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Ethicon Media Monitoring 4/22/2019
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J&J Win Shows Potential Limit To Mesh Injury Claims
Apr 19, 2019 | Law 360
By Matt Fair
After multiple damages awards against a Johnson & Johnson unit over allegedly defective pelvic mesh implants, a recent verdict clearing the company of claims over a Philadelphia-area woman’s worsening incontinence and pain during sex may mark the outer bounds... -
F.D.A. Halts U.S. Sales Of Pelvic Mesh, Citing Safety Concerns For Women
Apr 20, 2019 | Moms.com
By Joanna Mazewski
The U.S. Food and Drug Administration has halted the sale of all pelvic mesh products across the United States. Pelvic mesh is often used for urogynecology procedures, which includes the repair of the pelvic organ prolapse and stress urinary incontinence. -
Mother-of-three bravely shares horrific effects of vaginal mesh surgery after it left her in enormous pain
Apr 19, 2019 | Gloucestershire Live
By Anita Merritt and Jessica Mercer
A mother of three in Britain has spoken out about a controversial vaginal mesh implant after the "life-changing" procedure left her in enormous pain. -
Sales of pelvic surgical mesh for women could be stopped in India after US ban
Apr 20, 2019 | The Print
By Himani Chandna
The Modi government is considering stopping the sale of pelvic surgical mesh meant for women after the US health regulator, the Food and Drug Administration (FDA), banned it Tuesday. -
Bernstein Liebhard Still Seeking $13 Million in Fire Insurance Suit
Apr 19, 2019 | New York Law Journal
By Jack Newsham
Bernstein Liebhard, the plaintiffs firm that sued its insurer for more than $21 million in 2015 after a fire devastated its mass torts practice, is arguing that an adverse appellate court decision wasn’t as bad as it seemed. -
The grim stories behind seven of medtech’s worst failures
Apr 22, 2019 | Medical Design & Outsourcing
By Danielle Kirsh
Medical devices save or restore thousands of patient lives every year, but the dark side to medtech innovation is increasingly drawing attention.
Client Attorney Privileged/Attorney Work Product/At Request of Counsel
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J&J Win Shows Potential Limit To Mesh Injury Claims
Apr 19, 2019 | Law 360
By Matt Fair
After multiple damages awards against a Johnson & Johnson unit over allegedly defective pelvic mesh implants, a recent verdict clearing the company of claims over a Philadelphia-area woman’s worsening incontinence and pain during sex may mark the outer bounds of injuries juries are willing to attribute to the products.
While prior Philadelphia mesh trials that have resulted in six- and seven-figure damages awards involved claims that the devices had actually sawed through tissue around the implantation area and become exposed in the vagina, legal experts say that cases with less severe injuries, like the one that ended in a defense verdict on Wednesday, may prove more difficult for plaintiffs to win.
“It’s a signal to the plaintiffs that not every case is going to be a winner,” said Alan Klein, an attorney with Duane Morris LLP in Philadelphia. “This may be an important moment for plaintiffs to go back and look at their portfolio of cases and weed out the ones that are not as likely to be successful.”
J&J subsidiary Ethicon Inc. has faced nearly $145 million worth of damages in six mesh-related trials in Philadelphia since cases over the purportedly faulty devices started going to trial at the end of 2015.
The cases are part of a mass tort program in the Philadelphia County Court of Common Pleas that currently includes about 90 cases being teed up for trial.
In each of the prior cases, women have alleged that the devices, which are designed to hold pelvic organs in place to alleviate stress urinary incontinence, ended up eroding through the tissue around the implantation area and becoming exposed in the vagina.
In prior cases, the injuries have resulted in women receiving follow-up surgeries to have exposed portions of the mesh removed.
But in the case that ended with a defense verdict on Wednesday, plaintiff Malgorzata Krolikowski alleged only that her mesh — a so-called TVT-Secur implant — ended up worsening the incontinence it was designed to treat and that she began to experience pain during sex after receiving the implant a little more than a decade ago.
There was no erosion of the mesh in Krolikowski’s case and no follow-up surgeries to remove portions of the device.
