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Ethicon Media Monitoring 02/13/2017
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Ethicon Asks 4th Circ. To Rethink $3M Pelvic Mesh Verdict
Feb 10, 2017 | Law 360
By John Kennedy
Johnson & Johnson subsidiary Ethicon Inc. on Thursday urged the Fourth Circuit to review its recent decision upholding a $3.27 million jury verdict over its allegedly harmful transvaginal pelvic mesh implants, arguing that it could bring chaos to the circuit. -
Class action launched for victims of Johnson and Johnson mesh implants
Feb 10, 2017 | 9news.com.au
A potential health scandal of epic proportions has left thousands of Australian women living in chronic pain and despite warnings in other countries, the implant in question is still being used in Australia. -
GAO Report on Power Morcellators
Feb 10, 2017 | Mesh Medical Device Newsdesk
The GAO report on power morcellators finds there were 25 requests to market new power morcellator devices submitted to the FDA over a 23 year period, all were cleared for the marketplace. -
We have repaired over 3,000 victims of fistula, others —Prof. Adeoye
Feb 12, 2017 | Vanguard
By Chioma Obinna Read more at: http://www.vanguardngr.com/2017/02/repaired-3000-victims-fistula-others-prof-adeoye/
Our women are suffering. Another significant problem that we discovered was pelvic organ prolapse. It is like a hyena. It is a situation whereby the uterus (womb) dangles down the vagina, to the extent that part of the uterus or the whole uterus is outside the vagina completely.
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Ethicon Asks 4th Circ. To Rethink $3M Pelvic Mesh Verdict
Feb 10, 2017 | Law 360
By John Kennedy
Law360, New York (February 10, 2017, 8:11 PM EST) -- Johnson & Johnson subsidiary Ethicon Inc. on Thursday urged the Fourth Circuit to review its recent decision upholding a $3.27 million jury verdict over its allegedly harmful transvaginal pelvic mesh implants, arguing that it could bring chaos to the circuit.
If allowed to stand, the panel’s decision will effectively bar all U.S. Food and Drug Administration evidence in most product liability cases involving “Class II” medical devices, affecting more than 60,000 cases in seven multidistrict litigations in the Fourth Circuit and making it a magnet for many more, Ethicon said in its petition for en banc rehearing.
The FDA groups medical devices into three classes based on the risk of harm they pose. Class II devices, at issue in the instant case, pose intermediate risks and require manufacturers to show that they’re “at least safe and effective,” the company said.
The case, brought by plaintiff Jo Huskey, is one of the tens of thousands of cases involving a surgical mesh device called TVT-O. The MDL that Huskey’s case is a part of contains 28,000 cases, Ethicon said.
Huskey claimed that TVT-O was too heavy, but the FDA’s post-market review found that it and heavier meshes used by other manufacturers were safe. But the jury didn’t hear this information because the district court barred all mention of the FDA and the Fourth Circuit affirmed the ban, “even though — in fact, because — that evidence spoke directly and powerfully to TVT-O’s safety,” the J&J unit said.
“The clear takeaway from the panel’s decision is that district courts may now exclude all FDA evidence in trials addressing the safety of FDA-regulated Class II devices,” Ethicon said. “Indeed, if FDA’s conclusion after a comprehensive post-market review that a device is ‘safe and effective’ is not admissible, then no FDA evidence is.”
The company said that jurors know that the FDA plays an important role in regulating medical devices and thus expect to hear about the agency in a trial about the safety of an FDA-regulated device.
It also said that a ban on FDA evidence could encourage plaintiffs to hire non-mainstream experts to attack mainstream medical information, leaving defendants without FDA evidence to support their case and resulting in a battle of hired experts no matter how absurd the plaintiffs’ experts’ opinions may be.
The Fourth Circuit’s decision came on Jan. 26, when it rejected Ethicon’s argument that Huskey had failed to prove there was a specific flaw in the design of her TVT-O implant and foudn that she had offered enough evidence for a reasonable jury to find that the weight of the mesh had caused severe scarring and pelvic pain.
