Episode Transcript
Lawsuit on post-Gardasil POTS with Attorney Drew Downing
[00:00:00] Jill Brook: Hello, fellow POTS patients and lovely people who care about POTS patients. I'm Jill Brook, and today we are going to discuss HPV vaccines as a potential POTS trigger. These vaccines are typically given to young people for prevention of some forms of human papillomavirus, a sexually transmitted virus, and you have heard us mention the vaccine as a rare potential trigger of POTS in previous episodes.
It's in the literature and in some expert presentations on POTS where it shows up on lists of potential triggers, but we rarely hear details beyond that, right? And we know some of you are curious to know more because we get your questions, such as How exactly would it cause POTS? And if it did cause your POTS, are there any ways to receive financial compensation?
We all know how expensive it can be to have POTS, and for some it can be financially devastating. And so if there is a way for some patients to get some financial help, We know that is of great importance to some of you. So we have received your messages and we have heard you. So that's why today we are talking with someone who has extensively studied this topic and comes at it from the legal perspective.
Our guest today, attorney Drew Downing, has gone deep into the science on this because he is presenting that science in court as he represents POTS patients in their attempts to qualify for financial compensation. Drew has been an attorney for over 20 years and specializes in vaccine law in the United States.
So we're planning to discuss post vaccine POTS from two angles. First, from the legal side and potential for compensation. And then from the scientific side, specifically what scientific evidence does Drew plan to present in court, and what does he think is the exact mechanism by which some HPV vaccines could, in rare instances, trigger POTS?
So, Drew, thank you for being here today.
[00:02:04] Drew Downing: Yeah, hi, Jill. Thanks for having me. I'm looking forward to it.
[00:02:07] Jill Brook: So I wanted to start by just reading off a few facts about government compensation for vaccine injuries and vaccine court, facts from a government website, because I want listeners to know that we're not being controversial or anti vaccine here. I mean, your legal work is part of a vaccine court and compensation system set up by the government, and they even pay you for your role in it.
So I just wanted to quote here from www.hrsa. Gov/vaccine-compensation/about where it says taking some snippets here quote "The National Childhood Vaccine Injury Act of 1986 created the National Vaccine Injury Compensation Program, a no fault alternative to the traditional tort system. It provides compensation to people found to be injured by certain vaccines. It was established after lawsuits against vaccine manufacturers and health care providers threatened to cause vaccine shortages and reduce vaccination rates. The program began accepting petitions in 1988."
It goes on to say "the United States has the safest, most effective vaccine supply in history. In the majority of cases, vaccines cause no side effects. However, they can occur as with any medication, but most are mild. Very rarely, people experience more serious side effects like allergic reactions. In those instances, the National Vaccine Injury Compensation Program allows individuals to file a petition for compensation."
It mentions that attorneys are paid directly by the program. And I'm almost done, but I'm still quoting here.
"Since 1988, over 26, 000 petitions have been filed with 10, 000 of those determined to be compensable. Total compensation paid over the life of the program is approximately 5 billion dollars." And then they just have a report showing how much money was awarded in every year and for each vaccine since 1988. And so for example, in 2022, they gave away approximately $200 million to petitioners and about $23 million to attorneys representing those people.
So that makes me think you're not the only attorney there. There must be a lot if they made $23 million in 2022. But that's all money paid by the government from a fund that charges 75 cents on each vaccine dose. So, I just wanted to put that all out there from the government's website so that we can hopefully bypass any feelings that your work might be controversial because your work is Part of a system designed by the government to compensate vaccine injuries.
They're even the ones paying you to do this work. I know I've heard you say many times that you and your family are all fully vaccinated, so you're not challenging the idea of vaccines. Do I have all of this correct so far?
[00:05:11] Drew Downing: Yeah, Jill, you do. Vaccination is probably the single most important scientific advancement in the 20th century. So without a doubt it serves an extraordinarily important medical purpose in our community. But, as you say, adverse events do happen. No medication is 100 percent safe and this program, the Vaccine Injury Compensation Program, was specifically established for a couple of different reasons.
