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Morcellation Media Monitoring 07/20/2015
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Rep. Rosa DeLauro: A flawed attempt to cure our country’s ills
Jul 16, 2015 | The New Haven Register
By U.S. Congresswoman Rosa DeLauro
Last week, the House of Representatives voted on the Twenty-First Century Cures bill, legislation aimed at promoting biomedical innovation at the National Institutes of Health and in the private sector. That is a laudable goal, and one I share. However, I voted against the bill, because — as experts like former Yale Medical School Dean and Food and Drug Administration (FDA) Commissioner David Kessler have warned — it opens the door even wider to untested and potentially unsafe medical devices and drugs. -
Lina Medical Agrees to Settle Power Morcellator Lawsuit
Jul 17, 2015 | Injury Lawyer News
By Jacky Gale
Scott Burkhart, who had filed a wrongful death lawsuit against Lina Medical, has agreed to accept a settlement pertaining to power morcellator usage and the spread of cancer. The terms of the settlement were not disclosed. In accepting the settlement, the plaintiff agreed to drop his lawsuit against the defendant, whom he had contended was responsible for the allegedly unreasonably dangerous nature of power morcellators. The trial had been set for November 2015. -
How Does Power Morcellator use during Hysterectomy cause cancer spread?
Jul 17, 2015 | The Legal Examiner
By Shezad Malik MD JD
The family of a woman who died in 2013 after undergoing a hysterectomy at Brigham and Women’s Hospital has sued the medical center. The wrongful death lawsuit, was filed earlier in June in Suffolk County Superior Court in Boston. The complaint names the operating surgeon and device manufacturer Karl Storz GmbH & Co. KG. -
Wrongful Uterine Cancer Death from Hysterectomy?
Jul 19, 2015 | The Legal Examiner
By Shezad Malik MD JD
According to court filings, there are many personal injury, wrongful death and defective product liability lawsuits being filed against the manufacturers of power morcellator medical devices. The injured women and their grieving families claim that the patients and doctors should have been warned about the risks associated with use of the popular medical devices during minimally invasive, laparoscopic hysterectomies.
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Rep. Rosa DeLauro: A flawed attempt to cure our country’s ills
Jul 16, 2015 | The New Haven Register
By U.S. Congresswoman Rosa DeLauro
Last week, the House of Representatives voted on the Twenty-First Century Cures bill, legislation aimed at promoting biomedical innovation at the National Institutes of Health and in the private sector. That is a laudable goal, and one I share. However, I voted against the bill, because — as experts like former Yale Medical School Dean and Food and Drug Administration (FDA) Commissioner David Kessler have warned — it opens the door even wider to untested and potentially unsafe medical devices and drugs.
The bill urges the FDA to approve even the highest-risk medical devices, like brain stents and artificial heart valves, based not on full, controlled clinical trials — considered the gold standard — but on low-quality evidence, like the experiences of just one of two patients, or the summary information provided in a journal article. Once these devices are approved, some manufacturers will be able to make substantial changes to them without any outside scientific review of those changes by the FDA or anyone else.
There are equally troubling provisions on new drug approvals. For example, most new antibiotics will also no longer need to go through rigorous, well-controlled clinical trials, which have proved so effective at weeding out unsafe or ineffective drugs. Instead, medicines could be approved based on studies in only a few patients, or even just experiments in test tubes. This will weaken our safeguards and put patients at greater risk, especially at a time when diseases are developing resistance to antibiotics.
The bill would also urge the FDA to approve drugs for other serious diseases based not on direct evidence of their impact on patients’ health, but on studies in rats rather than humans, or on very preliminary findings.
This is deeply worrying, because our country’s drug and device approval process is weak as it is. Already, only 1 percent of medical devices are required to undergo clinical trials. This has led to the approval of devices like the power morcellator, which can spread uterine cancer to other parts of the body. Despite the risks, this device was until recently being used in around 50,000 hysterectomies every year. The FDA has issued a safety alert, but because the device was approved using a less rigorous process, it cannot rescind approval!
A flawed drug approval system has allowed a number of unsafe or ineffective antibiotics onto the market, including several that have since been shown to put patients at greater risk of death. The breast cancer drug Avastin was waved through without proof that it helped patients live longer. Years later, studies showed that women taking the drug not only lived shorter lives, but suffered from strokes and gastrointestinal perforations.
These tragic stories should prompt us to strengthen our approval system. Unfortunately, the Twenty-First Century Cures bill would do the opposite. I believe it would take us down a dangerous path for patient safety.
