In this episode of Justice with Dr. V, Greg Vigna, MD, JD, examines the biological plausibility behind the Depo-Provera meningioma litigation. He discusses how the birth control injection works, the history of Depo-Provera, scientific research involving DMPA and progesterone-only contraception, and questions surrounding what Pfizer knew about the potential risks. Dr. Vigna also breaks down research concerning progesterone-only contraception and meningioma recurrence, explaining why these studies may be significant for women who received Depo-Provera and were later diagnosed with a meningioma.
Watch the full video to learn more about:
• What the Depo-Provera birth control shot is
• The history of Depo-Provera •
The science behind the Depo-Provera lawsuits
• The biological connection between progesterone and meningiomas
• What Pfizer may have known about the potential risk
• Research involving DMPA and meningioma risk
• Progesterone-only contraception and meningioma recurrence
Subscribe to Justice with Dr. V for more medical and legal education regarding dangerous drugs, defective medical devices, neurological injuries, and patient safety.
Ben C Martin | Ben Martin Law Group 3500 MAPLE AVE. SUITE 400 DALLAS, TEXAS 75219 (214) 761-6614 | bencmartin.com
Greg Vigna, JD, MD | Vigna Law Group 8939 S. Sepulveda Blvd. Suite 102 Los Angeles, CA, 90045 817-809-9023 | vignalawgroup.com
Speaker 1
This drug is being sold in third world countries, where neurosurgeons can't be found for hundreds of miles. Why is this drug deemed appropriate when they're causing brain tumors ? Justice With Doctor Vigna, solo edition. Today we're going to be talking about Depo-Provera and meningiomas. And currently, my firm represents nearly 500 women who have suffered meningiomas we allege are possibly related to Depo-Provera.
00;00;26;05 - 00;00;58;09
Speaker 1
And we are preparing cases for trial. We have five cases that were selected in California GCCP. It's a consolidated litigation. And we're quite pleased with this. Depo-Provera as you might know, it's a birth control injection that came on the market in 1992 and is now known to be causally associated with meningioma. And it's important timeline for people to understand the concept, the biological plausibility.
00;00;58;11 - 00;01;28;25
Speaker 1
Because when adverse events happen, it is important to understand, well, hey, is this adverse event related to a drug? And that's all in the first analysis. And when risks are called into a company, the first analysis is: One, is this an important risk. An important risk is one that's defined as causing a serious injury. And then is it a potential adverse event.
00;01;28;27 - 00;01;57;10
Speaker 1
And potential adverse events are those that have some sort of mechanism that is related to the pharmacology of that drug. How that drug interacts with the body, that can share with the pathological process that leads to disease. And that is called biological plausibility, that if a a risk is reported to a company that's new. Is it biologically plausible?
00;01;57;17 - 00;02;36;15
Speaker 1
If it is, it becomes an important potential adverse event. And then if the body of literature or what is known inside the company shows that it's beyond potential, it then becomes a important identified risk. And the FDA has certain laws. Good clinical practice required by a pharmaceutical company requires these things to be disclosed. on the label. When was it known that it was biologically plausible to potentially cause meningioma?
00;02;36;18 - 00;03;19;26
Speaker 1
And you first need to really understand the history and the literature that relates to meningioma. And I'm going to go through that for those who are interested, because I'm interested. And the first association between women, hormones and meningioma was first identified in 1929 by a famous neurosurgeon named Doctor Cushing. And Doctor Cushing in 1929 identified a woman who was pregnant and had visual problems that, from a neurological exam, placed some sort of compressive lesion along the neurological pathways from the eyes to the occipital region.
00;03;19;28 - 00;03;53;28
Speaker 1
And he was able to localize that. There was likely a mass at the skull base that was responsible for the visual deficits that this woman had during pregnancy. And after she gave birth. The visual problems went away. And he found that very interesting. So what happened to this woman? Five years later, when she wasn't pregnant, she returned to Doctor Cushing with a recurrence of the symptoms of visual problems with headaches.
