B: I'm Ben C.

V: I'm Doctor V.

The medical legal guys... spring training edition!

V: So what have we been doing Ben Martin, over the past couple of weeks? What kind of comes to mind?

B: Well, we've been handling up on coloplast.

V: While the case Baltimore. And we're about to amend a complaint against coloplast and again catastrophic pain syndrome.

B: Pudendal neuralgia. 

V: Stiffness mesh worse outcomes with safer alternative designs.

B: This is a mid urethral sling. So what’s a mid urethral sling?

V: While mid urethral sling is used for women after they have childbirth they developed stress urinary incontinence as they get older. 

B: And it doesn't just have to do with childbirth. People, male and female can have a stress urinary incontinence, which means they leak. Okay, the case of many women, it comes forth after childbirth, age, gravity and so the mid urethral slings here to supposedly help that issue those issues. And mid urethral sling is made of polypropylene. If it's a coloplast sling and that's a plastic. And, tell us a little bit about the Arif device.

V: The aris is there trans operator sling it. Basically it's a sling that supports the mid urethra. And you have a vaginal component, and arm component that goes in the leg.

B: Used to lift up the urethra, which is the tube that goes from the bladder and out the body to its failure. That right?

V: Yeah. Polypropylene. The days of polypropylene are kind of on their way out because.

B: Polypropylene is on the ropes.

V: Basically. And it's because they're safer materials that don't include the plastic weave of mesh that causes inflammation and pain and erosions. And they have other materials that don't have that as they have less inflammation, they have less erosions, and the degree of inflammation is markablly less. And that other type of mesh is called PVD. And it doesn't shrink. Polypropylene shrinks. And if you have muscles under tension, a nerve is under tension. You could have muscle and nerve pain and unfortunately, those are the women that we represent. And we believe that this device, the outcomes show that it's the worst device. And warnings do not fully capture the frequency of risk and the severity of risks. And I don't think any doctor would choose polypropylene over PDVF.

B: And Dr. V, a doctor who knows who has told the truth about this product, we say, wouldn't put in the product, or at least is going to tell the patient about the product. And once the patient is told the truth about the product, then the patient has a decision to make. And patients, if told the truth, will make the decision not to have this link. 

V: So the big problem with this, in terms of pain, it causes 2.8 times the amount of frequency of dyspareunia. And that's kind of goes to the heart of the safety of the device because it's placed vaginally. But it also causes some extreme pain syndromes because it inserts on the obturator internist muscle, which is very close to various nerves. And that could cause muscle spasm, dystonia, pulling on nerves, and some serious pain syndromes. In PDF, it's gaining market share. And in Europe this PDF has been tested 1 to 1 against polypropylene trans obturator slings and was superior in terms of pain and erosions. And it's a better material. And so we're suing the manufacturer for failure to warn doctors of the specific increased risk of pain and dyspareunia, the severity of risks, but also that this is a design defect because there are safer materials that need to get to the market. And the Aris sling and the Altis device, they seem to be the worst.

B: All right. So there's your co-op class. We could go on for hours for days, but, that's the general update on what these cases are about. 

V: So we also filed a case. It's very important in Wisconsin okay. And it involves time is brain okay. And so it's a serious injury case.

B: The time is brain doesn't have anything to do with the colo plast. Doesn't have anything to do with the med rurethral sling. So let's talk about a new case we filed in Wisconsin. And other cases exist that are similar to this case.

V: Time is brain is now the standard of care. When a person presents to a hospital with symptoms or signs of a stroke, and there are certain tests that need to be done within a certain time frame, and interventions must be provided or offered because the outcomes are superior. When a person comes with an eschemic stroke from a blood clot in the brain. 

B: Eschemic stroke.

V: Yes.

B: And hemorrhagic stroke two types of strokes and doctor V just explained hemorrhagic hemorrhagic. Very nice. And there's also the eschemic brain that involves a loss of oxygen because of a lack of blood flow or a lack of oxygen. That's an ischemia, stroke and a hemorrhagic stroke. Which doc was talking about in time is brain is the type where you actually have a bleed, vessel bleed in the brain, and that's a bad thing. 

V: That's a bad thing. And obviously you want to get, proper care, proper blood pressure management, earlier treatment, the better, obviously, in terms of preventing complications. But clearly with ischemic strokes, you're on the clock, okay, to get this done. And our client unfortunately presented to the hospital had symptoms and signs we allege of a stroke. And then they didn't run the diagnostic test despite a code stroke that a nurse had significant concerns that a person was having a stroke and they didn't follow through on the policies and procedures. We allege in terms of the standard of care for the next test, which is to give a CT angiogram to see if there is a clot that can be either extracted with via thrombectomy, a catheter that can grab that clot and so that the blood flow can return, and or the thrombus lytic or blood clot clusters by veins. So it's really a sad situation. And then unfortunately, this gentleman then developed to a very big grade for bed sores.

B: Alright.

V: It's a nightmare hospitalization and could have been saved. He had other medical problems that would have been taken care of. 

B: So Time is brain. And that's what this is all about. The faster you get to the patient, faster you understand what's going on with the patient, faster you diagnose the possible problems, and then the faster you get to the problem. It's very important because the faster you get, the better opportunity there will be to save that patient's health.

V: And this occurred in the hospital within 12 hours, the change in neurological status. So it's kind of a bad story.

B: It is a bad story. But I want to talk about with doctor V today is just kind of some of the general aspects of time is brain and general aspects of what kind of diagnoses are made, what kind of, indicators are there, what kind of diagnostic tests are there to make a determination as to whether or not somebody coming in with symptoms that are consistent with a stroke actually may be undergoing a stroke? And why time is brain is so, important.

V: You know, these are serious. When you have a large vessel blood clot, that's like a hose that goes to various other parts of the brain. Okay. So it gets this hose and you lose a lot of brain, and the prognosis is significant. And the missed the large vessel stroke is very bad. And also small vessel stroke. There is benefit from thrombolysis better outcomes.

B: You had to do them. You had to do the diagnostics to see what kind of thing was going on, what kind of things are going on with the patient. That's called doc V. We talked about this before. That's called making a differential diagnosis. And you see in medical records a lot argue that means rule out this particular condition, this other condition, this other particular condition.

V: You know, a better code stroke. You know a nurse is ringing the bell. An ambulance driver is ringing the bell that they have a code stroke. And everyone in that hospital knows what should be done and what is next. Okay. It's a highly predicted diagnostic plan with certain minutes and and hours and windows where it shows outcomes are different. So there should have been nurses to say, hey, what about this? Okay. I mean, you have to think critically and understand, hey, this is what normally happens. Why why why not this case. Yeah. And ring the bell again.

B: That code we're talking about. So that's important because once usually once a code is call, then it's being called because this patient is suffering from something that is likely to be a stroke or something else. Very serious. Don't call code if somebody is not having a serious problem. Is that right?

V: Yeah. Yeah. There's coordination of care. There's expectations. You know, that the point that they then didn't identify or that there was a problem with the code strobe for two days.

B: I'm Ben C.

V: I'm Doctor V.

The Medical Legal Guys.. Casual Guys!

V: So yeah. So we're talking about, a recent decision by the FDA that goes to warning physicians and women about the dangers of Depo-Provera. And this is a big, big aspect of the litigation. And why is this FDA warning important as it relates to this litigation? 

B: So there's something called preemption, which basically is a legal concept that says if the federal government has preempted a state law, then you can't bring a case under that state law. And it's possible that preemption can result in the dissolution of coins. So that's basically the importance. But the argument was that, hey, if we had Pfizer, if we had told the federal government, the FDA that we wanted a warning, okay, then they may not have allowed us to have a warning. And they went a step further and they said, hey, we sought approval of a warning from the FDA. And the FDA said, no, okay, no warning. About a month ago, the FDA came out with a ruling, an order, and the FDA said, oh, yes, you must put a warning label on Depo-Provera about meningioma and indeed, there is one. So now, when they say it would be impossible to put a warning on because the FDA wouldn't allow it, they've allowed it.

V: We're going to talk about the warning, and that the FDA has ordered Pfizer to change the label to notify physicians of the risk of meningioma. So Ben, do you want to read the sections from the warning?

B: There are really two parts of the warning label the label change. Now, this is a 27 page document. We've talked about it before. And those are labels also called instructions for use or use instructions. And if you now look at what the FDA said, Pfizer must put under warnings and precautions. Meningioma discontinue Depo-Provera if meningioma is diagnosed. Monitor patients for signs and symptoms of meningioma. That's pretty straightforward. If if a doctor has a patient that has a meningioma, stop Depo-Provera. And there are reasons for that in the literature. And there's a second part of it and it's section 5.3. Let me get to it here. And that is 5.4. This is in the product insert the label, the packaging that goes with every injection of Depo-Provera. 

That doctor has that warning at their disposal. Meningioma cases of meningioma have been reported following repeated administration of medroxyprogesterone acetate. That's Depo-Provera, primarily with long term use. Monitor patients on Depo-Provera for signs and symptoms of meningioma. Discontinue Depo-Provera if a meningioma is diagnosed. So that's kind of going back up to the top of the warnings. What that's what part of this is about. The other part, though, is an indicator that cases of meningioma have been reported in the literature following repeated administration. And it says generally for a long term use or long term use in the pharmaceutical industry, long term use could be anything over six months. Be anything over a year. And these studies sometimes will use that short period of time, six months for a year to mean, okay, well that's a long term use, right. So so don't get the idea that they're saying generally takes five or 10 or 15 years. Long term use can be a pretty short period of time. Yeah.

V: So when I look at this label, you know, I see some issues. We're way past reported. Okay. So and we're going to go through the history.

B: Of recorded, if you read the British Medical Journal article that that came out last year, and if you read that study by Doctor Rowland and others, it's way more than a sort of a case study or a few reports here and there. They studied 108,000 women. And compared to women who took Depo-Provera or had the Depo-Provera injected in their bodies versus those who did not in, that's where they found close to a 600% more probability that a woman went on Depo-Provera is going to develop a meningioma than if she had not had the Depo-Provera. So that's as dark versus that a lot more than a reported case or two, which seems to be what, what the labels sort of suggesting the reports. Could it have been stronger? Yes. But is it something the company is required to warn about Depo-Provera and its association with meningioma? And the answer now is yes.

V: So in my view it's kind of a weak, weak warning. So we're going to go over the literature that kind of built up to this change. So we're going back to 2006. Was the first in the 20 years ago first indication that progestin have a relative risk for causing meningioma and explain what why relative risk of two is important from a legal standpoint. 

B: So let me explain what relative risk is. So relative risk is the associated risk of being on a pharmaceutical like depo provera versus the risk as compared with someone that is not on the drug or has not taken the drug. If you have a relative risk that two or higher, then there's no question about its association. Relative risk of two means you're doubling the risk that it's a 100% increase in the risk. And if you got a 100% increase in the risk, then legally that is a an important distinction as opposed to just barely an association of pharmaceutical causing something.

V: So so this article back in 2006 looked at birth control, types of birth control and their associations with gliomas, which is a type of brain tumor in meningioma and this article, 2006, showed that oral birth controls no increased relative risk of meningiomas, and when they combined the studies that looked at progestin that are embedded in IUDs and progestin that go underneath the skin and injections when they group those all together, that relative risk is two for prolonged use over five years. But the kicker is the IUD progestin. That dose is a lot less than Depo-Provera.

B: Yes.

V: So they have progestin in like Marina that are embedded in the IUD

B: You call them, yes.

V: So it's a form of birth control. So back in 2006, the pharmaceutical companies knew or should have known that progestins caused meningiomas. But if you look at the types, depo- Provera has a much higher dose of progestin than the other two forms, so it would have diluted the relative risk.

B: I think what you're saying, doctor V, is that since we know there is a greater than two times risk of these other progestin, because Depo-Provera is a higher dosage, you would expect there to be a greater relative risk, right and right.

V: So you're diluting the risk by having the two forms of birth control that don't cause meningioma. There's no Marina. There's no evidence that that causes meningeal. And then the underneath the skin progestin. We don't have the evidence that that causes meningioma.

B: At this time.

V: So they grouped both together. And the relative risk was still over two. That should trigger a study. That's right. You know you need to do something. And that's right. When the generics are getting rolled out, when generics are rolled out, the pharmaceutical liability goes way, way down. And explained why Pfizer when these medications were going generic, what would that do to Pfizer's liability?

B: Well, there was a U.S. Supreme Court case some number of years ago that essentially said that a case involving a generic drug is really preempted. Okay. Talked about preemption earlier. And if it is a certain type of generic, okay, an unauthorized generic, we'll call it not authorized by the manufacturer or the founder, then there's no liability on the part of the manufacturers under certain circumstances. And generic manufacture under certain circumstances is seen as having no liability, essentially because they say, well, wait, we're just we're forced to use the same formula as the original manufacturer, right? In this case, when you get down to it for liability purposes, that would have been Pfizer.

V: Yeah. So I'm thinking more of it that it's becoming generic. It's becoming a lot cheaper. It's being a more wide use because the price has gone down because it's going generic and Pfizer just sat there, looked at the data and did nothing. Okay. This is 2006.

B: Yeah. You're talking about almost 20 years ago.

V: 20 years ago, they could have studied. So then the next thing that really happened was 2015 study that identified the specific mutation that is associated with Depo-Provera. They didn't quite identify the link, but they identified the mutation that is most associated with Depo-Provera that causes multiple meningioma that tend to be on the skull base, which are the worst type of tumor.

vignalawgroup.com 

FREE Consultation: 817-809-9023 

Greg Vigna, JD, MD | Vigna Law Group 8939 S. Sepulveda Blvd. Suite 102 Los Angeles, CA, 90045 817-809-9023 | vignalawgroup.com 

Ben C Martin | Ben Martin Law Group 3500 MAPLE AVE. SUITE 400 DALLAS, TEXAS 75219 (214) 761-6614 | bencmartin.com

TRANSCRIPT:

B: I'm Ben C

V: I'm Doctor V

The Medical Legal Guys

B: Let me ask you this. So what now should happen with regard to what company should I gather that they ought to use a better product? Right.

V: That's a good point. This is brutal. Okay. That we have devices on the market. Okay. But the device is not getting studied. 1 to 1 against the inferior catheters, because the manufacturers of these inferior catheters are not going to agree for a study against the better catheters. You see, what I'm saying is that you're not getting the studies.

They're doing studies to show this and that. But the big question is a new technology, old technology study. This shelved the old technology, move forward, improve. From there we're stuck. We're stuck here. And it's sad.

B: You know, maybe here today should be on what leads a company in what leads the public to have knowledge of and what leads the scientist to determine that something is safer than something else. That particular disease or condition is caused by a product or particular pharmaceutical, a particular medical device. These are determinations that they don't just come out of the air.

People can't just guess at it and be accurate unless it's just totally about what doctor V, how do people and how to researchers go about determining what is the cause of a problem and what is a solution to a problem.

V: Ben, you know, you're the co-lead of the IBC litigation and that is to go, this sounds to the Cook Pharmaceutical. I was involved in a lot of that discovery in the select IVC filter was one of the worst devices on the market, because it had a tendency to perforate. And when that device perforated the IVC, then it would fracture and that device had horrible complications.

The company, Cook Pharmaceutical, they knew all the complications. And while they kept the bad device on the market without telling doctors, they devised a safer, alternative design to fix the problem of this device. That is what is supposed to happen. But you're supposed to study this device before it gets on the market so it doesn't get on the market.

Right. And in this situation, cook pharmaceutical. Medical. Cook medical. Sorry. Yeah. Medical out of Indiana. What they did was they had a problem. They fix the problem which they should have. They should have taken this device off the market. You know, they should have said, hey, this device is a bad device. We're sorry. We're going to pay for our sins.

Instead, they kept this device on the market. They introduced the better device. They kept this device on the shelves, didn't tell doctors, and they let doctors continue to use the inventory on the shelf.

B: Knowing that it had the perforation problem that the newer problem didn't have in as great of an incident.

V: Yeah. So, Ben, you know, our work, your work, you were the head lead in this IVC litigation. I was just kind of the guy who was looking at the documents. And this device, the IVC filter, would go in the vena cava of patients. And for a purpose of preventing blood clots that generally start in the legs to travel up into the lungs and cause death by way of pulmonary embolism. So this device was to prevent serious problems, including death. And the problem with this filter, it goes into the IBC and it looks like a wire kind of right. You've described it in trial. You describe.

B: So we don't see the picture. It's like a badminton, a smaller version of a badminton,, about three inches tall, two and a half, three inches tall in height. And it's an upside down badminton in, in it's fed up into the vena cava. The largest vein in the body. And what it's supposed to do is catch blood clots. If they go from the lower extremities to up towards the lungs and heart, which can be dangerous, not a problems with them. And we found out that they actually don't work.

V: It would go sometimes into the spine. It would go sometimes in the pancreas. It would sometimes go into the small bowel heart theorta. And it was a perforating device and it was narrow perforating machines. Pretty good word for it. Yeah. And so the work that Ben did, you know it got published in the Annuals of Internal Medicine about how this company got the device into the market by having data that's supported, it's approval by the FDA. 

Right. That's how devices can get on the market because they aren't studied properly. But when they're on the market, in the market and they're safer alternatives, those safer alternatives should always be worked on and advance to the public. And we're not seeing that because of cash cows. 

B: You need to tell doctors, you need to tell the patient so that they have a fully informed decision on whether or not to undergo placement, by inferior vena cava, filter and IVC filter or any of the other products. We get back to the PIC lines, we get back to the port catheters. If there's a safer alternative, use it.

And if you're not going to use it, tell that patient, tell that doctor a bad product. And if you're not going to sell the the good product, tell him, tell the doctors, tell the patients, you know, this isn't the best product for you. And let's see then what happens when you tell them.

V: It should come from the company.

B: The company has more knowledge and the ability to have more knowledge than anybody. They're the ones that are developing the product. They're the ones who have the best knowledge, the most knowledge of the studies that go into the determination as to how to manufacture the product, how to make the product the best product, how to use the best materials and put it all together.

Then they they use those studies, the experiments, the research, animal studies, the human studies, all of those things go together to get product on the market. If the product is safe, right, safe and effective and IVC filter, not only are they not safe, they're not effective.

V: You know, there is some litigation that doctors have turned their, their back on. And for example, in the mid urethral sling litigation, the ultimate device that we have a case in Chicago where we are suing a implanting doctor who caused a serious injury, neurological injury. And he failed to remove the device after it caused injury because he believed in the device.

