Ray Chester: [00:02:57] No problem. Thanks for having me.

Ray Chester: [00:03:27] Sure. Sharla Helton is a very unique individual and her case was unique in my experience. It’s the only Botox cosmetic case that actually went to trial. I tried several Botox cases across the country, but most of the others were for therapeutic or medical uses with higher dosages. Sharla is a medical doctor. She’s an ObGyn and she put herself through college and medical school, ended up being one of the owners and founders of the first women’s hospital in Oklahoma and Oklahoma City. She’s fantastic doctor, mother, wife, author. She’s just a fantastic person. But in her early 40s, like many of us do, the vanity got the best of her. And she got a couple of Botox injections. First one was no problem, after the second one she quickly developed generalized weakness. Couldn’t get out of bed, went to several doctors, couldn’t figure it out, eventually went to the National Institute of Health. NIH was diagnosed with botulism Iatrogenic botulism, which means from medication. She also developed a crippling peripheral neuropathy and was forced to give up her medical practice.

Ray Chester: [00:05:00] Right. She didn’t inject it herself, obviously. Well, right. Right. That was some people do, though.

Ray Chester: [00:05:38] Well, Sharla had already been turned down by basically every lawyer in Oklahoma. One of them actually filed her case at one point, but got completely run over by the Allergan lawyers and dropped her case. And so she contacted me as sort of a last resort because I was out in California trying different Botox case. And Allergan did absolutely everything they could to ruin her life and her husband’s life. They tried to discredit her. They called her a malinger. They called her a liar. Allergan is one of the most fearsome opponents in civil litigation that you could ever imagine. They hardly settle any cases. They make everyone go to trial and they make you earn it. That’s one reason why they’ve been so successful with their product and why people are so scared to sue over Botox cases.

Ray Chester: [00:06:42] We won. We got a verdict for fifteen million dollars. They appealed for three and a half years. It was eventually affirmed by the Oklahoma Supreme Court and with interest, it came up to over 18 million.

Ray Chester: [00:07:13] Well, I was really the only person ever doing Botox cases because of this intimidation factor. There was a Hollywood actress in the early 90s by the name of Irena Medavoy, who was married to a very famous producer out there. And she sued over Botox. She had similar problems, not not as bad as Sharla, but pretty bad. And that case went to trial and they collected attorney fees from her to the tune of a couple of million dollars and then made her sign an NDA where she couldn’t talk about it. So that was the only Botox case that had ever gone to trial. When when I started doing them and I ended up trying five of them, won three, lost one, got a hung jury on the other one. But I ended up settling about 50 other cases after I finally started beating them regularly.

Ray Chester: [00:08:25] Right, right. Over two thirds of the use of Botox in the United States is off label, and that’s by design off label means, not approved by the FDA. And that’s been Allergens marketing strategy since day one. And they get it approved for narrow uses and then they aggressively market it for off label use. Which is illegal and they have pled guilty and played it, paid a six hundred million dollar fine for off label marketing. And so most of the other cases are for medical uses, some of them were death cases, children who were injected with megadoses, children with cerebral palsy who suffered from limb spasticity and were injected with megadoses and died. Vietnam veteran who had Botox get into his brain, went into a coma and died. It’s been a variety of cases.

Ray Chester: [00:09:19] Another subcategory of Botox cases gone wrong are because Botox triggers an immune response in some people and can trigger an auto immune disease. One of the most frequent ones suffered by Botox users is a disease known as Guillain Barre Syndrome. Guillain Barre Syndrome is a very serious, progressive neuromuscular disease. Sort of like muscular dystrophy. Might have been the one you might might have heard of.

Ray Chester: [00:10:06] Right. And that that research has been there since the beginning, it was just hidden by Allergan and other botulinum toxin manufacturers. Botox is short for botulinum toxin, and that is a lethal neurotoxin. It’s actually the most potent toxin known to man. One gram can kill a million people. It was developed as a biological weapon. Saddam Hussein was known to have stores of it. Interesting fact. Anyone who fought in the Gulf War cannot get Botox injections or they can get them. But it won’t do anything to them because they were vaccinated against botulinum toxin before going overseas. And so Botox is a very potent line to be injected into a muscle. And then what it does is it attacks a neuromuscular junction, which is the nervous system in the muscle. And it, quite frankly, destroys the neuromuscular junction to where the muscle becomes disable.