Krolikowski’s attorneys focused the bulk of their opening and closing arguments on what they said was Ethicon’s failure to properly test the device before it went to market in September 2006.
In particular, they argued that the product had been tested on a mere 31 women over a period of five weeks, and that the trial had produced troubling results — a 30% failure rate and a 60% rate of complications — that went ignored by the company before launch.
But Ethicon countered that the mesh that was used in the TVT-Secur was the same as had been used in prior iterations of the implant that had undergone more thorough testing, even as the company has also faced lawsuits over injuries related to other versions of the implant.
The company also argued that the failure of the product to cure Krolikowski’s incontinence did not mean it was defective, and that there were other explanations — namely a history of uterine fibroids and the abnormal position of her uterus — to account for the pain she experienced during sex.
Ultimately, the jury agreed that the product had been negligently designed, marketed and sold, but that the negligence was not a factor in Krolikowski’s injuries.
Colin Burke, an attorney with Kline & Specter PC representing Krolikowski, told Law360 after the verdict came in that he believed the lack of erosion was a major weakness in their case.
“I think the fact that she didn’t have an erosion was probably a determinative factor for the jury, because, from the jury’s perspective, having that actual mesh erosion into the vagina is a real tangible injury,” he said.
And observers of the mesh litigation agreed.
“The fact that the jury didn’t have to hear about a graphic removal surgery or that the product had actually worn through the patient’s tissue likely made it a lot easier to appreciate the alternative causes of the symptoms and to recognize that nobody is guaranteed a perfect outcome,” said Peter Goss, an attorney with Blackwell Burke PA.
Indeed, cases where Ethicon has faced significant dollar-value verdicts have featured women who were forced to undergo subsequent surgeries to remedy mesh erosions.
Jurors returned a $57.1 million verdict — the largest mesh verdict in Philadelphia so far — in September 2017 for a woman whose attorney said had been cut open from “hip to hip” in an effort to remove portions of two mesh implants she received.
The second-largest mesh verdict to come out of the city — a $41 million verdict in January — was in favor of a woman who was forced to undergo nine surgeries and almost a dozen chemical cauterizations to address mesh erosions she experienced after receiving an Ethicon implant.
“Obviously these women incurred tremendous pain and suffering and anxiety, and that doesn’t seem to be the case [with Krolikowski],” Klein said. “Here it just seems the woman was unhappy with the product because it didn’t work as well as she thought it would work.”
Krolikowski is represented by Elia Robertson and Colin Burke of Kline & Specter PC.
Ethicon is represented by Julie Callsen and Jennifer Steinmetz of Tucker Ellis LLP, Sean Gallagher of Bartlit Beck LLP, Andrea La’Verne Edney of Butler Snow LLP, Kimberly Gustafson Bueno of Scott Douglas & McConnico LLP, Melissa Merk and Eileen Somers of Drinker Biddle & Reath LLP, Ilana Eisenstein of DLA Piper, and Jason Zarrow of O'Melveny & Myers LLP.
The case is Malgorzata Krolikowski v. Ethicon Inc., case number 140102704, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Editing by Kelly Duncan and Philip Shea.
https://www.law360.com/trials/articles/1151766/j-j-win-shows-potential-limit-to-mesh-injury-claims
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F.D.A. Halts U.S. Sales Of Pelvic Mesh, Citing Safety Concerns For Women
Apr 20, 2019 | Moms.com
By Joanna Mazewski
The U.S. Food and Drug Administration has halted the sale of all pelvic mesh products across the United States. Pelvic mesh is often used for urogynecology procedures, which includes the repair of the pelvic organ prolapse and stress urinary incontinence.
Doctors implant the mesh to reinforce a weakened vaginal wall for repair. It is also used to help support the urethra or bladder neck for the repair of stress urinary incontinence. However, the two major makers of the devices – Boston Scientific and Coloplast – have so far failed to prove any long-term safety measures of the benefit of the devices. Both companies will have about 10 days to withdraw their products from the markets.
According to The New York Times, Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health said in a statement to the press, “In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP. That evidence was lacking in these premarket applications, and we couldn't assure women that these devices were safe and effective long term."
