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Ethicon 10/8

    Client Attorney Privileged/Attorney Work Product/At Request of Counsel

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  1. Ethicon Can't Shake Consolidation In Mesh Design Defect MDL

    Aug 7, 2015 | Law360

    By Jody Godoy

    A West Virginia federal judge has refused to back down from his consolidation of 37 suits against Johnson & Johnson's Ethicon Inc. for trial on whether a type of pelvic mesh implant was defectively designed, calling one of Ethicon's proposed defenses a “useless relic.”
  2. Product Liability Cases To Watch In The Second Half Of 2015

    Aug 7, 2015 | Law360

    By Sindhu Sundar

    ...The pelvic mesh MDL in West Virginia involves devices by a number of manufacturers including C.R. Bard Inc., Endo International PLC unit American Medical Systems Inc. and J&J unit Ethicon Inc., and the litigation on the whole in the U.S. has seen a number of high-profile settlements and verdicts even in recent months...
  3. Pudendal Neuralgia and Pelvic Mesh: Serious Injury – Serious Decisions

    Aug 8, 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.

    Client Attorney Privileged/Attorney Work Product/At Request of Counsel

    Online Sources

  1. Ethicon Can't Shake Consolidation In Mesh Design Defect MDL

    Aug 7, 2015 | Law360

    By Jody Godoy

    A West Virginia federal judge has refused to back down from his consolidation of 37 suits against Johnson & Johnson's Ethicon Inc. for trial on whether a type of pelvic mesh implant was defectively designed, calling one of Ethicon's proposed defenses a “useless relic.”

    U.S. District Judge Joseph Goodwin, who oversees multidistrict litigation against Ethicon over several mesh implant devices, refuted Tuesday the company's arguments that the question of whether its TVT mesh product had design flaws could not be divorced from facts specific to each plaintiff. In particular, the judge trounced on Ethicon's assertion that trying the issue in a vacuum would affect its ability to defend itself under a principle of tort law known as “comment k,” which holds medical products are unavoidably unsafe though not unreasonably dangerous.

    “West Virginia has effectively rid itself of the need for the useless relic that is comment k,” Judge Goodwin said. “Accordingly, there is no reason to apply comment k separately in this case, as its principles have become a part of West Virginia law.”

    In June, the judge consolidated 26 of the roughly 23,000 suits against Ethicon for trial, later expanding that number to 37. The consolidated suits involve West Virginia plaintiffs who had surgery in the state to implant the company's TVT mesh device, according to the ruling. Because the surgeries all occurred within West Virginia, the suits are subject to the state's relevant laws, the judge said.

    Both parties then filed motions seeking clarification on the consolidation.

    In his memorandum on Tuesday clarifying the scope of the trial set for December, the judge said that the trial will be restricted to whether there was a design defect and “whether Ethicon acted as a reasonably prudent manufacturer in designing the TVT.” Other elements of the plaintiffs' negligent and strict liability claims for alleged design defects, such as liability and causation, are reserved for a second phase of trials, Judge Goodwin said.

    Ethicon had brought the judge a handful of arguments against consolidation, including that the trial would preclude it from bringing evidence of product warnings, which the company said “may be relevant” in cases where it asserts a defense to to design defect liability under comment k, which holds that a medical product is not unreasonably dangerous if it comes with the proper warnings.

    The judge offered an analysis of comment k, which is found in section 402A of the Second Restatement of Torts, saying that its purpose was effectively to create an exception to the criteria that a product is defective if it fails to perform as a reasonable consumer expected.

    But product liability law has evolved since the widely influential treatise came out in the 1960s, the judge said. Since then, many states have adopted a test balancing the intended utility of the product against its risks, thus making comment k redundant, Judge Goodwin added. In the judge's reading, a West Virginia appeals court was “ahead of its time” when it established the utility-risk standard as law in the state in a 1979 ruling.

    Judge Goodwin went further to say “comment k appears to be redundant even in states that retain the consumer-expectations test because it merely replicates the principles of negligence.”

