Preview Newsletter
Ethicon Media Monitoring 4/15/2019
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Pennsylvania appeals court upholds $14m plaintiff win in Ethicon mesh case
Apr 12, 2019 | Mass Device
By Brad Perriello
A state appeals court in Pennsylvania yesterday upheld the plaintiff’s $13.7 million win in a product liability lawsuit brought over one of Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon‘s pelvic mesh products. -
Pa. Appellate Court Affirms $13.5M Pelvic Mesh Verdict
Apr 12, 2019 | Law.com
By Max Mitchell
The Pennsylvania Superior Court has rejected a Johnson & Johnson subsidiary’s efforts to overturn a $13.5 million verdict over injuries a Philadelphia jury determined were caused by a pelvic mesh device implanted during surgery. -
J&J Loses Appeal of $13.5M Award in Pelvic Mesh Case
Apr 12, 2019 | Bloomberg Law
By Julie Steinberg
Johnson & Johnson and its Ethicon Inc. unit lost their bid to undo a $13.5 million award, including $10 million in punitive damages, to a New Jersey woman who alleged she was permanently harmed by a pelvic mesh implant. -
Washington State AG’s Ethicon Pelvic Mesh Lawsuit Headed To Trial, CVN To Webcast Live
Apr 12, 2019 | CVN News
By David Siegel
The first trial in a lawsuit brought by a state attorney general against Johnson & Johnson’s Ethicon unit over their allegedly defective pelvic mesh implants begins April 22 in Washington State court, and the proceedings will be webcast gavel-to-gavel by Courtroom View Network. -
Mum calls for vaginal mesh implant ban after pain ruined sex life with husband
Apr 14, 2019 | Mirror.co.uk
By Anita Merritt and Sam Rkaina
A mum is calling for vaginal mesh implants to be banned after surgery ruined her sex life with her husband. -
A desire for 'dry knickers' shockingly changed this Devon mum's life beyond recognition
Apr 14, 2019 | Devon Live
By Anita Merritt
A Devon mother-of-three is calling for controversial vaginal mesh implants to be banned after the ‘life changing’ operation she was promised left her at breaking point. -
H.R. 2164- Fighting for Your Right to Take Defective Medical Devices to Court
Apr 12, 2019 | Mesh Medical Device News Desk
By Jane Akre
H.R. 2164 would restore an Americans right to take a defective medical device maker to trial and receive compensation. -
Neurological Injuries: Path More Certain
Apr 12, 2019 | Mesh Medical Device News Desk
By Jane Akre
Neurological Injuries: Path More Certain. Sponsored Content. Dr. Greg Vigna, JD, talks about his continued focus on pelvic mesh injuries with a neurological or nerve injury component. -
Spalding publican: 'Mesh operation? Don't do it'
Apr 14, 2019 | Spalding Today
By Lynne Harrison
Spalding pub couple Pete and Steph Williams are considering hitting the campaign trail once more to warn people about the health risks from surgical mesh.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
Online Sources
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Pennsylvania appeals court upholds $14m plaintiff win in Ethicon mesh case
Apr 12, 2019 | Mass Device
By Brad Perriello
A state appeals court in Pennsylvania yesterday upheld the plaintiff’s $13.7 million win in a product liability lawsuit brought over one of Johnson & Johnson (NYSE:JNJ) subsidiary Ethicon‘s pelvic mesh products.
Plaintiff Sharon Carlino was awarded $13.5 million in damages in February 2016, after a Keystone State jury found that the Ethicon transvaginal polypropylene tape implanted during a 2005 hysterectomy was defective and that the company failed to adequately warn of its risks; Carlino needed three revision surgeries to remove the eroded mesh. That decision was upheld early the following year, with the court adding some $238,000 in delay damages.
Ethicon and Carlino cross-appealed, with the company pressing seven arguments seeking to overturn the decision and Carlino arguing that the delay damage award should have been calculated on both compensatory and punitive damages, not just the compensatory award.
Yesterday the Pennsylvania Superior Court ruled on the cross-appeals, backing the lower court’s decision on all fronts, including Ethicon’s challenge to the punitive damages award and the delay damages ruling.
