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Mesh implants 'as dangerous as asbestos' US lawyer tells MSPs
Feb 24, 2015 | BBC News
Vaginal mesh implants are as dangerous as asbestos, MSPs on Holyrood's petitions committee have been told. -
Mesh surgery scandal: US lawyer likens 'dangerous' implants to asbestos as he gives evidence to Holyrood committee
Feb 24, 2015 | Daily Record and Sunday Mail
By Lynsey Bews
A US lawyer has likened mesh implants to asbestos, describing them as "very dangerous devices", as he gave evidence to a Holyrood committee -
Mesh implant watchdog heckled over risks at Holyrood
Feb 25, 2015 | The Scotsman
By Scott MacNab
The head of a health watchdog has said there is “no evidence” of widespread problems with controversial mesh implants despite a Scottish Government ban. -
Reporting: Scotland Public Petitions Committee Hearing
Feb 24, 2015 | Video
Please see link for the full reporting segment -
Boston Scientific near deal to buy Endo's device unit: sources
Feb 24, 2015 | Reuters
By Olivia Oran
...Endo, which acquired AMS for $2.9 billion in 2011, reached an $830 million settlement last April to resolve legal claims from women who said they were injured by the company's transvaginal mesh device... -
Report: Is Boston Scientific closing in on deal for Endo's AMS medical device unit?
Feb 24, 2015 | Mass Device
By Brian Johnson
Endo bought pelvic devices maker AMS for $2.9 billion in cash in 2011. AMS has had a few issues over the years, including high-profile lawsuits over pelvic mesh implants and FDA warnings. -
Deals Rumor Mill: CSC, Lotte Group, Boston Scientific
Feb 24, 2015 | Law 360
By Benjamin Horney
...The unit Boston Scientific is gearing up to buy supplies devices that treat pelvic disorders.... -
Risperdal, pelvic mesh suits cause spike in filings at Philadelphia’s mass torts program
Feb 24, 2015 | Legal Newsline
By John O'Brien
...Specifically, 987 lawsuits over the drug Risperdal and 694 filed over pelvic mesh products led to 2,095 new lawsuits in 2014...
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Mesh implants 'as dangerous as asbestos' US lawyer tells MSPs
Feb 24, 2015 | BBC News
Vaginal mesh implants are as dangerous as asbestos, MSPs on Holyrood's petitions committee have been told.
They are holding an inquiry into the procedure, used to ease incontinence, after some women experienced painful complications.
Last year, the then Scottish health secretary Alex Neil urged health boards to suspend use of the implants.
Adam Slater, a US compensation lawyer, said "women are not told the truth" about the devices.
He was lead trial counsel in the first pelvic mesh trial against Johnson & Johnson and Ethicon, resulting in a compensatory and punitive damages verdict of $11.1m.
Giving evidence to members of the Scottish Parliament committee via videoconference, Mr Slater said the closest comparison to the mesh implant situation he could think of was asbestos.
He said: "Something that was thought to be a wonderful invention for a long time and now everybody in the world knows it's something you wouldn't want to go near.
"It's the closest analogy I can find to these horrible devices that are now in so many women."
EXPLAINER - Mesh implantsThe Scottish Parliament's petitions committee has been hearing evidence on a petition calling for the suspension of the use of medical mesh devices. Find out how the procedure has blighted the lives of some women.
The committee is considering calls to suspend mesh implant operations. Operations continue to be carried out by some health boards despite the health secretary's call to stop using them.
Mr Slater has worked almost exclusively on mesh cases in the US since 2007 and is currently the lead counsel for more than 7,000 cases in New Jersey.
He said some doctors are now refusing to use the devices, with one even branding them a "social cancer".
He told MSPs that studies into the safety of mesh have been influenced by manufacturers, who enjoy a "close relationship" with regulators of the products.
'High risk'
The lawyer said thousands of women in the US are suing both manufacturers and doctors on the grounds that mesh devices are defective or that there was a failure to warn them about the dangers and complications.
The US regulator, the Food and Drug Administration (FDA), indicated last April that it plans to reclassify mesh for pelvic organ prolapse as "high risk", but is yet to do so.
