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Morcellation Media Monitoring 07/27/2015
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Morcellator Manufacturers Object to Multidistrict Litigation
Jul 23, 2015 | Top Class Actions
By Laura Schultz
A group of morcellator manufacturers recently submitted a response opposing several plaintiffs’ requests to centralize the federal lawsuits that have recently been brought against the medical device manufacturers. The morcellator lawsuits allege that the device manufacturers created dangerous and defective medical instruments that caused serious harm to patients. -
First Morcellator Cancer Suit Settled
Jul 26, 2015 | Legal Reader
By Jay W. Belle Isle
Morcellator. It’s a world that leaves a funny (as in “Eeww!”) feeling in your mouth. That’s nothing compared to what the medical instrument leaves in your body. Morcellation (shudders) can spread previously undiagnosed malignant cancer cells throughout the patients’ pelvic and abdominal cavities, which shortens the patients’ life expectancy. The first morecellator cancer suit settled recently for an undisclosed amount. -
With Numerous Morcellator Lawsuits Filed, FDA Response To Cancer Crisis Underwhelms Critics, Tracey & Fox Reports
Jul 24, 2015 | KFJX Fox 14
By Press Advantage
On April 17, 2014, the US Food & Drug Administration announced a major safety risk of power morcellators, medical devices frequently used to grind uterine fibroid tissue: morcellators can spread and worsen uterine cancer. In November of that year, the FDA would expand on its warning in an updated Safety Communication, warning surgeons to avoid using power morcellators in all but the rarest circumstances. Recommending that all morcellator manufacturers revise their devices’ labeling with a “Black Box” warning, notifying patients and surgeons that “laparoscopic power morcellators during fibroid surgery may spread cancer,” the regulatory agency said that it was “consider[ing] other steps that may further reduce such risk.” -
Morcellator Wrongful Death Suit Settlement Announced, Says Legal-Bay
Jul 24, 2015 | Market Watch
By PR Newswire
Legal-Bay LLC, the Lawsuit Settlement Funding Company, announced today that LiNA Medical has settled a case against them for an undisclosed amount over a power morcellator death case. The company settled the case before it even went to trial, and there are approximately 20 other morcellator lawsuits at this time. According to Drug Watch, the company did not comment on the settlement. -
Power Morcellator Lawsuit Attorneys at Bernstein Liebhard Comment on Passage of Legislation to Improve Medical Device Monitoring
Jul 23, 2015 | University Chronicle
By Release Wire
The controversy surrounding the use of power morcellators (http://www.morcellatorlawsuit2015.com) in gynecological surgeries was the inspiration behind a legislative effort to improve medical device monitoring, Bernstein Liebhard LLP reports. On July 10, 2015, the U.S. House of Representatives passed the "21st Century Cures Act," which includes a provision that would require the make or model number of medical devices to be included in patients' medical records in order to improve the tracking of adverse outcomes.
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Morcellation
Full Text of Stories Below
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Morcellator Manufacturers Object to Multidistrict Litigation
Jul 23, 2015 | Top Class Actions
By Laura Schultz
A group of morcellator manufacturers recently submitted a response opposing several plaintiffs’ requests to centralize the federal lawsuits that have recently been brought against the medical device manufacturers.
The morcellator lawsuits allege that the device manufacturers created dangerous and defective medical instruments that caused serious harm to patients.
Several plaintiffs who have filed power morcellator lawsuits against several different medical device manufacturers recently submitted a motion to the multidistrict litigation panel requesting their cases be centralized for pretrial proceedings.
At the moment, there are at least 22 morcellation cancer lawsuits pending against morcellator device manufacturers in 16 different US federal districts. Each of these lawsuits alleges essentially the same claims of against the morcellator manufacturers.
The lawsuits allege that using morcellator devices during laparoscopic hysterectomy or myomectomy surgeries caused the spread of uterine cancer in each of the plaintiffs.
Centralizing lawsuits through a multidistrict litigation panel helps to create consistent and efficient pretrial rulings. An MDL helps to avoid duplicative discovery concerning common issues and prevents conflicting pretrial rulings before different federal judges.
In an MDL, all of the federal lawsuits would be heard before a single federal judge. The plaintiffs in the morcellator lawsuits requested the pretrial hearings be heard in a Kansas federal court.
The medical device manufactures who object to the motion to centralize the lawsuits claim that there are too few cases involved and too many different products at issue to justify establishing centralized proceedings.
