Pfizer is facing an unprecedented legal storm after more than 1,300 women in the United States filed class-action lawsuits against the company over its contraceptive injections.
Women claim that their use of the contraceptive injection Depo-Provera caused their brain tumors.
The number of these lawsuits has tripled since last May alone, with the total expected to reach between 5,000 and 10,000, in a case with potential damages amounting to billions of dollars.
The case is set to reach a critical juncture on Monday with a historic hearing in federal court in Pensacola, Florida. The hearing will focus on five "pilot" cases that will set the legal path for thousands of similar lawsuits.
The legal controversy centers on Pfizer's attempt to evade liability by using the "government approval" argument. The company claims that the FDA prevented it from including a brain tumor warning on the drug's packaging, thus exempting it from legal liability.
However, Virginia Buchanan, a lawyer representing the affected women, debunks this argument, saying, "Pfizer is hiding behind the pretext of government approval, but in reality, it has not provided the authorities with all the information." She explains that the company submitted a general and inaccurate application, deliberately combining high-dose Depo-Provera with other, less risky drugs, which led to the authorities' rejection.
These claims are based on scientific evidence, most notably a large French study published in the British Medical Journal in March 2024. The study revealed that continuous use of Depo-Provera for more than a year increases the risk of developing intracranial meningioma by a shocking 5.6-fold.
Depo-Provera, which has been marketed since the 1960s, is estimated to have been used by 74 million women worldwide.
Although these tumors are classified as "benign," their effects on patients are severe, causing loss of vision or hearing, epileptic seizures, and cognitive impairment, often requiring serious and risky surgeries.
Regulators around the world have begun to respond to this evidence, with the United Kingdom, Canada, and the European Union updating drug labels to include an explicit warning about the risk of meningioma.
The ramifications of this case are not limited to direct lawsuits. They also extend to independent investigations into whether Pfizer's board of directors breached its fiduciary duties. Similar lawsuits are looming in Australia, where a local law firm is gathering evidence from 2,000 women. This case represents a crucial test of accountability in the pharmaceutical sector and a delicate balance between medical innovation and public safety, at a time when global demands for greater transparency from pharmaceutical companies are increasing.