Some of the side effects reported have included permanent incontinence, severe discomfort, and in some cases, the inability to have sex. There have been several lawsuits in the states of Washington, California, Kentucky, and Mississippi, citing that the makers of the pelvic mesh did not fully disclose their safety risks. Some health professionals have opposed the lawsuits, saying that the procedure does work for women.
Surgical mesh has been in use since the 1950s while implanting the mesh for abdominal repair began in the 1970s. Statistics suggest that about one in eight women will need surgery to repair their pelvic organ prolapse sometime during their lives.
It was previously thought that vaginal mesh was a safe and effective treatment option. However, vaginal mesh surgeries have concerned many health professionals because of the increase number of complications that have been reported post-surgery. There have also been a lot of misconceptions that have led many women to think twice about their treatment options for pelvic prolapse.
Women who have had the procedures in the past are advised to have routine checkups, although no additional measures are needed if there are no complications or symptoms.
https://www.moms.com/fda-halts-sale-of-pelvic-mesh-prolapse/
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Apr 19, 2019 | Gloucestershire Live
By Anita Merritt and Jessica Mercer
A mother of three in Britain has spoken out about a controversial vaginal mesh implant after the "life-changing" procedure left her in enormous pain.
Ceri Baker, 43, from Devon, has been left in constant pain and discomfort from the surgery which she received in 2017, reports Devon Live.
Unable to partake in any of the hobbies and activities she enjoyed previously with her family, she is also unable to have sex with her husband of 20 years, Pete, without it being "extremely painful".
She has now spoken out about the procedure in a Youtube video in the hope it will act as a warning to women who are considering the procedure after 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 called "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
'Minimally invasive procedure'
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.Paid privately
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.
'Many women are fully housebound'
“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.
'I would not have risked all of that for dry knickers'
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."
To watch Ceri’s video diaries click here
https://www.gloucestershirelive.co.uk/news/uk-world-news/mother-shares-vaginal-mesh-surgery-2759260
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Sales of pelvic surgical mesh for women could be stopped in India after US ban
Apr 20, 2019 | The Print
By Himani Chandna
The Modi government is considering stopping the sale of pelvic surgical mesh meant for women after the US health regulator, the Food and Drug Administration (FDA), banned it Tuesday.
The mesh is a medical device popularly used to support the abnormal descent of the pelvis in women. It is a cloth-like piece of netting made of synthetic material that is used to provide additional support to weakened or damaged tissue; for instance, after childbirth or due to increasing age or hernia.
It has, however, been under the scanner in the recent past. Last year, a Netflix documentary, The Bleeding Edge, highlighted the injuries caused by vaginal mesh to American women.
Triggered by a significant rise in the number of adverse complaints associated with the use of the device, the FDA Tuesday ordered medical device companies to stop the sales and distribution of surgical mesh.
In turn, the Indian government is also reviewing the situation.
“We have taken the note of the move (taken by US FDA) and we are examining it in the Indian context,” Preeti Sudan, health secretary, Ministry of Health and Family Welfare told ThePrint.
“We track the US FDA and other health regulators on a daily basis and we are working on collecting the details on the usage of the device in India and importers of the product,” said a senior official, who is not allowed to speak to the media, at Central Drugs Standard Control Organisation (CDSCO), the national regulatory body for drugs and medical devices.
“The mesh is among the 23 regulated medical devices in India and a committee has been formed to discuss the US FDA move and its relevance to India.”Couldn’t assure the safety of devices in the long term: US FDA
In enforcing the ban, the FDA, in a statement Tuesday, said it found that the manufacturers, Boston Scientific and Coloplast, have not “demonstrated a reasonable assurance of safety and effectiveness for these devices”.
The companies will have 10 days to submit their plan to withdraw these products from the market.
“In order for these mesh devices to stay on the market, we determined that we needed evidence that they worked better than surgery without the use of mesh to repair POP,” Jeffrey Shuren, director of the FDA’s Center for Devices and Radiological Health said in the statement. “That evidence was lacking in these premarket applications, and we couldn’t assure women that these devices were safe and effective long-term.”
