Preview Newsletter
Morcellation Media Monitoring 01/14/2016
-
GOP Lawmaker Asks FDA for Criminal Inquiry Into J&J Device
Jan 11, 2016 | Bloomberg BNA
By Michael D. Williamson
The FDA's criminal investigators should examine why a device maker and hospitals didn't alert the agency to potentially fatal problems with a controversial gynecological medical device, according to a Republican lawmaker. -
Power Morcellation Can Free a Hidden Enemy
Jan 11, 2016 | LawyersAndSettlements.com
By Gordon Gibb
A laparoscopic power morcellation lawsuit filed last January, while a year old, is nonetheless a worthy representation of the issues involved with the use of power morcellation to bust up uterine fibroids via minimally invasive surgery. Specifically, concern continues to mount over the risk of spreading previously undetected cancer cells within the body, threatening the health of the patient in the process. -
Investigation into Morcellator Deaths
Jan 13, 2016 | Legal Examiner
By Andrew D'Acry
U.S. Congressman, Michael Fitzpatrick (R-PA) has asked the Food and Drug Administration’s Office of Criminal Investigations to investigate allegations that hundreds of women have died as a result of surgical procedures done with a power morcellator. This is a controversial device that can unwittingly spread cancer in women who had uterine fibroids removed or hysterectomies performed. The FDA has warned that morcellators should not be used in most patients. The agency said the risk of spreading a hidden cancer masking as a uterine fibroid was 1 in 352. The most prominent manufacturers of morcellators is Ethicon, a subsidiary of Johnson & Johnson. -
Ethicon Power Morcellator Uterine Cancer Lawsuits Make History With First Women-Majority MDL
Jan 14, 2016 | Press Release
By Banville Law
Banville Law reports on a significant moment in history as the lawsuits involved in the Ethicon power morcellator MDL (no. 2652) are given the first women-majority. Though this occurrence is long overdue, the topic at hand has been noted as perhaps the most important Women’s Issue Litigation since the transvaginal mesh lawsuits. Not only is this news exciting for those in the legal profession, but also for women involved in current power morcellator litigation. -
FBI Investigates Ethicon's Power Morcellator Knowledge Following Uterine Cancer Lawsuits
Jan 12, 2016 | Press Release
By Banville Law
Banville Law reports on a story released by The Science Times which discusses the investigation into whether or not Johnson & Johnson (Ethicon) was previously aware of the harm that their power morcellator tool could cause. The article states that pharmaceutical giant Johnson & Johnson is now under FBI investigation due to allegations that they had prior knowledge about the cancer-spreading dangers that have been linked to their power morcellator medical devices. -
Cancer Letter Article on Power Morcellator Uterine Cancer Reports Issues With Previous FDA Evaluations
Jan 14, 2016 | Press Release
By Banville Law
Banville Law reports on an article recently published by The Cancer Letter, which highlights some problematic aspects of the FDA’s prior evaluation of medical devices, in wake of the recent power morcellator cancer lawsuit surge.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
-
GOP Lawmaker Asks FDA for Criminal Inquiry Into J&J Device
Jan 11, 2016 | Bloomberg BNA
By Michael D. Williamson
The FDA's criminal investigators should examine why a device maker and hospitals didn't alert the agency to potentially fatal problems with a controversial gynecological medical device, according to a Republican lawmaker.
Rep. Michael Fitzpatrick (R-Pa.) asked George Karavetsos, the director of the Food and Drug Administration's Office of Criminal Investigations, to determine if Johnson & Johnson unit Ethicon, a manufacturer of power morcellators linked to deaths, failed to report problems with the device.
Power morcellators are used to remove uterine fibroids through a procedure known as a laparoscopic incision. However, if a uterine fibroid contains an undetectable cancer, the device can spread the disease throughout a woman's body.
