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Morcellation Media Monitoring 7/9/15
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Congressman Burgess (R-TX): Power Morcellators not recalled by FDA, “SO BE IT”!
Jul 9, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
On July 8, 2015 the House of Representatives Rules Committee killed the Fitzpatrick Amendments to a major healthcare bill, known as “21st Century Cures”, scheduled for a general assembly vote on July 9, 2015. -
LiNA Medical Settles Power Morcellator Death Lawsuit
Jul 8, 2015 | Drug Watch
By Michelle Llamas
One of the first laparoscopic power morcellator lawsuits filed in federal court settled for an undisclosed amount last week before it was scheduled to reach trial. Scott Burkhart filed the lawsuit against LiNA Medical in March 2014 after his wife, Donna, died of a uterine cancer called myelosarcoma after she underwent a hysterectomy performed with a power morcellator. The company settled the case before it was set to go to trial later this year, ahead of about 20 other morcellator lawsuits, but did not comment on the settlement. -
Power Morcellator Hysterectomy Lawsuit Update
Jul 7, 2015 | The Legal Examiner
By Shezad Malik MD JD
Laparoscopic morcellator lawsuits are increasing slowly but surely, filed by injured women who had undiagnosed uterine cancer spread during a minimally invasive hysterectomy. Recently, according to the Wall Street Journal, a settlement has been reached in one of the first federal lawsuits. -
Power Morcellator Lawsuit Settles Prior to Trial
Jul 8, 2015 | The Legal Examiner
By Steven Davis
The first laparoscopic power morcellator lawsuit expected to go to trial has been settled for an undisclosed amount, according to a report in the Wall Street Journal. The case was filed against morcellator maker Lina Medical ApS by a man whose 53-year-old wife died in 2013, eleven months after a morcellator-aided hysterectomy. After the surgery, the woman learned that she had a hidden cancer known as leiomyosarcoma. The lawsuit, as with other morcellation court actions, alleged that the company failed to warn consumers, including the plaintiff’s wife, about the risk of spreading cancer.
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Congressman Burgess (R-TX): Power Morcellators not recalled by FDA, “SO BE IT”!
Jul 9, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
On July 8, 2015 the House of Representatives Rules Committee killed the Fitzpatrick Amendments to a major healthcare bill, known as “21st Century Cures”, scheduled for a general assembly vote on July 9, 2015.
You can watch the killing of Fitzpatrick’s amendments on this video, at 3:58:04.
The Fitzpatrick amendments had resulted from the congressman’s full recognition of the “power morcellator” disaster in women’s health as a bellwether failure of the FDA’s medical device section to keep the American public safe. The faces of harm are clearly in our federal government’s view.
Congressman Burgess (R-TX), himself a gynecological surgeon, effectively dismantled and killed the Fitzpatrick amendments in the Rules committee.
Incredibly, Burgess admitted that his colleagues in gynecology had failed at their professional duty to protect their patients from the spread of cancer. You can watch Burgess’ acknowledgment that this was a failure on the part of gynecologists at this video, at 4:05:20.
But, in an astonishing diatribe, Burgess argued that congress had no role in evaluating the root cause of this deadly failure and that professionals should be left to deal with this egregious problem.
Most disturbing, however, was Burgess’ arrogance in stating that if FDA has failed to remove or regulate “power morcellators” from the market “SO BE IT!”.
You can watch this outrageous dereliction of congressional duty by Representative Burgess on this video, at 4:12:44.
The amendments proposed by Congressman Mike Fitzpatrick (R-PA), were aimed at drawing attention and eliminating a severe public health hazard and a deadly failure at FDA. You can read about this public health hazard created by the Food and Drug Administration here.
Buried in the “21st Century Cures” bill is a series of provisions for the medical device industry, which will very definitely leave that industry even less safe and more dangerously regulated than it currently is.
Congressman Burgess’ position is particularly incorrect and disturbing because he admits that the gynecological surgeons have failed and harmed many women, he admits that FDA has not done its job to protect patient – and his response is “SO BE IT!”.
Congressman Burgess’ response as a republican member of congress and a doctor himself represents a severe dereliction of congressional duty to the American people.
Burgess’ over-confident statement “SO BE IT” from the House Rules Committee will cost more American lives, and more lost health insurance dollars – because on July 8, 2015 he killed a series of amendments that could have opened up congress to protecting American patients from a severe “home-grown” threat.
