Preview Newsletter
Ethicon Media Monitoring 2/5/2019
-
Judge Grants Potential $550M in Pelvic Mesh Fees, Allocation Fight Looms
Feb 4, 2019 | Law.com
By Amanda Bronstad
A federal judge has issued an order that could result in about $550 million in common benefit fees and expenses to plaintiffs lawyers in the transvaginal mesh litigation, setting the stage for a possible fight over who gets what. -
We were forced to go to St Louis so this surgeon could finally ease our mesh pain. Please, minister, bring him to Scotland
Feb 3, 2019 | The Sunday Post
By Marion Scott
Mary McLaughlin and Iris Henderson used their savings to pay for surgery by Dr Dionysios Veronikis in St Louis, Missouri. -
Quantifying Risk of Psychiatric Illness Associated With Transvaginal Mesh Sling Complications
Feb 4, 2019 | Psychiatry Advisor
By Rita Aghjayan
Women with incontinence who require surgical intervention following a complication from midurethral mesh sling procedure are at significantly increased risk for depression and self-harm compared with women who did not need surgical intervention, according to a research letter published in JAMA Surgery. -
Turning a corner: The positives following a turbulent period for the medical device sector
Feb 4, 2019 | Medical Plastics News
By Reece Armstrong
When news that millions of patients across the globe had suffered serious side-effects due to medical devices, it seemed like a long time coming. After all, stories on patients experiencing life-changing effects due to devices such as surgical mesh, contraceptives and pacemakers have been circulating for years.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
-
Judge Grants Potential $550M in Pelvic Mesh Fees, Allocation Fight Looms
Feb 4, 2019 | Law.com
By Amanda Bronstad
A federal judge has issued an order that could result in about $550 million in common benefit fees and expenses to plaintiffs lawyers in the transvaginal mesh litigation, setting the stage for a possible fight over who gets what.
U.S. District Judge Joseph Goodwin of the Southern District of West Virginia, who is overseeing seven multidistrict litigation proceedings that at one point surpassed 100,000 lawsuits, granted a request from a fee and cost committee that defendants hold back five percent of all settlements and judgments to pay common benefit counsel. He rejected three objections from law firms including Philadelphia’s Kline & Specter, which had sought to halve that request, calling the mesh settlements “puny” in comparison to the jury verdicts.
“The court notes that this percentage results in a substantial amount of money awarded to common benefit counsel,” Goodwin wrote in his Jan. 30 order. “However, based on the numerous factors discussed above and the awards given in similar MDLs, this court believes that the award given is conservative and serves to justly compensate common benefit counsel for their work without unnecessarily burdening the plaintiffs in this litigation.”
In court documents, Henry Garrard of the Law Office of BBGA in Athens, Georgia, who is chairman of the fee committee, had called Kline & Specter’s criticisms “blatant hypocrisy.” Garrard did not respond to a request for comment.
“The court correctly notes that the most important factor in assessing such a fee request is the result obtained,” wrote Kline & Specter’s Shanin Specter, in an email. “The core of our objection is that the cases were settled for way too little and therefore the lawyers are asking for way too much. That objection was simply not addressed. Unfortunately, the court did not look at how much was obtained per claimant and whether these recoveries were good or bad, individually or generally.”
The eight lawyers on the fee committee made their request Nov. 12. They estimated that about 680,000 of the 900,000 hours that 94 law firms worked on the case was for the common benefit of everyone and sought a hold-back that would grant $366 million in common benefit fees based on the $7.25 billion in settlements so far. The final settlement price tag, though, could be closer to $11 billion, granting about $550 million in fees in the end.
In a Nov. 26 objection, Specter wrote that the hold-back should be 2.5 percent, noting that the average settlement was about $40,000, while the average award for the cases that have gone to trial is about $9.8 million. Many of those were in state court, such as a $57 million award that Specter won against Johnson & Johnson’s Ethicon Inc. subsidiary in 2017. Last week, he won another $41 million verdict against Ethicon.
Specter also found fault in lead counsel’s failure to get a global settlement, which he said was proof that that its work was not for the common benefit.
“The court strongly disagrees,” Goodwin wrote in his order. “Far from failing to provide a common benefit in the form of a global settlement, the plaintiffs’ leadership facilitated the settlement of tens of thousands of cases through its persistent efforts to weaken the defendants’ factual and legal standing compared to individual women across the country. Plaintiffs’ leadership also provided the MDL plaintiffs with all the work-product they created and educated individual plaintiff attorneys on how to prosecute a pelvic mesh case. These are global benefits.”
The judge called other arguments “premature.” Those included Specter’s claim that the fee committee hadn’t provided certain documents and that work by other firms would be uncompensated.
