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Ethicon Media Monitoring 6/5/2018
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Widespread failures threaten billion-dollar medical mesh market
Jun 4, 2018 | Medical Device Network
By GlobalData Healthcare
Throughout the Commonwealth and the United States, manufacturers of medical mesh are coming under fire for widespread device failures and questionable business practices. -
For years, we’ve exposed how mesh implants used to treat women incontinent after childbirth have left many in agony. Now we reveal bowel patients are victims, too...
Jun 4, 2018 | Daily Mail
By Lois Rogers
'How I will ever get over this, I just don’t know,’ says Philip Chatfield. ‘If I hear a loud scream, it takes me straight back: sometimes it went on for half an hour without stopping. -
No quit in trial bar after SCOTUS ruling, still filing lawsuits in favorite courts
Jun 4, 2018 | Legal News Line
By John O'Brien
Since last year’s U.S. Supreme Court ruling that dealt a blow to forum-shopping personal injury attorneys, companies threatened with sprawling, 50-state litigation have not been forced into defending cases all over the country.
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Widespread failures threaten billion-dollar medical mesh market
Jun 4, 2018 | Medical Device Network
By GlobalData Healthcare
Throughout the Commonwealth and the United States, manufacturers of medical mesh are coming under fire for widespread device failures and questionable business practices. Many mesh devices used to treat incontinence, hernias, or prolapses have already been recalled throughout the United States, the United Kingdom, Australia, and Canada. The medical mesh market has a fast-paced product development landscape, and is estimated to be worth roughly $1bn globally.
The most recent medical mesh scandal involves Boston Scientific, the subject of a 60 Minutes investigation. Boston Scientific has come under fire after losing access to its supply of plastic used in the production of the vaginal mesh devices. Its supplier, Chevron Phillips, halted production of the plastic for medical applications due to product liability concerns, after it was found that it degraded in the human body and should not be used for permanent implantation.
Using an alternative plastic would have required Boston Scientific to seek new FDA approval for its device, so it resorted to sourcing plastics from an unverified Chinese company. The company claims the Chinese plastic is the same as its original material, a stance backed by the FDA. However, leaked internal emails admitted that Boston Scientific was unable to trace the provenance of the plastics it had purchased and needed to obscure the purchase from customs agents while shipping the products to the United States.
Boston Scientific’s mesh scandal is perhaps the most recent example of questionable devices being pushed to the market, but they are far from alone. Ethicon’s TVT-Secur implant was found to have been tested in sheep and a small sample of 31 women before being brought to market. Despite consultants advising the company to perform more robust clinical tests, the company went ahead with sales and unsurprisingly, had to recall the device in 2012. Ethicon, J&J, Bard and Boston Scientific have all had to pull mesh devices that were known to cause pelvic pain, organ damage, and other serious complications but continued to push sales of similar devices.
In Australia, the use of vaginal mesh has been banned for most procedures, and the UK is soon to follow suit after the NHS was found to have ignored advice from watchdogs to limit use. Unfortunately in the US, where there have been over 100,000 vaginal mesh lawsuits filed, there is little likelihood that the FDA will ban this device. The FDA has previously rejected suits petitioning for the ban of transvaginal mesh, and continues to allow for the use of non-medical grade plastics in these implants.
While the US is the largest market for medical mesh, GlobalData expects that this market will be negatively affected by the pattern of bans being introduced in other countries. However, the medical mesh market is quickly changing due to innovation and the introduction of new technology, which may lead to safer versions of currently marketed devices. Hernias, incontinence, and organ prolapses are widespread ailments providing a high-opportunity market.
https://www.medicaldevice-network.com/comment/widespread-failures-threaten-billion-dollar-medical-mesh-market/
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Jun 4, 2018 | Daily Mail
By Lois Rogers
'How I will ever get over this, I just don’t know,’ says Philip Chatfield. ‘If I hear a loud scream, it takes me straight back: sometimes it went on for half an hour without stopping.
‘She was in agony. I just didn’t know what to do. She tried so hard to live with it but, in the end, she just gave up.’
Philip, 59, a sculptor from the Gower Peninsula in remote South Wales, is describing the final years of his former partner, Lucinda Methuen-Campbell, the mother of their son, Angus, who is now 19.
Lucinda, 58, committed suicide earlier this year. She was one of more than 100 patients to have complained of crippling pain after they received implantable surgical mesh to treat bowel problems.
The material used is the same as the controversial gynaecological mesh used to repair post-childbirth incontinence. In some women treated for incontinence, this material has fragmented and ‘migrated’, leaving many in permanent, agonising pain.
Some have suffered such severe nerve damage that they cannot walk and rely on wheelchairs.
Following a long campaign by Good Health, the use of the vaginal mesh is now the subject of a government inquiry, but no date has yet been given for its conclusion.
But now, there are concerns about the mesh used in rectal surgery (rectopexy), with up to 100 patients given the mesh by a Bristol surgeon, Anthony Dixon, embarking on legal action — against Mr Dixon himself, as well as Southmead Hospital in Bristol where he worked for the NHS, and the Spire Bristol Hospital, where he practised privately.
