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Ethicon Media Monitoring 2/8/2018
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The idea that only prolapse mesh causes problems is ‘utter nonsense’ say campaigners as they take their fight to the House of Lords
Feb 7, 2018 | Cambs Times
By Kath Sansom
A plea has gone to the Government to suspend pelvic mesh implants until the true number of women suffering is known. -
Australian Department of Health group warned pelvic mesh devices should be 'archived' as early as 2007
Feb 8, 2018 | Newcastle Herald
By Joanne McCarthy
AN Australian Department of Health monitoring group repeatedly issued safety warnings about pelvic mesh devices from as early as 2004 without response from regulatory bodies because of a “fragmented” health system that continues to place patients at risk, a Senate inquiry has been told. -
South Georgia County, Hospital Authority Sue Over Opioid Addiction
Feb 7, 2018 | Daily Report (Law.com)
By R. Robin McDonald
... Firm partner Henry Garrard is currently co-lead counsel in the transvaginal mesh MDL against medical supply manufacturer C.R. Bard in the Southern District of West Virginia. -
Appeals court upholds $19m Boston Scientific loss in pelvic mesh case
Feb 8, 2018 | Mass Device
By Fink Densford
Boston Scientific (NYSE:BSX) has lost another bid as it looked to overturn an $18.5 million loss in a product liability suit over alleged injuries caused by its Obtryx pelvic mesh. -
Boston Scientific Loses Bid to Reverse $18.5 Million Transvaginal Mesh Lawsuit Verdict
Feb 7, 2018 | RX Injury Help
By Laurie Villanueva
A federal appeals court has upheld the $18.5 million verdict awarded to four women who suffered serious complications following implantation of Boston Scientific Corp.’s Obtryx transvaginal mesh devices.
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Feb 7, 2018 | Cambs Times
By Kath Sansom
A plea has gone to the Government to suspend pelvic mesh implants until the true number of women suffering is known.
Lord Phillip Hunt sent out the plea during a House of Lords question time, joined by around 40 members of campaign group Sling The Mesh.
The support group has grown from 900 to 5,400 in the last year with new members assured by clinicians they were just unlucky mystery patients.
The House of Lords question comes amid a growing backlash against surgeons who say it is only prolapse mesh causing problems and the mesh tape for incontinence is an effective treatment.
A spokesman for Sling The Mesh, said: “A third of our members have prolapse mesh and two thirds incontinence mesh implants. The complications are exactly the same stories with the same personal tragedies.
“This notion that it is only prolapse mesh causing problems is utter nonsense. Surgeons need to listen to patient experience.”
Lord Hunt said: “An increasing number of women have reported suffering complications that include debilitating pain, infection, inflammation, the loss of sex life and mobility issues.”
He called for the controversial implants to be suspended on the precautionary principle until a Government audit is complete and new guidelines are issued by NICE.
Lord James O’Shaughnessy, parliamentary under secretary of state at the Department of Health, said: “I know t a lot of women are suffering as a result of complications from this procedure.
“I am aware that Australia and New Zealand are implementing bans for particular usage. I have asked NICE and MHRA to investigate why they have done that and to report to me urgently so that I can see the grounds for the ban.
“We have different regulatory systems, but I want to know what is happening there.
“For some women it can be positive and life-enhancing. But we also know that it carries a risk of complications.”
Lord Patel said: “The evidence suggests that of the 20 per cent of women who suffer from complications, most of them had been treated for pelvic floor prolapse, not stress incontinence.
“Banning their use completely at this stage for women with certain conditions who may benefit from them would, without further evidence, be completely wrong.”
Baroness Tonge opened herself up to a barrage of criticism from campaigners after she said: “Does the minister share with me a sense of puzzlement that this subject was brought to the House in the first place? I find it very odd given that we have royal colleges and NICE with people to assess the efficacy of particular treatments. Many treatments, both medical and surgical, carry a risk of complications. Are they all going to be brought to the House of Lords for discussion?”
Lord O’Shaughnessy said: “Our job in this House is to scrutinise the decisions that are made in our publicly funded health services. I think that it is absolutely right that we do scrutinise these issues and make sure that the care being provided in this country adheres to the highest and safest standards.”