According to the FDA, in December 2017, the Australian Therapeutic Goods Administration (TGA) removed from the market all uro-gynaecologic surgical mesh products due to the safety concerns.
In 2018, the United Kingdom and Ireland temporarily stopped the use of all surgical meshes placed transvaginally. In 2018, Scotland stopped all transvaginal mesh procedures until a new “restricted use protocol” could be developed.
Due to increasing lawsuits and complaints, some manufacturers, including Johnson & Johnson, had voluntarily stopped selling them in the US. Johnson & Johnson’s subsidiary, Ethicon, lost a $35 million lawsuit over its pelvic mesh.
By 2019, only two companies were selling the mesh in the US.
Plethora of sellers in India
In India, however, several players sell these devices.
According to an analysis by the All India Drug Action Network (AIDAN), an NGO, the CDSCO has granted registration certificates to over 10 companies to import the mesh. They include Johnson & Johnson, B. Braun Surgical, Davol Inc, Sofradim Production and Boston Scientific Corporation.
Local players producing the mesh include Suture India, HLL Lifecare and Suru International.
“As per AIDAN’s analysis, a number of mesh products for use in hernia repair, urinary incontinence and prolapse repair have been approved in India,” said Malini Aisola, co-convenor of AIDAN.
“Given the horrific adverse events associated with the mesh in Western countries, which has led to the US ban, the CDSCO must take immediate measures to protect Indian patients by initiating local investigations and issuing showcause notices before ordering the mandatory withdrawal of these products from India,” she said.
“The outcomes of mesh use in hernia repairs are similarly disastrous and warrants a full-scale investigation into these devices,” Aisola added.
Mesh is used in India despite complications
In India, the surgical mesh is used by gynaecologists for the repair of the pelvic organ prolapse (POP). The POP is a condition where the muscles of the pelvic floor of women, due to increasing age or childbirth, become weak. In this case, the organs on the pelvic floor such as the bladder and uterus start drooping and need support.
“The use of these meshes is very common to correct the prolapse. However, in the past, we had noticed several serious complications such as the slippage of the mesh into the urinary bladder,” said a gynaecologist who does not want to be named. “While most doctors use another safe technique to correct the prolapse, some still use these meshes. The ban is in the right direction so that we don’t get new patients suffering these serious complications.”
The move was long pending, says Rajiv Nath, forum coordinator of the Indian Medical Device Industry. “The move to curb import of unsafe vaginal mesh is overdue, especially after a Netflix documentary and investigative report by a newspaper, which mention the dubious nexus in sales of meshes and its side effects,” Nath said.
“Moreover, it has become a trend for globally reputed companies to continue to sell their products in India that are otherwise recalled or banned in international markets,” Nath added. “To protect the health of women in India, the government must follow the step taken by the US FDA and stop the sales of these meshes.”
https://theprint.in/india/governance/sales-of-pelvic-surgical-mesh-for-women-could-be-stopped-in-india-after-us-ban/223548/
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Bernstein Liebhard Still Seeking $13 Million in Fire Insurance Suit
Apr 19, 2019 | New York Law Journal
By Jack Newsham
Bernstein Liebhard, the plaintiffs firm that sued its insurer for more than $21 million in 2015 after a fire devastated its mass torts practice, is arguing that an adverse appellate court decision wasn’t as bad as it seemed. The New York firm claims the appellate ruling actually allows the firm to seek more than $13 million.
Bernstein Liebhard’s lawsuit argues Sentinel Insurance Co. was obligated to compensate it for the fees it would have earned on cases it could have brought on behalf of victims of the medication Risperdal, defective vaginal mesh and other medical torts.
The law firm’s case against Sentinel seemed headed for trial after Manhattan Supreme Court Justice Andrea Masley rejected Sentinel’s summary judgment motion in January 2018.
But the Appellate Division, First Department, reversed that decision last year. The court said “fee amounts that eventually result from settlements and judgments in cases [that would have been brought, if not for the fire] would not have been ‘earned’ by plaintiff” within the 12-month cutoff period in its business-interruption insurance policy.
