Mesh and Catastrophic Injuries Moving Forward

Dr. Greg Vigna, MD, JD

Dr. Greg Vigna, MD, JD, is a doctor and a lawyer and has been involved with mesh-related complications since 2013.

His focus is on pudendal and obturator neuralgia and complex regional pain syndrome. These are considered catastrophic injuries related to the placement of polypropylene mesh in women, used to treat incontinence and pelvic organ prolapse.

Dr. Vigna is currently working on catastrophic injury cases to take them to trial in state courts outside of the MDL (multidistrict litigation.) See his first case filed here.

As one of the few professionals who remains involved in caring for and representing mesh-injured and those newly injured women, he talked to Mesh News Desk about what’s happening in the year ahead.

MND, 2018, Chronic pain treatment protocol here.

MND, 2018, Exiting the MDL story here.

MND, 2013, Nurse writes about catastrophic injury symptoms here.

Harvard Patient Education

MND Q: You are focused on transobturator injuries – why?

Vigna: “Transobturator injuries are caused by the TOT (transobturator tape), also known as TVT-O. The TOT is a device that’s clearly defective and more commonly associated with catastrophic pain syndrome that is life-altering. I’m a catastrophic injury doctor and my legal practice is focused on catastrophic injuries. The TOT causes catastrophic pudendal, obturator and complex pain syndrome which destroys humans.”

“I believe this device needs to be removed from the market.”

“By litigating these cases in trials going forward filed in state court, the manufacturers will have to make a business decision that they will need to remove them from the market. This is not to say I’m not focused on retropubic slings (TVT) if there is a case of complex regional pain syndrome once diagnosed. Those I will look at on an individual basis because those, as well, can be litigated successfully.”

Q: Are you a member of AUGS (American Urogynecology Society)?

Inside AUGS 2016

Vigna: “No, I’m not a member AUGS. AUGS still says TVT and TOT are the Gold Standard. Many of these doctors are not familiar with catastrophic pain syndrome. They do not take care of these women. They do not have to live with women who are destroyed. They don’t know how to diagnose and how to treat and more often than not they do not know who to refer those patients to. It’s blind ignorance.”

Pudendal nerve from Painspa, UK

Q: Why are women denied disability with pudendal neuralgia (PN), obturator neuralgia (ON), and Complex Regional Pain Syndrome (CRPS) and what is needed to prove their claim?

Vigna: “I’ve never had a woman with a diagnosis of complex regional pain, pudendal neuralgia, or obturator neuralgia denied disability benefits that they are entitled to. However, I’ve had women with these diagnosis who have had to appeal to get benefits. Sometimes in the initial review before a judge, these women might lose their first attempt at getting disability. The judge has to consider they are diagnosis that are widely accepted as disabling diagnosis where a person is not anticipated to be able to work.”

Q: Could a settlement be larger with a catastrophic injury diagnosis?

Vigna: “Pain is just pain and if you don’t have a diagnosis of what caused it you’re going to have show multiple medical records and provide additional information from physicians that state she cannot work. But if there is a clear diagnosis of neuralgia complex, they rubber stamp this patient as disabled.”

Q: But some women are only getting $700 a month with disability?

Vigna: “A lot of women with complex regional pain and obturator damage continue to work despite horrific pain syndrome because their money is not adequate enough to live on. People are working wearing diapers because the money is not enough to survive. They are struggling every day until they get to court.”

Q: Women who remain in the MDL and still haven’t settled are some of the worse injured. Why?

Vigna: “They’ve been held hostage for years and they see lesser injured get paid more for minor injuries. The MDL left the most injured women far behind and the settlement matrix is to-date evidence of that. When a person has a catastrophic injury, these cases, where there is a deep-pocketed defendant, they often aren’t settled until the case has been tried in court, or before jury selection, or the defendant will wait until the end before it goes to the jury. Right now you have women going to mediation in West Virginia but still these women aren’t really close to trial so it’s very difficult for a settlement case in WV to get the compensation it deserves. You will have a greater change of obtaining one as you approach trial.”

Bryd federal courthouse, Charleston, WV, home of mesh MDL

Q: But women with catastrophic injuries are lingering. Why wait until the end to take care of them?

Vigna: “Mass torts are not designed for catastrophic injuries. These are as devastating as spinal cord injuries. They need individual litigation. You get to the point to where the person who can write a check can lose more money because punitive damages are available, versus settling the case where they can consider the life care plan, life expectancy, and lost wages. The people who write the check are not being tested. I have women going through specific causation diagnosis and I’m writing expert reports so yes, what we are doing right now with those who have not accepted settlements, we are taking expert depositions, client depositions, especially depos of people in Boston Scientific. We are working up our cases and getting ready for litigating catastrophic cases and signing up new ones."

