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Ethicon Media Monitoring 3/19/2018
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Surgical mesh group asks Jacinda Ardern to intervene in 'medical disaster' video
Mar 17, 2018 | Stuff
By Cate Broughton
An advocacy group wants Prime Minister Jacinda Ardern to "finally step in and take charge" and employ an independent commissioner to review surgical mesh products. -
Surgical mesh reform a failure - campaigners
Mar 17, 2018 | Newshub
Government measures that restrict the use of surgical mesh are a "smokescreen" and do not protect the majority of patients, campaigners say. -
Indiana Woman Wins $35 Million in Johnson & Johnson Transvaginal Mesh Lawsuit
Mar 18, 2018 | Lawyers and Settlements
By Anne Wallace
On the advice of her doctor, Barbara Kaiser had Prolift pelvic mesh implanted in 2009 to treat her pelvic organ prolapse. She then began to suffer from low pelvic pain. -
Attorneys at BBGA selected to 2018 Super Lawyers List
Mar 18, 2018 | Athens Banner Herald
... He is also actively working in hernia mesh litigation involving the C-Qur mesh products (he is State Liaison Counsel), the Ethicon Physiomesh product, and is co-lead counsel in all cases involving mesh products made by C.R. Bard Inc.
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Surgical mesh group asks Jacinda Ardern to intervene in 'medical disaster' video
Mar 17, 2018 | Stuff
By Cate Broughton
An advocacy group wants Prime Minister Jacinda Ardern to "finally step in and take charge" and employ an independent commissioner to review surgical mesh products.
Mesh Down Under said in its open letter to Ardern this week that it wanted "concrete changes" to regulation and monitoring of the products, which were used mainly in gynaecological procedures and to repair hernias.
Complications include severe abdominal and groin pain, perforation of the bladder and infection from eroded mesh.
The group's founders – Charlotte Korte, Carmel Berry and Patricia Sullivan – took a petition to Parliament in 2014 requesting a commission of inquiry into the products. A Health Select Committee followed and recommendations were endorsed by the Government in 2016.
But Mesh Down Under said only one of the recommendations had been implemented – an update of the adverse events reporting form for patients on the Medsafe website.
Recent action to ban some mesh products had not improved safety for most patients, the group said.
In December, Medsafe announced it had written to four mesh companies under Section 38 of the Medicines Act 1981 to limit supply of mesh products for sole use in pelvic organ prolapse and single incision mini sling used for stress urinary incontinence surgeries.
Other mesh devices were required to have their product information updated to include adverse events: "severe chronic pain", "groin pain", and "bladder perforation".
Korte said the group was "ecstatic" at the time but soon realised the action had failed to improve safety for the majority of mesh patients and was "a smokescreen".
Surgeons had already stopped the routine use of mesh in pelvic organ prolapse procedures before the announcement and the "single incision mini sling" mesh device for stress urinary incontinence had never been widely used in New Zealand, Korte said.
Johnson & Johnson had also withdrawn supply of its mesh products from Australia and New Zealand, but Korte said that created more risk.
"Surgeons will have to use unfamiliar products, and what guidelines are in place for that? And patients need to be informed the surgeon hasn't used the device before."
Updating product information with adverse events that were already well known would do nothing for patients, Korte said.
"How is adding that to a piece of paper a surgeon looks at, how is that making anything better for the patient?"
In the letter to Ardern Mesh Down Under expressed their "huge feelings of disappointment and betrayal" following a March 5 meeting with Medsafe director of protection, regulation and assurance Dr Stewart Jessamine and Associate Minister of Health Julie Anne Genter.
Jessamine told them no progress had been made on a cost-benefit analysis for a mesh register despite a commitment to begin work on it in October, Korte said.
A register to record all mesh procedures would enable patients to be tracked and help determine the scale of complications.
In a statement to Stuff Medsafe chief executive Chris James said a cost-benefit analysis of a register would be completed by the end of May.
Genter said she was disappointed by the delays and had asked the Ministry for monthly updates on progress.
