Transvaginal Mesh Implants May Lead to Serious, Life-Threatening Injuries

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Kendall Dunson: Welcome to the Beasley Allen Report. I’m Kendall Dunson and Gibson has a night off. Every year many people use a variety of medical devices. Consumers trust that these devices will be safe and will make their lives better. But sometimes they don’t work out the way they were designed and can result in serious injury. Tonight my guest is Beasley Allen attorney, Leigh O’Dell. Leigh joins me to discuss the most common medical devices known to be defective. Thank you for joining me, Leigh.

Atty. Leigh O’Dell: Good to be here. Thank you!

Kendall Dunson: Leigh, let’s start by telling the viewers a little bit about yourself.

Atty. Leigh O’Dell: Well, I’m originally from this area. I grew up in Prattville and went to Auburn and Alabama to Law School. And then I’ve been practicing, now, it’s about 20 years. It’s hard to believe. It’s going that fast.

Kendall Dunson: Time flies when you’re having fun. Leigh, everyone knows about our topic tonight is going to be defective medical devices.

Atty. Leigh O’Dell: Alright.

Kendall Dunson: Give us a general or background overview of what medical devices are and when we talk about being defective what that means?

Atty. Leigh O’Dell: Sure. Well, medical devices are governed by the Medical Device Safety Act and we think of knee replacements and maybe even a heart monitor. That can be a medical device. The ones we’re going to talk about tonight are called transvaginal mesh devices and they’re used for the repair of certain conditions that women experience, post-menopause.

Kendall Dunson: Okay. Now, we know we’re talking about transvaginal mesh. What is a transvaginal mesh?

Atty. Leigh O’Dell: Well, a transvaginal mesh is a mesh product that is used to repair pelvic organ prolapse and stress urinary incontinence. Pelvic organ prolapse, I never heard of that until a few months ago, and it’s when organs in the female pelvis move at a position as a woman grows older. And that often causes discomfort in other conditions and so that needs to be repaired, and that’s been happening for hundreds of years in the lives of women. But in the past probably 10 years instead of using traditional procedures they’ve been using mesh to try to repair those problems and that’s caused a lot of difficulties in the lives of women.

Kendall Dunson: Now, tell us a little bit about, we know that it’s just for women, so in terms of do we have any information about the number of women who might have to use transvaginal mesh?

Atty. Leigh O’Dell: Right. Well, in the course of a year there are probably 500,000 procedures that are done. Whether it’s for pelvic organ prolapse repair or stress urinary incontinence, and stress urinary incontinence procedures are probably the most common. And for many women stress urinary incontinence is something that’s not really discussed. It’s sort of embarrassing but it occurs when maybe coughing, or sneezing, or with exercise. And so that’s a condition that can be very embarrassing and so that procedure to repair those problems are done in hundreds of thousands of women each year. And until the last 10 years those procedures were done using traditional sutures or native tissue repair. But when other medical devices were introduced to address those conditions that’s when really some of these really challenging problems started to occur.

Kendall Dunson: Now, may I ask a difficult question Leigh, you may not know the answer but you talked about traditional means of dealing with these issues versus transvaginal mesh, are most of those half-million ladies who have these procedures are they now transvaginal mesh although some doctors do use those traditional procedures?

Atty. Leigh O’Dell: For the large majority of women they are implanted with mesh. And when we say transvaginal mesh what we’re really talking about is polypropylene mesh that is used to move the organs back into place, and polypropylene. What is polypropylene? Well, a fishing wire actually is made out of polypropylene. A lot of things are made out of polypropylene and that material can cause some significant problems when it’s placed into the female pelvis and so for a lot of women they are, I say, let me back up and say the grand majority of procedures now for stress urinary incontinence use polypropylene or transvaginal mesh. For pelvic organ prolapse until recently the large majority of those procedures also were done using pelvic mesh or transvaginal mesh. But recently the FDA put out a bulletin that really has caused a lot of doctors to rethink what they were using for pelvic organ prolapse.

Kendall Dunson: Okay, well you mentioned some FDA, when we come back from our break we’ll talk about the FDA.

Atty. Leigh O’Dell: That sounds good.

Kendall Dunson: You’re watching Beasley Allen Report. We’ve got more after this short break.

[Break]

Kendall Dunson: Welcome back to the Beasley Allen Report. I’m Kendall Dunson, Gibson has a night off. My guest tonight is Beasley Allen attorney Leigh O’Dell. Now Leigh before we left for the break we were talking about the FDA. Now this transvaginal mesh products, are they approved by the FDA?

Atty. Leigh O’Dell: Well, they’re actually what’s called cleared by the FDA through the 510(k) process these products are placed on the market often without testing in humans which is a surprise really to patients who receive them in physician to place these products and so there is no testing for safety by the FDA. There’s no review of studies in humans for the FDA to make a decision about safety. These products are really placed on the market with minimal testing in what they called a lab bench testing. And we feel like that’s one of the huge problems that are associated with these products.

