Preview Newsletter
Morcellation Media Monitoring 06/29/2015
-
Uterine Cancer Death After Hysterectomy Leads to Lawsuit
Jun 25, 2015 | Wall Street Journal
By Jennifer Levitz
The widower of a woman who died in 2013 after undergoing a hysterectomy at Brigham and Women’s Hospital has sued the prominent medical center, the latest in a series of lawsuits involving a controversial medical device used in the procedure. -
MDL Requested in Power Morcellator Cases
Jun 29, 2015 | Accident Injury Lawyer Blog
By Ronald Miller
Around 22 complaints involving power morcellators are pending in 16 different U.S. federal courts around the country. Plaintiffs are now requesting a federal judge to centralize proceedings for Multidistrict Litigation (MDL). I touched on the issues surrounding power morcellators on more than one occasion, but let’s talk about where these cases are and where they are going. -
Johnson & Johnson Faces Another Widower’s Morcellator Lawsuit, Lawyers Tracey & Fox Report
Jun 29, 2015 | Digital Journal
Since the US Food & Drug Administration warned surgeons that power morcellators can spread undiagnosed uterine cancers, Johnson & Johnson’s Ethicon division has been hit by a wave of lawsuits. Among the plaintiffs are many widowed husbands. Filing claims for compensation, these widowers say that their late wives suffered from significantly worsened sarcomas after undergoing hysterectomy procedures for the removal of supposedly benign fibroids. Following battles long and short, plaintiffs claim their wives succumbed to late-stage cancers exacerbated by power morcellators, medical devices that grind fibroid and uterine tissue into small pieces.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
-
Uterine Cancer Death After Hysterectomy Leads to Lawsuit
Jun 25, 2015 | Wall Street Journal
By Jennifer Levitz
The widower of a woman who died in 2013 after undergoing a hysterectomy at Brigham and Women’s Hospital has sued the prominent medical center, the latest in a series of lawsuits involving a controversial medical device used in the procedure.
Rick Kaitz, a Boston lawyer, alleges in the lawsuit that the Harvard University-affiliated hospital knew of the risks of the device, the laparoscopic power morcellator, in potentially spreading undiagnosed cancers but failed to inform his wife. Erica Kaitz died in December 2013 at age 52, about a year and a half after undergoing the surgery.
The wrongful death lawsuit, filed June 18 in Suffolk County Superior Court in Boston, also names the surgeon who performed the procedure and device manufacturer Karl Storz GmbH & Co. KG. A spokeswoman for the hospital declined to comment on pending litigation, as did the surgeon, Dr. Jon Einarsson. Karl Storz didn’t respond to requests for comment. Mr. Kaitz also declined to comment.
At least 22 lawsuits involving morcellators have been filed in 16 federal courts, and law firms are investigating an additional 300 cases, according to a recent filing with the U.S. Judicial Panel on Multidistrict Litigation by lawyers who are seeking to consolidate the cases in one court. Several other lawsuits are pending in state courts, the filing said.
Morcellators were being used in tens of thousands of minimally invasive procedures a year, mostly in hysterectomies, to cut up benign uterine growths known as fibroids. The tool allows the bulky tissue to be removed through small incisions.
Last year the Food and Drug Administration warned that women undergoing the procedure have an estimated 1 in 350 chance of harboring a dangerous hidden cancer that power morcellators can spread and worsen. The agency called for a black-box warning—its strongest caution—on the tool. Johnson & Johnson, which was the largest manufacturer of the device, pulled its version off the market last July. Many hospitals either have stopped or limited use of the device.
The Wall Street Journal reported in November that doctors at Brigham and Women’s continued to use the power morcellator for two years after compiling data in 2011 that questioned the safety of the device and its risks. Brigham said in November that the data was too limited in 2011 to support a change in hospital practice.
The hospital began limiting use of the device in December 2013, acknowledging it had spread cancer in two patients, Ms. Kaitz in 2012, and then-40-year-old Amy Reed in 2013. Dr. Reed, an anesthesiologist, now has advanced cancer. Brigham halted use of the morcellator early last year.
