Preview Newsletter
Morcellation Media Monitoring 12/03/2015
-
Will Congress move to stop women’s health disaster?
Dec 1, 2015 | Philadelphia Inquirer
By Amy Reed and Hooman Noorchashm
We first met U.S. Rep. Mike Fitzpatrick as he was walking along a New Year’s Day parade in downtown Yardley, Pa. We approached him with our six children in tow and asked if he had a moment to hear our story. -
Attorneys Appointed to Leadership Roles in Ethicon Morcellation Cancer Lawsuits
Nov 30, 2015 | AboutLawsuits.com
By Austin Kirk
As a growing number of Ethicon morcellator lawsuits continue to be filed on behalf of women diagnosed with uterine cancer following a laparoscopic hysterectomy or uterine fibroid removal, the U.S. District Judge recently appointed to preside over the litigation has appointed a group of plaintiffs’ attorneys to serve in various leadership roles during discovery and pretrial proceedings. -
FDA’s 510(k) Approval Process One Focus of Morcellator Lawsuits
Nov 30, 2015 | The Legal Examiner
By Steven Davis
Approximately 28 morcellator lawsuits have been transferred to the U.S. District Court for the District of Kansas as part of a multidistrict litigation (MDL) consolidation. -
FDA Cites Lack Of Power Morcellation Adverse Event Reporting Despite Federal Law Requirement
Dec 1, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a recent announcement by the United States Food and Drug Administration which noted that Federal Law requires the reporting of adverse events, though none concerning power morcellation have been reported to the agency for 8 years. Prior to December of 2013, according to FDA officials, the agency had not received any reports of adverse outcomes due to laparoscopic power morcellation. -
Power Morcellator Lawsuit From Missouri Alleges Device Spread Cancer Cells From Fibroid
Dec 1, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on another lawsuit which has been filed on behalf of a deceased woman by her family. The suit was filed in Western Missouri against Ethicon, the manufacturers of the power morcellator device used in this plaintiff’s surgery. It alleges that the power morcellator used during the woman’s uterine fibroid removal and hysterectomy caused the uncovering and spreading of previously undetected cancer cells. This spreading, the family alleges, created a high-grade and aggressive cancer which was ultimately the cause of the woman’s death. -
Officials To Investigate Dangers Of Power Morcellation On Uterine Fibroids
Dec 1, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports that the U.S. Government Accountability Office has announced that it will, in fact, be investigating the use of laparoscopic power morcellators during gynecological surgeries on uterine fibroids. The devices, which have been the topic of many recent lawsuits, are alleged to spread previously undetected cancers when used in this fashion.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
-
Will Congress move to stop women’s health disaster?
Dec 1, 2015 | Philadelphia Inquirer
By Amy Reed and Hooman Noorchashm
We first met U.S. Rep. Mike Fitzpatrick as he was walking along a New Year’s Day parade in downtown Yardley, Pa. We approached him with our six children in tow and asked if he had a moment to hear our story.
We told him about how a medical device, known as a “power morcellator”, had for over two decades been spreading occult uterine cancers to an incurable advanced stage in up to one in 350 women who undergo morcellation.
You can read about this devastating hazard here and here.
After listening to us for about 45 minutes in the cold rain, he said his office would be in touch. A few weeks later, we got the call. Fitzpatrick wrote a letter of inquiry to the FDA commissioner on Feb. 19 about how this medical device had stayed on the market for so long.
Fitzpatrick promised to inform the leadership and ranking members of the congressional committee on Energy and Commerce (E&C) of this issue, including Chairman Fred Upton (MI-06), Subcommittee on Health Chairman, Joe Pitts (PA-16) and Subcommittee on Oversight and Investigation Chairman, Tim Murphy (PA-18). He also brought the matter to subcommittee on Health, Dr. Michael Burgess (TX-26), a gynecologist.
Our multiple queries to Pitts for a comment on this topic have gone unanswered. Burgess single-handedly dismantled 12 common sense “concern of congress” amendments to a House bill, known as “21st Century Cures”, proposed by Fitzpatrick. Our repeated requests for comment from Burgess have also gone unanswered.
In the meanwhile, Fitzpatrick rallied a bipartisan group of 12 colleagues in the House to request an investigation of the power morcellator by the Government Accountability Office (GAO). This investigation will be initiated shortly.
Almost nine months after Fitzpatrick’s letter to FDA was submitted, he received a “partial-response” on November 12, authored by the FDA’s Acting Associate Commissioner on Legislation, Dayle Cristinzio.