Kendall Dunson: Well, I know you just said the FDA didn’t do any testing. What about the manufacturers? Do they test this product before they start you know and using more women across our country.

Atty. Leigh O’Dell: The only testing that they did on these products prior to placing them in hundreds and thousands of women is they placed them in cadavers. And cadavers would be, you know, bodies of people that have died that have been used for experiments, and that is unreal, unrealistic way to try to learn if these products are safe for the female pelvis which is a very dynamic part of our body.

Kendall Dunson: Okay, that led into what’s the real concern here? What are some of the injuries or what type of injuries are caused by this transvaginal mesh?

Atty. Leigh O’Dell: Well, and that’s really some of the saddest part of this story is that the problems are everything from erosion of the mesh through the vaginal wall which is very painful. There can be nerve pain that causes chronic pelvic pain. This often is a 24-hour, you know, 24/7 type of pain that women experience, chronic infection. They also can have permanent incontinence both urinary incontinence and fecal incontinence, and painful intercourse. These injuries caused tremendous quality of life problems for the women who experienced them.

Kendall Dunson: Yeah, that sounds serious now. What is it about the transvaginal mesh that causes this to cause these issues?

Atty. Leigh O’Dell: Right, well there are number of things that can cause these type problems in women. I think one of the huge things is the way that these products are implanted in women can cause tremendous nerve pain. They’re implanted through incisions into the vaginal wall and then through trocars that really cut through very nerve rich areas that can cause a lot of difficulty for women. The other thing is the mesh which manufacturers represented to the FDA would not change once it was placed in the body. It in fact does change and it begins to degrade, and when it degrades there are particles that are slough off essentially into the cavity of the woman and then that can cause inflammatory responses that lead to a lot of the chronic pain as well, so scarring chronic pain results from that type of inflammatory response that is caused by the mesh breaking down within the body. And so they’re just a myriad of causes of the problems that the women are experiencing. And for many of these women the treatment options are very limited.

Kendall Dunson: Ok, now you just mentioned something that struck me. You said that the manufacturers somewhat gave the FDA wrong or misleading information. Were there any consequences to them telling the FDA that mesh would not change?

Atty. Leigh O’Dell: Well, we’re proving that now that in fact what the manufacturers told the FDA was not the whole story, was not the true story essentially. And so what you’re seeing proven through the course of litigation is facts being established showing that in fact when the mesh is placed within the body it does break down and so we’re seeing the manufacturers now be held accountable for those statements to the FDA. Today the FDA has not taken any action on some of those statements.

Kendall Dunson: Ok. Now we heard earlier that the estimate was half a million of these procedures per year to have this transvaginal mesh installed. What’s the failure rate? I mean what percentage of women who have this install and then have subsequent issues or problems.

Atty. Leigh O’Dell: The failure rate is 10-25% depending on the product that is used in the type of procedure that’s done. And for pelvic organ prolapse patients, up to 25% of the patients who have been have received certain products will experience difficulties over their lifetime. And you have to remember that these products are placed and they’re intended to stay in the woman’s body for a lifetime, and so whereas some women don’t experience problems immediately but oftentimes 3, 4, 5 years down the road they can begin to experience problems as that inflammatory process continues to escalate.

Kendall Dunson: Explain to our viewers how it came to light that these products were causing these types of issues.

Atty. Leigh O’Dell: In 2008, the FDA issued a what they call a public health notice to give the first sort of warning signal that there might be problems but it wasn’t until July of 2011 when the FDA issued another bulletin. But this time very strongly worded basically establishing that for pelvic organ prolapse repair that the use of mesh was not appropriate unless it was some extraordinary circumstance where traditional procedure was not an option. And so that was really the first time I think for physicians and for a lot of patients they begin to understand this is a serious problem that is something that needs to be addressed. And for physicians in particular I think their habits in terms of what they were recommending to their patients really changed at that point.

Kendall Dunson: Let me ask you a question about the doctors and I know oftentimes when it comes to the litigation people assume that the doctors are complicit with the manufacturers. It sounds to me like in this particular case doctors were not complicit with the manufacturers. They were just like the consumers were.

Atty. Leigh O’Dell: I think that’s largely the case that women, excuse me, physicians who were implanting mesh into their patients had no idea it’d never been tested in patients prior to being placed on the market. They had no understanding of the true failure rate for these products. That the studies that they were reading in the scientific literature they had no idea that for the large majority of those they were sponsored and controlled and sometimes manipulated by the manufacturers of the products and really used essentially as marketing pieces rather than true scientific studies. And so for a lot of physicians I think that they look back now and realized that they weren’t told the truth and they weren’t given all the information they needed in order to make an informed decision about the risks and the benefits of these products.

Kendall Dunson: And then by the same token if the doctor is fully informed they can’t fully inform their patients.

