Since its FBA approval, millions of women have turned to Depo-Provera, a birth control injection, as a convenient and long-lasting contraceptive option.
Yet a growing body of evidence links it to severe health risks, including brain tumors. The FDA has issued stern warnings, and lawsuits have surfaced, alleging that manufacturers failed to adequately disclose these dangers to patients.
If you’ve used Depo-Provera and are now grappling with unexpected health complications, you may have legal options. Whether you’re seeking clarity on your next steps or simply want to stay informed, keep reading.
If Depo-Provera has affected your health, call a Michigan medical malpractice lawyer at (313) 438-4357 today to explore your options for pursuing justice.
Schedule a Free Initial Consultation Today!
What Is Depo-Provera?
Depo-Provera, the brand name for medroxyprogesterone acetate, is a prescription contraceptive injected every three months to prevent pregnancy. Its appeal lies in its simplicity—one injection offers reliable contraception without the daily commitment of oral pills or the insertion of devices.
The Health Risks of Depo-Provera
Over the years, researchers and healthcare providers have raised serious questions about its long-term effects on women’s health.
Depo-Provera’s Rocky Past
In 1960, Depo-Provera was introduced as an injectable treatment for endometrial and renal cancer. However, it wasn’t until 1963 that medical experts began clinical trials to evaluate Depo-Provera's effectiveness as a contraceptive.
Initial trials looked promising, but in 1967, the FDA ultimately rejected the first attempt to get Depo-Provera approved for contraception due to findings of cancerous tumors in animal trials. It was denied again in 1978 for the same reasons.
Bone Density Concerns: A Long-Recognized Issue
One of the most prominent risks associated with Depo-Provera is its impact on bone health. Long-term use has been linked to significant bone mineral density loss, increasing the likelihood of fractures.
A study published in Fertility and Sterility found that women using Depo-Provera for more than two years exhibited reduced bone density, particularly in weight-bearing areas like the spine and hips.
The U.S. Food and Drug Administration (FDA) responded to these findings by issuing a black box warning, the agency’s most serious alert, emphasizing the risks of prolonged use. The warning advises limiting Depo-Provera to two years unless no alternative is feasible.
The Link to Meningioma: A Brain Tumor Risk
Recent research has also unveiled an unsettling connection between Depo-Provera and an increased risk of meningioma, a typically benign but potentially harmful brain tumor.
A 2024 study published in The BMJ in March of that year found that women exposed to high-dose progestogen-based contraceptives, including Depo-Provera, were more likely to develop meningiomas compared to non-users. This risk, potentially exacerbated by improper administration of medication, escalates with prolonged use.
Despite years of knowing about the risks, this study finally broke the camel's back.
Shortly thereafter, Pfizer released a statement acknowledging the risks but did not officially take any action until July 2024, when they finally updated the prescribing guidelines for Depo-Provera in the U.S. to include information on brain tumor risks. However, they did not update the official warning label.
Legal Cases and Litigation
The Depo-Provera brain tumor lawsuits are just beginning to surface in courts nationwide, and they have yet to consolidate into a formal multidistrict litigation (MDL).
However, given the early indicators and the sheer size of the potential plaintiff pool, MDL consolidation seems almost inevitable.
According to the FDA, nearly 25% of sexually active women in the U.S. have used Depo-Provera as a contraceptive at some point. This translates to 30 to 50 million women.
Even if only 1% of these users develop meningiomas, the potential plaintiff pool would reach approximately 300,000 individuals—a staggering figure.
Historically, mass tort cases with plaintiff numbers of this magnitude tend to consolidate into MDLs to streamline the legal process. Thousands of lawsuits could emerge, making MDL consolidation the most practical path forward.
Pfizer, the primary defendant in these cases, will likely support MDL consolidation under these circumstances. Centralizing the cases would allow for coordinated pretrial proceedings and provide a more structured approach to handling what could become one of the largest product liability litigations in recent history.
What Is Informed Consent?
The foundation of these cases rest on a principle known as informed consent. This is the legal and ethical process of providing someone with all relevant information about a product’s risks, benefits, and alternatives, enabling them to make a voluntary, well-informed decision. This principle is codified under Michigan’s Public Health Code (MCL §333.17020).
Plaintiffs argue that Pfizer failed to uphold this standard by not fully disclosing the drug's serious risks and—as we’ll discuss below—a potentially safer alternative.
The lack of this information constitutes a medical error, depriving patients of the ability to weigh the benefits of Depo-Provera against its dangers or explore alternatives. This omission violates the patient's right to make informed medical decisions and serves as a central argument in these lawsuits.
Common Allegations in Depo-Provera Lawsuits
Here’s a summary of the most frequently cited allegations:
1. Inadequate Warnings
One of the most prevalent complaints involves the lack of clear and sufficient warnings about Depo-Provera’s risks, most notably evidenced by the stark contrast between the warnings provided to patients in Canada and Europe versus those in the United States.
