Johnson & Johnson Mesh Press (Ethicon’s Physiomesh) Conference by Bob Ferguson, Washington State Attorney General

Bob Ferguson: Good morning, everybody! Thank you so much for joining us today. We really appreciate it. Today, we’re here to announce that my office is filing a consumer protection lawsuit against Johnson & Johnson. The largest manufacturer and seller in the United States of a surgical mesh designed to treat pelvic floor conditions in women. The mesh has a substantial risk of severe and sometimes debilitating complications. You will see 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 and lying on their side, walking all became incredibly painful because 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 this in large part due to Johnson & Johnson’s deceptive conduct. Telling thousands of patients and doctors over the years that their product was safe, their product was effective, and the FDA approved it. 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 California to file a suit today, and other states are considering their litigating options.

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 company’s response. 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