Dr. Michael Carley, Baylor urogynecologist

Thanks to Courtroom View Network for access to a live feed in this Dallas courtroom of Judge Ken Molberg.  Carol Canvess v. Kowalczyk et al. #DC-14-04220.

MND, September 28, 2015 ~ 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

Dr. M. Tom Margolis, urogynecologist

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.

Dr. Shlomo Raz, UCLA Urology

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

Helen Kathryn Downs, Butler Snow, attny. for Ethicon

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

Prosima prototype

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. ##

The post Day Six: Cavness v. Ethicon Mesh Critic Blasts Polypropylene Pelvic Mesh appeared first on Mesh Medical Device Newsdesk.

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.”

 

Please read it..
http://www.drugwatch.com/fda-let-women-down/

The post Drugwatch: How the FDA Has Let Women Down appeared first on Mesh Medical Device Newsdesk.

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.  #

LEARN MORE: 
http://www.amjmed.com/article/S0002-9343(14)00772-4/abstract

https://en.wikipedia.org/wiki/Capillary_leak_syndrome

Consumer Affairs on Seterus
http://www.consumeraffairs.com/finance/ibm_lender_business_process.html?page=2

Seterus Reviews- a Total nightmare
http://seterus.pissedconsumer.com/

NIH – ALL MESH NOT INERT
http://www.ncbi.nlm.nih.gov/pubmed/22578730

JNJ Major shareholders
https://finance.yahoo.com/q/mh?s=JNJ+Major+Holders

The post Mesh-Injured Woman Facing Homelessness appeared first on Mesh Medical Device Newsdesk.

THANKS TO COURTROOM VIEW NETWORK FOR ACCESS TO THE LIVE FEED IN DALLAS COURTROOM. 

Prosima pelvic mesh prototype, Marcus

MND, September 29, 2015 ~ Continuing on what would be the final day of the Plaintiff’s case in Cavness v. Ethicon (Cavness v. Kowalczyk et al., case # DC-14-04220), Dr. Michael Margolis, a California urogynecologist and mesh removal expert took the stand for the second day to continue his damaging testimony about the pelvic mesh implanted in Carol Cavness. 

Prosima was marketed by J&J’s Ethicon division in January 2010. Two years later it was quietly taken off the market but not before it was implanted in an unknown number of women to treat pelvic organ prolapse (POP).

Dr Margolis had a dim prediction about the pain symptoms Ms. Cavness still experiences, three years after her implant in April 2012. It’s the same chronic pain thousands of other women with pelvic mesh implants feel every day.

MESH CAUSES OTHER PROBLEMS

Dr. Margolis likened it to a tennis net, pull one portion and the rest will follow.  In the pelvic area, when a mesh is implanted it will shrink and contract and pull causing a distortion. That’s what happened to her, said the urogynecologist.

It’s called a de novo prolapse because it affects an adjacent area of the vagina adversely.  Dr. Margolis insisted the Prosima mesh placed at the back of the vagina caused a prolapse, not unlike a hernia, between the vagina and rectum called an enterocele.

“I’m not the only one who believes that,” he said pointing to the literature.

Richard Freese, Freese & Goss

Interestingly, the Plaintiff attorney, Richard Freese pointed to a study by the inventor of the Prosima, an Australian doctor Marcus Carey and published in October 2007. It says new prolapse in nonrepaired compartments accounted for 58 % failures in 12 months.  See it here.

The study noted, further studies are required to establish the role of the surgery described in this study.”

Dr. Marcus Carey, U of Melbourne AU

Did those further studies ever occur, Mr. Freese asked Dr. Margolis.  They did not, he said .

Another study from The Netherlands echoes the same finding. In “Development of de novo prolapse in untreated vaginal compartment after prolapse repair with and without mesh: a secondary analysis of a randomized controlled trial”,  here, published Feb. 11, 2012 in BJOG.

The authors said that mesh-augmented prolapse repair in only one vaginal compartment is associated with a higher de novo prolapse rate in the untreated compartments compared with native tissue repair.

“We strongly discourage any preventive use of mesh in unaffected compartments because the long-term effects and complications of vaginal mesh are not yet fully known” it concludes.

That study was published in February 2012, two months before Carol Cavness was implanted.  Did Ethicon warn her doctor or the U.S. Food and Drug Administration? Was it included in the IFU (Instructions for Use) that go to the treating physician?

No, they did not, said Dr. Margolis.

MESH CAN’T BE REMOVED  

Ms Cavness wanted to attempt another mesh removal. She had already had two excisions by Dr. Michael Carley who thought he got all the mesh out.  Dr. Margolis said another attempt was advised. When he examined her in December 2014, he found obvious mesh erosion inside the posterior vaginal wall and dense, thick scar tissue along the entire posterior vaginal wall to the top of the vagina. That would be expected to be found in a woman who had three surgeries, he said.

But the likelihood of success was dim.

“I informed her all of the mesh cannot be removed. I told her it’s appropriate to try and get it out but I’m not a soothsayer we all know you’re never going to get it out.  I told her she’s going to have to live with pain for the rest of her life.”

Dr. Margolis likened it to being shot in the chest. When you remove the bullet, you’re not fine. “You’ve done damage and that damage is permanent,” he said referring to the continuum of inflamed tissue which causes nerve entrapment, pain, and dysfunction of the bladder and bowel.

Is this chronic pain, asked Mr. Freese.  “She meets all the criteria for chronic pain syndrome.”

Ms. Cavness is going to have to live with pain for the rest of her life, he added saying that the Life Care Plan, that forecasts a succession of medical needs in the future and admitted into evidence during yesterday’s testimony, was accurate and proper.

He added that smoking has no correlation to pelvic pain.  The Defense pointed out the Plaintiff is a smoker.   Smoking is not contraindicated in any Ethicon promotional brochure for Prosima.

CROSS EXAMINATION – AN UNCOMFORTABLE EXCHANGE

Kat Gallagher, Attorney for J&J

The afternoon cross exam conducted by Defense attorney Kat Gallagher with Dr. Margolis was an uncomfortable exchange with her punctuating a series of questions, some with attitude, and Dr. Margolis answering with as few words as possible.

First, she wanted to know aren’t there many causes of pelvic pain? Yes there are.

Kat Gallagher:  We can agree smoking has a negative effect on the body, she asked, proceeding. “One of the things it does is to reduce vascularity, it constructs blood vessels so oxygen is not getting to the body and that can affect how a person heals.” (Ms. Cavness is a smoker.). 

She continued, “Are you aware of the literature that smoking increases the risk for mesh exposure.” No, he said. “You have a responsibility to keep up with the literature in your field don’t you,” she asked.  He agreed.

Dr. M. Tom Margolis, urogynecology

The Defense attorney talked about the FDA’s Safety Communication of 2011. Dr. Margolis answered there was also one in 2008.

She said, “We’re talking about 2011. Are you with me?”

“Proceed,” said Dr. Margolis.

Ms. Gallagher suggested some patients have a good outcome with a Prosima implant.

“That’s a possibility,” said the doctor.  

The FDA expert panel in September 2011 had concluded that mesh used to treat incontinence (SUI) was safe, she reminded Dr. Margolis.

He said, “They concluded use of the sling was safe up to one year. Some societies came out in favor of polypropylene mesh. “I can think of one where paid consultants to Ethicon they submit an opinion paper that used to represent the urogynecology society, which they do not.”

Kat Gallagher continued.  “Is it fair to say you disagree with the FDA on the use of mesh for SUI.  Let’s talk about the basis for your opinions okay? You’ve never performed any studies on mesh degradation?

“No.”

You’ve never published on mesh degradation?

“No.

Gallagher: “What is GPC- gel permeation chromatography, another way to measure degradation. Are you familiar with that?

“No,” he said.  See here.

Gallagher: “My point is there is a set of people who measure degradation and that’s not something you do right?”

“Correct.”  Dr. Margolis said that was lab work and not his field as a surgeon.

Gallagher established that Dr. Margolis has never implanted a Prosima or an UltraPro, the other lighter weight mesh mentioned in this trial as a better alternative.

Gallagher: “And you wouldn’t implant it would you?

Margolis: “Not if I could avoid it.”

Changing course Kat Gallagher suddenly asked whether Dr. Margolis had any idea the total amount he’s been pain in this case.

He said he had no idea.

CAVNESS PAIN PRE-MESH

Kat Gallagher pointed out that it was pain that brought Ms. Cavness to the emergency room on April 21, 2012, before she ever had a Prosima pelvic floor mesh implant. She recounted that the Plaintiff had been listing an 80 lb. item and the pain was so bad she was prescribed hydrocodone.  The pain also created an immediate need to do surgery three days later, she said.

“Let the records speak for themselves” he said sternly.

Coming back, Gallagher asked if he was aware other doctors don’t agree with Dr. Margolis that more mesh is left behind.

Dr. Carley did not anticipate she will need further surgeries because he believed he got out all of the mesh.  The source of her complications he doesn’t believe are related to mesh. The pain doctor said “unknown etiology” to explain the pain.  Dr. Phillipe Zimmern, who did find more mesh on her third removal attempt, said the source of her pain has not been explained.

Dr Margolis said again, he would let the record speak for itself.

Their exchange was not productive.

“No more questions your honor,” said Kat Gallagher, closing the cross exam.

RE-DIRECT EXAM

Once more the Plaintiffs wanted to establish that Cavness is disabled. Dr. Margolis described it as a “Progressive diminution,” which will take years as opposed to decades.

Ms. Gallagher asked Dr. Margolis if the mesh was in a different spot, said Mr. Freese, are you surprised?

Prolene Mesh

“No not at all, mesh fragments and breaks off, it moves around and migrates, it erodes and moves around it changes its orientation. Once implanted it doesn’t stay the way it was when it was put in.  It breaks off and satellite lesions break off. “

“That’s all I have, your honor.” And with that the Plaintiff rested without putting the Plaintiff on the stand.

ETHICON’S VALUE

Judge Molberg told the jurors after a brief afternoon break that both sides have agreed to a stipulation between the parties, an agreement to certain facts.

As a final word, the Plaintiffs’ attorney read, the net worth of Johnson & Johnson.

“The audited net worth of  J&J based on financial statement prepared December 2014, in their Form 10-K annual report of the U.S. Securities and Exchange Commission is $69,752,000,000.  The audited network of Ethicon as of December 2014 for internal use only is $2,912,443,000.”

In the late afternoon hours, the Defense began its case. #

The post Plaintiffs Rest with $70 Billion Reasons Jury Should Find for Pelvic Mesh Victim appeared first on Mesh Medical Device Newsdesk.

August 9, 2015 ~ Greg Vigna, MD, JD, is both a doctor and a lawyer who is directing his expertise as a traumatic injury specialist now to pelvic mesh injuries.

As a physician he specializes in Physical Medicine and Rehabilitation caring for patients with severe traumatic brain injuries and spinal cord injuries. He understands` the game changing effects of these injuries on the patient and her family.

He is also a Certified Life Care Planner who understands the economic cost of a catastrophic injury both now and in the future. Third, he is a personal injury attorney who only represents those with catastrophic injuries. Dr. Vigna focuses on the severe pain syndrome of pudendal neuralgia or nerve pain from injury to the pudendal nerve. One of the most read stories on Mesh News Desk is about pudendal nerve damage from mesh used for pelvic organ prolapse (POP) and stress urinary incontinence (SUI). Dr. Vigna is a sponsor of Mesh News Desk.  Please visit his website here.

