FDA: No Reported Adverse Events Involving Morcellation Cancer Upstaging for 8 Years

Posted by Anapol Weiss on Feb 15, 2016 11:00:00 AM

Federal law requires the reporting of adverse events, but for eight years the U.S. Food and Drug Administration (FDA) did not receive reports of cases involving power morcellation and the spread of cancer.

morcellator_adverse_events.jpgBetween December 2013 and November 2014, however, the FDA received about two dozen reports discussing cancer and upstaging or dissemination – but all of them pertained to morcellation procedures women had undergone prior to December 2013.

Power morcellators use spinning blades to break up tissue and fibroids for laparoscopic removal. The devices have been touted as a less invasive surgical option in gynecological procedures such as hysterectomies and myomectomies. Unfortunately, one in 350 women undergoing a hysterectomy or myomectomy for fibroid treatment is found to have undetected uterine sarcoma – a type of uterine cancer that includes leiomyosarcoma. There is currently no reliable test to determine whether a woman with fibroids has a uterine sarcoma, so women could unknowingly have cancer blasted throughout their bodies during one of these routine procedures.

Ethicon withdrew its power morcellators from the market after the FDA warned about the potential to spread undetected cancerous and infected uterine tissue in women's bodies. In 2014, the FDA cautioned against using laparoscopic power morcellators in the majority of women undergoing hysterectomies or myomectomies for uterine fibroids.

All power morcellator cases against Johnson & Johnson’s Ethicon subsidiary were consolidated and transferred to the U.S. District of Kansas in October 2015. The litigation was renamed In Re: Ethicon, Inc. Power Morcellator Products Liability Litigation (MDL Case No. 2652). Anapol Weiss is proud to have a leadership role in the litigation and will work tirelessly to protect the rights of people who have filed morcellator lawsuits.

Contact Anapol Weiss if you underwent a minimally invasive hysterectomy or myomectomy and suspect recurring health problems may be related to the use of a power morcellator.

 

Topics: Ethicon Morcellator, Morcellator Cancer Link

Responses to Use of Power Morcellators by the FDA, FBI, GOA and Market

Posted by Anapol Weiss on Feb 3, 2016 11:30:00 AM

The first reference to power morcellators spurring the ongoing controversy was in December 2013 when the Wall Street Journal profiled Dr. Amy Reed, an anesthesiologist at Beth Israel Deaconess Medical Center in Boston. Dr. Reed underwent a routine morcellation laparoscopic hysterectomy at Brigham & Women’s Hospital to remove uterine fibroids and discovered – after the surgery – that the mass her surgeons had assumed was benign was in fact leiomyosarcoma.

Dr. Reed, who now lives in the greater Philadelphia region with her husband and six children, recently underwent surgery for a third recurrence of the disease. WSJ reporter Jennifer Levitz recognized in this article that the gynecological specialty worldwide was assuming that tumors of the uterus, known as fibroids or leiomyomas, are non-cancerous or benign.

FDA Warns against Power Morcellator Use during Laparoscopic Procedures

In April 2014, the FDA issued a safety communication advising against the use of power morcellators during laparoscopic procedures. After reviewing extensive medical literature, the FDA found that the risk of a woman undergoing a hysterectomy or myomectomy having an unsuspected sarcoma may be as high as 1 in 350 for all types of uterine sarcomas. Johnson & Johnson (J&J) responded by suspending world-wide sales and distribution of its power morcellators.

Both the FDA and J&J took greater steps in the months to follow. In July 2014, the FDA convened an advisory panel to discuss mounting concern with the use of power morcellators in gynecological surgeries. The FDA panel issued a directive discouraging doctors from using the device because of the risk of spreading undetected cancer. Days later, J&J called for a voluntary worldwide market withdrawal of the tool.

In November 2014, the FDA issued a black box warning – the highest level of caution – to help reduce the risk of spreading unsuspected uterine cancer in women being treated for uterine fibroids. The FDA recommended that manufacturers include warning that states in part: “The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients.”

Since the FDA's black box warning, other agencies have launched investigations into power morcellators and many physicians have recently spoken up as well.

Taking Action

Contact our firm if you underwent a minimally invasive hysterectomy or myomectomy and suspect your recurring health conditions may be related to the use of a power morcellator. Our attorneys are highly qualified to represent women and their families facing the devastation of upstaged cancer after morcellation.

 

Topics: Ethicon Morcellator, Morcellator Cancer Link

Power Morcellator Litigation: A Closer Look at Putting Women at Risk

Posted by Anapol Weiss on Feb 1, 2016 11:30:00 AM

46.