The first is, as you said, it's to guarantee the supply of vaccination in the United States. It's to promote vaccination in the community at large, because obviously our goal is to get to herd immunity. With regards to viral and bacterial things that we run into on a daily basis. But all that being said, the government acknowledges that there will be a handful of individuals who suffer life altering, severe adverse effects, just as from any other medication, and this program was designed to compensate those individuals who suffer For lack of a better word, took one for the team and that's my job here is to serve as the advocate for those victims.
[00:06:32] Jill Brook: Okay, okay, so can we ask, how did you become involved with the vaccine court, and how did you become interested in representing POTS patients as part of this?
[00:06:42] Drew Downing: Sure, yeah, so I started my practice in medical negligence and products liability and ironically in the late 90s A friend had an adverse reaction to a vaccine wanted advice from me on what they should do, and I stumbled across the Vaccine Injury Compensation Program. You know, I had been litigating in products and medical negligence and had never heard of it.
As most people have never heard of it. And so I did represent her and we ultimately won her case. And I slowly started getting into the vaccine program, essentially by word of mouth and you get added on to a referral panel with the court and the practice has just sort of expanded over the last 25 years in the practice I have today which is you know, I have my own firm and we specialize solely in vaccine injury litigation.
Breathing POTS is something that happened in, in the course of my practice and it wasn't really something on anyone's radar. It probably in the late 2000s, 2010, 2012, I was getting cases. Calls from clients saying, I got a vaccine, and about a week or two after that, I started experiencing all these weird, nebulous, nonspecific symptoms.
Headache, fatigue, nausea, joint pain, when I get out of bed in the morning, I'm dizzy, I have to like, lay back down to make that go away, and nobody knew what it was. I'd never heard the term POTS, I'd never heard of orthostatic intolerance, I'd never heard of the autonomic nervous system. So, we started working these cases up and sending them to rheumatology, to endocrinology, to all these specialty doctors who would look at them and go, I don't know what's wrong with that person.
And over time, as the medical literature evolved in this regard, which as you and your listeners know, has really only been over the last 15 years. The term, you know, postural orthostatic tachycardic syndrome became something that I use in common parlance now, but it hasn't been that way for more than 7 or 8 years, and so my experience in that regard evolved over time with clients calling and so forth.
And then I think I sort of developed a reputation in our small legal community in terms of vaccine litigation of the guy who will talk to POTS people. I've got experts in that regard that I use routinely. And today I get, you know, multiple calls with families, you're just trying to figure out what has happened to them.
So that process in terms of my representing POTS victims has evolved just like everyone else's knowledge of POTS has evolved really over the last 15 years or so.
[00:09:58] Jill Brook: I'm guessing that when you say you have a reputation for being the one who talks to POTS patients, I'm guessing that just like in the medical world, POTS is more complex. That the lawyers who take on the anaphylaxis or the Guillain Barre syndrome, that's easier because more people know about it. It maybe has more distinguishable symptoms and the POTS is the stuff that Is kind of this whole big ball of wax that not everybody knows what to do with.
[00:10:28] Drew Downing: that, that is it in a nutshell, Jill. I mean, the POTS cases are complicated from the beginning you know, from the manifestation of symptoms. Many of these victims go five, seven years before they get a diagnosis. And see multiple physicians who just don't know what they're looking at.
And when you turn to the legal nature of a POTS case. It's no different. I mean, if you don't know what you're looking at, you'll miss it. And so I think that's where my expertise in this comes in is I've seen probably more of these cases than any other lawyer. And I know what these, these families are going through.
I know what their medical records say even if a lot of frontline treating doctors don't. a lot of times with a POTS patient, you can look at the medical chart and it just leaps off the page at you, but only if you know what you're looking at.
[00:11:29] Jill Brook: Okay. Well, before we go forward, I know that the question in everybody's mind right now is given how complex this is, and given that it can take so long to get a diagnosis even, have any POTS patients yet been compensated?
Or is this still aspirational?
[00:11:48] Drew Downing: No, they have not not in the vaccine program. The vaccine program has taken a very hard line stance against POTS. Most of the POTS cases originate following the human papillomavirus vaccine Gardasil. They do happen occasionally following other vaccines, but nowhere near as often and across the board those cases have been denied by the vaccine program.
