Fidelma Fitzpatrick, Motley Rice

Fidelma Fitzpatrick, Motley Rice

Fidelma Fitzpatrick was the lead attorney representing Motley Rice on behalf of Mrs. Huskey.  Her closing arguments to the jury are here, as quickly as I could type.  I didn’t feel it was possible to try and edit them down.  This sums up the two week trial of Huskey v. Ethicon, a pelvic mesh case that is asking the jury to find the implant defective.

This coverage is provided in conjunction with We Are Mesh Survivors, a coalition of synthetic vaginal mesh implant survivors united to demand justice for those who have suffered and to demand that existing products be pulled from “the market until their safety can be demonstrated.

“This is my first and last day I will have the opportunity to talk to you, I appreciate your patience you’ve given this trial. We’ve spent a long time working on this case with Mrs. Huskey.   It’s taken us a long time to sift through the evidence and present it to you in the clearest way possible. “Sometimes simplification is the most difficult thing to do. That is really the hardest process we have as lawyers and jurors have as well. But I was reminded a few weeks ago it doesn’t have to be that difficult.

TVT-O from IFU

TVT-O from IFU

My daughter listened and said “Mom this is your opening statement. “And I thought this is cute. She really got it. She understood, as she put it, that machine thing is put in the human body and it hurts rather than helps. Plastic hardens, it shrinks. It can hurt people. The body is trying to push it out. Less mesh, less reaction. That’s what an 8 year-old derived. It’s so true; that’s what this case is about.

“What’s wrong with this mesh? It’s where Ethicon designed to put it in a human body. So it’s not just that the body tries to push it out, it’s that Ethicon chose to put it in a space where they knew surgeons don’t operate. They knew surgeons couldn’t get it out. And they knew if things go wrong it was ah, ‘oh well,’ sorry we can’t help you because it can’t come out. Dr. Pramudji finally admitted if you have to get it out of the transobturator space it involves detailed incisions, and everyone who does it says we’re not going to go in there and were not going to touch it because there is no way we are trying to get it out without hurting this woman worse than she is today.

Ethicon 200“Mr. Wallace talked about Aaron Kirkemo. He criticized all of the obturator slings, he said it was a” kludgy” device you put it out there and see what is going to happen. He criticized this product less than one year before Mrs. Huskey had it. No one told anyone in the IFU or anybody and even their own expert said this is not a good product, it creates problems with positioning and he said I don’t use it. He said I have another way of solving this problem without using this device. I do not need the TVT-O to cure SUI. I can go to something else. It’s hard to understand how Ethicon can say it’s safe and effective when their own medical director says its ill conceived and unsafe for women. I don’t think you need to know any more when you go back to deliberating.

“As far back as 2004 these very problems were known. Dr. Kirkemo identified this is a problem because we are putting it in the adductor muscles. But Ethicon didn’t stop in 2004 and they didn’t stop in 2009 when they had another meeting and said this small piece of mesh sits too close to these nerves, it goes into the muscles of thin active women and creates problems. This is 2009 they didn’t stop it when Dr. Kirkemo said it was a bad device. Or when Dr. Nilsson said I won’t use this mesh. It’s not just that they sold it but they didn’t tell anyone. They didn’t give Dr. Byrkit to look this evidence and say what’s best for their patients. E didn’t tell them and what happens then? What happens is we end up with a mesh in a space that cannot be removed. D. Siddique, he does more of these surgeries in So Illinois and he’s never gone in the obturator space to take out the mesh. Instead he went in and took out as much as possible. And he had to take as much as possible because Mrs. Huskey was having chronic foreign body response, just what Dr.. Hellhammer had warned of. Exactly what they knew could happen is what happened with this mesh. Dr. Siddique couldn’t get it out because Ethicon designed it to go somewhere it should not have gone. He had to get in there with a suture and try to pull it out of her pelvis. He had to dissect not suburethrally, he had to cut into the right later side wall of her vagina, he had to cut into the right wall and left lateral side wall of her vagina to get as much out as he cold. He was there 2 hours and couldn’t get it all out. He did the best he could under the circumstances.

