If you type “Depo-Provera” into Google, what pops up is not what you’d expect to see amidst a major lawsuit implicating one of the biggest pharmaceutical companies, concerning a drug that tens of millions of women around the world are currently using as birth control. What you’d see is… not much. Unless you specifically search for information on the ongoing Depo-Provera lawsuits, (which allege that drugmaker Pfizer failed to notify patients and doctors of the connection between Depo and a specific type of brain tumor), most of what you’ll find are health websites like the Clínica Cleveland and Planned Parenthood singing the birth control shot’s praises. Pfizer itself emphasizes the inject-it-and-forget-it convenience of the “Depo shot” in its product materials. But what Pfizer no ha said, to doctors and patients alike, is the reason they’re being sued.
What is Depo-Provera?
Before we discuss the Pfizer lawsuit, let’s take a step back. What IS Depo-Provera? From our Natural Womanhood primer on Depo, “Depo-Provera (produced by Pfizer) is the brand name of the drug medroxyprogesterone acetate and is the only form of the birth control shot available in the United States… As a progestin-only form of birth control, Depo-Provera prevents pregnancy by suppressing ovulation and thickening the cervical mucus to prevent sperm from coming into contact with an egg. It’s recommended as a highly effective form of birth control that eliminates the need to take a daily pill and does not include estrogen, which can cause blood clots…”
Depo’s sordid history
There’s lots no to love about Depo, including its increased risk of weight gain, increased risk of breast cancer, increased transmissibility of HIV, and more. Far from a secret or surprise, the most damning evidence against Depo has been available for decades. The link between Depo-Provera and cancer can be traced back to 1978 when the FDA originally denied Upjohn Co (later acquired by Pfizer), approval of Depo for contraceptive use, stating, “Never has a drug whose target population is entirely healthy people been shown to be so pervasively carcinogenic [with cervical and breast cancer] in animals as has Depo-Provera”.
“Never has a drug whose target population is entirely healthy people been shown to be so pervasively carcinogenic [with cervical and breast cancer] in animals as has Depo-Provera”.
FDA denial of Upjohn Co’s Depo-Provera application, 1978
Despite the FDA’s repeated refusals to approve Depo-Provera for contraceptive use, the World Health Organization (WHO) and the International Planned Parenthood Federation (IPPF) distributed Depo to millions of women in impoverished countries, particularly in Africa and South America. A 1979 Mother Jones exposé summed up:
“To the Third World consumer, a new product from the U.S. may seem to represent the latest in scientific research. But the overseas consumer of Depo doesn’t know that the ‘latest research’ is what prevented the contraceptive from being approved for use in the United States, and that is why it is being dumped.”
1979 Mother Jones article spelled out Depo’s risks
Among the potential complications of Depo use, the 1979 Mother Jones article also mentioned that “Depo-Provera causes nodules in the breasts and cancer in the reproductive organs of test animals….‘irregular bleeding disturbances,’ which have been described in one medical journal as ‘menstrual chaos… [reduced] resistance to infection… weight gain, headaches and dizziness.”
What’s more “Its effects are not readily reversible: use may be followed by long-term or even permanent sterility. If injected into a pregnant woman (and almost every field study has reported the accidental injection of pregnant women), it can cause birth defects, especially congenital heart defects, and, in the case of female fetuses, masculinization and enlargement of the clitoris.” And these abuses didn’t just happen overseas: in addition to experimentation on poor women in foreign countries, Depo was prescribed as a contraceptive to Native American women long before FDA approval.
Despite the myriad evidence of risk and its history of unethical research practices, Depo-Provera was finally approved by the FDA in 1992 as a contraceptive, provided that Pfizer listed the risk of bone density loss and the possibility of breast and cervical cancers on Depo’s packaging.
How is Depo-Provera connected to meningiomas?
Now, back to those modern-day Pfizer meningioma lawsuits.
Meningiomas are tumors on the membranes, or meninges, that cover the brain. Most, but not all, meningiomas are benign or non-cancerous, with 10-15% being cancerous. Although a “benign” tumor may sound less threatening than a cancerous tumor, according to Brigham and Women’s Hospital, “depending on location and growth rate, a benign meningioma brain tumor may impinge on vital nerves or compress the brain, causing disability. They may even become life threatening.” The tumor location determines the symptoms experienced, but the most common are headaches, blurred vision, seizures, numbness or weakness, difficulty with speech, and memory or hearing loss.
Often meningiomas grow slowly, causing a subtle onset of these symptoms before the tumor is finally discovered. As they typically do grow slowly, once found and if still small, doctors will monitor the tumor with regular CT or MRI scans. Surgery or radiation may become necessary in order to completely remove the tumor depending on the size and location.
While it’s still uncertain qué causes meningiomas to form, women are at higher risk than men. There is also a correlation between meningioma and increased radiation exposure, certain inherited genetic conditions, and using synthetic progesterone (i.e., progestin) or estrogen-based medications.
