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Ethicon Media Monitoring 01/02/2018
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Mesh News Highlights for 2017 Revisited!
Dec 30, 2017 | Mesh Medical Device Newsdesk
So much so that we sometimes forget what has transpired in the last twelve months in the world of mesh injuries. -
Dr Richard Reid in tribunal after NSW Health Care Complaints Commission investigation
Dec 30, 2017 | Newcastle Herald
By Joanne McCarthy
FORMER University of Newcastle associate professor Richard Reid sent a pelvic mesh surgery patient home with instructions she “self-catheterise for the rest of her life”, a tribunal considering complaints from 18 women has heard.
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Mesh News Highlights for 2017 Revisited!
Dec 30, 2017 | Mesh Medical Device Newsdesk
Mesh Medical Device News Desk, December 30, 2017 ~ It’s hard to imagine 2017 has passed so quickly, but it has.
So much so that we sometimes forget what has transpired in the last twelve months in the world of mesh injuries.
A review of the mesh news of 2017 reveals there have been many changes, often sparked by the participating of injured citizens who want to prevent harm to others.
Congratulations to all of those individuals who put compassion for others in the forefront!!!!
Here are some of the major changes that have occurred in 2017 concerning the mesh mess. Thank you all for your continued readership of Mesh Medical Device News Desk.
In December 2017 – The Hrymoc Trial in New Jersey wrapped up. It was the first in four years since the first mesh trial in New Jersey of Linda Gross in 2013. This one concerned two J&J products – Prolift and TVT-O – and a jury, after listening to two-weeks of testimony, decided to compensate the New Jersey woman $15 million which includes $10 million in punitive damages to punish Johnson & Johnson. Read the MND coverage here.
Also on the litigation front, in October, the $27 million award to four women implanted with Boston Scientific mesh was upheld after being challenged by the company. Read MND coverage here.
And the largest award so far, $57 million was awarded to mesh-injured Ella Ebaugh in a Philadelphia court. She was implanted with a J&J TVT-Secur. Her jury award includes $50 million in punitive damages. She was represented by Kline Specter of Philadelphia. Read MND coverage here.
Keeping an eye on the Trial Tallies so far, hundreds of millions of dollars are spend by mesh makers on trying these cases, appealing the verdicts and then having the plaintiff finally survive the appeals process, not to mention the very costly trial attorneys they employ. MND coverage here.
New Zealand says No to Pelvic Mesh. In December, New Zealand decided to restrict the use of all transvaginal mesh. Unlike the U.S. where the POP meshes have been reclassified to high risk, New Zealand will restrict the use of all transvaginal mesh implants, both SUI and POP (here) .
Essentially the same thing will be accomplished in Australia (here) where all pelvic mesh devices will be reclassified from moderate to high risk over the next 24 months.
December 2017 – After publicly campaigning in social media about the dangers of transvaginal mesh, campaigner Christine Lynn Brajcic lost her life after being repeated hospitalized for infections.
The cause of death has yet to be officially determined, but at age 42, and in good health prior to her implant with a J&J TVT Exact four years ago, ironically, her death may provide the research needed to definitively connect sepsis to her polypropylene implant, as many others suffer the same fate following a pelvic mesh implant. Read MND coverage here.
A Canadian pathologist (here), Dr. Vladimir Iakovlev, is advising the Windsor, Ontario coroner on what tissue samples will be needed to determine the accurate cause of death.
November 2017– Counterfeit mesh from China, No Problem, says FDA. The FDA found no problem with the allegedly counterfeit mesh brought in from China to make Boston Scientific mesh implants, even though the origin is unknown as is the composition.
The FDA allowed Boston Scientific to investigate its own products after a RICO lawsuit against it charged the company with illegally smuggling low quality polypropylene resin in from a known smuggler in China.
Jo Huskey Survives Appeal. Jo Huskey survived the final appeal by J&J in October (here) allowing her $3.27 million compensation to stand. She was implanted with a TVT-O and her trial was conducted in Charleston, WV in 2014. The litigation concluded that her pelvic mesh was defective.
