Pfizer Hiding Popular Contraceptive’s Link to Brain Tumors, Lawsuit Alleges
Pfizer failed to warn patients that its injectable contraceptive drug, Depo-Provera, can increase the risk of developing a brain tumor, a lawsuit filed Monday alleges.
Pfizer and its subsidiaries “knew or should have known for decades that Depo-Provera, when administered and prescribed as intended, can cause or substantially contribute to the development of meningiomas,” a type of brain tumor.
Yet the company failed to warn users and prescribers and failed to change its U.S. label, according to the complaint filed in the U.S. District Court for the Central District of California.
Plaintiff Taylor Devorak, of Crestline, California, developed a tumor in her brain after taking the drug regularly as prescribed for several years. She is suing Pfizer and its subsidiaries that developed and sold Depo-Provera and its authorized generic version.
Pfizer has a duty to stay informed on relevant literature and to do its own long-term studies, the complaint says. Despite research published over decades indicating a possible link to the tumors — some of which existed even before the drug was licensed as a contraceptive in 1992 — the company and its predecessors never investigated this link or adequately studied such possible adverse events among women taking the drug.
“Instead, Defendants did nothing, and therefore willfully failed to apprise the medical community, and the women patients receiving quarterly high dose injections, of this dangerous risk,” the complaint said.
The complaint cited a high-profile 2024 study in The BMJ that found prolonged use of medroxyprogesterone acetate medications like Depo-Provera increased the risk of developing intracranial meningioma by 555%.
When The BMJ published the study, Pfizer told The Guardian it was “aware of this potential risk.” It has since changed the Depo-Provera label in the E.U. and the U.K. — but not in the U.S., according to the complaint.
“Pfizer has included meningioma as a possible adverse reaction to Depo-Provera on its Canadian label since 2015,” Ellen Relkin, one of the attorneys from the Weitz & Luxenberg firm representing the plaintiff, told The Defender. “However, American women are not told of this risk.”
Devorak alleges that because of Pfizer’s actions, she and her physician could not have reasonably known or learned of these risks, and as a direct result of being prescribed the drug, she has been permanently and severely injured.
She’s seeking damages from Pfizer for failure to warn, defective design, negligence, misrepresentation and breach of warranty.
Devorak’s complaint comes in the wake of a handful of similar lawsuits filed in other federal courts in California in recent weeks.
Relkin told The Defender her firm has filed five similar cases throughout California, and they are reviewing hundreds of other potential lawsuits from women suffering the same condition.
They plan to petition the court to combine the cases into multi-district litigation, which would centralize the litigation process and allow multiple cases to share discovery and pre-trial proceedings.
This would allow them to put together a team of good lawyers who could share resources so they could have “a strong army to fight Big Pharma,” which can bring tremendous resources to defend itself in court, Relkin said.
Devorak took Depo for nine years, unaware of the risks
When she was 20 years old, Devorak’s healthcare provider at Planned Parenthood prescribed Depo-Provera as a contraceptive. For nine years, she received 36 regular injections of the drug as recommended and prescribed.
By August 2018, she began experiencing symptoms that included blurry vision, double vision and trouble focusing. She had a difficult time driving and performing her job as a phlebotomist. Tests revealed she had a meningioma, a slow-growing tumor impinging her optic nerve.
Devorak underwent a complex intracranial surgery but it failed to completely remove the meningioma. She was advised against further surgeries because they would present serious risks to her vision and health. As a result, she continues to suffer serious injuries and damages.
Devorak had no idea that her tumor was connected to Depo-Provera until she saw publicity about The BMJ study earlier this year. She alleges that with full information, she would have made a different choice about taking the drug.
Pfizer legally liable for effects of Depo-Provera and its authorized generics
Depo-Provera is an injectable contraceptive that Pfizer promotes as one of the most effective contraceptives in existence, second only to sterilization, according to the complaint.
A clinician must administer the drug — which is an intramuscular shot containing a high dose of progestin to suppress ovulation — every three months. Nearly 25% of sexually experienced women in the U.S. between 2015 and 2019 have taken the drug. However, young, lower-income and Black women are the most common users.
Upjohn first developed the drug in the 1950s. It was introduced in 1960 to treat endometrial and renal cancer. Over several decades, the U.S. Food and Drug Administration (FDA) rejected Upjohn’s application to approve the drug as a contraceptive three times. In 1992, the agency finally approved Depo-Provera as a contraceptive.
Pfizer acquired Upjohn and its Depo-Provera in 2002 and has marketed the brand-name drug since then. Pfizer also produced “authorized generics,” which are exact replicas of the brand-name drug, for which it can also legally be held liable.
“Authorized generics” differ from regular generics, for which the pharmaceutical companies that designed the drugs cannot legally be held responsible for adverse reactions, Relkin said.
When did Pfizer know?
The complaint provided an overview of science going back to 1983. The overview includes findings that indicate a “foreseeable potential” that a high-dose synthetic progesterone delivered in the deep tissue could cause or contribute to the growth of meningioma.
A “sophisticated pharmaceutical company” like Pfizer would have been aware of and best positioned to investigate that potential link. It also would have had the responsibility to do so, according to the lawsuit. If it had, the plaintiff and “countless others” would have been spared pain and suffering.
Relkin said they can’t be certain exactly when Pfizer knew about the link, which they plan to uncover through the litigation. However, she said, in 2015, Pfizer changed the label in Canada to add a warning about meningioma, so the company was aware of the issue by then.
That same year, a systematic review provided more evidence of the link. Since then, other studies also have provided evidence of the link, with risk increasing the longer a woman takes the drug.
The largest of these studies analyzed the cases of 18,061 French women undergoing surgery for meningioma between 2009 and 2018 and found that prolonged use of Depo-Provera resulted in a 555% increased risk of developing intracranial meningioma.
The study also found the drug was more dangerous than other comparable contraceptive drugs.
Another recent study published in Cancers found Depo-Provera was associated with a 53% increase in meningioma.
There’s a safer alternative, but Pfizer didn’t promote it
Pfizer makes another, much safer form of the same drug — Depo-subQ Provera 104. Women can self-administer the safer form subcutaneously, meaning that it goes into the fatty tissue under the skin rather than into the muscle. This type of injection allows a drug to be absorbed more slowly.
Depo-subQ Provera 104 also comes in a substantially lower dose and can be administered less frequently — and it is just as effective as the original form of Depo-Provera.
Relkin said Depo-subQ Provera 104 is sold widely around the world, yet Pfizer hasn’t promoted it in the U.S. as an alternative to the original Depo-Provera.
“There’s this expression in toxicology that we always hear from defendants, which is ‘the dose makes the poison,’” Relkin said. “And here they are, literally overdosing women unnecessarily to get the same effect of stopping ovulation. You can use a lot less drug, but they just didn’t do what they should have done to switch patients and switch doctors’ prescribing habits.”
“It’s an overdose story,” she said.
Pfizer did not respond to The Defender’s request for comment on the lawsuit.
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