Mr Slater urged UK regulator the Medicine and Healthcare products Regulatory Agency (MHRA) to "look at the studies that are relied on by the mesh manufacturers".
"Most of the studies they rely on are written or investigated by paid consultants," he said.
"I would throw those in the garbage immediately because if somebody is being paid by the manufacturer, there is a financial bias."
He added: "There has never been a high-level study...that has ever been done that has proven the mesh to be safe and effective."
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Feb 24, 2015 | Daily Record and Sunday Mail
By Lynsey Bews
A US lawyer has likened mesh implants to asbestos, describing them as "very dangerous devices", as he gave evidence to a Holyrood committee .
Adam Slater, who has worked almost exclusively on mesh cases in the US since 2007, said some doctors are now refusing to use the devices, with one even branding them as "social cancer".
He told the Public Petitions Committee that studies into the safety of mesh have been influenced by manufacturers , who enjoy a "close relationship" with regulators of the products.
The committee is currently considering calls to suspend mesh implant operations, which are aimed at treating prolapse and bladder problems, after some women experienced painful complications.
Operations continue to be carried out by some health boards despite a call to suspend them by the then health secretary Alex Neil in June last year.
Sunday Mail reporter Marion Scott has led the campaign for mesh victims with a series of hard-hitting stories .
Mr Slater is currently the lead counsel for more than 7,000 cases in New Jersey.
"The closest analogy I can find is asbestos," he told the committee.
"Something that was thought to be a wonderful invention for a long time and now everybody in the world knows it is something you wouldn't want to go anywhere near."
He said thousands of women in the US are suing both manufacturers and doctors on the grounds that mesh devices are defective or that there was a failure to warn them about the dangers and complications.
The US regulator, the Food and Drug Administration (FDA), indicated last April that it plans to reclassify mesh for pelvic organ prolapse as "high risk", but is yet to do so.
Mr Slater said the FDA consults device manufacturers and is being lobbied by them.
Gary F McHarg FOCAL ScotlandHealth Secretary Alex Neil meets mesh victims
"There is a close relationship there and it is unfortunate because it takes the FDA away from the neutral objective position it should hold," he said.
He urged UK regulator the Medicine and Healthcare products Regulatory Agency (MHRA) to "look at the studies that are relied on by the mesh manufacturers".
"Most of the studies they rely on are written or investigated by paid consultants," he said.
"I would throw those in the garbage immediately because if somebody is being paid by the manufacturer, there is a financial bias."
He added: "There has never been a high-level study...that has ever been done that has proven the mesh to be safe and effective.
"Many doctors are being caught up in this because they didn't have the full information and they believed what they were being told by the manufacturers about which women were appropriate women to have these put in their bodies."
He said some doctors were now refusing to use mesh products, with one specialist in California referring to them as "social cancer".
"He has seized putting this mesh in any women's bodies," he said.
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Mesh implant watchdog heckled over risks at Holyrood
Feb 25, 2015 | The Scotsman
By Scott MacNab
The head of a health watchdog has said there is “no evidence” of widespread problems with controversial mesh implants despite a Scottish Government ban.
Dr Neil McGuire of the Medicines and Healthcare Products Regulatory Agency (MHRA) was heckled by angry campaigners, many wheelchair-bound from mesh side-effects, as he told MSPs there are no plans to withdraw them from use.
Many health boards in Scotland have continued to use the controversial devices used to treat organ prolapse and urinary incontinence, despite former health secretary Alex Neil calling for them to be banned.
Dr McGuire said: “If we had a higher level of reporting that showed that there were more complications than we are seeing then we’re always prepared to change our view.
“So if we had thousands and thousands of reports to say this was an issue, that wasn’t in the complication rate that was deemed acceptable by the clinical community, then we would change our stance.
“But we can’t act without information - and that information does not appear to be out there.”
Greater Glasgow and Clyde, Borders, Fife and Grampian are among the health board areas which still carry out mesh implants and have used the MHRA report as the basis for this, This is despite former health secretary Alex Neil calling for a moratorium on their use, while further work is carried out into the safety concerns.
