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Morcellation Media Monitoring 07/16/2015
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Congressman Fitzpatrick (R-PA) vs. Burgess (R-TX): Industry protectionism triumphs over patient safety in Congress?
Jul 14, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
On July 10, 2015, Congressman Mike Fitzpatrick of Pennsylvania, remained steadfast as the lone voice of reason and ethics regarding a severe public health hazard in the medical device regulatory space in the United States. A popular bipartisan bill, known as "21st Century Cures" (H.R. 6), passed through the House of Representatives on Friday. Fitzpatrick was supportive of this bill - because it funded the NIH to facilitate life-saving research. -
Is this FBI Investigation a Threat to Johnson & Johnson?
Jul 16, 2015 | The Motley Fool
The FBI is investigating a surgical device used on tens of thousands of women each year, and this could be bad news for Johnson & Johnson. Last year, Johnson & Johnson voluntarily stopped selling power morcellators, a surgical instrument used to cut up large masses of tissue for removal during laparoscopic surgery. Now the FBI is investigating whether J&J had knowledge of the hazards and danger surrounding the power morcellator while it was still being sold. -
*New* Power Morcellator Controversy Spurs FDA Proposal – But Does it Go Far Enough?
Jul 13, 2015 | Mesh Medical Device News Desk
By Jane Akre
The morcellator is a tool that is used to grind up growths in the uterus, however a woman has a one in 350 chance that the fibroid is masking a dangerous cancer causing it to spread. See background story here on Mesh News Desk. The danger came to light over the very public prognosis last year of Dr. Amy Reed, who had the procedure. She and her husband, Dr. Hooman Noorchashm, MD, have taken to social media to call for a ban of the power morcellator. -
U.S. House passes provision to keep tabs on medical devices used on patients
Jul 16, 2015 | Fierce Medical Devices
By Joseph Keenan
The U.S. House of Representatives passed a far-reaching medical research bill on Friday that includes an amendment to better monitor the use of medical devices for patient safety. The provision in the bill was a result of the controversy over use of laparoscopic power morcellators. -
First Federally Filed Morcellator Cancer Lawsuit Settled by Southern Med Law
Jul 16, 2015 | Digital Journal
By ReleaseWire
The attorneys at Southern Med Law have settled the first federally filed morcellator cancer lawsuit against LiNA Medical APS. Kebomed AG & LiNA Medical US, the makers of power morcellators. The lawsuit was filed in March 2014 in the U.S. District Court, Eastern District of Pennsylvania by Southern Med Law on behalf of Scott Burkhart, a Pennsylvania widower whose wife died of disseminated leiomyosarcoma in February 2013, which she developed after undergoing a power morcellator hysterectomy. -
House Bill Would Intensify Medical Device Monitoring
Jul 14, 2015 | Outpatient Surgery
By Jim Burger
A bill passed by the U.S. House of Representatives last week includes a provision that would require the make or model number of a medical device used on a patient to be included in electronic health records.
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Jul 14, 2015 | The Philadelphia Inquirer
By Hooman Noorchashm, M.D., Ph.D. and Amy J. Reed, M.D., Ph.D.
On July 10, 2015, Congressman Mike Fitzpatrick of Pennsylvania, remained steadfast as the lone voice of reason and ethics regarding a severe public health hazard in the medical device regulatory space in the United States.
A popular bipartisan bill, known as "21st Century Cures" (H.R. 6), passed through the House of Representatives on Friday. Fitzpatrick was supportive of this bill - because it funded the NIH to facilitate life-saving research.
But, there was also a major catch. The provisions in H.R.6 directed at the medical device industry made an unsafe regulatory environment even more unsafe for the public. And Fitzpatrick recognized this very clearly.
So he proposed 8 Amendments to this bill, aimed at making H.R. 6 a "Safe bill" when it comes to regulation of medical devices in the United States.
Fitzpatrick's amendments were proposed because he understood that the "power morcellator" disaster in the women's health was a bellwether case of failure by the Food and Drug Administration's Center for Devices and Radiological Health. A failure that had cost many unsuspecting American women and their families their precious lives. Mike Fitzpatrick got tuned into this horrific disaster and its root cause, and he activated a full scale warning to his colleagues in the House of Representatives.
But, in an astonishing assault, his patient safety Amendments were killed in the Rules Committee of the House of Representatives. The man responsible for this attack on the Fitzpatrick amendments was a Congressman from Texas, Dr. Michael Burgess - himself a gynecologist supposedly committed to women's health. You can read about his action against public health at this link.