“Taken as a whole, and viewed in the light most favorable to the verdict winner, this evidence permitted the jury to find Ethicon acted with wanton and willful disregard of Ms. Carlino’s rights and that this conduct caused her injuries. The evidence showed that Ethicon knew that the TVT could cause permanent vaginal and muscular pain and sexual dysfunction, because of its mesh weight, pore size, pore collapse, and particle loss. Despite this knowledge, Ethicon promoted the TVT for patients who sought to fix SUI, knowingly understated the risks of the TVT in its IFU, and consistently misled physicians that the TVT produced few adverse results,” the Superior Court found.
“The evidence demonstrates that Ethicon knowingly understated the risks of the TVT in all six versions of the [instructions for use] published between 2000 and 2015. The IFU’s adverse reactions section did not change during that time, and it failed to acknowledge new information Ethicon was obtaining from treaters and its own researchers on adverse effects associated with the TVT. In addition, Ethicon consistently and misleadingly informed physicians that the TVT produced few adverse results and was intentionally evasive about common complications,” according to the ruling.
In January a Philadelphia jury hit Ethicon with a $41 million decision in another pelvic mesh suit brought over its Gynemesh, Prolift and TVT-O meshes. That verdict includes $25 million in punitive damages, $15 million in compensatory damages and $1 million for loss of consortium.
Ethicon has said it intends to appeal the decision and that it stands by its pelvic mesh products.
https://www.massdevice.com/pennsylvania-appeals-court-upholds-14m-plaintiff-win-in-ethicon-mesh-case/
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Pa. Appellate Court Affirms $13.5M Pelvic Mesh Verdict
Apr 12, 2019 | Law.com
By Max Mitchell
The Pennsylvania Superior Court has rejected a Johnson & Johnson subsidiary’s efforts to overturn a $13.5 million verdict over injuries a Philadelphia jury determined were caused by a pelvic mesh device implanted during surgery.
A unanimous three-judge Superior Court panel on Thursday affirmed the multimillion-dollar verdict in Carlino v. Ethicon, which a jury awarded in February 2016. The case was the second pelvic mesh trial in Philadelphia state court, and ended with a verdict of $3.5 million in compensatory damages and $10 million in punitive damages.
J&J subsidiary Ethicon had raised several issues to the appellate court in an effort to overturn the verdict, including contending that certain evidence and testimony should have been allowed in at trial and that the action should have been barred by the statute of limitations, but the court rejected all of those arguments.
Regarding the statute of limitations argument, Judge Victor Stabile, who wrote the majority’s 53-page opinion, said Ethicon made a “spirited argument,” since the plaintiff’s history of pain, advice by physicians and corrective surgery all indicated she should have been aware of the link between the problematic mesh and her injuries more than two years before she filed her suit. But, he also noted the plaintiff presented conflicting evidence on this issue, and determined that the trial court was correct to allow the jury to consider the case.
“Certain trial testimony indicates that Ms. Carlino’s physicians identified the TVT as the cause of Ms. Carlino’s problems in 2007 and 2010, but other medical records suggest that these physicians told her that her problems were risks of the surgery,” Stabile said.
Ethicon also challenged whether courts in Pennsylvania had jurisdiction to hear the claims, since Ethicon is based in New Jersey and the plaintiff, Sharon Carlino, is not a Pennsylvania resident.
Although the panel in Carlino noted recent Superior Court precedent rejecting that argument, the state Supreme Court is set to have the ultimate say on the jurisdiction question after it agreed to take up Ethicon’s appeal on the issue earlier this week.
Carlino’s case is one of nearly 90 cases that are pending in Philadelphia’s Complex Litigation Center, all of which contend that Ethicon failed to adequately warn about the risks of implanting pelvic mesh.
In an emailed statement Friday, Carlino’s attorney, Shanin Specter of Kline & Specter, who is also a lead attorney in the pelvic mesh litigation, said his client is “gratified by the Superior Court’s affirmance of her verdict.”
“This brave woman has been horribly injured by Johnson & Johnson’s vaginal mesh product that, unfortunately, they’re still making and selling for permanent implantation,” Specter said. “We hope J&J will get the message and take this product off the market for the health and safety of America’s women.”
In a statement Friday, Ethicon called the Superior Court’s decision “disappointing.”
“Ethicon doesn’t believe this case or other out-of-state cases belong in Pennsylvania and is looking forward to the opportunity to present our arguments to the Pennsylvania Supreme Court,” spokeswoman Mindy Tinsley said in an emailed statement.
