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Morcellation Media Monitoring 10/19/2015
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MDL Watch: Consolidation granted for Ethicon morcellators, GSK's Zofran, Honda cars
Oct 16, 2015 | Reuters
By Jessica Dye
A federal judicial panel has created new multidistrict litigation for products liability cases over power morcellators made by Johnson & Johnson's Ethicon Inc, GlaxoSmithKline's anti-nausea medication Zofran and Honda CR-Vs, while a second bid to consolidate cases over Eli Lilly's Cymbalta again fell short. -
Suits Alleging Ethicon Device Spreads Cancer Consolidated
Oct 15, 2015 | Law360
By Emily Field
The Judicial Panel on Multidistrict Litigation on Thursday consolidated in Kansas 15 product liability suits over a gynecological medical device made by Ethicon that may have spread cancer in women’s bodies, saying that the actions against the company involve common factual questions. -
Laparoscopic Morcellation Cancer Lawsuits Against Ethicon Centralized in MDL
Oct 15, 2015 | AboutLawsuits.com
By Austin Kirk
A panel of federal judges has decided to consolidate all federal laparoscopic morcellation lawsuits filed against Johnson & Johnson’s Ethicon subsidiary by women who had uterine cancer spread by the medical device, but rejected a call to include similar cases brought against other manufacturers. -
Morcellator Cancer Lawsuits Will Now Be Fast Tracked For Litigation, MDL 2652
Oct 16, 2015 | The Legal Examiner
By Andy Childers
The Judicial Panel on Multidistrict Litigation consolidated 15 federally filed morcellator cases on Thursday for pre-trial discovery and trial work up. The request for the Morcellator MDL was made by Plaintiffs in an effort to streamline the litigation and fast track the efficient handling of the claims affecting the lives of women all over the United States. -
Morcellator Cancer Lawsuits Filed Against Ethicon Centralized in Kansas Federal Court, Bernstein Liebhard LLP Reports
Oct 16, 2015 | Press Release
By Bernstein Liebhard LLP
A panel of federal judges has created a new multidistrict litigation to house more than two dozen power morcellator lawsuits (http://www.rxinjuryhelp.com/power-morcellator/lawsuit/) filed against Johnson & Johnson's Ethicon, Inc. subsidiary. According to a Transfer Order issued by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on October 15th, all pending federal cases brought on behalf of women who allegedly experienced the spread and upstaging of uterine cancers due to Ethicon morcellators will be transferred to the U.S. District Court, District of Kansas, as will any future filings. -
Weitz and Luxenberg Wins MDL Designation for Claims Against Johnson and Johnson Power Morcellators
Oct 15, 2015 | Press Release
By Weitz & Luxenberg
Nationally known personal injury and mass tort law firm Weitz & Luxenberg, P.C., today announced that one of its lead attorneys, Paul J. Pennock, successfully argued to a federal court judicial panel to consolidate into a single multidistrict litigation dozens of lawsuits claiming injuries from use of power morcellators manufactured by Johnson & Johnson subsidiary Ethicon Inc.
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MDL Watch: Consolidation granted for Ethicon morcellators, GSK's Zofran, Honda cars
Oct 16, 2015 | Reuters
By Jessica Dye
A federal judicial panel has created new multidistrict litigation for products liability cases over power morcellators made by Johnson & Johnson's Ethicon Inc, GlaxoSmithKline's anti-nausea medication Zofran and Honda CR-Vs, while a second bid to consolidate cases over Eli Lilly's Cymbalta again fell short.
The following orders were issued by the Judicial Panel on Multidistrict Litigation over the past week following oral arguments in New York City on Oct. 1:
No. 2652, In re Power Morcellator Products Liability Litigation
Nearly 30 lawsuits have been filed in the past year alleging that devices used to remove uterine fibroids, known as power morcellators, can cause cancerous cells to spread. Defendants include medical device makers Ethicon, Vention Medical, Richard Wolf and Karl Storz.