"Next week we file another BSC (Boston Scientific) case and they will understand they have a line of catastrophically injured women forming and we’re going to litigate or they will bring a checkbook to table. Bard, Boston Scientific, and JNJ. Coloplast certainly has the Aris sling, which is a terrible device.

Q: You bring up something - can women opt out and go to you for a pain and life care report?

Vigna: “These women should not fire their attorneys or they are stuck paying money for the value the firm performed.”

“Is there a statute of limitations? Is the value not sufficient? If a woman has neuralgia, complex regional pain or obturator neuralgia, the tier will not approximate their future medical care or lost wages, so if a woman has one of these diagnosis and the settlement is not adequate, they need to ask their attorney if they intend to litigate. If not, ask for permission in writing to talk to other law firms. If the case is valuable enough, there is some obligation on the part of the firm to take it forward and if they are not going to, they need to release those clients.”

“There is no reason for a woman with pudendal neuralgia, complex neuralgia, complex regional pain syndrome or obturator neuralgia, if they have these disabilities with ongoing medical care to linger. Understanding though women have been sitting around for many years with a diagnosis and not receiving care because they’ve given up.”

“It’s important, you need to be obtaining the care that you require and have these diagnosis, really before any business decision can be made by another.”

Pain by Jade R

Q: Can these women ever be relieved of pain?

Vigna: “The women who have pudendal nerve damage or neuralgia or complex pain syndrome can get significantly better with mesh removal but more often than not they continue to have intractable pain that is disabling. If you get proper treatment so the pain becomes bearable, you are happy.”

“We want the women to get the best medical care they can going forward and get to the doctor who can help. The cost is about $2-3 million for her lifetime for a 45-year-old woman. There has been a big cost shift with these settlements that have been inadequate to government payer sources (Medicare, Medicaid). So that is not fair for the public and we are independently litigating these cases so the cost is paid by the party causing the harm.”

Q: What about the future of women who received settlements and are catastrophically injured but it is not enough money to travel to specialists?

Vigna: “There are more doctors who can provide nerve blocks today. It’s not as bad as it was in 2012. Things are getting better from a medical standpoint, however, there are women diagnosed with PN (Pudendal neuralgia) with a retropubic sling that have reflex sympathetic dystrophy (RSD) so they are getting treatment for catastrophic pain syndrome and they might not be diagnosed correctly.”

“The TOT sling causes these cases and we are looking at them on a case-by-case basis to see if we need to add the doctor to the claim against the manufacturer. Certainly now there aren’t issues of inadequate warning. The malpractice component we have to consider over time as the doctors are getting pointed to by the manufacturer. Word will get out and their business will go out. We are looking at this again on a base-by-case basis.”

Actress Jennifer Aniston in 2014 movie about chronic pain, "Cake."

Q: Are you finding women are being newly diagnosed?

Vigna: “Yes. Newly implanted women are injured every day. The case we just filed in Arizona is newly diagnosed with PN. See the MND story here.

“Another case will be filed in the next week in California. Women are still being implanted with these devices. The Arizona case was implanted in 2016 and the women in California just started developing pudendal nerve problems. There are old implantations that become symptomatic caused by the mesh and they need to be filed in state court.”

“Obviously the women implanted with retropubic or TOT devices that have an erosion and need something done to fix the erosion might not be the best case for us to file. Unfortunately, you need a catastrophic injury to make that case viable from a cost-benefit standpoint. So we are looking pudendal neuralgia, obturator neuralgia and complex regional pain syndrome cases.” ###

LEARN MORE:

Complex Regional Pain Syndrome - Mayo Clinic
https://www.mayoclinic.org/diseases-conditions/complex-regional-pain-syndrome/symptoms-causes/syc-20371151

Complex Regional Pain Syndrome- National Institutes of Health
https://www.ninds.nih.gov/Disorders/Patient-Caregiver-Education/Fact-Sheets/Complex-Regional-Pain-Syndrome-Fact-Sheet

CRPS- Med News Today
https://www.medicalnewstoday.com/articles/184338.php

Pudendal Neuralgia Portal- Vigna, MD, JD
http://pudendalportal.lifecare123.com/

Pudendal Neuralgia- WebMD
https://www.webmd.com/pain-management/pudendal-neuralgia#1

Obturator Neuralgia, J of Minimally Invasive Gynecology, Miklos, Moore, 2015
https://www.ncbi.nlm.nih.gov/pubmed/25735602