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Morcellation Media Monitoring 4/16/2015
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Health Insurers Call for Stronger Rules on Medical Devices
Apr 15, 2015 | The Wall Street Journal
By Jon Kamp
The U.S. health-insurance industry is calling for tougher rules for approving and tracking medical devices, citing regulatory gaps exposed last year when a tool used for decades in hysterectomies was found to spread cancer. America’s Health Insurance Plans, a trade group, said in a letter to Sen. Bob Casey on Tuesday that the dangers of the laparoscopic power morcellator reveal weaknesses in how devices are cleared for use and monitored once they are on the market. The letter was reviewed by The Wall Street Journal. -
The death of medical ethics in America: “Ye cannot serve God and mammon”
Apr 13, 2015 | Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy Reed, M.D., Ph.D.
On April 10, 2015 a group of American physicians at Northwestern University’s Feinberg School of Medicine published a manuscript. This manuscript exemplifies the depth of ethical corruption possible in our contemporary medical establishment. Let us be specific. In this gynecological specialty paper, the authors are directly claiming that the continued upstaging of unsuspecting women’s cancers by minimally invasive gynecological surgeons, using a practice known as morcellation, is financially justifiable. -
Morcellator Lawsuit News: Jury Trial Scheduled
Apr 15, 2015 | PR Web
By Onder Law Firm
Attorneys handling morcellator lawsuit claims alleging the spread of cancer from the use of a power morcellator device provide an update on the progress of one of the first morcellator lawsuits* filed in U.S. courts. Attorneys handling morcellator lawsuits for the Onder Law Firm report discovery is underway, and is set to be completed this summer by July 30, 2015. A settlement conference will be held May 26, 2015 and the jury trial has been scheduled for November 23, 2015, according to the Onder Law Firm. -
Tissue Morcellator Lawsuit Filed Over Endometrial Stromal Sarcoma Recurrence After Hysterectomy
Apr 13, 2015 | About Lawsuits
By Irvin Jackson
A former Georgia mayor and her husband have filed a lawsuit against Johnson & Johnson and its Ethicon subsidiary, alleging that a Gynecare tissue morcellator caused the recurrence of metastatic endometrial stromal sarcoma, spreading hidden cancer cells contained in the uterus throughout the plaintiff’s pelvis and abdomen. -
Study Says Morcellation is More Cost-Effective Despite Cancer Risk
Apr 13, 2015 | Medical Device and Diagnostics Industry
By Marie Thibault
A study published recently in The Journal of Minimally Invasive Gynecology argues that a controversial surgical procedure that is no longer used in several hospitals is more cost-effective than alternatives. The research highlights the sometimes opposing factors hospitals consider when treating patients: medical risks and financial costs.
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Health Insurers Call for Stronger Rules on Medical Devices
Apr 15, 2015 | The Wall Street Journal
By Jon Kamp
The U.S. health-insurance industry is calling for tougher rules for approving and tracking medical devices, citing regulatory gaps exposed last year when a tool used for decades in hysterectomies was found to spread cancer.
America’s Health Insurance Plans, a trade group, said in a letter to Sen. Bob Casey on Tuesday that the dangers of the laparoscopic power morcellator reveal weaknesses in how devices are cleared for use and monitored once they are on the market. The letter was reviewed by The Wall Street Journal.
The Pennsylvania Democrat wrote the group March 24 in part to gauge the insurance industry’s response to a Food and Drug Administration warning about morcellators and whether health plans track adverse events related to the devices.
The FDA warned in November that the tool shouldn’t be used in the vast majority of women after a series of articles in the Journal highlighted the device’s risks. Morcellators had been used to remove benign uterine growths called fibroids, often in hysterectomies, since the 1990s.
Women undergoing surgery for fibroids have a higher risk of uterine sarcoma than had been previously understood, the FDA determined. The morcellator, which slices and removes tissue through small incisions used in minimally invasive surgery, could spread and worsen the malignancy, the agency said.
Insurers covering about 93 million Americans—including three of the four largest plans—have curtailed power morcellators or are considering limits.
Chief medical officers are reporting “a major reduction in the use of laparoscopic power morcellators in today’s market,” Karen Ignagni, the insurer group’s president and chief executive, said in the letter to Mr. Casey.
Morcellators are still available, although Johnson & Johnson, formerly the biggest maker of the devices, left the market last year.
Nearly all U.S. medical devices, including morcellators, reach the market through an FDA system known as 510(k), which clears tools deemed substantially similar to ones already on the market. That process typically doesn’t require clinical studies on people to prove safety and effectiveness.