"I personally have a number of unresolved questions from our meeting this week, and I have asked the Ministry of Health to address those before making any further decisions."
A spokeswoman for the Prime Minister said she had read Mesh Down Under's letter and was aware of their concerns.
"She is looking to get an update from Associate Health Minister Julie Anne Genter once she is back from New York at the weekend."
https://www.stuff.co.nz/national/health/102311061/surgical-mesh-group-asks-jacinda-ardern-to-intervene-in-medical-disaster
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Surgical mesh reform a failure - campaigners
Mar 17, 2018 | Newshub
Government measures that restrict the use of surgical mesh are a "smokescreen" and do not protect the majority of patients, campaigners say.
The Government announced in December that the use of surgical mesh products in urogynaecological (transvaginal) surgeries would be limited.
Suppliers are also now required to include details of adverse effects of surgical mesh on the products, including severe chronic pain, groin pain and bladder perforation.
But advocacy group Mesh Down Under says the recent ban of some mesh products has failed to improve safety for the majority of patients.
In an open letter to the Prime Minister Jacinda Ardern, the group asked for an independent commissioner to review surgical mesh products and make changes to the regulation and monitoring of these products.
Mesh Down Under co-founder Charlotte Korte told Stuff that the group were initially stoked with the government restrictions but realised shortly after it was a "smokescreen".
Updated product information would do little to protect patients, while companies withdrawing from supplying surgical mesh in New Zealand created more risk.
"Surgeons will have to use unfamiliar products, and what guidelines are in place for that? And patients need to be informed the surgeon hasn't used the device before."
Mesh Down Under also expressed their disappointment in the letter that Medsafe had failed to provide a cost-benefit analysis for a mesh register.
Medsafe chief executive Chris James told Stuff the analysis would be completed by May.
http://www.newshub.co.nz/home/health/2018/03/surgical-mesh-reform-a-failure-campaigners.html
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Indiana Woman Wins $35 Million in Johnson & Johnson Transvaginal Mesh Lawsuit
Mar 18, 2018 | Lawyers and Settlements
By Anne Wallace
Jury awards $10 million in compensation and $25 million in punitive damages for negligent design of Prolift transvaginal mesh and failure to warn of danger.
Chicago, IL On the advice of her doctor, Barbara Kaiser had Prolift pelvic mesh implanted in 2009 to treat her pelvic organ prolapse. She then began to suffer from low pelvic pain. It was only years later that she learned that this was likely a transvaginal mesh complication. Her doctor never told her about this and he, himself, claims to have not been aware of all of the risks, including the danger of severe and irreversible injury to his patients.On March 8, the jury awarded Ms. Kaiser $35 million. That included a whopping $25 million penalty to J&J and its subsidiary, Ethicon, for a policy of deception that put profits before patient welfare.
Edward A. Wallace of Wallace Wexler doesn’t see an anomaly in the verdict. While acknowledging the likelihood of an appeal, he told LAS, “The punitive damages are rationally related to the compensatory damages, and they are supported by the evidence.”
Wallace further told LAS, “These verdicts that are now coming in on a consistent basis will finally inform Johnson & Johnson that they can’t simply release a medical device without supporting safety data and with no idea about how they will affect these women for the rest of their lives.”
Disastrous transvaginal mesh complications
Women who suffer from pelvic organ prolapse may choose surgery to treat serious symptoms that do not improve with more conservative treatment. One method of repairing the pelvic floor involves implantation of transvaginal mesh.
Sometimes the remedy can be worse than the problem. Frequently reported complications include infection, pain, urinary problems, vaginal scarring and recurrence of prolapse and/or incontinence. Another complication cited by the FDA is erosion, in which the mesh gradually dislodges from the vaginal wall where it was implanted and moves into the surrounding tissue and organs. Mesh removal involves complicated surgery, is often unsuccessful and may increase a woman’s risk of additional complications or symptoms.
Truth be told, the injury often doesn’t stop with the woman in pain. Families and communities may be affected by the powerful person who is ill and no longer comes downstairs. Bad medicine is a stone cast in the water that rocks family and community far from the center.Why such secrecy?
