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Ethicon 2/22
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Johnson & Johnson loses another pelvic mesh suit
Feb 19, 2016 | Mass Device
By Brad Perriello
A federal jury in Georgia deliberated for 3 hours yesterday before delivering another loss to Johnson & Johnson (NYSE:JNJ) in a product liability lawsuit brought over pelvic mesh products. -
Pelvic Mesh and Risperdal Trials Show Punitive Damages Impact
Feb 22, 2016 | The Legal Intelligencer
By Max Mitchell
...He asked the jurors to look beyond his client's injuries and consider all the potential harm the device may have caused others, before he asked the jury to send a message to the defendant, Johnson & Johnson subsidiary Ethicon. -
Scotland’s Daily Record Reports on Reckless Charges by US Attorney to US Mesh Makers
Feb 22, 2016 | Mesh Medical Device News Desk
By Jane Akre
...Scott points out that this was the first trial for the TVT made by Ethicon, a division of Johnson & Johnson. The TVT (transvaginal tape) is one of the most used in Scotland and Scott writes these plaintiff positive outcomes may be giving hope to the hundreds of women in Scotland who have filed similar actions against mesh makers in that country. -
Scotland curbs use of transvaginal mesh amid global outcry
Feb 19, 2016 | Mass Device
By Arezu Sarvestani
Scottish health regulators are looking to curb use of transvaginal mesh products while independent investigators look into claims that the medical implants hurt women. -
Still Standing on Medical Management of Mesh Complications
Feb 22, 2016 | Mesh Medical Device News Desk
By Jane Akre
Still Standing was implanted with pelvic mesh years ago and has undergone eight major surgeries, five of them explant surgeries. She speaks highly of her present doctor, Dr. Charles Butrick, (here) a urogynecologist from Overland Park, Kansas. She says the ongoing care she’s received from him, both the explant and treating mesh-related pain, has given her good outcomes that continue to improve.
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Johnson & Johnson loses another pelvic mesh suit
Feb 19, 2016 | Mass Device
By Brad Perriello
A federal jury in Georgia deliberated for 3 hours yesterday before delivering another loss to Johnson & Johnson (NYSE:JNJ) in a product liability lawsuit brought over pelvic mesh products.
The jury in the U.S. District Court for Middle Georgia awarded plaintiff Teresa Taylor $400,000 in compensatory damages and $4 million in punitive damages after finding that the Mentor ObTape transobdturator vaginal sling she had implanted in March 2014 caused her injuries.
The ObTape device was implantd to treat Taylor’s stress urinary incontinence, according to court documents. Taylor alleged that the device eroded, causing “chronic infections, pain, exacerbation of her urinary incontinence, and the need for multiple additional surgical procedures and medical treatment as well as the need for extensive future medical care,” according to the documents.
Johnson & Johnson, which last month agreed to settle some 100 pelvic mesh cases brought against its Mentor subsidiary, lost a pair of similar lawsuits against its Ethicon unit in recent months. Earlier in February a Philadelphia jury docked the company $13.5 million in a suit filed over its Ethicon transvaginal polypropylene tape.
In December 2015, a jury in the same court added $7 million in punitive damages to the $5.5 million in compensatory damages it leveled against Ethicon in the 1st cases from a mass tort to go to trial in Philly.
Back in June 2010 Mentor agreed to settle another group of lawsuits filed against it over an allegedly defective device designed to treat female urinary incontinence.
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Pelvic Mesh and Risperdal Trials Show Punitive Damages Impact
Feb 22, 2016 | The Legal Intelligencer
By Max Mitchell
During closing arguments in the latest pelvic mesh trial in Philadelphia, plaintiffs attorney Shanin Specter called the conduct of the defendant company heads "beyond reckless," saying it made him want to throw his lectern out the courtroom window.
He asked the jurors to look beyond his client's injuries and consider all the potential harm the device may have caused others, before he asked the jury to send a message to the defendant, Johnson & Johnson subsidiary Ethicon.