Ms. Kaitz was diagnosed with fibroids and underwent a minimally invasive hysterectomy at Brigham in June 2012. She had uterine sarcoma, the post-surgery pathology report revealed.
The lawsuit filed in Boston by lawyer Thomas Greene alleges that Ms. Kaitz’s medical work-up showed she was a poor candidate for the surgery and that before the surgery, Dr. Einarsson told Mr. and Ms. Kaitz that the risk of a hidden cancer was 1 in 10,000 despite knowing that was a “drastic underestimate.”
In November, Dr. Einarsson said through a spokesman he “believes he likely” told Ms. Kaitz the risk was between 1 in 1,000 and 1 in 10,000 and said he was “saddened by the loss of his patient.”
-
MDL Requested in Power Morcellator Cases
Jun 29, 2015 | Accident Injury Lawyer Blog
By Ronald Miller
Around 22 complaints involving power morcellators are pending in 16 different U.S. federal courts around the country. Plaintiffs are now requesting a federal judge to centralize proceedings for Multidistrict Litigation (MDL). I touched on the issues surrounding power morcellators on more than one occasion, but let’s talk about where these cases are and where they are going.
Power Morcellator Litigation Heating Up
Power morcellators are surgical devices that are used to cut portions of the uterus into small fragments so they can be easily extracted through a patient’s stomach. Morcellators are utilized in laparoscopic hysterectomies where patients want to avoid traditional surgical scarring. Although morcellators are a great way of avoiding just that, the nature of the device and procedure often means that fragments of tissue are left behind after a procedure. Doctors and patients really didn’t worry about this too much because they were under the impression that the risks associated with leaving trace amounts of tissue behind were low.
Starting in 2006, however, pathologists informed a manufacturer of power morcellators, Johnson & Johnson, that their use has the potential to cause cancerous cells in the uterus to spread. Typically, these cells would have been contained in the uterus, but using a morcellator could break up cancerous fibroids in the uterus, increasing the risk of cancer spreading throughout the body. Granted, it’s not like every patient who undergoes a hysterectomy is faced with this risk. Current estimates suggest that about 1 in 350 patients who undergo this procedure have cancer cells contained within the uterus. So the incidence of cancer may be low, but considering that around a half-million patients have undergone a laparoscopic hysterectomy, around 1,500 patients were wantonly exposed to the risk of cancer.
The FDA actually had a formal meeting about power morcellators back in April of last year, after which they offered a warning about the risk associated with power morcellators. They did not issue a recall, but numerous hospitals have discontinued their use, while Johnson & Johnson temporarily suspended sales of the product. After issues began to pop up, lawsuits were filed throughout the country. Those lawsuits suggested that Johnson & Johnson did not adequately warn doctors and patients about the risks associated with power morcellators, meaning they did not have the information needed to make an informed choice about the procedure. Perhaps unsurprisingly, the FDA now insists that traditional hysterectomies are the safer way to go.The Current MDL
All of the current power morcellator lawsuits floating around the federal courts make similar allegations: the manufacturers failed to warn patients about the risks associated with the device. This being the case, the plaintiffs filed a motion to transfer with the Judicial Panel on Multidistrict Litigation asking for consolidation. An MDL would help the parties avoid doing the same discovery over and over again, while allowing one judge to make rulings on similar pre-trial issues. It is similar to a class action, but after discovery and bellwether trials, the cases would then be sent back to their respective districts for individual trials.
The plaintiffs involved in these cases are looking to consolidate the cases before Judge Kathryn H. Vratil in the District of Kansas. The manufacturers have until July 10, 2015 to respond to the request and oral arguments regarding an MDL will be heard sometime in October in New York City.
When cases are consolidated in an MDL, the parties then select certain cases to go forward as bellwether trials. These trials allow the parties to test their cases before juries, gauging how people react to evidence that is put forth. Their outcomes often have a direct influence on settlements and their value.
