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Ethicon 9/30
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Pelvic Mesh Users Slam Ethicon's Coaching Claims
Sep 29, 2015 | Law360
By Sindhu Sundar
The plaintiffs in multidistrict litigation over allegedly defective pelvic mesh implants fought back Tuesday against Johnson & Johnson unit Ethicon's arguments that their attorneys had improperly coached doctors before depositions, arguing that the drugmaker's strategy is similar to one that the court had previously rejected. -
Patient claims defective device was used during surgery
Sep 29, 2015 | Louisiana Record
By Brandon Caples
An Orleans Parish husband and wife are suing a popular medical company for implanting a faulty device in the wife, allegedly resulting in severe complications. -
Day Six: Cavness v. Ethicon Mesh Critic Blasts Polypropylene Pelvic Mesh
Sep 29, 2015 | Mesh Medical Device News Desk
By Jane Akre
Dr. Michael Carley, affiliated with Baylor-Health Texas, (here) first saw Carol Cavness June 14, 2012, two months after she had a Prosima pelvic mesh implanted to treat a prolapsing pelvic floor. -
Mesh-Injured Woman Facing Homelessness
Sep 29, 2015 | Mesh Medical Device News Desk
By Jane Akre
...Suzy is losing her home. Many women and men, disabled by their polypropylene pelvic and hernia mesh devices, have also lost their homes... -
Drugwatch: How the FDA Has Let Women Down
Sep 29, 2015 | Mesh Medical Device News Desk
By Jane Akre
Drugwatch, a publication of the Petersen law firm, goes above and beyond in this article ‘How the FDA has Let Down Women.”
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Pelvic Mesh Users Slam Ethicon's Coaching Claims
Sep 29, 2015 | Law360
By Sindhu Sundar
The plaintiffs in multidistrict litigation over allegedly defective pelvic mesh implants fought back Tuesday against Johnson & Johnson unit Ethicon's arguments that their attorneys had improperly coached doctors before depositions, arguing that the drugmaker's strategy is similar to one that the court had previously rejected.
In an opposition filed in West Virginia federal court, the plaintiffs said that Ethicon Inc. shouldn't be allowed to restrict the plaintiffs' attorneys from speaking to treating physicians, pointing to the same court's previous ruling denying C.R. Bard Inc.'s bid for similar restrictions in the MDL over its own pelvic organ prolapse products.
The plaintiffs said that the court previously upheld U.S. District Judge Mary Stanley's ruling against Bard's request to limit the plaintiffs from talking to their doctors.
In her 2012 ruling, Judge Stanley found that there are no rules calling for such restrictions and wrote that "it is accepted that attorneys are expected to prepare their witnesses for the rigors of giving testimony," according to her ruling. The plaintiffs in the immediate case urged the court to uphold that view in the context of Ethicon's similar request.
"Judge Stanley’s ruling has been the law of the case in these MDLs for more than three years, and has governed literally hundreds of doctor depositions taken to date in the various pelvic mesh MDLs," the plaintiffs said in their filing.
"All of the same arguments raised by Ethicon here were thoughtfully considered and addressed by Judge Stanley, and Ethicon offers no reasonable basis to revisit or alter this ruling that has governed this litigation for more than three years, other than perhaps the fact that it does not like the ruling," they added.
Ethicon has argued that its own attorneys don't have the same right of access as the plaintiffs' counsel to treating physicians outside of the formal discovery process and that the alleged coaching sessions create an imbalance in the case.
Seven MDLs containing more than 70,000 cases concerning transvaginal surgical mesh devices used to treat pelvic organ prolapse and stress urinary incontinence are assigned to U.S. District Judge Joseph R. Goodwin.
Last year, J&J won the first bellwether case against it in a five-day trial that concluded when Judge Goodwin granted the defendants’ motion for judgment. The Fourth Circuit upheld that judgment in March.
The plaintiffs steering committee in the MDL is represented by Renee Baggett and Bryan F. Aylstock of Aylstock Witkin Kreis & Overholtz PLLC and Thomas P. Cartmell ofWagstaff & Cartmell LLP.
The case is Edwards et al. v. Ethicon Inc., case number 2:12-cv-09972, in the U.S. District Court for the Southern District of West Virginia. The MDL is In re: Ethicon Inc. Pelvic Repair System Products Liability Litigation, case number 2:12-md-02327, in the U.S. District Court for the Southern District of West Virginia. -
Patient claims defective device was used during surgery
Sep 29, 2015 | Louisiana Record
By Brandon Caples
An Orleans Parish husband and wife are suing a popular medical company for implanting a faulty device in the wife, allegedly resulting in severe complications.
Debora Modica and husband Roland filed suit against American Medical System Inc. and American Medical System Holdings Inc. in the U.S. District Court of the Eastern District Court of Louisiana on Sept. 14, alleging that the companies' products are defective.