The number of cases currently pending in In re Ethicon, Inc. Powel Morcellator Products Liability Litigation (MDL 2652) pending in the District of Kansas (D. Kan. No. 15-md-2652-KHV).

1 in 352.

1 in 368.

1 in 278.

These figures represent estimates of the number of women who are at risk of having a deadly cancer spread when undergoing routine gynecological surgeries with a power morcellator. Generally speaking, this is a very high risk, especially considering we are dealing with an avoidable hazard: the use of a power morcellator in minimally invasive gynecological surgeries.

Power Morcellator Litigation (MDL 2652)

power_morcellation_litigation.jpgOn October 15, 2015, the United States Judicial Panel on Multidistrict Litigation (JPML) entered an order transferring all power morcellator cases against Ethicon. Inc., a subsidiary of Johnson & Johnson, to the District of Kansas for coordinated and consolidated pretrial proceedings. The JPML panel appointed Senior Judge Kathryn H. Vratil, a former JPML chairman, to oversee the pretrial proceedings and currently 46 cases have been transferred to her court, including at least one from the Eastern District of PA and three from the Middle District of PA.

The number of power morcellator lawsuits has more than doubled since the JPML approved consolidation of the cases and is steadily increasing.

While there are several companies that manufacture power morcellators, the JPML panel determined that an industry-wide multidistrict litigation (MDL) would not be appropriate because of major differences in product design and development, testing standards, product labeling, and marketing. The MDL is specifically for all federal power morcellator cases against Ethicon, Inc. – which was the largest manufacturer of power morcellators until voluntarily pulling its morcellation products from the market on July 30, 2014 in response to mounting concern over the controversial surgical tool.

The lawsuits allege a link between the use of power morcellators in gynecological surgeries and the spread of cancerous cells. The two main allegations include common questions of fact: first, morcellator manufacturers designed a “defective” device that was capable of spreading hidden cancers during approved use in hysterectomy or myomectomy (uterine fibroid removal). Second, patients were not properly informed of these risks by manufacturers with an accurate incidence ratio of undetected uterine cancer in women seeking a hysterectomy or myomectomy.

Judge Vratil has entered an ambitious scheduling order and the parties are working tirelessly to move these cases quickly. More cases are being filed every day and the Court is holding monthly status conferences for updates and to resolve any issues of dispute. Trials are anticipated as early as 2017.

Contact our medical device team if you underwent a hysterectomy or myomectomy and suspect recurring health conditions may be related to the tools used in the procedure. Our firm is highly qualified to represent women and their families facing the devastation of cancer after morcellation.

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Topics: Ethicon Morcellator, Morcellator Cancer Link

Medical Journal Highlights Current Power Morcellator Debate

Posted by Anapol Weiss on Jan 27, 2016 11:30:00 AM

This January issue of Obstetrics & Gynecology features two articles diametrically opposed in their messages as to the true risk of power morcellation.

morcellation_current_debate.jpg

In this month's issue, a group of 48 top gynecological surgeons, headed by William Parker of UCLA, and a few women’s health advocates, including Carla Dionne of the National Uterine Fibroid Foundation (NUFF.org), published a letter directed to the FDA in defense of the use of power morcellation and challenging the FDA on its oversight of the device.

In the article, the physicians advocate for the use of power morcellators, stating that the FDA's "… recommendations were not based on science, but rather on emotional and anecdotal information," and pointing to studies that show a lower risk than that touted by the FDA. The authors also point out that restricting power morcellators provides women with fewer options for fibroid removal and increases the risk of complications by having to undergo an open procedure.

Interestingly, in the same issue of the journal, another group of gynecologists estimated that the number of unsuspecting women having hysterectomies and myomectomies who are at risk of cancer upstaging from morcellation is one in 276.

A blog post on philly.com by Dr. Amy Reed and her husband, Dr. Hooman Noorchasm, a cardiothoracic surgeon, admonishes Dr. Parker and the other physicians for attempting to divert the conversation into a discussion of statistical uncertainty, instead of admitting that when it comes to an incorrect and avoidable surgical practice, it is not acceptable to put women at risk, whether they number one in 156 or one in 10,000.

Parker and his counterparts compare unavoidable risks of all surgery – i.e. wound infections, blood clots, or perioperative heart attacks - with the avoidable risk of spreading a cancer using morcellation.

Filing a Morcellator Cancer Lawsuit

Contact Anapol Weiss if you underwent a minimally invasive hysterectomy or myomectomy and suspect recurring health conditions may be related to the use of a power morcellator. We will investigate your situation and answer any questions you have.

 

Topics: Ethicon Morcellator, Morcellator Cancer Link

What Is a Power Morcellator?