Johnson & Johnson, one of the device manufacturers named in the morcellation cancer lawsuits, urges the panel to reject the creation of a multidistrict litigation for each device manufacturer. Johnson & Johnson argues that individual pretrial discovery is an important part of product liability lawsuits. The company also speculates that the number of morcellator lawsuits filed against its company will remain very low.
Other morcellator manufacturers involved in the litigation include Karl Storz, Richard Wolf Medical Instruments, and Gyrus ACMI.
Overview of Morcellator Lawsuits
In April of 2014 the Food and Drug Administration, or FDA, warned the medical community and consumers about uterine cancer risks associated with using power morcellators.
Morcellators allow medical professionals to perform hysterectomies and myomectomies through a small minimally invasive incision. The FDA estimates that one out of every 350 women who undergo uterine fibroid surgery have undiagnosed or unsuspected cancerous sarcoma cells contained within their uterus. Morcellators are suspected to rapidly increase the spread of cancer cells throughout a patient’s body.
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First Morcellator Cancer Suit Settled
Jul 26, 2015 | Legal Reader
By Jay W. Belle Isle
Morcellator. It’s a world that leaves a funny (as in “Eeww!”) feeling in your mouth. That’s nothing compared to what the medical instrument leaves in your body. Morcellation (shudders) can spread previously undiagnosed malignant cancer cells throughout the patients’ pelvic and abdominal cavities, which shortens the patients’ life expectancy. The first morecellator cancer suit settled recently for an undisclosed amount.
The suit, filed in 2014 in by Widower Scott B., against LiNA Medical, alleged that her aggressive uterine cancer was made worse by a power morcellator hysterectomy she had 11 months before her death.
The power morcellator has been a favorite of doctors for breaking up uterine fibroids and doing hysterectomies & myomectomies. It allows them to make smaller incisions, which aids recovery time. The problem with the popular device is that as it morcellates (almost chews) up the targeted tissue, if there is any cancer present it gets morcellated and spread throughout the area.
Scott’s suit alleged that there was no documented evidence, pre-morcellation, that his wife had “disseminated and/or metastatic cancer/disease.” However, she was diagnosed with an aggressive form of uterine cancer seven days after the procedure.
She was 53 when she lost her battle with cancer, only eleven months later. According to the FDA, up to 1 in every 350 women may have undiagnosed uterine cancer that can be spread via morcellation. Scott’s case was scheduled for trial in November 2015. There are at least 20 other claims against manufacturers for failure to warn patients of this risk.
In June, the U.S. Judicial Panel on Multidistrict Litigation (JPML) received a petition to consolidate existing federal morcellator cancer suits into a multidistrict litigation (MDL). This would put all of the cases in front of one judge, allowing for more efficient pretrial proceedings. Lawyers will discuss the issue of an MDL at a hearing in October 2015.
Several U.S. hospitals and insurance companies have limited or banned using morcellators in gynecological procedures including hysterectomies and myomectomies.
As more morcellator cancer lawsuits alleging uterine cancer are filed, a growing number of insurance carriers and U.S. hospitals have either limited or totally banned the use of morcellators in gynecological surgeries including hysterectomy and myomectomy.
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Jul 24, 2015 | KFJX Fox 14
By Press Advantage
On April 17, 2014, the US Food & Drug Administration announced a major safety risk of power morcellators, medical devices frequently used to grind uterine fibroid tissue: morcellators can spread and worsen uterine cancer. In November of that year, the FDA would expand on its warning in an updated Safety Communication, warning surgeons to avoid using power morcellators in all but the rarest circumstances. Recommending that all morcellator manufacturers revise their devices’ labeling with a “Black Box” warning, notifying patients and surgeons that “laparoscopic power morcellators during fibroid surgery may spread cancer,” the regulatory agency said that it was “consider[ing] other steps that may further reduce such risk.”
Six days later, Johnson & Johnson initiated a “voluntary market withdrawal,” asking surgeons around the world to return their power morcellators immediately. While Johnson & Johnson’s decision effectively removed the world’s largest morcellator manufacturer from the market, smaller companies have yet to respond. Questioned by the Wall Street Journal on their own plans, Karl Storz, Richard Wolf, LiNA Medical and Olympus Corporation failed to respond.
Meanwhile, patients who believe that a morcellator spread their undetected cancers have begun to file lawsuits. Amid allegations that medical device manufacturers failed to warn the public of morcellation’s risks, more than 20 claims have been filed so far. The first of these morcellator lawsuits, filed by Scott Burkhart on March 14, 2014*, has now been settled for an undisclosed amount by LiNA Medical.
