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Morcellation Media Monitoring 03/24/2016
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New England Journal of Medicine essay on morcellation prompts a call for retraction
Mar 24, 2016 | The British Medical Journal
By Michael McCarthy
An essay by a New England Journal of Medicine correspondent that questioned the US Food and Drug Administration’s (FDA) ruling that power morcellation was contraindicated in most women for the removal of benign uterine fibroids has prompted a call for a retraction and an apology by two doctors leading the fight against the device’s use. -
J&J moves to settle swath of lawsuits over power morcellator devices: WSJ
Mar 21, 2016 | FierceMedicalDevices
By Emily Wasserman
Johnson & Johnson ($JNJ) wants to put litigation to rest over its power morcellator devices, and it wants to do it quickly. To accomplish this goal, the company is settling a number of suits claiming that its product, which J&J has since pulled from the market, harmed women by spreading cancer. -
Johnson & Johnson looks to settle morcellator lawsuits
Mar 21, 2016 | Mass Device
By Brad Perriello
Johnson & Johnson(NYSE:JNJ) is reportedly looking to settle 100s of product liability and wrongful death lawsuits brought over its now-recalled laparoscopic power morcellators used during surgeries to remove ostensibly benign uterine tumors. -
Lawsuit Filed Over Leiomyosarcoma Death Allegedly Caused by Ethicon Morcellator
Mar 22, 2016 | About Lawsuits
By Irvin Jackson
As Johnson & Johnson’s Ethicon unit is attempting to quietly settle morcellator cancer lawsuits, a growing number of claims continue to be filed on behalf of women diagnosed with leiomyosarcoma following a laparoscopic hysterectomy or uterine fibroid removal. - -
Ethicon Morcellator Lawsuit Alleges Upstage of Endometriosis
Mar 24, 2016 | Top Class Actions
By Ashley Vanover
A new power morcellator lawsuit, filed by a South Carolina woman, claims that morcellator device manufacturer Ethicon, a subsidiary of Johnson & Johnson, was aware that morcellators could disseminate and upstage endometriosis and fibroids into other parts of women’s bodies. -
Illinois Wrongful Death Hysterectomy Uterine Cancer Lawsuit
Mar 23, 2016 | The Legal Examiner
By Shezad Malik MD JD
Hot on the heels of the recent Wall Street Journal’s report that Johnson & Johnson’s Ethicon unit is quietly settling morcellator cancer lawsuits, several undiagnosed uterine cancer injury claims are being filed. These new product liability claims are being filed on behalf of women diagnosed with leiomyosarcoma following a laparoscopic hysterectomy or uterine fibroid removal. -
Johnson and Johnson is Settling Power Morcellator Cases!
Mar 21, 2016 | Legal Reader
By Jay W. Belle Isle
The news was confirmed this past Friday: Johnson and Johnson is settling power morcellator cases! The Big Pharma/Medical Device company is not known for settling much of anything, but it has started the process of settling these product liability cases only months after many of them were consolidated into a multi-district litigation (MDL) by a judicial panel. -
Johnson & Johnson Settling Claims that Power Morcellator Spreads Women’s Cancers
Mar 22, 2016 | Press Release
By F.A Kelley
Johnson & Johnson is settling a series of legal claims and lawsuits alleging that a discontinued surgical device harmed women by spreading an undetected hidden cancer, according to court documents and lawyers with knowledge of the settlements.
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New England Journal of Medicine essay on morcellation prompts a call for retraction
Mar 24, 2016 | The British Medical Journal
By Michael McCarthy
An essay by a New England Journal of Medicine correspondent that questioned the US Food and Drug Administration’s (FDA) ruling that power morcellation was contraindicated in most women for the removal of benign uterine fibroids has prompted a call for a retraction and an apology by two doctors leading the fight against the device’s use.
Power morcellators use rapidly spinning blades to cut uterine tissue into fragments that can be easily removed through a small incision, reducing complications and recovery time. However, if the fibroid tissue harbors undetected uterine sarcoma there is a risk that the morcellator’s spinning blades will seed the abdomen with tumour tissue, resulting in difficult to treat metastatic disease. Concerns about this complication prompted the FDA to issue its warning about the device in 2014. Opponents of the FDA’S decision have said that the complication is rare and the benefits of the procedure outweigh the risks.