The award in Carlino came after more than two weeks of trial, with Kline & Specter attorneys Specter and Kila Baldwin, and Rich Freese of Freese & Goss representing Carlino. Ethicon was represented by William Gage of Butler Snow and Laura H. Smith of Friday, Eldredge & Clark.
https://www.law.com/thelegalintelligencer/2019/04/12/pa-appellate-court-affirms-13-5m-pelvic-mesh-verdict/
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J&J Loses Appeal of $13.5M Award in Pelvic Mesh Case
Apr 12, 2019 | Bloomberg Law
By Julie Steinberg
Johnson & Johnson and its Ethicon Inc. unit lost their bid to undo a $13.5 million award, including $10 million in punitive damages, to a New Jersey woman who alleged she was permanently harmed by a pelvic mesh implant.
Sharon Carlino’s suit was properly brought in Pennsylvania, the Pennsylvania Superior Court said. New Jersey companies J&J and Ethicon had enough Pennsylvania contacts, related to Carlino’s claims, to support jurisdiction there, it said.
The court relied on its earlier decision, Hammons...
Access to full text unavailable – subscription required.
Story can be found here: https://news.bloomberglaw.com/product-liability-and-toxics-law/j-j-loses-appeal-of-13-5m-award-in-pelvic-mesh-case
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Washington State AG’s Ethicon Pelvic Mesh Lawsuit Headed To Trial, CVN To Webcast Live
Apr 12, 2019 | CVN News
By David Siegel
The first trial in a lawsuit brought by a state attorney general against Johnson & Johnson’s Ethicon unit over their allegedly defective pelvic mesh implants begins April 22 in Washington State court, and the proceedings will be webcast gavel-to-gavel by Courtroom View Network.
Attorney General Bob Ferguson sued Ethicon in 2016, claiming the company failed to adequately warn patients and doctors about the potential risks and complications associated with transvaginal mesh implants, which include chronic pain, loss of sexual function and persistent infections.
Thousands of women have sued Ethicon and other pelvic mesh manufactures in state and federal court, with dozens of cases going to trial (including many found in CVN’s online video archive), but the pending trial will be the first involving a government entity as a plaintiff as opposed to individuals claiming they suffered specific mesh-related injuries.
Jury verdicts in mesh cases to date consist of a mix of plaintiff and defense outcomes. Ethicon and other mesh manufacturers like Boston Scientific and Endo International maintain their mesh products are safe and offer a less invasive alternative to major surgery to treat conditions like pelvic organ prolapse.
In court filings Washington State prosecutors allege tens of thousands of violations of the state’s consumer-protection laws, which could potentially result in penalties totaling millions of dollars. Ethicon supposedly sold nearly 12,000 mesh implants in Washington State.
The upcoming trial will take place without a jury before King County Superior Court Judge Suzanne R. Parisien. Expected to take at least five weeks to complete, the trial will be closely watched as similar cases are pending in California, Mississippi and Kentucky, and a victory by the Washington AG’s office could motivate AG’s in other states to pursue similar claims.
The case filed by former California Attorney General Kamala Harris is set for trial in July in San Diego. That trial could carry even greater stakes, with the California AG’s office claiming Ethicon sold 42,000 mesh implants in the state between 2008 and 2014.
The Washington State AG’s office is relying on in-house attorneys for the upcoming trial, while Ethicon and J&J are represented by a trio of law firms including attorneys from O’Melveny & Myers LLP’s Washington, DC office, Covington & Burling LLP’s Los Angeles office, and local Washington counsel from Calfo Eakes & Ostrovsky PLLC.
CVN’s coverage will commence at the start of the trial’s opening statements and continue gavel-to-gavel, both live and on demand, for the duration of the proceedings.
The case is captioned State of Washington v. Johnson & Johnson, et al., case number 16-2-12186-1 SEA in King County Superior Court.
https://blog.cvn.com/washington-state-ags-ethicon-pelvic-mesh-lawsuit-headed-to-trial-cvn-to-webcast-live
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Mum calls for vaginal mesh implant ban after pain ruined sex life with husband
Apr 14, 2019 | Mirror.co.uk
By Anita Merritt and Sam Rkaina
A mum is calling for vaginal mesh implants to be banned after surgery ruined her sex life with her husband.
Ceri Baker says she went from being fit and active to suffering constant pain and discomfort following an operation in March 2017.
She was given a 45 minute procedure that promised to ‘change her life forever’, bringing an end to urinary incontinence.