    Recently, medical device maker C.R. Bard Inc. used the piece of product liability law tosuccessfully defeat design defect claims in a mesh suit in Pennsylvania federal court.

    The judge also shot down Ethicon's argument that the court would need plaintiff-specific evidence to determine whether there was a safer design alternative, saying West Virginia does not require such a showing and finding that “plaintiff-specific information is not required to develop or defend against state-of-the-art evidence of a safer alternative design.”

    Counsel for the parties did not reply to requests for comment after hours on Friday.

    Ethicon and J&J are represented by David B. Thomas of Thomas Combs & Spann PLLCand Christy D. Jones of Butler Snow LLP.

    The plaintiffs steering committee is represented by Renee Baggett and Bryan F. Aylstock of Aylstock Witkin Kreis and Overholtz PLC and Thomas P. Cartmell and Jeffrey M. Kuntz of Wagstaff & Cartmell LLP.

    The MDL is In re: Ethicon Inc. Pelvic Repair System Products Liability Litigation, case number 2:12-md-02327, in the U.S. District Court for the Southern District of West Virginia.

    --Editing by Emily Kokoll.

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  2. Product Liability Cases To Watch In The Second Half Of 2015

    Aug 7, 2015 | Law360

    By Sindhu Sundar

    Attorneys following the General Motors ignition switch defect litigation are particularly interested in the scope of Jenner & Block chairman Anton Valukas' upcoming deposition, while trial lawyers will pay close attention to the first bellwether case in the Lipitor multidistrict litigation as well as the performance of the Zoloft plaintiffs' key expert witness. 

    Here are five cases that product liability attorneys will be tracking in the second half of the year:

    GM Ignition Switch Litigation 

    General Motors Co. and plaintiffs in the New York federal MDL over faulty ignition switches are fighting over what Valukas can and cannot be questioned on in an upcoming deposition in September. The plaintiffs want to be able to question Valukas — who wrote a controversial internal investigation report appearing to exculpate the automaker of fraud or concealment — on the basis for his conclusions and the evidence relating his findings.

    Anton Valukas testifies on the GM recall before a House panel last year. (Credit: C-SPAN)

    But GM has argued that the scope of what Valukas can respond to is vastly limited by issues of attorney-client privilege. U.S. District Judge Jesse Furman, who is overseeing the litigation, is expected to rule on the conflict over the Valukas deposition this month. 

    GM has separately accused the plaintiffs' attorneys in the case of releasing information unearthed in the pretrial discovery process to the press, which the automaker says is likely to prejudice potential jurors ahead of bellwether trials scheduled in the case for 2016.

    But GM and the plaintiffs proposed a resolution Friday that would allow personnel files and personally sensitive employment-related information of current and former GM employees to be treated as confidential if they're not already public, Robert Hilliard of Hilliard Munoz Gonzales LLP told Law360.

    Judge Furman signed off on the proposal Friday, which also requires plaintiffs' attorneys to provide a five-day notice of any plans to publicly disclose any deposition testimony or documents that haven't been labeled confidential so that the defendants have an opportunity to object.

    The plaintiffs are represented by Robert C. Hilliard of Hilliard Munoz Gonzales LLP, Steve W. Berman, Sean R. Matt and Andrew M. Volk of Hagens Berman Sobol Shapiro LLP, and Elizabeth J. Cabraser, Steven E. Fineman, Rachel Geman and Annika K. Martin ofLieff Cabraser Heimann & Bernstein LLP.

    GM is represented by Kirkland & Ellis LLP, King & Spalding LLP and Hood Law Firm LLC, among others.

    The case is In re: General Motors LLC Ignition Switch Litigation, case number 1:14-mc-02543, in the U.S. District Court for the Southern District of New York.

