In the US, patients have filed a lawsuit against Pfizer over incorrect instructions for contraceptives.

Hearings in the case will begin on September 30 in federal court in Pensacola, Florida. The number of lawsuits has exceeded 1,300. According to Levin Papantonio, representing the victims, the number of claims could reach 5,000-10,000 in the future. The potential value of the claims is estimated in the billions of dollars.

The lawsuit states that using Depo-Provera intramuscular suspension for longer than a year increases the risk of developing meningioma. According to a study published in the British Medical Journal in March 2024, the use of medroxyprogesterone increases the risk of tumors by 5.6 times.

Pfizer claims it attempted to add a warning about the risk of tumor development to the labeling, but the FDA rejected the proposal. The company maintains that the case falls under the protection of liability, where the federal regulator prohibits labeling changes. The plaintiffs' lawyers argue that Pfizer acted too broadly by listing the risks for all hormonal contraceptives, which is why the FDA rejected the change.

Depo-Provera has been used worldwide since the 1980s. For example, in the UK, it is used by approximately 15% of women, including for endometriosis. In 2023, the UK updated the labeling to include a warning about the risk of meningioma. Similar changes were made in Canada and other EU countries.

In addition to the class action lawsuit, another law firm, Berger Montague, is investigating whether Pfizer's board of directors breached its fiduciary duties in the marketing and sales of the drug, which could lead to a separate shareholder lawsuit.