Okay. So we're suing the doctor for failing to remove a device in a timely fashion on a woman who was severely injured. And, we're suing the manufacturer because the device has significant problems. And this doctor, we took his deposition a few weeks ago, and he refused to sign the confidentiality agreement, which would have allowed him to see the information that we gained through discovery, that he has never been told about the dangers of the device. 

And he refused to look at the internal data from the company on why this device causes pain, and why this device causes pain and frequencies that are unusual. So, you know, doctors have some responsibility in this mess. What's your thoughts on that case?

B: The fact that a doctor has the opportunity, you know, doctors usually want and doctors always need the most information, the best information, the most detailed information and some broad information. Every bit of information on a product that a doctor is putting in a patient's body is good information. It's good information. And to just think of a doctor who refuses to look at the information basis amazes me.

That's what I think about at that particular case. That's what I think about that particular doctor. And that's what I think about the company, is they don't ensure that that doc gets the information and make certain that they're aware of it, because these are internal documents, right? We can't get into them because of confidentiality orders and all that stuff.But let me just tell you, internal documents will tell the story usually. 

V: And in this trial that doctor is going to see some internal documents. 

B: It'll be sitting there right there. And he's going to see him at trial whether he likes it or not.

V: And when they become public and we'll be able to show them everywhere, and we're going to be able to show the public what the company knew and what this doctor, what this doctor did not want to see. And just shameful doctors want to know the information on safe. That's how they make an informed decision in terms of risk versus benefits.

I have to believe that had he known that this is the pain generating machine that was implanted, that he implanted, that was causing serious injury, that he would have removed that device in a very timely fashion? Okay, instead of this woman having to go elsewhere. Yeah. And it's sad.

B: What we do is we represent folks who have been injured by medical devices and other products, and then we follow suit and we try cases. 

If you or a loved one experienced complications from a MedPort, you may be entitled to a free case evaluation. 

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Ben C Martin | Ben Martin Law Group 3141 Hood Street, Suite 600 | Dallas, TX 75219 Office (214) 761-6614 | bencmartin.com

TRANSCRIPT:

B: I'm Ben C.

V: I'm Doctor V.

The medical legal guys.

V: Today, we're going to be talking about med ports, the complications of med ports, and the litigation that we are involved in.

B: What are med ports?

V: A med port is a medical device that allows easy access to the central being, a system so that medications can be given with just simply sticking the port with a needle. Picture a miniature hockey puck that is hollowed in the center of the puck. If it goes underneath the skin, you can stick a needle into that port and give medications through that port, because that port is also connected to.

B: They're port catheters?

V: Yeah, they're port catheters.

B: Explain what a catheter is.

V: A catheter is IV tubing. If you get an IV, it's a tubing that goes into a vein. The heart okay. So you have ports that go underneath the skin. You have the tubing that then goes into a bigger vein so that people can get medications very easily. The people who get these port catheters are generally very sick people. They often have cancer that they need to have chemotherapy that gets into their central vein, cannot tolerate nutrition by mouth for a they've lost a significant amount of their bowels so that they can't absorb nutrition. So they have to get IV nutrition. 

B: They're not able to swallow the food and get the nutrition from the food itself. Like that, but somewhere else.

V: It's much more healthy to take food by mouth. If you can't take food by mouth, get a feeding tube through the stomach. But people who who require IV nutrition, IV chemotherapy, those are very sick people. And the complications from ports are generally infection, fractures and blood clots.

B: A lot of blood clots form when you're talking about this tubing. That's the catheter part of it. And then you've got the port which is the hockey puck. Right? Correct. So how does it happen that these side effects, where these effects can develop.

V: Those are great questions. So if you have a tubing and these tubes are usually silicone or polyurethane, those tubing connect to the hockey pot and go into a central vein. Those tubing they cause a immunological response where the body understands that it's a foreign body. And when it causes a foreign body, it causes a foreign body reaction. And platelets then adhere to the tubing and they form blood clots. Okay. So now they're safe for materials that prevent platelets from adhering to the tubing. So it decreases the rate of blood clots. And if you get a blood clot with a device those blood clots can occlude central veins. Those blood clots can then travel through the heart into the lung. And you can have a pulmonary embolism. Having blood clots are bad deals.

Obviously polyurethane and silicone tubing because of the foreign body reaction it causes kind of a fibrous where there's kind of like a scar tissue formation along that tubing. And the more scar tissue you have, there is a tendency for that scar tissue to then get colonized by bacteria. So then you get infections to the newer materials, prevent bacteria from adhering to the tubing. So we're suing on behalf of people who are chronically sick, who have complications from blood clots and infection from these lines. And if you get an infection of the line that goes into the central vein, that's a very bad problem, okay, that causes sepsis and could cause death. It could cause an ICU stay low blood pressures, brain injuries and all sorts of problems.

In terms of the the hockey puck complications, these complications of the hockey puck, you can get clots within the hockey puck. The hockey puck can then sometimes flip

B: And migrate.

V: Migrate, flip. And if it flips, then you have a person who has big time medical problems having to have another surgery to fix that. And if you have surgery and you're immunocompromised, then the hockey puck can get infected. So there are safer materials that prevent a lot of these complications. These materials have been available for over a decade, but they're still implanting inferior materials into people who should have the safest material because they're set profits over safety.

B: Two concepts that come to mind. First of all, it's the material. And I'm going to guess that, when you say profits over safety, if there's a product on the market and it's been on the market for years and the company finds out product has problems but no one to pull this product off, the market because it's a money maker, right. And then let's say inserted within that idea is that the company has also become aware that there is a safer alternative. Safer means are methods okay? Meaning safer material, better material, less dangerous material. But here's the rub it's difficult for that company to want to give up that profit because it takes time, effort, and money. A lot of money sometimes to develop this new product so they may continue to market and sell the bad product knowing that there's a better product. Make sense?

V: Well, in this case, it's a little bit worse that this technology has been available for over a decade. And one of the companies bought the technology and shelled it.

B: What company was that?

V: That was BD Becton Dickinson. This is called super hydrophilic technology, and the concept has been around since the 1980s. And there are safer devices that are available.

B: Hydro meaning water right and fillic meaning good with water, right. If you're using these catheters, if you're using these hockey pucks, if you're using these ports, you want them to be hydrophilic. They get along well with water because we are water. 

V: Then bacteria and platelets, they are repelled by hydrophilic. Okay. So you're not getting the bacteria colonization of the tubing which reduces infection. And you're not having the platelets adhere to the tubing. So there is a prevention of clots. 

B: When those platelets are adhering to the tubing. And when and when you've got this clotting going on that's called hydrophobic. Let's think of phobia right. If you have a phobia to something you're afraid of, you're going to have a phobia from heights. Right? You don't want to go on a tall building just like this. Hydrophobic means, hey, I don't want to go there right? So you got a hydrophobic product because blood clots can cause infection and infections can lead to blood clots. And you can it can actually ultimately damage the material because it does not get along with water. And we are water.

V: So these concepts have been around. They're safer materials on the market. The the worst thing about this one thing that is really I find irritating is that some of the best literature that is coming out, the safer materials, they're coming from China, they are looking past the United States cash cows, and they are developing safer tubing for a purpose. Okay. If you have safer products, your people aren't going to get septic shock. They're not going to be in hospitals for weeks on end. And it's greater safety for the people. So, you know, why are the U.S. companies not going to the safer materials? Why are these studies coming from China? We need to be the place of innovation. We need to be the place of safety and profit over safety does not work.

B: Does not work for the betterment of.

V: Yeah, the patient, the public, and we should always be working towards better products, better medications, better avenues of care. And we're not doing this in terms of this medical product. Certainly it's good business for us. But we just find it despicable. Conduct from our manufacturers.

B: Manufacturers are responsible for putting on a safe product, putting a safe product on the market. 

V: It's the right thing to do. And for these companies to be using 1950s technology, 1960 technology, I mean, these companies need to be producing the best medical devices to prevent complication. 

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How patients may initially walk into a hospital with mild symptoms — but deteriorate rapidly 

The anatomy of the spinal cord and why it is so vulnerable to delayed care

 Real-world medical scenarios involving trauma, infections, and post-operative complications. 

The Vigna Law group created this episode is designed to educate patients, families, and medical professionals on why rapid response is essential and how early intervention can be the difference between recovery and lifelong disability.

Learn more about spinal cord injuries HERE: https://vignalawgroup.com/ 

Call NOW if you've suffered from a spinal cord injury: 817-809-9023

TRANSCRIPT:

B: I'm Ben C. 

V: I'm Doctor V. 

The Medical Legal Guys. 

V: Our topic today is a concept called time is spine.

B: What does that mean?

V: It relates to the onset of a spinal cord injury, and the time between the onset of neurological symptoms that relate to a spinal cord injury, and the time to the operating room to take pressure off the spinal cord. So injuries to the spinal cord can be caused by physical trauma. It can be caused by medical problems. So a physical trauma is a motor vehicle accident where there may be a fracture dislocation of the spine. 

A person is taken by the ambulance to the emergency room, and then they are taken to the operating room to take the bone, crushing the spinal cord and decompress the spine. 

B: Clear this up for me. So the spinal cord. Right? That's what you mean. Decompression of the spinal cord and the spinal cord. Is that a nerve? 

V: The spinal cord connects to the brain and descends from the goal all the way to the sacrum. And on the way it sends out the the nerve roots that turn into nerves as those nerves and supply the arms the bowel, bladder, heart, colon, all that, all the organs and your lower extremities is.

B: A spinal cord, a bony structure? 

V: No spinal cord is made of hundreds of millions and potentially billions of neurons that are nerve conducting.

B: So all right. And does the spinal cord, which you said is not a bony structure, does the spinal cord sit within a bony structure?

V: Yes. The spinal cord is by the spinal column. If you have infection of the bones around the spinal cord, that infection can press on the spinal cord and cause a spinal cord injury. You could have a spinal cord injury from a broken back where the bones are fractured, and some of those fractured fragments go into the spinal cord.

Whenever there is a spinal cord injury from pressure or trauma, the treatment is to take that pressure away and stabilize the spine. And that leads to the concept of time as spine, that the longer the spinal cord is under pressure, the less ALP. 

B: The less chance of a good out. Why is it that shorter time is better, right? Why is it that just generally the fewer seconds or minutes that it takes to get to where there is an actual decompression and decompression of the spine?

V: Meanwhile, a removal of whatever is pressing on the spinal cord.

B: Cord okay, and pressing on the spinal cord is bad why?

V: Because changes neurological function. If the pressure is severe for a short period of time, the injury can be permanent. If it's if the pressure is not horrible, it could be reversible if you take the pressure off.

B: But even a lesser pressure over a longer period of time can create the same or even a worse situation, then greater pressure for a shorter period of time, right?

V: Correct. And time as spine. They've been studying this for the last 50 years and the conclusion is now that the best outcomes occur within 24 hours, and that a person who's having neurological loss because of pressure or injury to the spinal cord, those patients should be decompress within 24 hours unless there is some other significant medical problem, such as a brain injury or a heart attack, or worse, significant bleeding, that you can't decompress.

Okay, there are some medical conditions that would take priority over a spinal cord injury, but those are catastrophic cases. But we're going to be talking about the patients who present to the hospital who are walking and not diagnosed with a spinal cord injury, then get admitted and then become paralyzed when we see those cases all the time.

B: So we're going to talk about patients that walk into the hospital, but they don't walk out of that hospital water to the causes for that.

V: The big causes for that are infection. And where patients might come in sick, they have fever. They're obviously getting septic or hypertension, and they're running fever.

B: Of septic means that's an infection of the blood, isnt it?

V: Infection. It's in the blood. And there are significant negative effects from that infection that is causing a person to be maybe confused. And these patients walk into the emergency room, they're sick. They're diagnosed with the pneumonia, but they may have severe back pain. They may have numbness in the legs. They may have some developing weakness, but they're admitted for pneumonia and they miss the opportunity for that diagnostic test.The MRI, the CT milligram that can diagnose a pending spinal cord injury.

B: So you've outlined one way and one reason and basis that somebody can walk in and not walk out. And that is:

V: the infection...It can also be that people sometimes have bleeding around the spine where they have -

B: that causes bleeding can cause pressure, right?

V: Yes. A hematoma where that blood collection that presses on the spinal cord that causes neurological loss.

B: Now I'm going to guess that in some ways, a spinal cord is resilient. Right. But you don't just touch a spinal cord and all of a sudden you become paralyzed. So it's a resilient material and obviously resilient part of the anatomy in some respects. But we know now that pressure on the spinal cord then can lead to catastrophic problems. Can you explain that a little bit?

V: Well, pressure if there's pressure on the spinal cord it could lead to symptoms. And then the main symptom is pain. Or it could also be numbness. If you have a thoracic bleed or a thoracic infection, you could have pain that goes around the ribcage. You could have some numbness of the legs. You could have problems with walking. So any symptom of back pain with neurological weakness, those people need to get a scan.

And we have clients who have come to us, who walk into the hospital and then ultimately have progressive neurological loss on the floor. And there's a delay in diagnosis, a delay in the nurses communicating with doctors of neurological findings. Patients are not getting decompressed in a timely fashion. They walk into the hospital, they leave in a wheelchair. They go to rehab.

If there is a scenario such as that, those are cases that we would want to evaluate and review. Me being a spinal cord injury doctor, I understand the standards of care and we could, you know, have an answer pretty quick in terms of if we have a case or so. 

B: There is a concept that you might want to talk about. I think most people know a little bit about this. Have I have some knowledge of the fact that at the level of the spinal cord, where the pressure is such that it damages the spinal cord and therefore damages the nerves and creates a situation, sometimes it's called necrosis, which is the death of tissue.

Right. So at the level of your spinal cord, the higher the level of injury, the less function you're going to have at a certain level of your body. In other words, if you're talking about the cervical spine, which is a C1 through the C7, that's the top right, you have a cervical spine injury that creates pressure at one level, say the C2 or the C3, because it goes up to down 1 to 7, right. You're up close to the brain C 2 or 3. That's going to be usually more problematic than if you have, let's say a spinal cord injury that is down near the lower spot.

V: So in terms of the levels of injury as a rehab doctor working with neurosurgeons and orthopedic surgeons, injuries that happen at the level of C2 three that would affect breathing and everything lower C5 injuries affect the shoulder, so people have weakness of the shoulder pain to the shoulders. If it advances to affect the whole spinal cord. Everything lower C6 wrist extension, C7 elbow extension C8, T1 hand function, thoracic T6 is out, the nipple line everything lower so you have the level of injury and distal loss -

B: Distal meaning away from..?

V: From the side of injury. Yeah. And further away from the brain. You know, of course, people who go to the hospital with serious medical problems, they have various complaints, they have various symptoms and signs. But the clients that we need to see and evaluate are those who walk into the hospital or have symptoms that aren't as severe when they present, and then they get worse in the hospital and they aren't decompress.

So we have a client in Los Angeles, an example. He was riding a bike and then couldn't ride his bike and was sitting on the curb, and he was taken to the emergency room, diagnosed with pneumonia and then diagnosed with an epidural abscess that is right next to the spinal cord. And he didn't get decompress for eight days. And he required a lot of function, a lot of help. He couldn't turn, he couldn't walk. He had progressive loss of mobility and strength, and he didn't get decompress. And he could have been saved. 

B : yeah, time is spine.

V: Time is spine. 

This episode also addresses emerging concerns regarding Depo-Provera and the increased scrutiny of meningiomas in patients with a history of long-term exposure. The focus of this discussion is educational and medical in nature, helping patients better understand diagnosis, treatment, and recovery considerations.

Visit Vigna Law Group for resources 

Vignalawgroup.com 

Call for FREE Consultation: 817-809-9023

TRANSCRIPT:

B: I'm Ben C

V: I'm Doctor V.

The Medical Legal Guys!

V: Today we're going to be giving an update on the Depo-Provera litigation. 

B: A meningioma is a type of brain tumor. And it is the type of brain tumor that is caused by Depo-Provera. How do people have different results from different meningioma tumors. How does that all work? When you got somebody that doesn't have a surgery and then you've got people who have massive craniotomy surgery.

V: The decision to operate depends on size, location, symptoms and signs.

B: You could have a meningioma that's taken years to develop and is five or 6 or 7 times bigger than another meningioma that's in a different part of the brain, like you say. And you could have a smaller meningioma that will actually cause more problems than the larger meningioma. 

V: True. And, you know, these are serious problems. And it's not like a knee replacement. There are places in the brain where it's more difficult surgeries. There's no real routine brains because bad things happen. Tumors will have more vascularity. They may have more bleeding during surgery. Not every brain tumor can be completely resected by all neurosurgeons. There might be just a few neurosurgeons who have the skill to provide complete removals. So this is very bad problem.

B: Not all neurosurgeons do brain surgery. So you've got a more limited number of people who even operate on the brain, right.

V: So neurosurgeons who do brain tumor work, they're often in academic centers with serious meningioma have to travel.

B: We want the best for our clients. And so, of course, the best thing is to get the best care. And the ultimate best thing would be for this to have never developed. But that's something that is beyond their control because of the lack of information and and in many respects beyond the physician's control, because through these years there was a lack of information being provided to the doctors.

V: The meningeal cell line that's in the meninges without Depo-Provera, those cells are still being replaced. Okay, because a cell doesn't live forever. Okay? And Depo-Provera will cause the cell division to be more often the more often you have cell division, you could have a mutation. Mutations happen all the time. Most mutations, they just kind of fade away. And that a mutation is when cells divide the DNA splits and then replicates.

B: And that's the problem.

V: Most mutations just go away. But then there are certain mutations that don't go away. And they become a meningeal.

B: And that's not a good thing. That's a bad thing. 

V: It's a bad thing if that mutation is one that causes cancer okay. Or benign tumors. So you have different mutations. The different mutations cause different types of meningioma. And now they understand which meningioma should have radiation therapy after resection because they're more aggressive. So they could understand based on the DNA how these meningiomas behaved. 

So symptoms of meningioma. So a common location is in the frontal area which is the front of the brain. Frontal tumors can affect smell. They can affect vision pressure in the brain, imbalance in coordination, cognitive problems and that could lead to, you know, the diagnosis of a meningioma and then complications from brain surgery. Those are the patients that I took care of in rehab hospitals.

And the main complication after meningioma resection is bleeding, okay. And if you bleed in the brain, that could cause neurological loss. Kind of like a stroke and swallowing problems, walking problems, significant level dependance. So these are serious injuries. You don't want a meningioma. You don't want to have to go to brain surgery. We have terrified women going for operations who can be relaxed going into a brain surgery. You know, I mean, it's terrifying. 