In an essay published on 10 March, Lisa Rosenbaum, national correspondent for the New England Journal of Medicine and a cardiologist at Brigham and Women’s Hospital in Boston, Massachusetts, criticised the decision.1She said that FDA regulators and others were being unduly influenced by stories of individual patients who had been injured. As a result, regulators gave too much weight to the harms associated with the product’s use and too little weight to the harms suffered by patients who were denied access to the product.
Rosenbaum wrote, “From a policy perspective the FDA has a mandate to keep the public safe, but medical products are associated with two types of risk: that caused by using the products and that caused by preventing their use. In making regulatory decisions the FDA considers both, but political pressure focuses more on the former than the latter.”
Rosenbaum cited the case of Amy Reed who had stage IV leiomyosarcoma diagnosed after having uterine morcellation for presumptive benign uterine fibroids at Brigham and Women’s Hospital in 2013. Reed and her husband, Hooman Noorchashm, a cardiothoracic surgeon at the hospital, subsequently filed a lawsuit against Brigham and Women’s and the device’s maker. They led a campaign against the procedure that gained nationwide attention and helped move the FDA to act.
Rosenbaum said that the couple’s campaign was an example of an “availability cascade.” She said this was a phenomenon in which advocates targeting particular drugs or devices feed accounts of tragic cases to reporters in order to shape the public’s perception about the products. In these campaigns, “anyone challenging those perceptions is vilified as immoral,” Rosenbaum wrote.
Rosenbaum said, “Policy debates often degenerate, their crux shifting from ‘Do this solution’s benefits outweigh its risks?’ to ‘Are you good or evil?’ Noorchashm insists that it’s unethical to consider morcellation’s majority benefit when some individual patients may face such serious adverse consequences.”
Reed and Noorchashm denounced Rosenbaum’s article for its characterisation of their efforts to have power mocellators banned as an “availability campaign,” and for a passage in the article that could be interpreted as claiming that Reed already had stage IV disease at the time of the initial surgery. In that passage, Rosenbaum wrote that Reed’s uterine fibroids “turned out to contain foci of leiomyosarcoma, a rare, aggressive cancer that has a 5 year survival rate of 63% when diagnosed at stage I. Reed’s leiomyosarcoma was stage IV, so her likelihood of surviving 5 years was only about 14%.”
Reed and Noorchashm said that Rosenbaum had been deliberately vague in order to undermine their legal claim against Brigham and Women’s—Rosenbaum’s employer—and called for an immediate retraction and an apology.
In a statement, the journal responded that Rosenbaum had not reported that the cancer was stage IV at the time of the initial fibroid surgery. “It would have been impossible to know this,” the journal said. It did not intend to issue any additional clarification.
Noorchashm and Reed also called Rosenbaum’s suggestion that they were “availability entrepreneurs” using Reed’s story to sway public opinion, a “heinous characterization that leaves us awestruck as to this physician’s [Rosenbaum’s] incapacity to see the scope of our public health campaign and the plight of the many women harmed and killed from upstaged uterine cancers—avoidably, prematurely, or unnecessarily.”
An article in Cancer Letter said that Reed had filed complaints with state and federal authorities and called for an investigation into whether, in researching the article, either Rosenbaum or her colleagues at Brigham and Women’s had accessed Reed’s medical records without consent.
The journal said that Rosenbaum had assured its editors that she had never accessed Reed’s medical records and that an audit done by the hospital had determined Reed’s records were not accessed by Rosenbaum. Much of Reed’s medical history was public knowledge, the journal said, having been widely reported in the press.
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J&J moves to settle swath of lawsuits over power morcellator devices: WSJ
Mar 21, 2016 | FierceMedicalDevices
By Emily Wasserman
Johnson & Johnson ($JNJ) wants to put litigation to rest over its power morcellator devices, and it wants to do it quickly. To accomplish this goal, the company is settling a number of suits claiming that its product, which J&J has since pulled from the market, harmed women by spreading cancer.
