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Morcellation Media Monitoring 02/11/2016
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Fee Fight Spurs Departures from Ethicon MDL Team
Feb 10, 2016 | National Law Journal
By Amanda Bronstad
A battle over legal fees and costs has prompted three lawyers to withdraw from the plaintiffs leadership team in the multidistrict litigation over power morcellators made by Johnson & Johnson’s Ethicon Inc. -
Officials Ask How FDA Was So Wrong on Risks of Power Morcellation
Feb 8, 2016 | LawyersAndSettlements.com
By Heidi Turner
With 34 power morcellator lawsuits filed against Ethicon consolidated for pretrial proceedings and the US government investigating allegations against the makers of power morcellators, 2016 could be a bad year for power morcellation device makers. The devices, used in laparoscopic hysterectomy or myomectomy, have come under scrutiny due to concerns that they could inadvertently spread cancerous tissue throughout a patient’s abdomen, increasing the risk of death. -
‘In Extremis’ Plaintiffs Given Priority in Power Morcellation Litigation
Feb 9, 2016 | Top Class Actions
By Ashley Vanover
In recent power morcellator news, the multidistrict litigation recently established for dozens of Ethicon power morcellation lawsuits is moving forward. -
Filing Of Morcellator Cancer Lawsuits Continue Against Ethicon Inc. Over Spread Of Uterine Cancer
Feb 10, 2016 | Southern Med Law
Another morcellator cancer lawsuithas been filed against Johnson & Johnson’s Ethicon unit on behalf of a Wisconsin woman who underwent a laparoscopic hysterectomy and was diagnosed with leimoyosarcoma, a life-threatening and aggressive form of uterine cancer. The complaint has claims similar to other power morcellator cancer lawsuits filed against morcellator manufacturers, Karl Storz, Richard Wolf, Blue Endo, and Lina Medical, which are accused of failing to warn that their medical devices have the potential to spread cancer.
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Fee Fight Spurs Departures from Ethicon MDL Team
Feb 10, 2016 | National Law Journal
By Amanda Bronstad
A battle over legal fees and costs has prompted three lawyers to withdraw from the plaintiffs leadership team in the multidistrict litigation over power morcellators made by Johnson & Johnson’s Ethicon Inc.
After a hearing on Wednesday before a federal judge in Kansas, two plaintiffs lawyers—Rebecca King, an attorney at Houston’s Tracey & Fox, and François Blaudeau, of counsel at Heninger Garrison Davis in Birmingham—resigned from the 20-person plaintiffs steering committee, according to co-lead counsel Paul Pennock.
A third committee member, Avram Blair, of Avram Blair & Associates in Houston, also resigned after a similar fee dispute, said Pennock, managing attorney at New York’s Weitz & Luxenberg.
The MDL’s committee was noted for being the first to involve a majority of women members.
Their departures leave 10 women attorneys on a 17-person committee.
Those lawyers along with two other plaintiffs attorneys, one of whom also served on the committee, claimed that they should not have to pay into a proposed common benefit fund for cases they had just settled.
A common benefit fund charges a “hold back” amount on settlements and judgments of individual cases in order to pay for the attorney fees and costs that lead counsel incur in an MDL.
Pennock, who moved to establish the fund on Dec. 31, had insisted that lawyers with recent settlements retroactively pay 2 percent of their fees and costs to the fund given that they were precipitated by the formation of an MDL and plaintiffs steering committee.
After the hearing, Pennock told The NLJ that he agreed to remove the 2 percent requirement and make other changes to the fund, though he declined to say what those would be. He also confirmed the committee’s resignations.
“We resolved our differences and they are out, and we’re moving forward,” Pennock said. He said he wasn’t sure whether the committee would replace them.
King, Blaudeau and Blair did not respond to requests for comment.
More than 30 lawsuits have been filed alleging that Ethicon’s power morcellators—medical devices used in laparoscopic uterine surgeries—have caused women to develop an aggressive form of cancer. Ethicon pulled those devices from shelves in 2014 following a U.S. Food and Drug Administration safety advisory. The cases against Ethicon were coordinated into an MDL on Oct. 15.
King and Blaudeau filed motions on Dec. 30 and Jan. 4 to resign from the committee after settling cases against Ethicon. Both lawyers joined Blair and Molly Hoffman of Fay Kaplan Law in Washington, another plaintiffs lawyer, in opposing the fund’s approval.
Pennock’s proposal also included holdbacks for future settlements of up to 12 percent fees and costs – an amount that another plaintiffs lawyer, Andrew Sciolla of Pogust Braslow & Millrood in Conshohocken, Pennsylvania, called “excessive” in a Jan. 21 motion.
Pennock said he would be talking with Sciolla in the coming weeks about those concerns. Sciolla did not respond to a request for comment.