Modica alleges that in November 2011 she was implanted with the AMS Monarc Mid Urethal Sling, which was performed at Tulane Medical Center in New Orleans to treat stress urinary incontinence and pelvic organ prolapse. Modica claims because of having the AMS product implanted in her, she has experienced significant mental and physical pain and suffering, including loss of physical relations with her husband Roland.
The plaintiff contends she has suffered continuing problems due to the device eroding inside of her, the complaint states.
An unspecified amount in damages is sought for medical expenses, loss of earnings, negligence, pain and suffering, mental anguish, emotional distress, embarrassment, companionship, disfigurement and loss of enjoyment of life.
The couple is represented by Charles M. Thomas and Brian P. Marcelle of Huber, Slack, Thomas and Marcelle of New Orleans.
U.S. District Court of the Eastern District of Louisiana case number 2:15-cv-04397-EEF-MBN
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Day Six: Cavness v. Ethicon Mesh Critic Blasts Polypropylene Pelvic Mesh
Sep 29, 2015 | Mesh Medical Device News Desk
By Jane Akre
Dr. Michael Carley, affiliated with Baylor-Health Texas, (here) first saw Carol Cavness June 14, 2012, two months after she had a Prosima pelvic mesh implanted to treat a prolapsing pelvic floor.
Her complaint was pain. She was concerned her job as an airline mechanic would be further compromised if she could not resolve the pain soon. Since her pain had not responded to conservative measures, she elected for a removal which Dr. Carley performed on July 9, 2012. It would be his first of two mesh excisions (removals)on the Plaintiff.
Dr. Carley removed several fragments of pink-red soft tissue adhered to synthetic material consistent with vaginal mesh. In aggregate, the specimen came out in fragments that measured collectively 4.3 x 2.5 x .6 cm. The pieces were removed transvaginally from the posterior wall of the vagina.
A second removal yielded calcified nodules ranging in size from 0.1 to 0.3 cm in greatest dimension.
Unfortunately, that did not resolve the pain. By August, Ms. Cavness reported stabbing pain. Conservative treatments such as pelvic floor exercises, steroids, anti-inflammatories, Celebrex or hydrocodone did not resolve the pain either.
Earlier the Defense suggested the removal surgeries and scar tissue formation from that may have caused her pain. No, it did not, said the doctor.
By January, 2015 she still has pain and vaginal discharge and she was referred to pain management. Dr. Carley concluded,
“There is a palpable foreign body in the patient’s right apex…” He identified “several bead-like foreign bodies, unclear whether these represent synthetic mesh or not.”DR MARGOLIS – CRITIC OF POLYPROPYLENE MESH
There was nothing unclear about the testimony in the courtroom of Dr. Michael Margolis, a urogynecologist from the San Francisco bay area (here). Double board certified in Ob-Gyn and Urogynecology, Dr. Margolis says he’s done more than 25,000 surgical procedures in his career including 5,000 to 6,000 for stress urinary incontinence and the rest- 14,000 or so were POP (pelvic organ prolapse) -related.
He does upward of dozen surgeries a week with almost half mesh removals. He made it very clear he, “Does not or ever has implanted transvaginal synthetic systems into any human being because of the well know and well established irreversible and magnificently bad complications associated with transvaginal polypropylene mesh systems, which is well described in the literature.”
Likening it to trying to remove rebar from the sidewalk, he insisted passionately to the jury that the risks of Prosima substantially outweighed the potential benefits to any patient, including Ms. Cavness. Her injuires are permanent and irreversible because of the design defect of the Prosima; the heavy weight of the Prosima and its Prolene PS mesh; the shrinkage capacity of Prosima (around 30 percent); the degradation of Prosima; the chronic foreign body reaction of Prosima.
He left no doubt to the Plaintiffs’ claims of a defective product grabbing a sheet of paper and crumbling it up in his hand to illustrate how mesh contracts, folds and shrinks.
“It distorts the normal anatomy and it causes new prolapse where there wasn’t prolapse before. It’s impossible to safely remove it all. Foreign body reaction causes it to scar into place.” he said, and that scar essentially locks the mesh in place. “You’re stuck with it for life.” he said.
Dr. David Robinson- Ethicon former Med. Dir.
Ethicon knew it had a faulty product an inner office email show. David Robinson, MD, the worldwide medical director said in February 2008, “Clinically there may be an impact of increased rigidity with any given mesh as it may increase vaginal stiffness postop with the potential to impair sexual function. Suffice it to say, however, that all meshes we are working on for future use will be less rigid than our current Gynemesh PS.”
But the improvements were never incorporated into a new mesh for Prosima. Under Texas law, the plaintiffs must show there was a safer alternative. Though he is no fan of polypropylene mesh, Dr. Margolis said the UltraPro was lighter using about 38% less mesh than the Prosima and was half the weight. It was softer, more elastic and partially absorbable. Even Ethicon said in an internal report, “Without any negative side effects when compared to traditional heavyweight meshes!”
