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Morcellation Media Monitoring 04/04/2016
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Will More Morcellator Makers Settle?
Apr 1, 2016 | Medical Device and Diagnostic Industry
By Nancy Crotti
Johnson & Johnson isn’t saying why it has been settling consumer lawsuits over power morcellators, but other manufacturers of the surgical devices linked to the spread of uterine cancer have surely taken notice. -
Attorneys Appointed in Ethicon Morcellation Cancer Lawsuits
Mar 31, 2016 | Top Class Actions
By Joanna Szabo
The federal judge presiding over morcellation cancer lawsuits has appointed a group of attorneys to serve during the proceedings. -
Power Morcellation amongst Most Dangerous Medical Procedures
Apr 3, 2016 | Lawyers and Settlements
By Gordon Gibb
Milwaukee, WIAbout a year ago we shared with you the story of Dr. Amy Reed, 42, an anesthesiologist and mother of six who is currently battling for her life after a diagnosis of leiomyosarcoma, a ferocious uterine cancer that spread through her body. She learned of the cancer about a week after she underwent Laparoscopic Power Morcellation on her uterus.
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Will More Morcellator Makers Settle?
Apr 1, 2016 | Medical Device and Diagnostic Industry
By Nancy Crotti
Johnson & Johnson isn’t saying why it has been settling consumer lawsuits over power morcellators, but other manufacturers of the surgical devices linked to the spread of uterine cancer have surely taken notice.The Wall Street Journal has reported that J&J, which manufactured about 75% of the morcellators on the market, has settled approximately 70 cases and is working on reaching settlements in more. This development came just a few months after the Judicial Panel on Multidistrict Litigation consolidated several morcellator cases against J&J’s Ethicon unit in U.S. District Court for the District of Kansas.
Ethicon and other companies manufactured morcellators used by surgeons to grind up uterine tissue during hysterectomies and myomectomies for laparoscopic removal. FDA estimates of undetected cancer among these patients have fallen from 1 in 10000 to 1 in 350, although some dispute the latter figure.
Power morcellators had been used to remove patients’ uteruses and fibroid tumors in laparoscopic procedures for about 20 years before consumer outcry prompted government investigations. Some surgeons continue to use morcellators because they believe the risks of morcellation outweigh the potential adverse events of alternative procedures, like open hysterectomy.
Some health insurers, including Highmark and United Healthcare, have said they will not cover use of morcellators during hysterectomies. A number of health systems and hospitals have stopped performing hysterectomies with morcellation.
Some patients and families are probably happy to settle their lawsuits and put the matter in the past, but not the husband and wife physicians who have been among the most outspoken about the devices. Dr. Amy Reed found out soon after having a hysterectomy with a device made by German manufacturer Karl Storz GmbH & Co. that she had uterine sarcoma.
Reed’s husband, Dr. Hooman Noorchashm, said he hopes their lawsuit and others will continue so the public can see “who the players are, how they behaved, what laws were violated or need to be in place.”
Reed, a mother of six, has had several recurrences of cancer, and the family has moved to Pennsylvania from Massachusetts to be closer to her relatives, Noorchashm said.
"Every one of these complaints is really an opportunity for a public record to be created, and for the public to really understand, and for government regulators to understand, what went wrong here,” he added.
Storz has moved to dismiss the couple’s lawsuit, according to court papers. The company did not respond to a request for comment to this story.
A couple of attorneys familiar with lawsuits over medical devices said they believe that J&J’s decision to begin settling these suits will likely spur other manufacturers to consider their options.
Amy Alderfer of law firm Cozen O’Connor’s Los Angeles office has worked on cases involving vaginal mesh, insulin pumps, spinal stimulators, and implantable cardiac devices. Having one defendant settle does not necessarily create a domino effect, in her experience.
“It really probably comes down to a business decision and just looking at your own portfolio and the documents you have,” Alderfer said. “When you have someone who has a major component of the industry settling, that is something that they’ll have to take notice and think about and decide if for them if it makes wise sense from a business point of view as well.”