00;03;54;00 - 00;04;35;29
Speaker 1
And in 1929, he did brain surgery. And what did he find when he cut past the eye? He found a meningioma, and he associated that with the female hormones in pregnancy. A very smart man, of course. Then in the mid 1980s, there was a large case study that doctors from academic centers started comparing tumors in pregnancy and understood that meningioma, as were most associated with pregnancy in 1990, what we call in-vivo studies, studies that are kind of in a test tube.
00;04;35;29 - 00;05;15;11
Speaker 1
And they found out that progesterone, when it binds to the PR receptors, it has an effect that leads to mitosis. And what is mitosis? Mitosis is when cells divide. So as we sit here, as we age, cells just don't live forever. You know, the cells live and they die and they replace. And what we understand is that if you could kind of picture cell division at a rate like this.... doop.... doop....doop..
00;05;15;14 - 00;05;51;14
Speaker 1
If you have progesterone in the system it binds the receptors. There's a net increase in mitosis. So instead of going boop boop boop it goes boop boop boop boop. And it leads to increased cell division. And you say, well why is that important. Because the more cell division you have, it leads to mutations. And mutations just mean that we have double stranded DNA in our body.
00;05;51;18 - 00;06;17;14
Speaker 1
There may be 15 to 20 genes that it can lead to a meningioma. So here we go. It's splitting. You get a mutation there, you get a mutation there. You get a mutation back there. There is another one here. So each one is a little bit different. But each one of those mutations can lead to a meningioma at a given frequency.
00;06;17;17 - 00;06;59;04
Speaker 1
What is now known, and it's been knowable since they figured out the DNA aspects of medicine, is that when progesterone is in the system, it preferentially affects the skull base because those cells have more PR receptors. And it's been known since 2018 that there is a specific mutation that occurs generally at the skull base that leads to meningioma. As they tend to be multiple because progesterone preferentially affects mitosis, where there's higher levels of PR receptors on those cells.
00;06;59;06 - 00;07;34;10
Speaker 1
So ultimately, if there's Depo-Provera, binding to those receptors will increase the frequency of mutations leading to meningioma and causing those meningioma to grow. And, you know, for Pfizer to say, hey, this wasn't knowable until 2024, really? Scientists on their own, without any help of this company, figured it out to the specific mutation most associated with Depo-Provera. And you have a company saying, well, we got no idea.
00;07;34;10 - 00;07;59;10
Speaker 1
This wasn't knowable. I mean, we're doing the best we can. Come on. This is a drug that causes specific mutations and was known since 2018. And we have a warning that came down in December of 2025. And we believe that this was knowable going back to 1992. I'm an old guy, okay. And I was doing my residency in Houston at Baylor.
00;07;59;10 - 00;08;19;02
Speaker 1
I was practicing medicine at night so I could earn extra money so I could go on trips, enjoy myself, go out with nice dinners, and I worked every other night at a family practice clinic and every other weekend I was the only doctor manning a very busy clinic, practicing medicine, and a very busy clinic where we would see.
00;08;19;06 - 00;08;43;04
Speaker 1
I saw on one Saturday, 120 patients myself and many of those people came in, and many there were many women who were coming in for pap smears, breast exams, kind of female medicine. Okay. And they'd come in for their injection of Depo-Provera. For me, it was just an assumption. It was on the market that this drug was safe.
00;08;43;05 - 00;09;07;01
Speaker 1
I'm not really that happy about that. Okay. I would have liked to know. Known at all times that this drug is tumor genic, and I was not provided that risk. Had I known it was tumor genic, I would not have prescribed it. Okay. And it was knowable. We allege at all times, because of the biological plausibility for Pfizer to say that this was not knowable.
00;09;07;04 - 00;09;44;01
Speaker 1
Let's talk about what happened in 2006. You know, in the early 2000, there was chatter that cell phones were causing brain tumors. And obviously the manufacturers of cell phones, they didn't like that kind of press. Right. So the cell phone companies sponsored a very big study called the inner Phone study. Okay. The inner phone study. And part of that study was to find out what tumors are, were related to cell phones and what tumors were related to other things.
00;09;44;01 - 00;10;17;16
Speaker 1
And there was a concern first written about in 1997, that there was a concern by epidemiologists that sex hormones, women hormones, were associated with meningioma because there's a 2 to 3 times risk of meningioma in women compared to men. And that was a red flag that this group of doctors recommended real epidemiological studies. And so in 2006, the inner phone group published their data.
