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Morcellation Media Monitoring 06/09/2016
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Bill Would Require Doctors to Report Medical-Device Hazards
Jun 8, 2016 | The Wall Street Journal
By Jennifer Levitz
Doctors would be required to report potentially serious problems with medical devices they use to the U.S. Food and Drug Administration, under a new bill that a pair of lawmakers is expected to introduce in Congress Wednesday. -
Bills aim to fix medical-device dangers
Jun 9, 2016 | Philadelphia Inquirer
By Jonathan Tamari
WASHINGTON - The medical procedure was supposed to help Amy Reed. Instead, it spread cancer through the Bucks County woman's body, and helped spark a national fight that arrived at the Capitol on Wednesday. With Reed and her family looking on, two lawmakers rolled out bills to increase oversight of medical devices like the one that harmed her. -
Bill aims to crack down on dangerous medical devices
Jun 8, 2016 | USA Today
By Brian Tumulty
WASHINGTON – Frank Interlichia of Rochester joined other patient advocates Wednesday to celebrate the introduction of House legislation they hope will lead to swifter action by the Food and Drug Administration to take dangerous medical devices off the market. -
"Medical Device Guardian's Act" To Expedite Self-Reporting Of Adverse Events
Jun 9, 2016 | Med Device Online
By Suzanne Hodsden
U.S. House Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-N.Y.) have sponsored the “Medical Device Guardian’s Act of 2016,” a bill that would require doctors and hospitals to report adverse events associated with medical devices while protecting them from potential liability exposed by their reports. Sponsors of the bill argue that medical practitioners are in the best position to observe concerning trends in device safety, and can report these events sooner than anyone else. -
Bill would require doctors to report faulty medical devices
Jun 8, 2016 | WOKV
By Justin Gray
Washington DC — A simple medical procedure can become a life-threatening tragedy if medical devices designed to heal instead cause harm. A new bipartisan bill in Congress aims to better regulate medical devices and protect patients, and for the first time require doctors to report issues that arise. -
J&J Hysterectomy Cancer Lawsuits Settled
Jun 7, 2016 | The Legal Examiner
By Shezad Malik MD JD
According to sources nearly 90% of the morcellator hysterectomy cancer lawsuits filed against Johnson & Johnson’s Ethicon unit have been settled.
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Bill Would Require Doctors to Report Medical-Device Hazards
Jun 8, 2016 | The Wall Street Journal
By Jennifer Levitz
Doctors would be required to report potentially serious problems with medical devices they use to the U.S. Food and Drug Administration, under a new bill that a pair of lawmakers is expected to introduce in Congress Wednesday.
The proposed legislation, known as the “Medical Device Guardian’s Act," is intended to help raise awareness of the possible risks of medical devices that could cause harm to patients. Sponsors of the bill said they were motivated to change the law after the long delay in public awareness of the risks of a women’s surgical tool called the laparoscopic power morcellator.
The FDA in 2014 called for a “black box warning” for power morcellators, sharply curtailing use of a device that the agency said can spread a hard-to-detect uterine cancer during surgery, primarily hysterectomies.
While medical studies and literature had highlighted the risk since the device’s debut in the 1990s, the FDA didn’t receive a report of this adverse event until late 2013 when Dr. Amy Reed went public after a hysterectomy at a Boston hospital.
“After that initial report from Amy, hundreds of other safety reports began to flow into the FDA,” U.S. Reps. Mike Fitzpatrick (R., Pa.) and Louise Slaughter (D.,N.Y.) wrote in a letter to colleagues introducing the bill.
“In retrospect, it should not have fallen on patients to get the FDA’s attention,” the lawmakers wrote, saying that “everyone in the chain of care” should be responsible for alerting the FDA about device hazards.
Currently, the FDA requires hospitals and device manufacturers to report deaths and serious injuries linked to medical devices to the agency’s database of adverse events. Doctors don’t have to report, although they are encouraged to and can even do so by smartphone.
The proposed legislation would add doctors and doctors’ offices to the list of mandated reporters. The sponsors said the bill protects doctors from having their reports to the FDA used against them in a civil case.