In this letter FDA confirmed that hospitals and medical device manufacturers have a legal duty to self-report adverse outcomes and deaths related to the use of medical devices. FDA also confirmed that in the case of power morcellators, no adverse outcomes had been reported until December 2013 - 20 years after the device began causing harm.
When the hazard finally was reported, it was patients, their families and advocates that brought the problem to the FDA.
On Nov. 17, Murphy’s office alerted us to a hearing being held that day at which the congressman would be questioning witnesses on “Examining the Regulation of Diagnostic Tests and Laboratory Operations.’’
The witness was the director of the FDA’s Center for Devices and Radiological Health, Dr. Jeffrey Shuren. Here is the exchange between Shuren and Murphy at the hearing – which makes it clear that Murphy recognizes that several medical device manufacturers and hospital corporations violated federal law by failing to report harm caused by morcellation. It also makes it clear that Murphy is joining Fitzpatrick in speaking out on the matter.
Time will tell if Congress as a whole follows the lead of these Pennsylvania Republicans in addressing this women’s health disaster.
-
Attorneys Appointed to Leadership Roles in Ethicon Morcellation Cancer Lawsuits
Nov 30, 2015 | AboutLawsuits.com
By Austin Kirk
As a growing number of Ethicon morcellator lawsuits continue to be filed on behalf of women diagnosed with uterine cancer following a laparoscopic hysterectomy or uterine fibroid removal, the U.S. District Judge recently appointed to preside over the litigation has appointed a group of plaintiffs’ attorneys to serve in various leadership roles during discovery and pretrial proceedings.
Last month, the U.S. Judicial Panel on Multidistrict Litigation ordered that all product liability lawsuits filed against Johnson & Johnson’s Ethicon subsidiary over the spread of cancer from uterine morcellation will be centralized before U.S. District Judge Kathryn H. Vratil in the District of Kansas as part of a federal MDL, or multidistrict litigation.
Following an initial status conference earlier this month to discuss the organizational structure for the coordinated pretrial proceedings, Judge Vratil issued an order (PDF) that appoints 20 different lawyers to take leadership roles in the MDL.
Attorneys Paul J. Pennock and Aimee Wagstaff were appointed to serve as Co-Lead Counsel, with Kirk Goza and Robert Horn appointed as Co-Liaison Counsel. An additional group of 16 lawyers were appointed to a Plaintiff’s Steering Committee, which will conduct the coordinated discovery, argue motions before the court and negotiate potential stipulations or settlements during the proceedings.
Status of Ethicon Morcellator Lawsuits
There are currently only about two dozen complaints pending in the MDL, but as Ethicon morcellation lawyers continue to review and file claims for women and families throughout the U.S., it is ultimately expected that several hundred claims will be centralized before Judge Vratil.
Each of the complaints raise similar allegations, indicating that Ethicon sold a defective and unreasonably dangerous medical device, failing to warn about the link between laparoscopic morcellation and cancer.
Morcellators have been used in recent years during minimally invasive hysterectomy and myomectomy procedures for removal of uterine fibroids, allowing the doctor to cut up and remove the uterus or fibroids through a small incision in the abdomen. However, the devices have been largely abandoned by the medical community over the past year after it was discovered that they pose a substantial risk for some women who may have undiagnosed cancer cells contained within their uterus.
In April 2014, the FDA estimated that about one out of every 350 women undergoing surgery for symptomatic uterine fibroids may have unsuspected sarcoma, which doctors are unable to detect or diagnose before the procedure.
For these women, side effects of morcellation may cause the rapid dissemination of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers to an advanced stage that is difficult to treat and often fatal.
Ethicon was the leading manufacturer of laparoscopic morcellators, but the company announced last year that it was no longer selling the devices after determining that there was no way to make them safer.
Plaintiffs allege that Ethicon knew or should have known for years about the cancer risks associated with morcellators, yet withheld information from women and the medical community. Lawsuits indicate that women may have avoided the rapid upstaging of their uterine cancer if alternative fibroid treatment options has bee used, such as traditional surgical hysterectomy performed vaginally or abdominally, catheter-based blocking of the uterine artery, high-intensity focused ultrasound, drug therapy and laparoscopic hysterectomy or myomectomy without use of morcellation.
-
FDA’s 510(k) Approval Process One Focus of Morcellator Lawsuits
Nov 30, 2015 | The Legal Examiner
By Steven Davis
Approximately 28 morcellator lawsuits have been transferred to the U.S. District Court for the District of Kansas as part of a multidistrict litigation (MDL) consolidation.
