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Morcellation Media Monitoring 06/25/2015
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MDL sought for Johnson & Johnson power morcellator lawsuits
Jun 22, 2015 | Reuters Westlaw
By Jessica Dye
Lawyers for six women suing Johnson & Johnson over injuries allegedly caused by its power morcellator medical devices have sought to consolidate more than 20 similar lawsuits in Kansas federal court. -
Power Morcellator Lawsuit Centralization Sought For Claims Over Cancer After Hysterectomy, Myomectomy
Jun 22, 2015 | AboutLawsuits.com
By Austin Kirk
As a growing number of power morcellator cancer lawsuits continue to be filed on behalf of women nationwide, alleging that the device used during laparoscopic hysterectomy and myomectomy procedures caused the spread of leiomyosarcoma or other uterine cancers, a request has been filed to centralize the litigation before one judge for coordinated pretrial proceedings. -
South Carolina Widower Files Morcellator Lawsuit After Wife’s Passing
Jun 25, 2015 | Digital Journal
On February 3, 2015, John Ostrander, a widower from Greenville, South Carolina brought a legal claim against Johnson & Johnson, the manufacturer of a medical device that Ostrander says exacerbated his wife’s previously undetected uterine cancer. Ostrander says that a power morcellator, used to grind fibroid tissue into small pieces, spread an undiagnosed leiomyosarcoma throughout his wife’s abdomen, cutting her prognosis tragically short and ultimately leading to her death.
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MDL sought for Johnson & Johnson power morcellator lawsuits
Jun 22, 2015 | Reuters Westlaw
By Jessica Dye
Lawyers for six women suing Johnson & Johnson over injuries allegedly caused by its power morcellator medical devices have sought to consolidate more than 20 similar lawsuits in Kansas federal court.
Paul Pennock of Weitz & Luxenberg filed the request on Thursday with the U.S. Judicial Panel on Multidistrict Litigation, encompassing at least 22 lawsuits pending in 16 different federal district courts. The motion seeks to transfer the cases to U.S. District Judge Kathryn Vratil in Kansas.
The cases have been filed amid growing controversy over the devices. Power morcellators are used to remove uterine fibroids, which are noncancerous growths on the uterus wall. The devices contain spinning blades that grind the fibroid into smaller pieces, which are then removed through small incisions in the abdomen.
The devices have been marketed since the 1990s as a less-invasive option for treating fibroids. But in April 2014, the Food and Drug Administration warned that they could potentially spread cancerous tissues throughout the body and said it was discouraging their use for fibroid treatment in many women.
Several weeks later, Johnson & Johnson suspended worldwide sales of the devices, and in July said it would ask doctors to return them. In November, the FDA said it was adding a black-box warning - its strongest - to the devices, and in May, the Wall Street Journal reported that the FBI was probing what Johnson & Johnson knew about the devices' possible side effects.
Since early 2014, at least 22 lawsuits have been filed in federal courts alleging that the use of Johnson & Johnson's power morcellators during fibroid removal spread cancerous tissues or recurrent parasitic fibroids, a rare but dangerous growth. Their claims include design defect and failure to warn, among others. Johnson & Johnson has denied that its devices are to blame.
Johnson & Johnson, which declined to comment on Monday, is due to file a response by July 10. There is no hearing date set yet.
In seeking to consolidate the cases, Pennock wrote that most of the cases were still in the early stages, and that putting them before a single judge now would avoid inconsistent rulings. And, he wrote, "Given the widespread use of power morcellators and the harm they cause, it is likely that additional similar actions will be filed in or removed to federal courts in the future."
Although Vratil is not presiding over any power morcellator suits, there is at least one pending in Kansas, Pennock wrote. Vratil would be an experienced transferee judge, he wrote, noting that she served nearly a decade on the JPML and is currently presiding over MDLs about Monsanto genetically engineered wheat and motor fuel.
The case is In re Power Morcellator Products Liability Litigation, U.S. Judicial Panel on Multidistrict Litigation, No. 2652.
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Jun 22, 2015 | AboutLawsuits.com
By Austin Kirk
As a growing number of power morcellator cancer lawsuits continue to be filed on behalf of women nationwide, alleging that the device used during laparoscopic hysterectomy and myomectomy procedures caused the spread of leiomyosarcoma or other uterine cancers, a request has been filed to centralize the litigation before one judge for coordinated pretrial proceedings.
A group of plaintiffs filed a motion to transfer (PDF) with the U.S. Judicial Panel on Multidistrict Litigation (JPML) last week, indicating that cases filed throughout the federal court system should be consolidated as part of an MDL, or multidistrict litigation, to reduce duplicative discovery into common issues, avoid conflicting rulings from different judges and to serve the convenience of the witnesses, parties and courts.
There are currently at least 22 complaints pending in 16 different U.S. District Courts against manufacturers of power morcellators, which all raise nearly identical allegations that inadequate warnings were provide about the risk that the devices may spread undiagnosed cancer cells following uterine fibroid surgery.
Power morcellators are medical tools used during minimally invasive laparoscopic hysterectomy and myomectomy procedures, allowing the surgeon to cut up the uterus or uterine fibroids and remove the tissue through a small incision in the abdomen. While these procedures are designed to reduce recovery time and the risk of infections, morcellators have largely been abandoned over the past year, due to the risk that they may cause the spread of aggressive cancers that were previously contained or hidden within the uterus.
In April 2014, the FDA issued a warning about the potential power morcellation cancer risk, indicating that an estimated one out of every 350 women undergoing surgery for symptomatic uterine fibroids may actually have unsuspected sarcoma.
