Failure To Warn: Can You Sue If You Weren’t Told About Depo-Provera Side Effects?

Depo-Provera, a long-acting injectable contraceptive containing medroxyprogesterone acetate, has been used by millions of women seeking a convenient, hormone-based method of birth control. While it’s proven effective for pregnancy prevention, serious concerns have emerged over the years about the safety of prolonged use, especially regarding bone density loss and, more recently, the potential risk of developing intracranial meningiomas. Many patients now allege they were never properly warned about these serious health risks.

When patients are injured by a medication and believe the drug manufacturer failed to disclose or adequately warn about known dangers, they may be able to bring a product liability lawsuit under a legal theory known as “failure to warn.” In the case of Depo-Provera, plaintiffs are beginning to ask whether Pfizer, the drug’s manufacturer, met its legal obligations to inform both physicians and patients about the risks of long-term use.

What Is a Failure to Warn Claim?

In Florida and throughout the United States, manufacturers of prescription drugs have a duty to warn of known or reasonably knowable risks associated with their products. This duty applies both to physicians, under the “learned intermediary” doctrine, and, in some cases, directly to consumers.

A failure to warn claim is a type of product liability lawsuit alleging that the manufacturer did not provide adequate warnings or instructions about a drug’s dangers. This claim often arises under negligence or strict liability theories. To succeed, a plaintiff typically must show that the manufacturer knew (or should have known) of the risk, failed to issue proper warnings, and that the lack of warning was a substantial factor in causing the injury.

With medications like Depo-Provera, these cases often involve arguments that either the prescribing information was insufficient or that known risks were downplayed, misrepresented, or delayed in being disclosed.

What Side Effects Were Allegedly Downplayed?

The most widely recognized serious side effect associated with Depo-Provera is bone mineral density loss. The FDA issued a black box warning—its strongest type of warning—for this risk in 2004. The label warns that prolonged use may result in significant bone loss, which may not be fully reversible, especially in adolescents and young women. Physicians are advised to evaluate the risks and benefits of continued use beyond two years.

More recently, concerns have been raised about the association between long-term Depo-Provera use and intracranial meningiomas, which are brain tumors arising from the meninges, the protective layers surrounding the brain and spinal cord. Although often benign, these tumors can cause serious neurological problems depending on their location and size. Meningiomas are known to be hormonally sensitive, particularly to progesterone, the synthetic form of which is a key component of Depo-Provera.

In 2024, a study published in the British Medical Journal reported that women who used medroxyprogesterone acetate for longer than five years had a significantly increased risk of developing meningiomas. The risk increased with both the dose and duration of exposure. Although this association is still being studied, it has led several international regulatory bodies to issue new warnings.

Health Canada and the French National Agency for the Safety of Medicines (ANSM), for example, have updated their safety labeling to reflect this potential risk. In contrast, as of this writing, the U.S. FDA has not added a black box warning for meningiomas associated with Depo-Provera. However, this regulatory silence does not necessarily shield the manufacturer from liability if it had knowledge of the risk and failed to take timely action.

Legal Theories: Negligent Misrepresentation and Defective Labeling

In addition to failure to warn, other legal theories may support a claim against Pfizer. Negligent misrepresentation occurs when a company provides false or misleading information, whether intentionally or not, that leads to harm. If marketing materials, physician prescribing information, or public statements by Pfizer downplayed serious risks or presented the drug as safer than it was, this may support such a claim.

Defective labeling, a form of strict liability, focuses on the sufficiency of the warnings and instructions provided with the drug. Even if Pfizer did not intend to cause harm, if the warning label failed to include crucial risk information that was reasonably known at the time, the label may be deemed defective.

Lawsuits may also examine whether Pfizer was slow to respond to emerging safety data from global health authorities, or whether it delayed updating its labeling in light of known risks. If the evidence shows that the company had access to internal data, adverse event reports, or international regulatory decisions and failed to act, it may support liability.

Patient Harm and the Right to Sue

Women who have suffered adverse effects from Depo-Provera, particularly those who developed meningioma, may now be facing long-term medical care, neurological damage, and reduced quality of life. If these outcomes could have been prevented with a proper warning, patients have every right to seek legal redress.

A successful lawsuit may recover compensation for medical bills, lost wages, loss of earning capacity, permanent disability, pain and suffering, and more. In some cases, punitive damages may be available if the manufacturer’s conduct is found to be especially egregious.

However, product liability cases involving pharmaceuticals are complex. They require thorough medical and scientific evidence, expert witnesses, and a clear causal link between the drug and the injury. Working with an experienced legal team is essential to navigate these challenges and to ensure that the manufacturer is held accountable for its actions or inaction.

Contact Halpern Santos & Pinkert

If you were prescribed Depo-Provera and later developed serious side effects, such as bone loss or a brain tumor, and were never warned about these potential risks, you may be eligible to file a lawsuit. The Florida injury attorneys at Halpern Santos & Pinkert are actively reviewing claims involving Depo-Provera and other pharmaceutical products where patients were not adequately informed.

Our team has a strong track record of holding manufacturers accountable for failing to put patient safety first. Call us today or visit https://www.hsptrial.com to schedule your free consultation. We are here to help you pursue the justice and compensation you deserve.

Sources:

pfizermedicalinformation.com/depo-provera/boxed-warning

alllaw.com/articles/nolo/personal-injury/failure-to-warn-defective-product-case.html