I think for a couple of different reasons. I think the first is, unfortunately, in 2023, the vaccine program is relying on precedent that they developed in 2015. One of the cases that they routinely cite to is one of my first cases where I didn't even plead POTS because I didn't know what it was.
I had this young woman who was vaccinated and every time she stood up, she would black out and had all these other symptoms and, you know, we called it something different. In looking back, it was a POTS case. That case was denied for sort of lack of a formal diagnosis and so forth.
And so that's the stuff that the vaccine program is relying on today to deny POTS cases in the vaccine program today. When in reality over the last five years, the medical literature on POTS and, and how it happens and, and what happens with these these individuals is very clearly understood now.
[00:13:22] Jill Brook: Yeah, that's so interesting that it sounds like there's a pace at which the legal system works and then there's a pace at which medical research works and it sounds like the legal pace is slower.
[00:13:36] Drew Downing: It is, that's an astute way of recognizing it because I'll draw an analogy. When the vaccine program added the flu shot in 2007, the flu shot had been around for years. And so you had a body of medical literature that had developed following that particular vaccine. You knew that it had the potential to trigger Guillain Barre syndrome and other neurological type of, of consequences.
All that had sort of been developed, and then the vaccine was added to the vaccine program. Gardasil, for example, was added to the vaccine program at the time it came out. So you don't have any... Experience in the market to show what is happening with this vaccination, what's the nature of the adverse complaints that we're seeing and so forth.
And that takes decades to develop essentially where we are today now with the Gardasil vaccination as an example. Now we have a body of medical literature and experience developing where we can look back and see trends and so forth. And that's part of the problem. Unfortunately with POTS, it's caught up in the lack of history like we have with a flu shot or an M M R vaccine or something else.
It's unfortunate to POTS victims in the vaccine program because they're, they're being injured by that.
[00:15:06] Jill Brook: Okay, and I think that you are working on something to kind of move this forward and we'll talk about that in a minute. But 1st of all, do you mind just briefly describing the legal process by which a person would go about trying to get compensated for a vaccine injury in the normal vaccine program that's laid out?
[00:15:28] Drew Downing: Sure. Yeah. The vaccine program, like we said, was created for this alternative approach. It basically to take the heat off of the vaccine manufacturers and put it into a government compensation program. So one of the toughest issues with vaccine injury litigation is the vaccine program has a three year statute of limitations.
It's three years from the first onset of symptoms. And it doesn't matter whether you are aware of the existence of the vaccine program. It doesn't matter whether you haven't been formally diagnosed yet. It doesn't matter whether your treating doctor either told you about the program or maybe even told you that they didn't think that your condition was vaccine related.
None of that matters. It's a strict three year process from onset of symptoms. Now,
[00:16:23] Jill Brook: That's so tough for POTS patients. Wow.
[00:16:26] Drew Downing: I was going to say, it's incredibly penalizing. Because, you know, if you develop Guillain Barré syndrome, as you said, after the flu shot, that shows up in four to six weeks. And you're able to draw the connection because you're like, oh, wait a minute, I was fine a month ago, and now I'm not. Now I'm in the hospital on a ventilator.
So, it's easy to draw that connection. With POTS patients, and this is a very huge problem that we have in this litigation that we're doing with the HPV vaccine. Many of these individuals never put two and two together within three years. Most of them may have not even been diagnosed yet.
You know, they've just been floundering in a medical system trying to figure out what's wrong with them. And because of the insidious onset of POTS, you know, where it may start with gastrointestinal complaints and a headache and fatigue that... Never in a million years would you think to yourself, Oh my God, I'm in the middle of an autoimmune response to a vaccine.
And you've never heard of POTS either. So yeah, it's horribly penalizing and something that we are in this litigation and in Congress, we are trying to combat to get the statute of limitations modified, but it is what it is right now. It's three years from the first onset of symptoms.
So, that's your window to be able to make a claim. The process from there, assuming that you're timely, is you submit the claim the responding party in the vaccine program is the Secretary of Health and Human Services. The good thing, and you alluded to this earlier, is that the vaccine program itself will compensate me or another vaccine injury attorney.
So, there's no economic downside for a victim to retain a vaccine injury attorney to represent them. You don't have to hire me, but you should hire somebody that practices full time in the vaccine program to represent you because it doesn't cost you anything. And there are a lot of pitfalls.