According to Sean Tracey, Esq., managing partner at Tracey & Fox, a growing number of critics say much more needs to be done than “warnings” and “recommendations.” Led by Amy Reed, an anesthesiologist whose undiagnosed uterine cancer was spread by a morcellator procedure in 2013, a vocal movement has formed around calls to ban power morcellators entirely. “Reed and her husband, Hooman Noorchashm, have bravely spearheaded several major changes already,” Tracey says.
Boston’s Brigham and Women’s Hospital restricted the use of morcellators in its own facilities after publicly acknowledging that Reed’s hysterectomy, performed at the hospital, had “upstaged” her cancer. Medical institutions across the country followed suit. Philadelphia’s Temple University Hospital announced that it would end the use of power morcellators completely, as did HCA Holdings Inc., a hospital network encompassing more than 270 facilities.
Tracey notes that several health insurance companies have also limited coverage for procedures involving the device, including UnitedHealth Group and Aetna, respectively the first- and third-largest insurers in the country. “But critics say changes from within the industry don’t go far enough. Reed and Noorchashm have called for regulatory action.” Tracey says that at least one legislator has heard those calls: Mike Fitzpatrick, a Republican Congressman from Pennsylvania.
Inspired by the passion of activists like Amy Reed, Fitzpatrick drafted seven Amendments for inclusion in the 21st Century Cures Act, a sweeping healthcare reform bill passed mid-July 2015. Fitzpatrick’s legislation targeted the medical device approval process currently employed by the FDA, and included measures to strengthen the agency’s postmarket surveillance program for devices.
“Medical device approval has been surrounded by controversy for years,” says Tracey. He cites Section 510(k) of the Food, Drug & Cosmetic Act, which allows the FDA’s Center for Devices and Radiological Health to approve new devices without safety testing, as long as manufacturers can demonstrate that their products are “substantially equivalent” to one approved previously. “In the case of morcellators,” Tracey continues, “manufacturers weren’t required to provide new safety data after the first device was approved. That was more than 20 years ago.” Tracey notes that most morcellators use a spinning blade to grind fibroid and uterine tissue into small pieces. But Olympus Corporation, a Japanese company, introduced an entirely new design in [date]. “Olympus’ morcellator uses energy, rather than blades, to split apart tumors. But even with that significant difference, it was deemed ‘substantially equivalent’ and approved quickly through 510(k).”
Mike Fitzpatrick’s proposed legislation sought to change that process, and ensure that all devices are sufficiently tested in both safety and efficacy. But upon the 21st Century Cures Act’s passage, the House of Representatives had rejected all but one of his Amendments. Surgeons will now be required to include a medical device’s make and model on electronic health records. But this is only one small change to what many consider a hopelessly ineffective approval process.
Tracey & Fox continues to provide free consultations to patients who believe that a morcellator procedure spread or worsened an undetected uterine cancer. For a case eligibility evaluation at no cost, call 713.495.2333.
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Morcellator Wrongful Death Suit Settlement Announced, Says Legal-Bay
Jul 24, 2015 | Market Watch
By PR Newswire
Legal-Bay LLC, the Lawsuit Settlement Funding Company, announced today that LiNA Medical has settled a case against them for an undisclosed amount over a power morcellator death case. The company settled the case before it even went to trial, and there are approximately 20 other morcellator lawsuits at this time. According to Drug Watch, the company did not comment on the settlement. This case was one of the first laparoscopic power morcellator lawsuits filed in federal court, and according to the U.S. FDA, as many as 1 in 350 women are "suspected of having undiagnosed uterine sarcoma that may be spread during morcellation." The victim's husband filed the suit, stating she had no evidence of cancer or disease prior to her surgery in March of 2012, however, about a week after she had the procedure, doctors told her she had cancer, and she died at 53 – only 11 months after the surgery. Johnson & Johnson's Ethicon unit and Blue Endo were also named in the lawsuit which was filed in the U.S. District Court for the Eastern District of Pennsylvania, claiming they failed to warn about the possible risk of the spread of undiagnosed cancer, however there has been no report that either J&J or Blue Endo settled their portion of the claims.
Morcellators have been used in different laparoscopic surgeries including hysterectomy and myomectomy procedures as well as laparoscopic spleen and renal surgeries. While the morcellator device provides a less-invasive surgery and quicker recovery time, the following have been listed as potential side effects: spread of malignant tissue, advanced-stage cancerous growths, and metastatic leiomyosarcoma, an aggressive uterine cancer. Johnson & Johnson has voluntarily pulled the Morcellator device product from the market (or recalled it) after facing harsh criticism for not failing to act faster in regard to their transvaginal mesh claims and DePuy Hip cases. In both of those cases, J&J agreed to settle a portion of those claims totaling over $2 billion.