The combination of a major manufacturer’s decision to settle and FDA actions surrounding a device “suggests that there are times when settlement is the better option than to fight to the death,” added Melissa Markey of Hall Render Killian Heath & Lyman’s Troy, MI, office.
“Johnson & Johnson has obviously made that cost-benefit calculus and have decided that from their perspective, it is a more appropriate course of action to settle rather than to try and litigate this, which may very well be a very reasonable course of action of them to choose,” Markey said. “It seems to me that given what is becoming known about those devices that it may be a very reasonable thing to do for the device makers to settle rather than to litigate this.”
FDA issued a safety communication about power morcellators in April 2014. J&J suspended sales that month and withdrew the devices from the market in July 2014. Last year, the FBI reportedly began investigating what J&J knew about its risks before the recall. The Government Accountability Office said in September that it planned to investigate how the surgical devices were sold for so long before widespread safety concerns were raised. A dozen members of Congress petitioned GAO to look into the regulatory clearance, marketing, training, and adverse event reporting associated with morcellator use. Petitioners also asked the watchdog to determine what
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Attorneys Appointed in Ethicon Morcellation Cancer Lawsuits
Mar 31, 2016 | Top Class Actions
By Joanna Szabo
The federal judge presiding over morcellation cancer lawsuits has appointed a group of attorneys to serve during the proceedings.
The number of morcellation cancer lawsuits filed against Ethicon continues to grow as more women are diagnosed with uterine cancer after going through either a laparoscopic hysterectomy or uterine fibroid removal.
The morcellation cancer lawsuits against Ethicon, a subsidiary of Johnson & Johnson, have been centralized in the District of Kansas as part of a federal multidistrict litigation, or MDL.
Earlier this month, a conference was held to determine the structure of pretrial proceedings. U.S. District Judge Vratil issued an order appointing 20 different lawyers to leadership roles in this MDL.
Ethicon Power Morcellator Lawsuits
The MDL currently only includes approximately two dozen pending complaints against Ethicon.
However, Ethicon lawyers continue to review and file claims from women who have allegedly suffered from morcellation cancer and their families across the U.S. Ultimately, the MDL is expected to include several hundred total morcellation injury claims.
The morcellation cancer lawsuits all allege similar circumstances. They claim that Ethicon’s power morcellator device is unreasonably dangerous, and that the company failed to adequately warn women and the medical community about the link between morcellation and uterine cancer.
Power morcellators have been used during hysterectomy and myomectomy procedures to remove uterine fibroids. The morcellator’s minimally invasive nature makes it easier for doctors to cut up and remove the uterine fibroids through a tiny abdomen incision.
Though the power morcellator may be minimally invasive during the surgery itself, lawsuits allege that its later effects can be devastating.
While the devices had been popular due to their ability to make tiny incisions, the use of the surgical tool has caused controversy within the medical community due to the association with spreading undiagnosed cancer.
The FDA estimated in April 2014 that approximately one out of every 350 women who undergoes surgery for uterine fibroid removal may have undiagnosed sarcoma cancer. This means that doctors, unable to detect or diagnose the cancer before the procedure, will go into surgery and unknowingly cause the spread of cancerous uterine fibroids with the power morcellator.
Ethicon, which had been the leading manufacturer of power morcellators, announced last year that it would no longer sell the devices.
Plaintiffs involved in morcellation cancer lawsuits claim that Ethicon either knew or should have known about the cancer risks associated with power morcellators. Despite this knowledge, the company withheld this information from women and the medical community about their product’s dangers.
The morcellation cancer risks include leiomyosarcoma. Leiomyosarcoma is a very rare, very aggressive cancer, and would be extremely dangerous or deadly if spread throughout the body.
Power Morcellation Cancer Lawsuits
A growing number of people have begun filing morcellation cancer lawsuits, alleging cancer diagnosis after a surgery that involved the use of a power morcellator. These plaintiffs allege that, had they been adequately warned about the potential dangers of power morcellation surgery, they would not have agreed to the procedure.