Anecdotal evidence abounds, and international studies suggest caution in the use of transvaginal mesh. So why is this still a common medical practice in the US?
Profit motive looms large in the realm of popular reporting. The story will undoubtedly continue to unfold. Edward Wallace remains sanguine about the prospects for women and families who have been injured.
The Kaisers were represented by Tom Plouff, Jeff Kuntz of Wagstaff Cartmell LLP and Ed Wallace of Wexler Wallace LLP.https://www.lawyersandsettlements.com/articles/transvaginal-mesh-tvt-sling/indiana-woman-wins-35-million-in-johnson-transvaginal-mesh-lawsu-22888.html
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Attorneys at BBGA selected to 2018 Super Lawyers List
Mar 18, 2018 | Athens Banner Herald
Seven attorneys at Athens law firm Blasingame, Burch, Garrard & Ashley have been selected to the 2018 Super Lawyers List.
Five shareholders were selected to the Super Lawyers list and two were selected to the Super Lawyers Rising Stars list.
Founding partner Dave Burch was selected to the Super Lawyers List for the 15th consecutive year. Burch has more than 50 years of experience and has served in leadership positions as president and chairman of multiple associations throughout his career. Burch’s areas of expertise include business litigation, corporate law, banking law, and health care.
Henry G. Garrard III is a dedicated Athens personal injury and plaintiffs’ litigation lawyer at BBGA. He has handled diverse and complex injury claims, including medical malpractice and products liability, as well as qui tam litigation, tort liability, and class actions. Garrard also has experience handling multi-district litigation. He was chosen this year for inclusion on the Super Lawyers List for the 15th year in a row.
This is Drew Hill’s 15th year being selected to the Super Lawyers List. While Hill’s practice focuses on many different types of personal injury cases, including medical negligence and products liability, he also handles complex mass torts (medical devices and opioid litigation) and truck accident cases. Over the course of his years in practice, Hill has successfully fought for and won multi-million dollar settlements and jury verdicts on behalf of his clients.
Evan Jones has been included on the Super Lawyers list for 14 years. Jones is a personal injury attorney whose focus is primarily on catastrophic injury cases, including those resulting from medical malpractice and nursing home negligence or abuse. He has been practicing nearly 27 years and his practice is statewide.
This is Jim Matthews’ 15th year being selected to the Super Lawyers List. Matthews is an experienced Athens personal injury attorney who handles a wide range of plaintiffs’ personal injury cases. He focuses his practice on medical negligence, trucking accidents, defective/dangerous medical devices, and mass tort cases such as opioid litigation. He is also actively working in hernia mesh litigation involving the C-Qur mesh products (he is State Liaison Counsel), the Ethicon Physiomesh product, and is co-lead counsel in all cases involving mesh products made by C.R. Bard Inc.
Partners Patrick Garrard and Michael Ruppersburg were selected to the 2018 Super Lawyers Rising Stars list.
Patrick Garrard has been selected to the Super Lawyers Rising Stars list for four years. He is a dedicated trial lawyer who is committed to helping catastrophically injured victims and their family members. His practice focuses on product liability cases, but he also handles mass torts such as opioid litigation, premises liability lawsuits, and pharmaceutical antitrust litigation.
This is Michael Ruppersburg’s seventh year being selected to the Super Lawyers Rising Star List. He is a trial lawyer whose primary focus is helping people who have been seriously injured and families who have lost a loved one due to the negligence of others. Ruppersburg has secured over $15 million in verdicts and settlements and argued and won cases at the Georgia Supreme Court and Court of Appeals. His practice areas include car wrecks, tractor-trailer wrecks, premises liability, dangerous and unsafe products, and nursing home negligence and abuse.
Super Lawyers is a nationally recognized rating service that annually selects the top attorneys in each state. Lawyers selected for the list are chosen using a multiphase selection process that incorporates peer nominations, evaluations, and independent research based on professional achievements. All-together, BBGA has 85 years of selection status.
http://www.onlineathens.com/news/20180318/attorneys-at-bbga-selected-to-2018-super-lawyers-list
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