In this episode, attorneys Ben Martin and Dr. Greg Vigna discuss lawsuits against Pfizer and other manufacturers over Depo-Provera, an injectable birth control drug linked to a 550% increased risk of meningioma, a serious brain tumor. They cite research from the British Medical Journal and explain that most Depo-Provera users are minority women, often due to limited access to other birth control options. The conversation covers the severe medical consequences of meningiomas, the lack of adequate warnings, and their firms’ nationwide efforts to hold pharmaceutical companies accountable.

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.