But now the 43-year-old is unable to have sex with her Peter, her husband of 20 years, without it being ‘extremely painful’, Devon Live reports .
The mum-of-three from Dartmoor can't sit comfortably or do any of the physical activities and hobbies she always previously enjoyed with her children either.
Ceri documents her experiences on her YouTube video channel Vaginal Mesh Story Time.
She's hit out at a decision by the National Institute of Health and Care Excellence (NICE) to issue new guidelines paving the way for the implants to be used again after a temporary ban.
“This procedure was sold to me by the NHS as a small, minimally invasive procedure to relieve the stress urinary incontinence which I had developed since having my three children,” Ceri said.
“It was something I did because I was leaking daily and it was annoying and embarrassing, especially when it came to running, carrying shopping and dancing on a night out.
"I was so bad I stopped having fun, but it caused no pain at all and I could in fact lead a perfectly ‘normal’ life, so long as I planned ahead.
“My surgeon said to me ‘this operation changes women’s lives’, and it did, dramatically for the worse.
"I was left in constant pain," she said. "It never went away. The nerve pain was so severe that I needed to take strong nerve blocking medication to function in any normal capacity.
“I was back and forth to my GP and the surgeon, and had steroid injections twice under general anaesthesia.
"It never got any better and I was even considering having a hysterectomy.”
In January the special educational needs coordinator suffered a huge nerve reaction and hasn’t walked for more than 30 minutes or sit comfortably since then.
“It was then I started making the YouTube videos," she said. "I felt I had reached breaking point as I couldn't sit at my desk to work and I felt constantly exhausted, and like I was being gradually poisoned.”
Removing the mesh was the only hope Ceri felt was available to her to achieve ‘any form of normality’, but she had to fund it herself.
The mesh implants are designed to be permanent and during the first weeks after surgery become embedded in the surrounding tissue to provide better pelvic support.
This means surgeons and doctors have to weigh up the risk of damage to nerves and nearby organs, including the bladder and bowel, before agreeing to their removal.
“The NHS waiting time for referral, scans and surgery was looking likely to be over a year away, which is quite frankly a disgrace given the damage they have done to me,” she said.
“I paid for it privately in order to save myself. If I waited a year it is very likely I would have been unable to work or lead anywhere near a normal life.
"I was already struggling to do so and having to spend many days lying on the sofa working from home as I couldn’t sit on a chair for more than 20 minutes comfortably.
“Now, post-removal, I am unable to do anything at all physically and we have had to cancel yet another family holiday.
"I will need three to six months off work to recover and have been told it will be up to two years for full nerve and muscle recovery.
“I am completely exhausted and maintaining good mental health is extremely challenging, especially as I am usually super active physically and mentally.
“My main sadness as a mother is that I am losing precious time with my children again that I can never get back or ever be compensated for.
Ceri, represented by medical negligence specialists Hudgell Solicitors, is currently taking legal action regarding the treatment she received and the impact the vaginal mesh implant has had on her life.
The implants are also currently the subject of an Independent Medicines and Medical Devices Safety Review into their use.
Baroness Cumberlege, who is leading the review, said a number of conditions must be met before the use of vaginal mesh could again be considered safe – conditions she says have not yet been met and will not be for ‘some considerable time'.
NICE said the "limited evidence" meant "the true prevalence of long-term complications following surgery with mesh is unknown".
An official at England's Department of Health and Social Care said: "NICE's new guidelines and patient decision aids on managing urinary incontinence and pelvic organ prolapse will help women make more informed choices about their treatment.
"The use of vaginal mesh was paused to ensure that patients receive a high-quality and consistent service.
"Mesh will still be a treatment for some women who understand the risks and following discussions with their consultant."
https://www.mirror.co.uk/news/uk-news/mum-calls-vaginal-mesh-implant-14311835
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A desire for 'dry knickers' shockingly changed this Devon mum's life beyond recognition
Apr 14, 2019 | Devon Live
By Anita Merritt
A Devon mother-of-three is calling for controversial vaginal mesh implants to be banned after the ‘life changing’ operation she was promised left her at breaking point.
Ceri Baker, 43, of Dartmoor, has gone from being a fit and active woman with a zest for life to being in constant pain and discomfort after having the surgery in March 2017.
She cannot sit comfortably or do any of the physical activities and hobbies she always previously enjoyed with her children, and is unable to have sex with her husband of 20 years, Pete, without it being ‘extremely painful’.