Pudendal Nerve, Wikipedia

Q: What brought pelvic mesh pelvic mesh injury cases to your attention?

A:    Pudendal neuralgia (PN) is a catastrophic injury as damaging to the life of an individual as paralysis from the waist down. As a physician I recognize there is a great cost to a catastrophically-injured person and their family, psychologically and economically. The purpose of going into TVM caused pudendal neuralgia is this is one of the most difficult, expensive disorders one has to live with. The lifetime cost in relation to treating pudendal neuralgia is easily $1.4 million to $2 million over a lifetime.

I see spinal cord and brain injuries all the time. A person is hit on the freeway by an uninsured motorists and suddenly they are no longer economically viable. Their families are now indigent. Here we have a similar situation. The purpose of product liability law is to cost-shift to those better able to handle the cost. In this litigation for the worst injured there has not been a successful cost-shift. These women are disproportionately left to become indigent. I’m pleased to say there are attorneys willing to step up to represent all, including the 2 percent who are severely injured.

Q: It’s fair to say you are not trying to represent or help all injuries resulting from pelvic mesh implants?

A: I believe one to two percent of women involved in this litigation have a pain syndrome consistent with pudendal neuralgia. Simply, there are only a few medical conditions as destructive to an individual and the family unit as a pudendal neuralgia. It is a horrendous pain syndrome that interferes with any meaningful mobility and interferes with sexual, bladder, and bowel function. As a physician who sees over ten spinal cord injured patients a day, without hesitation I would rather be paralyzed from the waist down than have what these women have.

 

Q: To what extent does the POP and SUI mesh surgery and the trocars play in causing pudendal nerve injury?

A: To date there has not been a trial that highlights pudendal nerve injury other than Linda Gross trial. In pelvic organ prolapse surgery (POP) there is a blind component, which offends common sense.   I’m more concerned with the word ‘blind’ than the use of trocars since ‘blind’ should not be in the same sentence as the word surgery. There are certainly anatomical variations in humans and even a properly placed device will come dangerously close to the pudendal nerve. There are pudendal neuralgias (pain) in appropriately positioned devices that may directly injure the nerve or over time will be pulled by traction as well as scar tissue from the foreign body response that causes entrapment and nerve damage.

Dr. Mario Castellanos, a urogynecologist specializing in mesh related pudendal neuralgia, published a study in 2012 that described the anatomic basis of pudendal neuralgia with the JNJ Prolift. This study shown that the arms of the device came within a centimeter of the rectal branch of the pudendal nerve.   There are no treatments for that damage. They have intractable rectal pain and dyspareunia and there is no decompression surgery that deals with the rectal branch. In SUI, the literature is clear, there is a six times greater chance of damage with any sling device that offends the obturator membrane.

TVT-O, Levin Law

There is a busy pain pelvic pain clinic in Phoenix that has only seen one case of a severe pain syndrome from a retropubic sling (TVT). All of the rest are from the TVT-O. Over time, I believe transobturator slings will cause more damage than POP devices. The FDA still has not moved on transobturator slings. Over time the litigation process will end transobturator slings. If not, I will sue them into perpetuity.

Q: Are they defectively designed?

A: Yes. When the obturator membrane is involved the obturator nerve and the pudendal nerve are at risk of injury, both acutely and over-time. They’re trying to make it smaller with less mesh, to hook onto the membrane but still these devices such as the mini-arc single incision device are all defective.

If you are going to ask one question, of your doctor who suggests mesh, I’d ask why not use the retropubic sling (TVT) versus the ones that offend the obturator membrane? If they say with the retropubic sling there is a potential of puncturing the bladder, those issues are easily dealt with because the bladder heals but nerve damage is nerve damage. The catastrophic pain syndrome that turn women into train wrecks are from the transobturator slings.

Pudendal Nerve, YouTube

Q: What are a woman’s chances of recovering from pudendal nerve damage?

A: If a pudendal nerve is entrapped, six months after decompression I can predict what kind of life care needs a patient will have. I’ve had clients who have improved; they can function and sit. My goal is to educate women to empower them to get the care they need to demand from their doctors the care they need and deserve. With education, they are empowered to ask their attorney if this is a situation that would require individual litigation. And if those attorneys want to proceed with individual litigation or meaningful settlement discussions, I can help with case management, ensuring the life care plan is adequate by reviewing the life care plan and critiquing it. I am offering that as a non-consulting expert through my company Litigation Support Consulting Service, LLC.

Q: What led you to Dr. Hibner who you did the e-book with?

A: Simply he was the only physician at the time providing what I believed was a rational treatment for pudendal neuralgia. The general tenant is that one must attempt complete mesh removal of the device both vaginally and abdominally with the Da Vinci Robot. If pain persist that is consistent with pudendal neuralgia there must be a diagnostic block and then pudendal neurolysis (or decompression) if the nerve is found to be entrapped in surgery.

Q: In general, how do you see this litigation going?

A: First, as a physician I must say the medical community has failed in mobilizing to protect and treat these women. There has been an utter lack of leadership from the American College of Obstetricians and Gynecologist. Simply by making a mandatory Continued Medical Education requirement for clinicians to participate in that describes the symptoms of pudendal neuralgia could have saved significant distress for women turned away by uneducated ears. To date I am unaware that American Medical Systems, JNJ, Boston Scientific, and Caldera informed their implanting surgeons of the symptoms of pudendal neuralgia which is clearly the most severe medical complication from both a properly placed mesh device or a malpositioned device which is an expected outcome of the flawed design.

Second, it is an impossibility to provide equitable compensation to everyone involved in an aggregate settlement of this magnitude. That being said, for the most part the settlements to date have done fairly well for 97 to 98 percent of the injured women understanding the cost and delays of individual litigation. I must clarify, that as a catastrophic injury physician and attorney I care most about those permanently disabled, who represent the 1-2%. These women with pudendal neuralgia are at risk of being left behind to become indigent.

Q: Why do you say they don’t provide for the most injured?

A: To date, disappointingly, there has not been a case go to trial with what I would determine to be an adequate life care plan for a mesh injured pudendal client. That being said, the Linda Gross vs. Ethicon case, medical care was awarded at $1 million over her life expectancy and she had pudendal neuralgia. The settlements to date are a fraction of that amount. I must state I am most concerned for the most injured in this litigation.

Life care plans are individualized and designed to help provide all necessary and appropriate medical care and non-medical services for the rest of her life. If she can’t manage around the house, if she can’t work in the yard, cook, clean, and play with the kids she is left with guilt because she cannot fulfill her role as a wife and a mother. We’re trying to take the burden off so she can assume the role with the help of monetary awards.

Q: Are you able to operate on nerves so she has a semblance of a normal life?

A: A lot of women who have ongoing pain with pudendal neuralgia go to a consultation with a pudendal neuralgia specialist such as Dr. Hibner and Dr. Castellanos and get a block that provides pain relief for a short time. Some have lasting improvement for 4-6 months and they simply have another block for ongoing symptoms. But for the women who are impaired with pain, they are candidates for a neurolysis. That procedure involves her lying flat on her stomach and cutting through a portion of the sacrotuberous ligament to expose the nerve. If it is entrapped, they decompress it. If they find retained mesh and scar tissue then they decompress. Its nerve surgery and there are only two doctors in North America, Dr. Hibner and Dr. Castellanos who can deal with this certain complication and mesh.

Burch Procedure

Q: Why aren’t there more doctors to address this condition?

A: PN was so rare there are only a few centers that would address it. Pudendal neuralgia would occur in people who would squat a lot. They took care of this at the Mayo Clinic with Dr. Stanley Antolak and at Baylor Medical Center there was a program. Also at Johns Hopkins. These physicians went to France where they studied pudendal nerve surgery at Nantes. When this mesh device hit the market with no regard for the nerves of the pelvis it created a whole generation of women with PN. Simply our medical system was completely unprepared to handle it. Sadly our medical community still does not understand it.

The American Academy of Ob-Gyn should have made everyone do a course on pudendal nerve injuries. The companies that sell pelvic mesh should have made sure every implanting surgeon was educated on the worst complications of the device, which is pudendal neuralgia. Basically these women are going to surgeons who don’t understand the symptoms.

I assist women on finding a doctor with the skills to diagnose, then assists them to find a physician who can treat. Another thing that’s important is that the ‘diagnosis of chronic pelvic pain’ will often be denied SSI disability without the specific diagnosis. I’ve never had a client with pudendal neuralgia denied earned disability benefits.

Q: How are you handing your pudendal damage cases?

A: It really depends about how they are progressing with their treatments. I am optimistic that many of my clients who have been unable to obtain the care they need because of financial constraints will have greater opportunities to afford necessary care because the lending community is now understanding the value of pudendal neuralgia. It is difficult to devise a valid life care plan when care has simply not been obtained. I have women that simply in good conscience I will not recommend any type of binding arbitration going forward unless similarly injured women receive favorable outcomes. Unfortunately, to date, there have been little precedent cases to determine the market value for this particular injury.

Q: What is your assessment of the legal representation overall to date? Are you optimistic about the future?

A: Yes. The leadership level attorneys understand that they must represent everyone on their docket. They are asking for my assistance as a medical expert to review their complex cases that have symptoms and disability that would suggest a pudendal neuralgia. They are asking me to develop life care plans for their clients and analyze cases.

The path to compensation for the worst injured is perilous but for those with pudendal neuralgia there is little else to lose. Signing the Settlement terms as it stands currently affords them a lifetime of being a medical indigent. I must say that any device used for Pelvic Organ Prolapse and any Sling that offends the obturator membrane is unreasonably dangerous. The medical evidence is clear. A docket of 400 to 700 pudendal neuralgia clients is obtainable if the leadership in this litigation works together and provides a path for a timely resolution for the worst injured. The Defendants do not want to see a pudendal case in court since there is simply too much for them to lose.

Regardless of the numbers, I plan on suing the manufacturers of the transobturator slings into perpetuity until the manufacturers understand that it is not in their financial interest to continue on with the device or the FDA rings the bell with a warning to allow the manufacturers of the device to hide behind an ‘informed’ consent.

I offer services for attorneys who have or may have pudendal clients and I represent women co-counseling with leading firms on pudendal clients. This implicates all manufacturers. I’m fortunate to have met capable attorneys willing to represent pudendal clients who might decide that they must go down the difficult and perilous path of individual litigation against a pharmaceutical company.

I’m there to help women in any capacity. I’ll help their attorneys. I want women to get the care.   #

LEARN MORE:

Drs.Vigna and Hibner e-book on pudendal nerve injury.  TVM_Ebook_Dr.Vigna

The following articles assisted a woman get the diagnosis and for her disability hearing. I send the below articles to every woman who calls from the TVM123.com website.

Most doctors cannot treat pudendal neuralgia:
http://tvm.lifecare123.com/pudendal-neuralgia-treatment-before-and-after-the-mesh-debacle_9000.html

Pelvic mesh kits cause pudendal neuralgia:
http://tvm.lifecare123.com/seek-a-rational-comprehensive-treatment-for-your-mesh-related-pain_8995.html

 

Myofascial Pelvic Pain Syndrome:
http://tvm.lifecare123.com/pudendal-neuralgia-vs-myofascial-pelvic-pain-syndrome-mpps-vs-both_8770.html

 

Use of Botox in management of pelvic pain:
http://tvm.lifecare123.com/the-clinical-use-of-botulinum-toxin-in-the-management-of-pelvic-pain_9002.html

 

Tight Clothes and pelvic pain:
http://www.prnewswire.com/news-releases/vaginal-mesh-implants—can-women-wear-tight-pants-204711421.html

 

Mesh News Desk, March 2013, Pudendal and other Nerve Damage http://meshmedicaldevicenewsdesk.com/pudendal-and-other-nerve-damage-posterior-femoral-cutaneous-ileoinguinal-and-obturator-in-the-transvaginal-mesh-patient

The post Pudendal Neuralgia and Pelvic Mesh: Serious Injury – Serious Decisions appeared first on Mesh Medical Device Newsdesk.