Doctors used power morcellators in tens of thousands of minimally invasive procedures annually to remove benign growths known as fibroids. But uterine cancers called sarcomas can masquerade as fibroids and can’t be reliably detected before surgery. Using a morcellator can inadvertently spread malignancies—and other diseased tissues—inside the body, possibly worsening outcomes, according to the FDA.
Doctors and patients typically learned that a patient’s “fibroid” was actually cancer after the surgery, when pathologists had tested the tissue.
The controversy sparked a probe, now under way, by the Government Accountability Office, and lawsuits.
Johnson & Johnson, which suspended sales of its power morcellator in April 2014 and withdrew it from the market in July 2014, has settled more than 100 legal claims and lawsuits tied to the device’s cancer-spreading risk, according to Paul Pennock, a plaintiff lawyer and co-lead counsel for the recently resolved consolidated litigation against the company.
“The resolution of these cases is not an admission of liability,” a spokeswoman for J&J’s Ethicon division said this week. “We believe that Ethicon acted appropriately and responsibly at all times in relation to its morcellation devices. We will defend ourselves in remaining lawsuits.” She declined to quantify settled claims or discuss terms.
Separate morcellation cases are pending against other morcellator manufacturers, including more than 40 in a Los Angeles court against Karl Storz GmbH. The company, which has denied wrongdoing in court filings, didn't respond to a request for a comment.
The scrutiny of power morcellators also highlighted gaps in the nation’s system for tracking serious device risks. In their letter introducing the legislation, the lawmakers noted that the hospital that treated Dr. Reed had a patient “harmed by a morcellator one year earlier” and yet didn’t alert the FDA.
Brigham and Women’s Hospital in Boston had confirmed two instances— Dr. Reed’s in 2013 and another woman’s in 2012—in which power morcellation spread cancer. But hospital officials initially determined these two cases weren’t reportable incidents because the “device functioned as expected and was used in the way it was intended, although with unintended and tragic consequences,” a Brigham spokeswoman said Tuesday, echoing her previous comments.
Brigham has since formally reported both cases, the spokeswoman said.
Requiring doctors and doctors’ offices to report would be a “huge step forward,” since these parties “are likely to be aware” of adverse events, said Rita Redberg, a cardiologist at the University of California San Francisco Medical Center who is critical of FDA surveillance efforts.
Still, the bill wouldn't be a cure-all, the FDA suggested in a statement Tuesday. The agency declined to comment on pending legislation, but said the current medical-device reporting system has “important limitations.”
Instead, the FDA has plans for a national evaluation system that would, among other steps, use data generated during patient care to identify safety issues more promptly. The FDA said it “needs support from Congress and industry to build this system."
People including Frank Interlichia, of Rochester, N.Y., say requiring more clinicians to sound alarms is a crucial start.
His wife, Linda, was diagnosed with uterine cancer in 2013 after a routine hysterectomy with a morcellator for a presumed fibroid, according to her medical records. She later learned of other women in Rochester, including one treated by the same doctor, who had the same outcome.
Ms. Interlichia died a year later at age 55.
Mr. Interlichia is suing the device maker and doctor, who have denied wrongdoing in court filings.
He said it is possible his wife might have undergone a different type of surgery had more doctors reported morcellator issues earlier to the FDA.
“Would [the doctor] have advised Linda differently? Maybe,” Mr. Interlichia said. “I’m deeply in favor of changing the current system.”
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Bills aim to fix medical-device dangers
Jun 9, 2016 | Philadelphia Inquirer
By Jonathan Tamari
WASHINGTON - The medical procedure was supposed to help Amy Reed.
Instead, it spread cancer through the Bucks County woman's body, and helped spark a national fight that arrived at the Capitol on Wednesday. With Reed and her family looking on, two lawmakers rolled out bills to increase oversight of medical devices like the one that harmed her.
Reed, an anesthesiologist from Yardley, had a hysterectomy in 2013 to address what doctors thought were benign growths in her uterus. Her doctors used a power morcellator to chop up her uterus. The tissue-slicing device, approved by federal regulators in 1995, enables gynecologic surgery to be done through tiny incisions, reducing blood loss and recovery time.