For most vaccine injury claims, the government will evaluate these cases. Some of them are very straightforward. We keep alluding to the flu shot and Guillain Barre syndrome. That's a well known adverse event. If you have a flu shot and you develop Guillain Barre syndrome within six weeks, causation is almost presumed and you usually can get those cases resolved fairly quickly.
Sometimes I have to get experts, the government will get experts to respond and when that happens, sometimes these cases have to go to a hearing and they turn into litigious product liability cases at that point. But. Most of the time, if it looks reasonable on its face and there's a basis for bringing the case and it looks like maybe it was vaccine related, a lot of times we can get those cases resolved for compensation for the family.
Gardasil has been another monster altogether. Like we alluded to, a lot of the injuries have been POTS or autonomic dysfunction, orthostatic intolerance, those sorts of claims, and those have been met with resistance. And the treatment of POTS victims in the vaccine program is essentially what has spawned the litigation against Merck that I think we're going to start talking about here pretty soon.
[00:20:05] Jill Brook: Okay. Okay. So it sounds like no POTS patient has yet gotten any compensation out of the normal vaccine program. So yeah. So you want to talk about what you are doing now to try to help the people that you are representing who have POTS?
[00:20:23] Drew Downing: Yeah, so back two years ago we, three years ago how time flies, we started looking into the HPV vaccine and, and what is going on here, because as I said, the lion's share of POTS victims following vaccination are Gardasil induced. I've had five or six hundred Gardasil induced POTS victims.
I think I had one flu shot and one tetanus shot case that we believe was related. Everything else is Gardasil. So, there is a massive disparity with this vaccine and that prompted us to start looking into it. And, you know, Jill, it's a lot worse than we thought when we first started. There are way more POTS victims.
So, we started litigation against Merck, the manufacturer of Gardasil representing these victims. We filed several cases around the country because 1 victim is in Florida. 1 victim is in New York. 1 victim is in California. 1 is in Kansas. And we quickly found that we were going to have hundreds to thousands of plaintiffs asserting the exact same complaints.
So we were granted what is called a multi district litigation, or MDL. What that allows is it consolidates all of the cases into one federal court. It's not a class action. All of these cases maintain their individuality. It is simply a vehicle where the cases are consolidated before one federal judge who will handle everything. He'll handle the motion practice, he'll handle the discovery disputes.
We will do the discovery against Merck document wise and depositions and it's an efficiency issue, too, where, you know, certain witnesses only have to testify one time, and everybody in the MDL gets to use that deposition. That was granted and is now centered in the Western District of North Carolina, in Charlotte, in front of Judge Conrad.
Judge Conrad has been wonderful. He's a very what I sometimes call judicious judge. He's trial judge, very smart, very no nonsense, doesn't like any shenanigans in his courtroom. And I think both sides so far have been very happy with Judge Conrad, which at the end of the day is really all you can ask. And so that case is ongoing. And we suspect... The first cases will in that MDL will probably go to trial at the end of 2024, beginning of 2025.
[00:23:21] Jill Brook: Okay. So if I'm hearing you correctly, all of the people that you are representing, they have a pretty big chunk of their case that's going to be identical. And so you're wrapping up that all into one, but then do they each ask for a different settlement? Like, is there also a part where each of them have a unique piece to their individual case?
[00:23:45] Drew Downing: Yeah, so that's a good question because MDL litigation is a weird animal altogether. So, like I said, every case maintains its own individuality. What you end up doing and what we have done in this case is you select what are called bellwether plaintiffs. They are plaintiffs whose cases are going to go to trial first, and in an M D L there's, you know, typically 10, 15 cases that are selected.
We picked some, Merck picked some, the judge picks some, and it creates a pool of victims that everybody thinks accurately represents a majority of the plaintiffs in the pool. Almost all of the bellwether cases with the exception of three or four are POTS cases because that is the lion's share of the cases in this MDL and the judge rightfully so said, well, you guys got to talk to me about POTS.
If this is the 70, 80 percent or more of the cases filed in this litigation, then we're going to try some POTS cases. I want to hear from the experts and all that, and so you're right the MDL initial cases will represent mostly POTS victims.
