Women file lawsuit against Pfizer in the US over contraceptive allegedly linked to brain tumors
Pfizer Faces Escalating Legal Battle Over Alleged Contraceptive Injection Risks
Class Action Lawsuit Against Pfizer Grows Amid Allegations
Pharmaceutical giant Pfizer is embroiled in a growing legal controversy as over 1,300 lawsuits have been filed in the United States by women alleging that the company’s contraceptive injection, Depo-Provera, led to the development of brain tumors. The suits claim Pfizer neglected to inform users and healthcare providers about the increased risk of developing intracranial meningiomas with prolonged use of the injection, which is administered quarterly.
Key Court Hearing Scheduled in Florida
A significant court hearing is set to take place in Pensacola, Florida, where oral arguments will be presented by the law firm Levin Papantonio, representing the affected women, and Pfizer. The hearing centers on the issue of pre-emption, commonly used in drug litigation, to determine if Pfizer can avoid liability by arguing that any warning about tumor risks was rejected by the Food and Drug Administration (FDA).
Legal Implications and Potential Outcomes
- The lawsuit’s potential value is estimated in the billions, with expectations for the number of plaintiffs to increase substantially.
- A British Medical Journal study found a 5.6-fold increase in risk for intracranial meningiomas linked to the progestogen medication in Depo-Provera.
- The hearing will involve five pilot cases to evaluate the validity of Pfizer’s pre-emption defense.
Pfizer Responds to Safety Concerns
Pfizer contends that it sought to include a warning on the drug’s label, but the FDA rejected their request, arguing that it grouped Depo-Provera with other lower-dose contraceptives—a factor that influenced the FDA’s decision. The company has asserted that the FDA’s rejection effectively constitutes a defense under pre-emption laws. Pfizer has also updated label warnings in Canada and Europe, acknowledging a potential risk with long-term use of progestogens.
Broader Implications for Women’s Health
| Usage Statistics | Market Regions |
|---|---|
| 247 million women worldwide use hormonal contraceptives | 15% of UK women use Depo-Provera for contraception and endometriosis |
| Nearly a quarter of U.S. sexually active women have used Depo-Provera | Label updates were made in the UK last year |
As the lawsuit progresses, the U.S. law firm Berger Montague is exploring potential shareholder actions, investigating possible breaches of fiduciary duty by Pfizer’s board in the marketing and sale of Depo-Provera. Virginia Buchanan from Levin Papantonio has argued that Pfizer’s defense strategy raises questions about whether the company adequately informed the FDA of risks involved, stating that pre-emption should not serve as a shield for inadequate warnings.
For ongoing updates on this developing legal battle and its implications for public health policy, continue following coverage from Emegypt.