Most are patients who developed constipation and extreme pain in mid-life, which subsequently turned out to be the symptom of a prolapsed bowel.
Lucinda was a private patient of Mr Dixon. ‘She developed a bowel problem in 2013 and said she was in terrible pain,’ recalls Philip.
‘She found Mr Dixon on the internet and went to see him as a private patient in December of that year. He said he knew exactly what was wrong and seemed pretty gung-ho about fixing it.’
She had the first operation to put in the mesh early in 2014 — ‘but it didn’t work’, says Philip. ‘She was literally screaming in agony. She had two more operations, but neither of them worked, either.’
Philip continues: ‘Although she and I had split up in 2001, when Angus was two, I felt I had to move back in to help her.
‘I had no idea I was going to be there trying to help her for the next four-and-a-half years.
‘I slept downstairs, but I could always hear her crying out. I couldn’t work. I spent all my time trying to do practical things to help her.’
Lucinda, who also had a daughter, Poppy, 35, from an earlier relationship, lived in a village outside Swansea, South Wales, and had been a much-loved classroom assistant at a local primary school.
‘I was the person who found her,’ says Philip. ‘The shock and trauma are very hard to cope with.
‘To try so hard for so long to help someone, and all for nothing, is very hard to bear.’
Like Lucinda, Sam Van Der Heijden, 58, a former NHS administrator from Bexhill-on-Sea, East Sussex, who has three adult children, found her way to Mr Dixon as a private patient, following an internet search in 2011. ‘He came up as a pioneering surgeon for bowel problems,’ she says. ‘He told me I needed a rectopexy. Mr Dixon told me the bowel was going to be pulled up and stapled with titanium tacks to the base of my spine.
‘I was so pleased something was being done. I didn’t question whether it would work.’
But she says she’s been left in agonising pain, which has affected her marriage and her ability to work. She has since undergone further surgery to remove the embedded mesh, which has caused permanent nerve damage. ‘This has ruined the past eight years of my life,’ she adds.
Another of Mr Dixon’s patients, Ian Waterfield, 56, a former chef from Huddersfield, is one of the first men to report life-limiting damage caused by mesh surgery.
A sports enthusiast who travelled the world swimming, skiing and attending music festivals, he developed digestive problems in mid-life, with bouts of projectile vomiting and severe constipation that began 14 years ago.
Despite several spells in hospital, his symptoms were repeatedly dismissed as irritable bowel syndrome — until 2009, when he was diagnosed with a prolapsed bowel. He was referred to Mr Dixon through the NHS and underwent the mesh repair operation in 2010. But the procedure did not work and led to repeated operations and the removal of a section of his bowel.
‘I have been a complete wreck ever since,’ he says. ‘I don’t have a life, I have an existence. I can’t work and my relationship broke down because of this. I am in constant pain — it’s like bits of broken glass sticking into me.
‘Some nights, I don’t bother going to bed. I only sleep for five minutes at a time.’
Sohier Elneil, a London-based gynaecologist who specialises in repairing injuries linked to implanted surgical mesh, has become a vociferous campaigner against its use for women with incontinence.
She believes rectopexy is now unravelling as a potential problem area, too.
‘In the past year, I have done repairs on 15 of Mr Dixon’s patients,’ she says.
‘There is a problem with the material itself — disintegrating and moving around inside people’s bodies — and with the technique being used to insert it.’
According to lawyer Madeleine Pinschof, of Thompsons Solicitors, who is representing 61 of Mr Dixon’s patients, the complaints about Mr Dixon ‘are mostly about whether the operations were appropriate in the first place’. She says some of the complaints relate to surgery that was performed up to ten years ago.
Last August, restrictions were placed on Mr Dixon’s practice by the General Medical Council, preventing him from carrying out bowel repair surgery.
Chris Burton, the medical director of North Bristol NHS Trust, which operates Southmead Hospital, would not tell Good Health when Mr Dixon had stopped treating patients at the hospital.
He said: ‘[Mr Dixon] is not currently providing any clinical services to patients at our hospital. We would like to reassure patients that we are taking this very seriously and our investigations are continuing. It would be inappropriate for us to comment on specific details while our investigations are ongoing.’
Dr Jean-Jacques de Gorter, medical director of the Spire Group, said it had suspended Mr Dixon’s practising privileges pending the investigation.
As the Mail has reported, last Friday, an inquest into Lucinda Methuen-Campbell’s death concluded she had taken her own life because of intractable pain.
Lucinda’s family say she had experienced mental health problems — which worsened after the death of her own mother in 2013 — before she saw Mr Dixon.
Her sister, Catherine, 53, a mother-of-four who lives in Lewes, East Sussex, says: ‘We can’t say if she killed herself because of the mesh. Mr Dixon should never have touched her, but he wasn’t to know she was mentally ill because she saw him as a private patient and her GP would not have told him.’
Details of patients’ complaints were put to Mr Dixon by Good Health through the Medical Protection Society, a doctors’ insurance company which is co-ordinating his defence. He declined to comment, citing patient confidentiality.
