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Ethicon Media Monitoring 8/3/2017
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Pa. Judge Will Revisit Out-Of-State Cases In Mesh Mass Tort
Aug 3, 2017 | Law 360
By Dan Packel
A Pennsylvania state court judge on Wednesday said he would weigh whether two recent U.S. Supreme Court decisions limiting the ability of trial courts to retain jurisdiction over claims from out-of-state plaintiffs affect nearly 100 cases in Philadelphia’s pelvic mesh mass tort program. -
Trimming An MDL Expert's Testimony On Remand
Aug 3, 2017 | Law 360
By Michelle Yeary
There is always a level of uncertainty when a case gets remanded from a multidistrict litigation. New judge; new interpretations of prior rulings; new rulings. It can be the cause of much anxiety on both sides. And the biggest question is — what’s left to be done? -
'Vaginal mesh surgery ruined my life and should be banned'
Aug 3, 2017 | BBC
Hundreds of women across the UK say the procedure - used to treat incontinence and prolapse after childbirth - has left them physically and mentally scarred. -
Court awards woman $1 million for surgical mesh infection
Aug 3, 2017 | The Sydney Morning Herald
By Harriet Alexander
A woman who developed a severe infection associated with surgical mesh has been awarded $1 million, after a court found the doctors did not account for her personal risk factors. -
Victorian Senator Derryn Hinch says Senators at a mesh inquiry are determined to get answers for women
Aug 3, 2017 | Newcastle Herald
By Joanne McCarthy
DERRYN Hinch says there have been “Watergate-style cover-ups” leading to thousands of Australian women living desperate, silenced lives because of pelvic mesh surgery.
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Pa. Judge Will Revisit Out-Of-State Cases In Mesh Mass Tort
Aug 3, 2017 | Law 360
By Dan Packel
Law360, Philadelphia (August 2, 2017, 6:31 PM EDT) -- A Pennsylvania state court judge on Wednesday said he would weigh whether two recent U.S. Supreme Court decisions limiting the ability of trial courts to retain jurisdiction over claims from out-of-state plaintiffs affect nearly 100 cases in Philadelphia’s pelvic mesh mass tort program.
In a one-page order, Philadelphia Court of Common Pleas Judge Arnold New said he would reconsider a 2015 ruling that kept alive a number of cases brought by non-Pennsylvania litigants against Johnson & Johnson subsidiary Ethicon Inc. Among the cases potentially impacted by the ruling is one that saw a defense verdict reversed earlier this month.
Ethicon argued in a June motion that the justices’ recent decisions narrowing the scope of jurisdiction for plaintiffs looking to pursue claims in venues outside either where they were injured or where a defendant is headquartered meant that 91 cases pending in the Philadelphia County Court of Common Pleas needed to be dismissed and refiled elsewhere.
The company had previously sought to have claims from out-of-state plaintiffs, whose cases are part of a mass tort program aimed at coordinating litigation over alleged pelvic mesh injuries, dismissed for a lack of jurisdiction, but Judge New rejected their bid in March 2015. Judge New is the coordinating judge of Philadelphia’s Complex Litigation Center, which handles the court’s mass torts.
Renewing its effort, Ethicon pointed to a ruling from the justices in June that found Bristol-Myers Squibb Co. did not have sufficient business contacts in California to confer courts there with jurisdiction over some 600 lawsuits brought by out-of-state plaintiffs over injuries allegedly caused by the blood-thinner Plavix.
The 8-to-1 opinion came just weeks after another ruling from the Supreme Court that found two out-of-state employees couldn’t sue BNSF Railway Co. in Montana given the company’s lack of a bona fide business presence in the state.
Ethicon emphasized that its position as a New Jersey-based business meant that non-Pennsylvanians could not bring their claims in Philadelphia County.
Attorney Shanin Specter, who serves as plaintiffs’ liaison counsel, was confident that Pennsylvania would continue to have jurisdiction over Ethicon.
“The basis for jurisdiction against Ethicon in Pennsylvania is even stronger now than when Judge New first denied Ethicon's objections to jurisdiction, because of additional evidence of Ethicon's already substantial and specific conduct within the commonwealth in relation to the development and marketing of transvaginal mesh, which we'll provide to the court,” he said in an email.
Specter added that the Bristol-Myers Squibb opinion included a word-for-word restatement of U.S. Supreme Court precedent on jurisdiction from the Daimler AG v. Barbara Bauman case, noting the latter case was briefed to Judge New when the issue was first decided.
“So the law is no better for Ethicon than before,” he said.