    Lipitor Litigation 

    Plaintiff Wilma Daniels, a 66-year old Colorado woman suing Pfizer Inc. over the alleged Type 2 diabetes risks of its cholesterol medication Lipitor, will face the drugmaker in the first bellwether trial in the MDL in South Carolina. The trial is currently scheduled for Nov. 4, and it may depend on the outcome of Daubert hearings scheduled in the litigation for late September. 

    The Daubert hearings are on general causation, and Pfizer has sought to exclude the testimony of plaintiffs’ expert John Abramson, as well as that of plaintiffs’ regulatory expert G. Alexander Fleming.

    Daniels, whose suit is among more than 2,000 in the litigation, claims she took Lipitor from 1998 to February 2014 and was diagnosed with Type 2 diabetes in 1998, according to an amended complaint filed in September. 

    "Millions of Americans have diabetes, and millions of people take Lipitor, and it would potentially open the door to some significant litigation if the plaintiffs were to prevail in an early bellwether trial in this litigation," said Peter Goss of Blackwell Burke PA. 

    "We saw years of litigation over atypical antipsychotics like Risperdal and their alleged risks of diabetes, and Lipitor was much more widely prescribed than those medications," he said.

    According to the CDC, more than 29 million Americans are living with diabetes, a quarter of whom aren't aware of their condition. More than 29 million Americans have been prescribed Lipitor, according to a website for the medication.

    U.S. District Judge Richard M. Gergel is presiding over the MDL, which the Judicial Panel on Multidistrict Litigation consolidated in February.

    Pfizer is represented by Mark Cheffo of Quinn Emanuel Urquhart & Sullivan LLP.

    The plaintiffs' lead counsel is H. Blair Hahn of Richardson Patrick Westbrook & Brickman LLC.

    The case is In re: Lipitor (Atorvastatin Calcium) Marketing Sales Practices and Products Liability Litigation, MDL 2502, in the U.S. District Court for the District of South Carolina.

    Chinese Drywall Litigation 

    The parties in the Louisiana MDL over allegedly defective drywall are now sparring over acontempt order that U.S. District Judge Eldon Fallon issued last July barring Chinese manufacturer Taishan Gypsum Co. Ltd. from doing business in the U.S. until it appeared in court to answer questions and pay a $2.7 million default judgment over defective drywall.

    Taishan eventually paid the judgment this year, but the plaintiffs in the case are arguing that many subsidiaries and affiliates of Taishan violated the contempt order. The plaintiffs have so far taken more than 30 depositions involving companies allegedly related to Taishan, including CNBM Group and BNBM group.

    There is a hearing before Judge Fallon scheduled Aug. 14 in which CNBM and BNBM are expected to argue that the  injunction should never have applied to them. There are also depositions set in Hong Kong for mid-September, in which plaintiffs say the chairman of entities that effectively control BNBM, CNBM, Taishan and others will be cross-examined under oath.

    Many of the defendants are also contesting the court's jurisdiction over them, but hearings on that dispute are not expected to take place until December or January, after the plaintiffs have conducted another 16 to 20 depositions in the case.

    The plaintiffs are represented by lead counsel Arnold Levin, Fred S. Longer, Sandra L. Duggan and Matthew C. Gaughan of Levin Fishbein Sedran & Berman, and liaison counsel Russ M. Herman, Leonard A. Davis and Stephen J. Herman of Herman Herman & Katz LLC.

    JPMorgan is represented by Michael D. Ferachi and Gabriel A. Crowson of McGlinchey Stafford PLLC.

    The case is In re: Chinese-Manufactured Drywall Products Liability Litigation, case number 2:09-md-02047, in the U.S. District Court for the Eastern District of Louisiana.

    Pelvic Mesh Litigation

    The pelvic mesh MDL in West Virginia involves devices by a number of manufacturers including C.R. Bard Inc., Endo International PLC unit American Medical Systems Inc. and J&J unit Ethicon Inc., and the litigation on the whole in the U.S. has seen a number of high-profile settlements and verdicts even in recent months.

