Pfizer is facing a landmark lawsuit in the US brought on behalf of more than 1,000 women who say they developed brain tumors after taking the popular contraceptive injection Depo-Provera.
On Monday, US time, Pfizer will appear in federal court in Pensacola, Florida, for a crucial hearing on whether the case — which could have a potential claim value in the billions of dollars — can proceed.
Thousands of women have filed lawsuits against Pfizer in different US states, alleging the pharmaceutical giant failed to warn patients and doctors about the increased risk of developing brain tumors when taking the birth control medication for more than a year.
Pfizer is seeking to have the case thrown out on the basis that the US Food and Drug Administration (FDA) rejected proposed label changes, shielding the company from liability in state courts under federal law.
“This is a clear pre-emption case because FDA expressly barred Pfizer from adding a warning about meningioma risk, which plaintiffs say state law required,” the company said in its court filings.
The plaintiffs will argue that Pfizer “misrepresented or withheld critical evidence in its label submission, rendering the pre-emption defence hollow”.
Judge Margaret Casey Rodgers, of the US District Court for the Northern District of Florida, will hear oral arguments on the pre-emption motion relating to five pilot cases in a hearing that will “set the course for the thousands of women awaiting their day in court”, the plaintiffs say.
“Pfizer is attempting to avoid accountability by invoking a pre-emption defence, yet there are serious questions about whether it ever provided the FDA with the full picture,” Virginia Buchanan, a partner at Levin Papantonio and court-appointed co-chair of the plaintiffs’ executive committee, told The Guardian on Sunday.
“Pre-emption was never meant to serve as a shield for drug companies that fail to warn patients adequately. Pfizer has consistently failed to take reasonable steps to alert patients and their physicians to this very real danger.”
As of last week, more than 1,300 women have filed lawsuits against Pfizer, with the cases consolidated into a multi-district litigation (MDL) brought by law firm Levin Papantonio.
An MDL is different from a class action as it consolidates multiple cases into one while allowing the plaintiffs to retain their original claims, meaning damages can be evaluated on a case-by-case basis.
Thousands more lawsuits are pending to be added to the MDL, with the potential number expected to rise to between 5,000 and 10,000, the law firm says.
“Patient safety is our top priority,” a Pfizer Australia spokeswoman said in a statement to news.com.au on Monday.
“We conduct rigorous and continuous monitoring of all our medicines, including assessments of reported adverse events, in collaboration with health authorities around the globe, including the Therapeutic Goods Administration, which makes independent decisions on safety and efficacy.
“Depo-Provera has been approved in more than 60 countries over the last 30 years and has been a safe and effective treatment option for millions of patients during that time.”
Medroxyprogesterone acetate, now marketed as Depo-Provera by Pfizer, has been available since the 1960s in the US and more widely in other countries since the 1980s, and is now used by millions of women worldwide.
Depo-Provera is a long-acting, high-dose hormone injection taken once every three months as an alternative to the contraceptive pill or other forms of birth control.
It works by preventing ovulation and is also used to treat menstrual disorders such as endometriosis.
Multiple studies have now linked Depo-Provera to diagnoses of meningioma, a type of benign tumor that affects the brain and spinal cord and often requires surgery to remove.
In March 2024, an extensive study published in the British Medical Journal, analyzing French national health data, found women who used long-acting contraceptives like Depo-Provera for more than a year had a five-to-six-fold increased chance of developing meningioma.
“In countries for which the use of medroxyprogesterone acetate for birth control is frequent (74 million users worldwide), the number of attributable meningiomas may be potentially high,” the authors wrote.
Similar studies in the US and Indonesia supported the findings.
While meningioma is non-malignant and slow-growing, it can put pressure on the brain and cause long-term side effects, including memory loss, seizures, worsening headaches, blurred vision, hearing loss and ringing in the ears, difficulty speaking, and weakness in the arms and legs.
The incidence of meningioma rises sharply after the age of 65, but is rare among women under 35.
“I thought my eye was watering and sore because of hay fever,” Sandra Somarakis, 61, who used Depo-Provera from 1996 until 2010, told Newsweek on Sunday.