Patty Kirby, COO and Head of Client Relations, commented on the recent settlement, "Although the first Morcellator case has been settled, liability still remains in question. In addition, it is uncertain as to the amount the awards could be. While most companies are not funding Morcellator pre-settlement cases, we continue to be a leader in mass tort funding and have approved these cases for plaintiffs and their families who wait for their cases to be heard in the courts."
Legal-Bay urges users of Morcellator products, or family members who have had a loved one injured or deceased as a result of a cancer diagnosis, to contact a law firm immediately. Legal-Bay works with nationally recognized Morcellator law firms and attorneys who can assist you with obtaining a free legal consultation on your potential lawsuit claim if you have not retained a lawyer yet. To request to speak with a qualified Morcellator lawyer, contact Legal-Bay at:http://lawsuitssettlementfunding.com/morcellator-lawsuit-loans.php.
Legal-Bay's programs are non-recourse lawsuit cash advances, also known as case funding. None of the programs should be considered to be a settlement loan, settlement loans, lawsuit loan, lawsuit loans, pre-settlement loans, or a pre-settlement loan. To learn more about Legal-Bay's Funding Process visit:http://www.lawsuitssettlementfunding.com/funding-process.php.
To apply right now for pre-settlement lawsuit funding, which can be approved within 24 to 48 hours, feel free to contact Legal-Bay on the company's 24-hour hotline at: 877.571.0405.
You may also fill out an online application to receive a free evaluation on your case at: http://lawsuitssettlementfunding.com.
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Jul 23, 2015 | University Chronicle
By Release Wire
New York, NY — (ReleaseWire) — 07/23/2015 — The controversy surrounding the use of power morcellators (http://www.morcellatorlawsuit2015.com) in gynecological surgeries was the inspiration behind a legislative effort to improve medical device monitoring, Bernstein Liebhard LLP reports. On July 10, 2015, the U.S. House of Representatives passed the "21st Century Cures Act," which includes a provision that would require the make or model number of medical devices to be included in patients' medical records in order to improve the tracking of adverse outcomes. The amendment was one of several morcellator-inspired provisions proposed by Rep. Mike Fitzpatrick, (R., Pa.), who according to The Wall Street Journal, opened a larger discussion about the way medical devices are tracked. Rep. Fitzpatrick's remaining amendments, including one that would have required the Government Accountability Office to investigate current regulations for reporting medical device safety, did not make the final version of the bill.
"Our Firm has been retained by a number of clients who allegedly experienced the spread of undiagnosed uterine cancers due to power morcellators, and we applaud Rep. Fitzpatrick for bringing this issue before Congress. The U.S. Senate has indicated that it may consider its own medical research bill later this year, and we hope that any such legislation will include a similar provision," says Sandy A. Liebhard, a partner at Bernstein Liebhard LLP, a nationwide law firm representing victims of defective drugs and medical devices. The Firm is providing free legal consultations to women who were diagnosed with advanced uterine cancer following surgery with a power morcellator.
Power Morcellator Controversy
Since April 2014, the U.S. Food & Drug Administration has issued two public alerts regarding the potential for power morcellators to spread and upstage undetected uterine cancers when used to perform minimally-invasive hysterectomies and fibroid removals. In its most recent alert issued in November 2014, the agency warned against the use of uterine morcellation in the vast majority of women who require such procedures.
Court documents indicate that more than 20 morcellator lawsuits are currently pending in courts around the U.S. On June 18th, a number of plaintiffs filed a motion with the U.S. Judicial Panel on Multidistrict Litigation (JPML) seeking the consolidation of all federally-filed morcellator cancer cases in a single court for coordinated pretrial proceedings. (In Re: Power Morcellator Products Liability Litigation, MDL No. 2652)
Earlier this month, it was disclosed that Lina Medical ApS had reached an undisclosed settlement in a power morcellator lawsuit that had been scheduled to go to trial later this year in the U.S. District Court, Eastern District of Pennsylvania. According to court records, the lawsuit was filed on behalf of a widower who lost his wife to uterine cancer in February 2013, just 11 months after she had undergone a morcellator hysterectomy. (Case 5:14-cv-01557-LS)
Women whose uterine cancers were allegedly spread via a power morcellator may be entitled to take legal action of their own. To learn more about filing a morcellator lawsuit (http://www.morcellatorlawsuit2015.com/uterine-sarcoma/), please visit Bernstein Liebhard LLP's website, or call the Firm directly for a free, no-obligation case review at 800-511-5092.
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