-
Johnson & Johnson Faces Another Widower’s Morcellator Lawsuit, Lawyers Tracey & Fox Report
Jun 29, 2015 | Digital Journal
Since the US Food & Drug Administration warned surgeons that power morcellators can spread undiagnosed uterine cancers, Johnson & Johnson’s Ethicon division has been hit by a wave of lawsuits. Among the plaintiffs are many widowed husbands. Filing claims for compensation, these widowers say that their late wives suffered from significantly worsened sarcomas after undergoing hysterectomy procedures for the removal of supposedly benign fibroids. Following battles long and short, plaintiffs claim their wives succumbed to late-stage cancers exacerbated by power morcellators, medical devices that grind fibroid and uterine tissue into small pieces.
On February 5, 2015, plaintiff Arthur T. Johnson became the most recent widower to echo these allegations, in a suit filed in the US District Court for the Eastern District of Pennsylvania. According to attorneys at Tracey & Fox, a law firm investigating potential morcellator claims, Johnson’s complaint paints a portrait of corporate negligence and personal tragedy. A copy of the court documents, filed under 2:15-cv-00553-JHS, can be found here.
In court documents, Johnson writes that his wife, Jonel Davis-Johnson, underwent a hysterectomy to remove uterine fibroids on June 19, 2012. He claims that Ethicon’s Morcellex Sigma Tissue Morcellator MX0200 was used to fragment his wife’s uterus during the operation. Following the procedure, a pathological examination of Davis-Johnson’s morcellated tissue found cancer cells. Johnson’s wife was diagnosed with leiomyosarcoma, an aggressive soft tissue cancer, and one that plaintiff says was completely undetected, despite a thorough cancer screening before the hysterectomy. But according to the FDA, “there is no reliable method for predicting or testing whether a woman with fibroids may have a uterine sarcoma.” As a result, the agency has deemed morcellation’s risks too high for it to be considered a safe option in “the majority of women undergoing myomectomy or hysterectomy for treatment of fibroids.” According to Johnson’s complaint, those risks became a reality for his late wife.
A subsequent operation revealed that Davis-Johnson’s leiomyosarcoma had spread from her uterus, where it began, to her right fallopian tube. After the malignancies were excised, she “continued to undergo regular monitoring and observation,” her surviving husband writes. Davis-Johnson was deemed cancer-free, but only for seven months. On January 9, 2013, a “diagnostic laparoscopy [...] revealed malignant cells consistent with a recurrence of leiomyosarcoma,” plaintiff claims. Johnson says that his wife passed away less than a month later, on February 6.
Johnson claims that his wife’s death was “a result of the use of” Johnson & Johnson’s power morcellator. He says that his spouse was never warned of the morcellator’s risk, that it could “disseminate and upstage occult cancer.” Johnson & Johnson ignored years of medical research, plaintiff writes, including studies he says demonstrated that power morcellators are unsafe by design. But in the face of this mounting evidence, plaintiff accuses the company of failing to adopt safety measures that could have minimized the device’s risks.
Johnson & Johnson, once the world’s largest morcellator manufacturer, pulled its devices from the market entirely in the wake of the FDA’s warnings. But whether or not the company’s response came soon enough is still a matter of debate. According to the Wall Street Journal, the US Federal Bureau of Investigation has begun to scrutinize whether or not Johnson & Johnson knew of the device’s risks long before recalling its own power morcellators. Interviewing public health advocates and surgeons, federal investigators have already brought one pertinent development to light: a retired pathologist from Lewisburg, Pennsylvania says that he warned Johnson & Johnson of the morcellator’s risks as early as 2006. In a correspondence with the medical director of Ethicon’s Women’s Health and Urology department, Dr. Robert Lamparter cautioned in no uncertain terms that if morcellation is performed on a woman with an undetected uterine cancer, “the patient’s survival is jeopardized.” Ethicon transferred his warnings to a complaint department, Lamparter told the Times, but his complaint was soon “dismissed.”
In response to these developments, the dangerous medical device attorneys at Tracey & Fox have begun investigating the claims of patients and survivors who believe that a power morcellator procedure caused the spread and worsening of an undetected uterine cancer. The firm’s experienced lawyers, who can be reached at 713-495-2333, have been providing free consultations to women who underwent uterine or fibroid morcellation.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
Full Text of Stories Below
Add recipients
Suggested