In Europe, Depo-Provera clearly warns about the increased risk of meningiomas. European regulators acknowledged the seriousness of this danger and required Pfizer to alert both patients and healthcare providers.
In the United States, however, Pfizer has not issued the same level of disclosure. The U.S. labeling for Depo-Provera omits explicit warnings about the risk of brain tumors, leaving healthcare providers and patients in the dark about a potentially life-altering hazard.
The inconsistency raises the question: if Pfizer recognized the need to warn European patients, why did they fail to extend the same protection to Americans?
This argument alone may seal the deal—if Pfizer could warn patients abroad, there is no excuse for withholding similar warnings in the United States.
2. Negligent Marketing Practices
Lawsuits have accused Pfizer of portraying the contraceptive as a universally safe and effective solution for long-term use, glossing over its significant risks.
Marketing materials often emphasized convenience and effectiveness while failing to adequately address:
- Time restrictions advised by the FDA due to bone health concerns.
- Alternative options that might better suit patients with specific health profiles.
Misleading marketing can be considered an unfair or deceptive trade practice under Michigan’s Consumer Protection Act (MCL §445.903), opening the door for legal claims from affected consumers.
3. Defective Design
Could Depo-Provera have been made safer? Absolutely—and ironically, Pfizer already developed a safer alternative.
Depo-SubQ Provera 104, a lower-dose version of the injection, delivers the same contraceptive effectiveness and therapeutic benefits with significantly less progestin. Administered subcutaneously, this option minimizes exposure to the synthetic hormone while maintaining its efficacy.
This alternative strengthens the argument for a defective design claim. By showing that a safer version of the product was both feasible and already in existence, plaintiffs can argue that Pfizer had the means to reduce harm but chose not to prioritize patient safety.
4. Unjust Enrichment
Unjust enrichment occurs when one party retains a benefit—typically financial—that was obtained through unethical, deceptive, or unlawful practices.
Plaintiffs argue that scientific evidence does not change based on geography—a risk identified in one country is equally valid in another if the product is the same. This suggests that Pfizer may have prioritized financial interests in the lucrative U.S. market over patient safety.
What You Can Do
Steps to Take If Depo-Provera Harmed You
- Document Your Experience
- Record any adverse symptoms or diagnoses linked to Depo-Provera, such as osteoporosis, fractures, or brain tumors.
- Gather medical records that detail your treatment and interactions with healthcare providers.
- Consult a Qualified Attorney
- Find a good medical malpractice lawyer to speak with a legal professional experienced in product liability and medical malpractice cases. An attorney will evaluate your case and explain the legal pathways available to you.
- Under Michigan law, plaintiffs must prove that a manufacturer or provider acted negligently or breached their duty of care. The state's statute of limitations for product liability cases (MCL §600.5805) typically allows up to three years from the date of harm, so it’s important to act promptly.
- Explore Compensation Options
- Victims of Depo-Provera-related injuries may pursue compensation for a range of damages aimed at addressing the physical, financial, and emotional toll of their experiences. These damages include:
- Medical Expenses: Reimbursement for both past and future medical costs, such as doctor visits, diagnostic tests, surgeries, physical therapy, or medications required to manage conditions like osteoporosis or brain tumors linked to Depo-Provera use.
- Lost Wages and Earning Capacity: Compensation for income lost due to time away from work for medical treatment or recovery, as well as diminished earning potential if injuries result in long-term disabilities.
- Pain and Suffering: Monetary relief for the physical pain, emotional distress, and reduced quality of life caused by side effects or complications from the drug.
- Long-Term Care Costs: Financial support for ongoing care, such as specialized medical equipment, in-home nursing, or rehabilitation services for those with lasting health impacts.
- Punitive Damages: In some cases, courts may award punitive damages to penalize the manufacturer for egregious negligence or willful misconduct, serving as a deterrent to future harm.
- Victims of Depo-Provera-related injuries may pursue compensation for a range of damages aimed at addressing the physical, financial, and emotional toll of their experiences. These damages include:
Take Control of Your Health and Legal Rights
The consequences of inadequate warnings and negligent practices demand accountability. If you’ve suffered harm after using Depo-Provera, our team at Michigan Injury Lawyers is here to help you get the justice you deserve.
Call Michigan medical malpractice lawyer at (313) 438-4357 today to take the first step in holding big pharmaceutical companies accountable for prioritizing profits over patient safety.
Schedule a Free Initial Consultation Today!
Thomas L. Stroble
FOUNDER
Mr. Stroble is a highly accomplished graduate of Michigan State University, with degrees in both science and law. He specializes in commercial lawsuits and personal injury cases. Licensed to practice law in Michigan and even the U.S. Supreme Court, he’s a well-qualified legal expert. Besides his career in law, he loves outdoor activities and volunteers as a part-time police officer in Birmingham.
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