Meanwhile, Ethicon defended its filing of reports with the FDA. The company appropriately files device incident reports in a timely manner “once information is received or noticed by the company indicating that reporting is appropriate under reporting requirements,” Matthew Johnson, the director of corporate communications for Ethicon, said in a Jan. 8 e-mail to Bloomberg BNA.Hospitals Also Involved
The lawmaker, in a recent letter, also urged Karavetsos to investigate why Brigham and Women's Hospital in Boston, Rochester (N.Y.) General Hospital and the University of Rochester (N.Y.) Medical Center (URMC) didn't report patient deaths associated with the morcellator devices.
A URMC spokeswoman, in a Jan. 8 e-mail to Bloomberg BNA, defended the hospital's decision not to report a 2012 death cited in the lawmaker's letter. Rochester General Hospital didn't respond to a request for a comment.
In response to an inquiry from Bloomberg BNA, Brigham and Women’s Hospital said Jan. 11 that it “first contacted the FDA about the case identified in Rep. Fitzpatrick’s letter in early 2014, and has responded cooperatively to the FDA’s subsequent inquiries on this matter. Due to pending litigation, we are not able to provide additional information at this time.”
The FDA is “aware of the letter and we plan to respond to the Congressman via our usual process,” agency spokeswoman Deborah Kotz told Bloomberg BNA in a Jan. 6 e-mail.Patient Safety Regulations Not Working?
Fitzpatrick wrote that under the medical device reporting regulations, user facilities, including hospitals, must report a suspected device-related death to the FDA within 10 days after any information suggests that a device has or may have caused or contributed to a serious injury of a patient.
Likewise, “medical device manufacturers must report a suspected device-related death or serious injury to the FDA” within 30 days of receiving any information that suggests a company's product may have caused or contributed to a death or serious injury, Fitzpatrick wrote.
However, the current reporting regulations may not be working, according to the Pennsylvania Republican. Fitzpatrick added the first time the FDA received a report of death or serious injury “was neither from a user facility nor a device manufacturer.”
In fact, the FDA's first report about problems with morcellators was from a doctor citing the case of a family member who has a disseminated cancer that was suspected to have resulted from a procedure in which a power morcellator was used, Fitzpatrick's letter said.
According to the lawmaker, it shouldn't take a family devastated by this device to raise the issue to the FDA. “Had the regulations worked as intended, it is likely many women's lives could have been spared from the horrific consequences of morcellation.”Ethicon Knew in 2006?
Fitzgerald also accuses Ethicon of becoming aware of information that laparoscopic morcellators could facilitate the seeding of cancerous tumors in a woman's body by 2006.
A Pennsylvania pathologist, Robert Lamparter, warned Ethicon in 2006 that in about one in 300 hysterectomies performed at his hospital resulted in an endometrial carcinoma (cancer) that was unexpected at the time of the surgery, Fitzpatrick wrote.
The congressman asked Karavetsos if Ethicon reported the warnings of serious injury and death to patients undergoing procedures involving laparoscopic power morcellators received from Lamparter to the FDA. “If not, please explain in detail the analysis as to why Ethicon did not believe that information to be a reported event.”Ethicon, URMC Justify Reporting Decisions
Johnson, the Ethicon corporate communications director, told Bloomberg BNA the company made a determination “when we received Dr. Lamparter’s letters in 2006 that there was not a reportable event because he did not report an actual morcellation experience with a patient.”
However, Lamparter's questions prompted Ethicon to supplement the precautions contained in the device’s instructions for use “to address the issue of the preoperative pathologic evaluation of the endometrium,” he said, adding, “Ethicon’s morcellation devices have always carried a warning about the potential spread of cancerous tissue.”
In his Dec. 18 letter, Fitzpatrick also asked Karavetsos several questions about decisions by Brigham and Women's Hospital, Rochester General Hospital and URMC to not report several deaths potentially linked to power morcellators.
Like many hospitals across the country, URMC's Strong Memorial Hospital “didn't initially report its 2012 morcellation case to the FDA because it didn't appear to meet the criteria for medical device reporting,” Barbara Ficarra, the associate director of public relations and communications at URMC, said in a Jan. 8 e-mail.