Six plaintiffs sought to consolidate the cases against all manufacturers in a single MDL before U.S. District Judge Kathryn Vratil in Kansas, saying the court's central geographic location would be convenient for parties around the country. Responding plaintiffs largely supported the request, while responding defendants opposed, saying the relatively small number of cases, large number of distinct defendants and individualized medical facts underlying each suit would make them unsuitable for a unified MDL.
The panel on Oct. 14 ordered the creation of an MDL before Vratil in Kansas, limited solely to lawsuits against Ethicon, which is the defendant in the vast majority of pending cases. The ruling said that while it agreed with defendants that an "industry-wide MDL is not appropriate," there are a sufficient number of cases against Ethicon involving common facts that consolidation would be appropriate for those lawsuits. Two actions naming Karl Storz as a co-defendant with Ethicon will also be part of the consolidation, the order stated.
For moving plaintiffs: Paul Pennock of Weitz & Luxenberg.
For Richard Wolf: Gregory Hauser of Wuersch & Gering.
For Gyrus: Michael Weiss and Jameson Carroll of Carroll & Weiss.
For Karl Storz: Robert Goodson of Wilson Elser Moskowitz Edelman & Dicker.
For Ethicon: John Winter of Patterson Belknap Webb & Tyler.
No. 2657, In re Zofran (ondansetron) Products Liability Litigation
GlaxoSmithKline has been hit with dozens of lawsuits alleging that its anti-nausea drug Zofran can cause birth defects in children born to women who took it while pregnant. The drugmaker sought to consolidate the cases before either U.S. District Judge Cynthia Rufe or U.S. District Judge Paul Diamond, both in the Eastern District of Pennsylvania, a court that has hosted similar birth-defect litigation over antidepressants Zoloft and Effexor.
Four plaintiffs supported the motion, while numerous others endorsed consolidation in a different court, such as the Northern District of Alabama, Northern District of Ohio or Massachusetts.
The panel opted to send the cases to Massachusetts, where five cases are pending, including the first one filed. The district is easily accessible for all parties, the panel wrote. The cases have been assigned to U.S. District Judge Dennis Saylor, who is currently overseeing four Zoloft lawsuits.
For GSK: Madeleine McDonough, Ann Havelka and Sean Wajert of Shook Hardy & Bacon
No. 2661, In re American Honda Motor Co Inc CR-V Vibration Marketing and Sales Practices Litigation
Honda is facing seven proposed class actions alleging that the 2015 CR-V vehicles have a defect that causes them to vibrate excessively. A plaintiff whose lawsuit was filed in the U.S. District Court for the Central District of California sought to consolidate the cases there, which Honda supported. Plaintiffs in four other cases requested that the MDL be sent to the Southern District of Ohio, where one of the suits was filed.
In an Oct. 9 ruling, the panel decided to send the cases to the Southern District of Ohio, citing Honda's "substantial presence" there, including the manufacturing facilities where the CR-V was made. The majority of plaintiffs support consolidation there as either their first or second choice, the panel wrote, and that district is home to just two other MDLs, compared to 12 in the Central District of California. The cases will be assigned to U.S. District Judge Michael Watson.
For moving plaintiffs: Eric Gibbs of Gibbs Law Group
For Honda: Michael Mallow of Sidley Austin
No. 2662, In re Cymbalta (duloxetine) Products Liability Litigation No. 11.
Last year, the JPML declined to consolidate 25 cases against Eli Lilly alleging that the company failed to warn about side effects that can occur when users stop taking its antidepressant Cymbalta, including nausea, suicidal thoughts and electric-shock-like sensations in the brain.
This year, two of 41 plaintiffs with federal Cymbalta lawsuits renewed the request, asking the panel to transfer the cases to the U.S. District Court for the Southern District of Indiana, where Lilly is headquartered. Lilly again opposed consolidation, saying that the cases are too far apart procedurally, with some nearing the end of discovery while others have just been filed.
On Oct. 9, the panel denied the request, saying that there was "no significant change in circumstances" since its decision in Cymbalta I. In both instances, the procedural disparity would make it inefficient to consolidate the cases, the panel wrote, and the cases are controlled by a small number of plaintiffs' firms, which would facilitate a more informal coordination.