About 100 cases have either been filed or prepared for lawsuits against J&J'sEthicon unit over the company's laparoscopic power morcellator device, which plaintiffs claim spread undetected tumors. Of those 100 claims, J&J has settled almost 70 over the past few months, Paul Pennock, a plaintiff lawyer and co-lead counsel on the steering committee for consolidated litigation in a Kansas City, KS, federal court told The Wall Street Journal.
It's difficult to estimate exactly how much J&J will shell out to settle the cases. Some of the company's settlements have ranged from $100,000 to about $1 million, a person familiar with the matter told the newspaper. It's safe to say that J&J will likely spend many millions to lay the claims to rest.
J&J declined to comment to FierceMedicalDevices about its recent settlements.
The New Brunswick, NJ-based company is also in talks to resolve other morcellator claims, lawyers with knowledge of those talks told the WSJ. Meanwhile, J&J still faces separate morcellation cases pending in state courts.
J&J's legal saga over its morcellator devices dates back a few years to when regulators began looking into alleged problems with the products. In 2014, the FDA warned against power morcellators. The agency estimated that about one in 350 women with fibroids also have uterine sarcoma, and that using morcellators on those patients can spread cancerous tissue in the abdomen and pelvis.
J&J subsequently suspended sales of its related devices. A few months later, the company pulled its power morcellator products from the global market. J&J's move was partly influenced by an FDA panel meeting, which recommended upgrading the devices' safety labels to reflect increased risks.
"Due to this continued uncertainty, Ethicon believes that a market withdrawal of Ethicon morcellation devices is the appropriate course of action at this time until further medical guidelines are established and/or new technologies are developed to mitigate the risk," J&J spokesman Matthew Johnson said at the time.
In November 2014, the FDA slapped power morcellators with a "black-box" warning--its strongest caution--and recommended against using the tools in the "majority" of women undergoing a hysterectomy. But the agency stopped short of banning morcellators altogether, saying the devices' benefits may outweigh the risks in some cases.
European device outfits Karl Storz GmbH, Richard Wolf GmbH and LiNA Medical also make power morcellators, but J&J has been the most widely scrutinized for issues tied to its devices.
Some lawyers for the plaintiffs are applauding J&J's move to settle cases over morcellator devices. "You certainly don't always see a company step up and take responsibility this early on. That's something we think is appropriate," Pennock said, as quoted by the WSJ.
But the plaintiffs themselves are more wary. Settlements could mean that less attention is drawn to the issue, and that history could repeat itself. "Each one of these cases is an opportunity to create a public record about what went wrong--both ethically and at a regulatory level--so nothing like it happens again," Hooman Noorchashm, a doctor and husband to Amy Reed, an anesthesiologist who went public with health issues tied to morcellator devices, told the newspaper.
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Johnson & Johnson looks to settle morcellator lawsuits
Mar 21, 2016 | Mass Device
By Brad Perriello
Johnson & Johnson(NYSE:JNJ) is reportedly looking to settle 100s of product liability and wrongful death lawsuits brought over its now-recalled laparoscopic power morcellators used during surgeries to remove ostensibly benign uterine tumors.
The morcellators, which use a cutting tip to shred and remove uterine tissue, have been implicated in the spread of a lethal cancer that can masquerade undetected as benign fibroids.
The FDA in April 2014 issued a warning about the devices, later convening a special advisory panel to evaluate their continued use in the surgical suite. The watchdog agency estimates that about 0.3% of women undergoing hysterectomy or fibroid surgery are found to have undetected uterine sarcomas, including the deadly leiomyosarcoma. In November of that year, the FDAordered so-called “black box” warnings for the labels on morcellators, advising doctors that the devices, until recently a mainstay of gynecological surgery, be avoided in nearly all fibroid-removal procedures.