A small subset of devices that are deemed high-risk receive more stringent FDA reviews that can include clinical trials.
The FDA cleared the first laparoscopic power morcellator for sale in 1991, and at least 10 more over the next two decades, through the 510(k) process. Though records show the agency understood in the early days that morcellators could spread dangerous cells, the FDA said the magnitude of the risk wasn’t realized until later.
America’s Health Insurance Plans called for strengthening the 510(k) system and efforts to track devices.
The 510(k) system has drawn criticism over the years, including a 2011 report from a panel at the influential Institute of Medicine, which called for scrapping the process. But the medical-device industry and FDA have defended it.
Steve Ubl, president and chief executive of the Advanced Medical Technology Association, a device trade group, called the 510(k) system “overwhelmingly safe.”
“FDA’s 510(k) review process for low- and moderate-risk medical technologies has a proven safety record and allows the agency to conduct a thorough review of the safety and effectiveness of these products in a timely fashion that facilitates patient access to needed medical advancements,” Mr. Ubl said in a statement responding to the letter from America’s Health Insurance Plans.
The FDA, which has said the device-approval process balances innovation and safety, declined to comment on the letter.
The agency requires hospitals and device makers to report serious problems with devices, which are logged in a huge database called Maude. But the system received no reports on the risk of a morcellator spreading cancer before December 2013, when the Journal first reported on the issue.
Tools like morcellators aren’t routinely included in medical claims data, making it difficult for insurers to know when they are used. Efforts are under way to create unique device identifiers to remedy that, and America’s Health Insurance Plans said speeding up those efforts would help track device issues.
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The death of medical ethics in America: “Ye cannot serve God and mammon”
Apr 13, 2015 | Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy Reed, M.D., Ph.D.
On April 10, 2015 a group of American physicians at Northwestern University’s Feinberg School of Medicine published a manuscript.
This manuscript exemplifies the depth of ethical corruption possible in our contemporary medical establishment.
Let us be specific.
In this gynecological specialty paper, the authors are directly claiming that the continued upstaging of unsuspecting women’s cancers by minimally invasive gynecological surgeons, using a practice known as morcellation, is financially justifiable.
Why?
Because, they state, “eliminating morcellation hysterectomy as a treatment for fibroids is not cost-effective under a wide variety of probability and cost assumptions. Performing laparotomy for all patients who might otherwise be candidates for morcellation hysterectomy is a costly policy from a societal perspective.”
In other words, the fact that morcellation AVOIDABLY spreads and upstages deadly uterine cancers in a minority, one in 200-500, unsuspecting American women is justifiable because it financially benefits society.
Now, this argument is the unspoken one that underlies the behavior of a large number of our corporations in the year 2015.
The almighty dollar, the profit margin, and the smooth flow of business trump lives and ethics – and when it is for the “benefit of the majority”, what could be better?
But to unabashedly make such a statement in writing betrays an incredible level of ethical blindness on the part of these specific medical doctors, and their specialty.
In bygone eras, entire empires, countries and groups had accepted, and even welcomed, the sacrifice of minority subsets of people for the real, or presumed, “benefit of the majority”.
But, America has repeatedly indicted such intellectual, political and societal positions as being “atrocious” and unethical – British imperialism over the American colonies, Slavery over men and women of African origin, Fascism, anti-semitism, Communism, etc.
These forces all had one specific thing in common: they were all willing to sacrifice the rights and lives of minority subsets of people for the real or presumed “benefit of the majority”.
In fact, America’s constitution was ultimately the main force that empowered a democratically governed republic to protect and preserve the rights and dignity of every individual human life – in almost every one of the cases listed above.
In the not so distant past, America went to war with such atrocious philosophical constructs. Sacred blood was spilled in defense of human dignity and diversity of culture, spirit and intellect: The American revolutionary war, the American civil war, World-War II, the Cold-War, and others.
But, it is astonishing that in the year 2015, an entire group of American doctors are acting in diametric opposition to the American cultural ethos.
Making the claim that sacrificing the lives of a minority subset of unsuspecting women is justified to presumably “reduce societal costs” and to “benefit the majority” is an unforgivable violation of hard won American cultural and ethical values.
And from within the heart of one of America's most prominent and progressive professions: Medicine!
Why is that?
The answer is strikingly clear: in our day, the principles of medical ethics are being easily overridden by the corporate need for revenue, by the need for streamlined practice volume and by liability managers.
The individual patient is no longer the prime focus of the establishment physician – instead, revenue, efficiency, billing, liability containment, corporate defense, or “innovation” are!