For moving plaintiffs: Steven Stein of Knox Ricksen
For Eli Lilly: Michael Imbroscio of Covington & Burling
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Suits Alleging Ethicon Device Spreads Cancer Consolidated
Oct 15, 2015 | Law360
By Emily Field
The Judicial Panel on Multidistrict Litigation on Thursday consolidated in Kansas 15 product liability suits over a gynecological medical device made by Ethicon that may have spread cancer in women’s bodies, saying that the actions against the company involve common factual questions.
The JPML said that the suits all involve common questions of fact that arise from allegations that the defective design of Johnson & Johnson unit Ethicon’s power morcellators made certain laparoscopic gynecological surgeries more likely to spread cancer and that the company failed to warn patients of these risks, given a recent Food and Drug Administration’s guidance that warned against using the devices in certain conditions.
The panel rejected Ethicon’s argument that unique factual questions about the plaintiffs overshadowed any common factual questions in its decision to centralize the suits in the district of Kansas.
“Though the actions may present individual factual issues, ‘this is usually true of products liability cases and medical device cases, in particular,’” the panel said.
The common factual questions in the suits surround the design, manufacture, and marketing of Ethicon’s power morcellators, including the warnings accompanying those devices and whether they should have included a bag to contain tissue, according to the JPML.
Most also involve questions about the risk that women undergoing hysterectomies and fibroid removal surgeries had cancer of an unknown origin, and what the company knew about that risk and when.
Centralizing these questions will eliminate duplicative discoveries and avoid inconsistent rulings before trial, as well conserve the resources of the parties and the judiciary, the JPML said.
The panel also rejected Ethicon’s contention that there aren’t enough actions pending to warrant consolidation and that the number of new cases will stay low.
“There are now at least 28 actions naming Ethicon as a defendant,” the panel said. “We find this to be a sufficient number of pending actions to warrant centralization, given the complexity of anticipated overlapping fact and expert discovery.”
The panel also noted that 650,000 women in the U.S. each year undergo surgery to manage symptomatic uterine fibroids, and that before the FDA’s safety communication about power morcellation, laparoscopic procedures with power morcellation had increasingly been used rather than conventional methods.
Morcellators break targeted tissue into fragments that can be removed through an incision in the stomach, according to the FDA.
Of the 500,000 hysterectomies performed every year, about 11 percent are done using this method, according to the FDA.
Although uterine fibroids are common and usually benign, about 1 in 350 women undergoing a hysterectomy or fibroid removal have an unsuspected uterine sarcoma, a type of uterine cancer, according to the agency.
In November 2014, the FDA put out a guidance warning that laparoscopic power morcellators may spread cancer and shouldn't be used in gynecological surgery that involves cancer or fibroids.
The communique was a sharp warning against the morcellators, gynecological tools used to perform hysterectomy or uterine fibroid removal. The FDA said that uterine tissue may contain unsuspected cancer and that using the morcellators may spread the cancer and decrease long-term patient survival.
The controversy over the tool's danger prompted Ethicon to execute a worldwide recall of its Morcelex brand devices in July 2014 after suspending sales of the devices that April.
In May 2014, Ethicon was hit with the first suit over the product in New York federal court. Brenda Leuzzi and George Leuzzi claim that Brenda Leuzzi was diagnosed with cancer after undergoing a robot-assisted hysterectomy with morcellation in 2012 and that the company did not adequately test its Morcelex product for potentially dangerous side effects.
“Because Ethicon acted appropriately and responsibly at all times in relation to our morcellation devices, we will defend ourselves in the lawsuits that have been filed against us,” an Ethicon spokesman told Law360 on Thursday.
The panel did agree with Ethicon that an industry-wide MDL wouldn’t be appropriate, as individual issues over differences from each company’s power morcellator would predominate.
Two suits included in the MDL also named manufacturer Karl Storz Endoscopy America Inc. as well as Ethicon as a defendant; the panel noted that during oral argument, certain plaintiffs’ counsel indicated that there would be few suits naming multiple defendants and most of those involved issues of product identification.