After rejection of seven out of Fitzpatrick's eight amendments to "21st Century Cures", on July 10, 2015, Mike Fitzpatrick rose on the floor of the House and made a speech. You can watch it at the following link.
In this speech, he complimented the bipartisan co-sponsorship of this bill, which hold the promise of saving many lives based on its funding of research by the National Institutes of Health. Then he warned his colleagues, again, of a severe safety deficit in the medical device regulatory space at the FDA - a hazard that was fully exacerbated by the provision in H.R. 6.
Fitzpatrick's presentation to congress was strong but down-to-earth, articulate and respectful of his colleagues.
He stated that the medical device provisions in this bill did "more good than harm".
In a courageous move, and specifically because of the hazardous medical device safety provisions, Mike Fitzpatrick voted "NO" to "21st Century Cures" - he voted on principle, on ethics and on conscience. Because to this congressman, making a clear legislative public health hazard even more dangerous for the American people was not an option - no matter what the projected long-term benefits of this bill might have been.
In sharp contrast, the man who killed the Fitzpatrick patient safety amendments in the Rules committee, Congressman Michael Burgess, an Ex-Gynecological surgeon is beholden to the medical trade organizations and industry. He engaged in a diatribe, lecturing Mr. Fitzpatrick as a medical "expert", not a fellow congressman and federal regulator - as though his opinion as a doctor was sacrosanct and definitive.
Burgess' opinion revealed a lack of understanding of the systemic nature of the power morcellator disaster and a deep seated dereliction of congressional duty to the American people, in favor of industry.
Where Fitzpatrick was politely focused on bringing congressional attention to a regulatory public health hazard, Burgess was arrogantly and over-confidently proclaiming that congress and FDA had no role in ensuring medical device safety - and that FDA's current conduct is good enough.
Of course, Burgess' position is very consistent with his campaign coffers - the medical specialty trade organizations and industry. You can view Mr. Burgess' campaign contributors here.
Again, in sharp contrast, Mike Fitzpatrick's campaign contributors are diverse and he is a popular leader. He is a congressman because he walks the streets of his constituency and listens carefully to those whom he represents - he is not just a puppet to the industry puppeteer.
So, is it a surprise that Mike Fitzpatrick falls on the side of the people where Burgess falls on the side of the medical profession and its associated industries? Is it a surprise that Burgess chooses medical industry protectionism where Fitzpatrick chooses patient safety and public health?
You see, Burgess killed amendments that were designed to draw attention to and protect patients from flawed or dangerous medical devices because he favors industry interests over lives.
On the other hand, Fitzpatrick sees that in our nation the lives and fundamental rights of minority subsets of people cannot be sacrificed or ignored by the federal government for the "benefit of the majority" or for the sake of smooth business. And those, dear reader, are true conservative values - those are the true values of a republican, who understands the purpose of the republic.
So the question now is how many others in the United States congress are able to focus squarely on the voice of the people and those harmed over that of the medical device industry and trade organization lobbyists. How many Mike Fitzpatricks are there in the United States congress? and how many Michael Burgesses?
Mike Fitzpatrick has come to represent a core group of women from across the nation, fallen to a disaster that the United States congress can and must contain. He is working to demonstrate to his colleagues that these women are to be recognized as "The Guardians" - their battle codified in the law - so they can stand watch and prevent another catastrophe like the "power morcellator" disaster from rearing its head in America again.
Or, perhaps, ours is wishful thinking.
Read more at http://www.philly.com/philly/blogs/healthcare/Congressman-Fitzpatrick-R-PA-vs-Burgess-R-TX-Industry-Protectionism-Triumphs-Over-Public-Health-and-Patient-Safety-in-Congress.html#IPBhDcrdZDUOeYcy.99 -
Is this FBI Investigation a Threat to Johnson & Johnson?
Jul 16, 2015 | The Motley Fool
The FBI is investigating a surgical device used on tens of thousands of women each year, and this could be bad news for Johnson & Johnson (NYSE:JNJ).
Last year, Johnson & Johnson voluntarily stopped selling power morcellators, a surgical instrument used to cut up large masses of tissue for removal during laparoscopic surgery. Now the FBI is investigating whether J&J had knowledge of the hazards and danger surrounding the power morcellator while it was still being sold.
Power morcellators had been commonly used during laparoscopic hysterectomies. Hysterectomy is the second most common surgery performed on women in the United States, with 500,000 performed annually. Roughly 40% of all hysterectomies are performed to remove symptomatic uterine fibroids, which are usually benign uterine growths. Power morcellators had been used in approximately 25% of fibroid-related hysterectomies, which amounts to roughly 50,000 fibroid-related hysterectomies annually.