Boston Scientific Corp., which also manufactures mesh products and is incorporated in Delaware and headquartered in Massachusetts, filed a similar motion in June but invoked only three cases. On July 24, Judge New dismissed its motion as moot.
One of the cases listed by Ethicon, filed by Ohio resident Kimberly Adkins, went to trial in May. In June, jurors ruled in favor of Ethicon for the first time in the five pelvic mesh cases tried in Philadelphia. But Court of Common Pleas Judge Michael Erdos overturned part of the verdict last month, agreeing with Adkins' contention that the jury had been inconsistent in its conclusion that while the mesh she received was defectively designed, it was not the cause of injuries that were acknowledged by both sides.
Judge New ordered the parties to file supplemental briefing on the question of jurisdiction and said he would set a date for oral argument.
"We are pleased that Judge New has called for briefs on this very important issue," said Ethicon spokeswoman Kristin Wallace. "Ethicon will vigorously defend itself in lawsuits concerning the use of our pelvic mesh products. There are various treatment choices for pelvic organ prolapse and stress urinary incontinence, including surgical treatment with implantable mesh, which is backed by years of clinical research and can be the preferred option for some women seeking to improve their quality of life."
Four trial losses in Philadelphia have left Ethicon facing nearly $50 million in damages. Jury selection in a fifth case, brought by a Pennsylvania plaintiff, is currently underway.
Ethicon is represented by Kenneth Murphy and Melissa Merk of Drinker Biddle & Reath LLP, and Julie Callsen of Tucker Ellis LLP.
The plaintiffs are represented by Shanin Specter, Lee Balefsky, Michelle Tiger and Christopher Gomez of Kline & Specter PC, and Clayton Clark of Clark Love & Houston.
The case is In Re: Pelvic Mesh Litigation, case number 140200829, in the Court of Common Pleas of Philadelphia County, Pennsylvania.
--Additional reporting by Matt Fair. Editing by Emily Kokoll.https://www.law360.com/articles/950791/pa-judge-will-revisit-out-of-state-cases-in-mesh-mass-tort
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Trimming An MDL Expert's Testimony On Remand
Aug 3, 2017 | Law 360
By Michelle Yeary
There is always a level of uncertainty when a case gets remanded from a multidistrict litigation. New judge; new interpretations of prior rulings; new rulings. It can be the cause of much anxiety on both sides. And the biggest question is — what’s left to be done?
That might seem simple. The case was remanded for trial. But cases rarely go back completely trial ready. Legal issues that turn more on state law are often left to the remand court to decide, as are case specific evidentiary decisions.
There are also often questions as to whether a particular issue was raised in the MDL or not. If so, what was the ruling? If not, was it waived? So, there is definitely wiggle room for remand judges to imprint their reasoning and conclusions on a case. And where you’ve made progress in the MDL, you certainly don’t want to lose momentum post-remand.
Which was likely the thinking of defendants in Walker v. Ethicon Inc., 2017 U.S. Dist. LEXIS 112738 (ND IL Jun. 22, 2017) when faced with expert reports that went beyond the scope of what was deemed permissible by the MDL court in the mesh litigation. In this case, the plaintiff served an expert report from Dr. Shull, a gynecologic surgeon.
Dr. Shull had previously been challenged by the defendants in the MDL but certain issues were reserved for the remand court. Certain issues had also been ruled on by the MDL court in the context of other cases and other experts — in the defendants’ favor. The defendant here asked the court to apply those rulings. Generally speaking the remand court found the plaintiff offered no justification not to.
First up was the expert’s opinion that different surgical procedures — ones not involving the use of the product — were safer alternatives to the defendant’s mesh product. Id. at *5. In addition to the vast body of case law holding that non-use is not an “alternative design” for the product, the mesh MDL court had so held in another case. Id. The remand court agreed.
The remand court also considered the impact of Illinois state law, because Illinois does not require plaintiff to prove the existence of a safer alternative design, but such evidence may be relevant. Id. at *7. The plaintiff tried to argue that because a product could be found unreasonably dangerous without evidence of a safer alternative design, it follows that a product could be found unreasonably dangerous with evidence of a safer alternative regardless of whether that was a different design or a different surgical procedure. Id.
But that disregards that what is relevant but not required under Illinois law is evidence of a safer alternative design. The plaintiffs offered no support for interpreting “safer alternative design” in Illinois any differently than any other state. Nor did they explain how the alternative procedure was relevant to any element of any of the plaintiff’s claims. Without relevance, the testimony was excluded. Id. at *8.