Huskey’s suit was the first bellwether case to go to trial in the massive MDL against Ethicon over its mesh implants. The trial ended on Sept. 5, 2014, with the jury deliberating for about three hours before returning its verdict.
A lawyer for Huskey declined comment Friday.
Ethicon and J&J are represented by Charles C. Lifland, Stephen D. Brody and David K. Roberts of O’Melveny & Myers LLP, Christy D. jones and Luther T. Munford of Butler Snow LLP and David B. Thomas and Philip J. Combs of Thomas Combs & Spann PLLC.
Huskey is represented by Edward A. Wallace and Mark R. Miller of Wexler Wallace LLP, Fidelma L. Fitzpatrick of Motley Rice LLC and Jeffrey Kuntz and Adam Davis of Wagstaff & Cartmell LLP.
The case is Huskey, et al., v. Ethicon Inc., et al., case number 15-2118, in the U.S. Court of Appeals for the Fourth Circuit.
--Additional reporting by Emily Field. Editing by Kelly Duncan.https://www.law360.com/trials/articles/890896/ethicon-asks-4th-circ-to-rethink-3m-pelvic-mesh-verdict-
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Class action launched for victims of Johnson and Johnson mesh implants
Feb 10, 2017 | 9news.com.au
A potential health scandal of epic proportions has left thousands of Australian women living in chronic pain and despite warnings in other countries, the implant in question is still being used in Australia.
A mesh implant manufactured by Johnson and Johnson and sold under their subsidiary Ethicon is one of several commonly used for women who have experienced a prolapse.
The controversial mesh implant products have been implanted in 100,000 Australian women since 2000 and it is believed between 4000 to 10,000 women may be impacted by chronic pain as a result.
There have been bans, withdrawals and warnings on these types of products in other countries, as well as up to 100,000 pending lawsuits in the US.
Joanne Mannion was an active, healthy woman until suffering a prolapse after giving birth.
"I can't exercise, I can't pick things up, I can be with my son," Ms Mannion told A Current Affair.
"It's nerve pain, it's like a burning pain. It feels like you've been cut and doused in petrol."
In Australia, there is no surgery to remove all of the mesh.
Ms Mannion travelled to the US for surgery, but it failed to remove it all.
"I thought it would be safe, I thought I could have it removed. I didn't think anything could go wrong," she said
"Financially, I am broke. Financially, all my savings have gone. I've sold my unit, I was living off the sale proceeds."
Myra Davis also claims to have been scared from the mesh implant.
"It's not right. It's not right that those things are taken away from someone," Ms Davis said.
"It seems to me that's the bottom line: money. People's lives don't seem to matter, the impact on people's lives don't seem to matter."
Professor Stephen Robson, president of the Royal Australian and New Zealand College of Obstetricians and Gynaecologists, says women should get a second-opinion when one has been recommended.
"Mesh was seen as a real breakthrough when it was introduced because it was dealing with a problem that was very difficult to fix surgically. But as years have gone by, it's become clear that there is an increasing problem," Professor Robson said.
"It probably shouldn't be used as a first-line treatment."
Shine Lawyers has launched a class action against Johnson and Johnson.
Head lawyer on the class action, Jan Saddler, says that for some women, their damages may be as high as millions of dollars.
"It erodes within the body, within the body's tissue because of where it is placed. In some cases, it's been known to cause perforation to the bowel and to the bladder," Ms Saddler said.
Senator Derryn Hinch has been pushing for a senate inquiry into safety of these types of mesh products and concerns the Therapeutic Goods Administration (TGA) approved it without clinical testing.
"I have seen so many women who... have had their lives ruined by this," Senator Hinch said.
"They've been using this mesh for years since they first got their warnings about it. It's a massive scandal and we've got to do something about it."