But the morcellator hurled then-undiagnosed cancer through her body. Reed, 43, has metastatic cancer and is undergoing treatment including experimental immunotherapy.
"Not one person had reported this deadly effect to the FDA" until Reed, a mother of six, experienced it herself, said Rep. Mike Fitzpatrick, a Bucks County Republican.
On Wednesday, he introduced a bill to require doctors to report serious problems with medical devices to the Food and Drug Administration, putting into law a provision that he said already exists in the American Medical Association's code of ethics.
"It should not have been falling to the patients to bring this to the FDA's attention," Fitzpatrick said.
Reed and her husband, cardiac surgeon Hooman Noorchashm, have led a national push to ban morcellators, and to increase oversight of medical devices.
They stood alongside Fitzpatrick at the news conference outside the Capitol with family members and other advocates.
Noorchashm called the proposed legislation "a litmus test" for Congress.
"This is not about politics," he said. "This is about protecting people's lives."
A second proposed bill was sparked by complaints about serious injuries from Essure, the female sterilization coils. It would allow patients to sue medical device makers for problems caused by products, like Essure, that are shielded from liability laws because they underwent a more stringent FDA approval.
Both bills were introduced by Fitzpatrick and Rep. Louise Slaughter (D., N.Y.).
Despite the bipartisan backing, they face long odds. They have no Senate sponsors, and Congress has little work time left this year before lawmakers break for their fall campaigns. Fitzpatrick is not seeking reelection and will leave Congress at the end of the year.
Though the FDA's device regulation has long been criticized as lax, there's no consensus on what to do about it. The medical-device lobby, meanwhile, has significant sway.
"The FDA represents the gold standard when it comes to providing safe and effective medical technologies for patients and providers," said a spokesman for the Medical Device Manufacturers Association. Replacing its expertise "with the lay opinion of a jury is not prudent."
Since Reed and Noorchashm began their push, many insurers have stopped covering the use of morcellators and hospitals have drastically scaled back their use - though some doctors' groups have defended the device's value.
Bayer Healthcare stands by the safety and effectiveness of Essure, though the FDA recently announced plans for a new safety study and tougher label warnings.
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Bill aims to crack down on dangerous medical devices
Jun 8, 2016 | USA Today
By Brian Tumulty
WASHINGTON – Frank Interlichia of Rochester joined other patient advocates Wednesday to celebrate the introduction of House legislation they hope will lead to swifter action by the Food and Drug Administration to take dangerous medical devices off the market.
The two bipartisan bills would make it easier for patients victimized by faulty devices to sue the manufacturers. They also would require physicians to tell the FDA about any problems the devices cause for patients.
Under current law, only hospitals and manufacturers are required to relay such information to the FDA, which patient advocates say leads to serious under-reporting. Physicians already are required to tell the FDA about adverse effects of prescription drugs, using an online database.
Democratic Rep. Louise Slaughter of Fairport and Republican Rep. Michal Fitzpatrick of Pennsylvania teamed up to introduce the legislation because each was approached by constituents with compelling stories about how a device used for minimally invasive hysterectomies caused an otherwise treatable cancer to spread.
“What should been a routine procedure has ended with a death sentence,’’ Slaughter said Wednesday, noting that Interlichia is one of three local men whose wives died as a result of the procedure. Slaughter has asked the Government Accountability Office to investigate why the FDA approved the device in question, known as a power morcellator. It dices up the uterus and fibroids, which in some cases can host malignant cancers.
“All of us share a similar sad story,’’ Interlichia said as he looked over a group of about two-dozen patient advocates who traveled from as far away as California for the announcement.
He said his late wife’s fervent wish was "to make sure this never happens to anyone else.’’
Fitzpatrick was approached by husband-and-wife physicians, Hooman Noorchashm and Amy Reed, after use of a power morcellator during Reed’s hysterectomy caused her undetected cancer to spread. The couple were the first people to file an official complaint with the FDA in November 2013.
“While we all agree that the majority of medical devices can and should prove to be invaluable, life-saving products,’’ Fitzpatrick said, “we must also note some well-intentioned products can cause harm and have devastating consequences on patient safety and patient health.’’