She has bravely shared her story in the hope it will ensure thousands more women do not choose to have the procedure in the wake of a controversial decision by the National Institute of Health and Care Excellence (NICE) to issue new guidelines paving the way for the implants to be used again.
The trauma she has endured has been documented in a YouTube video channel Vaginal Mesh Story Time in which she describes how she was assured by her surgeon that the ‘simple 45 minute procedure’ would ‘change her life forever’, bringing an end to stress urinary incontinence.
It follows a temporary ban of the implants last year that was put in place last year over health concerns.
Ceri, a special educational needs coordinator and a dyslexia specialist, says that by telling her story in the videos in an entertaining, informative and educational way, she hopes it will help inform women when making decisions over which course to take when dealing with complications after childbirth.
“This procedure was sold to me by the NHS as a small, minimally invasive procedure to relieve the stress urinary incontinence which I had developed since having my three children,” Ceri explained.
“It was something I did because I was leaking daily and it was annoying and embarrassing, especially when it came to running, carrying shopping and dancing on a night out. I was so bad I stopped having fun, but it caused no pain at all and I could in fact lead a perfectly ‘normal’ life, so long as I planned ahead.
“My surgeon said to me ‘this operation changes women’s lives’, and it did, dramatically for the worse. I was left in constant pain. It never went away. The nerve pain was so severe that I needed to take strong nerve blocking medication to function in any normal capacity.
“I was back and forth to my GP and the surgeon, and had steroid injections twice under general anaesthesia. It never got any better and I was even considering having a hysterectomy.”
In January Ceri suffered a huge nerve reaction. Since then she hasn’t walked for more than 30 minutes and has not been able to sit comfortably.
She said: “It was then I started making the YouTube videos. I felt I had reached breaking point as I couldn't sit at my desk to work and I felt constantly exhausted, and like I was being gradually poisoned.”
Removal was the only hope Ceri felt was available to her to achieve ‘any form of normality’, but she had to fund it herself.
“The NHS waiting time for referral, scans and surgery was looking likely to be over a year away, which is quite frankly a disgrace given the damage they have done to me,” she said.
“I paid for it privately in order to save myself. If I waited a year it is very likely I would have been unable to work or lead anywhere near a normal life.
"I was already struggling to do so and having to spend many days lying on the sofa working from home as I couldn’t sit on a chair for more than 20 minutes comfortably.
“Now, post-removal, I am unable to do anything at all physically and we have had to cancel yet another family holiday. I will need three to six months off work to recover and have been told it will be up to two years for full nerve and muscle recovery.
“I am completely exhausted and maintaining good mental health is extremely challenging, especially as I am usually super active physically and mentally.
“My main sadness as a mother is that I am losing precious time with my children again that I can never get back or ever be compensated for.
“Since becoming unmanageably unwell with my mesh injury I have joined many support groups online and seen that thousands of women are campaigning from all over the world for their voices to be heard and for vaginal mesh to be banned.
“The current lifting of the ban by the recent NICE guidelines is devastating for all mesh injured women and for future generations of women. They are clearly not hearing the reality of trying to live with mesh injury.
“Although my injury is significant and life-changing, I feel I have got off lightly. Many women are fully housebound and have lost everything.
“I will now recover into the ‘new me’ – whatever that may be. I just don’t know, I am heading into the unknown and hoping that I can rebuild now that the toxic and debilitating mesh is out of me. It would be great to be the person I was years ago, who loved fun and activities like cycling and dancing.
“I also want to demonstrate the wider loss to the whole community when it comes to mesh injury. Sadly, mesh injured women will never be the same. They have lost so very much and their bodies are damaged and altered forever.”
Before her injury, Ceri was an active fundraiser and used her passion, cycling, to help. Over seven years she helped to raise £25,000 for different charities through cycle fundraisers, including for her children's primary schools, for her local swimming pool, and other local charities.
After her surgery Ceri was unable to ride a normal bike for nine months, despite being assured by her surgeon before the procedure she would be back on her saddle in three weeks. She is now raising money for Action for Mesh Injured Patients.
Ceri is currently taking legal action and is being represented by medical negligence specialists Hudgell Solicitors with regards to the treatment she received and the impact the vaginal mesh implant has had on her life, with a key issue being investigated being the level of information provided to her.
She said: “My surgeon told me it would be a simple 45-minute procedure and that I’d be back on my bike within weeks. He said that if there were any minor issues it would be resolved quickly. He never actually told me what the true risks were.