The sad shame is that Burgess’ is consider a conservative member of the “Tea party”, proclaiming to be a champion for the people's voice and for a more efficient and just federal government – that seems to mean that he is willing to keep a blind eye to professionals and the FDA causing the preventable sacrifice of American lives to the altar of corporate interests.
And that is fully shameful!
Our many thanks continue to go to Congressman Mike Fitzpatrick (R-PA) for his courage and clarity in standing as a lone conservative voice of reason in a congress seemingly gone blind in the face of money and industry lobby power.
We, and many of his constituents and patients harmed across the United States, now ask that he vote “NO” on the “21st Century Cures”, on principle and on conscience.Hooman Noorchashm and Amy Reed, husband-and-wife physicians, have campaigned to ban electric morcellators since December 2013, soon after Reed’s unsuspected uterine cancer was spread by the device during a routine hysterectomy.
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LiNA Medical Settles Power Morcellator Death Lawsuit
Jul 8, 2015 | Drug Watch
By Michelle Llamas
One of the first laparoscopic power morcellator lawsuits filed in federal court settled for an undisclosed amount last week before it was scheduled to reach trial.
Scott Burkhart filed the lawsuit against LiNA Medical in March 2014 after his wife, Donna, died of a uterine cancer called myelosarcoma after she underwent a hysterectomy performed with a power morcellator. The company settled the case before it was set to go to trial later this year, ahead of about 20 other morcellator lawsuits, but did not comment on the settlement.
As many as 1 in 350 women is suspected of having undiagnosed uterine sarcoma that may be spread during morcellation, according to the U.S. Food and Drug Administration.
In November 2014 the agency announced that it was “warning against the use of laparoscopic power morcellators in the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.” It also required manufacturers to put a black box warning for the risk of spreading undiagnosed uterine cancer.
According to Burkhart’s complaint, Donna had no evidence of “dessimenated and/or metastatic cancer/disease” prior to her surgery in March 2012. About a week after the procedure, doctors informed her she had cancer.
Donna was 53 when she died just 11 months after her surgery.
Also named in the lawsuit filed in the U.S. District Court for the Eastern District of Pennsylvania was Johnson & Johnson’s Ethicon unit – the top manufacturer of morcellators prior to pulling its devices off the market – and Blue Endo. The complaint accused defendants of failing to warn about the risk of spreading undiagnosed cancer.
Burkhart told the Wall Street Journal that he would have been happy for the case to go to trial because his main goal in filing a lawsuit was to warn the public.
LiNA did not comment about the settlement.Widower Files Suit Against Hospital and Manufacturer
Another husband who lost his wife to uterine cancer after morcellation, Rick Kaitz, filed a wrongful death lawsuit against Brigham and Women’s Hospital on June 18 in Suffolk County Superior Court in Boston. Also named in the suit are the manufacturer, Karl Storz, and the doctor who performed the surgery.
Karl Storz previously threatened Dr. Hooman Noorchaschm after he began lobbying against the devices. Noorchaschm’s wife, Dr. Amy Reid, was also diagnosed with cancer after morcellation, and the couple now openly advocate against the devices.
Kaitz’s wife, Erica, died of uterine sarcoma at age 52 in December 2013 – about a year and a half after morcellation surgery in June 2012. The complaint says that the hospital knew that morcellators could spread undiagnosed cancer but failed to inform Erica.
This claim is the latest in a string of lawsuits barraging manufacturers of the controversial device.
Publicity surrounded the controversial surgical tools after a number of victims came forward and brought the problem to the media’s attention. The U.S. Food and Drug Administration (FDA) first released a warning in April 2014 discouraging the use of morcellators for hysterectomies and fibroid removal.
These surgical tools shred tissue and remove it through a small opening. However, cancerous cells may also be shredded in the process and spread throughout the uterine and pelvic cavities, worsening the disease and prognosis.Lawyers Expect Hundreds More Lawsuits
Attorney Paul Pennock of Weitz & Luxenberg who represents a number of women affected by the devices filed a request to consolidate lawsuits under U.S. District Judge Kathryn Vratil in Kansas.
According to the court filing before the U.S. Panel on Multidistrict Litigation, attorneys across the country are investigating at least 300 more claims against morcellators.
In the meantime, a growing number of hospitals and insurers have either banned or severely restricted use of the device. In May 2015, the FBI began investigating Johnson & Johnson and what the company knew about morcellator risk.
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Power Morcellator Hysterectomy Lawsuit Update
Jul 7, 2015 | The Legal Examiner
By Shezad Malik MD JD
Laparoscopic morcellator lawsuits are increasing slowly but surely, filed by injured women who had undiagnosed uterine cancer spread during a minimally invasive hysterectomy. Recently, according to the Wall Street Journal, a settlement has been reached in one of the first federal lawsuits.