A spokesman for NHS Resolution, which deals with litigation by patients, said it is currently negotiating a group ‘protocol’ to cover the various types of compensation claims against Mr Dixon, but he said as more claimants are continuing to come forward, the process is ‘ongoing’.
http://www.dailymail.co.uk/health/article-5805379/Bowel-patients-victims-mesh-implants-too.html
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No quit in trial bar after SCOTUS ruling, still filing lawsuits in favorite courts
Jun 4, 2018 | Legal News Line
By John O'Brien
Since last year’s U.S. Supreme Court ruling that dealt a blow to forum-shopping personal injury attorneys, companies threatened with sprawling, 50-state litigation have not been forced into defending cases all over the country.
Instead, the trial bar is continuing to try to force its way into preferred jurisdictions like California and Pennsylvania that are known for high-dollar verdicts, says one of the attorneys who helped Bristol-Myers Squibb win one in the high court’s recent series of jurisdictional decisions.
Anand Agneshwar said he was told to be careful what he wished for when he fought cases filed in California by out-of-state plaintiffs over the blood-thinner Plavix.
A victory could fracture the grouping of claims, leaving companies to defend themselves all over the country, he says he was warned.
“That’s not how the plaintiffs lawyers operate,” Agneshwar said at an event hosted Monday by the U.S. Chamber Institute for Legal Reform at the National Press Club. The ILR owns Legal Newsline.
“The way plaintiffs lawyers get leverage against the defendant is by aggregating claims in jurisdictions that are threatening to those defendants.
“And it’s the aggregation and the numbers that often push the defendants toward settling because all of a sudden, you have 500 cases pending in this (multi-district litigation) or that state court.”
Supreme Court justices ruled 8-1 last year in favor of Bristol-Myers Squibb after the company argued plaintiffs living outside California who alleged injury from BMS’s blood thinner Plavix should not be able to sue the company in that state.
The Supreme Court delivered an opinion that took on the issue of personal jurisdiction. Plavix was not designed or made in California, and the company is headquartered in New York, so it was inappropriate to join out-of-state plaintiffs with California plaintiffs for the purpose of filing the claims in California, the court ruled.
Two of the jurisdictions that have taken the ruling as gospel are Missouri and Chicago’s federal court, but panelists pointed at a recent Pennsylvania decision as a sign that some judges are still reluctant to shift their thinking.
Philadelphia’s court of common pleas has long been known as a haven for out-of-state plaintiffs. In 2016, more than 90 percent of filings in the city’s Complex Litigation Center came from out-of-state plaintiffs, boosted by thousands of Risperdal claims.
On May 18, Philadelphia judge Arnold New found that more than 100 lawsuits against pelvic mesh maker Ethicon would stay in his courtbecause Ethicon had used Bucks County-based Secant to help with the manufacture of the product.
New said that portion of the process gave the court specific personal jurisdiction over the claims, even though part of the BMS decision said jurisdiction couldn’t be established by tying in a California company with which BMS contracted to distribute Plavix.
“Bristol-Myers did not invite courts into fishing expeditions to look for companies related to the manufacturing process,” Agneshwar said.
Agneshwar says the Supreme Court wants lower courts to rule on jurisdictional issues early on, not after years of discovery that seeks to find a local defendant to establish jurisdiction.
But, he said, the old “paradigm” is engrained in a lot of the players in these types of cases, and the arguments can sway judges.
In California, where BMS fought the Plavix forum-shopping, plaintiffs attorneys continue their effort to land their cases there. The state’s courts have long been deemed unfair to defendants by business and legal reform groups.
Nineteen cases from the state’s Northern District federal court and eight from the Southern District have analyzed the BMS decision, according to ILR research announced at the event.
A Northern District judge ruled in cases against BMS that the allegation the company once held a clinical study in the state was enough to establish jurisdiction.
It’s part of a strategy that has plaintiffs lawyers trying to plug the holes in the BMS decision, Agneshwar said.
Justice Samuel Alito’s majority opinion, which reversed the California Supreme Court’s earlier decision, did not specifically mention such in-state trials and their effect on jurisdiction.
Agneshwar says the decision was if the case was open-and-shut – a “no-brainer” – and not necessarily a paradigm shift. But plaintiffs can now focus on what was missing from the decision, he said.
“It’s ironic that the state that got slammed down for its expanded use of jurisdiction is now the state seeing resistance to embracing the Supreme Court’s decision,” he said.
At a conference in May, members of the trial bar agreed that the decision hasn’t shut the doors to their favorite courtrooms.
“I don’t think it’s been some kind of bar on these kinds of mass torts,” Neblett, Beard & Arsenault attorney Dustin Carter said at a HarrisMartin conference.
“Everyone initially thought it would be this large precedent. But non-resident plaintiffs can still bring cases.”
A San Diego lawyer also taking part in the HarrisMartin conference agreed. Nicholas Drakulich says the ruling is simply forcing plaintiffs attorneys to work harder.
“As the saying goes: There’s the law, and it’s all shaped by facts,” he said. “And facts can be tough things. So our job is to go find those tough things, and then prove those tough things.”
https://legalnewsline.com/stories/511445368-no-quit-in-trial-bar-after-scotus-ruling-still-filing-lawsuits-in-favorite-courts
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