Ray Chester: [00:11:14] So if you think about the typical cosmetic use you injected into your four head for frown lines. And if everything goes right, hopefully it goes into the small muscles of the face. It destroys the neuromuscular junction. Those muscles become dysfunctional. The reason that it only lasts two to four months is because the body regrows new nerve endings at the neuromuscular junction. And then you have to get injected again and destroy your neuromuscular junction again.

Ray Chester: [00:11:58] No one knows the long term effects of botulinum toxin injections. But I can tell you in following up on your earlier question, the problem with almost all Botox side effects is if it gets it outside the muscles, either because it wasn’t injected properly. Occasionally, doctors use EMG guidance when injecting Botox to make sure it goes into a muscle. But 99 times out of 100, they just do it by feel. And so if it gets into the bloodstream, either because they missed the muscle with one of the injections or also what happens is a small muscle gets overloaded with Botox and just overflows it gets in your bloodstream.

Ray Chester: [00:12:44] Having botulinum toxin in your bloodstream is by definition, botulism. Allergen lobby, the FDA not to put the word botulism in the black box warning because they thought it would scare people, which it should. And so they instead use the term spread of toxin. But it’s kind of a perfect crime. And one reason that made these cases difficult to try is that it’s undetectable in the bloodstream after like the first 24 or 48 hours because it’s in such small, small quantities. I mean, we’re talking about nanograms. Like I say, one gram can kill a million. And I want, I want to talk to you about dose, when you’re ready to.

Ray Chester: [00:13:48] I don’t let anybody that I know or care about get Botox injections, or at least I try and talk him out of it. A lot of people get cosmetic injections and most of the time there’s not a problem. I freely admit that cosmetic injections are typically lower dosage. The typical cosmetic injection is 50 or 60 units all over the face. That’s over the FDA approved limit, by the way. It’s only approved for 20 units and that four head and 20 units in crow’s feet, but it’s typically injected at higher doses all over the face. But people get Botox for medical reasons, all kinds of medical reasons and back problems, migraines, underarm sweating. And sometimes they’ll get 100, 200, 300 units.

Ray Chester: [00:14:40] What people don’t understand about Botox. And what I found is a lot of the doctors who inject Botox don’t realize this is just exactly what a unit is, because Botox is not measured by weight or volume. It’s measured by unit in a unit as a mouse unit. And it’s CLD fifty for a mouse. And LD 50 is a toxicological term, meaning the lethal dose in 50 percent of mice injected. So on average, it’s how much botox it takes to kill a mouse. So if you go in for cosmetic injections and you get the typical dose of 50 units, you’re getting enough in your face to kill 50 mice.

Ray Chester: [00:15:28] I just don’t know any other way to put it. You should see the doctors faces, the plastic surgeons and staff when I’m asking them that on the witness stand. And it’s first time they’ve heard it. And they’ve been injecting Botox for 10 or 20 years.

Ray Chester: [00:18:30] Everybody’s familiar with the warning label on pills and medicines. When you get it, just total package, insert that unfold with all the fine print. It’s not a very effective way to warn people in general, but for Botox. It’s a joke because that’s in the box with the vial. The patient never sees it. The nurse or the doctor opens the vial and mixes the saline and then draws up the injection and gives you the shots so you never even see the warning. Even if you did, you might see the black box warning, because that’s a very serious warning label required by the FDA only for the most dangerous drug.

Ray Chester: [00:19:12] Relatively new. That came out in 2009. I was one of the people that got that put on the product. But actually, Botox sales have gone up since then. They’ve gone up every year since its inception. And the black box warning didn’t even put a dent in them because nobody ever sees it. Nobody even knows about it. There’s also a medication guide that’s required to be given to the patient. And the vast majority of patients never even see that. If they do, it’s attached to the back. And we all know how much we read those informed consent forms, especially when we’re in a hurry to get our cosmetic Botox and get on with our lives. So the whole warning system is totally flawed and the doctors are totally convinced it’s safe. That’s because of Allergan’s marketing there. Their safety department has asked four people in it and their marketing department has like thirty five hundred people in it. And that that is an accurate reflection of the emphasis of the company. So they’ve got the doctors totally convinced that it’s safe and and therefore the patients are convinced it’s safe.