Reed said physicians at the Boston hospital where her hysterectomy was performed failed to report the problem, even though another patient there was dying from a similar complication at the same time she had her surgery.
“In medical school they tell you all the time, if a patient has an adverse reaction to a drug, you need to report it,’’ Reed said in an interview. “They never say anything about device reporting. My hope is that there is a trickle-down effect now if it’s made into law, (that) it becomes part of the American Medical Association’s educational curriculum and that medical students think about medical devices the same way they think about drugs.’’
The legislation also could address widely reported problems with other medical devices, including a pelvic mesh, a redesigned blood clot filter and the permanent contraceptive known as Essure.
The online group known as the “Essure problems’’ group has 29,800 members, an advocate for the group said.
“When a medical device is not safe, we should have an efficient system to monitor and to remove it from the market,’’ said Fitzpatrick. “And those harmed should have legal recourse through the judicial system. And, unfortunately, today for some, that is just not the case.”
The two bills have no Senate sponsors as yet, but Fitzpatrick expressed optimism the legislation will be considered by the end of the year.
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"Medical Device Guardian's Act" To Expedite Self-Reporting Of Adverse Events
Jun 9, 2016 | Med Device Online
By Suzanne Hodsden
U.S. House Representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-N.Y.) have sponsored the “Medical Device Guardian’s Act of 2016,” a bill that would require doctors and hospitals to report adverse events associated with medical devices while protecting them from potential liability exposed by their reports. Sponsors of the bill argue that medical practitioners are in the best position to observe concerning trends in device safety, and can report these events sooner than anyone else.
The bill was motivated by growing concerns over power morcellators, a surgical tool used in minimal incision surgical (MIS) procedures such as hysterectomy or myomectomy, where organs are cut into pieces that can be removed laparoscopically. In 2014, the FDA issued guidance warning that these procedures excise tissue that is potentially cancerous and could risk the spread of cancer throughout the rest of the body.
Hooman Noorchashm and Amy Reed, two Philadelphia-based physicians, spearheaded efforts to raise awareness about morcellator safety after Reed was diagnosed with cancer not long after undergoing an MIS hysterectomy. In an editorial published by the Philadelphia Inquirer, Reed and Noorchashm praised a letter signed by 12 congressmen and women last August, calling on the Government Accountability Office (GAO) to investigate potential negligence on the part of the FDA in clearing and surveilling morcellation technology.
In a more recent editorial, Noorchashm and Reed proposed the Medical Device Guardians Act, which they claim is the most practical solution to medical device surveillance. Requiring the government to shoulder sole responsibility for “active surveillance” is likely to be costly and ineffective, argued Reed and Noorchashm, when doctors and hospitals are most likely to have the best access to relevant data.
“It is the fear of liability and the FDA’s lax enforcement of ‘self-reporting’ requirements that has created a ‘culture of complacency’ in the medical device space,” wrote Noorchashm and Reed. “Legislation that would protect individual practitioners from liability when reporting adverse outcomes associated with the use of medical devices, and prosecuting failures to ‘self-report’ would reveal problems very quickly.”
Current FDA policy requires manufacturers and hospitals to report all adverse events and additional labeling information to the agency, where it is available to the public through a centralized database.Though doctors are encouraged to report, they are not required to do so. The proposed bill would amend language in the current policy to add doctors’ offices to the list of reporters.
“In retrospect, it should not have fallen on patients to get the FDA’s attention,” wrote Reps. Fitzpatrick and Slaughter in a letter introducing the bill, reported the Wall Street Journal (WSJ). “Everyone in the chain of care” should be responsible for reporting adverse events to FDA.
The FDA has not commented on the bill, but suggested in a statement that current agency surveillance efforts with medical devices have “important limitations.” According to WSJ, the FDA has proposed a national evaluation system that would use data “generated during patient care to identify safety issues more promptly.”
In 2014, Johnson & Johnson halted international distribution of its portfolio of morcellation technology, but WSJ reported that many gynecologists were still performing the procedure, arguing that the devices are an important tool that reduces risk to women undergoing surgery. The FDA recently approved a first-of-its kind container bag for certain power morcellator procedures.