B: Well, and we know that and I know you know it because we've talked to the same clients who have been going into brain surgery. One recent client we've had many conversations with, and it's really a tough deal because you really don't know exactly what's going to happen. And the doctor will need to inform them all. I need to inform you, Miss Smith, that you are about to undergo this procedure.

It's a serious procedure. Usually it's a lengthy, multi-hour procedure, and then all of these things can happen during the surgery. So it also can sometimes really instill fear and anxiety and worry in the patient that is undergoing it. And unfortunately, it's the truth. And unfortunately those things can occur. And not every surgery results in a 100% recovery.

V: Then you have radiation therapy and radiation therapy, 7% risk of dementia, long term of taking care of people with post radiation dementia in younger people. It is a bad deal.

B: Does every patient who undergoes meningioma have radiation therapy?

V: The goal with any resection of a meningioma is always to try getting all of it out. But there are some tumors that you can't get out because they're in a location where there is a fear that you may cause more harm than good. If you have a grade one, that you can't get all of it out, you're going to have radiation therapy. 

If you have a grade two tumor and it's completely resected, that you may get a recommendation for radiation therapy. Grade three acts malignant. Generally those patients get resection plus radiation. So that's kind of the way it works. But I'm not a neurosurgeon. And those are questions that you you'll be asking your neurosurgeon. As a rehab doctor I would take care the patients who had complications. 

Those two had a operation that went bad with significant neurologic deficits or who have chronic meningioma and other problems. That's kind of the field that I used to practice. If you've suffered a meningioma with Depo-Provera - Ben Martin, myself, we will look at your case individually. But we understand the seriousness of these injuries. We are litigating these cases. We have developed our own experts and we prosecuted pharmaceutical litigations. 

B: For years. Every case is not a filed case. And sometimes they become unfilable because of the passage of time. It's rather important that we all remember that timing is important. And so it's important to remember these cases should be evaluated sooner rather than later. Been a pleasure today, doctor V, and forward to further discussions on Depo-Provera and the other things that we talk about. 

• The formation of the Depo-Provera MDL

 • Scientific and medical studies evaluating meningioma risk 

• Changes in Depo-Provera dosage and labeling 

• “Dear Doctor” warning letters sent to healthcare providers 

• Why patients may not have been fully informed of long-term risks 

This discussion is presented from a medical-legal perspective, focusing on how clinical data, prescribing practices, and patient safety intersect with product liability law. If you or a loved one used Depo-Provera for an extended period and were later diagnosed with a meningioma, you may have legal options worth exploring. Learn how medical studies and prescribing practices factor into Depo-Provera litigation.

Visit Vigna Law Group for resources 

Vignalawgroup.com 

Call for FREE Consultation: 817-809-9023

TRANSCRIPT:

B: I'm Ben C.

V: I'm Doctor V

The Medical Legal Guys 

V: Today we're going to be giving an update on the Depo-Provera litigation and how we're prosecuting these claims. So Ben do you want to give an update on the Multidistrict litigation and and what we're doing with that?

B: The Multidistrict litigation has been compiled and transferred, and created the MDL in Florida, Pensacola, Florida. As of a few days ago, there were just over 1500, possibly by now, 1600 cases filed in the MDL. And we have several dozen filed of those. So that's the MDL. And, Greg, maybe we should talk a little bit about the other filings or filings across the country in California, Washington state, about to be in Wisconsin, filings in, Utah and elsewhere that either have been filed or will be filed shortly. Cases filed in Connecticut, cases filed in New York. But the largest number of cases are filed in the MDL.

V: Yeah, So each case that comes in, we are looking from the get go where, we believe that case should be filed and where we filed the case is where we believe our client will have strongest venue.

B: There's a lot of thought that goes into where to file a case, how to file a case, the language in the case, the language in the complaint, which is what are the original filing? The lawsuit is a complaint. So all of these things, including, the venue venue means the place right where to file a case, whether it's state court, whether it's federal court, all of those things go into, the strategy and the basis of, well, what do we file? Where do we file it, and when do we file? Thing is that people ask me, well, how do you practice all over the country? How do you have cases filed in every state, which we did. The answer is that we always have a local lawyer who is licensed with a good background in whichever state we are filing. That local lawyer will get the lawsuit on file, and we'll do a procedure called a pro hack. That just means pro hack which means essentially that we're allowed to practice in that state for that case, for the period of that, that the pro hack exists.

V: We are evaluating those cases as they come in to understand. Well, is this case, should it be filed in the multidistrict litigation or in state court? And as we get into this, we feel very strongly about this litigation because women are continuing to get these injections for birth control. It's like, the doctors have no clue. And these are serious injuries.What's your thoughts on this, 2025? We're seeing women having craniotomy that are that are just stopping the medication after diagnosis.

B: So first, explanation of a craniotomy that is simply sometimes called a resection. Okay? A resection in this case, a resection where actual, saw opens up the skull. Right. And, of course, right behind the skull there. That's the brain. A meningioma is a type of brain tumor. And it is the type of brain tumor that is caused by Depo-Provera back in March of last year, 2024.

Getting close to the end of 2025. Now March of 2024, the British Medical Journal published an article. The lead author was Doctor Rolling several other articles, really smart people writing that researchers, doctors writing in that study. In that study, there were over 100,000 women who were studied And what the researchers were doing is making a determination as to whether or not there was an association between Depo-Provera and the creation of a meningioma, right? 

The development of a meningioma. A meningioma, a very, very serious condition, usually, necessitating a craniotomy or an open surgery through the skull into the brain to take that meningioma out. And these meningioma can be very serious because they're in the brain, in and around the brain. Second reason is they grow and they can grow fast. They can be existent for a long time before anybody starts having the symptoms that would lead them to then have a physician look at it and see if there was something there, and then they find the meningioma in it because it's a time factor.

The longer you go, longer that tumors there, and especially if you're continuing to receive Depo-Provera, then it's going to continue to grow usually. So it's a very important, very tragic condition. Actually part of the tragedy tragedy is that and as shown by the medical Journal, we're talking about a British Medical Journal study. In all these women compared the women who had taken Depo-Provera, had been injected with Depo-Provera, versus women who did not ever receive injections of Depo-Provera.

Okay. Those are called cohorts. One cohort, women that had the injections in their cohort, women without the injections. What that study found, what those researchers found is that there is almost a six times relative risk, 5.6 times relative risk of meningioma in women who were injected with Depo-Provera versus women who were not. That's almost a 600% greater probability of development of a meningioma in the population of people who have had this injections, as opposed to those who have not. That's a huge, huge relative risk. But these women did not know because there was no reason for them to know that this Depo-Provera had this huge, huge factor of risk factor. And so that that's where we are in the after it study came out. Then we started gathering these cases. And when I say gather, we treat it every case separately.

But we were getting these cases and we are getting these cases and we will hopefully be able to do some good things for for our clients who have this tragic development of a meningioma because they took or were injected with Depo-Provera.

V: Studies have been available for the past couple of decades, so this problem, you know, there have been safety signals that have been flashing and now it's like constant light in your face, okay. But there have been safety signals on Depo-Provera, synthetic progesterone, that have identified this association in the past.

B: You're talking about when you talk about safety signals that like a red flag, right. That the distinction I would make, doc V is the distinction between the safety signal that the company knew. Pfizer is the innovator of the drug. Let's say Pfizer developed this drug. And we know that there were safety signals, red flags that would have led any reasonable company to understand and know there was this association. 

You don't have to. This is my belief that if you have a drug that is six times more likely to cause a disease or condition, a serious condition like this, you're just not going to not have safety. So needless to say, there's a problem there. And the problem is how was it that for all these years this product was put on the market, 1992 for birth control? So what is that, 33 years, 33 years it took or 32 years it took, for this large universal study to come out.

V: And that study was not sponsored by Pfizer. Right. You know, I mean, a reasonable, pharmaceutical company if there is no association between synthetic progestin, we're talking 2009. 

B: But what happened in 2009?

V: Other synthetic progestin, they found dose dependent association.

B: And a dose dependent association means, as far as your, dosage either increases, as time goes on or stays the same, then you have a greater risk of the development of these meningioma in this case, that's the dose dependency, right? Higher the dose, but the longer the, dosage was taken, the higher the number, higher percentage of incidences of meningioma or whatever the disease or condition is for that particular drug, that's dose dependency.

V: You know, every case that comes in, I'm, reviewing the medical records. And so I'm seeing a whole lot of problems, such as a meningioma diagnosed in 2024. You know, it's it's a difficult surgery. And, and the neurosurgeon, because of the dangers of the location and the surgery, they want to follow this conservatively to ensure that if they were to expose that woman to a dangerous brain surgery, because of the size, location of that tumor, you know, they're observing over time, but they're not stopping the Depo-Provera because because the company has not sent out a your doctor letter, there is not a black box warning.

So doctors have not been managing these Depo-Provera dependent tumors. As you know, obviously you stop the drug, right? The tumors are just growing because they're not stopping the medication. And it is. You know, I'm a brain injury doctor. Okay? So I took care of people in rehab hospitals who've had strokes penetrating brain injury, tumors, cancer of the brain.

So, you know, the complications from meningioma, especially the ones that are unresectable, those are not not pleasant deaths. Watching a person who has a tumor that can't be resected, causing progressive neurologic deficits, that's not a good death.

B: We have had clients had been diagnosed with a meningioma, and there have been instances where nonetheless, the doctors continue to inject Depo-Provera diagnosed brain tumor, still injecting Depo-Provera. And because there is a dose dependent relationship between the dose and the event meningioma, it is very bad a situation when you've got that in some instances the physician will say, well, I didn't know, company didn't tell me, they didn't warn me.

Now, we haven't talked about this yet, doc V, but a company, if a company believes that there is a problem with their drug or their medical device, they can send without any connection with the FDA, without any request, they can send what's called a dear doctor letter. They could have send dear doctor letter through these years to the physicians who were injecting these. They they know who who the injectors are because they've got that in their records. They know that it's on this drug tube and it's unique to this particular drug that the patients aren't getting it. They're not going to the pharmacy and picking this up, you know, and it's coming from the doctors and the sales reps are getting the Depo-Provera to the doctors who then inject it. 

Guess where it's coming from. It's coming from the manufacturers. Those manufacturers in this case, Pfizer could have sent these dear doctor letters out and told the doctors, you inject this, you have a greater probability of your patient developing meningioma than if you don't think we've got a tragic case where a client developed something like 12 meningiomas over the years, she would continuing to get this Depo-Provera. 

Another thing not meaning to monopolize this, but now that I'm thinking about it, it takes a while sometimes for these to develop and the patient doesn't know it and their doctor doesn't know it. And let's say that, you know, meningioma can cause headaches. Well, a lot of things can cause headaches, right? So you had situations where a patient goes in with a headache. One of the things that the doctor is not going to do probably is immediately send that person in for a brain scan of some sort. Right. And so it takes a while to finally get one of these brain scans. And then the patient is in a situation where, my gosh, they probably developed this brain tumor months or years before, but they had no reason, and the doctor had no reason to go send them in for a brain scan because of the symptomology.

And and every case is different. It's from with problems because of the insidious nature of the disease and the fact that the doctors were not told by the company that, number one, there an increased risk in the development of meningioma. If you have been given Depo-Provera and number two, the recurrence and you got to stop the injections, your patient had developed a meningioma.

V: This is a different type of tumor, though. This Depo-Provera, this push tumor that, you know, looking at, as -

B: You say, you call it a pushed tumor?

V: Well, it pushes it. It pushes it to grow progestin. Their progestin receptors like progesterone, progestin is a hormone that can prevent ovulation and -

B: Ovulation being what? 

V: The egg being released by the ovaries, which then goes through the fallopian tubes. And then there's fertilization. But progestin pushed these tumors. So we're seeing some unusual tumor behavior that hasn't really been described yet. There's normal CT scans a year before. One year later, three centimeter meningioma. That's growing fast.

B: So and if you don't have a meningioma a year before that and you have A three centimeter one, you're almost the lucky one because you got it within a year. It hasn't been over a year old.

V: So it's all bad okay. But there is no bright side of anything with this war story. Okay, we are looking at state court filings, right now. We recently filed the case in Washington. We're looking at Iowa. We're looking at Wisconsin. We're looking at, a case in New Hampshire.Pretty much everywhere. And so we're looking at each case very carefully. And, you know, these injuries are just bad news. 

 If you have questions about HIE or cerebral palsy following birth, the Vigna Law Group can help you understand your options. 

Visit our website: https://vignalawgroup.com/ 

Call for FREE Consultation: (817) 809-9023

TRANSCRIPT:

B: I'm Ben C

V: I'm Doctor V

The Medical legal guys. 

B: My name is Ben Martin. I'm a lawyer in Dallas, Texas, and we have cases all across the country. And one of the types of cases that we handle and we work and we work, are what I would call the acute birth trauma cases. Those are the cerebral palsy cases. Those are the cases where you've got a hypoxic events that lead to lower oxygen leads to brain damage.

V: Even childhood schizophrenia is associated with hypoxic brain damage because that affects the dopamine centers, which leads to some of the psychosis. So this is interesting litigation. The science has evolved to be able to show particular findings in the brain that can identify hypoxic brain damage.

B: So one of the elements of a case in every one of these cases, the future harm is there, right? You don't cure profound cerebral palsy. You don't cure autism. There are treatments for each and for both which you don't cure. So what that leads to is what we call on law damages, right? What are the future damages? One is the angst, that mental anguish, that pain and suffering, that that type of injury to that child and some instances and in some states recoverable is the angst and the mental anguish of the parents.

Right? So that's one aspect of it. The other aspect of it is crunching numbers and it's crunching numbers with respect to what is this child going to eat? What is this family going to need in the future to help defer the cost of raising this child with respect to the injured? Right. I mean, some of these folks are really in need of as doctor visa, 24 hour care, depending on the severity and level of the condition. 

Some are not, but there is a full range. There is such a thing as minimal birth injuries right? There is like more minimal levels of future care needed. And then there are some that, you know, into the tens of millions of dollars and those things are all put together as part of the case so that it can be evaluated by complexity and its incompleteness.

V: Right. So, you know, as the case progresses, that's when, you know, we hire the pediatric neurology expert, the pediatric societry expert, to be able to delineate the care that the child will need their life expectancy. Many of these children developed scoliosis. And they need to have scoliosis surgery, because if you have brain damage, your spine will develop neurogenic scoliosis and that will interfere with breathing.

So these children at age 14 are getting major spine surgery. These are serious medical conditions. They get worked up. We have experts in neonatology, sports and pediatric neurology. We have a labor and delivery nursing experts have ObGyn experts. And you know, these are important cases and very expensive to bring. But we need to bring these cases. 

B: And there also the experts that are crunching the numbers and economists for instance, they're looking at this future care that in that future care is determined by expertise of folks called Life care planners certified life care players, people who have gone to school for years in order to become proficient in the knowledge of what it takes with respect to a child's injuries. What it's going to take for that lifetime care. Crunching those numbers and what they're going to do is make a damage model damages model, meaning a model of socioeconomics, so that we can evaluate and networks can evaluate these cases, and that the jury can evaluate these cases when they go to trial.

V: So wait and see. You know, we don't the wait and see aspects of taking care of a child who has had a complicated delivery. Neonatal encephalopathy the that is changing. And you know, so there's three grades of neonatal encephalopathy related to hypoxic encephalopathy. There is mild, moderate and severe. And historically only the the severe and moderate neonatal encephalopathies would get therapeutic cooling. Recent study showed that children with mild who aren't therapeutically cooled because they don't meet the therapeutic cooling criteria, they perform worse that were therapeutically cool.

B: There's been a study on that, and we've talked about that study. Right. Like where these children compare to the children that had the therapeutic to like the ones that did not versus the ones that did. And what these studies are called are clinical trials, right? They're different types of them. But what this particular study did was to compare these two groups so that we now know that therapeutic cooling works if it's used. And now doctors who are able to have the knowledge that they should have now to therapeutically cool these children, they're going to have a better result in the long term. They use this technology that is now known to work.

V: It's interesting. So now the centers, the major centers are they're identifying categories of severity of presentation at birth and then at two years, they're being graded in terms of how they're performing from a developmental standpoint, so that they have all this data now to be able to to identify treatments that work. Therapeutic cooling is the only treatment that helps protect the brain. And more kids who are born hypoxic are getting therapeutically cooled because the risk of therapeutic cooling is is really it's not that risky of a procedure.

B: Oh non existent As to the risk of therapeutically cooling a child, you're not going to injure a child if you use therapeutic cooling.

V: Correct. So, Ben Martin, you know, if you were to code right now and I were to, you know, do CPR and I revive him and he goes to the ICU, he would be therapeutically cool. So people who have cardiac arrest that are revived, they're getting therapeutically cool. The adults are, you know, and so this has been around this is the standard to care and wait and see attitude, the see how the baby does. 

So when we're talking about autism there are two factors that cause autism okay. That are known okay, hypoxic brain damage and genetics. You know, there's been a lot of legal opinions, expert reports regarding Tylenol and the association with autism. And from my review of the literature and the meta analysis, then the gobs of data and articles regard regarding this association of Tylenol and autism, the relative risks of the articles show that it's about 1.34. 

So the questions of being exposed to autism generally won't even be admissible because it lacks a certain level of confirmation. So do you want to talk about relative risks? 

B: So relative risk. I'm going to talk a little bit about something called epidemiology, what the causes of those diseases are and the way it works is that there are different levels of studies that are done to make a determination as to the incidence of whatever the illness or disease is in the in the population. So one of the things that's important is to determine what is the relative risk of a particular drug or medical device or other non-pharmaceutical cause. 

Right. It's in every particular area of science, every particular area of epidemiology. They do these studies. When you get to a relative risk, you're you're actually putting a number to what are the chances I'm going to get cancer if I smoke versus somebody who does not? Part of what we do that is the Depo-Provera litigation, where it is then determined in the British Medical Journal publication March of 2024 that if you took or were injected with Depo-Provera, a birth control injection, the only birth control injection that exists there is a five and a half times relative risk. 

If you have, developed a meningioma, which is a type of brain tumor, 550% chance greater that you're Depo-Provera, has caused your brain tumor as opposed to one who, does not have Depo-Provera. That's a pretty broad and pretty simple way to say it. But that's that's a relative risk.

V: So autism 1.34 is what we're kind of seeing in the literature. Okay, I'm not a epidemioigist. I just but 1.34 is kind of a problem.