Thanks to Courtroom View Network for access to Cavness v. Ethicon, underway in a Dallas courtroom. 

[This coverage is prepared by your editor, who has sat in the courtroom for five pelvic mesh trials (C.R. Bard, Ethicon) and has witnessed three additional trials (Boston Scientific , Ethicon) via CVN feeds.  Coverage is based on collective knowledge of the issues. Your reporter is not a lawyer. Additional comments are appreciated.]

Mesh News Desk, September 30, 2015 ~ The Defense began presenting its case late Tuesday afternoon, defending Ethicon, and its parent company, Johnson & Johnson, maker of the Prosima pelvic mesh used to treat pelvic floor prolapse.

Judge Ken Molberg, 95th Judicial District, TX

The trial is now in its seventh day before Judge Ken Molberg in the 95^th District Court of Dallas, Texas.

First on the stand for the defense was Dr. Teresa Kowalczyk, the physician who implanted Prosima in Ms. Cavness in April 2012.

She, along with Ethicon, are the subject of this product liability, medical malpractice trial.  The Plaintiffs hope to prove the Prosima was defective in its design and manufacture and in its instructions to the physician.  Without adequate information, the doctor cannot provide a true informed consent to the patient.  That quandary puts the doctor between a rock and a hard place – did she practice bad medicine or is she simply a pawn of reckless and aggressive marketing by the manufacturer?

Earlier in trial, under questioning by Plaintiffs’ attorneys, Dr. Kowalczyk told the jurors she would not have used the Prosima if she had knew what she has learned as a result of this litigation.

To rebut her damaging testimony, Defense played her deposition, recorded much before this trial when, presumably, she was still in the Prosima camp. She appeared to the jury via videotape.

Helen Kathryn Downs, Butler Snow, attny. for Ethicon

Helen Kathryn Downs of Butler Snow for J&J/ Ethicon questioned her on tape.

Dr. Kowalczyk said Ms. Cavness was in intense pain when she first visited in April 2012 and she couldn’t point to any one point of pain.

“These are the same reactions you can have with a regular pelvic repair” said the doctor, referring to a non-mesh repair.”  Around three to 10 percent of patients will have complications, she said.

There is some shrinkage of the mesh, the doctor admitted, but most complications can be easily managed without large expense.

Did the jury think the doctor was credible enough to rely on her opinion?  Does the jury think Ethicon is credible and transparent with its physicians?  In the Plaintiffs’ case, Ethicon has been shown in this trial so far to omit many known risks of its product in the IFU (Instructions for Use) that doctors rely on deciding whether to use a product or how to inform their patients about risks.

Helen Downs asked, “Did you ever feel Paul Courts II (sales rep for Ethicon) gave you false information about the Prosima?  “I don’t think so,” said Dr. Kowalczyk.

Earlier in this trial, Dr. Kowalczyk told jurors she was unaware of Ethicon’s discussions that the mesh was too stiff to use in the vagina and that another mesh, the UltraPro, was being developed as an alternative.

Dr. Kowalczyk added, it was important for her to see what Ethicon said about Prosima before she used it. She was provided information about a clinical study on Prosima by a sales rep for the company which encouraged her to use the product.

WHAT DR. KOWALCZYK WASN’T TOLD

Prosima for sale on ebay, Sept 21, 2015

On cross examination, Bill Blankenship for the Plaintiff interviewed Dr. Kowalczyk.

The sales rep had told her Prosima was safer than other meshes on the market and it had fewer complications. Rep Paul Courts said it was a very good product and he was considering using it for his own wife, she said.

Bill Blankenship, Lawyer, Dallas

Blankenship: “You expect J&J to provide fair and balanced information on its products don’t you?

Dr. K: “Yes.

Blankenship: “You would expect them to tell you if it was not appropriate for a condition or there were risk; you would expect to be told?

Dr. K: “Yes.

Blankenship: “If you knew Ethicon had decided to pull Prosima from the market in February 2012 because they didn’t want to do pending FDA studies, would you tell your patient about that?

Dr. K: “Yes.

Blankenship: “If you knew they were to pull it, would you use device on Carol Cavness?

Dr. K: “No.

Blankenship: “If you knew the FDA had ordered Ethicon to further study the device or remove it from the market, would you tell Carol Cavness about it?  

Dr. K: “Yes and I would not have used it, she said.

Dr. Kowalczyk said the sales rep explained the mesh product was being pulled from the market because it was too expensive to test Prosima. Prosima, along with three other pelvic meshes, were quietly removed from the market in June 2012. In doing so, Ethicon was relieved of extensive and expensive post-market testing on how the meshes were performing in its recipients.

Blankenship: “If you knew the complications would be life-altering would you use it? No. “Would you tell her?  “Yes.

Blankenship: “If you knew it would result in chronic pain which is not rare, would you tell Carol about it?” “Yes. “Would you use it?”  “No.”

Blankenship: “If you had been told Prosima posterior mesh does not provide any added benefit compared to traditional surgery without mesh would you tell Carol?”  “Yes.” “Would you use it?” “No.”

Blankenship: “If you knew Ethicon’s own preceptor, Vince Lucente, MD would called it a “reckless product,” would you tell Carol? “Yes. “Would you use it? “No, I would not.”

Blankenship: “If you knew in 2010, the first year at you used, a clinical trial using the same mesh (Prolene PS) was stopped (Prolift study see it here) because of complications would you tell Carol?”   Yes.   “Would you use on Carol?  “No.”

PAUL COURTS –TERRITORY ACCOUNT LEADER FOR ETHICON

Paul Courts was the sales representative who first introduced Ethicon’s Prosima mesh to Dr. Kowalczyk in 2010. The Prosima mesh was considered to be an innovation among pelvic floor meshes. It was smaller and didn’t have six anchor arms that are impossible to remove. It would substitute for the extremely large and complication-prone Prolift.

Attorney for the Plaintiff, Kevin Edwards asked whether Ethicon informed its own sales rep it was planning to decommercialize Prosima.  Courts said he was contacted at some time after the implant of Ms. Cavness in April 2012.

Paul Courts II, Sales rep, Ethicon, from LinkedIn

Mr. Courts didn’t know what an FDA  522 order was (an order to study the product post-market) and he was unaware in early 2012 Ethicon’s strategic business team decided to pull the mesh from market by mid-2012.

Edwards asked the sales rep if he was present in the operating room when Ms. Cavness had her implant.  Courts hesitated, then said “No.”

Edwards: “Were there other occasions?”  “Were there a lot?”  “Yes.” said Courts, referring to being present in the OR when mesh was implanted.

About Dr. Kowalczyk he said, “She wouldn’t make any decision without being 100 percent…she would ask me as much as she needed to ask me. She will go out and research and find everything she can find. She’s not one of the people you’re going to come in with, with  half the information.” 

Paul Courts said Dr. Kowalczyk was an extremely good surgeon, resourceful and skilled. She wanted to do what was best for her patients.  She did her due diligence and would ask questions. She learned about implanting Ethicon through a company DVD and didn’t go to the cadaver training.  He estimated the doctor performed close to 50 Prosima implants between 2010 and 2012.

Courts was asked if there was anything in the IFU (Instructions for Use) about the permanency of this pelvic mesh and its potential for life-altering pain? Did Ethicon tell you about the cracking of Prolene?  Did they tell you about the public health notification?

Courts said he had seen it but didn’t remember where.  Did Ethicon give it to him?  “They didn’t prevent me from having access it,” he said.

A Defense attorney asked Mr. Courts if the company hid information or was not forthcoming with information about the Prosima.

No, he said.

Dr. Jaime Sepulveda, urogynecologist for Defense

DAY 8 DEFENSE – Dr Sepulveda

Kat Gallagher, Ethicon attorney

Dr. Jaime Sepulveda, is a female pelvic medicine and reconstructive surgeon from South Florida. Originally from Puerto Rico, the doctor, in his mid-50’s, was brought to the courtroom as the second witness for the Defense in Cavness v. Ethicon. He spoke with a heavy accent that occasionally made it difficult to understand him as the camera is across the courtroom from the witness stand. 

As he spoke to Ethicon attorney Kat Gallagher, he seemed pleasant and sincere.

Dr. Sepulveda and 25 other doctors started the subspecialty of urogynecology, he said, as a matter of introduction.  He’s been practicing medicine for 26 years and in 1994, he opened the Miami Urogynecology Center.

Dr. Sepulveda first encountered Ethicon years ago to see sling procedures in a lab.

Rectocele, FDA

Knowing anatomy is first and foremost when doing surgical procedures and the opportunity to be trained in an Ethicon cadaver lab in France was an important part of his early education.  Eventually the doctor says he started teaching for Ethicon at the cadaver labs where he was compensated at about $100,000 a year.

Kat Gallagher got the obvious question out of the way. How many hours had he spent on the case? He’s spent 150 hours, compensated at a rate of $500 an hour, or roughly $75,000.

She said to him, “I want to go through Anatomy 101.  “I don’t think anyone who’s really qualified has done it.”

Getting out of the witness chair, Dr. Sepulveda stood before a chart with a light pointer to show the jury the image of a rectocele, a condition where the rectum drops below the body. Pain can come on suddenly when tissues are injured by stress that then weaken causing the rectocele.

An airplane mechanic, Ms. Cavness reported lifting an 80 lb. object at work just before she went to the ER with pain in her abdominal area in April 2012.

Pain, ultimately, was the reason for her Prosima surgery.

Was Prosima the right decision, he was asked? Yes, he agreed.

Surgery with Prosima is superior to a native tissue repair alone, Dr. Sepulveda told the jury.  You have a lower rate of recurrence when native tissue is reinforced with a polypropylene mesh implant, he said. That is in direct contradiction to the testimony by Dr. Michael Margolis for the Plaintiffs earlier this week. Dr. Margolis told jurors Ms Cavness’ native tissue repair, the one that remains behind today, is doing fine.

Dr. Margolis also mentioned the downside of mesh that is stiff, like the Prosima. It does not adapt internally, especially in an area where there is a lot of movement. Dr Sepulveda disagreed – the mesh doesn’t shrink and cause vaginal shortening. “We haven’t seen it. Haven’t seen it in Ms. Cavness,” he said.

What about mesh degradation, one of the most common complaints about pelvic mesh. Did he see any of these issues with Ms. Cavness he was asked. ” No.”

Marcus Cary, MD study on Prosima prototype

Kat Gallagher asked, “Are the IFU instructions adequate when using Prosima?”

Dr. Sepulveda agreed, “Yes they are adequate.”

He held the Prosima in his hand. As to the explant surgery of the mesh, done by Dr. Carley, Dr. Sepulveda said the specimen was in multiple pieces, as we’ve heard.

Did Dr. Carley think he got it all? Yes, said the doctor. The idea there is mesh imbedded somewhere, that’s not true, he said, because of the length of the inserter.

After her implant, Ms. Cavness continued to have problems with pain.

“There were no issues with the mesh,” Dr. Sepulveda volunteered. #

The post Defense on Prosima’s Low Complication Rate appeared first on Mesh Medical Device Newsdesk.

