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Morcellation Media Monitoring 09/17/2015
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Olympus Hit With 3rd Pa. Suit Claiming Device Spread Cancer
Sep 14, 2015 | Law360
By Matt Fair
An Olympus Corp. subsidiary has been hit with its third lawsuit in Pennsylvania state court alleging that a surgical device it manufactures was responsible for the spread of cancer-causing cells. Marlene and Joel Waltman, who filed suit on Friday, became the latest plaintiffs to level claims in Philadelphia County claiming the medical device and electronics manufacturer should have been aware of the cancer risks associated with its so-called PKS PlasmaSORD Bipolar Morcellator before it was used in a July 2011 surgical procedure. -
FDA’s morcellation safety communication and hysterectomy trends
Sep 16, 2015 | Contemporary OB/GYN
By Judith M. Orvos ELS, Miranda Hester, Marian Freedman
In the 8 months immediately following the US Food and Drug Administration (FDA)’s statement discouraging use of power morcellation during hysterectomy, practice patterns changed, according to a new study by University of Michigan Researchers. The retrospective analysis showed that rates of laparoscopic and vaginal hysterectomy increased, as did non-transfusion complications and 30-day hospital admissions. -
Fewer Women Getting Minimally Invasive Hysterectomies Since FDA Guidelines
Sep 14, 2015 | Science 2.0
Since the Food and Drug Administration (FDA) cautioned against using a minimally invasive method to treat fibroid tumors called power morcellation, there was a nearly quarter increase in hospital readmissions and 27 percent increase in major postoperative complications after hysterectomies in Michigan, a new University of Michigan study says.After the first FDA safety communication in April 2014, the percent of women receiving minimally invasive hysterectomies in a large Michigan database also went down by an absolute 1.7 percent decrease. -
First Morcellation Lawsuit Filed by Widower Settles
Sep 15, 2015 | Top Class Actions
By Melissa LaFreniere
The first power morcellation lawsuit filed by a widower against LiNA Medical has settled. The plaintiff filed the power morcellator lawsuit after his wife was diagnosed with uterine cancer nine days after a laparoscopic hysterectomy that used the medical tool. -
Medical Experts Offer Opinions About Power Morcellation
Sep 16, 2015 | Righting Injustice
By Jennifer Walker-Journey
The use of power morcellation for hysterectomies and the removal of uterine fibroids has slowed since the Food and Drug Administration (FDA) last year warned that the procedure could spread undetected uterine cancer and worsen a woman’s odds of survival. -
NJ Woman Succumbs To Leiomyosarcoma Days After Giving Deposition In Morcellator Cancer Lawsuit
Sep 14, 2015 | Southern Med Law
A 43-year-old New Jersey woman who filed a morcellator leiomyosarcoma lawsuit after undergoing a hysterectomy and developing a rare and aggressive cancer allegedly due to a morcellator, has died. Southern Med Law, which aggressively represents women in power morcellator lawsuits, learned that the New Jersey woman was diagnosed with metastatic leiomyosarcoma a few weeks after her surgery in October 2014. According to a report by NorthJersey.com, a federal morcellator cancer lawsuit was filed in July on her behalf that named three doctors, the hospital in which she had the surgery, and morcellator manufacturer, Karl Storz Endovision. (Case No.2:15-cv-05704, U.S. District Court, District of New Jersey) Due to her declining health, the woman was recently hospitalized and a request to immediately videotape her deposition was granted. The woman died a few days after providing her testimony for the lawsuit. -
Power Morcellator Lawsuit Filed By South Carolina Widower
Sep 15, 2015 | Press Release
By Tracey & Fox
Tracey & Fox have reported that the widower of a South Carolina woman has elected to file a complaint against Johnson & Johnson in the U.S. District Court for the District of South Carolina Greenville Division under case number 6:15-cv-00516-MGL. Johnson & Johnson manufactured and promoted a surgical device they named the Gynecare Morcellex. This device is one of many power morcellators marketed to the medical community for use in laparoscopic surgeries.
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Morcellation
Full Text of Stories Below
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Olympus Hit With 3rd Pa. Suit Claiming Device Spread Cancer
Sep 14, 2015 | Law360
By Matt Fair
An Olympus Corp. subsidiary has been hit with its third lawsuit in Pennsylvania state court alleging that a surgical device it manufactures was responsible for the spread of cancer-causing cells.
Marlene and Joel Waltman, who filed suit on Friday, became the latest plaintiffs to level claims in Philadelphia County claiming the medical device and electronics manufacturer should have been aware of the cancer risks associated with its so-called PKS PlasmaSORD Bipolar Morcellator before it was used in a July 2011 surgical procedure.