And this cancerous construct is systemic to our establishment, perhaps to our globalized economy - it is not just one institution or a few doctors. We are all susceptible to this deviation. We have all deviated from the purity that rests at the very foundation of the American revolution at this society’s inception.
So it is that in the year 2015, the faculty of Gynecology at Northwestern University’s distinguished Feinberg School of Medicine permit themselves to publish a document with words that sound disturbingly reminiscent of those promoted by ethically defunct empires of the past - that to save societal cost and for the presumed benefit of the majority, the sacrifice of a minority subset of people’s lives is justified.
Here it is, very specifically, an example published by Nazi Germany's Aktion T-4 in a pamphlet justifying euthanasia:
"This person suffering from hereditary defects costs the community 60,000 Reichsmark during his lifetime. Fellow German, that is your money, too."
“Societal cost containment” achieved by permitting the AVOIDABLE sacrifice of a minority subset of lives, for the "benefit of society".
Atrocious and worthy of war, indeed!
Perhaps the distinguished president, dean, and faculty of Northwestern University and the Feinberg School of Medicine, might look with more diligence than they are, at the make-up and philosophical orientation of their current gynecological colleagues – because at present theirs, as published, stands to be labeled as “atrocious” in the eyes of medical history.
Perhaps the reader might recall this arcane saying from the foundations of our civilization that, “No man can serve two masters: for either he will hate the one, and love the other; or else he will hold to the one, and despise the other. Ye cannot serve God and mammon.”
No physician can serve two masters: Ye cannot truly heal the ill and serve mammon.
So, we are at a crossroads in American Medicine.
American healthcare, its associated industries, and its leaders are seemingly serving two masters – this is catastrophic to the subset of patient’s who daily become “the harmed”, and it will spell out the establishment's own ethical ruin in the not so distant future.
To truly serve and honor the ill, the lame, the dying will never be possible in the era of corporate dominance in medicine.
For now, mammon is winning - and with it, medical ethics stands a good chance of dying in America.
Read more at http://www.philly.com/philly/blogs/healthcare/The-death-of-medical-ethics-in-America-Ye-cannot-serve-God-and-mammon.html#m0su3VLf56veEwmt.99 -
Morcellator Lawsuit News: Jury Trial Scheduled
Apr 15, 2015 | PR Web
By Onder Law Firm
Attorneys handling morcellator lawsuit claims alleging the spread of cancer from the use of a power morcellator device provide an update on the progress of one of the first morcellator lawsuits* filed in U.S. courts. Attorneys handling morcellator lawsuits for the Onder Law Firm report discovery is underway, and is set to be completed this summer by July 30, 2015. A settlement conference will be held May 26, 2015 and the jury trial has been scheduled for November 23, 2015, according to the Onder Law Firm.
The wrongful death case, Burkhart et al v. Lina Medical USA Inc., et al, was filed in U.S. District Court in the Eastern District of Pennsylvania. The plaintiff has filed this morcellator lawsuit on behalf of his wife, who died of cancer in 2013 which he alleges was a result of power morcellator surgery. Counts of negligence, strict liability, breach of express warranty, wrongful death and survival action have been brought forth, asserting that the companies and individuals who developed, marketed and promoted the surgical device possessed knowledge regarding the risks associated with the surgical device, yet failed to warn consumers of the danger of spreading undetected cancer cells and advancing the disease.
According to court documents, numerous medical centers and health insurance companies are now restricting the use of power morcellator devices for uterine surgery based on the risk of spreading cancer. One such institution, Johns Hopkins University, a leading voice in medical research, has created a new protocol limiting the use of laparoscopic power morcellators for uterine surgeries in order to decrease the risk of spreading unsuspected cancer following a review of morcellator cases over the past decade, according to court documents.
Johns Hopkins' new protocol stipulates that morcellation is not to be used for uterine fibroid removal and hysterectomy in women age 50 or older, and for women who have certain risk factors for developing uterine cancer, in order to reduce the risk of spreading and thereby worsening undetected cancer, according to court documents.
This new set of guidelines came after the FDA warned surgeons and health care providers of the risk of spreading undetected cancer when performing uterine surgeries by power morcellator on November 24, 2014, according to court documents.* The federal agency warned health care professionals that using a laparoscopic power morcellator, which minces and extracts tissues through miniature incisions, can spread cancer cells throughout the pelvic region and abdomen, potentially resulting in advanced stage and fatal cancer, according to court documents.
The Onder Law Firm, known nationwide for its superior work in family and product liability law, provides comprehensive information and timely news updates on morcellator surgery lawsuits at MorcellatorCancerLawsuitCenter.com. These morcellator lawyers offer no-cost, confidential case review to women and the family members of women who were diagnosed with cancer following morcellator surgery. Lawyers handling morcellator claims believe women who were diagnosed with cancer following uterine fibroid or hysterectomy surgery may be entitled to real compensation for the harm and damages they sustained.