MND, October 2, 2015 ~ About 3 pm Central Time, the case of Cavness v. Ethicon rested  and went to a Dallas jury for deliberation.  (Carol Cavness v. Kowalczyk et al., case # DC-14-04220).

**Late Word** The jury was dismissed 5:51 EST saying they needed more time. They were hungry and tired!  Monday they will continue deliberations! 

The 12 jurors will have to decide if the Prosima pelvic mesh, used to treat pelvic organ prolapse, is defective in its design and its manufacture and if the manufacturer, J&J’s Ethicon division,  failed to inform the end user doctors about its dangers, that is, whether it was also defective in its instructions.

Previous trials have resulted in $15.87 million in judgments against Johnson & Johnson, which makes the Prosima.  J&J has vowed to continue to try these cases rather than settle, as three other mesh makers have begun doing.

Jurors, art by Akre

JURY INSTRUCTIONS 

Before Judge Molberg this morning, both sides discussed jury instructions. Among the 20 or so questions for the jury to consider, the Defense wanted to change some of the language.  Defense suggested to Judge Molberg the instructions should say the Prosima is an unavoidably unsafe product because it is implanted surgically.  That suggestion was overruled.

Defense wanted the jury to be told the manufacturer does not have a duty to warn the patient about the rate of severity of adverse events because the device is a prescription device. That was overruled.

Also Defense wanted the jury to consider when there is reasonable disagreement in the scientific community, it should not representat a liability for the manufacturer. That too was overruled.

Judge Ken Molberg, 95th Judicial District, TX

BACKGROUND

The case began Monday, September 2 in the 95th Judicial District Court of Dallas County before Judge Ken Molberg who has presided over two other pelvic mesh cases, both of which resulted in jury awards for the plaintiff.

In the case of Linda Batiste, her case against Ethicon over its TVT-O, the jury found the mesh to be defective and awarded her $1.2 million.  In the case of Maria Salazar, the jury found for Ms. Salazar and awarded her $74 million over her Boston Scientific pelvic mesh. That amount was later reduced to half due to a state caps on jury awards.

Friday verdicts are not uncommon and at this writing everyone is sitting in the courtroom waiting.

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.

Thanks goes out to Courtroom View Network for access to a live feed in the courtroom proceedings. 

 

The post J&J PROSIMA Pelvic Mesh Case Goes to the Jury! appeared first on Mesh Medical Device Newsdesk.

Judge Ken Molberg, 95th Judicial District, TX

The jury had question about 11 am Central time for Judge Ken Molberg in his Dallas court.   The jury had a question they relayed to Judge Ken Molberg in a jury note.

What is Proximate Cause?

The judge answered.

“On page 3 of the charge of the court you will find a definition of proximate cause. You are to disregard that definition and substitute it with this definition.

Proximate cause means a cause which was a substantial factor in bring about an injury and without such cause the injury would not have occurred.  In order to be a proximate cause, the act or omission complained of must be such that a medical device manufacturing company using ordinary care would have foreseen the injury or some similar injury might reasonably result there from.

There may be more than one proximate cause of an injury.

Ordinary care means that degree of care a medical device manufacturing company or ordinary prudence would use under same or similar circumstances.

If you have answered either question one or two you should redeliberate using the definition I have given you in the supplemental charge because it is a proper legal definition.  It is the only answer I can give you at this time.

Signed this fifth day of October 2015.  That is the answer to your question, you should disregard the previous definition of proximate cause please return to the jury room to resume deliberations.

Mesh News Desk will be watching the proceedings via Courtroom View Network which has provided a live feed from the courtroom during the entire two week trial. Thanks to CVN for the access!!    www.cvn.com

BACKGROUND

On Friday, attorneys for Carol Cavness, 60, asked Johnson & Johnson to award $9.5 million in actual damages, including a sizable punitive damage award to send a message to the company about its Prosima pelvic mesh, which has since been taken off the market.

Ms. Cavness, 60, alleges she was injured by the Prosima pelvic mesh used to treat prolapse. Experts brought to trial on her behalf says she is permanently injured and some of the polypropylene mesh remains behind in her body to cause future injuries. Plaintiff attorneys’ brought life can plan experts to trial to show the financial needs she will have in the future due to the injuries from the Prosima mesh, which is made by Ethicon, a division of Johnson & Johnson.  This is the first product liability trial for Prosima.

J&J is facing 30,000 other defective mesh product liability trials ahead.

The post Monday Morning- Jury Still Out in Cavness Pelvic Mesh Trial Against J&J appeared first on Mesh Medical Device Newsdesk.

We Are Mesh Survivors, testifying to Parliament

Mesh News Desk, October 5, 2015 ~ According to a story in Scotland’s  The Daily Record, here, on Friday, the Health Secretary of Scotland published an interim report on the use of transvaginal mesh.

It says three of the four procedures doctors routinely recommend to treat incontinence and pelvic organ prolapse will no longer be used.

The reforms are outlined in a safety review by the government largely encouraged by a series of reports by Marion Scott and the Sunday Mail  as well as Scottish Mesh Survivors patient group. Their Hear Our Voice campaign carried to testimony before a Parliamentary Committee on the dangers of mesh implants.

See background stories here and here.

WHAT’S CHANGED

What will change is using pelvic mesh  to treat prolapse will not be approved, even though the U.S. version of the FDA, the MHRA, insists the procedure is safe and the benefits outweigh the risks.

Mesh procedures to treat stress urinary incontinence (SUI) also will not be routinely offered as a first line of care unless they are authorized by a multi-disciplinary medical team.

Hundreds of women in Scotland had complained to Parliament that their complications or adverse events were not being reported to the government. As a result, now that those incidents must be reported or the doctor will face possible sanctions.

Marion Scott tells Mesh News, “The mesh victims played a huge role in writing the patient information leaflets and they have ensured all possible side effects ate explained clearly.  The SUI leaflet has already been done and they are working on the POP leaflet as we speak.  This is a great example of what can be achieved. I’m so proud of all these incredible women who put their own pain to one side and pushed for these changes so no other women need suffer.  They really are incredible.” 

There is still voluntary reporting in the U.S. and the complications recorded by the U.S Food and Drug Administration are thought to represent one to ten percent of real-life complications.

Reporter Marion Scott began her series of investigations beginning in March 2013 for the Sunday Mail  where the injuries from pelvic mesh became front page news. Women told the paper they had dire complications including an inability to walk and function and still faced dozens of surgeries. As in the States, many patients were told the problems were in their head and they should get mental health treatment.

That too was taken into consideration by the independent reviewers who urged surgeons to increase their “listening and empathy” skills.

The campaigners had asked for a total ban on mesh products but Elaine Holmes told the Daily Record “We’re happy to support the review recommendations as long as they and our petition points are put in place and actioned before any suspension is lifted.”

She added that the safety of patients is finally being put first.

Marion Scott, Daily Mail reporter

Marion Scott tells Mesh News Desk,

“This is a momentous step forward and will ensure the devices which have caused the most damage will no longer be used and the one procedure that is left will only be used as a last resort rather than the first.  Doctors will have to go in front of a panel to justify each and every use of the one SUI procedure left available, using retropubic tapes, and it will only be carried out as a last resort and when patients are fully informed of all the risks. Doctors will also face possible sanctions if they fail to report adverse incidents as there is a strong feeling over their failure to report previously.  We reckon the new restrictions will have wide reaching effect.

“It has been a hard fought battle by women who have all suffered horrific injury.  They are the true heroines of the piece.  None of this will help them as their injuries are permanent. But they could not stand back and allow any other women to be injured.

“Thanks for all your support Jane.  We just hope other countries will follow suit.  I fully believe mesh will eventually be recognised as one of the biggest medical scandals of all time.  Keep up the good fight. “

 

LEARN MORE

Here is the report
http://www.gov.scot/Resource/0048/00486661.pdf

http://news.scotland.gov.uk/News/Mesh-implant-interim-review-published-1de9.aspx

 

The post Scotland Limits Use of Pelvic Mesh Implants appeared first on Mesh Medical Device Newsdesk.

Mesh News Desk, October 5, 2015 ~ In its second day of deliberations, the 12-member jury in Cavness v. Kowalczyk (et al., case # DC-14-04220) decided for the Defendant Johnson & Johnson, 10-2.  

In doing so, jurors found the Prosima pelvic mesh, made by Ethicon (J&J) is not defective in its design and in its instructions to doctors, the end users.

This is the first trial win for Johnson & Johnson after suffering $21.5 million in losses in four previous pelvic mesh trials.

Heated debate in the Cavness jury room resulted from confusion about the questions jurors had to answer about Design Defect of the Prosima pelvic mesh, and whether the Instructions to doctors were defective or inadequate.

Jurors told patient advocate, Joleen Chambers, the questions were “too legalese” for them and they were unclear how the questions related to the evidence shown in the case.  The female jury foreman, who reportedly took 100 pages of notes, and another woman voted for Ms. Cavness. The other jurors voted ‘No’ to both questions.

Plaintiff, Carol Cavnes, 60, broke down in the courtroom and was ushered out.  The two female jurors reportedly were also crying.

JURY QUESTIONS

[Jurors are invited to contact this editor, Janeakre@meshnewsdesk.com to share their story]

Chambers says jurors told her if one word was changed it would have changed the whole thing. Friday jurors were convinced they would render a quick decision in favor of the  Plaintiff, but that reportedly changed when they saw the jury questions, which they say, did not coincide with what they heard at trial.

Defense teams typically bring in lawyers specifically to write jury instructions at the end of trial. That reportedly happened here and the revised questions did not receive specific approval from Judge Molberg before going to the jury.

At trial, jurors heard about the injuries Ms. Cavness suffered and what the company knew prior to marketing Prosima.

Defense had asked for specific language in the two jury questions. Once Judge Molberg realized that, he spoke to the jury this morning asking them to change their thoughts about the definition of “Proximate Cause” to let jurors know they could find for the Plaintiff based on causation.

Molberg defined that as the cause which was a substantial factor in bringing about an injury and without such cause the injury would not have occurred.  

Judge Ken Molberg, 95th Judicial District, TX

“In order to be a proximate cause, the act or omission complained of must be such that a medical device manufacturing company, using ordinary care, would have foreseen the injury or some similar injury might reasonably result there from. There may be more than one proximate cause of an injury,” he said.

Around 11 am Central Time, Judge Molberg told jurors if they had answered either question, they should re-deliberate using the definition he just gave “because it is the proper legal definition.”  That was all he could say to them about legal theory.

One male juror told Chambers the deliberations were very difficult. He said he learned a lot about female anatomy quickly. He learned you can have an injury and it could reappear later.  He too said the language in the question made no sense given what they were told during trial.

DESIGN DEFECT 

Other pelvic mesh trials have focused on the polypropylene material used to form the woven plastic and how the resin makers specifically warned against using the raw polypropylene resin for use in implantable medical devices. The Material Safety Data Sheet, which contains the warning, was not presented in this trial.

This is the first trial win for J&J and its Ethicon division, maker of pelvic mesh implants.

On Friday, the Plaintiffs asked for $9.5 million in actual damages against J&J plus punitive damage awards.

Judge Ken Molberg, who had a previous appointment, had to leave while the jury deliberated today.

Judge Emily Tobolosky told the court the jury wanted to deliver a statement along with the verdict. Attorneys for Plaintiff Cavness did not want to hear the statement while the Defendant’s lawyers had no problem with the statement, which was not disclosed.