• The House of Lords question fell on the 100th anniversary of when women first got the right to vote on February 6, 1918. Around 40 members of Sling The Mesh held a rally in front of the statue of Winston Churchill before joining the peers from the public gallery. Two campaigners came in mobility scooters. Both were previously fit and healthy mums. One is now disabled from an incontinence mesh, the other from a hysteropexy prolapse mesh.
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Feb 8, 2018 | Newcastle Herald
By Joanne McCarthy
AN Australian Department of Health monitoring group repeatedly issued safety warnings about pelvic mesh devices from as early as 2004 without response from regulatory bodies because of a “fragmented” health system that continues to place patients at risk, a Senate inquiry has been told.
Health technology assessment bodies in 2008 recommended that pelvic mesh devices to treat prolapse in women should be “archived” after four annual “horizon scanning” reports warned of the lack of evidence supporting their safe use.
But fragmentation of Australia’s health system and lack of communication and transparency left some Department of Health groups issuing warnings without being aware devices were already being implanted in Australian women, while others failed to act despite being “in a position to call out or review” pelvic mesh procedures, Sydney academic and medical device analyst Dr Sally Wortley has told a Senate inquiry into pelvic mesh.
In a damning submission Dr Wortley said that by 2007, after a British National Health Service review raised serious concerns about prolapse pelvic mesh devices, they should have been referred to Australia’s Medical Services Advisory Committee for safety, efficacy and cost-effectiveness assessment, but weren’t.
A committee assessment in 2007 or 2008 might have recommended against public funding of pelvic mesh devices, or “at the very least” have recommended a separate Medicare Benefits Schedule number which would have allowed regulators to track the number of devices implanted and more accurately estimate complication rates, Dr Wortley said.
Instead an unknown number of prolapse pelvic mesh devices – estimated at up to 40,000 – were implanted in Australian women and subsidised by Australian taxpayers for nearly a decade until medical devices regulator, the Australian Therapeutic Goods Administration, cancelled the first prolapse devices in November, 2014. It took further action to remove all prolapse devices from the market over the following three years.
Dr Wortley told the inquiry a fragmented health system with separate federal and state health technology assessment processes, and hospitals left with the power to determine whether a new procedure or technology should be used, “is placing patients at risk”.
Dr Wortley said it was possible that prolapse mesh devices were not assessed by the Medical Services Advisory Committee in 2007 because of a misunderstanding about whether an assessment was “within the remit” of another assessment body.
“The issues around (pelvic) mesh implants illustrate the problems within the Australian health technology assessment system at the time ,and to some extent the problems that continue to be present,” Dr Wortley said.
“These problems included lack of communication and fragmentation across the agencies involved in the regulation and assessment of new technologies and procedures as well as a lack of transparency and rigorous methods for the pre‐market and assessment of safety for devices and prostheses.”
While problems have been repeatedly identified in reports – including a 2009 report that recommended greater “rigour” in the assessment of higher risk medical devices – recommendations are not implemented, she said.
During a final public hearing on Tuesday before the Senate Community Affairs References Committee inquiry into pelvic mesh devices, Therapeutic Goods Administration national manager John Skerritt said Australia had been “ahead of the pack” in responding to mesh.
“While the issue with meshes is a tremendous problem for those affected, and I’ve indicated we’ve had a few learnings from it, I am proud – if I can use that word – that we’ve actually moved faster, and some would argue further, than the major regulators globally. It has been a fairly nimble response,” Mr Skerritt said.
The Therapeutic Goods Administration has been contacted for comment.
Dr Wortley Sally is a Sydney University academic who has worked as an analyst assessing health technologies for the Australian and UK governments. Her research interest is in public engagement and health technology assessment.
The Senate report on pelvic mesh devices is due for release on February 14.
http://www.theherald.com.au/story/5215563/fragmented-health-system-puts-patients-at-risk-senate-inquiry-told/
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South Georgia County, Hospital Authority Sue Over Opioid Addiction
Feb 7, 2018 | Daily Report (Law.com)
By R. Robin McDonald
Attorneys at an Athens firm with a growing national reputation as leaders in medical MDL are representing Candler County and the county hospital authority in their fight against drug manufacturers and distributors.
An Athens law firm that’s building a reputation in medical multidistrict litigation is weighing in on the opioid crisis and what one partner says is its outsized impact on Georgia’s rural hospitals and counties.