Atty. Leigh O’Dell: Correct. Absolutely, and so for many many women they went into these procedures thinking that there was low risk and a large benefit. And had they known, and I think this is particularly true for those women who had stress urinary incontinence procedures. They had no idea that what they thought was going to be a very simple outpatient procedure could result in them having chronic pain for the rest of their life and into experience all the other difficulties that they’re having.

Kendall Dunson: Ok. Now, who are these manufacturers that were talking about?

Atty. Leigh O’Dell: Well, there are a number of manufacturers but the primary manufacturers are Bard, Boston Scientific, Johnson & Johnson and American Medical Systems and you see that they had the large percentage of the market share for these particular products.

Kendall Dunson: Ok, I think is a good opportunity for us to take now to talk to some of our viewers. We invite viewers to ask questions by emailing the show so let’s pause and take a few of those questions right now.

[Q&A Intro]

The Beasley Allen Report Q&A with Gibson Vance. You ask, we answer.

[End of Q&A Intro]

Kendall Dunson: Tonight our email question comes from Shay S, “I’ve heard it’s very difficult if not impossible to remove that mesh device. Is this true it?”

Atty. Leigh O’Dell: It is true that oftentimes that once the mesh has been in the body for more this as small amount of time is 30 days it can be very difficult to remove the mesh. And so for example many of the women that I represent have had multiple procedures trying to remove the mesh. And so that’s one of the most challenging aspects of this public health problem is that once the mesh is implanted it can be difficult to impossible to remove the mesh.

Kendall Dunson: Tracy emailed this question, “How can I find out what company manufactured the mesh product my mother had implanted?”

Atty. Leigh O’Dell: A number of ways you can do that. First you can call the physician who implanted the device and ask what device was used, that’s one way. You can get a copy of the operative report or what we call the sticker page which indicates the product that was used in the medical records, and through either of those two ways you can find out what device was implanted.

Kendall Dunson: Thank you Leigh for answering those questions we’ll be right back after this short break.

[Break]

Kendall Dunson: Welcome back to the Beasley Allen Report. I’m Kendall Dunson with the Beasley Allen Law Firm and my guest tonight is Beasley Allen attorney Leigh O’Dell. Leigh, we left off and answer some viewers questions but we talked a little bit about that bulletin that the FDA put out in 2011. What else has the FDA done to make people aware of this health issue?

Atty. Leigh O’Dell: Well, after the bulletin was issued in July of 2011 the FDA actually required the manufacturers to perform studies in actual patients and you would think that would have been done long before these products were placed on the market but it hadn’t been done. And so the FDA required manufacturers to do what they call Section 522 Studies. And in order to keep the products on the market the manufacturers and these were primarily for pelvic organ prolapse products had to perform studies in patients. And for the majority of the products once they were required to do studies in patients because of the fear that the studies would be negative and they would show that the risk was much greater than the benefit to these patients then most of the pelvic organ prolapse products were taken off the market. And there still remain products for stress urinary incontinence but large portion of the pelvic organ prolapse products now have been removed. And this is primarily because not only what the FDA did and requiring those studies but also because of the accountability that’s being brought to bear through the litigation process very frankly.

Kendall Dunson: Ok. Let me ask you this. Let’s say we would have a litigation process. Do you think those manufacturers would do the testing that they should have done before they put this stuff on the market?

Atty. Leigh O’Dell: You know, had the FDA not issued the bulletin and had pressure not been placed on manufacturers through the litigation process those products would still be on the market. In fact, the health problems and the safety concerns would have never been brought to light. I don’t think there’s any doubt about that. For 10 years manufacturers of these products did all that they could to suppress information about the risk associated with the products. And that was true not only for our physicians but true for patients as well so that they could not make informed choices about the risks and the benefits, and that’s really what we want, isn’t it? When we make a medical decision after consulting with our physician we want to know that we have the accurate information. And I know physicians want to know that as well unless the manufacturers be held accountable for these situations where they have not provided the true rate of risks, the true rate of complications then that can’t happen. And we feel like that that is something that a manufacturer should be held accountable for.

Kendall Dunson: Now, we’ve talked about this new process but they have to go back and do their testing, and some of the mesh material is being pulled from the market, or doctors now going back to the traditional methods either they have to come up with something else to take the place of these removed mesh product.

Atty. Leigh O’Dell: Right. Well, they’re going back to what’s called native tissue repair which is using the tissue of the woman who is the patient to do these repairs or suture base procedures and these were the traditional procedures. And just because something is traditional it does not mean it’s not effective and it can’t be the right approach. And so for a lot of physicians now they’ve gone back to the procedures that they had used in years past and for many women this results in a good outcome. In other words that their condition is repaired and without any of the risks that are associated with polypropylene mesh.

Kendall Dunson: Now, if we have someone out here who’s watching our show tonight and they have a mesh implant and they were having slight symptoms or even serious symptoms. Is there anything they can do where they can go seek treatment for that problem or that condition?