"I could feel the hair standing up on my neck," Specter recently said about going over the evidence during his closing in Carlino v. Ethicon.
That jury came back with a $13.5 million verdict, including $10 million in punitive damages.
Roughly two months before that verdict, when Thomas R. Kline, who, along with Specter, heads Kline & Specter, had made his closing argument in the same courtroom before the same judge in the latest Risperdal-related trial, he similarly assailed a Johnson & Johnson subsidiary, Janssen, over its conduct.
But Kline was prohibited from asking the jury to consider other potential victims, or to send the company a message, because the judge supervising the Risperdal mass tort previously barred the plaintiffs from seeking punitive damages in those cases.
"I was only allowed to ask for compensation," Kline said.
The jury in that case, Stange v. Janssen, returned a $500,000 plaintiffs award. According to attorneys, the punitive damages issue in the two mass tort programs is one of the key factors that have led the pelvic mesh litigation to two large plaintiffs' victories, while the Risperdal litigation has resulted in more of a mixed bag for plaintiffs.
"An early ruling that takes punitive damages out of the case is a very large step for the court and the litigants, because it removes a significant risk for the defendant, especially in the face of conduct which is egregious," Kline said.
Both pelvic mesh cases have resulted in more than eight-figure awards. While the Carlino case resulted in $13.5 million, the first case, Hammons v. Ethicon, ended with a $12.5 million verdict, including $5.5 million in compensatory damages and $7 million in punitives.
Before the $500,000 award in Stange, the Risperdal cases resulted in a $2.5 million and a $1.75 million award, as well as a settlement. A jury also handed up a defense verdict in the second Risperdal case to go to trial, although it found Janssen negligent in failing to warn about the potential risks of Risperdal.
Cozen O'Connor attorney James H. Heller said a ruling on the availability of punitive damages changes the standard for introducing prior-incidents evidence. Although it's not supposed to, Heller said, this can potentially lead juries to increase awards when considering liability and compensatory damages.
"The thought and fear is that the jury will instead use it to decide liability," Heller said. "Pain and suffering is subjective, and so being that it's so subjective, the jury has got a lot of leeway. If they get angry for lack of evidence on the defense side, or the amount of evidence of misconduct on the other side, the way they can show it is to use that subjectivity to increase the amount of the verdict."
He said the significant split between the $3.5 million in compensatory damages and the $10 million in punitives in the Carlino case indicates that the jury got mad at Ethicon.
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Scotland’s Daily Record Reports on Reckless Charges by US Attorney to US Mesh Makers
Feb 22, 2016 | Mesh Medical Device News Desk
By Jane Akre
While it is across the ocean the Daily Record and Sunday Mail (here) and Scottish reporter Marion Scott continues to follow the mesh controversy in the U.S. – more closely than any mainstream US media. This Sunday, Scott follows the Carlino trial that just concluded in Philadelphia witha $13.5 million jury verdict for Sharon Carlino.
Scott points out that this was the first trial for the TVT made by Ethicon, a division of Johnson & Johnson. The TVT (transvaginal tape) is one of the most used in Scotland and Scott writes these plaintiff positive outcomes may be giving hope to the hundreds of women in Scotland who have filed similar actions against mesh makers in that country.
Carlino’s attorney Shanin Specter told jurors in Philadelphia that Ethicon had been “beyond reckless.” Adam Slater, said: “This trial shows that these damages are meaningful to jurors. The manufacturers have completely failed to convince the jury that the injuries caused by this mesh are mild or acceptable.”
Ethicon faces at least 42,400 product liability cases around the world for its family of pelvic meshes used in women to treat prolapse and incontinence.
It was the work of Scottish Mesh Survivors’ Hear Our Voice campaign that spoke directly to Parliament and prompted a safety review of pelvic meshes. Last October, the country’s health secretary said three of four mesh devices will no longer be routinely used in hospitals.
The TVT will only be used as a last resort after a multi-disciplinary consultation.