The Onder Law Firm welcomes morcellator lawsuit inquiries from law firms in regards to handling them or working as co-counsel.
About The Onder Law Firm
Onder, Shelton, O’Leary & Peterson, LLC is a St. Louis based personal injury law firm handling serious injury and death claims across the country. Its mission is the pursuit of justice, no matter how complex the case or strenuous the effort. The pharmaceutical and medical device litigators at The Onder Law Firm have represented thousands of Americans in lawsuits against multinational conglomerates from products liability for manufacture of defective or dangerous products to deceptive advertising practices. Other firms throughout the nation often seek its experience and expertise on complex litigation. It is also a recognized leader in products liability cases such as window blind cord strangulation. The Onder Law Firm offers information from morcellator surgery lawyers athttp://www.MorcellatorCancerLawsuitCenter.com.*Burkhart et al v. LiNa Medical US, et al, United States District Court, Eastern District of Pennsylvania, Case 5:14-cv-01557-LS
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Tissue Morcellator Lawsuit Filed Over Endometrial Stromal Sarcoma Recurrence After Hysterectomy
Apr 13, 2015 | About Lawsuits
By Irvin Jackson
A former Georgia mayor and her husband have filed a lawsuit against Johnson & Johnson and its Ethicon subsidiary, alleging that a Gynecare tissue morcellator caused the recurrence of metastatic endometrial stromal sarcoma, spreading hidden cancer cells contained in the uterus throughout the plaintiff’s pelvis and abdomen.
The complaint (PDF) was filed last week in the U.S. District Court for the Northern District of Georgia by Eva Galambos, the former Mayor of Sandy Springs, Georgia, and her husband John.
Galambos underwent a laparoscopic hysterectomy in January 2011, during which doctors used a Gynecare tissue morcellator sold by Johnson & Johnson’s Ethicon division to cut up her uterus and uterine fibroids, allowing the tissue to be removed during a minimally invasive procedure. However, Galambos and her husband allege that Johnson & Johnson, Ethicon and Vention Medical Inc. failed to warn about the high-risk that use of the laparoscopic morcellator may disseminate and upstage occult, or hidden, cancer.
According to the lawsuit, testing and evaluation prior to surgery showed no evidence of disseminated or metastatic cancer. However, a biopsy of tissue taken during the procedure revealed endometrial stromal sarcoma/leiomyosarcoma, which she was diagnosed with after the surgery. She was told that she was cancer free until April 2013, when she was diagnosed with a recurrence of metastatic endometrial sarcoma, involving the pelvis and left anterior abdominal wall.
“Had the Laparoscopic Power Morcellator used on Plaintiff not disseminated fulminated cancerous cells and tissue, she would not have suffered and been diagnosed with a recurrence of her endometrial stromal sarcoma,” states the complaint filed by Galambos and her husband. “The Laparoscopic Power Morcellator used on Plaintiff during her 2011 surgery caused this specific cancerous condition, profoundly and gravely injuring Plaintiff.”
Galambos raises allegations similar to those presented in a growing number of morcellation cancer lawsuits filed by women throughout the U.S. who have been diagnosed with the spread of endometrial stromal sarcoma, leiomyosarcoma or other uterine cancers following a laparoscopic hysterectomy or uterine fibroid removal.Morcellation Cancer Concerns
Laparoscopic tissue morcellators are medical devices increasingly used in recent years to allow doctors to remove the uterus or uterine fibroids through a small incision in the abdomen, providing shorter recovery times and reduced risk of infection or other complications. However, over the past year, concerns have emerged over severe and potentially life threatening risks the devices may pose for women with occult or unsuspected sarcoma contained within their uterus.
In April 2014, the FDA announced that it was investigating the morcellation cancer risk, estimating that 1 out of every 350 women may have unsuspected sarcoma.
An FDA advisory panel was convened over the summer to evaluate the available data on the controversial devices, which resulted in a determination that there is no way to make power morcellators safer. However, the panel was split on whether to recommend morcellators be recalled or that stronger warnings be placed on the devices.
In a widely criticized move, the FDA announced in November that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer and more limited indications for appropriate use of the devices.
Many hospitals have already announced that they will no longer perform a hysterectomy with morcellation, and many experts agree that the vast number of prior procedures performed involving the device are no longer appropriate.