The appellate court called for judgment to be entered, but Bernstein Liebhard is now seeking to file a newly amended complaint.
In papers filed April 15, the law firm revealed that it submitted a new, $13.3 million claim to Sentinel that it believes comports with the appellate court’s decision. That figure is a far cry from the $27.2 million the firm sought in a 2017 claim submission that was filed in court records, but Sentinel has indicated that it still plans to fight it.
“In accordance with the First Department’s holding, Bernstein Liebhard is writing to formally amend its claim,” founding partner Stanley Bernstein wrote in a letter dated April 12. “Bernstein now claims damages in the sum of at least $13,275,000, representing approximately 75 percent of Bernstein’s fees it would have earned (on a quantum meruit basis) during the 12 months following the loss.”
Bernstein Liebhard said it missed out on the opportunity to file hundreds of profitable cases in the aftermath of the fire that swept through its offices on 40th Street in Manhattan in August 2013, destroying its computer system, phone system and main file room. Even files stored elsewhere were damaged or destroyed and had to be found and scanned, the firm has said.
Sentinel wouldn’t even let Bernstein Liebhard enter the file room until November 2013 so the insurer could conduct an investigation into the possibility of suing a computer manufacturer that may have played a role in sparking the blaze, the firm has said. Its mass torts practice experienced issues with remote backups and was simply “overloaded,” according to a proposed complaint.
In claim paperwork from 2017, it said it lost $18.7 million in fees from vaginal mesh cases and $7 million on Risperdal cases, each of which was estimated to net $60,000, and another $1.9 million on cases labeled “metal-on-metal hip revision surgery,” each of which was good for $75,000 in fees.
Sentinel has opposed Bernstein Liebhard’s effort to amend its complaint, contending the appellate decision gave the trial judge, Masley, no choice but to enter judgment in its favor and close the case. In a March brief, after Bernstein Liebhard revealed its intent to file a new complaint, Sentinel accused the firm of seeking “a second (or third) bite at the apple.”
“This case is over,” the insurer argued. “Under controlling First Department authority, this court may not properly conduct any further proceedings in this case, other than with respect to an award of costs to Sentinel, and potentially an award of attorney’s fees to Sentinel with respect to this frivolous motion.”
Stanley Bernstein and his firm’s lawyer, Jonathan Lerner of Lerner, Arnold & Winston, didn’t respond to requests for comment. Gerald Dwyer Jr., a lawyer at Robinson & Cole who represents Sentinel, declined to comment.
https://www.law.com/newyorklawjournal/2019/04/19/bernstein-liebhard-still-seeking-13-million-in-fire-insurance-suit/?slreturn=20190322033943
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The grim stories behind seven of medtech’s worst failures
Apr 22, 2019 | Medical Design & Outsourcing
By Danielle Kirsh
Medical devices save or restore thousands of patient lives every year, but the dark side to medtech innovation is increasingly drawing attention.
For all the good the industry does, it’s worth remembering that the costs can be high – even fatal – when medical device companies don’t get things right. The examples range from women facing a lifetime of pain and the loss of their sex lives from pelvic mesh products, to necrosis and infections from metal-on-metal hip implants, to deaths and serious “superbug” infections from inadequately sterilized duodenoscopes.
Added media scrutiny, including Netflix’s “The Bleeding Edge” documentary and the International Consortium of Investigative Journalists’ Implant Files, draws worldwide attention and could even lead to tougher device industry regulations in the U.S. and abroad. The FDA, for example, is already considering a reboot of the 510(k) clearance pathway, which critics say allows unsafe and ineffective devices onto the market.
Here are the stories of seven examples of medical devices that went tragically wrong.
Pelvic mesh
The FDA this month ordered Boston Scientific (NYSE:BSX) and Coloplast – the only remaining companies that sell pelvic mesh for pelvic organ prolapse in the U.S. – to immediately halt sales and distribution.
The agency concluded that Boston Sci and Coloplast failed to demonstrate an acceptable long-term benefit of mesh devices, compared to transvaginal surgical tissue repair without mesh and could not assure their safety and effectiveness. The mesh products, the agency said, did not have a reasonable assurance of safety and effectiveness.