Posted by Anapol Weiss on Jan 20, 2016 3:35:00 PM

Power morcellators are made by multiple manufacturers, and provide a less-invasive option in gynecological surgeries. They are shaped much like a drill, and can be inserted into a woman’s lower abdomen through a tiny incision. Once inside, during hysterectomies or myomectomies, they work by rapidly spinning blades which shred, grab and/or and chop up organs and tissue for removal through small incisions. The tool has been used with increasing frequency for laparoscopic gynecological surgeries in recent years

Morcellation_Cancer.jpgApproximately 650,000 women undergo hysterectomies and myomectomies a year in the United States for uterine fibroids and it is estimated that 50,000 to 100,000 are morcellation surgeries. In these surgeries, a power morcellator is used to slice the uterus and uterine tumors (fibroids) for ease of removal. The tool provides an alternative to the need for an open procedure, which many physicians feel poses other risk factors for women.

Upstaging Undetected Cancer

Serious health problems arise, however, when a power morcellator is used in a woman who unknowingly has cancer as there is currently no reliable test to determine whether a woman with fibroids has a uterine sarcoma. The cancerous tissue being chopped up by the tool is dispersed in the woman's body, thereby spreading (or upstaging) the cancer, which can attach to other tissue and organs and begin to grow. The spreading of the cancer cells is suspected of accelerating and advancing the cancer to a point where it often becomes untreatable.

Filing a Morcellator Cancer Lawsuit

Women who have filed lawsuits have undergone morcellation procedures only to be diagnosed with cancer post-surgery. In other words, the cancer has likely been spread before the women knew they had cancer.

Contact Anapol Weiss if you underwent a minimally invasive hysterectomy or myomectomy and suspect recurring health conditions may be related to the use of this tool. We can investigate your situation and answer any questions you may have.

 

Topics: Ethicon Morcellator, Morcellator Cancer Link

Larry Cohan Appointed To Ethicon Power Morcellator PSC

Posted by Anapol Weiss on Nov 24, 2015 3:02:37 PM

A hearing was held in the Ethicon Power Morcellator multidistrict litigation (MDL) in front of U.S. District Judge Kathryn H. Vratil and U.S. Magistrate Judge James P. O’Hara on November 18, 2015. Attorneys for plaintiffs and defendants were present. The Court entered an order memorializing its rulings and setting forth additional procedures.

PAGE_1_MDL_2652_Order_11_19_15_2.jpgThe Court appointed Anapol Weiss partner Larry Cohan to the Plaintiffs’ Steering Committee (PSC) – this committee will meet regularly with the Court and opposing counsel to oversee the strategy, progress, and activity in the lawsuit. The PSC works tirelessly to protect the rights of people who have filed lawsuits against Ethicon for injuries related to its power morcellators.

This PSC is particularly unique in that it is comprised of a majority of women attorneys, which is the first in the history of MDLs. I am proud to work alongside Larry Cohan to represent the women and families affected by this product.

The Court has proposed an ambitious schedule to promote efficient resolution of these cases, many of which sadly involve women with advanced cancers and poor prognoses.

Ethicon withdrew its power morcellators from the market after the U.S. Food and Drug Administration (FDA) warned that power morcellation can spread undetected cancerous and infected uterine tissue throughout women's bodies during a routine laparoscopic hysterectomy or myomectomy (fibroid removal surgery). In November 2014, the FDA issued a black box warning about these morcellator risks.

A power morcellator is a surgical tool that breaks up tissue and organs for laparoscopic removal. It has been used with increasing frequency for gynecological surgeries in recent years. 

Topics: Ethicon Morcellator, Morcellator Cancer Link

Power Morcellator Surgery Victims Have Their First Day in Court as Consolidated Cases

Posted by Anapol Weiss on Nov 18, 2015 2:37:16 PM

At 1:00 p.m. CST today, women and their families who suffered injuries as a result of a power morcellator will have their first day in federal court as a consolidated litigation in front of the Honorable Kathryn H. Vratil in the United States District Court for the District of Kansas.

morcellator_day_in_court.jpgOn October 15, 2015, the United States Judicial Panel on Multidistrict Litigation (JPML) entered an order transferring all power morcellator cases against defendant Ethicon to the District of Kansas for coordinated and consolidated pretrial proceedings. The litigation was renamed IN RE: Ethicon, Inc. Power Morcellator Products Liability Litigation, MDL Case No. 2652

After being appointed by the JPML, Judge Vratil entered her first order in the case on October 16, 2015. This order, titled Practice and Procedure Order #1, detailed certain rules and procedures that will govern the case as well as set an initial scheduling conference for plaintiffs’ and defendants’ attorneys for today, November 18, 2015.