Next were the doctor’s opinion on the duties of medical device manufacturers — testing, pharmacovigilance and training. The court excluded them all. The defendants challenged the opinion on adequacy of research and testing of the product on both the relevance and the doctor’s qualifications and competence. This is one of the topics on which the MDL court provided guidance but ultimately left the decision to the remand court.
On relevance, the MDL court found it doubtful, but was willing to leave the call to the trial court based on nuances in state law. Id. at *10. Pertinent to the defendants’ motion, the MDL court had also ruled that an expert “may not offer testimony that is solely a conduit for corporate information.” Id. On the qualification challenges, the MDL court did not exclude an expert on those grounds if the request for exclusion did not provide “specific content or context.” Id. at *11.
Applying those rulings to the specific case, the remand court found that the defendants had properly challenged Dr. Shull’s qualifications with enough specificity, and so that challenge was not denied, but reserved for the remand court. Id. So, on qualifications, Dr. Shull “is not qualified to testify regarding the standard of care for medical device testing.” Id. at *13.
The plaintiffs, however, argued that they were only offering testimony from Dr. Shull regarding what testing the defendants did or did not do — the extent of the testing rather than its adequacy. Id. at *12. The court took that as a concession, but went on to exclude that testimony as well. That is information found in company documents — the expert isn't needed for that. Id.
The plaintiffs also wanted Dr. Shull to testify about how the defendants monitored adverse events. They claimed he was not offering an opinion as to what systems the defendants should have been using, just that what they were doing was “woefully inadequate.” The court found this was a “distinction without a difference.” Id. at *14-15.
Dr. Shull’s experience as a surgeon does not give him the expertise to testify on the standard of care for adverse event reporting. Id. at *15. And again, if he planned to talk generally about adverse events, that material is in company documents and not an area for expert testimony.
Finally, Dr. Shull’s report included an opinion on whether the defendants appropriately trained physicians. On this point, the MDL court had already ruled that Dr. Shull could not testify about what should or should not be included in the instructions for use for the product — and that covers training of physicians. Dr. Shull could testify to the risks of the product and whether such risks were included in the product materials. Id. at *16. That’s it.
We’re not sure what remains in Dr. Shull’s report, but we certainly agree that the above portions were appropriately trimmed away.https://www.law360.com/articles/950356/trimming-an-mdl-expert-s-testimony-on-remand
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'Vaginal mesh surgery ruined my life and should be banned'
Aug 3, 2017 | BBC
Wales should ban the use of vaginal mesh implants, a campaigner has said.
Hundreds of women across the UK say the procedure - used to treat incontinence and prolapse after childbirth - has left them physically and mentally scarred.
A report by the NHS England-led Mesh Working Group, published last week, said the use of mesh was still "a safe option".
The Welsh Government said "very few adverse events" had been reported in Wales.
But Karen Preater, a member of the Welsh Mesh Survivors group, said the surgery ruined her life. Here, she tells her story.
I'm 40, yet I feel 100.
Before I had this operation, I had a good job in sales. I was a happy, active mum and I had a great relationship with my partner of 12 years.
Now I'm in constant pain, I walk with a stick, I lost my job and the intimate side of my relationship is ruined.
My life has changed beyond recognition and I struggle with depression. If it wasn't for my family, I probably wouldn't be talking to you now.
It started in 2014, when I had a tension-free vaginal tape (TVT) inserted to treat urinary incontinence.
I'd suffered with it for seven years, after my son was born weighing 10lb 1oz.
Eventually I was referred to a gynaecology department and they did a few tests and said the best thing they could advise was to have a sling (also called a mesh or tape) inserted.
I'd never heard of it before but they said 'oh it's just a little sling to pull you up and help with the incontinence'.
It sounded fantastic - the nurse said I'd only be in hospital a day but I ended up staying in for eight.
As soon as I came round from the anaesthetic, I was in excruciating pain with my left hip and thigh.
I couldn't pass any water so had to use catheters.
Hospital staff said that was normal because I'd just had an operation on my bladder but there was no real explanation given for the pain. I was given painkillers and kept in hospital.
I eventually hobbled out on crutches, still in pain, and still not being able to empty my bladder fully.
Three-and-a-half years later, I still have to self-catheterise five to six times a day.
And the pain is constant. It's in my hip, thigh and my groin.
There are things that aggravate it, like too much walking, or if I drive too far. But it never goes away - day in, day out, through the night, it just never lets up.
I don't use crutches any more but I do use a walking stick to take the pressure off my leg.
