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Morcellation Media Monitoring 01/11/2016
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PA rep Fitzpatrick wants FDA to launch criminal probe into morcellator deaths
Jan 7, 2016 | Mass Device
By Brad Perriello
Rep. Mike Fitzpatrick (R-Pa.) wants the FDA to open a criminal investigation of several deaths associated with laparoscopic power morcellators used during surgeries to remove ostensibly benign uterine tumors. -
FDA Investigates Uterine Cancer Wrongful Death Following Hysterectomy
Jan 8, 2016 | The Legal Examiner
By Shezad Malik MD JD
Michael G. Fitzpatrick, representative of the 8th district of Pennsylvania, has asked the FDA’s Office of Criminal Investigations, to investigate whether three hospitals violated mandatory reporting policies in wrongful deaths related to the use of power morcellators during gynecological surgery. -
U.S. Lawmaker Wants Morcellator Cancer Deaths Criminally Investigated By The FDA
Jan 9, 2016 | Press Release
By Southern Med Law
U.S. Rep. Mike Fitzpatrick (R-Pa.) has called for the U.S. Food and Drug Administration (FDA) to launch a criminal investigation into certain deaths linked to laparoscopic power morcellators at hospitals in New York and Massachusetts.
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PA rep Fitzpatrick wants FDA to launch criminal probe into morcellator deaths
Jan 7, 2016 | Mass Device
By Brad Perriello
Rep. Mike Fitzpatrick (R-Pa.) wants the FDA to open a criminal investigation of several deaths associated with 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 2014, the FDA ordered 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.
Fitzpatrick, citing FDA regulations requiring hospitals and medical device companies to report any incidents that “reasonably suggests that a device has or may have caused or contributed to the death of a patient of your facility,” asked the agency’s Office of Criminal Investigations to open a probe into deaths at Boston’s Brigham & Women’s Hospital, Rochester General Hospital and the University of Rochester Medical Center involving morcellators made by Johnson & Johnson(NYSE:JNJ) subsidiary Ethicon. That company recalled its morcellators in July 2014, after pulling them from the market in April of that year.
“For the over 2 decades since the power morcellator was 1st cleared for use on patients, the FDA’s Medical Device Reporting regulations failed to catch the severe dangers posed to women’s health by morcellation. The FDA stated in a response letter to my office dated Nov. 12, 2015, that ‘[p]rior to late 2013, FDA did not receive any adverse reports related to the spread or upstaging of unsuspected cancer through morcellation of uterine tissue,'” Fitzpatrick wrote.
“In fact, the 1st time the FDA received a report of death or serious injury was neither from a user facility nor a device manufacturer. It was ‘from a physician 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.’ It should not have taken a family devastated by this device to raise the issue to the FDA. Had the regulations works as intended, it is likely many women’s lives could have been spared from the horrific consequences of morcellation,” he wrote in the Dec. 18 letter.
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FDA Investigates Uterine Cancer Wrongful Death Following Hysterectomy
Jan 8, 2016 | The Legal Examiner
By Shezad Malik MD JD
Michael G. Fitzpatrick, representative of the 8th district of Pennsylvania, has asked the FDA’s Office of Criminal Investigations, to investigate whether three hospitals violated mandatory reporting policies in wrongful deaths related to the use of power morcellators during gynecological surgery.
Brigham and Women’s Hospital (of Boston); Rochester General Hospital; and the University of Rochester Medical Center are implicated in failing to report these surgical deaths, that were likely related to the use of morcellators at the hospital as part of surgical procedures there.
What are Power Morcellators?
Power morcellators are surgical medical devices that are used to grind up uterine tissue for easy removal during minimally invasive laparoscopic surgeries, during hysterectomies and myomectomies (removal of uterine fibroid tumors).
The use of these grinder devices has come under close scrutiny and warnings, because they may spread undetected uterine cancer cells, accelerating the death of a number of women who had morcellator-enabled surgeries.
Unreported Uterine Cancer Wrongful Death
Brigham and Women’s Hospital, where Erica Kaitz had surgery with a power morcellator on June 2012 and died of a leiomyosarcoma that was undetected and likely spread by morcellation.
Rochester General Hospital, where Barb Leary also had surgery with morcellation in 2009 and died of leiomyosarcoma that was undetected and spread by the surgery. Linda Interlichia, who was operated on in 2013 died the following year of the same cause.
University of Rochester Medical Center, where Brenda Leuzzi had surgery in 2012 that led to a similar outcome two years later.
Latest Power Morcellator Lawsuit
Audrey and Darryl Rayford from Louisiana, filed their complaint in U.S. District Court for the Western District of Louisiana on December 15, alleging that Audrey Rayford underwent a laparoscopic supracervical hysterectomy using power morcellation in December 2014.
According to the Rayfords, the power morcellator device manufactured by Storz Americaa, led to the spread of a potentially deadly uterine cancer in the wife. The Rayfords said the company failed to alert doctors and the general public to the risk that the device could spread undetected cancer cells, making the cancer much more difficult to treat.
Risk of Uterine Cancer Spread With Power Morcellation
Women with undetected uterine cancer that undergo power morcellation procedures may find the cancer spreads during the surgery, making it much more difficult to treat.
According to Rayford, prior to her surgery she had no evidence of metastasized uterine cancer but after her procedure, Rayford was told she had cancer of the uterus. She later discovered that the use of morcellation during her surgery cause the spread or upstaging of her cancer.
Deadly Uterine Sarcoma Spread Linked to Morcellators
Undiagnosed uterine sarcoma is a type of cancer that can be be spread by morcellation procedures. Uterine sarcoma is a rare form of uterine cancer that typically has a good prognosis if the cancer is detected before it spreads to the abdomen and pelvis. Once the uterine cancer has metastasized, cancer treatment becomes less successful and leads to early death usually within 2 years of diagnosis.