The lawsuits against Johnson & Johnson (J&J) involve power morcellators, currently one of the most controversial medical devices in the U.S. J&J is accused of hiding knowledge that its Ethicon power morcellator could spread undetected uterine cancer during hysterectomies and surgical procedures to remove fibroids.
The morcellator lawsuits also question the U.S. Food and Drug Administration’s controversial 510(k) approval process, since the power morcellator was cleared for sale under this protocol. According to a Wall Street Journal report, the FDA has approved 10 power morcellator devices under this 510(k) process over the last 24 years.
In 2012, U.S. Senator Jeff Merkley and Congressman Edward Markey sent a letter to the FDA expressing their concerns about the “weakness in the premarket review process used to evaluate most medical devices,” noting that “a flaw in the 510(k) process opens the door for defective devices to make their way onto the market and jeopardize patient safety.” However, the only revision made to the 510(k) process has been a 2014 guidance document for device manufacturers that “is not intended to implement significant policy changes to the current 510(k) review process.”
FDA’s 510(k) Process
The FDA’s 510(k) approval process enables manufacturers of medical devices to “fast track” a product’s approval by avoiding clinical trials. Technically, the FDA’s 510(k) process does not approve medical devices; rather, they are cleared for sale. If a product is cleared, the FDA will mail the manufacturer a letter with an assigned 510(k) number stating that they have determined that the device is substantially equivalent to legally marketed predicate devices, and the device may be marketed subject to the general controls provisions of the Food, Drug and Cosmetics Act.
The medical device manufacturer is required to register the device on the FDA website using the 510(k) identification number. The FDA also charges the manufacturer an annual fee to remain clear for medical device sales within the U.S. Once a FDA 510(k) number has been granted, it does not expire, but medical device manufacturers must remain in compliance with all FDA regulations to continue selling their product in the US.
-
FDA Cites Lack Of Power Morcellation Adverse Event Reporting Despite Federal Law Requirement
Dec 1, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on a recent announcement by the United States Food and Drug Administration which noted that Federal Law requires the reporting of adverse events, though none concerning power morcellation have been reported to the agency for 8 years. Prior to December of 2013, according to FDA officials, the agency had not received any reports of adverse outcomes due to laparoscopic power morcellation.
A statement by the agency to The Cancer Letter explained: “Of note, prior to December, the FDA had received no MDRs specifically on cancer and upstaging/dissemination.” In addition, they shared: “Since then, the agency has become aware of about two dozen that have discussed ‘cancer’ and ‘upstaging or dissemination’ as of November 2014. All of these reports pertained to procedures that took place prior to December 2013.”
Power morcellators are commonly used in gynecological surgeries such as hysterectomies and myomectomies. They provide a less invasive option to open surgery for the removal of troublesome uterine tissue and fibroids. Power morcellators work much like a drill. They are inserted into the abdomen through a small incision. Once inside, they whip around small blades designed to shred tissue into small pieces, so that it is able to be removed from the body. According to many recent lawsuits, however, as the device shreds the tissue, it can allegedly uncover previously hidden cancer cells and spread them throughout the body, accelerating the cancer and negatively impacting the life expectancy of the patient.
In 2014, the U.S. Food and Drug Administration announced a safety advisory warning and estimated that approximately 1 in every 350 women who undergo laparoscopic power morcellation to treat uterine fibroids may have previously undetected uterine sarcomas, including leiomyosarcoma. The FDA warned that most women should refrain from using power morcellation during surgeries to avoid the risk of spreading these undetected cancers.
Cases against power morcellators manufactured by Ethicon, (a division of Johnson & Johnson), have been consolidated under one court. This consolidation will help litigation to move more efficiently and will conserve resources for all involved. As these cases await trial, it is expected that additional suits will be filed.
The attorneys at Tracey and Fox are working to ensure that everyone who has undergone power morcellation and who was subsequently diagnosed with cancer has the opportunity to explore their legal rights. These individuals and their families may be entitled to substantial compensation.
For more information regarding power morcellator lawsuits or to ask questions, contact Tracey & Fox by calling (713) 322-5375.
-
Power Morcellator Lawsuit From Missouri Alleges Device Spread Cancer Cells From Fibroid
Dec 1, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports on another lawsuit which has been filed on behalf of a deceased woman by her family. The suit was filed in Western Missouri against Ethicon, the manufacturers of the power morcellator device used in this plaintiff’s surgery. It alleges that the power morcellator used during the woman’s uterine fibroid removal and hysterectomy caused the uncovering and spreading of previously undetected cancer cells. This spreading, the family alleges, created a high-grade and aggressive cancer which was ultimately the cause of the woman’s death.