J&J subsidiary Ethicon recalled its morcellators in July 2014, after pulling them from the market in April of that year. Now the healthcare giant is looking to settle some of the estimated 100 cases that have been filed or readied for filing, plaintiffs’ attorney Paul Pennock told the Wall Street Journal. The company has settled about 70 of the cases over the past few months, with amounts ranging from $100,000 to about $1 million, the newspaper reported, citing “a person with knowledge of some recently resolved cases.” A handful of cases are still pending in state courts,according to the journal.
Earlier this year, Rep. Mike Fitzpatrick (R-Pa.) asked the FDA’s Office of Criminal Investigations to open an investigation of several deaths associated with the morcellators, citing FDA regulations requiring hospitals and medical device companies to report any device-related serious injuries or deaths.
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Lawsuit Filed Over Leiomyosarcoma Death Allegedly Caused by Ethicon Morcellator
Mar 22, 2016 | About Lawsuits
By Irvin Jackson
As Johnson & Johnson’s Ethicon unit is attempting to quietly settle morcellator cancer lawsuits, a growing number of claims continue to be filed on behalf of women diagnosed with leiomyosarcoma following a laparoscopic hysterectomy or uterine fibroid removal.
There are currently several dozen product liability lawsuits pending over Ethicon Gynecare morcellators throughout the federal court system. However, new claims continue to be filed each week, and it is ultimately expected that the manufacturer will face several hundred, if not over a thousand, lawsuits over their controversial medical devices.
Power morcellators are tools used during minimally invasive laparoscopic hysterectomy and myomectomy procedures for women with symptomatic uterine fibroids. The devices allow the surgeon to cut and remove the uterus or fibroids through a small incision in the abdomen. However, they have largely been abandoned by the medical community since it was discovered that they pose an unreasonable risk for women with hidden or unsuspected sarcoma contained within the uterus.
According to a complaint (PDF) filed last week in the U.S. District Court for the Northern District of Illinois, Eddie Lee Jackson indicates that his wife, Bernadette McLaughlin-Jackson, died as a result of aggressive leiomyosarcoma cancer spread throughout her abdomen by an Ethicon morcellator.
McLaughlin-Jackson underwent a laparoscopic supracervical hysterectomy for uterine fibroid removal in April 2008. She died in May 2011, less than a month after she was diagnosed with advanced stage leiomyoscaroma.
Eddie Lee Jackson claims that his wife’s undiagnosed cancer was contained within the uterus, until it was rapidly upstaged to deadly levels by a morcellator. The lawsuit presents claims of negligence, strict liability, breach of warranty, fraudulent misrepresentation, violation of the Illinois Consumer Fraud and Deceptive Business Practice Act, loss of consortium. and wrongful death.
Ethicon Morcellator Lawsuits
The case will join other lawsuits filed on behalf of women diagnosed with leiomyosarcoma, endometrial stromal sarcoma or other aggressive forms of uterine cancer that was disseminated by Ethicon morcellators.
The litigation emerged after the FDA raised concerns about the link between uterine morcellation and cancer.
After concluding that there is no way to make the devices safe for women, Johnson & Johson’s Ethicon unit issued a morcellator recall in July 2014 and announced that they would no longer manufacturer or sell the devices.
Since October 2015, all Ethicon morcellator lawsuits filed throughout the federal court system have been consolidated as part of a federal MDL, or multidistrict litigation, which is centralized before U.S. District Judge Kathryn H. Vratil in the District of Kansas. Jackson’s complaint likely will be transferred into the MDL for coordinated discovery and other pretrial proceedings.
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Ethicon Morcellator Lawsuit Alleges Upstage of Endometriosis
Mar 24, 2016 | Top Class Actions
By Ashley Vanover
A new power morcellator lawsuit, filed by a South Carolina woman, claims that morcellator device manufacturer Ethicon, a subsidiary of Johnson & Johnson, was aware that morcellators could disseminate and upstage endometriosis and fibroids into other parts of women’s bodies.
During a laparoscopic hysterectomy that Plaintiff Joan S. underwent in April 2008, an Ethicon Gynecare Morcellex power morcellator was used to remove fibroid tissue.