I get random shooting pains and sometimes my leg just goes out from under me. A few times I have ended up at the bottom of the stairs, so my partner had to put in a banister on both sides to stop me falling.
I'd always worked full-time, I had a really good job in field sales but it involved a lot of driving and I had to give it up.
When you're used to seeing people every day, sitting at home alone when the kids are in school, you do start to go a bit stir crazy and there are days when I just think, 'just shut the door, keep everything out'.
It's massively affected my relationship with my partner and it's really tough on the kids. I used to do lots of things with them - going out for a walk or swimming - but now it's got to the point where they've just given up asking.
They won't say "can we go for a day out?" because a day out for me is usually not a day - it's a couple of hours with a lot of rests and it also means I then have to spend extra time recuperating.
I couldn't run in the parents' race at my son's sports day, even though I always did it for the older two. It's little things like that which might not seem a lot to somebody but it's a lot to me.
After I had my son, I did get a bit of post-natal depression, which turned into full depression. I was medicated slightly but these last three years my meds have been doubled.
I just have to get by reasoning that I am going to have really low days and I just need to get through that day, that's all that matters, just getting through one day and then starting the next one.
I've spent the last three-and-a-half years trying to find out what's wrong with me.
I've probably seen five or six different consultants in different departments, and they've all said "I'm really flummoxed as to what's the matter, it's not my speciality, I'll have to send you to a different doctor".
It wasn't until I saw Kath Sansom, the founder of the Sling the Mesh campaign, on the news that I thought 'well, maybe this is what's the matter'. I'm now waiting to see a gynaecologist.
There are specialists that can remove mesh but it's not an easy operation because the damage that's done is in the nerves.
I know of women that have had six or seven surgeries because it has to be taken out bit by tiny bit and at this point in time, I don't think I could mentally cope with that in-depth surgery and worrying that the pain could actually get worse.
There needs to be a suspension of this procedure in Wales and Wales needs to have its own inquiry into the complications.
So many women still don't have a clue and unless it's thoroughly looked into, we will still be in the same position in a few years' time.
http://www.bbc.com/news/uk-wales-40662037
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Court awards woman $1 million for surgical mesh infection
Aug 3, 2017 | The Sydney Morning Herald
By Harriet Alexander
A woman who developed a severe infection associated with surgical mesh has been awarded $1 million, after a court found the doctors did not account for her personal risk factors.
Kylie Bernadette Tinnock, 39, was rushed to Calvary Hospital in Canberra with a massive infection five weeks after she had surgery at Wagga Wagga Hospital to repair an abdominal hernia caused by caesarean section.
The doctors who performed the hernia operation, in June 2010, placed surgical mesh over the dissection to promote healing and reinforce the area, which is standard procedure in that type of operation.
But Supreme Court Justice Stephen Campbell found they did not adequately account for a trifecta of risk factors – that she was a smoker, obese and the wound was very low in her abdomen – when they opted not to use a surgical drain following the surgery.
They then failed to detect that the wound was infected when she returned to the hospital on several later occasions.
Expert witness Trevor Currer, a surgeon, told the court the site of the surgical incision was "worst possible site for operating to avoid an infection".
"This case is a nightmare, if I may say, for a surgeon," Dr Currer said.
Mrs Tinnock returned to hospital six days after the initial operation when the wound began to ooze and bleed, and put out an offensive odour.
Doctors admitted her to hospital and put her on a course of intravenous antibiotics, but a wound swab found no evidence of infection and she was discharged after five days without doctors taking a deeper swab, or washing out or removing the surgical mesh.
She reappeared again nine days later, to be put on another course of antibiotics, and a week after that.
By this time the Tinnock family was furious, and Mrs Tinnock's mother rang the emergency department to complain "volubly", Justice Campbell said.
But her treating surgeon Michael Payne again dismissed the notion that her symptoms indicated an infection and by this time it was clear the doctor-patient relationship had broken down. "This may have affected his perception."
As late as 24 hours before she was admitted to Calvary Hospital with a serious infection, Dr Payne put Mrs Tinnock's clinical signs down to her smoking and obesity.
But by this time it was already too late. Mrs Tinnock needed five additional surgical procedures over the following months to clean the wound, remove the mesh, change the dressings and revise the scar.
She claimed to have ongoing pain and discomfort, psychological injury, restricted capacity to perform daily activities and reduced earning capacity. She separated from her husband shortly afterwards and was caring for three children under five years of age.
Justice Campbell found Dr Payne's standard of care fell short, first in not using a drain at the time of the first surgery and, second, by failing to detect an obvious infection and treat it by removing the mesh and washing it or taking it out altogether.