Ray Chester: [00:20:42] Well, you’re not supposed to market it for off label uses at all. There’s supposed to be zero tolerance and now it’s approved for a few narrow uses for children. But prior to about four years ago, it was totally not approved for any pediatric use. But in the cases I was involved in were children were injured or killed. We would go to the clinic where the children were injected. A pediatric clinic. And it turns out the Botox sales rep had called on them, you know, once or twice a week for the last 10 years, taken the staff, you know, lunch, taken the doctor out to dinner. Stuff like that. And they it’s such an elaborate program. They actually established a or like they they co-opted. That was like an acronym is supposed to be a non-profit educational organization for parents of children with cerebral palsy. And they co-opted that group and had them published a lot of materials about how great Botox was for pediatric spasticity, even though that wasn’t approved by the FDA because of safety reasons. That’s one of the things they got caught doing by the Feds when they pled guilty.

Ray Chester: [00:22:20] Definitely there’s been some reforms in that area. It’s not near as bad as it used to be, but it’s definitely a problem. Same thing happened in the cosmetic arena for both talk show as an outfit called Advanced Aesthetics, which seem to be a completely independent educational organization. Turned out it was totally a front for Botox. The nurse who injected Sharla Helton and doesn’t even have to be a doctor that injects you. It just has to be, quote unquote, under the supervision of a doctor. But she was a trainer for advanced aesthetics. And it turns out that was totally funded by Allergan as well.

Ray Chester: [00:23:33] Well, that’s a pretty rare side effect, fortunately, and a very controversial one. But in the early 2000s, some Italian researchers, fellow name Dr. Antonucci. I had the pleasure of meeting one time, published a groundbreaking paper that traced Botox injected into rat whiskers into the brain. And that was the first time it was proven that Botox can cross the blood brain barrier. And that that came into play big time when I represented a gentleman in Richmond, Virginia, by the name of Douglas Ray. Douglas Ray fought in the Vietnam War. And he came home from that with a slight tremor in his hand and might have been from Agent Orange or no one really knew what caused that. And it was mild. Over the years. But as she got older, it became more pronounced. And he was being treated by a neurologist at the V.A. center there in Richmond. And one of the off label uses of Botox is to treat tremors in the hand. And so she injected him in the forearm. And I can’t remember the exact dose. Something was 80 or 100 units, certainly moderate dose for that kind of thing. And then it didn’t work. Sort of like your situation. So she hit him again in two weeks, which you really should wait three months before getting any repeat Botox injections if you’re gonna get them at all. But, you know, the natural reaction of doctors is it’s the first one doesn’t work. Just like in your case. Try try again.

Ray Chester: [00:25:17] So she injected him again. And then within 48 hours, he had developed a rash all over his body and he became so sleepy. There’s a medical term for it’s called somnambulism, where he could barely hold his eyes open or talk. And that lasted for a few months. And then he lapsed into a coma and he was basically in a coma. Not a deep coma. He could be roused with very loud, vigorous external stimuli. He could be roused for a few seconds. He actually came into the courtroom for a few moments. And his wife tried to rouse him. We tried that case in Richmond, Virginia. And the whole controversy was whether or not Botox to get to the brain. And we won. We proved that it could. We actually got the largest single of verdict in the history of Virginia at that time. Two hundred and twelve million, because the jury was very mad that Allergan had hid all these dangers. The doctor who injected him actually was incensed by what she had been told by Allergan and became a leading researcher, an anti-Botox advocate, and still is to this day. Although I’m not going to say her name because Allergan has set out to try and destroy her career as a result of the paper she’s published.

Ray Chester: [00:26:56] No. I mean, I don’t get any Christmas cards from them. You know, they don’t like me or anything, but, yeah, they they can’t really do anything to me. They’ve ruined several other physicians career so that have that have taken stands against them. I’ve talked to several them over the years. It’s hard to find expert witnesses to testify in these cases because of that.

Ray Chester: [00:27:48] Well, you know, everybody has to weigh the benefits and risks of any drug. And with Botox, it’s the most lethal neurotoxin on Earth. It’s measured its dosage is measured in lethality. It usually doesn’t hurt you. But there’s many, many thousands and thousands of cases of spread of toxin and or botulism, terrible neuromuscular diseases, brain damage. And so those are the risks. And then you have to weigh that against the benefit, which is you won’t have wrinkles in your forehead for three months. And if you’re unhappy, nobody will be able to tell because you have this permanently surprised look on your face and you can’t frown. So I just try and explain the facts to people and then let them decide for themselves.

Ray Chester: [00:28:49] A much tougher case is people that have children with severe cerebral palsy and severe spasticity. Suddenly, children are so affected that their limbs are permanently drawn up and they can develop very painful contractures in their joints as a result of spasticity. There’s no cure for spasticity. There’s some heavy duty oral and I.V. medications that have tons of side effects. There is some radical surgery that involves sawing through tendons and whatnot. The best therapy for it is just constant stretching and massage, which is partially effective. And a lot of work. And so these parents and their doctors, many of whom are well, most of whom are well intentioned, are desperately looking for a cure for that.