If you or someone you know has undergone a surgery where a doctor has used a power morcellator, and have since contracted cancer, you may be able to file a morcellation cancer lawsuit.
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Power Morcellation amongst Most Dangerous Medical Procedures
Apr 3, 2016 | Lawyers and Settlements
By Gordon Gibb
Milwaukee, WIAbout a year ago we shared with you the story of Dr. Amy Reed, 42, an anesthesiologist and mother of six who is currently battling for her life after a diagnosis of leiomyosarcoma, a ferocious uterine cancer that spread through her body. She learned of the cancer about a week after she underwent Laparoscopic Power Morcellation on her uterus.
According to an update of her story recently published in the Philadelphia Inquirer(2/15/16), Reed had been dealing with severe bleeding during menstruation. Following a decision to limit the size of their family to six children, and with both Reed and her husband busy with careers in medicine, it was decided that she would undergo a hysterectomy, which is one of the treatments for fibroids.
Reed had inquired about traditional invasive surgery, where the uterus would be removed in one piece. Instead, Laparoscopy was recommended, a minimally invasive procedure that would result in smaller incisions, faster healing and minimizing blood loss.
In reality, Power Morcellation was used to section the uterus while still in Reed’s abdomen, and subsequently removed in sections. Uterine cancer cells that might have been contained had the uterus been removed intact, were instead spread throughout Reed’s abdomen through use of the power morceallator.
Now Reed, as she fights her aggressive cancer with standard and experimental treatments, is embroiled in a crusade with her cardiac surgeon husband to have power morcellators banned. The US Food and Drug Administration (FDA) has only gone so far as to recommend that Laparoscopic Power Morcellation not be used, and certainly not the first option - but rather the option of last resort.
Some hospitals have since decreed that only sealed bags surrounding the uterus be employed to entrap both uterine tissue and any potentially cancerous fibroids. Other hospitals have discontinued the procedure altogether. Johnson & Johnson withdrew its leading brand of power morcellator from the market a few years ago.
Ovarian cancer is but one of a number of health concerns affecting women: the onset of menopause, the potential for a hysterectomy, are all things that lay in most women’s future and the safest treatments for fibroids and other health concerns are top of mind for women, their families, and their health care providers and advocates.
Power morcellation has evolved substantially since it was first approved by the FDA in 1995 at the forefront of minimally invasive laparoscopic surgery. From an initially promising medical procedure, laparoscopic power morcellation myomectomy and related procedures are now listed by many amongst the more dangerous medical procedures out there.
The statistics appear to be getting progressively troubling: once thought of as a risk to one in 10,000 women, the FDA now acknowledges that the spread of undetected sarcomas during hysterectomy or fibroid removal is more like one in 350.
Meanwhile, according to the Philadelphia Inquirer, the Federal Bureau of Investigation (FBI) and the Government Accountability Office are investigating why it took 20 years for the FDA to warn about the risks.The value of those warnings is compelling. The Inquirer reported that three women, who steadfastly refused power morcellation after reading about Reed’s plight, found out later that they turned out to have sarcomas that were removed intact through traditional surgery.
Meanwhile, it has been reported that Johnson & Johnson has begun the process of settling power morcellation lawsuits. Those lawsuits, in kind, keep coming. It was recently reported that Babette Davis, a plaintiff from Wisconsin, filed a power morcellation lawsuit against Johnson & Johnson and Ethicon, amongst other defendants. Davis alleges in her action that the Gynecare power morcellator, manufactured by the Ethicon unit of Johnson & Johnson, was responsible for the spreading of uterine cancer throughout the plaintiff’s abdomen and pelvis.
Davis filed her power morcellation lawsuit on January 27 of this year, Case No. 2:2016-cv-00101 in US District Court for the Eastern District of Wisconsin. Defendants are Ethicon Inc., Ethicon Endo-Surgery Inc., Johnson & Johnson Services, Johnson & Johnson, Venton Medical Inc., Venton Medical Acquisition Co, and Venton Medical Holdings Inc.READ ABOUT LAPAROSCOPIC PO
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