Marion Scott was awarded as Reporter of the Year in 2015 in her country for her unrelenting front page stories of mesh injured women who took their awareness campaign to the Parliamentary committee.
In Scotland, lawyer Cameron Fyfe represents nearly 400 women in civil actions against mesh makers. Scott reports it is the biggest civil court action Scotland has ever seen.
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Scotland curbs use of transvaginal mesh amid global outcry
Feb 19, 2016 | Mass Device
By Arezu Sarvestani
Scottish health regulators are looking to curb use of transvaginal mesh products while independent investigators look into claims that the medical implants hurt women.
The devices have come under increased scrutiny worldwide amid a campaign from patients and advocacy groups who warn that the devices do more harm than good. Hundreds of mesh-related lawsuits are already underway in Scotland as well as in the U.S. and Canada. The European Commission is also conducting its own investigation into the implants.
Scottish Health Secretary Alex Neil asked the country’s 14 regional health boards to suspend use of the mesh while he arranges for an independent review into the growing global outcry against the devices. Some of the boards have already phased out the procedure and others said they would comply with the Neil’s request, the BBC reported.
Scottish regulators plan to present the U.K.’s Medicines & Healthcare products Regulatory Agency with a cadre of cases and let the agency make the final call. MHRA has defended transvaginal mesh products as an important option for women with conditions such as pelvic organ prolapse, although regulators have ceded that some women have been injured by the implants.
Neil told reporters that the outcome of the European Commission report and Scotland’s own independent report would inform next steps in dealing with the devices. For the time being, he’s asked local healthcare providers to refrain from using both transvaginal mesh implants and tension free vaginal tape.
In the U.S., FDA regulators have considered increasing the risk profile for mesh devices as mesh-makers such as Johnson & Johnson (NYSE:JNJ), C.R. Bard (NYSE:BCR), Boston Scientific (NYSE:BSX) and American Medical Systems Holdings have come under fire from patients.
The FDA in 2011 issued safety communications about complications associated with the implants, saying that they may expose patients to unnecessary risk without offering clinical benefit above safer options. The agency’s Obstetrics and Gynecology Devices Panel recommended even then that the devices get high-risk treatment from reviewers. Lawsuits began piling upright away.
In January 2012 the FDA ordered mesh manufacturers to conduct postmarket surveillance studies, and in April 2014 the FDA in April issued a pair of proposals to increase regulatory oversight of the implants, a move that would bump surgical mesh from class II up to class III devices that require premarket approval from the FDA.
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Still Standing on Medical Management of Mesh Complications
Feb 22, 2016 | Mesh Medical Device News Desk
By Jane Akre
Still Standing was implanted with pelvic mesh years ago and has undergone eight major surgeries, five of them explant surgeries. She speaks highly of her present doctor, Dr. Charles Butrick, (here) a urogynecologist from Overland Park, Kansas. She says the ongoing care she’s received from him, both the explant and treating mesh-related pain, has given her good outcomes that continue to improve.
Professionally, Still Standing worked in hospice care for years and decided, during the worst days of her mesh pain, to go back to school and get a master’s degree in psychology with a focus on pain management.
“I had to do something that gives me a purpose rather than focusing on this. My first class was on my 60thbirthday,” she tells Mesh News Desk.
After her studies, she was certified in Neurobehavioral Pain Management and is a certified mindfulness instructor. Neobehavior Pain Management is based on the powerful mind/body connection.
Early on she told her professors she wanted to work with women suffering from chronic pelvic pain. There will not be enough of a market for that, they warned, but during a recent workshop on chronic pelvic pain, there was overflow crowd.
“We were full. We couldn’t have gotten another person in there. Next time it will have to be two days. Women stayed and connected. They become lifelines for each other. Relationships blossomed.”