"We are all very pleased and relieved in light of the nearly hour long oral argument," Paul J. Pennock of Weitz & Luxenberg PC told Law360 on Thursday. "These clients' cases have the best chance for rapid prosecution through an MDL before an experienced judge, and we now have that. We are disappointed that the other defendants were not also joined but it is a lesser magnitude litigation problem than no MDL at all would have been."
Ethicon is represented by John D. Winter of Patterson Belknap Webb & Tyler LLP.
The plaintiffs are represented by Paul J. Pennock, Jerry M Kristal, Ellen Relkin, Michael Pederson and Donald A Soutar of Weitz & Luxenberg PC, Charles A. Childers of Childers Schlueter & Smith LLC, among others.
The case is In Re: Power Morcellator Products Liability Litigation, MDL number 2652, in the U.S. Judicial Panel on Multidistrict Litigation. -
Laparoscopic Morcellation Cancer Lawsuits Against Ethicon Centralized in MDL
Oct 15, 2015 | AboutLawsuits.com
By Austin Kirk
A panel of federal judges has decided to consolidate all federal laparoscopic morcellation lawsuits filed against Johnson & Johnson’s Ethicon subsidiary by women who had uterine cancer spread by the medical device, but rejected a call to include similar cases brought against other manufacturers.
Following oral arguments presented earlier this month, the U.S. Judicial Panel on Multidistrict Litigation (JPML) issued a transfer order (PDF) this morning, indicating that more than two dozen product liability lawsuits involving cancer allegedly spread by Ethicon power morcellators will be centralized before U.S. District Judge Kathyryn H. Vratil in the District of Kansas for coordinated discovery and pretrial proceedings, as part of an MDL or Multi-District Litigation.
Ethicon was the leading manufacturer of laparoscopic morcellators, which have been increasingly used over the past decade during minimally invasive hysterectomy and myomectomy procedures for removal of symptomatic uterine fibroids. However, morcellation has been largely abandoned within the medical community due to the risk that some women may have undiagnosed cancer cells contained within the uterus that can be spread throughout the body during morcellation, rapidly upstaging leiomyosarcoma, endometrial stromal sarcoma and other cancers.
All of the lawsuits involve similar allegations, indicating that Ethicon knew or should have known about the risk that laparoscopic morcellation may disseminate uterine cancer, yet failed to adequately warn the medical community or women deciding to undergo a minimally invasive procedure instead of a traditional hysterectomy or myomectomy.
Centralizing the cases before one judge as part of a morcellator MDL is designed to reduce duplicative discovery into common issues, avoid conflicting rulings from different courts and to serve the convenience of the parties, witnesses and the judicial system.
In addition to lawsuits against Ethicon, similar complaints have been brought against other morcellator manufacturers, including Karl Storz, Richard Wolf Medical Instruments, and Gyrus ACMI.
While plaintiffs asked the U.S. JPML to centralize all claims brought against any manufacturer, regardless of the specific device used during the hysterectomy or uterine fibroid removal, the panel determined that an industry-wide MDL for morcellation lawsuits was not appropriate.
“While there will be some factual issues as to the risk of occult cancer in women undergoing hysterectomies and myomectomies that are common to all defendants, we find that the individual issues that result from the differences among each defendant’s power morcellator with respect to product design, development, testing, warnings, and marketing will predominate over the common issues,” wrote the U.S. JPML in the order issued October 15.
Power Morcellator Cancer Concerns
The litigation over power morcellators has emerged over the past two years, following an FDA statement in April 2014, which warned about the uterine cancer risks with morcellation.
FDA indicated at that time that estimates suggest one out of every 350 women undergoing surgery for symptomatic uterine fibroids may actually have undiagnosed and unsuspected sarcoma contained within the uterus. For these women, morcellators may rapidly spread cancerous cells throughout the body, rapidly upstaging leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers to an advanced stage that is difficult to treat and often fatal. This may greatly reduce the likelihood of long-term survival and the woman’s overall quality of life.
In the summer of 2014, two panels of FDA advisors determined that there was no safe way to use power morcellators for uterine fibroid removal. However, they could not agree on whether to recommend that the agency demand a power morcellator recall or simply add a black box warning.
