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Ethicon Media Monitoring 6/4/2018
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Martinez Mesh Trial – What Jurors Will and Won’t Hear
Jun 2, 2018 | Mesh Medical Device News Desk
By Jane Akre
The jury trial of Ana Martinz v Boston Scientific got underway May 31stin Middlesex County trial court in Woburn, Massachusetts, before Judge Thomas P. Billings. Case No. 1281CV03081. -
Mesh monitor group is just another whitewash, campaigners say
Jun 3, 2018 | The Sunday Post
By Marion Scott
Mesh campaigners refuse to work with Health Improvement Scotland’s Mesh Implants Oversight Group because they fear it will be used to reintroduce the controversial devices. -
Mesh manufacturers fail in bid to get cases thrown out
Jun 1, 2018 | Scottish Legal News
By Laura Connor
Victims of surgical mesh across Scotland and their legal teams have hailed a very important legal milestone made public today by the Court of Session. -
Hernia Mesh Hype: Manufacturers Now Face Over 54,000 Lawsuits
Jun 3, 2018 | The Ring of Fire Network
By Mike Papantonio
...These women were told here’s this vaginal mesh, it’s going to solve incontinence problems, no need to worry and once it was put in their body, they couldn’t get it out of their body.
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Martinez Mesh Trial – What Jurors Will and Won’t Hear
Jun 2, 2018 | Mesh Medical Device News Desk
By Jane Akre
The jury trial of Ana Martinz v Boston Scientific got underway May 31stin Middlesex County trial court in Woburn, Massachusetts, before Judge Thomas P. Billings. Case No. 1281CV03081.
Days before the trial got underway, the judge in this trial court decided what jurors will and will not hear, part of the Motions in Limine.
In December 2010, Ms. Martinez was implanted with two meshes made by the Marlborough – based company – the Pinnacle Pelvic Floor Repair system to treat prolapse, and the Obtryx mid-urethral sling to treat female stress urinary incontinence.
Image: Dr. Kord Strebel, YouTube
Dr. Kord Strebel, MD from Valley Hospital Medical Center in Las Vegas was the implanting physician. Ms Martinez resides in Nevada but since the company is based in Mass. that state is the proper venue.
Plaintiffs allege a design and manufacturing defect, a failure to warn, breach of express warranty (that its merchantability or fitness for intended purpose), loss of consortium, a violation of consumer protection laws, and they seek punitive damages.
SUMMARY JUDGMENT DENIED
Two days before trial, Judge Billings ruled on Boston Scientific’s (BSC) Motion for Summary Judgment.
The company alleged there is no evidence that the company breached its duty to the plaintiff because its actions did not fall below the reasonable standard of care. BSC said it followed the FDA guidelines for getting its meshes on the market, using the 510(k) clearance path, and that the plaintiff “cannot prove that a design defect of the devices caused her alleged injuries.”
Judge Billings denied the motion to dismiss the case.
MOTIONS IN LIMINE
The week of the trial, the docket shows a number of Motions in Limine were decided. Those are items of information both sides would like to eliminate from jury consideration.
Some of the controversial issues:
* The FDA’s 510(k) clearance process – and its lacking assurances for safety and efficacy. Judge Billings agreed to the plaintiffs’ Motion in Limine #3 to exclude the argument that the FDA approved the defendants’ use of Marlex PP in its mesh devices and any discussion of the 510(k) clearance process for the Pinnacle. Taking time to explore and dissect the FDA’s regulations takes valuable courtroom time with the potential to confuse the jury. The FDA is not on trial.
* MAUDE Database – The plaintiffs wanted to preclude any statistical compilation of the FDA database on complications stating these complications are “inherently unreliable.” The judge agreed.
* The Gold Standard – The judge agreed to exclude the sling and mesh products as being referred to as the Gold Standard by AUGS, the American Urogynecologic Society.
* Dr. M. Tom Margolis MD – The Defendant wanted to limit the testimony of M. Thomas Margolis MD; to limit evidence or arguments concerning the medical application caution contained in the Marlex MSDS. That motion was tabled by the judge.
* Mention of ProteGen – This was the first pelvic mesh on the market. Boston Scientific beat out its competition creating the ProteGen pubovaginal sling and it served as a “predicate” for generations of meshes to follow. ProteGen was made from polyester fabric woven and coated with bovine collagen, not polypropylene. Cleared by the FDA in April 1997, ProteGen was recalled in January 1999 after numerous reports of complications were reported.
“The probative value of this evidence is substantially outweighed by its potential for unfair prejudice, confusion and waste of time,” Judge Billings writes.
However, the judge added, the ProteGen evidence may have sufficient impeachment value to warrant its admission and the plaintiff may introduce the ProteGen evidence if the “door has been opened.