The jury decision came back just about 4 pm Central Time.

BACKGROUND

The Cavness case is the sixth product liability case filed against Ethicon over its pelvic mesh. Four cases that have gone to trial include Linda Batiste ($1.2 million) Jo Huskey ($3.57 million), Linda Gross ($11.1 million) and Coleen Perry ($5.7 million).  The Carolyn Lewis case was dismissed after Judge Joseph Goodwin granted J&J a directed verdict last year.

Other cases naming Ethicon/ J&J have settled including Budke and Wicker, as well as a few cases in Missouri.

So far, two juries have found the TVT-O, mesh used for incontinence, and made of the same mesh as the Prosima, to have been defectively designed and manufactured.

At this writing, J&J faces 28,960 cases filed in multidistrict litigation in federal court in Charleston, WV. Thousands of other cases are filed in state courts and around the world. J&J has vowed to take the pelvic mesh litigation to trial rather than settle, as several other manufactures have begun doing.

Ethicon knew the mesh used in the Prosima could prompt an immune system response that would cause degradation of pelvic tissue, but that information was withheld, says her complaint.   Instead the company called the mesh “safe and effective” in its marketing efforts.

“Contrary to the representations and marketing of defendants J&J and Ethicon, the pelvic mesh products have high failure, injury, and complication rates, fail to perform as intended, require frequent and often debilitating revision surgeries, and have caused severe and irreversible injuries, conditions, and damage to a significant number of women,” Cavness’ complaint states.

The Plaintiff’s complaint says implanting physician, Dr. Kowalczyk, failed to disclose the risks associated with the implantation and instead recommended it as a safe and effective.

Cavness was seeking compensatory damages for disfigurement, impairment, past and future medical expenses and mental anguish. Punitive damages were allowed, reports CVN, after Judge Ken Molberg denied Ethicon’s motion to deny punitive damages against the company.

The suit also included claims against the physician who implanted the mesh in Cavness, Teresa Kowalczyk.  The doctor was negligent in the care and treatment to her patient and did not act as a reasonably prudent physician in caring for her patient, says the complaint.

THANKS TO COURTROOM VIEW NETWORK FOR ACCESS TO THIS AND OTHER TRIALS!

David Matthews, Attorney for Cavness

Postscript * David Matthews of the Matthews law firm tells Mesh News Desk “This is a devastating loss and we are going to pursue all remedies on behalf of Carol Cavness. This story is not over.”  

The post Cavness v. Ethicon – First Jury Vote for Ethicon 10-2, Mesh Not Defectively Designed appeared first on Mesh Medical Device Newsdesk.

Ms. Cavness, art by Akre

Mesh News Desk, October 6, 2015 ~ Carol Cavness did testify to the jury in her trial on the afternoon of September 28th. Previously Mesh News Desk had reported she appeared by voice only.  

 On Monday, she lost her product liability trial against Ethicon/ J&J. This was the first jury decision for the pelvic mesh maker that faces in excess of 30,000 defective product cases filed over its family of  pelvic meshes.

The Plaintiffs may have the option to appeal the verdict but vow this case is not yet over.  

Here is an excerpt from her testimony from the witness chair before the jury rendered its decision. 

She is short, with short spiky hair wearing a dark grey suit. She is obviously nervous. Plaintiff Carol Cavness lives in Greenville, Texas where she recently moved after her divorce. She and Graham were married 15 years.

For almost 24 years she has worked as an airline mechanic at L-3 Communications. She started as a trainee and then advanced through the system to become the highest level, an A mechanic.

Bill Blankenship, Lawyer, Dallas

Attorney Bill Blankenship for the Plaintiff questioned the Plaintiff. His questions are leading because she is brief and hesitant in her delivery.

In April 2012, Ms. Cavness experienced pelvic organ prolapse as she lifted a heavy concrete pot out of the trunk of her car. She told jurors she experienced a sharp “ouch” pain. She went to work the next day then on Saturday, also at work, she kept going to the rest room.  One time she felt something coming out of her body.  She has an inspection mirror and saw something pink coming out of her vagina.  Her female supervisor told her to to the emergency room.

Cavness said she felt a lot of pressure. It was uncomfortable while she was talking.   On cross- the Defense would try to describe that as intense pain.

Ms Cavness speaks in a halting way. She is very nervous.   The ER doctor told her bladder was falling out of her vagina.  But days later visiting Dr. Kowalczyk she was told it was her colon descending in her body. ” I remember her saying she could fix that,” Ms. Cavness said of Dr. K.

Surgery was performed April 24, 2012 and Dr. Kowalczyk implanted a Prosima pelvic mesh made by Ethicon. She also did a native tissue repair at the same time. After surgery she had typical surgery pain but after six or seven weeks, Ms Cavness said she experienced a different kind of pain  – sharp stabbing pain.  

Q: Had you ever had that type of pain before?  No.

Since Dr. Kowalczyk didn’t see anything wrong and she didn’t understand what was causing the pain, she sent her patient to pain management. Ms Cavness sought another surgeon. Dr. Carley gave her steroids but they didn’t help. He told her what he thought was causing the pain. He said he thought it was the mesh and Dr. Carley recommended it come out.  He did surgery to try and take mesh out but Dr. Carley said he couldn’t remove it all because it was embedded in tissue and muscles. He retrieved about 65% of the mesh. It did not relieve that pain.

She had a lot of urinary tract infections and had leakage of urine. She had discharge and odor and Ms. Cavness winces when she says that.  How many UTI’s since the mesh? About ten of them and she was hospitalized 3 times as a result.  Dr. Carley did a second surgery to try and remove the rest of the mesh but was unsuccessful. The pain continued. Then a visit to a new doctor, Dr. Phillippe Zimmern of Dallas.

Even though she is not computer savvy, Ms. Cavness found Dr. Zimmern, a well known mesh removal doctor.  “I wanted this pain to stop, I wanted the mesh out,” she said emphatically.  Dr. Zimmern saw the mesh and performed removal surgery in December 2014.  But the surgery was very brief. By the time her family went to the cafeteria, they were paged. She was coming out of surgery. Dr. Zimmern did not remove any mesh.

“I was devastated  because I knew the pain wouldn’t stop.”

Q: “Do you continue to have vaginal pain today?”

“Yes.

Q: The same type you told us about earlier, the stabbing cutting pain you described?

Every day.

Ms Cavness is involved with pelvic therapy at UT Southwestern where a therapist massages pelvic muscles and tissues.  Is it painful? She wipes her eyes with a tissue and answers yes.

What followed was a series of questions by Mr. Blankenship about injuries on the job. Yes, there had been many, shoulder surgery, elbow, ankle surgery. She also took time off to care for her husband after he was burned.  She was always able to return to the same level of performance as before.

Today, to make accommodations at work, her co-workers help her and she is transferred to phase 4 interior finishing where she doesn’t have to do a lot of heavy lifting or crawl into cells.  “I just cant do the things I used to do,” she said.  That includes climbing on ladders and shooting rivets into a bucket bar.

She is prevented from taking hydrocodone on the job so instead she takes ibuprofen and Aleve.  Work now leaves her in pain and exhausted.  “I love my job” she said more than once and is afraid of losing it, especially at her age of 60. Ms. Cavness frequently squints like the light is too strong, like she is in pain.

Before the mesh was implanted what did you enjoy?  I enjoyed life, everything I did a lot of house remodeling landscaping, do it yourselfer, I did everything with the grandkids, swimming, fishing, biking, playing games.

Are you able to remodel around the house now, she was asked. No she is not.

Q: “What do you enjoy now in your spare time?

“I don’t much of anything.  I’m with my daughter and her family. We watch movies.”

As far as her husband, Ms. Cavness said there was no affection, closeness, and the couple stopped doing things together like gardening, family get-togethers, barbecuing, fishing and hunting.   Her chin quivers. She appears to be holding back tears.

How has the pain effected how you feel about yourself, Mr. Blankenship asks.

“I’m sad, I’m depressed I don’t feel like a woman anymore,” she said.

Your ability to eat and sleep? Your relationship with your family, is it all affected?

“I’m not active with them anymore I don’t want to be around them and show my weakness, things like that,”  she says wiping her eyes.

Q: “Carol why do you blame J&J and Ethicon for this?

“Because they made a bad product that’s inside of me.”   She is holding back tears now.

Q: “And are you asking this jury for punitive damages to punish J&J?”

“Yes, so no other woman has to go through this.”

Kat Gallagher, Ethicon attorney

For the Defense, J&J and Ethicon, attorney Kat Gallagher jumps in.  She asks about the day of the initial prolapse and asked if Ms. Cavness had described her pain as a 7 out of 10.  I was having pressure, she said correcting her.

Ms. Cavness saw no brochures or videos of the Prosima before agreeing to an implant, and she didn’t seek a second opinion.

Gallagher then went through the litany of on-the-job injuries and a previous hysterectomy in 1985 though the abdomen.  She had back pain had taken her out of work for awhile but it got better.  And didn’t Dr. Carley recommend physical therapy?  Yes, she said but she was afraid of losing her job and didn’t go.  Did he also recommend psychiatric therapy to help with the pain?  “I don’t remember that.” said Ms. Cavness.

Gallagher then suggested Ms. Cavness and her husband had marital problems before the Prosima and pointed to her deposition, page 31. She also asked how much she smokes (half a pack a day) and asked if she had been a smoker since high school (yes).

Q: “They warned you smoking could hurt your recovery?”

A: “I didn’t smoke a lot during my recovery.”

Q: “You smoke today?”

A: “Yes.”

On a final redirect, Bill Blankenship established that Mr. and Mrs Cavness lived together as husband and wife until December 2014 when they divorced. Her husband had accompanied her to all of her procedures and surgeries.  “We had our ups and downs but we worked them out,” she said. She filed for divorce. she didn’t want to be around her husband with the unpleasantness of UTI’s and other mesh complications.

Her face tightens and she softly cries.

Q:”Are there times you were confused in your deposition?”  “Yes.”

Q: “Were you and Graham considering divorce before April 2012?”

“Never. I still loved him and I still do today,” she cries and wipes her eyes.

Q: “Are you worried about the future? About losing your job?”

“Yes, because there’s restrictions there if I can’t do my job, I can’t work there. I’m too old to do anything else.”

She’s crying now.  Kat Gallagher concludes her questioning and Ms. Cavness leaves the witness stand.

The post Cavness Testimony – A Life Today of Pain appeared first on Mesh Medical Device Newsdesk.

Jurors, Hopnews

Mesh News Desk, October 7, 2015 ~ A juror in the Cavness trial has agreed to come forward after a call was put out on the last Mesh News Desk story.   Your editor has confirmed through two sources that she was an actual juror.  Here is what “Karen” has to say.  She wants to remain anonymous. Likely Karen will respond to your questions beneath this story.

Your editor thanks this juror for coming forward.  

Q: What was the discussion in the jury room?

“The discussion in the jury room was very different depending on the day & the topic.  We were given five questions to answer but if you answered “no” you could not proceed to the next set of questions.

‘The first question asked if there was a design defect with proximate cause in regards to Carol Cavness.  The definition of proximate cause is a “substantial factor” which is where the first confusion set in.  Substantial factor does not mean the LARGEST factor, it just means a large factor & that there could be numerous factors (which was explained to us by the judge).

‘This was the big go around on Friday. People said they do not think the mesh was the main cause & it was argued that it did not have to be the main cause.  This was on Friday afternoon.