Four years later in 2012, Joan was found to have endometriosis, a spreading of uterine cells into her abdomen, and leiomyomatosis, an overgrowth of fibroid masses, both of which are painful conditions. According to the power morcellator lawsuit, it was later determined that Joan’s condition could be directly attributed to the morcellation surgery.
Due to the severity of her condition, Joan had to undergo major exploratory surgery and will likely need additional surgeries and treatments in the future in order to combat the damage allegedly caused by the power morcellator device.
About Endometriosis
Endometriosis occurs when tissue that normally grows inside of the uterus, the endometrium, grows outside of the uterus. In most cases, this growth happens on and around organs in the pelvic cavity. The tissue in endometriosis acts just like it would inside the uterus: it grows, thickens and tries to shed with every menstrual cycle.
With endometriosis, this tissue has no way of leaving the body and can cause a lot of pain leading to other complications including infertility.
Power Morcellator Risks
Power morcellators are medical devices used during various laparoscopic surgeries, such as hysterectomies and myomectomies, which aggressively cut uterine tissue into small pieces permitting the tissue to be removed through a small incision site. The proposed benefits of this type of procedure include shorter recovery periods, fewer complications and less pain.
However, due to recent scrutiny and a rise in reports in the medical literature, the FDA issued a safety alert in April 2014. This alert discouraged the use of these devices in uterine and fibroid removal procedures, as they may spread an undetected or unsuspected benign or cancerous tissue that could lead to the dissemination of endometriosis or uterine sarcoma.
The inherent risk of power morcellation is the dissemination of the broken-up tissue. Benign tissue can become implanted on abdominal structures and organs, resulting in conditions such as fibroids, endometriosis and adenomyosis, potentially requiring further surgery.
Furthermore, power morcellators can spread malignant tissue from an undiagnosed uterine cancer, including leiomyosarcoma, endometrial stromal sarcoma, carcinosarcoma and endometrial adenocarcinoma. This can significantly worsen a patient’s prognosis from treatable to deadly.
In response to this FDA communication, Johnson & Johnson’s power morcellator manufacturing unit, Ethicon, suspended all worldwide sales and distribution of power morcellators and ordered a voluntary market withdrawal. The suspension and withdrawal affected all Johnson & Johnson morcellator products, including its Gynecare Morcellex, Gynecare X-Tract, and Morcellex Sigma. Several hospitals have suspended use of these devices.
Morcellation Lawsuits
The power morcellation lawsuit accuses Ethicon of personal injury, breach of express warranty, fraudulent misrepresentation and omission, fraud by concealment and negligent misrepresentation, seeking both compensatory and punitive damages.
Power morcellator lawsuits filed in federal courts across the U.S. have been centralized in the U.S. District Court for the District of Kanas. The number of power morcellator lawsuits included in the MDL is expected to increase over the coming months.
If you or woman you care about were diagnosed with upstaged endometriosis or uterine cancer following a power morcellation surgery, contact an attorney to determine whether you may be eligible to file a morcellator lawsuit.
The Ethicon Power Morcellation MDL is In Re: Ethicon, Inc., Power Morcellator Products Liability Litigation, MDL No. 2652, in the U.S. District Court, District of Kansas.
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Illinois Wrongful Death Hysterectomy Uterine Cancer Lawsuit
Mar 23, 2016 | The Legal Examiner
By Shezad Malik MD JD
Hot on the heels of the recent Wall Street Journal’s report that Johnson & Johnson’s Ethicon unit is quietly settling morcellator cancer lawsuits, several undiagnosed uterine cancer injury claims are being filed. These new product liability claims are being filed on behalf of women diagnosed with leiomyosarcoma following a laparoscopic hysterectomy or uterine fibroid removal.
Court documents note that there are about 100 cancer spread cases after hysterectomy cases have either been filed or readied for filing against the J&J’s Ethicon unit, a subsidiary. The litigation is centered around a medical device known as the laparoscopic power morcellator.
According to sources J&J has settled nearly 70 cancer injury cases over the past few months, and several are in settlement discussions. J&J will have to fork out hundreds of millions dollars in settlements by the time it is all said and done.