“You heard the injury was too far away from the mesh. When she was confronted with the records she had to tell you it was 2,3, 4 o’clock position. Dr. Siddique says it’s exactly where she had the surgery. The levator pain is caused by surgery in that area three times. He knows exactly what he is talking about. What else is wrong with this mesh? Wrong space, wrong material, wrong amount of material and it’s not necessary. This is not life saving. It deals with a quality of life issue. You know it’s not the only device. They kept trying to convince you the TVT was a great product. Every time they talk about the TVT device, they didn’t talk to you about the TVT laser cut. We are not here to dispute whether TVT is great or isn’t great. What Ethicon is doing here is saying the most popular car is the midsize sedan. Therefore every midsize sedan must be safe. If Honda Accord is safe so is the Toyota Camry, it must be safe, it’s the same class.

“Common sense tells you that’s not how it work. You look at the product. That’s how it works. Here with Mrs. Huskey, you look at the TVT-O laser cut mesh.

“Well, we know the TVT is a different device. Dr. Nilsson use it, Dr. Kirkemo will use when they won’t use the TVT-O laser cut mesh. And it’s not just these other mesh products. What we know the TVT-O doesn’t work any better than the other surgeries of native tissues repairs. They cure the same percentage of women, they work the same in curing SUI. There is huge difference beside efficacy. It is safety. It uses the body’s own tissue and they do not incite the FBR. So without a foreign body you cannot get this chronic inflammation, this woody tissue, the kinds of complications Mrs. Huskey was seeing with her particular device.

“You’ve also heard Ethicon say these other procedures are more invasive. They never told you what the backup for that statement is. You saw a chapter in the book this morning. There is no chapter dealing with pain from pelvic surgery or burch or fascial sling. But there is an entire chapter that says pain complications of MESH surgery, and they only arise with mesh, and there is now a new syndrome, chronic mesh pain syndrome. Dr. Pramudji tried to say that is just a book.   Who edited that book? Dr. Goldman who is an Ethicon consultant! He said they cause chronic, permanent, irreversible complications and they give arise to an entire new practice of medicine out there, people like Dr. Blavis.

“Now we look we know Ethicon know all of what I’m telling you. They knew in 2010 when they talked about getting the mesh out of the muscle. Look at Dr. Siddique says. He says there are centers developing around the country with specialists to deal with mesh complications. He doesn’t know where to send patients because this is new uncharged territory. Dr Blavais said he’s never seen things like this before. And he didn’t have information from Ethicon. He talked to his colleagues and he said we’ve got to figure it out for these women because they need help for a condition we don’t understand.

“I want to talk to you about Mr. and Mrs. Huskey. That is who this case is about. There is not a lot of disputed in this case about Mrs. Huskey. You met her and her husband. You heard about her life before the TVT device. Mrs. Dean called her spunky that’s the woman she remembered before the TVT-O was implanted. Her friend called her an elliptical queen. You saw pictures of her kayaking and celebrating marriage with a man who is the love of her life. Jo is a regular person. She had hobbies and activities. She embraced the life she had been given and she enjoyed it. There is absolutely no dispute about that. They described her as honest, she worked try and she tried hard. There is also no dispute all of that changed after Feb 2011 when the TVT-O was implanted. {Jo leans on her husband, he pats her back}

“I ask you to remember the emotional toll that this has taken on them individually as a couple. Remember what Allen told you about his wife? They hadn’t been married 5 yr before she had this. She said I broadened my horizons, she got me doing things I never would have done before. She improved my life and we’ve lost a lot of that now. That is what this ill conceived device has done to a real woman and real man and a real relationship.   Allen told you they hold onto each other. I think they are fortunate. I submit to you they deserved so much better than what has happened to them here.

“Dr. Pramudji told you there has been a dramatic decrease in Mrs. Huskey’s ability to function and to do life activities. This is not ‘take a couple aspirin and you’ll be okay’. She can’t walk because she doesn’t have that choice anymore. She can’t work. She can’t do the activities she did before she went over minimally invasive treatment. Her personal relationship with her husband has been devastated. She traded 30 minutes in an operating room for a lifetime of chronic pain.

“There is no dispute about the source of pelvic pain and dyspareunia they all identify the same thing, this firmness, tenderness scar tissue that’s on the left side of her vagina. The disagreement is whether the TVT-O had anything to do with that or as Dr. Pramudji said it was just a coincidence. So the medical records are very clear. You should look at what the treating physicians say. Dr. Siddique said the mesh erosion, and the two explants, and the mesh that remains will continue to cause pain.

“This is what the case is about. Mrs. Huskey’s injuries were caused by mesh, the inside out procedure, and the mesh surgery those three factors forms the legs of the stool Mrs. Huskey is forced to sit on today.