B: We're not saying that in some instances that Tylenol taken during pregnancy may not have something to do with autism, have some relationship, some association with with autism, but it's a lesser relative risk than, say, something like the Depo-Provera. So it's it's kind of early in the game to say one way or the other, but certainly relative risk is important in any one of these epidemiologic issues. 

V: If you have a child with low level autism who had a complicated delivery, was in the NICU and is looking at 24 hour care, was there a negligent delivery and is there diagnostic evidence of a hypoxic brain damage? So we're available again, I take first call and then shortly thereafter there will be an ObGyn discussing the birthing process and then we order records.

B: So look, if you have a situation where you have a child or you know, someone, a loved one, friend who has had a child and there was a complicated delivery, it might be worth taking a minute and chitchatting with them and letting them know that there may be some help for them, some help and some help and help be an answer. 

-How cerebral palsy develops in the brain 

-Spastic, athetoid, and hemiplegic CP explained

 -How CP impacts muscle tone, balance, and daily function 

-What families may notice during early childhood 

-Why brain cooling, temperature control, and expert evaluation matter (Coming In Part 2) 

If you believe your child or someone you know has CP from troubles at birth, feel free to reach out. We try to answer all questions, not just the legal ones. 
www.vignalawgroup.com 817-809-9023

TRANSCRIPT:

B: I'm Ben C!

V: I'm Doctor V.

The Medical Legal Guys!

V: Today we're going to be talking about cerebral palsy and how we work up these serious injury cases. And first of all, it's important to understand why does cerebral palsy occur. And that is because of hypoxia. And Ben, do you want to describe what hypoxia is.

B: Hypoxia. He's talking about. That is a lack of oxygen that is flowing to the brain. Generally it's called H.I.E.

V: Hypoxic ischemic encephalopathy. And encephalopathy simply means that the brain is not functioning properly. And there's various forms of encephalopathy that comes to mind then. Let's talk about babies. Hypoxic is a encephalopathy is a form of neonatal encephalopathy. Neonatal is newborn. So when babies are born and they have a lack of oxygen during the birthing process, they could suffer a brain injury. And sometimes those brain injuries are reversible because the baby is delivered and they're resuscitated and the baby is fine. Other times, they have suffered hypoxic brain damage.

B: When a baby suffers from a lower oxygen level in the brain than is normal, or that they should have. Right. It can cause harm if it's for a lengthy period of time or even a shorter period of time. If it's a major crop and in the level of oxygen. Hypoxia. Hypoxia meaning lower oxygen levels. Okay. So that's one of the causes of cerebral palsy. Doctor V to help tell everybody what cerebral palsy is?

V: Well, I first want to talk about how a baby presents at birth. And these babies when they are born they're they're blue. They're electrolytes or their oxygen level are is way off primarily the pH. And the oxygen level is what is important. And are they the notic. That means that the body is not getting rid of its waste.

So these babies are born limp. They they require intensive care, treatment. And they're often taken to the ICU for management. If a baby has hypoxic ischemia, encephalopathy, and it's severe or moderate, they are then treated with therapeutic cooling where they bring the body temperature down. And that is the only way to protect the brain. And then they're in the NICU for quite, quite some time after all.

B: Right. That sounds pretty basic and pretty simple. Is that the way it happens in every case, the let's talk about, cerebral palsy. But what is cerebral? 

V: Well, cerebral palsy is, basically a brain injury. Okay. And it's a hypoxic brain injury related to the birthing process. And there are mainly four types of cerebral palsy. They're spasticbyplegia. These kids generally have problems with walk in coordination and it's more of a motor problem then you have hemiplegia, cerebral palsy where they they look like they've had a stroke and they basically did have a stroke.

Generally the MRI will show a problem in the side opposite of their weakness. Then there is kind of a afa Toid cerebral palsy where these kids have in coordination and they're they're kind of always moving. But those are those are really the main types of cerebral palsy. And six cerebral palsy means that that the muscles just don't relax.

Okay. And other kids, they can't get out of a wheelchair because of the cerebral palsy. It affects all four extremities. And these kids are often, you know, very, very tight. And they need treatment to loosen them up so they could sit comfortably so they could be placed in a wheelchair. And and they need baclofen pumps, Botox, riseotomies and really lifelong care. You know. So these are serious injuries. And and what is interesting about cerebral palsy is that when you do MRI's on these these kids brain, 85% of the time they show problems in certain locations of the brain. But 15% of kids with cerebral palsy have normal MRI and the damage just doesn't show up. So they tend to be less severe, but they still meet the clinical diagnosis of cerebral palsy. The most important thing about this is that there are children who have hypoxic brain injuries. They have complicated deliveries. They're born hypoxic. They develop the developmental delay. They have problems in school. They might have problems with coordination, but they're not getting diagnosed as cerebral palsy.

So we know that these kids are injured. But it's hard. It was hard to prove it okay. And now children with, complicated deliveries with developmental delay than autism. Now when you get MRI DPI's it lights up in the same area of the brain as the kids with cerebral palsy. So it's kind of a a different presentation for a hypoxic brain damage.You understand what I'm saying? Yeah. So there are children that had no recourse. The families had no recourse because it was difficult to prove that this brain damage caused their developmental delay or made their autism worse.

B: One of the types of cases that we handle and we work and we work, our what I would call the acute birth trauma cases. Those are the cerebral palsy cases. Those are the cases where you've got hypoxic events that lead to lower oxygen, leads to brain damage in these in these kids, and leads to all these things that are offshoot of and form cerebral palsy.

But it almost always comes down to a lack of oxygen and lowering of that oxygen, either in the length of time that there is oxygenation levels that have gone down, or the depths of that lowered oxygen level to complete loss of arch heat, for instance. It may not be for long, but it's long enough to give the brain damage.

People come to us, parents of these babies come to us and children after years of like seeking some help. And well, how did this happen with this new technology in doctors and the lawyers are able to take that new technology in and use it because now, to explain something called causation. Right. So let's say that, there was negligence in the birth labor delivered, loss of oxygen, all that stuff. And then you have a baby with cerebral palsy. One of the things we have to do is that we have to prove that first there was lack of oxygen. Secondly, that that lack of oxygen is what caused the ORS to. Now we can do that. And more cases because the studies are more significant in their detail. Right. Does every case mean that there was lack of oxygen at birth?

Maybe not necessarily, because every cerebral palsy case will lead to the conclusion that the doctors, or the hospitals, or the nurses during the labor and delivery were negligent. No, no. But it is a situation where if a child has cerebral palsy and if there was a complicated delivery, these things can be studied.

V: Pediatricians, historically, when taking care of a child, aren't meeting their goals. You know, in terms of ability to roll, ability to suck on a bottle, the ability to sit up. Pediatricians have always traditionally had a wait and see kind of attitude, you know, well, let's just see how things go, okay. And now with these diagnostic studies, you can find the babies who are at most risk of not meeting their goals. If you have a baby who had a complicated delivery and is not meeting their goals, these children need to diagnose nurses so that it gets them into the treatment they need. And this wait and see attitude that was last decade and the decades before. And the reason why is, you know, I'm seeing this right now.

We had had a case and the birth history was terrible. Okay. The care was bad. And this was in Connecticut. They don't have a statute of limitations that protects babies there. You have to file the case within three years. The wait and see attitude. I got the call for an age four. There's nothing that we can do as lawyers if the law doesn't protect a baby. So you want to talk about statute of limitations for kids. 

B: Limitations being a time period after which you can't shoot? Okay, most states, even Texas, has a statute of limitations for minors that go much farther than than just age three. So some states, go to 14, some states go to age 12, some states go all the way to 18. Right. And so, many states two years after age 18. 

So that baby, now an adult is 20 years old, then a lawsuit can be brought. Right? All the states are different. So it's important that with respect to the statute of limitations that that be evaluated so that every lawyer wants to make sure that that statute limitations as well.

V: So we're not waiting for diagnosis of cerebral palsy. If a baby is if a child has the global developmental delay, that is a criteria for us to to investigate. And now hypoxic brain damage in children with autism, you can find those children who have hypoxic brain damage in those kids in studies perform much worse than the kids with autism, that there is a subgroup of autistic kids who have been exposed to hypoxic brain damage and they fall off the charts in terms of performance, those are the kids who require a 24 hour care to their life expectancy.

If they have a complicated delivery, you know, you know, those are cases that we are investigating. So I'd like to kind of describe how our law firms, evaluate a case and every, every case that comes into my firm. You know, I take the first call to kind of understand how the baby is functioning. Okay. And and to understand, is this a serious injury?

From there, the mother, and the father will be directed to our staff, ObGyn to be able to take the birth history, the prenatal care history, to understand the events as the parents experienced it, to see if the events suggest negligence and and if the events suggest hypoxic brain damage, and if it meets our criteria on the phone. That's when we are executing contracts and getting the the medical records. And we're getting the fetal straps. And then our ObGyn is reviewing, you know, was there a neglige nt delivery or our clients are talking to Experts from the start 

B: Yeah. It's pretty amazing how sometimes talk to folks who have been looking for an answer. Right. This is a very traumatic, obviously traumatic event. And their lives or family's life. Right. And it's really difficult sometimes when folks who are just reaching out trying to find answers, I don't think they necessarily care about litigation, but we get calls from folks who just want answers and sometimes that turns into litigation, sometimes it turns into a lawsuit.

But what, what I have seen is that, kind of almost a sigh of relief when we're able to have folks like that, staff look at the records and then talk to the family and put things together so that so that we can usually, you have the family and it and tell them what we think and what, our, our thoughts are with what has happened and the cause of what has happened.

And sometimes some cases are harder than others to get to those answers. But generally we get an answer in the families. Do give that sigh of relief when they're happy to hear even some bad news, but they're happy to hear that news because it's an age...

 • Why hernia mesh devices fail

 • Mesh erosion, adhesion, nerve pain 

• The latest mesh updates

 •When you may qualify for a lawsuit 

• What a revision surgeon looks for 

• Alternative mesh for patients (P4HB) 

📞 Contact Dr. Vigna for a FREE case review: vignalawgroup.com | 817-809-9023

📞 Contant Ben Martin for a FREE case review: bencmartin.com | 214-761-6614

TRANSCRIPT:

B: I'm Ben C.

V: And I'm Doctor V.

The Medical Legal Guys.

V: I'm Doctor Vigna I'm a physician lawyer. I sue pharmaceutical companies, doctors, hospitals and nursing homes and represent people with catastrophic injuries. And Ben Martin. He's been sueing pharmaceutical companies for 50 years now.

B: 30. 35, 40. Okay, quit saying thirty!

V: So today's topic is about hernia mesh. Hernia mesh has been around for 50 years. What we're referring to as mesh is the plastic material. Poly propylene. And this topic is about a safer alternative design called P4 HB. It's cultured from E.coli and natural occurring bacteria. And some pharmaceutical companies now have the ability to make this material into mesh. The outcomes show are that it works just as good. 

B: Just as good.

V: But complications long term are negligible because the device's been removed naturally. So it's not getting infected.

B: You don't want a hernia mesh infection. Can you imagine? 

V: We know that that this polypropylene is a defective product. We know that it causes chronic inflammation, that it gets infected. It causes bowels that adhere it causes obstruction of bowel. It causes chronic fistulas. When chronic mesh becomes infected, it becomes a hole. The you could have holes that you could put your fist in. I used to take care of those patients and my long term acute care hospital. Dreadful injury, horrible injuries. You know, since 2014, there's been a material that has been, increasingly used called P4HB.

B: What's P4HB?

V: P4HB is a natural polymer or a propylene is a plastic polymer, natural plastic. So that this natural material that's cultured from a bacteria called E.coli, when it's woven in crystallized, the body degrades that material. Over 18 months. They develop a big clob of this. They then crystallize it in and then weave it into a mesh material. And when they use this material, the body naturally grows into the mesh, and then the mesh degrades completely and goes away. And they have found in studies that the strength of repairs is nearly equal to mesh augmentation. And you don't have chronic infections and you don't have you have no more no more mesh. So you're not having mesh related pain reduction in complications. It's been huge.

B: It gives the body time to let the mesh do what it needs to do and get integrated into the body and serve. Is that what would you say mesh serves? 

V: It’s a scaffold. I'd call it a scaffold. Okay. It's something that keeps its structure and tissue grows in, supports that scaffold. And then you take the scaffold away and natural bodies left. The bodies getting rid of the natural

B: You know, most physicians in the United States use mesh in fixing a hernia. That's what occurs. There are several manufacturers of hernia mesh and the physicians have learned to use it. It's easy to put in. It's not it's complicated in some respects.

V: So it's not as complicated. I mean, they don't need others. Yeah. So plastic reconstructive surgeons, they they repair these injuries or hernias without mesh.

B: Whats a hernia?

V: Hernia is, is where there is a defect in the abdominal wall that keeps your intestines and other bits, your organs in the viscous or in the abdomen within its cavity. So when there is a break in the tissue that happens in the groin or by the navel or the belly button, or at a surgical scar site where they had to do a previous operation, like taking out a gallbladder, that you get a hernia through those areas. This P4, hb it cures the problem and then it's gone after 18 months.

B: Did you know that there is a group, hospital in Toronto that does non mesh hernia surgery? You heard that. 

V: One after another.

B: I have a neighbor who went there, and had hernia surgery, a year or so ago, a wonderful result. Reason he went I live in Dallas. Reason he went to to, Toronto was because he didn't want any of that mesh in his body. This is a polypropylene and poly, sometimes polyester substance that's put in the body. And actually, the old time way of repairing a hernia is the type of way they're doing it in Toronto with improvements. Right? So they're not using a foreign body. They're not using a foreign substance. They're not using plastic. I don't even have implant plastic in a patient in order to fix the problem. So that's why people are flocking to, Toronto.

V: And they do good work. So, you know, so there's a complication from hernia mesh where the device gets infected and, and, or there's a complication and there's bacterial spillage because it might involve bowel and and the results are terrible. I mean, I've taken care of dozens of people with gigantic wounds that would have to have a feeding tube or IV nutrition, antibiotics, long term wound care to allow that wound to grow in. And then they would, once it was clean of infection, they would try closing it with another mesh, or we'd have an abdominal plastic surgeon see if they could reconstruct. So anyways, with this P for B mesh, they're able to at the time of the complication Ben And they don't have to have the second procedure. And what they're the results are it works. And secondary complications are much less because you don't have mesh in there anymore. Okay. So people are getting these two stage procedures when you really get fix with P4, HB and then they're getting mesh put in again, and then that mesh gets infected and you're back to square one.

B: There's another problem with that second sometimes third and four surgeries to.

V: Patients don't get there.

B: Fix the mesh problem I'll tell you exactly what. An additional and it's serious problem is that whenever you're in the gut, the abdomen, and you're doing surgery like that, right, then you create scar tissue, integrates itself into the abdomen, and then if you have to go back in and do another surgery, a lot of times doctors will have to revise those regardless.

V: But if you’re putting in mesh, that's a it's like a scar tissue machine. It just builds scar tissue forever.

B: Every time you have to go into the abdomen and do another surgery, you have a greater degree of risk of of problems happening because you've got that scar tissue pulling against itself and pulling against the abdominal tissues and creating. One of the worst things that can create is a bowel obstruction. And a bowel obstruction is a. You ever heard of a strangulated bowel? That's bowel obstruction. And then that can be caused by all of the scar tissue developing from all of these surgeries. So if you have a surgery and the mesh goes bad, they're taking out that mesh, possibly putting some more in. And whatever they're doing is creating another sort of it creates more scar tissue.

V: It's it's just a big mess. So but we're really looking closely at the complications of mesh that are compounded because doctors are not providing P 4 HB. And these people, then they have secondary complications from the subsequent hernia mesh. So so we're looking at this both against the manufacturer and in a combo case because I mean I don't know why the doctor is not using P 4 HB when clearly the the data and all the literature is pointing that this is a superior prosthesis or implant.

B: Or what it's called legally in my business is a safer alternative, safer alternative design, a safer alternative device, which, which means just what it is. It's it's safer than the product that we're sueing on.

V: Yeah. So P4, HB it's manufactured asphasic mesh, but I think there might be other types of P4 HB out there. I know they're starting. They've used it on for slings and stress urinary incontinence. So so I think P4 HB is is going to replace polypropylene.

B: What about the polyester message that caused similar problems to the polypropylene. Yeah it's all plastic. It's all bad. And the other thing you do is you create scar tissue. And every time you go in and create scar tissue it creates more scar tissue. And so it's kind of a vicious circle.

V: The vicious circle is brutal because you're often having to wait three, four, five weeks for that, that initial damage where you have been cut open and cut out, dead mesh, well, dead dead tissue that's adherent to mesh, that's in fact, did you wait 3 to 4 weeks to let that granulation while you're in the hospital getting I.V. antibiotics and you're getting your wound packed? It's brutal. Okay, so so we represent those who have been implanted by mesh when against the manufacturers. And we are representing people who, instead of being having been offered this superior graft, have suffered serious early complications from that graft against the doctors who are not going to the safer alternative design.

B: Safer alternative design, safer alternative, important in our business because what we like to do and you don't have to do this in every case. But but what we, what we do is when we take a case, we look to see if there's a safer alternative to what they're doing, which people do have problems with in Ariat. It's a problematic thing, right? It's, I'll let the doctor talk for decades.

V: I mean, so we are looking at seriously injured people who were candidates for a safer material, but we're also obviously suing the manufacturers who continue to sell these defective devices and for the harm these devices have caused.

B: And the harm can be serious. It can be deadly. 

V: You could put your fist in these in these. They're they're gigantic. And I mean big cavities where they've had to take out mesh. It's just a miserable, serious medical problem that can be avoided.

B: So it's miserable when they're having to go through that at time. But it also can remain miserable. Some of these people have lifelong problems and it's all because of the defects in the products. And there there are two types of mesh product that generally we see. And that is and I'm talking about in the synthetic mesh industry that's polypropylene and polyester, two types of mesh. One is multi filament and one is monofilament. And what these things do they are plastic right. You remember mesh is a plastic. So every time someone has mesh put in their body they're having plastic put in their body.

V: And it stays in your body and it causes chronic inflammation. And if that mesh gets infected, thus those infections can be serious because the antibiotics can't get into the mesh to treat.

B: That's right. That bacteria on a mesh product, and implanted product like that, that bacteria goes for that mesh. And so it's a mesh lover.

V: So, so, so when you think about the safer alternative design of aphasic or P 4 HB, the material provides the support to allow for healing, and it continues to heal as the the scaffold is then disintegrated by the body. So these chronic complications that could be painful, that can be chronic pain from the mesh, the chronic inflammation, it's gone.