Attorneys with Blasingame Burch Garrard & Ashley have filed two federal suits in the Southern District of Georgia—one on behalf of rural Candler County and a second on behalf of the Candler County Hospital Authority—against some of the nation’s largest pharmaceutical manufacturers and distributors. Partner James Matthews said the suits are among the first to be filed in Georgia seeking restitution for the millions of dollars fighting the ravages of the opioid crisis.
On Wednesday, the firm filed a third identical suit on behalf of the Athens-Clarke County Consolidated Government. Athens is home to the University of Georgia.
Matthews said the suits are just the opening salvo in Georgia’s opioid litigation. The firm expects to file similar lawsuits in the coming weeks on behalf of other Georgia counties and hospitals that have been financially devastated by the opioid epidemic. Some of those hospitals may be forced to close.
Citing a 2017 white paper by the Substance Abuse Research Alliance, Matthews said Georgia ranks among the top 11 states with the highest number of prescription opioid deaths. According to the report, 55 of Georgia’s 159 counties had higher drug overdose rates than the 2014 national average. Of those counties, 60 percent are located in rural areas with limited access to substance abuse treatment programs.
Matthews said that, between 2009 and 2014, Georgia had a 100 percent increase in inpatient hospital stays related to opioid addiction—the largest increase in the nation. During the same period, the state was third nationally in the increase in emergency room visits associated with opioids. Candler County is one of Georgia’s five most affected counties, he said.
“You will see that the highest prescription rates are in the smaller cities, towns and smaller, least populated counties, he said. “They are in counties where more of the residents are white … where more people are uninsured or unemployed.”
Matthews said the Georgia suits will be folded into the multidistrict litigation pending before U.S. District Judge Dan Polster of the Northern District of Ohio.
Those suits, like the Candler County suits filed in Georgia’s Southern District on Jan. 29, allege aggressive, deceptive marketing practices and the widespread, indiscriminate distribution of the highly addictive drugs to physicians and clinics across the nation.
Polster already has appointed lead counsel in the MDL. But he has not yet named a steering committee. Matthews said his firm is seeking appointment to the plaintiffs’ steering committee.
“We think that’s important, because that will give Georgia counties and the hospitals we represent a better seat at the bargaining table,” Matthews said.
And although the Athens firm is small, it has already had an outsize impact in MDL litigation in Georgia and elsewhere in the country. Firm partner Henry Garrard is currently co-lead counsel in the transvaginal mesh MDL against medical supply manufacturer C.R. Bard in the Southern District of West Virginia.
He also serves on the executive committee in the Johnson & Johnson talcum powder cases in Los Angeles Superior Court in California.
Garrard also was appointed as sole plaintiffs’ lead and liaison counsel and to the plaintiffs’ steering committee in the Mentor ObTape MDL in the Middle District of Georgia and was lead counsel in that MDL’s first bellwether trial.
Last August, U.S. District Judge Richard Story appointed Garrard as co-lead plaintiffs’ counsel, sole liaison counsel and placed him on the MDL steering committee in the Ethicon physiomesh flexible composite hernia mesh products MDL, which was transferred to the Northern District of Georgia last June.
“People think we’re just a little old firm in Athens,” he said. “We are actually better known nationally than we are in the state.”
https://www.law.com/dailyreportonline/sites/dailyreportonline/2018/02/07/south-georgia-county-hospital-authority-sue-over-opioid-addiction/
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Appeals court upholds $19m Boston Scientific loss in pelvic mesh case
Feb 8, 2018 | Mass Device
By Fink Densford
Boston Scientific (NYSE:BSX) has lost another bid as it looked to overturn an $18.5 million loss in a product liability suit over alleged injuries caused by its Obtryx pelvic mesh.
A jury in West Virginia federal court in November 2014 found Boston Scientific liable to 4 women following a 10-day trial; the trial judge later ordered the Marlborough, Mass.-based company to pay each of the 4 women damages ranging from $3.25 million to $4.25 million (the 4th plaintiff later settled her case out of court and it was dismissed).
In its appeal, Boston Scientific argued that the court’s decision to consolidate the four cases into a single trial created potential prejudice and confusion amongst the jury.
The appeals court disagreed, saying that “BSC lacks evidence that the district court’s safeguards were inadequate or that consolidation in fact resulted in any prejudice or jury confusion.”