UltraPro was available at the time the Prosima was launched in January 2010.
Under questioning, Dr. Margolis and Cavness’ attorney established Ethicon knew full well that it had a problem with the heavier Prosima. Did it tell the FDA or Cavness’ implanting physician in letters, in an Instruction for Use (product label)? No, they didn’t said the doctor.
The jury was shown a July 2012 article Pain complications of mesh surgery by Lisa Rogo-Gupta and Shlomo Raz, MD, the father of mesh complications. It said mesh shrinks 30 to 60 percent and mesh degradation begins immediately following insertion.”Mesh placed in vaginal surgery is not inert,” said the article (here).
Inert means, the immune system doesn’t know it’s there.
Otherwise, Margolis explained, the bacterial contamination and subsequent inflammatory response releases noxious degradation products, enzymes and macrophages that attack the invader foreign body, the mesh.
Did Ethicon put any of this information in its IFU? No, in fact they call the inflammatory reaction “transitory,” and that the mesh remained “soft and pliable.” “It’s 180 degrees opposite. Its not true,” said Dr. Margolis in disgust.
MESH REMAINS BEHIND
Despite a third mesh removal attempt by Dr. Philippe Zimmern of Dallas, Dr. Margolis insisted all of the mesh cannot be removed, based on his 17 years experience “trying to dig this stuff out.”
“She has dysfunction of the bowel, the bladder, scarring, contraction of vagina, erosion, dyspareunia. She’s suffered prolapse to new areas. She’s suffered three attempted explant surgeries and all the pain and suffering associated with them and the stuff is still there. It has not been removed,” he said of Ms. Cavness today.
She received absolutely no benefit and all of the risk, he insisted.
Cavness attorney reminded the jury of the words of Dr. Martin Weisberg of Ethicon. Seven years before Ms. Cavness 2012 implant he asked in an inner-office memo, “Why would anyone spend any money on a device and take what they consider a risk of using a graft when they could get the same results for free with a native tissue? If we are not confident that this will be better than what our marketing has been claiming is inadequate (native tissue repair) why bother pursuing? ”
Did the company follow his instructions? No, they did not.
“This is exactly what happened to Carol. It breaks your heart.”
Dr. Margolis told the jury her native tissue repair done by Dr. Carney worked and is holding “perfect. She didn’t need the mesh.” he concluded.
LIFE CARE PLAN
What will the cost be to make life easier for the Plaintiff? Registered nurse and life care planner, Leigh Anne Levy, told the jurors the Plaintiff will need outpatient and therapeutic care, long-term care, medications, diagnostic services for the rest of her life for her disability.
The total lifetime costs are $570,383.50, and these she considers conservative numbers.
On cross examination, Helen Kathryn Downs of Butler Snow, asked if Ms. Levy was offering any opinion whether the injuries were caused by the mesh? No, said the RN, they make the plan based on the medical records and on her present disability.
Dr. Margolis, who examined the Plaintiff as recently as two days ago, has said Ms. Cavness likely will need two more surgeries in her lifetime. #
BACKGROUND
This is the first trial for Ethicon’s Prosima pelvic mesh used to shore up the pelvic floor from a prolapse. The plaintiff, Carol Cavness, 60, is in the courtroom listening to the proceedings.
Cavness is represented by Tim Goss and Richard Freese of Freese & Goss PLLC, Bill Blankenship of William F. Blankenship III PC, Richard Capshaw of Capshaw & Associates, Kevin Edwards and Peter de la Cerda of Edwards & de la Cerda PLLC, and Julie Rhoades and David Matthews of Matthews & Associates.
Ethicon is represented by William Massie Gage and Helen Kathryn Downs of Butler Snow LLP and Kathleen Gallagher of Beck Redden LLP. ##
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Mesh-Injured Woman Facing Homelessness
Sep 29, 2015 | Mesh Medical Device News Desk
By Jane Akre
She is a reader of Mesh News Desk. She belongs to several Facebook groups started by mesh- injured women. “Suzy” must remain anonymous because she is represented by legal counsel.
Suzy is losing her home. Many women and men, disabled by their polypropylene pelvic and hernia mesh devices, have also lost their homes. Many more are in the process. Being unable to work will cause a cascading series of events that eventually end up with failed mortgage payments. Banks do not care.
In Suzy’s case, her home will soon be turned over to Chase, which is a major shareholder of Johnson & Johnson, maker of her pelvic mesh implant.
She could simply not make her mortgage payments on disability checks. And Chase would not qualify her for any program or work with her to re-modify her mortgage payments even though her home is worth less than she invested. Her law firm has been unable to help. In fact they will be first in line when/if she receives a settlement from Johnson & Johnson.