* Pinnacle Recall – Pinnacle Pelvic Floor Repair system was the subject of an FDA Immediate Recall in May 2011 for malfunctioning, while a new version of Obtryx, Obtryx II, remains on the market. Generally, the current status of a mesh is not allowed in these cases.
The meshes are made of Marlex, a type of polypropylene plastic. In the 1950s, Marlex was used to make Hula Hoops and lawn mowers. Some history of polypropylene will be allowed before jurors.
Typically in these mesh product liability trials, past trial outcomes, the number of women injured, and the number of doctors still using mesh are not mentioned.
STRICT LIABILITY – Failure to Warn:
The plaintiff must prove the inadequate warning caused her injuries.
A warning is adequate if it communicates the dangers that may result from its use or foreseeable misuse, otherwise the product is defective, says the judge quoting case law.
The doctor is the so-called “learned intermediary.”
If the doctor is provided adequate warnings and all relevant safety information for that product, then the medical device manufacturer is immune from liability under the learned intermediary doctrine. The issue in this case will be how adequate was the warning that BSC provided.
Additionally, BSC says the instruction pamphlet, the so-called Directions for Use (DFU) list all of the possible complications including vaginal erosion, incontinence, device migration, dyspareunia and pain. The doctor was aware of these risks and regularly provided information to his patients.
Martinez’ attorneys argue the warnings were inadequate because BSC never performed any tests on PP’s effect on the human body.
Without that, “It could not possibly have issued an adequate warning of risks,” writes the judge.
The plastic materials should never have been implanted in the human body according to the MSDS, (material safety data sheet which accompanies raw resin) which Boston Scientific knew as early as 2004 but never included that fact in its DFU.
And missing from the DFU are risks such as chronic pain, pain syndromes; incapacitating pelvic pain; complex mesh erosions: chronic foreign body reaction; mesh retraction, shrinkage and folding of mesh; curing of mesh; permanent dyspareunia; inability to remove the mesh; bio incompatibility with human tissue; and rates of mesh erosion.
At the request of Boston Scientific in 2008, Joseph Macaluso conducted a search of the literature and at the conclusion he warned Boston Scientific that “mesh should only be used if really necessary.”
Expert Dr. Suzanne Parisian, formerly a regulator with the FDA, opinioned that the DFU are inadequate because BSC knew that permanent placement increased long-term exposure to PP mesh risks and that the mesh might not be able to be totally removed. That was not communicated to the doctors.
Dr. Strebel testified he was unaware of certain risks including the rate of erosion, the permanence of dyspareunia, the lack of clinical trials, foreign body reaction and the impossibility of mesh removal; if he had been so informed, he would have told the plaintiff.”
BAD TIMING
The trial timing is not ideal for Boston Scientific. Two weeks ago, the news magazine, 60 Minutes led its Sunday segment with damning evidence showing the company knowingly smuggled substandard polypropylene resin from China after its U.S. supplies would no longer sell to the company.
One of the reasons – the Material Safety Data Sheet (MSDS)- which accompanies raw materials processed in U.S. plants, explicitly said “MEDICAL APPLICATION CAUTION: Do not use this Phillips Sumika Polyproylene Company material in medical applications involving permanent implantation in the human body or permanent contact with internal body fluids or tissues.”
60 Minutes showed the emails between company executives as they knowingly hid the shipment marking from U.S. Customs by over bagging them. Despite the fact that BSC knew the lot number on the bags didn’t match lot numbers from the Texas-based petroleum company, which the Chinese importer said was the resin supplier, BSC bought enough raw resin to make pelvic meshes for the next 30 years.
A polymer expert told 60 Minutes that regardless of where it’s sourced, polypropylene has no business being permanently implanted in the human body.
https://www.meshmedicaldevicenewsdesk.com/martinez-mesh-trial-what-jurors-will-and-wont-hear/
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Mesh monitor group is just another whitewash, campaigners say
Jun 3, 2018 | The Sunday Post
By Marion Scott
Mesh campaigners refuse to work with Health Improvement Scotland’s Mesh Implants Oversight Group because they fear it will be used to reintroduce the controversial devices.
They are also concerned that the new group includes a doctor who worked with manufacturers of the material and a patient representative paid for taking part in its trials.
The group was set up on the recommendation of the Scottish Government’s Mesh Safety Review –which drew criticism for having people with connections to manufacturers on its expert panel.
The review is now the subject of an investigation by medical ethics expert Professor Alison Britton.
The remit of the new group is to “monitor the use of mesh implants” until a clinical network is established, even though their use has been suspended since 2014.
