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Morcellation Media Monitoring 06/13/2016
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New Law Could Help Protect Patients From Devastating Medical Device Failures
Jun 9, 2016 | Fortune
By Laura Lorenzetti
Doctors may have a new duty to report flaws with medical devices to the U.S. Food and Drug Administration if a new law introduced in Congress Wednesday passes. -
Will Congress choose to protect patients and doctors from dangerous devices?
Jun 10, 2016 | Philadelphia Inquirer
By Amy J. Reed, M.D., Ph.D. & Hooman Noorchashm, M.D., Ph.D.
On June 8, 2016, a bipartisan bill was proposed by U.S. Representatives Mike Fitzpatrick (R-PA), Louise Slaughter (D-NY) and Ryan Zinke (R-MT). -
Congressman Fitzpatrick bill calls for medical device regulation reform
Jun 9, 2016 | The Intelligencer
By Tom Boyle
The article is behind a paywall, what is available has been pasted below. -
Proposed U.S. bill would require docs to report medical device adverse events to the FDA
Jun 9, 2016 | FierceMedicalDevices
By By Alyssa Huntley
A proposed bill from U.S. representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) would have quite an impact on doctors when it comes to reporting potentially serious problems with medical devices. -
Bill Requires Physicians to Report Medical-Device Deaths
Jun 10, 2016 | Medscape
By Robert Lowes
Dr Noorchashm and Dr Reed claim that hundreds, if not thousands, of women have lost their lives to dispersed uterine cancer after power morcellation for more than 2 decades. -
Patient Safety Bills on Morcellators, Essure Introduced in House
Jun 10, 2016 | The Cancer Letter
By Matthew Bin Han Ong
Two House measures introduced earlier this week aim to strengthen federal requirements for reporting adverse outcomes caused by medical devices and to increase access to legal recourse for patients harmed by Class III high-risk devices.
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New Law Could Help Protect Patients From Devastating Medical Device Failures
Jun 9, 2016 | Fortune
By Laura Lorenzetti
Doctors are the key.
Doctors may have a new duty to report flaws with medical devices to the U.S. Food and Drug Administration if a new law introduced in Congress Wednesday passes.
The proposed legislation is known as the “Medical Device Guardian’s Act” and was developed by legislators after a certain medical device caused devastating effects in some patients but wasn’t reported directly to the FDA until years later, reported the Wall Street Journal.
The incident raised awareness that doctors, who are often the first to see the direct effects of a medical device, aren’t required by law to report poor or adverse outcomes due to devices, though both hospitals and device manufacturers are required by law to do so. The new bill would require doctors and doctors’ offices to report such incidences.
The device, which spurred the new bill, is known as a laparoscopic power morcellator. It’s used to perform hysterectomies and other female-centric surgeries like removing uterine fibroids. Early on after its debut in the 1990s, there was evidence that the device could spread a quiet yet dangerous type of uterine cancer. But, no adverse event was raised directly to the FDA until late 2013 when a patient (and herself a doctor) raised the red flag.
The morcellator works by slicing up typically benign uterine fibroids so they can be pulled out through a small surgical incision. However, some cancers can look like fibroids and doctors can’t confirm until they are biopsied post surgery. Using the morcellator tool can inadvertently spread cancerous cells around the body and “significantly worsen the patient’s long-term survival,” according to the FDA, which has warned against using such devices to treat uterine fibroids.
As many as 1 in every 350 women undergoing a hysterectomy or the removal of fibroids is found to have a type of unsuspected uterine cancer, and there’s no reliable way to predict whether a woman may have such disease prior to surgery. In a November 2014 release on the issue, the FDA called the risk “higher than previously understood.”
Both U.S. Reps. Mike Fitzpatrick and Louis Slaughter noted that after the first report of issues in 2013 linked to the morcellator, hundreds of others flowed into the FDA.
“In retrospect, it should not have fallen on patients to get the FDA’s attention,” the lawmakers wrote. The responsibility to report such issues should have fallen to “everyone in the chain of care.”
The new bill seeks to solve that issue, and Rep. Fitzpatrick has even called on Vice President Joe Biden to include better reporting of medical device-related issues in his “Cancer Moonshot” initiative.
“As part of the Cancer Moonshot, we have the chance to protect others from the harm caused by dangerous medical devices,” wrote Fitzpatrick. “While supporting the development of new devices to target cancer, we must ensure that the FDA is able to review, monitor, and quickly take action should those devices do harm.”
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Will Congress choose to protect patients and doctors from dangerous devices?