The Gynecare Tissue Morcellator, and all Ethicon-manufactured morcellators, were the subject of a morcellator recall issued by Ethicon in the summer of 2014. According to Johnson & Johnson and its subsidiary, company officials became convinced by emerging evidence that there was no safe way to conduct laparoscopic morcellation for uterine fibroid removal without potentially putting women at risk of spreading undiagnosed cancer. The company dominated the market at the time and was responsible for about three quarters of the morcellators on the market.
Galambos raises nearly identical claims to those brought by women diagnosed with the rapid dissemination of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers, indicating that they may have been avoided the aggressive disease if they had undergone other treatment options for symptomatic uterine fibroids, such as a traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.
The complaint filed by Galambos and her husband presents claims for negligence, designing a defective medical device, failure to warn, violation of Georgia consumer protection laws, and loss of consortium, seeking both compensatory and punitive damages.
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Study Says Morcellation is More Cost-Effective Despite Cancer Risk
Apr 13, 2015 | Medical Device and Diagnostics Industry
By Marie Thibault
A study published recently in The Journal of Minimally Invasive Gynecology argues that a controversial surgical procedure that is no longer used in several hospitals is more cost-effective than alternatives. The research highlights the sometimes opposing factors hospitals consider when treating patients: medical risks and financial costs.
It’s the latest chapter in the debate over laparoscopic power morcellation, a procedure used to perform minimally invasive hysterectomies. The procedure uses morcellators, which cut up tissue to make it easier to remove large amounts of tissue through a small incision, but which are also blamed for having the potential to spread and seed rare uterine cancers.
A group from Northwestern University Feinberg School of Medicine authored the journal article, “A Cost-Effectiveness Analysis Of Morcellation Hysterectomy For Fibroids,” in order “to estimate the cost-effectiveness of eliminating morcellation in the surgical treatment of leimyomas from a surgical perspective.”
According to the study results, non-morcellation hysterectomy using a laparotomy cost more than morcellation hysterectomy—$30,359.92 versus $20,853.15—while resulting in slightly more quality-adjusted life years (QALYs) (21.284 versus 21.280). The authors write that this points to an incremental cost-effectiveness ratio (ICER) for using non-morcellation hysterectomy of $2,184,172 per QALY. ICER is calculated by dividing the difference in cost by the difference in benefit or QALYs.
The analysis found that the major factors causing the difference in cost are prolonged hospitalizations and the costs to patients for spending a longer time away from work. The authors conclude, “Eliminating morcellation hysterectomy as a treatment for fibroids is not cost-effective under a wide variety of probability and cost assumptions. Performing laparotomy for all patients who might otherwise be candidates for morcellation hysterectomy is a costly policy from a societal perspective.”
A prominent activist who has worked to ban morcellation argues that putting a price on the lives of women who were diagnosed with cancer after a morcellation hysterectomy is unethical. Dr. Hooman Noorchashm and his wife, Dr. Amy Reed, have campaigned against morcellators since Reed had a morcellation hysterectomy in late 2013 and found out soon after that she had advanced stage uterine sarcoma.
“Basically, this is…making a financial argument to justify something…that places the lives of the minority subset of women in deadly harm’s way. That is ethically blind,” says Noorchashm.
In an opinion piece penned for Philly.com, Noorchashm and Reed wrote of the Northwestern study, “in our day, the principles of medical ethics are being easily overridden by the corporate need for revenue, by the need for streamlined practice volume and by liability managers.”
The corresponding author for the study did not respond immediately to a request for comment.
One key issue in the morcellator debate has been how common undetected gynecological cancers really are. Before the issue was brought to light, undetected uterine sarcoma and leiomyosarcoma was thought to be rare. An FDA safety communication published in November 2014 found that a review of data pointed to a “prevalence of unsuspected uterine sarcoma in patients undergoing hysterectomy or myomectomy for presumed benign leiomyoma is 1 in 352 and the prevalence of unsuspected uterine leiomyosarcoma is 1 in 498.” This is much more common than previously thought, though not everyone has accepted this higher prevalence.
The JMIG research points out that even if the analysis takes into account an incidence rate of occult sarcoma double the rate seen in medical literature, the ICER for non-morcellation hysterectomy is $644,393.30.
Morcellators have fallen out of favor over the last year. FDA has published safety communications on the devices and Johnson & Johnson issued a voluntary recall of its power morcellators in July 2014. A few major health insurers, including Highmark and United Healthcare, have said they will not cover use of the laparoscopic power morcellators during hysterectomies, and some health systems and hospital chains have stopped using the devices.
Still, Noorchashm tells MD+DI that nothing short of a complete ban on morcellators will be sufficient for patient safety.
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