A legal battle is brewing over Pfizer’s birth control injection, Depo-Provera, as more than 1,300 lawsuits have been filed alleging a link between the drug and the development of a type of brain tumor known as intracranial meningioma. The plaintiffs in these cases claim that Pfizer was aware of the potential risk but failed to provide adequate warnings or promote safer alternatives.
In Pensacola, federal judge M. Casey Rodgers recently heard oral arguments regarding Pfizer’s motion to dismiss the lawsuits on the grounds of preemption. Pfizer’s defense argues that they cannot be held liable under state law for failing to warn users about the potential risk because the change to the drug’s warning label is governed by federal law and the U.S. Food and Drug Administration (FDA).
Lead attorney for the plaintiffs, Virginia Buchanan, contends that Pfizer is using preemption as a strategy to evade accountability, asserting that the company may not have provided the FDA with complete information. Pfizer’s request to the FDA for a label warning was reportedly rejected because the request was too broad, combining Depo-Provera with other hormonal contraceptives, which led to the FDA’s decision not to approve the specific warning for brain tumors.
A recent study published in the Journal of the American Medical Association suggests that women receiving Depo-Provera injections have a higher relative risk of being diagnosed with meningioma, particularly with prolonged use and starting the medication at older ages. Despite this, the study notes a low clinical risk overall, given the high number needed to harm.
Buchanan argues that the body of evidence indicates significant risk, yet Pfizer has not taken reasonable steps to alert patients and physicians about the potential danger. As the legal proceedings continue, the outcome could have significant implications for how pharmaceutical companies handle warnings about potential side effects related to their products.
Pfizer has not provided any comments in response to these allegations. The case underscores the ongoing tension between pharmaceutical regulation at the federal level and individual state law claims, particularly in the realm of drug safety and consumer protection.