FDA alert
The FDA issued a rare safety alert in April 2014, in which it estimated that 1 in 350 women who underwent a hysterectomy for the treatment of fibroids was found to have unsuspected uterine sarcoma, a type of uterine cancer. The report stated that if laparoscopic power morcellation is performed on women with unsuspected uterine sarcoma, there is a risk that the procedure could spread the cancerous tissue within the abdomen and pelvis, significantly worsening the patient's long-term survival prospects.During a laparoscopic hysterectomy, the uterus is sliced, or morcellated, into smaller pieces in order to extract them via small abdominal incisions. However, FDA's alert implies that the morecellation process may spread microscopic cells throughout the abdominal cavity when any previously undiagnosed cancerous tumors are sliced, thereby releasing malignant cells contained within. Scientists are indicating that if malignant cells are released into the abdominal cavity, they can seed multiple new tumors. The most troubling aspect is that if the uterus had been removed intact, with the fibroids intact as well, the cancer would often also have been removed and the patient would have recovered. However, once this type of cancer, leiomyosarcoma, has spread, it is usually fatal.
What this means for Johnson & Johnson
In July 2014, soon after the FDA announcement, J&J halted sales of the power morecellator, contacted doctors, medical associations, hospitals, and advocacy groups, and issued a voluntary recall of the device. Before the company pulled the device off the market, Johnson & Johnson was the largest manufacturer of power morcellators, with an estimated 72% market share of all such devices in 2011.The FBI is currently investigating the potential dangers and hazards surrounding the morcellation procedure, and it is looking at Johnson & Johnson specifically to determine whether the company was aware of the risks prior to pulling its product off the market.
The FBI has been speaking with Robert Lamparter, a former pathologist from Pennsylvania, who in 2006 contacted Ethicon, a wholly owned subsidiary of Johnson & Johnson and the manufacturer of the company's power morcellator, about the device's potential risks. After noticing an increased number of morcellated cancer samples in his lab, Lamparter wrote to Ethicon, "If a morcellation is done, the patient's survival is jeopardized." A J&J spokesman confirmed that the 2006 correspondence with Lamparter took place and indicated that the doctor's concerns led the company to revise the instructions for use of the device.
A larger issue: Do medical devices lack FDA scrutiny?
Medical devices don't undergo the same level of scrutiny in the U.S. as medications do. "The FDA is essentially approving devices for marketing which have not undergone stringent enough safety testing," said Hooman Noorchashm, the husband of Amy Reed, an anesthesiologist who learned that she developed Stage 4 cancer after she had a laparoscopic hysterectomy with a power morcellator to remove uterine fibroids. Reed has spoken out about the dangers and risks associated with the power morcellator since her procedure in 2013.The FBI's investigation into morcellators and Johnson & Johnson's prior knowledge of any risks and hazards associated with the use of the device is ongoing. Meanwhile, it is uncertain whether this investigation will ultimately have any impact on the company. J&J does not provide sales figures for morcellators; however these devices likely represented a relatively small portion of the company's medical devices unit, which made up just over a third of Johnson & Johnson's total 2014 sales. Consequently, even though J&J had been the dominant provider of power morcellators, the impact of this product to the company's bottom line is relatively insignificant.
Although loss of this single device likely won't break the bank, investors should keep an eye on legal expenses tied to lawsuits that Johnson & Johnson will inevitably encounter. Earlier this month, the first power morcellator case was settled as Lina Medical ApS, a Danish manufacturer of these devices, reached a settlement for an undisclosed amount. Recent Johnson & Johnson settlements include a $2.2 billion settlement for its antipsychotic drug, Risperdal in 2013, and a settlement over transvaginal meshes and sling devices with more than 100 plaintiffs for an undisclosed amount earlier this year.
Investors should also take note that stories involving FBI investigations of large corporations and lawsuit settlements typically make headlines, and Mr. Market tends to react negatively to the news. This was indeed the case with J&J, as the company's stock price declined about 3.5% soon after the FBI story broke. The results of such investigations are frequently insignificant, and such declines in stock price can provide excellent opportunities to increase your ownership in the company. However, in this instance I believe J&J's stock is fairly valued, and like many other value investors, I buy or add to my positions only when I believe a company's stock is priced well below its fair value.
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*New* Power Morcellator Controversy Spurs FDA Proposal – But Does it Go Far Enough?
Jul 13, 2015 | Mesh Medical Device News Desk
By Jane Akre
The morcellator is a tool that is used to grind up growths in the uterus, however a woman has a one in 350 chance that the fibroid is masking a dangerous cancer causing it to spread. See background story here on Mesh News Desk.
