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Ethicon Media Monitoring 3/16/2017
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J&J Wants Pa. Mesh Cases Paused For Jurisdiction Appeal
Mar 15, 2017 | Law 360
By Matt Fair
A Johnson & Johnson unit urged a Pennsylvania state judge to pause more than a hundred pending cases from out-of-state plaintiffs over injuries allegedly caused by defective pelvic mesh products while the U.S. Supreme Court hears an appeal over jurisdictional issues. -
Medical expert quits mesh implant review group
Mar 15, 2017 | BBC
By Lucy Adams
An expert at the centre of the independent review group looking at the safety of mesh implants in Scotland has resigned. -
Health Minister under pressure as mesh group expert quits
Mar 15, 2017 | Herald Scotland
By Jody Harrison
HEALTH Minister Shona Robison has come under pressure to address the Scottish Parliament after an expert at the centre of a review group looking at the safety of mesh implants resigned. -
Surgical mesh used in hospitals across the region is set to be upgraded to a high risk medical device.
Mar 15, 2017 | Wisbech Standard
By Kath Sansom
Surgical mesh used in hospitals across Cambridgeshire looks set to be reclassified to a higher risk medical device under plans to improve patient safety. -
Therapeutic Goods Administration warnings about transvaginal mesh device complications are 'too little, too late'
Mar 16, 2017 | Newcastle Herald
By Joanne McCarthy
AUSTRALIA’S medical device gatekeeper and peak health regulator only listed 30 serious complications linked to women’s pelvic mesh surgery for the first time in 2016, more than two years after requiring manufacturers to provide evidence to back mesh devices, and after a meeting with women suffering mesh complications.
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J&J Wants Pa. Mesh Cases Paused For Jurisdiction Appeal
Mar 15, 2017 | Law 360
By Matt Fair
Law360, Philadelphia (March 15, 2017, 5:33 PM EDT) -- A Johnson & Johnson unit urged a Pennsylvania state judge to pause more than a hundred pending cases from out-of-state plaintiffs over injuries allegedly caused by defective pelvic mesh products while the U.S. Supreme Court hears an appeal over jurisdictional issues.
Ethicon Inc. said Monday that rulings in BNSF Railway Co. v. Tyrell and Bristol-Myers Squibb Co. v. Superior Court of California could result in the Philadelphia County Court of Common Pleas, as has been the company’s position throughout the litigation, being unable to exercise jurisdiction over out-of-state plaintiffs
“Rejection of personal jurisdiction would be fatal to exercising jurisdiction in the 106 cases at issue here,” the company argued. “Indeed, those decisions will definitively determine the precise issue defendants continue to raise with respect to personal jurisdiction: whether non-Pennsylvania plaintiffs whose claims have no connection to the commonwealth of Pennsylvania can bring actions in a Pennsylvania court against non-Pennsylvania defendants which are not subject to general jurisdiction.”
The BNSF case, the first of the two jurisdiction-related appeals the justices announced in January that they would hear, centers around a Montana Supreme Court decision finding that the railroad company’s business operations in the state allowed two injured workers from out-of-state to bring claims there.
Meanwhile, the Bristol-Myers case, which was accepted by the justices just days later, involves a California Supreme Court ruling that allowed almost 600 out-of-state residents to sue the drugmaker over alleged injuries from blood-thinner Plavix because of the company’s ties to the state.
Both cases are scheduled for argument at the end of April.
Ethicon claims that the two cases could impact whether the Philadelphia County courts, which established a mass tort program in February 2014 to deal with a glut of claims over injuries allegedly caused by defective mesh products, can continue to exercise jurisdiction over claims from out-of-state plaintiffs when the company itself is not subject to jurisdiction in the state.
Ethicon has repeatedly pushed the court to refuse to exercise jurisdiction over claims from out-of-state plaintiffs.
In March 2015, a Philadelphia County judge rejected the company’s arguments that plaintiffs in many of the mass tort cases had not claimed that their injuries had any specific ties to Pennsylvania sufficient to grant the court jurisdiction. The court has also rejected similar arguments leveled as part of preliminary objections in individual cases.
The company argued in its filing on Monday that the pending appeals before the Supreme Court put their jurisdictional arguments back at the forefront of the litigation.
“The decisions in Bristol-Myers Squibb and BNSF will likely determine whether those rulings can ultimately be sustained,” the company said.
