine cancer.
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Power Morcellator Lawsuit Numbers Climb
Sep 29, 2015 | The Legal Herald
By Laurence Banville
New Power Morcellator Lawsuits Are Filed Regularly
Several power morcellator manufacturers are facing a growing number of lawsuits after the FDA published a safety warning. As word spreads of the U.S. Food and Drug Administration safety warning regarding the use of power morcellators during gynecological procedures, numerous women and their families have come forward and filed lawsuits against several morcellator manufacturing companies.
The FDA Safety Warning
On April 17th, 2014, the FDAreleased a safety warning which informed the medical community and public that research suggested the use of a power morcellator during hysterectomies and myomectomies could potentially spread undiagnosed uterine cancer. This came as a shock to surgeons who had been using the morcellator for decades. Researchers determined that when the morcellator was used to cut through tissue the cutting jaws also disseminated cells throughout the body cavity. If cancer cells are disseminated to other organs, they may take root and result in metastases that otherwise would not have occurred.
Current Morcellator Lawsuits
At this time, 30 lawsuits have been filed against manufacturers such as Ethicon, Karl Storz, Richard Wolf GmbH, and Gyrus ACMI. Each lawsuit alleges that a women who underwent a gynecological laparoscopic surgery had undetected uterine cancer which was upstaged by the use of a morcellator. The majority of these lawsuits name a type of cancer called a leiomyosarcoma which is difficult to treat. Each plaintiff has undergone aggressive chemotherapy and radiation treatments. Sadly, several of the plaintiffs have passed away despite the treatment.
Ethicon Withdraws Morcellators From The Market
Shortly after the FDA safety warning, one of the biggest morcellator manufacturers, Ethicon announced that it was voluntarily withdrawing all of its morcellators from the market. The company also sent a letter globally to all doctors that had bought a product urging them to stop using the tool. The letter stated that “We believe Ethicon Morcellation Devices perform as intended and there are patients who can benefit from procedures using laparoscopic power morcellators, but the risk-benefit assessment associated with the use of these devices in hysterectomy and myomectomy procedures for removing fibroids remains uncertain. Because of this uncertainty, Ethicon believes that a market withdrawal of Ethicon Morcellation Devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk.” . At this time, none of the other manufacturing companies has withdrawn their products.
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Colorado Woman Files Power Morcellator Lawsuit Against Ethicon
Sep 28, 2015 | The Legal Herald
By Laurence Banville
Latest Power Morcellator Lawsuit Filed In Colorado
Ethicon, a company facing numerous power morcellator lawsuits, is named as the defendant in the newest power morcellator lawsuit. Ethicon has once again been sued by a woman who alleges that a power morcellator they manufactured spread her undetected uterine cancer.
Ethicon: A Subdivision Of Johnson & Johnson
Ethicon was one of the first companies to manufacture power morcellators after the surgical instrument was first introduced to the United States in the early 90’s. The morcellator was immediately embraced by the medical community because of its ability to be used in laparoscopic surgeries. The tool is inserted into the abdomen through a tiny incision where it cuts through tissue and allows the surgeon to remove the tissue in smaller pieces.
Power Morcellators And Uterine Cancer
Power morcellators were approved by the U.S. Food and Drug Administration under a 501(k). The 501(k) allows devices to be approved without undergoing the usual safety testing if the company submitting for approval can show that the device is “substantially equivalent” to a previously approved tool. Recently, the FDA released a safety communication to the medical community and the public, stating that the use of a power morcellator during gynecological surgeries may spread undetected uterine cancer to other areas of the body cavity. In many cases, women undergo hysterectomies and myomectomies to treat uterine fibroids. These fibroids were thought to be typically benign, however, the FDA now estimates that 1 in 350 women undergoing these procedures has undiagnosed uterine cancer.
The Colorado Lawsuit
In this latest case, the plaintiff underwent a laparoscopic procedure where the surgeon used a Dive LPM made by Ethicon. She had the surgery on April 4th, 2013, and was told soon after, that one of her fibroids contained leiomyosarcoma. Following this diagnosis, she has been treated with aggressive chemotherapy and radiation which has been painful and disabling. Her complaint states that, “Although evidence was available to the defendants for years before the plaintiff’s surgery, the defendants failed to respond to multiple published studies and reports describing the risk of disseminated and upstaging or worsening occult cancer. They failed to design their LPM products, including the Diva, in a manner to reduce this life-threatening risk.” The lawsuit is just one of many filed by either a woman who underwent a gynecological surgery where undetected uterine cancer was allegedly spread or the family of a woman who passed away from uterine cancer after a power morcellator was used.
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Deadly Uterine Sarcomas Potentially Spread by Morcellation
Sep 29, 2015 | The Legal Examiner
By Steven Davis
Power morcellators have been used in laparoscopic surgical procedures for several decades. In women, two of the most common laparoscopic procedures performed are hysterectomies and myomectomies, as suggested by a surgeon for the treatment of uterine fibroids.
Pre-Surgical Testing Ineffective in Diagnosing Some Uterine Cancers
When a woman undergoes pre-surgical testing, doctors are not able to determine if the uterine fibroids contain uterine cancer. Power morcellators are used to chop up benign uterine tissue intended for removal, but if the blades of the device come into contact with cancer cells, the risk of metastasis is increased because the cells are distributed throughout the abdominal cavity.
Most uterine fibroids, or growths in the uterus, are benign. However, the U.S. Food and Drug Administration (FDA) reported recently that approximately one in 350 women who undergo surgery for uterine fibroids are actually harboring undetected uterine cancer. The most dangerous of these uterine cancers are known as uterine sarcomas, of which there are several types that can be potentially spread by morcellation:
Uterine Leiomyosarcoma
Uterine leiomyosarcoma is the most common and deadly form of uterine sarcoma. Leiomyosarcoma tumors are extremely metastatic, and if they found to be in other areas of the body when diagnosed, there is only a 14 percent chance of a five-year survival rate, according todata compiled by the American Cancer Society.
Endometrial Stromal Sarcoma
Endometrial stromal sarcoma begins in a layer of the mucous membrane called the endometrium, and is considered less aggressive than leiomyosarcoma, meaning it will not typically spread as quickly.
Undifferentiated Endometrial Sarcoma
Undifferentiated endometrial sarcoma is considered a high-grade version of endometrial stromal sarcoma, and is usually much more aggressive.
Carcinosarcoma
Carcinosarcoma is a very rare and aggressive form of uterine sarcoma, and has only a 35 percent five-year survival rate.
Although the FDA has issued warnings about the cancer risks associated with morcellation, the devices have not been removed from the market, although recommendations were made regarding screening out patients for whom morcellation might present accelerated risks, such as women over 50 or those considered high risk for uterine cancer.
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Morcellation
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