The danger came to light over the very public prognosis last year of Dr. Amy Reed, who had the procedure. She and her husband, Dr. Hooman Noorchashm, MD, have taken to social media to call for a ban of the power morcellator.
One manufacturer, Johnson & Johnson has taken its device off the market but the morcellator remains on hospital shelves and it and other versions are still used by some hospitals and doctors despite the risks. The FDA added a black box warning but did not order a recall saying it could beappropriate for some patients.
The couple parent six children while they fight to have the technology abandoned. See theirChange.org petition. Meanwhile, her cancer has returned.
Dr. Reed continues to speak out about patient safety and the role the FDA fails to play. She and her husband have met with the FBI which is investigating what Johnson & Johnson knew about the risks of its morcellator back in 2006. Meanwhile, insurance giant Aetna has ended coverage for the power morcellator.
Bill Includes Unique Device Identifier (UDI)
The proposed improvement would include a bar code be added to medical devices. Two years ago the FDA proposed requiring the unique device identifier (UDI), not unlike a VIN number on your car. It allows the vehicle or device to be tracked if there’s a recall.
The FDA takes the “least burdensome approach in all areas of medical device regulation” (least burdensome on the manufacturer) and UDIs are not currently included in all electronic health records, making it virtually impossible to track any trends in patient harm can be tracked.
The bill does not appear to address the 510(k) approval process of the FDA which allows about 90 percent of medical devices, including the power morcellator and pelvic and hernia mesh onto the market with very little regulation. Long considered a hole in the patient safety net, the 510(k) allows manufacturers to exchange paperwork with the FDA while giving assurances its medical device is safe, without the burden of clinical trials.
21st Century Cures Bill
The amendment passed Friday is part of the so-called 21st Century Cures Bill, sponsored by Rep. Mike Fitzpatrick (R-Pa). It increases funding for patient safety, research and changes drug approvals.
It also uses words such as “streamlining the drug and device development process,” in other words making it easier to put devices on the market. The 510(k) approval process for manufacturers takes under $5,000 and under 90 days to approval with no clinical trials. Considering the harm done to pelvic mesh patients and those injured by the power morcellator, should medical device approvals really be made easier?
Rep Fitzpatrick said it was the power morcellator that moved his action.
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U.S. House passes provision to keep tabs on medical devices used on patients
Jul 16, 2015 | Fierce Medical Devices
By Joseph Keenan
The U.S. House of Representatives passed a far-reaching medical research bill on Friday that includes an amendment to better monitor the use of medical devices for patient safety. The provision in the bill was a result of the controversy over use of laparoscopic power morcellators.
The Wall Street Journal reported that the amendment calls for the make or model number of a device used to treat patients to be included in medical records so they can be tracked. That kind of information isn't currently "incorporated into all electronic health records, which makes it difficult to fully achieve the benefits to patient safety," according to a statement from Rep. Mike Fitzpatrick (R-PA), who sponsored the provision.
The amendment is part of what is being touted as the 21st Century Cures bill aimed at increasing federal funding for medical research and the way drugs are approved.
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Fitzpatrick, who is also a cancer survivor, said he was moved to offer the amendment to the bill in the wake of the controversy surrounding the use of power morcellators, and he hopes it creates a larger debate about how medical devices are regulated and tracked.
"What happened with the power morcellator should never be allowed to happen again," he said.
According to a study conducted by researchers at the University of Michigan's health system and published earlier this year in the journal Obstetrics & Gynecology, 1 in 368 women who underwent hysterectomies for uterine fibroids had an undetected sarcoma that could be spread by a morcellator. Those numbers were almost identical to those from a study cited by the FDA last year that said women undergoing minimally invasive procedures with morcellators to remove uterine fibroids carried a 1-in-350 risk of uterine sarcoma.
Last fall, the FDA recommended against using the devices for most women undergoing a hysterectomy or the removal of uterine fibroids, advising that manufacturers should add boxed warnings and two contraindications on product labels. But the agency has stopped short of banning morcellators altogether, saying the devices' benefits may outweigh the risks in some women.
