Preview Newsletter
Morcellation Media Monitoring 08/03/2015
-
Morcellator Hysterectomy Cancer Spread Injury and Death
Jul 30, 2015 | The Legal Examiner
By Shezad Malik MD JD
There are many product liability lawsuits being filed against the manufacturers of power morcellators. The injured women claim that patients and doctors should have been warned about the risks associated with use of the medical devices during minimally invasive, laparoscopic hysterectomies. -
Morcellator Manufacturers Oppose Lawsuit Consolidation As New Claims Mount, Tracey & Fox Reports
Jul 30, 2015 | Digital Journal
By Tracey & Fox
With more than twenty power morcellator lawsuits already filed in Federal Courts, a group of Plaintiffs have asked the Judicial Panel on Multidistrict Litigation to consolidate the claims for pretrial proceedings. “Consolidation would eliminate redundant or divergent rulings made by multiple judges acting independently of one another,” says Sean Tracey, Esq., managing partner at Tracey & Fox, a firm currently counseling women who believe that a power morcellator spread undetected cases of uterine cancer.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
-
Morcellator Hysterectomy Cancer Spread Injury and Death
Jul 30, 2015 | The Legal Examiner
By Shezad Malik MD JD
There are many product liability lawsuits being filed against the manufacturers of power morcellators. The injured women claim that patients and doctors should have been warned about the risks associated with use of the medical devices during minimally invasive, laparoscopic hysterectomies.
What Are Power Morcellators?
Power morcellators are medical devices that are used during laparoscopic hysterectomy and myomectomy procedures. The device allows the surgeon to grind up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. The medical device is used during minimally invasive surgery, and reduces recovery time, scarring and speeds up recovery time.
Morcellator Uterine Cancer Spreading Risk
According to medical experts and the FDA, about one out of every 350 women undergoing a laparoscopic hysterectomy with morcellation may have undiagnosed sarcoma, which doctors are unable to detect before the surgery.There is no bullet proof way for doctors to diagnose the uterine cancer before using the morcellator devices to grind up the uterus or remove the uterine fibroids, which is also known as myomectomy procedure. Because of this, the FDA strongly urged doctors to avoid using the devices for laparoscopic hysterectomy or myomectomy procedures in April 2014. The FDA issued a BLACK BOX WARNING against the use of these devices in November 2014.
Power morcellators spread this undiagnosed leiomyosarcoma, endometrial stromal sarcoma or other cancer throughout the pelvis and abdomen during the grinding process, leading to rapid upstaging of the cancer and reducing the risk of long-term survival. As this risk becomes known, many doctors have stopped the use of power morcellators over the past year.
Morcellators Approved Under the 510(k) Program
The controversial 510(k) program allows medical devices to be approved without pre-market testing requirements. Under the program, the manufacturer just needs to show that the devices are “substantially equivalent” to devices already on the market. Power morcellators were approved under the 510(k) process without any safety testing.
Ethicon Morcellator Recall
All Ethicon power morcellators were recalled by the manufacturer, earlier last year. J&J, acknowledged that the devices pose an unreasonable risk of disseminating uterine cancer. Ethicon, a J&J subsidiary requested that hospitals voluntarily return all laparoscopic surgery morcellators. The company, noted that it will no longer sell the devices since there is no way to make them safe.
Morcellator Black Box Warning
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.
Power Morcellators Under the Gun
Power morcellators have been under under fire since the well-publicized case of anesthesiologist Amy Reed, who underwent a hysterectomy, for fibroid removal in October 2013. Dr Reed, then discovered that power morcellation had spread an undiagnosed uterine leiomyosarcoma.
The FDA’s warnings last year triggered a widescale retreat from tissue morcellation. Johnson & Johnson voluntarily withdrew its morcellators from the market because of cancer “uncertainty.”
Most recently, health insurer Aetna announced that it will no longer cover most hysterectomies and myomectomies that utilize power morcellators to remove uterine fibroid tumors “because the safety and efficacy of this approach has not been demonstrated.”Power Morcellator Cancer Litigation
Many complaints have been filed in the federal court system nationwide. These women were diagnosed with the spread of leiomyosarcoma, endometrial stromal sarcoma or other cancers following uterine fibroid surgery.
All of the lawsuits filed against manufacturers of these devices claim that hysterectomy morcellators are unreasonably dangerous and that information about the risk of uterine cancer being spread was withheld from the patients and doctors.
-
Morcellator Manufacturers Oppose Lawsuit Consolidation As New Claims Mount, Tracey & Fox Reports
Jul 30, 2015 | Digital Journal
By Tracey & Fox
With more than twenty power morcellator lawsuits already filed in Federal Courts, a group of Plaintiffs have asked the Judicial Panel on Multidistrict Litigation to consolidate the claims for pretrial proceedings. “Consolidation would eliminate redundant or divergent rulings made by multiple judges acting independently of one another,” says Sean Tracey, Esq., managing partner atTracey & Fox, a firm currently counseling women who believe that a power morcellator spread undetected cases of uterine cancer.
Morcellators, non-invasive medical devices used to grind fibroid and uterine tissue, first came to widespread attention in April of 2014. That month, the US Food & Drug Administration released one of its most sweeping safety warnings to date: announcing that the spinning blade of a power morcellator can spread undiagnosed uterine sarcomas and discouraging the device’s use in most female patients. “The risks of morcellation were thought to be extremely low,” Tracey reports, “but an FDA analysis of existing medical literature revealed that as many as 1 out of every 350 women undergoing a procedure may be at risk of harboring a uterine cancer. Once it’s cut into by the blade of a morcellator, a stage 1 cancer goes to stage 4 in an instant.”
Patients who had been diagnosed with an “upstaged” uterine cancer after undergoing a hysterectomy or myomectomy began filing product liability lawsuits soon after. As the lawsuits accumulated, many legal experts saw Multidistrict Litigation, or MDL, on the horizon. “When a growing number of claims bring similar allegations against Defendants, MDL is the usual direction taken by the court system,” Tracey said, adding that consolidation can make both pretrial proceedings and the process of filing new claims more efficient.
But Plaintiff’s request to consolidate has seen some pushback from the Defendants. In four separately-filed briefs submitted on July 10, 2015, Johnson & Johnson1, Karl Storz GmbH2, Richard Wolf GmbH3 and Gyrus ACMI4 oppose the idea, arguing there are too few claims, filed against too many different companies to warrant consolidation. Johnson & Johnson contends that each lawsuit’s Discovery phase, in which Defendant and Plaintiff obtain evidence from one another, will be so specific to each Plaintiff’s situation that conducting a coordinated Discovery across claims would be counter-productive.
According to Tracey, at least one new morcellator lawsuit has been filed since the four Defendants voiced their misgivings over consolidation. He says that in Federal Courts, Johnson & Johnson currently faces 16 morcellator lawsuits, Karl Storz faces 5, and Richard Wolf and Gyrus ACMI both face 1, although a dozen additional morcellator claims may be filed in state courts.
Tracey & Fox is providing free consultations to women who believe that a power morcellator may have spread or “upstaged” a previously-undiagnosed uterine cancer. For more information, call 713.495.2333.
Read more: http://www.digitaljournal.com/pr/2629482#ixzz3hlJJGspk
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
Add recipients
Suggested