The company said that one of the 106 cases it singled out for a stay was slated to get under way in the weeks before the Supreme Court was expected to issue its ruling in the two cases.
Two trials have already resulted in a pair of damage awards against Ethicon totaling some $26 million.
Boston Scientific Corp., which is also facing claims that their own mesh products had injury-causing defects, has also urged the court to pause cases from out-of-state plaintiffs pending the two appeals.
Lee Balefsky, an attorney with Kline & Specter PC representing the plaintiffs, wrote off Ethicon's motion when contacted by Law360 on Wednesday.
"J&J has already lost their jurisdictional argument in Philadelphia County and the current motion is merely an attempt to delay the litigation," he said.
Ethicon is represented by Kenneth Murphy and Melissa Merk of Drinker Biddle & Reath LLP and Julie Callsen of Tucker Ellis LLP.
The plaintiffs are represented by Lee Balefsky and Michelle Tiger of Kline & Specter PC, Irene McLafferty of Messa & Associates, Laura Feldman of Feldman & Pinto PC, Clayton Clark of Clark Love & Houston, William Barfield of the Potts Law Firm, James Barger and Bryan Aylstock of Aylstock Witkin Kreis & Overholtz PLLC and Stefanie Colella-Walsh of Stark & Stark.
The case is In Re: Pelvic Mesh Litigation, case number 140200829, in the Philadelphia County Court of Common Pleas.
--Editing by Orlando Lorenzo.https://www.law360.com/articles/902385/j-j-wants-pa-mesh-cases-paused-for-jurisdiction-appeal
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Medical expert quits mesh implant review group
Mar 15, 2017 | BBC
By Lucy Adams
An expert at the centre of the independent review group looking at the safety of mesh implants in Scotland has resigned.
The consultant, who does not wish to be named, stepped down following the revelation that an entire chapter of the final report had been removed.
It follows the resignation of two patient representatives who claimed the report had been watered down.
Health Secretary Shona Robison said no evidence would be hidden.
Transvaginal mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.
What's the issue with mesh implants?
Over the past 20 years, more than 20,000 women in Scotland have had mesh or tape implants but some have suffered painful and debilitating complications.
There are more than 400 women currently taking legal action against Scottish health boards and manufacturers as a result of mesh implant surgery.
In 2014 former health secretary Alex Neil called for the suspension of such procedures, and an independent review group was set up to look at safety issues.
An interim report published in October 2015 did not advocate a blanket ban on mesh implants but noted that some women do experience serious complications and it made suggestions for reducing the risks. The final report is expected shortly.
Earlier this month, the BBC revealed that an expert member of the review group had written to its chairwoman, raising concerns about the final draft.
The letter states that an entire chapter, which highlighted concerns about the use of mesh in some procedures and contained tables displaying the risks of treatment, had been taken out.
Patients representatives Olive McIlroy and Elaine Holmes, who have both suffered complications as a result of such surgery, resigned from the review earlier this month, claiming that the final report now lacked integrity and independence.
Responding to the latest resignation, Health Secretary Shona Robison said clinical experts sometimes disagreed on complex medical matters.
She said: "I want to reassure the Scottish Mesh Survivors Group their views have been heard, and I want them to remain at the centre of the crucial work.
"I have been clear that all evidence must be made publically available alongside the report once published. The chair of the Review Group has stressed to me the evidence has been fully considered by the review and none has been hidden.
"This is a complex, technical area and on occasions professionals will disagree. I am aware of the resignation of a clinical member from the group and, while this is unfortunate, their views and contribution to the review is much-appreciated and have proven valuable."
Ms Robision is due to meet Olive McIlroy and Elaine Holmes later this week to discuss their concerns.
In December, the BBC revealed that hundreds of mesh implant operations had been performed in Scotland despite ministers recommending their suspension.
Figures obtained by the BBC revealed that 404 women had received mesh and tape implants since the health secretary called for the suspension in June 2014.
http://www.bbc.com/news/uk-scotland-39279028
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Health Minister under pressure as mesh group expert quits
Mar 15, 2017 | Herald Scotland
By Jody Harrison
HEALTH Minister Shona Robison has come under pressure to address the Scottish Parliament after an expert at the centre of a review group looking at the safety of mesh implants resigned.
The unnamed consultant quit the independent panel following the revelation that an entire chapter of the final report, due to be published soon, had been removed.