“I only found out what the risks for me were two years later when I saw a letter the surgeon had sent to my GP at the time. It said we had discussed the success rate and reoperation risks together with the risk of pelvic organ damage, chronic pain, dyspareunia (difficult or painful sexual intercourse), mesh erosion and rejection, but that I still wished to proceed. This was simply not true at all.
“If any person, without a life-threatening condition, was offered that selection box of possible outcomes, would they wish to proceed? I wouldn’t. I would not have risked all of that for dry knickers.
“I fear now that with these new guidelines women will think it has been given the all clear, and that surgeons can’t get it wrong. They can. Listen to the women who have been there and are suffering. Don’t take the risk.”
The controversial implants are currently the subject of an Independent Medicines and Medical Devices Safety Review into their use.
Baroness Cumberlege, who is leading the review, said that a number of conditions must be met before the use of vaginal mesh could again be considered safe – conditions she says have not yet been met and will not be for ‘some considerable time.
The mesh implants are designed to be permanent and during the first weeks after surgery become embedded in the surrounding tissue to provide better pelvic support. This means surgeons and doctors have to weigh up the risk of damage to nerves and nearby organs, including the bladder and bowel, before agreeing to their removal.
Under the new guidelines, each patient would receive a "decision aid" - detailing all the latest evidence on available treatments - and mesh implants would be used only after non-surgical options, such as lifestyle changes and pelvic floor training, had failed.
NICE said the "limited evidence" meant "the true prevalence of long-term complications following surgery with mesh is unknown".
An official at England's Department of Health and Social Care said: "NICE's new guidelines and patient decision aids on managing urinary incontinence and pelvic organ prolapse will help women make more informed choices about their treatment.
"The use of vaginal mesh was paused to ensure that patients receive a high-quality and consistent service.
"Mesh will still be a treatment for some women who understand the risks and following discussions with their consultant."
https://www.devonlive.com/news/devon-news/desire-dry-knickers-shockingly-changed-2753089
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H.R. 2164- Fighting for Your Right to Take Defective Medical Devices to Court
Apr 12, 2019 | Mesh Medical Device News Desk
By Jane Akre
H.R. 2164 would restore an Americans right to take a defective medical device maker to trial and receive compensation.
Under current law, if a device is Class III, you have lost that right. This group wants to change that and they could use your help.
A group of women injured by medical devices, including Essure birth control and pelvic mesh, is going to Washington D.C. next month to fight a restriction that prevents Americans from taking their medical device injuries to court.
In all, nine women will be there who have been impacted by medical devices – Essure birth control, Metal-on-metal hips, breast implants, and pelvic mesh.
H.R. 2164 , known as The Medical Device Safety Act (#MDSA) amends the FDA so that your lawsuit for a defective product is not thrown out under what’s known as “federal preemption.”
“In layman’s terms, it restores people right to litigation,” says Angie Firmalino referring to H.R. 2164. She was featured in the film, The Bleeding Edge and is an Essure survivor.
Firmalino and Amanda Rusmisell tried to find a law firm to take their Essure cases but were turned down because Essure was a Class III device which underwent Premarket Approval, supposed to be the most stringent review for safety and efficacy by the FDA.
Amanda says, “Anyone who approaches an attorney with a Class III device, they automatically say “preemption” and will not take that on. We fought for years to take on preemption hurdle. By the time we found one, statutes of limitations had run out. It’s not fair. We knew we were harmed, no one would take it. Now we are fighting a statute of limitations problem.”
Class III Devices
At the present time there are currently 157 medical devices that are premarket approved (PMA) and if you are injured by them, you are prevented from filing a lawsuit to be compensated.
They include Essure birth control device, heart valves, implanted pacemakers, implanted cerebral simulators and an IUD among others.
How Did Federal Preemption Happen?
How did we get to the point where the public lost its right to go to court to seek compensation?
Consider the case of Charles Riegel v. Medtronic.
Riegel had a blocked artery so his doctor implanted a Medtronic catheter and tiny balloon which was supposed to stretch open a blocked artery. Instead it ruptured during Riegel’s heart surgery. Riegel went on life support but survived.
The Medtronic device is a Class III medical device that received the FDA’s premarket approval (PMA) that is supposed to guarantee safety.