Dr McGuire, a consultant in intensive care and anaesthesia, was asked if Mr Neil was being “irresponsible” in calling for the ban.
“I think that would be probably be a question I wouldn’t answer,” the clinician added.
Tory committee member Jackson Carlaw said: “I’ll take that to mean Yes.”
The medic added that the Scottish Government has imposed the moratorium without any new evidence being provided.
MSPs at Holyrood have been investigating the issue, following a number of harrowing examples of women suffering infections and bleeding following the surgery and long-term side effects.
Campaigners say many are left with chronic pain, permanent disability and the need for wheelchairs and walking aids or even the loss of a kidney or bladder.
The Scottish Government’s review into the use of mesh impants will report ir
But Elaine Holmes of the Scottish Mesh Survivors campaign group, who attended yesterday’s meeting branded Dr McGuire “dismissive and evasive.”
She said: “We’ve been going through this for years. They say there’s a lack of evidence to support a mesh suspension or indeed even to issue a warning. What more evidence does he need?”
“They say there’s only been 88 reports to the MHRA, but women have surgery they’re not told if you have an adverse reaction you must report it to the MHRA. Women are often to ill to understand there can be a process for this.”
Olive McIlory, who has jointly lodged a petition at Holyrood calling for ban, said the MHRA is aware of under-reporting and there are no long-term studies.
“Patient safety is righat the bottom of the agenda - they’re not interested,” she said.
MSPs also heard yesterday frm US lawyer Adam Slater who likened mesh implants to asbestos and described them as “very dangerous devices.”
The lawyer has worked almost exclusively on mesh cases in the US since 2007, said some doctors are now refusing to use the devices, with one even branding them as “social cancer”.
He is currently the lead counsel for more than 7,000 cases in New Jersey.
“The closest analogy I can find is asbestos,” he told the committee.
“Something that was thought to be a wonderful invention for a long time and now everybody in the world knows it is something you wouldn’t want to go anywhere near.”
He said thousands of women in the US are suing both manufacturers and doctors on the grounds that mesh devices are defective or that there was a failure to warn them about the dangers and complications.
The US regulator, the Food and Drug Administration (FDA), indicated last April that it plans to reclassify mesh for pelvic organ prolapse as “high risk”, but is yet to do so.
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Reporting: Scotland Public Petitions Committee Hearing
Feb 24, 2015 | Video
The full Reporting Scotland segment is available through this link:http://beta.criticalmention.com/app/#clip/view?13119061/token/00597503-9152-4054-8efb-1ae9ff5b64a8
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Boston Scientific near deal to buy Endo's device unit: sources
Feb 24, 2015 | Reuters
By Olivia Oran
Boston Scientific Corp (BSX.N) is close to buying Endo International PLC's (ENDP.O) AMS medical device unit, a deal that could value the business at around $2 billion, according to people familiar with the matter.
The companies are aiming to finalize an agreement within a matter of weeks, the people said this week, cautioning that discussions are continuing and could still fall apart.
A representative for Boston Scientific declined to comment. A representative for Endo could not be reached for comment. The sources asked not to be named because the matter is not public.
Based in Minnetonka, Minnesota, Endo's AMS unit supplies devices to treat pelvic disorders. Endo, which acquired AMS for $2.9 billion in 2011, reached an $830 million settlement last April to resolve legal claims from women who said they were injured by the company's transvaginal mesh devices.
The purchase would end a nearly decade-long deal drought for Boston Scientific, which has not completed a large takeover since its 2006 acquisition of heart device maker Guidant Corp for $27 billion, which left the company laden with debt and dealing with a slew of Guidant product recalls.
For Endo, the divestiture is part of an effort to sell non-core businesses and grow aggressively through new acquisitions.
Led by former Valeant Pharmaceuticals International (VRX.TO) executive and serial dealmaker Rajiv De Silva, Endo last October agreed to acquire Auxilium Pharmaceuticals Inc AUXL.O for $2.6 billion for its men's health drug portfolio.