B: What we do is we represent folks who have been injured by medical devices and other products, and then we follow all suits and we try cases. 

What the new IFU and clinical data reveal about the Altis Mini Sling from Coloplast. 

Common complications: mesh exposure, pelvic pain, urinary retention, pudendal neuralgia, obturator neuralgia and more 

If you or a loved one has experienced complications after an Altis or other mesh sling implant, we are here for you. Our team can help you understand your medical records, rights, and options.

 📞 Contact Greg Vigna, M.D., J.D.

 ➡️ Visit: www.vignalawgroup.com

 ➡️ Email: info@vignalawgroup.com 

➡️ Call: (817) 809-9023 for a FREE case review 
 

TRANSCRIPT:

B: I'm Ben C.

V: I'm Doctor V, the medical legal guys! 

B: Casual version today. 

V: Today we're going to be talking about instructions for use and in particular room be talking about instructions for use of the Altis Mini sling produced by coloplast 

B: Called a package insert.

V: What is a package insert?

B: When you go to the doctor and you have a surgery performed on you and a medical device is placed inside your body or on your body with it, according to FDA regulations. An IFU or a product, insert a basically a pamphlet, right is put in the box or in the container of whatever device is being put in, right by law that has to occur. And then the doctors who implant these devices, they have to look they have to read the IFU instructions for use. Instructions for use contain things like the actual instructions on how to put the product in, what to avoid. Then it has precautions. It might have warnings right? In each of these things have different value, so to speak.

In different categories of things that they actually use. Right. So so one for instructions, one for how to put it in, one for how to board, one for warnings. One for caution. But the bottom line it's it's to tell the doctor about the important things regarding the product. So when the doctor is having his conversation or her conversation with the patient, then that doctor must inform the patient of the important things.

The important risk of placement for product and the benefits. Right? So, every placement of device involves risk versus benefit, okay. And the discussion that the doctor has with the patient is called a risk benefit discussion. But it's all about what are the risks and the benefit. Right. So if the importance of the instructions for use that if a physician doesn't know what the risks are of a device and the placement of a device, then the physician can't tell. The patient can’t inform the patient and cannot have that informed consent discussion we talked about a minute ago. So it's really important. Maybe one of the most important things, maybe more important than the device itself, are the instructions for use. Right. So because if you don't have a warning listed for a complication and that complication occurs and that complications is related to the placement or the use of the device or the device itself, that's a real problem because the patient must have proper informed consent.

And then form consent comes first from the manufacturer. The chain so to speak is manufacturer informs the doctor and the doctor informs the patient. I'll also say this that nowadays you need used to not be like this, but nowadays the patient gets information directly from the manufacturer, not just from the doctor. What the doctor gets from the manufacturer. The patient gets information off the television set as they used to call them, or streaming devices. The patient will hear all of these things that the manufacturer needs to tell it before it can put a commercial on television, right. So that's when you hear all of these risks at about 100 miles an hour.

V: The thing is, though, with instructions for use, is, is that they must tell the doctor what is material in terms of risks. That could be frequency in that could be severity. So in this list Ben this device the all this mini slang can cause peudnendial neuralgia which is a separate diagnosis. The government recognizes that it's a disabling diagnosis or treatment protocols injections, local therapy, different types of medications, stimulators, implantable devices for this diagnosis and that diagnosis is not listed on this document. This is the instructions for use from Colo Plast. And it doesn't include obturator neuralgia, which has similar disabling pain, stabbing and burning. So it doesn't mention two conditions to medical diagnosis that are the most severe. But they mention everything else.

B: What you're saying is, and we've talked about it before, on this podcast, but, there are two conditions, that are extraordinarily, bad that can result from the implantation of an altis device, right, the pudendial nerve is in the distribution of a saddle, if I'm not mistaken. Right, Greg? Absolutely right. And an opterator nerve is in the region, but not particularly in the same location. It innervates the inner leg thigh and hip And these two conditions are the one we hear of about most. And the one that probably occurs most is pudental neuralgia. And what happens with pudential neuralgia? 

V: Women have catastrophic pain that they can't have sexual relations. They have limited sitting. Any kind of touching there is is they normal touch becomes burning. So it's a severe injury and it requires nerve blocks to women's life expectancy when they're going to die. And and it requires muscle injections sometimes stimulators. So it's a diagnosis and it really is kind of a buzzword. When people see for pudendial neuralgia or obturator neuralgia, it could trigger a doctor who might not know what that is when they read the instructions for use. But a doctor might not know about this. They should read about it. And that's why it should be listed in the IFU 

B: That's a good point. Actually hadn't thought about that aspect of it, but that's a reason why the instructions for use have to have a warning about the specific condition, especially if it's a severe and debilitating condition. Pudendal neuralgia itself, the name is it speaks to severe injury, serious serious bodily harm. Right. And so what needs to be outlined in this instruction is pudendal neuralgia. Because we all know now that the altis causes pudendal neuralgia. 

V: So obviously we we believe that doctors should have this information of pudendal an obturator neuralgia a losing intimate relations where it's not even possible needs to be on this IFU and people with who are diagnosed with prudential neuralgia and doctors who see patients come in with the diagnosis of pudendal neuralgia, most of those women aren't having any type of reasonable intimate relations. These women have to go to physical therapy to even attempt sexual intercourse pudendal neuralgia and pudendal neuralgia. That needs to be and by an IFU Everyone knows that obturator neuralgia needs to be in the IFU , everyone knows that. So another disappointing aspect of of coloplast IFU that we think any reasonable manufacturer would have in their instructions for use is is that they did a 522 study after this just within the past. 

B: Tell us what a 522 study is Dr. V

V: A 522 study is one that FDA orders them to provide safety and efficacy because they feel like the device from a literature standpoint and a safety standpoint, has not been proven.

B: The truth of the matter is, in the 510 K process, where, where you got another product that is supposedly similar, substantially similar to the one they want to put on the market, as long as the substantially similar device, the first one has gone through the process of the analysis and, and all of the testing and all of the studies and stuff that get it to the point where the FDA says it's a safe and effective drug or device. All you have to show is that this device is substantially similar in its safety and effectiveness. As the prior device, and that's the same type device. Now, what's interesting is now, wait, the regulations are a manufacturer of a new device. It as long as any previous device, whether it's the device that was tested for safety or not, is on the market.

And you can point to that previous existing device as being substantially similar to the new one when we're up on the market, long as substantially similar, you can put the new one on the market, and even if the prior device has not been tested for safety.

V: Never guess what the all this device, their predicate or their device that they relied on was the just and there just isn't on the market at this point

B: Okay, that's that's a perfect example. Doctor V of a problem with the system and the problem with the system that a manufacturer of it wants to exploit. Right. Of course, I want to talk about these two trials, device related and a procedure related. So the device if any part of the device, anything about the device is the cause of the complication and only the cause of the complication. That is a device related application. And then you have a procedure related complication. I would say it like this didn't matter what kind of mesh you put in or what product or what brand you put in, it could even be a different product. If the surgery itself, the procedure itself, caused the problem, then that's a procedure related device.

V: Again, the the responsibility of a company is to inform the doctor of material risk. And material risk is how this device is different than the other devices on the market. And and coloplast does something pretty sly. And there are instructions for you said that they aren't telling doctors that this device causes unusual leg pain, which they're one of their own studies show the 522 study that this device causes two and a half times the risk of dyspareunia, compared to other devices that are on the market. 

The 522 study is is is critical. Okay. The government told coloplast that they need to provide this data, okay. And they identified this pain and that pain. They said in that article, we don't know what they told FDA was from positioning, which doesn't make sense because both groups have the same position.

This device causes pain. Okay. It causes leg pain. It causes this Bruni a two and a half times more. It causes dspeurunia, pudendal and obturator neuralgia. You will never see pudendal and obturator neuralgia in the IFU, you'll be waving this around in the trial in the courtroom. It's not there. You're going to be showing them that coloplast reports all this pain procedure related or or device related. They just combine them and they list all of them so that no doctor can tell, wow, this thing and this thing is a device related complication, that they include them all and in a picture. But then in small print, we say device related events include voiding dysfunction, urinary retention. Those are normal.

Those are device related complication. See what they call procedure related everything that includes pain. This company is saying it's procedural related. They don't include it as device in this document they wrote in the study. One line saying that this was due to positioning. It's the same procedure this group, their legs are up there, they're under anesthesia. They're getting basically the same procedure. They added this lying there ben and our discovery we have subpoenas out and our discovery is who was responsible for that lying I want to know who made that opinion and who put that in that article because it's ludicrous. They're the same procedure, the positioning of the patients is the same. 14 women on this group. Zero. And the other group. IFU is saying this is all procedural related. The position is the same, right? 

You know, this document is is killing me because it doesn't say prudential on obturator neuralgia. It doesn't talk about procedural, the product related problems with this device that causes pain. And it's been proven in this, subsequent randomized controlled study that women should not be getting this device. And it is a terrible device. 

For listeners who have a loved one suffering from bedsores, contact Dr. Greg Vigna at (817) 809-9023 or visit vignalawgroup.com.

TRANSCRIPT:

Welcome to justice with doctor V. I am a doctor and a lawyer. I have a national litigation practice and represent those who have suffered catastrophic injuries. Today's episode we're going to be talking about:

Kennedy ulcers, a major point of confusion in patient care. The difference between a true end of life skin change and a preventable pressure injury that gets mislabeled as a Kennedy ulcer. We talk about how facilities use this label to avoid accountability. What actually causes these wounds, and how families can understand when it's a natural part of dying versus when it's the result of neglect. 

I've been in this litigation for over a decade, and these are serious injuries.

Before we go into the term, Kennedy ulcer, could you give me a backstory on what a bedsore generally is? 

We have bedsores caused by nursing, not turning people. But there is also something called the restraint related bedsores that we have clients who were agitated and were restrained into the bed so that they could not walk because they might fall or cause problems down the hallway, that they were restrained and develop the bedsores. That's a bad injury because the government causes injuries from a restraint and never event bedsores.

Stage three and stage four is never event. So in other words, we have clients who we represent who have two never events serious injury caused by restraint and a bedsores because the restraint was preventing these our clients from moving. So the restraint was basically pinning them down, developing the saw on there. That's a serious injury. And talk about the distress that our client would have to endure while he's being strapped to a surface. And that drainage is causing the pressure. 

And how severe can bedsores like this be? 

Yeah. We represent clients who have lost limbs because of restraint. We represent a client who we allege had a wrist restraint and lost blood flow to the hand and lost their arm. We have clients who have been restrained and into bed and develop a heel sore because they're trying to move, but they're restrain. They press their heel against the bed and and develop a pressure ulcer to the heel. 

How is this preventable or what is the treatment plan for when stuff like this does happen? 

A doctor's role in in bed sore management? First of all, if you're in a hospital and you're a doctor and you're the attending and you get notified that there is a bed sore at the hospital, cause you need to examine that bed sore and and make sure that patient is safe from further injury. If it's a serious bed sore where there's dead tissue that attending doctor should console plastic surgeon or general surgeon if there's area of dead tissue that may needed debridement.

We have clients who develop dead areas on their body and they get sent to a nursing home before the dead tissue is cut off and that becomes infected, smelly, chronic infection in the bone. And that hospital just discharge that patient to a nursing home. That's an unsafe discharge. The standard of care is pretty well decided that people who developed serious bedsores, they should have access to a doctor who can direct them to surgical management versus conservative management.

If you have a serious injury, you need a doctor who can have access both treatments and discuss risks versus benefits of both. If you don't have the capable of operating on that person for cure, these things go bad often with people who have serious bedsores, and you hope that wound care will slowly allow the body to heal in. That could take a year, year and a half, and during this time, these patients become malnourished, they become septic, they get admitted with septic shock. We know that 17% of people who have a stage four bed sore with a bone infection, they die at one year. 44% are readmitted. If there's a hospital cause bed sore, that patient needs access to a doctor who can help.

We are suing hospitals for failure to prevent and failure to treat. If they discharge that person to a nursing home that does not have the capabilities for a plastic surgeon, that's an unsafe discharge. We're suing doctors and hospitals for at these harms. 

If a patient does receive a stage four bedsores, what are the next steps in treatment? 

So again, I ran a flat program when I practice medicine. And a person who was admitted with a stage four bed sore with osteomyelitis, we would put them on a clinic run bed. Maybe that we would order labs to see what their nutrition is. If they're malnourished, we might have to include a feeding tube, allow for proper nutrition to allow for wound healing.

Treatment is very easy for these bed sores. It doesn't take Harvard plastic surgeon. It's reliable pressure relief either on a clinic run bed or with nurses providing reliable pressure relief, nutritional support, surgical debridement of the dead tissue, wound care and when that wound sufficiently is closing in and you see the body healing, you can provide a flap with the plastic surgeon to rotate muscle over that hole. The redundancy skin. You close these wounds with I.V. antibiotics, secure that underlying infection that's generally always present, and you flap these patient patients who don't want to flap, which is not unusual in the elderly population. You tell them the risk of non flap versus conservative measures. And you then provided conservative measures wound care nutritional support. But what you don't do is send that person to a nursing home that doesn't have access to a plastic surgeon.

You need you need to be refer people, people who are injured with stage A deep stage three. Stage four. Bedsores really just needs a doctor who has the capabilities to fix these wounds surgically with flaps, or provide conservative wound care because the patient really doesn't want a flap. Surgical flap closure of of serious bed sores is really the standard of care. 

Now that you've given some background, why do facilities like nursing homes use the term Kennedy ulcer connected it to bed sores? 

It's unfortunate, even today, that nursing homes are telling patients families that their loved one has developed. The Kennedy and Kennedy ulcers means that there is imminent death ahead because of the presence of a sore, and that sore is a hallmark sign that a person is nearing their death. Kennedy. Ulcers don't really exist, that pressure ulcers are pressure ulcers.

The reason why they're calling it a Kennedy ulcer is that bed sores caused death, and they're saying this is a Kennedy ulcer, that it appeared because the person is supposed to. It is a myth, this nursing home where there was a nurse named Kennedy, she reported all of these patients who develop these sores near their death, and they wrote it up. Those patients would become patients at my rehab hospital. And I would then save those patients. If we got a lot of people with stage three, stage four bedsores from nursing homes, if they didn't get to my hospital where we had plastic surgeons to fix them. Yes, that bedsores would kill that person going forward. And there are still nursing homes that are telling patients, families that there's a Kennedy Olson, and we need to bring in hospice.

Where did the term Kennedy ulcer come into play? 

Yeah, Kennedy ulcers in the late 1990s, is a term that indicates a serious ulceration in the skin that looks just like a pressure ulcer that occurs spontaneously just prior to death. That was described in a nursing home. And they describe dozens of patients who this developed in what that nursing home was, was a unsafe nursing home that wasn't providing reliable pressure relief.

And these patients develop bedsores and then they die. That term is still alive. I don't know how it's alive because they can't offer any kind of reliable mechanism on how that would occur. And it's mythical and it's a lie. They'll have a nurse expert and a defense expert testify to that, and we will cross them very hard that then died. They believe that those sores that looked just like bed sores occurred spontaneously.

For families that do have members that are in these nursing homes, what do they need to know about Kennedy Ulcers?

First, if you've been told that your loved one has a Kennedy ulcer and are near death, that means that your loved one is not safe, that your loved one needs to be in a hospital. Number two, I hope you give me a call because we cross that nursing home hard and find out who and that nursing home is pushing for this diagnosis to be told to families of injured people. We're going to do discovery and we are, if punitive, are allowed by law, we're going to be after punitive damages. Kennedy ulcer is a mythical term, and we will, cross whoever brings that diagnosis.

So how is the term Kennedy ulcer used to avoid responsibility in these facilities?

Well, I think nursing homes use this term Kennedy ulcer, hoping that the family will go online to learn what they are or understand the seriousness of pressure ulcers. That's how they try and avoid a lawsuit, because they don't want to tell the families that they didn't turn their loved one, and now their loved one has a dead piece of flesh on their body that needs surgical debridement and can cause chronic infections and lead to septic shock. And they're trying to push this patient who they injured to hospice. 

If your family member developed a severe bed sore while under medical care, you may have legal rights. Early intervention can prevent infection, sepsis, amputation, or wrongful death. 

📞 If your loved one has suffered from untreated or severe bed sores, visit VignaLawGroup.com for more information. FREE CASE REVIEWS at https://vignalawgroup.com/contact/ 

TRANSCRIPT:

B: I want to get a little bit even more granular, right. So what is a bed sore? 

V: A bed sore is a area of dead tissue caused by pressure. So the muscle dies first. If a person is not reliably turned. If the muscle dies, then the skin will die because it loses its its blood supply, which comes from the muscle. And over 2 to 4 weeks time, that skin will become dead. And eventually you could put your fist and or two fingers into the wound because it's a serious injury. 

V: Good morning. I'm a doctor. Vigna I'm here with Ben Martin, and we're going to talk about bed sores. So, Ben, you've sued on pretty much any type of serious personal injury. Pharmaceutical injury, medical malpractice, 18 Wheeler injuries, paraplegia. What is it about bed sores? You know, you you have a lot of bed sore clients. So tell us why you're in this litigation.

B: I've represented people for many, many years, decades who have had experience with a bed sore. Right. But at some point it was happening so often that it just to me, was becoming an epidemic. And so then I looked at the specifics of why is this happening? You know, so we we got involved together and looking at bed sore cases, in you from the medical aspect of it and both of it from the legal aspect of it. And, and it really did seem to me that it was becoming an epidemic. I hadn't remember bedsores being such a problem 20 years ago, 30 years ago. Why is it becoming such a problem now? Tons of people, many people are getting these these bed sores in hospitals, in nursing homes. 

V: They're supposed to be safe places.

B: It makes no sense to me.

V: All bed sores are bad injuries. And stage three, stage four, they're all preventable. And someone is making a profit on providing bad care. 

B: Right

V: What's your thoughts on hospital acquired bedsores? 

B: Okay. So that's that's really what got me back into looking at bed sores in bedsore cases across the country, because I was really shocked that hospitals were over and over again causing these bed sores. 

V: Tell us about Never events and what that means to a lawyer and prosecuting a case.

B: So there's a specific meaning for the term never event and never event. And you can you can correct me on this, Greg, because you're, you're as much of an expert or more than I am. 

V: I'm more of an expert than you are.