In October 2017, Autoimmune Registry – Mesh News Desk helped gather participants for the UCLA autoimmune registry (here). Researchers there will try to determine why there appears to be an extraordinary number of autoimmune reactions to a polypropylene mesh implant. The effort was started by Hope Pagano, a woman who developed Lupus after her mesh implant. See her story here.
Internationally, Scotland called for an International Summit on the Mesh Crisis, (here) thanks in part to vocal and organized campaigners and reporter Marion Scott, who was allowed to follow the issue aggressively and accurately.
British Parliament faced off with Sling the MeshCampaigners in October, bringing to the front pages the mesh crisis. The group promises to keep up the public pressure on public officials. See coverage here.
Settle or be Dropped Lawyers are increasingly telling their clients that they must agree to settlement dollars. Some even go so far as to threaten that their case will be dropped if they do not accept the amount, which in many cases, are far short of any realistic compensation for medical bills, loss of job, pain and suffering, and to “make whole” the person before her injury.
Some firms are worse than others and according to legal experts, may be in violation of their ethical obligations. See Mesh News Desk’s August coverage here.
In a related August story on Multidistrict Litigation – Is it working? Mesh News Desk (here) got a variety of opinions on whether the MDL has served clients well. Start here with Part One of this two-part story.
For many law firms- transvaginal mesh became a numbers game, amassing huge numbers of cases with the intention of churning them through the system. (here)
Incentivized with Lamborghinis, some of the documents being released in the Sydney Australia trial of 700 women against Johnson & Johnson includes documents that say “Surgery is the Cha-ching thing” (here) and uses luxury automobiles to entice surgeons to use the company’s mesh products. That trial continues today and is the largest class action so far in terms of the number of plaintiffs being heard at one time.
What does the U.S. Supreme Court have to do with mesh litigation? Simply look at the Bristol Myers Squibb decision. In June, the U.S. Supreme Court dealt a blow to injured consumers seeking redress in a court of their choosing, with Judge Sonya Sotomayor the only dissenting vote.
The decision led to cases thrown out of a Missouri court where talcum powder/ovarian cancer cases are being heard and Boston Scientific and Johnson & Johnson attempted to have nearly 100 pelvic mesh cases thrown out of the Philadelphia Court of Common Pleas, citing Bristol Myers Squibb. See MND coverage here.
April 2017 – Campaigners gathers in New Brunswick, New Jersey for the annual J&J Shareholders meeting. One woman inside spoke to Alex Gorsky and the Board of Directors about her pain from a DePuy Hip implant. While cameras on the second story of the State Theater focused on the injured crowd outside, inside, investors heard stories of how the company focuses on “Sustainability” and “Putting Patients First.” MND was there, read it here.
June 2017– CR Bard Appears to Remove Pelvic Mesh Products from the Market, In June, C.R. Bard was sold to Becton Dickinson for $24 billion. After that Bard appears to have cleared its pelvic meshes from inventory.
January 2017 – Caldera Medical appears to have settled its transvaginal mesh cases with the smaller amount given to the injured among all of the manufacturers. This privately held company has announced plans to sell its pelvic meshes to third world countries. MND coverage here.
In January, Danish researchers (here) concluded that TOT Mesh has twice the risk of reoperation of transvaginal tape. TVT-O has already been found defectively designed in several product liability trials.
Media Coverage has been huge during 2017, more so than ever before. While a documentary in the U.S. is underway, The Netherlands aired an expose on J&J in its Radar Program, (here) concluding the healthcare giant knew the risks of Prolift before it was launched in 2015.