Endo also acquired generic drugmaker Dava Pharmaceuticals for $600 million last June. A $1.6 billion acquisition of Canadian specialty drugmaker Paladin Labs last year allowed the company to shift its tax domicile from Pennsylvania to Ireland, where corporate tax rates are lower, in a so-called inversion deal.
Boston Scientific has largely sat on the sidelines amid a spate of large deals in the medical device sector in the last year, including Medtronic PLC's (MDT.N) $42.9 billion acquisition of Covidien and Zimmer Holdings Inc's (ZMH.N) acquisition of Biomet Inc for $13.4 billion
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Report: Is Boston Scientific closing in on deal for Endo's AMS medical device unit?
Feb 24, 2015 | Mass Device
By Brian Johnson
Endo Health Solutions may have found a buyer for its American Medical Systems subsidiary in Boston Scientific, according to a Reuters report,
Endo International, PLC (NSDQ:ENDP) may have found a buyer for its American Medical Systems subsidiary after months of speculation that the Irish pharma company had put its medical device business on the block.
Boston Scientific (NYSE:BSX) is said to be nearing a deal to buy Minnetonka, Minn.-based AMS, according to a report from Reutersnews service, which cited sources "familiar with the matter."
Representatives for the Marlborough, Mass.-based Boston Scientific declined comment on the deal, according to the news service.
Endo bought pelvic devices maker AMS for $2.9 billion in cash in 2011. AMS has had a few issues over the years, including high-profile lawsuits over pelvic mesh implants and FDA warnings. The Wall Street Journal first reported that Endo had put AMS on the block back in August. At the time of the report, anonymous sources cited by the Journalspeculated that Endo could garner $2 billion for AMS.
If Boston Scientific were to acquire AMS for $2 billion it would be the largest deal the company has made since acquiring Guidant Corp. in 2006 for $27 billion, according to Reuters.
During 2014, Endo paid $830 million to settle some 20,000 product liability lawsuitsover pelvic mesh products. Endo admitted no guilt in settling the lawsuits, but the hit pushed the company into the red for the 1st quarter of 2014.
In February 2014,Endo also took a $500 million write-down on the value of its AMS segment, saying at the time that it would book a $316 million pre-tax charge to boost its product liability reserve to $520 million to cover "all known, pending and estimated future claims primarily related to vaginal mesh cases."
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Deals Rumor Mill: CSC, Lotte Group, Boston Scientific
Feb 24, 2015 | Law 360
By Benjamin Horney
Information technology giant Computer Sciences Corp. has been in talks with French consulting company Cap Gemini SA and private equity firm Carlyle Group LP concerning a potential buyout, Reuters reported Tuesday, although it's possible the discussions have begun to peter out recently. The companies have been discussing the buyout since late last year, but it's not clear whether any deal will wind up taking place, the report said. New York City-based Computer Sciences Corp., which is valued at about $10 billion, is working with Royal Bank of Canada to review its options, the report added. Computer Sciences Corp. has been seeking suitors since at least September, when reports said it had initiated talks with Blackstone Group LP and Bain Capital LLC.
South Korean conglomerate Lotte Group has made a bid to buy a majority stake in Italian travel retailer World Duty Free, Reuters reported Tuesday. According to the report, the offer is estimated to be between 3 trillion to 4 trillion won ($2.71 billion to $3.61 billion). But Lotte faces competition as previous reports have named French conglomerate Lagardere SCA and private equity outfits KKR & Co. LP and CVC Capital Partners as other interested parties. According to Tuesday's report, Lotte officially submitted the offer over the weekend.
Boston Scientific Corp. is nearing a deal to buy the AMS medical device unit of Irish pharmaceutical company Endo International PLC for about $2 billion, Reuters reported Tuesday. The transaction could be completed within the next few weeks, the report noted, while also cautioning that the deal could still fall apart. The unit Boston Scientific is gearing up to buy supplies devices that treat pelvic disorders.
State-controlled aircraft and maintenance company Dubai Aerospace Enterprise Ltd. is hoping to sell its aviation services unit for upward of $1.8 billion, Reuters reported Tuesday. Dubai Aerospace has hired Moelis & Co. to help run an auction for the unit, which is known as StandardAero, the report added. No prospective suitors were mentioned in the report.