“Instead, it asks us to infer jury confusion based on the similarities of the damages awarded to each plaintiff. Attempting to reverse engineer the jury’s thought processes based on its verdicts is always a dangerous enterprise, because we have no way of knowing what really happened during jury deliberations,” the court wrote, according to official documents. “Here, there is little reason to be suspicious of the verdicts given that BSC had a chance to fully develop its defenses and that the judge properly instructed the jury throughout the trial to keep the cases separate. What is more, the four plaintiffs did not receive identical damage awards, but instead received damages that varied by $1 million across plaintiffs. That the total damages awards were of the same order of magnitude appears to reflect the very similarities between the cases that justified consolidation in the first place.”
Appeals court judges agreed with the district court ruling, saying that it was “well within its discretion in consolidating these four cases for trial,” according to court documents.
Boston Scientific lost another bid looking to overturn the case in October 2016 after arguing that the plaintiffs failed to show that Obtryx is not reasonably safe because it’s within the standard of care for stress urinary incontinence.
https://www.massdevice.com/appeals-court-upholds-19m-boston-scientific-loss-pelvic-mesh-case/
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Boston Scientific Loses Bid to Reverse $18.5 Million Transvaginal Mesh Lawsuit Verdict
Feb 7, 2018 | RX Injury Help
By Laurie Villanueva
Laurie Villanueva is an attorney with Bernstein Liebhard LRX Injury Help
A federal appeals court has upheld the $18.5 million verdict awarded to four women who suffered serious complications following implantation of Boston Scientific Corp.’s Obtryx transvaginal mesh devices.
The case was decided in November 2014, after a jury in the U.S. District Court, Southern District of West Virginia, found that the company’s Obtryx Transobturator Mid-Urethral Sling System was defectively designed. The four plaintiffs were awarded $18.5 million (damages to each ranged from $3.25 million to $4.25 million).
Two of the women have since agreed to settle their transvaginal mesh lawsuits out of court for undisclosed amounts. However, Boston Scientific appealed the remaining verdicts, arguing that the Court’s decision to consolidate the four individual cases for trial created prejudice and confusion among the jurors.
The Fourth Circuit Court of Appeals disagreed with the company’s assertions in a decision handed down on Tuesday, finding that Boston Scientific had failed to provide any evidence of prejudice or confusion.
“Here, there is little reason to be suspicious of the verdicts given that BSC had a chance to fully develop its defenses and that the judge properly instructed the jury throughout the trial to keep the cases separate,” the Court wrote in its decision. “What is more, the four plaintiffs did not receive identical damage awards, but instead received damages that varied by $1 million across plaintiffs. That the total damages awards were of the same order of magnitude appears to reflect the very similarities between the cases that justified consolidation in the first place.”Boston Scientific Pelvic Mesh Settlements
Boston Scientific is just one of several medical device manufacturers that have been accused of marketing defective pelvic mesh to treat women suffering from pelvic organ prolapse and stress urinary incontinence
In a recent filing with the U.S. Securities and Exchange Commission, the company acknowledged that it had been named a defendant in approximately 48,500 product liability claims involving the implants.
“As of October 25, 2017, we have entered into master settlement agreements in principle or are in final stages of entering one with certain plaintiffs’ counsel to resolve an aggregate of approximately 44,000 cases and claims,” the filing stated.
Just this past December, Boston Scientific settled 378 additional transvaginal mesh lawsuits that were pending in the Southern District of West Virginia. The company announced its first transvaginal mesh settlement in April 2015, when it agreed to resolve 2,970 cases for about $119 million.Transvaginal Mesh Complications
The U.S. Food & Drug Administration (FDA) began investigating an increasing number of reports linking transvaginal mesh to serious and life-changing adverse events in 2008. In July 2011, the agency warned that injuries and complications associated with transvaginal mesh prolapse repair were not rare, a change from its previous position on the issue.
In 2016, the FDA reclassified transvaginal mesh indicated for prolapse repair as Class III (high risk) medical devices, making the implants ineligible for the agency’s 510(k) clearance program. This program allowed the products to come to market without the first undergoing human clinical trials because manufacturers were able to demonstrate that the implants were “substantially equivalent” to a device that had already been through to the agency’s more stringent premarket approval process.
https://www.rxinjuryhelp.com/news/2018/02/07/boston-scientific-loses-bid-to-reverse-18-5-million-transvaginal-mesh-lawsuit-verdict/
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