The BBC in September talked to men in pain from hernia mesh (here) and in December, BBC’s Panorama magazine ran The Operation that Ruined my Life, (here) a half-hour devoted to EU mesh issues.
https://www.meshmedicaldevicenewsdesk.com/mesh-news-highlights-2017-revisited/
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Dr Richard Reid in tribunal after NSW Health Care Complaints Commission investigation
Dec 30, 2017 | Newcastle Herald
By Joanne McCarthy
FORMER University of Newcastle associate professor Richard Reid sent a pelvic mesh surgery patient home with instructions she “self-catheterise for the rest of her life”, a tribunal considering complaints from 18 women has heard.
Dr Reid wrote the letter to the woman’s general practitioner in November, 2013, saying it was “absolutely mandatory” the woman commit to a “regimen” of self-catheterisation morning and night.
In evidence to the NSW Civil and Administrative Tribunal in December Dr Reid acknowledged that “nobody wanted to self-catheterise”, but the woman was “at least in a situation where her bladder was working well enough during the day”.
The woman is one of two of Dr Reid’s pelvic mesh patients who complained to the NSW Health Care Complaints Commission from March, 2014 after instructions for long-term self-catheterising following repeated pelvic mesh surgical procedures to treat prolapse and incontinence.
The tribunal heard Dr Reid, an obstetrician/gynaecologist suspended in America in the 1990s after complaints from a number of women leading to civil settlements of up to $7.6 million, was suspended by a Sydney private hospital in April, 2013 after one of his pelvic mesh surgery patients was rushed to Royal Prince Alfred Hospital with severe haemorrhaging.
“It was a rare, freak occurrence but it could have had horrible consequences,” Dr Reid told the tribunal.
The “dramatic” incident led him to train on the “minimally invasive” Australian-invented Tissue Fixation System (TFS) pelvic mesh device in May, 2013, and complete the first TFS mesh surgeries at Sydney Private Hospital from June 11, 2013, Dr Reid told the tribunal.
He described the first TFS surgery, performed by Dr Reid with support from TFS inventor Dr Peter Petros and TFS trainer Max Haverfield, as “kind of a bit celebratory” and a “big advance” for himself and the hospital.
But the tribunal heard some of his first TFS patients complained of severe and intractable complications including disabling and chronic pain. By November, 2013 Dr Reid defended TFS mesh to one patient’s general practitioner as “not in any way experimental”.
By March, 2014 the HCCC had the first of 18 complaints from women implanted with TFS and other mesh by Dr Reid. By November, 2014 TFS was one of the first pelvic mesh devices in the world to be cancelled because of poor evidence backing its safe use.
Dr Reid agreed that a brochure on TFS given to women in 2013 and 2014, where he was described as professor and associate professor despite losing the right to use the titles by early 2012, was “enthusiastic” in its support for TFS mesh and he would “write it differently” today.
“I used TFS with great optimism but unfortunately we did get some pain syndromes,” Dr Reid said.
He relied on the registration of TFS by Australia’s medical device regulator, the Therapeutic Goods Administration, and told the tribunal he believed the regulator would have evidence before registering devices.
He rejected an allegation by one of his first TFS patients that he required her to undertake “unusual, invasive, personal” examinations after she experienced severe chronic pain following surgery which left the mesh tape close to the major pudendal nerve.
“She had a disabling pain syndrome. Sometimes to get to the muscle it could be done better by putting people in different positions,” Dr Reid said.
The HCCC alleges Dr Reid did not disclose to the NSW Medical Council that he had been suspended from the Sydney private hospital in 2013.
The tribunal heard Dr Reid wrote to the Medical Council saying he did not operate for more than a month because he required a course of physiotherapy following a mishap with a steak knife.
The physiotherapist named by Dr Reid advised the tribunal she was unwilling to give evidence unless compelled and “I did not treat Dr Reid in any medical capacity”.
A barrister for Dr Reid told the tribunal that “Richard Reid accepts he did not undergo a one-month course” of treatment with the physiotherapist.
The hearing resumes in April for final submissions.
http://www.theherald.com.au/story/5143480/woman-told-to-self-catheterise-for-life-after-pelvic-mesh-surgery/
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