B: I see never event is something that that, Medicare and the federal government say, oh, we're not going to pay for anything related to a bed sore once. Once you create a bed sore your hospital, you create a bed sore. We ain't paying for it because it's a never event. It should never happen. 

V: And am I right? Yeah, exactly. And they go one step farther that it tends to indicate that the quality of care is bad. And if a hospital causes a bed sore, whatever care that bed sore required in that hospital going forward, they would be responsible for that cost. But that doesn't prevent a hospital to simply discharge that person who they seriously injured to a nursing home or another hospital, and they won't get billed with it. So what's your thoughts on that? 

B: So that's that's another tragedy that we've seen that occurs is that a hospital will create this never event. Right. It's never supposed to happen. You're never supposed to a patient should never have a bed sore, should never develop a bed sore in a hospital. In the reason is that they're always preventable. So I'm going to interrupt.

V: Theres one tiny little sliver that may contribute substantially to bed sores, but I have never seen seen that one has eyes. If a person has septic shock and have profound hypertension, that that they can't support their own blood pressure, their can be the development of pressure because the person just can't supply their their tissues. When I've been in that situation that patients are profoundly sick and they can't be turned, and, you know, I put them on a clinic trolley and I've never seen this entity. But but it's described in the literature and, and it there's sustained and ongoing hypertension that may be causative. And and you know, that's why we have experts involved in each case to understand how this occurred. 

B: So I'm understanding. So I'm understanding from your perspective, Greg, as a doctor. And by the way, you've treated what hundreds of patients who are, who are in a hospital setting that have developed bedsores.

V: Where they were transferred to my hospital to fix the bed sore because I created a program, a flat program. And so we were getting patients from 500 miles away from hospitals, nursing homes, home health who had serious bedsores and they were either going to be at high risk of death from sepsis or make it to my hospital for closure. 

B: Back to the question of the bed sores in hospital related bed sores. I would say rare situation where you've got hypertension that's, in this case, massively low blood pressure that occurs as a result of sepsis. That may be something that could be argued isn't preventable. Right. But in the vast majority of cases, a bed sore a decubitus ulcer it's also a pressure wound is completely preventable. And it's preventable through good care, through the standard of care in a hospital. And that's turning people right. Can you can you explain that, how that all occurs? How are bedsores prevented? 

V: Prevention of any patient who is dependent on others because of illness or injury require manual repositioning to change their side. If they're laying on their back after two hours before two hours, they need to be turned on the side. Two hours later, they could be turned back on their back or the other hip. And that skin observed, it's just routine nursing care, okay, that that all nurses are taught every hospital will have ongoing should have ongoing education of nursing. Every hospital should be monitored turning, monitoring their occurrence of bed sores, ongoing education. But we're seeing hospitals now and we're seeing nursing homes being bought by private equity. We're hospitals are hedge funds, hedge funds, hedge funds. Yeah. Private equity is buying community hospitals for profit. They are taking the profit instead of reinvesting in the education of nurses and nurses aides and people are getting bedsores. And it's what they consider the price of business. So so we're suing a lot of hospitals that are owned by private equity. Now. 

B: Here's my question. How does a bed store develop and why does it develop and get into the minutia if you need to of of of how it affects the circulation and how pressure affects. Did you explain all that stuff?

V: Yeah, I got it. So say you are lying on your back and you are not moving, okay? Because you're sedated on a ventilator and you're laying on your back. So you have your sacral bone and the skin compressing because of gravity and pressure from the bed. The muscle, the muscle is under the skin in between the bone and the muscle gets pressed. When the muscle is getting pressed or pressure on that muscle, it prevents blood flow. And if you if it prevents blood flow for too long, the cells lose their oxygen supply and that cell on an individual basis will die. And if there's a lot of cells, then you are losing tissue. You're losing muscle. And over 2 to 4 weeks that muscle will die, liquefy, and there will be an appearance of a dead tissue on the skin where all the skin will turn black. The the muscles get underneath it and it goes all the way to bone. That is a bed sore. That's a stage four bed sores and that's a serious injury. So we have clients who develop up these dead areas of their skin, big areas on their sacrum, which is on top of the buttock or on their hip or on their heels. And the hospitals are just simply discharging them to a nursing home without a formal plan for getting them to cure.

B: Okay. So and that's what I still don't understand. What is the motivation of a hospital? Having a patient with a bed sore, probably created by the hospital and then discharging the patient to a nursing home without any plan of care. And I'm talking about a patient that may or may not have even been to a nursing home patient in the first place. In other words, someone who walks into the hospital, it lives it home, lives in assisted care and and then all of a sudden develops, bed sores and a hospital then is sent to a nursing home. How does that happen? 

V: The conduct is is appalling and unconscionable that hospitals are sending people to a lower level of care where there is not a pathway to cure. They're getting the patient who they injure off their books because because insurance companies will force them to pay for that cost if that patient stays at their hospital and gets care. So these hospitals, hospitals have a lot of different doctors. They have plastic surgeons, they have general surgeons, they have infectious disease doctors, they have internal medicine. Doctors have orthopedic doctors, all of which are sometimes needed to treat a complex wound. And they're discharging patients to other hospitals that might not have the staff do not have the program to to fix these wounds, or they're sending them to a nursing home where they rarely will even see a doctor with a dead piece of flesh on their body to get infected, to develop septic shock. It's unconscionable. There's no other explanation.

B: So what's the I mean, when a hospital sends a patient to a lower level of care, they've got an ongoing bed sore, so it hasn't been fixed. What is expected to happen to the patient? 

V: It's miserable. Okay. These these patients are miserable. They have big wounds. They're confined to bed now because they can't see if you have a bed sore on your butt, it's hard to sit on your butt. Okay. And so you're basically in bed turning side to side. And you're getting wound care with hopes that the wound will, over time, grow in. For that to happen, a lot of good things have to happen 44% of the time. When you have a stage four bed sores or down to bone that's infected, that patient is going to be admitted back to the acute care hospital with sepsis. 

B: 44%

V: 17% of those people who are discharged without a flap die. All conservative care, whatever it is, is associated with a 17% risk of death compared to flap surgery. Flap surgery. Every plastic surgeon in their residency knows how to do flap surgery. It's not that it's not that hard. It would be hard for me to do. But plastic surgeons, that's what they do. That's what they're trained to do. And hospitals are discharging patients that they could fix that they caused injury to a lower level of care. 

B: Explain what a flap surgery is. 

V: Yeah. So the way you treat a bed sore when you have a big, big area of dead tissue on a person's, but that is black, you have to get the dead tissue off. Okay. You have, that dead tissue is going to start getting infected. It will get, malodorous. And what does that mean, malodorous? Just a nasty smell. Okay. It's horrible. Okay, well.

B: What causes a bed sore of to bring forth a nasty smell? I hate to give you a specific.

V: But it's infected with staph. It's infected with gram negative bacteria. So these wounds have to be the treated. You have to have reliable pressure relief. You could, put them on a $60,000, clinic bed. That will make it so that there's absolutely no ongoing pressure that that person will suffer from. 

B: If they if that occurs, if all of that occurs, can a person get better? 

V: Yes. If a person has reliable pressure relief and the wound is cleaned out, debris and there's no infection and there's adequate nutrition, wounds can grow in over time. Okay. But that could take months. And sometimes over a year. And you have to have perfect care and not get infected during that time. So the standard of care ever since I've been practicing has been to flap these patients. And that is you bring in a plastic surgeon, they move muscle that's next to the wound over that. There's redundant skin and that wound becomes closed. You have a drain there that you keep in place for, a couple of weeks and that wound becomes healed. So in four weeks after a flap, these patients are generally up in the chair involved in rehab. Okay. Trying to get better now. So I'm a spinal cord injury doctor. Okay. So I've taken care of spinal cord patients my whole life, and I'm in this, I'm in this small rural hospital, that I developed the flap program in northern Louisiana, and I was referred a bed sore case from a New Orleans, a major teaching hospital in New Orleans on a African American who developed a pressure ulcer right after injury. And they were trying to rehab him. You know, they had him going through rehab with the bed sores on his butt, that's impossible if you don't have legs and can't walk and you have a big old sore on your butt, how are you supposed to learn how to transfer from bed to chair, chair to toilet? If if you have a dressing on your butt and you have to do pressure relief, it's a it's a set up for failure. So this patient got referred to me, my hospital, and they wasted 4 to 6 weeks doing rehab on a spinal cord. Patient who couldn't be rehabbed. And so he comes to my hospital and and he's expecting wound care. And I'm like, you know, I recommend that that we close this wound. Okay. We fix this wound and then rehab. You okay? Because he needed more rehab to get what happened, and, well, we fixed him and he left the hospital as an independent, paraplegic man who able to take care of himself without a wound. He didn't have to go home with home health, go side to side. It's kind of common sense, isn't it? You fix the wound and that's the standard of care. It's been the standard of care. And now since 2023, the national guidelines say that these wounds should be closed to finally.

B: Okay, I want to get a little bit even more granular. Right. So what is a bed sore? 

V: A bed sore is a area of dead tissue caused by pressure. So the muscle dies first. If a person is not reliably turned, if the muscle dies, then the skin will die because it loses its its blood supply, which comes from the muscle. And over 2 to 4 weeks time, that skin will become dead. And eventually you could put your fist and or two fingers into the wound because it's a serious injury. 

B: Are there different names that, medicine uses for a bed sores?

V: Well, bed sores are called bed sores, decubitus ulcer pressure injuries. They're all the same thing. Pressure. Yeah. They're all and and we call them never events okay. And and it indicates that nursing care was bad. If there's bad bedside care, then there's other problems in that hospital that are likely. Because what happens at bedside is by far the most important thing that occurs with a patient. Because if a patient's not being turned, that means that nurses are not going in there to assess the patient. If they're not being assessed, then doctors aren't being notified of medical changes. So that's it. It's usually the tip of the iceberg. 

B: What type of patient would be subject to development of a bed sore? Like, let me ask you this question. Someone who walk into a hospital and they're there for a surgery, that they're a young, healthy person, they're going to be in the hospital for, a couple of days and be released. Are you expecting that that patient might become subject to a bed sore? 

V: Any patient who, because of illness or injury, has a period of time. Generally, it could be as little as a day that they can't provide their own turns. They need to be turned because bed sores can can occur. We have serious bed sores on patients who go in for elective knee surgery, for knee replacements, surgery, okay that they walk into the hospital, they have knee replacement surgery, they have a difficult rehab. And and because of pain, because of other complicating factors aren't able to turn and we have a wrongful death in Texas on on a knee replacement, a patient and an elderly person who got a bed sore, you know, so this happens to anyone because of illness or injury who cannot turn themselves. So I'm a rehab doctor. I take care of spinal cord patients. I take care of brain injured patients. I take care of people with amputations, catastrophic orthopedic injuries, people who have heart attack strokes. My whole population was at risk for bedsores. So in terms of prevention monitoring, we were on okay. So during my clinical practice, there were two patients of mine who developed bedsores that required surgery and surgical intervention to cure. And in both of those those patients, I did not allow them to be discharged until I figured out a path to get them fixed. And I found a surgeon in the community to help me. And I kept that patient in my hospital, and I had them fixed and then ultimately developed flat programs after that so they can occur. It's usually it happens when nurses aren't doing their jobs and, you know, but certainly in those situations, people were held accountable for their failures.

B: What about physician liability? Just just meaning so so when I say liability, I'm asking, what about a physician's responsibility for a bed store or the physician's ever responsible. 

V: Yes. So in terms of there's there's two parts. So in terms of causing a bed sore, you know, generally that's in the indicative of nursing care because that's the doctors aren't they're turning a patient. Okay. But we are seeing hospitals and in nursing homes where a person is developing a bed sore and a doctor is notified, and the doctor never actually looks at the wound and is deferring treatment to the nursing staff. If you are the attending doctor, you need to look at that wound, you need to stage that wound, and you need to make sure that patient is safe. We're seeing hospitals who now own or employ hospitalist, you know, so a hospital causes a bed sore. They're hospitalist who they employ doesn't assess the wound. They provide ineffective care. And then that hospitalist signs the discharge order, having them go to a lower level of care. We're suing those doctors, their employer, which is the hospital, the nurses in the hospital. So there's failure to prevent and the failure to treat. And then there's the unsafe discharge. Brutal story end.

B: Brutal.

V: So if you've suffered a bed sore, you know, we we are prosecuting these cases across the country. But we have experts, you know, plastic surgeons, general surgeons, orthopedic surgeons, nursing home administrators, hospital administrators, infectious disease doctors, nurses and nursing experts. And and so we're prosecuting these cases across the country. 
 

For listeners who have developed a meningioma after using Depo-Provera for at least one year, contact Dr. Greg Vigna at (817) 809-9023 or visit vignalawgroup.com.

TRANSCRIPT:

B: 85% of the population of users. Depo-Provera are minority women, largely African-American. The association of Depo-Provera and meningioma is a type of brain tumor, a serious, serious condition. 

V: I'm Doctor Vigna I'm a doctor and a lawyer. I sue pharmaceutical companies. And I'm here with Ben Martin. Ben has been suing pharmaceutical companies ever since I was in residency. Oh. Time ago. Tell us about it then. 

B: So my name is Ben Martin. I'm a lawyer in Dallas, Texas, but we practice law, file cases, and, sue people all over the country. And I've been at it for close to 40 years now, and I've been doing pharma litigation for about 30 of those 40 years.

V: What interests you about Depo-Provera and meningiomas what about that? 

B: So last year, out of the British Medical Journal, I think it was March. Greg. We had, note that there was a British Medical Journal article about the association of Depo-Provera and meningioma. Meningioma is a type of brain tumor.

V: It's a serious medical condition. Generally requires brain surgery. It's a serious medical problem. Tell us about it. 

B: So? So last year, March of last year, British Medical Journal came out with an article that showed an association stronger than its association. And I'll explain that in a minute. An association between Depo-Provera and injectable birth control progesterone product given once every three months to women. And, there's an association it found between those injections and meningioma, which is a type of brain tumor, usually benign. But don't let that word fool you. It's a serious, serious condition. So for every 100,000 women, general population, first general population, nine women are going to have a meningioma. Just they're they're going to get it. You're going to get them an meningioma with Depo-Provera. You multiply that by 5.5 to get real specific to about 52 or 53 women out of those, 100,000, if they've taken Depo-Provera, will have this brain tumor called a meningioma. It's a very specific type of brain tumor, and it is, benign. They say when a woman has a meningioma, usually the methodology of treating it is to do brain surgery. Greg, do you want to explain the surgery that goes along with, meningioma treatment?

V: Yeah. So the brain surgery really depends on where the tumor is. Okay. There's some places in the brain that a neurosurgeon can get to relatively easy. Okay? Believe me, if I was having any brain surgery myself, I'd be kind of scared. Okay? Just because it's scary. Okay. And and but it really goes to where the tumor is. And there are some locations that, are in tight spaces hard to get to where, where, these tumors are difficult to take out. And sometimes they're an respectable. So, women will have to have radiation.

B: What does that mean, unresectable.

V: Unresectable means that the doctor believes that the risk of removing the tumor because of the location, size, what structures are next to it that he believes that keep letting the tumor stay there is a better option than cutting it out and taking it out. And that woman would generally be referred to radiation therapy to help shrink it and sometimes treat fully, a meningioma. But again, radiation, it has their risk. Okay. And people can, develop dementia within seven years of getting radiation. That's costly. That's scary in itself. These are serious medical conditions. And I've taken care of people who have been gravely disabled from meningioma. And the complications of surgery. So, these are important lawsuits. 

B: So there are several manufacturers of Depo-Provera or the chemical name of Depo-Provera, the proxy progesterone. So there are several manufacturers. Pfizer is considering the innovator of the product. And that's important because some states have what's called innovator liability. So that even if Pfizer was not the actual manufacturer of the drug itself, in the specific woman with the meningioma, and maybe it was a generic manufacturer, Pfizer was responsible as an innovator of the product. That's called innovator liability.

V: Where where are the states? 

B: Well, two of the states are California and Massachusetts. That doesn't mean that if you're not a California resident or you didn't receive your Depo-Provera in California, that you don't have the case. What it means is the case proceeds differently maybe than, otherwise it would if it were a Pfizer product from the start. Right? Pfizer's the main defendant in these cases. In about 2003, 2004. Then other manufacturers came onto the market, and started producing this product generically. Greenstone is one Pascal is another, several what are called qualified generic manufacturers. So you've got Pfizer, you got greenstone, you got others all manufacturing the what is commonly known as Depo-Provera. What's the active ingredient in Depo-Provera? 

V: Depo Provera is a synthetic progesterone. And synthetic means that it has similarities to progesterone and a medication was being studied in Atlanta that that it would cause mama mammary, tumors. That's a type of breast tumor that, beagle dogs that these dogs would have mammary tumors. That's a bad thing. There's also an issue where often women would have to pay for birth control pills, but if they get an injection in the doctor's office, Medicaid would pay for that injection. So women who did not have traditional insurance would have to pay for birth control at a pharmacy, as opposed to using Medicaid to get an injection. So it's almost, you know, it's kind of a it's kind of brutal.

B: So how it turns out, Greg, is that 85% of the population of users of Depo-Provera are minority women, largely African-American. So what you say may hold, some truth. However, it all happened that what we know is the approximate population of, Depo-Provera users in it's and it's largely and mostly minority females.

V: Yeah. So they've known since, the 1980s, 1990s that depo Provera in Beagle Dogs would cause those beagle dogs to develop breast tumors in 2009, because of Depo-Provera, in rats caused mutations in rats. Then 2018 Depo-Provera was ongoing use of Depo-Provera, which shortened the disease free period after resection of the tumor specific mutation, was identified in 2018/19.

B: But let's talk about that 2018 study. And this is interesting because this drug is still on the market and, it's on the market without a warning of what we're talking about here. But getting back to your 2018 study, my understanding of that study is it did two things. What it did was it proved that, the use of progesterone increased the risk of recurrence. Right. So when you say multiple meningioma as you're talking about recurrence, essentially, right, you've got one or more meningioma. And then even if those meningioma are taken out, if the woman is given the depo-provera and she keeps taking it, it keeps, being injected with it, she's subject to developing more meningioma. 

V: What's your thoughts on physician liability for for reoccurrence?