The decision to step down followed the resignation patient representatives Olive McIlroy and Elaine Holmes earlier this month amid claims the final report had been watered down.
The resignations come after public health expert Dr Lesley Wilkie, the chair of the review group, stood down in December.
Transvaginal mesh implants can be used to treat women suffering from prolapse and bladder problems, but an independent review was ordered in 2014 after some patients suffering from painful complications lobbied Holyrood.
The then health secretary Alex Neil asked health boards to suspend the use of the implants after a campaign by women who have suffered serious side effects.
A final report is expected shortly, but Labour MSP Neil Findlay warned that it is in danger of being seen as a whitewash following the resignations.
He said: “Shona Robison must update Parliament on this urgently. The SNP government cannot stand by as this report becomes a whitewash.
"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 stands by as the review draft is rewritten and all the while more and more people lodge damages claims against our NHS.
“We need a statement to Holyrood on this as soon as possible, SNP ministers should be less focused on dividing Scotland and more focused on governing focused.”
There are more than 400 women currently taking legal action against Scottish health boards and manufacturers as a result of mesh implant surgery.
However, hundreds of mesh implant operations have been carried out since ministers called for them to be suspended.
After resigning from the review group, Elaine Holmes, from East Renfrewshire, said she had seen a draft of the final report and it was like "night and day" when compared to the previous interim study.
She said: "We looked at one chapter and it was completely biased. It would speak of the benefits of mesh but not the risks.
"For the non-mesh equivalent, which is called colposuspension, it would talk about the risk but not the benefits. It was just so biased it was unbelievable."
Olive McIlroy added: "The colposuspension non-mesh procedures have been going on since the sixties. We are just trying to get at the truth and they don't want the real truth to come out.
"There is no litigation with them, there is no campaign of patients who have been severely adversely injured through the procedure.
"Alarm bells are ringing all over the world. It's not just us and it's not just here.
"We are not trying to sensationalise or make a point, we are just trying to get at the truth and they don't want the real truth to come out."
http://www.heraldscotland.com/news/15158591.Health_Minister_under_pressure_as_mesh_group_expert_quits/
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Mar 15, 2017 | Wisbech Standard
By Kath Sansom
Surgical mesh used in hospitals across Cambridgeshire looks set to be reclassified to a higher risk medical device under plans to improve patient safety.
The polypropylene plastic mesh material, used to fix women’s pelvic floor problems of incontinence and prolapse, and also hernia repairs, is among a list of devices that will be moved up a notch in the risk scales.
The news has been welcomed by campaigners who want to see the mesh implants taken off the market and a switch back to traditional repairs that do not carry risks of foreign body reactions where a patient rejects or has allergic reactions to the plastic material.
Campaigner Ann Boni, of Sling The Mesh, said: “As time goes on, up and coming young surgeons are gradually losing the skills needed for women’s pelvic floor reconstruction or hernia repairs using traditional methods.
“Instead they are heavily relying on plastic surgical meshes for a quick fix. Sadly as time passes we are seeing more people suffer from the painful consequences of that mesh.
“Plastic does not have a place inside the human body where it can change under body temperature to shrink or degrade causing horrific internal injuries and crippling pain.”
Currently surgical mesh has a IIb rating.
If reclassified it will be come a III.
This means it must undergo stricter testing before it is allowed to be unleashed on patients.
It must also be followed-up with post market studies for up to three years to make sure any problem are tracked and traced.
Other medical devices set to be upgraded, as outlined in a European medical directive document, are breast implants, devices that come into direct contact with the heart and those that are wholly or mainly absorbed .
With Brexit looming it is unclear how the document will affect the UK but an MHRA spokesperson said: “The MHRA remains wholly committed to effective regulation of drugs and devices.
“This will not change after the UK leaves the EU.
“We have been working closely with industry and other stakeholders and we have established an internal taskforce which is exploring a range of possible models for the future regulation of medicines and medical devices in the UK – this is still under negotiation.
“The European Medical Device Regulations are currently being redrafted and are due to be finalised in Spring 2017.
“Although the European Council has published the latest version of the new regulations, this text may still be subject to amendment, so we are currently not in a position to offer any formal guidance or definitive interpretation of what is meant by ‘surgical meshes’.”