“On Friday afternoon everyone was insanely exhausted.  We were to be there at 9 & they were not ready for us until 11:30. So we sat in a very small jury room for over 2 hours. Then we had to sit through closing arguments & then we were read the charges & by the time they let us deliberate it was Friday @ 3:30.  As you know-best decisions are not made at 3:30 on a Friday afternoon, so we decided to call it quits for the day around 4:45 because we felt as though we were getting nowhere & Monday we would have had fresh minds.”

Q: Did the jury think they had reached a decision for the Plaintiff on Friday afternoon? 

“I do not believe anything discussed Friday was relevant. No one was focused. Everyone was very stressed, tired & numerous other emotions. It’s a lot to have been thrown on us for a Friday.”

Q: What changed?

“Let me talk about what changed between Monday morning & Monday afternoon.  When we got there Monday we submitted the question about proximate cause.  Once that was explained we took a vote on the first question. The results were 9-3, in favor of the plaintiff.  We had to reach 10-2 so this is the route we took.  We asked the 3 (for the defendant) to explain why they thought what they thought & how they came to reach their decision. During that time people began to agree or say they were on the fence.  We took another vote & it was 4(defendant)-3(plaintiff) 5-Maybe’s.

“The MAIN reason people changed their vote was because in all the doctor’s reports & evidence given, her pain was the same before the surgery as it was after the surgery.  If her pain was exactly the same – how could it be the mesh?  The defendants also argued throughout the case it was a pulled muscle in the pelvic floor & pelvic floor therapy would help substantially.  This was recommended to her numerous times throughout the years & she barely started going Mid-2015; which did not help the case & although she is going now the jurors said “well now they have years & years to correct in therapy vs. if she would have gone in 2012.”  That was a very large portion of what had changed.”

Q: What was the confusion about?

“The confusion was 100% with the question – “Was there a design defect.” We had sat in that court room for 2 weeks.  We heard about her job, her family, her numerous surgeries to remove the mesh, whether the mesh was still inside Carol, whether the mesh took tissue out of Carol when it was explanted, internal emails from Ethicon asking “If there is no benefit with the mesh over native tissue repair why are we doing it.” We heard this for 2 weeks & the “design” of the Prosima was never discussed.

“It wasn’t that it was disproven that there WAS NOT a defect.  It was not proven to us either way. The questions we were expecting were “should Ethicon ever have put this on the market” “is there still mesh in Carol Cavness” etc etc. Not if there was a design defect. They did talk about how the mesh was denser than that of Prolift or Prolift+M (not sure the technical name)- but it was brief & that is not a defect, it’s just their opinion.”

Q: Who was that guy who told the lawyers he didn’t like corporations and yet remained on the jury, he was not stricken?

“I have no idea who this would be? There were only 4 men (5 with an alternate) & I do not remember anyone saying that.  We also did not find out Ethicon was a part of Johnson & Johnson (a giant corporation) until the juror’s were picked & opening statements started.”

“Let me know what else you may need!

“I am very, very sorry for the loss Carol Cavness has faced & the fact that she had to air all her “dirty laundry” to complete strangers.  I hope & wished she would have won.  Unfortunately, not everyone thinks the way I do.”

The post Juror Talks in Cavness Pelvic Mesh Case! appeared first on Mesh Medical Device Newsdesk.

Advantage Fit sling

MND, October 12, 2015 ~ It was last May when the highest jury award in mesh litigation was issued so far – $100 million to Deborah Barba and her husband. 

Ms. Barba had been implanted with Boston Scientific’s Pinnacle Pelvic Floor Repair Kit as well as an Advantage Fit mid-urethral sling system.

See the Mesh New Desk story on the verdict here.

On October 9, Judge Mary M. Johnston was asked to grant a Defense motion for a new trial and to set aside the jury decision.

The requests were denied.

What Judge Johnston did grant was a reduction in the $75 million in punitive damages saying the amount “shocked the court’s conscience and sense of justice.”

Punitive damages were reduced to $7.5 million while Judge Johnstone reduced the compensatory damages to $2.5 million bringing the total jury award to $10 million.  Boston Scientific filed an appeal after the original verdict. [This story has been updated and corrected.]

See the jury questionnaire form here. 

See the Judge’s decision here. 

Judge Johnstone said the Delaware jury was attentive and diligent during the two-week trial which featured the testimony of 15 experts.

BACKGROUND

The 51-year-old from Newark, Delaware, Ms. Barba sued manufacturer Boston Scientific for her permanent and serious injuries caused by the company’s Advantage Fit and Pinnacle transvaginal meshes.  She was implanted in 2009 and has suffered significant complications and endured two surgeries that did not fully remove the devices.

The jury found Boston Scientific was negligent in its design and manufacture of the Pinnacle and Advantage Fit devices and that the warnings were insufficient to unsuspecting doctors and their patients.

The Advantage Fit remains on the market. Pinnacle was voluntarily recalled May 2011, three years after it was launched, after a growing body of adverse events or complications were coming in.

That voluntary recall is not something the jury is not allowed to hear in this case as both sides have agreed to motions to limit the scope of the trial. See background story, The Problem with Polypropylene.

In asking for a new trial, Boston Scientific claimed a “failure to warn” claim is barred by the learned intermediary defense. In other words, it is the doctor whose job it is to warned a patient since he or she is the “learned intermediary.”

Boston Scientific also claimed there was no evidence presented at trial that the company departed from manufacturing specifics.  The Plaintiff failed to identify a safer alternative, the company claimed. These claims were denied.

Massachusetts law prohibits punitive damages in the absence of wrongful death or special statutory provisions, Boston Scientific claims. The case should have been tried in Massachusetts because that’s where the company is based.

The case is Deborah Barba v. Boston Scientific Corporation, Superior Court of the State of Delaware in and for New Castle County, C.A. No. N11C-08-050 MMJ.#

The post Boston Scientific Denied New Trial in $100 Million Barba Case, Jury Award Reduced appeared first on Mesh Medical Device Newsdesk.

Mesh News Desk, October 14, 2015 ~ As trial lawyers gather in Las Vegas for the twice-yearly Mass Torts Made Perfect, hosted by Levin Papantonio Law, one cannot help but notice the agenda for the last day – areas ahead for future litigation or areas that are waning.

As you might have guessed, transvaginal mesh is on the list.

Know that active litigation has been ongoing for close to four years so one can only imagine that it is in the “wrapping up” category.   Attorney Henry Garrard (Blasingame Burch) will be addressing the topic.

POWER MORCELLATOR

Good to see that other areas are being addressed such as the power morcellator, another experimental medical device that was cleared for use on women by the U.S. Food and Drug Administration (FDA) under its 510(k) fast-track clearance program.

Last year the FDA warned doctors against using the power morcellator because it can spread hidden cancers hiding in the uterus.  The morcellator grinds up a uterus during hysterectomy making it easier to remove.

The power morcellator was approved beginning in 1991.  Johnson & Johnson makes one brand.  Although it has not been recalled and doctors are warned about its use, power morcellator remains a tool some doctors still insist should remain in their “toolbox.”

BACKGROUND:  See the Wall Street Journal article:

The Short Answer: How Medical Devices Like Morcellator Get to Market

The WSJ reports over the last 20 years, the FDA cleared at least 10 such power morcellator made by various companies.

The 510(k) process was created by Congress in 1976 and today at least 90% of medical devices are “cleared” for marketing under the provision.  There are roughly 3,000 new medical devices that enter the U.S. market every year.

In contrast, under the FDA,  new drugs must undergo clinical trials and PMA or premarket approval to prove safety and efficacy.  According to the WSJ, there are about 30 new drugs approved for the U.S. market annually.  #

The post Transvaginal Mesh- Emerging or Resolving? appeared first on Mesh Medical Device Newsdesk.

Uphold, Taranakiobgyn, NZ website

MND, October 19, 2015 ~ On Friday, October 16, Boston Scientific (BSC) received a favorable jury verdict in a Statesville, North Carolina courtroom in a product liability trial filed by Martha Carlson, 65.

The case, Ramona Winebarger, et al. v. Boston Scientific Corp., No. 15-57, was heard in the Western District of North Carolina. It was remanded from federal court and multidistrict litigation. The case number is 5:15-cv-00057-RLV-DCK.

“While disappointed, especially for our client, this is the first in many upcoming cases set for trial.  We look forward to our next trial which we think will conclusively prove that Boston Scientific marketed an unsafe product that has hurt thousands of American women” said Jeff Larimore of Mueller Law of Austin, Texas.

In 2010, Ms. Carlson was implanted with an Uphold pelvic mesh device to treat pelvic organ prolapse. Today she says she has debilitating, chronic pelvic pain, incontinence and dyspareunia or painful sex.

In its decision, the jury said Ms. Carlson did not prove Boston Scientific acted unreasonably in designing the Uphold device that caused her injuries.  According to the jury in its 12-0 vote, Ms. Carlson did not prove by the preponderance of the evidence that Boston Scientific breached an implied and implied warranty of merchantability.

The case was a defense pick.  Jurors said afterward they did not think that her injuries were related to the mesh and that her injuries were not very significant.

After partial summary judgment in April before Judge Richard Vorhees, of the Western District of N.C., evidence was allowed to be admitted about the 510(k) clearance procedure of the U.S. Food and Drug Administration (FDA) that allows pelvic mesh to make it to market with little scrutiny for safety.  The case was pared down to claims of negligent design, breach of implied warranty of merchantability and punitive damages.

Judge Vorhees also denied her failure to warn claim, meaning the doctor received adequate information from Boston Scientific.

TRIAL BRIEF

According to her trial brief, the polypropylene used to make the Uphold is “impure, non-medical-grade” known as Marlex that “shrinks, hardens, bunches and degrades,” in the body.  The weave is so small that bacteria is entrapped and so are nerves, resulting in pelvic pain.

After a partial removal attempt, Ms. Carlson says the mesh broke apart into small pieces.

Marlex resin is issued by Chevron Phillips. Its Material Safety Data Sheet says it is not to be used in implantable medical devices that come in contact with internal bodily fluids or tissues.

See the Martha Carlson Trial Brief.

BOSTON SCIENTIFIC CLAIMS

For its part, Boston Scientific said Ms. Carlson’s injuries are not from the Uphold, which is made of Polyform mesh. Made by Proxy Biomedical, Polyform mesh is uncoated monofilament macroporous polypropylene. The company says that mesh is safe and effective and that Ms. Carlson’s pelvic organ prolapse improved after she was implanted.

The company also says there is no reasonable alternative to the Uphold design.

The trial went to the jury October 16, ten days after it began, which returned the verdict on the same day.

Uphold Lite is still on the market.

BACKGROUND

The Carlson case was originally filed in multidistrict litigation underway in Charleston, W. federal court where Boston Scientific is facing 19,222 cases facing Boston Scientific alleging defective design and manufacture and a failure to warn.  See the court calendar here. 

The jury in the case of Barba v. BSC issued an unprecedented $100 million award in May. Last week, it was reduced by the Delaware federal judge and BSC was denied a new trial. See story here.

The Los Angeles trial of Sanchez v. Boston Scientific settled just before it went to the jury last May (2:12-cv-05762).  See the story here.

Boston Scientific suffered a $73.5 million jury loss in the September 2014 case of Martha Salazar.  The jury also found Boston Scientific was “grossly negligent” and included $50 million in punitive damages. That amount was later reduced by half due to tort reform.  See story here.  