Now what happens in an MDL if and when, but if Merck decided that they wanted to try to resolve it with us. Then a lot of times what will happen is they'll tender X amount you know, 10 billion. Here's 10 billion dollars, you guys figure it out. And at that point each case still maintains its individuality.
Usually settlements like that will be better than, you know, what an individual plaintiff could get on their own, but they are not forced into a settlement. It's not a class action, like where the lawyers make all the money and the... you know, the victim gets a coupon to Starbucks. It's a situation where, you know, we create algorithms and stuff to evaluate cases and so forth and an offer is presented.
If ultimately a family didn't think it was sufficient or whatever, they are still entitled to have their own trial. That carries consequences of its own whenever you do that, and we probably don't have time on this to get into civil procedure on how all that stuff works, but they do have that right. Nothing is shoved down their throat.
[00:26:16] Jill Brook: So okay, so let's move on to the science part of this because I was really surprised to hear you mention molecular mimicry because that's something that we have discussed on the POTScast before. We've talked about autoimmunity before and so there's something funny about seeing the hypotheses that we discuss now being presented in court.
But can you talk about your legal case that you plan to make and especially what is the scientific evidence that you will present to make your case that Gardasil caused POTS in your clients?
[00:26:55] Drew Downing: Yeah, yeah, no, molecular mimicry is a relatively foreign concept to anybody who either doesn't have an autoimmune disease or me, because,
[00:27:05] Jill Brook: should probably review it in case our listeners haven't been like studying up on every episode.
[00:27:11] Drew Downing: yeah, well, I'll explain it a little bit because the interesting thing in my practice, and this is sort of where I fit in with the Merck litigation and everything, I'm the vaccine guy. And the reason that that's important is in every other MDL, if it's, you know, a drug or a medical device or whatever that has caused injury, that is direct harm.
You took a drug and you responded to it poorly. Or you had a hip implant and, you know, because it released chromium and cobalt into your bloodstream, the tissue died and you had to have it explanted and now you're part of an MDL for that. That is not how vaccine injuries work. Vaccine injury, all vaccine injuries, with the exception of anaphylaxis or some sort of hypersensitivity response that happens immediately to the vaccine, every other vaccine induced injury is autoimmune.
What that means is that something came into your body to provoke an immune response. It could be a vaccine. It could be bacteria. Anything that provokes an immune response, the way that works is your body recognizes a foreign pathogen over, you know, millions of years of evolution, our immune systems have learned how to do this, and it recognizes the foreign invader, breaks it down, processes it, and then manufactures a killer cell whose sole purpose is to kill that thing that just came into the body, and those are called T cells.
For the T cells then start to circulate in the bloodstream and you and I have thousands of T cells designed to be programmed to kill something that we got infected with five years ago. But they're dormant. So what happens is in rare individuals, that process works exactly how it's supposed to. Let's use Gardasil as an example. Gardasil is injected and provokes the immune system to manufacture antibodies that are designed to kill certain strains of human papillomavirus. The current vaccine is designed to protect against nine strains of human papillomavirus.
So the body produces those antibodies. And then they start circulating. But in a rare individual, like a lot of POTS victims, the body's immune system makes a mistake, and it targets something that it's not supposed to. And the reason for that is it's running around looking for protein structures that look like human papillomavirus.
But because there is similarity, In protein sequences all over the place but if those auto antibodies circulating see something that looks enough like human papillomavirus, it's not human papillomavirus, but it looks enough like it, the immune system will make a mistake and it will target that host tissue. Because it thinks it's attacking HPV, when in reality, it's attacking you.
[00:30:41] Jill Brook: Okay.
[00:30:42] Drew Downing: in POTS patients, we know that the trigger for POTS can be an autoimmune attack on what are called adrenergic and muscarinic receptors, which are responsible for maintaining homeostasis on the autonomic side of this.
Tachycardia, blood pressure muscle tone and constriction. All of those are adrenergic and muscarinic driven. So we know that those receptors are responsible for POTS. That's been proven in an animal model. And it is, yeah, it was a rabbit model that they used.