• Read the draft European medical device regulations here. The section on surgical mesh can be found on page 469/70.
http://www.wisbechstandard.co.uk/news/surgical_mesh_used_in_hospitals_across_the_region_is_set_to_be_upgraded_to_a_high_risk_medical_device_1_4933484
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Mar 16, 2017 | Newcastle Herald
By Joanne McCarthy
AUSTRALIA’S medical device gatekeeper and peak health regulator only listed 30 serious complications linked to women’s pelvic mesh surgery for the first time in 2016, more than two years after requiring manufacturers to provide evidence to back mesh devices, and after a meeting with women suffering mesh complications.
The Therapeutic Goods Administration (TGA) website carried the list in a public statement in August that acknowledged complications involving mesh devices are “most likely under-reported” and “some patients may not realise their symptoms are associated with an adverse event”.
The acknowledgement appeared eight years after an expert committee advised the TGA that mesh erosion into women’s vaginas and rectums were “common adverse events with these types of devices”, and 13 years after Newcastle Dr Alan Hewson and Brisbane Dr Chris Maher warned that a mesh device procedure “cannot be recommended” because of complications and lack of supporting evidence of safety and efficacy.
It also came as estimates of the global cost of mesh legal cases could reach $20 billion.
The TGA’s response has been slammed by Australian Pelvic Mesh Support Group founder Caz Chisholm as “too little, too late”, after telling the Newcastle Herald that women were treated as “guinea pigs, we just didn’t know until it was too late”.
“The women who went to that meeting used their own money to get to Canberra. Women in the group donated money to pay for my flight and the women's accommodation,” Ms Chisholm said.
“If it were not for the women contributing financially and being there for each and every one of us, we would not have had that meeting.
“The TGA have ignored women's phone calls about their complications, they have not responded in a timely manner. They told us they would put out a media campaign to let women know that their complications may be mesh related, and yet all they did was put the complications list on their website where no woman can find it and no general practitioners know about it.
“The complications list has not been broadcast Australia-wide at all and women are still being treated like hypochondriacs at the appointments because this TGA alert is not known to the medical community.”
The TGA have ignored women's phone calls about their complications, they have not responded in a timely manner.- Australian Pelvic Mesh Support Group founder Caz Chisholm
The TGA warned that transvaginal mesh – implanted via the vagina to treat incontinence or prolapse problems after childbirth – could cause punctures of vessels, nerves, structures or organs, including the bladder, urethra or bowel and requiring surgical repair; serious infection; mesh tape rejection; erosion into the vagina or rectum; chronic pain; painful sexual intercourse for women and their partners; permanent lower urinary tract obstruction; acute and chronic pain in the groin in the legs, pelvis and abdomen; vaginal discharges; bleeding and defecation dysfunction.
In the public statement the TGA urged patients and health professionals to report complications with the devices to the TGA’s incident reporting and investigation scheme, despite mesh device manufacturers having a mandatory requirement to report complications.
Between July, 2012 and June, 2016 the TGA received 99 adverse event reports involving transvaginal mesh devices, with pain and mesh erosion into organs including the vagina and rectum as the most frequent complaint.
During the same period 450 women registered as part of a class action run by Shine Lawyers against Johnson and Johnson over incontinence and prolapse devices sold on the Australian market, another 300 women have registered for a class action against American Medical Systems, and many more have taken, or are taking, action against other manufacturers because of mesh complications.
In August, 2013 an expert panel advising the TGA on pelvic mesh devices after tens of thousands of women around the world initiated legal cases alleging complications, said there was “recognition of significant under-reporting” of complications in Australia, in a system that relied on manufacturers to make mandatory reports.
The TGA estimated it only received 10-20 per cent of all adverse events following transvaginal mesh surgery and expert panel members were aware “that company representatives aren’t reporting all complications to the TGA”.
The expert panel advised that “surgeons do not have a strong awareness of Australia’s adverse event reporting systems”. The TGA “only has the legislative power” to require manufacturers, but not doctors, to report complications and adverse events.
“It was noted that with mandatory reporting by (manufacturers) and spontaneous reporting from other sources, it is not possible to determine an incidence rate from adverse event reports,” minutes of an expert panel meeting advising the TGA on transvaginal mesh devices said.
The Herald has put a list of questions to the TGA about its adverse events reporting system and what action, if any, it took against manufacturers where there was evidence they had not reported complications involving their products.
http://www.theherald.com.au/story/4533002/regulator-quietly-reveals-pelvic-mesh-risks/
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