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Officials Ask How FDA Was So Wrong on Risks of Power Morcellation
Feb 8, 2016 | LawyersAndSettlements.com
By Heidi Turner
With 34 power morcellator lawsuits filed against Ethicon consolidated for pretrial proceedings and the US government investigating allegations against the makers of power morcellators, 2016 could be a bad year for power morcellation device makers. The devices, used in laparoscopic hysterectomy or myomectomy, have come under scrutiny due to concerns that they could inadvertently spread cancerous tissue throughout a patient’s abdomen, increasing the risk of death.
Back in August 2015, 12 members of Congress sent a letter (8/7/15) to the US Government Accountability Office (GAO), requesting the GAO examine how power morcellators remained on the market despite evidence of a risk of undetected cancer being spread.With 34 power morcellator lawsuits filed against Ethicon consolidated for pretrial proceedings and the US government investigating allegations against the makers of power morcellators, 2016 could be a bad year for power morcellation device makers. The devices, used in laparoscopic hysterectomy or myomectomy, have come under scrutiny due to concerns that they could inadvertently spread cancerous tissue throughout a patient’s abdomen, increasing the risk of death.
Back in August 2015, 12 members of Congress sent a letter (8/7/15) to the US Government Accountability Office (GAO), requesting the GAO examine how power morcellators remained on the market despite evidence of a risk of undetected cancer being spread.The risk of hidden uterine sarcoma is an important one, because women undergoing power morcellation do so to break up uterine fibroids - benign masses in the uterus. In some cases, however, the uterine fibroids are actually uterine sarcomas, and blasting them with power morcellators can cause the sarcomas to break apart and spread through the patient’s abdomen, decreasing the chances of survival. A risk of one in 10,000 is vastly different from a risk of one in 500, especially when doctors cannot tell prior to the procedure if the fibroids are sarcomas.
In 2014, the FDA issued a black box warning about the use of power morcellators, but the members of Congress asked the GAO to investigate whether the agency was able to adequately identify the risk of adverse events before approving the devices, whether reporting regulations were adequately followed, whether clinicians were given training on use of the morcellators, and what steps the FDA is taking to ensure power morcellators are safe to remain on the market.
Meanwhile, patients have filed lawsuits of their own, alleging they were harmed by the use of the power morcellators. Thirty-four lawsuits have been consolidated for pretrial proceedings in MDL 2652, In Re: Ethicon, Inc, Power Morcellator Products Liability Litigation, before Judge Kathryn Vratil. -
‘In Extremis’ Plaintiffs Given Priority in Power Morcellation Litigation
Feb 9, 2016 | Top Class Actions
By Ashley Vanover
In recent power morcellator news, the multidistrict litigation recently established for dozens of Ethicon power morcellation lawsuits is moving forward.
Court documents indicate that discovery is now underway in cases filed on behalf of plaintiffs considered to be “in-extremis,” which includes women who are in dire health condition or near death.
At least 34 power morcellation lawsuits are pending in the U.S. District Court in the District of Kansas, where all such federal claims involving devices manufactured by Ethicon, Inc. have been consolidated for the purposes of coordinated pretrial proceedings. All of the cases were filed on behalf of women who allegedly experienced the spread and upstaging of dangerous uterine cancers due to one of the company’s morcellator devices.
According to an Order issued by the Court on January 7th, discovery in cases involving living plaintiffs who are “in extremis” was to begin on or after January 11th.
“A person will be considered ‘in extremis’ when she is expected to reach, within the next twelve months, a state or condition of difficulty in testifying competently in a deposition or being no longer capable of testifying competently in a deposition and is unlikely to recover sufficiently to provide competent testimony at a later date,” the Order states.
What Is a Power Morcellator?
A morcellator is a medical device (tool) used during uterine procedures such as hysterectomies or myomectomies. During morcellation surgery, the device slices fibroids (uterine masses) or the uterus into small pieces or fragments in order for the tissue to be removed through small incisions in the abdomen in minimally invasive surgery.
Uterine fibroids are non-cancerous growths that develop from the muscular tissue of the uterus and are developed by most women during their lives, although most cause no symptoms. However, for those women that are experiencing symptoms such as heavy or prolonged menstrual bleeding, pelvic pressure or pain, and frequent urination, they may need to undergo treatment for their condition.
Treatment for uterine fibroids could be traditional surgical hysterectomy or myomectomy. Many women choose the laparoscopic morcellation surgery (hysterectomy or myomectomy) as an alternative because of the shorter post-operative recovery time and reduced risk of infection.
Morcellation Surgery Risks
On April 2014, the U.S. Food and Drug Administration (FDA) announced to the public and physicians that they discourage the use of laparoscopic power morcellation when it involves the removal of the uterus or uterine fibroids. They stated, “based on an analysis of currently available data, it poses a risk of spreading unsuspected cancerous tissue, notably uterine sarcomas, beyond the uterus.”
This reduces the patient’s likelihood of long-term survival. It is further explained that there isn’t a reliable method for predicting whether a woman with fibroids may have a uterine sarcoma.
Approximately 1 in 350 women have unsuspected uterine cancer known as sarcoma, according to the FDA. The FDA has also estimated the tool has been used in 50,000 hysterectomies a year.
