The drugmaker Pfizer faces a US lawsuit brought on behalf of women who developed brain tumours, which they say are linked to their use of the company’s contraceptive injection Depo-Provera.
The class action lawsuit alleges that the US pharmaceutical company failed to warn women and doctors about the increased risk of developing an intracranial meningioma if Depo-Provera, a quarterly injection, is used for more than a year.
A court hearing will take place in Pensacola, Florida, on Monday.
Since May, the number of lawsuits filed by women in the US against Pfizer has tripled to more than 1,300, which have been consolidated in the multi-district litigation, according to the law firm Levin Papantonio, which is bringing the action.
The potential claim value could be several billion dollars, with the number of lawsuits expected to rise to between 5,000 and 10,000 from women in the US.
A study published in the British Medical Journal in March 2024 found that prolonged use of certain progestogen medications was linked to a greater risk of intracranial meningioma, which are tumours that form in tissues around the brain. Medroxyprogesterone acetate, sold as Depo-Provera, was linked to a 5.6-fold higher risk.
Meningioma is the most common type of benign brain tumour. They grow slowly and are not usually cancerous but can cause vision or hearing loss, headaches and seizures, and often need surgical removal. The surgery carries risks, such as potential damage to brain structures near the tumours.
Other studies also found an elevated risk associated with the Pfizer drug.
The hearing on Monday will address oral arguments from Levin Papantonio, on behalf of affected women, and Pfizer concerning the issue of pre-emption. It will focus on five pilot cases to test whether the company can rely on a pre-emption defence – common in drug litigation – to avoid liability.
Pfizer argues that it tried to have a tumour warning attached to the drug’s label, but this was rejected by the US regulator, the Food and Drug Administration (FDA).
The company said in its court filings: “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 plaintiffs argue that Pfizer’s pre-emption defence fails because its request to the FDA was too broad, grouping Depo-Provera with other lower-dose hormonal contraceptives, and this led to the regulator’s decision not to approve a tumour warning on the drug’s label in the US.
It is thought about 247 million women worldwide take hormonal contraceptives. In the US, nearly a quarter of sexually active women have used Depo-Provera in their lifetime.
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Marketed in the UK since the 1980s, Depo-Provera is used by 15% of women in the country, also for endometriosis. The warning label was only updated last year. Pfizer has said that it is “aware of this potential risk associated with long-term use of progestogens” and has also updated label warnings in Canada and Europe.
Virginia Buchanan, partner at Levin Papantonio and court-appointed co-chair of the plaintiffs’ executive committee, said: “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.
“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.”
The US law firm Berger Montague is investigating whether Pfizer’s board breached its fiduciary duties in its marketing and sale of Depo-Provera, for a potential shareholder legal action.