Jun 10, 2016 | Philadelphia Inquirer
By Amy J. Reed, M.D., Ph.D. & Hooman Noorchashm, M.D., Ph.D.
On June 8, 2016, a bipartisan bill was proposed by U.S. Representatives Mike Fitzpatrick (R-PA), Louise Slaughter (D-NY) and Ryan Zinke (R-MT).
This bill, the “Medical Device Guardians Act” (H.R. 5404), was named in honor of the hundreds, if not thousands, of women whose lives were devastated or ended prematurely, using a flawed medical device known as a Power Morcellator.
The Guardians Act targets a very serious defect in the FDA’s “self-reporting” requirements for medical devices.
Current law requires that hospital corporations and manufacturers report adverse outcomes related to the use of medical devices to FDA. In the case of the power morcellator, this legal requirement was not followed and lives were compromised for over two decades.
This bellwether failure is but one example of a dangerous disconnect between some practitioners and their hospital administrations and medical device manufacturers.
Why are physicians not required to “self-report” device-related adverse outcomes as a matter of routine? After all, a doctor or practitioner using a medical device that causes a complication in a patient has the most accurate perspective on any dangers.
Wouldn’t it make sense for the FDA to have access to such signals directly from doctors themselves?
The Guardians Act also protects physicians, by shielding them from civil liability in any malpractice cases that arise based on their reports.
This bill is a win-win that protects both patients and physicians. Plus, it codifies into law a specific mandate of the American Medical Association’s Code of Medical Ethics that doctors should be following anyway.
But the Guardians Act faces two potential threats.
First, medical device advocacy groups, like AdvaMed and MDMA are already objecting to this bill because it will uncover potential problems requiring work on the part of medical device companies to remedy. But, good stewardship requires that such advocacy groups keep patient safety at the forefront of their activities.
The second threat to The Guardians Act is congressional complacency and bad timing.
Without a question representatives Fitzpatrick, Slaughter, Zinke and a core group of other representatives have risen strongly to this cause. But, we have already seen some terrible resistance and lethargy in securing the medical device regulatory space from prominent members of Congress.
Additionally, with a break approaching quickly for Congress, and with Mr. Fitzpatrick in his last term in the House, the fate of the Guardians Act (H.R. 5404) remains very much in the balance.
The hazard in the medical device regulatory space in America is quite clear and well described. So whether Congress and the president choose to expedite this simple and common-sense legislative measure is a litmus test of their integrity as our representatives.
Let us hope that the House, the Senate and the president take note of the Guardians Act.
Agreeing on a non-political bill that will save American lives should be a no-brainer on the Hill.
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Congressman Fitzpatrick bill calls for medical device regulation reform
Jun 9, 2016 | The Intelligencer
By Tom Boyle
A Yardley woman's life changed forever three years ago when the use of a medical device during a hysterectomy shredded a cancerous tumor and spread the poisoned cells throughout her body. While she continues her fight to survive with the support of her husband and six children, Dr. Amy Reed has some hope that new legislation introduced in the U.S. House of Representatives will prevent others from suffering her fate.
Reed, an anesthesiologist, and her husband, Hooman Noorchashm, a cardiac surgeon, traveled to Washington, D.C., on Wednesday to witness Congressman Mike Fitzpatrick, R-8, and Congresswoman Louise Slaughter, a Democrat from New York, submit a package of bills designed to reform the review process for medical devices and grant more legal recourse for victims of unsafe devices, such as the permanent birth control implant, Essure.
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Proposed U.S. bill would require docs to report medical device adverse events to the FDA
Jun 9, 2016 | FierceMedicalDevices
By By Alyssa Huntley
A proposed bill from U.S. representatives Mike Fitzpatrick (R-PA) and Louise Slaughter (D-NY) would have quite an impact on doctors when it comes to reporting potentially serious problems with medical devices.
The Medical Device Guardians Act would require physicians and physicians' offices to report "adverse events" that occur when a medical device is in use and would also consider those individuals and institutions "protected." Bill sponsors want to change the law after a "long delay in public awareness of the risks of a women's surgical tool called the laparoscopic power morcellator," the Wall Street Journal reported.
Starting in 2014, concerns arose about the likelihood for power morcellator devices to spread undetected sarcoma during certain gynecological procedures, and in November 2014 the FDA recommended against the use of the devices. However, medical studies and literature calling the devices' safety into question had been floating around since the 1990s, the WSJ reported, though the FDA never received a report until 2013 when Dr. Amy Reed spoke up after a hysterectomy.