Three of the five surgeons who gave expert evidence said a suction drain should have been used to control bleeding and reduce the risk of infection, given Mrs Tinnock's particular circumstances and the largeness of the surgical mesh, and all of them would have used one if she had been their patient.
Justice Campbell said it was clear a surgical drain should have been used in a case as complex as Mrs Tinnock's and the risk of harm that materialised when a drain was not used was "both foreseeable and not insignificant".
He ruled that the Murrumbidgee Local Health District was liable for damages and ordered it to pay $1,005,509 plus legal costs.
Just 10 per cent of medical negligence claims cost more than $500,000 in 2011-12, according to the latest figures from the Australian Institute of Health and Welfare.
Mrs Tinnock's damages included $230,000 for non-economic loss, $40,000 for past and future out-of-pocket expenses, $224,000 for past economic loss, $257,000 for future economic loss, $66,000 for past domestic assistance and $93,000 for future attendant care.
http://www.smh.com.au/nsw/court-awards-woman-1-million-for-surgical-mesh-infection-20170802-gxnv77.html
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Aug 3, 2017 | Newcastle Herald
By Joanne McCarthy
DERRYN Hinch says there have been “Watergate-style cover-ups” leading to thousands of Australian women living desperate, silenced lives because of pelvic mesh surgery.
The claim was made months after he compared pelvic mesh with the drug Thalidomide and successfully called for a Senate inquiry, after describing mesh as “one of the greatest medical scandals and abuses of mothers in Australia's history”.
At the first public hearing day in Melbourne the former journalist turned Victorian Senator said he is expecting “horror stories” from women left with permanent and life-altering injuries, and challenges to regulators about how so many pelvic mesh devices were cleared for use without evidence of safety and efficacy.
“The Therapeutic Goods Administration’s going to come under great scrutiny. I’m going into this with my journalistic background,” he said.
“I don’t know where this is going to go, but I’m just bloody determined to find out how this happened.”
The Senate community affairs references committee will hold a full-day hearing in Melbourne from 9.15am before a second hearing day in Perth on August 25. Committee chair Senator Rachel Siewert, Senator Hinch and three other senators will hear from women who have had mesh surgery, doctors groups, university researchers, consumer health groups and regulators.
In a submission to the inquiry the Federal Department of Health estimated about 150,000 pelvic mesh devices for incontinence and prolapse have been supplied in Australia since the first meshes were cleared for use in 1998. Because it is common for more than one device to be implanted in women, the number of women who have had mesh surgery is estimated at 100,000.
The breakdown is about 106,000 devices for incontinence, where randomised controlled trials have supported the use of mesh in some circumstances, and more than 31,000 devices for prolapse, where mesh implanted via the vagina is not recommended as a first line treatment for any prolapse.
I don’t know where this is going to go, but I’m just bloody determined to find out how this happened.- Victorian Senator Derryn Hinch.
In its submission the Therapeutic Goods Administration, which is Australia’s peak medical device regulator, said the “safety signal for urogynaecological mesh devices was relatively slow to emerge”, with the first adverse event report to the TGA not until 2006.
But internal working group documents for the TGA show it knew in 2013 that manufacturers were not reporting adverse events, despite being mandatory reporters, and doctors had a low level of awareness of the adverse event reporting system.
In 2013 the TGA conceded internally that it was only receiving 10-20 per cent of complaints about pelvic meshes. Although the TGA had only received 226 adverse event reports by May, more than 1000 Australian women have registered for class actions against two major mesh device manufacturers, and more than 2200 have responded to a survey by a Victorian consumer health group.
Australian Pelvic Mesh Support Group founder Caz Chisholm, whose meeting with Mr Hinch in 2016 led to the push for a Senate inquiry, said it would allow women to be heard.
“The trust between patient and doctor has been lost on mesh injured women,” Ms Chisholm said.
“The patient needs to be heard, acknowledged, empowered. At a minimum, the patient deserves these rights.”
She has called on the inquiry to recommend that doctors are obliged to report mesh complications, after years of doctors dismissing or minimising women’s complaints of serious complications.
In 2013 there were about 100 pelvic mesh devices on the Australian market, with variations on 42 registered devices. After a review following global recognition of major problems with mesh, the TGA and mesh manufacturers cancelled 23 devices.
There are now 14 registered mesh devices in Australia, with variations of the 14 taking the final number of available mesh devices to 29.
http://www.theherald.com.au/story/4829531/hinch-predicts-mesh-cover-ups/
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