It was published in the American Heart Association journal two years ago, where they actually induced POTS in rabbits by attacking the adrenergic and muscarinic receptors. And then they reversed POTS by blocking the attack on those receptors and that's proof of concept. So the animal model for POTS being autoimmune is beyond attack.
[00:31:50] Jill Brook: I could just summarize to make sure that everybody's on the same page. I think what you're saying is that the way that vaccines are designed to work is that they put a little bit of a pathogen, a deactivated pathogen in your bloodstream so that your immune system will create a response. It will create antibodies so that you are then protected from, in this case, the human papillomavirus strains.
But in some cases, people maybe get unlucky. There might be other reasons, but Part of your own human tissue at a molecular level looks very similar to that pathogen. And so it ends up getting attacked too. And you're saying in this case, it's those muscarinic and adrenergic receptors that can get attacked by your own antibodies. So you get damage there. And when enough damage accumulates, you start having the symptoms of POTS.
[00:32:50] Drew Downing: Yeah, you're invited to come present to the court in our MGL. That, no, that's it in a nutshell, Jill, and it's complicated, cutting edge science, but it's really not that hard. Molecular mimicry has been around for decades as the theory behind how a foreign pathogen can trigger an autoimmune disease.
Whether it's Sidenham's chorea, or lupus, or rheumatoid arthritis, or multiple sclerosis, or any of those, they're all autoimmune and they're all triggered by something. We weren't born this way. Nobody was born with POTS. It was triggered and unfortunately, they're a susceptible individual, but something triggered it. There's other things with POTS, I mean, it can be genetic, that's pretty rare. It's very clear in 2023 where it may not have been in 2015, But it is now, that a fairly large portion of POTS patients are autoimmune.
[00:34:00] Jill Brook: So if I were playing devil's advocate here, I would say, it sounds like you just described something where the vaccine didn't do something wrong, the immune system did something wrong.
[00:34:16] Drew Downing: Well, that's true but no different than you know, any other sort of eggshell plaintiff type of theory. I mean, clearly, there are some people who are susceptible where I didn't get Gardasil because I know about Gardasil, but I've had other vaccines.
I got my COVID shots you know, like I was supposed to and I'm not walking around with autoimmune disease. But certain individuals are. It's a combination of factors. It's a loss of immune tolerance. It's the aluminum adjuvant that is part of Gardasil. There are a lot of things that go into this, but the problem is, That it's not just you had this poor soul over here that was predisposed and ultimately developed POTS.
The litigation is, Merck hid it. I mean all you have to do is look up what Merck did with Vioxx. It's essentially the exact same playbook. You fudge the clinical trials so that they don't detect any adverse events and it's very clear how they did it here.
They did not use a placebo. They didn't use an inert control in the clinical trials. They used an aluminum vaccine. Or they used all of the stuff in Gardasil, the aluminum polysorbate 80, all of the other ingredients. That's what the control group was given. So when they measure, well, here's all the bad outcomes we had in the control, and here's all the bad outcomes we had with Gardasil, and they're about the same.
So there's no risk. Well, that is a classic shell game, and it's what they did with Vioxx. And you would've thought they would've learned, but they didn't. they did it again with Gardasil and it worked. they got approval. And you know, here we are. I mean, the, the Vioxx playbook and the Gardasil playbook are exactly the same.
You know, they misrepresented clinical trial results. They didn't undertake clinical trials that were designed to detect anything. And then if anybody spoke out about it, they get blacklisted. By, you know, Merck's rapid response team, whatever they call it. It's the same playbook.
And here we are in 2023 dealing with the exact same pharmaceutical company over the exact same issues.
[00:36:46] Jill Brook: Wow, so yeah, so this is, this is a lot to show, and earlier when you had mentioned discovery, can you say what discovery is in a case?
[00:37:00] Drew Downing: Yeah, sure. So, a lot of it is document discovery. We are trying to get documents all, dating all the way back to, you know, 2002, 2004, when they were in the process of working on Gardasil. We're in the process of getting documents with regards to, you know, their own internal tracking of adverse reactions stuff like that.
What do they present to the regulators? That type of stuff. That is paper discovery, and Merck is entitled to ask that from us as well. You know, they want to see with these young girls and boys, for example, with Gardasil who develop POTS, they want to see school records. They're entitled to see their medical records.