All matters relating to pretrial and discovery proceedings will be addressed in today’s conference. Among other items, the parties will specifically address the appointment of leadership among the attorneys and the scheduling of various deadlines.

We are proud to represent women who were harmed by power morcellators, and we will provide an update as to what occurred.

 

Topics: Ethicon Morcellator, Morcellator Cancer Link

Power Morcellators – the Risk of Spreading Uterine Cancer and Fibroids Exposed

Posted by Anapol Weiss on Nov 13, 2015 4:07:40 PM

One in 352 Women

Women undergoing a routine laparoscopic hysterectomy or myomectomy (fibroid removal surgery) with a power morcellator are at risk of spreading cancerous and infected uterine tissue throughout their bodies, reported the U.S. Food and Drug Administration (FDA) in April 2014. According to the analysis of scientific literature, the prevalence of unsuspected uterine sarcoma – a type of cancer – in women undergoing these routine surgeries was one in 352.

morcellator_1_in_352_women.jpgMeaning: One in 352 women were unknowingly at risk for dispersing cancer throughout their bodies.

Johnson & Johnson’s Ethicon unit, the largest manufacturer of power morcellators, pulled its power morcellators from the market after the FDA’s report. In November 2014, the FDA issued a black box warning – the highest level of caution – to help reduce the risk of spreading unsuspected uterine cancer in women being treated for uterine fibroids. The FDA recommended that manufacturers include warning that states: “The use of laparoscopic power morcellators during fibroid surgery may spread cancer and decrease the long-term survival of patients.”

A power morcellator is a surgical tool used predominantly in minimally invasive surgeries to chop up and remove tissue and organs. It has been used with increasing frequency for gynecological surgeries in recent years; approximately 650,000 women undergo hysterectomies and myomectomies a year in the United States for uterine fibroids. Serious health problems arise when the morcellator also slices cancerous tissue or benign fibroids and disperses the tissue in a women’s abdomen, pelvis, and elsewhere. The tissue can attach to other tissue and organs and begin to grow.

Contact the medical device team at Anapol Weiss today if you underwent a minimally invasive hysterectomy or myomectomy and suspect recurring health conditions may be related to the use of this tool. The spread of cancer can be accelerated, and fibroids can grow throughout your body (parasitic fibroids).

Our attorneys are highly qualified to represent women and their families facing the devastation of leiomyosarcoma after morcellation.

Topics: Ethicon Morcellator

Ethicon Morcellator Lawsuits Consolidated in Kansas

Posted by Anapol Weiss on Oct 16, 2015 9:52:00 AM

The Judicial Panel on Multidistrict Litigation consolidated lawsuits against Johnson & Johnson’s Ethicon unit involving its power morcellators in its order dated October 15, 2015. Judicial Panel on Multidistrict Litigation (referred to as the “JPML” or “MDL Panel”) consists of seven sitting federal judges who were appointed to serve on the MDL Panel by the Chief Judge of the United States Supreme Court. The MDL Panel found that the lawsuits against Ethicon involving its power morcellators involve common issues and centralized them to the United States District Court of the District of Kansas on October 15.

A power morcellator is an electrically powered medical device used in laparoscopic gynecological surgeries. The device has a grasper and a rapidly spinning blade to break tissue into fragments for removal through an incision. Power morcellators are used in hysterectomies (removal of uterus) and myomectomies (removal of fibroids).

The lawsuits against Ethicon allege the company failed to warn patients about the true dangers of the power morcellator and that the defective design of its morcellator can spread undetected cancerous tissue in a woman’s body during a gynecological surgery.

As many as 650,000 women undergo surgery for symptomatic uterine fibroids in the U.S. each year, the MDL Panel noted.

On April 17, 2014, the U.S. Food and Drug Administration (FDA) issued a Safety Communication discouraging the use of power morcellators during hysterectomies and myomectomies for uterine fibroids because of a risk the procedure will spread unsuspected cancer. Following the warning, Ethicon first suspended sales of the device and then took the drastic step of pulling the product from the market in July 2014. In November 2014, the FDA issued a “black box warning” for power morcellators, which is the most serious warning that can be placed in a label. The first power morcellator lawsuit against Ethicon was filed in May 2014 in New York federal court.

Before the FDA’s serious warning and the company’s withdrawal of the product, laparoscopic procedures using power morcellation had been increasingly preferred over traditional techniques. Approximately one in 350 women undergoing a hysterectomy or fibroid removal have an unsuspected uterine sarcoma, according to the FDA.

The case is titled In Re: Power Morcellator Products Liability Litigation, MDL number 2652.

Topics: Ethicon Morcellator, Morcellator Cancer Link

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