There are some good things in the bill. For example, it would boost the budget for the National Institutes of Health. While the bill’s $1.75 billion per year increase would not suffice to reverse the precipitous drop in NIH’s purchasing power over the last five years, it would be a step in the right direction. But we should not be willing to provide that funding at the expense of patient safety. Protecting American families is our government’s first duty. I voted against Twenty First Century Cures because I am not prepared to see that duty compromised any further.
Rosa L. DeLauro, a Democrat from New Haven, represents Connecticut’s 3rd Congressional District.
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Lina Medical Agrees to Settle Power Morcellator Lawsuit
Jul 17, 2015 | Injury Lawyer News
By Jacky Gale
Scott Burkhart, who had filed a wrongful death lawsuit against Lina Medical, has agreed to accept a settlement pertaining to power morcellator usage and the spread of cancer. The terms of the settlement were not disclosed. In accepting the settlement, the plaintiff agreed to drop his lawsuit against the defendant, whom he had contended was responsible for the allegedly unreasonably dangerous nature of power morcellators. The trial had been set for November 2015.
Use of power morcellation
Power morcellators are surgical instruments that were routinely used during hysterectomy procedures in which the surgeon uses a minimally invasive approach, also known as a laparoscopic approach. In this type of surgery, the surgeon creates multiple small incisions, rather than one large incision. This means that the uterus and other reproductive organs must be divided into small pieces so that the surgeon can remove them through the small incisions.
Power morcellators are the tools surgeons use to accomplish this. Surgeons may also use power morcellators during surgery to remove uterine fibroids.
However, safety concerns have recently come to light regarding these medical instruments.Advocates calling for a ban on these devices say that they can spread in situ cancer cells well beyond their point of origin, effectively turning early stage cancer into advanced stage cancer. This has grave consequences for a cancer patient’s prognosis. Advanced stage cancer is much more difficult to treat and patients have drastically lower survival rates.
Lawsuits over power morcellators contend that about one in every 350 women undergoing these procedures have undiagnosed sarcoma, a type of cancer. The late Donna Burkhart was allegedly unaware that she had leiomyosarcoma before she underwent a hysterectomy, which used power morcellation. She had the surgery on March 6, 2012, at which point there was no apparent evidence of cancer in her body. However, she was diagnosed with cancer on March 15. As a result of metastatic cancer, she died on February 2, 2013 at the age of 53.
Before accepting the settlement offer for his lawsuit alleging that power morcellation spread his wife’s cancer, Burkhart contended that Lina Medical failed to conduct appropriate product tests, and failed to warn consumers and healthcare professionals of the potential risks.
Other power morcellator lawsuits may be centralized
A growing number of plaintiffs have filed lawsuits with regard to the spread of cancer by power morcellators. This particular settlement is believed to be among the first; however, other settlement offers may be forthcoming. As more lawsuits continue to be filed, a group of plaintiffs has filed a petition with the U.S. Judicial Panel on Multidistrict Litigation (JPML). They request that the JPML form amultidistrict litigation (MDL) to centralize power morcellator lawsuits for the purposes of streamlining pretrial proceedings.
The plaintiffs have requested that U.S. District Judge Kathryn H. Vratil manage the MDL in the U.S. District Court for the District of Kansas. The defendant manufacturers were expected to respond to the petition for centralization by July 10, 2015 and a hearing session for oral arguments pertaining to the centralization is scheduled for October.
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How Does Power Morcellator use during Hysterectomy cause cancer spread?
Jul 17, 2015 | The Legal Examiner
By Shezad Malik MD JD
The family of a woman who died in 2013 after undergoing a hysterectomy at Brigham and Women’s Hospital has sued the medical center. The wrongful death lawsuit, was filed earlier in June in Suffolk County Superior Court in Boston. The complaint names the operating surgeon and device manufacturer Karl Storz GmbH & Co. KG.
According to Rick Kaitz, the husband, the hospital knew of the risks of the device, the laparoscopic power morcellator, in potentially spreading undiagnosed cancers but failed to warn his wife of the risk. Erica Kaitz died in December 2013 at age 52, about eighteen months after undergoing the surgery.
Power Morcellator Company Settles Wrongful Death Claim
Lina Medical recently reported that it has agreed to settle Scott Burkhart’s wrongful death claim of his wife, who had undiagnosed leiomyoscarcoma spread throughout her body by a Lina power morcellator.
Burkhart’s case was the first of several hysterectomy morcellation lawsuits, which allege that several different medical device manufacturers sold a defective and unreasonably dangerous product, and failed to warn about the serious risk of cancer women may face if the morcellator is used during a minimally invasive surgery.
What is Power Morcellator?
Power morcellators are medical devices used during thousands of minimally invasive laparoscopic hysterectomy and fibroid removal procedures. The device grinds up the uterus and uterine fibroids, allowing the easy removal of the tissues through a small incision in the abdomen.