Shortly afterwards, Ethicon, who previously dominated the power morcellator market, decided that it will no longer manufacturer the devices, essentially issuing an Ethicon power morcellator recall after determining that there is no way to make the devices safer.
While the FDA has allowed laparoscopic morcellators to remain on the market, with much stronger warnings about the potential cancer risks, many hospitals and doctors have announced that they will no longer perform hysterectomy or myomectomy procedures with morcellation, indicating that there is no way to justify the risk.
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Morcellator Cancer Lawsuits Will Now Be Fast Tracked For Litigation, MDL 2652
Oct 16, 2015 | The Legal Examiner
By Andy Childers
The Judicial Panel on Multidistrict Litigation consolidated 15 federally filed morcellator cases on Thursday for pre-trial discovery and trial work up. The request for the Morcellator MDL was made by Plaintiffs in an effort to streamline the litigation and fast track the efficient handling of the claims affecting the lives of women all over the United States.
IN RE: POWER MORCELLATOR PRODUCTS LIABILITY LITIGATION, MDL 2652, will include the following defendants: Johnson & Johnson; Johnson & Johnson Services; Ethicon, Inc.; and Ethicon Endo-Surgery, Inc. (Collectively together, Ethicon Defendants).
WHAT IS A MORCELLATOR?
A morcellator is a device used in tens of thousands of laparoscopic hysterectomies and myomectomies each year. It is used to shred tissue. If a woman has a hysterectomy involving a morcellator, the device is used to shred the uterus into small pieces that can be removed via a small incision, allowing for a faster recovery.
In the case of a myomectomy, the device is used to cut and remove fibroids from uterine tissue.
HOW DOES A MORCELLATOR SPREAD CANCER?
The FDA estimates that 1 in 350 women who undergo uterine surgery has an undetected sarcoma, or cancer, in the uterus. The risk of this cancer appears to increase with age, according to a study by the Journal of the American Medical Association.
The shredding action of a power morcellator can spread the cancerous tissue throughout the abdomen, hastening the cancer’s development.
According to the JPML Panel in its Order of October 15, 2015:
We are persuaded that the District of Kansas is an appropriate transferee district for this nationwide litigation. This district is centrally located and easily accessible for all parties. Furthermore, centralization in this district allows us to assign the litigation to a skilled and efficient jurist with a wealth of MDL experience.
IT IS THEREFORE ORDERED that the actions listed on Schedule A are transferred to the District of Kansas, and, with the consent of that court, assigned to the Honorable Kathryn H. Vratil for coordinated or consolidated pretrial proceedings.
Cancer is a physical, emotional and financial hardship. If you were harmed due to a morcellator, you shouldn’t have to bear this cost. You have a right to seek accountability and compensation for the company that sold this device, and we may be able to help you do it.
You want an attorney who has handled cases involving defective medical products before. At Childers, Schlueter & Smith, we are those attorneys and already have filed morcellator lawsuits in this morcellator litigation. Andy Childers in our office heads up our Morcellator claims department and would be glad to speak with you about your specific situation.
Childers, Schlueter & Smith
1-800-641-0098 or email us at intake@cssfirm.com.
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Oct 16, 2015 | Press Release
By Bernstein Liebhard LLP
A panel of federal judges has created a new multidistrict litigation to house more than two dozen power morcellator lawsuits (http://www.rxinjuryhelp.com/power-morcellator/lawsuit/) filed against Johnson & Johnson's Ethicon, Inc. subsidiary. According to a Transfer Order issued by the U.S. Judicial Panel on Multidistrict Litigation (JPML) on October 15th, all pending federal cases brought on behalf of women who allegedly experienced the spread and upstaging of uterine cancers due to Ethicon morcellators will be transferred to the U.S. District Court, District of Kansas, as will any future filings. (In Re: Ethicon, Inc., Power Morcellator Products Liability Litigation – MDL No. 2652)
"Court records indicate that at least 28 Ethicon morcellator lawsuits are pending in federal courts around the country, and it's likely that more cases will be filed in the future. The creation of this new multidistrict litigation will allow these claims to move more efficiently through the court system," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm has been retained by a number of clients whose uterine cancers were allegedly spread via morcellation, and continues to provide free legal consultations to women who may have suffered similar harm as a result of these devices.