They want to see stuff like that. So paper discovery happens first, and then you move to depositions where we want to depose the, you know, people who were involved in the clinical development of Gardasil, who was making the decisions as to who got told what that type of thing.
And then the bellwether plaintiffs, the ones that have been selected as the initial trials, they will have to be deposed, too. As, you know, could be family members, maybe treating doctors. All of that is discovery. It's document discovery and then we all get to talk to whoever has personal knowledge about the issues that we're dealing with in the litigation.
[00:38:21] Jill Brook: And that's something that does not exist in the original vaccine court that we were talking about, right? So this that you're doing now goes back to sort of like the normal world of lawsuits where when it's time for discovery, you can ask for evidence from people's documents or history or whatever. And that's what would be new and different about this kind of lawsuit.
Is that correct?
[00:38:46] Drew Downing: It is. In the vaccine program, we still produce an entire medical file. So the government gets to see the medical file because obviously we have to figure out what we're dealing with and what it is. And then in rare cases, if it does have to go to hearing, sometimes the victim will testify, family, treaters.
And so forth. But in the vaccine program, Merck's not there. it is the victim and the government. And so, in the vaccine program, there's no discovery from Merck. We don't get any of that documentation about how the clinical trials were fudged for lack of a better word. We don't get any of that type of stuff.
So the discovery in the Merck litigation, the MDL is the first time that we are getting this type of stuff from Merck as to what happened here.
[00:39:35] Jill Brook: Wow. Okay. So this sounds like a really big deal. Is there still a three year deadline for this?
[00:39:43] Drew Downing: So the, the three year statute of limitations from the first onset of symptoms is a vaccine program deadline to file in the vaccine program and obviously you have to go to the vaccine program first. It's an administrative remedy that someone who feels as though they've been injured by a vaccine has to do first before you can get your permission to go after Merck.
Once you decide to go after Merck, that limitations period is controlled by your home state law. So, if you're in Florida or you're in Texas or, you know, wherever, Texas law or Florida law would control the limitations period in order to sue Merck. Because that's a product liability you know, negligence, fraud case outside of the vaccine program. So all those things like awareness and what's called the discovery rule. The discovery rule then comes into play then. You may have been injured back in 2014, but if you just put two and two together last week by reading something online or watching Jill Brook's podcast about the Gardasil litigation, if that's when you first became aware of the fact that you might have a remedy or the fact that Gardasil may have did this to you, then that is handled under your home state law under an awareness doctrine. It doesn't mean that Merck won't object. But there are different things that apply then.
[00:41:21] Jill Brook: So like, what's a range of times in different states?
[00:41:24] Drew Downing: yeah, a lot of states the statute of limitations is two years for these types of allegations. Some states have for fraud, have as short as a one year statute of limitations. Again, it starts to run, or what we say, your cause of action accrues.
When you are fully aware of what's happened to you and that you have a remedy, so, you know, if you've got listeners out there that even think there's a possibility that they need to talk to somebody about what happened to them, they need to do it sooner rather than later because there are time constraints all over the place.
There's time constraints in the vaccine program. There's time constraints in your home state. And they may be different for the allegations in the litigation. Like I said, it might be one year for fraud, two years for products liability. So you don't want your fraud allegation thrown out because you're untimely.
[00:42:26] Jill Brook: Yeah. So if there's patients out there listening right now who are wondering if maybe their POTS, you know, if they say, oh, wow, you know, now that I think of it this did happen within some short time period after a Gardasil shot, what should they be doing? Is there a place where they can go read more about this? Is there a book? Is there a website? Can they call you? What can they do?
[00:42:53] Drew Downing: Yeah, well, certainly the first thing that I would suggest is I think I would say there's, there's two places you should go. One is you can call me. For sure, or you can go to my website. And I'm happy to visit with whoever feels like they have questions in terms of figuring out what happened to them.
[00:43:14] Jill Brook: We'll put that in the show notes.
[00:43:16] Drew Downing: okay, perfect. Yeah, good. And then I would also recommend years back, 3, 4 years now, I partnered up with the Wisner Baum firm in LA. Michael Baum Bijan Isfandiari. They're great lawyers, and they are sort of spearheading the Merck MDL I'm on the plaintiff steering committee, but I'm a small firm and they are the mass tort firm.
