Women filing Depo-Provera lawsuits base their cases on several legal theories, primarily focusing on product liability claims against Pfizer and its subsidiaries.
These lawsuits allege the pharmaceutical giant failed in its duty to protect consumers by withholding key safety information about brain tumor risks while continuing to market the injectable contraceptive as safe for long-term use.
Most cases involve plaintiffs who received multiple Depo-Provera injections over periods exceeding one year before developing meningiomas.
Their legal teams must establish a direct causal link between the medication and their brain tumors while demonstrating that Pfizer knew or should have known about these risks based on available scientific data and regulatory actions in other countries.
Failure to Warn Allegations
Lawsuits against Pfizer center on claims that the company knew about meningioma risks but failed to warn U.S. patients while providing clear warnings in other markets.
The Canadian Depo-Provera label has mentioned meningiomas as a potential “post-market adverse drug reaction” since approximately 2015, nearly a decade before similar warnings appeared on U.S. packaging.
European Union and United Kingdom labels explicitly list meningioma under “special warnings and precautions for use,” yet identical U.S. labels lacked these warnings despite containing the same medication formulation.
A study published in the British Medical Journal reports a 5.6-fold increased risk of meningiomas with prolonged use has become central to plaintiffs’ claims that Pfizer should have identified and disclosed these risks much earlier.
Manufacturing and Design Defect Claims
Beyond warning failures, lawsuits argue Pfizer had safer alternatives but chose not to promote them to protect market share for the original formulation.
Legal filings point to Depo-SubQ Provera 104, a subcutaneous version containing the same active ingredient but administered differently, as a potentially safer alternative that Pfizer “hardly markets in the US.”
The standard 150mg intramuscular injection delivers a substantially higher hormone load than many alternative contraceptive methods, which may directly contribute to the increased tumor risk.
Plaintiffs argue Pfizer should have either promoted the subcutaneous option or redesigned the original formula to mitigate risks while maintaining effectiveness as a contraceptive.
These design defect claims focus on whether Pfizer prioritized profits over user safety by continuing to market the higher-dose version without adequate warnings, even after developing alternative delivery methods.