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First Federally Filed Morcellator Cancer Lawsuit Settled by Southern Med Law
Jul 16, 2015 | Digital Journal
By ReleaseWire
The attorneys at Southern Med Law have settled the first federally filed morcellator cancer lawsuit against LiNA Medical APS. Kebomed AG & LiNA Medical US, the makers of power morcellators. The lawsuit was filed in March 2014 in the U.S. District Court, Eastern District of Pennsylvania by Southern Med Law on behalf of Scott Burkhart, a Pennsylvania widower whose wife died of disseminated leiomyosarcoma in February 2013, which she developed after undergoing a power morcellator hysterectomy. The terms of the settlement are not being disclosed at the moment, but could prove positive for other power morcellator lawsuits that may be consolidated into a multidistrict litigation (MDL) in Kansas. Scott Burkart stated in this lawsuit that there was no evidence of disseminated cancer in his 53-year-old wife, Donna Burkhart, prior to having a robot-assisted hysterectomy in March 6, 2012. She was diagnosed with the aggressive uterine cancer just 9 days after having surgery. (No. 5:14-cv-1557)
Southern Med Law's Founder, Dr. Francois Blaudeau, an attorney and obstetrician-gynecologist who is representing the Burkart family, said power morcellators are used in about 10 percent of the 600,000 hysterectomies that are performed in the U.S. annually. Power morcellators shred uterine tissue into small pieces so that the fragments can be removed through small incisions in the abdomen. The undetected cancer cells spread into the peritoneal cavity as the uterine tissue is being removed. Power morcellators are used more commonly in less invasive laparoscopic procedures, which require a much smaller abdominal incision than traditional open-surgery hysterectomies.
Dr. Blaudeau and Southern Med Law are currently representing numerous women in morcellator lawsuits and urge women who have been diagnosed with uterine cancer following a hysterectomy using power morcellation to contact the firm. The firm offers free legal evaluations and you can speak with Dr. Blaudeau or one of his associated by calling 205-515-6166 or 205-547-5525. You can also visit www.southernmedlaw.com for all of the current news on morcellator cancer lawsuits and other medical litigation.
Power Morcellator News
In the wake of the filing of power morcellator lawsuits and the U.S. Food and Drug Administration's (FDA) warning against using the surgical devices because of the cancer risk, some insurance carriers are forgoing coverage of this procedure. In September, Highmark Inc., one of the largest Blue CrossBlue Shield plans in the country, was the first health care insurer to announce that it would stop power morcellation in gynecological procedures. The health insurer stopped coverage in its service area of Pennsylvania, West Virginia and Delaware. Aetna, the nation's third largest insurer, announced in May that it will no longer cover morcellation "in most circumstances because the safety and efficacy of this approach has not been demonstrated." Aetna now requires doctors to "precertify" a myomectomy (removal of fibroids) or hysterectomy (removal of the uterus) and is encouraging doctors to talk to their patients about the risks and benefits of uterine morcellation and its alternatives.
In addition to the FDA warning and drop in insurance coverage, the FBI announced the launch of an investigation into power morcellators where the bureau's probe includes the largest morcellator manufacturer, Johnson & Johnson's Ethicon unit, which stop selling its morcellators after the FDA's warning in April 2014. The FBI will examine what Johnson & Johnson knew about the cancer risk before the company took its morcellators off the global market.
Morcellator Cancer Lawsuits
According to court records there are currently 22 power morcellator lawsuits pending against Ethicon Inc. in 16 different federal courts nationwide. The 22 plaintiffs recently filed a petition with the U.S. Judicial Panel on Multidistrict Litigation (JPML) and asked the panel to transfer their complaints as well as other subsequent federally filed power morcellation lawsuits, to the U.S. District Court, District of Kansas for coordinated pretrial proceedings. The plaintiffs requested a multidistrict litigation because all of the complaints allege that laparoscopic power morcellators that are used during a hysterectomy or a myomectomy to remove uterine fibroids can spread and upstage cancer or the development of recurrent parasitic fibroids, according to the petition. The JPML is scheduled to hear oral arguments on the request on October 1. -
House Bill Would Intensify Medical Device Monitoring
Jul 14, 2015 | Outpatient Surgery
By Jim Burger
A bill passed by the U.S. House of Representatives last week includes a provision that would require the make or model number of a medical device used on a patient to be included in electronic health records.
The amendment to the 21st Century Cures Act, which was sponsored by Rep. Mike Fitzpatrick (R-Pa.), is a response to the controversy surrounding power morcellators, which have been shown to spread cancer in a small percentage of women undergoing minimally invasive hysterectomies and other procedures.
"Unfortunately, it is becoming clear that the reporting system for faulty and deadly devices is broken," says Mr. Fitzpatrick in the Congressional Record. "What happened with the power morcellator should never be allowed to happen again."
Recent reports suggest that Johnson & Johnson, which no longer manufactures power morcellators and which has asked customers to return them, may have known of potential issues with the device as early as 2006. The devices are still being sold by other companies.
The FDA began looking into the issue last year and eventually issued a black box warning. It decided, however, that banning morcellators would do more harm than good.
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