“Historically, FDA required device facility users to report information when there is a patient death or serious illness or injury of a patient, caused or contributed to by instances of device failure, malfunction, improper or inadequate device design, manufacture, labeling or user error,” the URMC spokeswoman told Bloomberg BNA. “Based on our interpretation of this language at the time, it did not fit the definition of a device ‘failure.' The device functioned as expected and was used in the way it was intended, although with unintended and tragic consequences.”History
In November 2014, the FDA issued a “black box” label warning for the morcellators, which noted the devices could spread undetected cancer and decrease the long-term survival of patients.
More recently, a bipartisan group of House lawmakers last August urged the Government Accountability Office to investigate if the FDA's device clearance policies sufficiently identified risks of adverse events before the agency allowed the laparoscopic power morcellator to enter the market.
Several plaintiffs have sued Ethicon and parent company Johnson & Johnson over the effects of power morcellators.
-
Power Morcellation Can Free a Hidden Enemy
Jan 11, 2016 | LawyersAndSettlements.com
By Gordon Gibb
A laparoscopic power morcellation lawsuit filed last January, while a year old, is nonetheless a worthy representation of the issues involved with the use of power morcellation to bust up uterine fibroids via minimally invasive surgery. Specifically, concern continues to mount over the risk of spreading previously undetected cancer cells within the body, threatening the health of the patient in the process.
In this case, the plaintiff went into the hospital for a hysterectomy and a bilateral salpingectomy - one of the most common treatments for fibroids. Historically, such a procedure at one time involved invasive surgery. However, as modern medicine has moved to less-invasive techniques that require less healing time and an equally smaller draw on hospital resources, power morcellation was soon embraced as a preferred method of treatment.
This is no longer a preferred option, given the havoc power morcellation can wreak, with an impact to health far more devastating than merely a longer convalescence.
The plaintiff in question underwent the hysterectomy and a bilateral salpingectomy by way of power morcellation. It should be noted that prior to the power morcellation procedure, the plaintiff was cancer free.
That wasn’t the case following her treatment. Post-surgery, the patient was diagnosed with stage-4 cancer that subsequently spread into her bones and breasts.
In her laparoscopic power morcellation hysterectomy lawsuit, the plaintiff asserts that the process of morcellation to shred the fibrous tissue for subsequent removal freed previously undetected cancer cells encapsulated with the uterine fibroids, spreading cancer throughout her body.Some hospitals, at the point during which this started to become an issue, insisted on the use of an abdominal bag to trap and capture both the morcellated fibroid tissue and any potential cancer cells, preventing the potential spread of the undetected cancer. Other hospitals stopped using power morcellators altogether.
Ethicon, a division of Johnson & Johnson, pulled its power morcellator from the market. However, other manufacturers have yet to follow suit.
The US Food and Drug Administration (FDA) has since determined that power morcellation is no longer the preferred method by which to remove fibroids and has suggested its use is among dangerous medical procedures best avoided.
The power morcellation case referenced here is against Karl Storz Endovision Inc., the manufacturer of the particular power morcellator used in the procedure. The lawsuit, bearing Case No. 2:15-cv-10352-TGB-APP, was filed January 26 of last year in the US District Court for the Eastern Division of Michigan. -
Investigation into Morcellator Deaths
Jan 13, 2016 | Legal Examiner
By Andrew D'Acry
U.S. Congressman, Michael Fitzpatrick (R-PA) has asked the Food and Drug Administration’s Office of Criminal Investigations to investigate allegations that hundreds of women have died as a result of surgical procedures done with a power morcellator. This is a controversial device that can unwittingly spread cancer in women who had uterine fibroids removed or hysterectomies performed. The FDA has warned that morcellators should not be used in most patients. The agency said the risk of spreading a hidden cancer masking as a uterine fibroid was 1 in 352. The most prominent manufacturers of morcellators is Ethicon, a subsidiary of Johnson & Johnson.
In August, 2015, Rep. Mike Fitzpatrick, Rep. Louise Slaughter (D-NY), and a bipartisan group of lawmakers sent a letter to the U.S. Government Accountability Office, asking them to scrutinize what criteria the FDA used to clear morcellators and whether the medical device reporting regulations are being followed correctly.