The suit alleges that use of the device during a gynecological procedure aimed at removing what were thought to be benign tumors from Marlene Waltman actually ended up spreading and seeding cancerous cells throughout her abdomen.
“The PKS PlasmaSORD Bipolar Morcellator disseminated and seeded cancer throughout plaintiff’s abdominal cavity, thereby causing and accelerating the metastases and spread of her cancer, worsening the long-term prognosis and the natural course of her cancer,” the complaint said. “The spread of the life-threatening cancer suffered by the plaintiff was a direct result of the use of the PKS PlasmaSORD Bipolar Morcellator during her 2011 surgical procedure.”
The U.S. Food and Drug Administration issued a warning in November that laparoscopic power morcellators, gynecological tools used to perform hysterectomy or uterine fibroid removal, should not be used in surgery that involves cancer or fibroids. The agency said that uterine tissue may contain unsuspected cancer and that using the morcellators may spread the cancer and decrease long-term patient survival.
The Waltmans said that there were studies in medical journals as early as the 1990s reporting on the risk of spreading undetected cancer through the use of the devices, and that Olympus “knew or should have known that their laparoscopic power morcellators could cause malignant tissue fragments to be disseminated and implanted in the body.”
The Waltmans argued in their complaint that a two-year statute of limitations on their claim should be tolled because they had only recently learned of the connection between her cancer and use of the medical devices.
“Despite diligent investigation by plaintiffs into the cause of her injuries, including consultations with plaintiff’s medical providers, the nature of plaintiffs’ injuries and damages, and their relationship to PKS PlasmaSORD Bipolar Morcellator, was not discovered, and through reasonable care and due diligence could not have been discovered, until a date shortly prior to the filing of plaintiffs’ claims,” the complaint said.The suit levels negligence, fraud and design-defect claims and seeks both compensatory and punitive damages for Waltman’s injuries.
Two other nearly identical suits were filed against Olympus in Philadelphia County in May on behalf of two other women, Betty Dobson and Anita Whittaker, who say they developed cancer after they were operated on using the device in 2009 and 2010, respectively.
Whittaker’s attorneys voluntarily dropped her case at the end of July, according to court records.An Olympus spokesman declined to comment on the suit on Monday.
The Waltmans are represented by John Boundas and Margret Lecocke of Williams Kherkher Hart Boundas LLP.
Counsel information for the defendants was not immediately available on Monday.
The case is Marlene Kay Waltman et al. v. Gyrus Acmi LP et al., case number 150900680, in the Court of Common Pleas of the State of Pennsylvania, County of Philadelphia.
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FDA’s morcellation safety communication and hysterectomy trends
Sep 16, 2015 | Contemporary OB/GYN
By Judith M. Orvos ELS, Miranda Hester, Marian Freedman
In the 8 months immediately following the US Food and Drug Administration (FDA)’s statement discouraging use of power morcellation during hysterectomy, practice patterns changed, according to a new study by University of Michigan Researchers. The retrospective analysis showed that rates of laparoscopic and vaginal hysterectomy increased, as did non-transfusion complications and 30-day hospital admissions.
The data are from a cohort of patients who underwent hysterectomy for benign indications in the Michigan Surgical Quality Collaborative from January 2013 to December 2014. Rates of hysterectomy (abdominal, laparoscopic, and vaginal), rates of major postoperative complications, and 30-day hospital readmissions and reoperations were compared before and after the FDA’s April 17, 2014 safety communication. Major complications included blood transfusions, vaginal cuff infection, deep and organ space surgical site infection (SSI), sepsis, pulmonary embolism, cardiac arrest, respiratory failure, and death. The median episode cost related to readmissions was calculated using Michigan Value Collaborative data.
During the reviewed period, 18,299 hysterectomies were performed. Of them, 2753 were excluded due to non-benign indications including cancer, cervical dysplasia, or endometrial hyperplasia and 174 due to missing covariate data. Compared to the 15 months before the safety communication, in the 8 months following the FDA statement, use of laparoscopic hysterectomies decreased by 4.1% (P=0.005), while abdominal and vaginal procedures increased by 1.7% (P=0.112) and 2.4% (P=0.012), respectively.
Major surgical complications, excluding blood transfusions, significantly increased, from 2.2% to 2.8% (P=0.015). Rates of hospital readmission within 30 days also increased from 3.4% to 4.2% (P=0.025). No significant changes were seen in rates of reoperations or for all major surgical complications. The median risk-adjusted total episode cost for readmissions was $5847 (interquartile range $5478-$10,389).