Atty. Leigh O’Dell: If you’re having pain, chronic pelvic pain, incontinence, painful intercourse, maybe you feel erosion of the mesh and many women experience that and because it’s such a sensitive subject many are hesitant to talk to somebody about it. But I would encourage you to talk to your doctor about what you’re experiencing and have a test to see in fact if the mesh is something that’s causing those difficulties that you’re experiencing, so go to your doctor. And I think for many who maybe have been to their doctor and still have unanswered questions then I would encourage them to seek consultation from what’s called a urogynecologist which is a specialist that is trained to treat these types of conditions in women, this pelvic organ prolapse and stress urinary incontinence conditions. And so I would seek those medical opinions to get more information to see if there’s something that they can be done to help your problems that you may be experiencing. For those of you maybe you’re not experiencing problems yet I think it’s something just to be aware of, and to seek follow-up in fact if you do experience problems in the future.

Kendall Dunson: Ok. I feel a good place for us to conclude this discussion is for you to give us an update on the current state of litigation around the country involving these mesh materials.

Atty. Leigh O’Dell: Well, for the last 18 months litigation has been ongoing and against the primary manufacturers we talked about. And a lot of that litigation is denuded in West Virginia and there was a recent trial that took place. In fact the jury returned a verdict on Friday for a woman who had a pelvic organ prolapse procedure and had two surgeries trying to remove the mesh. It’s still not completely removed and has had tremendous problems and the jury returned a verdict in favor of this plaintiff for the problems that she’d experienced. And really for punishment of Bard was the manufacturer on that particular case and it was a verdict for $2 million. And for that particular woman that was a very good outcome and light up all that she’s experienced in life altering problems. So trials are ongoing in fact another trial started today and I think there will be trials of many cases over the next year, not only in West Virginia, but New Jersey and other courts around the country. And we’re pleased about that because it’s in a courtroom that these facts come to light, and regular people like you and me can hear this information and learn more and really realize what’s been done in these cases, and so we’re very pleased about what’s coming.
Kendall Dunson: Well, thank you Leigh for being my guest tonight, that’s all the time we have. You can catch the Beasley Allen Report on Sunday nights after the ten o’clock news and on Monday nights at the news at 9 on WSFA12.2 channel Bounce TV. Thank you for joining us.

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February 22nd, 2017

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Johnson & Johnson Mesh Press (Ethicon’s Physiomesh) Conference

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Bob Ferguson: Good morning everybody! Thank you so much for joining us today we really appreciate it. We’re here today to announce that my office is filing a consumer protection law suit against Johnson & Johnson. The largest manufacturer and seller in the United States of a surgical mesh designed to treat pelvic floor condition in women. The mesh has substantial risk of severe and sometimes debilitating complications. You will be seeing an example of the mesh right here into Lisa’s left.

For more than a decade Johnson & Johnson misrepresented the risks associated with their products taking away the right of thousands of Washington women to make informed decisions about their medical care. Johnson & Johnson sold nearly 12,000 of these mesh devices in Washington State between 2005 and 2015. This is an important consumer protection case because of how harmful misrepresentations work. For many victims, their health and their quality of life were forever changed as a result of this deception.

Sitting upright, lying on their side, walking all became incredibly painful because of the device they and their doctor was assured was proven safe and effective. They are worse off today than they were before they start treatment. These women were robbed of the ability to live and work in the way that they once did. On top of that there’s no safe and reliable way to remove the mesh, and the damage it causes when it is removed can be irreversible. One victim told us, I’m quoting, “I want to go back to work. I want to have a normal life. I don’t get that choice. It’s not even an option anymore.”

