Pfizer continued in us for contraceptives which, according to women, caused brain tumors | Pfizer

The manufacturer of drugs Pfizer faces an American trial brought in the name of women who have developed brain tumors, who, according to them, are linked to their use of the contraceptive injection of the company.

The collective appeal alleges that the American pharmaceutical company has not warned women and doctors of an increased risk of developing 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 prosecutions deposited by women in the United States against Pfizer has tripled for more than 1,300, which have been consolidated in the multi-disclint dispute, according to the law firm Levin Papantonio, which leads to the action.

The potential value of the complaint could be several billion dollars, the number of prosecutions that should reach between 5,000 and 10,000 women in the United States.

A study published in the British Medical Journal in March 2024 revealed that the prolonged use of certain progestinic drugs was linked to a greater risk of intracranial meningioma, which are tumors that form in the tissues around the brain. Médroxyprogesterone acetate, sold under the name of Depo-Provera, was linked to a risk of 5.6 times higher.

Meningioma is the most common type of benign brain tumor. They develop slowly and are generally not cancerous but can cause a vision or hearing loss, headache and convulsions, and often need surgical withdrawal. Surgery has risks such as potential damage to brain structures near tumors.

Other studies have also found a high risk associated with the Pfizer medication.

The audience on Monday will address the oral arguments of Levin Papantonio on behalf of the women affected, and Pfizer concerning the question of preemption. He will focus on five drivers to test if the company can rely on a pre -emption defense – common in medication disputes – to avoid responsibility.

Pfizer argues that he tried to have a tumor warning attached to the drug label, but this was rejected by the American regulator, the Food and Drug Administration (FDA).

The company declared in its judicial files: “This is a clear pre -emption case because the FDA expressly prohibited Pfizer from adding a warning concerning the risk of meningioma, which, according to the complainants, say that the law of the state required.”

The complainants argue that the defense of Pfizer’s pre-emption fails because its request to the FDA was too wide, bringing together Depo-Provera with other low-dose hormonal contraceptives, which led to the regulator’s decision not to approve a tumor warning on the drug label in the United States.

It is believed that around 247 million women worldwide take hormonal contraceptives. In the United States, almost a quarter of sexually active women used Depo-Provera in their lifetime.

Sales in the United Kingdom since the 1980s, Depo-Provera is used by 15% of women in the country, also for endometriosis. The warning label was updated last year.

Pfizer said that it was “aware of this potential risk associated with long -term use of progestins” and has also updated label warnings in Canada and Europe.

Virginia Buchanan, partner of Levin Papantonio and co -chair appointed by the court of the complainant’s executive committee, said: “Pfizer tries to avoid responsibility by invoking a defense of pre -emption, but there are serious questions on the question of whether it has ever provided the FDA the complete image.

“The pre -emption has never been supposed to serve as a shield for pharmaceutical companies which cannot warn patients adequately.

The American law firm Berger Montague investigation to find out if the board of directors of Pfizer has violated its fiduciary tasks in its marketing and sale of Depo-Provera, for a potential legal action of shareholders.