“Dr. Blavias has worked on this area for years. You can see his lectures, his books and this is his CV. This is Dr. Pramudji’s. They do not line up in the types of qualifications in assessing patients like Mrs. Huskey.  He will tell you the IFU does not warn physicians about the type of injuries Mrs. Huskey sustained and the medical community is not aware of the type of complications like those that happened to Mrs. Huskey.  Dr. Pramudji said mesh does not cause problems beside erosion. That’s what she believes. We showed her article after article that says they are all real, they exist and they are permanent. She didn’t tell you anything about mesh related pain; she doesn’t know so how can Ethicon tell you doctors in community understand when their own expert didn’t understand. It just doesn’t make sense.

Prolene mesh

Prolene mesh

“Dr. Blavias said chronic inflammation caused pain and removal and they are not transitory problems. A 30 min procedure, problems for the rest of her life.   Even Dr. Pramudji said two o’clock 3 o’clock 4 o’clock just where Dr. Siddique excised the mesh just where he had to perform levator injections. Dr. Blavias agrees with everyone. They’ve all seen the same thing on examination. Dr. Blavias, Dr. Mueller Dr. Pramudji, Dr. Siddique. Pramudji came in to contradict Ethicon’s own experts. She was trying to make excuses for Ethicon documents and findings. She contradicted Dr. Kirkemo, Dr. Nilsson, she contradicted Kirkemo on obturator slings, he said he hates them she contradicted Dr. Nilsson she said the TVT inventor doesn’t have an opinion about the safety of that product. She contradicts Dr. de Leval about the concerns about using this in active women. She disagrees, no research, she knows better than these people who worked for Ethicon and are familiar with these problems. She also contradicted all health providers. When she didn’t like what Dr. Siddique said about surgery in the very area she had pain, she said he’s wrong.   And when Mrs. Dean talked about she’s not able to have sexual relations, she Dr. Pramudji didn’t even ask Mrs. Huskey about that. She didn’t think it was important during her medical examination.

“Dr. Pramudji told you there isn’t a definitive diagnosis. Dr. Siddique said its pelvic pain after excision of pelvic mesh. Dr. Pramudji said it’s just a coincidence.

“Here’s what the reality is, Mrs. Huskey had removal surgery 2 times. The scar tissue formed in the levator muscles are in that area of her pain. It’s not a coincidence. You look or the obvious answer you don’t look for the one that doesn’t make sense. She wanted to find it was everything but the TVT-O and she said it’s a coincidence. Mrs. Huskey deserves more than that.

“They said no harm no fowl because everyone know about these complications, but then she tell you it can’t happen with the mesh. We’ve got to think about this in real life terms. What we understand is if it’s not right you don’t do it. If it’s not honest, you don’t say it. It’s a basic principle we all live by.   What they have in there (the IFU) isn’t true. They say its transient pain, 24 to 48 hours pop some Tylenol and you’ll be fine.   Privately they say I understand the presence of this foreign body will introduce more chronic pain syndrome. They omitted the important information. They say transitory foreign body response may occur. Internally inside Ethicon, they say excessive foreign body reaction, according to Dr. Hellhammer may potentiate an existing infection. In other words it doesn’t make an existing infection worse, you can get an whole new infection that’s not what the IFU says. They say the material isn’t absorbed, the propensity of PP to degradation and the effects on erosion rates is not known. They know it degrades yet they told the physicians it isn’t. There is a whole stuff they didn’t put in there – frequency of complications, severity of complications, chronic pain, the surgery you have to get; if there is a problem and this stuff has to come out; scarring, and they do not tell you you can end up with problems like Mrs. Huskey has and it’s not just Mrs. Huskey who has problems with the IFU. And Dr. Robinson says it’s important everything be in there. Significant risks have to be in there! He says it has to be in there. Dr. Chen says she is looking at complaints coming in she is looking at pain everyday like Mrs. Huskey has. She has also heard reports of pain, dyspareunia and sexual dysfunction.

“And what we have there is not transitory, it is permanent. She said the updated IFU had to go to doctors and it didn’t. And that’s Mrs. Huskey’s case is about and what I want you to think about when you consider the legal process. I want you to think about the real life of two people and what happens when they went to get a minimally invasive procedure because complications known by Ethicon were not shared. We asked you to return a jury verdict for Mrs. Huskey on her design defect, failure to warn and negligence claims. Thank you.”