00;10;17;23 - 00;10;52;09
Speaker 1
They wanted to look at what we call confounding variables. And so they independently studied oral contraceptives and other forms of birth control. So they had one category that's in one table that included Norplant, the little pellets that go underneath the skin, which is a synthetic progestin, injectables. And the only one on the market was Depo-Provera. And they also included the Marina type IUD that was kind of laced with artificial progestin.
00;10;52;11 - 00;11;33;22
Speaker 1
They just could have it all in one category. And what that study showed was that there was a two times risk of meningioma was associated with the drugs that are in this bucket, which are all progestin, artificial progesterone. And there was a two times risk after three years of use. You have to understand that the dosage and the relative strength of Depo-Provera was loads higher than Marina, loads higher than Norplant, so that two times risk.
00;11;33;24 - 00;11;59;21
Speaker 1
If someone would have looked further, would have been able to identify hey, Depo-Provera, that's the problem. And no one looked at it. You know why? Because if you read the article, it doesn't even mention it. Because it was about cell phone. So, you know, I'm looking at this article and I see the table. I'm like, hey guys, where is this?
00;11;59;22 - 00;12;34;19
Speaker 1
Okay. It was ignored, largely ignored, and it was ignored until very smart doctors in Indonesia. And his name was Dr. Wada. Dr. Wada wrote his experience with meningioma in women who were on oral contraceptives and other contraceptives. And he identified a very large relative risk of Depo-Provera, and he discovered this problem. Problem is, it was a journal in Indonesia, so it was largely myth.
00;12;34;19 - 00;13;10;05
Speaker 1
But you have to understand a reasonable company that's making money selling drugs. They are supposed to review the literature, review the adverse events that come in, understand biological plausibility, update their warning. If there's adverse events, that's a problem. Then in 2018, Doctor Harlins actually was a resident neurosurgeon. She was working in the neurosurgery department at University of Colorado when this group of doctors in Colorado did a meningioma resection.
00;13;10;05 - 00;13;44;23
Speaker 1
That was grade one. They studied how these women did when they went back on birth control, and they had Depo-Provera women after resection of a meningioma and oral contraceptives. And what they found was that women who continued on with Depo-Provera, they had a higher recurrence rate than oral contraceptives, and the tumors that came back were larger than the women who were on oral contraceptives.
00;13;44;25 - 00;14;10;12
Speaker 1
Hey, that's a big red flag, okay? I would have liked to have known as a brain injury, doctor all of this. Okay. And where is the company saying this is important? And now we know that Depo-Provera is causative. It causes meningioma and it causes them to grow. There's a tendency to be multiple. Again, these are brain tumors. I mean, I'm a personal injury lawyer.
00;14;10;14 - 00;14;39;12
Speaker 1
I am a biochemistry major. I've taken care of people who have suffered serious complications from craniotomy and these are life changing surgeries. They change. People, cause psychological distress, PTSD, for those people who have even good outcomes. We feel quite good about this litigation and we believe Pfizer, Upjohn, RCA have reasons to know. We look forward to taking these cases to trial.
00;14;39;13 - 00;15;05;15
Speaker 1
The reason why we take cases to trials, because the story needs to be heard. The world needs to understand the risks that were known and the risks as this goes forward. Because right now, you know, in the United States, I don't see any kind of compelling reason that Depo-Provera is being used. There's other options. This drug is being sold in third world countries and where neurosurgeons can't be found for hundreds of miles.
00;15;05;15 - 00;15;26;06
Speaker 1
Why is this drug, deemed appropriate when they're causing brain tumors? What the company knew and what I call the sins of a company, what they should have done with that information to when these cases go to trial, these are going to be state court cases. They should be on TV. And we look forward to prosecuting these cases.
00;15;26;06 - 00;15;40;25
Speaker 1
I'll be prosecuting these cases for the next 20 years. I'm Greg Vigna Doctor Vigna, and I'm the principal owner of the Vigna Law Group. And my phone number is (817) 809-9023.