Congressman Fitzpatrick is asking for an investigation of Ethicon which halted sales of morcellators in 2014. He also asked the FDA to investigate hospitals that used the devices extensively. In his letter to the FDA, Congressman Fitzpatrick specifically mentions three women who likely died from cancer upstaged by the device. The letter also questions whether those deaths were properly reported to the FDA.
Fitzpatrick has been aggressive in seeking to curtail the use of medical devices he believes are unsafe. Last year, he introduced the E-Free Act that would require the FDA to withdraw approval for Bayer’s Essure contraceptive. Also last year, he worked to have an amendment added to the 21st Century Cures Act, recommending that “unique device identifiers” be included in electronic health records to help improve the tracking of device-related adverse events.
-
Ethicon Power Morcellator Uterine Cancer Lawsuits Make History With First Women-Majority MDL
Jan 14, 2016 | Press Release
By Banville Law
Banville Law reports on a significant moment in history as the lawsuits involved in the Ethicon power morcellator MDL (no. 2652) are given the first women-majority. Though this occurrence is long overdue, the topic at hand has been noted as perhaps the most important Women’s Issue Litigation since the transvaginal mesh lawsuits. Not only is this news exciting for those in the legal profession, but also for women involved in current power morcellator litigation.
The new power morcellator multidistrict litigation leadership team includes incredibly intelligent and dedicated female legal advocates. Appointing Judge Kathryn H. Vratil, a Senior Judge in the United States District Court of Kansas has been applauded for these historic decisions, along with the plaintiff’s leadership team. Many believe, with good reason, that those best qualified to represent women are women. Now, these capable female attorneys will step forward to fight for justice for other women who underwent laparoscopic power morcellation and were later diagnosed with serious and even fatal cancers.
In making her choice for this MDL, the Honorable Judge Kathryn Vratil spoke eloquently but poignantly about “best practices” for future MDL’s, potentially changing the way that many people prepare for litigation moving forward.
Laparoscopic power morcellators are devices which are used to remove a woman’s uterine fibroids or troublesome pieces of tissue from the uterus during myomectomies and hysterectomies. The tool is considered capable of minimally-invasive surgery, as it can enter the abdomen through a small incision and work from inside, reducing the recovery time significantly for the patient involved.
Unfortunately, however, many have come to believe that as the tool is inserted into the abdomen to shred the fibroid tissue into small pieces which can later be removed from the body, it can also suddenly expose and spread previously undetected uterine cancer cells. This exposing and disseminating causes an aggressive and widespread cancer to form; one that is difficult to treat and often deadly. It significantly impairs the life expectancy for patients who undergo the procedure and is currently the subject of an FBI and FDA investigation.
Women in this situation deserve justice. For those who have been through this unfortunate experience but who have not yet filed suit to join this powerful, female MDL; it is likely not too late. The attorneys at Banville Law are currently working to assist power morcellator victims to pursue justice by offering free legal consultations. These women may be entitled to significant compensation.
To request information or ask questions, please contact Banville Law by calling 888-997-3792.
-
FBI Investigates Ethicon's Power Morcellator Knowledge Following Uterine Cancer Lawsuits
Jan 12, 2016 | Press Release
By Banville Law
Banville Law reports on a story released by The Science Times which discusses the investigation into whether or not Johnson & Johnson (Ethicon) was previously aware of the harm that their power morcellator tool could cause. The article states that pharmaceutical giant Johnson & Johnson is now under FBI investigation due to allegations that they had prior knowledge about the cancer-spreading dangers that have been linked to their power morcellator medical devices.
Though the devices were originally intended to provide a less invasive alternative to open surgeries for hysterectomies and myomectomies involving uterine fibroids, many now allege that the procedure actually exposes and spreads dangerous and even fatal uterine cancers among patients who undergo it.