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Fewer Women Getting Minimally Invasive Hysterectomies Since FDA Guidelines
Sep 14, 2015 | Science 2.0
Since the Food and Drug Administration (FDA) cautioned against using a minimally invasive method to treat fibroid tumors called power morcellation, there was a nearly quarter increase in hospital readmissions and 27 percent increase in major postoperative complications after hysterectomies in Michigan, a new University of Michigan study says.
After the first FDA safety communication in April 2014, the percent of women receiving minimally invasive hysterectomies in a large Michigan database also went down by an absolute 1.7 percent decrease.
The findings appear in the American Journal of Obstetrics&Gynecology.
Laparoscopic power morcellation is a minimally invasive method of removing fibroid tumors from the uterus or removing the entire uterus by fragmenting it into smaller pieces. The FDA guidelines followed concerns that the technique could potentially spread unsuspected tumors that appeared as benign fibroids.
"We know that for a significant number of women, a minimally invasive procedure that avoids the risks of surgery is a viable option and often the safest. Since the FDA communication, we saw a decrease in minimally invasive hysterectomies," says John Harris, M.D. M.Sc., a Robert Wood Johnson Foundation Clinical Scholar in the U-M Department of Obstetrics and Gynecology and member of the Institute for Healthcare Policy and Innovation.
"We found that since the FDA communication, the risk of postoperative complications for women undergoing hysterectomies actually increased. We did not examine the underlying cause for these changes, but it is associated with the FDA communication on morcellation and cancer risk."
Researchers analyzed 18,299 hysterectomies during the study period and compared data from the 15 months preceding the FDA safety communication to the eight months afterwards.
The study did not examine any outcomes around diagnosis of occult cancer or the rate of morcellation surgeries. The study also did not compare whether the same patient is more or less likely to receive a more invasive technique, however findings suggest that women in Michigan are less likely to have a minimally invasive method for hysterectomy after the FDA safety communication.
Reference: "Practice Patterns and Postoperative Complications Before and After Food and Drug Administration Safety Communication on Power Morcellation," American Journal of Obstetrics & Gynecology, 2015.
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First Morcellation Lawsuit Filed by Widower Settles
Sep 15, 2015 | Top Class Actions
By Melissa LaFreniere
The first power morcellation lawsuit filed by a widower against LiNA Medical has settled.
The plaintiff filed the power morcellator lawsuit after his wife was diagnosed with uterine cancer nine days after a laparoscopic hysterectomy that used the medical tool.
According to the morcellation cancer lawsuit, prior to the procedure the woman had undergone testing to see if uterine cancer was detected. Although results showed no evidence of cancer, she was told she had leiomyosarcoma just days later.
The plaintiff claimed that the couple was never warned that using a power morcellator could cause the spread of uterine cancer. The settlement is undisclosed.
The Power Morcellator Lawsuit is Case No. 5:14-cv-1557, in the U.S. District Court for the Eastern District of Pennsylvania.
What is a Power Morcellator?
A power morcellator is medical tool used in laparoscopic surgery to remove uterine fibroids. The surgical device is inserted through an incision and then breaks up tissues into small pieces.
Power morcellation was once considered a medical breakthrough as patients undergoing a hysterectomy or myomectomy would have a much shorter recovery time when compared to more traditional surgery.
However, using the surgical tool on unsuspected cancerous tissues can cause cancer to spread quickly throughout the abdomen. Recent studies have found that one in 350 women who undergo laparoscopic surgery for a hysterectomy or myomectomy in which a power morcellator is used will be diagnosed with uterine sarcoma.
Morcellator Cancer Risks
The cancer risk linked to the medical device urged the U.S. Food and Drug Administration to issue a “black box” warning on all power morcellators. This is the strongest caution the federal agency will assign before removing a product from the market.
In 2014, the FDA released a safety warning about the risks involved with using morcellators to break up uterine fibroids. The agency stated that “if laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s likelihood of long-term survival.”
The FDA also encouraged physicians to consider other treatment options for removing symptomatic uterine fibroids. After the FDA released its caution about the possible link between power morcellators and uterine sarcoma, some of the largest health insurance companies across the nation began changing the way the surgical tool is classified.
Cigna, UnitedHealth Group, Aetna and other insurance companies are making it difficult for patients to obtain insurance coverage for power morcellation use.
Morcellation Cancer Lawsuits
Hundreds of power morcellator cancer lawsuits have been filed across the nation. In general, plaintiffs allege that manufacturers insisted that the surgical tool was a safe device while they ignored years of studies that showed a link between the device and uterine sarcoma.
In addition, some plaintiffs claim that power morcellator manufacturers knew of the cancer risks linked to the device but failed to warn patients.