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Bill would require doctors to report faulty medical devices
Jun 8, 2016 | WOKV
By Justin Gray
Washington DC — A simple medical procedure can become a life-threatening tragedy if medical devices designed to heal instead cause harm. A new bipartisan bill in Congress aims to better regulate medical devices and protect patients, and for the first time require doctors to report issues that arise.
There's no current law in place requiring doctors to report problems or complications from medical devices, leaving the FDA sometimes unaware that problems exist.
Amy Reed, a mother of six, a doctor and now a cancer patient, went in for a routine surgery for fibroids. The medical device that was used spread a previously undiagnosed cancer throughout her body.
"These people had been shredding tumors inside people for 20 years," Reed said.
As a patient, Reed reported the problem with the device to the FDA. She was the first to do so, but hundreds of other complaints followed. An FDA warning was later sent out about the device, called a power morcellator.
The Medical Device Guardians Act would require that doctors report problems or possible complications from medical devices directly to the FDA. Reporting is currently not mandatory.
"Who knows how many devices have been hurting people and at what frequency because people haven't really been reporting it," said Reed.
Rep. Mike Fitzpatrick, R-Pennsylvania, and Rep. Louise Slaughter, D-New York, introduced the bill.
"Hundreds of Americans are being harmed by the very medical devices that they and their physicians have turned to for help," Fitzpatrick said.
Doctors already report problems with prescription drugs.
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J&J Hysterectomy Cancer Lawsuits Settled
Jun 7, 2016 | The Legal Examiner
By Shezad Malik MD JD
According to sources nearly 90% of the morcellator hysterectomy cancer lawsuits filed against Johnson & Johnson’s Ethicon unit have been settled.
Cancer ridden women afflicted with leimyosarcoma, an aggressive form of uterine cancer and their families filed personal injury and defective product liability lawsuits. The injured women claimed that the cancer spread by a surgical tool used during laparoscopic hysterectomy or urterine fibroid removal procedures.
Links between laparoscopic power morcellators and cancer have triggered lawsuits throughout the United States just as the FDA issued a recall on three Johnson and Johnson devices.
The FDA and doctors were alarmed about the safety of surgical procedures that use power morcellators. These devices have been proven to be effective in some minimally invasive surgeries. But when they are used to break up uterine fibroid tumors or in some kidney and spleen surgeries, they tend to spread cells that lead to malignant tumors in men and women.
Metastatic leiomyosarcoma, a type of uterine cancer, that can develop in women as a result of the power morcellators.
J&J Ethicon Multidistrict Litigation
Approximately 42 product liability lawsuits were filed in U.S. District Courts against Ethicon, which was the leading manufacturer of power morcellators, and a multidistrict litigation (MDL) was formed to coordinate pretrial proceedings for the cases in October 2015. The Ethicon MDL litigation is centralized before U.S. District Judge Kathyryn H. Vratil in the District of Kansas.
FDA Morcellator Warnings
In 2014 the FDA issued a safety alert in response to reports of links between power morcellators and cancers. The alert from the FDA discouraged the use of such instruments to remove fibroids or the uterus in women.
What are Power Morcellators?
Surgeons use power morcellators in hysterectomies and other minimally invasive procedures to remove uterine fibroids, called myomectomies. The benefits of using power morcellators in these procedures was that it involved less time in the operating room, a shorter recovery time, and less blood loss by the patient.
How does Morcellator spread Cancer?
Power morcellators use spinning blades to grind up the uterus, making it easier to remove during laparoscopic surgery. The blades on the power morcellators can spread bits of uterine or fibroid tissue through the pelvis and abdomen. These bits of tissue can stick to other tissue and organs then begin to grow.
Some symptoms that might signal cancer after going through a procedure where morcellators were used include:
-Vaginal bleeding or spotting, between periods or especially after menopause
-Abdominal or pelvic pain or a mass
-Abdominal or pelvic swelling
-Weight loss
If you or a loved were diagnosed with uterine cancer following a procedure that involved power morcellators, contact us to find out if you have a case against the makers of the device. Our office handles power morcellators lawsuits throughout the United States against J&J Ethicon, and other manufacturers of similar devices, including Karl Storz, Richard Wolf Medical Instruments, and Gyrus ACMI.
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