Elaine Holmes of Scottish Mesh Survivors said: “We refused to lower ourselves to become part of yet another Scottish Government whitewash into what is being recognised around the world as the biggest medical scandal of our time.” Review member Isobel Montgomery, from Aberdeen, who received £3,000 from two mesh studies undertaken since 2012 and had a “positive mesh experience” is a member of the new oversight group.
Another member is gynaecologist Mahesh Perera, who received training from mesh companies Johnson & Johnson, Boston Scientific, American Medical Systems and Bard.
The Glasgow-based surgeon was awarded fellowship and travel grants from Johnson & Johnson’s Ethicon, Bard, and American Medical Systems, and has described himself as a consultant for Allergan.
Neither has had to declare these past links to the new group, as they date from more than a year ago.
There is no suggestion that either has done anything wrong, but campaigners insist all previous links should be declared.
Health Secretary Shona Robison was criticised for her decision to accept the review with more than 100 MSPs from across all parties signing a petition objecting to the “whitewash” report which opened the door for some mesh implants to be reintroduced.
Campaigners and one of the medical experts – urogynaecologist Wael Agur – resigned from the review claiming the report was distorted.
Healthcare Improvement Scotland said: “The group consists of members appointed by a mix of professional organisations for the clinical expertise and knowledge they provide and other members that we believe play an important contribution to the goals of the TVMO group.
“All members are required to declare their interests in line with the current guidance.”
Asked whether her payments from taking part in mesh trials should have been declared, Isobel Montgomery declined to comment.
A spokesman for NHS Greater Glasgow & Clyde said that Dr Perera was following declaration guidelines.
He said: “The member of staff declared interests going back one year as requested by the Healthcare Improvement Scotland Mesh Implant Oversight Group.”
https://www.sundaypost.com/fp/mesh-monitor-group-is-just-another-whitewash-campaigners-say/
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Mesh manufacturers fail in bid to get cases thrown out
Jun 1, 2018 | Scottish Legal News
By Laura Connor
Victims of surgical mesh across Scotland and their legal teams have hailed a very important legal milestone made public today by the Court of Session.
Hundreds of women from all parts of the country are currently taking legal action against the manufactures of surgical mesh after suffering horrific side effects.
Many have been left in constant and extreme pain. The mesh implants are medical devices used by surgeons to treat pelvic organ prolapse and incontinence in women, conditions that can commonly occur after childbirth.
Today’s legal opinion by Lord Boyd means that attempts by the mesh manufacturers to have these cases dismissed has been rejected so that victims legal action can proceed.
Thompsons Solicitors who represent the majority of mesh victims in Scotland said they and their clients were greatly heartened by what Lord Boyd had to say and would move quickly to the next stage of the legal action.
Elaine Holmes and Olive Mcilroy who set up The Scottish Mesh Survivors Group said: “This is another very important day in our fight for justice. The large multinational companies that produced this faulty mesh that has torn apart the bodies of women and ruined their lives thought they could have our cases thrown out.
“Well today they know that’s not going to happen. We know that there is still a fight to come but there is huge solidarity among mesh survivors and we believe justice will be done. We would like to thank all the support we have had from across the political spectrum in Scotland and from the Scottish public who have always been right behind us. The fight goes on.”
Laura Connor, partner with Thompsons who is leading the legal action, added: “The women that we represent are greatly encouraged that Lord Boyd has not allowed the companies that made this faulty mesh to succeeded in their attempt to stop these cases.
“It’s important to remember that these are large faceless multi billion pound companies which have enormous legal resources at their disposal.
“They are engaged in an attempt to silence our clients and end their claims. These mesh manufactures have huge responsibility in causing one of the biggest scandals in the history of our NHS.
“Many of the women have suffered the most horrific internal injuries due to mesh with little prospect of recovery. They will not be silenced and we are confident that we will secure them legal victory and hopefully prevent other women having their lives ruined by mesh.”
http://www.scottishlegal.com/article/mesh-manufactures-fail-in-bid-to-get-cases-thrown-out
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Hernia Mesh Hype: Manufacturers Now Face Over 54,000 Lawsuits
Jun 3, 2018 | The Ring of Fire Network
By Mike Papantonio
Transcript:
Mike Papantonio: Hernia mesh implants have become a widely popular procedure for patients suffering from any kind of hernia but with more than 54,000 lawsuits filed against the manufacturer of these implants, many now are wondering if what they were sold was really pure hype rather than a solution to their problems. Joining me to talk about this is attorney, Robert Price.
Robert, hasn’t hernia mesh been around forever? I mean, what’s going on with this?
