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Ethicon Media Monitoring 3/7/2017
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Judge OKs $12M Caldera Pelvic Mesh Deal Amid Protests
Mar 7, 2017 | Law 360
By Dorothy Atkins
Despite three dozen objectors, a California federal judge on Friday approved Federal Insurance Co.’s proposed $12.25 million deal to resolve thousands of insurance claims alleging Caldera Medical Inc.’s transvaginal mesh implant caused injuries in more than 2,700 women. -
Mesh implant sufferers quit inquiry panel over ‘whitewash’
Mar 7, 2017 | The Times
By Jeremy Watson
Two women have resigned from the independent review group looking at the safety of mesh implants in protest at what they claim is a whitewash. -
Mesh implant victims quit review ahead of “unrecognisable” report
Mar 7, 2017 | Holyrood
By Tom Freeman
Two women who suffered severe complications with mesh implant surgery have quit the independent review group tasked with investigating the safety of the practice.
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Judge OKs $12M Caldera Pelvic Mesh Deal Amid Protests
Mar 7, 2017 | Law 360
By Dorothy Atkins
Law360, San Francisco (March 6, 2017, 10:05 PM EST) -- Despite three dozen objectors, a California federal judge on Friday approved Federal Insurance Co.’s proposed $12.25 million deal to resolve thousands of insurance claims alleging Caldera Medical Inc.’s transvaginal mesh implant caused injuries in more than 2,700 women.
Under the non-opt-out settlement, Federal Insurance agreed to distribute $10.58 million among 2,710 class member claimants and to pay class counsel $670,020 in attorneys’ fees and costs. In exchange, the claimants will release Caldera and Federal Insurance from all future claims, according to court documents.
U.S. Judge Stephen V. Wilson said in his order on Friday that the settlement is fair, reasonable, adequate and “consistent with due process.”
The deal marks an end to a federal interpleader suit that Federal Insurance launched against Caldera and a class of claimants in January 2015. At the time, multiple lawsuits had been filed against Caldera in California state court over its transvaginal mesh implant used to treat pelvic organ prolapse and stress urinary incontinence in women.
The suits, which were consolidated in state court, alleged that Caldera knew or should have known that the transvaginal mesh devices it manufactured and sold were hazardous and dangerous. The plaintiffs sought damages from Caldera, which in turn filed insurance claims with Federal Insurance.
Federal Insurance argued in its complaint that Caldera was depleting its $25 million policy cap by fighting the litigation in state court, and noted that it had already paid out more than $6.3 million in settlements even though there were thousands of additional claims pending. Federal Insurance asked the court to certify a class of claimants and enjoin the claimants from pursuing further suits affecting the insurance policy.
The state litigation was stayed pending the resolution of the insurance suit, and in December 2015, the parties reached a settlement under which Federal Insurance would pay a $12.25 million lump sum, including a $500,000 holdout, to resolve pending claims against it and end its policy with Caldera. Under the proposed settlement, claimants couldn’t opt out of the deal.
But 36 women objected in June, saying they wanted evidence showing whether the payout would be greater if the company liquidated. An independent audit was the only way to ensure that Caldera was offering the maximum amount possible to women injured by the medical device, the objectors argued.
In court in June, Caldera and Federal Insurance argued to Judge Wilson that an independent audit wasn’t needed since Caldera had already produced financial records showing it was cash-poor, not generating a profit and only had its insurance proceeds to settle the lawsuit claims. Further, there was nothing to suggest that the liquidated value of the company would exceed the settlement amount on the table, they said.
But the following month, Judge Wilson refused to approve the deal, saying that Caldera needed to submit evidence supporting its assertions.
Caldera filed another motion for final settlement approval in September, along with an expert report that showed the company’s liabilities “substantially” exceeded its assets, and that any attempt to liquidate Caldera would result in a net loss, according to court documents.
The objectors again challenged the deal, arguing that the expert report doesn’t prove that Caldera has no liquidation value, and at least one objector asked to be excluded from the deal.
But earlier this month Judge Wilson refused to excuse the objectors from the settlement, finding that there’s no justification for such relief, according to court documents. He also found that the report sufficiently addressed his concerns and therefore he approved the deal.
Federal Insurance attorney Michael F. Perlis of Locke Lord LLP told Law360 Monday that the deal satisfied the company’s promise to protect its insured, provides compensation for claimants and satisfies all of its obligations under its policy.
Gordon W. Renneisen of Cornerstone Law Group, who represented the class of claimants, said Monday that he’s also pleased the deal was approved, particularly because it was a complex case with “a lot of balls in the air.” Caldera’s only real asset is its insurance policy, so this is the only real way the claimants were going get anything, Renneisen said.
Representatives for Caldera and the objectors didn’t respond Monday to requests for comment.
Federal Insurance is represented by Michael F. Perlis, Richard R. Johnson and Lilian M. Khanjian of Locke Lord LLP.
Caldera is represented by Dennis M. Cusack and John D. Green of Farella Braun & Martel LLP.
The claimants are represented by Gordon W. Renneisen of Cornerstone Law Group and David Bricker of Waters Kraus & Paul. The 36 objectors are represented by Lee B. Balefsky of Kline & Specter PC.
The state litigation is In Re. Transvaginal Mesh Litigation, case number JCCP 4733, in the Superior Court of the State of California for the County of Los Angeles. The instant case is Federal Insurance Co. v. Caldera Medical Inc. et al., number 2:15-cv-00393, in the U.S. District Court for the Central District of California.