FDA 2014 Warning
In April 2014, the FDA issued a warning notifying doctors and patients that power morcellators could spread undetected uterine cancer cells. There is no reliable method to diagnose if cancer cells are present prior to a hysterectomy procedure, and so the FDA recommended at the time that patients be counseled on the risks associated with power morcellators.
The FDA also advised that morcellators should not be used in the majority of hysterectomies and myomectomies, since open or vaginal procedures are associated with better results and fewer complications.
FDA Morcellator Black Box Warning
On July 30, 2014, Johnson & Johnson subsidiary, Ethicon, announced a voluntary power morcellator recall. The Johnson & Johnson company, controlled more than 70% of the market, notified doctors to return all of its power morcellator products, stop using them and said it was withdrawing from the power morcellator market.
The FDA announced November 24, 2014 that it is adding a black box warning to uterine morcellator devices that remain on the market. A BLACK BOX WARNING, is the strongest warning that can be placed on any medical device.
Patients, doctors and hospitals are now on notice of the potential danger of increased uterine cancer spread risk associated with the use of these devices. Furthermore, the FDA announced that power morcellators should not be used with women near menopause or post-menopausal, or in women who could have tissue removed through the vagina or via a small incision.
This contraindication prohibits the use of the devices in the vast majority of women who undergo laparoscopic or vaginal uterine morcellation procedures.
Federal Multidistrict Litigation
In October 2015, all federal lawsuits involving Johnson and Johnson Ethicon only power morcellators were coordinated into multidistrict litigation in Kansas, for pre-trial discovery and consolidation.
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U.S. Lawmaker Wants Morcellator Cancer Deaths Criminally Investigated By The FDA
Jan 9, 2016 | Press Release
By Southern Med Law
U.S. Rep. Mike Fitzpatrick (R-Pa.) has called for the U.S. Food and Drug Administration (FDA) to launch a criminal investigation into certain deaths linked tolaparoscopic power morcellators at hospitals in New York and Massachusetts. Power morcellators are also reasons why women and their surviving loved ones have filed morcellator cancer lawsuits claiming that the surgical tools used in removing fibroid tumors can spread and upstage cancer. (In Re: Power Morcellator Litigation, MDL Case No. 78)
"Southern Med Law commends Rep. Fitzpatrick for asking the FDA to open a criminal investigation into laparoscopic power morcellators," says Dr. François Blaudeau, founder of Southern Med Law. who filed the first federal power morcellator cancer lawsuit in the United States. The claim against LiNA Medical APS, Kebomed AB & LiNA Medical US, on behalf of a Pennsylvania widower whose wife died of cancer in February 2013, following a morcellator hysterectomy was settled for an undisclosed amount.(Case No. 5:14-cv-1557, U.S. District Court, Eastern District of Pennsylvania) Southern Med Law is currently representing women in claims involving Ethicon.
Southern Med Law is currently representing women and their families in morcellator cancer lawsuits. Dr. François Blaudeau was recently appointed to The Plaintiffs' Steering Committee for power morcellator litigation (MDL No. 2652), that are currently pending in the U.S. District Court, District of Kansas. Dr. Blaudeau also negotiated the first cancer lawsuit settlement for an undisclosed amount. Morcellator cancer lawsuits claim medical device manufacturer, Johnson & Johnson's subsidiary, Ethicon Inc. failed to disclose that its laparoscopic power morcellators have the potential to spread undetected leiomyosarcoma or uterine cancer in women undergoing a laparoscopic hysterectomy or myomectomy.
In a December 18 letter to the FDA's Office of Criminal Investigations, Fitzpatrick asked the federal regulatory agency to probe the deaths at Boston's Brigham & Women's Hospital, Rochester General Hospital and the University of Rochester Medical Center associated with power morcellators manufactured by Johnson & Johnson's Ethicon unit. Under FDA rules, hospitals and makers of medical devices are required to report incidents in which devices may have caused or contributed to a patient's death. Yet, the first time the FDA received a report of death or serious injury due to a power morcellator was from a doctor whose family member was diagnosed with cancer associated with the morcellationdevice, Fitzpatrick stated in his letter.
This is not the first time Fitzpatrick has called for a probe into the controversial medical devices. In August, Fitzpatrick was among 12 bipartisan Congressional members who asked the U.S. Government Accountability Office (GAO) to investigate power morcellators, the cancer deaths linked to morcellators, and why the FDA "took so long" to warn about their potential to spread cancer. The GAO agreed to conduct the probe.
Laparoscopic power morcellators are used during a hysterectomy and myomectomy to remove uterine fibroids. The morcellator's spinning blades grind uterine tissue into fragments so that the pieces can be removed through small incisions in the abdomen. Undetected cancer cells can hide within the uterine tissue. In November 2014, the FDA issued a strong warning that power morcellators should be avoided in the majority of women who require a hysterectomy and a myomectomy due to its potential to spread undetected cancer cells.
Ethicon Inc., and other morcellator manufacturers including Gyrus ACMI, Richard Wolf GmbH, Karl Storz GmbH, and LiNA Medical APS are defendants in morcellator cancers lawsuits that allege power morcellators can potentially spread undetected uterine cancer, including the aggressive leiomyosarcoma. All federally filed lawsuits against Ethicon Inc. were consolidated in October in the U.S. District Court, District of Kansas for coordinated pretrial proceedings. Dr. Blaudeau was appointed to the Plaintiffs' Steering Committee which will represent the common interests of all plaintiffs in the litigation against Ethicon. (In Re: Power Morcellator Products Liability Litigation – MDL No. 2652)
About Southern Med Law and Filing A Power Morcellator Cancer Lawsuit: 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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