Robert Price: Hernia mesh repair, you know, hernia, the use of mesh to repair hernias has been out there for decades, even since the 1950s. But what we’ve seen with the big manufacturers is that there’s this evolution or a de-evolution, if you will, of taking these meshes and putting them into experimental designs and experimental kits and, as you mentioned a moment ago, the idea here is that it’s a market. Get as much of this stuff out there on the market as possible. And the premise behind a lot of these kits is that they’re easy to use, they’re easy to put in and they have this special coating on them that’s going to make them easy, theoretically you can put them closer to the bowel, you can do a lot of things with them that, sort of, empowers surgeons to use them but, really, what we’re learning is that their designs are very defective.
Mike Papantonio: Well isn’t part of the problem … it used to be not everybody performed hernia surgery. You had to have some training, you had to understand what you were doing but these manufacturers, what they did is came out with this package where they tell doctors, oh, you know, this is easy to do, just mix and shake and you got a hernia mesh solution. Isn’t that kind of what happened and who are these manufacturers? Who’s responsible for this? I mean, it is really a healthcare catastrophe when you start looking at the numbers of cases where this had gone bad causing real serious injuries and even death. Who are these manufacturers?
Robert Price: It’s the same manufacturers we’ve seen in a lot of the mesh litigations. The biggest manufacturers are Johnson and Johnson, C.R. Bard, and a company called Atrium, that’s from New Hampshire. Those manufacturers are … The idea, what you started off saying is exactly correct. The idea is that there are some hernia repair clinics around the country that specialize in hernia mesh repairs and a lot of hernias out there don’t need mesh to repair them but surgeons have used mesh to … when mesh is needed but the concept of when mesh is needed has just exploded over the past decade or so as more and more surgeons are being told, hey, you can use this kit, you can use this type of mesh.
Manufacturers are saying you can take this mesh and you can place it right up against the bowel, it’s got this special coating on it, it’s got a chemical coating that’s going to help protect the bowel, which is not backed by studies. It’s not backed by adequate science so a lot of this mesh is being placed in patients that’s experimental in design and it’s the same manufacturers, many of the same manufacturers, that did the women’s pelvic mesh years ago that we’ve seen lawsuits over that. So, some of the same actors here, same meshes, same problems.
Mike Papantonio: That ended up killing a good number of women. These women were told here’s this vaginal mesh, it’s going to solve incontinence problems, no need to worry and once it was put in their body, they couldn’t get it out of their body. It had migrated to all different parts of the body. The mesh would break, it would migrate to their brain, their heart, all over their body and the manufacturers knew then … matter of fact, I took a deposition on that case and I remember that one of the descriptions of what it looked like inside the body was it looked like concrete and rebar, trying to remove it from the body was like trying to remove concrete from rebar.
So, this is really no different. What are they doing with the meshes that make the design so bad, Robert? Why is this such a big problem for people? Why should people say hell no, I’m not going to have this in my body if I have an alternative?
Robert Price: I’ll give you a couple of examples. There’s a lot of different designs out there with a lot of different problems but I’ll give you a couple of the worst designs and here’s what they are. There’s a laparoscopic technique where, essentially, if you have a ventral or a hernia in the stomach region, there’s a technique where instead of opening up through an incision, you can get a laparoscope and come through laparoscopically and some manufacturers, including Johnson and Johnson, they allow the mesh to be placed right up against the bowel on the inside of the skin, on the inside of what’s called the perineum, that layer right there, and be placed right up against the bowel. And allegedly the special coating is supposed to stop the mesh from integrating in the bowel. Well, what we found out is it actually does the reverse. The coating on the mesh actually stops the mesh from integrating into the tissue, which is what you want, and it does something called a reverse integrates and eats into the bowel. That’s one example.
Another example of this experimental coating is the Atrium Corporation, for example, coats its meshes in fish oil. Now, there’s no studies, there’s no studies out there that prove that it’s safe to coat a mesh in fish oil and put it in humans. It is unstudied design, there are a couple of studies in rats that showed it actually caused massive adhesions in rats. But literally, they’re taking fish oil from barrels, pouring it over mesh, coating it and then sticking that in a human body. You see massive infections, bowel removals, bowel recessions, some patients have to live with a colostomy bag after some of the stuff that they’ve been through.
Mike Papantonio: Too often they go in a doctor’s office, the doctor says this is how it is. The patient doesn’t do research to find out what the doctor’s just told them, it’s a huge mistake. The second problem is that we believe that the FDA actually is there to help us. The FDA has become as dysfunctional as the EPA and the FCC and every other regulatory agency in this country, maybe even worse because it’s our health that the FDA’s supposed to be looking out when it comes to things like mesh and pharmaceuticals and they have totally, totally become an extension of corporate America. They’re absolutely useless as a regulatory agency.
Thanks for joining me, Robert.
https://trofire.com/2018/06/03/hernia-mesh-hype-manufacturers-now-face-over-54000-lawsuits/
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