Last November, the company lost two separate federal trials alleging the company made defective pelvic mesh – one in West Virginia where jurors delivered an $18.5 million verdict to four plaintiffs plus an additional $1 million in punitive damages. See Tyree v Boston Scientific (2:12-cv-08633) The jurors there too concluded the company acted with “gross negligence.”

In a Miami federal court last November, four women injured by the company’s Pinnacle mesh, were collectively awarded $26.7 million. See the story here.

Boston Scientific received favorable jury verdicts twice before, in the Maria Cardenas case in Massachusetts where the jury ruled her Obtryx mesh was not defectively designed, and in the Albright case, also heard in the same Woburn, Mass courtroom over the Pinnacle pelvic mesh.

The Defendant began settling 3,000 cases for $119 million cases earlier this year. See story here.

Pinnacle

RECALLS 

BSC’s Pinnacle Pelvic Floor Repair kit was recalled by the company in 2011 because of concerns a needle may detach from the mesh during placement.

Boston Scientific’s ProteGen was the first mesh sling to be manufactured and used as a prototype or “predicate” for a generation of meshes to follow.  The company pulled it from the market in 1999 because it had higher than expected rates of erosion and did not perform as intended. See story here.

Even though it was used as the basis for future designs, the FDA has no  process to review the subsequent designs that named ProteGen as its predicate device.  #

The post Jury Finds for Boston Scientific in North Carolina Pelvic Mesh Trial appeared first on Mesh Medical Device Newsdesk.

TVT Secur, Megamed Service, RU

October 27, 2015 ~ The Josephine Marie Rabiola v. Ethicon trial, scheduled for Monday, October 26 in Austin, Texas has been rescheduled to February 2016 at the Austin court’s request.  The judge is not set in this rotating docket. The case is expected to be rescheduled one more time at a later date, perhaps mid-2016.

Rabiola is represented by the Matthews Law Firm as well as Freese and Goss.

The case was remanded from multidistrict litigation in Charleston, WV to Austin, Texas – Josephine Marie Rabiola v. Ethicon, 53rd Judicial District Court, Austin TX. Case no. D-1-GN-13-002039.

Ms Rabiola, of Austin, Texas, was 63 years old when she was implanted with two meshes – first the Gynecare TVT Secur System to treat stress urinary incontinence (SUI) on May 24, 2010. She was then implanted with Gynecare Prosima Pelvic Floor System to treat pelvic organ prolapse (POP) on November 2, 2011.

TVT Secur tip, Neuman Urology, Israel

The meshes are made by Ethicon, a division of Johnson & Johnson and include polypropylene mesh tethered in place with two arms that extend up through the buttocks.  They were approved through the FDA’s 510(k) approval process.

Both meshes were removed from the market in 2012.  See the Mesh News Desk story here.

Even though they were voluntarily removed, a quick online search fines one can purchase the TVT-Secur for a suggested price of $900 here.  (No date of this post is given.)

A legal victory was just handed to Ethicon this month in the Dallas trial of Cavness v. Ethicon. She was implanted with the Prosima mesh for pelvic floor repair.

Rabiola has included her implanting doctors in the action – Tomas G. Antonini M.D. of Lone Star Urogynecology and Continence Center, Seton Healthcare Family of Hospitals including its Medical Center, Johnson & Johnson and Ethicon.

THE COMPLAINT

The complaint says despite the claims polypropylene mesh is inert, scientific evidence shows the material is “biologically incompatible with human tissue and promotes an immune response.”  In addition,  it degrades, causing severe adverse reactions to the mesh including shrinkage from 30-50%, erosion and bacteria harbored in the small weave.  Polypropylene is impure, the complaint says.

“There is no such thing as pure polypropylene. Polypropylene contains about 15 additional compounds which are leached from the polypropylene and are toxic to tissue which enhances the inflammatory reaction and the intensity of fibrosis.”

Mesh anchors are likely to pass through and injure major nerve routes in the pelvic region. Welding of the mesh during its production creates a toxic substance that contributes to the mesh degradation, says the complaint.

These mesh products were marketed to the public through aggressive campaigns despite the high failure and complication rates, according to attorneys for the Plaintiff who add that J&J and Ethicon have consistently under-reported and withheld information about the propensity of its products to fail and cause injury.

Injuries include mesh erosion, mesh contraction, infection, fistula, inflammation, scar tissue, organ perforation, dyspareunia, blood loss, acute and chronic nerve damage and pain, pudendal nerve damage, pelvic floor damage, chronic pelvic pain, urinary and fecal incontinence and prolapse of organs.  Many women must undergo repeat surgeries, pain control, injections, explant surgeries and repair surgeries in an attempt to rebuild what has been damaged.

She suffers physical pain and mental anguish, now and likely in the future; disfigurement; physical impairment and medical expenses, both now and in the future.

Tomas Antonini, M.D.

Ms. Rabiola was implanted on May 24, 2010 by Dr. Chris Hart with the TVT Secur to treat stress urinary incontinence.  Dr. Antonini owns the medical group and he knew or should have known the pelvic mesh products had a high failure and injury rate, failed to perform as intended, and often required additional surgeries.

Ms. Rabiola went to Dr. Antonini to consult on the TVT Secur System and he recommended the Gynecare Prosima Pelvic Floor Repair System be implanted.  He failed to inform her of all of the risks involved, according to her complaint.  Had she known, she would not have consented to the implantations. On November 2, 2011, she had the products implanted to treat SUI and POP.

CAUSE OF ACTION

The causes of action include Negligence– J&J and Ethicon failed to use reasonable care in designing, manufacturing, marketing labeling and packaging its pelvic mesh products.

The doctor and hospital failed to select the proper treatment for SUI and POP patients and improperly selected her as a candidate for such products.

Other cause include Strict Liability, Design Defect – Dr. Hart and Antonini were in the business of supplying these products, which were defectively designed when they were sold and were unreasonably dangerous. The Plaintiff was not warned about the risks.  This was proximate cause the damage and injuries to the Plaintiff.

Breach of Implied Warranty – The Plaintiff relied on the implied warranty of merchantability of the Defendant, which they breached because the products were not suited for their intended use.

Breach of Express Warranty – The Defendant made assurances to the public, to hospitals and doctors about the safety and fitness of their pelvic mesh products.  Ms. Rabiola relied on those promises.

BACKGROUND ON TVT-SECUR

This will be the first trial of the TVT-Secur System, a mini-sling that mimics the TVT-Obturator placement.   See European Urology  here.

The only other trial of the TVT-Secur involved the case of Stacey Wilkins which was settled in a Joplin, Missouri State Court in May 2014 for an undisclosed amount. Adam Slater was her attorney.  See the Mesh News Desk story here. 

The TVT-Secur was intended to be the third generation and an improvement on TVT (transvaginal tape).  In the case of a similar product, the Abbrevo mini-sling, Plaintiff Coleen Perry received a $5.7 million jury award in March 2015.  #

The post Rabiola Trial Rescheduled to 2016, First Trial for TVT-Secur appeared first on Mesh Medical Device Newsdesk.

Jane Akre, editor MND

MND, November 1, 2015 ~ Welcome to Mesh News Desk, AKA Mesh Medical Device News Desk.   For more than four years now, this effort has focused on putting a face on the mesh-injuries suffered by thousands of people globally. It should be front-page news.  It is not.  The injuries come from the use of polypropylene mesh for treatment of pelvic floor prolapse, hernias and incontinence.

It’s quite clear with hundreds of thousands of injuries globally that there is a problem with the polypropylene. Numerous trials have uncovered the material shrinks, erodes and harbors bacteria. Anecdotally, many report they developed autoimmune issues after they received their mesh implant. Frightening when you consider it is still used today by mainstream doctors. Even meshes already found to be defectively designed in a court of law are still used by many doctors who view mesh as an improvement over old fashioned suture reinforcement or using a patient’s own fascia to reinforce weakened tissue. 

The use of mesh has become a front line defense rather than a last effort. Even our U.S. Food and Drug Administration says the risks may outweigh the benefits!

It’s quite clear that many readers are new to the issues and there will be more stories upcoming on the basics of mesh.  Please use the search option to research your topic of interest. Join the mailing list to receive an occasional newsletter. 

Settlement talks are underway with four of five manufacturers and many women are finding their case is worth virtually nothing. Remember when you sign a settlement document, you agree not to disclose anything and you agree not to pursue legal remedies in the future for any mesh-related injuries. Think carefully about what you are throwing away. Many women insist their case go forward to trial, no matter how long that may take.   

This is not just a U.S. problem as we export our mesh products globally and the number of pelvic mesh injured women exceed 100,000 globally.

Pudendal Nerve, YouTube

If you have not checked into it, please consider a further medical workup for pudendal nerve damage.  Life Care Solutions and Dr. Greg Vigna, who is a sponsor, is offering to work with your law firm on that diagnosis and a life care plan to outline your medical needs in the future. The dollar amounts will be considered as part of your settlement before the Special Master.

Dr. Christopher Walker of Orlando is also a sponsor. A caring, kind and compassionate doctor, he understands mesh injuries and is very willing to lend his expertise to consult with you.  Click on his photo to contact him. 

There are now 85,000 lawsuits filed in one court, consolidated before Judge Joseph Goodwin in Charleston, WV.  That will be the location of many of the upcoming trials.  Expect rallies outside of the court.

As a publisher, Mesh News Desk will do what it can to provide information to empower those injured.  This is not intended to substitute for advice from your law firm (your editor is not a lawyer or a doctor). Law firms are welcome to issue a press release to their clients and reach thousands of readers a day through this website.  Mesh News Desk is not a legal referral service.  

Our policy is to label sponsored content as such. Comments on this site may result in enrollment in a Mesh Newsletter, which is published occasionally. Please consider writing for Mesh News Desk. You can remain anonymous.  Your opinions are welcomed and valued. 

Federal courthouse, Charleston, WV

PayPal donations are much appreciated. See Page One for the link.

Stay well everyone. I’d love to hear your thoughts.   Let’s carry on shall we?

Your editorial assistants! Ella, Bruiser and Peanut

~ Jane Akre, Editor and editorial assistants
Mesh News Desk
janeakre@meshnewsdesk.com

The post Welcome to Mesh News Desk appeared first on Mesh Medical Device Newsdesk.

Removed Essure coils, The Denver Channel

Essure Facebook page

MND, Nov. 3, 2015 ~ There has been a lot of organized attention by consumers harmed by the Essure birth control device made by Bayer Healthcare Pharmaceuticals.

Metal coils are implanted in the fallopian tubes with the goal of having them scar over, therefore preventing pregnancy. The coils contain polyethylene fibers and are held in place by stainless steel and nickel titanium alloy.

Approved in November 4, 2002 by the U.S. Food and Drug Administration, Essure has gathered thousands of complaints from women who report complications – autoimmune issues, pain, migrating metal, sensitivity to metal, pelvic inflammatory disease, uterine bleeding, and deaths of four women and five unborn children.

A bill filed Wednesday by Rep. Michael Fitzpatrick (R-PA), the E-Free Act, would force the FDA to pull Essure from the market. Rep. Rosa DeLauro (D-CT) has also asked the FDA to remove Essure from the market because its “benefits do not outweigh the risks.”

Read more here.

Rep. Fitzpatrick called this a “woman’s issue, a regulatory issue and a safety issue with faces and names.”

The Essure Problems Facebook page has organized its 22,000 members to be outspoken advocates for the 5,000 women who have filed adverse event complaints with the agency. Activist Erin Brockovich has brought attention to the issue.

See the video of Rep. Fitzpatrick here.

Essure birth control home page by Bayer is here.