In their lawsuit, the Riegels’ argued the device was defective and the company negligent. But eventually the U.S. Supreme Court ruled the FDA’s Medical Device Amendment of 1976 (MDA) prevents state lawsuits that challenge safety or effectiveness. Since the device went through premarket approval from the FDA, and Medtronic had allegedly provided evidence of safety and effectiveness during the so-called rigorous approval process, state law could not require more than what the FDA imposed.
The case has set a precedent for all of the Class III devices that followed.
Device makers favor “Federal Preemption” because it shields them and provides immunity from lawsuits and punitive damages often awarded by state court juries.
Class II Devices
Pelvic and hernia mesh along with more than 90% of medical devices are cleared for marketing in the U.S. through the controversial and fast-tracked 510(k) process. The process requires naming a similar “predicate device” already on the market, pay a few thousand dollars, and exchanging paperwork then wait a few months before being cleared to sell.
Pelvic mesh for incontinence is a Class II device and therefore not subject to federal preemption, however in 2012 pelvic organ prolapse (POP) mesh was reclassified as Class III which would shield manufacturers. Any new Class III meshes to be marketing in the future would also not be subject to litigation.
Pelvic and hernia mesh, metal-on-metal hips, and power morcellators, devices are cleared through 510(k). While clinical trials are not required, an injured plaintiff can file a lawsuit to seek compensation and punitive damages.
The Group
Led by ASHES, Advocating Safety in Health Care – E Sisters, the group will talk to Congress to advocate for – HR 2164 – which will be reintroduced to Congress in May.
The plans are to lobby the House one day (May 15) and the Senate the next (May 16). Melynda Fitt and Tonya David from the mesh community will be there. They could use your help with a GoFundMe (below).
H.R. 2164 amends the Federal Food, Drug, and Cosmetic Act by adding the following:
“NO EFFECT ON LIABILITY UNDER STATE LAW – Nothing in this section shall be construed to modify or otherwise affect any action for damages or the liability of any person under the law of any State.”Six members of the House are co-sponsoring the bill and Senators are needed to introduce a companion bill. Ashes has the links to your representative and a suggested script here.
Amanda Rusmisell at 704-968-5824 rusmisell@att.net is your contact for any questions.
Update on Essure
Angie Firmalino says Essure, was fast-tracked onto the market because there was not another device like it.
“The approval was full of conflicts of interest between regulators and industry. Normally you have a 2 year waiting period to start clinical trials but with Essure it was started in a couple of months. Many lead investigators had stock and investment in the product themselves.”
Angie and Amanda say it was the revelation that Conceptus withheld 33,000 adverse event reports from the FDA that broke open the doors to litigation on the basis of failure to warn.
So far there are more than 29,400 lawsuits filed by Essure victims seeking compensatory and punitive damages against Bayer including 25,000 pending cases in California, and 4,000 between Philadelphia, St. Louis, Illinois, Pittsburgh, and Indianapolis.
With Bayer announcing it would stop selling Essure as of the end of 2018, women were expected to file even more claims which launched a barrage of late night legal ads for Essure clients.
The first Essure trials are scheduled for November of this year.
Future Actions Needed
There is a national grassroots movement growing by patients injured by medical devices to further address what they believe are the failings of the FDA. After federal preemption, ASHES intends to address overhauling the 510(k) clearance process after the thousands of injuries reported from the lax regulation, including about 150,000 pelvic mesh injury lawsuits filed in the U.S.
The adverse event reporting system is broken too, says Amanda, as complication reports go to the manufacturer first and in a fox watching the hen house move. If the device maker deems the injury related to its device, only then does it forward the complaint to the FDA.
https://www.meshmedicaldevicenewsdesk.com/h-r-2164-fighting-for-your-right-to-take-defective-medical-devices-to-court/
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Neurological Injuries: Path More Certain
Apr 12, 2019 | Mesh Medical Device News Desk
By Jane Akre
Neurological Injuries: Path More Certain. Sponsored Content. Dr. Greg Vigna, JD, talks about his continued focus on pelvic mesh injuries with a neurological or nerve injury component.
Since the Vaginal Mesh Multidistrict Litigation in West Virginia closed to new cases in the June 21, 2018 order by Judge Joseph Goodwin, the path to adequate compensation has become more certain for injured women with a neurological diagnosis caused by transvaginal mesh devices.
Greg Vigna, MD, JD, a damages expert, practicing physician, and national pharmaceutical injury attorney, talks about this focus.