"They best thing they could do now is put a hold on it until there's proof it's not dangerous."
The TGA told A Current Affair it has been monitoring urogynaecological meshes since 2008.
A review found the reported rate of complication was low and when it did occur, it was closely linked to the skill and training of the surgeon, and the patient selection.
Johnson and Johnson said their mesh is "backed by years of clinical research."
"The use of implantable mesh is often the preferred option to treat certain female pelvic conditions, including POP and SUI."
"Ethicon acted appropriately and responsibly in the research, development and marketing of its pelvic mesh products."
http://www.9news.com.au/national/2017/02/10/19/18/class-action-launched-for-victims-of-johnson-and-johnson-mesh-implants
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GAO Report on Power Morcellators
Feb 10, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, February 10, 2017 ~ The GAO report on power morcellators finds there were 25 requests to market new power morcellator devices submitted to the FDA over a 23 year period, all were cleared for the marketplace.
The U.S. Government Accountability Office (GAO) has just issued a report (here) on the use of power morcellators. Power morcellators are used during “minimally invasive” surgery on women to grind up uterine fibroids.
The alternative is an abdominal hysterectomy or removal of fibroids, which a larger incision.
During the morcellation process, undetected, hidden cancers can be spread throughout the body cavity, as was the case with Dr. Amy Reed. She and her husband, Dr. Hooman Noorchashm, both medical doctors with six childeren, have headed an aggressive campaign to get morcellators off the market, however, they remain in use with some awareness by the FDA and users.
This report finds the FDA system has failed this couple and hundreds of Americans. Read their story here.
Instead of a one in 10,000 chance of a undetected cancer as previously thought, the risk is now thought to be one in 350. There are 50,000 power morcellator procedures a year, reports the GAO.
Had Dr. Reed’s aggressive cancer been removed whole, she would have a 50% survival rate at five years. Instead, after the morcellator spread cancer debris within her body, those chance of survival drop from 0 to 20%.
From 1991 to 2014, there were 25 submissions for laparoscopic power morcellators to the U.S. Food and Drug Administration. They were all cleared for market through the 510(k) fast-track clearance process. Manufacturers include Cook, Gynecare, Cuto, SKEA Steiner and FemRx, among others.
All of them had the same intended use, to pulverize fibroids in order to remove them from the uterus. A uterine sarcoma is a cancer of the muscle and supportive tissue. Less than 4% of uterine cancers are uterine sarcomas, finds the GAO.
Leiomyosarcoma is a type of uterine cancer difficult to diagnose because it resembles fibroids. That is the cancer Dr. Reed has been fighting since her diagnosis of a stage 4 cancer following her power morcellator procedure.
An FDA safety communication in November 2014 issued guidance to doctors and to manufacturers to add a boxed warning.
In 2014, the FDA discouraged the use of power morcellators in hysterectomys or myomectomys (removal of fibroids).
By July 2014, the FDA convened an expert panel overseeing morcellators.
By December 2015, the FDA inspected select hospitals with high numbers of adverse event reports of injuries from the morcellators. They found a failure to report adverse events within the time frames required and a lapse in maintaining files on medical devices.
The GAO concludes the medical device reporting system is “passive” and relies on doctors and manufacturers to identify harm. Before November 2014, doctors or hospitals would not consider the spread of an unsuspected cancer following a power morcellator procedure to be a reportable adverse event.
Since September 2016, the FDA has identified 285 adverse event reports of spreading cancer following a power morcellation.