B: Well, in every instance, the manufacture you're, in my opinion, is responsible. They put out the product, they put it out for use. If the product didn't exist, if it wasn't manufactured and marketed, then people would not, who wouldn't otherwise get a meningioma. People who who get it otherwise wouldn't get it right. So so the manufacturers always responsible for a meningioma? In a woman who was, treated with injected with, prescribed Depo-Provera. At some point, the knowledge base of the doctors gets to the point of, well, maybe there's liability of a physician who, even after the development of meningioma vision, knowing this, a process room physician knowing or maybe the physician should know of these late studies, right? Maybe ought not to be injecting women with Depo-Provera and certainly women who have a meningioma.

V: Then what about the staff that that is working on this, this important docket in your law firm? 

B: It is important. And we treat every client as a separate client. We have a lot of we have a lot of cases. We have hundreds of these cases. And the reason we got into these cases, quite frankly, is I was aghast. I don't know if I answered your question, but it was important to me and to my law firm, my lawyers and my staff. It's important what this company did to the women who developed this meningioma. And why did it occur? You know, it's, it's really, it's really kind of raunchy. It's really kind of bad. What happened? How could you possibly put out? How could a manufacturer possibly put out a product that increases the risk? 550%, 550% increased risk of a woman who takes this drug, who is prescribing, injected with this drug, receiving a meningioma, developing a meningioma as opposed to someone who did not. That's a huge risk. That's a huge increase risk. And that's why I got involved in this litigation. That's why I got involved in representing women. That's why I do represent women, and that's why I represent women with these meningioma. It's who took this drug. 

V: It's especially when at all times, at all times alternatives were available that could achieve. 

B: Like what? What? Greg, you're the doctor. What what alternative is were there.

V: Combination estrogen progesterone pills or ortho Novum and the packs that women used to that still they carry and and combination estrogen progesterone.

B: This little pill packs of fat. Yeah the round.

V: Pill packs I mean and then you pick up at a pharmacy and and unfortunately women who did not have access to insurance cards who, desired a responsible birth control, they would be able to get free birth control. And they were offered Depo-Provera because, generally that would be paid for in a doctor doctor's office. 

B: Is this all about money?

V: It's all about money. Yeah. So, Pfizer makes money on the drug. Doctors make money on the injection. They're cutting out the pharmacy generally. And so it's about money. And that's why, African-Americans and minorities are the primary, patients who have received this drug. And, again, at all times are safer alternatives. There's IUDs. There are. And the combination birth control with estrogen and progesterone don't have the risk. Kind of shocking. And and what we know now, okay. Is that when you look at the, they call it farmaco, kinetics of this drug, 

B: What does that mean?

V: It's, it analyzes how much drug you're getting, how long that drug stays in your system and how long it lasts. What they've learned in 2021 is that if you were getting the injection, the 150 milligram injection four times a year only really needed to take it twice a year. 

B: First things first. If a woman has taken Depo-Provera or the generic Depo-Provera and has developed a meningioma, you know, that's if she's taking it for at least a year, right? She's taken forever for at least a year. Then there's a pretty strong probability that that meningioma was caused by the Depo-Provera or its generic equivalent. Right.

V: That's terrible.

B: And so it's pretty straightforward and pretty simple as to the patient population of our clients. Right now we're taking cases where you've taken Depo-Provera. A woman has taken Depo-Provera for at least a year. That's four injections. And then has, has developed the, meningioma. So that's, that's what we're looking for. That's what. 

V: That's why we're filing cases, yeah.

B: So, so as to filing cases, we are filing cases and, we're filing cases across the country, and, we're filing cases in some instances against physicians, in some instances, only the manufacturer and only the manufacturers. In other instances, every.

V: Case, it will involve a manufacturer, though. 

B: Yes, we as I said, the manufacturer has the responsibility in these cases. 

V: Ben, where is your law firm?

B: My firm's located in Dallas. We practice, we litigate against and file cases all across the country, and we probably represent women from every state in the country on Depo-Provera. And we file these cases not just in Dallas, but we file them in California and Florida and numerous, numerous places across the country. The place that you file a case, depends on a lot of different things can depend on. But where the drug was manufactured or where the drug was produced, or where the for the defendant pharmaceutical company is where its principal place of business is the place of its incorporation, the place where the injections occurred, where the woman lives, all of these different things going to the determination of where cases filed and, who is the case to be filed against. Right. They're all going to be filed against the manufacturer. Right. Where where are you located? 

V: I have a law firm in California of several offices, and I have, office in, in Connecticut as well as Washington, D.C.. I, sue pharmaceutical companies with Ben and prosecute personal injury cases of all kinds, primarily medical malpractice. And I've been litigating pharmaceutical company cases, with Ben since 2015. 

For listeners who are struggling with vaginal mesh pain or complications, contact Dr. Greg Vigna at (817) 809-9023 or visit vignalawgroup.com.

TRANSCRIPT:

I'm Ben C!  I'm doctor V.   The medical legal guys. 

V: I'm doctor Vigna. I am a doctor, lawyer and medical expert on injury medicine. And I have a national litigation practice in California, in Washington, D.C., as well as Connecticut. 

B: I'm Ben Martin. I'm a lawyer. I live in Dallas, Texas, and that's where my law firm is. But we practice law all over the country. 

V: Today we're going to be talking about the Altis Mid Urethral Sling and the litigation my law firm and Ben Martin's law firm is pursuing across the country on behalf of women who have been injured by what we believe is the worst device on the market.

B: So a altis sling is a single incision sling, slightly different. And in a lot of ways, a lot different than the standard issue full length mid urethral sling. And I'm going to let Doctor Vigna explain that 

V: Mid-Urethral slings, have been used since 1997 for the treatment of stress urinary incontinence, in women. And it basically supports the urethra, the tube that goes from the bladder to the exit of the body, called the urethral meatus, and it holds up the urethra to help reduce the involuntary loss of urine, which is in convex. The Altice mid urethral sling was, brought to the FDA. With hopes that it would be approved in 2009. And the FDA had some concerns with this new device. Since, like the other devices, it was made of plastic. It was made basically of similar materials, but it had a different anchoring mechanism and, a suture mechanism that allowed that sling to be tensioned. And the FDA had concerns that this was a substantial change in the device, and they wanted this device to be tested before it would come to the market. 

B: Well, let me ask you something, doctor Vigna, a couple of things you said in there. I want you to explain it a little bit more. When you say stress urinary incontinence, let me give it a try. And you correct. So stress urinary incontinence. Everybody knows what incontinence is, right? Your bladder is out of control. Peeing your pants up your pants. Okay. And, you can have mild, you can have moderate, you can have severe, it's not a life threatening condition at all. I never killed anybody. But it can be. I would say uncomfortable can be embarrassing. Inconvenient. So back in the 90s, these companies put out slings and urethral slings. I call them, right in the middle of the urethra to help prevent stress urinary incontinence. And they put these devices in this Altis device. They cause problems. 

V: So in 2009, Coloplast asked the FDA through a submission, the 510 process, to get this device onto the market and just described the 510 process for us. 

B: Well, is 510 okay. And the 510 K process allows a company to point at another product on the market, medical device and say, hey, our device is pretty closely similar to that other device. And hey, FDA, don't make us go through testing of our device and presentation of anything except the fact that, hey, we're similar to another device. Let us put our product in the market as opposed to a premarket approval, where these companies go through all kinds of studies for the FDA to then approve the device and actual approval of device. The 510 K product is not a product that has been approved for sale. It's just been cleared. 

V: The two other devices that it said it was substantially similar, the mini arc from American Medical Systems and the adjust length from Bard. They're no longer on the market.

B: Wonder why? Let's just talk about mid urethral slings themselves. And I don't know if we've explained that well enough what a mid-urethral sling is. Greg, can you explain what a mid urethral sling is? 

V: So you have full length slings. This is the full length slings generally get placed through the vagina, where there is an incision on the ventral aspect of the vagina, and they place the sling right underneath the urethra. And generally it has arms that leave the body either out the side wall through your groin or by the bikini line. But these device, these are all made out of plastic. And that plastic is called polypropylene. They're used for stress urinary incontinence. 

B: Well, and some of the problems with putting plastic in the body. And polypropylene studies have shown that it creates a foreign body reaction. First of all, where your body is trying to fluff it off and get rid of it. When you have a, a foreign object in the body, the body's natural immune system tries to get rid of that foreign body. And so when you're putting plastic in a person's body, not everyone has this problem. But a lot of people try to reject that foreign body. And that's called a foreign body reaction. And FBR and that's bad. 

V: The foreign body reaction happens with any type of foreign material that's implanted in the body. There are some materials that don't really react with the body at all, such as platinum. Okay. And and then there are materials that the body can tolerate better than others. Polypropylene has has been used since the 1950s. It's been known to cause significant foreign body reaction in a significant number of of people who receive polypropylene. And that causes inflammation, scarring, pain, scar tissue, causes contracture, and it can cause significant pain and then in itself called mesh related pain. Or it can cause nerve and muscle related pain because it inflames and scars adjacent tissues, organs and, and nerves. 

B: So if you've got this sling and it's put in the body, there have been studies that show some of these slings contract over 50%. In other words, they shrink. So if you've got a piece of plastic that's attached to some tissue in a body and then it begins to contract, what's going to happen? It's going to pull what it's attached to, and it's not good for the body. And to this day, the manufacturers have not come up with an excuse to explain, oh, it's okay, no problem, no problem. Shrinks. But we put a piece of plastic in, but it shrinks. That's okay. Don't worry about it. 

V: There are other, materials that are currently on the market out of this country. So far, companies that have plenty of money have not, gone ahead to go through the process of bringing safer materials to the United States market. So, in other words, women in the United States are getting 1950 mesh 1990 mesh 2004 mesh, while they're safe for materials that are available at this time. And then the nice organization out of England, they don't allow this device, the single incision slings, they don't allow this device to be implanted in England unless it's part of a study. So what does that tell you? Tell us about the nice organization. 

B: Let me tell you what you now see is it's the National Institute for Health and Care Excellence. A British organization there recommend recommendations, help practitioners and commissioners get the best care to people fast while ensuring value for the taxpayers. That's the NRC. And they actually watch out for the patients in Great Britain. And they speak about patients receiving these devices all over the world. 

V: And their opinion is this device should be studied more before they implant this device. In the United States, this device is being placed in women all the time. The coloplast In 2009, submitted a 510 K to the FDA and and the FDA asked for another study that they wanted this device to be tested to ensure that it is at least as safe and efficacious that it works as well as the other slings that are on the market. And Coloplast, they wanted this device on the market. So they went through what is called an investigational drug exemption. Ben. So tell us about what a IDE study is.

B: An investigational device exemption. And that's it. And all that means is that if a company wants to put a product in the market under the 510 K process, in other words, they want their product cleared just like product A was cleared and B was cleared and C was cleared, not approved. They want to put a product on the market and do the shortcut. They use that 510 K. And they can ask the government or the FDA can tell them, well, why don't you do an IDE study before you put this product in the market so they can do that? They did do that. 

V: So, this investigational drug exemption study provided by Colaplast device and the FDA accepted it and the device got on the market. The one year data had an interesting finding. And I'm going to read it. What they found, they found the most common device and or procedure related adverse event was non pelvic pain occurring in 8% of the subjects. Non pelvic pain consisted of groin, hip or thigh pain. In all cases non pelvic pain was defined as procedural related the woman's up in stirrups during surgery and then subsequently has groin or inner leg, thigh or hip pain. And they said that complaint of pain was from the positioning in surgery and not from the device. Again, they reported in this article, 8% of of women had inner leg, thigh or hip pain from the procedure. It wasn't from the device, it was from positioning. Okay. And they submitted this data to the FDA. 

B: Let me stop you there. So what they were saying, they being coloplast that research that it's their study, yet what they're doing is they're pointing that finger to the doctors. They're going to say, oh, there's nothing wrong with our device. There's nothing wrong with this plastic that shrinks and, erodes. It's the doctors that are putting them in wrong. 

V: Essentially, yes, but they didn't exactly point at the doctor on this. They said, oh, we happened to be because of positioning during surgery. 

B: Who puts the who puts the patient in the position during surgery. Gets the what. Right. Okay. So what's the company doing? The company is saying, hey, not me, not me, doctor. It's the positioning, the patient. It's not the device. That's what they're saying. 

V: They attributed this pain to positioning, not related to the device. And this device gets on the market with what we consider a safety signal. And what is the safety signal? 

B: Way back when there was, a drug called thalidomide. It's back in the 60s, I think, and a lot of women who were pregnant were given thalidomide. And as I recall, I think it was for nausea, during pregnancy and then there were folks who mothers took this thalidomide, and they were born with birth defects, a particular type of birth, in fact. And that was kind of a safety signal. Nobody had put two and two together until studies were done to show that thalidomide caused these, these very serious birth defects. And since then the thalidomide was taken off the market. That safety signal was when those first few babies seem to have had these birth defect. The the company has a duty to do post-market surveillance. They've got to follow along the people who have these products. And there's pre-market analysis for these two different times that safety signals can be seen. But many times these products get on the market just like this one did with problems. And then post-market surveillance goes out the window and you end up with the product on the market for years and years, and it may stay on the market. This product still on the market. Altis is still on the market.  

V: So here in this case, these devices, these polypropylene vaginal mesh devices were having problems. And the FDA said, hey guys, we need to do what is called the 522 study to show that this device is safe and effective. And they asked for another study, a three year study that's called the 522 study. So guess what? After three years is this FDA 522 study showed that safety signal. This device in this 522 study had significant leg, thigh and hip pain, which was not seen in the other devices. And, if you look at table four, in this three year study, you could see cases of leg pain. And in the comparator group, the full length sling group, there was no such leg pain. What was their conclusion? The authors conclusion 522 study they said that it was related to positioning. Same excuse as the ID study. Hey guys. The women in the full length sling group, they're positioned in the same way. They're in the same position. No complaints of leg pain in the full length group. The single incision group 12 cases. When the three year study comes out. They blame it on positioning, and it's statistically not possible if you're in the same exact position during surgery, same amount of time. There is a problem with this device. 

B: I want you to let me do something. Yeah. Talk about this is my machine. Okay, so while Greg was talking, I pulled up an ICE All right. And then. An ICE it's the United Kingdom's National Institute for Health and Care Excellence. Okay. What the NRC says is that with a limited long term follow up and with the potential for complications such as mesh erosion, pain, difficulty urinating, which necessitates proper patient counseling regarding the risks and potential benefits and the doctors and the patients were not given back. Coloplast. The ability to understand what all of the problems are with these slings, right? And so that that's what we're dealing with. 

V: The Altis group caused more pain at all time periods than all the other devices had more dyspareunia than all the other devices at all periods of time, and required analgesics, pain medicine, pain interventions than all other devices at all time.

B: Wow and thats Coloplast. What's the worst sling on the market today? 

V: There's no doubt it's the altis device. And and women who are choosing to have their incontinence treated with the mid urethral sling, they are not being warned that they're being implanted with a device that causes two and a half times the risk of, dyspareunia compared to full length slings. Women are not getting warned that there is inner leg, thigh and hip pain more so than any other device on the market.  

B: I wanted to talk about something that's really important to me. It's important to these cases. You know, we represent women who have this altis device, right? These women all over the country. And you can't believe how badly hurt and hurting some of these women are. We've talked about pain. Pain is a relative thing. Tell us what you have experienced in looking at these cases and the particular problem that they have that leads to these really, really devastating, painful injuries. 

V: Yeah. So I became an expert on nerve related pain and neuralgia. Pain. These devices cause burning and stabbing pain. This Altis device causes neuralgia pain in the Prudential distribution, which has the branch to the clitoris, the perineum, which is the area of your private area and it prevents touching. It causes intractable vaginal pain. It causes intractable bladder pain. It causes anal, rectal pain. And these women are pretty much done okay. Their sexual function is over, they often can't work anymore, and many of them become very immobile because they have to spend time laying down, and because they can't sit there. Catastrophic injuries. 

B: Doctor Resnick there's a study published in the New England Journal of Medicine, 2012. I believe it was. And it was determined in that study, published in the most respected journal in the world, found that only one out of every 200 complications were reported. So let's get away from the study for a minute. Let's just look at underreporting. Think about that. One out of every 200 actual complications is ever reported. Do we even really know, number one, what those people were feeling? Five years? Whole group of people who got it. Not just talking about the 8%. I'm talking about all of them. Why don't we know what happened to those people five years down the road? Because I'll just tell you, because it wasn't study, it wasn't followed up on. Coloplast didn't follow up on it. And why would they? 

V: So get this, Okay. So you have a woman who has intractable vaginal pain, thigh pain, and they need to have this mesh device removed. And obviously they've been hurt bad and they want complete mesh removal even in the best of hands. Sometimes when doctors are trying to get this mesh device out, the anchors break off and they remain in the body, and that foreign body remains in the muscle that is irritated and primarily responsible for the nerve pain it stays in forever. We know this device is the worst on the market. The IDE showed a safety signal. The 522 study showed inner leg, thigh and hip pain. This huge study out of England shows it has more pain at all time periods. Tell us about these. The warnings that these these companies provide. They list every type of complaint known to mankind. Is that a real warning? Doesn't frequency of complications mean anything anymore in medicine?

B: So when physicians are talking to their patients about whether or not a particular device is to be placed into the body, there's a conversation that should take place in a conversation that normally does take place, kind of a risk benefit analysis of the risks. These are the benefits. You're going to be able to improve your stress urinary incontinence by putting in one of these devices. But in making that decision, do the risks outweigh the benefits or do the benefits outweigh the risks? The important risks, the risks that cause problems need to be discussed. If something happens one out of a thousand times as much different than if something happened, 50 out of a thousand times, or 150 out of 1000 times. Right? So that's the frequency of the risk. And then the physician and the patient need to know about the severity of the risk. If there's a risk of pain, how often is it going to happen if there is a risk of another side effect, how often is that going to happen and how serious is the pain? Well, Doc V just explained that particular pedendul neuralgia very severe lifelong problem. And it's harmful. You know, I think what doctor V is getting at is that this company did not tell doctors who were putting this in the body, didn't tell the patients of frequency or the severity of something like pudendal neualgia 

V: Or obturator neuralgia. And in fact, they don't mention prudential neuralgia and obturator neuralgia on their warning 

B: Dr. V has talked about prudential neuralgia. I hope that everyone now can understand and know that's a serious painful sometimes called the suicide disorder prudential neuralgia because it's so painful and it affects these women's lives so much. I hate to say it, but it brings women to that point. Sometimes that's written about. 

V: So doctors have a responsibility here that this data is available in the literature. But I'm Doctor Vigna and I read all the literature okay. And doctors really need to be warned this by the manufacturer of the significant frequency. When women have these acute complications, they are just reassuring women instead of removing these devices early before the body grows in and make these things very difficult to remove. You know, I have to believe that if doctors knew this data by way of warning, they would not implant this device.