All these in large part due to Johnson & Johnson’s deceptive conduct. Telling thousands of patients and doctors over the years that their product was safe, that their product was effective, and FDA approved. None of that was true. We alleged to training and instructional materials Johnson & Johnson provided to physicians which they rely on to contain accurate information about the risks associated medical products perpetuated these deceptions and prevented doctors from educating their patients about the risks of this potential treatment even after Johnson & Johnson began receiving complaints from doctors and patients. But the serious complications with these products the company did nothing to change its marketing and information. It wasn’t until 2015 that Johnson & Johnson finally admitted and I’m quoting, “The safety and effectiveness of this product has not been validated in clinical trials.” In fact, nearly 30% of patients experienced complications made them devastating. The mesh its construction, and infection, and insertion have caused chronic infection, chronic inflammation, permanent loss of sexual function and permanent urinary or (inaudible – 2:51) dysfunction, chronic foreign body reaction and chronic inflammation as the body constantly fights to rid itself of this foreign material are lifelong risks. One company expert described this at a 2006 meeting saying, “Even after 20 years the tissue is still reacting to the mesh.” Another victim said, “I’ve been so hopeless and worthless for so long. I blame myself because I sign up for something based out of what I was being told and the truth and facts weren’t there.” Imagine if it were someone you love, your mother, your wife, your daughter. What makes this conduct even more egregious is that the conditions this mesh is designed to treat are not life-threatening and there are effective alternatives that have been used for decades that do not pose the same risks. A Washington patient brought this issue to our attention in 2012 and after initial investigation revealed potential consumer protection act violations, we initiate this litigation. Johnson & Johnson knew about these risks. They failed to inform consumers and they misrepresented doctors and the public the severity and risks of these complications. I’m here to tell you today that we will hold Johnson & Johnson accountable for their actions. I’m joined today by number folks from my team and special guests. We will also be hearing from them. Assistant Attorneys General we have three of them with us, Lisa Erwin to my left, Andrea Alegrett, and Leilani Fisher. Our investigator (name unclear – 4:21) to my right and then (patient) to my left here is Johnson & Johnson mesh victim. Lisa will speak next in a bit more detail about the case and what’s been going on and the details of our investigation uncovered then you’ll hear directly from (patient). We really appreciate as you might imagine, (patient) came to speak the details of the harms from this product are deeply personal in many respects. We really appreciate her being here. We do ask that no questions be directed to her. Her statement will be her statement but she won’t be taking questions. And then afterwards of course we will open up to any questions of those have. At this point I’ll turn it over to Lisa Erwin, E-R-W-I-N, Assistant Attorney General in our office.

Lisa Erwin: Thank you Bob! Good morning! I’m going to give you a little bit of background about polypropylene. That is what the mesh is made of. Polypropylene is probably in your cameras, it’s in your dashboards of your car. It is basically plastic. And the mesh that to my left are the devices. The one up top, the large piece that is measuring 20 inches is for the pelvic organ prolapsed. What that does is it is designed to be inserted in the vaginal canal and hold up whatever organ has been prolapsing, and prolapsing means falling down, so for women who have bladder issues the bladder may fall down into the vaginal canal. That piece of mesh goes in there in the vaginal canal to keep the bladder from falling in. We did provide you some photographs of the brochures which are very helpful in explaining what the product does and where the product goes so please don’t hesitate to ask me any questions that you have about that. The challenge in this lawsuit of course is the ability to explain it in a way that makes sense so let me give it a shot. The other use of the material is if you have stress urinary incontinence. The mesh can be inserted under your urethra to lift up the urethra so you don’t have chronic leakage of urine. So those are the two ways in which the product is supposed to be used. For many patients however, mesh immediately caused pain. They had persistent and often debilitating pain and because of the mesh several women have become disabled then can no longer work. The range of complications they experienced includes permanent loss of sexual function, permanent urinary dysfunction and a lifelong risk of infection. As Bob alluded to, the company knew that putting polypropylene in the vaginal canal may but because you dragged through the vaginal canal you pick up bacteria and by dragging it through the vaginal canal, it cannot be cleansed. In other words it will pack up bacteria as it goes into its placement. And if it does in fact have bacteria that bacteria is going to stay in the weave of the mesh and disgustingly colonize, and so what that means is you will have an infection six years later, ten years later and women are having mesh removed 10 years afterward and the mesh is infected. Those risks were not disclosed to physicians. Moreover, they were disclosed to consumers. The mesh is designed as you can see with the hole in it. If you’ll get closer you’ll be able to see that it looks like basically a basket weave. The mesh is designed to have tissue grow into the mesh so that it can support itself in the body. Unfortunately for some people when it’s doing that process it becomes chronically inflamed and the body starts trying to get rid of the mesh and that’s where chronic inflammation, chronic infection, and chronic foreign-body reaction that’s the fancy medical term for chronically trying to rid the body of mesh. We have another woman who described her pain. She’s a Johnson & Johnson victim and she reported this information to Johnson & Johnson. I had all kinds of problems with chronic pain, bleeding, painful sexual intercourse, even my husband complains of scraping and poking. The pelvic pain was keeping me awake at night and the only relief was to sit on a tennis ball. The thought of living like that sitting on a ball, wearing a diaper, splinting my (inaudible – 8:37) to have a bowel movement, having infrequent and miserable sex and marital problems with almost more than I could bear. The company never told consumers about the risk of erosion that led to this woman’s problem or that it would be as severe as it was for her. Not every person has these kinds of complications. But not disclosing the risk of the complication is what this case is about and then they downplay the risks that they did disclosed. We have another woman who complained to Johnson & Johnson and said, “It felt like my urethra was being strangled, I couldn’t pee, walking was out of the question, sitting was agony, I couldn’t lie on my left side due to severe pain and numbness. Over the course of the next 14 weeks I visited or was admitted to the hospital 10 times. I had no quality of life. My consultant likened mesh removal as trying to remove chewing gum from hair. It can’t be done.” The company never told consumers that there is no safe way to remove the product. If you have a knee replacement and it goes awry, the physician knows how to remove that knee replacement. But not true with mesh. There were no instructions given to physicians on how to remove the device and they were not told that in the process of removing the device there will be damage to the organs that the mesh is surrounding. So if the mesh has become inflamed and growing into the bladder because of infection that piece of the bladder that is infected is going to need to be removed as well as the vaginal canal. When doctor told Johnson & Johnson in 2009 this is a quote, “I am currently getting a patient to OR who had an anterior and posterior pro-lift, which is the upper device the large piece of mesh, implanted by another physician. She will likely lose any coil function as her vaginal length is now 3cm and the mesh is extruding literally everywhere. The patient will have a permanently destroyed vagina. We also alleged that Johnson & Johnson misrepresented the risks and complications not just to consumers but to the physicians because that’s how doctors and patients communicate. If the physician is not informed of the risk the physician can’t then inform the patient of the risk. One of the major misrepresentations we’ve found is the company told doctors that mesh was approved by the FDA and it is not approved. Johnson & Johnson also made specific references to doctors about the product so the representations that it is soft, that is flexible and in fact it hardens in the body and basically becomes immovable. And so imagine if you will a piece of immovable plastic over the vaginal canal or under the vaginal canal when you have to go to the bathroom, and you want to have sex, and you want to jog, and you want to laugh. Let me tell it, it sounds painful to me. One of those troubling I think issues in the case is that women can be permanently disfigured and there’s no compensation in the world that can take care of that issue. A patient described it this way and I’m quoting, “My body is deformed. I have scars all over the front and not just in the back of my bottom. I just don’t know what to say it’s horrific.” So to summarize, it’s always hard to get a lawyer off the camera but the known risks and complications that these devices have should have been closed to doctors, patients and consumers. The failure to do so is why we filed this action today. I would like to introduce (patient) who will tell us what her journey with mesh has been like.