Some are so desperate, they discount what they can do for themselves. I couldn’t think for three years, I lost it all. I was in so much pain. It’s so deep and so personal. The first thing I thought about in the morning was my vagina and the last thing and all day. I couldn’t go to parties, to lunch, you tend to self-isolate. Friends look at you like you are crazy, not because they don’t believe you but because they can’t imagine it.”
When the money comes you are not any better off, so you have to start now! Do things for yourself now and if they help great, if not you haven’t lost anything.”
Besides mindfulness, Still Standing talks about lifestyle and diet changes to less acidic food to help conquer pelvic pain in an upcoming chapter. After visiting with an integrative medicine doctor as well as Dr. Butrick, she would like to share what she’s learned about the medical management of pelvic pain.
CHRONIC PAIN AND MEDICAL MANAGEMENT
Chronic urinary tract infections (UTIs) are a constant complaint of women implanted with polypropylene mesh in the pelvic region. Some suggestions for the medication management of UTIs might include:
Antibiotics – These must be by prescription. Still Standing says she began having UTIs after her first mesh revision. They would clear up with antibiotics but then return. “Finally I went on long-term antibiotics for seven months, but when you do that you have to add all other things, such as probiotics to replenish the good bacteria. Really, you have to find out what is irritating your bladder. Avoiding acidic foods will help.
“I would do it half assed after all what’s more comforting than high fat foods, and coke and chocolate, that’s what gives you comfort. I found it difficult to do that. When Dr. Butrick explained to me how the bladder wall, irritated with acidic foods, it will cause a lot of UTI’s. It’s just like a scrape or irritation to the bladder lining. You have to give it a break to get it to heal.”
“So finally last year I said, okay. I really started eating less acidic food – no citrus at all, no soy, anything acidic or carbonated. You can buy a less acidic coffee at World Market, because coffee is normally very acidic. Antibiotics are not going to do anything if you keep eating foods that will inflame your bladder. It’s not forever, it’s just for a little bit. I still suffer if I eat the wrong things. That’s why this doctor integrative medicine doctors has helped me a lot.” ~ Still Standing
Probiotic– If you are taking an antibiotic a probiotic is needed to counter the effect of killing bacteria in your guy. FlorAstor is one, Plexus is another.
Azo Tablets and Azo Blue – This UTI pain reliever is a homeopathic over-the-counter medicine for bladder health. The Blue version is a bit stronger. It calms the symptoms of a UTI, according to Still Standing. Source them here.
Hyophen – This prescription medication is used to relieve the urge to urinate and cramps of the urinary track system caused by an infection or surgery. Downside- cost is about $400 a prescription which may be covered by your insurance or may be too costly for many. Another potential downside – if you are on an SSRI (serotonin syndrome reuptake inhibitor) do not take Hyophen because it can enhance the effect of the SSRI and you’re your depression symptoms worse by flooding the brain with too much serotonin. Read more at Web MD (here).
Estrogen cream – This is a prescription medication. Dr. Butrick uses it to keep the urethra plumper. If it is dry, bacteria has a much easier way to travel from the rectal to vaginal area. Still Standing says she’s always been on estrogen cream because the vaginal wall thins out and has much more opportunity to erode. Estrace or Premarin are common brands. Do not use soy products, however yam-based products may work.
Cranberry tablets – If you have a UTI cranberry juice irritates the bladder so cranberry tablets are best. Azo offers one and they are found over-the-counter in stores such as Target.
Natural Calm Plus Calcium– This is a balanced Magnesium-Calcium drink. Magnesium is necessary for your muscles to relax and women with pelvic pain have tight muscles from the pain. It helps muscles relax and reduces constipation as well as helps you sleep. Still Standing says many people are deficient in Magnesium. “It changed a lot of things for me and I don’t ever get constipated.” Vitacost has it here.Prelief – Taken to reduce the acid in foods. Available in most drug stores.
http://www.prelief.com/Mesh News Desk plans on forming affiliate relationships with suppliers of helpful medications for the mesh injured. Please sign up for the newsletter to stay up to date on this important new chapter and to receive coupons. Thank you!
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