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Medical Experts Offer Opinions About Power Morcellation
Sep 16, 2015 | Righting Injustice
By Jennifer Walker-Journey
The use of power morcellation for hysterectomies and the removal of uterine fibroids has slowed since the Food and Drug Administration (FDA) last year warned that the procedure could spread undetected uterine cancer and worsen a woman’s odds of survival.
Since then, says Jubilee Brown, MD, “things are continuing to evolve in the medical landscape, and practitioners and industry are looking into how to make this procedure safer for patients within the guidelines that the FDA has established.” Brown is an assistant professor in the department of gynecologic oncology and reproductive medicine at The University of Texas MD Anderson Cancer Center, and offered her opinions regarding power morcellation to HemOnc Today.
Power morcellators are surgical tools that are fitted with a tube-like blade that shreds uterine growths or entire uteruses within the pelvic cavity and removes them through an incision in the abdomen. The procedures were favored by many doctors over open surgeries because they allow for a smaller incision, quicker recovery, fewer side effects, and lower rate of complications.
Recently, researchers determined that about 1 in 352 women who undergo hysterectomy ormyomectomy (uterine fibroid removal) had undetected uterine cancer, and that 1 in 498 had an unsuspected leiomyoscarma, an aggressive form of uterine cancer. The process of power morcellation could throw bits of cancerous tissue throughout the abdominal cavity, seeding new cancer growth and making the cancer more difficult to treat.
“Most organizations are limiting morcellation … and there are only a few morcellators on the market now,” David Mutch, MD, professor of obstetrics and gynecology and division chief of gynecologic oncology at Washington University School of Medicine in St. Louis, told HemOnc Today. “Use of thepower morcellator has declined without question, and I think this is the right way to go.”
However, some doctors are reluctant to abandon the procedure altogether.
“There is still great interest in trying to understand if there are cases where the morcellator is beneficial, and there is ongoing research examining other tissue extraction methods, such as placing the uterus in a bag and morcellating within the bag,” Jason D. Wright, MD, chief of the division of gynecologic oncology and associate professor of obstetrics and gynecology at Columbia University Medical Center, told HemOnc Today.
A study was conducted by researchers at Washington University to gauge the safety of this alternative technique, called contained morcellation. The data is expected to be published soon in the journalObstetrics & Gynecology.
“Even if the use of power morcellation comes back, informed consent from the patient is needed, which is something we were not doing much of before,” Mutch added.
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NJ Woman Succumbs To Leiomyosarcoma Days After Giving Deposition In Morcellator Cancer Lawsuit
Sep 14, 2015 | Southern Med Law
A 43-year-old New Jersey woman who filed a morcellator leiomyosarcoma lawsuit after undergoing a hysterectomy and developing a rare and aggressive cancer allegedly due to a morcellator, has died. Southern Med Law, which aggressively represents women in power morcellator lawsuits, learned that the New Jersey woman was diagnosed with metastatic leiomyosarcoma a few weeks after her surgery in October 2014. According to a report by NorthJersey.com, a federal morcellator cancer lawsuit was filed in July on her behalf that named three doctors, the hospital in which she had the surgery, and morcellator manufacturer, Karl Storz Endovision. (Case No.2:15-cv-05704, U.S. District Court, District of New Jersey) Due to her declining health, the woman was recently hospitalized and a request to immediately videotape her deposition was granted. The woman died a few days after providing her testimony for the lawsuit.
“Our thoughts and prayers go out to the woman’s family. The firm knows all to well the legal and medical issues involved in morcellator lawsuit claims as we are representing women across the country who have developed leiomyosarcoma after a laparoscopic procedure using power morcellation,” says Dr. François Blaudeau, founder of Southern Med Law.
Government Investigation Into Power Morcellator Risks
The law firm notes that laparoscopic power morcellators have come under fire by patients and their survivors, U.S. lawmakers and the U.S. Food and Drug Administration (FDA), which strongly warned in November to avoid using morcellators in the majority of women who require a hysterectomy and a myomectomy because of the morcellators’ potential to spread undetected cancer. In wake of the FDA’s warning, national health insurance companies, including Aetna Inc. and UnitedHealth, announced that they would either end or restrict coverage for uterine morcellation surgeries. In June, CBS News reported that the FBI launched an investigation into power morcellators and will question Johnson & Johnson, the largest power morcellator manufacturer, on what it knew about the cancer risks associated with its morcellators. Johnson & Johnson, which sold morcellators through its Ethicon Inc. unit, suspended global sales of the devices after the FDA’s warning. Recently, the U.S. Government Accountability Office agreed to a request made by 12 bipartisan Congress members to investigate power morcellators.