Q: How does this help the injured?
“First, the June 21, 2018 order requires the cases of newly injured women to be filed in State Court. When I say newly injured that refers to old implants that become symptomatic and newly implanted slings that cause new injuries. We have two pudendal neuralgia cases filed in State Court since the close of the MDL so we are able to work these cases up like a normal catastrophic personal injury case which they are.”
Q: What do you mean normal personal injury case?
“It allows us to simply look at the device and the medical records to determine if the injuries claimed match up to the defect of the device and determine if we have causation. If there is causation, then simply looking at damages will determine if we go forward. Damages is past financial harm from medical bills, past and future lost wages, and cost of future care medical and non-medical via a life care plan. It involves vocational rehabilitation experts to discuss vocational loss, life care planners, and an economist to prove the economic damages.”
Q: Why is there a perception that these cases are difficult?
“The Discovery provided by the leadership of the Plaintiff Steering Committee was more than adequate for General Causation and the internal documents that lead to punitive damages have been discovered by the exhausting work provided by the leadership. All the Daubert issues have been settled. My team have been and are developing our own experts for specific causation for the neurological diagnoses.”
Q: So, these cases are not difficult?
“When I say not difficult, I believe the science as it relates to why these devices are defective match up with the severe neurological injuries. They are expensive cases to take forward and requires experienced pharmaceutical plaintiff injury attorneys. The attorneys on my team have been in court for decades against pharmaceutical companies in the vaginal mesh litigation, other national litigations including IVC Filters, Big Tobacco, and Mesothelioma cases.”
Q: What is the risk of going forward with a lawsuit?
“In every case there is the risk of a loss despite a perfectly litigated case. Severely injured women will have to weigh the risk of proceeding past the certainty of the Matrix Settlements and uncertainty of individual litigation. My experienced litigation team will discuss and evaluate this risk with each potential client.”
Q: Why has your focus been on neurological injures?
“I believe the neurological diagnoses are the most injured. The lives of women with pudendal neuralgia, obturator neuralgia, and Complex Regional Pain Syndrome have been destroyed. These women must receive the compensation they deserve so they can rebuild their lives. They are often divorced, homeless, and require assistance for basic activities of daily living by their families. Others are struggling with severe pain every day while they go to work just to get by financially.”
Q: So, your focus is only neurological injures?
“No, I look at all injuries but understand the cases I accept to go forward in the Wave Discovery Process required by the MDL or new injury cases are those who are disabled or nearly disabled to a certain degree and have a measurable impact on their lives.”
https://www.meshmedicaldevicenewsdesk.com/neurological-injuries-path-more-certain/
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Spalding publican: 'Mesh operation? Don't do it'
Apr 14, 2019 | Spalding Today
By Lynne Harrison
Spalding pub couple Pete and Steph Williams are considering hitting the campaign trail once more to warn people about the health risks from surgical mesh.
The Punchbowl publicans became ardent supporters of campaign group Sling the Mesh after Steph had a surgical mesh implant that left her in agony for more than a year.
They say newly published guidelines from NICE (National Institute for Health Care Excellence) open the door for more mesh injuries.
The All Party Parliamentary Group on Surgical Mesh Implants says the NICE guidelines on treatment for urinary stress incontinence and pelvic prolapse in women “do not go far enough in acknowledging the terrible problems many women have faced following mesh surgery”.
Steph is relatively lucky as she had her mesh implant removed last summer.
But Pete says: “A lot of the pain is still there because of the nerve damage that was done.
“At the age of 62 it is just debilitating - it just controls your life, what you can and you can’t do, all of the time.”
Pete has a simple piece of advice for anyone considering a mesh implant.
“I would tell them not to do it,” said Pete. “Just absolutely not to do it.”
He says there are 7,000 members of the Sling the Mesh Facebook group and says anyone considering an op should look at the injury stories there.
Sling the Mesh founder Kath Sansom says the NICE guidelines “clear the way for the next generation of women to be harmed”.
She said: “Our Sling the Mesh survey shows one in 20 women have attempted suicide and more than half have regular suicidal thoughts because of chronic pain, loss of sex life, constant infections and auto immune disease.”
The Williams have previously visited London with fellow Sling the Mesh campaigners in a bid to have mesh operations stopped.
https://www.spaldingtoday.co.uk/news/spalding-punchbowl-pub-couple-to-hit-campaign-trail-on-mesh-9067077/
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