Pfizer Sued In Us Over Contraceptive That Women Say Caused Brain Tumours

The drugmaker Pfizer faces a US suit brought connected behalf of women who developed encephalon tumours, which they opportunity are linked to their usage of nan company’s contraceptive injection Depo-Provera.

The people action suit alleges that nan US pharmaceutical institution grounded to pass women and doctors astir nan accrued consequence of processing an intracranial meningioma if Depo-Provera, a quarterly injection, is utilized for much than a year.

A tribunal proceeding will return spot successful Pensacola, Florida, connected Monday.

Since May, nan number of lawsuits revenge by women successful nan US against Pfizer has tripled to much than 1,300, which person been consolidated successful nan multi-district litigation, according to nan rule patient Levin Papantonio, which is bringing nan action.

The imaginable declare worth could beryllium respective cardinal dollars, pinch nan number of lawsuits expected to emergence to betwixt 5,000 and 10,000 from women successful nan US.

A study published successful nan British Medical Journal successful March 2024 recovered that prolonged usage of definite progestogen medications was linked to a greater consequence of intracranial meningioma, which are tumours that shape successful tissues astir nan brain. Medroxyprogesterone acetate, sold arsenic Depo-Provera, was linked to a 5.6-fold higher risk.

Meningioma is nan astir communal type of benign encephalon tumour. They turn slow and are not usually cancerous but tin origin imagination aliases proceeding loss, headaches and seizures, and often request surgical removal. The room carries risks, specified arsenic imaginable harm to encephalon structures adjacent nan tumours.

Other studies besides recovered an elevated consequence associated pinch nan Pfizer drug.

The proceeding connected Monday will reside oral arguments from Levin Papantonio, connected behalf of affected women, and Pfizer concerning nan rumor of pre-emption. It will attraction connected 5 aviator cases to trial whether nan institution tin trust connected a pre-emption defence – communal successful supplier litigation – to debar liability.

Pfizer argues that it tried to person a tumour informing attached to nan drug’s label, but this was rejected by nan US regulator, nan Food and Drug Administration (FDA).

The institution said successful its tribunal filings: “This is simply a clear pre-emption lawsuit because FDA expressly barred Pfizer from adding a informing astir meningioma risk, which plaintiffs opportunity authorities rule required.”

The plaintiffs reason that Pfizer’s pre-emption defence fails because its petition to nan FDA was excessively broad, grouping Depo-Provera pinch different lower-dose hormonal contraceptives, and this led to nan regulator’s determination not to o.k. a tumour informing connected nan drug’s explanation successful nan US.

It is thought astir 247 cardinal women worldwide return hormonal contraceptives. In nan US, astir a 4th of sexually progressive women person utilized Depo-Provera successful their lifetime.

Marketed successful nan UK since nan 1980s, Depo-Provera is utilized by 15% of women successful nan country, besides for endometriosis. The informing label was only updated past year. Pfizer has said that it is “aware of this imaginable risk associated pinch semipermanent usage of progestogens” and has besides updated explanation warnings successful Canada and Europe.

Virginia Buchanan, partner astatine Levin Papantonio and court-appointed co-chair of nan plaintiffs’ executive committee, said: “Pfizer is attempting to debar accountability by invoking a pre-emption defence, yet location are superior questions astir whether it ever provided nan FDA pinch nan afloat picture.

“Pre-emption was ne'er meant to service arsenic a shield for supplier companies that neglect to pass patients adequately.

“Pfizer has consistently grounded to return reasonable steps to alert patients and their physicians to this very existent danger.”

The US rule patient Berger Montague is investigating whether Pfizer’s committee breached its fiduciary duties successful its trading and waste of Depo-Provera, for a imaginable shareholder ineligible action.