“K&S is essentially arguing certain slices of the pie are too small before the court has even issued its order determining the size of the pie,” he wrote. “The purpose of this court’s order is to evaluate the reasonableness of the aggregate proposed award that will be individually allocated in a later order.”
More generally, he found the fee request to be “very reasonable” given the investment of tens of millions of dollars, the complexity of the cases and, most importantly, the amount obtained. He calculated the lodestar—or the total amount billed multiplied by an average hourly rate of $400—to be less than $272 million. But the award, he wrote, was comparable to other “super-mega-fund” cases, like the $2.4 billion settlement over Actos, in which a judge assessed an 8.6 percent holdback.
He called the other two objections “untimely.”
One of those, by Andrus Wagstaff, which hired Blank Rome attorney Andrew Williamson to file its objection, alleged that the fee committee hadn’t treated the firm fairly. Another came from Philadelphia’s Sheller, which on Jan. 18 called the fee request a “ ‘smoking gun’ admission” that the fee committee had been “hijacked by a small band of profiteers, outrageously demanding unsupervised use of the common benefit fund as their personal ATM.”
Neither Aimee Wagstaff, a partner at the Lakewood, Colorado-based Andrus Wagstaff, nor Stephen Sheller of Sheller, responded to a request for comment.
Other firms did not challenge the hold-back percentage overall but have grumbled about the specific amount that the fee committee has earmarked for them—a fight that could magnify in the coming months as special master Dan Stack, a retired judge on the Madison County, Illinois, Circuit Court, reviews the fee allocation.
One of those firms is Mazie Slater Katz & Freeman, which obtained a $68 million jury verdict last year in Bergen County, New Jersey, Superior Court against C.R. Bard Inc.
“Eight law firms took two-thirds of the money, and 91 firms got the rest,” said partner Adam Slater. “We are hopeful and optimistic that Judge Stack, and, ultimately, Judge Goodwin, will apply the criteria in a fair and equitable way to fairly compensate all the law firms.”
The fee committee also got support from other law firms. Those included San Francisco’s Levin Simes Abrams; Birmingham, Alabama’s Freese & Goss; and Matthews & Associates in Houston.
https://www.law.com/2019/02/04/judge-grants-potential-550m-in-pelvic-mesh-fees-allocation-fight-looms/
-
Feb 3, 2019 | The Sunday Post
By Marion Scott
Mary McLaughlin and Iris Henderson used their savings to pay for surgery by Dr Dionysios Veronikis in St Louis, Missouri.
Mesh campaigners are calling on the government to bring Dr Veronikis, who has an acclaimed record in removing mesh implants from women, to Scotland.
Health Secretary Jeane Freeman has so far rejected calls to bring Dr Veronikis to Scotland, instead referring victims to the same hospitals which carried out many of their original operations.
Now Dr Veronikis has offered to speak to MSPs and Scottish Government officals by video conference in order to explain what he can do and, campaigners hope, change this stance.
Mesh patient Mary, 55, a law lecturer from Belfast, said: “After years of being desperately ill and in constant pain following mesh implant surgery 10 years ago, the decision to go to the US was my only real option as the NHS had failed me.
“I don’t regret it. It cost £15,000 to go to the US and as far as I’m concerned, Dr Veronikis saved my life.
“After years of being pushed from pillar to post, seeing surgeons who are in denial about mesh and costing the NHS thousands along the way, only now can I finally look forward to getting my life back.”
Mary said her mesh implant had perforated her bladder and caused her horrific problems with pain and recurrent infections.
She said: “I’ve put everything on the line to pay for this surgery as I did not want to go on living with the pain and uncertainty, and that the next infection could bring about septic shock and I would die like other mesh injured women who have lost their lives.
“I’m only a couple of weeks after Dr Veronikis removed 28cms of mesh from my body in a four-hour operation, and already I feel like I’m alive again.
“My pain is virtually gone, apart from post-surgery discomfort, and at last I have hope that my nightmare is over.
“My hope now is that Scotland does the right thing and gets Dr Veronikis over and women there can get the relief Iris and I now have.
“None of us asked to be mesh-injured and the very least our NHS should be doing is taking this unique opportunity to learn from Dr Veronikis and ensuring women get the treatment they need to be pain-free again.”
Iris, 62, from Larne, County Antrim, had two implants removed by Dr Veronikis. The former regional manager of a business services firm had already paid £2,000 in private fees in the UK after years of “being on the NHS merry-go-round”, before spending a further £17,000 to fly to the US for treatment.
She said: “After researching extensively, Dr Veronikis was the only surgeon I could find who had performed more than 2000 complete removals. He pulled no punches and told me I was facing a difficult surgery, but he has managed to remove both mesh devices, one of 27cms and the other 26 cms.
“NHS surgeons were only promising to remove half that, and so were private surgeons.
“I wanted both implants fully removed as I’d suffered so much pain and infection over the last eight years.