An FDA advisory panel met in September and said Essure should remain an option for some women.

A New York Times story at the time called the Essure FDA approval a “fast-track” review process. See the story here… and see the FDA page on Essure here. #

The post Bill Would Have Essure Birth Control Removed from Market appeared first on Mesh Medical Device Newsdesk.

MND, Nov. 5, 2015~ Your editor recently sat down at the Mass Torts Made Perfect session on multidistrict litigation (MDL) to hear the latest on the settlements purported to be in the works concerning transvaginal mesh.

Attorney Henry Garrard told the crowd that four of five mesh manufacturers are in the settlement mode. 

It started with American Medical Systems (AMS).  Judge Goodwin who heads the multidistrict litigation (MDL) in Charleston, West Virginia, has praised AMS for setting forth the first settlement model, though many complain it is short in compensation dollars, certainly not enough for a lifetime of medical management.

Henry Garrard III

AMS – MDL 2325  ~ In April 2014, AMS, now part of Endo Health Solutions, announced $830 million to settle 20,000 product liability lawsuits. That number was upped to $1.6 billion by September to resolve about 25,000 mesh injury claims.  See the story here.

The settlements vary and are reached by individual law firms, some working together to hammer out an agreement.  The agreements may not all be the same, but regardless, they have been slow in coming. Many women report to MND they have their paperwork yet no dollar amount has been specified.

The higher “Tiers” of injury are worked out individually. The lower Tiers may represent no compensation after a 40% legal fee is removed, along with any outstanding liens or medical bills.

Remember, when you agree to a settlement, you forever give up your right to seek redress through the courts as do your family members.  You do have the option to refuse the settlement and insist your law firm take your case to court.  At that point you may get pushback from your firm.  It’s easier for the law firm to settle and move on, but it may not be in your best interest.  They are officers of the court who must act in your best interest!  Check with your state Bar Association to see if you can be dropped as a client if you refuse a settlement!

A June 2013 agreement specifies $54,500,000 as a Settlement Fund held in escrow. It requires 95% of claimants to participate.  There is no admission of liability by the company in offering the millions to women implanted with the Perigee, Apogee and Elevate transvaginal mesh implants. See the Master Settlement here.

Endo Health Solutions took over AMS in 2011 for $2.9 billion and in doing so acquired more than 22,000 lawsuits claiming the polypropylene mesh is defective and doctors were not adequately warned about the complications associated with the mesh.

Boston Scientific – MDL 2326 ~ Boston Scientific announced it would pay $119 million to settle 2,970 cases back in April of this year.  According to Garrard, Boston Scientific is working with national settlement counsel of the Sedgewick firm of New Jersey, specifically Mike Tenanbaum. See him here.

At least 130 cases may be sent back to their own District Courts in the state where they originated in an effort to reduce the load on the MDL in Charleston, WV.

Boston Scientific says it has over 27,000 product liability cases.  More than 2,700 claims have been assigned to one judge in state court in Massachusetts. In its August 2015 SEC filing (here), the company says last April it entered into a master settlement agreement with certain plaintiffs’ counsel.  It will provide $119 million to resolve 2,970 cases including the federal court in Dallas County, Texas. The company has also entered into a Master Settlement, without admitting any guilt or liability, regarding 1,627 pending cases.

Boston Scientific says it plans “to vigorously contest the cases and claims asserted against us.”

C.R. Bard – MDL 2187 ~ Bard is less than forthcoming about the number of lawsuits it’s currently facing and settling in its October SEC report. The good news, according to Garrard, is that Nina Gussack, a partner with the Pepper Hamilton LLP law firm of Philadelphia (here), a settlement firm is helping things along says Garrard and they are about to settle 60 percent of the docket.

Bard was reported to be prepared to settle 500 product liability pending actions for $21 million last year.  See the MND story here.

Bard’s October 2015 SEC report (here) says there are about 90 pending claims in federal and state courts involving the Composix Kugel hernia repair products.

Additionally, the company says its reached agreements with 6,470 Women’s Health Product Claims agreeing to pay Medtronic $121 million toward these potential settlements.  These are claims not included in the  12,850 claims presently in the MDL, making the actual number of product liability lawsuits murky in this report.

Bard says two subsidiaries of Medtronic (as a successor to Covidien plc) supplied the company its mesh products and therefore has an obligation to defend and indemnify Bard from product defect liability. Bard has reached agreement with 6,470 claims agreeing to pay Medtronic $121 million toward these potential settlements.

While Bard continues to talk to Plaintiff law firms regarding potential resolutions and “intends to vigorously defend the Women claims that do not settle, including through litigation, it cannot give any assurances that the resolution of these claims will not have a material adverse effect on the company’s business, results of operations, financial condition and/or liquidity.”

Bard Avaulta, Miklos and Moore website

Covidien – MDL 2187 ~  The company based in Ireland is now part of Medtronic and two subsidiaries of Covidien supplied pelvic mesh products to C.R. Bard, which is named in the litigation.  According to Garrard, they are reaching settlement with Williams and Connolly’s Joseph Petrosinelli (here).

In July of last year, Covidien announced it planned to take $180 million from its third quarter profits to pay the costs associated with pending lawsuits.  In July 2015 Covidien and Bard agreed Bard would pay Covidien $121 million toward the settlement of those claims while other claims remain unsettled ( see the Bard story above).  Law firms represent about 11,300 claimants and as of September, Covidien has reached agreements to settle about 2,300 of those claims.

See the Corporate 10-Q September 9, 2015 filing here.

See PTO #181 (here), June 23, 2015.   Cathy Yanni was appointed the Special Mater for administration of the settlement reached between Blasingame, Burch, Garrard & Ashley P.C., and Covidien.  By September, Blasingame, Burch, Garrard & Ashley, P.C. set up an Escrow Agreement account with Wells Fargo bank.  Law firms Motley Rice and Beasley Allen also filed motions to establish a qualified settlement fund.

Judge Joseph Goodwin

Coloplast – MDL 2387 ~ The Danish company has been in the settlement mode since day one, according to Garrard, but they’ve not had much discussion of settlement with Plaintiffs’ lawyers. Now they are reported to be in a speed- up mode.  See Coloplast Pretrial Order #77 (here). 

Judge Joseph Goodwin, who oversees the MDL, says if significant progress is not made in the MDL he will put a half docket in the fast track for work up.  It would be on the trial dockets in early 2016. A Minnesota judge working up PSI order in 15 days and pushing discovery. The judge in Minnesota is pushing those cases.

In September, Coloplast announced it would increase its mesh legal budget by $448 million for a total of about $727 million.  The company had settled 400 lawsuits last year for $16 million.  Coloplast is facing 2,323 lawsuits filed in the MDL and likely more claims globally.  Since it is not a U.S. company, there is not SEC report filed. See the announcement here.

TVT Secur, Megamed Service

Ethicon – MDL 2327 ~ Is the ten thousand pound elephant in the room.  A trial is set for December for 30 Plaintiffs implanted with the TVT (transvaginal tape) which will be a product defect case only.  There are no individual cases. As a sterile design defect the trial is a disadvantage to the Plaintiff, however if they are successful with the TVT trial, it will represent a major problem for Ethicon, a division of Johnson & Johnson.

Ethicon is facing 44,400 personal product liability cases,  according to an October SEC report. See it here.

Also set were 200 cases for November addressing the oldest filed Ethicon cases.  These are good for the Plaintiff because many of the older cases are the better cases.  Recently Judge Goodwin sent out a notice to Plaintiffs’ firms to work up another 200 cases and have that to him by November 9. That process puts pressure on the Defendant.

The problem with Ethicon it says it will not settle TVT and TVT-O cases with a product in place and a non-surgical outcome because there is no demonstration of injury, says Ethicon. We are exploring how to deal with that said Garrard.

See Pretrial order #203 which dismisses without prejudice the 87 Plaintiffs listed in Exhibit A attached to PTO #199.  That means then can be filed in the District Court closest to the Plaintiff, in this case North Texas.  Here is the list of Plaintiffs.

According to Garrard, the mass advertising campaign currently seen on late night television is not helpful to get the Ethicons of the world resolved, largely because these cases dilute the better cases.

Ironically, not five minutes after a conversation with Mr. Garrard, I got a call on my cell phone from “Steve” of Medical Healthcare Center.  He told me medical compensation might be offered if I had bladder sling surgery in the past, which I have not.   #

The post Settlement Dollars are Slow in Coming in Transvaginal Mesh Claims appeared first on Mesh Medical Device Newsdesk.

Christine Scott from The Bakersfield Californian

MND, November 4, 2015 ~ It largely slipped by unnoticed, until now.

In July 2012, Plaintiff Christine Scott went to trial against C.R. Bard over her Bard Avaulta Plus mesh kit in a Bakersfield, California courtroom. It would be the first trial to be held naming a major mesh manufacturer.

In a precedent setting decision, the jury found the company was negligent and awarded the Scotts $5.5 million which included $500,000 for loss of consortium for her husband. The surgeon charged with 40% of the fault.

That left the company to appeal its $3.6 million judgment, which it did.  See the story here.

Bard, of Murray Hill, N.J.,  has now exhausted its appeals and the amount was paid on Marc  20, 2015. The information is contained in the company’s 10-Q quarterly report to the Securities and Exchange Commission (SEC) issued October 23, 2015. See it here.

See the Opinion as posted here. It’s a good summary of the case.

The implanting physician Dr. Tillaikaransi Kannappan who had received a one day training lab on the Avaulta taught by Susan Tate, a urogynecologist.  Dr. Kannappan was not told Avaulta should not be used in women who are sexually active or for mild prolapse.  Scott had incontinence while participating in sports and mild pelvic prolapse of the bladder and rectum.   As a treatment, in January 2008 Dr. Kannappan implanted a mesh sling and two Avaulta Plus mesh kits one for anterior one for posterior.  Dr. Kannappan says she did not read the instructions for use on the Avaulta plus but did watch a DVD on the surgical technique about a week before Scott’s surgery.

Bard Avaulta, Miklos and Moore website

In an interview with KGET-TV 17 in Bakersfield, attorney Elaine Houghton said that the TVM product was tested on “16 rats, 12 rabbits, four sheep and, by their own researcher’s admission, the next living being this product went into was women.”

On appeal the decision was affirmed by the appellate court in November 2014.  Then Bard filed a petition to have the issue go before the California Supreme Court.  That was denied in February of this year.

This is not only the first trial over transvaginal pelvic mesh, but the first one to be paid following a jury trial and not a settlement.  Her attorneys were Houghton and Gene Lorenz of Bakersfield.

The Cisson case followed. It was the first bellwether trial naming Bard in multidistrict litigation also over its Avaulta Plus. See the story here. In August 2013, Cisson was awarded $2 million, but the company filed an appeal.  The next two cases to be heard in Charleston, Vigil and Queen, received settlements before they went to trial.

Bard is facing in excess of 21,000 product liability lawsuit over its Women’s Health Product (transvaginal mesh).  As of this week, there are 12,735 of those cases filed in multidistrict litigation (MDL) in federal court in Charleston, WV. The Master Complaint was filed in the MDL in July 2012. See it here.

Upon winning her lawsuit, Scott was quoted as saying “Thank you God. We can finally get the word out to women.”  See the story here.

Bard stopped selling the Avaulta in July 2012 right after the U.S. Food and Drug Administration requested three-years of post approval monitoring.  #

The post C.R. Bard Pays $3.6 million in Precedent Setting Scott Pelvic Mesh Case appeared first on Mesh Medical Device Newsdesk.