Chicago, Illinois Wrongful Death Morcellator Claim
Eddie Lee Jackson from Chicago filed a wrongful death morcellator uterine cancer claim in the U.S. District Court for the Northern District of Illinois.
Jackson alleges that his wife, Bernadette McLaughlin-Jackson, died from complications of malignant leiomyosarcoma cancer, which was spread throughout her abdomen by an Ethicon morcellator.
McLaughlin-Jackson underwent a laparoscopic hysterectomy for uterine fibroid removal in April 2008. She died in May 2011, shortly after she was diagnosed with an aggressive advanced stage leiomyosarcoma. According to Jackson, Bernadette’s undiagnosed cancer was localized to the uterus, but it was upstaged to metastatic levels by the morcellator use.
What are Power Morcellator Devices?
Power morcellators grind up fibroids which are benign growths in the uterus, so doctors can remove the chopped up or morcellated tissue through small incisions made during a laparoscopic hysterectomy.
Gynecological surgeons routinely used the devices before April 2014, but then when the U.S. Food and Drug Administration warned that women undergoing fibroid operations have a 1 in 350 chance of a uterine sarcoma that can’t be reliably detected before the procedure.
The FDA said that power morcellators can spread undiagnosed uterine cancer tissue within the abdomen and pelvis, significantly worsening a woman’s chances of long-term survival. Women who developed uterine cancer after hysterectomy, in many cases are facing a death sentence with an appalling 5 year survival, despite aggressive chemotherapy regimens which is usually ineffective.
Many women have been diagnosed with leiomyosarcoma, endometrial stromal sarcoma or other aggressive forms of uterine cancer that was spread by Ethicon morcellators. J&J’s Ethicon unit had the largest morcellator share of the market, with over 70% of units used.
J&J Ethicon Morcellator Wrongful Death Claims
The plaintiffs have filed wrongful-death and product-liability claims against J&J’s Ethicon division alleging that the medical device giant company knew or should have known that the surgical tools sprayed undiagnosed cancer cells but didn’t take adequate action, and that the products were essentially a defective design because of the difficulty of differentiating a fibroid from a uterine sarcoma.
FDA Reluctantly Investigates
The FDA began looking into possible risks of laparoscopic hysterectomy surgery with the device after a 40-year-old anesthesiologist Amy Reed, went public in a Wall Street Journal article detailing her worsened cancer after a hysterectomy using the device.
Dr Reed has sued another morcellator maker, Karl Storz GmbH, in a case pending in a Massachusetts state court, as well as the Boston hospital and doctors involved in her care. Dr Reed, a mother of six who now lives in Philadelphia, has had multiple recurrences and continues to fight advanced metastatic cancer.
According to several medical experts, many women never had the chance to discover why they developed the deadly cancer and those they left behind have no idea what happened to them. There must be be hundreds of grieving families who to this date have not made the connection to the death of their loved one from post hysterectomy cancer and the deadly morcellator device.
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Johnson and Johnson is Settling Power Morcellator Cases!
Mar 21, 2016 | Legal Reader
By Jay W. Belle Isle
The news was confirmed this past Friday: Johnson and Johnson is settling power morcellator cases! The Big Pharma/Medical Device company is not known for settling much of anything, but it has started the process of settling these product liability cases only months after many of them were consolidated into a multi-district litigation (MDL) by a judicial panel.
According to Aimee Wagstaff of Andrus Wagstaff, a co-lead plaintiffs’ lawyer in the MDL, there are about 100 cases either ready to file or already filed and J&J has already settled several of them. She added that other attorneys have many more cases ready to be added to the MDL, “I know that there are hundreds that remain under investigation around the country.”
The Judicial Panel on Multidistrict Litigation (JPML) found that 650,000 women have surgery to take care of symptomatic uterine fibroids. The JPML also discovered that laparoscopic power morcellation procedures were becoming more popular than conventional procedures. It came to this knowledge in October 2015 when it decided to create the MDL.