Patient: Thank you, Lisa. Good morning, my name is (patient), and I am a Johnson & Johnson mesh victim. In 2008, I learned I needed a partial hysterectomy. My gynecologist said that as long as he was doing exploratory surgery he could take care of some urine leakage issues that I had mentioned that previous and annual exams by implanting Johnson & Johnson mesh. My incontinence was not something that was interrupting my life enough so that I needed surgery for it but my doctor suggested as long as he was already performing other surgeries he could take care of it by implanting a transvaginal mesh. I was told mesh was safe. I was told that it may work it may not, and if it didn’t work one possible outcome could be erosion. When I heard the word erosion I thought it was like when I was a child I had ear tubes, surgically put in, and eventually they grew out and they just fell out my body, expelled them. That’s what I thought that erosion meant. I was not told that erosion means it could poke into other organs. I was not told that erosion would affect my sex life. I was not told that there would be chronic urinary tract infections. I was not told that I’d have long-term pelvic pain and I was not told that after the mesh is put in it becomes permanent in my body. I began having problems immediately such as terrible soreness, the pain, the inflammation, the itching, the urinary tract infections continued for three years. Every time I went to my doctor I was told it was nothing to worry about. It was normal. It would eventually heal and everything would be fine. In 2011, I went to a different doctor still having infections because the pain and constant infection just kept going and going. My new doctor did an exam and was baffled because something foreign was protruding into and eroding my vaginal wall. I told her I have the implant and she said I need to go back to my doctor. I was told the only way to fix it would be to remove it which I decided needed to be done immediately. I had serious complications which began with the mesh removal. A week later after the mesh removal I had severe pain and was rushed into emergency surgery to remove a twisted ovary. During that surgery there were complications and a week later I had a third surgery to repair a bowel obstruction. I was in and out of the hospital for six weeks and I was extremely ill all because a Johnson & Johnson mesh product was implanted and then removed from my body three years later. At least I thought it was totally removed. Sorry. The change in my urine leakage after my mesh removal is much worse than it ever was before the mesh implant. It continues to get worse each year. I have to wear a pad 24/7 for incontinence. I can’t go anywhere without making sure I have extras with me. I often have to change pads three to five times a day. It interrupts my plans and my daily activity. It is embarrassing. A couple of times the leaking was so bad I had visible accidents and I had to leave work. Now I keep a spare change of clothes at the office so I don’t have to leave work. Last fall my new doctor explained that if I have more surgery to fix my urine leakage they may find my old mesh. I was confused and said that I thought the mesh was gone. I learned for the first time that it is almost impossible to remove the entire mesh then it becomes a part of you. This is very upsetting news because there’s a foreign plastic object remaining in my body. There may be more erosion, more pelvic pain, more infections and more unknown complications that could necessitate future surgical and medical treatment. My urine leakage should have been taking care of back in 2008 but with other options instead of Johnson & Johnson mesh. In 2008, I trusted what the doctor told me that the mesh was safe and I didn’t know there could be serious complications. I did not investigate if there were any other perhaps safer options. Today I understand that I actually have many choices to repair my urine leakage. Now that I know my options my choice is in no mash and no more pain. If I had known the potential complications could be so severe in 2008 I never would have allowed Johnson & Johnson mesh product to be implanted in my body. Thank you for listening to my story.