“When the first implant failed, a surgeon simply implanted another. No wonder I was left in such a mess.
“If the NHS fails to learn from this exceptional surgeon, it will be the biggest betrayal of all.”
Dr Veronikis says he has had between 85 and 88% success, leaving women pain-free following full removal and can even help women who have had a partial removal. He said: “It is always more difficult to operate on someone who has had revision surgery, but I have had success removing the mesh left behind. The relief my patients feel is a good measure of that.”
He says he does not blame surgeons for the mesh crisis.
He said: “We all believed what we were told about these implants, that they were safe and effective. However, now we all need to accept that many women have been injured because of them. We must concentrate on finding the right way to help them.”
Dr Veronikis hopes Scottish MSP’s and government officials will take up his offer of a video-conferencing link. He said: “I’d like to explain the process I use, and to show what can be achieved to help women. All I need is a hospital operating theatre and a team to assist me and my assistant.
“If I get a commitment from Scotland that I’ll be welcomed, I will apply for my General Medical Council registration so I can operate in the UK.”
MSPs are supporting moves by Labour’s Neil Findlay to get Dr Veronikis to Scotland. He said: “I will be seeking a meeting with the Cabinet Secretary for Health to see how we can take forward this initiative.
“Full mesh removal offers hope to so many mesh injured women and men, we should seriously look at every option to deliver this.”“The mesh caused such rippling pain …. I thought about suicide to end the nightmare.”
Care assistant Joan Macdonald was left in such pain that she was unable to walk after a mesh implant.
Initially told her pain was not caused by the implant, she finally managed to persuade doctors that removal surgery should be attempted.
But despite hopes that the op had been successful, she was still left in pain and was devastated when a scan from a private clinic showed more than half of the device was still inside her.
Joan, 53, from Inverness, said: “Right from the start, the mesh implant caused such rippling pain I couldn’t even walk up the stairs and found my legs collapsing underneath me.
“Despite repeated trips to specialists, I was told I simply needed a hysterectomy and that would sort my problems out.
“They did that and, of course, nothing changed.
“Finally, after being driven to think about taking my own life rather than live in this nightmare, I was told I could get a mesh removal.”
Her Aberdeen-based surgeon Mohamed Abdel-Fattah, who once ran a controversial study which offered a trip to a Rio de Janeiro conference to the doctor who managed to recruit the most patients to a mesh trial, declined to comment on individual patients yesterday.
However, he said that full removal would only ever be carried out in Edinburgh or Glasgow and said he would be happy to discuss her surgery with Joan, who says she got the impression her mesh had been removed after the operation in 2014.
It quickly became apparent the procedure had not eased her suffering.
She said: “I was still in agony and I even had to self-catheterise. I felt worse than before.”
In December, she sought a scan at a private health provider in England and was shocked to be told at least 60% of the TVT-O device was still inside her.
She said: “The specialist told me only a small part in the middle had been snipped away and the remaining mesh was still causing me the same level of pain on both the left and right side of my groin.
“This is why we need Dr Veronikis to come here and get this stuff out of us. I’m begging our Health Secretary to do the right thing and get him here to help us.
“Our surgeons are trying their best, but they don’t have Dr Veronikis’ experience.”The expert:
Calls to bring Dr Veronikis to Scotland have been backed by Chris Harding, one of Britain’s top urological surgeons.
Mr Harding, chairman of the British Association of Urological Surgeons subsection of Female, Neurological and Urodynamic Urology, said that while there are UK surgeons who can completely remove mesh, Dr Veronikis has far more experience than most and has developed his own methods.
He said: “Dr Veronikis can bring to the table his huge experience of mesh removal cases, which is something very few UK surgeons possess. However, there is so much surgical talent in the UK and I am confident we can negotiate this mesh crisis.
“Dr Veronikis has developed his methods and we could potentially learn a lot from him.
“Visiting other units to observe surgical practice is nothing new and I regularly have visiting surgeons to my hospital – it’s a very good method of learning and sharing experience in my opinion.
“Observing Dr Veronikis would almost certainly result in a refinement of our own existing mesh removal techniques which can only be good for our patients.”
https://www.sundaypost.com/fp/we-were-forced-to-go-to-st-louis-so-this-brilliant-surgeon-could-finally-ease-our-pain-please-minister-bring-him-to-scotland/
-
Quantifying Risk of Psychiatric Illness Associated With Transvaginal Mesh Sling Complications
Feb 4, 2019 | Psychiatry Advisor
By Rita Aghjayan
Women with incontinence who require surgical intervention following a complication from midurethral mesh sling procedure are at significantly increased risk for depression and self-harm compared with women who did not need surgical intervention, according to a research letter published in JAMA Surgery.