The following month, the FDA issued a guidance warning about the laparoscopic power morcellators. The instruments – essentially grinders that break up larger chunks of tissue for removal via stomach incision – could cause the spread of cancer in those patients with undiagnosed cancers. The guidance warning said that the morcellators should not be used in any gynecological surgery dealing with cancer or fibroids. The FDA found that if uterine tissue contained an undiagnosed cancer, the morcellators could actually spread it throughout the abdomen, thus decreasing the chances of long-term patient survival.
According to the FDA, roughly 11% of the 500,000 hysterectomies done in the U.S. every year are done with power morcellators. Uterine fibroids are a common health issue and are typically benign, however, around one in every 350 women having fibroids removed or a hysterectomy performed has an undiagnosed uterine cancer known as uterine sarcoma.
In July 2014, J&J’s Ethicon unit (producers of the morcellators) conducted a worldwide recall of the Morcelex brand morcellators due to the potential dangers of its use. The company had suspended sales of the product in April 2014. The first lawsuit against Ethicon regarding power morcellators was filed in May 2014.
According to an Ethicon spokesperson’s October 2015 comment to Law360, “Because Ethicon acted appropriately and responsibly at all times in relation to our morcellation devices, we will defend ourselves in the lawsuits that have been filed against us.”
Something has obviously changed between then and now, as J&J is settling morcellator cases. No comment was available from Ethicon when the news broke on Friday.
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Johnson & Johnson Settling Claims that Power Morcellator Spreads Women’s Cancers
Mar 22, 2016 | Press Release
By F.A Kelley
Johnson & Johnson is settling a series of legal claims and lawsuits alleging that a discontinued surgical device harmed women by spreading an undetected hidden cancer, according to court documents and lawyers with knowledge of the settlements.
An estimated 100 cases have either been filed—or readied for lawsuits—against J&J’s Ethicon unit related to power morcellator, a device used in uterine fibroid surgery and hysterectomies. A consolidated litigation is underway in a Kansas City, Kansas federal court, the Wall Street Journal reports.
The power morcellator is used in uterine fibroid surgeries and hysterectomies. The device is inserted via a small incision. The morcellator’s rapidly spinning blades cut tissue into tiny pieces that can be removed through the incision. But if the uterine tissue contains cancerous cells—which are virtually impossible to detect prior to surgery—the procedure can spread the cancer throughout the abdomen, where it rapidly becomes more aggressive and this sharply reduces the woman’s long-term survival chances.
Of the 100 or so claims, J&J has settled nearly 70 over the past few months, according to an attorney involved. Individual settlements vary by case, but so far have ranged from $100,000 to roughly $1 million, according to the WSJ. Talks are reportedly ongoing to settle other morcellator claims. The amounts in individual settlements are confidential and they vary depending on such factors as the woman’s age, her medical condition, and whether she has children, according to people familiar with the settlements. Lawyers for the plaintiffs are pushing for cases to move quickly because many of the women are seriously ill.
The power morcellator was routinely used before April 2014, when the U.S. Food and Drug Administration (FDA) warned women undergoing fibroid surgeries that they have a 1 in 350 chance of harboring cancer that cannot reliably be detected prior to surgery, according to the WSJ. Although the morcellator has not been banned—as some have called for—many hospitals have restricted its use to carefully screened patients and a number of health insurers have decided they will no longer cover routine use of the morcellator in fibroid surgery and hysterectomies.
J&J said the company discloses overall litigation expenses in its regulatory filings, but does not break out morcellator litigation costs separately. A company spokesperson declined to comment on the settlements. The company suspended sales of its morcellator in April 2014 and withdrew it from the market in July 2014.
Dr. Hooman Noorchashm, husband of a woman who has brought suit because morcellator surgery worsened her cancer, lamented that settlements would prevent a public airing of all the facts about morcellators, the WSJ reports. “Each one of these cases is an opportunity to create a public record about what went wrong—both ethically and at a regulatory level—so nothing like it happens again,” he said.
The U.S. Government Accountability Office is in the midst of a probe of why the device remained on the market for two decades before the FDA warned it can spread uterine cancer. The FDA has said it plans to fully cooperate with the investigation.
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