The connection between Depo-Provera and meningiomas came to light decades ago
Almost 10 years antes de Depo-Provera was approved by the FDA, there was a study published by the European Journal of Cancer & Clinical Oncology in 1986 on the relationship between progestins and meningiomas. Out of 67 meningioma tissue samples from 64 different patients, 80% of the samples had a very high concentration of progesterone receptors, i.e., certain proteins that act like magnets for progesterone (and its synthetic counterpart, progestin). The Depo shot, with its high concentration of progestin, may not only causa these usually-benign tumors, but also help them grow larger with each subsequent dose [2].
What started the current lawsuit over Depo-Provera and meningioma risk?
The impetus for the current lawsuits against Pfizer concerning Depo-Provera, which will likely be consolidated into what’s called multidistrict litigation, was the March 2024 publication of a French study comparing the use of different types of progestins with the subsequent likelihood of meningiomas forming [3]. It found that women who took the Depo shot for 12 months or more were 5.6 times more likely to develop meningiomas than women who were not on Depo.
The French study found that women who took the Depo shot for 12 months or more were 5.6 times more likely to develop meningiomas than women who were not on Depo.
In fact, out of the 8 different types of progestins that were tested for correlation with meningiomas, medroxyprogesterone acetate, the specific progestin found in Depo-Provera, by far carried the más significant risk of meningiomas [2].
Pfizer is being sued for “failure to warn”
The lawsuits against Pfizer allege several things, including that the drugmaker rushed Depo-Provera to market without conducting adequate long-term safety studies. They further claim that Pfizer failed to address and even purposely downplayed adverse event reports. Pfizer is also accused of “failure to warn,” i.e., despite having evidence of meningioma risk, the drug company never updated product warning labels to reflect that risk, or notified doctors and pharmacists of the risk.
According to one Chicago-based personal injury lawyer, failure to warn lawsuits stand on the grounds that pharmaceutical companies have a duty to “warn via intermediaries–such as pharmacists and physicians. If they fail to warn these intermediaries of known side effects, then the manufacturer is responsible for any effects that occur.” And, according to the Lawsuit Information Center sitio web, failure to warn also “means that even if the drug itself is not inherently defective, a manufacturer can still be held liable if they fail to adequately disclose serious side effects or risks that are reasonably foreseeable.”
“In the case of Depo-Provera,” continues the Lawsuit Information Center, “the link between the drug and meningiomas was not listed as a potential risk or side effect in the drug’s warning label, at least not in the United States. Depo shot lawsuits will argue that Pfizer knew or should have known of the risks, so its failure to update its warning label to reflect this potential danger makes a failure to warn claim.”
Is Pfizer really at fault?
Had the company not known about the relationship between progestins and meningiomas, a “failure to warn” lawsuit might not stand. However, the studies mentioned in this article are just some examples of decades-old research, of which it is highly unlikely Pfizer was unaware.
Let’s take a look at what Pfizer has to say about its own drug, from the patient information section of their Depo-Provera page:
Depo-Provera CI can cause serious side effects, including:
- Use of Depo-Provera CI may cause you to lose calcium stored in your bone and decrease your bone mass. The longer you use Depo-Provera CI, the greater your loss of calcium from your bones. Your bones may not recover completely when you stop using Depo-Provera CI.
- If you use Depo-Provera CI continuously for a long time (for more than 2 years), it may increase the risk of weak, porous bones (osteoporosis) that could increase the risk of broken bones, especially after menopause.
- You should not use Depo-Provera CI for more than two years unless you cannot use other birth control methods.
- It is not known if your risk of developing osteoporosis is greater if you are a teenager or young adult when you start to use Depo-Provera CI
What Pfizer tells doctors
On the section of the Pfizer Depo page for prescribing doctors, there are additional warnings listed that are no on the patient information page: “loss of bone mineral density, thromboembolic disorders, cancer risks (breast, cervical, and “other” cancers), ectopic pregnancy, anaphylaxis and anaphylactoid reaction, injection site reactions, liver function, convulsions, depression, bleeding irregularities, weight gain, carbohydrate metabolism, fluid retention, return of fertility, interference with laboratory tests.”
Tellingly, there is not one mention of meningiomas on the consumer-facing or prescriber-facing website despite Pfizer’s statement after the publication of the March 2024 French study: “We are aware of this potential risk associated with long-term use of progestogens and, in collaboration with regulatory agencies, are in the process of updating product labels and patient information leaflets with appropriate wording.’”
Lo esencial
It’s hard to see how Pfizer no es at fault when looking at the decades’ worth of studies showing a link between progestins, cancers, and meningiomas, combined with the duty pharmaceutical companies have to provide doctors and their patients with the information needed to make informed healthcare decisions. There are approximately 74 million women around the world (and 2 million in the US alone) taking Depo-Provera, and many aren’t just taking it for birth control, but to manage symptoms of other medical conditions like polycystic ovary syndrome (PCOS) and irregular periods. Pfizer’s continued lack of transparency on the dangers of Depo has likely caused thousands of women to endure the suffering caused by these brain tumors–whether benign or not. These women deserve justice, and they deserve better options for both family planning and for healing from reproductive disorders than a drug that might be giving them brain tumors.