While current regulation requires manufacturers, importers and hospitals to report adverse events and product issues to the FDA, individual doctors don't share the same burden. They are encouraged to and have been provided with multiple ways of doing so, including via smartphone.
Should this bill be adopted, doctors and doctors' offices would be required all the same to report adverse events, and in doing so would be protected from those FDA reports being used against them in a civil case.
While many are praising this requirement--such as Rita Redberg, a cardiologist at the University of California San Francisco Medical Center, who told the WSJ it would be a "huge step forward"--the FDA noted that the current reporting system has "important limitations."
The outlet also noted that the FDA is working on plans for a system that would use data collected during patient care to better understand safety issues and address them more quickly. The FDA also told the WSJ that the agency needs Congress and industry support to build such a system.
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Bill Requires Physicians to Report Medical-Device Deaths
Jun 10, 2016 | Medscape
By Robert Lowes
Dr Noorchashm and Dr Reed claim that hundreds, if not thousands, of women have lost their lives to dispersed uterine cancer after power morcellation for more than 2 decades.
"There were many physicians who knew about this problem," Dr Noorchashm told Medscape Medical News. "Cases existed in the medical literature. But not a single physician bothered to report it to the FDA (until Dr Reed)."
Dr Reed, who continues to receive treatment for metastatic cancer, works part-time at the Hospital of the University of Pennsylvania training critical care fellows, according to her husband. She was not available for comment.
GAO Investigation Under Way
Although power morcellators remain on the market, they have fallen into disfavor. In April 2014, the FDA warned against using the devices for hysterectomies or myomectomies in most women with uterine fibroids because of the risk of spreading occult uterine cancer, put at 1 in 350 women undergoing these procedures. Later that year, the FDA added a boxed warning to product labels. One manufacturer, Johnson & Johnson, voluntarily withdrew its morcellators from the market, major insurers have dropped or restricted coverage of the procedures, and fewer surgeons are using the devices.
The American College of Obstetricians and Gynecologists and some individual physicians, however, have argued for retaining power morcellators, saying that the risks of open surgery are far greater.
Besides sponsoring the Medical Device Guardians Act, Fitzpatrick along with 11 other members of Congress have instigated an investigation by the federal General Accountability Office into the FDA's original approval of power morcellators, and why it took so long for the agency to warn about their dangers.
Bill Mirrors AMA Ethical Code, Says Dr Noorchashm
Under current federal law, hospitals, ambulatory surgery centers, and other so-called device-user facilities must report any deaths linked to a medical device within 10 working days to the FDA as well as the manufacturer. The definition of device-user facilities excludes physician offices.
In the case of serious injury or illness, or any other significant adverse event, these facilities must immediately inform the manufacturer, and file an annual report about these mishaps, as well as any deaths, with the FDA. Such reports cannot be admitted into evidence or otherwise used in civil litigation unless the facility knew that the information in its report was false.
The Medical Device Guardians Act includes physicians and physician offices in the list of parties who must report device-related deaths and injuries. As with hospitals, any report filed by a physician can't be used in a lawsuit.
The bill mirrors a section of the ethical code of the American Medical Association that obligates physicians to report serious adverse events linked to a drug or medical device to the FDA, Dr Noorchashm noted.
Second Bill Inspired by Essure-Related Mishaps
The other bill introduced on June 8, called Ariel Grace's Law, would remove the legal immunity enjoyed by manufacturers of medical devices that have gone through the FDA's premarket approval (PMA) process, its most rigorous. Their manufacturers can't be sued in state courts when something goes wrong.
Fitzpatrick named the bill after an unborn child named Ariel Grace, whose death in the womb is blamed on Essure permanent contraception, a flexible metal coil inserted into a woman's fallopian tubes. Fitzpatrick contends that the device has led to the deaths of at least four women and almost 300 fetuses. Essure'smanufacturer, Bayer, is shielded from state lawsuits on account of the device's PMA status.
In an email to Medscape Medical News, Bayer said that the bill "upends the very carefully crafted balance established by Congress to promote medical device research and innovation, and could potentially delay or stifle significant health benefits such devices provide." The company also said that the vast majority of deaths that Fitzpatrick characterized as fetal deaths don't warrant that description, at least by the FDA's standards, because they involved ectopic pregnancies and miscarriages.
In February, the FDA proposed a boxed warning for Essure permanent contraception, as well as a patient checklist that highlights possible adverse events such as perforation of the uterus or fallopian tubes, device migration, hypersensitivity reactions, and persistent pain. However, the FDA said the device should stay on the market for now — provided women are apprised of the risks — because "it is extremely effective at preventing pregnancy when used correctly."