Bob Ferguson: (Patient), and I were chatting before we came here and I mentioned that I have no doubt, that comments would no doubt help other woman as well trace awareness with what’s happening and perhaps encourage others post as well so thank you very much. A few final thoughts and then we’ll turn to questions that you might have. So just to lay out some specifics we alleged tens of thousands of violations of the Washington State Consumer Protection Act. We believe that for each piece of mesh sold the company made numerous misrepresentations or omissions including the risk of serious complications, and its marketing efforts which included consumer-directed brochures, radio advertisements, television advertisements, phone scripts, you name it, Johnson & Johnson represented that it’s mesh products were safe and post minimal risk. The company made similar misrepresentations and omissions in materials disseminated to doctors. It may be years before we can fully understand the extent of the damage done by the deception in this case. We are asking the court to prohibit Johnson & Johnson’s misleading marketing of their mesh product to fine the company violating the Washington State Consumer Protection Act and to impose the maximum civil accountability of $2,000 for each of those many thousands of violations. You can do the math, with tens of thousands of violations of $2,000 each that could reach well into millions of dollars. In conclusion, it’s my view that Johnson & Johnson put profits for patients, patients like (patient). What they did was wrong. The impacts to patients like (patient) and many other Washington State women are profound and as you’ve heard from (patient) deeply deeply personal. My team are part of this case and we’ll continue forward until Johnson & Johnson is held accountable for what they did. With that, for those on the phone will do as well start the questions here in the room and there might be some folks on the phone. Allison, help remind me. I’ll try to repeat the questions as they come in from the room so folks on the phone can hear them then we’ll turn to folks on the phone to take any questions there as well. So we’ll open up to any questions that you want me.

Man1: Thank you for sharing your story. I’m just wondering how many women are in Washington State who have suffered the side effects about tens of thousands of violations. By how many women are we talking about in Washington State?

Lisa Erwin: Yes, we know that 12,000 devices were sold in the state of Washington and there’s no hard-and-fast absolute on the number of those specifically who’ve had complications of the complication rate is about 30%. That doesn’t mean that every single person has had the misfortune that (patient) has had. Some of them have complications that can be treated fairly easily and then they run the range of (patient)’s experience which is multiple surgeries and multiple complications.

Man 1: What kinds of efforts were made? This went on for a long time. What kinds of efforts were made to stop Johnson & Johnson doing this on the part of Washington State? What did you all do?

Lisa Erwin: Yes, the question is, what did Washington State do to stop Johnson & Johnson earlier? So let me give you the timeline. As Bob alluded to we had an employee in 2012 who called into the Consumer Protection Division. She works in the Attorney General’s Office and she called and told me her story that she had, it’s not a Johnson & Johnson product but she had a device, a mesh device that went very wrong and she asked us to consider opening an investigation so that’s what we did. We actually looked at whether there was a consumer protection angle. There are lots of personal injury lawsuits against these companies for these products going on so we looked at whether there was a standalone marketing claim. In other words it’s not illegal to sell the product but did the company make misrepresentations and its marketing sales that led to the sales of the devices so that’s the consumer protection. So once we looked at their marketing and their internal documents we issued a civil investigative demand which is the subpoena. We subpoenaed their records in 2013 and we looked at them, and we thought that we needed more information so in 2014 we shoot them another civil investigative demand asking for more documents. And we have tried to resolve this matter by investigating and negotiating with the company and when that is no longer possible we asked the ability to file suit and so that’s why we’re here today.

Man 1: Have other states file a suit?

Lisa Erwin: I expect that California will file a suit today and other states are considering their options in terms of litigating.

Bob Ferguson: Any questions from anybody here? And just for the folks online on that last question. The question was, “Have any other states filed suit.” One of the other states would file a suit today, that being California, confirmed with California. Other states who will suit they do moving forward. But today there’s Washington and potentially California. I see there’s anyone on the phone line who might want to ask questions so if you don’t mind just identify yourself. If not, any final questions? Yes, go ahead.

Man 2: Let me ask you about what is this say, how much doctors rely on all these companies to give them information. I mean, patients obviously in many cases don’t completely understand what is being prescribed to them. But doctors, how much do doctors rely on the company giving them accurate information.

Bob Ferguson: Yeah, I’ll repeat the question, although Lisa will take the first shot. I may add to it. But the question is, how much do doctors, how much thus this case demonstrate the importance of doctors relying on information presented to them. And so Lisa, why won’t you take the first shot and I may add to it.