The move capped years of controversy about the mesh products, which were meant to treat the weakening of the muscles and ligaments supporting a woman’s pelvic organs.
The federal safety watchdog cleared the first mesh device for transvaginal repair of pelvic organ prolapse in 2002. Since then thousands of lawsuits, citing harm including pain, excessive bleeding and loss of sexual function, have produced millions in settlements for the plaintiffs and a series of recalls for the defendants. Device makers have won a few of the pelvic mesh cases that made it to trial, including one this week in which the jury cleared J&J unit Ethicon of claims that a mesh product was the cause of the plaintiff’s injuries, even though it found that Ethicon was negligent in designing, marketing and selling the device.
Metal-on-metal hips
Orthopedic device companies touted metal-on-metal hip implants as stronger than other types of implants after they first introduced them in the late 1990s. But the implants came under fire after the high-profile August 2010 recall of DePuy Orthopaedics’ ASR XL acetabular and ASR hip resurfacing systems. Parent company Johnson & Johnson pulled the implants after receiving reports that a higher-than-normal number of patients required surgeries to correct or remove defective implants.
As of the end of last year, J&J still faced lawsuits from 10,500 plaintiffs with direct claims related to the Pinnacle acetabular cup system, as well as 1,800 directly affected by the DePuy ASR XL acetabular system and DePuy ASR hip resurfacing system, according to J&J’s most recent annual report.
Other device makers have found themselves pulled into the controversy since 2010. Even metal-on-metal implants that haven’t undergone a recall have become embroiled in personal injury lawsuits.
In 2013, the U.K.’s National Institute for Health & Care Excellence found failure rates as high as 43% for some metal-on-metal implants. Worse, reports have warned of hundreds of thousands of patients potentially exposed to toxic compounds from the implants, putting them at risk of developing cancer, cardiomyopathy, muscle and bone destruction and changes to their DNA. One study found that metal ions that were released from the cobalt-chromium-molybdenum metal devices when they rubbed together would penetrate bone marrow and impede bone-growing cells from forming.
Duodenoscope reprocessing
Duodenoscopes are flexible, lighted tubes threaded through the mouth, throat and stomach into the top of the small intestine. They’re an important tool for endoscopic retrograde cholangiopancreatography (ERCP) — a procedure that combines endoscopy and fluoroscopy to treat bile and pancreatic duct problems ranging from gallstones to scarring to cancer. U.S. health providers perform about half a million ERCP procedures each year, according to FDA.
The tools, though, are complex with many small working parts. Reprocessing is tricky. By 2015, there were alarming reports about deadly “superbug” infections potentially associated with the devices. FDA eventually warned the three major duodenoscope makers — Olympus (TYO:7733), Fujifilm Holdings (TSE:4901) and Hoya’s (TYO:7741) Pentax subsidiary — and ordered them to conduct post-market surveillance studies about the effectiveness of scope reprocessing.
Last year, FDA once again warned the three companies, saying they were failing to comply with the order. Dr. Jeffrey Shuren, director of the FDA’s Center for Devices & Radiological Health, this month said there would be possible “additional action” if deadlines are meant.
FDA, in fact, said this month that the problem is worse than previously thought, with a contamination rate for high-concern bugs like E. coli and Pseudomonas aeruginosa that’s around 5.4%.
Late last year, Olympus and a former senior executive in Japan pleaded guilty in federal court in Newark, N.J., to failing to file required adverse event reports involving infections connected to duodenoscopes. A previous LA Times and U.S. Senate committee investigation found that Olympus for years did not disclose problems to FDA and the U.S. public, even as it issues warnings in Europe.
Essure
Bayer’s Essure device was marketed as a permanent birth control device in the U.S. The device has since been taken off the market because of complaints from women about unexpected pregnancies and injuries following implantation.
One study found that the Essure female sterilization device was more than 10 times more likely to require surgery after implantation than those who had laparoscopic sterilization. The British Medical Journal study showed that after one year of having the implant, 2.4% of women who had Essure needed a follow-up surgery, compared to the 0.2% of women who had a minimally invasive tube-tying procedure, according to a British Medical Journal study.
