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N.C. Federal Judge Refuses to Reinstate Failure-To-Warn Claim in Uphold Transvaginal Mesh Case
Oct 1, 2015 | HarrisMartin Publishing
A North Carolina federal judge refused to reinstate a failure-to-warn claim in an action involving Boston Scientific Corp.’s Uphold transvaginal mesh device, agreeing with the MDL court that it is barred by the learned intermediary doctrine. -
Pudendal Neuralgia and Pelvic Mesh: Serious Injury – Serious Decisions
Oct 1, 2015 | Mesh Medical Device News Desk
By Jane Akre
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. -
Defense on Prosima’s Low Complication Rate
Oct 1, 2015 | Mesh Medical Device News Desk
By Jane Akre
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.
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N.C. Federal Judge Refuses to Reinstate Failure-To-Warn Claim in Uphold Transvaginal Mesh Case
Oct 1, 2015 | HarrisMartin Publishing
A North Carolina federal judge refused to reinstate a failure-to-warn claim in an action involving Boston Scientific Corp.’s Uphold transvaginal mesh device, agreeing with the MDL court that it is barred by the learned intermediary doctrine.
In a Sept. 30 order, Judge Richard Voorhees of the U.S. District Court for the Western District of North Carolina noted that although the plaintiff’s implanting physician testified that he was aware of the device’s risks, he also stated that it was a safe and effective option for treating the plaintiff’s pelvic organ prolapse.
Martha Carlson sued BSC in connection with ...
Subscription required for full article, please see: http://harrismartin.com/article/19959/nc-federal-judge-refuses-to-reinstate-failure-to-warn-claim-in-uphold-transvaginal-mesh-case/
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Pudendal Neuralgia and Pelvic Mesh: Serious Injury – Serious Decisions
Oct 1, 2015 | Mesh Medical Device News Desk
By Jane Akre
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 onMesh 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, theLinda 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. #
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Defense on Prosima’s Low Complication Rate
Oct 1, 2015 | Mesh Medical Device News Desk
By Jane Akre
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.
The trial is now in its seventh day before Judge Ken Molberg in the 95thDistrict 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 nothave 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 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
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.”
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. #
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