Ray Chester: [00:29:47] And the risk of spasticity are high. And so people are willing to take a chance. Unfortunately, the doses required to treat spasticity in children are reaching toxic levels. And most of the worldwide deaths from Botox are children being treated for pediatric spasticity. So that one’s a tougher call because it’s a life or death situation either way. But I just try and explain the facts to them and anybody that all the people that I’ve talked to over the years that have learned the facts ahead of time. Have chosen not to get Botox and have dealt with spasticity other ways. The ones that do choose to get treated usually end up hiring me after the fact under not so great circumstances.

Ray Chester: [00:30:54] Well, not much is the short answer. I talk to people about this all the time. There’s no cure for any of these Botox side effects. There’s no cure for botulism. People that develop severe botulism from eating tainted food, they get put on a ventilator. It’s just it’s just supportive care. All you can do is, is treat the symptoms. If you have an auto immune disease, there are certain treatments for auto immune disease, but none of them terribly effective. Usually the Botox side effects, if you survive them, will eventually wear off. That’s not guaranteed. Some of them are permanent. Another thing that it causes in children that are injected is seizures. And seizure disorder is usually a lifelong and life-threatening affliction. And there’s no diagnostic test that can confirm what you’re suffering from was due to Botox. Now, there is a anti-toxin available from the CDC, but it has to be ordered by a physician and it’s only effective within like the first two or three days and it’s only partially effective. But they won’t even give it to you. There’s no sense in even taking it after the first two or three days. So medically speaking, I’m not a doctor, of course, but just treat the symptoms and try and get a lot of diagnostic tests to make sure it’s not something else.

Ray Chester: [00:32:31] There’s something else going on where it’s just a coincidence of the timing. But if it is from the Botox, there’s not much you can do except treat the symptoms. Legally, what you can do these days is almost a similarly limited so quick primer on pharmaceutical litigation. There’s three types of ways to hold a product manufacturer liable in the United States. If there’s a manufacturing defect if there’s a bad batch. That’s very rare and never has really occurred with Botox that we can prove, there’s a design defect, which is these products are so inherently bad that they should never be used on the market. And the proof for a design defect is so difficult that it will not apply to Botox and it would apply to 99 percent of pharmaceutical products.

Ray Chester: [00:33:31] And so almost all of the pharmaceutical litigation that you hear about Vioxx, Botox and stuff like that, Phin, and all of those, all of those masked towards, those are all failure to warn cases. That’s really the only cause of action available to victims pharmaceutical injuries in the United States. And failure to warn case is based on the premise that the manufacture had information about the risks, that it didn’t pass along to the medical community and the public in the form of the label, the package insert.

Ray Chester: [00:34:07] And before Botox had a black box warning in 2009, they had all the information about all the risk because deaths and injuries were being reported to them all the time. They had problems in their own clinical trials. They had all the information. They just chose to not publish it. So they didn’t want to hurt sales. And so almost all of the cases I tried were people that were injected prior to 2009 before the black box warning came out. So now if you got a Botox shot and suffered ill consequences and tried to sue them for failure to warn they would pull out the package insert and they would read to you a warning that exactly what happened to you, your doctor was warned against. And so that has the effect of insulating the manufacturer pretty much from liability. And it puts the onus on the doctor. So then people basically your only option is some kind of medical malpractice action. And those suits, those have rarely been successful.

Ray Chester: [00:35:53] Well, I just I’m glad you had me on because I spent so much time and have spent so much time over the last 10, 12 years talking to people after the fact they got Botox. Nobody warned them about anything. And now they’re very, very sick and scared and wanting to know what to do. And you’ve just heard my speech on what you can do, which is not much. And it’s it’s just very depressing to me. And so I relish the opportunity to talk to people perhaps on the front end and not trying to tell you what to do. But I’d just like for people to have all the facts. And so I’m glad you gave me this opportunity today.

Ray Chester: [00:36:50] Well, I don’t know much about that. I’ll leave that to you. But in terms of what we’ve been talking about, Botox and especially with women and men, I think the human face is designed to express emotions and to change gracefully over the years. And any attempt to alter that is just not natural. It doesn’t really improve your looks. You might think it does in the short term, but just just age gracefully and naturally and be able to use your expressions in your face. We want to know what you’re thinking.