The complaints have been worldwide, with legal complaints being filed in France and Australia in addition to the ones in the U.S. Side effects associated with the device’s failure include depression, dizziness, uterine perforation and autoimmune disorders.
In April 2018, the FDA restricted the U.S. sales of Essure after it concluded that some of the patients were not properly warned of the risks.
heranos and its so-called finger prick blood testing
Theranos was a medical device company started by 19-year-old college dropout Elizabeth Holmes in 2003. The company’s device, called the Edison, was touted as being a blood test machine that could test for hundreds of things with only a small amount of blood.
The company was valued at nearly $10 billion before its downfall in 2015. The Edison device, which was only FDA approved to test for the herpes simplex virus outside of a clinical laboratory setting, was supposed to automate and miniaturize blood tests and offer in-home blood tests.
Theranos’s technology was never peer-reviewed despite the company claiming there was data backing the accuracy and reliability of the test results they did publish. In early 2016, Theranos allowed the Cleveland Clinic to perform validation studies. The findings of the Cleveland Clinic were that the device’s blood test results were outside their normal range about 1.6 times more often than other testing services. It also showed that lipid panel test results from the Theranos device and other clinical services were nonequivalent.
In 2015, John Carreyrou, a Wall Street Journal reporter, published a story saying that Theranos was using Siemens’s blood testing machine to run tests for its own devices. He also reported that the Edison device might have inaccurate results.
By 2016, Theranos and Holmes were under criminal investigation by federal prosecutors and the Securities and Exchange Commission for lying to investors about its technology. It was found that the company voided years of Edison test results and that 1% of its test results were voided or created from its machines.
Holmes reached a settlement with the SEC that required her to pay a $500,000 fine, as well as give up 19 million shares of company stock while agreeing to be banned from holding any kind of leadership position for 10 years. Facing other investigations and lawsuits, Theranos shuttered its doors officially in September 2018 and released all assets and remaining cash to creditors. Holmes and her business partner Sunny Balwani face multiple counts of wire fraud and conspiracy to commit wire fraud in federal court.
Medtronic Infuse bone cement
Approved in 2002 for use in spinal fusion surgery, Medtronic’s Infuse bone cement at one point had annual sales of nearly $1 billion. But the bone-grafting product has since been linked to abnormal bone growth, certain cancers and male reproductive problems.
Critics say that Fridley, Minn.–based Medtronic not only downplayed the product’s risks but also promoted it for off-label use.
By mid-2017, Medtronic had settled lawsuits from most of the 6,000 people claiming that Infuse bone graft had injured them, according to the company’s most recent annual report. The company announced in March 2018 that a shareholder lawsuit brought over Infuse was over; the U.S. Supreme Court declined to review the case.
CRM device leads
Leads in the past have been a problematic component of cardiac rhythm management devices, dogging the medical device companies that make them.
One of the worst recalls occurred in 2007, when Medtronic pulled its Sprint Fidelis defibrillator leads from shelves worldwide. Already inside an estimated 268,000 people, the leads were suffering wire fractures that affected device performance — causing unnecessary shocks or no shock at all when a shock was necessary, MDO’s sister site MassDevice reported back in 2010.
More than 100 deaths occurred around the Fidelis leads, though Medtronic said that the leads were a “possible or likely contributing factor” in only 13 of the fatalities.
Fidelis-related lawsuits, however, didn’t fare well after the U.S. Supreme Court’s Riegel v. Medtronic decision in 2008. The case barred state lawsuits involving medical devices with PMAs from FDA. Medtronic settled Sprint Fidelis suits for $268 million in 2010.
Medtronic isn’t the only company that has run into problems with defibrillator leads. St. Jude Medical, now part of Abbott, pulled its silicone-coated Riata and Riata ST leads from the market in 2010. Some of the internal conductors had worn through their insulation, a situation that could cause unwanted shocks.
https://www.medicaldesignandoutsourcing.com/the-grim-stories-behind-seven-of-medtechs-worst-failures/8/
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