Morcellator use has decreased over the past year, because of the risk that the devices may cause the spread of aggressive uterine cancers that were undiagnosed in the uterus.
Johnson & Johnson, which was the largest manufacturer of the device, pulled its version off the market last July.
2014 FDA “Black Box” Strongest Cancer Risk Warning
In April 2014, the FDA issued a strong warning about the risk of power morcellation cancer, noting that one out of every 350 women undergoing surgery for uterine fibroids may actually have undiagnosed sarcoma.
An FDA advisory panel determined that there is no way to make power morcellators safer. Late last year, the FDA announced that it will allow hysterectomy morcellators to remain on the market with substantially stronger warnings about the risk of cancer.
Many hospitals have announced that they will no longer allow morcellation hysterectomy to be performed and some health care insurances will no longer cover the procedure.
Brigham and Women’s Hospital Under Fire
According to the The Wall Street Journal, 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.
How does Power Morcellator Increase Cancer Risk?
The grinding action of a power morcellator may cause widespread dissemination or spread of cancer cells throughout the abdomen and pelvis. This metastatic cancer spread significantly reduces long-term survival for women.
Morcellator Lawsuits
According to a recent filing with the U.S. Judicial Panel on Multidistrict Litigation, there are at least 22 lawsuits involving morcellators that have been filed in 16 federal courts, and an additional 300 cases are under investigation. Several other lawsuits are pending in state courts, the filing said.
All of the complaints shared similar allegations that morcellator use caused widespread leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers diagnosed following a laparoscopic hysterectomy or fibroid removal surgery.
According to plaintiffs, the rapid spread of leiomyosarcoma, endometrial stromal sarcoma or other uterine cancers may have not occurred if alternative treatment options had been used, including traditional surgical hysterectomy performed vaginally or abdominally.
Federal Multidistrict Litigation Pending
In June, the U.S. Judicial Panel on Multidistrict Litigation (JPML) received notice seeking to transfer complaints filed in U.S. District Courts to one judge for coordinated handling during pretrial proceedings.
This is known as an MDL, or multidistrict litigation, and the centralizations of the lawsuits are designed to speed up the trials.
The plaintiffs are requesting that Lina Medical and other manufacturers of power morcellators be held with U.S. District Judge Kathryn H. Vratil in the District of Kansas.
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Wrongful Uterine Cancer Death from Hysterectomy?
Jul 19, 2015 | The Legal Examiner
By Shezad Malik MD JD
According to court filings, there are many personal injury, wrongful death and defective product liability lawsuits being filed against the manufacturers of power morcellator medical devices. The injured women and their grieving families claim that the patients and doctors should have been warned about the risks associated with use of the popular medical devices during minimally invasive, laparoscopic hysterectomies.
What Are Power Morcellators?
Power morcellators are popular medical devices that are used during laparoscopic hysterectomy and myomectomy procedures. The device has blades that 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 laparoscopic surgery, and reduces operative recovery time, scarring and speeds up recovery.
Unfortunately, the rotating blade of the power morcellator scatters undiagnosed aggressive cancer tissue fragments around a women’s abdomen and pelvic area, accelerating the disease’s progression.
Approximately 600,000 unsuspecting women annually are undergoing this minimally invasive procedure throughout the United States.
According to research, about 40 percent are done to remove presumably benign or noncancerous fibroids that are causing heavy bleeding, pelvic pressure or pain, or other symptoms. The actual number of morcellations is not tracked, leading experts to call for a nationwide registry of gynecological surgeries that would include information on the devices used.How Morcellator Increases Uterine Cancer Spreading RiskAccording 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 aggressive 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.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.
FDA Black Box Warning November 2014
On November 24, 2014, the FDA issued a Safety Communication, in which they attached a “Black Box” warning to power morcellators because of the extreme risks they pose to users. A BLACK BOX warning is the strongest warning that the FDA can issue, short of nationwide recall. Unfortunately the FDA did not issue a nationwide recall.
The FDA stated that the risks posed by morcellators outweigh any potential benefits that, in almost all circumstances, the use of these devices should not be used. The FDA noted that the use of these devices puts too many women at risk.
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.
Johnson & Johnson 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.
Power Morcellators Under FirePower 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 hospital chain HCA Holdings prohibited their use at its facilities for removing uterine fibroids. Highmark, a health insurer in the eastern United States, stopped paying for laparoscopic power morcellation in gynecologic procedures.
In February 2015, United Healthcare announced that, it would require preauthorization for all hysterectomies other than vaginal procedures performed on an outpatient basis.
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.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Morcellation
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