Morcellator Cancer Lawsuits
As a result of Southern Med Law’s legal aggressiveness, the firm’s attorneys settled the first federally filed morcellator cancer lawsuit in July against morcellator manufacturers, LiNA Medical APS, Kebomed AG & LiNA Medical US. The firm represented Pennsylvania resident, Scott Burkhart, whose 53-year-old wife, Donna, died of disseminated leiomyosarcoma in February 2013, which she developed after undergoing a robot-assisted hysterectomy involving a power morcellator. (Case No. 5:14-cv-1557, U.S. District Court, Eastern District of Pennsylvania) The law firm is currently representing a Michigan woman who developed an upstaged endometrial stromal sarcoma, a rare type of uterine cancer that was allegedly disseminated by the morcellators made by defendants Karl Storz Endoscopy-America, Inc., Karl Storz Endovision, Inc., and Karl Storz GMBH & Co.KG (Case No. BC588075, Superior Court of California, Los Angeles County)
Laparoscopic power morcellators are used in minimally invasive surgeries such as a hysterectomy or a myomectomy. The spinning blades of the morcellator shreds and grinds uterine tissue so that the fragments can be removed through small incisions made in the abdomen. The undiagnosed cancer cells are contained in the morcellated uterine tissue fragments being removed. The cancer cells are spread into the abdominal and pelvic cavity or they attach to surrounding organs, and then travel throughout the body, according to the morcellator cancer lawsuits.
Court documents indicate that oral arguments are scheduled on October 1 on a petition filed with the U.S. Judicial Panel on Multidistrict Litigation to consolidate all federally filed power morcellator cancer lawsuits alleging that power morcellators have the potential to spread cancer during gynecological procedures.
Southern Med Law is a full service law firm representing victims of negligence, personal injuries, medical malpractice, dangerous drugs, faulty medical devices and defective products. Led by Dr. François Blaudeau, an attorney and a practicing obstetrician/ gynecologist, and the legal staff at Southern Med Law possesses a deep understanding of the complex medical and legal questions at issue in all manner of power morcellators. They are not afraid to take on the manufacturers to make them accountable and enable all of their clients to have the aggressive legal representation they deserve.
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Power Morcellator Lawsuit Filed By South Carolina Widower
Sep 15, 2015 | Press Release
By Tracey & Fox
Tracey & Fox have reported that the widower of a South Carolina woman has elected to file a complaint against Johnson & Johnson in the U.S. District Court for the District of South Carolina Greenville Division under case number 6:15-cv-00516-MGL.
Johnson & Johnson manufactured and promoted a surgical device they named the Gynecare Morcellex. This device is one of many power morcellators marketed to the medical community for use in laparoscopic surgeries.
Power morcellators have been used for the last several decades by surgeons who are performing minimally invasive procedures. Two of the most common laparoscopic surgeries in women are hysterectomies and myomectomies, which are often recommended by doctors as a treatment for uterine fibroids. Uterine fibroids are typically benign, but can grow so large that they distort the uterus causing pain and bleeding.
The wife of the plaintiff, in this case, was suffering from menometrorrhagia, a condition where there is excessive uterine bleeding both during the menstrual period and other irregular times. In some cases, the bleeding can be so excessive that the patient suffers from anemia due to the blood loss. Her doctor recommended a total robotic hysterectomy and cystoscopy to treat her condition.
Prior to her surgery there was no evidence that she was also harboring any form of uterine cancer, but devastatingly when her doctor received the biopsy report he informed her that some of the uterine tissue which had been shredded by the power morcellator contained leiomyosarcoma. She aggressively fought the cancer, but two years after her hysterectomy, she passed away. The complaint alleges that “The device, in cutting and shredding the uterine fibroid, ruptured the capsule containing the cancerous tissue and spread the shredded tissue in her abdominal cavity. That action changed the course and prognosis of the leiomyosarcoma cancer which had been encapsulated; upstaging it and profoundly injuring the patient, leading to her death.”
Several months after her death, the U.S. Food and Drug Administration updated a safety warning regarding the use of power morcellators during gynecological laparoscopic surgeries. This warning stated “If laparoscopic power morcellation is performed in women with unsuspected uterine sarcoma, there is a risk that the procedure will spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient’s long-term survival.” The FDA also created a “black box” label for all power morcellators which reads, “The FDA warns that uterine tissue may contain unsuspected cancer. The use of laparoscopic power morcellators during fibroid surgery may spread cancer, and decrease the long-term survival of patients. This information should be shared with patients when considering surgery with the use of these devices.”
For more information regarding this press release, call Tracey & Fox at (713) 322-5375.
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