Ethicon, just one of many power morcellator manufacturing companies, is a subsidiary of pharmaceutical giant Johnson & Johnson. Since being named in an increasing number of lawsuits, Ethicon has ceased all manufacturing of their power morcellator devices and has even recalled those currently on the market.
Details of this specific lawsuit state that the Missouri woman underwent surgery with a laparoscopic power morcellator in order to remove uterine fibroids that had developed and were causing her pain. The morcellator is designed to use small, whipping blades to shred the fibroid tissue so that it is able to be removed from the body. As it does this, however, many plaintiffs now allege that it can also uncover cancer cells encapsulated in those fibroids, and spread the cancer cells outside of the uterine walls and around the body. This process allegedly accelerates the cancer and greatly threatens the life expectancy of the patient. In this particular case, the woman was given a fatal cancer diagnosis after surgery, and died due to metastatic uterine cancer less than two years later.
As many who have experienced similar outcomes allege, the family states that if the cancer cells had not been disseminated by laparoscopic power morcellation, the cancer would have remained encapsulated within the uterine fibroid, and the cancer may have responded to treatment before it spread.
As lawsuits have increasingly appeared alleging that laparoscopic power morcellation during uterine fibroid surgeries can cause the spread of cancer, the United States Food and Drug Administration also issued a safety warning concerning the topic. They stated that their estimates showed that around 1 in every 350 women who undergo gynecological surgeries with a laparoscopic power morcellator may have undetected cancer within their uterine fibroids. The FDA suggested that most women should refrain from undergoing power morcellation procedures of these types, due to the risk of spreading uterine sarcomas.
Current lawsuits surrounding power morcellation have now been consolidated to form multidistrict litigation. This consolidation is designed to help litigation move forward more smoothly. It avoids duplicate discovery and different rulings from multiple judges, and also conserves the resources of those involved.
As these cases await trial, the attorneys at Tracey & Fox are helping to ensure that everyone who has undergone laparoscopic power morcellation and who has subsequently been diagnosed with cancer has the opportunity to explore their legal rights. These women and their families may be entitled to significant compensation. The attorneys at Tracey & Fox are offering free power morcellation legal consultations.
To obtain additional information on power morcellation and cancer, or to ask questions, please call the attorneys at Tracey & Fox at (713) 322-5375.
-
Officials To Investigate Dangers Of Power Morcellation On Uterine Fibroids
Dec 1, 2015 | Press Release
By Tracey & Fox
Tracey & Fox reports that the U.S. Government Accountability Office has announced that it will, in fact, be investigating the use of laparoscopic power morcellators during gynecological surgeries on uterine fibroids. The devices, which have been the topic of many recent lawsuits, are alleged to spread previously undetected cancers when used in this fashion.
Power morcellators provide a less-invasive gynecological surgery option for women getting hysterectomies or myomectomies. The tool is able to be inserted through a small incision in the lower abdomen, where it rapidly spins tiny blades designed to shred uterine tissue and uterine fibroid tissue apart. These torn tissue pieces are then able to be removed from the abdominal cavity. As many plaintiffs in the current lawsuits state, however, as the tool shreds these tissues, it can uncover previously hidden cancers and spread those cancer cells throughout the body, upstaging the cancer and helping it to spread. This can significantly impair the patient’s chances of survival.
The U.S. Food and Drug Administration has recently spoken out regarding the process as well, indicating that an estimated 1 in every 350 women who undergo laparoscopic power morcellation on uterine fibroids may have hidden sarcomas, which can be spread by the device. The FDA warned that most women should refrain from undergoing gynecological surgeries involving power morcellator devices.
It has recently been reported that the Government Accountability Office has agreed to conduct an official investigation into laparoscopic power morcellation use. They were contacted about looking into the matter in August by 12 members of congress who wrote a concerned letter discussing the device. According to a Wall Street Journal article, the letter stated: “Hundreds, if not thousands of women in America are dead because of a medical device known as the laparoscopic power morcellator.”
Lawsuits have been filed against multiple power morcellator manufacturers. Those involving claims against Ethicon morcellators (a division of Johnson & Johnson), have been consolidated to form multidistrict litigation for pretrial proceedings. As these lawsuits await trial, many anticipate that others will join them.
The attorneys at Tracey & Fox are working to ensure that everyone who has undergone laparoscopic power morcellation and who was subsequently diagnosed with cancer will have the opportunity to explore their legal rights. These individuals and their families may be entitled to substantial compensation. Tracey & Fox is offering free legal consultations for those affected.
For more information on power morcellation lawsuits, or to ask questions, contact the attorneys at Tracey & Fox by calling (713) 322-5375.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
Add recipients
Suggested