Power Morcellator tools are inserted into the abdomen through a small incision, where they rapidly spin shredding blades designed to cut up uterine fibroid tissue into small pieces so that it can later be removed through a small, suctioning tube on the front of the device. Plaintiffs involved in the ever-increasing number of lawsuits surrounding the devices, however, allege that as the tool shreds apart tissue, it can uncover previously undetected cancer cells. In addition, they allege that the spinning motion of the tool then spreads and therefore accelerates these cancer cells, creating a widespread, high-grade cancer diagnosis post-surgery, and significantly impacting the life expectancy of the patient.
The article indicates that the FBI’s investigation specifically centers around how long Johnson & Johnson may have been aware of this cancer spreading danger, before they took action. After a 2014 safety warning regarding the device by the FDA, the company ceased all production of the tools and recalled those currently in use and on the market. However, many indicate that this action should have taken place years before, as complaints connecting the device to the spreading of cancer and even death have been noted from 10 or more years ago.
According to the article: “With the investigation ongoing, details from the FBI have been scarce, but it appears complaints from medical personnel about the potential dangers of the morcellator have been ongoing for years. By law, manufacturers, doctors, and hospitals are required to notify the FDA of any potential harmful effects of medical products. Physicians involved in the investigation claim they notified Johnson & Johnson as far back as 2006 about the dangers of using the morcellator on women at high risk for cancer.”
During the FDA’s 2014 safety warning, they estimated that approximately 1 out of every 350 women who currently undergo laparoscopic power morcellation for fibroid removal may have unsuspected uterine sarcomas. If encapsulated within a uterine fibroid, the cancer cells are virtually impossible to detect prior to surgery.
As cases against various power morcellator devices continue to surge, the attorneys at Banville Law are working to help those who have suffered. All women who have undergone power morcellation and who were later diagnosed with cancer may qualify for legal action and significant compensation. To help these women and their families seek justice, Banville Law is currently offering them free legal consultations.
To ask questions or request further information on power morcellation lawsuits, please contact Banville Law by calling (888) 997-3792.
-
Jan 14, 2016 | Press Release
By Banville Law
Banville Law reports on an article recently published byThe Cancer Letter, which highlights some problematic aspects of the FDA’s prior evaluation of medical devices, in wake of the recent power morcellator cancer lawsuit surge.
According to information found within the article, the FDA does not assess the risks potentially posed by a vast majority of medical devices currently used. The article says, in a bulleted statement, “Instead of focusing on risk, FDA’s Class II 510 (k) process clears products for the market based on ‘substantial equivalence’ to comparable devices that are already on the market. The power morcellator is one example where preemptive risk assessment by the agency might have gauged the potential for harm to a subset of women, experts said to The Cancer Letter.”
Plaintiffs involved in lawsuits against the device commonly discuss this 510(k) approval process and the issues that could lie within it. Power morcellator tools were approved through this process, so their approval was fast-tracked, skipping much of the rigorous testing due to the fact that they were similar to devices which had already been approved and released to the public.
Another interesting point that The Cancer Letter article brings up is that, although there are stipulations currently in place which require hospitals and manufacturers to “self-report” adverse outcomes directly to the U.S. Food and Drug Administration, the FDA does not “actively look for those” who neglect to report.
As these issues are brought to light, they continue to draw concern. Currently, lawsuits filed against various manufacturers of power morcellator devices continue to add up, and those filed against Ethicon morcellators have been consolidated by the JPML in multidistrict litigation number 2652. These cases will be heard in the United States District of Kansas and overseen by Judge Kathryn H. Vratil. Plaintiffs involved all similarly agree that when women undergo laparoscopic power morcellation during gynecological surgeries, they are putting themselves at increased risk for the spreading of uterine cancer cells they may be completely unaware of.
The attorneys at Banville Law are dedicated to helping ensure that all women who have experienced a serious cancer diagnosis after undergoing power morcellation to remove uterine fibroids will have the opportunity to explore their legal rights. These women may be entitled to legal action and compensation. Banville Law is offering complimentary consultations to those involved.
To request more information regarding power morcellators, or ask questions, please contact the attorneys at Banville Law by calling 888-997-3792.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
Add recipients
Suggested