B: So if a woman is presented with a choice, you can have a device that does cause problems, specific problems, pain in the groin, pain in the thigh. Would you rather have the device that causes those problems? Would you rather have the device that doesn't cause the problems? The issue is, and the problem is that doctors and patients weren't told about this situation. 

For listeners who are struggling with vaginal mesh pain or complications, contact Dr. Greg Vigna at (817) 809-9023 or visit vignalawgroup.com.

TRANSCRIPT:

Welcome to Justice with Doctor V. I am a doctor and a lawyer. I have a national litigation practice and represent those who have suffered catastrophic injuries. Today's topic is the vaginal mesh litigation lawsuit involving a mid urethral sling used to treat stress urinary incontinence in women. Vaginal mesh litigation really has been going on since the end of 2009. I was still in law school. 

I was practicing medicine in law school. I woke up one morning and and I looked at the types of devices. I thought, wow, that's pretty interesting where they're putting these devices to support women with pelvic organ prolapse and mid urethral slings, that women were having pain. And I thought that was pretty interesting. So I got online and I wanted to hear what the women were complaining of.

And what I was hearing is women were complaining of symptoms of pudendal neuralgia, which is the catastrophic pain syndrome that used to be very rare that most doctors never really heard of. And it presents as intractable pelvic pain where you have pain, where you sit so you can't sit comfortably. It causes you to have in the perineum. The perineum is the area of your body that would be in contact with a horse if you're sitting on a saddle, and it makes that area painful to touch, so that women who had pudendal neuralgia from these devices, they couldn't wear tight pants, they would have intractable pain. That touch would be burning sensation. They would also were complaining online that they were having stabbing pain and growing pains. So I understood that these women had symptoms of neurological injury.

They didn't know it and doctors weren't diagnosing them. They were ultimately getting surgery to take out part of the mesh that the doctor thought was causing pain, and they would take out little pieces of mesh, thinking that they were helping it, trying to help them. But the pain is from the arms that are into the legs and going up high up in the pelvis that are getting near nerves.

And women were having 7 to 10 surgeries to remove bits and pieces of the mesh and they weren't getting better. And ultimately there was big multidistrict litigation that ended. Thankfully, and ended in 2018. And I was the first lawyer in California to file a pudendal nerve injury case. And I've been suing manufacture for pudendal neuralgia, obturator neuralgia, you know, intractable pain since that time. 

So women are having up to ten surgeries to get this mesh removed. Why is this mesh still being used? 

Well, we're going to talk about what mesh does and what mesh is. So vaginal mesh mid urethral slings and they're all made from polypropylene. And polypropylene is basically plastic with a theory that if you put it in it will keep stay in the same place and be able to support structures and the body will grow in that device will be incorporated into the soft tissues and muscles to support things.

That's why women with prolapse, that's the falling of the uterus. It could be the bladder, be the rectal. Rectal prolapse. It supports pelvic organ prolapse for women who had babies. So it sounds like a good idea, you know. And then mid urethral slings, they hold up the urethra because if the urethra sags from pelvic, from loosening of the soft tissues around the urethra, the urethra can be supported with the mid urethral sling holding up the tube that goes from the bladder to the external medius. And the urine flows from the bladder through the urethra and then out. 

What's the biggest issue with using mesh in these surgeries? 

A mesh is basically polypropylene. It's plastic, and when it's implanted into a woman, it causes chronic inflammation. Inflammation can cause pain. That mesh can cause scarring. You could have muscle pain from the mesh, or you could have mesh impacting nerves that cause neuropathic or neuralgia type pain.

Neuralgia is a bad word. If you're a doctor, you know what neuralgia is. It's most severe pain that you can have. That means burning and stabbing pain. These devices can cause pudendal neuralgia and Opteron ader neuralgia to pudendal neuralgia is is known to be a catastrophic pain syndrome. It prevents you from sitting becomes burning, irritated. You can't be touched down there and therefore sexual relations, becomes impossible.

Obturator neuralgia, that's pain in the leg and thigh that is burning and stabbing. These are these are catastrophic pain syndromes and destroying women. So when you talk about severity, they get by being on an easy chair like this, tilting back and staying off their bottom. If they start sitting, they get uncomfortable. It becomes very painful and it feels like they're getting stabbing pain. So their best position is is on a reclining chair with pillows underneath their thighs.  

Not even being able to sit comfortably is something that affects everyday life. How long do these women have to deal with this pain? 

Women who have few pudendal neuralgia or obturator neuralgia? Unfortunately, those are life altering pain syndromes that continue the treatments that people can have.

You hope that the pain gets 50 to 60% better, and women who get better, 50 to 60% with pudendal and obturator neuralgia, they're very happy with that outcome. These devices, they learned that if a person has one of these catastrophic pain syndromes taking out just a piece of the mesh that might be eroding through the vagina, that won't help the underlying pain.

So over the past seven years, there was an article that came out. He proved that for pain, complete mesh removal is superior to partial mesh. What does that mean for an individual patient who has to decide, or individual woman who has to decide between partial mesh and complete mesh removal? Okay, these aren't just small little surgeries. They're they're going into the leg, the vagina going around the urethra.

You know, these are big deal revision surgeries. So women need to get to a doctor. They trust that they have confidence and understand his or her decision making with regards to partial mesh removal and complete mesh removal  

Pain this severe, how has this not become public knowledge to doctors or patients?

So the vaginal mesh litigation, the end result of the vaginal mesh litigation, the big multidistrict litigation where over 100,000 women in a court in West Virginia, the companies made these devices had to admit their warnings to doctors were insufficient to describe the risks of their devices.

So they agreed to change their label and they agreed that the device can cause various bad things like chronic inflammation into perpetuity. Scarification, shrinkage of the device, erosion, serious, catastrophic, life altering pain that may not go away with surgical revision. Every complication they were required. These companies put on their warning. 

If this warning isn't expressed about slings, how long does it take a woman to realize that something's wrong? 

Pain from caused by a urethral sling can be immediate. It could be within the first few days or any time. And these have been pretty well studied. That polpropylene mid urethral slings 15 to 20% of of the complications are after five years. So these complications can occur ongoing in the time we know that if a woman gets a mid urethral sling, 8% of those women will need to have another vaginal surgery to cut that sling or remove all of it or part of it.

For women who have these mid urethral slings, 18% of them will have another surgery of some sort, either a failure of the device to correct incontinence or a complication caused by the device. That's 18% at 15 years  

Is there a safer alternative design?

Yes, there are safer alternatives in other parts of the world that have not made it to the United States market. DVD that causes less inflammation, less scarring, less pain, and is just as effective as polypropylene. And that's used in Europe and other parts of the world. And now there is a new polymer that's a natural polymer grown from E.coli, which is a bacteria called P4. HB that is completely biodegradable. And you're not going to get chronic complications caused by the device because the device is completely biodegradable. That device isn't on the market. 

This is huge news for women who've already suffered the pain of this surgery to know there is alternatives. There are other options. Where does the accountability come in? 

We're suing Colo Plast and the doctors who implant these devices when they cause serious pain, including pudendal and obturator neuralgia, or have significant disabling pain, that women can't have sexual relations or they lose vocational employment because they can't sit and work. We believe that this causes more pain than any other mid urethral sling on the market. We believe that this device causes more dyspareunia and has a defective design, and we are also suing them for failure to warn nowhere. And they're warning do they display the frequency of pain. This device has more pain and more pain that requires medications than other devices on the market.

If I had known about all these things and the severity, I would have at least taken the device out quickly. That's a serious harm. When women don't get treated for severe pain after a surgical procedure that may be impacting nerves, there are women who are getting reassured are in a bad spot financially. Socially mobility is impaired. So these are important lawsuits. 

What else would you want these women to understand on filing the case? 

Each state has different rules in terms of when a person who is injured and needs to file a claim to preserve their rights. Every state is different. If you're seriously hurt, if you can't sit, if you can't be touched down there, if you have problems with sexual intercourse, mobility, a doctor has told you the meshes is causing your problem.

You need to have your rights preserved. You need to call a lawyer pretty much within a few days. From a doctor telling you that the mesh is causing your problem. If mesh removal surgery is planned, we generally preserve the mesh for every client that we, represent, because mesh has will have, pathological evidence of generally chronic inflammation and scarification these things you just can't sit on. 

He also sheds light on the troubling history of Depo-Provera, its unopposed progesterone risks, and how drugmaker Pfizer has issued stronger warnings in Europe and Canada—but not in the United States—leaving American women vulnerable. Beyond the medical dangers, Dr. Vigna addresses who may be held accountable in these cases, from the prescribing doctors to the manufacturers, and explains the ongoing litigation aimed at securing justice for affected women.

For listeners who have developed a meningioma after using Depo-Provera for at least one year, contact Dr. Greg Vigna at (817) 809-9023 or visit vignalawgroup.com.

TRANSCRIPT:

Welcome to justice with doctor V. I'm a doctor and a lawyer. I have a national litigation practice and represent those who have suffered catastrophic injuries. In today's episode, we're going to talk about Depo-Provera and meningioma. Depo-Provera is a birth control medication given by injection we know causes meningioma. As if that women received at least four injections over the course of a year. 

Depo-Provera is a birth control. Women as young as 15 are prescribed. What are your thoughts on this birth control shot? 

The risk of Depo-Provera has been figured out that if you've taken Depo-Provera, you have a 5.5 times the risk of developing meningioma compared to women who have not received a year's worth of Depo-Provera. So that's a big risk. We know that depo Rivera causes mutations, a specific mutation that causes multiple meningioma. Those are tumors that are in the brain, and they tend to be on the skull base, the skull base meningioma, as are those tumors that tend to be harder to get to.

If you've had used it for over a year, you have at least a 5.5 times the risk of developing meningioma as compared to women who have not received that. So your overall risk still is rare, but certainly you don't want to be on a drug that causes a specific mutation. There are plenty of other medications that are available and have been available at all times, that you can achieve sterility temporarily. 

Ever since the 1980s, they've known that meningioma is grow in pregnancy. When you're during pregnancy, you know that placenta is a progesterone factory. So women develop meningioma. And meningioma is grow during pregnancy and after birth. The meningioma is they know, shrink. So we know that the cell line is involved with meningioma as is reacted to progesterone. 

A brain tumor is one of the scariest things someone could hear coming from a doctor. What is the severity of a meningioma? 

Women who develop meningioma often require surgical resection. Women who have surgical resection, they may have recurrences. There are women who have had recurrences that have required radiation therapy. There are women who have had radiation therapy for a meningioma that then develop radiation related dementia. There are women who develop meningioma that can't be operated on because the location is such that removal of the tumor more dangerous than slowly becoming more incapacitated by the tumor. 

So if you've taken Depo-Provera or a generic for at least one year and you've developed a meningioma, you need representation. 

What is the diagnosis for these meningiomas? How do women know that they are at risk? 

How are people diagnosed with meningioma? People who have brain tumors can have weakness of their limbs. They could have visual loss. They could have balance problems. They could have headaches that lead to a diagnostic test. And that diagnostic test is generally a CT scan or MRI. And the diagnosis is generally made with diagnostic imaging. These tumors tend to be benign or often calcified. 

They tend to be more circular. Of course, you will never know for sure that you're dealing with meningioma until biopsy. Biopsy is usually obtained at the time of resection, but for the most part, you tend to look at it on an MRI and know what you're dealing. 

This drug seems to have a lot of baggage. How long has Depo-Provera been on the market? 

Depo-Provera was developed beginning in the 1970s and 1980s and was approved in the early 1990s, and it was studied in Atlanta, at Grady Hospital. Generally been used in the African American women. Certainly there are better options, and in many doctors stopped using Depo-Provera when it became understood that unopposed progesterone can have complications of osteoporosis and other medical problems. 

Also, doctors didn't like unopposed progesterone because hormones cause things to grow. When you had combined estrogen with progesterone in the form of birth control, birth control with estrogen, progesterone. They tend to cancel each other out, and you're not seeing the complications related to unopposed progesterone. 

I want to talk about liability for these women who have suffered from these brain tumors. From the birth control shot known as Depo- Provera, who is liable in these types of cases for these women that you represent? 

So when we get a case, we are always evaluating a case to see if this is the case that there was physician malpractice versus pure case against Pfizer and the authorized generics. At some point, the doctors should not have been prescribing this medication, and doctors are still prescribing this medication. Pfizer has changed the warnings for Depo-Provera in Europe, in Canada, but has not changed the warnings in the United States, but still think that doctors do have a responsibility and we are evaluating every case to see if that's the case, that we should bring against both the doctor and the manufacturer.

 We have cases filed in the Multidistrict litigation. For example, we have clients that were diagnosed with a meningioma in 2021, over ten years of Depo-Provera. And they had the tumor resected and they continued on Depo-Provera, and they developed multiple recurrences and required another surgery and continue with Depo-Provera. 

I've taken care of meningioma since 1996. I'm a brain injury doctor. I testify as an expert on brain injuries, and I manage hundreds of patients who have had meningioma resections, its most common brain tumor, and people who have complications from meningioma resection tend to make it into rehab. And I was a rehab doctor. I've taken care of people who have hemi paresis from meningioma hydrocephalus, where they need a shunt for meningioma. 

So I understand the chronic complications of this drug, the chronic complications of meningioma. And I'm a brain injury doctor, and I sue Pfizer for Depo-Provera related meningioma. These are serious injuries by a very bad drug. Pfizer still is not warning doctors and they're still women who are receiving this bad drug. This is serious litigation.

A key focus is on the preventable nature of many of these infections and the existence of safer materials that manufacturers aren't widely adopting due to cost considerations. Dr. V discusses the most vulnerable populations - including premature infants who may develop cerebral palsy and cancer patients requiring long-term central access.

The episode concludes with legal guidance for those affected by PICC line infections, explaining how Dr. V's firm pursues cases against both device manufacturers and healthcare providers who fail to properly monitor or diagnose complications. For listeners who have suffered septic shock or blood clots from central line infections, Dr. V can be contacted at (817) 809-9023 or vignalawgroup.com. 

TRANSCRIPT: 

Welcome to Justice with Doctor V. I'm a doctor and a lawyer. I have a national litigation practice and represent those who have suffered catastrophic injuries.

We're talking about a hidden danger: PICC lines and other central line bloodstream infections. What is a PICC line? And if you can measure their relationship with infection, what would that look like? PICC lines or any other central line - they're generally made from polyurethane and silicone. We know that this type of device will be associated with a certain percentage of infections, about 1.8 bloodstream infections every 1,000 patient days.

We know that. Okay. And 2 in 1,000 doesn't sound like much. But when you think about it, many of these patients have PICC lines and central lines for 30, 45 days. What are the risks for these patients? We're talking about a known risk that a certain number of people will get infected from. And some of those patients will develop septic shock.

We know that. And of those patients who develop septic shock, we know the mortality is significant - upwards of 40%. We're talking some permanent organ dysfunction. We're talking about amputation. We're talking about brain injuries from septic shock. I feel as if many people have heard about septic shock but don't know the actual description. Could you give us a description?

That means your body is fighting that bacteria in the blood in such a way that there are some bad responses to the massive inflammation that is occurring as the body tries fighting this bacteria. Where can septic shock be acquired?  What we are concerned about is hospital acquired infections. And many times these infections that occur in the hospital are preventable.

And what we know about hospital related sepsis is that it's a different type of sepsis compared to what you get in the community. When you get bacteria in the community, they generally are not the super antibiotic resistant organisms that live in hospitals. The mortality is nearly twice as much for hospital related sepsis.

The length of stay adds nearly 14 days if you get a hospital acquired sepsis and septic shock. So hospital related sepsis is extremely important to diagnose and treat quickly. How long does a hospital have to act when an infection from a PICC line happens? Every hour there's a delay in treatment with antibiotics, there's an increase in 8% mortality.

The benchmarks for hospitals to get IV antibiotics on board is generally 1 to 3 hours. After three hours, it's really considered a delay. And it makes a difference. Is this preventable?So we know about this hidden risk from PICC lines that they can get infected because anything could get infected.

These PICC lines are defective because there is safer material now available. It's on the market that reduces the risk of bloodstream infections, and they reduce the risk of blood clots associated with the line. I want to stay on the subject of these new materials. How do they compare to PICC lines and why aren't they being used more?

We're not seeing infections with the new materials that are on the market. So why are these old PICC lines still on the market? It's because they're cheaper and these are cash cow devices where companies have been making millions of dollars on these devices for years, and they simply aren't bringing the safer materials to the market.

They're not describing the benefits and the risks of their type of device compared to the new material. And doctors don't know and patients don't know and their families don't know. Speaking of patients, who is affected by these bloodstream infections? We know that kids who are born premature - if they get a bloodstream infection, septic shock - that's associated with cerebral palsy.

Okay, so we're seeing serious injuries from preventable illnesses that are occurring in newborns. Patients who have cancer, they have to have central lines and PICC lines, and they're the most vulnerable. And they're at the highest risk. And shouldn't they have a safer device? 

Who does your law firm represent in these cases? Who do we represent with PICC line injuries? Those are people who develop septic shock from hospital acquired or outpatient acquired bloodstream infections caused by an infected PICC line. Those people that we represent would have ongoing and permanent disability related to that septic shock. 

Who is usually at fault for these infections? And how do you fight back? So we do our own discovery. This discovery is generally confidential. But when cases go to trial and people get to see these documents, they are not confidential anymore. And when pharmaceutical companies do bad things, they need to be called out on it. And we do that kind of work on some very tough cases.

We are suing the manufacturers and we are also suing the people who are putting in these devices and monitoring these devices and failing to diagnose complications when they occur. 

What would you tell to the people that are listening who have been affected by these bloodstream infections, specifically from PICC lines? If you've suffered a central line infection, developing septic shock, or a blood clot that went to the lungs associated with one of these lines, call me: (817) 809-9023. And we'll be talking shortly.

Dr. Vigna - Medical Doctor, Attorney, and National Litigation Specialist

In This Episode:

• What bedsores really are and how they develop
• Why they're called "never events" and what that means
• The anatomy of pressure injuries: stages 1-4 and affected body areas
• Who's most at risk and warning signs to watch for
• Financial and human costs of inadequate treatment
• How to advocate for proper care and prevent unsafe discharges
• When to involve patient advocates and seek legal help

Contact Information: For legal consultation on pressure injury cases: (817) 809-9023

Content Warning: Medical discussion of serious injuries and patient neglect