Power Morcellators and Cancer
Power morcellators are used in minimally-invasive hysterectomies and myomectomies (uterine fibroid removal) to shred tissue so that it may be removed via a small abdominal incision. Since April 2014, the U.S. Food & Drug Administration (FDA) has issued two public health alerts regarding the potential for these devices to disseminate undiagnosed uterine sarcoma cells and other malignancies during gynecological procedures, which can greatly worsen a patient's chances for long-term survival. The FDA's most recent warning, which was released in November 2014, cautioned against the use of power morcellators in the majority of women who undergo uterine surgery, and required device manufacturers to add strong new warnings to their product labels regarding this risk.
Ethicon, Inc. was once a leading marketer of power morcellators. But in July 2014, the company suspended sales of its three morcellator products: Gynecare Morcellex," "Morcellex Sigma" and "Gynecare X-Tract." The Ethicon morcellator lawsuits currently pending in U.S. courts all put forth similar allegations regarding design defects that purportedly increase the risk that the company's devices will promote the spread of uterine cancer. Plaintiffs also accuse Ethicon of failing to provide appropriate warnings to doctors and patients regarding this risk.
Victims of uterine cancers that were allegedly spread via a power morcellator may be entitled to compensation for their injury-related damages. To learn more about filing a morcellator lawsuit, please visit Bernstein Liebhard LLPs website, or call the Firm directly for a free, no-obligation case review at 800-511-5092. -
Weitz and Luxenberg Wins MDL Designation for Claims Against Johnson and Johnson Power Morcellators
Oct 15, 2015 | Press Release
By Weitz & Luxenberg
Nationally known personal injury and mass tort law firm Weitz & Luxenberg, P.C., today announced that one of its lead attorneys, Paul J. Pennock, successfully argued to a federal court judicial panel to consolidate into a single multidistrict litigation dozens of lawsuits claiming injuries from use of power morcellators manufactured by Johnson & Johnson subsidiary Ethicon Inc.
Power morcellators are surgical instruments used on women in procedures to remove either the uterus or uterine fibroids. However, women risk death or serious injury from these instruments due to the capacity of the devices to spread hidden cancers and parasitic fibroid.
In addition to receiving the hard-fought go-ahead for consolidation, Weitz & Luxenberg also successfully persuaded the United States Judicial Panel on Multidistrict Litigation to assign the matter to the U.S. District Court for the District of Kansas.
"This decision by the panel is an extremely important one because it ensures that these cases will move at the fastest possible pace," Paul J. Pennock, Weitz & Luxenberg, P.C. Chair of the firm's Defective Drug & Medical Device practice group said.
"We believe this will allow our clients to obtain justice much more swiftly and reliably than might otherwise be the case if each client were compelled to battle the defendants in isolated courtrooms scattered across the country," Pennock said.
Injuries Suffered Due to Power Morcellator Use:
The plaintiffs in these actions against Johnson & Johnson-Ethicon are suing because they allege injuries suffered as a result of power morcellator design defects and inadequate warnings.
A power morcellator has rapidly spinning blades that cut fibroids and other tissues into easily removable bits, but sometimes the blades also cut up hidden cancers and allow them to aggressively spread throughout the abdomen. The U.S. Food and Drug Administration in 2014 sent doctors and patients a letter to warn them of the risks and dangers posed by power Morcellators.
Weitz & Luxenberg said that approximately 650,000 women in the U.S. each year undergo a surgical myomectomy or hysterectomy for the management of symptomatic uterine fibroids. Power morcellators are used in about 11 percent of these procedures, the law firm estimates.
Weitz & Luxenberg said the strategic victory was achieved despite exceptionally rigorous questioning by the judges sitting on the multidistrict authorization panel.
The case is In re: Power Morcellator Products Liability Litigation, MDL Number 2652.
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