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Patient Safety Bills on Morcellators, Essure Introduced in House
Jun 10, 2016 | The Cancer Letter
By Matthew Bin Han Ong
Two House measures introduced earlier this week aim to strengthen federal requirements for reporting adverse outcomes caused by medical devices and to increase access to legal recourse for patients harmed by Class III high-risk devices.
Sponsored by Reps. Mike Fitzpatrick (R-Pa.) and Louise Slaughter (D-N.Y.) and introduced June 8, the bills address harm to patients from two high-profile medical devices:
• The power morcellator, a Class II minimally invasive gynecological device known to spread undetected uterine cancer during hysterectomy and myomectomy, and
• And Essure, a Class III permanent sterilization device inserted in the fallopian tube. FDA has received nearly 10,000 reports from patients about complications resulting from the nickel-based metal coil, which has been known to perforate uterine walls and abort pregnancies.
The Medical Device Guardians Act was created in response to lapses in FDA’s regulatory system for medical devices, which mandates reporting of adverse outcomes by hospitals and device manufacturers.
This means that only institutions, not individual practitioners, are liable, removing the incentive for physicians to report adverse outcomes.
The second bill, Ariel Grace’s Law, would allow patients harmed by Class III devices to file lawsuits against manufacturers. The 1976 Medical Device Amendments, along with a 2008 ruling by the Supreme Court, sharply limit the types of recourse patients might have for injuries from medical devices. This applies to Class III products such as the Essure device, which go through premarket approval, FDA’s highest bar for demonstration of safety and effectiveness (The Cancer Letter, Dec. 18, 2015).
“I’m eternally grateful for all the families that have worked with Congressman Fitzpatrick and me to prevent more people from going through the tragedy that they’ve endured,” Slaughter, the highest ranking Democratic member of the House Committee on Rules, said in a statement. “These bills are about saving lives. We’ve seen firsthand how devastating it is when a medical device has an unintended, adverse consequence.
“It’s time for Congress to make commonsense changes to protect patients and give them the information that could help save lives.”
In the case of the power morcellator, FDA said it did not receive any reports of adverse outcomes from manufacturers and hospitals prior to December 2013. (The Cancer Letter, Nov. 19, 2015).
In November 2014, The Cancer Letter first reported on Brigham’s role in upstaging a patient’s leiomyosarcoma via power morcellation performed in 2012. Erica Kaitz, the patient, died on Dec. 7, 2013. In October 2013, another patient, Amy Reed received her cancer diagnosis at Brigham. Reed subsequently led a campaign against widespread use of the procedure (The Cancer Letter, Nov. 21, 2014).
In a study by Brigham physicians Michael Muto and Michael Seidman published November 2012 in PLOS ONE, the authors identify four patients—out of 1,091 patients—who showed evidence of peritoneal dissemination of leiomyosarcoma after undergoing power morcellation. Three of the four patients died, with an average post-diagnosis survival of 24.3 months.
It is not publicly known where the four patients were treated.
Ethicon—a subsidiary of Johnson & Johnson, and the largest manufacturer of the devices—said it didn’t know of the dangers of power morcellators prior to December 2013, when Reed and her husband Noorchashm filed a Medical Device Report to FDA. Whistleblower Robert Lamparter, a retired pathologist from central Pennsylvania, disagreed, and produced documents from 2006 proving that he had reported to J&J a near-miss case as well as risk estimates similar to FDA’s numbers (The Cancer Letter, Nov. 20, 2015).
In 2015, Fitzpatrick, Slaughter and 10 members of Congress commissioned a Government Accountability Office investigation on who knew what, and when.
The GAO joins three other federal agencies in looking into potential violations of statutory requirements for hospitals and manufacturers to report adverse outcomes: the Federal Bureau of Investigation, the FDA Office of Criminal Investigations and the Subcommittee on Oversight and Investigations of the House Committee on Energy and Commerce.
“While many medical devices prove lifesaving, we know that some can cause harm and have devastating consequences for patients,” Fitzpatrick, vice chairman of the Subcommittee on Oversight and Investigations, said in a statement June 8. “I think everyone would agree that when a medical device is found to be unsafe, there needs to be an effective process in place to track these failures, to remove devices from the market, and provide legal recourse for those impacted. Currently, that process is failing us, and our constituents are paying the price.
“It’s time we reform the FDA, its processes and procedures to allow for maximum innovation and maximum safety. Agencies, physicians and lawmakers should all be committed to this common cause, and open to these bipartisan solutions.”
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