A Canadian team of investigators conducted a population-based study to understand the effect of transvaginal mesh complications on the risk of depression or self-harm.
The primary outcome was presentation to a clinician for treatment of depression. The secondary outcome was evidence of self-harm defined as a suicide attempt or parasuicide behavior presented at the emergency department, or recent history of suicide attempt or parasuicide behavior that resulted in hospital admission.
A total of 57,611 women who underwent a midurethral mesh sling procedure over the 12-year study were eligible for participation. Of the cohort, 1586 women (average age, 52.5 y) underwent surgical correction for transvaginal mesh complication and 56,025 did not need any surgical correction.
There was a statistically significant increase in risk of depression among women younger than 46 years who underwent surgical correction (absolute risk increase, 5.18%; adjusted hazard ratio [HR] 1.38). Similarly, an increased adjusted HR of 1.68 was reported for self-harm in women younger than 46 years; women between ages 46 and 66 years had an adjusted HR of 2.36.
“This age-dependent interaction is potentially a result of a stronger association between transvaginal mesh complications and intimacy among younger women,” the authors wrote. “When managing women with complications, surgeons should be aware of the potential serious psychologic implications of these complications.”
https://www.psychiatryadvisor.com/home/topics/mood-disorders/depressive-disorder/quantifying-risk-of-psychiatric-illness-associated-with-transvaginal-mesh-sling-complications/
-
Turning a corner: The positives following a turbulent period for the medical device sector
Feb 4, 2019 | Medical Plastics News
By Reece Armstrong
When news that millions of patients across the globe had suffered serious side-effects due to medical devices, it seemed like a long time coming. After all, stories on patients experiencing life-changing effects due to devices such as surgical mesh, contraceptives and pacemakers have been circulating for years.
The Implant Files highlighted the scale of the issue though and showed the regulatory cracks and loopholes through which ‘faulty’ or ‘poorly-tested’ devices have reached the market and ultimately patients.
If anything, the investigation highlights to the public the potential dangers that medical devices can bring with them. Public awareness over the safety of medtech products is inarguably important, especially when information regarding the risks posed by devices has been limited to both patients and doctors.
The response from the medtech industry was mixed, with certain groups such as the Advanced Medical Technology Association (AdvaMed) stating stories from the Implant Files “counterfeit the life-changing and life-saving solutions delivered to billions of people worldwide.”
MedTech Europe took issue with the investigation’s view on how the industry works, iterating that “every day millions of people benefit from medical devices,” but that it has “always supported a regulation that better serves patients and provides a predictable, sustainable and appropriate regulatory environment.”
Perhaps then more of the blame should be directed at regulatory agencies including the Food and Drug Administration (FDA) and Europe’s notified bodies.
In particular, the FDA’s 510(k) process has come under strong criticism due to the way it can ‘fast-track’ medical devices to market on the basis of equivalence. This means that if a medical device manufacturer can demonstrate its device is as safe and effective as another predicate device already on the market, then it doesn’t have to undergo clinical trials.
Fortunately the FDA seems to have responded to criticisms regarding the 510(k) process and has announced new steps to ‘modernise’ the premarket programme.
Going forward, the FDA will introduce an alternative premarket approval system that aims to do away with the focus on predicate devices and will remove devices that are more than 10 years old as a basis for safety equivalence. The organisation believes that this alternative system will give patients and doctors a choice among older and newer versions of devices, and ensure that medtech products have adopted modern features that improve safety and performance.
Additionally, in 2019 the FDA hopes to finalise guidance on its alternative 510(k) pathway which will be based on safety and performance criteria. The FDA’s terminology is vague, pertaining to manufacturers of certain “well-understood” devices, but it essentially boils down to a set of guidelines through which predicates which will be based on to support new devices.
This new “Safety and Performance Based Pathway”, is being touted by the FDA as a transparent approach for classifying the safety and effectiveness of low to moderate risk devices.
In response to the modernised 510(k) pathway, president and CEO of AdvaMed, Scott Whitaker, said: “While we believe the 510(k) pathway has proven its effectiveness over the years, we have always maintained that any process can be improved, and we stand ready to work with FDA and all stakeholders toward the shared goal of enhancing the current review paradigm.”
Hopefully the medtech industry responds positively to the FDA’s new changes but what’s most important is that the regulatory updates benefit patients in the long run. So far, announcements made by the FDA in regard to post-market surveillance and women’s health products, including gynaecological surgical mesh, appear to be genuine in concern to the efficacy of these devices.
The medtech industry has always been a bastion for medical innovation but ignoring the global cry of patients threatens its very foundations. Let’s hope then that the Implant Files investigation represents a landmark moment for the regulation of medical devices all across the world.
https://www.medicalplasticsnews.com/news/opinion/turning-a-corner-the-positives-following-a-challenging-year-/
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
Add recipients
Suggested