Canadian private equity group Onex Corp. is exploring a sale of call center operator Sitel Worldwide Corp., Reuters reported Tuesday. According to the report, Sitel could be valued at nearly $1 billion including debt in a potential deal. Goldman Sachs Group Inc.has been tasked with running the sale process for Onex, the report said. No prospective suitors were disclosed.
Huntington Bancshares Inc. is set to buy the equipment finance unit of Australia'sMacquarie Group Ltd. for roughly $380 million, Reuters reported Tuesday. According to the report, the deal — which is meant to boost the equipment leasing business for Huntingon Bancshares — could be announced as soon as this week. The unit in question makes loans to hospitals for equipment, in addition to providing other services like asset management and equipment trading. The sale process has been going on for about three months, the report said, and Huntington Bancshares beat out "several" other bidders.
O1 Properties, the property company owned by Russian billionaire Boris Mints, could soon acquire a stake in Austrian property group Immofinanz, Reuters reported Tuesday, citing Austrian outlet Die Presse. O1 already owns a 26 percent slice of CA Immo, another Austrian property company, the report noted. No potential price tag was disclosed.
Cushman & Wakefield Inc.’s owner is selling the company and could get as much as $2 billion with the sale, the Wall Street Journal reported, citing sources with knowledge of the matter. Exor SpA, the Italian family that bought a 67.5 percent stake in the real estate services firm for $565.4 million eight years ago and now owns 81 percent of Cushman, has enlisted Morgan Stanley and Goldman Sachs Group Inc. to search for a buyer, the journal said. -
Risperdal, pelvic mesh suits cause spike in filings at Philadelphia’s mass torts program
Feb 24, 2015 | Legal Newsline
By John O'Brien
Mass tort filings in Philadelphia’s Complex Litigation Center jumped more than 150 percent from 2013 to 2014.
A yearly statistical breakdown provided to Legal Newsline and the Pennsylvania Record by the CLC, which houses lawsuits in 11 mass tort areas, shows that lawsuits against pharmaceutical makers shot up after two relatively calm years.
Specifically, 987 lawsuits over the drug Risperdal and 694 filed over pelvic mesh products led to 2,095 new lawsuits in 2014.A graphic provided by the CLC breaks down the mass tort lawsuits still pending.
There were more Risperdal lawsuits filed in 2014 than all mass tort programs combined in 2013, when only 813 were filed.
Along with 2012’s 816, those two figures represented an effort to correct the CLC’s reputation after the American Tort Reform Association named Philadelphia the No. 1 Judicial Hellhole in its 2011 report.
ATRA blamed the CLC’s heavy activity, which reached its pinnacle with 2,690 lawsuits filed in 2011, on former coordinating judge Sandra Mazer Moss and Philadelphia Court of Common Pleas President Judge Pamela Pryor Dembe.
ATRA accused Moss of inviting mass tort filings and Dembe of promoting the CLC in order to use the fees associated with those cases to help with the court’s budget.
In 2012, Court of Common Pleas Administrative Judge John Herron signed an order that eliminated the CLC’s controversial practice of reverse bifurcation, in which a damages trial is held before a liability trial in the same case, and limited consolidation in mass tort cases.
That year, only 816 new cases were filed and 1,803 concluded. That continued in 2013, when 813 were filed and 1,908 concluded.
But 2014’s new filings outnumbered those that concluded by almost 800. There were 4,643 pharmaceuticals cases pending as of Jan. 4.
The records also show that out-of-state plaintiffs are dominating the pharmaceuticals filings.
Of the 1,827 new pharmaceutical cases, 1,617 (89 percent), came from out-of-state plaintiffs.
The 89 percent is consistent with the court’s history. The lowest percentage was 2005’s 81 percent.
The figures also show that 268 new asbestos cases were filed in the CLC, the lowest since 2009’s 238 and down 62 cases from 2013’s record 330.
Figures from 2005-11 reflect new filings, as well as cases transferred to the CLC. From 2012-14, only new filings were counted.
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