While the cancer can often be safely removed and treated when it is contained within the uterus, use of a power morcellator may send cancerous cells throughout the abdomen, causing the rapid dissemination of the cancer to other areas of the body. This may greatly reduce the likelihood of long-term survival and the woman’s overall quality of life.
“Evidence linking the dissemination and upstaging of occult cancer or the development of recurrent parasitic fibroid and similar injury risks were not disclosed to or shared with the public, including Plaintiffs, by any Defendant,” the brief notes. “Instead, Defendants’ strategy beginning in the early 1990’s has been to aggressively market Power Morcellators by falsely misleading potential users about the products and by failing to protect users from serious dangers which Defendants knew or should have known could result from the use of these products.”
Plaintiffs seek to centralize product liability lawsuits filed against various different manufacturers before U.S. District Judge Kathryn H. Vratil in the District of Kansas, where the litigation will be managed in a manner similar to a power morcellator class action. However, each claim would remain an individual lawsuit, and may be remand back to the U.S. District Court where it was originally filed if settlements or other resolutions are not reached following pretrial proceedings and a series of bellwether trials.
According to a briefing schedule posted by the U.S. JPML, manufacturers are not expected to respond to the petition until July 10, 2015. Oral arguments over whether to establish a power morcellator MDL are likely to be heard during an upcoming hearing session scheduled for October 1, in New York City.
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South Carolina Widower Files Morcellator Lawsuit After Wife’s Passing
Jun 25, 2015 | Digital Journal
On February 3, 2015, John Ostrander, a widower from Greenville, South Carolina brought a legal claim against Johnson & Johnson, the manufacturer of a medical device that Ostrander says exacerbated his wife’s previously undetected uterine cancer. Ostrander says that a power morcellator, used to grind fibroid tissue into small pieces, spread an undiagnosed leiomyosarcoma throughout his wife’s abdomen, cutting her prognosis tragically short and ultimately leading to her death.
A copy of his complaint, filed in the US District Court for South Carolina, Greenville Division under case number 6:15-cv-00516-MGL, can be read here (http://traceylawfirm.com/dangerous-drugs-and-devices/morcellator/lawsuits/current-cases/#ostrander).
According to the dangerous medical device attorneys at Tracey & Fox, Ostrander’s claim is one of more than twenty lawsuits to be filed against power morcellator manufacturers since March 2014. Ostrander himself is one of four widowers to file on behalf of deceased loved ones. To find a comprehensive timeline of the morcellator litigation visit Tracey & Fox’s website.
Suffering from severe uterine bleeding, Mrs. Ostrander underwent a hysterectomy on October 2, 2012, her husband writes. The procedure, intended to remove what were believed to be benign fibroids, involved the Gynecare Morcellex power morcellator manufactured by Johnson & Johnson. Prior to her procedure, plaintiff claims that Mrs. Ostrander underwent “all reasonable and standard procedures for detecting cancer.” According to court documents, no evidence of leiomyosarcoma, an aggressive form of soft tissue cancer, was found. Ostrander was deemed cancer-free and cleared for surgery, her surviving husband writes.
During her operation, surgeons used Johnson & Johnson’s morcellator to grind “three large fibroid specimens.” These small fragments of tissue were then removed from the patient’s abdomen through minor incisions. But after pathological scrutiny, it was determined that the morcellated tissue also contained samples of cancer. Mrs. Ostrander received her diagnosis: “leiomyosarcoma cancer.” Plaintiff claims that his wife’s cancer had remained completely undetected until after her morcellation procedure. According to a recent US Food & Drug Administration safety announcement, cautioning against the use of power morcellators, “there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.”
A subsequent examination would confirm that Ostrander’s cancer had spread beyond her uterus. Cancer cells were identified in her vaginal cuff, “at areas around her ureters, and throughout the omentum,” a portion of the stomach. Malignancies were also noted in areas of her abdomen, as well as within her lymphatic system. After a two year battle against leiomyosarcoma, Ostrander died on September 25, 2014, her widowed husband claims.
Writing that the company “knew, or should have known” that its device posed the danger of spreading undiagnosed cancers, Mr. Ostrander accuses Johnson & Johnson of “failing [...] to properly warn of the [power morcellator’s] risks.” He says that his wife’s passing “was completely avoidable and would have been avoided but for [Johnson & Johnson’s] breaches of duties.” And while the FDA has cautioned surgeons against using morcellators as of April 2014, Ostrander claims that Johnson & Johnson was notified of the device’s risks as early as 2006. He says that the company “failed to notify the FDA of this notice and danger, and [...] took no action to warn surgeons [...] and did nothing to make the device safe for use.”
Johnson & Johnson was once the world’s largest morcellator manufacturer. Since the FDA’s warning, the company has issued a “market withdrawal,” asking physicians across the world to return their power morcellators immediately. According to the Wall Street Journal, Johnson & Johnson has come under FBI investigation, with federal officials attempting to determine what Johnson & Johnson knew about the morcellator’s dangers before pulling the device from the market. But for many patients, including John Ostrander’s wife, the company’s newfound caution may have come too late.
Experienced power morcellator attorneys at Tracey & Fox note that an estimated 60,000 women undergo gynecological procedures involving power morcellators every year. And while increased regulatory pressure may have limited the medical device’s use to some degree, many hospitals continue to employ morcellators in fibroid removal procedures. The lawyers expect many patients to step forward in the coming months.
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