--Additional reporting by Bonnie Eisinger. Editing by Jill Coffey.https://www.law360.com/articles/898643/judge-oks-12m-caldera-pelvic-mesh-deal-amid-protests
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Mesh implant sufferers quit inquiry panel over ‘whitewash’
Mar 7, 2017 | The Times
By Jeremy Watson
Two women have resigned from the independent review group looking at the safety of mesh implants in protest at what they claim is a whitewash.
The campaigners Elaine Holmes and Olive McIlroy were patient representatives on an investigation set up three years ago into the dangers of the controversial surgery. They both suffered severe complications after mesh implant surgery and claimed that the final report had been watered down.
They have resigned only a month before the inquiry’s final report is published claiming that crucial evidence of the implants’ dangers had been ignored. Shona Robison, the health secretary, said last night that she would meet the women to discuss their concerns.
Ms Holmes and Ms McIlroy were asked to participate in the inquiry after the former health secretary Alex Neil agreed to a full investigation into how implants used to treat bladder problems and pelvic organ prolapse left victims with appalling injuries.
The women welcomed an interim report, published 15 months ago, which said that NHS Scotland should stop routinely using the implants, which have crippled hundreds of thousands of women worldwide.
They are furious, however, about the final report, which they have seen a draft copy of and which they say favours a resumption in the use of the procedure. The women have claimed that the report excluded evidence, in some cases from the Scottish government’s own experts, that showed that mesh implants for bladder problems could cause “life-changing injuries”. They said that it ignored evidence from the US that up to 40 per cent of women were injured by the hooks used to anchor mesh implants.
They said the report ignored European Union guidelines that reclassified all surgical mesh as “high risk”. The report panel, which includes surgeons, NHS personnel and government officials, has rejected calls by some of its own medical members for the mandatory reporting of all complications associated with implants in favour of a system used by only one in four specialists.
Ms Holmes, 52, from Newton Mearns, East Renfrewshire, who spends long periods in a wheelchair because she has extensive nerve damage, said: “We’ve been betrayed. This independent review has chosen to ignore all the warnings and rejected or buried evidence which does not suit an agenda dictated by pro-mesh surgeons.”
The pair fear that a suspension in mesh surgery ordered by Mr Neil in 2014 will be lifted and procedures they want banned will be reintroduced.
They are also angry that the report makes no mention of three criminal investigations by the US government against mesh manufacturers, some of which have already paid out £1.5 billion in compensation to victims.
The campaigners have claimed that they are not the only people involved in the inquiry who are concerned by the final findings.
Ms McIlroy, 60, from Renfrew, who walks with the aid of crutches, said: “At least one expert within the group has alerted everyone involved about their concerns over the report’s failings.”
The Labour MSP Neil Findlay, who has been campaigning on the issue, told BBC Scotland: “The mesh scandal is a global scandal but in Scotland we had the chance to lead the world in protecting women from life-changing injuries, but instead of doing so the government has shown themselves to be complicit in one of the biggest medical cover-ups in the history of Scotland’s NHS.”
George Clark, a lawyer with Quantum Claims, which represents hundreds of victims, said: “The outcome of this review is astonishing given [that] Scotland is facing the biggest medical claim in legal history.”
http://www.thetimes.co.uk/article/mesh-implant-sufferers-quit-inquiry-panel-over-whitewash-7mj7fqrtr
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Mesh implant victims quit review ahead of “unrecognisable” report
Mar 7, 2017 | Holyrood
By Tom Freeman
Two women who suffered severe complications with mesh implant surgery have quit the independent review group tasked with investigating the safety of the practice.
Transvaginal mesh implants are medical devices used to treat organ prolapse and incontinence in women.
Following a petition by survivors of complications in the procedure in 2014, the Scottish Government ordered a suspension of their use while a review group investigated their safety.
It is due to report soon.
Olive McIlroy and Elaine Holmes today told the BBC they were “saddened and appalled” that the forthcoming report has been altered and watered down since the interim report in 2015.
“Patient-friendly, shared-decision tables” had been destroyed, they said, and replaced with “clinician's directive counselling” which speaks only of the benefits of mesh implants.
“They just diluted the content in favour of mesh procedures,” McIlroy said.
“It seems to me unacceptable that they can risk even one patient suffering severe complications. It's not about the numbers, it's about the severity of the complications when things do go wrong.”
The latest resignations follow the departure of the group's chair Public Health expert Dr Lesley Wilkie, who stood down in December.
Health secretary Shona Robison said she would meet with McIlroy and Holmes directly to hear their concerns. "The independent review continues its work to produce its final report and we expect them to publish it this Spring. I am grateful to all members for their expertise and considerable efforts over the years," she said.
Scottish Labour MSP Neil Findlay, who convenes the Scottish Parliament’s Health and Sport Committee, said the two patients had participated in the review “in good faith” to prevent there being further victims.
“But these latest revelations show that they have been strung along by the medical establishment and the Scottish Government,” he said.
"The mesh scandal is a global scandal but in Scotland we had the chance to lead the world in protecting women from life changing injuries but instead of doing so the Government has shown themselves to be complicit in one of the biggest medical cover ups in the history of Scotland's NHS."
https://www.holyrood.com/articles/news/mesh-implant-victims-quit-review-ahead-%E2%80%9Cunrecognisable%E2%80%9D-report
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