“They sent me for an MRI, and an ophthalmologist called almost immediately — they’d found a tumor in my left eye socket. Within days, I was diagnosed with a meningioma.”
Somarakis had the tumor removed, but continued taking the injection. “I was never told that Depo-Provera might be linked to meningiomas,” she said.
16 months later, which she also had removed in January 2010 before undergoing six weeks of radiation therapy.
“Even now, I’m not the person I used to be,” Ms Somarakis said.
“I’ve lost many cognitive skills, and I can no longer work in the kind of high-pressure jobs I once excelled at. I have tinnitus and have lost hearing in my left ear — I’ll need a hearing aid for the rest of my life. I still get terrible headaches — it feels like my frontal lobe is about to explode. My left eye is still watery, swollen, and sometimes it pops out slightly.”
According to the US Centers for Disease Control and Prevention (CDC), 24.5 per cent of American females aged 15 to 49 have used Depo-Provera at some point.
In Australia, Depo-Provera has been available since the early ‘90s and is used by more than 24,000 women.
The drug has long been mired in controversy, with a history of being prescribed to drug users, the homeless, prisoners, and patients in psychiatric hospitals, ABC reported last year.
Potential Aussie lawsuit
Shine Lawyers announced in December that it was investigating a potential Australian class action against Pfizer on behalf of Depo-Provera users.
“Since opening registrations, we’ve heard from close to 2,000 Australian women, with many reporting diagnoses of at least one meningioma following use of Depo-Provera,” a Shine Lawyers spokeswoman told news.com.au.
“There may be many more women who have been affected.
“These tumors can have horrific side effects and are often extremely debilitating, impacting brain function, vision, hearing, and other senses. We’ve recently communicated with those who have registered their interest to date to gather further details that will help us progress the case.
“Subject to the outcome of our ongoing investigation, we anticipate being in a position to file a claim in the coming months.”
Australian women have previously raised concerns that they were not adequately warned of the possible health risks of taking Depo-Provera long-term, including meningioma as well as osteoporosis.
Warnings about osteoporosis and other serious side effects, including “seizures, paralysis, fainting and memory loss”, can be found on the consumer medicine information leaflet from the Therapeutic Goods Administration (TGA), although the document — last updated in March 2024 — does not explicitly reference meningioma.
The UK’s medicines regulator updated its warning label for Depo-Provera last year to include the risk of developing meningioma.
“If you notice any symptoms such as changes in vision (e.g. seeing double or blurriness), hearing loss or ringing in the ears, loss of smell, headaches that worsen with time, memory loss, seizures, weakness in your arms or legs, you must tell your doctor straightaway,” it reads.
TGA responds
The TGA confirmed it approved the addition of meningioma as a warning for Depo-Provera in February 2024, after Pfizer Australia submitted the change.
“Meningiomas have been reported following long-term administration of progestins, including MPA (medroxyprogesterone acetate),” a TGA spokesperson told news.com.au.
“MPA should be discontinued if a meningioma is diagnosed.”
The regulator said the Consumer Medicine Information was updated in March 2024 and “while the CMI does not mention ‘meningioma’ by name, it does contain information on what a patient should do if they experience the following symptoms: headaches, dizziness, nausea and vomiting, hearing loss, seizures, paralysis (symptoms of meningioma).”
The TGA added that “patients are best placed to talk with their health practitioners, for example their GP, about any concerns” as it does not provide clinical advice about treatments.
Researchers from the University of Queensland and QIMR Berghofer Medical Research Institute, in a study published earlier this year, found long-acting contraceptives were as safe as the pill when it came to invasive cancer risk.
“However, we only at looked at invasive cancers (meaning those that start at a primary site but have the potential to spread to other parts of the body),” the authors wrote in The Conversation.
They noted the recent French study linking prolonged use of the contraceptive injection to meningioma. “However, meningiomas are rare, especially in young women,” they wrote.
“There are around two cases in every 100,000 in women aged 20–39, so the extra number of cases linked to contraceptive injection use was small.
“There are benefits and side-effects for all medicines, including contraceptives, but it is important to know most very serious side-effects are rare.”