Lina Medical reportedly has agreed to settle Scott Burkhart’s wrongful death claim of his wife, who had undiagnosed leiomyoscarcoma spread throughout her body by a Lina power morcellator.
Burkhart’s case was the first of several hysterectomy morcellation lawsuits, which allege that several different medical device manufacturers sold a defective and unreasonably dangerous product, and failed to warn about the serious risk of cancer women may face if the morcellator is used during a minimally invasive surgery.
There is no sure fire way for doctors to determine which women may have unsuspected sarcoma contained within the uterus.
What is Power Morcellator?
Power morcellators are medical devices used during minimally invasive laparoscopic hysterectomy and fibroid removal procedures. The device grinds up the uterus and uterine fibroids, allowing the easy removal of the tissues through a small incision in the abdomen.
Morcellator use has been curtailed over the past year, because of the risk that the devices may cause the spread of aggressive uterine cancers that were undiagnosed in the uterus.
2014 FDA Strong Cancer Risk Warning
In April 2014, the FDA issued a strong warning about the risk of power morcellation cancer, noting that one out of every 350 women undergoing surgery for uterine fibroids may actually have undiagnosed sarcoma.
An FDA advisory panel determined that there is no way to make power morcellators safer. The panel was unsure whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.
Late last year, the FDA announced that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer.
Many hospitals have announced that they will no longer allow morcellation hysterectomy to be performed and some health care insurances will no longer cover the procedure.
How does Power Morcellator Increase Cancer Risk?
The grinding action of a power morcellator may cause widespread dissemination or spread of cancer cells throughout the abdomen and pelvis. This metastatic cancer spread significantly reduces long-term survival.
Morcellator Lawsuits
To date, about 20 power morcellator cancer cases have been filed in various federal and state courts through out the country.
All of the complaints shared similar allegations that morcellator use caused widespread leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers diagnosed following a laparoscopic hysterectomy or fibroid removal surgery.
According to plaintiffs, the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have not occurred if alternative treatment options had been used, including traditional surgical hysterectomy performed vaginally or abdominally.
Federal Multidistrict Litigation Pending
In June, the U.S. Judicial Panel on Multidistrict Litigation (JPML) received notice seeking to transfer complaints filed in U.S. District Courts to one judge for coordinated handling during pretrial proceedings.
This is known as an MDL, or multidistrict litigation, and the centralizations of the lawsuits are designed to speed up the trials.
The plaintiffs are requesting that Lina Medical and other manufacturers of power morcellators be held with U.S. District Judge Kathryn H. Vratil in the District of Kansas.
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Power Morcellator Lawsuit Settles Prior to Trial
Jul 8, 2015 | The Legal Examiner
By Steven Davis
The first laparoscopic power morcellator lawsuit expected to go to trial has been settled for an undisclosed amount, according to a report in the Wall Street Journal.
The case was filed against morcellator maker Lina Medical ApS by a man whose 53-year-old wife died in 2013, eleven months after a morcellator-aided hysterectomy. After the surgery, the woman learned that she had a hidden cancer known as leiomyosarcoma. The lawsuit, as with other morcellation court actions, alleged that the company failed to warn consumers, including the plaintiff’s wife, about the risk of spreading cancer.
Leiomyosarcoma and Morcellation: A Deadly Combination
Leiomyosarcoma is a rare and aggressive soft tissue cancer that forms in the smooth muscle cells of the body, most commonly in the uterus. The exact cause of Leiomyosarcoma is unknown, and there are no known recommendations regarding how to prevent its development. Because Leimyosarcoma cannot be reliably detected before surgery, and because the blades of the power morcellator slice up tissue for removal through small incisions, morcellation has been found to spread and worsen this type of cancer.
FDA Warns Against Morcellator Use
The U.S. Food and Drug Administration (FDA) warned in 2014 about the risks of morcellation, and the agency’s intervention, along with adverse publicity surrounding power morcellators, have caused a steep drop in the use of the device.
In November 2014, the FDA issued a black box warning, its strongest caution, on power morcellators and recommended that the tool not be used in the majority of women contemplating minimally-invasive fibroid surgery or hysterectomy. As a result, many hospitals have limited use of the device, insurers are refusing to cover procedures utilizing it, and former top morcellator manufacturer Johnson & Johnson voluntarily stopped making and marketing the tool in July 2014.
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