Her story is being echoed around the country – Thousands of dollars that might have kept her doors opened went to her medical care. “There are no standards for care in mainstream for mesh complications,” she complains. “Men and women are dying but not before being treated really horribly by mainstream medicine due to the lack of standards for complications.”
“These patients are being tested and retested repeatedly to standards that do not apply. These patients are humiliated, belittled, drugged, ignored, dismissed, told they are crazy, thrown out of ER’s begging for help, treated as drug seekers, repeated hospitalized without resolutions, they are metabolic messes in excruciating mind-blowing pain – that has the intensity of childbirth pain but is 24/7 with no relief in sight. They are flat out being treated less than human.”
And there are only a handful of doctors worldwide that can actually help them.
Along the way, Suzy visited the Mayo Clinic in Minnesota to have the middle piece of her TVT-O removed. Altogether she’s had eleven surgeries, some exploratory just to find the mesh and many guided nerve blocks. She’s had over 80 tumor growths removed from an area around her pelvis where the mesh was. Dr. Hibner in Arizona removed about eight more inches of mesh within in the last ten months finally giving her some relief.
At this point, Suzy says her options are exhausted. Chase is just waiting for the Sheriff to throw her out of her home. She found out about the sale on the courtroom steps just days before it happened. She did everything the bank told her to do but the sale went through anyway. “They are dirty low down crooks,” she says about Chase.
Fall leaves
Suzy paid $335,000 for her home in 2004. She says back then it was a “dump” so she spent thousands cleaning and repairing it. She needed a home for her children.
Suzy worked in the medical field. She was able to invest a sizable $112,000 as a down payment. Then she got sick after a TVT-O implant. She says it became an issue immediately and she was paralyzed within eight months post-op. Currently her home’s value is $159,337 (after the hit in real estate values in 2008).
“Chase jerked me around from day one. They didn’t care I was sick and disabled. They threatened me, my kids, folks showed up at my door, parked in the driveway and constantly were coming and taking pictures.”
Why … she doesn’t know. “There was constant submission of documents, phone calls, each person tells you something else at their office. You never get the same response twice.” Lately she is being passed around between what she calls the “Greedy-Tier (Chase/Seterus/Fannie Mae)”.
Suzy says Chase did a mortgage modification but it was $400 over her current mortgage she was already having trouble paying on disability. Chase has sent the policy to Seterus to decide how much she’d owe to keep her home. It was all over the board, first $135,000, then $351,000. Now Chase wants over $466,000, she says, for a house worth $159,337. She recently found out her mortgage was backed by Fannie Mae so she complained to them. She feels she should have qualified for something through them long ago. No entity would even help to relocate.
Leaving her homeless is like a death sentence, says Suzy. She suffers from Clarkson Syndrome, which is a stealth, autoimmune systemic shock-like condition she developed post-mesh. She has nowhere to go. Thanks to the foreclosure on her record, most landlords will not even show her an apartment let alone rent her one. And again no one seems to care.
Suzy would like others to be aware of what is happening all over the world and in mainstream medicine so that others may avoid the hell that she and her family has had to endure. She has no idea how she will break the news to her youngest. Her youngest will even have to give up her fur babies and has already lost out on so much over the last 5 years. Just breaks Suzy’s heart even more. Suzy says “The children of mesh have suffered and seen so much. No child should ever have to see that nor their parents in that condition.”
Susy want’s everyone to know if any doctor offers you a blue polypropylene mesh, device, sling or tape or any reason do not walk away but rather RUN FOR YOUR LIFE!!!! All MESHES per the NIH’s own admission ARE NOT INERT. Some may just be worse than others.
*Postscript – Monday Suzy met with a judge. “He didn’t want to hear anything,” she tells MND. The judge did grant me ten extra days to get out of my home. I get to tell my daughter we’re homeless for her b-day. So tired of no one wanting to hear anything nor caring. I almost lost it in court. I told the chase lawyer she works for a horrible corporation and she laughed. So tired of this, thanks for listening. #
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Drugwatch: How the FDA Has Let Women Down
Sep 29, 2015 | Mesh Medical Device News Desk
By Jane Akre
Drugwatch, a publication of the Petersen law firm, goes above and beyond in this article ‘How the FDA has Let Down Women.”
The agency has dropped the ball on women’s health issues from the power morcellator to the Essure birth control device, surgical pelvic mesh and on and on. Reporter, researcher, Michele Llamas writes an excellent big picture story of the many ways the FDA is not protecting women, the majority consumer of medical products and procedures.
“When it comes to the availability of life-saving medical products and the safety of drugs and devices, men still have the upper hand. One of the greatest and most powerful health agencies in the world, the U.S. Food and Drug Administration (FDA), is a big part of the problem.”
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