So I would include the Wisner Baum firm's contact information. They've got a great section on their website devoted to the Gardasil litigation. It's very educational. I've got stuff on mine as well. But you know, if it looks like something that they really want to explore in terms of the Merck MDL, I would say start with Wisner Baum.
They're the tip of the spear on this issue, and, and that's where I would go. And like I said, we're working together on all these cases, hoping to bring a positive end to a lot of POTS victims struggles over the past 10 years.
[00:44:17] Jill Brook: Yeah, it's definitely rare to talk to an attorney who's so deep into the POTS world and so familiar with our struggles. That's just really interesting to talk to you. Is there anything else that you think people in our community should know right now?
[00:44:36] Drew Downing: You have a very educated and specialized audience with regards to POTS and autonomic dysfunction. There's a couple of things that I always find whenever I'm dealing with people who call me for the first time or, or whatever. Most of the time they still haven't been seen by a specialist. Even if they're going to a frontline cardiologist or whatever. There are folks out there that specialize in this.
And even if you have to drive a ways, it can be life changing to be seen by an autonomic specialist, typically an autonomic neurologist that is used to dealing with these types of cases, understands what you're going through, and is on the cutting edge of treatment protocols. Unfortunately, as everyone listening in is aware, I mean, there's no pill, there's no magic potion or anything that can fix POTS. But what you need is you need a specialist that understands what all of those treatment protocols are and can specifically tailor one to you, whether it be immunosuppressive therapy, medication, diet, exercise, a combination of any of the above you have to find your own treatment cocktail that might help you specifically because there's no book on POTS.
And I always think it's worth it to see somebody that all they do is autonomic nervous system issues. And, those people are out there and actually. One of my good friends is Mitch Miglis at Stanford, who is in the autonomic clinic there, and I know that he was asked in 2021 to be a part of the NIH's consensus group about POTS, because they've seen enough of a safety signal now with this disease to recognize that there's something weird here going on, and the two things that the NIH committee recommended was, one, funding.
And what they did, they compared the amount of funding that the NIH gives out for MS and lupus each year, which was hundreds of millions of dollars, and then they looked at how much funding was given by the NIH for POTS, and I think in 2021, or 2020, the last time they did it, that the amount of funding that was given out for POTS research was under 2 million, which, you know, is a 200 fold factor less than Than what they grant for MS, lupus, and other autoimmune diseases.
So number one was funding, and the second thing, which I thought was interesting, was a treatment network. The NIH needed to sponsor a treatment network in the United States that all of these autonomic specialists could become a part of, so that a patient had a resource to go to.
you struggle finding those individuals who specialize in this rare, weird you know, life altering disease.
I don't know what's going to come of that, whether we'll get more funding or not, but you know, write your congressman. Especially with COVID, POTS has gained some notoriety over the last couple of years. You know, you hear all those reports of long COVID and all that stuff, and anybody who's seen a POTS patient goes, that's POTS.
They've got POTS. So I think that there is a public awareness now more than ever about POTS that maybe wasn't there before.
[00:48:22] Jill Brook: Great. Well, thank you so much for all of your time and your information today and for what you're doing to help POTS patients get maybe some financial compensation if they've got their POTS in that particular way. And I'm sure you normally get a very high hourly fee, so we're really appreciative of your time.
[00:48:41] Drew Downing: Yeah, no, and Jill, thank you for having me on. Anybody that is involved in POTS and me, I'm no different. Awareness is the number one thing I think that we struggle with. It's getting the word out of what this disease is, what it does to people. You know, you can have debilitated POTS victims walking around on the street, and if you look at them, they don't look like they're hurt, which is one of the problems with this disease.
So I'm happy to have been on and obviously if any of your listeners have questions, you'll put my contact info up and I'd be more than happy to visit.
[00:49:14] Jill Brook: Okay, perfect. It will be in the show notes. So, thank you, Drew. We really appreciate you. And okay, listeners, that's all for now. We'll catch you next week. But in the meantime, thank you for listening. Remember, you're not alone. And please join us again soon.