From Philadelphia Magazine: But as always in this couple’s struggle, it’s one step forward, one step back. As noted by the New York Times, the GAO report comes just as the Trump administration has called for loosening, not tightening, regulations for approval of drugs and medical devices. “Instead of being 9,000 pages, it’ll be 100 pages,” Trump promised of FDA regs.
http://www.meshmedicaldevicenewsdesk.com/gao-report-power-morcellators/
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We have repaired over 3,000 victims of fistula, others —Prof. Adeoye
Feb 12, 2017 | Vanguard
By Chioma Obinna Read more at: http://www.vanguardngr.com/2017/02/repaired-3000-victims-fistula-others-prof-adeoye/
Established by a former first lady of Ebonyi State, Mrs.Josphine Elechi, before it was taken over by the Federal Government in 2011, the National Obstetric Fistula Centre, Abakaliki was mandated to offer free treatment to indigent women afflicted with fistula, a condition caused by obstructed labour. Sunday Vanguard visited the hospital and spoke with the Chief Medical Director, Prof Sunday Adeoye. According to Adeoye, the centre, which started with a small building, has ballooned to a three-star hospital, both in services and facility. He said the hospital has not only achieved the vision of the founder but has also surpassed its mandate of instilling hope in the lives of helpless women. He said no less than 2,280 fistula, 625 vagina prolapse, five sling surgeries, and 80 uretheric surgeries had been carried out for women across 26 states of the federation.
Primarily, this place is an obstetric fistula centre. In other words, we operate on VVF patients. Somebody will ask, how come VVF is in the South? We use to think that VVF is the problem of the Northern part of the country because of small girls that are given out in marriage. The truth of the matter is that VVF is the product of prolonged obstructed labour.
Simply put, it is a situation where a woman had been in labour for several hours because of disproportions between the baby she is carrying and her pelvic. In a layman’s term, the baby she is carrying is bigger than her pelvic. Normally, the answer should be a Caesarean section, CS. But when the CS is not timely for whatever reason and the labour now becomes prolonged obstructed labour, VVF is the result. Whether it is the small or teenage girl in the North or the mature woman in the South, the basic fundamental is the baby is bigger than the pelvic.
If the baby is not delivered for whatever reason, be it religious reason, financial reason and cultural reason, among others, and the CS is not done early enough, the woman is bound to come down with VVF, irrespective of her position in the society.
Unfortunately, fistula is associated with high foetal wastage. In over 90 percent, the baby will be dead and the woman will be leaking urine or faeces and in some cases both. It is not just the small girls of the North. It is the same basic principles everywhere.
Burden of VVF The burden of VVF is bigger in the North because of early marriage but it is equally significant in the South. And that’s why we have been able to provide completely free treatment to over 2,280 patients with VVF from over about 26 of the federation thus far.
Often times when you come to the hospital it is like a melting point for all the states. When you move from one bed to another, you will see a Kogi woman, next is Delta, Rivers. It brings people from different states. That tells you the spread of what we are doing here.
Apart from repairing fistula clients, what we are doing now is providing urethral surgeries for women who have injuries to their urethra. Unfortunately, people do surgeries which they do not have the necessary competence for and a lot of complications do arise. But I must equally say that even when the best of hands do surgeries, complications can also arise but they are fewer. The less competent the fellow is, the higher the complications. So we do have patients that come with uretheric injuries. We have about four in the ward currently. They may have occurred during the course of surgeries such as hysterectomy, etc.
We have done close to 80 of such surgeries to re-implant the urethra. If the people were to pay for such surgeries, they will be paying hundreds of thousands of naira. And many of the VVF patients cannot afford it.
But they are offered the treatment completely free and they are equally fed and taken care of courtesy of the Federal Government because they are the major supporters of what we do here for indigent patients.We equally do sling operations. Some women, when they laugh, they pass urine depending on their age apart from fistula patients. Even after they have been repaired, they leak urine from the urethra.
This urine comes from the urethral not from the fistula. We do sling operation to correct that. Recently, arising from complications of the fistula due to significant loss of tissue, even when you repaired them the capacity of the vagina is grossly reduced. The condition is associated with vagina scar and reduced vagina capacity. Some patients will even tell you that they will rather have their vagina than to lose it.