Lisa Erwin: Yes, so our contention is very simple. This was a new product. There had never been mesh implanted in the vaginal area before Johnson & Johnson and other companies came out with this new revolutionary product as they advertised it. And then because it’s their product they did not tell doctors the risks early on, and so physicians then didn’t pass on complications because they weren’t told of the complications when this new product came out. So we believe that both doctors and consumers were misled by the marketing materials that Johnson & Johnson put out. They also put out trainings. They offer trainings to physicians and they made the same kinds of misrepresentations in the doctor trainings. Now the smart person is saying well doctors should know that if put an implant in there can be complications. There are things that are unique about mesh that the company knew, that the company did not tell physicians. So you wouldn’t know about the colonizing, the bacteria as something gets dragged through the vaginal canal. Doctor’s know to apply antibiotics when someone’s undergoing surgery. What they didn’t know is that that is not necessarily effective because of the design of this product. I have a close-up picture of the mesh and what happens is the bacteria get stuck in the little tiny strands of mesh that are made the knots and so bacteria can’t get cleaned out by our immune system when they’re inside those small knots and that’s what leads to colonizing bacteria. And that’s what doctors didn’t know. Doctors were told, use your normal antibiotic regimen and that should work for mesh, and it doesn’t work for mesh, and we believe they knew that. So that’s an example of the kind of thing that physician should have been told so they could calculate their risk and they can tell the patient that the risk of infection with this product goes on and on and on and that’s a critical piece to making a decision about whether you put something in your body.

Allison: I believe there is someone asking questions online.

Bob Ferguson: Well, Allison is saying that someone online might be trying to ask questions so I’ll open up again, anyone online who might want to ask a question. I heard two voices, maybe not. Ok, any other questions here in the room? Yeah?

Man 3: One other question, what is being done to make women whole? I understand you’re filing suits today and I understand there’s $2,000 from each of those violations. But, how does that specifically helping women like (patient) who has suffered the side effects?

Bob Ferguson: So the question is, how does this case or any other individual piece that might be going on help make women whole? And I’ll ask Lisa to speak to that and I’ll, again kind of put the context of other may be personal litigation might be going on as well.

Lisa Erwin: So there are many avenues for redress here so. I alluded to the personal injury action several women believe there’s approximately 30,000 women who have filed personal injury lawsuits against Johnson & Johnson and that’s where they can recover emotional distress, damages, the wages from not being able to work. A consumer protection case gives you a different remedy. We want the court to declare their conduct illegal. We want the court to enjoin them from making misrepresentations in their marketing materials today. So we have a different remedy that’s why we looked at it from a different viewpoint. We’ve asked the court for restitution and global relief so we would hope that a court would award women restitution their out-of-pocket expenses. How you describe restitution, you can’t get two recoveries so if someone has made whole and there are damages are covered in their personal injury settlement you probably wouldn’t get restitution but it would depend on how the court fashions the remedy.

Bob Ferguson: I’m glad you asked that question. Just to make sure we’re certainly clear that there are individuals who can bring their own lawsuit, and like Lisa mentioned emotional stress that type of thing. My authority as Attorney General for case like this comes under the state Consumer Protection Act. You cannot engage in an unfair or deceptive business practice, ok, so that’s our allegations. We’ve emphasized it’s a deceptive nature of Johnson & Johnson communications to doctors and two women like (patient). So separate type of litigation and we can ask for different things from the court that individual women can their lawsuits against Johnson & Johnson.

Man 3: What is the response of the company? Have you heard from them?

Bob Ferguson: Yes, so what the company at least may want to add, the question is, what’s been the response from the company. And I think as Lisa mentioned, we won’t go to a whole lot of detail here. I’m sure you’ll understand. But Johnson & Johnson obviously is aware of our investigation for some period of time. For years, we’ve had direct ongoing communications with Johnson & Johnson. This lawsuit will not come as a surprise to them but it’s ere to say that I was not satisfied with Johnson & Johnson’s offer to resolve these claims. And as a result, we don’t take lightly filing litigation in this office. But if I need to go to court to hold a company like Johnson & Johnson accountable that’s what we do. So we engage in numerous conversations with Johnson & Johnson over the years but we reach a point where we realize, what we felt was equitable and to our satisfaction that’s why we’re here to file litigation. Final questions before we wrap up? If none, thank you all very much for being here and thanks to all on the phone and we’ll be around for a few minutes afterwards to get additional questions. Thanks so much everybody I really appreciate. I do want to wrap up by saying, thanks to our team for working hard. There are a lot of folks here from our office, folks behind me and working in this case for a long time. It’s a big case. It’s a complicated case. And to (patient), again, thank you so much. It takes a lot of courage to get up as you folks might imagine in front of a bank of cameras and talk about such a deeply personal experience. But again I have no doubt that (patient) you happen to help a lot of folks today. Thank you all so much I really appreciate it.

As found on Youtube

AG files major lawsuit against Johnson & Johnson over concealed risks of pelvic mesh

AG’s filed a consumer protection lawsuit

February 18th, 2017

Posted In: Hernia Mesh, Transvaginal Mesh

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