In May 2015, the Wall Street Journal reported morcellator news regarding an investigation the Federal Bureau of Investigation (FBI) launched into whether Johnson & Johnson’s Ethicon division was aware of and failed to disclose to government safety regulators and the physicians the risk of cancer being spread by morcellators.
Power Morcellator Litigation
Ethicon, which actually withdrew its morcellator products from the market in July 2014, is not the only device company facing litigation over the devices. Morcellator cancer lawsuits are also pending against other manufacturers including Karl Storz, Richard Wolf Medical Instruments, and Gyrus ACMI. However, only those involving Ethicon have been centralized in a single federal court.
If Ethicon fails to settle the pending multidistrict litigation, the Court will proceed in scheduling bellwether trials. According to morcellator news sources, the next status conference is set for February 10 where issues including case-specific discovery and disclosure orders will be addressed.
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Filing Of Morcellator Cancer Lawsuits Continue Against Ethicon Inc. Over Spread Of Uterine Cancer
Feb 10, 2016 | Southern Med Law
Another morcellator cancer lawsuithas been filed against Johnson & Johnson’s Ethicon unit on behalf of a Wisconsin woman who underwent a laparoscopic hysterectomy and was diagnosed with leimoyosarcoma, a life-threatening and aggressive form of uterine cancer. The complaint has claims similar to other power morcellator cancer lawsuits filed against morcellator manufacturers, Karl Storz, Richard Wolf, Blue Endo, and Lina Medical, which are accused of failing to warn that their medical devices have the potential to spread cancer.
The Wisconsin woman uterine cancer lawsuit claims Ethicon’s Gynecare laparoscopic power morcellator caused the spread and upstaging of hidden cancerous tissue. After her cancer diagnosis was confirmed, the woman underwent multiple cycles of chemotherapy treatments for over two years, the lawsuit said. In April 2011, the woman had a CT scan that showed three large masses within her abdomen and pelvis. As a result, the woman had to undergo additional chemotherapy treatment. The morcellator cancer complaint purports that the woman still suffers from the disease because Ethicon’s morcellator disseminated her leiomyosarcoma. (Case No. 2:16-cv-00101, U.S. District Court, Eastern District of Wisconsin)
“The details in morcellator cancer complaints continue to reveal the long-lasting and devastating effects that laparoscopic power morcellators have on women who undergo surgery to remove uterine fibroids,” says Dr. François Blaudeau, founder of Southern Med Law, which is currently representing women in multiple power morcellation lawsuits against Ethicon Inc.
Additionally, Southern Med Law was the first Firm in the country to file a federal power morcellator lawsuit. The firm represents Scott Burkhart, a Pennsylvania man whose wife, Donna Burkhart, died of disseminated leiomyosarcoma in February 2013, which she developed after undergoing a power morcellator hysterectomy in March 2012. The lawsuit, which was filed against morcellator manufacturers, LiNA Medical APS, Kebomed AB & LiNA Medical US, was settled in July for an undisclosed amount. Dr. Blaudeau also serves on the Plaintiff’s Steering Committee for morcellator litigation. (Case No. 5:14-cv-1557, U.S. District Court, Eastern District of Pennsylvania)
More than 650,000 women undergo a myomectomy or hysterectomy each year in the United States, according to morcellator cancer complaints. In the last few decades, laparoscopic procedures with electric power morcellator devices have increasingly been replacing traditional open abdominal surgical hysterectomies (removal of the uterus) and myomectomies (removal of uterine fibroids). Power morcellators have spinning blades that shred, grind, and core uterine tissue into small pieces or fragments so the tissue can be removed through small incisions in the abdomen. The fragments can be left in the abdomino-pelvic cavity, or attach to surrounding organs, and tissue cells can travel to remote areas of the body. Complications can occur if the fragments contain cancer cells and seed in other tissue or organs.
The U.S. Food and Drug Administration (FDA) estimates that 1 in 350 women who undergo a hysterectomy or myomectomy is found to have an unsuspected uterine sarcoma. In November, 2014, the FDA issued a warning that all but banned the use of power morcellators in the vast majority of women who undergo the laparoscopic surgical procedures. The FDA’s process for approving power morcellators, and the medical device itself, are currently under investigation by the U.S. Government Accountability Office. Last year, the power morcellator controversy triggered a probe by the FBI over whether Johnson & Johnson knew about the cancer risks associated with its morcellators.
[fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm424435.htm, FDA, November 24, 2014]
[pittsburgh.cbslocal.com/2015/06/15/fbi-investigating-johnson-johnson-over-morcellators/, June 15, 2015]About Southern Med Law and Morcellator Cancer Lawsuits: Southern Med Law is led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist that is determined to stop the morcellator companies from injuring more women. The legal staff at Southern Med Law is an experienced group of attorneys who posses a deep understanding of the complex medical and legal questions at issue in all manner of product liability and personal injury claims. They’re not afraid to take on the nation’s largest corporations in their pursuit of justice, and are committed to ensuring that all victims have access to the type of aggressive legal advocacy that assures success.
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Morcellation
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