We face a lot of challenges trying to correct this because, after the surgery, many of the women will come back to ask you what happened to their vagina. Some will tell you to undo whatever that was done on them. Majority prefer to have the road open and leak than not having the road. And not having the road means no more sexual relationship. You can imagine when a young woman has been repaired but will no longer have a quality sexual relationship. It is a serious matter. We understand fully the burden they have and we empathise with them. What we now do for them is to create vagina through extensive surgery.
We are able to use the colon or a graft from some other part of the body to fashion a vagina or create a vagina for them. We have done about five cases. One of them that we did was combined case of abdomen and vagina and it took us almost nine hours. I wonder if she was asked to pay if she would have been able to pay. For such surgery, she would have up to N5 million before anybody will listen to her even though it is not a common surgery that you can walk into any hospital and do. It is a highly complex surgery. We have expanded our services not only to fix fistula holes but also some of these surgeries.
Burden In 2008, I had a mandate to determine the burden of fistula in Ebonyi before then I was a surgeon in a teaching hospital. We moved with a team to have an idea of the burden. I went to 12 local governments in the state I couldn’t go to the 13th LGA because there was a crisis.
In all the women who came out that were leaking urine, over 308 had fistula. But significantly, we noticed another problem which we did not know that they were there from that community screening. It is not every woman who is leaking urine that actually has VVF. Some have copious vagina discharge. Apart from asking if they were leaking urine, we went a step further to physically examine them. I must give credit to Mrs Elechi for her leadership role then. We had a burden of over 56 percent.
Our women are suffering. Another significant problem that we discovered was pelvic organ prolapse. It is like a hyena. It is a situation whereby the uterus (womb) dangles down the vagina, to the extent that part of the uterus or the whole uterus is outside the vagina completely. You can imagine a woman having her entire womb that is supposed to be anatomically situated now dangling down her vagina with the wrapper and legs rubbing on it. The number of patients we saw with the condition during the screening was worrisome. But we could not handle it then because our mandate was to attend to VVF patients.
AS of the time we stopped registering women, we had registered over 900 women. Eventually, when we decided to give the prolapse cases attention, we were embarrassed by the number of women that came to the hospital. It was like a market. The women of this country are suffering. The patient load was embarrassing. We knew we could not combine the two, so we decided with the support of UNFPA to start something.
By 2014, UNFPA had stopped giving us support but, thus far, we have been able to offer free treatment to these women, but with the financial situation in the country, we could not sustain the free care for the prolapse patients any more. We have been able to provide surgery for over 625 women with the condition since we started the surgery in 2012.
The significant thing about this surgery is that, even in most teaching hospitals across the country, if they do about 50 cases in a year. then they have tried. For us to do 625 in less than four years should tell you the volume of what we have done. We still have quite a number of patients that could not pay for the surgery and it grieves my heart. We don’t have any form of support for us to perform free surgery for these women because they are the indigent women of Nigeria.
We are looking for partners that can support us. FistulaCare raised my hope that we are going to have support with them. We even had a meeting with them in New York. We were ready to escalate because we don’t have the capacity.
Why prolapse patients pay a token
As of December last year everything including three times a day feeding was less than N60, 000 and they will stay here for 16 days depending on how serious their case is. It was more of service for the poor. If we are able to get some form of support from partners, individuals, companies and organisations, not necessarily from abroad in terms of drug, tools, we don’t need money from anybody or organisation what we need is the tools to work. You can buy the infusions, gloves, sutures, antibiotics etc that we will need to operate, then we can roll with it and we will give you result.
Appeal for support
I am appealing to indigenous organizations to say ‘I am giving you enough infusions’, and we will go back in making the prolapse free. We develop a training programme around the prolapse because if you don’t do it well, you may end up giving the woman hysteretic fistula or Vesico Vagina Fistula. In the process of providing care, you may give them other fistulas. It is not just enough
http://www.vanguardngr.com/2017/02/repaired-3000-victims-fistula-others-prof-adeoye/
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