    In July, American Medical Systems Inc. said it resolved more than 100 injury suits, more than a year after its parent Endo said that it had agreed to pay $830 million to settle a large chunk of suits over the alleged mesh injuries.

    In May, Boston Scientific Corp. was hit with a $100 million verdict in state court in Delaware in favor of plaintiff Deborah Barba, who claimed she suffered serious complications after being implanted with the device maker's Advantage Fit and Pinnacle mesh products to treat pelvic organ prolapse and urinary incontinence.

    Attorneys say they will be watching to see if such developments prompt larger-scale settlements in the MDL.

    "The context of this litigation, to me, would augur well for some kind of global settlement of the claims," said Alan Klein of Duane Morris LLP. "You probably have to partition the settlement among the defendants and have a settlement that would recognize each individual defendant's potential liability."

    The plaintiffs' steering committee in the MDL is represented by Renee Baggett and Bryan F. Aylstock of Aylstock Witkin Kreis and Overholtz PLLC and Thomas P. Cartmell ofWagstaff & Cartmell LLP.

    The MDL is In re: Ethicon Inc. Pelvic Repair System Products Liability Litigation, case number 2:12-md-02327, in the U.S. District Court for the Southern District of West Virginia.

    Zoloft Litigation 

    The long-anticipated Daubert hearings in this litigation over Pfizer's antidepressant Zoloft's alleged birth defect risks center around the testimony of plaintiffs' causation expert Nicholas Jewell. The hearings began in July, only to be halted quickly over doubts cast on a key study.

    Pfizer's expert Stephen Kimmel said that a 2007 study in the New England Journal of Medical contained erroneous data showing a statistically significant association between the Pfizer Inc. drug and serious cardiac birth defects.

    U.S. District Judge Cynthia Rufe, who is over seeing the MDL in Pennsylvania, said the potential errors could impact a contested report submitted by plaintiffs’ expert Nicholas Jewell concluding that Zoloft use by pregnant women could be positively linked to certain birth defects in their children.

    The Daubert hearings have been rescheduled for September. Plaintiffs in state court litigation have already lost two trials over Zoloft's alleged risks of causing heart health defects in children born to women who took the medication during their pregnancy. Federal bellwether trials are scheduled for 2016.

    "If the plaintiffs can't manage to prevail in one of these cases, we won't be seeing much more of this birth defect litigation with respect to SSRIs," Goss said, referring to selective serotonin re-uptake inhibitors, the class of antidepressants to which Zoloft belongs.

    The plaintiffs are represented by Robinson Calcagnie Robinson Shapiro Davis Inc.,NastLaw LLC, Reilly Pozner LLP, Aylstock Witkin Kreis & Overholtz PLLC, Tracey Law Firm and Stark & Stark, among others.

    Pfizer Inc. is represented by Sheila L. Birnbaum, Mark S. Cheffo, Bert L. Wolff and Jonathan S. Tam of Quinn Emanuel Urquhart & Sullivan LLP, Pamela J. Yates, Bert L. Slonim and Aaron H. Levine of Kaye Scholer LLP, James E. Hooper Jr. and Andrew H. Myers of Wheeler Trigg O'Donnell LLP, and Robert C. Heim and Judy L. Leone of Dechert LLP.

    The case is In Re: Zoloft (Sertraline Hydrochloride) Products Liability Litigation, case number 2:12-md-02342, in the U.S. District Court for the Eastern District of Pennsylvania.

    --Additional reporting by Jody Godoy and Matt Fair. Editing by Jeremy Barker and Philip Shea.

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  3. Pudendal Neuralgia and Pelvic Mesh: Serious Injury – Serious Decisions

    Aug 8, 2015 | Mesh Medical Device News Desk

    By Jane Akre

    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.

     

    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.

    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.

     

    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.

    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 Damagehttp://meshmedicaldevicenewsdesk.com/pudendal-and-other-nerve-damage-posterior-femoral-cutaneous-ileoinguinal-and-obturator-in-the-transvaginal-mesh-patient

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